CorMedix at Leerink’s Global Healthcare Conference: Strategic Insights

On Monday, 10 March 2025, CorMedix (NASDAQ: CRMD) presented at Leerink’s Global Healthcare Conference 2025, highlighting its strategic advancements and challenges. The company celebrated achieving EBITDA profitability in the fourth quarter of 2024, just six months post-launch of its lead drug, DefendCath. However, navigating the TDAPA structure and proving long-term value remain key challenges.

Key Takeaways

• CorMedix achieved EBITDA profitability in Q4 2024, marking a significant milestone.
• DefendCath targets catheter-related bloodstream infections, particularly in hemodialysis patients.
• The company is expanding clinical initiatives and partnerships to drive growth.
• Operating expenses are projected to rise due to new clinical investments.
• CorMedix holds ten years of market exclusivity for DefendCath, with a patent extending to 2042.

Financial Results

• Break-Even Status: Achieved in 2024, with EBITDA profitability in Q4 2024.
• Operating Expenses: Historically $15-16 million per quarter, expected to increase to $17-19 million due to new clinical initiatives.
• Revenue Drivers: Primarily from outpatient hemodialysis, with significant contributions from US Renal Care, DCI, and IRC.

Operational Updates

• Customer Base: US Renal Care as an anchor customer, with new adoptions from DCI and IRC.
• Inpatient vs. Outpatient Strategy: Restructured outpatient team, partnered with Syneos Health for a dedicated inpatient team.
• Veterans Administration: Collaboration with WSI, approved at VA formulary levels.

Future Outlook

• LDO Contracts: Key focus on securing contracts with large dialysis organizations.
• Medicare Advantage (MA): Engaging with MA plans to capitalize on cost-saving opportunities.
• Label Expansion: Focus on total parenteral nutrition (TPN) and pediatric hemodialysis, with commercialization targeted by 2027.
• Oncology: Feasibility analysis for an all-comer study across multiple cancer types.

Q&A Highlights

• IP Protection: Ten years of market exclusivity, with a patent extending to 2042.
• Real World Evidence Study: Tracking data for over 2,000 patients to demonstrate significant impact.
• Standard of Care: Aiming to establish DefendCath as the standard for catheter locking.

For further details, readers are encouraged to refer to the full transcript below.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Roana Ruiz, Senior Biotech Analyst, Leerink: Thanks everybody for coming to our Leerink Global Healthcare Conference. My name is Roana Ruiz and I’m one of the senior biotech analysts here at Leerink and it’s my pleasure to introduce the CEO of CorMedix, Joe Tedisco. Thanks for joining us.

Joe Tedisco, CEO, CorMedix: Thank you, Rona.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yeah, great to have you. And, I think planned for today, I’ll start with some bigger picture questions and drill down more specifics. So just for investors who may be new or revisiting the CorMedix story, just could you summarize the company’s mission and differentiation in infection prevention and particularly as it relates to your lead product, DefendCap?

Joe Tedisco, CEO, CorMedix: Sure. Thanks. I guess, I’ll just start by describing a little bit about who we are, right? So, we’re currently a small cap, now commercial stage biotech company. We just launched our lead drug, DefendCath, in the middle of last year.

The core technology that underlies our main product is our turoline platform, which is a proprietary new chemical entity, amino acid derivative that has broad spectrum antimicrobial capabilities. It’s got broad activity against gram positive and gram negative bacteria, as well as fungus. But it is not an antibiotic. So it’s definitively a unique molecule. DefenCath itself is a combination of our molecule, turolodine and heparin sodium.

Right? So DefendCath is what’s called a catheter lock solution. It sits in a catheter in between the time that a catheter is being accessed. Many patients with different diseases have to wear a catheter for vascular access. The initial indication for our drug is in reduction of catheter related blood stream infections in catheterized hemodialysis patients.

Hemodialysis patients, about eighty percent of them start with a catheter for vascular access. About twenty five percent of them remain on a catheter long term for vascular access. They have incredibly high infection rates, upward of twenty five to a third of patients will encounter a bloodstream infection, in the HD space. And most of those infections happen fairly quickly. So about half of patients will get an infection in the first ninety days they have a catheter instilled.

And they have incredibly high mortality rates. So these infections are absolutely critical unmet medical need. They happen often, they happen fast and they kill at an alarming rate. So the way that DefendCath works, it sits in the catheter in between dialysis sessions. Typical patient, hemodialysis patient receives dialysis three times a week, fifty two weeks a year.

