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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>WASHINGTON, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM 8-K
</B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>PURSUANT
TO SECTION 13 OR 15(d) </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>OF THE SECURITIES EXCHANGE ACT OF 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of report (Date of earliest event reported): September&nbsp;16, 2013 (September 10, 2013) </B></P>
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<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>DELCATH SYSTEMS, INC. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top" ALIGN="center"><B>001-16133</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>06-1245881</B></TD></TR>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or Other Jurisdiction</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of Incorporation)</B></P></TD>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification Number)</B></P></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>566 Queensbury Avenue, Queensbury, New York, 12804 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Address of principal executive offices, including zip code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(518) 743-8892 </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Registrant&#146;s telephone number, including area code) </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>NONE </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or
former address, if changed since last report) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">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): </P>
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<TD ALIGN="left" VALIGN="top">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) </TD></TR></TABLE> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;
Compensatory Arrangements of Certain Officers. </B></P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%">&nbsp;</TD>
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<TD ALIGN="left" VALIGN="top">Delcath Systems, Inc. (the &#147;Company&#148;) announced on September&nbsp;13, 2013 that the Company&#146;s Board of Directors has implemented a leadership transition plan under which Jennifer Simpson, Ph.D., M.S.N.,
C.R.N.P. (age 45), the Company&#146;s current Executive Vice President, Global Head of Business Operations, and Graham Miao, Ph.D., M.S., MBA (age 49), the Company&#146;s current Executive Vice President and Chief Financial Officer, have been
appointed to serve as Interim Co-President and Co-Chief Executive Officers. In addition to her role as Interim Co-President and Co-Chief Executive Officer, Dr.&nbsp;Simpson shall continue to serve as the Company&#146;s Executive Vice President,
Global Head of Business Operations. In addition to his role as Interim Co-President and Co-Chief Executive Officer, Dr.&nbsp;Miao shall continue to serve as the Company&#146;s Executive Vice President, Chief Financial Officer. </TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">The employment of Eamonn P. Hobbs as President and Chief Executive Officer with the Company was terminated as of September&nbsp;10, 2013; Mr.&nbsp;Hobbs has also resigned from the Board of Directors. Mr.&nbsp;Hobbs is
expected to receive certain severance payments pursuant to his employment agreement with the Company dated August&nbsp;10, 2011. </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">Dr.&nbsp;Simpson joined Delcath in 2012, and has an extensive background in pharmaceutical and oncology product development, clinical trials and global marketing. Prior to her appointment at&nbsp;Delcath,
Dr.&nbsp;Simpson served as the Vice President, Global Marketing, Oncology Brand Lead at&nbsp;ImClone Systems, Inc.&nbsp;(a wholly- owned subsidiary of&nbsp;Eli Lilly and Company). In this role, she was responsible for all product commercialization
activities and launch preparation for one of the late stage assets. While at ImClone, Dr.&nbsp;Simpson also held various positions of increasing responsibility including serving as the Vice President, Product Champion and the Associate Vice
President, Product Champion. Previously, Dr. Simpson held several leadership positions at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in immunology, oncology and nephrology. Prior to
her time at Ortho Biotech, Dr.&nbsp;Simpson spent over a decade as an oncology-nurse practitioner and educator. </TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="1%">&nbsp;</TD>
<TD WIDTH="2%" VALIGN="top" ALIGN="left">&#149;</TD>
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<TD ALIGN="left" VALIGN="top">Dr.&nbsp;Miao joined Delcath in 2011 as Executive Vice President and Chief Financial Officer and is a senior financial executive with extensive experience in global business operations, financial planning and analysis,
and business development in&nbsp;the United States,&nbsp;Asia&nbsp;and&nbsp;Europe. Previously, he served as Chief of Staff of the Global CFO Organization and member of the Financial Leadership team of Dun&nbsp;&amp; Bradstreet Corporation. Prior to
joining Dun&nbsp;&amp; Bradstreet, Dr.&nbsp;Miao was Executive Vice President&nbsp;&amp; CFO of Pagoda Pharmaceuticals&#151;a&nbsp;Shanghai-based specialty pharmaceuticals and medical device company focused in urology and allergy. In addition,
Dr.&nbsp;Miao has held various leadership positions, including division CFO roles, with Symrise, Inc., Schering-Plough Corporation and Pharmacia Corporation, and served as a biotech equity analyst with J.P. Morgan. </TD></TR></TABLE>

