Good afternoon. I'm Serge Belanger, one of the healthcare analysts at Needham & Company. Want to welcome everybody to Needham's 25th Annual Healthcare Conference. We're happy to have for our next fireside chat session, CorMedix. We have the company's CEO with us, Joe Todisco. Welcome, Joe, and I'll hand it over to you. Maybe we can start with just a quick overview of the company for those who aren't familiar with CorMedix, and then we'll jump to Q&A.
Thanks, Serge. Yeah, happy to be here. Good to see you again. CorMedix, today, is a diversified specialty pharmaceutical company with a portfolio of pharmaceutical products that are focused on institutional settings of care, right? These are largely injectable drug products utilized in settings where a healthcare professional administers drugs directly to a patient, usually injectable drugs. That would be hospitals, infusion clinics, outpatient dialysis clinics for our product DefenCath. We just came out of a fairly transformative year for the company, heading into 2025. We were largely a single product company focused around DefenCath, which is used predominantly in the outpatient hemodialysis setting, but also in the hospital inpatient setting.
We acquired Melinta toward the back part of last year, which brought in a portfolio of products as well as a key pipeline asset in REZZAYO, which has completed its phase III study, and we're waiting data readout in the Q2 .
All right. Thanks for the overview. Maybe let's start there with where you ended on REZZAYO, since we have a, I guess, imminent.
Mm-hmm.
Phase III readout now that we're in the Q2.
Yep.
Maybe if you want to start kind of introducing REZZAYO, what it is.
Sure.
What its current label is.
Yeah. REZZAYO is rezafungin for injection. It's a once-weekly echinocandin injection. It's FDA-approved and currently indicated for the treatment of invasive fungal infections caused by Candida, the Candida strain of fungus. This is a modest total addressable market opportunity of about $250 million-$350 million. Most of the utilization, or use for the total addressable market, is in the inpatient hospital setting. Some of it's in the outpatient infusion clinic setting. We only closed on the Melinta transaction at the end of last year and have just kind of really dug into the potential and the marketing tactics for REZZAYO in its treatment indication. The larger total addressable market opportunity is in prophylaxis, in prevention of fungal infections, largely in immune-compromised patients.
There are a large number of patients that have multiple underlying conditions, including those that have hematological malignancies that have to, today, receive prophylactic antifungal therapy, right, as part of their medical treatment. And the phase III clinical study for REZZAYO prophylaxis being done in a subset of patients that are undergoing bone and marrow transplant. Now, the patients in that study have multiple underlying conditions, different types of leukemia. But ultimately, they've received, typically as the standard of care today, antifungal prophylaxis for usually a month leading up to a bone marrow transplant and eight to 10 weeks after.
Okay. Just remind us again how long the product has been approved in its current indication.
It was approved in late 2023.
Okay.
I'm forgetting the exact approval date, as it predates our acquisition of Melinta. I believe they began commercialization in early 2024.
Okay. Would you say it's a well-known product in that indication, widely used, or still kind of new?
Well, look, I think like most products that are utilized in an inpatient hospital setting, the ramp tends to be fairly slow. It takes a long time to get through hospital P&T committee for drugs that are utilized in an inpatient setting. Particularly, doctors, especially in academic settings, want to see real-world evidence. They want to see more utilization. The TAM is somewhat modest, right?
Yeah.
It's not a huge total addressable market. We've taken over the last couple of months since closing, I think we've taken a look at some of the things that went well with launch and some of the things that maybe could've been done better, and we're kind of tweaking the approach over the course of this year and looking to get a little bit more growth out of the treatment indication than maybe what the historic trend was.
Yeah. You mentioned the prophylaxis indication that potentially be achieved with this upcoming phase III trial readout is much larger.
Mm-hmm.
What are kind of the unmet needs that REZZAYO could be to address?
