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Delcath Systems, Inc. (DCTH)

Q3 2013 Earnings Call· Wed, Nov 6, 2013

$10.19

-3.46%

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Transcript

Executives

Management

Doug Sherk – IR Jennifer Simpson - Interim Co-President, Co-CEO, EVP and Global Head, Business Operations Graham Miao – Interim Co-President, Co-CEO, EVP and CFO

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Third Quarter 2013 Delcath Systems’ Earnings Conference Call. My name is Jacky, and I will be your coordinator today. At this time all participants are in a listen-only mode. Following the prepared remarks, there will be a question and answer session. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes. I would now like to turn the presentation over to Mr. Doug Sherk. Please proceed.

Doug Sherk

Management

Thank you, Jacky, and good afternoon, everyone. Thank you for joining us today for this conference call and webcast to provide an update on Delcath’s fiscal third quarter 2013 results and recent developments. A replay of the conference call 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 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 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 Delcath’s Interim President and Co-CEO, Jennifer Simpson and Graham Miao. Jennifer is also Delcath’s Executive Vice President, Global Head of Business Operations and Graham Miao was Delcath’s Executive Vice President and Chief Financial Officer. Following their opening remarks, we will open the call to questions from analysts and institutional investors. The webcast participants questions can be submitted electronically via the webcast interface and questions will be summarized and addressed. Feel free to send us your questions during the course of this call and we will summarize and address them during the Q&A session. And with that, I’d like to turn the call over to Jennifer.

Jennifer Simpson

CEO

Thanks Doug. And good afternoon everyone. I am pleased to be joined by Graham Miao, Interim Co-President and Co-CEO to discuss the path forward that we are striding for Delcath. This afternoon, I’d like to review the focus we assigned to our clinical development programs and to driving clinical adoption of CHEMOSAT in Europe. Later, I’ll turn the call over to Graham, who will review the recent actions we’ve taken to strengthen the company, discuss our third quarter financial results and provide an update on the availability and use of resources now and in the coming months. To begin, clinical leadership transition we announced in September, we had made significant progress in streamlining our business and increasing our operating efficiencies actions which were designed to maximize our available resources on two primary goals. First, advancing our clinical development program by investing in new trials both company sponsored and invested – excuse me, investigator-initiated studies or IIT. To generate data, that will help support our business. Secondly, executing on initiatives already underway that will potentially expand European clinical adoption of the CHEMOSAT system and help secure compelling reimbursements for the CHEMOSAT procedures in European markets. We believe a focused effort on these priorities will provide a strong foundation to support clinical adoption of CHEMOSAT and the Melphalan Hepatic Delivery System as well as potential revenue growth over the long term. I like to begin with an outline of our current clinical development program. We are presently finalizing plans for a clinical program to investigate the Melphalan Hepatic Delivery System which we refer to as Melphalan HDS for first-line treatment of patients with unresectable advanced hepatocellular carcinoma or HCC which is primary liver cancer. In looking at the HCC market, we believe our greatest opportunity for Melphalan HDS is indeed in the…

Graham Miao

Management

Thank you Jennifer and good afternoon everybody. Jennifer and I have been working together to develop in improvement a number of staffs to properly align the company’s management structure. Staff levels and a strategic focus necessary to execute our plans and move the company forward and we are making progress towards increasing operational efficiencies, reducing our cash spend and strengthening the company’s financial condition. With that let me turn to our third quarter results. First and foremost I’m going to talk about the results of our initiatives to optimize the use of company’s resources. To deal with the challenges of the recent NDA step back we made tough decisions to right size our work force commence the rate with company’s priorities and reduce our cost structure to a level that we believe is more sustainable. Cash spend for the quarter was $6.9 million a reduction of 53% or $7.8 million year-over-year for the same period and a reduction of 34% or $3.6 million sequentially from the second quarter of 2013. Importantly we have met our cash spend guidance for the last two quarters and this quarter beat our reduced guidance of $7 to $8 million. As part of our efforts on October 4th we announced the completion of a strategic reorganization which included the reduction of 21 positions or 33% of the work force. We expect the reorganization in conjunction with other cost saving measures to further reduce our quarterly cash spend to $6 to $7 million in the fourth quarter this year and to $5 to $6 million average per quarter next year 2014 while continuing to ensure resources are optimized and are focused on key priorities. Aside from controlling costs we raised additional capital by a combination of an equity offering and our ATM program to further strengthen…

