NEW YORK, May 7, 2014 /PRNewswire/ -- Delcath Systems, Inc.
(NASDAQ: DCTH) today reported financial results and corporate
developments for the fiscal first quarter ended March 31, 2014. Highlights for the quarter and
recent weeks subsequent to quarter end are as follows:
- Continued adoption of CHEMOSAT in Europe, with 103 procedures performed on 72
patients to date since the product became commercially available in
early 2012
- First quarter 2014 cash utilization of $4.5 million, lower than guidance of $5 to $6 million
- Submission of HCC Phase 2 trial protocols to regulatory
authorities in the U.S. and Germany; IND amendment for HCC Phase 2 trial
cleared by FDA; a separate HCC Phase 2 trial protocol under review
by German health authorities
- Regained compliance with NASDAQ listing rules
"We continue to see CHEMOSAT clinical adoption in Europe,
where centers have performed over 100 procedures since the product
was first launched two years ago," commented Jennifer K.
Simpson, Interim Co-President and Co-CEO. "Regarding our clinical
development program, our supplemental IND became effective in
March, and protocols for the HCC Phase 2 program are under
institutional review in the U.S. and Germany."
Financial Results
For the first quarter ended March 31,
2014, total product revenue was $0.3
million compared with total product revenue of approximately
$0.1 million in the first quarter
2013. Operating expenses decreased by approximately 50% to
$5.3 million from $10.6 million for the same period in 2013. The
decrease is primarily due to a significant reduction in expenses
related to the Company's NDA submission to the FDA, as well as the
Company's overall cost management efforts. Operating loss was
$5.3 million, as compared with an
operating loss of $12.8 million.
Cash and cash equivalents as of March 31,
2014 were $31.3 million.
During the quarter, cash used in operating activities was
$4.5 million, a 59% reduction
compared to $10.9 million in the
comparable period in 2013. The decrease in cash utilization was in
part due to a reduction in NDA submission-related costs, and
improved organizational and operational efficiencies. The Company
believes it has sufficient resources to execute its plan through
the first half of 2015.
During the first quarter, the Company raised approximately
$4.5 million before related expenses
through its At-the-Market offering program.
"I believe our efforts in the second half of 2013 enabled us to
begin 2014 as a more efficient and focused organization. We are
pleased to have reduced quarterly cash burn by 59%, and we will
continue to evaluate our activities to advance the Company's
strategy," said Graham G. Miao,
Interim Co-President and Co-CEO.
Conference Call and Webcast
The Company will host a conference call today, May 7, 2014 at 4:30 p.m.
ET to discuss its financial results for the first quarter
ended March 31, 2014, and provide an
update on recent corporate progress. The dial-in numbers for
the conference call are 800-706-7749 (U.S. participants) and
617-614-3474 (international participants); both numbers require
passcode 27241849. To access the live webcast, go to the Events
& Presentations page on the Investor Relations section of the
Company's website at http://www.delcath.com/investors/events/.
A taped replay of the call will be available beginning
approximately two hours after the call's conclusion and will be
available for seven days. Dial-in numbers for the replay are
888-286-8010 and 617-801-6888 for U.S. and International callers,
respectively. The replay passcode for both U.S. and International
callers is 49674508. An archived webcast will also be
available at http://www.delcath.com/investors/events/.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and medical
device company focused on oncology. Our proprietary
product—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
the systemic exposure to those agents. The Company's principal
focus is on the treatment of primary and metastatic liver cancers.
In the United States, the
Melphalan/HDS system is considered a combination drug and device
product, and is regulated as a drug by the United States Food and
Drug Administration (FDA). The Melphalan/HDS system has not
been approved for sale in the United
States. In Europe, our
proprietary system to deliver and filter melphalan hydrochloride is
marketed as a device under the trade name Delcath Hepatic
CHEMOSAT® Delivery System for Melphalan (CHEMOSAT). In
April 2012, we obtained authorization
to affix a CE Mark for the Generation Two
CHEMOSAT system. The right to affix the CE mark
allows the Company to market and sell the CHEMOSAT system in
Europe. The Company has initiated
plans to investigate the Melphalan/HDS system for primary liver
cancer.