And our product works by inhibiting biofilm buildup in the catheter, which has led to in clinical trials, we demonstrated a seventy one percent reduction in infections compared to locking with heparinolone, which is the standard of care.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. That’s really helpful. So I think, lately you’ve recently achieved breakeven fiscal status in 2024. I was curious, can you talk about this financial milestone for the company and how does that tee up other priorities going into 2025?

Joe Tedisco, CEO, CorMedix: So I think, us getting to break even before the end of the first year of launch was an incredible milestone for the company, something we’re very proud of. I know that we had talked quite a lot about getting to break even on a run rate basis. We actually achieved EBITDA profitability for the full for the full fourth quarter, which is essentially only six months of our full launch, which really kicked in in July of this year. Now in the outpatient hemodialysis space, there’s two settings of care where our drug is currently being utilized. One is in outpatient hemodialysis.

The other is in inpatient hospitals. Now the thrust of the market opportunity is on the outpatient side. About 90% of the market opportunity is outpatient. And you have a large amount of consolidation amongst those customers. So there’s five dialysis operators, represent about 90 of the market.

Two large guys, David and Fresenius, and then three smaller guys, US Renal Care, DCI and IRC. We’ve talked quite a lot about the last year. U. S. Renal Care was our initial anchor customer and that’s kind of they’ve been kind of the driving force behind our initial growth.

But what now what we need to focus on is onboarding new customers and then continuing to grow patients with existing customers.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. And I know you recently gave, cash position and OpEx guidance. So maybe could you just give us a highlight about that and how you balance investing across just executing on the DefendCath launch and just thinking about pipeline opportunities down the road?

Joe Tedisco, CEO, CorMedix: Sure. So we’ve been a fairly SG and A light organization even through launch. We were running only at about $15.16000000 a quarter of OpEx over the past year. We’re giving guidance for this year. That’s just a tick above that probably about $17,000,000 to $19,000,000 a quarter throughout the year.

And most of that delta that increase is for investment in new clinical initiatives. So we’ve announced four, essentially four clinical initiatives, one of which is already underway, which is our real world evidence study with US Real Care. We see that as an important value driver for us long term, the data that we want to capture in a variable setting beyond just infection rate. We want to show that we have an impact on hospitalizations, that we have an impact on antibiotic use, on other downstream, sequelae from CRBSI. That’s data that will be important for us as we make our case to Medicare Advantage plans down the road.

Now from a broadening the label standpoint, we’ve announced, we’ll be kicking off a clinical initiative in total parenteral nutrition showing that the product works for reducing blood sugar infections in that patient population. We expect first patient in, in the first half of this year, likely in the second quarter. Pediatric study, which is an FDA requirement, is a much smaller study, only about 35 patients, should also kick off later this year. And then lastly, we’ve stood up an expanded access platform for patients that are at risk for infection, but are in some smaller niche, disease states where we’re not going to be funding clinical expansion.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep. Got it. And I did want to take a step back a little bit. And for for some of the audience that might be newer to defend cath, can you just remind us, is it a device? Is it a therapy?

How is it exactly used in patients?

Joe Tedisco, CEO, CorMedix: Thank you. We get that question. We get that question quite often because in other parts of the world, the catheter lock solution is considered a medical device and outside in Western Europe, historically that’s been the case. But the FDA considers it to be a drug product and turoline to be a new chemical quantity. So it’s absolutely classified as a therapeutic agent.

In The U. S, we had to undergo a full NDA development program and submission process. Okay.

Roana Ruiz, Senior Biotech Analyst, Leerink: Sounds good. And just so coming off of your preliminary four q announcement, it looks like there’s a lot of good strength in defend cath revenues. So, can you talk about the adoption there and the I think it’s mostly the outpatient setting you said earlier. And what are some of the factors that fueled this growth? Sure.

Joe Tedisco, CEO, CorMedix: So we actually pre announced our fourth quarter earnings back in January. So I’m going to be a little bit careful and not kind of get ahead of anything that, you know, wasn’t in our pre announcement because we’re going to be reporting earnings in the next couple of weeks. But, but you’re right. So, a lot of the initial uptake has been in the outpatient segment. Much of it driven by our anchor customer, which is US Renal Care, who who kind of came on board in early July.

We started to see adoption from two of the other mid sized players, DCI and IRC in November and kind of pushed us through the back part of the year. So, really pleased with where we ended up at the end of the year. One of the things that I guess I wasn’t pleased with was the uptake on the inpatient side. So we kind of launched middle of the year with a field team that was combined and calling on both therapeutic segments. Right?

