<SEC-DOCUMENT>0001341004-14-000210.txt : 20140317
<SEC-HEADER>0001341004-14-000210.hdr.sgml : 20140317
<ACCEPTANCE-DATETIME>20140317160547
ACCESSION NUMBER:		0001341004-14-000210
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20140312
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20140317
DATE AS OF CHANGE:		20140317

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DELCATH SYSTEMS, INC.
		CENTRAL INDEX KEY:			0000872912
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				061245881
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-16133
		FILM NUMBER:		14697658

	BUSINESS ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		35TH FLOOR
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
		BUSINESS PHONE:		(212) 489-2100

	MAIL ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		35TH FLOOR
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	DELCATH SYSTEMS INC
		DATE OF NAME CHANGE:	19990607
</SEC-HEADER>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">CURRENT REPORT</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">PURSUANT TO SECTION 13 OR 15(D) OF THE</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">SECURITIES EXCHANGE ACT OF 1934</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Date of report (Date of earliest event reported): <font style="DISPLAY: inline; FONT-WEIGHT: bold">March 17, 2014 (March 12, 2014)</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman Bold, Times New Roman, serif; FONT-SIZE: 16pt; FONT-WEIGHT: bold">DELCATH SYSTEMS, INC.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">(Exact name of registrant as specified in its charter)</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">810 Seventh Avenue, 35<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">th</font> Floor, New York, New York, 10019</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Item 7.01. Regulation FD Disclosure.</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">On March 12, 2014, Delcath Systems, Inc. (the &#8220;Company&#8221;) hosted a conference call to discuss the Company&#8217;s financial results for the fourth quarter and full year ended December 31, 2013 and recent operational development.&#160;&#160;A copy of the transcript of the conference call is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">The following exhibit is filed herewith:</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt"><font id="TAB1" style="MARGIN-LEFT: 36pt"></font>Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</font></div>

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<div style="LINE-HEIGHT: 1.5; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Patty Eisenhaur</font><font style="FONT-STYLE: italic; DISPLAY: inline"> EVC Group - IR Contact</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt; FONT-WEIGHT: bold">Operator</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Thank you, Denise. Good afternoon, everyone.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Thank you for joining us today for this conference call and webcast to provide an update on Delcath's fiscal fourth-quarter and year-end results for 2013, as well as recent developments.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">A live webcast of this call is also available at www.delcath.com. The call will also be archived on the company's website.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Before we begin, I would like to remind you that some of the statements made during this conference call will contain forward-looking statements within the meaning of the Safe Harbor provision of the US Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties, and actual results could differ materially from those projected in any forward-looking statements.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Participating on today's call are Delcath's interim Co-President and Co-CEOs, Jennifer Simpson and Graham Miao. Jennifer is also Delcath's Executive Vice President, Global Head of Business Operations; and Graham Miao is Delcath's Executive Vice President and Chief Financial Officer.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">And with that, I would like to turn the call over to Jennifer.</font></div>

