Good day and welcome to the Delcath Systems’ First Quarter 2025 Earnings Call. All participants will be in listen-only mode. [Operator Instructions] Please note that this event is being recorded. I would like to turn the conference over to Mr. Hoffman, Delcath General Counsel. Please go ahead, sir.

Thank you. And once again welcome to Delcath Systems first quarter 2025 earnings and business highlights call. With me on the call are Gerard Michel, Chief Executive Officer; Sandra Pennell, Chief Financial Officer; Kevin Muir, General Manager, Interventional Oncology; Oya Lukovic, 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 Security Exchange Act 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 in a material manner 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 first quarter 2025 results is available on our website 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 for joining us today to review our first quarter's financial results and business updates. I'm proud of our continued progress this quarter in terms of both revenue growth and incremental center openings. Both HEPZATO and CHEMOSAT have had an impressive first quarter of 2025, generating a combined revenue of $19.8 million. HEPZATO sales in the U.S. contributed $18 million while CHEMOSAT sales in Europe added $1.8 million. Thanks to the exceptional efforts of our commercial team, we ended the quarter with 17 treating sites and have since opened an additional two centers, bringing our total to 19 active centers in the U.S. In the first quarter, we continued to solidify the company's finances with positive cash from operations of $2.2 million net income of $1.1 million and positive adjusted EBITDA of $7.6 million. Additionally, we ended the quarter with no debt and approximately $59 million in cash and investments. With this strong financial footing, we will continue to leverage cash from operations to support HEPZATO's research and development initiatives beyond metastatic uveal melanoma patients. Given our belief that HEPZATO and the underlying hepatic delivery system platform has the potential to benefit a much broader set of patients suffering from cancer in the liver. Turning back to center activations. In the first quarter, we activated the University of Kansas Health System, Cleveland Clinic and Providence St. John's. So far in the second quarter, we activated Northwestern Memorial Hospital and the University of Miami. In addition to the 19 active treating centers, there are currently 10 centers now accepting referrals and pending activation. With our pace of opening between 3 to 5 centers per quarter, I am confident that we are well on track to achieve our previously stated goal of 30 active centers by year end. In the first…

Thank you, Gerard. Revenue from our sales with HEPZATO was $18 million and CHEMOSAT was $1.8 million for the first quarter of 2025 compared to just $2 million for HEPZATO and $1.1 million for CHEMOSAT during the same period in 2024. We recognized gross margins of 86% in the first quarter compared to 71% for the same period in the prior year. Research and development expenses for the quarter were $5 million compared to $3.7 million for the same period in the prior year. Selling, general, and administrative expenses for the first quarter were $11.3 million compared to $8.8 million for the same period in the prior year. Our first quarter 2025 net income was $1.1 million compared to $11.1 million net loss in the first quarter of the previous year. Non-GAAP positive adjusted EBITDA for the first quarter was $7.6 million compared to an adjusted EBITDA loss of $7.3 million for the same period in 2024. As Gerard mentioned, we ended the quarter with approximately $59 million in cash and investments, positive operating cash flow of $2.2 million compared to a $1 million operating cash burn in the previous quarter. As of today, we have no outstanding debt obligations and no outstanding warrants. The exercise of series F warrants resulted in $16.2 million of funding in 2025. The warrants were previously issued in May of 2020 as a component of a private placement, had an exercise price of $10 per share, and expired recently on May 5. Thank you all for participating today. That concludes our prepared remarks, and I'd ask the operator to open the phone lines for Q&A. Thank you.

Thank you. [Operator Instructions] Our first question comes from Chase Knickerbocker of Craig-Hallum Capital Group. Please go ahead.

Good morning. Congrats on the strong results here. Continued progress and thank you for taking the questions. Just first on center ads. Gerard, you had previously said that you expect the majority of ads to be in the second half of the year. I would say that this is kind of stronger progress than we had expected. You've got visibility on a further 10. Can we add another two to three centers in Q2 here? I mean, do you kind of still stand by those comments that the majority of the ads will be in the second half? Just kind of an update there.

I think it will be a little more even throughout the year than I anticipated. As you know, I've had a less than perfect track record in predicting center activations for some reason. The hospitals don't always listen to our timing, but it is a solid queue. I know a few of those 10 will all of a sudden will hit a barrier. I don't know what it will be that will slow them down. So I'm balanced looking at it. I think 30 is about the right number to expect by the end of the year. Hope to do better, but I'm not going to bank on that.

