UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): January 10, 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, Suite 3505, 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 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Item 9.01(d) of the form 8-K filed by Delcath Systems, Inc. on January 10, 2011 is hereby amended to replace Exhibit 99.1 with the corrected version thereof attached hereto.
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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: January 11, 2010
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By:
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/s/ Peter Graham
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Name:
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Peter Graham
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Title:
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Executive Vice President &
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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
1
Investor Presentation
January 2011
NASDAQ: DCTH
Concentrating the Power of Chemotherapy TM
2
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, the progress of our research and development programs and
future clinical trials; acceptance of our New Drug Application by the FDA and
approval thereof, acceptance of our CE mark Technical File by our Notified Body and
approval thereof; our ability to successfully commercialize the Delcath
Chemosaturation System in the United States and foreign markets and any
corresponding revenue, our ability to enter into distribution and strategic alliances in
the US and foreign markets and any corresponding revenue, the actions of
regulatory authorities; our ability to obtain reimbursement coverage for the
Chemosaturation System; overall economic conditions; the availability of capital;
and other factors described in the section entitled ‘‘Risk Factors’’ in our most recent
Annual Report on Form 10-K and the Quarterly Reports on Form 10-Q that we file
with the Securities and Exchange Commission.
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, the progress of our research and development programs and
future clinical trials; acceptance of our New Drug Application by the FDA and
approval thereof, acceptance of our CE mark Technical File by our Notified Body and
approval thereof; our ability to successfully commercialize the Delcath
Chemosaturation System in the United States and foreign markets and any
corresponding revenue, our ability to enter into distribution and strategic alliances in
the US and foreign markets and any corresponding revenue, the actions of
regulatory authorities; our ability to obtain reimbursement coverage for the
Chemosaturation System; overall economic conditions; the availability of capital;
and other factors described in the section entitled ‘‘Risk Factors’’ in our most recent
Annual Report on Form 10-K and the Quarterly Reports on Form 10-Q that we file
with the Securities and Exchange Commission.
3
Company Highlights
§ Our mission is making established chemotherapeutic drugs work better in target
organs
organs
§ Chemosaturation delivers ultra-high dose chemotherapy to the liver, while
complementing systemic cancer therapies
complementing systemic cancer therapies
§ Minimally invasive approach to regional cancer therapy that combines well-established
drug with catheter-based delivery and filtration system
drug with catheter-based delivery and filtration system
§ Successful Phase III trial results reported
§ Filed NDA for orphan drug and delivery apparatus and CE Mark for device
§ Platform technology with potential use in multiple liver-based cancers, and other
regions or organs
regions or organs
§ Large, unmet market opportunity: 2.6 million liver cancer patients worldwide
§ Issued patents, orphan drug designations present competitive barriers
§ Deep and experienced management team
Concentrating the Power of Chemotherapy
4
Significant Combination Product Approval and Commercialization Experience
Deep and Experienced Management Team
Executive
Title
Prior Affiliation
(s)
Years of
Experience
Eamonn Hobbs
President and CEO
AngioDynamics
, E
-
Z
-
EM
30
David McDonald
CFO
AngioDynamics, RBC Capital Markets
2
8
Krishna Kandarpa, M.D., Ph.D.
CMO and EVP, R&D
Harvard, MIT, Cornell, UMass
3
7
Agu
stin Gago
EVP, Global Sales &
Marketing
AngioDynamics, E
-
Z
-
EM
2
9
Peter Graham
, J.D.
EVP & General Counsel
Bracco, E
-
Z
-
EM
1
6
John Purpura
EVP, Regulatory Affairs &
Quality Assurance
E
-
Z
-
EM,
S
anofi
-
A
ventis
2
7
Bill Appling
S
VP
Operations & Medical
Device
R&D
AngioDynamics
25
Bernie Tyrrell
SVP N. American Sales &
Marketing
Epicept
, Otsuka,
Astra Zeneca,
Johnson &Johnson, Eli Lilly
33
Dan Johnston
,
Ph.D.
