CorMedix at Needham Conference: Strategic Growth and Challenges

On Tuesday, 08 April 2025, CorMedix Inc. (NASDAQ: CRMD) presented at the 24th Annual Needham Virtual Healthcare Conference, offering a strategic overview of its recent progress and future plans. The company highlighted its strong start to 2024, driven by increased orders for its DefenCath product, while also addressing challenges such as the complexities of TDAPA reimbursement.

Key Takeaways

• CorMedix exceeded initial revenue expectations for the first quarter of 2024 due to higher-than-anticipated orders from existing customers.
• The company raised its revenue guidance for the first half of 2025, anticipating continued growth despite a slight dip expected in the second quarter.
• A Phase 3 clinical study for DefenCath's label expansion to include TPN patients is set to begin, with a significant market opportunity.
• CorMedix maintains a strong financial position with $77 million in cash, no debt, and positive cash flow.
• The company is exploring new business development opportunities in infectious disease and critical care.

Financial Results

• First Quarter Performance: Surpassed expectations with orders from US Renal Care driving growth.
• Revenue Guidance: Increased for the first half of 2025 due to better visibility into customer inventory and order patterns.
• Monthly Revenue: Currently at $11-12 million net sales per month, with growth expected in the latter half of the year.
• Cash and Profitability: CorMedix reported $77 million in cash, no debt, and is cash flow positive with strong EBITDA margins.

Operational Updates

• US Renal Care: Strong performance with processes to identify patients, contributing to increased utilization.
• Inpatient Segment: Sales remain low, but a dedicated team is in place to boost performance.
• TPN Label Expansion: A Phase 3 trial is planned, targeting a market opportunity of $500-750 million.
• VA Partnership: Efforts to target 12,000-15,000 catheterized veterans with ESRD are underway.

Future Outlook

• Revenue Growth: Expected in the latter half of the year through increased utilization and new customer acquisitions.
• TDAPA Reimbursement: CorMedix is hopeful for improvements through rulemaking and legislation.
• Medicare Advantage: Plans to contract directly with Medicare Advantage for sustainable reimbursement.
• Business Development: Actively seeking commercial-stage or near-commercial-stage assets in relevant medical fields.

Q&A Highlights

• Inventory Levels: US Renal Care's lower inventory levels led to higher orders in March.
• TDAPA Details: The program offers unique reimbursement terms, with changes expected after the initial period.
• Medicare Advantage Penetration: Currently at 50%, with growth expected to 60-70%.

In conclusion, CorMedix's presentation at the conference highlighted its strategic growth initiatives and financial strength, while also addressing ongoing challenges. For more details, readers are encouraged to refer to the full transcript provided below.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Serge Belanger, Health Care Analyst, Needham: Hi. Good afternoon. I'm Serge Belanger, one of the health care analysts at Needham. Wanna welcome everybody to, day two of Needham's twenty fourth, annual health care conference. For next fireside chat session, we have CorMedix with us and, and the company's CEO, Joe Joe Tadesco.

Before I hand it over to Joe to so he can give us an overview of the company and discuss discuss some recent developments. I just wanna highlight to the audience that you have the option to, submit questions on the portal that you're watching this presentation on. We'll take those questions as they come in. So with that being said, I'll hand it over to Joe so he can give us an overview of the company and especially for those who aren't familiar with Alright. No.

Thanks, sir.

Joe Tadesco, CEO, CorMedix: It's great to be here. So CorMedix is a commercial stage, small cap biotechnology company. Got our lead product approved at the end of twenty twenty three and began commercialization in early twenty twenty four. The product is what's called a catheter lock solution. It sits in the catheter in between times a catheter is accessed.

The proprietary new new chemical entity in our formulation is tyrrolidine, which is an amino acid that has broad spectrum antimicrobial activity against gram positive and gram negative bacteria as well as fungus. Tyrolidine is combined with heparin in our in our formulation. And the lead indication or the initial indication is for reduction of incidence in catheter related bloodstream infections in hemodialysis patients that get hemodialysis through a central venous catheter. Now hemodialysis patients that are catheterized have very high infection rates, upwards of twenty five to thirty three percent of patients will contract a CRBSI, you know, while they have a catheter. And those infections, come with an incredibly high mortality rate.