Operator

Operator

Ladies and gentlemen, we’re ready to open up the lines for your questions. (Operator Instructions).

Doug Sherk

Management

Operator, why don’t we take the question we have from the webcast participants? You referenced that you were focusing your efforts on Germany and the UK. Will the CHEMOSAT no longer be available or supported in the other EU countries, wouldn’t this limit your opportunities for generating revenues.

Jennifer Simpson

CEO

Thanks Michael. I think it’s important just to clarify, CHEMOSAT continues to be available in the market that we’ve been targeting namely Italy, the Netherlands, Spain, France and Ireland. And we continue to support clinical adoption through investigator-initiated trials in these markets. We’re not stopping our efforts in these countries just taking more focused approach on the UK and Germany as we believe these two countries do offer the clearest path for interim reimbursement in the near term.

Doug Sherk

Management

We have another question coming in. Are you still planning to work with Dr. Yuman Fong as part of the HCC site?

Jennifer Simpson

CEO

Yes, absolutely. Dr. Fong has agreed to act as a Chairman of our HCC program and Memorial Sloan-Kettering multi inactive studies to the active study site, we are indeed pleased that Dr. Fong will lend his guidance and expertise to the program which will truly help us knew our HCC program as a whole forward. His expertise in diseases relates to liver specifically in liver targeted loco-regional therapy will be invaluable to us going forward.

Doug Sherk

Management

And we have a third question coming in right now. Why are you choosing to delay the start of the HCC clinical program by one quarter?

Jennifer Simpson

CEO

Our – as most of you know our original plan was to move forward with the second-line phase for HCC. And as we’ve looked up the HCC market, we believe our greatest opportunity for Melphalan HDS is indeed in the first-line setting. So, we made a prudent decision to engage with the FDA on our proposed HCC protocol and expect to have written comments from the FDA by year end. So, once we receive those comments, we’ll incorporate those and we will be looking at a first quarter start.

Doug Sherk

Management

And we have a fourth question. Although addressed on the prepared comments. What are you going to do to address NASDAQ compliance, what’s your plan?

Graham Miao

Management

Thank you, for the question. So, as we previously announced, we are in the first to 180-day compliance period. If the deficiency is not corrected by December 10th we intend to contact NASDAQ and request an additional 180 day extension. And we will look of course to disclose our plan for regaining compliance at the appropriate time.

Operator

Operator

(Operator Instructions) And your first question comes from the line of [indiscernible] Please proceed.

Unidentified Analyst

Analyst

What are your current plans in moving the corporate headquarters out of the City of New York and either to New Jersey or to Queensberry?

Graham Miao

Management

So, we do have a plan as we announced in the earlier in the mid-year, now we’re looking for a suitable place that the rent is more economical. And but keeping in mind that we have a lease committed lease here in New York City and we have an obligation. So, we’re looking at a different options making sure that not only the lease here can be covered and through means such as in another sub lease where the appropriate tenant to assume the space at the same time the space lease to be available in a lower cost place. So, there – and to your question the answer we’re continuing to look at economic options.

Operator

Operator

At this time with no further questions, I would like to turn the presentation back to management.

Graham Miao

Management

Thank you, everybody. And we’ll keep you updated and we look forward to speaking with you in the next few months in the next reporting period.

Operator

Operator

Ladies and gentlemen, that concludes today’s presentation. Thank you for your participation. You may now disconnect. And have a great day.