Using the same team to cover both outpatient, renal, as well as inpatient hospitals. And that team was largely experienced in the outpatient renal setting. But as we moved through the third quarter, we took a couple of learnings. One of which was we didn’t need as large field presence to drive uptake on the outpatient side because much of it is done off contract, right, and done at the decisions made at the parent level. So we shrunk the outpatient team down a little bit and combine it with our market access unit, and have decided to stand up a completely independent inpatient team.

So we’ve partnered with Syneos Health on staffing that organization. It’ll be dedicated essentially CorMedix employees. They were utilizing Syneos for some operations logistics support, but they’ll be dedicated CorMedix employees. And with the goal of standing that team up by the end of the first quarter.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. Great. And in terms of sustainability of demand or any sort of qualitative comments you can make in terms of what you’re hoping to see in 2025?

Joe Tedisco, CEO, CorMedix: Well, look, I think the big variable, which everyone is going to want an update on our next earnings call is where we at with we’ve announced previously that we signed one of the two LDOs to a contract. And that LDO’s target was to put it in about ten percent of their catheterized patients. So we’ll be updating investors on where we stand with that customer as well as with the other that we don’t have or didn’t announce a contract with when we get to our earnings call in a few weeks. But that’s the largest, I guess, variable in our value prop, so to speak, to the extent that we do materially more, materially less than what’s forecasted, right, that’s the, that’s what everyone wants to understand.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep, got it. And just to double click on, you mentioned just leading more into the inpatient hospital setting. So what are some of the goals of that expanded field rep team?

Joe Tedisco, CEO, CorMedix: Well, I think first, I just want to say from an inpatient standpoint, while it’s a smaller market opportunity in terms of it might only be 10% of the market volume for hemodialysis. First, we think there’s better price durability in the hospital segment. So the dollar value might be a little bit higher. But we do think it’s important from a longer term standpoint. Certainly, as we talk about TPN, right, a third of TPN is used in the inpatient setting.

Then beyond TPN, there’s going to be a number of other, we think, opportunities for spillover on a long term basis. So having a robust and credible inpatient team is vital to kind of the future, I view, the future uptake of DefendCAF.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep. Got it. I think there’s a question in the audience.

Unidentified speaker: Just on the fact that the product’s a drug as opposed to being a device, how does that change your ability to defend your IP and put motes around your product relative to other catheter products in the marketplace?

Joe Tedisco, CEO, CorMedix: So it doesn’t I wouldn’t say it changes the landscape for having IP. What it creates though, when you’re a drug product, there is a clearly defined IP process for patent challenges. Right? So you have this A and D A. They call it a paragraph four certification.

So our product, first, has ten years of market exclusivity. So generic can’t be approved for a decade. But we also have an Orange Book listed formulation patent that goes to 2,042. So there are statutory procedures by a generic filer that they have to fulfill in order to challenge that patent. They can’t file an ANDA until a certain point in time.

It has to be one year prior to the NCE exclusivity date, which would be year five. And then there’s a litigation process. Now, we feel pretty good about the validity of our patent claims and the difficulty that generic would have in designing around that patent. So we feel good about the IP protection that we have. But I think it affords investors a lot of clarity and visibility, as opposed to on the device side.

I don’t believe that that type of pathway exists. You’re welcome.

Roana Ruiz, Senior Biotech Analyst, Leerink: Great. I’ll keep rolling if there are no other questions. So just thinking about, I think you mentioned being able to, having some partnerships, accessing the VA and federal facilities, things like that. Can you talk about the eligible patient population there? And what does that look like?

So

Joe Tedisco, CEO, CorMedix: it’s a little bit tough to tease out data on the Veterans Administration. But we do know there’s about fifty five thousand ESRD patients that are receiving hemodialysis, or there are veterans receiving hemodialysis. Our estimate is about twenty five percent of those have a catheter. So they may be eligible. Now all of them are getting dialysis at a VA site.

Some may be going to other third party sites. They could be going to a US Renal Care or DaVita site. But we think that at least somewhere between thirty percent and fifty percent of them are getting dialysis at a Veterans Administration facility. So there’s about 171 VA hospitals nationwide, and about 71 of those perform outpatient hemodialysis services. So we do think the opportunity is material enough.

