CorMedix at RBC Capital Markets: Strategic Expansion and Growth

On Wednesday, 21 May 2025, CorMedix Inc. (NASDAQ:CRMD) participated in the RBC Capital Markets Global Healthcare Conference 2025, highlighting its strategic initiatives and growth prospects. The company presented an optimistic outlook on the commercialization of its flagship product, DefenCath, while addressing challenges in securing long-term reimbursement and navigating potential policy changes.

Key Takeaways

• CorMedix forecasts net sales of approximately $70 million for the first half of 2025.
• The company has secured contracts with four of the five largest dialysis operators.
• A real-world evidence study is underway to demonstrate DefenCath’s cost-effectiveness.
• Expansion into the inpatient market is being pursued through a partnership with Syneos Health.
• CorMedix aims to achieve cash flow positivity and maintain a lean SG&A structure.

Financial Results

• CorMedix guided first-half 2025 net sales to about $70 million, reaching the top of its previous guidance.
• Research and development costs for the total parenteral nutrition (TPN) study are expected to be $1-2 million.
• Tariff exposure is minimal, estimated at 35 to 40 cents per vial.
• The company projects no significant increase in SG&A expenses for DefenCath’s commercialization.
• Potential peak annual sales for DefenCath in the TPN market are between $500 million and $750 million.

Operational Updates

• DefenCath’s commercialization began mid-last year, with contracts secured with major dialysis operators.
• Three of these operators have already implemented DefenCath, with more expected to follow.
• A new field team has been launched to target the inpatient hospital market.
• 6% of unit shipments in April were directed to the inpatient segment.
• A real-world evidence study with US Renal Care was initiated in July 2024.

Future Outlook

• CorMedix seeks to secure long-term reimbursement for DefenCath beyond the TDAPA period.
• Plans include contracting directly with Medicare Advantage plans.
• The company is pursuing an additional indication for DefenCath in TPN, with commercialization targeted by the end of 2027 or early 2028.
• The total addressable market for DefenCath in TPN is estimated between $500 million and $750 million.
• CorMedix is considering engaging with the administration for broader adoption of DefenCath and pursuing FDA approval for a broader label indication.

Q&A Highlights

• CorMedix is open to incorporating data on DefenCath’s higher efficacy into FDA discussions.
• The average hospital stay for catheter-related bloodstream infections is about two weeks, with a recurrence rate over 72%.

For a deeper dive into CorMedix’s strategic plans and financial outlook, refer to the full transcript below.

Full transcript - RBC Capital Markets Global Healthcare Conference 2025:

Greg Brenza, Biotech Equity Research Analyst, RBC: Welcome back everyone to the twenty twenty five RBC Global Healthcare Conference.

Joe Tobisco, CEO, CorMedix: My name

Greg Brenza, Biotech Equity Research Analyst, RBC: is Greg Brenza, one of the biotech equity research analysts, and we’re pleased now to be joined by CorMedix. Joining us from the company, CEO Joe Tobisco. Joe, it’s great to have you. Good to see you, and thanks for joining us.

Joe Tobisco, CEO, CorMedix: Thanks, Greg. Good to see you as well.

Greg Brenza, Biotech Equity Research Analyst, RBC: Great. Look look forward to the discussion. And for those who who aren’t as familiar with the CorMedix story, could you provide an introduction to the company to BenCath, that burden of catheter related bloodstream infections and and end stage renal disease?

Joe Tobisco, CEO, CorMedix: Sure. So, you know, in present time, we’re a publicly traded, commercial stage biotech company. Market cap currently just under under $900,000,000. Our lead product, DefendCath, is indicated for the reduction in risk associated with catheter related blood treatment infections, in patients undergoing chronic hemodialysis through a central venous catheter. I know that’s that’s kind of a mouthful.

Now the the product itself is what’s called a catheter lock solution. It’s a combination of heparin, which keeps catheter patency flowing, and our proprietary new chemical entity, tyrolidine. Right? Tyrolidine is an amino acid with broad spectrum antimicrobial activity against gram positive and gram negative bacteria as well as against fungus. In our phase three clinical study, we demonstrated a seventy one percent reduction in risk associated, with, catheter related bloodstream infections.

