NEW YORK, Nov. 10, 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 and nine months ended September 30, 2015.
Financial and other highlights for the third quarter of 2015 and
recent weeks included:
- 84% increase in total revenue compared with the third quarter
of 2014
- 23% decrease in total operating expenses compared with the
third quarter of 2014
- Establishment of national reimbursement coverage for
CHEMOSAT® procedures in Germany
- Treatment of first patient in the intrahepatic
cholangiocarcinoma (ICC) cohort of the Global Phase 2 HCC/ICC trial
program
- Acceptance for publication of prior Melanoma Phase 3 trial
results in the Annals of Surgical Oncology
- Presentation of data supporting Delcath's Hepatic
CHEMOSAT® Delivery System at the CIRSE, ECCO and EADO
annual meetings
- Appointment of Jennifer Simpson,
Ph.D., MSN, CRNP, President and CEO of Delcath to the Company's
Board of Directors
"Our performance in the third quarter and recent weeks was
strong, with significant achievements in all of our commercial and
clinical priorities," said Dr. Simpson. "Highlighting the period
was the establishment of ZE reimbursement for CHEMOSAT procedures
in Germany beginning in 2016,
which represents our first national reimbursement mechanism and an
important step towards increasing commercialization of CHEMOSAT in
Europe. We also continued to drive
commercial adoption of CHEMOSAT in other European markets, as
evidenced by a nearly 84% increase in third quarter revenue
compared with last year. In fact, our year-to-date revenue
has already exceeded full-year 2014 revenue. This performance was
achieved while maintaining disciplined expense management, which
allowed us to beat our operating expense guidance of $4-5 million per quarter."
"During the period we also continued to advance our clinical
development program, with the first treatment performed in the ICC
cohort of our Global Phase 2 HCC/ICC trial program in October and
data supporting CHEMOSAT presented at three major medical
conferences. Adding to this growing body of evidence will be data
from our prior U.S. Phase 3 clinical trial, which will published in
the Annals of Surgical Oncology in the coming weeks.
Publication of these results will be an important tool that will
enhance our efforts to expand reimbursement in certain European
countries, and will also help increase awareness of the value of
this therapy in Europe."
"We held a productive meeting with the U.S. Food and Drug
Administration regarding our plans for a global pivotal Phase 3
clinical trial in patients with ocular melanoma (OM) that has
metastasized to the liver, with overall survival as the primary
endpoint. The dialogue was constructive and the FDA is
working with Delcath to advance the initiation of this important
trial."
"Our team is executing our plan and entirely focused on
delivering value for shareholders. We look forward to continuing
this momentum through to the end of 2015 and beyond," concluded Dr.
Simpson.
Third Quarter Financial Results
Total revenue for the third quarter of 2015 of $0.4 million increased 83.9% from $0.2 million for the third quarter of 2014.
Selling, general and administrative expenses during the third
quarter were $2.3 million, a decrease
of $2.2 million or 48.9% from
$4.5 million for the same period in
2014.
Total operating expenses for the third quarter of 2015 decreased
by 23.1% to $4.0 million from
$5.2 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, as well as a
reduction in facility expenses.
The Company recorded a net loss for the third quarter of 2015 of
$2.4 million, or $0.12 per share, a decrease of $2.2 million or 47.8%, compared with a net loss
of $4.6 million, or $0.48 per share, 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
$0.8 million change in the fair value
of the warrant liability, a non-cash item.
Nine Month Financial Results
Total revenue for the first nine months of 2015 of $1.3 million increased 62.5% from $0.8 million for the first nine months of
2014. Selling, general and administrative expenses during the
first nine months of 2015 were $7.8
million, a decrease of $5.2
million or 40.0% from $13.0
million for the same period in 2014.
Total operating expenses for the first nine months of 2015
decreased by 27.7% to $12.0 million
from $16.6 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, as well as a
reduction in facility expenses.
The Company recorded a net loss for the first nine months of
2015 of $9.6 million, or $0.67 per share, a decrease of $4.8 million or 33.3% compared with a net loss of
$14.4 million, or $1.54 per share, for the same period in 2014.
This decrease is primarily due to a $4.7
million reduction in operating expenses, a $0.4 million improvement in gross profit and a
$0.2 million change in the fair value
of the warrant liability, a non-cash item.
