DCTH - NASDAQ

Greetings, and welcome to Delcath Systems' Second Quarter 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. David Hoffman, Delcath General Counsel. Thank you. Mr. Hoffman, you may begin.

Thank you. And once again, welcome to Delcath Systems second quarter 2024 earnings and business highlights call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Senior Vice President of Finance; Kevin Muir, General Manager, Interventional Oncology; Vojislav Vukovic, Chief Medical Officer; and Martha Rook, Chief Operating Officer. I'd like to begin the call by reading the safe harbor statement. This statement is made pursuant to the safe harbor for forward-looking statements described in the Private Securities Litigation Reform Act of 1995. All statements made on this call, with the exception of historical facts, may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Although the company believes that expectations and assumptions reflected in these forward-looking statements are reasonable, it makes no assurance that such expectations will prove to have been correct. Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties. For a discussion of such risks and uncertainties which could cause actual results to differ from those expressed or implied in the forward-looking statements, please see risk factors detailed in the company's annual report on Form 10-K, those contained in subsequently filed quarterly reports on Form 10-Q, as well as in other reports that the company files from time to time with the Securities and Exchange Commission. Any forward-looking statements included in this call are made only as of the date of this call. We do not undertake any obligation to update or supplement any forward-looking statements to reflect subsequent knowledge, events or circumstances. Our press release with our second quarter 2024 results is available on our website, www.delcath.com, under the Investors section, and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website. Now I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone for joining. During today's call, we will review Delcath's second quarter financial results, our ongoing commercial activities, including projections for both site activation and average treatment rates for the balance of the year, as well as some important medical and clinical updates. In the second quarter, Delcath reported $7.8 million in total revenue, including $6.6 million in U.S. revenue from HEP

Thank you, Gerard. Revenue from our sales of HEP

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] The first question comes from the line of John Newman with Canaccord Genuity. Please go ahead.

Hi, there. Congratulations on the quarter, and thank you for taking my question. I know it's still a bit early in the launch, but could you comment on what you're seeing in terms of the mean number of treatments for HEP

Sure. So it's anecdotal at best given we're really getting this from the reps and the clinical support specialists who are in most of the procedures. But it seems like most patients are progressing on to two, three, four, or five or more. It's too early now to say whether or not they'll match what we saw in the trial, which was 4.1 on average. But I suspect we'll do at least that well over time. But no indication that it will be lower than that at this point.

Okay. Great. If I could sneak in one additional question. It seems like there's a lot of potential for HEP

Yeah. I think we’re going to do a mix of things. So Voji right now is working with both advisory committees to think through larger randomized studies with control arms, as well as single and multicenter investigator-initiated trials. And those would probably more likely be single arm, although some of those have the control as well. So I think you’ll see a mix of things from us, ranging from sponsored trials that are randomized and have a control arm. We might think some trials, we have some trials in mind that would look at historical data. So a single arm with a control arm to increase specified sort of like a registry data, for example. So it will be a mix of things. And the goal, again, will be a mix as well. The goal will be ranging from giving adequate data, so physicians can make an informed judgment for certain patients whether or not they want to treat and try to get reimbursed for the patients, to informing potential guidelines down the road, all the way to trying to expand the label. So it will be a mix.

Great. Thank you.

Thank you. Next question comes from the line of Marie Thibault with BTIG. Please go ahead.

Hi, Gerard. Hi, Sandra. Very nice quarter, this quarter. Wanted to dig a little bit on the average treatment per center metric. Thank you for giving us that detail. If we were to strip out the highest volume center, I don't know if it's still Moffitt, I know it was last quarter. Is there a way to think about the average for kind of that remaining group? And you mentioned that they are pausing just to check on billing and things. Is everything going smoothly on that front? I know with the J code going into effect, that was, of course, supposed to help quite a bit.

