CorMedix (NASDAQ:CRMD) Chief Executive Officer Joseph Todisco told attendees at the Leerink Global Healthcare Conference that the company has undergone a significant shift over the last year, moving from what he described as a “single product company” to a diversified specialty pharmaceutical business focused on institutional settings of care following its 2025 acquisition of Melinta.
Todisco said CorMedix is now centered on largely injectable therapies used in hospitals and clinics, with a portfolio that is “largely anti-infective” today. Rather than focusing on a single therapeutic area, he said the company aims to leverage its commercial infrastructure across multiple specialties that share similar sites of care, including hospitals and infusion clinics.
DefenCath adoption and the TDAPA transition
Much of the near-term focus, Todisco said, is navigating the end of DefenCath’s Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement window on June 30. TDAPA provides a two-year “buy and bill” reimbursement period before the therapy becomes bundled under CMS payments. Todisco said CorMedix is working with customers to preserve utilization through the transition, with a goal of stabilizing patient continuity into 2027.
He said the company has been using the U.S. Renal Care real-world evidence and other unpublished data in discussions with Medicare Advantage (MA) plans, which he characterized as the “future largest market opportunity” for utilization growth. Todisco said the company is seeking separate reimbursement from MA plans outside the bundled system, arguing that MA payers bear the total cost of care and are therefore incentivized to invest in prevention. He said he hopes to show progress over the course of the year and provide updates to shareholders.
Inpatient dialysis opportunity and contracting approach
On DefenCath’s inpatient opportunity, Todisco said CorMedix launched an inpatient field team early last year and began to see some uptake, but integration work tied to the Melinta transaction temporarily reset those efforts. He said the legacy Melinta field team has now been trained on DefenCath and will be calling on inpatient institutions.
Todisco characterized inpatient dialysis as a smaller volume opportunity—about 10% of dialysis volume—with roughly two-thirds of that tied to acute kidney injury patients who “crash land into the hospital” and are more likely to have temporary catheters that can become infected at higher rates.
On contracting with dialysis operators during the TDAPA transition, Todisco said agreements were structured to account for periods when bundled adjustments may not fully capture DefenCath expenditures. He said CorMedix is working through contract amendments and is seeking to align pricing for the third and fourth quarters and for 2027 based on expected bundled adjustments. He said it is too early to provide an update on Medicare Advantage contracting progress.
REZZAYO Phase 3 prophylaxis data expected in Q2
Todisco also discussed the company’s development-stage catalyst for REZZAYO (rezafungin), describing it as a long-acting echinocandin dosed once weekly by IV and currently indicated for treatment of Candida infections. He said the current addressable market is “fairly modest,” which he estimated at $250 million to $350 million, and that much of today’s utilization is inpatient.
The larger opportunity, he said, is a potential prophylaxis indication. CorMedix expects Phase 3 data from the ReSPECT study in the second quarter, with Todisco pointing to a mid-to-late second quarter timing. The trial, run by global partner Mundipharma (which acquired original developer Cidara), is a 650-patient head-to-head non-inferiority study versus standard of care, with a primary endpoint of fungal-free survival at day 90 and a secondary endpoint focused on discontinuation rates.
Todisco said the standard prophylaxis regimen typically includes an azole (posaconazole or fluconazole) plus Bactrim, and noted known concerns with azoles such as hepatotoxicity and drug-drug interactions that can interfere with chemotherapy regimens. He said he will be watching not only whether the study meets the primary endpoint, but also whether REZZAYO shows differentiation on discontinuation and how outcomes look by pathogen, including Candida, Aspergillus, and Pneumocystis. He cited preclinical activity against Aspergillus as a potentially important feature, given that some echinocandins lack activity against that pathogen.
If data are positive, Todisco said CorMedix would augment its capabilities with what he described as a modest build—potentially 15 to 20 additional hires—adding expertise in bone marrow transplant and hematology/oncology centers across commercial and medical functions. He said the company is already receiving inbound interest in investigator-initiated trials (IITs). Assuming a supplemental NDA filing in the third quarter, he said the company would work toward a first-quarter 2027 launch timeframe, though he suggested adoption could begin earlier as physicians see the data and medical education expands.
DefenCath in TPN: Phase 3 trial targeting early 2027 completion
Todisco also outlined a second Phase 3 program: DefenCath for prevention of central line-associated bloodstream infections (CLABSI) in patients receiving total parenteral nutrition (TPN). He said CorMedix has previously discussed a $500 million to $750 million market opportunity and emphasized high infection and mortality rates in this population. Unlike hemodialysis, he said TPN would not involve an add-on payment or bundled reimbursement system, with CorMedix market research suggesting reimbursement would be predominantly Medicare Part B and commercial outpatient coverage, including in the home setting.
He described the TPN study as an adaptive trial with a minimum of 90 patients and a maximum of 200, with a 2:1 randomization to DefenCath versus comparator. An interim analysis is planned after 15 cumulative infections; depending on the infection ratio between arms, the FDA could allow completion at the 90-patient level or require continued enrollment toward 200 patients. Todisco said CorMedix is targeting completion in early 2027 and noted that enrollment has been slower than originally forecast due to inclusion and exclusion criteria, despite early interest from the TPN community and ongoing requests for patient access.
Cash position, buyback, and tuck-in business development
On capital allocation, Todisco said CorMedix ended last year with about $150 million in cash and $150 million of debt, which he characterized as “zero net debt essentially.” He said the company expects to be cash-flow generating through 2026.
Todisco said CorMedix is not looking to fund another transformational deal with equity and is “not looking to do anything dilutive,” instead focusing on tuck-in opportunities that fit the current sales deployment and could be funded with existing debt and additional debt capacity. He also noted the board approved a $70 million stock repurchase program, which he said the company has begun executing and expects to remain active on throughout the year.
In closing remarks, Todisco said he believes the public market is undervaluing CorMedix, pointing to what he described as a roughly 4.5x forward EBITDA valuation compared to peer ranges he cited of 9x to 14x. He suggested investors may be waiting for REZZAYO prophylaxis data and may not be assigning sufficient value to REZZAYO’s prophylaxis opportunity or to DefenCath’s TPN program, while also questioning whether DefenCath’s 2027 revenue expectations will materialize.
About CorMedix (NASDAQ:CRMD)
CorMedix Inc is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to reduce inflammation and prevent infection in critically and chronically ill patient populations. The company’s lead product candidate, Neutrolin, is a catheter lock solution that combines taurolidine, heparin and citrate to prevent catheter-related bloodstream infections (CRBSIs) in patients undergoing hemodialysis. Neutrolin has received market authorization in the European Union under the CE Mark and is positioned to address a significant unmet medical need for infection prevention in dialysis centers.
In addition to its lead asset, CorMedix is advancing a biochemical portfolio aimed at mitigating complications associated with peritoneal dialysis and other high-risk procedures.
