Welcome back to Leerink Global Healthcare Conference. My name is Roanna Ruiz. I'm one of the senior biotech analysts here at Leerink, and it is my pleasure to introduce Joseph Todisco, CEO of CorMedix. Thanks so much for joining us.
Thanks, Roanna. Nice to be here.
Yeah. I'll start with a big picture question before we dive into the details. Maybe for investors who are new or revisiting the story, could you talk a bit about CorMedix's strategic focus areas today, and how has the business evolved so far?
Sure. Thanks, Roanna. The business has changed a lot over the last 12 months. Historically, we were a single product company built off of an asset, DefenCath, which is a broad antimicrobial drug that prevents bloodstream infections in patients that have catheters. The current indication in the hemodialysis space, we transformed the company in 2025 with the acquisition of Melinta into a broad multiproduct diversified specialty pharmaceutical company focused on institutional settings of care. These are largely injectable drugs used in a hospital or clinic setting. A large percentage of our current portfolio are anti-infective drugs.
Where we are looking to pivot to and grow is not to pigeonhole ourselves into one specific therapeutic area, certainly not in the renal space, but looking to be, as I said, focused more on setting of care as opposed to a particular therapeutic area, leverage that sales, marketing, commercial infrastructure into the hospital, into the infusion clinics across multiple therapeutic areas. We have 2 assets currently in development. REZZAYO in Phase 3 studies for the prophylaxis of invasive fungal infections. That Phase 3 data readout is expected in the second quarter. We're likely looking mid-to-late second quarter for data readout. That product, we're very excited about. Large total addressable market would pivot us more into the hematology oncology clinic setting.
We have DefenCath in Phase 3 for prevention of CLABSI in patients that are getting total parenteral nutrition through a catheter. You know, that study is currently targeted for completion early 2027. But again, that's largely institutional setting of care in the inpatient hospital setting, both inpatient as well as outpatient infusion clinics, and then there's some home use.
Mm-hmm
for infusion as well. We're excited about where we're driving the company. We think we have a lot of catalysts over the next, say, 12-18 months.
Yep. Great. That was an awesome overview. I'll start. You mentioned DefenCath, so I'll start there. It's seen pretty strong adoption in the outpatient setting in particular. Could you just recap some of the main growth drivers that you see there? You know, what should investors be watching for going forward?
Sure. I mean, the product itself is has a phenomenal impact, right, on patients from a clinical standpoint. The Phase 3 clinical study showed a 70% reduction of CRBSIs, which are very similar to CLABSIs, we were able to replicate that impact in a real world evidence setting with U.S. Renal Care, in addition show material impact on hospitalizations, a 70% reduction in hospitalizations. You know, this is not just something that impacts, right, patient outcomes, but also takes cost out of the healthcare system. Right. Billions of dollars a year are spent by CMS on hospitalizations associated with these CRBSIs. Now, in terms of customer impact, we have seen pretty, what I think is really good utilization.
The DefenCath for its initial indication in renal has a little bit of a unique reimbursement called the TDAPA, right? This Transitional Drug Add-on Payment Adjustment, which provides a two-year window for buy and bill reimbursement, and then it becomes bundled by CMS. That two-year window, you know, I think we did a really good job of maximizing, call it maximizing the value of that reimbursement period and driving utilization. We're, you know, we're coming up on the end of that kinda cliff on June thirtieth. We're working with customers right now to preserve patient utilization. I think we have a plan to grow utilization with Medicare Advantage patients and some other strategies.
Right now, the focus for the third and fourth quarter of this year is really on stabilizing patients and keeping them, keeping continuity as we move into 2027.
Yep. I hear you. You mentioned the U.S. Renal Care pilot study data.
Mm-hmm.
I was curious, how are you leveraging that in conversations with large dialysis organizations? You mentioned Medicare Advantage strategies. Like, how are you using that to sort of drive more utilization of DefenCath?
Yeah. That data and some other real world evidence data that we haven't been able to publish, but we are able to use privately, we are utilizing in concert, you know, first with the Medicare Advantage plans. We think that is the kinda future largest market opportunity to grow patient utilization, you know, for DefenCath. Ultimately, when we talk about those billions of dollars of costs associated with hospitalizations, you know, the MA plan is the payer, right? They have the total cost of care for the patient. They're the ones bearing the cost of each hospitalization, treating each infection, and they're the ones most incentivized to invest in prevention. Right?