Yes. Let me answer the second question first. I have heard of no fundamental problem with reimburse with the hospitals when they do things right. I have heard of a couple of cases where they've done things wrong and they've had to go back and fix it and then get paid. But if they do things right, they get paid. And if they don't, they always have the opportunity to go back, which takes a little bit longer. So no fundamental issue there that I've seen at all. Everything has been very positive. In terms of the average treatment rates, I'm going to hesitate from giving -- breaking it down to that level. I will say if you stripped out the Moffitts and the Thomas Jeffersons, yes, the average treatment per week would drop. But I do think most centers will eventually do at least two a month, and many will be more than that. Thomas Jefferson and of Moffitt clearly are bringing the averages up. In addition, as new centers come on, not all of them, but many of them seem to do a couple of patients and wait and then start to hit the gas. So those new centers really will drive, I think, the average -- the downward pressure on the average, but maturing centers will keep the average kind of flat. So net-net, that's why I think it will be somewhere between 1.5 to 2 for the balance of the year.

Okay. That's really helpful. For a follow-up here, I wanted to underscore how good your margins were this quarter, both gross margins and OpEx control. Help us think about the sustainability of some of that. Are you needing to add more sales reps to kind of keep up with your launch plans? Was there a reason the control is so good on the operating spend side? Just any more detail you can give us there. And thanks for taking the questions.

Sure. I think we're fairly disciplined on the OpEx side. A lot of the players here have come from another similar company who kind of know, spend money wisely. We don't need a huge sales force to reach all the centers. This is going to be a specialty product that has small number centers. I think in the past, I talked about maybe getting to 25 to 30. Our thinking is evolving there. We might decide to get to more like 35 or 40, that might have a marginal increase on SG&A relative to where we are now, but not a huge increase. In terms of cost of goods, we're great for three, four years before we have to do any meaningful tie-up of CapEx, I believe. So we’re in good shape there. So I think the biggest variable really is – and I might be preempting a question, is R&D spend. How much do we decide that we want to invest into R&D? And we’re going to be very thoughtful about that. But there’s no doubt we will increase R&D at some point for some additional trials. It would just be – we’d be remiss if we didn’t because this product has tremendous potential in many other much larger indications. But I’m not going to kind of forecast what that’s going to be 1.5 years out from now. I’ll just say, look, we’re going to try to be very prudent. And we understand there’s an E in EPS, and I mean – and that’s an EPS, excuse me, in terms of number of shares. So we’re going to be very prudent to try to keep the cost down, so really don’t have to raise much more money going forward.

Very good. Thank you.

Thank you. Next question comes from the line of Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.

Good afternoon. Regarding the center activations, now that you have eight centers activated or almost 10 by the end of this month, what are the learnings from the -- if there's any push or pull on it? And how is that helping you not only educate internally, but also the preceptors so that the next set of activations go smooth?

Yeah. I don't think there's any dramatic learnings aside from we need to address project stakeholders kind of in parallel and really help try to educate some of the stakeholders in the hospitals and get ahead of kind of the various committee approvals and stuff. The preceptorship training stuff is really just a Rubik's cube of scheduling. As we get further along and we have more proctors available and people who can do preceptorships, it will get a bit easier. But right now, it's just difficulty in scheduling. Kevin, I don't know if you want to chime in about any learnings in terms of site activation, preceptorship or anything like that.

Sure. Thanks, Gerard. Gerard, I like the analogy, the Rubik's cube of scheduling. And to the more sites that we have active and the more procedures that we have, it lessens the -- or it increases, I should say, it increases the opportunities for preceptorships and proctorships. So in that respect, it should make the account activation cycle a bit easier. The other thing or eight to 10 centers that we're working with right now, it allows for peer-to-peer conversations that kind of happen organically behind the scenes. So physicians call each other and hospitals do for some manner of checking on reimbursement and understanding how to set things up. So the net-net of all of this is that, when these centers are -- will help us and should kind of streamline the activation process as we go forward in the second half of the year.

Regarding the NTAP that you received, that HEP

Yeah. I don't think getting NTAP is going to make much of a difference in terms of uptake. I think it is helpful for the hospitals when they have the infrequent inpatients. It will lessen the financial burden on the hospital. It's a rather complex formulary. They have to have a certain loss amount, then it covers a certain percentage, up to a certain percentage, which I don't think it's worth going into that level of detail because I don't think is that critical. I think the most important thing or telling thing is it's more of a sign of how innovative this therapy truly is. People look at -- it's melphalan, it's a device, etc. But the bar to get the new technology add-on payment is pretty high. You really do need to prove that you're an innovative therapy and doing something that nothing else does is out there. And I think it's fantastic that we got it. And I think, although it seems unrelated, the physician reaction we're getting from the radiologists and oncologists who are using the product, the response rate, they're seeing they're incredibly positive. So it's just -- it shows that again, this is a filter, it's old school chemo. It is truly something new that's making a real difference for patients. And I think that's why we got the NTAP. It is a modest tailwind, but it's not that big of a deal. We don't need it.