The collaboration we have with WSI is not a large commitment on our part from an SG and A standpoint, spend standpoint. So we think that the approach is the right one to take to see what type of traction we can get. We were added to VA formula. We were approved at the VA non formulary. So we don’t have a tremendous obstacle to uptake.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. Great. And thinking about your recent contracts with large and medium dialysis organizations, can you talk about how that helps boost scalability for DefendCath and any lessons that you’re learning right now that you can lean into more going into the future? Sure.

Joe Tedisco, CEO, CorMedix: Look, I think having a contract in place is essential to getting any utilization within the organization. So unless the parent organization is kind of signed off on from a formulary standpoint, you ultimately end up getting blocked off regardless of whether treating physicians want to use the product. So that’s critical. Look, I think I’ve taken a lot of learnings over the last year that I could apply both to our ongoing launch going forward, as well as to any future launch we did in the renal space that had to adapt, so to speak. It wouldn’t be DefendCath, but some other type of product.

So it is a very unique niche, space. So, yeah, I guess I’ll leave it at that.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep. That makes sense. And, I know things are still going on in real time, but I was curious, how are your pair negotiations progressing with both Medicare and Medicaid? And what percent of the dialysis market do you expect to penetrate over time, like this year, next year?

Joe Tedisco, CEO, CorMedix: So I guess I’m going to start with the first part of that question. So we don’t, at this point in time, while 80% of our patients are Medicare, right? So 80% of our patients are Medicare. Half of those are fee for service. Half of them are Medicare Advantage.

Almost all of them are eligible for TDAPA, right, for the most part. And that doesn’t require any proactive negotiation on our part. What we are very cognizant of is over time, we expect two things. One, the trend is that patients are shifting more and more away from Medicare fee for service into Medicare Advantage. So Medicare Advantage, a couple of years ago, was only twenty five percent of ESRD patients states 50.

We think in a few years, it’s gonna be seventy percent. We see that as a huge opportunity for defend health because the Medicare Advantage plan is the payer, right? Unlike fee for service, the way that the privatized MA plan, whether it’s United or or Humana or Aetna look at things, they’re seeing both sides of the ledger. Right? So we have a we have a unique product opportunity that can, you know, not only improve patient outcomes, but can ultimately save the payer money, right, by reducing, you know, other costs that they have to pay out of pocket for treating infections, hospitalizations, antibiotic use.

So, you know, I mentioned before our real world evidence study that we’re running in combination with US Renal Care, a lot of the data that we’re hoping to generate out of that study will be used for discussions with MA plans that we intend to start later this year. So, you know, we do have relationships. We are in communication, but we’re not at the point yet where we’re aggressively pushing to put a contract in place, Right? So and this would also be somewhat of an end of one situation. I don’t know that there’s been another to DAPA product like ours that has, you know, I’d say, you know, prophylactic utility, right, that could potentially be a cost offset for the EMA plans.

Yep.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. And maybe taking a step back for a second, for new investors, can you just remind us what is TDAPA? How does it play in this Sure. This question you gave?

Joe Tedisco, CEO, CorMedix: Sure. So TDAPA is a transitional drug add on payment. Most patients that, or all patients that are Medicare that have end stage renal disease, the dialysis operator gets paid a fixed bundleized payment, for the provision of dialysis services. Now to incentivize the utilization of innovative drugs like ours, CMS has created a transitional drug add on payment adjustment, which has two phases. The first phase is two years where the dialysis operator gets reimbursed at ASP, which is in theory the most profitable period of time for the provider.

And then there’s three more years after that with a with a calculation and a bundleized adjustment. So it’s a continually evolving program, I would say. Now by statute, it somewhat applies to fee for service, but the Medicare Advantage plans are following, their obligated to follow to DAPA. But long term, we see that as the opportunity to enter into direct negotiations with Medicare Medicare Advantage.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep. Yep. And I just want to give you a chance also to highlight the real world evidence study as well. Like, how does that play into the long term trajectory of Defend Kath, thinking about TDAPA changes and things like that?

Joe Tedisco, CEO, CorMedix: Well, look, as I said before, I think it’s going to be essential for whatever we do with Medicare Advantage, right? So this is critical data that doesn’t just our clinical study is great. We demonstrated a seventy one percent reduction, head to head against heparin. But when you’re designing a phase three study, you’ve got your primary and secondary endpoint. With a real world evidence study, we can track a large number of other metrics and outcomes and really show in potentially thousands of patients, it’s going to be more than 2,000.

We’re already over 2,000 patients for which we’re tracking data, and we’re hoping to show a significant impact on a number of scores.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. So also looking forward to the future and label expansion for DefendCath. So I know you mentioned TPN in the beginning. So just to level set here, what’s the unmet need and population size, etcetera, for TPN?