We commercialized the product or began commercializing the product about midyear last year. We I’ve I’ve announced three quarters of sales. We’ve given our first half of the year guidance. Launch is going very well. We’ve guided first half of the year to the top end of our our previous guidance range, which was 62 to 70, and we’re we’re currently estimating about 70,000,000 of net sales for the first half of of twenty twenty five.

Greg Brenza, Biotech Equity Research Analyst, RBC: Great. And certainly wanna talk about the the feedback, the launch traction that DefenCath is getting. But maybe first, Joe, want to just take a step back and just talk about the treatment and the care management landscape for hemodialysis patients with CVCs. How does DefenCath fit in there? We get a lot of questions on this and that patient management.

Maybe walk us through some of those, some of that picture, please.

Joe Tobisco, CEO, CorMedix: Well, certainly, the first and foremost, there’s a number of things from a hygiene standpoint that that patients should be doing and their caregivers should be doing, to keep the catheter clean. If you’re asking from a competitive landscape standpoint and from a drug product standpoint, we’re the only approved, drug product, from from FDA as a catheter lock solution, right, that that has demonstrated antimicrobial activity, and and demonstrated in a in a large scale phase three study a reduction in risk associated with, with catheter related abutment infections. There are other antimicrobial based products in the market, mostly devices. There are antimicrobial caps. They can be used with DefenCath, and I think certainly that’s the the future of where we would be guiding, providers, right, to do as much as possible, for patients in terms of of preventing infections.

Greg Brenza, Biotech Equity Research Analyst, RBC: Excellent. So with DefenCath now now being being on market for a little bit in the launch, know, well received in the in the outpatient segment. Just talk to us a bit about what’s been working well for the for the program, for the product that’s really been behind its uptake?

Joe Tobisco, CEO, CorMedix: Well, look, it’s a it’s a fairly straightforward concept, right, in terms of every patient that has a catheter that’s getting hemodialysis, they’re getting hemodialysis three times a week. That catheter needs to be locked with with a with a lock solution. Right? Traditionally, that’s been heparin or saline. Neither of those demonstrates any antimicrobial capabilities.

So from a workflow standpoint, it it it really isn’t much different. Right? You’re now you’re locking with with the FENCATH instead of instead of heparin or saline. So from that standpoint, it it it has been fairly fairly seamless in terms of in terms of education. You know, we we see a large amount of concentration amongst the customer base in outpatient hemodialysis.

Right? You have two two large dialysis operators, three midsized dialysis operators. Those five combined make up somewhere around 92%, I think, of the market. You know, we’ve got four of those five under under contract, three of which have have implemented. Obviously, we’ve talked quite a bit.

US Renal Care was the initial mid sized dialysis operator that adopted, utilizing the product. That ramp has gone very well. We onboarded, two others, IRC and DCI, late last year, and continue to to increase patient numbers with with both of those providers, and we’re we’re optimistic. As I said, we we haven’t one of the l two LDOs under contract, we haven’t disclosed which one. We’re we’re optimistic on on starting utilization around midyear, and, you know, certainly, we’ll we’ll keep shareholders and investors updated once we we officially make, you know, progress and and begin implementation.

Greg Brenza, Biotech Equity Research Analyst, RBC: And and with the progress over the past quarters as far as keeping investors updated, I think it’s been applauded for for many team, that transparency, that visibility on on what you think the performance could look like. Always certainly cautiously optimistic, but maybe transitioning to optimism. Just talk about some of the progress stacking up to your base case assumptions. You’ve done a nice job of providing the guidance for the first part of the year. You helped you helped the analysts and and investors out last year even on on a sequential sequential basis.

