Delcath Systems, Inc : DELCATH REPORTS FOURTH QUARTER AND FULL YEAR 2012 RESULTS

   Delcath Systems, Inc : DELCATH REPORTS FOURTH QUARTER AND FULL YEAR 2012
                                   RESULTS

            - Conference Call and Webcast Today at 4:30 p.m. ET -

NEW YORK, March 13, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today reported
financial results and operational highlights for the fiscal fourth quarter and
full year ended December 31, 2012.

Highlights from the 2012 fiscal year and recent weeks include:

  *Acceptance by the U.S. Food and Drug Administration (FDA) for  substantive 
    review of the  Company's New  Drug Application (NDA)  for its  proprietary 
    drug/device combination product  with the proposed  brand name of  Melblez 
    Kit^TM (Melblez (melphalan) for Injection for use with the Delcath Hepatic
    Delivery System), with a proposed indication for the treatment of patients
    with unresectable  ocular  melanoma metastatic  to  the liver  -  the  FDA 
    assigned a PDUFA goal date of June 15, 2013

  *Announcement of an Oncologic Drugs Advisory Committee (ODAC) panel meeting
    on May 2, 2013 to assess the Company's NDA

  *Initiation of U.S. Expanded  Access Program (EAP)  and treatment of  first 
    EAP patient in the U.S.

  *Q4 cash utilization reduced by 33% compared to Q3 

  *First commercial sales in Company history

  *Treatment of first patients in Europe with the CHEMOSAT^® Hepatic Delivery
    System for melphalan hydrochloride

  *Value 4 interim reimbursement coverage  granted in Germany and  identified 
    an  existing  DRG  code  for  partial  reimbursement  in  Italy-hospitals 
    submitting interim reimbursement applications in both countries

  *Receipt of  CE  Mark approval  for  CHEMOSAT Hepatic  Delivery  System  to 
    deliver and filter doxorubicin hydrochloride injection

"Last year was  one of  significant accomplishments  for Delcath,  led by  the 
FDA's acceptance  of  our NDA  for  the  Melblez Kit  System  for  substantive 
review,"  said  Eamonn  P.  Hobbs,  President  and  CEO  of  Delcath  Systems. 
"Submission of our application was the  culmination of an intensive effort  by 
our team, and FDA's acceptance of our  NDA and designation of a June 15,  2013 
PDUFA goal date are the most important developments in our history. During the
year, we also established our initial commercial footprint in Europe, recorded
our first commercial sales,  and in recent weeks  began negotiations with  the 
FDA on our Clinical Development Program  with the goal of expanding the  label 
for concentrated, liver-directed therapy."

"We introduced CHEMOSAT into  Europe this past  year, establishing a  presence 
for the treatment in all seven of our target countries," continued Mr.  Hobbs. 
"Patients with  liver dominant  disease from  multiple tumor  types have  been 
treated, and  physician interest  in the  therapeutic approach  with  CHEMOSAT 
remains strong. We  believe publication of  our Phase 3  melanoma and Phase  2 
multi-histology  clinical  trial  data  will  further  drive  this   interest. 
Development of compelling  reimbursement is  a key driver  of utilization  and 
revenue growth. We are working closely with experts and our partner hospitals
to bring various interim reimbursement mechanisms online, and in parallel  are 
engaged  in  the  applications  process  to  establish  permanent,  compelling 
reimbursement. Though  these  mechanisms  have  come  online  slower  than  we 
anticipated, which  has  impacted  revenue ramp,  physician  interest  in  our 
therapy is strong and we remain  optimistic about the long-term prospects  for 
CHEMOSAT in Europe." 

