Good day, welcome to the Delcath Systems Reports Q1 fiscal 2023 financial results call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to David Hoffman, General Counsel. Please go ahead. Thank you. Once again, welcome to Delcath Systems 2023 Q1 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, General Manager of US Interventional Oncology, John Purpura, Chief Operating Officer, and Anthony Dias, Vice President of Finance. I'd like to begin the call by reading a 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 27 A of the Securities Act of 1933 and Section 21 E 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. Since filing the NDA resubmission on February 14th and receiving a notice on March 20th that FDA determined resubmission constituted a complete Class 2 response, the company has been working with the agency on the review process as the August 14th PDUFA date approaches. This primarily entails a routine information request that would be expected during an NDA review. Since I know the question will be asked, at this time we have received no indication about whether the agency will schedule an advisory committee meeting. Of course, until we hear otherwise, we will continue to assume one will be scheduled. Given the recent financing and the approaching PDUFA date, we are accelerating our preparation for the commercial launch of HEPZATO, if approved. Our commercial model will be comprised of referring oncologists and treating centers. A core part of that preparation is the identification of potential commercial treating sites, which are sites that are either trained in treating patients in the Expanded Access protocol prior to launch or committed to becoming trained within a few months after approval. As we have mentioned before, Delcath currently has three sites enrolled in the Expanded Access Program, with four more sites undergoing startup activities. In addition, approximately five other sites have expressed their intention in becoming treating sites if the HEPZATO KIT is approved. In total, we believe there are over 10 sites with the potential to become treating sites in a relatively short timeframe post-launch. While we will continue to seek additional treating sites, we believe this number of identified sites will ensure that we do not have treatment bottlenecks as referrals build from medical oncologists post-launch. A second key component to a successful launch is outreach to medical oncologists. Recall that the majority of our U.S. investigators in the FOCUS trial were surgical oncologists. While we have a number of very supportive metastatic ocular melanoma KOLs, we need a broader set of medical oncologists familiar with our data. Thus, we have started to build a medical affairs team. We will have MSLs out in the field by next month. Post-launch, the MSLs will continue to focus on medical education with oncologists. We have also begun recruiting for the sales force management team. The sales force will be bifurcated, with one team focused on supporting existing treatment centers and working on opening new treatment centers, with the second team focused on calling our medical oncologists to facilitate the potential referral of appropriate patients to treatment sites. Turning to ongoing clinical work, because we have spoken about the preliminary CHOPIN results extensively on past calls, I won't review those results yet again. However, I will note that the independent investigators conducting that study have informed us that they are on track to publish a pre-planned interim analysis by the end of this year. The analysis will include 40 of the planned 76 randomized patients comparing percutaneous hepatic perfusion with CHEMOSAT alone, with percutaneous hepatic perfusion with CHEMOSAT plus Ipilimumab and Nivolumab. Based on conversations with treating medical oncologists, we know there is strong interest and anticipation for these pending interim results, given the signal seen in a small phase I study and the prevalence of immuno-oncology therapy in the treatment of metastatic ocular melanoma patients. As previously reported, on March 29, the company closed a private investment in public equity deal with healthcare-focused institutional investors as well as existing investors that will provide up to $85 million in gross pre-proceeds, including approximately $25 million up-front funding. The financing was led by Vivo Capital with participation from Logos Capital, BVF Partners, Stonepine, and Cerrado Capital, as well as existing investors, including Rosalind Advisors. We are delighted to have the financial backing from these high-profile healthcare-focused funds, and we believe the initial $25 million will be adequate to support the ongoing commercial launch preparations. The previously mentioned financing will trigger another $35 million in gross proceeds upon approval and then another $25 million in gross pre-proceeds upon achieving $10 million in quarterly revenue. We announced that we had reached an agreement with Avenue Capital to resume the interest-only period on the Avenue loan from March 31st, 2023 to September 30th, 2023, deferring approximately $4.3 million in principal payments. Together, these two financial transactions greatly enhance our ability to appropriately fund launch preparations and should eliminate any perception of a financing overhang, which often hinders share price appreciation upon product approvals. I look forward to taking questions in a moment, first we'll turn the call over to Tony to review the financials. Tony? Thank you, Gerard. As stated in our earnings release, we're in the process of completing our customary year-end close and review procedures, including certain valuation work associated with the issuance of the warrants and preferred stock in Delcath's previously announced private placement that closed on March 29th, 2023. As of and for the quarter end March 31st, 2023. Delcath's full Q1 2023 financial results will be reflected in the quarterly report on Form 10-Q, which will be filed no later than May 22th, 2023. Revenues is expected