NEW YORK, March 21, 2016 /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 and 12 months ended December 31, 2015.
Highlights for the fourth quarter of 2015 and recent weeks
include:
- Fourth quarter 2015 revenue increased 51% to $0.4 million and full year 2015 revenue of
$1.7 million increased 63% compared
with 2014;
- Initiation of patient enrollment in the global Phase III trial:
FOCUS Clinical Trial for Patients with Hepatic Dominant Ocular
Melanoma (the FOCUS trial), which is being conducted under a
Special Protocol Assessment (SPA) agreement with the U.S. Food and
Drug Administration (FDA) to support marketing approval in the
U.S.;
- Publication of prior Phase 3 metastatic melanoma clinical trial
results in the prestigious peer-reviewed journal Annals of
Surgical Oncology;
- Establishment in Germany of
the first national reimbursement mechanism for the Delcath Hepatic
CHEMOSAT® Delivery System (CHEMOSAT);
- Initiation of patient enrollment and first patients treated in
the intrahepatic cholangiocarcinoma (ICC) cohort of the Company's
European Phase 2 HCC/ICC program; and
- Completion of more than 300 treatments with CHEMOSAT since the
second generation of the system was launched.
"Throughout 2015 we advanced every key element of our clinical
development program and commercialization priorities for CHEMOSAT,
achieving noteworthy milestones in all areas of our strategic
plan," said Dr. Jennifer K. Simpson,
Ph.D., MSN, CRNP, President and Chief Executive Office of Delcath.
"Our efforts in 2015 allowed us to kick off 2016 with the
agreement by the FDA of our request for a Special Protocol
Assessment of a clinical protocol for initiation of the
FOCUS trial in January of this year. If successful, the FOCUS trial
will provide a clear pathway to approval for the treatment of
hepatic dominant ocular melanoma for Melphalan/HDS. We are
delighted to have a number of leading U.S. cancer centers committed
to participate in this study and look forward to opening these
sites in the coming months. Proceeding with the trial under
the SPA agreement also represents the satisfaction of a substantial
number of the requirements of the FDA's 2013 Complete Response
Letter. During 2015 we also advanced our Phase 2 clinical trial
program in Europe for intrahepatic
cholangiocarcinoma, with the ICC cohort now open for enrollment and
treating patients.
"We are particularly pleased with the steady progress we are
making with the commercialization of CHEMOSAT in Europe. Product revenue for the year was
$1.7 million, an increase of more
than 60% compared with 2014. Importantly, we received our first
national reimbursement coverage with the establishment of ZE
reimbursement for CHEMOSAT procedures in Germany. We anticipate coverage levels for
CHEMOSAT to be defined by mid-2016, and together with publication
of our prior Phase 3 clinical trial results, expect they will
provide important support for the growth of CHEMOSAT procedures in
Germany and will enhance our
reimbursement efforts in other European markets. During the
year, we were particularly pleased to report the completion of more
than 300 CHEMOSAT procedures since adopting the second generation
of the filtration system. In addition to the steady growth in
commercial procedures, clinical data obtained with CHEMOSAT were
presented at five international medical conferences and published
in two peer-reviewed journals.
"Our team continues to execute effectively on our strategic plan
while maintaining disciplined expense management, and is
entirely focused on delivering value for shareholders. We look
forward to continuing this momentum in 2016 and beyond," concluded
Dr. Simpson.
Fourth Quarter Financial Results
Total revenue for the fourth quarter of 2015 was $0.4 million, a 51% increase from the
$0.3 million reported for the fourth
quarter of 2014. Selling, general and administrative expenses
during the fourth quarter of 2015 were $2.2
million, a decrease of $0.6
million or 23% from the $2.8
million reported for the same period in 2014. Research and
development expenses increased to $2.4
million in the 2015 fourth quarter from $0.7 million for the same period in 2014,
primarily due to increased clinical development initiatives.
The increase was partially offset by organizational efficiencies
implemented through a phase out of the medical science liaison
program and workforce restructurings.
Total operating expenses for the fourth quarter of 2015
increased by 31% to $4.6 million from
the $3.5 million reported for the
same period in 2014. This reflects an increase in our clinical
development initiatives, which was partially offset by a reduction
in severance and compensation-related expenses following
significant workforce and lease restructurings throughout 2014 and
2015, as well as a reduction in facility expenses.
The Company recorded a net loss for the 2015 fourth quarter of
$5.1 million, or $0.23 per share, an increase of $2.1 million or 73%, compared with a net loss of
$2.9 million, or $0.31 per share, for the same period in 2014.
This increase is primarily due to a $1.1
million increase in operating expenses, a $0.1 million improvement in gross profit and a
$1.2 million change in the fair value
of the warrant liability, a non-cash item.
2015 Financial Results
Total revenue for 2015 of $1.7
million increased 63% from the $1.1
million reported for 2014. Selling, general and
administrative expenses for 2015 were $10.0
million, a decrease of $5.8
million or 37% from $15.8
million in 2014. For 2015, research and development
expenses increased to $6.5 million
from the $4.3 million reported in
2014.
Total operating expenses for 2015 decreased by 18% to
$16.5 million from $20.1 million for 2014.
The Company reported a net loss in 2015 of $14.7 million, a decrease of $2.7 million, or 15%, compared with the net loss
for 2014. This decrease is primarily due to a $3.6 million decrease in operating expenses and a
$0.5 million improvement in gross
profit, which was offset by a $1.4
million change in the fair value of the warrant liability, a
non-cash item.
Balance Sheet Highlights
As of December 31, 2015, Delcath
had cash and cash equivalents of $12.6
million, compared with $20.5
million as of December 31,
2014. During 2015, the Company used $16.4 million of cash for its operating
activities. Delcath believes it has sufficient capital to fund its
operating activities through the third quarter of 2016.
