All right. Thanks everyone for joining us. For this session, we've got CorMedix, represented by their CEO, Joe. Thanks for being here. Thanks for having me. A lot going on at the company across different lines of business, but I wanted to start on some recent data for REZZAYO, just given that that's new, exciting, forward-looking. I guess, can you talk to us about how you're thinking about that data and what it means for an expansion into the prophylactic setting? Yeah, no. Thank you. We were very excited to put out It is preliminary top line. We only put out a couple of data points. The full data package hopefully will be out in the coming weeks. The study was run head-to-head against a standard of care regimen and prophylaxis of fungal infections in patients undergoing allogeneic bone marrow transplant. What we were hoping to show and looking to see, which we do see in the data, is comparable efficacy to the standard of care and then hitting some of those secondary safety endpoints that we'll look to differentiate ourselves, right? Particularly around discontinuations, drug-drug interactions, things like that we've talked about being somewhat problematic with the current standard of care, right? We've gone into this in detail in some of our past discussions that patients right now with a number of hematological malignancies, they get antifungal prophylaxis, usually with posaconazole or fluconazole, both of which have known risks in the safety profile for the drugs, hepatotoxicity, as well as a number of drug interactions with other drugs that these patients are receiving. We see that as the opportunity to be able to differentiate ourselves. Ultimately, the product, and I think you're kind of hinting at what are your thoughts on the data as it's respect to the total addressable market opportunity. Ultimately, that's going to come down to the label, right? What FDA approves as the final label. I think there are a couple of areas where certainly we're going to want to push for, we'll say, is broadness, right? Having all three pathogens in the label, I think we're happy that we believe that the data shows efficacy and prevention against all three pathogens, Candida, Aspergillus, and Pneumocystis. Also, we want to work with FDA to make sure that we have a label similar to posaconazole, where it's not limited only to patients that are getting bone marrow transplant, right? BMT is a procedure, right? That patients with hematological malignancies undergo, right? We had a number of patients with different underlying conditions in our study, and our expectation is that the label would reflect that. You touched on some of the secondary endpoints. I know you can't speak directly to what's in the data yet, but I guess, to whom are these secondary endpoints important? Is it for payers and payer negotiations? Is it for docs? Is it for uptake? I think both. I think once we have the full data package out published, we're certainly going to have to go do another round of call it market research with stakeholders, and that's both on the payer side as well as the clinician side, to really understand, okay, assuming this data and the label is what we expect it to be, how would you see yourself utilizing this? I think some of those secondary endpoints are important for payers because it gets to the types of things that add additional cost into the system, right? The ability to take cost out of the system, hopefully with a better mousetrap, is what we'd be looking for. Got it. Maybe you referenced some of the market survey work you've done before. I guess obviously that'll have to be updated to some degree, but what were the initial findings on sort of what you'd expect in terms of willingness to pay for this? Look, I think, and again, it comes down to the perception of the data and ultimately once we do our pharmacoeconomic analysis around cost offsets. There are, as I said, known safety risks with the standard of care that not only add cost to the system, they do, to some extent, jeopardize patient care, right? Patients have to discontinue the antifungal therapy. It leaves them susceptible to infection. They have to delay their BMT if they're in another underlying condition like a solid organ transplant, right? That's even more problematic, or as problematic. We do think that it will be meaningful, right? To have that. I don't want to get ahead of those discussions. Mm-hmm. Sorry. You guys are working with your partner, Mundipharma o n sort of next steps. Yep. Can you just remind us, you have the data, sort of what happens between now and an NDA filing? Sure An sNDA filing? Sure. We acquired this asset through the acquisition of Melinta, who had signed the license agreement with Cidara, who was acquired by Mundipharma, right? That's the kind of nature of the history of the relationship. Mundipharma holds ex-U.S. marketing rights and global rights to the IP. Currently, they are the owner of the NDA submission. The terms of the agreement on approval of a prophylaxis sNDA, the NDA will transfer to under our control. Right now, they are in control of those discussions with the agency, and we're working together with them. It also is a global submission they plan to submit in Europe, right, for EMA filing. The next step is to, which we have, request a pre-NDA meeting with FDA, take feedback, and work towards submission of the sNDA in the second half of this year. I know second half