But so more even in the first half and so call it potential for two or three more of those centers in Q2 to come on?

Yes, I think so. And I think it's going to be more of along the lines of roughly four quarters, but again, very difficult we're talking about small ends and complex processes, but yes.

Got it. And has there been anything that's changed about the process, any learnings that have kind of smoothed it out? And then you've got a little over two treatments per center per month in Q1. You'd said a little under two for the rest of the year. Can you just give us an update on who these centers are for the last 10? Do you expect them to be pretty is there some pretty good potential adopters in there? And any reason why we're going to see that a little bit of a decrease sequentially from that Q1 treatments per center per month number?

Yes, there are some that we would hope would be, have really high value. If you look at the script data [Ph] who treats metastatic uveal melanoma Miami should be theoretically a big center, Cleveland Clinic, etc. But what we found is even these centers with a lot of patients, it takes a while before they start doing a lot. They'll do a few patients wait and see, and that wait and see can take when I say wait and see, it doesn't mean they stop, but they're not going to do a lot. And that could be like a 6-month lag before they really hit their stride. So that's why I'm keeping the number a little under two for the balance of the year. And it's been pretty consistent since we launched, just under two. In this first quarter, you're doing some quick math, it was about two, maybe a little over. But I think as we get the continue to increase the pace of new centers, I think just under two is probably the right number. Now you would ask are there any learnings. I think we're getting better at anticipating where there are hiccups and being much more aggressive to get the multiple, multiple stakeholders in the hospital or the center around the table and talk to them beforehand to try to preempt some of the barriers. So on the margin, yes, I think we've gotten better at it as we've learned. But still there's just a lot of uncontrollable variables that we have to deal with as they come up.

Got it. And just last for me. Sandra, as we think about basically asking kind of cadence of OpEx here, how we expect kind of R&D to ramp as these studies ramp up and connected with that, how are you thinking about EBITDA kind of through the year as those expenses ramp for the trials?

Yes. So total OpEx, yes, we expect it to increase obviously over 2024 as you've already seen in Q1. 2025 SG&A for will increase probably 60% over 2024, and that includes our noncash stock compensation. Stock comp is comprised about 35% of that. Now R&D is expected to increase probably at a higher rate over 2024 around 150%, again, with stock comp comprising about 20% of that balance. In terms of EBITDA, yeah, we had EBITDA margins of 38% this in in Q1. There is no current target to maintain that that EBITDA margin. Now in the near term and executing site opening and clinical trial initiatives, we should remain EBITDA positive this year.

Thank you.

Our next question comes from Swayampakula Ramakanth of H.C. Wainwright. Please go ahead.

Thank you. This is RK from H. C. Wainwright. Excellent quarter. It's good on all fronts. In general, in terms of patients undergoing procedures, are you seeing any repeat procedures done on patients over the period that it has been commercial so far? And also, in terms of, the centers coming on board, just trying to understand the cadence in the sense, are some of these centers kind of in that competitive situation where they feel they're within a certain geographic jurisdiction that they need to grab patients as soon as they can and some of them are in that process and that's why you're seeing this higher than expected increase in terms of coming on board.

Sure. In terms of your question about frequency of treatment, in the clinical trial, it averaged 4.1. And it's as we look backwards, patients who came on board a year ago, six months ago, etc., it seems like we're going to be pretty much have exactly what happened in the trial or close to it. So I think for those modeling, 4 is a good number, 4.1 is a good number. It might bounce down to 3.9 at some point or up to 4.2 or 3, but it's definitely in that range. And that is a big driver for overall revenue is how many treatments do these patients get. In terms of pace of opening, this is about what we expected. Maybe it's a center over or so, but it's about what we expected in terms of pace. Our center is feeling competitive pressure to get this. It's human nature. I'm sure there's a bit of, “Hey, XYZ center has it, so I need it as well.” I think the biggest -- the larger driver though is there aren't that many patients in this area. Nobody's really except perhaps Thomas Jefferson -- nobody is no one has a foundation of their practice based on uveal melanoma except outside of some docs of Thomas Jefferson. So they talk to each other and share information. And it's very collaborative across centers, we've noted in this particular disease state with docs. And they're just hearing about good results. And I think that's the biggest driver. An IR or an oncologist speaks to another one at a conference, and they say what they're seeing with HEPZATO. I think that's the biggest driver for centers wanting to bring the product on board.

