CorMedix at Citizens JMP: Strategic Growth and Market Expansion

On Thursday, 08 May 2025, CorMedix Inc. (NASDAQ:CRMD) participated in The Citizens JMP Life Sciences Conference 2025, where CEO Joe Tedesco highlighted the company’s strategic initiatives. The focus was on the successful commercial launch of DefenCath, a catheter lock solution, which has driven profitability within a year. While the company boasts a strong financial position and promising clinical results, challenges such as price erosion under the TDAPA program remain.

Key Takeaways

• CorMedix achieved profitability within 12 months of launching DefenCath.
• First-quarter sales reached $39 million with an adjusted EBITDA of over $23 million.
• The company maintains a robust cash position, expecting nearly $100 million by mid-year.
• DefenCath shows a 71% reduction in CRBSI risk, with over 3,000 patients at US Renal Care.
• CorMedix is exploring business development opportunities and potential acquisitions.

Financial Results

• First-quarter 2024 sales totaled $39 million.
• Adjusted EBITDA exceeded $23 million.
• The company holds $77 million in cash, projecting close to $100 million by mid-year.
• No debt on the balance sheet, highlighting financial stability.
• A slight decrease in Government ASP from $2.45 in Q1 to $2.41 in Q2, with further decreases expected.

Operational Updates

• Over 3,000 patients at US Renal Care are using DefenCath.
• Implementation with IRC and DCI is ongoing, with these providers matching US Renal Care in size.
• A dedicated inpatient sales team was established, increasing inpatient unit shipments from 3% in Q1 to 6% in April.
• CorMedix is conducting a pharmacoeconomic study with over 2,000 patients to support DefenCath’s value proposition.

Future Outlook

• Focus remains on DefenCath adoption and exploring acquisitions in the renal or hospital space.
• Potential peak sales in the TPN market are estimated at $150 to $200 million.
• Shifting reimbursement strategy towards direct contracting with Medicare Advantage payers to counter TDAPA-related price erosion.

Q&A Highlights

• Bloodstream infection reporting is a challenge due to frequent misdiagnosis.
• An interim analysis of the US Renal Care study is being considered for the third quarter.

For a more detailed understanding, readers are encouraged to refer to the full transcript.

Full transcript - The Citizens JMP Life Sciences Conference 2025:

Jason, Citizens Life Science Conference: Thank you again for being with us this morning at the Citizens Life Science Conference. We’re, excited to be joined next by CorMedix. CorMedix is a company focused on the launch of DefendCath, a a catheter lock solution in the dialysis setting today, but with an opportunity much broader than we think than the dialysis setting alone. Happy to be joined by Joe Tedesco, the company’s CEO. Joe, welcome.

Maybe just ask you to give a a quick intro, thirty thirty second overview of the company.

Joe Tedesco, CEO, CorMedix: Sure. Yeah. No problem. And and thanks Jason for having us here. And as I as I just explained, I I’m apologizing to the room, the fact that I’m wearing running shoes.

I’m not trying to be Steve Jobs. I came in last night and forgot my forgot my dress shoes. So but they are way more comfortable now than I’ve been walking around. So no. But thanks for having us.

So CorMedix today is a commercial stage biotech company. We launched our lease our lead product middle of twenty twenty four, which is DefendCath. DefenCath is what’s called a catheter lock solution. It sits in a catheter in between the times the catheter is accessed. Our product is a combination of our proprietary new chemical entity, tyrolidine, which is an amino acid that has broad spectrum antimicrobial activity against gram positive and gram negative bacteria as well as fungus.

That molecule is combined with heparin which protects catheter patency. So the initial indication for which we pursued approval from FDA is in the reduction in risk of catheter related bloodstream infections in patients undergoing hemodialysis with a CBC. So we commercialized the product middle of last year. The settings of care where our product is currently applicable with the label that we have is in the outpatient hemodialysis setting as well in the inpatient hospital setting. About ninety percent of our target volume is outpatient hemodialysis, ten percent is in the hospital.

We are about three quarters into announced results of commercialization. I’m very pleased with what we’ve announced. We just announced our first quarter results. First quarter sales were just over $39,000,000. First quarter EBITDA was just over 20 adjusted EBITDA over $23,000,000.

