NEW YORK, Aug. 6, 2014 /PRNewswire/ -- Delcath Systems,
Inc. (NASDAQ: DCTH) today reported financial results and
operational developments for the fiscal second quarter ended
June 30, 2014. Developments for the
quarter and recent weeks subsequent to quarter end are as
follows:
- Adoption of CHEMOSAT in Europe
continued with 50 treatments performed in the first seven months of
2014, as compared to 22 treatments in the same period of 2013
- Since initiation of European commercialization, 123 treatments
performed on 83 patients as of July 31,
2014
- Delcath-sponsored Phase 2 study in primary liver cancer
(hepatocellular carcinoma or HCC) opened for enrollment at first
center in Germany; Johan Wolfgang
Goethe University Hospital in
Frankfurt
- Two investigator-initiated clinical trials initiated; Leiden
University Medical Center, Leiden, Netherlands enrolls and treats first patient
in study of CHEMOSAT to treat liver metastasis in colorectal
cancer; Johan Wolfgang Goethe
University Hospital in Frankfurt trial open for patient enrollment to
study use of CHEMOSAT to treat HCC
- Second quarter 2014 quarterly net cash utilization of
$4.0 million; Company lowers average
cash utilization guidance for the remainder of 2014 to $4 to $5 million a quarter; Cash as of
June 30, 2014 was $27.3 million
"We continue to see steady clinical adoption of CHEMOSAT
in Europe," commented Jennifer K.
Simpson, Interim Co-President & Co-CEO. "As of
July 31st of this year, a total of 50
treatments, of which 22 were retreatments, were performed at
leading European cancer centers. This compares with 22
treatments and six retreatments during the first seven months of
2013. We believe the growth in performed treatments reflects
expanded European clinical experience with CHEMOSAT. Our
company-sponsored clinical program for HCC is also moving forward
as the first site in Germany is
now active and identifying appropriate patients for
enrollment. In addition to this first site, Johan Wolfgang
Goethe University Hospital in
Frankfurt, we expect to add
additional German sites, as well as sites in the UK and US during
the remainder of 2014. Our goal is to have interim data from
the company sponsored Phase 2 studies in the first half of
2015. We are pleased that two leading centers in Europe have opened their investigator
initiated trials and believe that data from these trials will
support our European efforts and contribute to our clinical
program."
Financial Results
For the second quarter ended June 30,
2014, total product revenue was $251,000. The company did not record revenue in
the year-ago second quarter. Operating expenses decreased by
approximately 41% to $6.1 million
from $10.3 million for the same
period in 2013. The decrease is primarily due to a significant
reduction in expenses related to the Company's NDA submission to
the FDA, as well as the Company's overall cost management efforts.
Operating loss was $5.9 million
during the second quarter, as compared with an operating loss of
$10.6 million in the same period of
the prior year.
For the six months ended June 30,
2014, total product revenue was $561,000, as compared with $81,000 in the year-ago same period.
Operating expenses decreased by approximately 45% to $11.4 million from $20.8
million for the first half of 2013. The operating loss
for the first six months of 2014 was $11.0
million as compared with $20.8
million for the first half of 2013.
Cash and cash equivalents as of June 30,
2014 were $27.3 million.
During the quarter, net cash used in operating activities was
$4.0 million, a 62% reduction
compared to $10.5 million in the
comparable period in 2013. The decrease in cash utilization was in
part due to a reduction in NDA submission-related costs, and
improved organizational and operational efficiencies.
"Our cash utilization, which again was lower than our guidance,
demonstrates our continuing efforts to reduce our operational costs
and focus on key priorities. Recent expense reduction initiatives
include a sublease agreement for 50% of our corporate offices for
the remaining lease term of approximately seven years. As a
result of this transaction, we expect to achieve total net savings
of $2.6 million over the lease
term. In addition, as a result of our successful efforts, we
are revising our forecasted average quarterly cash utilization
lower to a range of $4 to $5 million
for the remaining quarters of 2014, as compared to our previous
average quarterly cash utilization guidance of $5 to $6 million," said Graham G. Miao, Interim Co-President and
Co-CEO.
Conference Call and Webcast
The Company will host a conference call today, August 6, 2014 at 4:30
p.m. ET to discuss its financial results for the second
quarter ended June 30, 2014, and
provide an update on recent corporate progress.
