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Delcath Systems, Inc. (DCTH)

Q2 2012 Earnings Call· Tue, Aug 7, 2012

$10.19

-3.46%

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Transcript

Operator

Operator

Good day ladies and gentlemen. Thank you for standing by. Welcome to the Delcath second quarter 2012 corporate update conference call. During today’s presentation, all parties will be in a listen-only mode. Following the presentation the conference will be open for questions. (Operator instructions) This conference is being recorded today, August 7, 2012. I would now like to turn the conference over to Doug Sherk. Please go ahead sir.

Doug Sherk

Management

Thank you operator, and good morning everyone. Thank you for joining us today for this conference call and web cast to provide an update on Delcath’s second quarter 2012 results and recent corporate progress. A replay of the conference call will be made available beginning approximately 2 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 available at www.delcath.com and the call will also be archived on the website. Before we begin, I would 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 US 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 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 Eamonn Hobbs, President and Chief Executive Officer; and Graham Miao, Executive Vice President and Chief Financial Officer. Following their opening remarks, we will open the call to questions from analysts and institutional investors. To maximize the time allowed for Q&A, please ask two questions and if you have additional questions please requeue to ask those additional questions. In advance, we thank you for your cooperation. And now I would like to turn the call over to Mr. Hobbs.

Eamonn Hobbs

President

Thanks Doug, and good morning everyone. Since we last spoke with you in May, Delcath has made important progress on a number of fronts. During our second quarter and in recent weeks, we made substantial progress towards completion of our new drug application, and are on schedule for submission to the FDA this month, received FDA acceptance of the IND Amendments for use of our Generation 2 filter in our US Expanded Access Program, expanded the total number of leading European cancer centers participating in our CHEMOSAT launch program to 13, recognized our first-ever commercial revenues, raised approximately $21 million in net proceeds through a follow on offering, and strengthened our board of directors with the appointment of two pharma industry veterans. On our call this morning, I will provide some detail on these operational highlights and then Graham will review our financial results. Then we will be happy to take questions. I will begin with an update on our NDA submission. I am pleased to report that as we reported at our annual meeting we resolved all outstanding safety queries and locked the database on May 25. After data lock, we conducted statistical analysis and began finalizing the various modules that comprise our NDA submission. Our NDA is based on the efficacy and safety datas generated from the use of our Generation 1 system in our clinical trial. At the same time, after consultation with a variety of experts and the FDA, we have agreed to include the addition of the Generation 2 filter in the NDA as a technical change as part of the CMC or Chemistry, Manufacturing, and Control module. We believe it is in the best interests of US patients to accelerate availability of Generation 2, and that this approach represents the fastest regulatory review path…

Graham Miao

Management

Thank you Eamonn, and a good morning everyone. Let me begin by providing an update on the company’s financial condition. Our cash balance as of June 30, 2012, was approximately $29.3 million, [and includes $29.3 million,] and includes the $27 million net proceeds raised from the secondary offering in late May, and our ongoing ‘at the market’ program. We remain debt free, although as we announced in the first quarter we secured a $20 million working capital credit facility with Silicon Valley Bank. This facility provides us with additional financing options to access capital to support our commercialization plans. Our ‘at the market’ equity facility remains in place, and currently has approximately $31 million available to us. Turning to use of cash, our gross cash spend in the second quarter of 2012 was $14.2 million, a decrease from the $14.7 million in the first quarter, but a significant increase compared to the $8.2 million in the same period in the prior year. The sequential quarterly decrease reflects the company’s commitment to effective cost management. The year-over-year increase was primarily driven by the costs of the consultants and the external vendors related to the NDA submission preparation, and the costs associated with staff increases in various functions to support EU commercialization. Average monthly gross spend was $4.7 million, which was in line with our expectation of between $4 million to $5 million a month, and represents a decrease from $4.9 million in the first quarter of 2012. Following the anticipated NDA submission, we expect average monthly cash spend to decrease to between $3 million to $4 million for the fourth quarter of 2012. Turning to the income statement, during the second quarter we generated $106,000 in commercial revenue from the sale of CHEMOSAT kits in Europe, first in a significant milestone…

Operator

Operator

Thank you sir. (Operator instructions) And our first question comes from the line of Matt Dolan with ROTH Capital Partners. Please go ahead. Matthew Dolan – ROTH Capital Partners: Hi, guys. Good morning.

Eamonn Hobbs

President

Good morning.

Graham Miao

Management

Good morning. Matthew Dolan – ROTH Capital Partners: First question is on the US regulatory side, obviously you have a big milestone coming in the next week, so we had two points of clarification, I know you anticipate the PDUFA date to be in February, what are you expecting now for a panel to be convened, and the second part is around gen 2, the ability to submit that device as a technical change I believe was your best case scenario, so can you just kind of walk us through the genesis of that nod so to speak from the FDA and your confidence level that that will be fully included in the NDA? Thanks.