I think we’re a rare story that has achieved profitability within twelve months of launch and as well as doing it while while maintaining in my view a pretty clean balance sheet. We have no debt on the balance sheet, pretty strong cash position, and and we’re looking to continue our growth.

Jason, Citizens Life Science Conference: So the launch has gone great so far. We’re going talk a lot about the launch, but maybe just before we get there, can you just talk about the product itself, the phase three data, why the opportunity is so compelling for patients?

Joe Tedesco, CEO, CorMedix: Well sure, I mean certainly in the disease state for which we pursue the label in end stage renal disease patients or patients receiving chronic hemodialysis that have a central venous catheter, incredibly high infection rates. So there’s a critical unmet medical need. You have infection rates upward of over twenty five percent and with that you also have incredibly high mortality. About a quarter of patients that get a CRBSI will ultimately die from that CRBSI. So was critical unmet medical need from a catheter lock solution standpoint.

There is no FDA approved, other FDA approved drug product other than DefenCath as a catheter lock solution that has antimicrobial activity. So the standard of care for locking catheters is typically heparin or saline, neither of which has any antimicrobial capabilities. That’s the opportunity that we seek to or the problem we seek to remedy. From a clinical trial standpoint, our phase three clinical study, the LACA100 study, incredibly impressive results. We had a seventy one percent reduction in risk associated with CRBSI compared to the standard of care in that trial which was heparin.

We are currently undergoing a second phase three study for an expanded label in patients receiving total parenteral nutrition or IV nutrition therapy through a CVC. That study, first patient in, should be this week and we’re hoping to run that study. It’s a twelve month study, less than 150 patients, we’re hoping to run it in about eighteen months end to end.

Jason, Citizens Life Science Conference: And then just one more question here. End stage renal patients, what is the consequences of getting infections both to the patient and to the overall healthcare system?

Joe Tedesco, CEO, CorMedix: Significantly large. You’re dealing with a patient population that’s already pretty sick. If you’re an end stage renal disease patient, obviously you’re getting hemodialysis, chronic hemodialysis three times a week. You have a number of other comorbidities most likely that have developed because you have end stage renal disease. The cost of the healthcare system is significant, right?

If a patient that gets, an ESRD patient that gets a CRBSI and has to be hospitalized, I think the average cost is somewhere between 90 and $120,000 per infection. And then once hospitalized, these infections, they’re persistent. Right? They have incredibly high repeat rates, right, in terms of recurrence. Right?

So I think more than half of infections recur within thirty days.

Jason, Citizens Life Science Conference: Okay. Right. So let’s let’s talk about the launch. You’ve had a lot of success early on in the launch in the outpatient setting. Can you talk about where that success has been driven from and specifically US Renal is your largest customer today.

How have they approached adoption of the product?

Joe Tedesco, CEO, CorMedix: Sure, so in outpatient hemodialysis, which again is the largest market opportunity from a volume standpoint right now, you have a very concentrated customer base, right? There’s five players that make up about 90% of the market. The third largest is is US Renal Care. They they essentially were our anchor customer. They’re the first to come in, started adopting the product in July of twenty twenty four.

They’ve done an excellent job of creating internal criteria of which they triage their patients, they determine who is an ideal patient for DefendCath and then they’ve done a really good conversion. You know, we believe that we’re currently in over 3,000 patients right now at US Renal Care and we’re very happy with the way that that has progressed. Later in the last year we brought on IRC and DCI who were the fourth and fifth largest and that implementation is still currently ongoing.

Jason, Citizens Life Science Conference: So if you think about those 3,000 patients and the profile, how many patients do you think the other two providers, the mid sized providers, You

Joe Tedesco, CEO, CorMedix: know, the other two providers combined are about the size of US Renal Care, So, know, where they can get to, I’m not really sure yet, don’t want to commit to a number, but certainly there is the potential there for them combined to be equal in size, right? You know, if we are able to convert as many patients.

Jason, Citizens Life Science Conference: So let me ask a question you get asked all the time, large two providers. One of them you’re contracted with, you’re working towards getting them to start ordering, where are you in that process and what do you think is necessary to get them to the final step?