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<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt; FONT-WEIGHT: bold">Jennifer Simpson <font style="FONT-STYLE: italic; DISPLAY: inline">- Delcath Systems, Inc. - Interim Co-President &amp; Co-CEO, EVP - Global Head of Business Operations</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Thanks, Patty. Good afternoon. everyone.</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">This afternoon, I would like to provide updates on our two main priorities, our HCC Clinical Development program and CHEMOSAT clinical adoption in Europe.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Later, I will turn the call over to Graham, who will review the continued actions we have taken to strengthen the company, discuss our fourth-quarter and full-year financial results, and provide an update on the availability and use of our resources.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">I will begin with an outline of our current Clinical Development program. We are continuing to work on our Clinical Development program to investigate the Mephalan HDS for first-line treatment of patients with unresectable advanced hepatocellular carcinoma, or HCC, also known as primary liver cancer.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">We received comments from the FDA at the end of 2013 on our proposed HCC trial protocol and incorporated their comments into our IND submission. We then submitted a supplemental IND to the FDA for this trial in February of 2014.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In addition to the FDA's assessment of the IND, the submitted protocol is now proceeding through a scientific review committee and the institutional review board at our participating institutions. Pending any further comments from the FDA, and clearance of the protocol by our participating institutions, we now anticipate being activated in the second quarter of 2014.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">As a reminder, the global HCC Phase II trial program is focused on first-line unresectable advanced hepatocellular carcinoma in approximately 30 patients. The Phase II trial will incorporate additional safety measures from experience gained in our EU commercial cases, as well as the US ocular melanoma program.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">The program aims to assess the overall objective response rate, progression free survival, also known as PFS, as well as safety parameters. This study should provide us with valuable information on safety and efficacy before moving into a Phase III study with overall survival as the primary endpoint.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Our priority right now is to help the US and international sites complete the documentation and institutional reviews required in order to activate the trial. Though the February submission of our IND has pushed out the anticipated launch date for our HCC program, we will update investors on the status of our HCC trial on our Q1 2014 call.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In addition to our HCC clinical program, we are also generating clinical data to support adoption of CHEMOSAT in Europe. Last year we completed a retrospective data collection trial, which collected data post hoc from two hospitals in Europe where therapy with the CHEMOSAT system was administered in a non-clinical trial setting.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">This provided a retrospective view of hematology results reliably from seven patients treated with the CHEMOSAT system in Europe. While limited and not part of a formal clinical trial design, this retrospective data collection appears to support a reduction in myelosuppression in patients reported anecdotally from commercial centers in Europe.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">We are also initiating a patient registry in Europe, which will prospectively collect data from EU commercial cases. The first hospital participating in the registry submitted the protocol to its ethics committee in January 2014, and we anticipate that the first site will begin enrolling patients in the registry in our second quarter.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">We believe that the registry will provide valuable safety data and potential signals in various tumor types from a commercial setting, which we believe can be used to support our efforts for clinical adoption and commercialization in Europe.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In addition to the retro and prospective data collection, we are also supporting investigator initiated trials or, IITs, as suitable opportunities present. Presently two IITs -- one in HCC at JWG Hospital in Frankfurt, Germany, and another in colorectal cancer liver metastases at Leiden University Medical Center in the Netherlands -- are nearing activation.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 6pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Knowledge Light, sans-serif; COLOR: #ffffff; FONT-SIZE: 12pt">MARCH 12, 2014 / 08:30PM&#160;&#160;GMT, DCTH - Q4 2013 Delcath Systems, Inc Earnings Conference Call</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Beyond data generation, our immediate commercialization efforts are primarily focused on Germany and the UK. Markets which represent a majority of the total potential liver cancer market, both primary metastatic in the EU and where progress in securing reimbursement for CHEMOSAT treatments offers the best near term opportunities.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Obtaining reimbursement for CHEMOSAT procedures in Europe remains our primary objective on the commercialization front. As a reminder, physician use and advocacy are key drivers of the reimbursement process.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Physicians directly influence reimbursement decisions. So expanding clinical adoption is a prerequisite for gaining interim reimbursement and then, ultimately, permanent reimbursement.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In 2013, physicians and patients in Germany submitted individual funding requests, or IFRs, seeking reimbursement for the treatment of liver metastases with the CHEMOSAT system. IFRs are a case-by-case appeal for reimbursement made to the patient's insurance carrier.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">While each IFR is evaluated independently, we have been advised that the majority of these applications have been approved in recent months. We expect the IFRs to be the key reimbursement vehicle in the German market in 2014.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In January, we announced that we were again granted NUB Value 4 status for 2014 interim reimbursement in Germany, which provides hospitals the opportunity to negotiate a budget to fund the CHEMOSAT procedures with their regional insurance carriers.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">The CHEMOSAT application was submitted by 71 hospitals in Germany, which represents a significant increase in the level of institutional support the procedure received over 2013.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">It is important to note that for 2014 reimbursement, a total of 618 medical procedures were submitted to InEK, the German reimbursement authority, for consideration under the NUB scheme, with only 16% of procedures receiving Value 1 status and 6% of the procedures receiving Value 4.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">The remaining 78% of procedures were denied coverage or unevaluated, which we believe illustrates how challenging the reimbursement environment is for new procedures in Germany.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">InEK first established NUB Value 4 status for CHEMOSAT procedures in 2013, though we have been advised that hospitals performing the CHEMOSAT procedure did not successfully negotiate reimbursement budgets for CHEMOSAT during the year. In 2014, we believe that a number of hospitals performing the procedure intend to pursue reimbursement under Value 4 status.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Remember, NUB is an annual process, and participating centers are required to apply each year for subsequent coverage under the NUB scheme.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Turning to the UK, the reimbursement process has been driven by partner centers and their clinical community, with the centers applying for funding for a limited number of patients with ocular melanoma.