NEW YORK, Aug. 5, 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 six months ended June 30, 2015.
Highlights of the second quarter and recent weeks included:
- Quarterly product revenue of $0.5
million, an increase of nearly 85.7% compared with the
second quarter of 2014
- Total operating expenses decreased by 35.1% to $4.0 million from $6.1
million in the second quarter of 2014
- Enrollment opened for an intrahepatic cholangiocarcinoma (ICC)
cohort of the Company's global Phase 2 trial of Melphalan/HDS in
hepatocellular carcinoma
- Positive data regarding the Delcath Hepatic
CHEMOSAT® Delivery System highlighted at ASCO 2015
- Exceeded 200 commercial treatments performed with CHEMOSAT
since the product was launched in Europe
- Multiple abstracts accepted for presentation at upcoming major
medical conferences, including CIRSE, ESMO, and EADO
- Benefits of CHEMOSAT therapy to liver cancer patients affirmed
by Key Opinion Leaders at European forum
- Jennifer Simpson, Ph.D., MSN,
CRNP named President and CEO
- Granted U.S. Orphan Drug Designation for Melphalan/HDS for the
treatment of cholangiocarcinoma from the U.S. Food and Drug
Administration (FDA)
"We made considerable progress toward achieving our key
milestones for 2015 as evidenced by continued revenue growth,
increasing procedure volumes and advancement of our clinical
development program," said Dr. Simpson. "We once again
achieved record quarterly product revenue with year-over-year and
sequential increases that have us already meeting our full-year
2014 sales on a local currency basis. This growth underscores
our commercial progress in key European markets and highlights
continued market adoption of CHEMOSAT.
"The opening of enrollment of the ICC cohort of our Phase 2 HCC
study was a meaningful milestone as we believe our Melphalan/HDS
treatment may offer significant clinical benefit for ICC patients
who face limited treatment options. A positive efficacy
signal may provide a regulatory path to a U.S. registration trial
in this indication, and consolidated safety data from the HCC and
ICC cohorts will offer valuable information for us to provide to
the FDA. Our recent receipt of orphan drug designation from the FDA
for melphalan for the treatment of cholangiocarcinoma, which
includes ICC, highlights the medical need for viable treatments in
this indication.
"We continue to advance our plans for a global pivotal Phase 3
clinical trial in ocular melanoma (OM) that has metastasized to the
liver with overall survival as the primary endpoint. We hope
to initiate this trial by the end of 2015.
"The positive feedback from the three-day Key Opinion Leader
Forum we convened with leading clinicians from across
Europe who are using CHEMOSAT was
very encouraging. We look forward to these favorable findings
being published in a white paper in a peer-reviewed journal.
"We are pleased with the meaningful progress made this quarter.
With the additional resources secured through our recent public
offering, we are well positioned to achieve several critical
milestones during the second half of 2015," concluded Dr.
Simpson.
Second Quarter Financial Results
Total revenue for the second quarter of 2015 of $0.5 million increased 85.7% from $0.3 million for the second quarter of
2014. Selling, general and administrative expenses during the
second quarter of 2015 were $2.5
million, a decrease of $2.1
million or 45.6% from $4.6
million for the same period in 2014.
Total operating expenses for the second quarter of 2015
decreased by 35.1% to $4.0 million
from $6.1 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 following sub-leases of its 810
Seventh Ave location in 2014.
The Company recorded a net loss for the second quarter of 2015
of $3.7 million, a decrease of
$0.9 million or 19.6%, compared with
a net loss of $4.6 million for the
same period in 2014. This decrease is primarily due to a
$2.1 million reduction in operating
expenses, a $0.1 million improvement
in gross profit and a $1.3 million
change in the fair value of the warrant liability, a non-cash
item.
First Half Financial Result
Total revenue for the first half of 2015 of $0.9 million increased 62.2% from $0.6 million for the first half of 2014.
Selling, general and administrative expenses during the first half
of 2015 were $5.5 million, a decrease
of $2.9 million or 34.1% from
$8.4 million for the same period in
2014.
Total operating expenses for the first half of 2015 decreased by
29.9% to $8.0 million from
$11.4 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 following sub-leases of its 810
Seventh Ave location in 2014.
The Company recorded a net loss for the first half of 2015 of
$7.2 million, a decrease of
$2.7 million or 27.2% compared with a
net loss of $9.9 million for the same
period in 2014. This decrease is primarily due to a $3.4 million reduction in operating expenses, a
$0.2 million improvement in gross
profit and a $0.9 million change in
the fair value of the warrant liability, a non-cash item.