So just walk through how that trajectory is stacking up. Look. I mean, giving guidance is always a challenge. Certainly, there’s a

Joe Tobisco, CEO, CorMedix: reason why a lot of launch stage companies don’t give guidance. Right? Because forecasting is difficult, especially when you’re you’re in launch mode. And what we try to do is give as much visibility to to analysts and investors as as as we possibly can. The most we’ve been able to guide so far this year was the first half of the year, and and that’s a large in part because the timing of when our LDO comes on board and the scale of which they implement really could can drive wide variability in the back part of back part of the year, and we don’t have enough, color yet, on either of those items to say, you know, we can give a revenue range or we can give we can give a forecast range today.

And, hopefully, as we progress over the next couple of months, we can get closer to giving that that that that type of guidance. But I I think in terms of the first half of the year, certainly, I’m very pleased with with the the trajectory. You know, we’ve talked about and the reason why we guided over the first half of the year was, you know, we had there were some profit or or price related incentives why US Reno bought a little more inventory in the first quarter versus the second quarter, but we are seeing, you know, that inventory increase in being used in the second quarter. Right? So, you know, as we talk about the full year, I do expect to see growth of utilization with existing customers, the existing base business in terms of new patients on board, as well as adding new customers, both, you know, hopefully, the LDO coming on board as well as, patients on the inpatient side, which we’ve talked, or or hospitals on the inpatient side that we talked quite a bit about, launching that new field team earlier this year and starting to see progress.

Greg Brenza, Biotech Equity Research Analyst, RBC: Yeah. That that’s great. Maybe we’ll just talk about that, that mix of outpatient versus versus inpatient. The inpatient partnership with with Syneos, you you have a history with with with the organization as well. How how is that progressing?

At at what rate do you anticipate some of that contribution from the inpatient side?

Joe Tobisco, CEO, CorMedix: Well, first, I just wanna say it’s it’s great working with Syneos. I’ve had a number of experiences working with them in the past. When we talk about representative themselves, the key account managers, I view them as CorMedix employees. Right? They might be their paychecks might come through Syneos, but they’re dedicated to CorMedix.

They’re trained by CorMedix. They’re interviewed and hired essentially by CorMedix. You know, the flexibility that Syneos provides is they’ve got deep resources in terms of recruiting, in terms of data, right, in terms of the ability to manage fleet, a number of things that, you know, a company of our size would have to have a number of in house employees to be able to to handle those functions. So they really offer me a lot of flexibility there. But in terms of the the quality of of the of the key account managers, that’s on us.

Right? We have to interview them. We have to hire good people, and I’ve been very impressed with the team so far that that that we’ve put out in the field. Progress is is has been going well. You know, inpatient itself, as we talked about on the last call, I think for for April itself, about 6% of our unit shipments went went to the into the inpatient segment.

Now I don’t expect you know, should the LDO come on board and and and take larger volumes, that 6% is not gonna remain the same. But I think, directionally, I would expect the amount of shipments to grow as we add new accounts as we as we progress throughout the year.

Greg Brenza, Biotech Equity Research Analyst, RBC: K. Great. Great. I wanna talk TDAPA. The big topic for for investors, thinking about it, the post TDAPA opportunity.

And for those that aren’t fully up to speed, just walk us through the current TDAPA reimbursement process and what it means for

Joe Tobisco, CEO, CorMedix: So the current TDAPA is a five year adjustment to the dialysis bundle. Right? So patients that have end stage renal disease under CMS, essentially, the you know, all goods and services in terms of providing hemodialysis are part of a bundledized payment system. Now CMS created an incentive for innovative you know, to invest innovative products, which would be an add on payment to that bundle, but it’s it’s transitory. Right?

So there’s two years the first two years where reimbursement is essentially at at what they call ASP, and then there’s three years of a of a bundleized adjustment that has some some price adjustments. Now the the the structure of TDAPA is largely for fee for service patients. Now Medicare Advantage right now, at least with respect to our product, we’re seeing good claims in terms of the MA plans following TDAPA, right, and reimbursing TDAPA claims. So that’s that’s been beneficial. But what we wanna do for the long term of DEFENCATH, we’re doing a couple of things.