Joe Tedesco, CEO, CorMedix: Look, don’t know that anything more is necessary. Right? Over the last, as I said on the earnings call earlier this week, over the last five weeks, we’ve seen, right, a heightened amount of activity at the, call it, medical and operations level between our two staffs, probably more activity than we saw right in the six months prior. So that gives me some sense of optimism that hopefully we’re getting close to implementation but you know, we’re still waiting on them to give us a plan, a date, a target number of patients. Right?

We’ve built out our inventory around some initial numbers that they gave us and we’ve communicated publicly which was 4,000 patients, but you know, we’re still waiting for an update into where, you know, what they ultimately decide and you know, we’re ready to go when they when they are.

Jason, Citizens Life Science Conference: And then the the second large provider, just what’s what’s your progress there?

Joe Tedesco, CEO, CorMedix: Look, as I said, again, on the earnings call on Tuesday, you know, there are a couple of different avenues of which we are still working communications with them. I don’t think anything is imminent. I also don’t think over time that they’re insurmountable, but they’re, as I said, they’re not going be early adopters. They’re likely to wait and see what happens in the market over the first one to two years, and then hopefully we’ll make progress.

Jason, Citizens Life Science Conference: So reimbursement is a real important part of this, dynamic. Maybe just start off with, at a a basic level, you’ve talked about net price this year. Can you just walk us through the dynamics and how we should think about net price in the second half of the year?

Joe Tedesco, CEO, CorMedix: Look, don’t think, you know, we’ve analyzed this in a number of different ways. You know, when you talk about our net selling price versus reimbursement, which is government ASP, right? Government ASP, as we’ve talked about publicly, is is gonna erode a little bit. Right? So it was $2.45, let’s say, in the first quarter and I think it was $2.41 in the second quarter.

In the third quarter, we think it’s gonna come down a tiny bit a tiny bit more, but our net selling price I think over the first two quarters is fairly stable and we said on the earnings call. I think second quarter, our net selling price may be actually a little higher than the first quarter. That’s a reflection of a little bit of business mix. You know, the more hospital inpatient business we ship, which is a little bit higher priced, it brings up the overall overall net selling price. Also, as some of the volume incentive rebates that we had in place through the first quarter of last year expire, net price overall is is gonna be a little bit higher.

So I think that second quarter net pricing should be a little bit probably more favorable than the first quarter, and then third quarter may be a little bit more in line with where the first quarter was, right, kind of thing. So the back half of the year, I I I’m thinking is probably going to be more for third and fourth quarter more in line with what we saw in the first quarter.

Jason, Citizens Life Science Conference: Okay. So reimbursement in the outpatient setting today is covered through the TDAPA program. Can you just walk us through that program and how it will impact net price over the first couple years but then then

Joe Tedesco, CEO, CorMedix: after. Well look, mean TDAPA was set up by CMS to incentivize innovation in products that used in the end stage renal disease setting. It’s essentially a five year program, right? The first two years reimbursement to the providers is at government ASP and then for years three, four and five there’s there’s a bundleized adjustment based on a calculation. Now what we’ve seen over the last few years is is TDAPA’s kind of been incrementally improved a little bit each year as they’ve gone along.

So this July we’re, you know, we’re kind of obviously keen eye looking to what comes out in July. Do they make any additional improvements? There’s been a number of comments submitted by stakeholders such as ourselves and everyone else who’s kind of in this renal space that touches to DAPA to say, alright, can you expand the first two years reimbursement to be all five? I mean, can you can you can you restructure this in a little bit different way? So, you know, wanna see kind of what transpires in July but assuming it’s status quo, right, and it stays stays put, you you would accept to expect to see some price erosion in years three, four, and five.

That’s that’s how TDAP is designed. That’s how we priced our product from the start, right, with the understanding of that price was gonna have to come down in years three, four, and five, and with the expectation of, you know, we’ll shift our strategy a bit in those out years to focusing more on volume, right, and how do we drive much much more volume. Part of that as we’ve talked about publicly is is changing our strategy with with Medicare Advantage. Right now we’re in a passive position with Medicare Advantage. To a large extent almost all of the plans are reimbursing to DAPA based on the contracts that they have with providers.