As I said, you've got large numbers of patients that have to get antifungal prophylaxis, right, because getting a fungal infection could bounce you from a bone marrow transplant, or if in other disease states, from a solid organ transplant, right, if you get an infection. These are patients that are undergoing immunosuppressive therapy, so they're super vulnerable to these types of fungal infections. Now, when we look at the market today, and you look at the standard of care for prophylaxis, the standard of care is largely either it's an azole, right? It's usually either fluconazole or posaconazole in combination with Bactrim. Our market research indicates that there's issues related to the standard of care from a discontinuation rate standpoint because of reasons of toxicity. When you look at posaconazole specifically, it's known to be hepatotoxic.
You also have drug-drug interactions that come into play, where it interferes with the absorption of other drugs that are being utilized for these patients' underlying conditions. Bactrim itself is known to be myelosuppressive. You have issues with discontinuation, and that's one of the secondary endpoints of the phase III study, where we're hoping to find some differentiation between rezafungin and the current standard of care.
Yeah. The phase III trial is being conducted by Mundipharma?
Right. It's a global study that is being led by Mundipharma. If you'll remember, Cidara Therapeutics was the original sponsor, had licensed U.S. rights to Melinta, and then global rights they sold to Mundipharma. Mundipharma is the global sponsor, is running that study. They are our partner for that study.
Okay, just in terms of design, the number of patients, the endpoints?
Yeah. I think the study was fully enrolled at, I think, 660 patients or 680 patients.
Oh, wow. Sizable.
Yeah, sizable study, one to one randomization of REZZAYO compared to either fluconazole or posaconazole plus Bactrim. Primary endpoint was fungal-free survival at day 90, and then there are a number of secondary endpoints. One that we tend to focus on is discontinuation for reasons of toxicity. Our market research has indicated that depending on the underlying condition, discontinuation rates are anywhere from 10%-20% for the standard of care, which we see as a meaningful detriment for that patient population. That's where we're hoping to see some differentiation in the clinical results.
Okay. Bar for success is obviously meeting the primary endpoint, stat sig.
Yep.
That ticks off one box.
One or more secondary endpoints, we can show some differentiation. Yes.
Okay. That would enable a pretty broad label for use as a prophylactic?
Well, when you talk about broad label, I think there's a lot of factors. It's ultimately going to come down to probably a discussion with FDA and the strength of the data being submitted. The study's being run. The primary endpoint is fungal-free survival, but we are evaluating three different pathogens, Candida, Aspergillus, and Pneumocystis. We're going to have to see how the specific pathogen data looks relative to the total endpoint of fungal-free survival. The study's also being run in patients that are undergoing allogeneic bone and marrow transplant. I think there's some precedent out there. As I said, there are patients with multiple underlying conditions that are getting BMT. Whether or not the label ultimately is specific to BMT patients or not is going to be a discussion with the agency.
Okay. I know we're probably a ways out here, but assuming everything goes well, and you do get approval, how do you think about pricing? Is it kind of anchored by the original indication?
Well, it is. You can only have one WAC price for the course of therapy. The course of therapy for prophylaxis, certainly in the subset of patients that are engaging in the study, is much longer than for treatment. Treatment's four weeks. This is 13 weeks. You've got a larger cost of therapy, so to speak. The pricing for the WAC, the list price essentially, is not going to change for the drug.
Okay.
When I say not going to change, I mean subject to normal.
Yeah, normal price increases that you see on an annual basis.
Yeah.
Sure. In terms of commercialization, you would need to build a presence in the Hema clinic setting? That's where most of the-
I think it's a small incremental build. We've talked about 15-20 incremental headcounts. Some of it's a shift of resources right in terms of and trying to cover both hospital-affiliated clinics as well as hematology clinics with certain institutions. It's not going to be a large infrastructure build from where we are.
Okay. As we think of this data readout, it's already proven in indication, so seems to be de-risked to me. What do you think are the main risks for a prophylactic versus?
We did a lot of diligence prior to.
Yeah.
We were acquiring Melinta around this exact question, and obviously we had a lot of confidence in a lot of the underlying data. Certainly, rule of thumb, if something has efficacy for treatment, it should also have efficacy for prophylaxis from a Candida pathogen standpoint. There's a decent amount of both in vitro as well as animal data that shows activity in other pathogens, in Aspergillus and in Pneumocystis. We have a decent amount of comfort in the probability of success and hopeful for a good outcome when we read out results.
