NEW YORK, March 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 12 months ended December 31, 2014.
Highlights of 2014 and recent weeks include:
- Opened for enrollment a global Phase 2 clinical trial program
for Melphalan/HDS for first-line treatment of patients with
unresectable hepatocellular carcinoma (HCC) or primary liver cancer
at leading cancer centers in Europe and at the Moffitt Cancer Center, the
first U.S. clinical site;
- Achieved product revenue of $1.1
million in 2014, an increase of more than 100% compared with
product revenue of $490,000 in
2013;
- Submission of the manuscript of its Phase 3 clinical trial data
with the Delcath Hepatic Delivery System (Melphalan/HDS) for
publication in a peer-reviewed medical journal;
- Selection of a poster highlighting Melphalan/HDS for treatment
of melanoma liver metastases for presentation at the 2015 Society
of Surgical Oncology Annual Meeting;
- Presentation of data highlighting positive clinical experiences
with Melphalan/HDS from three leading cancer hospitals at the 2014
European Society of Surgical Oncology (ESSO) congress;
- Affirmed Value 4 coverage status for the Delcath Hepatic
CHEMOSAT® Delivery System (CHEMOSAT)
by the German federal reimbursement agency for 2015;
- Raised gross proceeds of $2.8
million through a public offering of common stock and
warrants;
- Reorganized and strengthened its Board of Directors by
appointing Dr. Roger G. Stoll as
Executive Chairman and adding three new Directors: Dr. Dennis H. Langer, William D. Rueckert and Dr. Marco Taglietti.
"Throughout 2014, we continued to make progress across all areas
important to our strategic plan including clinical, commercial, and
corporate initiatives," said Jennifer
Simpson, Ph.D., MSN, CRNP, Interim President and Chief
Executive Officer of Delcath.
"We are pleased with the continued sales growth of CHEMOSAT in
Europe. During the year, 79 treatments were performed
compared with 40 in 2013, underscoring growing interest and
adoption in our key European markets. Submission of our Phase 3
data for publication in a peer-reviewed journal is another key
milestone for Delcath. If published, this article will be a
significant tool in support of our efforts to obtain reimbursement
in a number of European countries. Together with inclusion of our
results in important medical and scientific programs, such as the
2014 ESSO Congress and the upcoming 2015 SSO Congress, we believe
publication of our data will continue to increase awareness of the
value of this therapy.
"Our global Phase 2 HCC clinical trial program is now open for
enrollment with the initial patients being treated in Europe. We look forward to adding additional
European and domestic sites to this study and are preparing to
expand the program to include a cohort of patients with
intrahepatic cholangiocarcinoma (ICC) in the European segment of
this trial.
"We are advancing plans to initiate a pivotal Phase 3 clinical
trial in ocular melanoma (OM) that is metastatic to the liver with
overall survival as the primary endpoint. Based on the strength of
the hepatic progression free survival efficacy data in OM
metastases obtained in our previous Phase 3 clinical trial, and the
reports of an improved safety profile from more than 100 patients
treated in commercial settings in Europe, we believe this Phase 3 program offers
the fastest path to potential approval of Melphalan/HDS in the
U.S.," concluded Dr. Simpson.
Fourth Quarter Financial Results
Total revenue in the fourth quarter of 2014 of $0.3 million was comparable to total revenue of
$0.3 million in the fourth quarter of
2013. Selling, general and administrative expenses decreased
to $2.8 million in the fourth quarter
of 2014 from $3.7 million in the
fourth quarter of 2013. Research and development expenses in the
fourth quarter of 2014 decreased to $0.7
million from $2.0 million in
the same period a year ago.
Total operating expenses for the fourth quarter of 2014
decreased by approximately 40% to $3.5
million from $5.8 million for
the same period in 2013. The decrease reflects a reduction in
severance and compensation related expenses following the company's
significant work force restructurings throughout 2013 and 2014.
