Good day, and welcome to the Delcath Systems Fourth Quarter and Full Year 2022 Financial Results Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, Delcath's General Counsel. Please go ahead.

Thank you. And once again, welcome to Delcath Systems' Fourth Quarter and Full Year 2022 Earnings Call. With me on the call are Gerard Michel, Chief Executive Officer; Dr. Johnny John, Senior Vice President of Medical Affairs and Clinical Development; Kevin Muir, Vice President of Commercial Operations; John Purpura, Chief Operating Officer; and Anthony Dias, Vice President of Finance. 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 earnings 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. Now I would like to turn the call over to Gerard Michel. Gerard, please proceed.

Thank you, everyone, for joining today. We have had a very productive 4 months since our last earnings call. I'd like to include the resubmission of the HEPZATO NDA on February 14 and the subsequent receipt of PDUFA date of August 14 from the FDA, the announcement of significant financing with high-quality investors and the continuation of a steady small publication for both commercial usage and clinical investigation of CHEMOSAT in Europe. On February 14, we filed the NDA resubmission for HEPZATO. And on March 20, the FDA determined the resubmission constituted a complete Class 2 response and set up PDUFA date of August 14. We look forward to working with the FDA through the review process of our resubmission. Since I know I will be asked, at this time, we do not know whether the application will be the subject of an ADCOM, but we will continue to prepare for 1 unless we receive notification otherwise. Obviously, receiving the FDA acceptance was a major milestone for the company, and it represents a culmination of many, many years of hard work by Delcath employees, our various partners, investigators and patients. Today, we announced a private investment in public equity or pipe deal, with health care-focused institutional investors as well as existing investors that will provide up to $85 million in gross proceeds, including $25 million in upfront funding upon closing. The financing was led by Vivo Capital with participation from the Logos Capital, BVF Partners, Stonepine and Serrado Capital as well as existing investors, including Rosalind Advisors. We are grateful for the participation of our existing investors and are delighted to have the financial [ backing ] of an additional set of investors. The new investors are well-known, long-term health care-focused funds who conducted an extended amount of due diligence…

Thank you, Gerard. Product revenues for the 3 months ended December 31, 2022, was approximately $639,000 compared to $246,000 for the prior year quarter from the sale of CHEMOSAT in Europe. In the fourth quarter of 2022, the company was selling direct and is not comparable to the fourth quarter of 2021, which we generated product revenues with our European distributor on a revenue share arrangement. Other income of $1.9 million for the fourth quarter of 2021 was related to the acceleration of amortization of the license agreement with medac, which ended in December 2021. Research and development expenses for the quarter increased to $4.4 million, compared to $3.6 million in the prior year quarter, primarily due to higher professional service costs, relating to the preparation of our NDA resubmission, which occurred in February 14, 2023. Selling, general and administrative expenses for the quarter were approximately $3.8 million, compared to $3 million in the prior year quarter. The increase was primarily due to higher headcount-related costs such as share-based compensation expense. On December 31, 2022, the company had cash, cash equivalents and restricted cash totaling $11.8 million, as compared to cash, cash equivalents and restricted cash totaling $27 million on December 31, 2021. During the year ended December 31, 2022, and December 31, 2021, we used $25 million and $22.6 million, respectively, of cash in our operating activities. The use of cash and operating activities partially offset by 2 private placements during 2022, resulting in net proceeds of $10.9 million. Also on March 15, 2023, we returned to Avenue the $4 million held in restricted cash to pay down a portion of our outstanding loan balance. On December 13, 2022, the company closed a private placement for the issuance and sale of approximately 1.5 million shares of common stock and…

[Operator Instructions] Our first question comes from Scott Henry with ROTH Capital.

And congratulations for just a lot going on in the past day or so or the past few days. A couple of questions I had. First, with regards to the PDUFA date, if you did get approval on that date about how long would it take between approval and product availability?

I think the fast this would be about 3 weeks, and it might take as long as 6 weeks. And the gating item, I think you know this pretty well, Scott, is not having have a product per se, but having a label product on hand. We can do that pretty quick. We are at our site in Queensbury, but our partner Neopharma who manufactures the melphalan, they'll need to label that with the FDA accrued label came through their QC processing and give it to us. John Purpura, our COO, has already negotiated with them then to hold some. I think it's more bright stock in hand, broken -- sublot, which they normally wouldn't do, so we can do that quickly. But I think 3 to 6 weeks is probably the range that we'll shoot for.

