Good morning, and thank you everybody for joining us at the Citizens Life Sciences Conference. Really excited to be joined next by CorMedix and CEO Joe Todisco. Joe, thank you for being with us this morning. Thank you. Great to be here. Maybe let me just throw it over to you to give a quick 30-second, you know, overview of where we are today with CorMedix. Well I guess let me start with who we are, right? We're a specialty pharmaceutical company with a broad portfolio of mostly injectable drugs utilized in institutional settings of care. Most of those drug products are currently anti-infective drugs, a lot that are used in either inpatient hospital settings. DefenCath is used predominantly in outpatient hemodialysis centers. But we, you know, we're focusing heavily now on some of our development stage assets, right? REZZAYO, which is in phase III study for prophylaxis of fungal infections in patients that are immune compromised, and DefenCath, which we are in phase III studies for prevention of CLABSI in patients that are undergoing IV nutrition therapy. It's gonna sound odd for a company that has more than five approved products, but I really want to talk about the pipeline first. REZZAYO phase III data and prophylaxis coming very soon. Let me ask this real simple question. This is a drug that's approved for treating fungal infections. Yes. You're running a trial in prophylaxis. Mm-hmm. Why wouldn't it work? Well, look, I think we obviously have a high level of confidence, right, in terms of the drug's ability. We know that it has strong activity against Candida, Aspergillus, Pneumocystis, right? We've seen that in preclinical data. We've seen it against Candida in treatment study. There are two ongoing phase II studies for treatment, one in Aspergillus, the other in Pneumocystis. Yes, we have a high degree of confidence in terms of the drug's activity against the various pathogens. You know, the phase three study expected to read out in the second quarter. Right now we're thinking it's probably gonna be later in the second quarter. You know, the study design from a design standpoint, primary endpoint is fungal free survival at day 90. It's running head-to-head against the standard of care for prophylaxis, right? It's being run in allogeneic bone marrow transplant patients. These are patients that routinely get antifungal prophylaxis as part of their prep for bone marrow transplant, and it continues beyond the BMT. The standard of care today is usually an azole, either posaconazole or fluconazole in combination with Bactrim. The secondary endpoint and the standard of care is known to have a number of issues, right, from a safety standpoint, right? You know, both posaconazole and fluconazole are known to be hepatotoxic, right? You have a large amount of adverse events related to liver toxicity. They're also known to have a number of drug-drug interactions with various drugs that are used in these patient populations. The secondary endpoint in terms of discontinuation of REZZAYO compared to standard of care is also something that we're keenly gonna be focused on. The primary endpoint is a non-inferiority endpoint. The non-inferiority of 90-day survival, and then within that, obviously what we wanna look at is the specific pathogen data related to Candida, Aspergillus, and Pneumocystis. Do you have any sense of the, you know, trial conduct now? Are you getting a good representation of those different pathogens in- Right now that data is blinded to us. Okay. Right? I think, you know, as I said, that's something we're gonna wanna get a look at. Okay. What's the success in the trial? Well, look, I think obviously success is first hitting the primary endpoint, right? Specific Did we hit the primary endpoint? Did we hit the secondary endpoint, right? I think these are the two things. Within the primary endpoint, I think there's various levels of success with respect to the pathogens, right? I think you know, the product is approved for treatment of Candida, right? I don't wanna say Candida is a foregone conclusion, but. Mm-hmm You know, I think, you know, there's high confidence there, right? We know that it has activity against Aspergillus, so we'd like to see that, and then Pneumocystis, right? We wanna, you know, in an ideal world, we've got good activity against all three, prevention of all three pathogens. Let's turn around a little bit and talk about on-label opportunity today. What has been the experience with the drug, in the commercial setting? I think that it's still early. In the treatment indication, which is a smaller TAM, right? Especially if it's limited to Candida, right? Which is the current on label. You've got a smaller total addressable market, and a lot of that utilization is on the hospital inpatient side. You know, CorMedix acquired Melinta only, you know, less than six months ago, right? We've come in, we've done a pretty deep dive on kind of what we thought or what we think went right over the last year and what we think we can do a little bit differently. You know, what I'd say is I think we've got pretty good formulary coverage, but I think