Over over twenty percent, of those infections can improve fatal. So absolutely a critical unmet medical need. The initial indication, as I said, is in hemodialysis. We are now, exploring expanded indications and about to kick kick off our, our clinical study phase three clinical study for, patients undergoing parenteral nutrition and hope to have first patient in by the April and have that study completed within eighteen months. So we launched the product in the hemodialysis setting around early to middle of last year.

First '2 quarters or three quarters now of of sales, I think, have, been a real strong trend, and we're happy about the progress. Great. And you

Serge Belanger, Health Care Analyst, Needham: guys had an update this morning kind of pronouncing one q results and updating your January guide your 01/2025 guidance. Looks like you had some, surprise new orders in the final week of of the quarter. So maybe just highlight,

Joe Tadesco, CEO, CorMedix: you know, what Yeah. Yeah. And I think it's a I think it's a really good question, sir. So, you know, we we, you know, we had our fourth quarter earnings call a couple weeks ago. And and at that point in time, you know, we decided to kinda give first quarter guidance and then maybe first half guidance of of where we, you know, we thought we were gonna land.

You know, at that point in time, you know, we didn't have full visibility or that we have now of how much inventory was was kind of in the in the trade, and we our largest customer, US Renal Care, right, we had estimated they probably had somewhere between forty five and sixty days on hand. And to that extent, thought, you know, March orders last week March orders would be much lighter than they ended up being. Right? So as we as we got into the March, you know, we saw higher than expected orders, which is great. And we also got better visibility of of inventory on hand with not only renal US Renal Care, but some some other customers.

And we saw that while they were holding a, you know, a little bit more than thirty days, weren't quite holding as much as as, you know, our concerns, you know, were. So that gave us the flexibility to increase guidance, which we're we're happy to announce this morning, as well as land the first quarter, you know, much higher than than, you know, where we, you know, where we thought. So really happy with with that first quarter performance and what we we think we're gonna see over the first half of the year. And when I think also back around, you know, what we talked about in earnings, I think one of the things, you know, just in talking to investors over the last couple weeks that was not properly understood, You know, we do think we have a small timing issue now of shipments between the first quarter and second quarter, maybe not as large as as as what it could have been, but we, you know, absolutely think, you know, volume with existing customers is gonna increase over the third and fourth quarter. We do think we're still, onboarding patients with with all customers that we're currently shipping to and would expect, you know, to see, you know, volume increases over, you know, second, third, and fourth quarter.

Serge Belanger, Health Care Analyst, Needham: Okay. And I guess so just to be clear, this was not a new customer. This was just a No. No. Existing customer reordering product?

Joe Tadesco, CEO, CorMedix: Yeah. It would actually ended up you know, we we had made an assumption. Let let's say that if if someone was holding forty five days, you know, across, let's say, 400 clinics that they might move inventory between clinics. Yeah. Right.

Not all clinics were holding the same amount of inventory. And what we saw was as some of the other clinics, you know, ran low, they they placed new orders as opposed to shifting inventory, you know, which we see as a very positive sign for for ongoing demand. Right? Not just the support clinics, but the clinics that are comfortable holding a little bit more inventory. So, look.

Indicative of a of a really positive trend. You know, I think the way that that I'm looking at the business right now, Serge, from what's just called a base business revenue standpoint is that, right, on a monthly basis for the first half a year, let's say we're we're we're likely running somewhere between $11,000,000 net sales and $12,000,000 net sales a month. Yeah. You know, to the extent that we're, you know, we're at 11, we'll be at the midpoint of our guidance. If we're at 12, we'll be the top point of our guidance.

But we also obviously left room if we've overestimated a little bit. But I think this with the visibility that we have now, this is what we see, and and we are expecting, you know, growth in the back part of the year from from base business as well as potentially new new customers coming on board. Got it. And then for for the second quarter, you mentioned I mean, you had discussed this on the earnings call, kind

Serge Belanger, Health Care Analyst, Needham: of a a tick down from from the first quarter, not because of a decrease in utilization, but just the the timing of shipments. So just maybe kind of provide a little more color what's going on with those movements.

Joe Tadesco, CEO, CorMedix: And I think a lot of it's with US Renal Care. I think they bought one or two weeks extra inventory in the fourth quarter, maybe one to two weeks in the in the second quarter. Now if we if we do start to see much more patient patient growth, that'll normalize faster. But I think in our guidance, we've left ourselves a little bit of room here for, you know let's say, they're holding forty five days, they end up moving down more to thirty or twenty five days right on hand. But I think utilization is is absolutely growing, right, in terms of patient numbers that we're seeing over fourth quarter to first quarter, now hopefully in the second and third quarter.

