Okay, good morning, everybody. Welcome to day three of the Cantor Healthcare Conference. Happy to be joined by Joe Todisco, the CEO of CorMedix. Thanks so much for being here, Joe. Really appreciate it. Thank you, Kristen. Happy to be here. Yeah, we're fresh with some new information, your recent acquisition. I look forward to speaking with you more about that today. Just to start, may I ask for the typical generic overview question of the company? Sure. As you said, it's changed in only the last four days, right? I used to say we're a, you know, a small-cap single-product company focused on commercializing our lead product, DefenCath, which is a novel antimicrobial catheter lock solution, indicated to reduce the incidence of bloodstream infections in patients getting hemodialysis, right? That's a mouthful. We were pleased to announce a few weeks ago and then close last Friday and announce this past Tuesday the acquisition of Melinta Therapeutics, which really has been and will be transformational for CorMedix, right? Taking us from a single-product company largely focused in the renal and hospital sector, and really migrating us to a multi-product diversified, call it specialty injectable hospital acute care platform, right? From which we can really grow and build this business. Okay, thank you. On the basis of that, I would love to just kind of jump right into the acquisition. As you look at the business that you've built with CorMedix, what attracted you to the opportunity with Melinta? What ultimately convinced you that it was the right time to make this acquisition? Oh, sure. We started talking, I think, publicly about it shortly after we launched DefenCath, right? Around what was next for the business. We talked quite a bit about the type of business development and the type of M&A we were looking for. We put out certain criteria. We wanted something that was highly synergistic from a call point standpoint with either the renal space or with hospital specialty space. We wanted something that was going to be near-term accretive, right? We didn't want to invest in something that was going to have many years of R&D expense before providing value. We're looking for a stable base of revenue, the ability to take significant operating and revenue synergies and drive business. We also wanted growth, the opportunity for something that was going to provide growth. The Melinta acquisition checked all of those boxes for us. It really kind of was a direct bullseye for the types of things we were looking for. To get into it a little bit more, as we look at the business, it gave us seven commercial products, six that are largely, call them anti-infectives or antifungals, that fit very well with our existing deployment in the hospital specialty space. A stable base business, call it revenue of around $130 million, midpoint of what we guided this year for the business, but with a tremendous opportunity in the pipeline asset that is the expanded indication for REZZAYO, in prophylaxis of fungal infections in patients undergoing allogeneic bone marrow transplant. Okay, thank you. Can you please talk about what form the potential post-acquisition synergies may take? Are you looking at how much overlap there could be in terms of accounts and hospital systems that you're already selling into? Sure. Obviously, when you do a transaction like this one, you're going to have operating and cost synergies, but you're also going to have revenue synergies, right? From an operating cost standpoint, we're still looking at, you know, the business itself. We're only four days post-closing, but as you would expect, you know, a business doesn't need two CEOs, right? There's a certain amount of cost overlap. There's a lot of non-employee cost overlap as well, right? Insurance, you know, data that both of us purchase, and those types of things add up pretty quickly. From a strategic synergy standpoint, when we talk about revenue, right, DefenCath and the ability to expand DefenCath on-label and hemodialysis in the inpatient setting, as well as where we want to, or we intend to take, DefenCath for the TPN indication fits incredibly well with the existing Melinta deployment and kind of experience base. Okay. How could this acquisition help to inform potential expansion for DefenCath? As I mentioned, it's highly synergistic with the existing call point in the hospital space, right, for DefenCath with hemodialysis. Where we want to take DefenCath, the two indications, the one that's actively in clinical study for preventing collapse in patients getting parenteral nutrition, a large part of that market opportunity is in the hospital sector, as well as infusion clinics and then in the home. Another potential future indication for DefenCath in preventing collapse in patients that are undergoing a type of chemotherapy regimen will fit very well with where we expect REZZAYO to be promoted for prophylaxis. Okay, thanks. Bless you. You talked about REZZAYO having significant growth opportunity. Can you help us understand what the fungal infection prophylaxis market could look like, and how this could add to the already approved indication? Sure. I think it'd be helpful to start and do that in reverse, right? Let's start a little bit with the approved indication that's for the treatment of invasive fungal infections. Look, that's a smaller market opportunity. I think we've guided that the total addressable market for treatment is about $250 million total, right? It's a shorter duration of therapy. It's a smaller patient population. You also have some reimbursement headwinds as a lot of that utilization is hospital inpatient utilization, right? You have fixed bundled payments, a DRG, and hospitals don't always utilize new therapies, right? They're going to go with cheaper generic therapies first. If we pivot into prophylaxis, and specifically the, you know, let's call it directly on-label prophylaxis for invasive fungal infections for patients that are undergoing allogeneic bone marrow transplantation, you've got a longer duration of therapy, right? Thirteen