Okay. Great. And when product is available on the market, would you expect to book revenue simultaneous with product usage? Sometimes there's a lag -- and just trying to get to think of how we should think about potentially late 2023 revenues?

Sure. So we're going to sell direct. We're not going to go through or [ Cardinal ]. So there won't be any stock into the wholesalers or anything like that. Given the specialty product and the volumes you're talking about that wouldn't make much sense. So I think really, the revenue is going to be 1 of 2 models. One is it's going to be on consignment and when they use it, we'll book it or alternatively, they won't be on consignment and we'll book it as soon as it's shipped to them and they buy. Either way, I think the revenue -- I don't think any hospital is ever going to be carrying a lot of inventory of this. So I think the booking and the revenue is on a track very closely with the actual usage or procedures with the patients, unlike a more typical infused therapy or a pill where you have a fair amount of inventory purchased and held by wholesalers.

Okay. Great. And then with regards to build-out of reps, could you give us a sense of when you would start to hire people and approximately how much reps or marketing liaisons or how many employees would you expect to have in that unit?

Yes. So in terms of the overall field force, Kevin and I have been talking about probably something in the range of 8 reps. And the current thinking is 4 of those, roughly, again, this could evolve, we'll be more focused on medical oncologists and kind of pulling patients in into -- or pushing patients into the referral networks. And then for medical device types we're very familiar with interventional oncology, and they'll be kind of centered around the actual treating centers. And then those 2 reps will kind of partner together to help develop referral networks as well as open new sites. So I think all told about 8 of those. We've just recently signed a contract with the company to help us build a modest-sized medical science related sales force. I'm hoping to have the first of them out there and obviously kind of an estimate maybe as soon as 2 months hopefully sooner. And they'll start calling on medical oncologist's preapproval to try to establish those referral networks. So maybe 2 or 3 of those. But all told, even taking into account training, et cetera, I don't see having more than, let's say, 12 to 15 people in the field upon launch.

Okay. Great. And I'll just finish it up with a couple modeling questions. First, a lot of moving levers, shares outstanding, it looks like it will be about $10.1 million in Q1, jump up to $18-ish million in 2Q and then we'll deal with the warrants when that stuff happens. Is that assumption correct?

Yes. If you take a look at the I think Slide 36 of the investor presentation, we updated today and on the website. On an as-converted basis, the series preferred and E1s and the prefunded warrants, all of which are just plain vanilla, they're simply blockers for Rosalind. We doesn't want to go over 9.9%. That totals about 12.7 million equivalent common. The deal we did today of those preferred announced today, when those preferred apps convert, that will be about another 7.6 million shares. So in total, a bit over 20 million shares.

Okay. Great. And then just a final question. Could you just give me an estimate of pro forma cash and debt after everything kind of has went through the system here?

Okay. I need someone have to ask me a hard question. So I think about $23.5 million payment will come in that from the deal we did today. We were on getting kind of low, but -- and we paid back $4 million of Avenue debt. It's probably about, I'd say, let's call it about $24 million on the balance sheet. Now in terms of overall debt, there is probably about, call it, $9 million of debt, but we still owe. And there's another maybe $2 million or so of that, that is owed to ], but the that is essentially equity, and that was converted to about $11 per share. So that's probably the best way I think of that as another 200,000 shares there. So in terms of debt that we really have to pay back, it's roughly $9 million right now.

Our next question comes from Bill Maughan with Canaccord Genuity.

Congrats on the acceptance. So now with some more clarity on your financial outlook for the next few quarters, does that update your plans for your EAP? And if you could just run through those numbers in terms of how many patients you expect to have on around the time of launch and how many sites you expect to have up and running at that point?

Yes. I hesitate to -- I can tell you what I'd like to see happen in EAP, it really is -- we're going to really start testing it once we get some people out in the field talking to these treating centers that from which we want to have patients referred to our treating sites. But in terms of how many sites we have now, we have 3 that are open, really just 1 enrolling. The other 2 were trying to get the coordinated to get trained. But if a patient shows up, they will be trained. Then we have another 3 Thomas Jefferson, Stanford, Ohio. We're having discussions with -- the Mayo Clinic has 2 sites, and they're probably the most aggressive in terms of trying to get themselves up and running. So I'd say on the conservative side, it would be 5 EAPs up and running at launch and probably on the more aggressive side up to 8 or 9. In terms of how many patients would we like to see in the network, I mean, ideally, we'd be getting maybe 1 patient every other week, which is not a lot, but I think it will take approvals before we start getting them flooded. But if we had 1 patient every other week, let's say, in 6 centers, that would be a run rate of about, I don't know, $10 million, if that ran right into -- as soon as we launched that became paying customers, $10 million a quarter. Yes, that's -- we'll have to see how it proceeds. But again, I think one way to look at it, I think, is cap the number of centers we have, I think, a good healthy clip probably not out of the gate would be 1 a week. And then eventually, we try to peak towards 20 centers and 1 to 2 a week as we ramp up.

