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): October 8, 2013 (October 3, 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 that Dr. Krishna Kandarpa, Executive Vice President, Chief Scientific Officer, is no longer employed by the Company, effective October 3, 2013. It is anticipated that Dr. Kandarpa will receive certain severance payments, and will continue to serve as a consultant to the Company.
Item 8.01 Other Events.
On October 4, 2013, the Company issued a press release announcing that as part of its efforts to increase operating efficiencies, the Company has completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
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 October 4, 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: October 8, 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 October 4, 2013 | |
Exhibit 99.1
DELCATH SYSTEMS ANNOUNCES STRATEGIC REORGANZATION
Company Implements Plan to Reduce Operating Costs; Expected Cash Spend for Q32013 Lower than Previous Guidance
New York, NY – October 4, 2013 – Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology, announced today that as part of its efforts to increase operating efficiencies, the Company has completed a strategic reorganization under which it has eliminated 21 positions, or approximately 33% of its global workforce. The Company expects this reorganization, in conjunction with other cost saving measures, to significantly lower cash utilization.
For its fiscal third quarter 2013, the Company expects cash utilization to be between $7.0-8.0 million, as compared to its previous guidance of $9.0-10.0 million for the period. For its fiscal fourth quarter 2013, the Company currently expects cash utilization to be at the lower end of its previous guidance of $6.0-8.0 million. Additionally, as a result of the initiatives implemented over the past three weeks, the Company expects to reduce annual operating costs by approximately $10 million. The Company believes that these actions will help preserve the Company’s ability to initiate the strategic objectives currently under evaluation. Most of the savings are expected to come from marketing, administrative expenses and research and development. As of September, 30 2013, the Company estimates cash and cash equivalents of approximately $28 million.
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 the liver, while controlling the systemic exposure of those agents. The Company’s initial focus is on the treatment of primary and metastatic 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 for melphalan hydrochloride. 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 addition, the Company has initiated plans to investigate the Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System for primary liver cancer. 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: efficiencies and reduction in cash utilization achieved through September 2013 staff reductions, the leadership transition plan and its impact on the Company, the Company’s ability to satisfy the requirements of the FDA’s Complete Response Letter and provide the same in a timely manner, clinical adoption, use and resulting sales, if any, for the CHEMOSAT system to deliver and filter melphalan in Europe, 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, our ability to obtain reimbursement for the CHEMOSAT system in various markets, the timing and results of future clinical trials including without limitation the HCC trials, 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 and revenue, if any, of the same, uncertainties relating to the timing and results of research and development projects,, and uncertainties regarding our 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 212-850-6020/951-316-0577 |
EVC Group 212-850-6021 | |
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