Joe Tedisco, CEO, CorMedix: So TPN patients, patients that are receiving, you know, continuous, IV nutrition therapy, it’s often through a catheter. And very similar to hemodialysis, these catheters have incredibly high infection rates, you know, upwards of twenty five percent and, you know, mortality rates that are similar to HD. So, again, another critical unmet medical need. And it is a I think the size of the market is somewhere around 5,000,000 infusions a year, which is about 10,000,000 vials of DefendCAF. So it’s a meaningful market opportunity.

We’ve guided investors. We think peak sales in this space can be in the $150,000,000 to $200,000,000 range for DefendCAF. And we’re hopeful, as I said, we expect first patient in the second quarter. We believe we can run the study end to end in around eighteen months. That’s and it’s a little ambitious, but that’s what we’re pushing for with the hope of commercializing by the end of twenty twenty seven.

Yes.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. And then, in terms of enrollment cadence, like what’s your expectation for TPN patients in particular?

Joe Tedisco, CEO, CorMedix: Look, I don’t want to give specific numbers, but we had a lot of inbound interest immediately upon approval for, doctors looking, to get Defend Kath for their TPN patients under an expanded access. And we somewhat had to hold that off while we stood up the clinical study, because we want to bring those patients into a clinical study. But we have stood up expanded access and we will be putting or making available to pediatric TPN patients through expanded access.

Roana Ruiz, Senior Biotech Analyst, Leerink: And speaking of pediatric, I know you’re also looking at pediatric hemodialysis a little bit more broadly. I think the trial is going to start later this year, if I remember. So, just thinking about that patient pool, what safety and efficacy benchmarks do you want to see with DefenCath there?

Joe Tedisco, CEO, CorMedix: Well, the primary endpoint is a safety endpoint. And the secondary is going to be, incidence of a reduction in CRBSI. Now, you’re only talking about thirty six patients. So the pediatric study is an FDA obligation, right? This is part of the commitment.

You give the agency when you get your FDA approval. The overall market size for pediatric isn’t tremendously large. We do think patient enrollment is going to be very slow, right? Because, you know, there aren’t one, the patient population is small, two, parents are always, you know, are maybe reluctant to enroll their children in a study like this. So, we should have the study kicked off by the end of the year.

Again, 36 patients, and with the primary endpoint being safety.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep. Got it. And so if I zoom out a little bit and think about profitability trends for DefendCath in the long term, like, how are you balancing, executing on the launch for DefendCath now with internal R and D and these new indications coming up in the pipe, like TPN, pediatric, etcetera?

Joe Tedisco, CEO, CorMedix: Well, look, as I mentioned before, we run the business fairly SG and A light, right, historically $15,000,000 60 million dollars a quarter. The R and D commitment, right, we’re increasing this year into the call it $18,000,000.19000000 dollars range a quarter. A lot of that is R and D, but the R and D initiatives we’re kicking off aren’t huge spends comparative to other disease states. I think the largest study obligation we have is going to be TPM, which is going to be about $12,000,000 14 million dollars over two years. So expanded access is less than $1,000,000 Real world evidence is less than $1,000,000 a year.

And pediatric is probably going to be about $4,000,000 to $6,000,000 over maybe four or five years. So it’s going to be a longer, slower spend. So still, we feel that we run the business pretty SG and A light even with the R and D increase.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. Yes. Sounds good. And then I know you’ve also alluded to oncology, ICU, critical care. Where does DefendCAF fit in those worlds?

Joe Tedisco, CEO, CorMedix: So we are in the process of doing some feasibility analysis around oncology. As you know, oncology is not a disease state, right? It’s an umbrella that encompasses multiple different disease states. So our goal would be to design what we would call an all comer study, multiple different types of cancer, with the common thread being, they have either a catheter or a port, right? We’d like to actually cover both.

But you have catheters being accessed in completely different intervals. So it’s a little bit of a challenge, but we do see tremendous long term value in being able to demonstrate efficacy in that disease state specifically. So I know I’ve in the past put timing around, hey, I wanted to get a proposal in front of FDA for for oncology by x date. But what I want to make sure is we get the right proposal in front of FDA, right, that designs this study in a way that, best sets us up for success.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. And, we also learned in some of our doc checks that some hospitals are penalized by CMS for high infection rates or re hospitalizations. Like, where does the FenCath fit and be the solution?