there's areas where we're gonna focus a little bit more on pull through now going forward and a little bit in terms of the patient journey. I think, you know, focus a little bit more on not just hospital inpatient, but the transition of that patient into the outpatient setting of care where they may be getting therapy at an infusion clinic. I think there's some opportunity to grow REZZAYO on label in treatment and that's, you know, later this year I'll have more feedback for you on that. How does that translate into the prophylactic setting then in terms of the patient journey? I mean, some of the patients are gonna be the same, right? They get a breakthrough infection even though they may have been on prophylaxis. But I think it's a little bit different of a patient journey, right, when you're talking about prophylaxis, right? These are patients that, you know, have an underlying condition, usually a leukemia or something. Certainly it's just a little different. Yeah. Can we just talk about the TAM then for- Sure prophylaxis? Like the TAM for prophylaxis, and when you talk about, I think you talk about on label, off label, and it's, you know, we'll have to wait and see what the ultimate label is from the FDA. The patient population where we're running the study is in the allogeneic bone marrow transplant patients. Now, that's not a disease state, that's a treatment, right? They have a number of underlying conditions. If you look at just the patients that are getting prophy associated with BMT, you know, that TAM is about $500 million or more than $2 billion in terms of total number of patients that get prophy for various pathogens. The way that we kinda break out the TAM of that over $2 billion, about $1.4 billion of that is patients that start getting prophylaxis for multiple pathogens, be it Candida, Aspergillus, Pneumocystis. Then there's another $800 million or so that continue on for Pneumocystis only. Mm-hmm. Right? In terms of that's how we kinda break out the TAM. There's a number of underlying conditions, so to speak, of patients that are getting prophy. I say the second largest after the BMT is gonna be the solid organ transplant patients, right? It's various different types of organ transplants, whether it's, you know, liver, heart, lung, and they get different durations of antifungal therapy depending on which organ is being transplanted. You've done a lot of work since the acquisition on really diving into that market, and one of the things that's come out of that is, your point you just made, that there are different patients are gonna stay on drug for different lengths of time. Yes. How does that impact where you see the value of the asset, where you're gonna, you know, really? Well, in terms of how we constructed the TAM, we actually did that calculation. Yeah We kinda broke it down by disease state. In terms of where we spend our time, obviously, we're gonna start with, you know, bone marrow transplant with transplant centers, right? Yeah. We're gonna start there. Obviously, a number of these patients also, with the underlying hematological conditions will be focused on hematology. You know, we've got a lot of requests for IITs already, right. Mm-hmm in areas like organ transplant, right? I think it will organically, you know, spill outside of where we are focusing our promotional efforts, and, you know, we'll have to wait and see how it progresses. I get the point that you're gonna have to see the data. As you think about, you know, the potential label now and additional studies you might run, what more work could need to be done for to maximize the value potential? Look, yeah, that's tough to answer today, right? I think we need to see ultimately what the FDA agrees to in terms of a label, right? You know, where it's used versus, you know, where it's labeled. You know, these are patient populations where, you know, drugs are routinely used off label, right? We're not out promoting them for those uses, but that's just a natural occurrence in this space. I think that's something we'll regroup on after we see the data. Yeah. Sorry, I can't give you more clarity on that today. Can you talk about access? We, you know, so today, like you said, smaller TAM. Right. You're planning for, you know, getting payers ready for a much bigger TAM. How do you think about making sure that the access is Look, I th- Readily available? I think in terms of even though this is theoretically a costlier drug than a generic azole, right? In terms of the scheme, the total cost of care in the scheme of things, you know, the cost of the therapies that these patients are on are in the hundreds of thousands of dollars, if not millions of dollars. Yeah of dollars, right? The cost of prophylaxis with REZZAYO is de minimis, right, in terms of total scheme. That said, we still do have to have discussions with payers, make sure they understand the value proposition, the clinical data, the outcome. I think that's one reason why it is, I think, important that we differentiate ourselves on that secondary endpoint from a safety standpoint, with, you know, lower level of