Again at the Citizens JMP Life Science Conference. I'm Jason Butler, one of the biotech/biopharma analysts here at Citizens JMP. Excited to start, at least my day off, by introducing CorMedix. With us is Joe Todisco, the company's CEO. Joe, welcome. Thanks. An exciting time for CorMedix, currently launching their first commercial drug, DefenCath, in the dialysis setting. We'll talk about the data, the launch, et cetera. But I'll start off just by turning it over to Joe to give a quick intro and overview of the company from a high point. Sure. So CorMedix is now, it feels good to say this, a commercial stage biotech company. We're in the process of launching our first drug, which is DefenCath. DefenCath is the first-ever catheter-lock solution approved by FDA, as well as antimicrobial catheter-lock solution approved by FDA. The initial indication is for the reduction in risk associated with catheter-related bloodstream infections for patients undergoing hemodialysis through a central venous catheter. The product is a combination of taurolidine and our proprietary new chemical entity of heparin and our proprietary new chemical entity taurolidine, which is a non-antibiotic, antimicrobial, has broad spectrum activity against Gram-positive and Gram-negative bacteria, as well as fungi, but has not demonstrated any antimicrobial resistance. So we've built out the field team. We launched in the inpatient setting on April 15th. We're in the process of gearing up. Our outpatient launch is scheduled for July. Those two dates are determined based on reimbursement. On the inpatient side, we already had a New Technology Add-on Payment and reimbursement for inpatient facilities. Our TDAPA, which is our add-on payment to the dialysis bundle, takes effect in July. So we're working with dialysis operators on the outpatient side to affect that launch in July. Great. Obviously, you want to spend most of the time talking about the launch. But don't want to forget the phase III data, because it was so strong. So can you just give us an overview of what the product has shown it can do? Yeah. As you mentioned, incredibly strong phase III clinical data. Our LOCK-IT-100 study demonstrated a 71% reduction in risk associated with catheter-related bloodstream infections compared to the standard of care, which was locking the catheter with heparin. I think as important as efficacy from a safety standpoint, there were no material differences between the two arms of the study from an adverse event standpoint. Good. And I guess just underlying this, I think it's really important to remember the risk and the burden to the patient. So can you just give us kind of. Look, it's one of the most debilitating side effects associated with getting hemodialysis through a central venous catheter. These catheter-related bloodstream infections happen incredibly often, right? Up to about a third of patients are going to get an infection at some point. Most of them happen in the first 90 days that a catheter is inserted, right? So they happen a lot, and they happen incredibly fast. But most troubling is that they kill at a very high rate, right? 20%-25% of patients who contract a catheter-related bloodstream infection ultimately will die from the infection. So it absolutely is a critical unmet medical need. I think we're thrilled to be the first FDA-approved drug product, right, as a preventative measure against catheter-related bloodstream infections. And as I said, we're in the process of launch. Then just one more point here. Not only have you shown the patient burden, you've also generated some data to talk about the cost to the health care system. Sure. Sure. Look, it's a tremendous cost in terms of a number of factors. But I think the one that's most telling is most of these patients are Medicare, right? And the cost associated with treating these infections and all the downstream costs, outpatient-derived infections alone are costing the federal government about $2.3 billion a year, right? Then you have inpatient-derived infections adding another $1 billion and change, right? So it's over $3 billion a year of cost that the U.S. federal government is incurring to treat these infections and then the associated repercussions of these infections. Great. So let's talk about the launch. You mentioned both the inpatient and the outpatient setting. So start with inpatient, because you're already there. Just again, walk us through that NTAP reimbursement piece, what it gives you, how long it provides coverage for? Sure. So a typical NTAP is 2-3 years. Most of them get extended to 3 years. But it's essentially for 2. And it provides additional reimbursement to the hospital facility. So when a patient gets admitted for an inpatient stay in the hospital, the hospital typically gets for a Medicare patient something they call the DRG, right, a Diagnosis-Related Group payment. It's a lump sum payment, essentially meant to cover all drug services associated with that treatment. In order to incentivize innovation, the government has created a New Technology Add-on Payment. It