"In the  United States,  we  continue to  work closely  with  the FDA  in  its 
evaluation of our  NDA, and  are preparing for  our presentation  to the  ODAC 
panel on May 2^nd. Our engagement with  the FDA has been constructive, and  we 
are hopeful that the agency will conclude  its review on the PDUFA goal  date. 
Assuming our NDA is  approved, our plan  is to launch in  the U.S. during  the 
fourth quarter, focusing initially on  those hospitals that are  participating 
in our recently  launched EAP and  have participated in  our clinical  trials. 
With that goal in  mind, we are currently  evaluating an ultra-orphan  pricing 
and commercialization strategy in the U.S. for unresectable metastatic  ocular 
melanoma," concluded Mr. Hobbs.

Fourth Quarter and Full Year Financial Results

For the three months ended December 31, 2012, Delcath recorded revenue of $0.2
million. Operating loss was $11.8  million, which included approximately  $0.9 
million in  non-cash stock-based  compensation expense,  as compared  with  an 
operating  loss  of  $16.0  million,   including  $0.9  million  in   non-cash 
stock-based compensation  expense, in  the same  prior year  period.  Selling, 
general and administrative (SG&A)  expenses were $6.4  million for the  fourth 
quarter of 2012, compared  to $6.1 million  for the same  period in 2011.  The 
higher SG&A  expense  was  primarily due  to  increased  EU  commercialization 
expenses. Research and development  (R&D) expenses were  $5.6 million for  the 
fourth quarter of 2012, compared to $9.8 million for the same period in  2011. 
The lower  R&D  expenses  reflect  lower  consulting  expenses  following  the 
submission of the NDA on August 15, 2012.

For the year ended December 31, 2012, Delcath recorded revenue of $0.3 million
and  an  additional  $30,000  of  deferred  revenue  related  to  orders  from 
distribution partners. The Company's operating  loss was $53.9 million,  which 
included approximately  $3.8  million  in  non-cash  stock-based  compensation 
expense. The increase in expense is primarily related to EU  commercialization 
efforts. Operating  loss  for the  year  ended  December 31,  2011  was  $46.5 
million, which  included approximately  $4.3 million  in non-cash  stock-based 
compensation expense.  SG&A expenses  were $28.0  million for  the year  ended 
December 31, 2012, compared to $21.3  million for the year ended December  31, 
2011. R&D expenses were  $26.2 million for the  year ended December 31,  2012, 
compared to $25.2 million during the year ended December 31, 2011. 

At December 31, 2012, cash, cash equivalents and certificates of deposit  were 
$23.7 million, compared  with $30.8  million at  December 31,  2011. For  the 
fourth quarter cash utilization was $9.7 million, a 33% reduction compared  to 
$14.6 million in  the third quarter.  This was consistent  with the  Company's 
previously announced expectations for average monthly cash utilization between
$3 million  and  $4 million  for  the fourth  quarter.  The decrease  in  cash 
utilization was  primarily  driven  by  a  reduction  in  consulting  services 
following submission of the NDA as well as overall effective cost management.

The Company successfully completed its  "at the market" (ATM) equity  offering 
program,  and  between  January   1,  2013  and   February  28,  2013   raised 
approximately $20.9 million before related expenses. At February 28, 2013, the
Company's  cash   and  cash   equivalents  were   approximately  $38   million 
(unaudited). The Company has entered into a new ATM equity offering  program, 
under which the Company may  sell up to $50 million  in its common stock  from 
time  to  time  once  the  associated  shelf  registration  statement  becomes 
effective.

"We remain committed to maintaining our reduced quarterly cash utilization  of 
$9 million to $12 million for 2013," said Graham Miao, Ph.D., Delcath's  Chief 
Financial Officer. "We believe that with  our current cash balance and  access 
to capital  resources, we  have  the financial  resources and  flexibility  to 
execute our operating plan for the next twelve months and beyond."