VP, Pharma R&D
Pfizer, Wyeth
10
5
§ Built leadership team with deep pharmaceutical, device and commercialization
experience
experience
§ Established manufacturing facility
§ Reported successful Phase III Trial results
§ Signed long-term supply agreement with leading melphalan manufacturer
§ Raised over $70 million in equity capital
§ Submitted for regulatory approvals in U.S. (NDA) and EU (Class III medical device)
§ Positioned for 2011 commercialization
Executing on Sustainable Growth Strategy
Recent Accomplishments
6
Spectrum of Liver Cancer Treatments
Existing Treatments Involve Significant Limitations
Type of Treatment
Advantages
Disadvantages
Systemic
ü
Non
-
invasive
ü
Repeatable
-
Systemic toxicities
-
Limited efficacy in liver
Regional
(
e.g.
,
IHP)
ü
Therapeutic effect
ü
Targeted
-
Invasive/limited repeatability
-
Multiple treatments are
required
Focal
ü
Isolated
removal of tumor
-
90% unresectable
-
Invasive and/or limited
repeatability
7
IHP: Proof of Concept, but High Morbidity and Non-Repeatable
Open Surgical IHP - Where It All Began
8
Advantages of
Chemosaturation
Chemosaturation
§ ISOLATION
§ Treats entire liver
§ SATURATION
§ Allows for ~ 100x
effective dose
escalation of drug
agents at tumor site
effective dose
escalation of drug
agents at tumor site
§ FILTRATION
§ Controls systemic
toxicities
toxicities
The Delcath Chemosaturation System
Note: Image not to scale.
Converts Traumatic Open Surgery to Minimally Invasive, Repeatable Procedure
9
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
A Great Drug For Liver Cancer Therapy
Type
Dosing (mg/kg)
Multiple Myeloma (label)
0.25
Chemoembolization
0.6
2
Surgical Isolated Hepatic Perfusion (IHP)
1.5
0
Myeloablation
2.50
-
3.50
Chemosaturation
(PHP)
3.00
10
What Chemosaturation Offers
Attractive Clinical and Economic Proposition For Patient and Providers
Patients:
• Significant improvement in disease control in the liver compared to standard
of care in patients with unresectable hepatic melanoma mets
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 liver directed treatment to complement other cancer therapies
• Repeatable, percutaneous procedure
• Ability to treat the entire liver, including both visible and micro tumors
• Ability to continue treating patients for extra-hepatic disease
11
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
therapy to treat cancer in Liver
Transferred for
chemosaturation
chemosaturation
Diagnosis of
Cancer
Identification of liver
involvement
involvement
with no improvement
from systemic
therapy
from 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
Current Patient Referral Path
12
Interventional
Radiologist
Offers Chemosaturation
therapy
therapy
Patient
Primary
Care
Surgical
Oncologist
Diagnosis of
Cancer
Cancer
Resection
Medical
Oncologist
Offers systemic therapy to
treat cancer
treat cancer
Identification of liver
involvement
involvement
with no improvement
from systemic
therapy
from 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
Future Patient Referral Path
13
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
currently approved labeling for melphalan
Trial Outcomes Favorable and Consistent with Special Protocol Assessment
14
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)
Best Alternative Care (BAC)
Investigator and patient decision
(any and all treatments)
Cross-over
Primary Trial Endpoint
§ Statistically significant difference in Hepatic
Progression Free Survival (“hPFS”): p < 0.05
Progression Free Survival (“hPFS”): p < 0.05
§ Over 80% of Oncologic drugs approved by FDA
between 2005 - 2007 on endpoints other than
overall survival
between 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
Fully Powered, 93 Patient, Randomized, Multi-Center NCI Led Study
Pre-CS (Baseline)
Post-CS (22+ Months)
Hepatic Response - Metastatic Melanoma
15
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 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
16
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)
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)
§ Safety profile as expected - in line with current FDA approved labeling for IV administration of Melphalan
and Phase I CS/PHP study results
and Phase I CS/PHP study results
a) Treatment related Deaths:
§ 3/40 patients (7.5%) 3/116 procedures (2.6%)
§ Neutropenic Sepsis (n=2) 5%, Hepatic Failure (n=1) 2.5% (95% tumor burden)
§ Current approved labeling for Melphalan - 3% to 10% mortality rate.
b) Instituting REMS (Risk Evaluation & Mitigation Strategy) to address proper management associated with safe
use.
use.
