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): April 26, 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 7.01. Regulation FD Disclosure.
A copy of Delcath System, Inc.’s updated investor presentation slides that the Company 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: April 26, 2011
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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, 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
April 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; uncertainties relating to the time
required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if
any, for the chemosaturation delivery system in the EEA, our ability to successfully commercialize the
chemosaturation system and the potential of the chemosaturation system as a treatment for patients with cancer
in the liver, 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 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 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.
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; uncertainties relating to the time
required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if
any, for the chemosaturation delivery system in the EEA, our ability to successfully commercialize the
chemosaturation system and the potential of the chemosaturation system as a treatment for patients with cancer
in the liver, 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 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 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
§ 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
§ Positioned to address potential $3.0 billion European labeled market opportunity
§ Expect to re-file 505(b)(2) NDA to FDA for orphan drug and delivery apparatus by end
of 2011
of 2011
§ 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
4
• Seeking initial indication for
Melanoma liver mets in USA
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
melphalan to the liver permits
physician 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 initial U.S. labeled indication only
Potential $3.75 Billion Labeled Market Opportunity*
5
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
6
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
7
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 Promising 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
8
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
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
9
Interventional
Radiologist
Current Patient Referral Path
Patient
Primary
Care
Medical
Oncologist
Offers systemic therapy to
treat Cancer
Surgical
Oncologist
Offers resection or other focal
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
10
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
currently approved labeling for melphalan
Trial Outcomes Favorable and Consistent with Special Protocol Assessment
11
Phase III Clinical Trial Design
Randomized to CS
92 patients: ocular
or cutaneous melanoma
CS/Melphalan
Best Alternative Care (BAC)
Investigator and patient decision
(any and all treatments)
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
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
12
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
13
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)
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
§ 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.
Encouraging Survival Data With Expected Safety Profile
1 Source: Unger et. al. Cancer 2001;91: 1148
14
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 (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
15
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 is to resubmit by end of 2011
§ Submitted 505(b)(2) NDA to FDA on December 22, 2010
§ Refusal to file (RTF) letter received February 18, 2011
§ Manufacturing plant inspection timing
§ Product and sterilization validation
§ Additional safety data
§ Additional statistical analysis clarification
§ Currently assembling the requested information
§ Current expectation is to resubmit NDA by end of 2011
Approved in Europe With U.S. Decision Expected in 2H 2012
16
Product Development Pipeline
Robust Development Program Planned
• Melanoma liver mets
• Proprietary drug-melphalan &
apparatus
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
17
• US – largest opportunity for Melanoma
• China – largest opportunity for HCC
• CRC – largest opportunity worldwide
Market Opportunity* by Disease (patients)
*TPM Total Potential Market
18
§ CE Mark approval covers European Economic Area (EEA)
§ EEA includes 32 countries
§ 14 countries currently have Melphalan for injection
commercially available
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).
Ireland (IE), Italy (IT), Lithuania (LT), Luxembourg (LU), Netherlands (NL), Sweden (SE), Slovakia
(SK), United Kingdom (UK).
§ 6 top countries (DE, UK, FR, IT, SP, NL) represent 85%-
90% of total potential market
90% of total potential market
Large European Market Opportunity Concentrated in Six Countries
EEA – Landscape
19
Germany
(Direct)
2,834
UK
(Direct)
1,735
France
(Indirect)
1,314
Italy
(Indirect)
1,398
Spain
(Indirect)
628
Netherlands
(Direct)
662
Total Potential
(patients)
8,571
Potential Market
($ millions)1,2,3
$257.1
Total Potential Market #Patients
Ocular Melanoma
403
296
294
284
197
79
1,553
$46.6
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 $12K (device only)
3. Assumes mix of direct sales and distributors
Cutaneous Melanoma
Market by Disease – EEA Device Only
20
Liver Metastasis
Potential Market
# Patients
Potential Market
# Procedures
(Avg 2.5/patient)
Potential Market ($MM)
$20K ASP **
Ocular
Melanoma
1,622
4,055
$81.1
Cutaneous
Melanoma
$594.2
11,883
29,708
TOTAL MELANOMA
(Initial Expected Label)
13,505
33,763
$675.3
CRC
38,423
96,057
HCC (Primary)
12,386
30,964
$619.3
NET
9,986
24,965
$499.3
TOTAL OTHER
(Potential Label
Expansion)
$1,921.1
60,794
151,985
$3,039.7
*TPM Total Potential Market
** Estimated ASP
Market by Disease – USA
21
China
(Drug)
S. Korea
(Drug)
Japan
(Device)
Taiwan
(Drug)
Australia
(Device)
Total 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
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
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 – Australia/Asia
Initial Target Markets (China, Japan, S. Korea, Taiwan, Australia)
22
Reimbursement Strategy
Reimbursement is a Multi-Faceted Work in Progress
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
§ Other oncology therapies currently reimbursed, despite lacking randomized data
§ Have retained leading reimbursement experts
§ Focused on highlighting clinical value proposition and demonstrating cost effectiveness
United States:
§ Have retained leading reimbursement experts
§ Seek chemosaturation specific codes:
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
§ Request new DRG based on costs above those of existing DRGs and clinical dissimilarity to other hepatic
procedures in current DRGs
procedures in current DRGs
23
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
Southern Europe with commercialization expected to begin in late 2011
§ Gain additional regulatory approvals and expand commercialization
§ Goal: leverage CE Mark to gain additional country approvals in Australia, South
America, and Asia
America, and Asia
§ Re-file NDA by end of 2011
§ Goal: receive FDA approval of NDA in 2012 and build out direct specialty sales force
for U.S.
for U.S.
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
Combination of Direct Sales Model, Partnerships & Distributors
24
2011 European Commercialization
§ Initiate test market in 2011 for 3-6 months to validate assumptions and
finalize model
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)
Science Liaisons)
§ Distributors in Spain, Italy, & France
§ 5 Clinical Specialists to support site initiations and training
§ Establish European operations
§ Develop EEA Centers of Excellence and KOLs for training and support
§ Establish European website to facilitate patient education & awareness
§ Full commercialization in 2012
Direct Sales Model in Northern Europe & Distributors in Southern Europe
25
US Commercialization in 2012
§ Initial focus on top 50 cancer centers and referring community
hospitals
hospitals
§ 12 Sales & Medical Science Liaison territories ultimately
expanding to as many as 60 territories as revenues ramp
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
for training and support
Direct Sales Model in the United States Focused on Leading Cancer Centers
26
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
27
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
Agustin 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, Sanofi-Aventis
2
7
Bill Appling
SVP 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
28
Financials
29
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: ~ 23% at December 31, 2010
§ Market Capitalization: ~ $317 million as of March 31, 2011
§ Avg. Daily Volume (3 mos) ~ 1.1 million
* As of March 31, 2011 fully diluted includes an additional 4.1 million options at $5.07, 2.5 million warrants at $3.51, and 50,790 unvested restricted shares.
Capital Structure Strengthened Significantly in 2010
30
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
§ Positioned to address potential $3.0 billion European labeled market opportunity
§ Expect to re-file 505(b)(2) NDA to FDA for orphan drug and delivery apparatus by end
of 2011
of 2011
§ 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
31
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."
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