All right. Well, I'm looking forward to that. Let's move to DefenCath. I think we're getting near the two-year anniversary of the launch.
Mm-hmm.
I think in the inpatient segment, you had actually started earlier, right?
We did. When we say we started, it was really from a promotional standpoint, right?
Yeah.
In terms of being out, and we shipped a little bit of product early on. The real launch occurred in July of 2024 when TDAPA kicked in, right?
Yeah.
Because most of the volume and the utilization.
Sure
Right, for DefenCath for its initial indication in reduction of CRBSI in patients that are undergoing hemodialysis is going to be in those outpatient hemodialysis centers.
Yeah. Revenues ramped up pretty quickly once you launched.
Yep.
July two years ago. There's going to be a kind of a reset on the TDAPA pricing at the two-year anniversary. You did provide some guidance on what to expect. Maybe just walk us through the process here and how the TDAPA works.
Yeah, look, TDAPA, as it currently stands, and we can probably talk about, right, the TDAPA bill that's pending or other things that we're hopeful CMS potentially could do with rulemaking. Right now, it's two years of reimbursement at ASP, and ASP is a government-calculated average selling price that's based on a two-quarter lag of reported pricing. Dialysis operators, providers would buy product from us, and they get reimbursed at ASP, which essentially resets each quarter right now, right, based on rebates and discounts and the pricing that we report into the government every quarter. Now, starting July 1st, that mechanism is going to shift under TDAPA, and it becomes a bundle-ized adjustment where CMS does a calculation of trailing 12 months utilization.
They apply an average selling price, then they discount that by 35%, and then they allocate that money across dialysis operators today, essentially based on market share of total dialysis claims submitted, right? Provider that does the most amount of dialysis is going to get the largest amount of money, and it's not really related to utilization of drug product, right? That will go on for three years under TDAPA.
Yeah.
Now, what happened to DefenCath is we have an unusual situation where our TDAPA straddles a mid-year, right? Everything that CMS does, I guess they try to do on a calendar year basis. For us, the prevailing logic was that they would kind of shift their calendar year, right, or do it on a TDAPA year basis, and ultimately, they elected not to do that. What they've created is a two-quarter, we've been calling it a stub period, where for the Q3 and Q4 of 2026, they're going to be using an older period, right, of time of utilization to calculate the add-on to that bundle for two quarters. In 2027, they're going to be using a more current period that actually more accurately reflects current utilization and current pricing of DefenCath.
Unfortunately, there's going to be two quarters where reimbursement is really going to be kind of subpar to what current run rate is of utilization.
Yeah.
We think it's going to rebound upward in 2027 a bit. That's been the challenge we've been dealing with over the last few months in negotiating with customers of how to keep patient numbers stable, right, through the back part of the year, so that coming into 2027, we've got better pricing and the same or higher utilization.
Okay. We know what's going to happen with price.
Mm-hmm.
I think you kind of laid it out here. In terms of volumes, I guess what should we expect? First, is volume still growing from where you ended in 2025?
Well, I'd say we're kind of at a run rate right now in terms of our volumes, which we believe are largely fee for service patients through the providers.
Yeah.
We don't know that 100%, but I think we're reasonably confident from the third-party data we see that more than 90% of our utilization is going into fee-for-service patients. In terms of really moving the needle on volume, one of two initiatives, I think, we need to onboard the one outstanding larger customer that's not utilizing the product today, or we need to make inroads with Medicare Advantage. That's really where we're focusing a lot of our efforts in terms of the future of DefenCath. Because right now, in the ESRD space, Medicare Advantage, the last update I got was that it's crossed 50% of patients, right? It's more than 50% of the patient population in ESRD, and we have very little utilization there, if any.
