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Delcath Systems (DCTH)
Q3 2012 Earnings Call
November 07, 2012 4:30 pm ET
Doug Sherk - Founder and Chief Executive Officer
Eamonn P. Hobbs - Chief Executive Officer, President and Director
Graham G. Miao - Chief Financial Officer and Executive Vice President
Jason R. Mills - Canaccord Genuity, Research Division
Gregory R. Wade - Wedbush Securities Inc., Research Division
Jason N. Butler - JMP Securities LLC, Research Division
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I would now like to turn the presentation over to your host for today's call, Mr. Doug Sherk, please proceed.
Thank you, Erica and good afternoon, everyone. Thank you for joining us today for this conference call and webcast to provide an update on Delcath’s third quarter 2012 results and recent corporate progress.
A replay of the conference call will be made approximately -- excuse me, will be available approximately 2 hours after the conclusion of today’s call and it will be available for 7 days. The operator will provide replay details at the conclusion of today’s call. A live webcast of this call is available at www.delcath.com and the call will also be archived on the website.
Before we begin, I'd 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 U.S. 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.
Factors that could cause actual results to differ are discussed from time to time in the company’s filings with the SEC, including our annual report on Form 10-K, and our reports on Form 10-Q and 8-K. These documents are available on the Investor Relations section of our website and we encourage you to review the material. The company has no obligation to publicly update or revise these forward-looking statements to reflect the events or circumstances after the date they are made.
Participating on today’s call are Eamonn Hobbs, President and Chief Executive Officer; and Graham Miao, Executive Vice President and Chief Financial Officer.
Following their opening remarks, we'll open the call to questions from analysts and institutional investors. [Operator Instructions]. In advance, we thank you for your cooperation with this procedure. And now let's turn the call over to Mr. Hobbs.
Eamonn P. Hobbs
Thanks, Doug and good afternoon, everyone. Since our call with you in early August, the team at Delcath has achieved several significant milestones. Most important of these was FDA acceptance of our New Drug Application for our proprietary chemosaturation system with melphalan hydrochloride for injection for substantive review. As we announced recently, the FDA has designated a PDUFA goal date of June 15, 2013. Acceptance of our NDA is the combination of many months of work and we hope represents the first step towards U.S. commercialization.
Also during the quarter, we continued to implement our launch in Europe, completing applications for interim reimbursement in key markets and signing our exclusive distribution agreements in Italy and Spain. Recently, we also received regulatory approval for our Generation Two CHEMOSAT Delivery System in Australia and have satisfied all the requirements to affix the CE Mark to the Hepatic CHEMOSAT Delivery System device for interhepatic arterial delivery and extracorporeal filtration of doxorubicin in October 2012, which helps establish a pathway for regulatory approval in large key Asian markets. These developments help lay the foundation for realizing the full potential of our system in the U.S. and other markets around the world.
After reviewing these achievements with you briefly, I will turn the call over to Graham for a review of our financial results.
I'll begin with the most important development for Delcath in many years, the FDA's acceptance of our NDA. This is a tremendously important development, not only for Delcath but for the patients in the U.S. who have a critical need for our treatment. We look forward to working closely with the agency throughout the review process with the goal of securing approval of our application. Our most important objective is to be able to provide patients in the U.S. with unresectable metastatic melanoma in the liver a new option for treating their disease. The NDA was accepted with our Generation Two hemofiltration cartridge included as a technical change in the chemistry manufacturing and control module of the NDA. Assuming our NDA is approved, this potentially represents the rapid availability of Gen 2 for U.S. patients we've always hoped for, and will help enhance our launch of the system in the United States. Our NDA has been assigned a Prescription Drug User Fee Act or PDUFA goal date of June 15, 2013.
FDA also advised us that we should expect an Oncology Drug Advisory Committee or ODAC panel to be convened as part of the review process. No date has been set and we will announce the date once it has been determined. While we work with the FDA on review of our application we continue to move forward with our expanded access program in the United States. As you know, the FDA accepted our amendments to our Investigational New Drug or IND application and our EAP to include the Generation Two filter. These amendments permit physicians at select U.S. cancer centers to use the Generation Two system in expanded access and compassionate use cases after they obtain Institutional Review Board or IRB approval. We expect to enroll 6 centers under the EAP all of which were Phase III trial sites. One of which, has already obtained IRB approval and the others are in various stages of their IRB approval process. We are also working with each site to finalize the clinical trial agreements necessary to begin treatments under the program and we continue to expect patient treatments under the EAP program to begin this fall. This program will play a valuable role in providing access to patients in urgent need of our treatment while our NDA is under review. As we said on our last call, the IND amendments also laid the groundwork for the use of Generation Two system in the clinical trials we have planned as part of our clinical development program, and it is our intention to use Gen 2 in all upcoming perspective clinical trials.