DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K for the period ended December 31, 2011 contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 with respect to our business, financial condition, liquidity and results of operations. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “could,” “would,” “will,” “may,” “can,” “continue,” “potential,” “should,” and the negative of these terms or other comparable terminology often identify forward-looking statements. Statements in this Annual Report on Form 10-K for the period ending December 31, 2011 that are not historical facts are hereby identified as “forward-looking statements” for the purpose of the safe harbor provided by Section 21E of the Exchange Act and Section 27A of the Securities Act. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements, including the risks discussed in this Annual Report on Form 10-K for the fiscal year ended December 31, 2011 in Item 1A under “Risk Factors” as well as in Item 7A “Quantitative and Qualitative Disclosures About Market Risk,” our Quarterly Report on Form 10-Q for the period ended September 30, 2011 in Part II, Item 1A under “Risk Factors” as well as in Part I, Item 3 “Quantitative and Qualitative Disclosures About Market Risk” and the risks detailed from time to time in our future SEC reports. These forward-looking statements include, but are not limited to, statements about:
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the progress and results of our research and development programs;
our estimates regarding sufficiency of our cash resources, anticipated capital requirements and our need for additional financing;
our estimates regarding sufficiency of our cash resources, anticipated capital requirements and our need for additional financing;
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the commencement of future clinical trials and the results and timing of those clinical trials;
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the commencement of future clinical trials and the results and timing of those clinical trials;
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submission and timing of applications for regulatory approval and approval thereof;
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our ability to successfully source certain components of the system and enter into supplier contracts;
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our ability to successfully manufacture and commercialize the Delcath chemosaturation system; and
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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
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submission and timing of applications for regulatory approval and approval thereof;
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submission and timing of applications for regulatory approval and approval thereof;
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our ability to successfully source certain components of the system and enter into supplier contracts;
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our ability to successfully manufacture and commercialize the Delcath chemosaturation system; and
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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
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our ability to successfully source certain components of the system and enter into supplier contracts;
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our ability to successfully source certain components of the system and enter into supplier contracts;
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our ability to successfully manufacture and commercialize the Delcath chemosaturation system; and
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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
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our ability to successfully manufacture and commercialize the Delcath chemosaturation system; and
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our ability to successfully manufacture and commercialize the Delcath chemosaturation system; and
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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners
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our ability to successfully negotiate and enter into agreements with distribution, strategic and corporate partners
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
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our estimates of potential market opportunities and our ability to successfully realize these opportunities.
Many of the important factors that will determine these results are beyond our ability to control or predict. You are cautioned not to put undue reliance on any forward-looking statements, which speak only as of the date of this Annual Report on Form 10-K. Except as otherwise required by law, we do not assume any obligation to publicly update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this Annual Report on Form 10-K or to reflect the occurrence of unanticipated events.
Item 1. .
Unless the context otherwise requires, all references in this Annual Report on Form 10-K to the “Company”, “Delcath”, “Delcath Systems”, “we”, “our”, and “us” refers to Delcath Systems, Inc., a Delaware corporation, incorporated in August 1988, and all entities included in our consolidated financial statements. Our corporate offices are located at 810 Seventh Avenue, 35th Floor, New York, New York 10019. Our telephone number is (212) 489-2100.
Company Overview
We are a development stage, specialty pharmaceutical and medical device company focused on oncology, initially cancers in the liver. Since our inception, we have directed our research efforts towards the development and clinical study of the Delcath chemosaturation system.
The Delcath chemosaturation system allows the administration of concentrated regional chemotherapy by isolating the circulatory system of the targeted organ. Once the organ is isolated, the Delcath chemosaturation system delivers high doses of chemotherapeutic agents directly to the liver, while limiting systemic exposure and the related side effects by filtering the blood prior to returning it to the patient. The Delcath chemosaturation system involves a series of three catheter insertions, each of which is placed percutaneously through standard interventional radiology techniques. The procedure is minimally invasive and repeatable allowing for multiple courses of treatment with chemotherapeutic drugs and the potential for concomitant cancer therapies. We believe that the Delcath chemosaturation system is a platform technology that may have broader applicability, including the use of other drugs to treat the liver, as well as for the treatment of cancers in other organs and regions of the body.
On April 13, 2011, we obtained the right to affix the CE Mark to the Delcath Hepatic CHEMOSAT® Delivery System (CHEMOSAT System). The right to affix the CE mark allows us to market and sell the CHEMOSAT System in the European Economic Area (EEA). In the EEA, the CHEMOSAT System is regulated as a medical device indicated for the intra-arterial administration of chemotherapeutic agent (melphalan hydrochloride) to the liver with additional extracorporeal filtration of the venous blood return. We have filed an application seeking CE Marking for Generation 2 of our CHEMOSAT System with melphalan as an amendment to the original CE Mark for the CHEMOSAT system and that application is currently under review with the Notified Body.
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We believe the CHEMOSAT system may ultimately fulfill an annual unmet clinical need for as many as 100,000 liver cancer patients in the EEA. We intend to focus our initial efforts on seven target markets including Germany, United Kingdom, France, the Netherlands, Italy, Spain and Ireland. We believe these countries represent a majority of the total potential liver cancer market in EEA countries. We plan to use a combination of direct and indirect sales channels to market and distribute the CHEMOSAT system in the EEA. Our European commercialization strategy involves the establishment of clinical training and centers of excellence to educate and train physicians in these countries in order to develop key opinion thought leadership and foster initial market acceptance. To support our commercialization efforts in the EEA, we have established our European Headquarters in Galway, Ireland.
On November 21, 2011 we announced that we had entered into an initial training and marketing agreement with the European Institute of Oncology (IEO) in Milan, Italy. We have also entered into initial training and marketing agreements with the Frankfurt University Hospital in Frankfurt, Germany, as well as with University Medical Center Schleswig-Holstein in Kiel, Germany. In February 2012, we commenced our first European patient treatments with the CHEMOSAT system at IEO in Italy and Frankfurt University Hospital in Germany. The initial patients involved were treated for inoperable liver-dominant metastases from ocular melanoma, cutaneous melanoma, breast cancer and gastric cancer. We plan to add additional cancer centers in France, the United Kingdom, Netherlands, Spain and Ireland in the near future.