Equity research analyst here, and we're pleased to have with us today CorMedix. Joining us from the company is the Chief Executive Officer, Joe Todisco. Joe, it's good to see you. Thanks, Greg. Appreciate it. Yeah, so a really important time for CorMedix, and maybe for those who aren't as familiar, let's just run through a brief introduction to the company and to DefenCath, which- Yeah just a recently approved product. Sure. Thanks, Greg. And, it's good to be here, this year and being able to characterize us as a commercial stage biotech company, right, as opposed to pre-commercial stage. So, we got approval for the lead product, in November, which, as you mentioned, is DefenCath. DefenCath is a, is a novel product approved by FDA, for the prevention or, sorry, the reduction in risk associated with catheter-related bloodstream infections for hemodialysis patients that are undergoing hemodialysis with a CVC. That's a bit of a mouthful, I understand. That's the initial indication. Obviously, there's other areas that we're exploring, beyond, which we'll talk about momentarily. But the product is the first ever, catheter lock solution approved by FDA. It's the first ever antimicrobial, catheter lock solution approved by FDA. The drug is a combination of heparin, which is traditionally used to lock catheters, and our proprietary new chemical entity, which is taurolidine. Taurolidine is a non-antibiotic antimicrobial. It is broad-spectrum activity against Gram-positive and Gram-negative bacteria, as well as fungus, but it does not demonstrate any antimicrobial resistance. So the product was approved in November. We're in the process of launch. We commenced our inpatient launch on April fifteenth, and we're targeting commencement of our outpatient launch on July first. The utilization of the product, specifically in chronic hemodialysis, spans both settings of care. The larger market from a volume standpoint is on the outpatient side, where we estimate the market size is about 40 million vials a year. The inpatient market is about four. We commenced launch first in the inpatient setting because of the timing of reimbursement. Inpatient reimbursement, by way of NTAP, was already in place. Our outpatient reimbursement, which is another acronym called the TDAPA, takes effect July first. And, you know, I feel like we're firing on all cylinders right now. Yeah. Great. Yeah, congrats on the progress, not just the approval, of course, but the launch. It's an important milestone for any company. And just for a running start, and you touched on this a bit, but how is DefenCath differentiated from the current management of infection prevention related to catheters and bloodstreams? Certainly, many ways to do that, maybe not as standardized as a label product. I think there's some key features to go through about DefenCath. Yeah, sure. So, largely, there, you know, there are a large number of providers that aren't taking any mitigation steps, right? You know, for the, for the reduction or prevention of infections. So, you know, from a catheter lock solution standpoint, DefenCath is the first, ever approved by FDA. There are some institutions that do use, on a limited basis, some compounded, whether it's gentamicin or, they can compound minocycline. I think there's a large number of reasons why you wouldn't want to use a compounded antibiotic, certainly on a long-term basis. Building antibiotic resistance. In addition, antibiotics tend to only have activity against certain strains of bacteria, right? They tend to either focus on either gram-positive or gram-negative bacteria. There are also providers that are using antimicrobial caps from a standpoint that have been on the market for about 10 years. You know, I'd say despite the presence of all of those products in the market, you know, when you look at macro-level data, catheter-related bloodstream infections have continued to grow. Right, they grow at about 5%-7% year-over-year. So clearly additional intervention is needed, and it's still a critical unmet medical need. These infections are the most debilitating side effect, I think, associated with getting hemodialysis through a central venous catheter. They happen at a very high rate. About a third of patients experience an infection at some point. They happen fast. More than half of infections happen in the first 90 days that a catheter is inserted, and then they kill at a very high rate. Right, about 20%-25% of these infections end up fatal. So you know, the change in life expectancy between having an infection versus not having infection is pretty drastic. Great. And one month in, very early, but how should we be gauging initial launch success and that progress in the inpatient setting, and maybe just pointing us to what we should be looking at and tracking? Sure. So, you know, obviously, this is not a traditional product from a standpoint of a retail product. It gets prescriptions, and you look, right, prescriptions and the trends. So I know that's difficult to look for kind of leading indicators of how launch is going. On the inpatient side, you know, our initial deployment is focused on just under 900 hospitals that represent about 65% of the market opportunity, right? 