hepatotoxicity, lower level of discontinuation related to adverse events and drug-drug interactions. I think, you know, that's something that is meaningful, right, to a payer. We look at it as a, I think I said yesterday, speed bump as opposed to like a roadblock, right, type thing. Last one on REZZAYO. Would you talk about the commercial infrastructure you have in place today, the call points today, and how that evolves over time with prophylaxis? Look, I think we have a good field organization which came through the integration. A lot of our field organization is largely legacy Melinta, right? The KAM team, market access is a combination of CorMedix and legacy Melinta. We've got a good MSL team with largely a background in infectious disease. I think, you know, as we, you know, scale up throughout the year, you know, we've guided OpEx, cash OpEx of $145-$160. Kind of what we've said is, you know, once we see the data, you know, the back part of that, the high part of that range is really based on some additional heads that we plan to add, as we move throughout the year. I think, you know, we see it somewhere as 15-20 kinda incremental heads, maybe 15 on the commercial side, mostly with contracting experience with hematology, oncology clinics, and then likely a handful of MSLs with a background in hematology. Got it. Okay. Melinta transaction, like you said, less than six months in. The word transformational gets thrown around too much. You really went out with the intention of diversifying the business. Yes. You were massively successful in doing that. I think one of our biggest positive surprises at the end of last year was how much the Melinta products, the base business actually grew. Yes ... since you got the product. Largely a group of IV antibiotics, but just walk us through, the background of the transaction and- Sure what you're doing today to maximize. Well, when we entered 2025, I think we were pretty transparent that we wanted to do a large deal, transformational deal for CorMedix. You know, DefenCath is a great product and we're excited about what it's done in hemodialysis, and we've got a strategy to keep growing utilization in hemodialysis, as well as what it can be in TPN. It has a very atypical reimbursement, right? This TDAPA that causes a revenue curve with where we had a bolus of revenue over the first 24 months, and then we're gonna incur some price erosion, and we need to grow volume, right, as we progress over time. It was important to us to bring on something that was highly synergistic, something that had a stable base of revenue but also growth potential, right? When we sat down, it was late 2024, when we had a short list of targets, and Melinta was number one on the list, right? You know, that deal evolved over the course of 2025 and, you know, we're super thrilled to get that across the finish line. As I said, it provided products like Vabomere and Minocin, which we view as kinda highly durable, established, entrenched anti-infectives. They do not require a large amount of SG&A, right, to kinda maintain that sales, but also then Rocephin, which we kinda see as the big growth opportunity. What is that investment today? What does the commercial infrastructure look like for the Melinta products? Well, right now, we've got about 35 key account managers, which, you know, more of a kind of traditional medical education rep type. We've got about 12 people in market access. We've got, you know, comms and data analytics team. I mean, it's not a huge commercial organization, probably only around 80 heads. How do you think about the profitability of the franchise as a whole? Look, I think it's driving, as I said, good stable cash flow. I think it was important given what we're gonna see with DefenCath for the third and fourth quarter of this year, where we're gonna have this kinda two-quarter stub period of, you know, lower bundled reimbursement. We're transitioning DefenCath to a bundled reimbursement, or CMS is transitioning to a bundled reimbursement starting in July. We're gonna have a kind of a two-quarter fluctuation where it's gonna be a little bit lower, and then the reimbursement should come up in 2027. It's important to add that, you know, that $150 million of kinda now stable base revenue to kinda help with that, you know, weather that, you know, that cycle. Okay. Let's talk about DefenCath. Yeah, sure. It's been a great launch, right? Let's talk about the demand that you've grown. Mm-hmm So far, let me split it into two buckets. You know, the large dialysis provider and everybody else. Starting with everybody else, where is the utilization today, and can that be maintained? That's the goal is to maintain it, and that's, you know, why when we came out in January and gave our financial guidance for the year, and we said, "Look, a lot of this revenue is front-ended," 'cause in the back part of the year, we originally signed with all the customers five-year contracts that tracked kind of the five years of TDAPA. And we made a commitment in those contracts if there are periods where, let's say, the bundle adjustment is not sufficient, right, where