Balance Sheet Highlights
Cash and cash equivalents as of June 30,
2015 were $14.1 million,
compared with $20.5 million as of
December 31, 2014. During the first
six months of 2015, net cash used in operating activities was
$9.0 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. 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2015
|
|
2014
|
|
|
(Unaudited)
|
|
|
Assets:
|
|
|
|
|
Current
assets
|
|
|
|
|
Cash and cash
equivalents
|
|
$ 14,053
|
|
$
20,469
|
Accounts receivables,
net
|
|
460
|
|
174
|
Inventories
|
|
281
|
|
349
|
Prepaid expenses and
other current assets
|
|
1,097
|
|
974
|
Total current
assets
|
|
15,891
|
|
21,966
|
Property, plant and
equipment, net
|
|
1,498
|
|
1,798
|
Total
assets
|
|
$ 17,389
|
|
$
23,764
|
|
|
|
|
|
Liabilities and
Stockholders' Equity:
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Accounts
payable
|
|
$
528
|
|
$
748
|
Accrued
expenses
|
|
2,060
|
|
3,603
|
Warrant
liability
|
|
761
|
|
225
|
Total current
liabilities
|
|
3,349
|
|
4,576
|
Other non-current
liabilities
|
|
929
|
|
1,043
|
Total
liabilities
|
|
4,278
|
|
5,619
|
|
|
|
|
|
Commitments and
Contingencies
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares
issued and outstanding at June 30, 2015 and December
31, 2014,
respectively
|
|
—
|
|
—
|
Common stock,
$.01 par value; 170,000,000 shares authorized; 12,991,707and
9,740,397 shares issued and 12,385,016 and 9,708,841
shares outstanding
at June 30, 2015 and December 31, 2014,
respectively
|
|
130
|
|
97
|
Additional paid-in
capital
|
|
266,721
|
|
264,592
|
Accumulated
deficit
|
|
(253,702)
|
|
(246,513)
|
Treasury stock, at
cost; 1,757 shares at June 30, 2015 and December 31,
2014, respectively
|
|
(51)
|
|
(51)
|
Accumulated other
comprehensive income
|
|
13
|
|
20
|
Total stockholders'
equity
|
|
13,111
|
|
18,145
|
Total liabilities and
stockholders' equity
|
|
$ 17,389
|
|
$
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
June 30,
|
|
Six months ended
June 30,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
|
Revenue
|
|
$
466
|
|
$ 251
|
|
$
910
|
|
$ 561
|
|
Cost of goods
sold
|
|
137
|
|
66
|
|
$
270
|
|
160
|
|
Gross
profit
|
|
329
|
|
185
|
|
640
|
|
401
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
2,502
|
|
4,597
|
|
5,542
|
|
8,416
|
|
Research and
development
|
|
1,450
|
|
1,492
|
|
2,430
|
|
2,949
|
|
Total operating
expenses
|
|
3,952
|
|
6,089
|
|
7,972
|
|
11,365
|
|
Operating
loss
|
|
(3,623)
|
|
(5,904)
|
|
(7,332)
|
|
(10,964)
|
|
Change in fair value
of the warrant liability, net
|
|
(48)
|
|
1,297
|
|
161
|
|
1,092
|
|
Other income
(expense) and interest income (expense)
|
|
(28)
|
|
7
|
|
(18)
|
|
(6)
|
|
Net loss
|
|
$ (3,699)
|
|
$ (4,600)
|
|
$ (7,189)
|
|
$ (9,878)
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
$
7
|
|
$ (20)
|
|
$
(7)
|
|
$ (22)
|
|
Comprehensive
loss
|
|
$ (3,692)
|
|
$ (4,620)
|
|
$ (7,196)
|
|
$ (9,900)
|
|
|
|
|
|
|
|
|
|
|
|
Common share
data:
|
|
|
|
|
|
|
|
|
|
Basic loss per common
share
|
|
$ (0.30)
|
|
$ (0.49)
|
|
$ (0.62)
|
|
$ (1.06)
|
|
Diluted loss per
common share
|
|
$ (0.30)
|
|
$ (0.52)
|
|
$ (0.62)
|
|
$ (1.08)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic common shares outstanding
|
|
12,241,154
|
|
9,426,169
|
|
11,552,572
|
|
9,363,123
|
|
Weighted average
number of diluted common shares outstanding
|
|
12,241,154
|
|
9,480,933
|
|
11,552,572
|
|
9,462,717
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/delcath-reports-2015-second-quarter-financial-results-300123968.html
SOURCE Delcath Systems, Inc.