Conference Call and Webcast

The Company will host a conference call today, March 13, 2013 at 4:30 p.m. ET.
The  dial-in  numbers   for  the  conference   call  are  877-299-4454   (U.S. 
participants) and  617-597-5447  (International  participants);  both  numbers 
require passcode  99502530. 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 41198605. 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  drug/device combination  product,  the 
Delcath  Hepatic  Delivery  System,  is  designed  to  administer  high   dose 
chemotherapy and other therapeutic agents to diseased organs or regions of the
body, while controlling the systemic  exposure of those agents. The  Company's 
initial focus is on the treatment of primary and metastatic liver cancers.  In 
2010, Delcath  announced  that  its  randomized Phase  3  clinical  trial  for 
patients with metastatic melanoma in  the liver had successfully achieved  the 
study's primary endpoint  of extended hepatic  progression-free survival.  The 
Company also completed a multi-arm Phase 2 trial to treat other liver cancers.
Outside of the United  States, our proprietary product  to deliver and  filter 
melphalan hydrochloride  is  marketed under  the  trade name  Delcath  Hepatic 
CHEMOSAT^® Delivery  System  (CHEMOSAT  Delivery System  for  Melphalan.)  The 
Company obtained  authorization to  affix a  CE Mark  for the  Generation  Two 
CHEMOSAT Delivery System for Melphalan in April 2012. The right to affix  the 
CE mark allows the Company to market and sell the CHEMOSAT Delivery System for
Melphalan in  Europe.  In October  2012,  the  Company satisfied  all  of  the 
requirements to affix  the CE  Mark to  the Hepatic  CHEMOSAT Delivery  System 
device for intra-hepatic  arterial delivery and  extracorporeal filtration  of 
doxorubicin   hydrochloride   injection   (CHEMOSAT   Delivery   System    for 
Doxorubicin), providing a regulatory pathway for the CHEMOSAT Delivery  System 
for Doxorubicin for countries in  Asia that accept the  CE Marking as part  of 
their national regulatory requirements. The Company has not yet received  FDA 
approval for commercial sale of its system in the United States. The Company's
NDA has been accepted for filing and substantive review by the FDA. For  more 
information, please visit the Company's website at www.delcath.com.

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 outcome  of the ODAC  meeting, 
and the impact, if  any, of the advisory  panel's recommendation on the  FDA's 
decision regarding  the  Company's  new  drug  application  (NDA),  timing  of 
completion of the FDA's  review of our  NDA, the extent to  which the FDA  may 
request additional information or data and our ability to provide the same  in 
a timely manner, acceptability of the Phase 1, 2 and 3 clinical trial data  by 
the FDA,  FDA  approval of  the  Company's NDA  for  the treatment  of  ocular 
metastatic melanoma to the liver, adoption,  use and resulting sales, if  any, 
in the  United States,  adoption, use  and resulting  sales, if  any, for  the 
CHEMOSAT system to  deliver and filter  melphalan in the  EEA, our ability  to 
successfully commercialize the chemosaturation system and the potential of the
chemosaturation system as a treatment for patients with primary and metastatic
disease in the  liver, market acceptance  of the Gen  Two CHEMOSAT system  and 
patient  outcomes  using  the  same,   approval  of  the  current  or   future 
chemosaturation system for delivery  and filtration of melphalan,  doxorubicin 
or other chemotherapeutic agents for various  indications in the US and/or  in 
foreign markets, actions by the FDA or other foreign regulatory agencies,  our 
ability to  successfully enter  into  strategic partnership  and  distribution 
arrangements in foreign markets including Australia and key Asian markets  and 
timing an revenue, if any, of the same, the approval of the Hepatic  CHEMOSAT 
Delivery System device to deliver and filter doxorubicin in key Asian markets
and patient outcomes using the same,  our ability to obtain reimbursement  for 
the CHEMOSAT  system, uncertainties  relating  to the  timing and  results  of 
research and development  projects, uncertainties relating  to the timing  and 
results of future clinical trials, and uncertainties regarding our ability  to 
obtain financial  and  other  resources  for  any  research,  development  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:
Investors:                  Financial Media
Gregory Gin/Patty Eisenhaur Chris Gale
EVC Group                  EVC Group
646-445-4801/951-316-0577   646-201-5431

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Source: Delcath Systems, Inc via Thomson Reuters ONE
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