Right, toward those out years at DAPA we’re going want to shift a little bit. We’re going to want to contract directly with Medicare Advantage in a more traditional sense to try to drive more volume.

Jason, Citizens Life Science Conference: So just walk us through the patient mix there. What percentage of the market is Medicare Advantage versus fee for service and just where are you in terms of that numbers on the earnings call?

Joe Tedesco, CEO, CorMedix: So most of these patients are Medicare. So if you start by cutting the pie, about 90% of the patients are Medicare and then within that about half of those are fee for service and half are Medicare Advantage. But the Medicare Advantage piece is growing. Right, a couple years ago it was 30%, now it’s 50. I would imagine in three or four years it’s gonna be 70%, right?

So the future is Medicare Advantage which also we see as the best opportunity, right, because the Medicare Advantage payer, they act a little bit more like a traditional commercial payer. They see both sides of the ledger, right? They’re the ones who are ultimately on the hook for the cost of these infections, right, so they are most incentivized to invest in prevention, right. So there is, you know, from our view, from a contracting standpoint, there’s an ability to negotiate with them, right, fixed dollar amount per year, however we want to structure the agreement to invest in prevention per patient and that’s what we want to shift to over the next probably one to two years.

Jason, Citizens Life Science Conference: Got it. Okay. One other thing that you’ve been doing thinking about the long term reimbursement dynamics is generating some more data to support the pharmacoeconomic value of the product. Just walk us through the study that you’re doing and

Joe Tedesco, CEO, CorMedix: So we kicked off a study last July with US Renal Care. The goal was to enroll over 2,000 patients and we are over 2,000 patients now in terms of data that’s being captured with the goal of being able to use that, utilize that data not just with other providers but with payers such as Medicare Advantage payers. And we’re tracking a number of metrics that weren’t tracked in our initial clinical study. And I think the most important would be in addition to the infection rate, the hospitalization rate. Right?

We want to know exactly how many folks go into the hospital that are on DefendCath versus those that go in that are that are part of the traditional cohort that we’re also tracking that are not not on DefendCath. And I think that right there, that plus lost chair time for the provider, antibiotic use for this patient population, I think there’s a lot of metrics that go to the cost of treating these infections that are going be really meaningful from a payer standpoint.

Jason, Citizens Life Science Conference: Great. So let’s transition to the inpatient setting. Let me start here. Can you talk about the size of the opportunity in the inpatient setting?

Joe Tedesco, CEO, CorMedix: Sure. Know, we’ve talked about the TAM in terms of number of vials. I think we’ve always said that the TAM for inpatient is about 10% of the market opportunity. But from a dollar standpoint, you know, I think it’s a little bit larger than that. Right?

We think that the pricing in the inpatient setting is gonna be a little bit more a little bit higher, a little bit more sustainable than than in the outpatient hemodialysis market because you’re not dealing with TDAPA. You’re dealing with traditional inpatient DRG. We do have an NTAP that heads onto the DRG. That NTAP has been extended to November of twenty twenty six. So we I’d say launched in the inpatient segment last year, but it’s a very long road, right, on the inpatient side.

You’re working through P and T committees, you’re working through a very long cell cycle and decision making process on on hospital systems. Late in the year, you know, we actually made the decision to kind of reorg our sales team a little bit. We shrunk the size of the the output should, excuse me, footprint based on right, feedback and what we’d learned over six months and then we decided to build a dedicated inpatient team. That inpatient team staffed up in the first quarter and is fully trained and went live in April. So we’ve seen even before they hit the field some good traction over the first couple months of the year on the inpatient side based on the work that we did last year.

You know, in the first quarter, we shipped about, let’s say 3% of our units went in, 3% of the units we shipped went in the inpatient setting. In April, we’ve already increased that to about 6%. So I wanna see that trend keep continuing, you know, in terms of growth in the inpatient segment as we add new accounts and as the existing accounts, right, expand their ordering.

Jason, Citizens Life Science Conference: Can you just give us a sense of,

Joe Tedesco, CEO, CorMedix: excuse me,

Jason, Citizens Life Science Conference: the the the number of hospitals where you have got formulary approvals? You know, is there a is there a goal to get to, you know, mid year, end of the year?