Serge Belanger, Health Care Analyst, Needham: Got it. And the the ASP movements, from first quarter to second quarter, what are you expecting there?

Joe Tadesco, CEO, CorMedix: Yeah. So and that's a good question. I think and that's another question on the earnings call. May maybe we didn't explain as clearly as as we could have. So I think it's important to understand the difference between government ASP and our net selling price, which are two, you know, two different different numbers.

Government ASP is what the providers get reimbursed. It's a calculation that the government does based on data we report, around discounts and rebates and deductions, right, from the net selling price, and the government calculates it on a two quarter lag. So by nature, you know, the first two quarters, our our our government ASP was the WAC, the list price on the product. It was $250. And for the first quarter, after they they account for some rebates on a on a two quarter lag, it it went to $2.45, and now we're at $2.43.

Now I I do think for the third quarter, we're gonna see a little step down for government ASP, but it does necessarily mean we're gonna see a step down in our net selling price. Right? So so I think and and we're trying to get an accurate calculation here. Our our net selling price for the second quarter might be a notch higher than the first quarter, like our internal price, and then, you know, moderate a notch lower in the third quarter. But we're talking, you know, total movements of probably low single digit percentages.

Right? Not not not not huge movements. And I think that that that's that's important for for investors to understand. So I I think over the course of the year, it should it should even itself out.

Serge Belanger, Health Care Analyst, Needham: Okay. So you mentioned on the opening, US Renal Care has been one of your big customers. Just curious what the other MDOs have been contributing and Mhmm. How you get them on board and start increasing their utilization and orders.

Joe Tadesco, CEO, CorMedix: Well, look. They're growing. Right? So they they came on board later. I mean, US Renal Care did a great job, came on board July of last year, had a had a great process in place to to identify patients, and has continued to expand that to different cohorts as we've as we've, you know, continued to roll out with them.

The two other MDOs, which are IRC and DCI, they came on later in the year last year, began buying around November. I'd say one of them is running a little bit further ahead than than the other is right now. We're working with both of them to kinda increase utilization. But we have seen a positive trend with both, right, from November up through the up through the first quarter, and it's still certainly early. But if you you know, in terms of what we can do to increase utilization, we just did a a large virtual training session for around 200 nurses with one of them, kind of a train the trainer type thing, and we're we're providing additional resources to the other and and hopeful to see, you know, continued momentum as we move through 2025.

Serge Belanger, Health Care Analyst, Needham: K. And so far, how's unit US Renal Care kind of integrated their product and their protocol? Or Look.

Joe Tadesco, CEO, CorMedix: As I said, they they they established their own process and procedures in place. They triage their patients. Have criteria for who's a DefenCath patient, who is not. They have an alternate an alternative process for for patients that don't fit the criteria for DefenCath, and and it's it's been going quite well. Okay.

Serge Belanger, Health Care Analyst, Needham: So the idea is to replicate that same same kind of model in the the other MDOs? Well, look.

Joe Tadesco, CEO, CorMedix: It's not it's not it's not our model to replicate. Right? We can we can advise any different different dialysis operators, have different SOPs, need to do things differently, certainly have different medical perspectives. But, you know, we're, you know, we're happy to advise on what we've seen and what we've seen be successful, and and and, hopefully, we can we can replicate some semblance of that at at other customers.

Serge Belanger, Health Care Analyst, Needham: Okay. And I don't if you've disclosed this, but, you know, how much of a number of patients or maybe a percentage of patients, within US Renal Care that they're receiving utilization?

Joe Tadesco, CEO, CorMedix: We we don't have exact numbers, and and and, you know, we we are tracking data with them through the the real world evidence study. Right? So to that extent, we we know that we are, let's say, deployed or have been deployed in in in over 3,100 patients. But I don't know that you you can't just extrapolate that and say it's that's steady state. Right?

Because there's there's patients that miss sessions. There's patients that transition in and out of clinics. And but we like the pay the trend that we've seen, right, as we've been tracking data. We're not actually able to see the data, but we see the pay total patient numbers that, that that are part of the, the process.