provides reimbursement to the facility based on a predetermined calculation that incentivizes the utilization of innovative drugs. So it is incredibly helpful as you're launching a product to have reimbursement in the inpatient setting. I think it's important just to remember as well that every hospital or hospital institution that would choose to use the product doesn't have to go and get their own reimbursement. It's already there, right? Well, no. They don't have to eat the cost out of what they're being paid already for the patient that's coming in, right? So our initial label, being limited to patients undergoing chronic hemodialysis through a central venous catheter, essentially straddles two areas of inpatient setting: patients that are there, that are already end-stage renal disease patients that come in, whether they're in for that or in for something else, and they have to be dialyzed while in the hospital. There are also people who crash-landed in the hospital with acute kidney injury, right, and have to be dialyzed, and they're there for several weeks, right? So those are the two areas. Now, there's probably more than a couple dozen DRG codes associated with those various admissions, right? They can range anywhere from $10,000-$80,000 of payment. But the NTAP ensures that the facility gets compensated above those DRGs, right, if the cost of treatment goes beyond the DRG? So then let's talk about your launch strategy. Talk to us about the size of the commercial organization, who you're focused on today, and why you're focused on certain institutions. So for the initial phase of the launch, the commercial team is fairly lean, right? And we've talked about this. I think the biggest hurdle right now and two completely different market sizes, right? The outpatient market is much larger volume. We've talked about it being about 40 million vials in terms of market size, but with much more consolidated purchasing. We have a handful of large dialysis operators and some midsize guys. Only about 7-8 people make up 92% of the market size. On the inpatient side, it's a smaller market, right? It's about 4 million vials. That's kind of how we estimate it. We do think there's going to be better price stability, right, in the inpatient stay. But again, it's much more fragmented, right, because you've got a larger number of hospitals. You do have some large systems that have 200 hospitals. But for the most part, there's 7,500 hospitals in the United States. Now, our initial call focus is on around just under 900 of them is where we're focusing our initial launch. And that represents about 65% of the inpatient dialysis treatments in the United States. So 12% of the hospitals do 65% of the inpatient dialysis, which is the majority of our target market for DefenCath. So the focus of the field team right now is on the P&T process, right, getting through formulary, whether it's at the system level. In our core target, most of them are part of systems, right? There's a handful of independents. But we're focusing on the larger systems first. There's an old expression that if you've seen one IDN, you've seen one IDN, right? All of these hospitals act a little bit differently. Some have a very centralized P&T process. Others are a little more decentralized, where they allow their member hospitals to have a separate P&T. But it can be a long process, right? So we've talked publicly. It can be anywhere from 3-9 months. I'm pretty happy with the progress we've made in only a couple of weeks in the field in terms of the amount we've met with probably over half of the 900 targets. I'd say we've got verbal confirmation of more than 50, call it systems representing more than 200 hospitals recommending the product for P&T, right, committee. And we've got about 20 scheduled dates, right, of P&T meetings. So within a couple of weeks, I'm happy with where we sit. P&T, as I said, it's going to be a slower ramp. But I think it's going to be, in the long term, right, a little bit more durability. Whereas I think on the inpatient side, on the outpatient side, I think it's a quicker ramp, right? We're probably going to have price erosion over a couple of years of TDAPA. But the market opportunity for DefenCath is going to have to be a blend of inpatient and outpatient. Just before we dig into P&T a little bit more, if a hospital wanted to use the product today, are there any mechanisms that allow certain hospitals to do that? No, absolutely. We've already had a couple of facilities pull down DefenCath. As I said, I'm not expecting material sales in the second quarter, because most will not until they've gone through their P&T process. But a handful have ahead of their P&T. We had two facilities somewhat quickly add it on a non-formulary basis, right, while they're going through their P&T process. So that gives the doctors access to the drug. But they have to go through a couple of hoops to get there. So no, it's available. As I said, I don't expect material uptake in the second quarter. I'm hoping to see that. On the inpatient side, a lot