65% of the inpatient dialysis procedures are performed at only about 12% of the hospitals. So it's a highly concentrated number of institutions, mostly in urban centers, right, that are performing the dialysis. So I think we've only been field deployed, you know, for it. You can still measure it in weeks, right? In terms of how we're field deployed. I've been really happy with the level of progress we've seen, in a short period of time in terms of... It's a long process to get, inpatient uptake for any drug, right? You have to get through this, P&T process, within the health systems and the hospitals. First step is building a champion within the other institution and getting scheduled for P&P formulary review. In only a few weeks, we've had good progress. We've had, call it more than 50 key accounts that represent about 200 hospitals, essentially give us a verbal that they're gonna take the product to, to formulary review. We've got about 20 meeting dates, right? We're still working to get meeting dates for the rest of those 50. Those meeting dates vary, right? We've got some dates that are as early as May and some as far out as September. It really depends on what the meeting cadence is for the, for the institution and when we can get that, get that scheduled. But I've been really happy with the progress that we've seen. I think I've guided on the inpatient side, right? The sales ramp's gonna be slow. When I think about what our inpatient strategy is, I think it's much more long term about building a sustainable, durable business, right? And helping patients in that segment, that's probably gonna take a couple of years to build to get to, to peak. I think on the, on the outpatient side, in contrast, which we're, we're kicking off in July, I think you're gonna see a little steeper, steeper ramp. I think you're gonna see quicker ordering. I think it's easier to initiate therapy in the outpatient setting at the institutional level, and I think it'll just be a little bit faster of a ramp. Great, and I certainly wanna talk about and cover the outpatient launch and that prep. But as you're into the inpatient and working on all those key efforts, maybe just provide some of those anecdotes or some of that initial feedback that you're receiving from the centers, and certainly with those where that participated in the trialing and have had access. But also just about the logistics and the uses as really you're forming the market and establishing those touchpoints. You're talking about on the inpatient side? Yes. Okay. So on the inpatient side, you know, I think it's a little earlier. We really haven't had any P&T committees yet. And that's the feedback that I'm actually looking to see and what's formulary determinations are made and how they actually whether they put it, whether they approve it on formulary or they approve it formulary on label, right? I think those are the determinations that we're looking to see that will then inform, all right, how much additional work do we need to do, if any, for pull-through, right, at the-- at those institutions. So I expect over the next couple of months, we'll be getting that feedback. You know, we've seen a small amount of units trickle out of some hospitals. As I said, I don't expect material uptake on the inpatient side until, you know, you start getting formulary adoption, yeah, and, and it really starts getting into the standards of care within those institutions. Yeah. Okay. All right. And then just on the gear-up for the outpatient launch, just talk about that strategy on a regional basis, the aspects of the supply chain that will be in place. Well, I think before I get to supply chain, let's talk about the customer a little bit. So, right, you've got a very concentrated market on the outpatient side. You've got two large dialysis operators, you know, let's say they're 75% of the market. You've got another three in the top five, they get you to 90%, and, you know, another couple more, they get you to 95%. So it's very concentrated within the top 10 dialysis providers. You know, from a supply chain standpoint, right, the logistics of shipping there, it essentially, some have their own internal 3PL, right? A large dialysis operator may have one ship to point. Some of the mid-sized guys might need, you know, a distribution set up where you're shipping to 500 clinics. So, those are actually the details we're working through right now with a number of the dialysis operators, trying to figure out how many, you know, where do they want us to ship to, how often, how are the orders coming in? Do they have EDI capabilities? These are the kind of the logistical hurdles that I mentioned on the earnings call that we're working through. This is what we're talking about. I haven't seen anything insurmountable, right? I think it's all a matter of how we structure it and make sure that we accommodate, right, the ordering needs of the customer up front kind of thing. Great. Great. And, and then, just in terms of the ARC Dialysis agreement in April, I believe it was, and just walk us through sort of the sequencing there and what that means. Well, look, I think ARC is a good, call them a small to mid-sized dialysis