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<TD ALIGN="left" VALIGN="top">In addition, under the transition plan, Gabriel Leung has been appointed Chairman of the Board. He replaces Dr.&nbsp;Harold Koplewicz as Chairman, who remains a member of the Board of Directors. </TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">Mr.&nbsp;Leung joined the Delcath Board of Directors in March 2011, and holds a wealth of experience in successfully gaining regulatory approval for and launching oncology drugs. Mr.&nbsp;Leung previously served as
President of the Pharmaceuticals Business at OSI Pharmaceuticals, overseeing its oncology, diabetes and obesity businesses prior to the Company&#146;s acquisition by Astellas Pharma Inc. in June 2010. Prior to OSI, Mr.&nbsp;Leung served as Group
Vice President, Global Prescription Business&nbsp;&amp; Head of the Global Oncology Franchise for Pharmacia Corporation. Previously, Mr.&nbsp;Leung held several leadership positions at Bristol-Myers Squibb. Currently, Mr.&nbsp;Leung serves on the
Board of Directors of Albany Molecular Research, Inc., and is Executive Vice Chairman of the Board and Chair of the Global Commercialization Team of Novocure, Ltd., a privately-held oncology medical device company. </TD></TR></TABLE>
<P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top">The Board has also appointed a Transition Committee to assist the Board and management with the leadership transition including the search process for the next President and Chief Executive Officer of the Company. This
Committee will also assist the Board in its rigorous evaluation of potential strategic options for the Company going forward. The initial members of this committee are current Board members Douglas Watson and Roger Stoll, as well as
Dr.&nbsp;Koplewicz and Mr.&nbsp;Leung. </TD></TR></TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On September&nbsp;13, 2013, the Company issued a press release announcing the above matters, a copy
of which release is filed as Exhibit 99.1 to this Form 8-K and which is incorporated by reference herein. </P>

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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;9.01. Financial Statements and Exhibits. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The following exhibit is filed herewith: </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d) Exhibits. </P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1.00pt solid #000000; width:25.30pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>No.</B></P></TD>
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<TD VALIGN="bottom" NOWRAP> <P STYLE="border-bottom:1.00pt solid #000000; width:39.50pt; font-size:8pt; font-family:Times New Roman"><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Press Release of Delcath Systems, Inc., dated September 13, 2013</TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">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. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" COLSPAN="3">DELCATH SYSTEMS, INC.</TD></TR>
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<TD VALIGN="top">Dated: September&nbsp;16, 2013</TD>
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<TD VALIGN="bottom">By:</TD>
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<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ Peter J. Graham</P></TD></TR>
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<TD VALIGN="bottom">Name:</TD>
<TD VALIGN="bottom"><FONT STYLE="font-size:8pt">&nbsp;</FONT></TD>
<TD VALIGN="bottom">Peter J. Graham</TD></TR>
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<TD VALIGN="bottom">Title:</TD>
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<TD VALIGN="bottom">Executive Vice President, General Counsel</TD></TR>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>EXHIBIT INDEX </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="bottom" NOWRAP><B>Description</B></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top">Press Release of Delcath Systems, Inc., dated September 13, 2013</TD></TR>
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Form 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT
TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): September 16, 2013 (September 10, 2013)
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware
001-16133
06-1245881
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification Number)
566 Queensbury Avenue, Queensbury, New York, 12804
(Address of principal executive offices, including zip code)
(518) 743-8892
(Registrant's telephone number, including area code)
NONE
(Former name or
former address, if changed since last report)
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):
¨
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers;
Compensatory Arrangements of Certain Officers.
•
Delcath Systems, Inc. (the "Company") announced on September 13, 2013 that the Company's Board of Directors has implemented a leadership transition plan under which Jennifer Simpson, Ph.D., M.S.N.,
C.R.N.P. (age 45), the Company's current Executive Vice President, Global Head of Business Operations, and Graham Miao, Ph.D., M.S., MBA (age 49), the Company's current Executive Vice President and Chief Financial Officer, have been
appointed to serve as Interim Co-President and Co-Chief Executive Officers. In addition to her role as Interim Co-President and Co-Chief Executive Officer, Dr. Simpson shall continue to serve as the Company's Executive Vice President,
Global Head of Business Operations. In addition to his role as Interim Co-President and Co-Chief Executive Officer, Dr. Miao shall continue to serve as the Company's Executive Vice President, Chief Financial Officer.