of the meeting dates that we have are in the third quarter. And then even from there, there's some time to get it into implementation and get orders flowing. So P&T committees are everybody's favorite topic because of how long they can take, especially through COVID. We've seen delay after delay. I think we're back to a more normal status now. So the fact that you're seeing meetings get scheduled in a timely manner is encouraging. What do you expect the committees to focus on? I mean, what's the real debate here? What pushbacks do you expect? Well, the typical P&T committee is going to focus on, right, what is the efficacy of the drug? What is the price of the drug? What's the health economic benefits? I think for DefenCath, there's two other unique aspects of the drug that lend it very well, right, to the discussions of P&T. And one is antibiotic stewardship, right? The ability to reduce the utilization of antibiotics, I think, is kind of a core, right, for DefenCath. And then the other is hospitals, obviously, get evaluated based on their infection rate and remission rate. And this is a source of cost for them. I think DefenCath fits squarely within their mandate, right, to reduce infection, reduce readmissions. Got it. What happens if a P&T committee says no? Well, look, I don't know if that is going to happen, right? I mean, I don't know any drug that's ever had a 100% success rate getting through P&T on an inpatient basis. I think, by and large, we'll focus on efforts where we think we're making the most progress. We've had pretty good success in building internal what we call champions, right? We can't bring the product to P&T. We need someone in that health system to bring it to P&T. I think we'd want to understand why was it not recommended for formulary inclusion and try to address any concerns or issues that the P&T committee had. For the most part, there's four outcomes when you can go to P&T, right? You have the two poles, which is it's absolutely blocked, right, and no. And then it's used completely unrestricted, which is also unlikely, right? The other two is where I think you see most of your decisions, which is it's approved non-formulary or it's approved formulary with restrictions, meaning it's either on label, right? It's restricted to the usages in the label. And I think those are likely the outcomes, right? And to the extent that we do get approved non-formulary, we want to try to turn those into formulary, right, on label. The label covers all dialysis patients? It covers anyone getting chronic hemodialysis through a central venous catheter. Are there patient subsets that you're going to tell hospitals that you think the product should be used in more if you get down that road of restriction or? Well, I think we'd want to focus it on ESRD and AKI patients, which is the market that we've talked about, right? I don't know that we're going to want to. We're certainly not going to want to discuss anything except off-label utilization with hospitals. But I think that market is sizable enough. That's what we've discussed. Moving over to the outpatient setting, just walk us through the reimbursement process there. You've got reimbursement that will be approved and available as of July 1. Expect July 1. Right, through the TDAPA program. What is the TDAPA program? And again, just talk about how that plays out over the next couple of years. Sure. So TDAPA is a Transitional Drug Add-on Payment Adjustment. So typically, most of these patients are Medicare, we've talked about. The federal government pays a fixed amount per dialysis session, Medicare Fee- for-S ervice patients, obviously. And what TDAPA does is, for the first 2 years, it reimburses the drug at ASP over that 2-year period. And then for years 3, 4, and 5, there's a calculation based upon prior year utilization and how they adjust it to the bundle. So as we have our discussions with customers, and we've recently announced our first agreement with ARC Dialysis down in Florida, we've structured these agreements to allow for the change in reimbursement dynamic over those 5 years. And obviously, along with that, we do expect some price erosion during that 5-year period of time when we've structured the agreements for that. OK. And then what happens after the five years? Well, at current, after five years, it presumably gets absorbed into the bundle. And we're going to have to, obviously, have a negotiation with customers around the value proposition that DefenCath brings to market. But we're doing a lot of things now to prepare for that, right, in terms of preparing for phase IV marketing study real-world evidence, right? We really want to demonstrate that we can replicate our clinical results in a real-world setting, have a material impact on costs, on patient outcomes. One other thing you've talked about in the past is going back to CMS to discuss the product not being in the bundle. I know that's a longer-term focus now. Just remind us of what. It is a longer term. I don't believe the door is fully closed, right, for that discussion. I do think