Now, the MA plan itself is the one that, in our view, is most incentivized to want to use DefenCath because they're on the hook for the cost of the infections, right? They have the total cost of care for the patient as the payer. They see their own data, right, in terms of what they're paying for hospitalizations, what they're paying for treatment of infections. Ultimately, the real-world evidence we've been able to generate with dialysis operators in those fee for service patients, we think it's relevant in terms of trying to create a dynamic with Medicare Advantage where we separately contract for reimbursement outside the bundle, right? Now, this is part of our growth strategy to drive volumes over the next couple of years.
Candidly, we are trying to do something that's really not been done before, which is take a product that's in the bundle and contract it.
Yep.
But in all fairness, we don't have a lot of predecessors, right? There's only been a handful of TDAPA launches.
Sure.
I don't think any have really been, of the last two, have been as successful as DefenCath has been, either in terms of call it commercial success or health impact on the patient population, right? What we've been able to do in terms of reducing infections across thousands and thousands of patients, I think there's a compelling pharmacoeconomic case that we are making and that hopefully will bear fruit in the future with Medicare Advantage. Those are how we would really look at the ability to kind of increase volumes of DefenCath.
Okay. Overall volumes should maintain themselves.
Well, look, that's what we're trying to do, right?
Yeah.
The next couple of months, really, we're all looking to see also, CMS will be publishing their 2027 proposed rule in June, most likely. That's the timeline. That'll give a read-through to, all right, what's the reimbursement rate going to be for 2027, right? We all can do math, and we all believe it's going to increase significantly above what they've put for those two quarters, but that'll actually be concrete, right? Evidence that customers can rely on. We've laid out a framework with customers where we've volunteered to reduce price for those two quarters significantly.
Right.
We want to keep patients on therapy and then come into 2027 and hopefully have some price appreciation. Yeah, that puts us in line with the guidance that we put out, right, for DefenCath in 2027?
Yeah. For the Medicare Advantage opportunity, do you still have to work with your LDOs and MDOs? Is that kind of hand-in-hand?
There'd have to be some amount of work. Well, there'd have to be pull-through on us there, right?
Yeah.
The goal would be that if we are able to get an agreement in place with an MA plan to separately reimburse DefenCath at a, call it, fixed dollar amount, we would then go work with the DOs on pull-through that, hey, let's identify, right, how many patients do you have for this particular provider, and hopefully start to transition.
Okay. You mentioned the other LDO, we won't name them, but just curious if there's been any progress or maybe they're waiting for separate reimbursement?
We're always in communication, but nothing I can really comment on, right?
Yeah.
To say that, "Hey, this is going to happen or not going to happen," we continue to provide them with updates and data, real-world evidence, and have what I'll call is a good dialogue, right?
Yeah. I believe you were running a real-world study with one of your MDOs.
Yep. With U.S. Renal Care.
... for dialysis. We've seen some interim results.
Mm-hmm.
Should we expect additional results or final results from this study?
Yeah. The collection period will end on June 30th. I'd imagine it's going to take a couple of months, right, to aggregate data.
Sure.
We're going to want to work with them on publishing that data together jointly, right? That's the goal.
Okay.
I don't have a timeline yet of when it'll formally publish, but that is the goal.
Based on the interim data, it should lays out what the close part.
Look, I'm not expecting to see anything in the final data that's different from the interim data.
Right.
We were excited, right, to see not just the infection reduction, but the hospitalization reduction, right, because that's real cost, right? To be able to reduce hospitalizations takes significant cost out of the healthcare system.
Yeah. Okay. You talked a little bit earlier about the potential legislation to modify TDAPA.
Mm-hmm.
Do you feel that's moving forward or does that need to move forward?
Look, I think the legislation has a lot of support, and I'll be headed back to Washington shortly, right, to pound the pavement on the Hill a little bit more. It's not been a challenge, I think, to find people that understand the logic, understand the issue, think something needs to be done, right? The barrier to getting it across the finish line is really just the dynamic of Washington right now, and there being, I think, a suitable vehicle to attach the bill to that can get bipartisan support for full passage and then signed by the President, right? Think about, there's so much focus right now on Iran, on Homeland Security funding, that it's unlikely there's going to be anything super quick, right?
Yeah.