provider, regionally based down in town in South Florida. They're growing quite quickly, you know, 20 dialysis clinics, so a fraction of the size of one of the larger guys. But I think it's important, first of all, to get that kind of first brick in the foundation laid. I think it's for a smaller dialysis center, it's—I think it's a little easier for them to move quickly. Obviously, trying to implement a drug product in 20 centers is a lot easier than 2,000. But no, I think that's an important relationship for us. I think we're gonna have to put together a number of those small to mid-size centers as we, you know, we look for growth. You know, certainly, you know, we've disclosed last week on our earnings call where we're what we're calling advanced stages of negotiation with one of the two large dialysis operators and a couple of the mid-sized guys and smaller people. So I think the hope is over the next few weeks that, you know, we communicate more in the way of agreements, and they can start talking about what does uptake look like. Great. Great. And you've mentioned this, a path to a break even, and maybe just remind us of some of the assumptions or base cases in order to get there. I think the way that I would frame it, or the way that I framed it on the earnings call, is, right, we've said it's a pathway to run rate break even by the end of December. You know, we think we've guided operating expense between $15-18 million a quarter. I think that, when you think about the size of the market, right, in total, the% of penetration that you kinda need to get there, outpatient wise, right, it's not that substantial. I think in our base case, what we've communicated is we've got some limited adoption at one of the large dialysis operators, and then, you know, some adoption from some midsize and small people, right? So it's not, it's not as if we're counting on massive adoption, right, to get to the break-even point that quickly. Maybe just frame up just the reimbursement via TDAPA, just in terms of those differences in the first couple of years, the latter three years. There's just certainly a dynamic impact that this could present, and it's always complicated, so- No, absolutely. And it's TDAPA, first of all, is a fairly new reimbursement program. It's that CMS has, I think, refined 2 times already, and I think they're probably gonna. And for the better, and I think they'll continue to refine it for the better. Obviously, they want to incentivize innovation. You know, the way it is structured today, you get essentially it's 2 years reimbursement. The first 6 months will be kind of at WAC, right? It gets reimbursed, and it's WAC plus 0, then ASP plus 0 for the next 18 months. And then years 3, 4, and 5, there's a bundleized adjustment that's based upon. There's a formula, and it's based upon the prior year of utilization. So, you know, in theory, the dialysis operators would have incentive to maximize utilization that second year for the benefit of bundle. You know, I do think you'll see you potentially could see some adjustments to year 3, 4, and 5, such that reimbursement should track the product as opposed to bundleizing. I think that's certainly something that's been discussed, not guaranteed. But I think if, as an example, if you had one dialysis operator adopt and another not, you know, it wouldn't make sense to reimburse them for not utilizing the product. But you know, I think we're happy with having a 5-year structure because it allows us to structure essentially a 5-year agreement with a dialysis operator and account for that change in reimbursement built into the contract. Great. Great. And then I know you're taking steps to basically de-risk the supply chain and afford some redundancy. So what's the latest on the manufacturing and building for the longer term? Yeah. So, from a finished goods standpoint, as you know, we have a great relationship with our primary manufacturer, Rovi, out of Spain, where we've gotten the product approved. As I mentioned on the earnings call, we've just submitted a supplement adding Siegfried in Germany, who's a very large, well-known, CMO. And we'd expect them to come online, early next year, assuming that the supplement gets approved late this year. You know, between the two of them, I think we have more than enough capacity to supply over 100% of the market, right? If we had that market demand need. You know, and beyond that, what we're looking at now is, you know, with respect to our two core APIs, you know, we're in the process of putting plans in place to de-risk those as well. Fantastic. And then when it comes to just exploring additional opportunities, certainly have some white space, but also some degree of prioritization and sensibility about where to take DefenCath next. Yep. And while focus is certainly on the launch, how are you thinking about that and laying out those potential paths? Yeah. So, again, we talked about a little bit more about this last week. You know, in a perfect world, DefenCath could pursue an indication for just prevention of infection in catheters, but that's not, unfortunately, how you're able to design studies from an FDA standpoint. They look at things on a disease state