Balance Sheet Highlights
Cash and cash equivalents as of September
30, 2015 were $16.7 million,
compared with $20.5 million as of
December 31, 2014. During the first
nine months of 2015, net cash used in operating activities was
$12.2 million.
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 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), and expect to initiate a global Phase 3 trial in ocular
melanoma (OM) 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 impact, if any, of
publication of the Phase 3 trial manuscript to support the
Company's efforts, 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 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, 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
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:
Investor Contact:
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com
-Tables to Follow-
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
(Unaudited)
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenue
|
|
$
399
|
|
$ 217
|
|
$ 1,308
|
|
$ 778
|
Cost of goods
sold
|
|
90
|
|
50
|
|
$
360
|
|
209
|
Gross
profit
|
|
309
|
|
167
|
|
948
|
|
569
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
2,276
|
|
4,538
|
|
7,818
|
|
12,956
|
Research and
development
|
|
1,683
|
|
683
|
|
4,112
|
|
3,632
|
Total operating
expenses
|
|
3,959
|
|
5,221
|
|
11,930
|
|
16,588
|
Operating
loss
|
|
(3,650)
|
|
(5,054)
|
|
(10,982)
|
|
(16,019)
|
Change in fair value
of the warrant liability, net
|
|
1,253
|
|
519
|
|
1,414
|
|
1,612
|
Other expense and
interest expense
|
|
(25)
|
|
(23)
|
|
(43)
|
|
(29)
|
Net loss
|
|
$ (2,422)
|
|
$ (4,558)
|
|
$ (9,611)
|
|
$ (14,436)
|
Other comprehensive
loss:
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
$
(4)
|
|
$
(6)
|
|
$
(12)
|
|
$ (27)
|
Comprehensive
loss
|
|
$ (2,426)
|
|
$ (4,564)
|
|
$ (9,623)
|
|
$ (14,463)
|
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share
|
|
$ (0.12)
|
|
$ (0.48)
|
|
$ (0.67)
|
|
$ (1.54)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares outstanding
|
|
19,729,374
|
|
9,447,887
|
|
14,301,105
|
|
9,391,793
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Balance Sheets
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
|
2015
|
|
2014
|
|
|
|
(Unaudited)
|
|
|
|
Assets:
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
16,666
|
|
$
20,469
|
|
Accounts receivables,
net
|
|
432
|
|
174
|
|
Inventories
|
|
402
|
|
349
|
|
Prepaid expenses and
other current assets
|
|
665
|
|
974
|
|
Total current
assets
|
|
18,165
|
|
21,966
|
|
Property, plant and
equipment, net
|
|
1,402
|
|
1,798
|
|
Total
assets
|
|
$
19,567
|
|
$
23,764
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity:
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Accounts
payable
|
|
$
221
|
|
$
748
|
|
Accrued
expenses
|
|
2,022
|
|
3,603
|
|
Warrant
liability
|
|
2,935
|
|
225
|
|
Total current
liabilities
|
|
5,178
|
|
4,576
|
|
Other non-current
liabilities
|
|
874
|
|
1,043
|
|
Total
liabilities
|
|
6,052
|
|
5,619
|
|
|
|
|
|
|
|
Commitments and
Contingencies
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares issued and
outstanding at September 30, 2015 and December 31, 2014,
respectively
|
|
—
|
|
—
|
|
Common stock, $.01
par value; 170,000,000 shares authorized; 22,341,707 and 9,740,397
shares issued and 21,763,864 and 9,708,841 shares outstanding at
September 30, 2015 and December 31, 2014,
respectively
|
|
223
|
|
97
|
|
Additional paid-in
capital
|
|
269,460
|
|
264,592
|
|
Accumulated
deficit
|
|
(256,125)
|
|
(246,513)
|
|
Treasury stock, at
cost; 1,757 shares at September 30, 2015 and December 31, 2014,
respectively
|
|
(51)
|
|
(51)
|
|
Accumulated other
comprehensive income
|
|
8
|
|
20
|
|
Total stockholders'
equity
|
|
13,515
|
|
18,145
|
|
Total liabilities and
stockholders' equity
|
|
$
19,567
|
|
$
23,764
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-reports-2015-third-quarter-financial-results-300175319.html
SOURCE Delcath Systems, Inc.