Encouraging Survival Data With Expected Safety Profile
1 Source: Unger et. al. Cancer 2001;91: 1148
17
Phase I/II NCI Trials - Neuroendocrine
Neuroendocrine Tumor Trial Results (n=23)*
Promising Initial Response Rate in Attractive Market
Pre-CS
(Baseline)
Post-CS #2
(+4 Months)
Post-CS #1
(+6 Weeks)
*Presentation at American Hepato-Pancreo-Biliary Association 2008 annual meeting
Number (n)
Carcinoid
3
Pancreatic Islet Cell
17
Not Evaluable
(Tox
icity
, Incomplete T
reatment
,
O
rthotopic
L
iver
T
ransplantation
)
4
Progressive Disease
1
Minor Response
/
S
table
D
isease
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
18
Product Development Pipeline
Robust Development Program Planned
• Melanoma liver mets
• Drug-melphalan & apparatus
• All liver cancers - melphalan
• Class III device
• 3rd party melphalan
• 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
19
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 ocular
melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as
for doxorubicin in the treatment of HCC
melanoma, cutaneous melanoma and metastatic neuroendocrine tumors, as well as
for doxorubicin in the treatment of HCC
§ Additional Orphan Drug applications to be filed for other drugs and indications,
including HCC and CRC
including HCC and CRC
Multiple Levels of Protection
20
• Initial indication for
Melanoma liver mets in USA
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 cancers
delivery of melphalan to the
liver permits physican use on
a broad range of liver cancers
• Asia potentially requires long
term clinical development
pathway
term clinical development
pathway
• Australia- Niche opportunity
(high melanoma incidence) -
device approval following EU
CE Mark
(high melanoma incidence) -
device approval following EU
CE Mark
• Significant potential label
expansion opportunity
expansion opportunity
Transparent Areas
Represent Potential
Additional Indications
Represent Potential
Additional Indications
13,505**
101,563
355,712
*TPM Total Potential Market
**TPM for potential U.S. labeled indications only
Market Opportunity* by Geography
(patients)
21
• US - largest opportunity for Melanoma
• China - largest opportunity for HCC
• CRC - largest opportunity worldwide
*TPM Total Potential Market
Market Opportunity* by Disease
(patients)
22
*TPM Total Potential Market
** Estimated ASP
Market by Disease* - USA
23
§ CE Mark approval in EU-covers 29 countries
§ 14 Countries currently have Melphalan for
injection commercially available
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), Slovakia (SK), United Kingdom (UK).
(FR), Ireland (IE), Italy (IT), Lithuania (LT), Luxembourg (LU), Netherlands (NL), Sweden
(SE), Slovakia (SK), United Kingdom (UK).
§ 6 initial target countries (DE, UK, FR, IT, SP, NL)
represent 89% of total potential market
represent 89% of total potential market
EU - Landscape
Initial Target Markets (DE, UK, FR, IT, SP, NL)
24
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|
|
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|||||
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Germany
(Direct)
|
UK
(Direct)
|
France
(Indirect)
|
Italy
(Indirect)
|
Spain
(Indirect)
|
Netherlands
(Direct)
|
Total Potential
(patients)
|
Potential Market
($ millions)1,2,3
|
|
|
|
||||||||
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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
|
8.571
|
$257.1
|
|
CRC
|
18,978
|
10,155
|
10,490
|
13,952
|
7,694
|
3,151
|
64,420
|
$1,932.6
|
|
HCC (Primary)
|
3,941
|
1,734
|
3,645
|
6,253
|
2,616
|
197
|
18,386
|
$551.6
|
|
NET
|
2,168
|
1,624
|
1,645
|
1,579
|
1,185
|
438
|
8,639
|
$259.2
|
|
TOTAL
|
25,087
|
13,513
|
15,780
|
21,784
|
11,495
|
3,786
|
91,445
|
$3,047.1
|
Europe is Potential $3.0 Billion Market Opportunity for Device Only
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $12K (device only)
3. Assumes mix of direct sales and distributors
Market by Disease - EU Device Only
Initial Target Markets (DE, UK, FR, IT, SP, NL)
25
|
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|
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|||||
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Germany
(Direct)
|
UK
(Direct)
|
France
(Indirect)
|
Italy