•
The employment of Eamonn P. Hobbs as President and Chief Executive Officer with the Company was terminated as of September 10, 2013; Mr. Hobbs has also resigned from the Board of Directors. Mr. Hobbs is
expected to receive certain severance payments pursuant to his employment agreement with the Company dated August 10, 2011.
•
Dr. Simpson joined Delcath in 2012, and has an extensive background in pharmaceutical and oncology product development, clinical trials and global marketing. Prior to her appointment at Delcath,
Dr. Simpson served as the Vice President, Global Marketing, Oncology Brand Lead at ImClone Systems, Inc. (a wholly- owned subsidiary of Eli Lilly and Company). In this role, she was responsible for all product commercialization
activities and launch preparation for one of the late stage assets. While at ImClone, Dr. Simpson also held various positions of increasing responsibility including serving as the Vice President, Product Champion and the Associate Vice
President, Product Champion. Previously, Dr. Simpson held several leadership positions at Ortho Biotech (now Janssen Biotech), a Pennsylvania-based biotech company that focuses on innovative solutions in immunology, oncology and nephrology. Prior to
her time at Ortho Biotech, Dr. Simpson spent over a decade as an oncology-nurse practitioner and educator.
•
Dr. Miao joined Delcath in 2011 as Executive Vice President and Chief Financial Officer and is a senior financial executive with extensive experience in global business operations, financial planning and analysis,
and business development in the United States, Asia and Europe. Previously, he served as Chief of Staff of the Global CFO Organization and member of the Financial Leadership team of Dun & Bradstreet Corporation. Prior to
joining Dun & Bradstreet, Dr. Miao was Executive Vice President & CFO of Pagoda Pharmaceuticals—a Shanghai-based specialty pharmaceuticals and medical device company focused in urology and allergy. In addition,
Dr. Miao has held various leadership positions, including division CFO roles, with Symrise, Inc., Schering-Plough Corporation and Pharmacia Corporation, and served as a biotech equity analyst with J.P. Morgan.
•
In addition, under the transition plan, Gabriel Leung has been appointed Chairman of the Board. He replaces Dr. Harold Koplewicz as Chairman, who remains a member of the Board of Directors.
•
Mr. Leung joined the Delcath Board of Directors in March 2011, and holds a wealth of experience in successfully gaining regulatory approval for and launching oncology drugs. Mr. Leung previously served as
President of the Pharmaceuticals Business at OSI Pharmaceuticals, overseeing its oncology, diabetes and obesity businesses prior to the Company's acquisition by Astellas Pharma Inc. in June 2010. Prior to OSI, Mr. Leung served as Group
Vice President, Global Prescription Business & Head of the Global Oncology Franchise for Pharmacia Corporation. Previously, Mr. Leung held several leadership positions at Bristol-Myers Squibb. Currently, Mr. Leung serves on the
Board of Directors of Albany Molecular Research, Inc., and is Executive Vice Chairman of the Board and Chair of the Global Commercialization Team of Novocure, Ltd., a privately-held oncology medical device company.
•
The Board has also appointed a Transition Committee to assist the Board and management with the leadership transition including the search process for the next President and Chief Executive Officer of the Company. This
Committee will also assist the Board in its rigorous evaluation of potential strategic options for the Company going forward. The initial members of this committee are current Board members Douglas Watson and Roger Stoll, as well as
Dr. Koplewicz and Mr. Leung.
On September 13, 2013, the Company issued a press release announcing the above matters, a copy
of which release is filed as Exhibit 99.1 to this Form 8-K and which is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
The following exhibit is filed herewith:
(d) Exhibits.
Exhibit
No.
Description
99.1
Press Release of Delcath Systems, Inc., dated September 13, 2013
SIGNATURES
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.
DELCATH SYSTEMS, INC.
Dated: September 16, 2013
By:
/s/ Peter J. Graham
Name:
Peter J. Graham
Title:
Executive Vice President, General Counsel
EXHIBIT INDEX
Exhibit
No.
Description
99.1
Press Release of Delcath Systems, Inc., dated September 13, 2013