CorMedix at Jefferies Healthcare: Strategic Expansion and Financial Growth

On Thursday, 05 June 2025, CorMedix Inc. (NASDAQ:CRMD) presented at the Jefferies Global Healthcare Conference 2025, outlining its strategic initiatives and financial achievements. The company highlighted the successful commercialization of its product, DefenCath, while also addressing future market expansion and ongoing clinical trials. Despite positive financial growth, challenges remain in capturing a broader market share.

Key Takeaways

• CorMedix launched DefenCath, an FDA-approved catheter lock solution, with a soft launch in April 2024 and a full-scale launch in July 2024.
• The company reported $39 million in net revenue and over $23 million in adjusted EBITDA for Q1 2025.
• DefenCath is currently used by over 4,000 patients, with agreements in place with four of the top five outpatient dialysis operators.
• CorMedix anticipates approximately $70 million in revenue for the first half of 2025 from existing purchasing customers.
• Plans are underway to expand DefenCath’s indication to total parenteral nutrition (TPN) and initiate a pediatric hemodialysis study.

Financial Results

• Q1 2025 Net Revenue: $39 million
• Q1 2025 Adjusted EBITDA: Over $23 million
• H1 2025 Revenue Guidance: Approximately $70 million
• Full-Year Operating Expense Guidance: $72 million to $78 million
• Cash Position: Over $77 million at the end of the last quarter
• Market Cap: $850 million

Operational Updates

• Commercial Launch and Market Penetration:

- Soft Launch: April 2024

- Full-Scale Launch: July 2024

- Agreements with top outpatient dialysis operators

- DefenCath used in over 4,000 patients

• Inpatient Expansion:

- Established a dedicated inpatient field team in early 2025

- Partnership with WSI to target VA facilities

• Expanded Access Program:

- Collecting data on high-risk populations, including pediatric TPN and oncology patients

Future Outlook

• Clinical Trials and Expansion:

- Phase 3 TPN trial commenced, targeting NDA filing by end of 2026

- Pediatric hemodialysis study expected to commence later this year

• Market Opportunity:

- Outpatient Hemodialysis: Estimated market of 40 million vials

- TPN Market: Estimated at 10 million vials with peak sales potential of $150 to $200 million

CorMedix’s presentation at the Jefferies Global Healthcare Conference 2025 provides a comprehensive overview of its strategic direction and financial health. Readers are encouraged to refer to the full transcript for more detailed insights.

Full transcript - Jefferies Global Healthcare Conference 2025:

Unidentified speaker: Good? Alright. Hi, everybody. Try and squeeze in and find a seat where you can. Just a quick look at our forward looking statements.

So who is CorMedix? Alright. We are a publicly traded, small cap, commercial stage biotech company, in the process of commercializing our lead product, DefenCath. DefenCath is an FDA approved, first in class, non antibiotic antimicrobial catheter lock solution initially indicated to reduce the incidence of catheter related bloodstream infections in the limited population of adult hemodialysis patients receiving chronic hemodialysis through a central venous catheter. The product was approved in late twenty twenty three.

We began commercialization with a soft launch in April of twenty four and a full scale launch in July of twenty twenty four. And we’re in the process of building the business and we’ve given our first half revenue guidance for this year of around $70,000,000 of net sales from existing purchasing customers. We’ve also recently commenced a phase three clinical trial for an expanded indication in total parenteral nutrition. First patient in for that study dosed just this past month. It is a relatively small study, less than 150 patients.

Twelve month study end to end. We’re hoping to run it in around eighteen months and file our NDA by the end of twenty six or beginning of twenty twenty seven. So in terms of our commercial launch, I do believe our commercial launch has gone incredibly well. In terms of the market opportunity for DefenCath, it spans two settings of care currently. The first or largest from a volume standpoint is in outpatient hemodialysis.

The other is on the hospital inpatient side. In outpatient hemodialysis, we have very concentrated customer base. The top five customers represent just under 90% of the market. We currently have agreements in place with four of the top five outpatient dialysis operators and have begun implementing with three of them, those being the mid size operators. We have an agreement signed with one large dialysis operator and we are optimistic of beginning implementation in patients in the middle of twenty twenty five.

Currently DefendCath is being used in more than 4,000 patients across our existing customer base. Largely on the outpatient hemodialysis side, but we are beginning to see utilization ramp up on the inpatient side as we recently rolled out a dedicated inpatient field team in the beginning of twenty twenty five. And we anticipate continued upward growth in the setting of care over the next few years. CorMedix has a deep and experienced leadership team. Many of us have decades of experience across, several different, therapeutic areas in pharma.

And I am joined, here today by our CFO, Doctor. Matt David. So let’s talk a little bit about the problem of CRBSI specifically within the ESRD community or the dialysis community. In ESRD, about eight hundred thousand patients are receiving hemodialysis every year. Eighty percent of those patients start with a catheter for vascular access.

About twenty five percent of those patients are going to remain on a catheter for vascular access until they ultimately qualify for an organ transplant. On the hospital side, acute kidney injury patients also receive hemodialysis when hospitalized. Incidence of AKI is around five million admissions per year. But a smaller percentage of those, about ten percent of those receive inpatient hemodialysis while they are hospitalized. In terms of CRBSI’s, catheter related blood sugar infections are one of the most debilitating side effects you can get or that is associated with getting hemodialysis through a CVC.