to be approximately $600,000 for the three months ended March 31st, 2023, compared to $378,000 for the three months ended March 31st, 2022. The estimated increase in product revenue is due to the transition to direct sales in Europe, which occurred in March 2022, as well as an approximately 37% increase in unit volume. For the three months ended March 31st, 2023, research and development expenses are expected to be relatively flat as compared to $4.5 million for both periods compared to the three months ended March 31st, 2022. As of March 31st, 2023, Delcath had cash equivalents and restricted cash totaling $24.3 million, as compared to cash equivalents and restricted cash totaling $11.8 million as of December 31st, 2022. The increase in cash of $12.5 million was due to proceeds from the private placement which closed on March 29th, 2023, offset by the use of $4.3 million of cash in operating activities and $6.3 million of principal payments towards the company's existing loan with Avenue. That concludes my financial remarks. I'll ask the operator to open the phone lines for Q&A. Can you please check for questions? Thank you. We'll now begin the Q&A session. To ask a question, you may press star then one on your touch tone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our roster. Our first question comes from Yale Jen from Laidlaw & Company. Please go ahead. Good morning, and thanks for taking questions and congrats on all the progresses. I've got two here. One is that, given you guys already have, you know, will have, more, cash, any thoughts or any plans in the pipeline development? I have, follow-up questions. Yeah, Yale, we're gonna restrict, you know, our pipeline activities to probably advisory committee meetings for the time being. I think our primary focus is a successful launch. With that said, there will be activity in parallel going on with the care, but I don't see any significant, you know, actual clinical dosing patients probably till sometime next year. Now, with that said, you know, we are prepared to support investigator-initiated trials as they are, you know, put in front of us by interested oncologists. You know, we're hopeful that we'll have a number of those started probably later this year, whether it's additional combination trials with immuno-oncology agents or trials in other indications. Next year, without a doubt, we will be running trials, in other indications, both other tumor types, and likely, other indications combined with immuno-oncology agents. Okay, great. That's very, very helpful. Then maybe one more question here, which is one of the competitors, I think, recently reported that their studies in the ocular melanoma both in the first line as well as in the broad lines. Any thoughts, any comments on the whether what type of possible sort of competition may happen or not happen? Any color would Yeah. thanks. Yeah, I think we re-referring to CHOPIN data, which I thought looked quite good myself. Their ORR and duration of response, you know, looks more like in the realm of what we're seeing with our product. I think what's important to note is two things. One, most patients go through more than one line of therapy. The second thing is most medical oncologists treat this disease, believe patients should get both a systemic therapy, as well as a local regional therapy. The latter, of course, is what we are. I don't see additional systemic therapies coming out as being a direct competitor with us. You know, I think the question is what goes first, a systemic or a local regional therapy? I think more data needs to be generated to determine really what's best for the patients. I would note that most of these patients, when they do succumb to the disease, it is usually due to liver failure from liver mets. I know there'll be a place for us at some point for most of these patients. Okay, great. That's very helpful, and I appreciate that. Yeah, congrats on the progress. Thank you. Yeah. Our next question comes from Swayampakula Ramakanth from H.C. Wainwright. Please go ahead. Thank you. This is RK from H.C. Wainwright. Good morning, Gerard. Just a couple of quick questions from me, too. In terms of the EAP program that that's being run, could you give us an idea of how many patients have been treated so far or being treated under this program? Also, any commentary on the experience so far, from both physicians and the patients? Right now, well over I think we may hit 40 patients at the start of this year, so they're probably well past the 40 at this point. I don't have a precise number. If I had to guess based on the pace, and it's an estimate from me, it's probably somewhere in the range of 50 patients out of the 76 that need to be treated. It is, you know, a randomized trial. ORR is the objective response rate is what we reported in the interim data, and they're not sharing those results with us as time goes on. Of course, as is appropriate, they should not share that with us. All I can say is we're very hopeful that the data, the signal that was seen in the small number of patients, seven patients early on, will continue to hold, but we'll have to wait. If we turn to the seven patients, they tolerated the sequential treatments quite well. I don't believe there were any toxicities that the physicians didn't think they could handle or that would be undue for the patients. That was a very important issue to start with. Then again, as I've talked about before, very, very high response rates, 100% duration... 