We are utilizing that data in an attempt to work with MA plans for, call it, a separate reimbursement for DefenCath outside of a bundled payment system. You know, I'm hopeful that we'll have progress as we move through this year, and we'll be able to update shareholders accordingly. You know, from a dialysis provider standpoint, I don't wanna say the data's less meaningful, but we have a lot of them utilizing it, right? It is helpful for them to see the value of their own real-world impact, right? We've heard from a number of our customers anecdotally that several have had results even better than what we've seen in the real-world evidence with U.S. Renal Care, and that's very heartening, right?
To see the actual impact on that we've had on their health system and their infection rates and certainly we wanna keep utilizing that data as we move through the next couple of years, right? To show the impact, the value, and the utility of keeping DefenCath as part of the patient treatment algorithm.
Yep. That makes sense. I know you were alluding to inpatient as well for DefenCath. What should investors be thinking about that segment going forward, either on pricing or volume?
Yeah
or growth? Like, how should we think about it?
Look, I think that's part of our strategy for this year and next year, is to, I guess intensify our activity in the inpatient segment, right? We launched an inpatient field team early last year, and we started to see a little bit of growth and uptake, but as we announced the Melinta transaction, we had to go through an integration, right? Part of that was integrating the field team and field operations into the legacy Melinta field team, which we've just now trained on DefenCath, and they're gonna be out calling on inpatient institutions. You know, that caused a little bit of a reset on the inpatient side, but we're excited about the potential there. It's a smaller volume market opportunity, right?
It's only 10% of the volume of dialysis gets done in an inpatient setting, and two-thirds of that is acute kidney injury patients. These are patients that crash land into the hospital. These are also patients that are more likely to have a temporary catheter, right? Those catheters tend to get infected at a higher rate. I do think there's an opportunity there, and that as we progress through the year, again, look forward to updating kinda shareholders on progress on kinda all fronts.
Yep. That makes sense. I know earlier this year you gave some guidance thinking about DefenCath going forward and through the TDAPA transition. Could you just recap, you know, the main takeaways from that guidance, any assumptions that are worth considering that are baked into that that we're thinking about?
Yeah, look, we were pretty conservative with what we guided for, and I think, you know, we tried to be as clear as possible about that. What we wanted to do was educate investors on, you know, how CMS calculated the bundled adjustment for the third and fourth quarter of this year, which led to us. As I said, our goal was to maintain patient volumes moving into 2027, and then, you know, also in the back part of this year, look to grow patients with Medicare Advantage. But the patients that we have now, as the CMS bundled adjustment for the third and fourth quarter, you know, didn't fully capture the current run rate of of utilization, right? It was based on an older period of time where they did the calculation.
You know, we've committed to our providers to reduce selling price, maintain, to try to maintain patient volumes, and then we expect with a larger bundled adjustment in 2027 for the selling price to appreciate. We took that extra step to give, we'll call it, 2027 base guidance, right? We were very clear that, look, what we're guiding here is kinda the base revenue of what we see of DefenCath, current patient run rates with a range of selling prices where we think it'll, it could shake out. There is upside, right? Potential should, you know, we have success with Medicare Advantage, should we onboard additional customers, should we get more meaningful uptake on the inpatient side.
I think there's a lot of potential for future growth that's not yet baked into that guidance.
Yep. I think it's interesting how you framed it as base guidance and some levers that could move it to the upside or potentially doing better than that. In terms of these levers like Medicare Advantage contracts and large dialysis customers, et cetera, which do you see as the most likely to happen, if you look into your crystal ball a little bit and-
Yeah, I unfortunately can't. That's not something I can opine on.
Okay. Fair enough.
Right? Kinda hedge that what's more likely, but that's a good try.
Okay. Fair enough. I'll switch gears to another exciting program that you're working on with Roanna-
Yep
in terms of bringing that product on-
Mm-hmm
with the Melinta acquisition and working on, prophylaxis as well. For investors who are less familiar with this product, could you just recap for us the key differentiators for it today? How do you-
Sure
Expect it to be further differentiated with additional data coming?
Sure. It is a long-acting echinocandin. It's a once-weekly IV currently indicated for the treatment of Candida, right? And fungal infections. The current total addressable market is fairly modest, right? It's somewhere between $250-$350 million, and a lot of that is inpatient utilizations, right? You do have some of those inpatient headwinds from a payer standpoint. We're really excited about the potential for the product as it moves into the potential prophylactic indication, right? It's in Phase 3 studies for prophylaxis of invasive fungal disease. It's running head-to-head against the standard of care. It is a non-inferiority study with the primary endpoint being fungal-free survival at day 90.