That this gets attached to doesn't mean that even if it gets approved later in the year, that it can't potentially benefit DefenCath patients. Right now, the climate in Washington is difficult. We've been also focusing our efforts on hopefully we're working with CMS on what they can do by rulemaking, right? They do have authority to make certain changes to TDAPA that are beneficial in their rulemaking process, and hopefully something comes out in the proposed rule that maybe is beneficial to prior versions.
Okay. This version, the main change would be just an extension of that first period of TDAPA?
Well, I think that would be great, right? That certainly could be a stopgap, right, to bridge to a legislation.
Right.
Which could come, right, later this year, early next year. We don't know, right? I think one of the bigger changes that's in the legislation that we'd love to see make its way into practice is how they bundleize, right? Just have the concept of having reimbursement follow the patient, I think is an important dynamic that really incentivizes the providers, right, to utilize the drug and doesn't incentivize, right, people to not utilize the drug, right, kind of thing.
Okay. We mentioned earlier you had launched in the inpatient segment. Where is that effort?
Well, we've been through a couple iterations of the inpatient side, and if you remember, we did a kind of a sales team revamp last year, but then went through the Melinta transaction and had to go through an integration, right? We ultimately kept the legacy Melinta organization, and then had to go through training them on DefenCath in the Q1 of this year. They're really now just hitting the ground, right, in terms of hospital inpatient. Now, I'm happy with what I'm seeing in terms of progress. The way we've deployed the sales team now, we have, they call it the inpatient key account manager team that's really focused on DefenCath and REZZAYO in the hospital setting. We have an inside sales team that's a smaller team, that's focused on VABOMERE and MINOCIN, and promotion of those drugs.
That's how we currently have our sales deployment. We're obviously anxiously awaiting the REZZAYO prophylaxis data.
Yeah.
... before we make any other kind of structural changes to field deployment that we might do for prophylaxis. But official prophylaxis approval and launch wouldn't be until next year anyway, right? So-
Yeah. The inpatient segment for DefenCath is still only about 10% of the overall TAM?
It's 10% of the TAM. I think we've said this from a dollar standpoint. I think it's a larger addressable market than 10% because a little bit better pricing capabilities in that segment.
Yeah.
Yeah.
Okay. You're looking to expand the DefenCath label to TPN, total parenteral nutrition.
Yep.
Phase III is underway.
Yes.
I guess update in terms of where you are in enrollment and when we could see results here?
Look, we'll probably give another update on timing and enrollment when we report earnings later in May. We need to have a sit-down with statisticians, right? See kind of where we're trending, right? It had been enrolling slow, right? We've opened more sites. We're hoping to increase that enrollment. It's also a function of total infections, right? If infection rates are low, you end up needing a higher number of patients to kind of hit that.
Threshold. If all of a sudden you get a couple infections really quick, it changes your numbers. We're going to be sitting down with the statisticians in the next few weeks, and we'll have an update when we report earnings.
Okay. In terms of infection, I think in your LOCK-IT study for DefenCath, in its original indication, you're in the 70-some range on efficacy?
Yeah. I think what I'm referring to is more of the incidence rate of infections relative to total catheter days.
Okay.
Think about, our original estimate was that we could see 15 cumulative infections within 90 patients or so between the two arms. Now we're going to have to wait and see where we're kind of trending over the next couple of weeks. I would love to, from an efficacy standpoint, though, mimic the efficacy in hemodialysis in the TPN patient population. Right? Ultimately, I think the way we view the world is a catheter is a catheter, right? The underlying condition isn't as important as how often the catheter is accessed, right? I think that's what's kind of common. In TPN, they're accessing it every day. In hemodialysis, it's usually three times a week. Hopefully we see comparable efficacy.
Okay. In terms of market opportunity, how does it compare in terms of potential vials versus the outpatient segment?
