NEW YORK, May 6, 2015 /PRNewswire/ -- Delcath Systems, Inc.
(NASDAQ: DCTH), a specialty pharmaceutical and medical device
company focused on oncology with an emphasis on the treatment of
primary and metastatic liver cancers, announces financial results
for the three months ended March 31,
2015.
Highlights of the first quarter and recent weeks
include:
- Achieved quarterly product revenue of $0.44 million, an increase of more than 43%
compared with the first quarter of 2014;
- Activated a prospective patient registry in Europe to collect uniform essential patient
safety, efficacy and Quality of Life (QoL) information from
commercial cases;
- Received approval to expand the global Phase 2 hepatocellular
carcinoma (HCC) program to include patients with intrahepatic
cholangiocarcinoma (ICC) in Europe;
- Expanded the global Phase 2 program for the treatment of
patients with unresectable HCC or primary liver cancer with the
addition of Montefiore Medical Center in the Bronx, New York;
- Reported the submission of the manuscript of its Phase 3
clinical trial data with Melphalan/HDS for publication in a leading
peer-reviewed medical journal;
- Affirmed Value 4 coverage status for the Delcath Hepatic
CHEMOSAT® Delivery System (CHEMOSAT) by the German federal
reimbursement agency for 2015; and
- Raised gross proceeds of $2.8
million through a public offering of common stock and
warrants.
"2015 is off to a strong start with important advances in
commercial and clinical programs, and the recent reduction in
operating expenses," said Jennifer
Simpson, Ph.D., MSN, CRNP, Interim President and Chief
Executive Officer of Delcath. "This record quarterly product
revenue highlights the growing interest in CHEMOSAT in Europe and continued market adoption. The
initiation of our European patient registry will allow us to
benefit from the ongoing commercial utilization of CHEMOSAT by
providing important outcomes data that should be instrumental in
furthering both reimbursement and market adoption.
"We are particularly pleased with the significant progress we've
made with our clinical development program. We expanded our
global Phase 2 HCC clinical program to include an ICC cohort and we
also added Montefiore Medical Center, a nationally recognized
Center of Excellence for cancer care and clinical research.
We believe the consolidated safety data from the HCC and ICC
cohorts will offer valuable information for us to provide to the
FDA.
"We remain on track to initiate a global pivotal Phase 3 overall
survival clinical trial in ocular melanoma (OM) that has
metastasized to the liver by the end of 2015. Statistically
significant hepatic progression-free survival data in OM metastases
achieved in our previous Phase 3 clinical trial, combined with
positive patient outcomes and improved safety profile demonstrated
in more than 100 patients treated in commercial settings in
Europe and our U.S. Expanded
Access Program, give us confidence this Phase 3 program offers the
fastest path to potential approval of Melphalan/HDS in the
U.S.
"We expect to achieve a number of important milestones
throughout the balance of 2015 that should advance the Company's
mission to bring our CHEMOSAT/Melphalan/HDS therapy to benefit
patients with cancers of the liver worldwide," concluded Dr.
Simpson.
First Quarter Financial Results
Total revenue for the first quarter of 2015 of $0.4 million increased 43% from $0.3 million for the first quarter of 2014.
Selling, general and administrative expenses during the first
quarter of 2015 were $3.0 million
compared with $3.8 million in the
year-ago period. During the first quarter of 2015, the
Company recorded workforce restructuring charges of $0.4 million. Excluding those charges, selling,
general and administrative expenses were $2.6 million for the first quarter of 2015,
compared with $3.8 million for the
first quarter of 2014, a decrease of $1.2
million.
Total operating expenses for the first quarter of 2015 decreased
by 25% to $4.0 million from
$5.3 million for the same period in
2014. This decrease reflects a reduction in severance and
compensation-related expenses following significant workforce
restructurings throughout 2014 and into 2015.
The Company recorded a net loss for the first quarter of 2015,
of $3.5 million, a decrease of
$1.8 million, or 34%, compared with a
net loss of $5.3 million for the same
period in 2014. This decrease is primarily due to a $1.2 million reduction in operating expenses, a
$0.1 million improvement in gross
profit and a $0.4 million favorable
change in the fair value of the warrant liability, a non-cash
item.
Balance Sheet Highlights
Cash and cash equivalents as of March 31,
2015 were $18.5 million,
compared with $20.5 million as of
December 31, 2014. During the first
quarter of 2015, net cash used in operating activities was
$4.4 million.
On February 11, 2015 Delcath
raised gross proceeds of $2.8 million
in a public offering of common stock and warrants.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology with a principal focus on the
treatment of primary and metastatic liver cancers. Our proprietary
Melphalan Hydrochloride for Injection for use with the Delcath
Hepatic Delivery System (Melphalan/HDS) is designed to administer
high-dose chemotherapy to the liver while controlling systemic
exposure. In April 2012 we obtained
authorization to affix a CE Mark to our second-generation system,
which is currently marketed in Europe as a device under the trade name
Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT).