There is a secondary endpoint around discontinuation of rezafungin versus standard of care. Why we find or why we're excited about that is that the current standard of care is an azole, usually either posaconazole or fluconazole, which is being used in our study, plus Bactrim. The azoles are given for prophylaxis of Candida and Aspergillus, and then the Bactrim is added for the Pneumocystis. You know, some echinocandins don't have activity against Aspergillus. Rezafungin has demonstrated preclinical activity against Aspergillus, so you know, the ultimate goal would be to see, I mean, not just the primary endpoint, but how do we you know, stack up at the pathogen level, right? Candida, Aspergillus, Pneumocystis.
In combination with, if we're able to show, you know, a difference in discontinuation rate, right? 'Cause the standard of care, these are known, right? The posaconazole is known to have high level of hepatotoxicity, right? Where echinocandins, you know, do not. They also have a high level of drug-drug interactions that, you know, that can cause disruption with the chemotherapeutic regimens and other medications that the patients are taking. If we can, we see that as a differentiating factor, right, for, you know, for REZZAYO.
Yep. I hear you. How does that translate in terms of into the clinic and the value prop for patients and physicians? Like, what's the feedback you're getting on going potentially into prophylaxis?
Right. Look, I think the feedback from thought leaders has been positive, right? Overall, it's, you know, first everyone wants to see the data, right? I think, you know, the pathogen data is gonna be meaningful if you have the ability to eliminate, you know, more than one drug from the standard regimen. I don't think, you know, we're not here saying, "All right, we're gonna completely replace the standard of care across the board." I do think, one, you know, anecdotally, we've gotten a lot of feedback that the discontinuation rate of posaconazole is fairly high, and I don't know if that's 10% or 15%, but I'm curious to see how that plays out in the clinical study.
I think that's certainly low-hanging fruit, right? If you've got a total addressable market that's over $2 billion and 10% of these patients are discontinuing, that's certainly an opportunity. I think we wanna see how the clinical data plays out, and then we'll kinda know, I think, you know, how to position the product and what we've got.
Yep. You kinda alluded to this a little bit. I wanted to dig into this readout that's coming, and the trial itself.
Mm-hmm.
That's the Phase 3 ReSPECT study for prophylaxis for REZZAYO. For any investors that are newer to this, can you just recap the trial design and the endpoints and what-
Yeah
You think would be. You alluded to this a little bit with discontinuations, et cetera.
Right.
what would be like a really strong data set across the board that you'd be excited about?
Sure
to bring to clinicians, et cetera?
Well, there's various degrees of success, right? I think there's hitting the primary endpoint, and there's other measures that we can talk about. But it is a large study, 650 patients, I believe, enrolled running head-to-head against the standard of care, which is a combination of either fluconazole or posaconazole. They're both in the study plus Bactrim. The primary endpoint is fungal-free survival at day 90. Secondary endpoint is discontinuation of rezafungin versus the standard of care. You know, and as I said before, what we wanna see is, number one, I wanna see it hit the primary endpoint, right? That goes without saying.
I think number two, I wanna see, you know, see us hit that secondary endpoint and have a meaningful differentiation in discontinuation. Then number three, I think we're looking at the pathogens, right? Right, within the non-inferiority, you know, how did we separate ourselves with respect to Candida, Aspergillus, and then Pneumocystis, right? You know, obviously, all three of those, I think, is, you know, if you're asking what's a home run, it's hitting all the endpoints and having all three, you know, all three pathogens.
Yep. I hear you. Let's say everything works out, if the ReSPECT study is positive, across, you know, a bunch of endpoints here, thinking ahead, how would you initially plan the commercial strategy? Roll out into prophylaxis and-
Yeah
Can you frame a little bit of, you know, how are you, what you're thinking there?
Yeah. I think, I mean, I think the first question is around announcement of the data, right? The study is being conducted by our global partner, Mundipharma. Right? They acquired Cidara, which was the original developer of the drug, and are currently the sponsor of the study. You know, we're working with them on likely a, you know, our current expectation is somewhere mid to late second quarter, right, for data publication. You know, I think from there, right, you know, we're gonna have to, assuming the data is all positive, you know, do a little bit of augmentation to our current capabilities, right? Not a huge build, but probably a 15-20 additional headcount.
Want to bring in some expertise from the BMT centers, right, from hem/onc centers, a combination of a few commercial heads, a few folks on the medical side. You know, we're starting to already do outreach for potential where we're getting inbounds for IITs, right, assuming the data is going to be positive. We're starting to kinda prioritize those which, you know, IITs potentially, you know, we wanna evaluate and move forward. You know, as we move through the back part of the year, assuming the sNDA is filed in the third quarter, we'd be working toward hopefully a first quarter 2027 kinda called a launch event, but it's.