Serge Belanger, Health Care Analyst, Needham: Okay. And then you entered a partnership with, one of the LDOs. I believe it was in September. Anyway, what's any updates since, the last

Joe Tadesco, CEO, CorMedix: Yeah. Look. We've we've been in touch with them regularly over the last two months and and certainly, again, since the last earnings call. I I think what I would what I'm comfortable saying, I'm cautiously optimistic of of of of making progress on on the timeline that we we disclosed, which was which was about midyear. As I said, I'm happy with the communication that's going back and forth.

The types of questions that we're getting are more around opera how to operationalize, and and and I think I have a better appreciation now for, you know, maybe why it's taken so so long and and and the size of the organization and and how complex it is. But, you know, as I said, Mike, we are being as supportive as possible and and responsive to requests that come in, whether that's for training materials or or or other resources we have for benefits verification, hub support, and, you know, we're just we're just hopeful to implement, hopefully, by midyear.

Serge Belanger, Health Care Analyst, Needham: Okay. So the agreement doesn't hold them to order any kind of minimal? Or

Joe Tadesco, CEO, CorMedix: No. They don't they don't have a minimum. They don't they don't have a minimal work quantity. Okay.

Serge Belanger, Health Care Analyst, Needham: And nothing's changed from the original agreement? I think that there was a 4,000 patient number associated with that. Yeah.

Joe Tadesco, CEO, CorMedix: The 4,000 patients weren't necessarily in the agreement. That was a target that their medical folks had given us of of how they were they were planning to implement. Now what what I can sense from the questions we're being asked is, obviously, they're looking at at, you know, how they wanna go about implementing and and and but they haven't communicated to us anything differently than 4,000 patients. Right? So, you know, we're we're just you know, we're here, we're ready to go when they're ready to go.

Serge Belanger, Health Care Analyst, Needham: Okay. And, clearly, 4,000 patients would be pretty impactful to utilization relative to where it is now?

Joe Tadesco, CEO, CorMedix: Yeah. I I'd say it probably about double where we're where we're currently running at, but I think it's for an LDO, it's a small percentage of their of their categorized population. So I I do think, you know, once we get off the ground and start implementing, you know, there's there's good upside.

Serge Belanger, Health Care Analyst, Needham: Right? Okay. So when they do start over, it'll be it'll be obvious on the on the the sales trajectory.

Joe Tadesco, CEO, CorMedix: I I would I I would expect so.

Serge Belanger, Health Care Analyst, Needham: Okay. And then on the other LDO, any updates there regarding

Joe Tadesco, CEO, CorMedix: No. We we continue to to to make approaches, and we've had some dialogues. I think, you know, all they've communicated to us is for the time being, they're they're you know, they they believe they have an acceptable infection rate. They don't publish that that that data. You know, we see their their mortality data, right, which is up, and and we have to guess that some portion of that is is related to BSIs.

So we're gonna, again, continue to to to try to make inroads. And and perhaps once we, you know you know, get, you know, the other LDO up and running, it'll, you know, kinda put pressure on. That's what we hope.

Serge Belanger, Health Care Analyst, Needham: You feel this is a market where usage can be contagious if the MDOs and one of the LDOs are using the product, then they'll be they'll putting pressure on Look. I think that's all

Joe Tadesco, CEO, CorMedix: of medicine with a key opinion leader type, right, type mentality. Right? It's it's if he's using it, I'll use it type type mentality. Okay.

Serge Belanger, Health Care Analyst, Needham: I think the other question we get from investors in in CorMedix or those interested in CorMedix is is TDAPA. Yep. Feel it's not, you know, it's not a reimbursement mechanism that's common to to all products. So Right. You know, maybe if you can just describe it for us in in its various phases and how you think the the price will move through those phases.

Joe Tadesco, CEO, CorMedix: Well, look. It it is unique. It's a unique reimbursement program. It's not perfect. It's something that has evolved over time from CMS, and I think it is gonna continue to evolve.

And, you know, we're aware of you know, one, there's a lot of momentum with stakeholders either through rulemaking at c CMS to make improvements to TDAPA, but also there may be pending legislation later this year. There's there's trade group and patient advocacy group working on on generating bipartisan legislation that would increase the length of TDAPA, change a little bit of the payment dynamics, and and and make it even more of an incentive to invest in innovative therapies for end stage renal disease. Right? Ultimately, that's what this is about is how do you incentivize, right, biotech companies and investors to support development in end stage renal disease. And, you know, I think TDAPA was a a novel idea, but it's improved over time, and I think it'll continue to improve.