Yeah, look, we've kind of put some revised TPN data out there. We think it's around 7.5 million infusions a year, TAM of about $500 million-$750 million, depending on pricing. Some patients do get infused every day. Some are a couple times a day, right? It does vary a little bit. Overall it's not a huge patient population that is difficult to reach. I think what we like about it, compared to hemodialysis, you're not dealing with a bundle-ized reimbursement process like a TDAPA and then post a TDAPA. It's fairly more straightforward. Our market research indicates Medicare Part B reimbursement, which is a little bit more straightforward, like buy and bill reimbursement.
Yeah. I assume this market is similar to your original market in the outpatient dialysis segment in terms of there's no other product like DefenCath?
No, certainly there's nothing FDA-approved for reduction of infections, right? There are physicians out there that have been using ethanol, right? Ethanol, one, is toxic, and two, it eats through the catheter, right? It's become fairly expensive to utilize ethanol. There really isn't a good or an opportunity out there for physicians to use something with the same safety profile as DefenCath that's FDA-approved.
Yeah.
Can go into this patient population.
Based on your research, are the CRBSIs or CLABSI?
We use the nomenclature CLABSI for TPN, and a lot of doctors use them interchangeably, but there's a little bit of a nuance.
Yeah.
CLABSI is a central line-associated bloodstream infection, and CRBSI is a catheter-related bloodstream infection, and catheters and central lines are essentially the same thing. I'm not a doctor, so I hope I don't misspeak, but I think the main clinical distinction between the two of them is in a CRBSI, it has been determined with a swab that the catheter is the source of the infection as opposed to a CLABSI where it's likely that it's the source of infection, right?
Yeah.
I think it's a small nuance where all CRBSIs are CLABSIs, but all CLABSIs are not CRBSIs.
Got it. I was going to ask whether the incidences of either CLABSIs or CRBSIs are higher in the TPN population versus dialysis.
Fairly similar. Our research indicates it's about 25%, right, incidence rate.
Oh, okay.
...of infection in.
It's a significant number.
Pretty high. Yeah.
Yeah. Okay. There is a significant unmet need here.
Yeah. 100%.
I wanted to talk a little bit about the Melinta product portfolio.
Mm-hmm.
I feel it doesn't get much attention. Just in terms of, well, I think there's six products. I may have the wrong number, but how is it performing and what is the growth potential of it going forward?
Well, I think it depends on the product, obviously, and I think we've been happy with the performance, and we see a lot of the growth potential coming from REZZAYO, right? Certainly, as I said, we're kind of revamping the promotional efforts around the treatment indication, and we're hopeful for really good data on prophylaxis, which will be a really good catalyst for that product. VABOMERE and MINOCIN are a little bit more entrenched, and we look at them as durable anti-infectives that have some growth potential, right? Some modest growth potential we've seen year-over-year. We have them, as I said, with our inside sales team, and I think we're content with how they're performing. The oritavancin products, which were KIMYRSA and ORBACTIV, and it's built into our guidance, are going to contract a little bit this year.
Another drug in the class went generic, which is DALVANCE. A lot of the utilization of those drugs, the two of them combined, were kind of smaller piece of the overall pie. They were combining to about $20 million of sales. For the next, I'd say 12 months, there's a profit incentive for the infusion clinics to utilize that generic DALVANCE in the class.
Mm-hmm.
By the mid to late 2027, I think that profit arbitrage goes away, and we could begin putting promotional efforts again behind KIMYRSA and looking to kind of grow it back into that market. Kind of there's just some small, steadier assets. BAXDELA and TOPROL-XL are just smaller contributors, but fairly stable.
Okay. In terms of IP duration for these products, are there still some decent runway?
You're talking about patent protection?
Yeah.
Yeah. You can go through our corporate deck. We've got the IP and patent dates and exclusivity dates. REZZAYO specifically has, similar to DefenCath, not only new chemical entity exclusivity, but also QIDP. Right? Nobody can even file an ANDA against REZZAYO until 2032. Right? On top of that, you have patent protection that goes out well into the 2030s. MINOCIN is probably the most near term, had been in a Paragraph IV litigation. That is up on appeal and we're waiting for an opinion by the appellate court. As I said, we felt really good about kind of the way that appeal hearing went and hopeful for an outcome in our favor.