In the U.S. Melphalan/HDS is considered a combination drug and
device product, and is regulated as a drug by the U.S. Food and
Drug Administration (FDA). Melphalan/HDS has not been approved
for sale in the U.S. We have commenced a global Phase 2 clinical
trial in Europe and the U.S. to
investigate Melphalan/HDS for the treatment of primary liver cancer
(hepatocellular carcinoma or HCC), and have expanded the study to
include a cohort of patients with intrahepatic cholangiocarcinoma
(ICC). We are also advancing plans to conduct a global Phase
3 trial in ocular melanoma that has metastasized to the liver.
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 timing and results
of the Company's clinical trials including without limitation
the HCC, ICC and OM clinical trial programs, timely
enrollment and treatment of patients in the global Phase 2 HCC and
ICC clinical trial, FDA and European Health Authority approval of
the global Phase 3 OM clinical trial protocol, IRB or ethics
committee clearance of the Phase 2 HCC/ICC and/or Phase 3
OM protocols from participating sites and the timing of
site activation and subject enrollment in each trial, acceptance of
the Phase 3 manuscript at a leading peer reviewed medical journal
and the impact of publication to support the Company's business,
future clinical results consistent with the data presented,
approval of Individual Funding Requests for reimbursement of the
CHEMOSAT procedure, the impact, if any of Value 4 status on
potential CHEMOSAT product use and sales in Germany, clinical adoption, use and resulting
sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in Europe including the
key markets of Germany and the UK,
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 U.S. 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, our ability to maintain NASDAQ listing, 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:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
-Tables to Follow-
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
|
(Unaudited)
|
|
|
|
Assets:
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
$ 18,462
|
|
$
20,469
|
|
Accounts
receivables, net
|
312
|
|
174
|
|
Inventories
|
274
|
|
349
|
|
Prepaid
expenses and other current assets
|
982
|
|
974
|
|
Total
current assets
|
20,030
|
|
21,966
|
|
Property, plant
and equipment, net
|
1,620
|
|
1,798
|
|
Total
assets
|
$ 21,650
|
|
$
23,764
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity:
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable
|
$
268
|
|
$
748
|
|
Accrued
expenses
|
3,135
|
|
3,603
|
|
Warrant
liability
|
836
|
|
225
|
|
Total current liabilities
|
4,239
|
|
4,576
|
|
Other
non-current liabilities
|
987
|
|
1,043
|
|
Total
liabilities
|
5,226
|
|
5,619
|
|
|
|
|
|
|
Commitments
and Contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Preferred
stock, $.01 par value; 10,000,000 shares authorized; no
shares issued and outstanding at March 31, 2015 and December
31, 2014, respectively
|
--
|
|
--
|
|
Common
stock, $.01 par value; 170,000,000 shares authorized; 12,200,397
and 9,740,397 shares issued and 12,169,706 and 9,708,841 shares
outstanding at March 31, 2015 and December 31, 2014,
respectively
|
122
|
|
97
|
|
Additional paid-in capital
|
266,349
|
|
264,592
|
|
Accumulated deficit
|
(250,002)
|
|
(246,513)
|
|
Treasury
stock, at cost; 1,757 shares at March 31, 2015 and December
31, 2014, respectively
|
(51)
|
|
(51)
|
|
Accumulated other comprehensive income
|
6
|
|
20
|
|
Total stockholders' equity
|
16,424
|
|
18,145
|
|
Total liabilities and stockholders' equity
|
$ 21,650
|
|
$
23,764
|
|
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
2015
|
|
2014
|
Revenue
|
$
444
|
|
$ 310
|
Cost of goods
sold
|
133
|
|
93
|
Gross
profit
|
311
|
|
217
|
|
|
|
|
Operating
expenses:
|
|
|
|
Selling,
general and administrative
|
3,040
|
|
3,819
|
Research and
development
|
979
|
|
1,457
|
Total
operating expenses
|
4,019
|
|
5,276
|
Operating
loss
|
(3,708)
|
|
(5,059)
|
Change in fair value
of the warrant liability, net
|
209
|
|
(205)
|
Interest
income
|
2
|
|
1
|
Other income
(expense) and interest income (expense)
|
9
|
|
(15)
|
Net
loss
|
$ (3,488)
|
|
$ (5,278)
|
Other comprehensive
income (loss):
|
|
|
|
Foreign currency
translation adjustments
|
$
(14)
|
|
$
(2)
|
Comprehensive
loss
|
$ (3,502)
|
|
$ (5,280)
|
|
|
|
|
Common share
data:
|
|
|
|
Basic and diluted
loss per share
|
$ (0.32)
|
|
$ (0.57)
|
|
|
|
|
Weighted average
number of basic and diluted common shares outstanding
|
10,857,142
|
|
9,300,078
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-reports-2015-first-quarter-financial-results-300078512.html
SOURCE Delcath Systems, Inc.