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Delcath Systems, Inc. (DCTH)

Q1 2014 Earnings Call· Wed, May 7, 2014

$10.19

-3.46%

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Q1 2014 Delcath Systems Incorporated Earnings Conference Call. My name is Patrick, and I will be your moderator 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, this conference is being recorded for replay purposes. I would now like to turn the call over to Michael Polyviou. Please proceed sir.

Michael Polyviou

Management

Thank you, Patrick, and good afternoon, everyone. Thank you for joining us today for this conference call and webcast to provide an update on Delcath’s fiscal first quarter 2014 results as well as 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 in the Company’s website. Before we begin, I’d like to remind you that some of the statements made today 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 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 is 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. And with that, I’d like to turn the call over to Jennifer.

Jennifer Simpson

Management

Thanks, Michael, and good afternoon everyone. This afternoon, I’d like to provide updates on our two main priorities, our HCC clinical development program and CHEMOSAT clinical adoption in Europe. Later, I’ll turn the call over to Graham, who will discuss our first quarter financial results and provide an update on the availability and use of resources. I’ll begin with an outline of our current clinical development program. As a reminder, this program is designed to investigate Melphalan HDS for first line treatment of patients with unresectable, advanced hepatocellular carcinoma or HCC, also known as primary liver cancer. We are pursuing a phased clinical strategy initiating a Phase II Signal Seeking clinical trial program in 30 patients followed by a Phase III trial program if the initial responses are positive. Based on key opinion leaders’ feedback regarding differences in treatment practice patterns and regulatory requirements between Europe and the U.S. We’re establishing separate European and U.S. Phase II clinical trials with different inclusion and exclusion patient selection criteria. Clinical observations from the two trials are designed to be complementary, and data between the two Signal Seeking trials will be analyzed collectively to help support in future Phase III pivotal study designs. The trials will also incorporate additional safety measures from experience gained in our EU commercial phases as well as the U.S. Ocular Melanoma Program. For the U.S. portion of our program, our IND amendment has been cleared by the FDA, and once the trial protocol clears Ethics Committee review at participating sites, they will be ready to recruit patients in the U.S. portion of the study. For the European study, we submitted a separate HCC Phase II trial protocol to the German Health Authorities to initiate the trial in Germany. This protocol is also proceeding through the Central Ethics Committees…

Graham Miao

Management

Thank you Jennifer. Good afternoon everybody. Our financial results this quarter illustrates our continued progress to enhance operational efficiencies, reduce our cash spend, and strengthen Delcath’s financial condition. Cash spent for the quarter was $4.5 million. This was a reduction of 59% or $6.4 million year-over-year for the same period due in part to a reduction in NDA submission-related costs and improved organizational and operational efficiencies. We also reduced the cash spend by 13% or $0.7 million sequentially from the fourth quarter of 2013. This reduction was achieved largely by improved organizational and operational efficiencies. Importantly, we have met our cash spend guidance for the last four quarters. In this quarter, our cash spend was lower than our reduced guidance of $5 million to $6 million. We are confident that we remain on target to achieve our average quarterly cash spend target of $5 million to $6 million in 2014. In addition to improving our cost structure, we raised additional capital to further strengthen our balance sheet. As we mentioned on our year-end earnings call; during the first quarter, we raised approximately $4.5 million before related expenses through our at-the-market offering program. As of March 31, 2014, cash and cash equivalents were $31.3 million, including $0.5 million in accounts receivable collection. We believe that the actions we have taken will enable the company to help advance its strategy and extend its cash runway through the first half of 2015. Turning to the income statement, for the first quarter ended March 31, 2014, we recognized $0.3 million in revenues. As we have mentioned previously, we expect the revenue ramp will be slow until permanent reimbursement is secured in Europe. Total operating expenses during the first quarter of 2014 decreased by 50% to $5.3 million from $10.6 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 FDA as well as the company’s overall cost management efforts. The reduction also reflects our more streamlined operations. For the first quarter, operating loss was $5.3 million, which included non-cash, stock-based compensation expense of $0.2 million as compared with an operating loss of $12.8 million including $0.6 million in non-cash, stock-based compensation expense in the prior year. Lastly, on April 8, 2014, we effected a one-for-sixteen reverse stock split which had previously been approved by shareholders. Following the reverse split, we were notified that we had achieved the minimum bid requirement and had regained NASDAQ listing compliance. In summary, we continue to optimize the use of resources and expect to maintain our streamlined operations in an efficient and effective manner by focusing on markets where we believe we have the best chances for success and on clinical programs that we believe will offer us the greatest potential reward. With that, let me turn the call over to the operator, and open the call for questions.

Operator

Operator

(Operator Instructions) Your first question comes from the line of Edward Nash with Cowen & Company; please proceed sir, your line is open. Yun Zhong - Cowen & Company: I missed the first part of the call, but just wanted to find out when do you expect to receive feedback from the FDA regarding the product [indiscernible] and when do you expect to initiate the clinical trial?

Jennifer Simpson

Management

Sure. We did commit the IND to FDA, and we have passed the tolerance period, so we are good to go. From that perspective, and right now the protocol is making its way to the Institutional Review Board at the U.S. Institutions, and we believe right now that we are on target to have those sites open to recruiting patients by the first half of 2014. Yun Zhong - Cowen & Company: Okay great, and going to Europe, are you able to share with us the new patients and the number of new centers that were added during the first quarter of ’14?

Jennifer Simpson

Management

In terms of the number of new centers during the first quarter, we do not have any new activation of sites. In terms of the number of patients treated, I should have to look back, first quarter, roughly 10 to 12 patients. Edward Nash- Cowen & Company: And I think the reimbursement situation is largely dependent on the publication of the Phase III clinical results, and when do you expect that to happen?

Jennifer Simpson

Management

Yes. [Indiscernible] is tied to Phase III publication. I mean, at this time we continue to work with the investigators and we are at -- it is at their discretion as to when they submit the publication. So, this time I don’t have a definitive date for you.

Operator

Operator

I’m showing that we have no additional questions in queue. I would now like to turn the call back over to management for closing remarks.

Graham Miao

Management

Thank you operator, and thank you everyone for joining us today.

Operator

Operator

Thank you ladies and gentlemen. This concludes today’s conference. We do thank you for your participation. Also please be advised that the replay will be available two hours after the end time of this call. You can access the replay by dialing 866-233-1854, and using replay code 52886168. Again thank you for joining the call today, and have a good afternoon.