Thanks for that, Gerard. One last question for me. On the European front, if I heard it correctly, the revenues were up 26%, but you're saying it's not a major contributor yet. I get that. But at the same time, every quarter we are watching that and it's kind of inching higher and higher. So what is working there? And do you think you would want to put additional resources or you just want to wait for it to grow organically to a certain point before you start adding more resources? I know you're also looking for other countries to get reimbursement through and if there's any comments on that front.

Yes. So aside from Germany, there is no other reimbursement in Europe. And we hope to get reimbursement in the U.K. We've put our submission in. And hopefully, we got approval sometime this year and fund next year. The issue we have is twofold. One is when they look at the price of this, they include the cost of the procedure. The second thing is when they come up with pricing, they do look at the trial and they say this is a single arm trial. We factor all that in. We don't think we're going to get much more than maybe a seventh of the U.S. price, which is roughly what we're doing now. So whatever the TAM in is in the U.S., you kind of have to divide that, let's say, Europe's roughly equivalent, you have to divide that by 7. So there's just less to go after at this price point. It's just not feasible to get the price point we have in the U.S. and Europe. I would invest more if there was reimbursement. And when we do get reimbursement, we will invest more in certain markets. But right now, I am willing to do IITs and that sort of thing anywhere in Europe because it generates clinical data. I'm managing it roughly on a breakeven basis. So we've probably added three people in the last two years in Europe, which isn't a lot, but we're incrementally adding people when we think it will do some good. So yes, my focus in the short to medium term is let's get a lot of clinical data out of Europe. At some point, an indication will come along at high enough volume with the right type of data to get better pricing and higher volume and reimbursement. That's probably not going to be with uveal melanoma, maybe it will be with colorectal breast or one of the other indications we'll pursue.

Yes. So if I may, one really one last question on the R&D front because you just talked about, additional indications. So you on the opening remarks, we did talk about the CRC and breast cancer. But at the same time, I know since CHEMOSAT has been in Europe for a longer time. Are you seeing any additional indications that the centers are wanting to do, especially with a liver metastasis in it? And if so, is that indication at a point where we can start thinking about? Or is it just too early?

Yes. No. Centers in Europe have done breast cancer. They've done quite a bit of ICC. We've had centers say they'd like to do cutaneous melanoma, and but these are like N=2, 3, 6. Not enough to generate real world data. The most data that's out there on the product is uveal melanoma. And while docs like to, I don't want to call it experiment, try this for some patients, what we're really driving is us either funding an IIT when a doc raises their hands and asked about it and getting that published for a sponsored trial. But we're trying to get these docs to publish case studies or small series when I have the data. And hopefully, we'll get some more papers out of Europe based on these small and retrospective analyses. But I don't think from a revenue perspective, I don't think there's anything to bake into a model that's meaningful.

Thank you. Thank you very much, Gerard, and good luck.

Thank you.

Our next question comes from Marie Thibault of BTIG. Please go ahead.

Hi, good morning. Thanks for taking the questions, Gerard and Sandra, and congrats on a very impressive start to the year. Wanted to ask here very quickly, I heard mention of the patient access program. I want to understand if there's been any hurdles in terms of payments or anything that you're seeing on the patient access front that's led to the creation of this program or if this was always sort of intended and planned as we typically might see with some of these more rare diseases. So any detail on that and any impacts you might see or expect from it on adoption pace would be great?

No. In terms of I mean, we put this in place primarily for co-pays – co-pay assistance and the rare patient that had no coverage whatsoever. In terms of the hospitals getting reimbursed, aside from the hiccups that were driven by submitting claims incorrectly, we have seen nothing that gives us any pause about either commercial or Medicare coverage. So I think this is sort of thing that is helpful to patients that can lower their co-pay. If they don't have any coverage at all, we can point them towards various charities that do assist with the patients with rare diseases. And I think as you said, Marie, it is kind of standard practice to have this type of service up and running. If we had been a company with more resources moving into the launch, we probably would have had it in day one, but we had to wait a bit till we could gather the resources necessary to launch it.