TDAPA has evolved a number of times and may continue to evolve. They're going to put out their TDAPA recommendation going forward in July. It'll be open for comment. I think one of the concerns folks have raised with year four and five is that payment should follow the product, right? And I think a lot of folks feel the same way. So I wouldn't be surprised to see some adjustments to TDAPA over that period of time. Also, there's a lot of advocacy groups that are pushing for much longer, more sustainable reimbursement for innovation, right? We definitely want to incentivize innovation in kidney care and treating ESRD. And again, I think it's important to reiterate, you have five years to. No, we have five years. We have a good runway. Beyond hemodialysis, we do expect, over the next five years, to pursue label expansion to other indications. Before we go there, let's just go back to the outpatient setting. You said, obviously, a highly concentrated customer base. How are you thinking about well, what are you doing today ahead of the launch? And how are you thinking about what is your launch strategy with the biggest providers? Sure. So leading up to approval and then post, we've engaged with essentially everyone in the top 20, right, have engaged with in some sense or form. As I mentioned last week on our earnings call, I'd say we're actively in discussions with eight of the top 10 right now, including one of the two large dialysis operators that is in what I would characterize as advanced stages of negotiation. I'm optimistic over the next few weeks or months that we'll be announcing additional agreements similar to ARC, obviously, some small and midsize, hopefully at least one large one. And we're going to continue to execute from there. Can you maybe give us a little bit of background of how the ARC agreement came into place? Why do you think they were first or just the importance of establishing a first partnership? Well, look, I think it was important to lay that first brick in the foundation. I think smaller providers can be easier to operationalize. I think some of the, not that they're hurdles, but the things that we're working through now with some of the midsize and larger providers aren't necessarily around commercial terms or legal aspects of agreement, but actual implementation, right, and how it gets rolled out, how distribution gets done to hundreds of clinics and things like that. Does that change the workflow? Within the clinic itself, for the most part, it doesn't change the workflow if they're locking with heparin. If they're not locking with heparin, there may be some states where they're using a tech to access the catheter, right? So DefenCath is a drug product. Some states will require a nurse to administer. I'll just say, any questions from the audience, let us know as we keep going through here. I guess just I'll ask the last kind of open question. What should we think about, other than the metric of sales, how should we think about gauging success as you move through the launch in both the inpatient and outpatient setting? And I get it. People are going to talk about how many formulary approvals you have. That's clearly. Well, look, I mean, formulary approval is great. Certainly, we want to see, as I said, I think the win that we're looking for would be on formulary, on label, right? I think that's certainly a win. And I don't know how much public communication we're going to put out about specific hospitals and formularies. I think sales is probably the better determinant. And I think folks are going to want to see pull-through on the outpatient side as well. It's one thing to get an agreement done. It's another to get that implementation right and to get the product into the patient. Just to reiterate what you said before, in the inpatient setting, you think it's going to be a slower ramp out the gates. Absolutely. In the outpatient setting, even though it's stepped back, it could be a faster ramp? It should absolutely be a faster ramp because of the consolidated nature of the decision making. That said, if it's somebody large and you're trying to implement in 1,500 or 2,000 dialysis facilities, it's not going to go everywhere all at once, right? So it's going to have to be some type of staged rollout. That's why, as an example, you said ARC, right, with the 20 inpatient clinics, it's an easier lift from a rollout standpoint because it's smaller and more manageable. Just one more here. From a physician perspective, to what extent does one launch impact the other? Are there physicians that fall into both the inpatient and outpatient, could have patients in both of those settings? Oh, absolutely. I mean, ultimately, I think what we want to get to in five years, I would like to see this broadly deployed as the standard of care across inpatient and outpatient and the product following the patient. If you really want to have an impact on infection rates, right, if the product's instilled in the outpatient setting, but then the patient goes into the hospital and that hospital's not adopted, right, the