The dial-in numbers for the conference call are 877-703-6105
(U.S. participants) and 857-244-7304 (international participants);
both numbers require passcode: 33935953. To access the live
webcast, go to the Events & Presentations page on the Investor
Relations section of the Company's website at
http://www.delcath.com/investors/events/.
A taped replay of the call will be available beginning
approximately two hours after the call's conclusion and will be
available for seven days. Dial-in numbers for the replay are
888-286-8010 and 617-801-6888 for U.S. and International callers,
respectively. The replay passcode for both U.S. and International
callers is 93152789. An archived webcast will also be
available at http://www.delcath.com/investors/events/.
About Delcath Systems
Delcath Systems, Inc. is a
specialty pharmaceutical and medical device company focused on
oncology. Our proprietary drug/device combination product, the
Delcath Hepatic Delivery System, is designed to administer high
dose chemotherapy and other therapeutic agents to the liver, while
controlling the systemic exposure of those agents. The Company's
initial focus is on the treatment of primary and metastatic liver
cancers. Outside of the United
States, our proprietary product to deliver and filter
melphalan hydrochloride is marketed under the trade name Delcath
Hepatic CHEMOSAT® Delivery System for melphalan hydrochloride. The
Company obtained authorization to affix a CE Mark for the
Generation Two CHEMOSAT Delivery System for Melphalan in
April 2012. The right to affix the CE
mark allows the Company to market and sell the CHEMOSAT Delivery
System for Melphalan in Europe.
The Delcath Hepatic Delivery System for Melphalan has not been
approved for sale in the United
States by the U.S. Food and Drug Administration. The Company
has initiated plans to investigate Melphalan Hydrochloride for
Injection for use with the Delcath Hepatic Delivery System for
primary liver cancer.
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: the Company's
ability to achieve the estimated average quarterly cash utilization
for 2014, the timing of site activation and subject enrollment in
the HCC Phase II global clinical trial, the time to complete
the HCC Phase II global clinical trial program and the results of
the same, the timing and results of future clinical trials
including without limitation Company sponsored clinical trials or
investigator initiated trials, continued clinical adoption, use and
resulting, sales, if any, of the CHEMOSAT system in Europe including the UK and Germany, the Company's ability to successfully
commercialize the Melphalan HDS/ CHEMOSAT system and the potential
of the Melphalan HDS/CHEMOSAT system as a treatment for patients
with primary and metastatic disease in the liver, our ability to
obtain reimbursement for the CHEMOSAT system in various markets,
the Company's ability to satisfy the requirements of the FDA's
Complete Response Letter and provide the same in a timely manner,
approval of the current or future Melphalan HDS/CHEMOSAT system for
delivery and filtration of melphalan or other chemotherapeutic
agents for various indications in the US and/or in foreign markets,
actions by the FDA or other foreign regulatory agencies, the
Company's ability to successfully enter into strategic partnership
and distribution arrangements in foreign markets and the timing and
revenue, if any, of the same, uncertainties relating to the timing
and results of research and development projects, and uncertainties
regarding the Company's ability to obtain financial and other
resources for any research, development, clinical trials 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:
|
Michael Polyviou/Doug
Sherk
|
John
Carter
|
EVC Group
|
EVC Group
|
212-850-6020
|
212-850-6021
|
Delcath Systems,
Inc.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
for the three and
six months ended June 30, 2014 and 2013
|
(Unaudited)
|
(in thousands, except
share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
June 30,
|
|
|
Six Months Ended
June 30,
|
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
Product
revenue
|
$
|
251
|
|
$
|
-
|
|
$
|
561
|
|
$
|
81
|
Other
revenues
|
|
-
|
|
|
-
|
|
|
-
|
|
