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Delcath Systems, Inc. (DCTH)

Q2 2014 Earnings Call· Wed, Aug 6, 2014

$10.21

-3.22%

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Transcript

Executives

Management

Michael Polyviou – Investor Relations Jennifer Simpson – Interim Co-President and Co-Chief Executive Officer, Executive Vice President-Global Head of Business Operations Graham Miao – Interim Co-President and Co-Chief Executive Officer, Executive Vice President, Chief Financial Officer

Operator

Operator

Good day, ladies and gentlemen and welcome to the Delcath Systems’ Second Quarter 2014 Conference Call. My name is Christel, and I will be the operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. (Operator Instructions) As a reminder, the conference is being recorded for replay purposes. I would now like to turn the call over to your host for today, Mr. Michael Polyviou with Investor Relations. Please proceed.

Michael Polyviou

Investor Relations

Thank you, Christel, and good afternoon, everyone. Thank you for joining us today for this conference call and webcast to provide an update on Delcath’s fiscal second quarter 2014 results, as well as recent developments. A replay of the conference call will be available approximately for two hours after the conclusion of today’s call, and it will be available for seven days. The operator will provide replay details at the conclusion of today’s call. A live webcast of this call is also available at www.delcath.com, and the call will also be archived on the company’s 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 these – 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 events or circumstances after the date they are made. Participating on today’s call are Delcath’s Interim Co-President and Co-CEO’s, Jennifer Simpson and Graham Miao. Jennifer is also Delcath’s Executive Vice President, Global Head of Business Operations; and Graham Miao is Delcath’s Executive Vice President and Chief Financial Officer. Following their opening remarks, we will open the call to questions from analysts and the institutional investors. And with that, I’d like to turn the call over to Jennifer.

Jennifer Simpson

Investor Relations

Thanks, Michael and good afternoon everyone. This afternoon, I’d like to provide updates on our two main priorities: our clinical development program and CHEMOSAT adoption in Europe. Later, I’ll turn the call over to Graham, who will discuss our second quarter financial results. I’ll begin with an update of a Melphalan – Melphalan Hepatic Delivery System or HDS clinical development program. Our current Phase II trial is designed to investigate Melphalan HDS for first line treatments, our patients with un-resectable advanced hepatocellular carcinoma or HCC also known as primary liver cancer. We are pleased to report that the global Phase II Signal Seeking clinical program, which is sponsored by Delcath, has commenced in Germany. Clinicians at Johan Wolfgang Goethe University Hospital in Frankfurt also known as JWG are actively treating patients for enrollment in the trial. Currently, we expect add additional sites in Germany, the United Kingdom and the United States during the remainder of 2014. As a reminder, based on differences in treatment practice patterns and regulatory requirements between Europe and the U.S., we are establishing separate European and U.S. Phase II clinical trials with different inclusion and exclusion patient selection criteria. Clinical observations from the trials are designed to be complementary, and are expected to be analyzed collectively. If positive results are archived, this will help support our future Phase III pivotal study design, which would evaluate overall survival. The trials will also incorporate additional safety measures from experience gained from EU commercial phases as well as the U.S. Ocular Melanoma Program. In Europe, the Phase II program will investigate the safety and efficacy of Melphalan HDS treatment without sorafenib in patients with unresectable liver cancer confined to deliver. In the U.S., the Phase II program will investigate the safety and efficacy of Melphalan HDS treatment with sorafenib…

Graham G. Miao

Management

Thank you, Jennifer, and good afternoon everybody. Our financial results this quarter illustrate our continued progress to enhance operational efficiencies, reduce our cash spend, and strengthen Delcath’s financial condition. During the quarter, net cash used in operating activities was $4 million, a 62% reduction compared to the $10.5 million in the comparable period in 2013. The reduction was driven by the decrease in new drug application or NDA submission-related costs, and improved organizational and operational efficiencies. Importantly, we have met our cash utilization guidance for the last five quarters. Based on our successful efforts, we are revising our cash utilization guidance lower for the remaining quarters of the year. We now expect our average quarterly cash utilization to be in the range of $4 million to $5 million for the remainder of the year, as compared to the previous guidance of $5 million to $6 million per quarter. As of June 30, 2014, cash and the cash equivalents were $27.3 million. We believe that the actions we have taken will enable the company to adhere its strategies for at least the next four quarters. Turning to the income statement, for the second quarter ended June 30, 2014, we’ve recognized $251,000 in revenue. This compares with no revenue, recorded during the second quarter of 2013. For the six months of 2014, we’ve recognized revenue of $561, 000, as compared to $81,000 for the six months of 2013. As we have mentioned previously, we expect the revenue ramp to be slow until permanent reimbursement is secured in Europe. Total operating expenses during the second quarter of 2014 decreased by approximately 41% to $6.1 million from $10.3 million for the same period in 2013. the decrease is primarily due to a significant reduction in expenses related to the company’s NDA submission to the…

Michael Polyviou

Operator

Christel, we are ready to take questions now.

Operator

Operator

(Operator Instructions)

Michael Polyviou

Operator

Christel, I believe we don’t have any questions. So I want to hand call back over to Jennifer and Graham.

Graham G. Miao

Management

Thank you very much for participating in the second quarter call. And we look forward to updating you for the upcoming quarter.

Michael Polyviou

Operator

Thank you, Graham.

Operator

Operator

Ladies and gentlemen, that concludes today’s presentation. You may now disconnect. Have a great day.