So right. The the way it works right now is the first two years, the reimbursement is at ASP, government ASP, over over the first eight quarters. And then for the years three through five, there is a bundleized adjustment that takes place. There's a calculation that they have, and then a a bundleized adjustment is made to providers. So I think what you know, we're hopeful is to see rather than a bundleized adjustment, a shift toward reimbursement following the product, right, where where it's dispensed with the patient, but also longer durations of time.

Right? That that two years is a very tight time period for that initial period initial phase, and and we'd like to see like to see that expand. I think for us, though, we're we're in a little bit of a unique, I think, situation compared to other products that have been deemed a renal dialysis service. Right? So us as a preventative and as a, you know, a product that that prevents bloodstream or as a preventative that reduces the incidence of bloodstream infections, we're we're in a position to hopefully save the end payer significant amount of money that is spent on these downstream infection costs.

So, you know, the Medicare Advantage as an example, which currently is about half of ESRD patients, they're on the hook for, you know, over a hundred thousand dollars of cost per infection, right, including hospitalization and other other downstream costs. We're in a position to, you know, to offset, you know, to the extent we can prevent infections, a large amount of that cost. So that, for us, I think, presents an opportunity as we move through toward the back part of TDAPA to actually shift toward you know, right now, we're in a passive approach with Medicare Advantage to being more active, contracting with MA plans, and and contracting for more sustainable, long term reimbursement.

Serge Belanger, Health Care Analyst, Needham: Okay. So would that contracting be potentially be in place by next summer when the first phase of TDAPA move? Yeah. That that Thank you.

Joe Tadesco, CEO, CorMedix: That's actually something we're discussing internally is what is the appropriate time point. Is it is it year three? Is it year four? I don't I don't know that yet. I think first, I'd like to see, you know, what pros progress is made either through rulemaking for the the current TDAPA period or with pending legislation.

Yeah. But I think as we move through this year, that's a decision we'll have to make.

Serge Belanger, Health Care Analyst, Needham: Okay. So on the legislation front, you would would expect something to happen within within a year? I mean, it seems

Joe Tadesco, CEO, CorMedix: I I I do I expect somebody to bring a bill forward? Yes. Do I expect that bill to become a law?

Serge Belanger, Health Care Analyst, Needham: I mean, come on. That's good story.

Joe Tadesco, CEO, CorMedix: What I what I can say is it is ESRD and and and investment in innovative therapies for ESRD patients are a bipartisan issue. This isn't really a controversial issue. So it is probably more of a timing issue of all the things that are going on right now in the world and the ability to get visibility, right, for

Serge Belanger, Health Care Analyst, Needham: Yep.

Joe Tadesco, CEO, CorMedix: Legislation like that. And as I said, I'm hopeful as as some of the things that we're seeing now in The US hopefully calm down over the next couple of months, that there'll be there'll be room for this type of legislation to to make its way through congress. Okay.

Serge Belanger, Health Care Analyst, Needham: So I guess too early to start having real visibility on what the the price could be moving forward after July 2026.

Joe Tadesco, CEO, CorMedix: Yeah. And I'm not yeah. We're not we're not gonna guide on price at at this point in time. And and, you know, hopefully, as we get more visibility, right, to to to DAP environments, but also to our own utilization, right, we can we can get a better sense around that.

Serge Belanger, Health Care Analyst, Needham: So utilization is gonna play a big role in the calculation?

Joe Tadesco, CEO, CorMedix: Under the current structure of TDAPA, yes.

Serge Belanger, Health Care Analyst, Needham: Okay. So getting the LDO on board is is important for the calculation?

Joe Tadesco, CEO, CorMedix: Under the current structure, yes.

Serge Belanger, Health Care Analyst, Needham: Okay. Got it. And then touch it a little bit on this, the Medicare Advantage versus fee for service. I think you've talked about that the market's eventually gonna move more towards Medicare Advantage. Well, we've just

Joe Tadesco, CEO, CorMedix: seen that. That's just a shift that we've seen. Medicare Advantage, right, maybe three years ago was twenty percent of ESRD patients. It's grown to fifty. Right?

So so patients are are are selecting, right, Medicare Advantage as as part of their process. And I think that percentage is gonna grow. I think it it may become sixty, seventy percent of patients, which, as I said, for us, I think is a is a is an opportunity. Right? Because it it functions much more like a commercial framework that where where you have the ability to contract.