100% disease control, 86%, I think, response rate and, you know, two and a half years roughly of duration of response and, PFS, at this, the last data cut. Fingers crossed that that level of response and duration, can be held with the larger end when we get the interim data, later this year. Fantastic. It's encouraging that, you know, you're getting more centers, signing up for getting ready to adopt when HEPZATO becomes, you know, approved. At this point, what do you think is the market in terms of, like, number of centers who regularly do liver-directed therapies, and, you know, which can be, I don't know if you're kind of dividing the market into different tiers as, like, early adopters and, you know, adopters that you have to work on to gain their confidence and start using HEPZATO? In terms of the number of centers that do liver-directed therapy, it's. I don't know the precise number. It's at least in the hundreds. If we think about TACE and Y90, which are, you know, the two primary liver-directed therapies. For this particular indication, we have no need, nor would it be prudent to try to get into any meaningful percentage of that. You know, I think if we had 10 centers up and running within three to six months or within three months, let's say, of launch, that would be fantastic. I can't see us ever going past, and this number might flex down or up, but I can't see us going much past 20 centers, maybe 25 at peak. The reason for that is we wanna keep close tabs of these treating centers, and again, recall that it is only about. Well, it's hard to say, but we're saying some people say we're conservative, but we're saying our chance is 800 patients. You know, I don't wanna have a center doing, you know, one of these every three months. You know, I'd like to see centers doing at least two a month just to make sure they're well-trained, the team is up to speed. Again, I think, you know, 25 at the most to peak. I'm very happy with 10, you know, one to two quarters, post-launch, if we can accomplish that. You know, that'll be the phenomenal launch if we'd have the referrals, you know, up the pipeline to support that, to support those centers. Very good. Thank you very much for taking the questions. Again, if you have a question, please press star then one. Our next question comes from William Plovanic from Canaccord Genuity. Please go ahead. Good morning, and thanks. Of the initial 12 or so sites that are either currently online or have expressed interest, do you have a sense of how many patients they represent? Then second question, are you at the point yet where you can have even preliminary discussions with payers? Do you have any sense of how they, how they'll onboard, you know, payment for HEPZATO as it launches or any sort of timeline on that? Thanks. Sure. Let me handle that first part of the question in terms of how many they represent. Kevin, I'm going to ask you to talk through kind of the dynamics with hospitals and reimbursement in a moment. In terms of the number of patients they represent, shooting from the hip, maybe 30% of those 10, maybe 40, because we're that surprisingly focused on centers that already have a set of patients. That's not really, you know, that's not what's so. That's only part of the equation. The other part of the equation is going out to medical oncologists, we're not intending to open sites and getting them to refer to these treating sites. That's the other part of the equation. Now the reason, you know What we have to make sure for both parts of that kind of equation is for treating sites, you know, some sites might not be able to do more than 1, you know, two a month. Others might be able to do eight a month. It varies. If we assume that That four a month is the average size, so if you think about one a week probably will be kind of average for sites. If we assume that, you know, then 15, 20 sites is more than enough to generate $700 million worth of revenue. The key to that is getting the patients referred to those treating sites. Again, as I said before, we don't want sites that do, you know, one every two months. Ideally, we'd have a site doing about four a month. This concludes our Q&A session. I would like to turn the conference. Oh, hang on. No, no. What we did... No, no. Oh, I'm sorry. Kevin, can you chime in? Kevin, can you chime in on the reimbursement for the hospitals when it comes to that dynamic? I can. Yeah, I can. You know, over the past period of time, we have done some significant market research with the payers. So far, you know, through that market research, we found We think our strategy is prudent. We have a market access team in place, and we are prepared to handle the questions that we get. The true outreach to the payers will happen shortly upon approval when we are taking our EAP patients and converting them from clinical patients to commercial payments. Like I said, you know, I mean, from a market research standpoint, we think we have a sound strategy. We've talked to some of the payers, but we'll see how that w e will, and we're confident that when we take those payers or, I mean, the patients from, clinical to commercial, the strategy will prove itself out. Yeah, I think that's important. Got it. Kevin, is, you know, the majority of the patients will be outpatients, correct? Yes. The reimbursement will be under a C-code, correct, initially? Initially, we'll start with, the traditional path of a, of a C-code and, hopefully go to a J-code shortly after. Right. For the majority of patients, it will be a passthrough expense. Yes. Given this is an ultra orphan product with the minority of patients that may end up being treated on an inpatient basis, i.e., they need to stay an extra, you know, night past a single night, what our hub services told us, is that given, you know, the small number of patients here and the fact that these are very sophisticated, academic centers they're working with, that they probably. It's not going to be an issue of bundle payments. They'll be able to maneuver through that. Again, the bulk of these patients will be outpatient patients, so it'll be a passthrough. Got it. Thank you very much. Okay. This concludes our Q&A session. I would like to turn the conference back over to Gerard Michel for any closing remarks. Yeah. I just wanna thank everyone for taking the time this morning to listen in. We have, you know, a lot of work ahead of us as we prep for a launch, but, you know, we're gonna keep our heads down and push forward. Thank you again for the support. Have a great day. Conference is now concluded. Thank you for attending today's presentation. You may now disconnect.