weeks versus four weeks. You've got a larger number of patients between that group. What I would say would be other potential spillover into hematology or oncology indications where patients are immune suppressed. They're going through either chemotherapy or, you know, they're getting ready for solid organ transplant. They're on immunosuppressive drugs like tacrolimus, so they need to get prophylactic antifungal therapy. The standard of care there today is a combination of posaconazole and Bactrim. Both of those products, right, have, you know, certain, let's say, issues associated from an adverse event standpoint. Posaconazole has a known drug interaction with tacrolimus, right? The tacrolimus has to be dosed lower. There's also known hepatotoxicity with posaconazole. From the Bactrim side, it's known to be myelosuppressive, right? Rezafungin, the molecule, has a differentiated profile compared to both of those for both of those areas. In addition, the way that we've designed the study, should we meet the endpoint, could eliminate the need to give Bactrim in addition to an antifungal as well, given that rezafungin is known to have activity against pneumocystis, which is why they give the Bactrim. We're excited about the potential, right, for what the product can do, obviously depending on clinical results. We expect the clinical trial to complete early to mid-2026. We're kind of full steam ahead and we're really excited about that. I think that is, when you talk about what is not fully understood, right, with the Melinta acquisition. People understand the rationale for the synergy of the deployment and the cost synergies and the revenue base. I think the upside associated with what REZZAYO can be, I don't think is fully understood. Okay. You helped us understand some of the peak sales potential, but what pricing, prevalence, or other assumptions are baked into the estimate? Where can there be upside, for example? Sure. I think that's fair. I'm not going to get into specific pricing. I think the way we've sized the market and we've said the pro-fee indication alone has a total addressable market of over $2 billion. We've calculated that essentially by taking the patient population and applying the current cost of therapy for REZZAYO. I think we've guided, we see peak annual sales of over $200 million. We've based that merely on meeting the endpoint of the study and the key stats I just mentioned to you about the comparison against the standard of care. I think there's, depending on the clinical results, potential for this to be larger. I think we tend to lean conservative when we put numbers out there, whether it's a financial guidance or a peak annual sales number. We're going to wait and see what the financial results are. I mean, what the clinical trial results are. Maybe we have another conversation. Okay, great. Looking at the other assets that were brought in via this acquisition, what are some of the highlights you would point out in terms of adding to revenue now or also potential for future growth? Look, you've got what I'll call solid, stable products used largely in a hospital inpatient setting, like Minocin and Vabomere. They occupy very, you know, definitive kind of spaces in the treatment algorithm for their respective infections. You have products like the ORI franchise over to Vansen, which, they're smaller, less contributors, but those are the types of things we're looking at right now. When you underwrite a deal, you look at the stability of kind of the base business. Now we're looking at opportunities to grow those products. Over the next couple of months, hopefully we'll be talking more about what we're going to be doing with the ORI franchise. Okay, thanks. I appreciate you walking us through. Congrats again on just getting that close. Great timing for our conference, thanks for that as well. Turning to DefenCath, you raised guidance for 2025 net revenues to $200 million- $215 million. What does this bake in in terms of ramp in the second half of the year? Can you speak to the visibility that you have now in customer ordering that's helping with this confidence? Yeah, I don't know how much I can comment about ramp, but what I think I'm comfortable saying is that I think investors know we onboarded what we call our LDO customer in July. They rolled out to a smaller subset of clinics, and then in August, they rolled it out more broadly nationally. That was not really the driver of this decision to increase guidance. It was actually what we were seeing from a trend in the other parts of the business. We're really excited about what the potential for DefenCath could be this year as we move through the back part of the fourth quarter. We have an earnings call coming up in another couple of weeks, right? It's another opportunity for us to take a look at the trend line. Obviously, we're bullish on what we saw, right? Otherwise, we wouldn't have read guidance, and we're excited about it. Thank you. Can you help us understand how the dialysis market breaks down along the lines of large dialysis operators versus smaller organizations? What's really been the focus of the launch to date and patients that you can potentially have access to? Sure. The dialysis market is fairly concentrated, right? You've got five providers that are probably, you know, 90%- 95% of the market combined, depending on the metric that you're using. There are two large providers who are DaVita and Fresenius. There's a mid-sized provider, U.S. Renal Care, which was our first customer, right? That came on board early. There is IRC and DCI. Beyond that, there's a number of smaller, we call SDOs, smaller dialysis organizations, CFKC, Atlantic Renal, right? There are a number of smaller throughout the country, right? They might have five clinics or 15 clinics. From a scale standpoint, you know, DaVita and Fresenius each have, you know, 2,500- 3,000 clinics. U.S. Renal Care, 550 clinics, right? The size is not necessarily comparable. Okay. You recently announced a large dialysis operator customer initiated DefenCath