2012-11-07 22:04:20 -
--Conference Call and Webcast Today at 4:30 p.m. ET--
NEW YORK, November 7, 2012 - Delcath Systems (NASDAQ: DCTH) today announced
financial results for its third quarter 2012 ended September 30, 2012 as well as
recent operational progress.
Highlights for the third quarter 2012 and recent weeks include:
* FDA acceptance of Delcath's New Drug Application (NDA) for its proprietary
chemosaturation system with melphalan hydrochloride for injection.
* FDA assignment of a Prescription Drug User Fee Act (PDUFA) goal date of June
15, 2013.
* Secured national interim reimbursement in Italy; submitted reimbursement
applications for the CHEMOSAT procedure in other key European markets, with
positive responses expected in some markets during first quarter of 2013.
* Hosted well attended expert symposiums at the European Society for Medical
Oncology Annual Congress and the Cardiovascular & Interventional
Radiological Society of Europe Annual Congress
* Executed first European distribution agreements with established
distributors in Italy and Spain; received first distributor order for
CHEMOSAT kits.
* Approval in Australia for the Generation Two Hepatic CHEMOSAT® Delivery
System for use with melphalan hydrochloride.
* Satisfied all requirements to affix the CE Mark to the Hepatic CHEMOSAT
Delivery System device for intra-hepatic arterial delivery and
extracorporeal filtration of doxorubicin in October, 2012.
"During the past three months, Delcath accomplished several significant
milestones that help lay the foundation for realizing the full potential of our
system in the U.S., Europe and other markets around the world," said Eamonn P.
Hobbs, President and CEO. "FDA acceptance of our NDA and designation of a June
15, 2013 PDUFA goal date are the most important developments in our history, and
we look forward to working closely with the Agency throughout the review process
with the goal of securing approval of our application. During the quarter we
also successfully secured procedure reimbursement in Italy under existing
coding, and are pursuing other New Technology Payment programs in Italy, Germany
and the United Kingdom that we expect to be in place in certain markets in early
2013. We also announced CE Marking for our Hepatic CHEMOSAT Delivery System
device for intra-hepatic arterial delivery and extracorporeal filtration of
doxorubicin, which provides a regulatory pathway for key Asian Markets. The
recent approval of our Generation Two CHEMOSAT system in Australia enhances our
opportunity to address a potential market of $50-70 million as we seek an
exclusive distributor in this region."
For the three months ended September 30, 2012, Delcath recorded sales of
$97,000, $58,000 of which was deferred revenue associated with an initial order
from our Italian distributor. Operating loss was $12.2 million, which included
approximately $1.0 million in non-cash stock-based compensation expense, as
compared with an operating loss of $12.2 million, including approximately $0.9
million in non-cash stock-based compensation expense, in the year ago period.
Selling, general and administrative (SG&A) expenses were $7.0 million for the
third quarter of 2012, compared to $5.7 million for the same period in 2011. The
higher SG&A expense was due primarily due to increased EU commercialization
expense. Research and development (R&D) expenses were $5.3 million for the third
quarter of 2012, compared to $6.4 million for the same period in 2011. The lower
R&D expenses reflect the anticipated lower consulting expenses following the
submission of the NDA submitted on August 15, 2012.
At September 30, 2012, cash, and cash equivalents were $28.3 million as compared
with $29.3 million as of June 30, 2012 and $30.8 million at December 31, 2011.
Gross cash spend in the third quarter 2012 was $14.6 million as compared with
$14.2 million in the second quarter. The increase was primarily driven by
efforts to prepare submission of the NDA to the FDA and ongoing
commercialization efforts in the EU. Average monthly operating gross spend was
$4.9 million for the third quarter, comparable with $4.7 million reported in the
second quarter. Delcath continues to expect average monthly cash spend to be
between $3 million to $4 million for the fourth quarter of 2012.
Conference Call and Webcast
The Company will host a conference call today, November 7, 2012 at 4:30 p.m. ET.
To participate in the live call by telephone, please dial 800-299-0148 for
domestic participants and 617-801-9711 for international participants; both
numbers require passcode 42632846. To access the live webcast, go to the Events
& Presentations page on Delcath's website at
www.delcath.com/investors/events/.