Right? Because we recognize that, right, TDAPA is transitory, and we wanna demonstrate long term sustainable or achieve long term sustainable reimbursement for the product. So we’re we’re in the process of running a real world evidence study with US Renal Care. We started data collection back in in July of twenty twenty four, but the goal would be to utilize data that that can demonstrate reduction in hospitalizations, lost chair time, reduced antibiotic use, a number of metrics that really get to the cost, you know, per patient of a CRBSI. We’ve got a number of data points over the years that point to somewhere between 90,000, a hundred 20 thousand dollars per infection is the cost to Medicare or Medicare Advantage of of of a patient receiving one of these infections.

So our goal would be, as we progress through to DAPA, to kind of change our strategy and and seek to contract directly with the MA plans. Right? Because the MA plan ultimately is the one for their patients. It’s on the hook for for both sides of the of the equation. Right?

They’re the ones that are paying the hospitalization costs as well as paying the drug costs. Now from a from a longer term standpoint in terms of the value of DEFENCATH, we’ve also started running additional Right? So we’ve we’ve kicked off, our study in total parenteral nutrition. First patient dosed last week, so we’re we’re very happy about that.

It’s a relatively modest sized study with less than a 50 patients. We think we can run it end to end in less than eighteen months with the goal of of hopefully commercializing by the end of twenty seven, early ’20 ’8. You know, that indication will fit very well with our existing field deployment in the on the hospital inpatient side as well and provide, you know, additional revenue growth opportunities longer term.

Greg Brenza, Biotech Equity Research Analyst, RBC: Okay.

Greg Brenza, Biotech Equity Research Analyst, RBC: That’s and maybe we’ll we’ll stick with with TPM because we we certainly view that as as a a nice expansion opportunity. We wanna get back to get get get get back to current, hemodialysis patients. But it’s and sticking with that growth, I think you’ve recently and over this year, you’ve put some some numbers on what the the TPN opportunity could be. Very reassuring that you get the first patient, you’ve got the the trial listed. So think about running a fileable trial, a pivotal phase three.

Just walk us through, number one, what opportunity are you coveting here? And number two, just the steps in the process when it comes to the clinical trial. Sure. So from a from

Joe Tobisco, CEO, CorMedix: a total addressable market standpoint, we we see that, you know, the TAM somewhere between 500,000,000 and $750,000,000, right, depending on on price point. There’s some variability in terms of size of the market, in terms of volume. We think it’s around 10 to 12,000,000 vials a year of three milliliter DefenCath. So, you know, we’ve put out some peak sales guidance that, you know, depending on penetration, we think we could be somewhere between a 5,200,000,000 peak peak annual sales for for DefenCath in that in that space. About a third of it is hospital inpatient.

About two thirds is in the home. A little bit more traditional reimbursement landscape, a lot of commercial patients, compared to ESRD, right, which is which is 85% Medicare. And when

Greg Brenza, Biotech Equity Research Analyst, RBC: you think about that broader kind of peak guidance that that you’re you’re you’re laying out, you know, what what sort of legwork is required for diff to FinCath in that that larger majority of TPN patients that reside at home? How operationally would, what would execution look like? So that

Joe Tobisco, CEO, CorMedix: is something we’re still gonna have to work through as we get closer to really understand what type of additional resources we’re gonna need and instructions for caregivers. Right? So so we have explored to to a limited extent home hemodialysis. Right? And and we’re we’re starting to do a little bit of research, and we think that will be able to lend itself.

The work we do for for, support of home hemodialysis should be able to transport over over to TPN as well. But, it’s a it’s a valid point, something we’re gonna look at over the next year.

Greg Brenza, Biotech Equity Research Analyst, RBC: And just as far as the risk reduction, any benchmarks that we can be thinking about? Certainly, the prior the prior data that led to the the approval, and when we think of TPN, you know, what what what what performance would we wanna see to Pentecast sort of pull up?

Joe Tobisco, CEO, CorMedix: Well, look, I’d certainly like to see as good or better, right, than than than than what we’ve seen in in DEFENCATH. I think the threshold set in the study is is lower, right, to meet, statistical significance. But, you know, I’m as I said, I’m I’m hopeful and optimistic that we’re gonna show as good or better result in TPN. At the end of the day, our our view is that a catheter is a catheter. Yeah.