Joe Tedesco, CEO, CorMedix: Yeah. Look, I I I’m not, you know, we’re not gonna put metrics out around that that right now. What I’d say is right now we have a handful of hospital systems that have begun adopting, right, and kind of really driving utilization. We have one, call it large national system that is adopted on a regional basis and then they’re they’re they’re starting to implement in that regional setting and we’re seeing pretty good uptake there. What we wanna see obviously is that system take it nationally.

And that’s what we’re hoping to see. Now I think it’s a good question. Know, we’ll think about what metrics we can put out over the next coming months around inpatient folks can understand what progress we’re making beyond just how we’re announcing sales and giving those metrics.

Jason, Citizens Life Science Conference: And can you maybe help us understand the profile of the patient that is getting the product or the product’s being used for in the inpatient setting versus outpatient?

Joe Tedesco, CEO, CorMedix: Well, think it’s twofold. In the outpatient setting, it’s almost exclusively ESRD patients, right? You’re an ESRD patient, you’re getting dialyzed at an outpatient hemodialysis center, you’re getting dialysis three times a week, fifty two weeks year. And you have a catheter, right? In the inpatient setting I think there’s a little bit, there’s two buckets, right?

You have that ESRD patient that gets hospitalized for whatever reason and has to be dialyzed while they’re there but you also get folks that crash land into the hospital and have to be dialyzed, right? So you have a large number of AKI patients and then a certain percentage of those AKI patients require dialysis. And then AKI patients tend to be dialyzed daily, right? So they’ll be dialyzed every day for two weeks or three weeks while admitted. They also have very high infection rates And because they’re being dialyzed for the first time in the hospital, those are hospital acquired infections, right?

Which also have incredibly high recurrence rates.

Jason, Citizens Life Science Conference: Okay. So when you’ve you’ve gone you’re going through this formula process, you knew it was gonna take a long time. What what have you learned through the process or or or how have you evolved your strategy to get on formularies?

Joe Tedesco, CEO, CorMedix: As I said, think we, the biggest piece that we evolved was realizing that, you know, one sales team couldn’t effectively cover outpatient hemodialysis and inpatient. And the profile of who we originally hired was much more experienced on the outpatient renal side. Right? So what we wanted was the profile of who I want in the inpatient team needed to shift a little bit. Right?

We needed to have folks who predominantly inpatient based experience, predominant experience with new product launches, innovative product launches, and bringing something through P and T in the past, right? Understanding how to get champions within the health system has to be cross functional in terms of the therapeutic area that the doctor specialized in. It’s not just renal, you need the infectious disease folks on board, you need antibiotic stewardship on board. So all of that is kind of what we’ve pivoted over the first year of the launch and what we’re working on now.

Jason, Citizens Life Science Conference: Great, okay. Just one more on the inpatient setting. It’s early, right? The team’s only been out there for a few weeks, but how would you assess how well it’s going or?

Joe Tedesco, CEO, CorMedix: Look, think it’s going great. I like what I see in terms of the feedback that I’m getting from the organization, the types of meetings we’re seeing scheduled, we’ve already, you know, seeing additional orders, right, even though small from some of the institutions that are being called on but so far so so far I like what I see. Also, you know, recently announced a partnership with WSI for a handful of dedicated sales reps calling on VA facilities. And we’ve already started to see our first couple of orders from VA facilities under under that partnership as well and want to see that grow over the course of the year too.

Jason, Citizens Life Science Conference: Okay. Mentioned you’re starting a phase three trial in total parenteral nutrition, enrolling the first patient this week. Yep. Just maybe frame for us that opportunity, the size of that opportunity.

Joe Tedesco, CEO, CorMedix: Yeah, so we, I think we’ve talked about, we see the total addressable market, we’ve put a dollar number out there, somewhere between 500 and $750,000,000 is kind of how we see the market. We say, we think the peak sales for our product in that space could be in the $1.50 to 200 range. We see that market, about one third hospital inpatient, two thirds home use, but we see it as a more traditional reimbursement landscape, probably more akin to what investors are used to seeing and call it a Medicare B type situation. So, you know, we feel good about our ability to commercialize in that space.