And what is driving that movement?

Serge Belanger, Health Care Analyst, Needham: Is it just patients opting for Medicare Advantage?

Joe Tadesco, CEO, CorMedix: Or My understanding is that's that's largely what's driving it, I think, fine to say. I think it's economics and patients patients electing that. Okay.

Serge Belanger, Health Care Analyst, Needham: Got it. Let let's talk about the inpatient launch of of the product. Sure. I think you've always said it would be well, it's a smaller market opportunity, but it'll also be a a slower launch ramp. So here's where you're you're currently at.

Well, look.

Joe Tadesco, CEO, CorMedix: It it obviously, we when I say we launched inpatient, right, we started calling in hospitals early last year. But inpatient launches, it is a very slow ramp. It takes a lot of time to get in front of a P T meeting. Takes even more time to get a decision from from from a P and T committee, right, to get on formulate our hospital. And even, you know, large systems might have multiple P and T committees for, you know, for regions or different for for, you know, for different hospitals.

You know, I I wasn't thrilled with the progress we're making on the inpatient side at the end of last year. You know, in January, we announced that, you know, we were gonna kinda bifurcate our field team and build a dedicated inpatient team. You know, we've we've just finished staffing that team, and and training should be wrapped up this week. And they'll be in the field next week next week or week after once they finish certification. But I'm I'm excited about the opportunity.

Right? We've we've changed the profile of, you know, what our key account managers are from a background standpoint. You know? Initially, we had tried to straddle both settings of care with one field team that was largely heavily experienced in outpatient renal, and we've we've built now a dedicated team of folks with experience in launching innovative products in the inpatient setting, a lot of whom have infectious disease experience. And I think that's good that's gonna be beneficial.

Outside of that team, we have started to see some traction over the first quarter. I think when we we kind of preannounced, I had I had said that, you know, where we were running was about three percent of units and 4% of dollars being in the inpatient. I was I was happy with that percentage. That that was before we got those larger than unexpected orders on the outpatient side. So those percentages are probably pretty a little bit lower, but still a really, really positive trend inpatient that I wanna see those volumes with those accounts keep growing over the course of the next few months and then add in with this field team, add in new inpatient accounts as well.

Serge Belanger, Health Care Analyst, Needham: Okay. And you talked about a partnership with Syneos Health and Yeah. So that's that's online now?

Joe Tadesco, CEO, CorMedix: Yeah. Well, that's the that's the that's the hospital field team. So Syneos, by and large, I mean, they're a contract sales organization, but, you know, this is not a a field team we're we're sharing with anyone or any other products. These these key account managers are dedicated to CorMedix. They carry a CorMedix business card.

You know, what we rely on Cineos large for is their their back office support resources. Right? Their ability to manage fleet, ability to do recruiting, CRM, a lot of things that for a business our size, it made a lot of sense. We could scale that team a lot faster by by working with Syneos, and that's been really helpful.

Serge Belanger, Health Care Analyst, Needham: Okay. So it's been more I guess, close to a year. I guess, April next week, it's gonna be a year since you launched in the inpatient segment. So just curious here. Do you think the market opportunity is kind of the same as when you had first set out the the launch and Well, think from

Joe Tadesco, CEO, CorMedix: a from a size standpoint in terms of amount of dialysis sessions, yeah, I don't think I don't think that has changed. You know, I I do think, you know, inpatient launches are are tough mainly because there are a lot of institutions that will wait to see what other larger institutions do. It's as I said, it's the kind of the key opinion leader mentality. So Yeah. I you know, we have right now, I'd say, we have a regional piece of a large national that has started to to adopt, and I'm hopeful that that can be a kind of a start to to a broader relationship with that health system.

And then, know, there, I think there'll be someone folks might look to to, you know, as a key opinion leader.

Serge Belanger, Health Care Analyst, Needham: And within that opportunity, there is one that you highlighted with the VA?

Joe Tadesco, CEO, CorMedix: Well, that's a sep I mean, that's separate. So VA, we've we've signed a a separate promotional agreement. This is this is more of a shared field team with WSI that has an existing deployment in that in that space, which is is is very specialized. You know, the the the rep the reps or managers for VA need to be credentialed, need to have experience and relationships with those VA facilities, need to understand how to navigate, you know, contracting, right, from with with VA institutions. And they've just, you know, started over the last couple weeks kind of making inroads.