A taped replay of the conference call will also be available beginning
approximately two hours after the call's conclusion and will be available for
seven days. This replay can be accessed by dialing 888-286-8010 for domestic
callers and 617-801-6888 for international callers, both using passcode
87111973. An archived webcast will also be available at
www.delcath.com/investors/events/.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical device company
focused on oncology. Delcath's proprietary system for chemosaturation is
designed to administer high dose chemotherapy and other therapeutic agents to
diseased organs or regions of the body, while controlling the systemic exposure
of those agents. The Company's initial focus is on the treatment of primary and
metastatic liver cancers. In 2010, Delcath announced that its randomized Phase
3 clinical trial for patients with metastatic melanoma in the liver had
successfully achieved the study's primary endpoint of extended hepatic
progression-free survival. The Company also completed a multi-arm Phase 2 trial
to treat other liver cancers. The Company obtained authorization to affix a CE
Mark for the Generation Two CHEMOSAT® delivery system for melphalan
hydrochloride in April 2012. The right to affix the CE mark allows the Company
to market and sell the CHEMOSAT system for melphalan hydrochloride in Europe. In
October 2012, the Company satisfied all of the requirements to affix the CE Mark
to the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial
delivery and extracorporeal filtration of doxorubicin, providing a regulatory
pathway for CHEMOSAT with doxorubicin hydrochloride injection for countries in
Asia that accept the CE Marking as part of their national regulatory
requirements. The Company has not yet received FDA approval for commercial sale
of its system in the United States. The Company's NDA has been accepted for
filing and substantive review by the FDA. The Company is seeking approval for
its proprietary chemosaturation system with melphalan hydrochloride as a
treatment for patients with unresectable metastatic melanoma in the liver. For
more information, please visit the Company's website at www.delcath.com.
Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements made by the Company or on its behalf. This news
release contains forward-looking statements, which are subject to certain risks
and uncertainties that can cause actual results to differ materially from those
described. Factors that may cause such differences include, but are not limited
to, uncertainties relating to: our ability to address the contents of the 74 Day
Letter from the FDA, timing of completion of the FDA's review of our NDA, the
extent to which the FDA may request additional information or data and our
ability to provide the same in a timely manner, acceptability of the Phase 1, 2
and 3 clinical trial data by the FDA, 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,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 chemosaturation system as a
treatment for patients with primary and metastatic disease in the liver, market
acceptance of the Gen Two CHEMOSAT system in Australia and our ability to
commercialize the CHEMOSAT system in Australia, patient outcomes using the
Generation 2 system, approval of the current or future chemosaturation system
for other indications, actions by the FDA or other foreign regulatory agencies,
our ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets including Australia and key Asian markets and
timing of the same, the initiation of clinical trials in key Asian markets with
the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial delivery
and extracorporeal filtration of doxorubicin and timing and results of the same,
approval of the Hepatic CHEMOSAT Delivery System device for intra-hepatic
arterial delivery and extracorporeal filtration of doxorubicin in key Asian
markets, patient outcomes using the Hepatic CHEMOSAT Delivery System device for
intra-hepatic arterial delivery and extracorporeal filtration of doxorubicin,
our ability to obtain reimbursement for the CHEMOSAT system, uncertainties
relating to the results of research and development projects and future clinical
trials, and uncertainties regarding our ability to obtain financial and other
resources for any research, development and commercialization activities. These
factors, and others, are discussed from time to time in our filings with the
Securities and Exchange Commission. You should not place undue reliance on these
forward-looking statements, which speak only as of the date they are made. We
undertake no obligation to publicly update or revise these forward-looking
statements to reflect events or circumstances after the date they are made.
Contact Information:
Investor Contact: Media Contact:
Doug Sherk /Gregory Gin/Patty Eisenhaur Janine McCargo
EVC Group EVC Group
415-568-4887 /646-445-4801/951-316-0577 646-688-0425
DELCATH SYSTEMS, INC.