We’re not treating, you know, short bowel syndrome, we’re not treating hemodialysis. Right? We’re we’re we’re theoretically, the other product’s preventing biofilm buildup in the catheter, and that biofilm leads to bacteria and leads to leads to infection. Right? So to the extent that that could be replicable across disease states, it it really should be irrelevant what the disease state is as opposed to, I think, factors that are more relevant would be how often the catheter is accessed, how long the the stent gets sits in the catheter, things like that.

K.

Greg Brenza, Biotech Equity Research Analyst, RBC: Alright. Great. And then when

Greg Brenza, Biotech Equity Research Analyst, RBC: it comes to maybe political tide shifting, maybe policy momentum, how should we be thinking about reimbursement evolution within CMS with respect to DefendCast? Lots of macro issues, and Right. Know you get asked about this quite considerably. How do you put it into context?

Joe Tobisco, CEO, CorMedix: No. These are these are questions we we get quite often, that along with tariffs. Right? And I’ll I’ll just throw that out there that, you know, we we view our tariff exposure as as fairly minimal. Most of our cost of goods sold comes from The United States.

We do, you know, the our fill finish in Europe, but we think the tariff exposure there is is quantifiably low, probably in the 35 to 40¢ a vial. Okay. So so not something that that that we see as overly significant. Now now over the last few weeks, there’s been a lot of communications around pharmaceutical out of this administration. You know, certainly, is is familiar with, president Trump’s executive order on on, most favored nation pricing.

You know, we’ve looked at that as well with respect to DefenCath. You know, we currently don’t think that we we have any exposure in that area. We we’ve not pursued approval, of our product outside The United States as a pharmaceutical, and and, to our knowledge, no other jurisdiction in the world has has approved this combination of heparin Trolloline as a pharmaceutical product. Right? So there’s really no apples to apples comparison there.

Now I think what you’re getting at is some of the, communications that came out of CMS over the last couple of weeks, which are which for us are are incredibly interesting. Right? So, you know, you had a a recent forum with with doctor Oz and and his and one of his, you know, deputies, Abe Sutton, that really talked about, you know, the future of CMMI and the future of of of CMS for this administration and wanting to focus on things like prevention. Right? You know, how do we how do we engage in preventative health care that also brings down costs and brings down overall spending with Medicare?

And I think that’s a great opportunity for us. So so, you know, there’s a lot of things that we have going on, you know, certainly behind the scenes where, you know, we’re looking to engage, you know, more directly with with this with this administration, hopefully, you know, fulfill, you know, the the goal of of of both of those things. Right? More widespread adoption, bring down overall health care costs, improving patient health.

Greg Brenza, Biotech Equity Research Analyst, RBC: Yeah. Great. Great. And even near term, when talking about the real world evidence study that you’re running with USRA and also continuing to build a body of data, and as we translate that to this year into ’26, what metrics do you believe MDOs and LDOs are looking to to encourage continual ordering of of DEFENCAT?

Joe Tobisco, CEO, CorMedix: Look, I think if we can demonstrate in a real world setting, you know, a material impact on infection rates itself, I think, you know, right there. That’s that’s, I think, the key data point that if people see, you know, what we can do for, you know, for infections. You know? Is that a corollary that, you know, if we can have if we can show in that study that we have an impact on mortality, that’s even bigger. You know?

Right? So those are the things that, you know, that that we we certainly wanna show, right, to the to the LDOs. Right?

Greg Brenza, Biotech Equity Research Analyst, RBC: To the payers, we wanna show cost impact. Yep. Right. Excellent. And then as you mentioned, LDO come come coming online.

Investors are are really keying in on essentially that that delta that we can anticipate on the top line and not asking for guidance, but maybe just set the stage for so when it comes to the pace of of operationalization with your LDO partnership. How should we consider the inputs of quantifying that?