So I think there's a good opportunity there. About 55,000 veterans, you know, suffer from ESRD. You know, my estimate is somewhere around twelve to fifteen thousand of them are catheterized. Yeah. And probably forty to fifty percent of those get their outpatient hemodialysis at a VA facility.

Right? So there's there's opportunity for for inpatient, right, for all of the catheterized patients, you know, if and when they they are are hospitalized, but also for outpatient hemodialysis services. Okay. Is that right? If I had to if I had to ballpark the size of the VA, I'd say they're about equal to a midsized dialysis operator in terms of total.

Serge Belanger, Health Care Analyst, Needham: Could be significant. Mhmm. And then just to to round out our conversation on DEF and CAT, given a number of studies that are ongoing, you talked about the the one with US Renal Care. Is that fully enrolled at this point?

Joe Tadesco, CEO, CorMedix: And No. It's it's not a study that has a max enrollment. Okay. We're we're working with them, and we're tracking. You know, I think we said over 2,000 patients, but we're well over 2,000 patients that we're tracking data on at this point with the goal of, you know, over the course of of the study, hopefully, that we show a meaningful impact, not just on infection rates, but on hospitalization rates, on antibiotic use, on lost chair time, all these other metrics that I think will be incredibly helpful, you know, for those discussions we wanna have with Medicare Advantage as an example.

Serge Belanger, Health Care Analyst, Needham: Okay. You'll be able to start generating data from that that I mean, it's happening now, I guess.

Joe Tadesco, CEO, CorMedix: But So the day the data collection started, right, the day we, you know, the day we kicked it off in in July of of twenty four. Right? We we set it up as a twenty four month study. You know, we've we've discussed the possibility of doing a mid study check-in. It's something we'll evaluate later in the year.

We'd have to amend the protocol, but it's it's something we possibly could do.

Serge Belanger, Health Care Analyst, Needham: Got it. Okay. I think there's a a p d pediatric trial that's also Mhmm. Planned or about to get underway?

Joe Tadesco, CEO, CorMedix: Pediatric first patient, could go in in the third quarter. That's an FDA requirement pediatric study. Okay. It's small study, 35 patients. It's it's up on clinicaltrials.gov.

We, you know, we think patient enrollment's gonna go fairly slowly just because of its, you know, super vulnerable patient population, not always a lot of interest enrolling, you know, these types of patients in a study. But, you know, we've budget for it to to take three to five years and and kinda be a slow burn from a, you know, from a spend standpoint.

Serge Belanger, Health Care Analyst, Needham: Yeah. Is there a market opportunity in pediatric fairly small?

Joe Tadesco, CEO, CorMedix: It's very it's very small. Right? I said, we're not we're not we're you know, we're running as I said, we're running that study as an FDA obligation not because Yeah. There's a meaningful market opportunity. You know, pediatric physicians that want this product for their patients are are likely able to access it.

We also have an expanded access study that has been set up also on clinicaltrials.gov. Yeah. Large number of, different indications, that are listed, where where patients who, you know, have exhausted all other options for infection prevention can can get access.

Serge Belanger, Health Care Analyst, Needham: Okay. And is that a kind of a basket study to explore additional patient populations?

Joe Tadesco, CEO, CorMedix: Or No. Look. We're we're we're tracking data, and and hopefully, of it will be useful, specifically, like, pediatric TPN Yeah. As part as part of expanded access. But, you know, standing up something something like expanded access is really more about making the product available to vulnerable patients.

We get a lot of requests from physicians Yeah. That that want the product. So the the product, you know, if you qualify for the for the study, right, it it comes free, right, to to the to the patient.

Serge Belanger, Health Care Analyst, Needham: Got it. And then, on the TPN label expansion plans, I think this morning, the press release had some additional numbers around the the opportunity. Yeah.

Joe Tadesco, CEO, CorMedix: I thought we I I you know, I I realized we really hadn't put a a total addressable market out, right, kind of Yep. The universe. I thought that was important to do as a as a frame of reference. You know, we we think it's a a meaningful market opportunity from from a dollar standpoint, somewhere between 500 and $750,000,000 depending on ultimately where where the product is is able to be priced from a from a net price standpoint. But we think, you know, in terms of peak sales, if if approved, we have the potential to do hundred 50 to $200,000,000 of of incremental, revenue.

Serge Belanger, Health Care Analyst, Needham: Maybe highlight how this this patient population would differ from the the, the original indication for DEF and CATH?