is a wide range. I don't want to guide to a specific time point just yet. We want to take that FDA feedback and then work with Mundipharma on putting together the most robust package possible, to go into the agency. Got it. As you guys think about the business, you've also talked about scaling some of the operating expenses to potentially enable a successful REZZAYO launch. I guess, how do you think about that? To what extent is that going to the sales force, headcount increases? It's a modest ramp, and we talked about it just last week on our earnings call a little bit, where we affirmed our OpEx guidance for the year. This ramp is in the back part of this year is within our original operating expense guidance. It's modest headcount. We're talking about 15 to 20 incremental headcount, probably split between commercial and medical. Some of it is more of a redeployment and a shifting of existing headcount into whether it's a different call panel or slightly different role, and we're rolling that out right now internally. Essentially preparing the organization for the Prophy launch. Mm-hmm. I guess how much overlap is there between the current targeting for REZZAYO and sort of what you'd expect in the future? A little bit, it's a completely different patient, well, not patient population, but clinician population that is treating prophy. A lot of them, you're calling on the hematologist, you're calling on the BMT transplant specialist. ID is still involved, who is the majority of the calls on the treatment side. There's absolutely new stakeholders that we need to begin to engage with right once the data is fully published. Our medical folks can start having those kind of pre-approval information exchange discussions. Mm-hmm. I guess maybe related to that, REZZAYO's obviously currently marketed for the treatment of fungal infections. Should we think about any halo effect? I think it's possible. It's a little premature for that. Let's get the full data out there and see how the back part of the year progresses. That's not unlikely. There should be a little bit of a tailwind on that, right. We're also doing some other things on the treatment side. We only closed on the Melinta transaction end of last year. Took the opportunity to really assess tactics and how we were going about promoting REZZAYO for treatment, and we're doing a couple of things a little bit differently that I think will yield some growth in the back part of the year. Got it. Maybe just touching on the rest of the Melinta portfolio that you guys acquired. Perhaps from investors doesn't get as much focus, but there's still growth there. Yep. How do you think about sort of the importance of those products, which ones you can continue to drive growth with? Look, I think what's really great about MINOCIN and VABOMERE as an example is that with very minimal direct sales and marketing expense, we are getting low single-digit growth. They're fairly entrenched in their treatment algorithm and how they're used in the hospitals. We think there's some stickiness there, and we like those brands. The KIMYRSA and ORBACTIV this year, and we've talked about this as well, are going to contract a little bit. They are one of only two long-acting drugs in their class, the other being DALVANCE went generic at the end of last year. We see about another year or so where from an infusion clinic standpoint, they have a strong profit incentive to use that generic DALVANCE. That's going to dissipate through the back part of next year, and we think we'll have the opportunity almost for a promotional relaunch of KIMYRSA in the infusion clinic space. We'll start to see, or we think we'll start to see growth in the back part of next year for KIMYRSA. Got it. Maybe shifting gears to DefenCath. There's a lot of focus on volumes right now and continuing to drive volume. I guess, can you talk about what you expect for the balance of this year in terms of your ability to drive? We were really pleased last week when we announced earnings. We increased our guidance, specifically increased our DefenCath guidance for this year, and that's based on a couple of things. One of them was the one-timer, the adjustment to accruals. We also saw from the fourth quarter to first quarter increased utilization at some of our largest customers, which was great to see. We do see, as we progress through the year, on June 30th, we're going to have a change in our reimbursement structure under CMS. The first two years of TDAPA gives way to the third year, which is a bundled approach. As we've talked about, the amount of the bundle adjustment for those two quarters, Q3 and Q4, isn't commensurate with the current run rate from a utilization standpoint. We're working with customers. Essentially, our intention is to keep customers on therapy through the back part of this year and then come into 2027, where we're expecting higher bundle adjustment from CMS based on their methodology, which will allow for better net pricing with customers and presumably more revenue for DefenCath, which is why we took the unusual step of giving that 2027 revenue guidance. I know it's early, and you may not be able to comment, but I guess, are you seeing that existing customers are planning to continue to use the same volume going forward? That's been the nature of all of our discussions is more around, okay, what price point do we need to be at to make sure that this product