Yeah.
Again, VABOMERE and the oritavancin products have good patent protection as well.
I'm curious, when you think about potential BD, since you already have an infrastructure commercializing these antibiotics, antifungals in a hospital setting, is that a focus for you to keep adding hospital products to leverage that sales force?
Yeah, no, absolutely, it's a focus. I think in terms of where we were at last year strategically, and I think we were pretty clear, we needed to do something transformational, right? Largely, that involved having to use stock as a component to be able to.
Yeah.
We wanted to be able to fund the transaction of the size we were looking to do. Now we're looking at things that are more kind of add-on and tuck-in, right, things that are going to fit either with the hospital infrastructure that we have, potentially the infusion clinic or the hematology space where we're hoping to go with REZZAYO. From a financing standpoint, where we trade today, equity wouldn't be our first preference, right, to kind of fund growth. Likely we'd be looking at the types of deals that we can fund with a combination of cash on hand plus new borrowing against the profitability that we'd be acquiring, right? We're looking at things that are largely commercial. We are not trying to get into things that require a large R&D expense for ongoing phase III study right now.
I think the Talphera deal that we did is a great example of a good shot on goal. Modest risk. We took a small minority equity stake, gave ourselves, or were granted a right of first negotiation to acquire the business.
Yeah.
On the readout of phase III data, and hopefully that data is going to be favorable. That's a really good product from our standpoint that fits with our sales deployment. It's an anticoagulant used in a continuous renal replacement therapy process, so it's ICU patients that are in the hospital. It overlaps with renal, where we do have some presence and deployment. I think that's a good fit in the type of deal that we can look to do.
Have they provided an update on when they could report this phase III trial, or it's still a moving target?
No, I think they've broadened their range to this year. They're hoping to complete the study this year. When they give updates, we'll give updates.
Yeah. Is it just a question of patient enrollment for that type of study?
Yeah, I think it is just, when you run these studies, patient enrollments, it's not an exact science of always being able to say, "If I'm here, I'm always going to be here," right? They've added on. I think it's been a little lumpy in terms of patient additions, and hopefully it completes this year.
Yeah.
Look, we like the product, so it's not a time-sensitive situation for us. Whether the study completes this year or next year isn't as much of my concern as whether the data's good.
Right. That makes sense.
Yeah.
I think we only have a few minutes, so maybe if we can spend a little time on kind of the balance sheet and capital allocation, things like that, to end.
Yep. We finished last year with about $150 million cash on hand. We've not put out our cash number yet.
Okay.
We'll be, as I said, reporting in a couple of weeks. I know historically we may have pre-announced. We're going to, going forward, get out of the cadence of pre-announcing. It's a little bit too much of a burden on the finance organization, right?
Sure.
To try to do that in a couple of days after the quarter. We finished, as I said, last year, 12/31, about $150 million cash, $150 million debt. Zero net debt. We did announce in the early part of the year a stock buyback program.
Yeah.
Up to $75 million of stock over the next two years. We started to be active in the Q1, throughout the Q1. We've not put out a number yet of what we've bought back. I think, for us, it's going to be a balance, right, of wanting some dry powder for new business development opportunities, as well as buying back stock, periods where we see it as being significantly undervalued, which obviously is right now, we see every day, right, feeling like the stock's not being fairly valued by The Street. As I said, we'll update a little bit more when we get to the earnings call in a couple of weeks.
All right. Well, I'll let you wrap up with on anything you feel is misunderstood or underappreciated, and like you just mentioned, the stock, so-
Well, look, it's always from our perspective, a lot, and the question is, where is it being unappreciated? Whether that's on the DefenCath longer term vision or REZZAYO prophylaxis data and the potential impact of that, it's hard to say. I think all we can do is keep focused on execution, hopefully have a positive phase III data readout, right?
Yeah.
Coming up, and then we'll move from there.
Well, Joe, thanks for spending time with us this afternoon, giving us an overview of CorMedix.
We appreciate your participation in our conference.
All right. Thank you, Serge. Appreciate the time.