Joe Tadesco, CEO, CorMedix: Well, it's a different patient population. You have a lot of patients, most of them with with shortcut syndrome, right, that have to have continuous IV IV nutrition therapy. They they, as a patient population, have very high infection rates as well with with also with large mortality. Right? So it's it's another unmet medical need area.

And, you know, when we got approved last year, we we got a lot of requests for expanded access for for TPN. And, unfortunately, we couldn't because we were going to kick off the study, weren't able to include them in in expanded access.

Serge Belanger, Health Care Analyst, Needham: Okay. So from a trial perspective, the the risk of the risk of that trial is fairly low. We should see something similar to

Joe Tadesco, CEO, CorMedix: Look. I I think so. I mean, the way I think I view this is a catheter is a catheter. I think you have a very uniform patient population. Catheters are all accessed in regular intervals.

So, you know, I I think the study is very straightforward. It's gonna be less than a 50 patients. And, look, I'm hopeful we're gonna, you know, you know, have better results, right, than than than HD.

Serge Belanger, Health Care Analyst, Needham: Sure. And the the reimbursement coverage approach here,

Joe Tadesco, CEO, CorMedix: not no It's It's a there's no TDAPA. This is an end stage renal So it's it's a combination. About a third of it is inpatient, which would put it into a DRG, and then, two thirds is is home use. And and we're gonna do a little bit more payer research, but the initial initial research says it's a combination of commercial, Medicare b, Medicare d. Right?

There's multiple multiple types of of reimbursement from home home use standpoint.

Serge Belanger, Health Care Analyst, Needham: Got it. Okay. In terms of financials, maybe just give us an overview of where the cash is. And Yeah. I think you highlighted the, EBITDA generation for the first quarter, but, you know, where it takes you in terms of profitability.

Joe Tadesco, CEO, CorMedix: Look. I think we're we're in an incredibly strong profitability position currently. Right? I think we're one of the few companies in in our peer set right now that, you know, sitting here cash flow positive, pretty strong EBITDA margin coming out of the first quarter, '70 '7 million dollars cash on hand in the first quarter, and no debt on the balance sheet. Right?

And I think, you know, we're a company that, you know, has the ability to, you know, fund our operations and fund, you know, our ongoing, you know, clinical studies from operating cash flow. And I think that that's that's, you know, somewhat rare in this small cap biotech space right now in terms of what we're seeing from from our peers.

Serge Belanger, Health Care Analyst, Needham: Okay. Any any appetite for BD and adding new assets at this point?

Joe Tadesco, CEO, CorMedix: Or Yeah. Absolute absolutely. I think, yeah, something we've talked about over the over, you know, the past couple months. You know, we've we've got fixed infrastructure and experience in two areas. One is in outpatient renal.

The other is in in, on hospital and, inpatient. Could be infectious disease, could be critical care. So we are absolutely, you know, out scouting and and looking for opportunities.

Serge Belanger, Health Care Analyst, Needham: Ideally commercial, or you're willing to put down on the energy?

Joe Tadesco, CEO, CorMedix: Ideally commercial or at least near term commercial. What what I'm not looking to do is is settle the company in long term r and d expense. Yeah. Right? I think it it would likely need to be something where the the NDA is filed or or about to be filed type situation.

But very it would have to be very late stage or or commercials is what I'm looking for.

Serge Belanger, Health Care Analyst, Needham: Got it. Okay. I guess maybe just to wrap up, anything about, DEF and CAT or or CorMedix that you feel is underappreciated or is so misunderstood?

Joe Tadesco, CEO, CorMedix: Well, I think the last couple of weeks, I think, obviously, a lot a lot of my a lot might have been misunderstood, but that's why we're, you know, we're we're out talking to investors and and and do and doing, you know, fireside chats. You know, I think we've got, you know, we've got a good trajectory. We're executing on our on our on our goals. And I think, you know, we're you know, trying to impress upon investors that we've got strong credibility. Right?

If if we when we put an obligation or we put a target out there, we intend to achieve it.

Serge Belanger, Health Care Analyst, Needham: Yep. Okay. Alright. I guess we'll we'll end it here. So, Joe, wanna thank you for spending time with us this afternoon and giving us more color on the this recent update that you guys provided this morning.

Joe Tadesco, CEO, CorMedix: Alright. No. Thank you, sir. Appreciate being here.

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