For the fourth quarter of 2014, the Company recorded a net loss
of $2.9 million or $0.31 per share, a decrease of approximately 40%,
compared with a net loss of $4.8
million or $0.63 per
share.
2014 Financial Results
Total revenue in 2014 was $1.1
million compared with $0.8
million in 2013, of which $0.3
million related to the recognition of previously deferred
revenue.
Selling, general and administrative expenses decreased to
$15.8 million in 2014 from
$20.7 million in 2013. The decrease
reflects a reduction in severance and compensation-related expenses
following the Company's workforce restructurings throughout 2013,
partially offset by the recognition in 2014 of $1.3 million in expenses related to vacating the
Company's previous corporate office space.
Research and development expenses decreased to $4.3 million in 2014 from $12.7 million in 2013, primarily due to a
significant reduction in regulatory and clinical expenses related
to the Company's New Drug Application (NDA) submission to the FDA,
as well as a reduction in severance and compensation- related
expenses following significant workforce restructurings throughout
2013.
Operating expenses decreased by approximately 40% to
$20.1 million in 2014 from
$33.3 million in 2013. The decrease
is related to costs incurred for the Company's NDA submission to
the FDA in 2013, the phasing out of the Company's medical science
liaison program and the Company's successful efforts to increase
organizational efficiencies.
The operating loss in 2014 was $19.3
million, compared with $33.0
million in 2013.
Delcath recorded a net loss in 2014 of $17.4 million or $1.84 per share, a decrease of $12.9 million, or 43%, compared with a net loss
in 2013 of $30.3 million or
$4.81 per share. The narrowing of the
net loss is primarily due to a $13.3
million decrease in operating expenses in 2014.
Balance Sheet Highlights
Cash and cash equivalents as of December
31, 2014 were $20.5 million,
compared with $31.2 million as of
December 31, 2013. During 2014, net
cash used in operating activities was $15.6
million, a 54% reduction compared with $34.1 million used in 2013. The decrease in cash
utilization was due in part to a reduction in NDA
submission-related costs, and improved organizational and
operational efficiencies.
On February 11, 2015 Delcath
raised gross proceeds of $2.8 million
in a public offering of common stock and warrants.
Conference Call
Delcath management intends to host periodic "Business and
Clinical Update" conference calls in the future, which will allow
management to time such updates to meaningful corporate and
clinical developments.
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 we are planning to evaluate
patients with intrahepatic cholangiocarcinoma (ICC) in a Phase 2
clinical study. 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, the impact of the presentations at ESSO
and SSO 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 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.
|
Consolidated
Statements of Operations and Comprehensive Loss
|
for the three and
twelve months ended December 31, 2014 and 2013
|
(in thousands,
except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months
Ended December 31,
|
|
|
|
|
|
|
2014
|
|
|
2013
|
|
|
2014
|
|
|
2013
|
|
|
Revenue
|
|
$
|
291
|
|
$
|
338
|
|
$
|
1,069
|
|
$
|
490
|
|
|
Other
revenues
|
|
-
|
|
|
-
|
|
|
-
|
|
|
300
|
|
|
|
Total
revenue
|
|
291
|
|
|
338
|
|
|
1,069
|
|
|
790
|
|
|
Cost of goods
sold
|
|
(81)
|
|
|
(78)
|
|
|
(291)
|
|
|
(464)
|
|
|
|
Gross
profit