stays in patients and we're working to get there certainly with our three largest customers, but we're trying to do it with everyone. I think fortunately for us, we do have pretty high concentration on DefenCath with the top three customers are probably about 93%-95% of the business. If we can successfully keep those three intact, we'll be in a really good place. There's another large customer that you guys could potentially add. I guess anything to note on any discussions there? Yeah, I think we continue to have really constructive discussions. Obviously, we've generated a lot of real-world evidence over the last two years. I think the clinical case for DefenCath is becoming more and more compelling. I think all I'd be comfortable saying now is I'm happy the way those discussions are going. I'm cautiously optimistic that it could lead to some type of utilization in their system. I don't want to overpromise. Yeah. No, understood. Similarly, you guys are trying something unique in maybe contracting DefenCath outside of the bundle for Medicare Advantage. I know it's still early days, but can you talk about the receptivity to that strategy that you've heard so far? As you point out, we are trying to do something that's not been done before, but it's not as if there's a long history of TDAPA products, right? There's only a couple. We're the only one that's preventative. To my knowledge, I think we have one of the strongest pharmacoeconomic benefit cases to the MA plan, which is ultimately not just the payer of the drug cost, but the payer of the hospitalization costs, right? We've been targeting the top five MA plans to start with. There's been a lot of receptivity around the clinical benefit, the pharmacoeconomic benefit, and that part of it, what I'm encouraged with is discussions haven't really focused around that part of it. Discussions have focused more around, okay, well, how do we operationalize something like this? It's not just about putting an agreement in place between us and the MA plan. The MA plan also has to have likely a revised amendment to their agreement with each particular dialysis operator as well. It requires us to engage our customers' payer teams as well as the MA plan payer teams and try to have a kind of tri-party discussion. I'm happy we are making progress. It's not going to happen overnight. Again, I'm cautiously optimistic that as we move through the year, that we'll start to make some progress. You guys shared some real-world data last year, sort of an initial look. I guess, should we expect more real-world data to be coming? Oh, absolutely. I do know that. To start with, the data that we put out was only interim, right? First, we have the U.S. Renal will have the final data at some point later this year. I do understand they're also going to be publishing some additional analysis that they've done on economic impact of DefenCath in their clinics, which is helpful. IRC, which is our third largest customer, recently didn't publish, but put out data showing the tremendous impact DefenCath's had on their infection rates. Over a 90% decrease in infections in their clinics by using DefenCath. We're real happy that while they didn't publish anything, Fresenius talked about the clinical impact that DefenCath has had in their clinics on their last earnings call. That was also really great to see, as I said, that the clinical utility and impact is finally being recognized. Yeah. I wanted to touch on TDAPA, I guess, directly. I think due to some of the timing of launch and such, you guys are getting hit in 2026, but there's potential for add-on payments to increase in 2027. I guess, how are you thinking about what that step-up could be? As you think even longer term, I guess, how do you think about where pricing could stabilize? Look, I think, we guided 2027 revenue and said we think that the add-on goes up between 3x and 5x from where it is today. I know that's a broad range, because we just wanted to be careful. Under the current methodology, it's really just about math, right? It's an equation that takes utilization, most recent ASP, takes a 35% haircut, then it divides it by about 30 million dialysis sessions. When you know the inputs, you kind of get a sense for directionally where that add-on is going to go. We do have an idea in mind where pricing will be for our three largest customers in 2027, right? We're certainly not going to put those price points out there. As I said, directionally, it's more about making sure that those patients stay on therapy so that coming to 2027, you have that kind of base of business to appreciate from. Look, long-t erm, and when we talk long, long- term, post-TDAPA add-on 2030 and beyond, a couple of things need to happen for DefenCath. First, we are engaged in a scale-up process to reduce our cost of manufacturing. To the extent that this does become more commoditized, we have the cost structure to be able to supply in that time of framework. I think over the long term, it is going to be critical to have success with Medicare Advantage, right? They're the ones that are most incentivized to reduce the total cost of care for their patients. They actually have a structure in place that allows them to do that as opposed to traditional Medicare, is somewhat bound by the constraints of the statutes that govern ESRD. It's going to be, as I said, the goal would be 2030 and beyond higher volume, a little