Okay. Glad to see it and glad to confirm that billing is going well. And then we're expecting CHOPIN data I think later this year. Any chance we could start to sort of understand what the bar for what will be impressive to clinicians is? I don't know if you can start to help us set up some expectations for that data at this point, Gerard?

Yes. The endpoint is PFS. So I think a meaningful increase in PFS is what we're looking for. What might that be? I think it's in the eyes of the beholder. I think anything -- any increase of given how severe this disease is for patients, I think, for example, a four-month increase should be phenomenal, because that's probably translates into four months of more life. So something in that range, I think, would be great, but we'll have to see. But that's my kind of personal bar, about four months increasing success would be great.

Okay, great. Congrats again on the nice quarter.

Thank you.

The next question comes from Sudan Loganathan of Stephens. Please go ahead.

Hi, Gerrard and Sandra. Congrats on the great quarter and thank you for taking my questions. My first one is going to be kind of on the territories that you mentioned. Does the 6 territories you mentioned cover the lower 48 states and get you to that eventual peak site activation to the potentially 40 sites like you've mentioned before? Does your current boots on the ground get you to the over 30 sites? Or will there need to be some kind of increase to that SG&A effort to support site activation growth over 30 sites?

I think we can get to 40 with the 6 territories. With that said, if it looks like the number of boots on the ground, as some say, is limiting the growth, we'll do more. Luckily, this is not a huge expense. If we went from 6 territories to 8, that would be an incremental 6 people. So it doesn't move the needle very much one way or another. So time will tell. Right now on paper, our models say, hey, we should be able to get by with these 6 territories.

Okay. Great. And then my second one, you know, with the, FDA clearance now in hand for the Phase II trials for HER2 negative breast cancer and CRC, what are the remaining tasks prior to initiating the first patient on trial? And what's kind of the bars now from initiating a patient maybe this quarter itself versus waiting into the third or fourth quarter of this year?

Sure. I've got Vojo virtually here with me. So our CMO, I'm going to ask Vojo to chime in there.

Sure. Happy to address the question. So once the FDA clears a protocol, here in the U.S., we engage with clinical trial sites, major centers, to review and approve the protocol, train the site if necessary and also do the contracting to make sure that the cost of the trial and procedures is covered. So because we typically go to large academic centers, which are quite complex to navigate. This process can take anywhere between 6 and twelve 12 months for the typical treatment centers. So that's why there's a gap between the FDA clearing the protocol and us actually enrolling patients. In Europe, it's a similar situation. We file typically in Europe protocols for regulatory clearance after the FDA has lessened, and that's what we've done for these two trials. And in parallel, we're engaging sites and we're doing the same process. Activation of sites in Europe can also take anywhere between 3 and 12 months depending on what type of site in which country it is. So there's always an operational lag between clearance of the protocol and staff official enrollment. I hope that addresses your question.

Yes. Thank you for the clarity there. I really appreciate it. And one more last one, if I can squeeze one in. And I think I believe you may have noted before that that achieving that around $13 million in revenues should kind of yield like a breakeven EPS and then over that could yield a positive EPS with current OpEx levels, which you now proven in the first quarter. So congrats on that great milestone. Now that is proven about your business and with the cash positions you currently have, is there any interest in deploying that cash to in license a companion diagnostic device or therapeutic that go hand-in-hand with HEPZATO KIT and be accretive to the business maybe in a shorter timeframe than running clinical trials for label expansion and going that route. Just curious, what your level of consideration is for that kind of a strategy.

We always keep an open mind, and a number of things have come across our desks to look at, none of which seem like it makes sense. I think usually in licensing, it's usually along the lines of what else could the sales force sell in this type of business. I think taking our eye off this very profitable product to sell something that is high volume, low margin that takes a lot more sites to sell into doesn't make a lot of sense. Now if something comes along that is more a profile in terms of focused highly technical sale, that might make some sense, but nothing's come across to date. In terms of a companion diagnostic or something, if we do move into an adjuvant setting, which is probably something we do talk about, but it's not actionable yet. If there was something that, for example, predicted one will get liver mets, we might be interested in funding something like that. There's no such thing out there right now, but just to pick up its commercialized, that would be more of an R&D investment. But we look at complementary things like that. If there might be a synergistic systemic, something that for some reason fits with our liver targeted, we would look at that if there's a good clinical and medical rationale. But I don't think there's a lot out there in the near term that fits well within the business. We're certainly not going to in license something just to have a larger top line.