Thank you. One last question for me. On the U.K. reimbursement, since there are a couple of hospitals, if I remember correctly, from the U.K. that have used CHEMOSAT for a longer time than others, how is that going to play into the reimbursement review when it comes time?

Yeah. I have no doubt we're going to get reimbursement. They went from a semiannual review to an annual review. That was a surprise to us. That's what pushed it back into next year. That just was a recent change in how often they do the review. But we'll get reimbursement, I have no doubt about that. The question is, what will the reimbursement be? I don't have high hopes that it will be a significant step up from where we are right now. But again, as I mentioned before, we're going to manage Europe on a kind of roughly breakeven basis. But we're going to continue to invest in there on a measured basis because I think it's -- as clinical sites and a source to generate publications, it's a very, very important strategic asset for the company.

Perfect. Thank you very much, Gerard.

Thank you. Next question comes from the line of Sudan Loganathan with Stephens, Inc. Please go ahead.

Hi, Gerard, Sandra and Delcath team, congrats on a great quarter. I have two questions. My first one is regarding the marketing strategy. Is the main focus geared towards selling the kit to hospitals to bring on more additional sites, or trying to focus them more towards the patient and physician awareness? And then as you go into next year and progress this launch, will there be any changes to that marketing strategy? And then secondly, what quarterly and yearly revenue run rate in OpEx range do you anticipate you need to be at to achieve a breakeven or positive EPS? I understand you might also have aspirations and other indications for the HEP

Sure. I think, Sandra, why don't you pick up where you think we need to be at to hit breakeven, okay, on a quarterly basis, under current R&D spend?

Yes. Currently, probably around the 60 to 80 kits, just depending, a quarter in order to be breakeven or cash flow positive, and we obviously dependent on additional SG&A, marketing spend and R&D that will be incurred the rest of this year. But I think we're well on the course of becoming cash flow positive, hopefully, by Q1 of 2025.

And that's about $30 million a quarter in revenue.

Yes.

All right. Now in terms of the FOCUS market, I mean right now, I think, Kevin, chime in if you disagree, we're probably FOCUS is 80% site activation, 20% trying to get patients to the sites. That will switch over time. But all elements of the marketing mix are important at the moment. Kevin, maybe I don't know if you want to give a couple of word -- a couple of sentences about our priorities now and how that might evolve over the next year, 1.5 years.

Sure. And I think with the patient population that we have right now, one of our main goals is to that 20% is to drive awareness and increase patient access to what we think is a wonderful option for these patients. And while opening sites is important, it's not our main goal. Our main goal is not to open as many sites as we can. As Gerard pointed out in his remarks, we've started with a goal of 20 and with our ultimate goal of probably roughly around 40 sites. And it’s more the quality of sites. Are we going to the correct sites? Are we giving patients access at these sites? So that’s been our focus, opening the right sites and getting patients access to those sites.

Thanks. Appreciate. It.

Thank you. [Operator Instructions] Next question comes from the line of Chase Knickerbocker with Craig-Hallum Capital Group. Please go ahead.

Good afternoon, everyone. Thanks for taking the questions. Just first from me, are there any other high-end early adopters in the pipeline kind of like Moffitt or Thomas Jefferson? Or should we think of kind of everyone else from here as those that maybe pause a bit after a couple of patients and kind of generally drag down that average kits per center per month number over the first quarter or so of them being active?