basis. And, you know, so we've identified, I think is, is kind of two critical areas where, we do see somewhat either high rates of infection or high rates of risk from infection to the patient population. The first of those being total parenteral nutrition, right? So total parenteral nutrition, where the patient population is, is smaller than, than in hemodialysis, but the catheter needs to be locked every day, right? And they have a very high rate and risk of infection. So we've submitted our type C meeting request to FDA earlier in this year. We're expecting to get comments back from the agency around a potential study design and protocol for TPN. We elected to prioritize that ahead of oncology, even though oncology is potentially a larger market opportunity because of what we perceive as the cost and speed of the program and the ability to hopefully get an expanded label a little more quickly. On the oncology front, I think we wanna wait and see some of the answers to what we've proposed on TPN, and then we'd hope to come back to FDA later this year with another meeting request and a protocol for an expanded label in oncology. Okay, great. And just remind us of just the patent estate and the intellectual property perspectives of DefenCath, especially as it's always understandable that folks wanna think about generalization and other competitors entering the market longer term. Sure. So right now we've got four Orange Book-listed patents, right? And we've got a market exclusivity of ten years. That's five years of new chemical entity, five years of QIDP. We could potentially get another half year of exclusivity for running a pediatric study, which is currently in discussions with FDA. And, you know, three of the Orange Book-listed patents do expire before the ten years of market exclusivity, but we do have one that goes out to 2042, which we do think provides reasonable protection from generic competition. Great. Great. We talked about breakeven a bit, but maybe just remind us of, you know, your, your resource positioning, your cash in that runway. So, we closed the last quarter with just under $60 million cash on hand. Sorry. That was me. Okay. With just under $60 million cash on hand. And we recently just took steps to give ourselves, let's say, flexibility, if as we're progressing through the year, you know, we end up tracking either our base case or even better than our base case, right? So, you know, as I said, we've estimated we can get to run rate breakeven by the end of December. Doesn't mean we're necessarily gonna allow minimum cash to run below certain levels. You know, we were asked on the last earnings call why we didn't do a raise post-approval. and I think my, you know, my answer to that is it'd be premature and potentially irresponsible, right? To do something unnecessarily dilutive to the stock. Right now, we see us tracking toward our base case. You know, we're gonna continue to evaluate that. You know, once we really get a look at orders in July and August- Mm-hmm. you know, we'll know if any additional capital is needed for a bridge. We've put an ATM in place, as well as we've just announced, an LOI for a $25 million revolving credit facility, that we hope to close in the next couple of weeks, which will allow us to draw down against receivables. So I think those two provide good alternatives. Obviously, you know, we take dilution very seriously and would look, you know, when possible, to minimize dilution, but also wanna be able to make cost of capital-based decisions, right, you know, between debt and equity. Great. Great. Any questions from the room? Thanks, Joe, for taking my question. I just wanted to understand a little bit about the integration when it comes to expansion, you know, TPN oncology. You know, maybe if you could just lay out the integration process for DefenCath, if approved in any of these indications. Do you need to go through a formulary process from scratch on the inpatient front? Or can you cut down on the timeline to sort of accelerate that ramp on inpatient in these indications? Thank you. Are you talking about for inpatient, you're talking about hemodialysis or TPN? For TPN and then oncology. Okay. So for TPN, I look, and this is all obviously a lot of hypothesizing, right? Because we're talking a couple of years down the road. My expectation would be that if we're, you know, already on, right, formulary, right, for HD in a health facility from an inpatient standpoint, I do think there'd likely be potentially additional PNT review. I would hope that if we're already have already shown efficacy, it would be a very quick, quick review. But I still would believe there's some type of administrative process, right, to... When a formulary adopts an institution, they usually adopt it with restrictions, and those restrictions being the label, right? For them to expand, even if a label expands, you know, probably requires additional buy-in from the right, the ID docs. You're welcome. Looks like we're good. No, no other questions. Joe, great to see you. Appreciate all the updates, and look forward to all the updates to come. Thank you. Thank you, Greg. All right. Thanks, Joe. Appreciate it. Thank you, guys.