Mm-hmm
You know, it's a commercial product, right? You know, once the data is out there, right, it'll be more like a rolling type situation where I do think there'll be some physicians that potentially, you know, look to the early adopters and we're gonna wanna provide medical education where possible.
Yep. Could you remind us, how big is that opportunity in prophylaxis, like relative to REZZAYO's current in-label indication?
Look, it's a big TAM, right? There are a lot of patients that are immunocompromised that are getting prophylactic antifungal, right? You know, the study that we've run in allogeneic bone marrow transplant patients, you know, I think we've sized that TAM at around 500, that part of the TAM at around $500 million. These are patients that, you know, BMT is a treatment. It's not a disease state, right? You have patients within the study that have multiple underlying conditions, different types of leukemia. You know, we have to wait and see what the ultimate label is that's approved by the FDA.
You know, that said, feedback that we have gotten, certainly we're gonna be looking to do IITs, but I do think there's just gonna be natural spillover. You know, solid organ transplant is another large total addressable market opportunity. These are patients where, right, a drug-drug interaction can cause a significant disruption to, you know, to their eligibility for a transplant. I think, you know, there'll be some organic kinda spillover.
Yep. Makes sense. Then I think you've also noted that REZZAYO could be covered under Part B rather than Part D, which is used for the oral azoles. Like, how significant is that dynamic, and, you know, how are you thinking about payer formulary coverage going forward?
Look, we've done some initial kinda payer landscaping, and I think the feedback has been positive, right? You know, these are patients that are on a number of medications, you know, receiving medical care that is in the hundreds of thousands of dollars, if not potentially millions, right, for some folks. Yes, you know, the azoles are cheap and generic, but they're also potentially problematic, right? You know, I think we are well positioned to have these discussions with payers. I do. We don't at this time expect them to be a roadblock, right, as opposed to maybe, like, a speed bump, you know, type situation. Just, you know, most of these situations require prior authorization, right?
You know, that's something we're equipped, right, to manage and help patients manage, and it'll be part of the commercial launch strategy.
Yep. Got it. I'll switch gears a little bit to back to DefenCath, but in TPN.
Mm-hmm.
Can you help frame just how high is the unmet need there and how I think you've sized the market at around 500 to-
Mm-hmm
$750 million as an addressable market. What are some of the assumptions that go into that as well?
Well, look, you've got a modest amount of patients, let's say, that are getting TPN mostly daily, right? The average is something like 6 times a week, and they're getting it almost in perpetuity, right? These are patients that are dealing with severe, you know, debilitating conditions. You know, the way that we look at it, you know, there's a value to preventing infection rates, which are extremely high in this patient population. Mortality is extremely high in this patient population. Very similar to hemodialysis from that standpoint. You know, what's unique about or different about TPN, again, it comes from a payer landscape. We're not dealing with an add-on payment or a bundled payment system.
You know, our market research indicates that it's gonna be predominantly Medicare B again, you know, and commercial outpatient reimbursement, even in the home setting of care, right? I think the payer landscape and the value that the product brings to preventing infections, you know, I think it's gonna be a meaningful opportunity.
Yeah.
Right?
for the Phase 3 study for DefenCath in TPN
Mm-hmm
Can you talk about, just recap the design elements and, you know, what you put into that study?
Sure
What would be a clinically meaningful result coming out of that?
Well, look, I think ideally you wanna show very comparable results to what we showed with LOCK-IT-100, right, for hemodialysis, the ability to reduce CLABSI by 70%. To some extent, the design of the study is similar to LOCK-IT, but it's an adaptive study, a minimum of 90 patients, a maximum of 200 patients. It is a two-to-one study of DefenCath to comparator, with an interim look once we hit 15 infections.
The way in which, you know, I think we expect this to go is, you know, when we hit 15 cumulative infections, there'll be a look at the data, a look at the ratio of infections in each arm, and if there is a material discrepancy, if we've crossed the threshold, potentially, you know, the FDA could say, "Okay, keep enrolling to hit your 90," or, "No, you're not there yet. You've got to keep enrolling to, you know, till you get enough infections and get to 200." Certainly we're hopeful that if we can replicate, right, the impact we've seen in LOCK-IT in the real world evidence that, you know, we'd be on track for that 90-patient kinda early termination.
Yep. I hear you. Also, what's the KOL feedback been about potentially going into TPN, and any highlights there?