Condensed Consolidated Statement of Operations
for the Three and Nine Months Ended September 30, 2012 and 2011
(in thousands, except share and per share data)
Three months ended September Nine months ended September
30, 30,
2012 2011 2012 2011
------------------- -------------- --------------- --------------- --------------
Revenue $ 39 $ - $ 146 $ -
Cost of goods sold - - -
-
-------------- --------------- --------------- --------------
Gross profit 39 - 146
-
Operating expenses:
Selling, general
and
administrative(1) $ 6,960 $ 5,744 $ 21,604 $ 15,148
Research and
development(1) 5,254 6,437 20,589 15,333
-------------- --------------- --------------- --------------
Total operating
expenses 12,214 12,181 42,193 30,481
-------------- --------------- --------------- --------------
Operating loss (12,175) (12,181) (42,047) (30,481)
--- ---
Change in fair
value of warrant
liability, net 446 3,872 1,025 14,864
Interest income 9 1 16 1
Other expense and
interest expense (93) - (204) -
-------------- --------------- --------------- --------------
Net loss $ (11,813) $ (8,308) $ (41,210) $ (15,616)
-------------- --------------- --------------- --------------
Common share data:
Basic and diluted
loss per share $ (0.18) $ (0.18) $ (0.72) $ (0.35)
-------------- --------------- --------------- --------------
Weighted average
number of basic and
diluted common
shares outstanding 67,219,224 46,961,123 56,844,697
44,315,838
-------------- --------------- --------------- --------------
Other comprehensive
income (loss):
Foreign currency
translation
adjustments $ 87 $ - $ 83 $ -
Unrealized loss
on securities - (3) -
(14)
-------------- --------------- --------------- --------------
Other comprehensive
income (loss),
total 87 (3) 83 (14)
-------------- --------------- --------------- --------------
Comprehensive loss $ (11,726) $ (8,311) $ (41,127) $ (15,630)
-------------- --------------- --------------- --------------
Note 1:
Includes non-cash stock-based
compensation as follows:
Three months ended Nine months ended September
September 30, 30,
------------------------------ ------------------------------
2012 2011 2012 2011
-------------- --------------- --------------- --------------
General and
administrative $ 665 $ 525 $ 1,828 $ 2,186
Research and
development 372 371 1,094
1,173
-------------- --------------- --------------- --------------
Total stock-based
compensation
expense $ 1,037 $ 896 $ 2,922 $ 3,359
-------------- --------------- --------------- --------------
DELCATH SYSTEMS, INC.
Condensed Consolidated Balance Sheets
as of September 30, 2012 and December 31, 2011
(in thousands, except share data)
September 30, December 31,
2012 2011
----------------------- ---------------------
Assets:
Current assets
Cash and cash equivalents
$ 28,298 $ 25,777
Investments - Certificates of
deposit - 4,980
Inventories
941 -
Accounts receivables
43 -
Prepaid expenses and other
current assets 1,440 1,231
----------------------- ---------------------
Total current assets 30,722 31,988
Property, plant and equipment
Land 154 154
Building and building
improvements 449 -
Furniture and fixtures 969 880
Machinery and equipment 1,435 1,371
Computer software and
equipment 2,136 1,212
Leasehold improvements 1,698 1,148
----------------------- ---------------------
6,841 4,765
Less: accumulated
depreciation (2,556) (1,512)
----------------------- ---------------------
Property, plant and
equipment, net 4,285 3,253
----------------------- ---------------------
Total assets $ 35,007 $ 35,241
----------------------- ---------------------
Liabilities and Stockholders'
Equity:
Current liabilities
Accounts payable and accrued
expenses $ 5,148 $ 6,398
Warrant liability
4,561 2,439
----------------------- ---------------------
Total current
liabilities 9,709 8,837
----------------------- ---------------------
Deferred revenue
358 300
Commitments and contingencies
- -
Stockholders' equity
Preferred stock, $.01 par -
value; 10,000,000 shares -
authorized; no shares issued
and outstanding at September
30, 2012 and December 31, 2011
Common stock, $.01 par value;
170,000,000 shares authorized;
73,422,008 and 48,237,634 734 482
shares issued and 73,393,908
and 48,209,534 shares
outstanding at September
30, 2012 and December
31, 2011, respectively
Additional paid-in capital
212,324 172,613
Accumulated deficit
(188,150) (146,940)
Treasury stock, at cost;
28,100 shares at September
30, 2012 and December 31, 2011 (51) (51)
Accumulated other comprehensive
income 83 -
----------------------- ---------------------
Total stockholders'
equity 24,940 26,104
----------------------- ---------------------
Total liabilities and
stockholders' equity $ 35,007 $ 35,241
----------------------- ---------------------
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Delcath Systems, Inc via Thomson Reuters ONE
[HUG#1656079]