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. the Melphalan/HDS system 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 our global Phase 3 FOCUS clinical trial for Patients with
Hepatic Dominant Ocular Melanoma (OM) and a global Phase 2 clinical
trial in Europe and the U.S. to investigate the
Melphalan/HDS system for the treatment of primary liver cancer
(HCC) and intrahepatic cholangiocarcinoma (ICC).
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 OM, HCC ,and ICC clinical trial programs, timely
enrollment and treatment of patients in the global Phase 3 FOCUS
Clinical Trial for Patients with Hepatic Dominant Ocular Melanoma
and the global Phase 2 HCC and ICC clinical trials, 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, the impact,
if any, of publication of the Phase 3 trial manuscript to support
the Company's efforts, the impact of the presentations
at major medical conferences and future clinical results consistent
with the data presented, approval of Individual Funding Requests
for reimbursement of the CHEMOSAT procedure, the impact, if
any of ZE reimbursement 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, 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 remaining 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.
Investor Contact:
Anne Marie
Fields
LHA
212-838-3777
afields@lhai.com
-Tables to Follow-
DELCATH SYSTEMS,
INC.
|
Consolidated
Balance Sheets
|
as of December 31,
2015 and December 31, 2014
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
|
2015
|
|
2014
|
Assets:
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
12,607
|
|
$
|
20,469
|
|
Accounts receivables,
net
|
|
277
|
|
|
174
|
|
Inventories
|
|
757
|
|
|
349
|
|
Prepaid expenses and
other current assets
|
|
960
|
|
|
974
|
|
|
Total current
assets
|
|
14,601
|
|
|
21,966
|
|
Property, plant and
equipment, net
|
|
1,132
|
|
|
1,798
|
|
|
|
Total
assets
|
$
|
15,733
|
|
$
|
23,764
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity:
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts
payable
|
$
|
284
|
|
$
|
748
|
|
Accrued
expenses
|
|
2,243
|
|
|
3,603
|
|
Warrant
liability
|
|
3,785
|
|
|
225
|
|
|
Total current
liabilities
|
|
6,312
|
|
|
4,576
|
|
Other non-current
liabilities
|
|
820
|
|
|
1,043
|
|
|
Total
liabilities
|
|
7,132
|
|
|
5,619
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2015
and December 31, 2014, respectively
|
|
|
|
|
|
|
|
—
|
|
|
—
|
|
Common stock, $.01
par value; 170,000,000 shares authorized; 22,341,574 and 9,740,394 shares issued and 21,763,817
and 9,708,841 shares outstanding at December 31, 2015 and December
31, 2014, respectively
|
|
|
|
|
|
|
|
223
|
|
|
97
|
|
Additional paid-in
capital
|
|
269,654
|
|
|
264,592
|
|
Accumulated
deficit
|
|
(261,217)
|
|
|
(246,513)
|
|
Treasury stock, at
cost; 1,757 shares at December 31, 2015 and December 31, 2014,
respectively
|
|
(51)
|
|
|
(51)
|
|
Accumulated other
comprehensive income
|
|
(8)
|
|
|
20
|
|
|
Total stockholders'
equity
|
|
8,601
|
|
|
18,145
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
15,733
|
|
$
|
23,764
|
Delcath Systems,
Inc.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
for the three and
twelve months ended December 31, 2015 and 2014
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
|
|
|
|
2015
|
|
|
2014
|
|
|
2015
|
|
|
2014
|
|
Revenue
|
|
$
|
439
|
|
$
|
291
|
|
$
|
1,747
|
|
$
|
1,069
|
|
Other
revenues
|
|
-
|
|
|
-
|
|
|
-
|
|
|
-
|
|
|
Total
revenue
|
|
439
|
|
|
291
|
|
|
1,747
|
|
|
1,069
|
|
Cost of goods
sold
|
|
(102)
|
|
|
(81)
|
|
|
(462)
|
|
|
(291)
|
|
|
Gross
profit
|
|
337
|
|
|
210
|
|
|
1,285
|
|
|
778
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
2,191
|
|
|
2,828
|
|
|
10,009
|
|
|
15,783
|
|
|
Research and
development
|
|
2,374
|
|
|
667
|
|
|
6,486
|
|
|
4,299
|
|
|
|
Total operating
expenses
|
|
4,565
|
|
|
3,495
|
|
|
16,495
|
|
|
20,082
|
|
|
|
Operating
loss
|
|
(4,228)
|
|
|
(3,285)
|
|
|
(15,210)
|
|
|
(19,304)
|
|
Derivative instrument
income
|
|
(850)
|
|
|
330
|
|
|
564
|
|
|
1,942
|
|
Interest
income
|
|
3
|
|
|
1
|
|
|
9
|
|
|
5
|
|
Other expense and
interest expense
|
|
(18)
|
|
|
9
|
|
|
(67)
|
|
|
(24)
|
|
|
|
Net loss
|
$
|
(5,093)
|
|
$
|
(2,945)
|
|
$
|
(14,704)
|
|
$
|
(17,381)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share
|
$
|
(0.23)
|
|
$
|
(0.31)
|
|
$
|
(0.91)
|
|
$
|
(1.84)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted
common shares outstanding
|
21,763,876
|
|
|
9,632,192
|
|
|
16,161,687
|
|
|
9,452,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
$
|
(23)
|
|
$
|
(70)
|
|
$
|
(28)
|
|
$
|
(76)
|
|
Comprehensive
loss
|
$
|
(5,116)
|
|
$
|
(3,015)
|
|
$
|
(14,732)
|
|
$
|
(17,457)
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-announces-2015-fourth-quarter-and-full-year-financial-results-300238623.html
SOURCE Delcath Systems, Inc.