They happen incredibly often. About twenty five to thirty three percent of patients will get a bloodstream infection. Half of them occur within the first three months that a catheter is inserted. They lead to double the number of hospitalizations, four times the hospitalization, four times length of hospital stay, and double the length of hospitalization, double the hospitalization cost. Apologies.

I think most troubling though, a patient with a CRBSI is three times more likely to die than a patient without a CRBSI. If you look at these Kaplan Meier curves and you can see how quickly they separate from each other, it really is a compelling unmet medical need in the ESRD space. CRBSIs are the second leading cause of death in the HDCVC community after ESRD itself. As I said, about fifteen to twenty five percent of the patients that get a CRBSI ultimately will die from them. In addition to the patient mortality risk, it’s a tremendous impact on the health care system from a cost standpoint.

Each hospitalization can cost upwards of $60,000 or more. The federal government itself or the health care system itself, most of which is Medicare, spends about 3 and a half billion dollars a year on the hospitalizations and downward costs associated with CRBSIs. So let’s talk a little bit about our solution and what it is. Right? So DefenCath, it’s a combination of Tyrolidine and heparin.

Tyrolidine being a non antibiotic antimicrobial that has broad spectrum activity, a gram positive and gram negative bacteria as well as fungus. But it is not an antibiotic and has not demonstrated any antimicrobial resistance. It is combined with heparin, right, and it’s as a catheter lock solution. It’s instilled into the catheter in between times that a catheter is accessed. From a clinical trial standpoint, our lock at 100 study is the largest study ever run for a catheter lock solution.

Just under eight hundred patients. The study demonstrated a seventy one percent reduction in risk associated with CRBSI. And I think as impressive as the efficacy from a safety standpoint, no material difference in adverse events compared to the standard of care in this study which was locking with heparin. From a market opportunity standpoint, as I mentioned before, the product currently spans two settings of care where it’s predominantly used. The first is on the outpatient dialysis side, where as I mentioned, five dialysis operators make up approximately 90% of the market opportunity.

This is a sizable market opportunity. We believe about 40,000,000 vials of DefenCath make up the total addressable market. We’re just under 40. Other setting of care is on the inpatient side where inpatient hospitals perform about, overall about ten percent of the volume of dialysis treatments split between end stage renal disease patients that need to be dialyzed when they go into the hospital Or acute kidney injury patients who are crash landing into the hospital and need to be dialyzed. From a commercial execution standpoint, as I mentioned, I believe our launch is going incredibly well.

We commenced the soft launch in April of last year and a full scale launch, in July. We are very much an s g and a light, in my view, platform. On the outpatient side, our sales team is comprised of a handful predominantly market access and contract related sales people. On the inpatient side, we have recently built a dedicated inpatient field team. Currently 28 field based professionals are calling on roughly eight seventy five facilities.

Those eight seventy five facilities represent about 80% of the market opportunity that we see for DefenCath. We also recently announced a partnership with WSI to bring in six key account managers to call on VA facilities. Which we believe could be a meaningful opportunity for DefenCath growth as well. We’re currently in the midst of, as I mentioned earlier, looking to expand DefenCath to other therapeutic indications. The first of which is in total parenteral nutrition.

Patients that typically receive IV nutrition through a central venous catheter have very high rates of infection. And those infections also often lead to increased mortality. In addition to the study, we’ve recently kicked off in TPN. Later this year, we expect to kick off a pediatric study in pediatric hemodialysis. We expect that study to span a couple of years.

We’ve also recently stood up an expanded access program. So beyond adult TPM which is in our phase three study, in our expanded access we expect to collect data on high risk populations such as pediatric TPM, peritoneal dialysis patients, neutropenic oncology patients, and other patients that are at high risk for infection and have exhausted other options for infection mitigation. Turning back to TPN, as I mentioned, incredibly high infection rate. Approximately twenty five, twenty six percent of patients will incur a CRBSI or a CLABSI, a central line associated bloodstream infection in this condition, which also lead to higher rate of mortality. Twelve to twenty five percent.

In addition, TBN increases the risk for fungal infection which is a much higher rate of mortality of greater than thirty percent. And it’s important to note at this point that DefenCath, in addition to having activity against gram positive and gram negative bacteria, is also active against multiple strains of fungus. Most notably C. Auris, which is one of the most lethal strains of fungus. In terms of the total addressable market for TPN, we have sized the market at just under 5,000,000 infusions a year, which we believe approximates to about 10,000,000 vials of DefenCath three milliliter.

We’ve also put out public guidance around the dollar size of the total addressable market. We see between 507 hundred $50,000,000. And we believe the peak annual sales potential for DefenCath in this market is a hundred and 50 to $200,000,000 a year. Just a quick look at our financial metrics. Currently based on today’s or last week’s closing stock price, fully diluted market cap around $850,000,000.

We closed last quarter with just over $77,000,000 in cash on the balance sheet. We obtained cash flow positivity late in the fourth quarter. We’re cash flow positive for the first quarter of twenty twenty five. Reported first quarter twenty five net revenue of $39,000,000 and first quarter adjusted EBITDA of just over $23,000,000. We’ve guided first half of this year revenue, as I mentioned, to about $70,000,000 and that’s from existing purchasing customers.

And we’ve given full year operating expense, cash operating expense guidance of 72 to $78,000,000. Relatively short presentation today. I’m happy to take questions from the audience. Going once. Alright.

Well thank you everybody. I appreciate your time. And I appreciate your interest in CorMedix. Thank you.

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