|
|
210
|
|
|
260
|
|
|
778
|
|
|
326
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
2,828
|
|
|
3,737
|
|
|
15,783
|
|
|
20,657
|
|
|
Research and
development
|
|
667
|
|
|
2,049
|
|
|
4,299
|
|
|
12,688
|
|
|
|
Total operating
expenses
|
|
3,495
|
|
|
5,786
|
|
|
20,082
|
|
|
33,345
|
|
|
|
|
Operating
loss
|
|
(3,285)
|
|
|
(5,526)
|
|
|
(19,304)
|
|
|
(33,019)
|
|
|
Change in fair value
of warrant liability, net
|
|
330
|
|
|
410
|
|
|
1,942
|
|
|
2,756
|
|
|
Interest
income
|
|
1
|
|
|
2
|
|
|
5
|
|
|
20
|
|
|
Other expense and
interest expense
|
|
9
|
|
|
322
|
|
|
(24)
|
|
|
(81)
|
|
|
|
|
Net loss
|
$
|
(2,945)
|
|
$
|
(4,792)
|
|
$
|
(17,381)
|
|
$
|
(30,324)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic loss per common
share*
|
$
|
(0.31)
|
|
$
|
(0.63)
|
|
$
|
(1.84)
|
|
$
|
(4.81)
|
|
|
|
Diluted loss per
common share*
|
$
|
(0.31)
|
|
$
|
(0.63)
|
|
$
|
(1.84)
|
|
$
|
(5.10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic common shares outstanding*
|
|
9,632,192
|
|
|
7,558,372
|
|
|
9,452,050
|
|
|
6,300,614
|
|
|
Weighted average
number of diluted common shares outstanding*
|
|
9,632,192
|
|
|
7,558,372
|
|
|
9,452,050
|
|
|
6,569,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
$
|
(70)
|
|
$
|
(325)
|
|
$
|
(76)
|
|
$
|
59
|
|
|
Comprehensive
loss
|
$
|
(3,015)
|
|
$
|
(5,117)
|
|
$
|
(17,457)
|
|
$
|
(30,265)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Reflects a
one-for-sixteen (1:16) reverse stock split effected on April 8,
2014.
|
DELCATH SYSTEMS,
INC.
|
Consolidated
Balance Sheets
|
as of December 31,
2014 and December 31, 2013
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
|
|
|
2014
|
|
|
2013
|
|
Assets:
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
20,469
|
|
$
|
31,249
|
|
|
Accounts receivables,
net
|
|
174
|
|
|
349
|
|
|
Inventories
|
|
349
|
|
|
719
|
|
|
Prepaid expenses and
other current assets
|
|
974
|
|
|
1,711
|
|
|
|
Total current
assets
|
|
21,966
|
|
|
34,028
|
|
|
Property, plant and
equipment, net
|
|
1,798
|
|
|
3,069
|
|
|
|
|
Total
assets
|
$
|
23,764
|
|
$
|
37,097
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders' Equity:
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
748
|
|
$
|
582
|
|
|
Accrued
expenses
|
|
3,603
|
|
|
3,740
|
|
|
Warrant
liability
|
|
225
|
|
|
2,310
|
|
|
|
Total current
liabilities
|
|
4,576
|
|
|
6,632
|
|
|
Other non-current
liabilities
|
|
1,043
|
|
|
366
|
|
|
|
Total
liabilities
|
|
5,619
|
|
|
6,998
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares issued and outstanding at December 31, 2014
and December 31, 2013, respectively
|
|
—
|
|
|
—
|
|
|
Common stock, $.01
par value; 170,000,000 shares authorized; 9,740,397 and 8,402,922 shares issued and 9,708,841
and 8,401,165 shares outstanding at December 31, 2014 and December
31, 2013, respectively *
|
|
97
|
|
|
84
|
|
|
Additional paid-in
capital
|
|
264,592
|
|
|
259,102
|
|
|
Accumulated
deficit
|
|
(246,513)
|
|
|
(229,132)
|
|
|
Treasury stock, at
cost; 1,757 shares at December 31, 2014 and December 31, 2013,
respectively
|
|
(51)
|
|
|
(51)
|
|
|
Accumulated other
comprehensive income
|
|
20
|
|
|
96
|
|
|
|
Total stockholders'
equity
|
|
18,145
|
|
|
30,099
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
23,764
|
|
$
|
37,097
|
|
|
|
|
|
|
|
|
|
|
|
|
* Reflects a
one-for-sixteen (1:16) reverse stock split effected on April 8,
2014.
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-reports-2014-fourth-quarter-and-full-year-financial-results-300048439.html
SOURCE Delcath Systems, Inc.