DCTH

Delcath Systems, Inc. (DCTH)

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Delcath Systems (DCTH)

Q4 2012 Earnings Call

March 13, 2013 4:30 pm ET

Executives

Douglas 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

Analysts

Matthew Dolan - Roth Capital Partners, LLC, Research Division

Jason N. Butler - JMP Securities LLC, Research Division

Gregory R. Wade - Wedbush Securities Inc., Research Division

Presentation

Operator

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2012 Delcath Systems Earnings Conference Call. My name is Derrick, and I'll be your operator for today. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the conference over to Mr. Doug Sherk. You may proceed.

Douglas Sherk

Thank you, Derrick, and good afternoon, everyone. Thank you for joining us today for the conference call and webcast to provide an update on Delcath's fourth quarter and full year 2012 results and recent progress. A replay of the conference call will be made approximately -- excuse me, a replay of the conference call will be made available, and it will be made 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 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 risk 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]

And now, I'd like to turn the call over to Mr. Hobbs.

Eamonn P. Hobbs

Thanks, Doug, and good afternoon, everyone. After making some opening remarks, including a brief review of our achievements during 2012, as well as our priorities and potential key milestones in 2013, I'll turn the call over to Graham Miao, our Chief Financial Officer, who will review the financial results for the fourth quarter. Then I'll take your questions.

We had numerous accomplishments during 2012. The most significant one was the acceptance for review of our NDA for the Melblez Kit system by the U.S. Food and Drug Administration. You'll note that we have changed the brand name of our system here in the United States, a decision that resulted from numerous discussions our team has had with the FDA since the NDA was accepted for review back in October. Melblez is our proposed brand name for melphalan. We continue to work closely with the FDA in its evaluation of our NDA, and we are quite focused on preparations for our presentation to the ODAC panel on May 2. Our engagement with the FDA has been constructive, and we are very hopeful that the agency will conclude its review on the PDUFA goal date of June 15.

Our team remains fully committed to bringing a new treatment option to U.S. patients with unresectable ocular melanoma liver metastasis. Assuming we are granted FDA approval by the PDUFA date, our current plan is to begin U.S. commercialization efforts in the fourth quarter of 2013. At this point, we would plan to market our product under the proposed trade name, Melblez Kit, which stands for Melblez melphalan for injection for use with the Delcath Hepatic Delivery System.

We continue to develop our U.S. launch plan for the Melblez Kit, with significant work being done in marketing, sales and reimbursement. As part of our planning, we have begun a comprehensive pricing analysis in the U.S. for the ultra-orphan disease state of unresectable metastatic ocular melanoma. There are currently no approved or effective treatment options for ocular melanoma metastatic to the liver, so there is a clear unmet clinical need among patients suffering from this disease. Our objectives with the pricing analysis are to optimize the value for treatment with the Melblez Kit, establish economic basis for reimbursement and ensure patient access to treatment.

Our initial marketing efforts in the United States would be focused on those hospitals that participated in our clinical trials and are part of our recently launched Expanded Access Program. These hospitals will provide a base of experienced procedure teams trained in the use of the Melblez Kit. Our focus will then expand to include other member hospitals of the National Comprehensive Cancer Network, which are Centers of Excellence for cancer care in the United States, that see a majority of the advanced metastatic ocular melanoma patients. To address this market, we plan to build a small direct sales force supported by medical science liaisons, which will provide clinical-based education to the health care professionals that make up the procedure team using the Melblez Kit.

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