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">The current application seeks funding for 50 to 75 ocular melanoma patients, and 15 to 20 cutaneous melanoma patients. The mechanism under which block funding is granted is new, and ongoing delays in policy changes in the National Health Service or NHS make it difficult to predict the likelihood and timing of the block grant funding.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Though Germany and the UK are our primary focus, we continue to support clinical adoption of CHEMOSAT in other EU markets where we have established a footprint. During our fourth quarter, CHEMOSAT treatments were performed in Germany, Italy, the Netherlands and Spain.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In other target countries in the EU, we continue to evaluate various interim reimbursement pathways. We believe these mechanisms will help build a foundation for commercialization and help support long-term revenue growth.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 6pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Knowledge Light, sans-serif; COLOR: #ffffff; FONT-SIZE: 12pt">MARCH 12, 2014 / 08:30PM&#160;&#160;GMT, DCTH - Q4 2013 Delcath Systems, Inc Earnings Conference Call</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">We are pleased to see an increase in the number of patients receiving repeat treatments at centers that have been able to secure an interim source of funding. Physicians at these centers are observing a beneficial response in patients that have received repeat treatment cycles.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Since November, three more clinical centers have come on board. SPIRE, in Southampton UK, is one of the most recent cancer centers to begin performing procedures, and as our first private hospital treating patients in the UK, acts as an important access point for patients being funded by the large private healthcare sector in the UK.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Private hospital treatments are funded entirely by either private health insurance companies or self-paying patients and, as such, are independent of the National Public Reimbursement System.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">University of Leiden Medical Center also performed its first cases, and its CHEMOSAT team is fully trained in the procedure and is ready to begin its IIT in the near-term. Jena University Hospital in Germany also began performing procedures in our fourth quarter.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">To conclude on Europe, we continue to see an increase in CHEMOSAT procedures and re-treatments, which we believe is a function of expanding clinical experience, interim funding mechanisms getting established, and clinical buy-ins from influential key opinion leaders.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">With that, I would like to turn the call over to Graham Miao for a review of our financial results; and then we will take questions.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Graham?</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Thank you, Jennifer. Good afternoon, everybody.</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">I am pleased to report that we continue to make progress on our efforts to enhance operational efficiencies, reduce our cash spend, and strengthen Delcath's financial condition.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Cash spend for the fourth quarter was $6.2 million. This was a reduction of 36%, or $3.5 million, year over year for the same period and a reduction of 10%, or $0.7 million, sequentially from the third quarter of 2013.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Importantly, we have met our cash spend guidance for the last three quarters, and this quarter was at the low-end of our reduced guidance of between $6 million to $8 million.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">For the full-year, cash used in operating activities was $34.1 million, a 32% reduction compared to $50.0 million in the comparable period in 2012. The decrease in cash utilization was in part due to a reduction in NDA-submission-related costs and improved organizational and operational efficiencies.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In conjunction with other cost-saving measures, we remain on target to further reduce our average quarterly cash spend to between $5 million to $6 million in 2014.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In addition to controlling costs, we raised additional capital to further strengthen our balance sheet.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">In 2013, we raised approximately $43.2 million before related expenses, including approximately $26.7 million through the Company's At-the-Market equity offering program, $9 million through its Committed Equity Financing Facility program, and approximately $7.5 million through a registered direct offering.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">As a result, cash and cash equivalents as of December 31, 2013, were $31.2 million compared with $23.7 million at December 31, 2012.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">During the first quarter through February 28, 2014, we raised approximately $4.5 million before related expenses through our At-the-Market offering program. As of February 28, 2014, cash and cash equivalents were $32.7 million, including $0.4 million in accounts receivable collection.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Total operating expenses during the fourth quarter 2013 decreased by 52%, to $5.8 million, from $12 million for the same period in 2012. 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. The reduction also reflects our more streamlined EU operations.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">For the full-year ended December 31, 2013, total revenue was approximately $0.8 million, of which $0.3 million was related to the recognition of previously-deferred revenue. Total operating expenses for 2013 decreased by approximately 38%, to $33.3 million, from $54.2 million in 2012.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">For the fourth quarter, operating loss was $5.5 million, which included non-cash stock-based compensation income of $0.3 million due to cancellation of previous stock grants resulting from staff reduction. As compared with an operating loss of $11.8 million, including $0.9 million in non-cash stock-based compensation expense in the year ago period.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Chris, do we have questions in the webcast?</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">We have a question from the webcast that reads, you have referenced that you are focusing your efforts on Germany and the UK. Will CHEMOSAT no longer be available or supported in the other EU countries? Won't this limit your opportunities for generating revenue?</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Thanks Chris. Just to clarify CHEMOSAT is available in all countries where it is approved and we continue to support the clinical adoption, and as referenced before through IITs, or investigator initiated trials, we are not stopping our efforts in other countries, just taking a more focused approach on the UK and Germany as these two countries offer the clearest pathway for reimbursement in the near-term.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">We have another question from the webcast. It reads, I thought you were hoping to initiate patient enrollment by the end of first quarter. Is this delay related to the FDA concerns or institutions you are working with?</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">Thanks Chris. As we mentioned, we made the prudent decision to engage with the FDA on our proposed HCC protocol and we did have a review with the FDA by year-end as originally planned. The FDA provided very productive feedback, as well as our clinical institutions, and we adjusted the protocol accordingly.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 8pt">So where we are now is, the clinical sites are now submitting the protocol to their scientific review committee as well as the institutional review board at the participating institutions. And subject to any further FDA comments, and also clearance from the institutional review boards, we hope to have the sites open for enrollment in the second quarter.</font></div>

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