|
300
|
|
Total
revenue
|
|
251
|
|
|
-
|
|
|
561
|
|
|
381
|
Cost of goods
sold
|
|
(66)
|
|
|
(332)
|
|
|
(160)
|
|
|
(363)
|
|
Gross
profit
|
|
185
|
|
|
(332)
|
|
|
401
|
|
|
18
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative1
|
|
4,597
|
|
|
6,263
|
|
|
8,416
|
|
|
12,346
|
Research and
development1
|
|
1,492
|
|
|
3,992
|
|
|
2,949
|
|
|
8,462
|
|
Total operating
expenses
|
|
6,089
|
|
|
10,255
|
|
|
11,365
|
|
|
20,808
|
|
|
Loss from
operations
|
|
(5,904)
|
|
|
(10,587)
|
|
|
(10,964)
|
|
|
(20,790)
|
Change in fair value
of warrant liability, net
|
|
1,297
|
|
|
5,115
|
|
|
1,092
|
|
|
2,842
|
Interest
income
|
|
1
|
|
|
5
|
|
|
2
|
|
|
15
|
Other expense and
interest expense
|
|
6
|
|
|
(15)
|
|
|
(8)
|
|
|
(395)
|
|
|
Net loss
|
$
|
(4,600)
|
|
$
|
(5,482)
|
|
$
|
(9,878)
|
|
$
|
(18,328)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss Per Common
Share
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per common
share*
|
$
|
(0.49)
|
|
$
|
(0.91)
|
|
$
|
(1.06)
|
|
$
|
(3.22)
|
|
Diluted loss per
common share*
|
$
|
(0.52)
|
|
$
|
(0.91)
|
|
$
|
(1.08)
|
|
$
|
(3.22)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average
Common Shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic shares outstanding*
|
|
9,426,169
|
|
|
6,023,785
|
|
|
9,363,123
|
|
|
5,683,380
|
|
Weighted average
number of diluted shares outstanding*
|
|
9,480,933
|
|
|
6,023,785
|
|
|
9,462,717
|
|
|
5,683,380
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive
Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
$
|
(20)
|
|
$
|
6
|
|
$
|
(22)
|
|
$
|
369
|
|
|
Comprehensive
loss
|
$
|
(4,620)
|
|
$
|
(5,476)
|
|
$
|
(9,900)
|
|
$
|
(17,959)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 1:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Includes non-cash
stock-based compensation as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended June 30,
|
|
Six Months
Ended June 30,
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
Selling, general and
administrative
|
$
|
84
|
|
$
|
11
|
|
$
|
240
|
|
$
|
529
|
|
|
Research and
development
|
|
14
|
|
|
140
|
|
|
77
|
|
|
284
|
|
|
Total stock-based
compensation expense
|
$
|
98
|
|
$
|
151
|
|
$
|
317
|
|
$
|
813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Reflects a
one-for-sixteen (1:16) reverse stock split effected on April 8,
2014.
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Balance Sheets
|
as of June 30,
2014 and December 31, 2013
|
(Unaudited)
|
(in thousands, except
share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
|
|
2014
|
|
|
2013
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
27,284
|
|
$
|
31,249
|
|
Accounts receivables,
net
|
|
172
|
|
|
349
|
|
Inventories,
net
|
|
600
|
|
|
719
|
|
Prepaid expenses and
other current assets
|
|
852
|
|
|
1,711
|
|
|
Total current
assets
|
|
28,908
|
|
|
34,028
|
|
Property, plant and
equipment, net
|
|
2,421
|
|
|
3,069
|
|
|
|
Total
assets
|
$
|
31,329
|
|
$
|
37,097
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts
payable
|
$
|
239
|
|
$
|
582
|
|
Accrued
expenses
|
|
4,087
|
|
|
3,740
|
|
Warrant
Liability
|
|
1,075
|
|
|
2,310
|
|
|
Total current
liabilities
|
|
5,401
|
|
|
6,632
|
|
Other non-current
liabilities
|
|
748
|
|
|
366
|
|
|
Total
liabilities
|
|
6,149
|
|
|
6,998
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares issued and outstanding at June 30, 2014 and
December 31, 2013
|
|
—
|
|
|
—
|
|
Common stock, $.01
par value; 170,000,000 shares authorized; 9,451,870 and 8,394,397 shares issued and 9,447,392
and 8,392,641 shares outstanding at June 30, 2014 and December 31,
2013, respectively *
|
|
95
|
|
|
84
|
|
Common Stock, to be
issued
|
|
—
|
|
|
—
|
|
Additional paid-in
capital
|
|
264,072
|
|
|
259,102
|
|
Accumulated
deficit
|
|
(239,010)
|
|
|
(229,132)
|
|
Treasury stock, at
cost; 1,757 shares at June 30, 2014 and December 31,
2013
|
|
(51)
|
|
|
(51)
|
|
Accumulated other
comprehensive income
|
|
74
|
|
|
96
|
|
|
Total stockholders'
equity
|
|
25,180
|
|
|
30,099
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
31,329
|
|
$
|
37,097
|
|
|
|
|
|
|
|
|
|
* Reflects a
one-for-sixteen (1:16) reverse stock split effected on April 8,
2014.
|
SOURCE Delcath Systems, Inc.