Yeah. I think there's a third surprise center to us that I wouldn't say that they're at that level, but might approach it given some recent activity. And I think there'll be a number of others that will reach that level. And I think some of the centers were opening that weren't at that level in terms of a book of business, once they have our treatment, they will increasingly become kind of a destination for a lot of patients. So I don't think that -- I don't think we're going to have a ton of centers doing six a week. But will we end up having quite -- I mean, six a month, excuse me. Will we end up having quite a few centers that are doing maybe one a week and quite a few centers being more than four or five? Yes, I think so, eventually. So if you look at -- if you look at the kind of the Pareto analysis of centers, those are the big guys who you mentioned. But I think a lot of centers, once they have our therapy, will end up treating patients maybe that aren't appropriate for our therapy, but they're going to start bringing them in. So they'll start becoming destinations.

Should we think of kind of a max level kind of per week treatments that some of those high adopters could do? I mean any way for us to kind of think about that of kind of what the constraint is on the high end? And then second, of the centers that are kind of awaiting that initial commercial treatment scheduling, do we get a sense of kind of how long it takes to activate those patients? I know we kind of gave a lot of numbers on the call, so forgive me if I'm making you repeat yourselves. But just kind of those four, for example, that were just kind of awaiting the schedules to line up, do we have a kind of a general kind of feel for how long that takes?

No, it's been all over the map. And that's why I was off of it in my projections. I thought we'd have 10 by the end of last quarter, and we didn't. We had seven, now we're at eight. And in about three or four weeks, we should be at a -- two or three weeks, we should be attentive, if nobody -- a patient doesn't get a call, then all the proctors can show up, etc. It really is all over the map. In terms of what you think of what is a max or run rate, we have a couple of centers in Europe that, if it's not summer vacation, were doing pretty regularly on a week. And that seems to be kind of a natural high-volume rate for centers, although we've had -- we had one center recently do three in one day, believe it or not. So that center may end up being a six a month, seven a month type place. So I think as people get used to this or are willing to train a second team or have a couple of backup people, they might end up doing six or seven a month. But right now, I think four months will likely be what the high end does for a bit and others are going to be one or two a month. I think eventually we'll see some sites that it regularly do one to two a week. But that will take a bit of time. And again, we saw a center just the other -- I think two weeks ago, that did -- last week, they did three and one day. So they were able to push them through.

Got it. That's helpful color. And then just last for me. Just maybe speak to a little bit about -- I know it's early, but the progress that you're having in the community kind of driving referrals to some of these centers. And then maybe kind of an early look at how your therapy is going to interact with those that are -- with those patients that are eligible for tebentafusp. Are those kind of patients who are eligible getting tebentafusp first or is this something where physicians are viewing it kind of in-line treatment? Just kind of give me an early look there.

We've had patients before tebe and we've had patients after tebe. And it really has more to do with whether the doc believes that liver directed therapy should go first because this liver meds are usually what these patients succumb to. So if they're going to prioritize treatment, some docs want to prioritize liver-directed therapy. So it's all over the map, and it will settle out over time probably one way or another. But most patients do live long enough to get more than one line of therapy. So whether they go first on tebe or first on us, I think patients who are HLA2 positive should get both. It's probably the right thing for the patients. In terms of referrals, it's still early days. Voji's team and Kevin's team are both working on -- Voji's medical affairs team and Kevin's commercial team are both working on setting up referral patterns. We've had, I don't know, quite a few referrals to date. They're usually peer-to-peer referrals. So a lot of times, we've been getting referrals from centers that are waiting to finish their preceptorships or finishing up their -- the various approval committees they need to have. They have a patient they want to have treated. They send them to another site, knowing the patient is going to come back to them, hopefully, once the fall of the approvals occur at their centers. So we've seen those peer-to-peer referrals. And we've also sent some patients directly due to phone calls we've made in such 100 treating sites. In terms of a good, well-oiled machine referral process, we're developing that right now. That's something that will become increasingly important. We're confident we can do it. It's going to evolve a lot of direct patient things work through advocacy centers. The advocacy groups are very excited about the product. So we'll work with them so the patients know where this is available. We have reasonable data as to who's treating these patients. So we know who has just one of them, just two of them, just free of them. And we are -- we have developed a process where through e-mails, phone calls, perhaps surprise visits, we try to get in front of these docs to tell them about HEP

Got it. Thanks, Gerard and congrats again on the great early progress here.

Thank you.