bit more commoditized pricing, to build a kind of a stable, durable cash flow business. Got it. You've talked about how you've spent a fair amount of time in Washington lately. I guess, what are you hearing both on the ground and who are you talking to? What are you maybe hoping to achieve in D.C. with all your policy visits? Look, I've spent so much time there in the last probably six weeks, I should probably file a tax return in D.C. Don't say that on a public call. Look, we've had a lot of really good bipartisan meetings on the Hill, senators, congressmen, staff, committee leadership. It's funny. With this bill specifically, you don't get any pushback on the merits. On both sides of the aisle, everybody universally agrees, okay, the status quo is not working. This is a reasonable fix. While not perfect, it's a reasonable fix to incentivize innovation in the ESRD space, which is a concern. One of the most kind of daunting statistics is right now there's only one active phase III program in the ESRD space, and there's 750 in oncology. That tells you it's not for a lack of patients in ESRD, it's because there's a lack of sustainable long-term reimbursement. TDAPA was a good step in the right direction. Now that we've had a couple of years of it needs to be improved upon for the betterment of patients. I do think there's a decent likelihood that KCAPPA happens eventually, right? Excuse me. That said, the climate in Washington to get anything done before this upcoming midterms could be problematic. We're working hard. Hopefully there can be a vehicle that it can get attached to, not just for the benefit of DefenCath or CorMedix, but for the benefit of ESRD patients and long-term innovation. Separately from those discussions, we have been having discussions with CMS directly, both career and political staff. There are things that they have the ability to do through the upcoming rulemaking process. I think we're hopeful to see some type of changes to the TDAPA system. If not this year, next year. Those are the things we've been working hard on. Got it. You guys, you've guided for 2026, you've guided for 2027, I guess just putting it all together and considering the fact that you have a history of beating your guides and raising, I guess, what do you need to see to feel more confident on raising the 2027 number? I think it's premature. I think I'd like to get into the back part of the year and make sure that volumes do what we think they're going to do. Then likely lock down pricing amendments for 2027 with the major customers. Those are the things that give us better clarity and certainty. In terms of increasing guidance, I'd also like to see success on the Medicare Advantage side. That's one of the biggest levers and biggest untapped market opportunity. Half of these patients are Medicare Advantage. Right now, we have very little penetration into that patient pool. Got it. You guys are also exploring DefenCath for other indications and alluding to TPN. Maybe we can talk about two things there. I guess first, the size of the opportunity. How do you think about the unmet need there and the urgency to? Well, it's absolutely an unmet need. There's nothing FDA approved in the space that reduces or prevents bloodstream infections, which are quite common. They've got an infection rate over 20% in this patient pool. We've talked about the TAM being $500 million- $750 million-ish. We discussed last week on earnings call, the clinical trial is having a little bit of a challenge with enrollment. We're doing some things to try and speed that up. One of those is an amendment that will amend some of the exclusion criteria. Hopefully broaden the pool of patients that are available. There's no lack of patients. The issue is a lack of patients that are eligible to be enrolled in the study, so to speak. Commercially, from a commercial opportunity standpoint, the market need is absolutely there. Got it. You guys also have an option on an asset from Talphera. I guess, what drew you to that asset? Well, look, it's highly synergistic with our call point in the hospital, and somewhat tangential to DefenCath. It's used in the continuous renal replacement therapy process. These are patients that require around-the-clock dialysis. It's, again, similar to DefenCath, it's a better mousetrap. We view it as a better mousetrap compared to what the standard of care is. Much like our product REZZAYO, where the secondary endpoints and the safety endpoints were meaningful for differentiation, same on the Talphera side. Where those secondary endpoints, though, really get to potential savings for the hospital. If they can reduce the amount of filter changes in that CRRT process, those filters are thousands of dollars each. If you go through eight or 12 or 16 of them, it's quite costly for the hospital. If we can reduce that number down, it can have a meaningful impact. We like th e product a lot from a fit standpoint, from a market size standpoint. I know that Talphera is guided to data later this year. I think whether it comes later this year or next year isn't as concerning to us as it meets those endpoints. We like the product. If and when we get the study data, we'll do a more complete diligence and as part of our right of first negotiation, and we'll make a decision. Got it. Unfortunately, that's all the time we had. Thank you so much for joining us. No, thank you for having me. Appreciate it.