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 Company's
ability to achieve the estimated average quarterly cash utilization
for 2014, IRB clearance of the Phase II HCC protocol from
participating sites and the timing of site activation and subject
enrollment in the HCC Phase II trial program, the timing and
results of future clinical trials including without limitation the
HCC clinical trial program, the ability of hospitals in
Germany to successfully negotiate
and receive reimbursement for the CHEMOSAT procedure in their
region under Value 4 status and the amount of reimbursement, if
any, to be provided under Value 4 status in 2014, approval of
Individual Funding Requests for reimbursement of the CHEMOSAT
procedure, the impact 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 US 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:
|
Media
Contact:
|
Michael
Polyviou/Patty Eisenhaur
|
John
Carter
|
EVC Group
|
EVC Group
|
212-850-6020/951-316-0577
|
212-850-6021
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Balance Sheets
|
as of March 31,
2014 and December 31, 2013
|
(Unaudited)
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
2014
|
|
|
2013
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
31,254
|
|
$
|
31,249
|
|
Accounts receivables,
net
|
|
|
181
|
|
|
349
|
|
Inventories,
net
|
|
|
619
|
|
|
719
|
|
Prepaid expenses and
other current assets
|
|
|
1,292
|
|
|
1,711
|
|
|
Total current
assets
|
|
|
33,346
|
|
|
34,028
|
|
Property, plant and
equipment, net
|
|
|
2,738
|
|
|
3,069
|
|
|
Total
assets
|
|
$
|
36,084
|
|
$
|
37,097
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
334
|
|
$
|
582
|
|
Accrued
expenses
|
|
|
3,476
|
|
|
3,740
|
|
Warrant
liability
|
|
|
2,399
|
|
|
2,310
|
|
|
Total current
liabilities
|
|
|
6,209
|
|
|
6,632
|
|
Other non-current
liabilities
|
|
|
225
|
|
|
366
|
|
|
Total
liabilities
|
|
|
6,434
|
|
|
6,998
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
-
|
|
|
-
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Preferred stock, $.01
par value; 10,000,000 shares authorized; no shares issued and outstanding at March 31, 2014
and December 31, 2013
|
|
|
|
|
|
|
|
|
|
-
|
|
|
-
|
|
Common stock, $.01
par value; 170,000,000 shares authorized; 9,433,703 and 8,394,397 shares issued and 9,431,907
and 8,392,641 shares outstanding at March 31, 2014 and December 31,
2013, respectively*
|
|
|
|
|
|
|
|
|
|
94
|
|
|
84
|
|
Additional paid-in
capital
|
|
|
263,923
|
|
|
259,102
|
|
Accumulated
deficit
|
|
|
(234,410)
|
|
|
(229,132)
|
|
Treasury stock, at
cost; 1,757 shares at March 31, 2014 and December 31, 2013*
|
|
|
|
|
|
|
|
|
|
(51)
|
|
|
(51)
|
|
Accumulated other
comprehensive income
|
|
|
94
|
|
|
96
|
|
|
Total stockholders'
equity
|
|
|
29,650
|
|
|
30,099
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
36,084
|
|
$
|
37,097
|
|
|
|
|
|
|
|
|
* Reflects a
one-for-sixteen (1:16) reverse stock split effected on April 8,
2014.
|
DELCATH SYSTEMS,
INC.
|
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
|
for the three
months ended March 31, 2014 and 2013
|
(Unaudited)
|
(in thousands,
except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
March 31,
|
|
|
|
|
2014
|
|
2013
|
REVENUES
|
|
|
|
|
|
|
|
Product
revenue
|
|
$
|
310
|
|
$
|
81
|
|
Other
revenues
|
|
|
-
|
|
|
300
|
|
|
Total
revenues
|
|
|
310
|
|
|
381
|
|
|
|
|
|
|
|
|
|
COSTS OF
SALES
|
|
|
|
|
|
|
|
Cost of goods
sold
|
|
|
(93)
|
|
|
(31)
|
|
|
Gross
profit
|
|
|
217
|
|
|
350
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Selling, general and
administrative1
|
|
$
|
3,819
|
|
$
|
6,083
|
|
Research and
development1
|
|
|
1,457
|
|
|
4,469
|
|
|
Total operating
expenses
|
|
|
5,276
|
|
|
10,552
|
|
|
Loss from
operations
|
|
|
(5,059)
|
|
|
(10,202)
|
OTHER INCOME
(EXPENSE)
|
|
|
|
|
|
|
|
Change in fair value
of warrant liability, net
|
|
|
(205)
|
|
|
(2,272)
|
|
Interest
income
|
|
|
1
|
|
|
10
|
|
Other
expenses
|
|
|
(15)
|
|
|
(381)
|
|
|
Net loss
|
|
$
|
(5,278)
|
|
$
|
(12,845)
|
|
|
|
|
|
|
|
|
|
LOSS PER COMMON
SHARE
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share *
|
|
$
|
(0.57)
|
|
$
|
(2.40)
|
|
|
|
|
|
|
|
|
|
WEIGHTED AVERAGE
COMMON SHARES
|
|
|
|
|
|
|
|
Basic and diluted
weighted average common shares outstanding *
|
|
|
9,300,078
|
|
|
5,342,976
|
|
|
|
|
|
|
|
|
|
OTHER COMPREHENSIVE
INCOME (LOSS)
|
|
|
|
|
|
|
|
Foreign currency
translation adjustments
|
|
$
|
(2)
|
|
$
|
364
|
|
|
Comprehensive
loss
|
|
$
|
(5,280)
|
|
$
|
(12,481)
|
|
|
|
|
|
|
|
|
|
|
Note 1:
|
|
|
|
|
|
|
|
Includes non-cash
stock-based compensation as follows:
|
|
|
|
|
|
|
|
|
|
|
Three months
ended March 31,
|
|
|
|
|
2014
|
|
2013
|
|
Selling, general and
administrative
|
|
$
|
157
|
|
$
|
520
|
|
Research and
development
|
|
|
63
|
|
|
144
|
|
Total stock-based
compensation expense
|
|
$
|
220
|
|
$
|
664
|
|
|
|
|
|
|
|
|
|
|
* Reflects a
one-for-sixteen (1:16) reverse stock split effected on April 8,
2014.
|
|
SOURCE Delcath Systems, Inc.