Earnings Labs

Delcath Systems, Inc. (DCTH)

Q4 2013 Earnings Call· Thu, Mar 13, 2014

$10.19

-3.46%

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Transcript

Executives

Management

Patty Eisenhaur – IR Jennifer Simpson – Interim Co-President, Co-CEO, EVP and Global Head, Business Operations Graham Miao – EVP and CFO Chris Gale – IR

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2013 Delcath Systems’ Incorporated Earnings Conference Call. My name is Denise, 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, this conference is being recorded for replay purposes. I would now like to turn the conference over to Patty Eisenhaur. Please proceed.

Patty Eisenhaur

Management

Thank you, Denise, and good afternoon, everyone. Thank you for joining us today for this conference call and webcast to provide an update on Delcath’s fiscal fourth quarter and year end results for 2013 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 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 materials. 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, 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 institutional investors. For 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, Patty 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 review the continued actions we’ve taken to strengthen the company, discuss our fourth quarter and full year financial results and provide an update on the availability and the use of our resources. I’ll begin with an outline of our current clinical development program. We are continuing to work on our clinical development program to investigate Melphalan HDS for first line treatment of patients with unresectable advanced hepatocellular carcinoma or HCC, also known as primary liver cancer. We received comments from the FDA at the end of 2013 on our proposed HCC trial protocol and incorporated their comments into our IND submission. We then submitted a supplemental IND to the FDA for this trial in February of 2014. In addition to the FDA’s assessment of the IND, the submitted protocol is now proceeding through a scientific review committee and the institutional review board at our participating institutions pending any further comments from the FDA, and clearance of the protocol by our participating institutions, we now anticipate being activated in the second quarter of 2014. As a reminder, the global HCC Phase II trial program is focused on first line unresectable advanced hepatocellular carcinoma in approximately 30 patients. The Phase II trial will incorporate additional safety measures and experience gains in our EU commercial cases as well as the U.S. ocular melanoma program. The program aims to assess the overall objective response rate, progression free survival, also known as PFS, as well as safety parameters. This study should provide us with valuable information on safety and efficacy before moving into a Phase III…

Graham Miao

Management

Thank you Jennifer and good afternoon everybody. I am pleased to report that we continue to make progress on our efforts to enhance operational efficiencies, reduce our cash spend and strengthen Delcath’s financial condition. Cash spent for the fourth quarter was $6.2 million, this was a reduction of 36% or $3.5 million year-over-year for the same period and a reduction of 10% or $0.7 million sequentially from the third quarter of 2013. Importantly, we have met our cash spend guidance for the last three quarters and this quarter was at the low end of our reduced guidance of between $6 million to $8 million. For the full year, cash used in operating activities was $34.1 million, a 32% reduction compared to $50 million in the comparable period in 2012. The decrease in cash utilization was impart due to a reduction in NDA submission-related costs and improved organizational and operational efficiencies. In conjunction with other cost savings measures, we remain on target to further reduce our average quarterly cash spend to between $5 million to $6 million in 2014. In addition to controlling costs, we raised additional capital to further strengthen our balance sheet. In 2013, we raised approximately $43.2 before related expenses including approximately $26.7 million through the company’s aftermarket equity offering program. $9 million through its committed equity financing facility program and approximately $7.5 million through a registered direct offering. As a result, cash and cash and cash equivalents as of December 31, 2013 were $31.2 million compared with $23.7 million at December 31, 2012. During the first quarter, through February 28, 2014, we raised approximately $4.5 million before related expenses through our aftermarket offering program. As of February 28, 2014, cash and cash equivalents were $32.7 million including $0.4 million in accounts receivable collection. We believe that the…

Operator

Operator

(Operator Instructions)

Jennifer Simpson

CEO

Chris, do we have questions in the webcast?

Chris Gale

Management

We have a question from the webcast. It reads, you have referenced that you are focusing your efforts on Germany and the UK. Will CHEMOSAT no longer be available or supported in the other EU countries, once it limits your opportunities for generating revenues?

Jennifer Simpson

CEO

Thanks, Chris. Just to clarify, CHEMOSAT is available and all countries where it is approved and we continue to support the clinical adoption, and as referenced before through IITs or investigator initiated trials, we are not stopping our efforts in other countries just taking a more focused approach on the UK and Germany as these two countries offer the clearest pathway for reimbursement in the near term.

Chris Gale

Management

We have another question from the webcast. It read, I thought you are hoping to initiate patient enrollment by the end of first quarter, does this delay relates to the FDA concerns or institutions you are working with?

Jennifer Simpson

Operator

Thanks, Chris. As we mentioned, we made the prudent decision to engage with the FDA on our proposed HCC protocol and we did have a review with the FDA by year end as originally planned. The FDA provided very productive feedback as well as our clinical institutions, and we adjusted the protocol accordingly. So where we are now is the clinical sites are now submitting the protocol to their Scientific Review Committee as well as the institutional review board at the participating institutions. And subject to any further FDA comments and also clearance from the institutional review boards, we hope to have the sites open for enrollment in the second quarter. Operator, do you want to queue up anymore Q&A for the live call?

Operator

Operator

At this time we have no audio questions. (Operator Instructions)

Graham Miao

Management

So we want to thank you for participating in today’s call. We look forward to updating you during the Q1 2014 call. Thank you.

Operator

Operator

Ladies and gentlemen, this replay will be available 1-888-286-8012 using access code 49674508. This concludes today’s conference. You may now disconnect. Have a great day.