Got you. Thanks, Gerard. I really appreciate all the color there. And again, congrats on the great part of the year.

Our next question comes from Bill Maughan of Clear Street. Please go ahead.

Hi. Thanks for taking the question. Congrats on the quarter. So looking at revenue in Q1, I just kind of want to look at it from any angle to see kind of how stable this base is going forward with it being such a strong number. So was there any month-to-month variability that might suggest any quarter-to-quarter variability going forward? And were there any headwinds from beginning of the year insurance resets? Thanks.

In terms of the latter part, we expected to perhaps see something with the co-pays resetting and we didn't expect we wondered. That's probably a better way to put it. But with the disease such as this, it seems relatively, I won't say, immune to it, but it is less of an effect. In terms of kind of month-to-month variability, we're still talking about relatively small ends. So by definition, you're going to have some level of variability. It's tough to tease out a pattern. Since patients are treated every 6 to 8 weeks, we're probably closer to 8, we do see kind of see an up and down effect month-to-month depending on if January has a lot and February has a bit fewer than March is likely to have a lot and April a bit fewer just due to the returning patterns. But it's not that meaningful. And again, the ends are relatively small, so there's noise in there as well.

Thank you.

Our next question comes from Yale Jen of Laidlaw & Company. Please go ahead.

Good morning, Gerard, and congrats on a great quarter. I had few short questions here. First, in terms of the CRC trials, how many sites you are anticipating to activate for the study?

Sure. We anticipate more than 20 sites across the U.S. and Europe to participate in the colorectal trial.

Okay, great. And the second one is that I don't remember whether you haven't mentioned that how many HEPZATO units been sold in the quarter. I guess, we can calculate that, but would you be able to just provide a number as well?

We had a price increase mid first quarter, so it probably isn't quite as clear as that. But I think if you just divide by about, let's say, $185,000 you'll get the number or close to within two units or so.

Okay. So could you elaborate the level of price increase?

Sandra, will you share the price increase to the timing?

Yes. We started the year on January 1 with a price of $182.5 and on February 1, we went up to $187.5

Okay, great. That's very helpful and thanks. The next question is that in terms of have you guys start to track to see how many patients -- the breakout of patients that are actually referred -- initially referred by oncologist versus those patients already in the interventional oncology, so to track in terms of the performance of the sales team toward the oncologist.

So are you asking, out of the patients or just how many of those patients were already at that center versus referred into that center?

Yes.

Kevin, can you give an estimate on that?

Yes, that's a great question and something we attempt to track as some of our indicators for the health of these centers that we're in. And I would say that right now, it's probably around 30% to 40% of the patients are organic to the sites that we have opened, with the remainder being referred from the outside.

Okay, great. That's actually go ahead, sorry.

Yes, I'm going to say and what's kind of there's two contravening forces there. We try to get better at generating referrals into the centers. On the flip side, as more centers open, there's less need for referrals. But that's a healthy. I mean, the reason we structured these territories with three different types of professionals, the liver-directed therapy manager, the clinical support or specialist is in there and then the oncology manager. That third person, their job is to get those referrals to those centers. And so they're clearly doing a decent job. Now some of these patients are self-referrals, but definitely, we're doing the introductions for many, many of these patients, oncologist to oncologist, to keep feeding the pipeline into these centers.

Okay, great. Maybe the last question here is that I'm just doing a quick scan in terms of the top line, particularly HEPZATO in the United States. And I just realized that you got roughly a $4 million quarter-over-quarter revenue increase up to this quarter. So it's almost 5 quarters when we started. I mean, was there any meaning you can extract from this or simply that just what happened kind of thing?

I think it's driven by center activation, and it hasn't been the same number of centers every quarter, but it's that's roughly what's causing that increase. We had, let's call it, three to five centers a quarter or three to that you're going to end up at the pace at which centers do treatment to kind of lead to that fixed increase every quarter. So it's not an exponential growth like you might get with a drug, but we'll keep this is kind of more of a typical device ramp, as you enter more centers, you get the growth.

And actually, let me see the last one here, which you may or may not answer, which is that can we extrapolate at least for toward the end of this year?

I'll pass on that one, yes.

Okay, great. Thanks a lot and congrats really congrats on the performance.

Thank you.

Ladies and gentlemen, that brings us to the end of today's event. [Operator Closing Remarks]