Earnings Labs

Delcath Systems, Inc. (DCTH)

Q3 2014 Earnings Call· Wed, Nov 5, 2014

$10.65

-1.75%

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Transcript

Operator

Operator

Good day, ladies and gentlemen. And welcome to the Third Quarter 2014 Delcath Systems Earnings Conference Call. My name is Derrick, and I’ll be your operator for today. At this time, all participants are in a listen-only mode. We shall facilitate a question-and-answer session at the end of the conference. (Operator Instructions) As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to Mr. Michael Polyviou of Investor Relations. Please proceed.

Michael Polyviou

Analyst

Thank you, Derrick, 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 2014 results, as well as recent developments. A replay of the conference call will be available approximately 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 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 President and CEO, Dr. Jennifer Simpson; and Barbra Keck, Delcath’s Vice President and Controller. Following their opening remarks, we will open the call to questions from analysts and the institutional investors. Additionally, in today’s press release, we ask investor to submit questions via email that will be answered in the Q&A session. That email address is, mpolyviou@evcgroup.com, again, mpolyviou@evcgroup.com. Just a reminder, there is now assurance that all questions will be selected on today’s call. And with that, I will turn the call over to Jennifer. Jennifer?

Dr. Jennifer Simpson

Analyst

Thanks, Michael, and good afternoon, everyone. On today’s call I will provide an update on the recent activity in our clinical development program and our prudent pursuit of commercial development in the European marketplace. Later, I will turn the call over to Barbra Keck for review of our financials and then we will take some of your questions. Let me begin with the expansion of our clinical development strategy for our Melphalan hepatic delivery system, which we refer to as Melphalan HDS. In recent weeks, we revised and expanded this program to support the investigation of multiple tumor types in a cost efficient manner. The program’s focus is on the generation of data in multiple tumor types in a controlled clinical trial setting and includes a global Phase 2 trial in primary liver cancer or HCC and an additional cohort to study intrahepatic cholangiocarcinoma or ICC, as well as a global Phase 3 trial to study liver metastases from ocular melanoma. Additionally, the program will also include support from Investigator Initiated Trials or IITs in cancers such as colorectal cancer that has metastasized to the liver. Cancers of the liver remain a major unmet medical need globally with approximately 1.2 million patients diagnosed annually with primary liver cancer or cancer that have metastasized to the liver. In the near term, we believe our expanded strategy will allow us to obtain proof-of-concept in the treatment of HCC and ICC, clinically validate the safety profile seen in commercial cases by treating physicians in Europe and position us to potentially pursue regulatory approvals in at least one of these tumor types. I would spend a few minutes highlighting these efforts as there has been significant progress in all three indications since we last spoke in August. Beginning with our global Phase 2 trial…

Barbra Keck

Analyst

Thank you, Jennifer. During the quarter net cash used in operating activities was $4 million at the low end of our $4 million to $5 million quarterly cash utilization projection, the sixth consecutive quarter of meeting our projections. For the first nine months, net cash used in operating activities was $12.4 million, a 57% reduction compared to $28.9 million in the comparable period in 2013. The reduction was driven by the increase in NDA submission-related cost, the phasing out of the company’s medical science liaisons program, and improved organizational and operational efficiencies. Importantly, we have met our cash utilization guidance for the last six quarters. We expect our average quarterly cash utilization to be between $4 million to $5 million for the fourth quarter. As of September 30, 2014, cash and cash equivalent were $23.3 million. We believe that the actions we have taken and resources we have available today are adequate to fund our operations through the next 12 months. Turning to the income statement, for the third quarter ended September 30, 2014, we recognized total product revenue of $217,000, compared with total product revenue of $72,000 in the year-ago third quarter. For the nine months of 2014, total product revenue was $778,000, compared to total product revenue of $152,000 for the same period in 2013. Despite the year-over-year increases, we continue to expect modest revenue ramp until permanent reimbursement is secured in Europe. Total operating expenses during the third quarter of 2014 decreased by approximately 24% to $5.2 million from $6.8 million in 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. Total operating expenses for the nine months was $16.6 million, down 40% from the $27.5 million in operating expense recorded during a year ago period. For the third quarter operating loss was $5.1 million, compared with an operating loss of $6.7 million during the same period in 2013. The operating loss for the nine-month period was $16 million as compared to $27.6 million for the same period in the prior year. Now, I will turn the call back to Jennifer for final comments.

Dr. Jennifer Simpson

Analyst

Thanks Barbra. In closing, the HCC, ICC and ocular melanoma trials along with the IITs and the EU registry form a robust clinical development strategy designed to generate data in multiple tumor types. We believe these efforts and a continued commercialization of CHEMOSAT in Europe, further increase our potential opportunities to help maximize shareholder value. We are pleased with the progress made over the past few weeks and are focused on executing on the program we have laid out for you today. I look forward to sharing our progress on our major milestones with you on the fourth quarter conference call in early 2015. With that, let me turn the call over to the operator and open the call for questions.

Operator

Operator

(Operator Instructions)

Michael Polyviou

Analyst

All right. While the operator is reviewing the queue, we will take some of the questions that were submitted to us via email. Again, if you would like submit a question, please send to mpolyviou@evcgroup.com. The first question, why did you decide to pursue ocular melanoma?

Jennifer Simpson

Analyst

Thanks, Michael. It is important to note that ocular melanoma remains an unmet medical need with no current standard of care. We have confidence in the efficacy data that we have seen during the Phase 1, 2 and 3 trials prior, which was strong, and the improved safety data from over 130 patients treatment mostly gives us confidence that we have address the FDA’s earlier comment. Additionally, the recent abstracts of ESSO combined with our existing data, further confirm our belief in this program. And as per full valuation, we believe this clinical trial, which is focused on overall survival, potentially represents the fastest route to an NDA approval in the U.S. and we look forward to meeting with the FDA to discuss the program.

Michael Polyviou

Analyst

Thank you, Jennifer. We have one more question. What is the prominence of the ESSO Congress and how significant are these three abstracts?

Jennifer Simpson

Analyst

So for those of you that aren’t familiar with ESSO, its aim is to advance the science and practice of surgical oncology. They promote high standards in the surgical care arena and management of patients with solid tumors. So I was out last week to ESSO Congress and was encouraged to see over a 1,200 leading clinicians attend. This is one of the largest number of patients reported for us, are predominantly using our current device and procedure at the scientific meeting, so we were quite pleased with the presentations.

Michael Polyviou

Analyst

Thank you, Jennifer. There appear to be no questions coming in via the phone line. So we will take a third and final question that came in through the email. Do you expect procedure growth next year, that come from existing centers, with surgeons doing more procedures or from new centers coming on?

Jennifer Simpson

Analyst

Thanks, Michael. We expect both. Certainly, growth from our existing centers as clinicians have demonstrated positive result, as well as new centers coming on board.

Michael Polyviou

Analyst

All right. Derrick, I don’t believe there are any more questions. And we can throw the call back now to Jennifer for her closing remarks.

Jennifer Simpson

Analyst

Thanks, operator. We will take our -- I’m sorry. I think that concludes our call. And we thank you all for joining us and look forward to speaking with you again.