it triggers a floor obligation theoretically under our contract. We expect to be at a fairly low, you know, transfer price to maintain patient volumes for the third and fourth quarter, but we also have the flexibility, and we're in discussions with the customers for that to adjust upward in 2027. We took the unusual step to give 2027 revenue guidance for DefenCath because it's going where our expectation is it'll be at a price point and run rate that's higher than where we exit the third and fourth quarter. Now we've also tried to clearly communicate this, is the guidance we've given, we see as call it like a base business guidance, right? It's our existing utilization run rates, and, you know, we've kind of given a range based on where we see supply prices, kinda shaking out. when we look at the volume of DefenCath today and we look at kind of payer claims, more than 95% of our business is Medicare fee-for-service patients, right? That's, I think, just organically how it's been deployed by dialysis operators, I think, because fee for service, they're guaranteed to get to TDAPA. That's kind of where they've rolled out from a patient standpoint. Medicare Advantage patients today are half of ESRD patients and growing, right? It could be 70% in a couple of years. That for us is the largest untapped market opportunity. One of the strategies that we've had that we started to kind of execute on in January, when we got our real-world evidence data with U.S. Renal Care, was utilizing that data and making the value proposition to the Medicare Advantage payer to instead of bundling, to separately reimburse DefenCath. We're starting to make some progress. In terms of those discussions, it's early, right? We really reached out in January. We're only sitting here, it's the first week of March. But I think long term, I think that's where we, you know, we're hoping to grow DefenCath utilization, because ultimately the Medicare Advantage plan is they see both sides of the ledger, right? They just don't have drug spend, right? They've also got the cost for these hospitalizations, cost for these infections, and I think the most meaningful endpoint that came out of the interim analysis on the real-world evidence was the reduction in hospitalizations, right? Mm-hmm. A 70% reduction in hospitalizations is a meaningful and tangible cost savings for the payer and for the healthcare system. What's the goal with Medicare Advantage? What can actually be achieved in terms of what Well. Percentage of your business could that ultimately be? Ultimately, we, you know, we'd like to see it be, you know, at least from a volume standpoint, the size of the business we're doing in fee-for-service. Okay. I think from a dollar standpoint, it could end up being larger, right, depending on, you know, how we ultimately blend or transfer pricing to customers with a mix of fee-for-service and Medicare Advantage. I think over time if the trend we are seeing of ESRD patients moving from traditional Medicare into MA, it could ultimately become the driver, right, of the business. Let's talk about the LDO as well, the large dialysis organization. Where have they got to in terms of utilization from the data you see, and how does that compare? Yeah to your expectations, and then how do we think about their volume use? Look, we're in a large number of patients and the LDO. I think we've you know said before that we you know we are actively supplying Fresenius right is kinda who we're is the LDO that we are actively engaged with. Yeah, unfortunately I can't give an exact patient number, right? This is something that's confidential to Fresenius. I think we're really pleased, right, with the deployment of the volume. There's a large number of patients. There still is opportunity there, right? Certainly I think you know assuming that most of the utilization is in fee-for-service, right, that on the Medicare Advantage side I think that's a big untapped opportunity. As you said, Medicare Advantage is just really a few weeks in to that process. Mm. Any early feedback or learnings about your strategy there? Look, I think the early feedback was largely positive in that this makes medical sense, right? That this is a great product, great clinical result. I think now what we're hoping for is for the MA plans to kind of validate on their side when they look at their internal costs, what they're spending, that there is a dollar amount they're willing to invest in prevention, right? Mm to offset hospitalizations. Okay. Great. Expansion opportunities for DefenCath. You're running the TPN study. You're also investing in a couple of other studies. Just talk to us about where you are with TPN and when we'll see data. Look, you know, I think we were pretty aggressive in terms of the timelines we put out last year, right? I think we were hoping to run the study end to end in 18 months, which was probably a little bit ambitious, and we were originally targeting late 2026. Or we said late 2026 to early 2027, so we're kinda in that early 2027 timeframe right now in terms of potential study completion. We're just under a