purchases. Are there any precedents you've seen from launches in the dialysis space to show whether these organizations tend to adopt certain approaches after competitors? Does this help validate this perspective? I think what we've learned over the last year is, there was an old saying in the hospital IDN space, which is if you've seen one IDN, you've seen one IDN, right? They all make their decisions a little bit differently. I think we're seeing somewhat of the same type of dynamic with outpatient hemodialysis centers, specifically product launches. I don't think there's a good precedent for DefenCath. A lot of that may have to do with DefenCath specifically being a preventative drug product as opposed to a therapeutic that treats active disease. It's used prophylactically in patients, so there really isn't a good comparator. I think we've been happy with the rollout. Obviously nothing turns on like a light switch, right? It takes time to onboard customers. We were happy to get the LDO on middle of this year. We were hoping to do it earlier in the year. In the dialysis space, there was a little bit of capacity constraint for bandwidth when all the phosphate binders moved into the bundle, took up a lot of resources for all the dialysis organizations to focus on that project. I think we're happy with where we are today. Okay. With the launch ongoing, are there any new real-world evidence studies that we should look out for to help better understand the budget impact and patient outcomes for DefenCath in hemodialysis through [CDC]? Sure. We announced a year ago that we began a real-world evidence study with U.S. Renal Care, who was our first customer tracking several thousand patients. I also announced recently that we committed to do an interim readout of the study later this year. I don't have data to share yet. I'm optimistic that we're going to have very positive results to put out later this year. I guess folks will have to wait for the data, but that's certainly on tap for later this year. All right. We'll be looking out for that. With the other indications you're pursuing for DefenCath, especially TPN, how should we be thinking about potential for expansion? Are there any significant milestones on the horizon for this franchise? I think in terms of milestones from a clinical standpoint, we just dosed our first patient a couple of months ago. I think that study is progressing well. We're hoping to complete that study by the end of 2026. Ideally, have an approved indication by the end of 2027. That's the prevention of collapse in patients getting TPN tracked. On the oncology track, I think we're still working around what a clinical trial design could look like. It's a little bit more complicated than TPN. In TPN, you have patients that are, it's all very, they're getting access daily. They're all getting similar regimens. Catheters are accessed in regular intervals. In oncology, it's not a disease state, as you know. It's a broader term. You have different chemo regimens, different types of cancer patients whose catheters are accessed weekly, biweekly, monthly. You have ports, right? There's a lot of variables that we're working through right now, trying to figure out how do we design this study to ultimately get hopefully the broadest indication possible. I think given the efficacy of DefenCath, and what I'm about to say, we don't really have a pathway for, but ultimately, where I think we'd like to get to, 10 years from now, is that this becomes the standard of care for locking catheters, overall, for preventing collapse and encryption, agnostic of disease state. I really think that the variable that matters more is how often the catheter is accessed, as opposed to necessarily what disease state a patient has. Now, that's not an indication that we don't have a pathway, at this point in time, for FDA for something like that. I think given the clinical relevance and what we've shown from an efficacy standpoint, I think from a public health standpoint, that would be beneficial. With the commercial hospital acute care platform that's coming together post-acquisition, how should we be thinking about future BD opportunities and help us understand the decision-making process for future potentially accretive transactions? Yes. Thanks. Fair question. I think you slipped that word in there at the end, and I think it was important, accretive transactions, right? That is still the top criteria that we probably put up on our board when we say, okay, what do we want to do next from a business development standpoint? We want something that'll fit still synergistically, whether it's with renal, hospital acute care, and eventually in the oncology space with REZZAYO. We want near-term accretion, right? If it's an M&A deal, we want the ability to take synergy and the ability to drive value for shareholders in very short order while also providing upside, right? Finding both sides of that coin, I think, is imoortant. Okay. Joe, I would love to turn the floor to you. Anything else you'd like our audience to take away today? I think we hit a lot of the salient points. I think the acquisition of Melinta is transformational for us, right? As I said, it gives us the ability to transition from a single-product company into a multi-product company, multiple shots on goal, new growth opportunity for REZZAYO, which, as I said, I don't think is fully understood or appreciated, so to speak, by investors currently. I think, to a large extent, DefenCath being a product that has to DAPA, right? We have some uncertainty around where pricing is going to go in the out years. I think this transaction provided a really good level of risk mitigation in that regard and potentially a bridge between the hemodialysis indication and the TPN indication for DefenCath. We're going to keep executing on our strategy. We're going to integrate with Melinta. We're going to look for new opportunities that meet the criteria that I just mentioned, and we're full steam ahead. Okay, thank you so much. We're rooting for you. Thank you. Appreciate it.