patient's at risk, from my view. So I think, ultimately, that's something that, over the next couple of years, we're going to focus heavily on. Is that something that you could even see implemented in treatment guidelines? That's the goal. I think the treatment guidelines aren't updated every year, right? So it takes time to get that done. But yes, we've discussed that. OK. So last few minutes here, I wanted to talk about label expansions. You gave an update recently that you're focused on the oncology piece. No. Sorry, the other way around. TPN. TPN. First, note that we're not pursuing oncology. So what we communicated last week in earnings, I wanted to manage everyone's expectations around timing. We submitted a Type C meeting request to the agency. In those meetings, you only have a limited amount of time, right? You can't address every issue at once. We prioritized two issues before we get to label expansion. The first was the pediatric study, right? We had an agreement with FDA, right, to run a pediatric study. In exchange, we get the six months of pediatric exclusivity. As we started discussing with investigator sites, the structure and the protocol of the study that we had discussed with FDA doesn't look like it's going to be feasible from a patient enrollment standpoint. We've kind of gone back to FDA and said, look, first, I mean, we could consider a waiver. But if not, here's how we would propose to run the pediatric study. So we proposed an alternate structure for the pediatric study. Separately with that, we decided to focus first, for label expansion purposes, on total parenteral nutrition, on TPN. The reason being, the proposal that we've made, we believe, gets us some valuable data, is probably a faster and less costly approach than what I think we're going to need to do for oncology to get a label expansion. And we'd like to get FDA's buy-in on some core concepts first, right, that we'll be able to utilize in our discussions from an oncology standpoint. So we submitted the Type C meeting request. We're anticipating getting feedback from FDA by the end of June. Hopefully, that feedback is definitive answers and not just questions, right? But if there are questions, we'll respond and address accordingly. Once we have, I think, good directional guidance from FDA around TPN, then we can submit, hopefully, later this year, a request around oncology. Yeah, OK. You've talked before, just at a high level, about a catheter is a catheter, an infection in a catheter. That's what I believe, right? So I think the main variable, really, isn't necessarily the disease, but how often the catheter is accessed. I think that's the main variable across these disease states. Obviously, the more often it's accessed, the higher the risk of an infection, you would think. I think so, yes. Yes, yeah, OK. Can you just talk about the size of the opportunities in TPN and oncology versus? So we're in the process right now of refreshing our market research around that. We're going to put something out later this year. I don't want to put any numbers out there right now on market size. And so we've got that completed. Maybe just at a really high level, is the magnitude roughly similar to dialysis? Or is it much smaller? So I'd say the patient population in total parenteral nutrition is much smaller. But it needs to be locked every day, right? So that's kind of the focus of TPN. Now, oncology is a little bit different in that you have a lot of different regimens, right? Some are weekly, biweekly, monthly. But you've also got catheters and ports, right? So that's another dynamic that, as I said, we're being strategic about how we get our guidance from FDA. That's kind of part of the equation, is catheters versus ports. Good. Let me just check one more time. Any questions from the audience? Let me just wrap it up with one question about financial resources, where you are today, how well funded you think you are for the launch. Look, I think we're in pretty good shape. We did the raise last year, as we talked about. Our base case scenario gets us to break even on a cash flow basis by the end of this year, on a run rate basis, not on a full year basis. Obviously, our base case assumptions, we talked about in the earnings call, the adoption by at least one of the two large LDOs on a limited basis, as well as some traction in midsize and smaller players. So far, what we see is that we're trending toward that base case. Now, are we going to allow minimum cash to run below a certain level? Certainly not. So we've taken some prudent steps. We announced on our earnings call a letter of intent for a revolving credit facility that, hopefully, will close over the next couple of weeks. We've put an ATM facility in place that gives us flexibility to raise little bits of capital to the extent that it's needed. But at the present moment, we don't have an immediate cash need from that standpoint. Joe, thank you for being here with us this morning. Excited to watch the progress with the launch. Thank you. Appreciate it. Cheers. Thanks, Jason.