And now looking just at the overall mOM market, there is a convenient comp in a competitive launch that's going on now. When you look at HEPZATO versus Kimmtrak, is there a drawback that says that the kind of numbers that Kimmtrak is putting up or out of reach for you guys? Or do you think that what they're putting up is the kind of blue sky for HEPZATO?

Yes. I think a couple of dynamics at play there. The first is, well, let's what they did in the fourth quarter was $38 million in the U.S., $50 million globally. But in the U.S., we just focused on that. They're doing at about $152 million or so, I think, [ $174 million ] in revenue, which is fantastic for them on an annualized basis in the U.S. That probably represents half of the market that they have available. It's a little hard to tell. They have about 350 patients we estimate available to them. We have about 800 to the specific HLA phenotype. So if we did -- if we were priced exactly equivalently, we could do slightly under half the penetration in our and get the same type of revenue. Now we're not saying we're going to price exactly the same. I think many of you have heard me just throw out $150 million as [ 100 ] a kit as a placeholder, which is probably about 3/4 of the price point, give or take. But we'll just leave that as a placeholder for the time being. It's clear that what they need to do is get product into, I don't know, how many centers they have, let's call it, 100 centers and patients, those patients who will be able to drive and get their treatment and their medical oncologists just managing them probably doesn't really need to send them anywhere too far. The difference with us is we're going to have to get patients, most of them are going to have to get on an airplane, and we're going to have to give the medical oncologists to refer them out. It is not always so easy to get docs to refer patients out. So we have --…

Our next question comes from Swayampakula Ramakanth with H.C. Wainwright.

Congratulations. One quick question from me. With HEPZATO, the surgeon or the physician needs to learn the procedure as well. So how easy is it to learn the procedure? And also, would you be having any training centers, so that you can increase that option beyond the initial centers, who are involved in the study?

Yes. Thanks for that question, RK. No particular step in this procedure is technically difficult for the interventional radiologist or the anesthesiologist who's there or the perfusionist technician. What's important is that these things are done in a coordinated fashion, and that really is -- will be the focus of train. It doesn't make sense for us to put together a training center, because I don't think we'll have volume of doctors, who need to be trained. I know when we were at -- when I was at Vericel, we would do, the lack of a better phrase, pop up training centers where we bring in a bunch of cedaberties for -- to use the cell therapy unit, and we have 40 docs in it. I don't think that type of thing will work here. I think what we will do is have didactic training online that they can go through and it will be broken up by a team member. And then they will either attend the case, either directly or virtually watch a case. We'll set up probably both of those mechanisms for them. And then we will have a proctor come in. And the first case that is done will have someone proctor. We will likely have our own person capable of proctoring as well to augment that. So it will be a mix of all of us. But it will start with didactic training. Then we will have them virtually or see a case or travel to see a case and then when we'll have a proctor sit through the initial case for the team. And then we will have somebody pretty much in every procedure until we're confident that the team has it down. Yes, we don't need to do any technical type, very difficult technical portion of this, it's really a matter of making sure that the filters come out at the right time, the balloons go out at the right time, the blood pressure is managed in the right way at the right time. So again, it's a matter of coordination, not technical difficulty.

Okay. And then the second question is in terms of the CHOPIN study. You said there will be an update later this year. That's an IIT at this point. So would you take it under your wing once you get the approval for HEPZATO?

Yes. I think we hadn't really considered transitioning. And I don't know -- I've never been involved where you actually transition in IIT. In terms of a sponsored trial for a combination of immuno-oncology agents and have set -- CHEMOSAT, that's definitely something that we're very interested in doing, whether or not it's in this particular indication, metastatic ocular melanoma or another indication where IO is introduced. So I think it's definitely top of the list, on the top 2 or 3 things that we want to do is to continue to explore immuno-oncology agents in combination with HEPZATO. And I've talked about this before, this compelling rationale for that, a side effect of the product, which one could say was a bad thing. It's actually a good thing, and that's the local hepatic myeloablative effect that really resets the tumor microenvironment in the liver that ends up having probably systemic effects. So yes, we will definitely take under our wing, the idea or some type of trial or trials combining our treatment with combination immunotherapy.