Look, I think the feedback's been great in terms of, you know, the minute we got DefenCath approved for hemodialysis, we got a lot of inbounds from the TPN community, which is why we were probably so aggressive with our original timeframe for the study. Now, you know, in a clinical study, it's a little bit different, right? You've got a inclusion/exclusion criteria, which made patient enrollment move a little bit slower than I think what we originally forecasted, but we're still kinda estimating early 2027, which was in the outer bound of our original range. You know, we do get requests, you know, to you know for patients today, right, in TPN.
Yep. I hear you. Okay, great. Also a bigger picture question on the financial side. You know, how are you thinking about your cash position? You also I think announced a buyback as well.
Mm-hmm.
In terms of balancing commercial investment, clinical stage development, you know, moving multiple pieces forward together.
Yeah, look, I think we're in a good position to do a lot of those things at once, right? We finished last year in a really strong cash position, about $150 million cash on hand, $150 million debt, so that's zero, you know, zero net debt essentially. You know, we expect to be cash flow generating, right, through 2026. You know, we wanna do a couple things. From a business development standpoint, you know, 2025, it was really important to us to do something transformational, right? We raised equity, essentially at risk ahead of getting the Melinta deal signed. We used equity as a component in that transaction. Where we sit today, right, we're not looking to use equity to do something transformational, right?
We're not looking to do anything dilutive. The types of things we're looking at from a business development standpoint are more tuck-in things that we would use maybe a combination of debt on hand and some additional debt capacity, you know, to fund those types of activities. We also think we have dry powder available to execute on the buyback, right? I was glad the board of directors approved a $70 million stock repurchase program, which we've started the process of repurchasing and expect to be active throughout the year.
Yep. I noticed you mentioned some potential tuck-ins, et cetera.
Mm-hmm.
Any types of products or indications that you might wanna consider?
Yeah, look, I think we're not looking to be completely therapeutic area agnostic yet, right? We'd like something that fits with the existing sales deployment. You know, that could be something that fits with where REZZAYO could go in prophylaxis, could be something that fits with the inpatient field team, either in infectious disease or in renal or something that's utilized in the infusion clinics. You know, where I think we're really excited about, we took a minority stake in Talphera, which has a really interesting product that's used in a hospital inpatient setting for CRRT. You know, that clinical data hopefully comes this year. Those are the types of things, if you're looking at something that's a tuck-in that fits strategically, that we like.
Yep. I hear you. Wanted to circle back to DefenCath a little bit more. I mean, one of the questions that I get is just investors trying to understand your overarching contracting strategy going forward. Anything unique or interesting for investors to think about of how you're thinking about contracting through the TDAPA transition?
When you say contracting, are you talking about with the dialysis operators? You're talking about with the MA? Which type of contract?
Dialysis operators.
The dialysis operators. Okay.
If there's anything interesting on the Medicare Advantage side.
Well, look. With the dialysis operators, we structured these agreements from the start to allow for periods where potentially the bundled adjustment didn't fully capture, right, the expenditure, right, of DefenCath. Now, I think the CMS threw us all a little bit of a curveball with this 2-quarter stub period based on an older calculation. The agreement is structured, you know, to account for a situation like that, but we are working through some, call them amendments to the contracts with customers. What we wanna do is somewhat agree to hopefully pricing for the third and fourth quarter and 2027, right? Based on the methodologies and what we expect to be the bundled adjustment in 2027.
You know, for Medicare Advantage, I think it's too early, right?
Mm-hmm
To give an update on where we are.
Okay. Fair enough. That's interesting.
Yep.
Then, I'll wrap it up with a bigger picture question. What do you think the market currently underappreciates most about CorMedix story? What would you wanna highlight for investors?
Look, that's a good question because this is something that we do wrestle with, 'cause something is clearly, in my mind, being missed by investors or how public markets are valuing the company, right? We're being valued at about 4.5x forward EBITDA, which is, you know, way below peers, right? Which are on the low end, 9x. On the high end, 14x. I think my gut tells me that not enough value is being ascribed to REZZAYO for prophylaxis. I think maybe there's a wait and see on the data, and that's possible.
I think there's certainly likely not enough value going on DefenCath and TPN, and maybe there's some, you know, folks that are wondering whether our 27 guidance on DefenCath is gonna materialize. You know, as we move through the year and we start to update things, I think I'm hopeful we'll start to see a convergence of actual value with what we see as reality. You know, the way I, you know, kinda feel today is that the business is operationally probably the strongest it's been in the last four years since I joined the company. I'm excited about that and where we are and the catalyst that we have.
Okay. Great.
Hopefully value takes care of itself.
Yeah. Super exciting. Looking forward to more updates.
Thank you.
With that, I think we're basically at time. Thanks so much, Joe, for joining us.
All right. Thank you. Thanks for having me, Roanna.
Yep.
All right.