Delcath Systems, Inc. (NASDAQ:DCTH) Q3 2023 Earnings Call Transcript

Unidentified Participant: Okay. Yeah, that all makes sense. I appreciate the added color there. Maybe I could use my follow-up here on some of the VAC approval process questions. How long do these usually take? I mean we hear for other products that could take six months to 12 months? I assume that it’s probably a bit quicker here. I recognize it’s not just a check-the-box kind of item, but — just wondering your thoughts on how long those VAC approvals you expect to take?

Gerard Michel: Yeah. I think what’s unique about this is — well, this is not another antibiotic for hospital-acquired infection or another stent. This is a product where there is nothing else like it for this patient set. And our individual radiologists and medical oncologists are very happy to champion this and push this forward outside the regular scheduled meetings. Now what I’m doing here is repeating what Kevin has told me, but Kevin, is there anything I left out in terms of the process or any further color?

Kevin Muir: No. But to add a little color to the question, you’re right. I mean, throughout my entire career, of budgeted nine months for one of these Value Analysis Committees. And again, it’s kind of been what has been too encouraging about this is that we have — its ultra-rare disease, it’s lack of standard of care for some of these patients, and we’re also at the right hospitals. And so they recognize the need for the product that we’re bringing and we’re kind of moved outside of that nine months, and we’re probably closer to three months and even in some scenarios, maybe shorter than that. So it’s been very encouraging from the response that we’ve received from these committees.

Unidentified Participant: Okay. Really helpful. Maybe just a clarification question. How many of the proctor sites do you have in the U.S. that could essentially do the proctor cases that you expect to have?

Gerard Michel: Kevin?

Kevin Muir: Yeah. Looking at my list right now, we have the three EAP sites that are ready to go. The rest of the focus trial sites have abbreviated training requirements. So that would be another one, two, three, four. So we’ll have some.

Gerard Michel: Kevin, in terms of proctor teams ready to go, it’s Moffitt, right?

Kevin Muir: Oh proctor team, yes. Yes. I’m sorry, I misunderstood the question.

Gerard Michel: And that’s one of the reasons it’s going to be a bit slow, but we’ll have another team, two or three teams up and going within a few months, and we have a number of teams in Europe who are more than happy to fly over and proctor. So that’s – we’re probably going to end up relying on some European teams as well.

Unidentified Participant: Got it. Okay. Thanks for taking the questions.

Operator: The next question comes from Yale Jen with Laidlaw & Company. Please go ahead.

Yale Jen: Good afternoon and thanks for taking the questions and congrats on the progress. A couple of quick – good evening, just a couple of quick ones. First one is that in terms of your inventory preparation for the launch by beginning of the — end of this year or beginning of next year, what do you think your inventory level might be? And how would that be — how adequate the supply — the anticipated — potentially anticipated use over the next — the subsequent quarters?

Gerard Michel: Okay. I got the first question. The inventory level, I’ll answer for that is, we’re trying to maintain at least a year’s worth of inventory. I think once and so that will be a rolling demand forecast looking forward. I think once we get past the $10 million revenue milestone that will bring more cash to the balance sheet, we’ll be just short of being breakeven then on an EBITDA basis. I think we’ll probably increase safety stock beyond the year on certain components, just to be careful because it’s not always easy to switch out components of suppliers change. So that’s answer to your first question. What was the second, Yale?

Yale Jen: When you start to launch the product, you have adequate or how do you see that preparation at that time?

Gerard Michel: So do we have adequate. I think we will probably, based on orders coming in this year, and once the melphalan shows up, we’ll have — every component we will have at least a year’s worth of stock.

Yale Jen: Okay. Great. That’s helpful. And my second question here is that given you indicated there’s roughly 10 sites ultimately will be in the queue for the, I guess, first half of next year. What is your estimate of the total potential patient size or procedure number of the all the 10 combined?

Gerard Michel: So are you asking what I think the volume will be for the full year?

Yale Jen: For the full year, from the other 10, I guess, hospitals insight.

Gerard Michel: Yeah. Let me stick with what I said before and then that is — I mean — and that is — and I think you can probably do the math, and that is with a little bit of range, which is I’m trying to ensure here, is five — by the end of the quarter, we’ll definitely have five sites up and running. And I think ending the quarter, they’ll be doing at least one a month. Middle of the year, at least 10 sites up and running, end of the year, at least 15 sites up and running, and they should end the year doing at least two a month exiting the year. You can get to a fairly wide range, plus or minus 30% in terms of volume depending on when you assume they get there within the quarter. In terms of how many patients that represents, whatever number you have divide it by four.

Yale Jen: Okay. Sounds good. [Multiple Speakers] And maybe the last question here is that — is there any patient you anticipate or to be in the procedures when you launched the product in other words, they become our patients and presumably people calling [indiscernible]. Any number and colors on that?