(Indirect)
|
Spain
(Indirect)
|
Netherlands
(Direct)
|
Total Potential
(patients)
|
Potential Market
($ millions)1,2,3
|
|
|
|
||||||||
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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
|
8.571
|
$342.8
|
|
CRC
|
18,978
|
10,155
|
10,490
|
13,952
|
7,694
|
3,151
|
64,420
|
$2,576.8
|
|
HCC (Primary)
|
3,941
|
1,734
|
3,645
|
6,253
|
2,616
|
197
|
18,386
|
$735.5
|
|
NET
|
2,168
|
1,624
|
1,645
|
1,579
|
1,185
|
438
|
8,639
|
$345.6
|
|
TOTAL
|
25,087
|
13,513
|
15,780
|
21,784
|
11,495
|
3,786
|
91,445
|
$4,062.8
|
1. Assumes 2.5 treatments per patient
2. Assumes ASP of $16K, when Delcath branded melphalan is available
3. Assumes mix of direct sales and distributors
Europe Represents Potential $4.1 Billion Market Opportunity
Market by Disease - EU
Initial Target Markets (DE, UK, FR, IT, SP, NL)
26
|
|
|
||||||
|
China
(Drug)
|
S. Korea
(Drug)
|
Japan
(Device)
|
Taiwan
(Drug)
|
Australia
(Device)
|
Total Potential
(patients)
|
Potential
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
|
6,219
|
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
|
1,760
|
66
|
175
|
31
|
96
|
2,128
|
$47.9
|
|
Cutaneous 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
|
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
Asia Represents Potential $8.2 Billion Market Opportunity
Market by Disease - Asia
Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia)
27
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 U.S.
§ Direct and Distribution partners OUS
Pursue Asian Strategic Alliances
§ Chi-Fu Trading Company Ltd. signed 2/9/2010 for Taiwan
§ Proprietary drug and delivery apparatus approval for HCC
Establish U.S. and EU Pharma Alliances
§ Co-develop and fund additional indications for Delcath Chemosaturation
System™
System™
Direct Sales Model, Complemented by Partnerships & Distributors
28
Reimbursement Strategy
Reimbursement is a Multi-Faceted Work in Progress
• 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 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
• Europe: developing plans for initial focus countries
29
Financials
30
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 Ownership: ~ 21% at September 30, 2010
§ Market Capitalization: ~ $419 million as of December 31, 2010
§ Avg. Daily Volume (3 mos) ~ 1.2 million
* As of September 30, 2010 Fully diluted includes an additional 3.8 million options at $4.78, 2.70 million warrants at $3.52, and 232,910 unvested restricted shares.
Capital Structure Strengthened Significantly in 2010
31
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
• HCC development plan in Taiwan/Asia
• US label expansion plans and proposed studies
Commercial
• Initial US commercialization
• Initial EU commercialization
Significant Value Creation Expected in 2011
32
Company Highlights
§ Our mission is making well-established chemotherapeutic drugs work better in target
organs
organs
§ Chemosaturation delivers ultra-high dose chemotherapy to the liver, while
complementing systemic cancer therapies
complementing systemic cancer therapies
§ Minimally invasive approach to regional cancer therapy that combines well-established
drug with catheter-based delivery and filtration system
drug with catheter-based delivery and filtration system
§ Successful Phase III trial results reported
§ Filed NDA for orphan drug and delivery apparatus and CE Mark for device
§ Platform technology with potential use in multiple liver-based cancers, and other
regions or organs
regions or organs
§ Large, unmet market opportunity: 2.6 million liver cancer patients worldwide
§ Issued patents, orphan drug designations present competitive barriers
§ Deep and experienced management team
Concentrating the Power of Chemotherapy
33
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.
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
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>.
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.
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.
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.
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Investor Presentation
January 2011
NASDAQ: DCTH
Concentrating the Power of Chemotherapy TM