Joe Tobisco, CEO, CorMedix: Look. I I don’t have enough, I I think, clarity today to give you to give you that specificity, but, I’m hoping to have it right over the next couple of weeks. You know, when we report our second quarter, I’d like to be able to to give a little bit more directional guidance on on where we think, you know, the second half revenue could could land or or or, you know, put put, you know, folks in a ballpark.

Greg Brenza, Biotech Equity Research Analyst, RBC: Great. And maybe just just in closing, we think about the the financial structure of the company. Spend some time just talking about your cash position and Mhmm. And and just the cost structure with with respect to the the the partnerships and with respect to the spend to

Greg Brenza, Biotech Equity Research Analyst, RBC: Yep.

Greg Brenza, Biotech Equity Research Analyst, RBC: To really grow and get to to that maintain that cash flow positivity.

Joe Tobisco, CEO, CorMedix: Yeah. Look. We operate the business on a pretty s g and a light structure compared, I think, to other similar sized companies, especially going through launch. Right? So the the footprint, even with the new inpatient field team, is relatively modest.

We’ve got about 30, you know, all in 30 key account managers and directors, that are out in the field. On the outpatient, side, it’s it’s an even smaller team. Right? A lot of the because of the concentration of the customer base, we’ve got a handful of got some inside sales folks, and we’ve got some key account managers focused on small accounts. Excuse me.

The larger accounts, right, we handle more at the executive level, right, in terms of in terms of those negotiations. So from an SG and A spend standpoint, I I don’t expect any, you know, material increases over time with with SG and A for the commercialization of of DefenCath. R and D spend is gonna take up a little bit. We’ve talked about, you know, we the TPN study is gonna be, you know, $1,214,000,000 dollars over over the cost course of the study. But, you know, for the most part, you know, it’s a we’ve, you know, we’ve guided what our what our what our full year cash s g and a spend should be, and I I don’t expect any significant deviation in 2026 either.

Should be largely in line.

Greg Brenza, Biotech Equity Research Analyst, RBC: Well, just in the last few minutes, wanna see if there are any questions from from the audience in New York.

Greg Brenza, Biotech Equity Research Analyst, RBC: One here.

Joe Tobisco, CEO, CorMedix: Oh, that’s an interesting question. Look. I think any data that that supports certainly, if it shows higher efficacy, right, I think that that’s beneficial, that we would certainly look to, you know, to to loop that into into into the conversation. You know, we we we know we say, obviously, right, a catheter is a catheter. I think that that, you know, we certainly view that.

What we’d also like to be able to to do with that data, I think, longer term is a broader conversation with the FDA. Right? That combined with our expanded access excuse me. Sorry. Where, you know, we’ve got a a number of disease states where we’re gonna be tracking data to to go to excuse me.

Sorry. Sorry. To go to FDA and, seek a broader broader label indication.

Greg Brenza, Biotech Equity Research Analyst, RBC: Right. Sorry.

Greg Brenza, Biotech Equity Research Analyst, RBC: Oh, wow. Sorry. Any any other questions One more?

Joe Tobisco, CEO, CorMedix: Well, look. I mean, infections happen pretty fast. Right? For the most part, data shows that about fifty percent of CRBSIs happen the first thirty days patient has a catheter. So so they can happen quickly.

Typically, they get diagnosed at the hospital. Patient presents to the hospital, gets diagnosed. Average length length of stay, I think, is around two weeks usually, with a very high recurrence rate. Recurrence rates are over seventy two percent. So, you know, my thought is within you know, we haven’t decided whether to do an interim look into the into the real world evidence study, but I would think or I’m hopeful a year of of data might be sufficient, to show the meaningful impact that we’re looking for.

Greg Brenza, Biotech Equity Research Analyst, RBC: Looks like we’re just just popping up on on time. Joe, really appreciate it. Thanks for for for the update. Lots of exciting, developments with DefenCath, and look forward to the progress.

Joe Tobisco, CEO, CorMedix: Thank you so much. I really appreciate it.

Greg Brenza, Biotech Equity Research Analyst, RBC: Thank you.

Joe Tobisco, CEO, CorMedix: Apologies.

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