Joe Tedisco, CEO, CorMedix: Well, I think it’s part of the value prop as we go to P and T Committee on the inpatient side is I think the biggest penalty that they receive. One, yes, there’s quality scores. But But, when they have a readmission for a blood sugar infection, within thirty days, they don’t get reimbursed, right, for that continued treatment. So that’s a it’s, you know, it’s you could consider it a financial penalty, but they end up eating a large amount of cost. You have inpatient infection rates are incredibly high, right?

But if you get an infection, the readmission rate is even higher, right? I think it’s somewhere between seventy percent and ninety percent of patients getting readmitted within thirty days, right, for recurring infection. So that I think that’s an area where absolutely we can have an impact.

Roana Ruiz, Senior Biotech Analyst, Leerink: And in terms of just hearing things from your field force, what’s the feedback been on DefendCat use so far and how are hospitals and clinics responding?

Joe Tedisco, CEO, CorMedix: Well, I think obviously most of our use has been on the outpatient side. And I think, you know, feedback from administration standpoint has been kind of seamless, right? Because you’re either locking the catheter with heparin or saline or you’re locking the defense catheter. So there’s really no change to workflow. So it’s not from an operation standpoint.

We haven’t had any problematic feedback. Now, what we’re hoping to start seeing, and it’s a little bit still premature because we’re only six months into rollout. And this is a large part of what we want to see in the real world evidence study is we want to see an impact on infection rates. Right? That’s what we want to show.

We want to show that, you know, we’re not just, you know, impacting infection rates, that we’re reducing hospitalizations, that we’re reducing, you know, other comorbidities. That’s what we’re hoping to show.

Roana Ruiz, Senior Biotech Analyst, Leerink: Yep. Got it. And then, maybe I’ll pause here, see if anybody in the audience has extra questions. Okay. I’ll keep rolling.

We have a couple minutes left. So, tying it all together, so you’ve got a lot going on. You’ve got launching DefendCath now, leaning into the inpatient setting, VA rollout, etcetera, TPN trial, ramping up. So what milestones should investors follow from here on out? And what do you think is most interesting for them to look at?

Joe Tedisco, CEO, CorMedix: Well, I mean, obviously, as we talked about before, I think the biggest future potential value driver for us are the LDL contracts and how we convert on those and generate kind of patient acquisition through those agreements. Beyond that, we are, over time, looking to develop beyond being a single product company. So we’ve got the R and D initiatives we have in place. But we’re also open and looking for business development opportunities, right, looking at things that are commercial fit with our infrastructure, kind of our infrastructure light mindset. There’s two areas where we’ve got core competency and one is in the renal space, right, specifically around TDAPA, right, the other, on the hospital, in the hospital segment, right.

So we can be a little bit therapeutic area agnostic on the hospital side because it’s, it’s more about the therapeutic setting of care than it is specific disease state. But those are areas that we’re actively out looking.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. And then, one last question before I close out. Just what do you think investors least understand or least appreciate right now in the story for CorMedix? And what should they look for going in the next couple of years?

Joe Tedisco, CEO, CorMedix: Well, I think when you’re thinking about the FancF, you have to look at it on a longer term basis and not quarter to quarter, I think. What’s least understood is also, I think, what’s most worried about, which is the TDAPA structure, right? And it’s a little bit unique, right? It’s not something that applies across, I think, any other disease state, right? But I don’t think it’s something that, from a long term standpoint, gives me a lot of anxiety.

Because we’re focused on growing the label, growing the opportunity, and over time, shifting to much more of a kind of volume play, making this. We’d like to see this to become the standard of care. That’s ultimately the goal, whether that’s in hemodialysis or hemodialysis plus TPN. You know, from a long term basis, this should be the standard for which people lock catheters. Yeah.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. Well, I’ll squeeze in one more. Since you were talking about becoming the standard of care, like what steps need to happen for DefendCare to be there?

Joe Tedisco, CEO, CorMedix: Well, I think time is a big part of it, right? So one of the things, the obstacles when you’re launching a drug that you come across, is you will come across a large number of physicians that will say, oh, this sounds fantastic. Let’s talk in a year after you’ve been on the market for a year. I’d love to see some real world results. And that’s exactly why we’re running the study.

So we want to over we have a much more longer term mindset in terms of what DefendCath can be and part of that is generating data that shows the impact. Yep.

Roana Ruiz, Senior Biotech Analyst, Leerink: Got it. Well, super interesting. We’re looking forward to more updates and thanks again, Joe, for joining us.

Joe Tedisco, CEO, CorMedix: Appreciate it. Thank

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