Eamonn Hobbs

President

Well, if we have an ODAC panel, which we will be informed of when the FDA accepts our NDA, and issues a PDUFA date. If they grant us priority review of 6 months that would put our PDUFA date in February, and our best guess at an ODAC would be in early December. There currently is a tentative scheduling I believe on December 3rd and 4th for an ODAC panel, and that would put us approximately in the right time frame for a February PDUFA date. With regard to your -- the question regarding the inclusion of gen 2 in the NDA, we -- first I think it is important to understand that gen 2 is a refined gen 1 software. So there is a -- we believe a very strong argument that gen 2 is a technical change that does not impact the efficacy of the procedure because the filter is involved after the liver is treated to remove chemotherapy from the blood. And after consultation with numerous external consultants on both the device side and the drug side, and the submission and acceptance of our IND amendment to allow us to use gen 2 in the USA, we got into a considered discussion with the FDA, and FDA informed us that it was acceptable for us to include gen 2 in our NDA as a technical change as part of our CMC module. So we feel hopeful that this will produce the shortest time to review and approval in the United States, and are very pleased with the way that all evolved and worked out. Matthew Dolan – ROTH Capital Partners: All right. Well, that is great to hear. And then the second question is on Europe, obviously the number of centers are tracking ahead of schedule, I think on the last call you indicated that you expect the number of centers to be added next year should be a multiple of the 2012 number. Is there anything you can give us at this point in time to help us hone in on that target, either on a center or a utilization per center basis?

Eamonn Hobbs

President

I’m afraid Matt it is still very early to [bring] it all down to a formula. There is a couple of things that it is important to note about our commercial rollout program in Europe. The first is we are definitely ahead of schedule. We’re having 13 now, and we do plan to add additional, some additional centers for critical mass purposes to support individual reimbursements, individual country and regional reimbursements. But our plan is more to go deep than to go broad. So in our centers that we have established, our 13, our goal by the end of the year is to get them doing as many cases as we can. And rather than I guess every major cancer centre in Europe doing just a few cases, the ultimate market we believe in Europe is approximately 170 major cancer centers spread across our seven target market. And we are going to feel our way as far as the best return on investment, balancing going deep and going broad. So we know from our experience in the United States and already from our initial experience in Europe that cancer patients will travel to get treatment. We have already had a patient from Spain fly to Milan to receive treatment because the Spanish centre, local Spanish centre, was not up and running yet. So, there’s going to be a balance between how deep our centers go in producing cases versus adding a new center and incremental cases above that.

Operator

Operator

Thank you. Our next question comes from the line of Jason Mills with Canaccord Genuity. Please go ahead. Jason Mills – Canaccord Genuity: Good morning Eamonn and Graham.

Eamonn Hobbs

President

Good morning Jason. How are you? Jason Mills – Canaccord Genuity: Well, thank you. Congratulations on the update and just sticking with Europe I mean for a little bit, I would love to hear some early statistics if you have them from your Quintiles relationship, specifically generating the leads, you have exceeded expectations in the number of centers you are in, obviously that is great, but the endgame is to get the patients through the centers. So have you seen any early successes or any early data that you could point to that would give us some inside into how the referral stream is going in Europe? Excuse me.

Eamonn Hobbs

President

Well, you are absolutely right. And we totally agree that the name of the game is driving patients through established centers, and really we have -- yet to see the fruits of the MSL network because the centers are really just getting established. So as we walk through all the bits and pieces, or the sequence of events that have to happen to get a centre up and running, and unfortunately it is a -- not a short process on a timeline. It is not tremendously complex, but it is very hard to accelerate it. So we’re just now getting to the point where the MSLs can start to generate referrals from the catchment area of a center such as the IEO in Milan and Gustave-Roussy in Paris, and J.W.G. in Frankfurt to be able to drive patients in there. Of course, we are further handicapped a bit during the summer months because frankly you don’t want to get sick in Europe during August because the clinicians are not home. They are all out taking their holidays. So, we expect on our next call to be able to point to some success stories of being able to drive patients through from the MSL push. Jason Mills – Canaccord Genuity: Okay. That is helpful, and just on the pricing side, congrats on your first commercial revenue, I know it is early, but do you have any reason to believe that the ASP is any different, higher or lower than what you would have predicted in the past, and maybe you could give us an updated thought on that?

Eamonn Hobbs

President

We are pleased with the early results on average selling price so far, and it is extraordinarily early. So everything we are looking at we are trying to take with a grain of salt. But so far so good. We’re tracking slightly above the average $15,000 price that we use in our modeling, which was a blend of direct and indirect sales in Europe. So the orders we received so far and the orders that are in the queue from additional centers are trending towards an average selling price that would give us more comfort that $15,000 is an appropriate number in our model. So, so far so good. Jason Mills – Canaccord Genuity: That is wonderful. One US question, I will get back in queue, if the FDA decides not to give you priority review, maybe so that we can just in our minds ascertain a worst-case scenario for lack of a better term, what would that timeline look like in your mind?

Eamonn Hobbs

President

Well, a standard review would be 10 months. So it will be four months from February. Jason Mills – Canaccord Genuity: Okay. So, we’re talking mid-year.

Eamonn Hobbs

President

Yes, exactly. Jason Mills – Canaccord Genuity: Not a huge difference. Okay, I will get back in queue guys. Thanks.

Operator

Operator

(Operator instructions) And I am showing no further questions at this time, I would like to turn the call back to management for any closing remarks.

Eamonn Hobbs

President

Thank you operator. I would like to thank everyone for participating in today’s call. We look forward to seeing you next week at the Wedbush and Canaccord conferences, as well as updating you on our progress in early November. Have a great day.

Operator

Operator

Ladies and gentlemen that concludes today’s conference call. If you like to listen to a replay of today’s conference, please dial 1800-406-7325 or 303-950-3030 and enter access code 454-8817. Thank you for your participation and have a good day.