third, just under 30% of patients enrolled. The way the study is designed, it's an adaptive study with a minimum of 90 patients, a max of 200. There's a hurdle rate, right, built into the study that you wanna see from an efficacy standpoint. I think the way the study is designed, there'll be an interim look once we hit 15 cumulative infections, right? Then they'll look at the disparity between the DefenCath arm and the Heparin arm. If there is a material separation, right, similar to what, you know, we would expect to see, right, coming out of LOCK-IT, the study could be halted early, right? Yeah They could say, "You know, just enroll to the 90 patients and finish." If it's not a wide enough separation they'll say, you know, "Keep, you know, keep enrolling and go to the 200 closer to the 200 patients." That'll give us a better sense on timing. I think you know the early 2027 would be based on hitting the 90, not the 200. Look, we know the product works, right? Yeah. It worked in LOCK-IT. It worked really well in real world evidence with U.S. Renal Care. We've had some anecdotal, or a little more than anecdotal, other customers' presentations at their respective medical internal medical conferences have actually seen higher reductions in infections than even what we saw in LOCK-IT or with U.S. Renal Care. Really happy with what we're seeing from an efficacy standpoint with the product and, you know, the hope is that just that translates. You know, it's not treating a disease, right? It's preventing infection. A catheter is a catheter, right? Prevailing logic would say that this should have the same level of efficacy in TPN. When you think about the potential launch timing, you're gonna know a lot more about DefenCath in the dialysis setting and where you are from, you know, Medicare Advantage, et cetera. How does that impact how you think about a very different reimbursement environment for TPN? Well, look, I think that's one of the things that's attractive about TPN is you're not dealing with a bundled payment system, right? You're dealing with, for the most part, Medicare Part B reimbursement. We have a strategy to kinda differentiate pricing across the therapeutic settings, seek a separate J-code. You know, I think, you know, as we get closer to filing we'll be able to give a little bit more clarity around that. Got it. Okay. Big picture, you've gone through. We've said this transformational, when I do use the word appropriately, I think here. Yeah. Where are you, where's your appetite for more transactions? Yeah. I've talked about this quite a bit too. You know, 2025 it was important for us to do this transformational deal, right? We really needed to not only kinda call it stabilize the base revenue, put us on a pathway with additional growth drivers. Now I think the types of opportunities we are looking at are more tuck in, right? Mm Type things. Not looking to. You know, we've raised equity, right, ahead of the Melinta transaction. We used equity as part of the Melinta transaction. You know, that's not the type of deals we're looking at right now. The thought process would be that the. You know, and I'll never say never, but for the most part the things we're looking at would be, you know, a combination of cash on hand, maybe some additional debt capacity, but, opportunities that would fit synergistically either with the future call point for REZZAYO and prophylaxis or potentially the existing call point on the hospital inpatient side. Yeah, those are the types of things we're looking at. Okay. Just when you think about you giving guidance obviously for 2026, beyond that, what are the measures of success? You know, REZZAYO is a huge catalyst. From- Yeah The commercial side of things, what's a good year for 2026? Look, I think a good year for any public company is to be in a beat and raise situation as you move throughout the year, right? That's ultimately the goal. I think we've always shown to have an air of conservatism when we've kind of issued our guidance, and I think I'm pleased with the way the business has kinda come out the gate for 2026. You know, we'll revisit guidance when we report first quarter, and if we're in a position to update at that time we will. You know, that's where we're at. Just one more question there. Do you think that the investment in the current businesses is at the right level? When you say investment, what are you- The operational spend the OpEx? Yeah. Yes. I think. Look, and we've historically run a pretty lean. Yeah a pretty lean operation, and that's my philosophy. I don't believe in overbuilding infrastructure, and I also don't believe in building infrastructure at risk for the most part, right? I wanna see the phase III data on REZZAYO Prophy, and then that'll guide what additional infrastructure we wanna build and when. I think we are appropriately scaled today. Really appreciate you being with us this morning, Joe. I'll say it again, I think people really should be paying attention to the REZZAYO data. It's something we're really excited to see the data. Thank you. Same. Same here. All right. Appreciate it. Thank you.