CorMedix Eyes REZZAYO Expansion as DefenCath Reimbursement Shift Looms

Key Points

• CorMedix sees a potential expansion of REZZAYO into fungal infection prophylaxis, with preliminary data showing comparable efficacy to standard of care and possible safety advantages versus existing antifungal regimens.
• The company plans to pursue a broader FDA label and move toward an sNDA submission in the second half of the year, while also preparing commercially with added staff and new physician stakeholders if the launch proceeds.
• DefenCath faces a major reimbursement change on June 30 as CMS shifts from TDAPA to a bundled model, and CorMedix is working to preserve utilization with customers while also pushing policy changes and longer-term pricing improvements.

CorMedix NASDAQ: CRMD CEO Joe said the company is preparing for several potential commercial and regulatory catalysts across its infectious disease and dialysis-related portfolio, including a possible expansion of REZZAYO into fungal infection prophylaxis and continued work to sustain DefenCath utilization through changes in federal reimbursement.

Speaking at a company event, Joe said CorMedix was “very excited” by preliminary top-line data for REZZAYO in the prophylactic setting. The study evaluated REZZAYO head-to-head against a standard-of-care regimen for preventing fungal infections in patients undergoing allogeneic bone marrow transplant.

REZZAYO Prophylaxis Data and Regulatory Plans

Joe said the company had disclosed only a limited number of data points so far, with a fuller data package expected “in the coming weeks.” He said the data showed what CorMedix had hoped to see: comparable efficacy to standard of care, along with secondary safety endpoints that could help differentiate the product.

He cited potential areas of differentiation including discontinuations and drug-drug interactions, noting that current antifungal prophylaxis regimens such as posaconazole or fluconazole carry known safety risks, including hepatotoxicity and interactions with other medicines used in these patients.

Joe said the ultimate market opportunity will depend on the FDA-approved label. CorMedix plans to seek a broad label that includes prevention against Candida, Aspergillus and Pneumocystis, and one that is not limited only to bone marrow transplant patients.

The REZZAYO asset came to CorMedix through its acquisition of Melinta. Joe said Mundipharma currently holds ex-U.S. marketing rights, global rights to the intellectual property and control of the NDA submission. Under the agreement, the NDA would transfer to CorMedix control upon approval of a prophylaxis supplemental NDA.

Joe said the next step is a pre-NDA meeting with the FDA, followed by work toward an sNDA submission in the second half of the year. Mundipharma also plans to submit in Europe, he said.

Commercial Preparation for REZZAYO

CorMedix is preparing for a potential prophylaxis launch with what Joe described as a “modest ramp” in operating expenses that remains within the company’s previously stated guidance. He said the company expects to add roughly 15 to 20 incremental employees, likely split between commercial and medical roles.

Some changes will involve redeploying existing employees to different call panels or roles. Joe said the prophylaxis opportunity involves new stakeholders, including hematologists and bone marrow transplant specialists, while infectious disease physicians remain important.

Asked whether the prophylaxis data could have a halo effect on REZZAYO’s current treatment business, Joe said it was possible but premature to assess. He said CorMedix has also changed some tactics for promoting REZZAYO in treatment and expects those efforts to yield growth in the back part of the year.

Melinta Portfolio and Other Products

Joe said other products acquired with Melinta continue to play a role in the company’s business. He pointed to MINOCIN and VABOMERE as brands generating low single-digit growth with minimal direct sales and marketing expense, saying they remain entrenched in hospital treatment algorithms.

He said KIMYRSA and ORBACTIV are expected to contract this year because DALVANCE, another long-acting drug in the class, went generic at the end of last year. Joe said CorMedix sees an opportunity for a promotional relaunch of KIMYRSA in infusion clinics once that generic-related pressure dissipates, with potential growth in the back part of next year.

DefenCath Volumes, Reimbursement and Real-World Evidence

Joe said CorMedix was pleased to increase its DefenCath guidance following earnings, citing an accrual adjustment and increased utilization from the fourth quarter to the first quarter among some of the company’s largest customers.

He said a key issue for DefenCath is the upcoming June 30 change in CMS reimbursement, when the first two years of TDAPA give way to a bundled approach in the third year. Joe said the bundled adjustment for the third and fourth quarters is not commensurate with current utilization levels, and CorMedix is working with customers to keep patients on therapy through the back half of the year.

Joe said the company expects a higher CMS bundle adjustment in 2027 based on the agency’s methodology, which could allow for better net pricing and potentially more DefenCath revenue. He said CorMedix has guided that the 2027 add-on could rise by roughly 3x to 5x from current levels.

CorMedix’s DefenCath business is highly concentrated, with the top three customers accounting for about 93% to 95% of business, Joe said. He said discussions with those customers have focused on the price point needed to keep the product in use.

Joe also said discussions with another large potential customer remain constructive, and that the company is “cautiously optimistic” they could lead to some utilization.

On Medicare Advantage, Joe said CorMedix is pursuing a strategy to contract outside of the bundle, beginning with the top five plans. He said receptivity has been strong regarding DefenCath’s clinical and pharmacoeconomic benefit, though discussions are now centered on how to operationalize agreements among CorMedix, Medicare Advantage plans and dialysis operators.

Additional real-world evidence is expected, Joe said. U.S. Renal is expected to provide final data later this year and publish additional analysis on DefenCath’s economic impact. Joe also cited data from IRC showing more than a 90% decrease in infections in clinics using DefenCath, and noted that Fresenius discussed DefenCath’s clinical impact on its recent earnings call.

Policy Efforts and Pipeline Opportunities

Joe said he has spent significant time in Washington, D.C., meeting with lawmakers, staff and committee leadership about reimbursement policy in end-stage renal disease. He said there has been bipartisan agreement that the current system is not working and that reforms are needed to encourage innovation.

He said CorMedix is also engaging with CMS staff through the rulemaking process and is hopeful for changes to the TDAPA system, either this year or next year.

Beyond its current indications, CorMedix is studying DefenCath in total parenteral nutrition, where Joe said bloodstream infections are common and there is no FDA-approved product to reduce or prevent them. He reiterated a previously discussed total addressable market estimate of roughly $500 million to $750 million, while noting that clinical trial enrollment has been challenging and that the company is amending exclusion criteria to broaden the eligible patient pool.

Joe also discussed CorMedix’s option on a Talphera asset used in continuous renal replacement therapy. He said the product is highly synergistic with CorMedix’s hospital call point and could offer hospitals savings by reducing the need for costly filter changes. CorMedix will conduct more complete diligence after study data are available, he said.

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.

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