Jason, Citizens Life Science Conference: When you think about reimbursement and talking to Medicare, where does Medicare Advantage fit into this and is there a conversation that ultimately involves both indications?

Joe Tedesco, CEO, CorMedix: Eventually, maybe because there’s definitely going to be Medicare Advantage patients that are part of that cohort, but you also have a higher amount of commercial patients that are in the TPN space versus, versus what you have in ESRD. So that lends itself very well to much more traditional contracting type structure.

Jason, Citizens Life Science Conference: Can you talk to us a little bit about the phase three trial and let me ask a slightly obvious question. If the drug works to prevent infections in the hemodialysis setting, why would it not work in other catheter settings?

Joe Tedesco, CEO, CorMedix: Well, that’s our prevailing assumption as well. So I can’t come out and just state that. What we view is a catheter is a catheter. We’re not out treating a disease state. The way that our drug works, it’s by inhibiting biofilm buildup in the catheter.

That biofilm ultimately becomes bacteria and leads to infection. So, you know, theoretically, you know, what’s what’s I think more important is how often the catheter is accessed, how often it’s instilled with with the fem cath versus, you know, whether the patient is a TPN patient or an ESRD patient or has some other disease. We have an expanded access program that we’ve opened for a number of disease states, some in oncology, some in peritoneal dialysis. Pediatric TPN is gonna be part of expanded access. So so I think our view is to your point a catheter is a catheter.

Jason, Citizens Life Science Conference: So, you mentioned at the start impressively, you’re you’ve achieved profitability within the first year of product launch. You you very rarely see that if at all. Talk to us about bigger picture strategy. How do you think about reinvesting that capital? Do you see clearly the priority today is Defend CAF, but as you think out two, three, five years, what’s the strategic focus?

Joe Tedesco, CEO, CorMedix: Well look, I think, you know, right now is an interesting time in the small cap biotech space. I think there’s a lot of opportunity out there. You know, we’ve not been bashful about saying, you know, we are out there looking on the business development front to see, you know, what potentially we could put with DefenCath. I think my focus is on opportunities that are either commercial or about to be commercial. Could be something that’s either adjacent in the renal space in that outpatient hemodialysis space or something that’s adjacent in the hospital space, right, where we have two call points and have built kind of infrastructure and experience in both of those areas.

But you’re right, we are generating cash flow. We just reported a cash number for the end of first quarter around $77,000,000. Right? We’re on a trajectory for mid year to have somewhere just maybe under a hundred million dollars if if this trajectory continues. And we wanna be able to deploy that cash, you know, in a way that that, you know, provides a good return for shareholders.

Jason, Citizens Life Science Conference: So just wrapping this up, as we think about the rest of the year, revenue obviously being the number one metric, but how how should we be gauging success of the DefendCath launch as as we move through the

Joe Tedesco, CEO, CorMedix: Look, I think, you know, revenue is the revenue and profitability, right, those are the primary metrics by which any any investor is gonna gauge success in the company. But I think, you know, folks are gonna wanna see, alright, how successful are we and I think you asked a good question about inpatient metrics. Right? We should put out some metrics that allow folks to to track inpatient progress and and understand, you know, what type of gains we’re making on that front. You know, how do we do in terms of adding new accounts on the outpatient hemodialysis side.

I think those are all soft metrics that folks can look at and kind of say, all right, this is still, you know, this is working the way they say it’s going to go.

Jason, Citizens Life Science Conference: Let me just check, any any questions in the room? Yeah. On the BSIs, those have, do the, do they have to report those to any national?

Joe Tedesco, CEO, CorMedix: I believe there is a reporting requirement for bloodstream infections. I think oftentimes they go misdiagnosed or undiagnosed until the patient actually presents at the hospital is a little bit more common. But yes, I do believe they have a reporting requirement if they diagnose. At US renewal? No.

No. We have not we have not done any type of interim analysis on the data yet. So the the study was designed as a twenty four month study. Correct. We’re about to hit the midpoint in July.

’1 of the things we are exploring is whether we we do wanna amend the protocol to do an interim, look in which which will make that decision in the third quarter.

Jason, Citizens Life Science Conference: Great. Joe, thank you. Really appreciate you

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