Our next question comes from Yale Jen with Laidlaw & Company.

And congrats on all the development. Just a couple of quick ones. The first one is that, in terms of the financing, the remaining committed again, $65 million or $60 million. What sort of milestone that was anticipated and expected, so they will move those funding forward?

Sure. So we just got a $25 million right now as we speak, it's being wired in a $25 million financing. The second -- the first warrant tranche will be for about 7.8 million warrants that are exercisable at $4.50, which is about $35 million. Those are 3-year warrants. However, the expiry of the warrant is accelerated once we're approved to 21 days after approval. So essentially, the warrant holders need to exercise that warrant once we're approved. So that's the first milestone that would -- should yield $35 million in gross financing. Once we achieved $10 million in gross revenue in a quarter, that will trigger a second accelerated expiry within 21 days of us announcing that. And that will yield a little later 4.2 million warrants priced at -- excuse me, exercise plus $6 a share, and that's another $25 million to the business. So that's why we think in aggregate things build according to plan, and we know things don't always go according to plan. But if things go according to plan and we have a bit of question here, we should be able to get the cash flow positive without having to do any more financing.

Okay. Great. That's very helpful. And the next question is that you and I talked about before and that you have talked about the pipeline development and giving what the cash you may have going forward, certainly, many of those can be executed. So have you sort of set up some sort of priority and the region -- the areas to explore in terms of the pipeline development, other indications, for example?

Yes. We have 3 areas that we're very interested in ICC, because there's tremendous interest in investigators, especially in Europe for that, and there's really the large unmet need there. That's another orphan indication. Then colorectal begets the #1 metastatic -- liver metastatic cancer. And there are a number of sidings we can go with there. And then the third is kind of a more of a basket area of liver mets where the primary cancer is being treated with IL agents. Now in terms of how quickly we can get to that, our hands are rather full at the moment, prepping for an ADCOM answering or be ready to answer FDA information requests as well as prepping for launch overall. I think we'll have to build out the team with all of that on our plate before we can aggressively pursue other indications. With that said, we will do work such as advisory committees exploring some of these ideas, trying to write some protocols, get those down on paper. So even if we move with reasonable speed, it probably would be a good year or so before we could spend any significant amount of monies on that from where we are right now. So I think the shorter answer is we'll be planning and planning for 1 of 1 or all of those 3 areas I just discussed. But in terms of actual impact on our P&L and increasing our burn in the R&D area, it will be at least a year out.

Okay. Great. That's very helpful. And then maybe the last question is that given that you take back the European sales, do you anticipate with the approval in the -- potential approval in the United States going forward? You maybe have also increased the price for the product and maybe just increase the revenue in the regard as well?

Yes, I think as you probably know, it's tough to move prices up in Europe once they're set. We're not approved yet. The reimbursement in the U.K. we used there. That would probably be the first test to see how far we can move things up from where it is now. Germany, the price is set, it would be kind of hard to move it up too much. And it is a very difficult situation that the price will be surprisingly quite a bit lower for the device stand-alone in Europe versus the combination drug device in the U.S. There are advantages for how we're approved in Europe. Given that it's a CE Mark and the CE Mark is for the use of CHEMOSAT to the liver , and it is tumor agnostic, and that gives us a bit more flexibility in terms of developing the product and doing smaller trials and such and letting investigators use it on their own where they think it's applicable and having open conversations about it. So it's -- you've noted the amount of data coming out of Europe without us really doing much besides supplying product that will likely continue to happen in a variety of cancer types, which might yield benefits in the U.S. given that small publications, although they're not going to get you labeled for use and we are not going to promote based on small publications. Doctors do note it and it can lead to reimbursement of the doctor believes it's worth a shot. So we have ICC publications that come out because of the invent work investigators. And again, that's partly driven by the CE Mark used for in any cancer. And we've had used in breast cancer and a number of other things that look promising. So it may be that it's just a source of publication for us despite the low price, we may end up being very happy with just the data it's been generating.

This concludes our question-and-answer session. I would like to turn the conference back over to Gerard Michel for any closing remarks.

Thank you. I appreciate everyone's questions and attention today, and I'd like to thank our existing and new investors, who've gotten involved with the business. Without those folks, we'd be nowhere. And I look forward to speaking to everyone in about 2.5 months with another update. Have a good evening.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.