CorMedix (NASDAQ:CRMD) reported second-quarter 2026 consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million, while reaffirming its full-year revenue outlook and raising adjusted EBITDA guidance. The company also said it signed a multiyear commercial supply agreement for DefenCath with an additional large dialysis organization, giving it supply agreements with each of the five largest U.S. dialysis providers.
Chairman and Chief Executive Officer Joseph Todisco said the newly signed dialysis organization has placed an initial order and is expected to begin a DefenCath pilot during the third quarter. The pilot could expand in 2027, though management said it was too early to provide detailed expectations for next year.
DefenCath Trends Following TDAPA Transition
CorMedix said DefenCath order volumes in July were consistent with pricing under the 2026 post-TDAPA reimbursement environment. In some cases, the company said it has pricing and volume commitments extending into 2027, intended to help keep patients on therapy during the reimbursement transition.
Todisco told analysts that July volumes had stabilized among larger dialysis providers, while the company had seen some expected attrition among smaller providers. He said meaningful DefenCath volume growth could come from adoption by the newly contracted dialysis organization or through Medicare Advantage contracting.
The company said it is continuing to devote resources to Medicare Advantage discussions, but it has not included any contribution from Medicare Advantage in its 2026 guidance. Todisco said the contracting process can take time, though management is cautiously optimistic that agreements could begin to affect volumes early next year.
Management also said it expects additional real-world evidence related to DefenCath to be presented during the fourth quarter, assuming submitted abstracts are accepted by the American Society of Nephrology’s Kidney Week and IDWeek. Liz Hurlburt, CorMedix’s chief operating and commercial officer, said the expected presentations include data on catheter-related bloodstream infections, the use of DefenCath with chlorhexidine antimicrobial caps, and clinical and economic outcomes related to reduced tPA use in outpatient hemodialysis facilities.
Second-Quarter Financial Results and Outlook
Revenue for the quarter rose from $39.7 million in the second quarter of 2025. The 2026 total included $66.1 million in DefenCath sales and $35.8 million from the acquired Melinta portfolio. Chief Financial Officer Susan Blum noted that year-over-year comparisons reflect the inclusion of a full quarter of Melinta operations in 2026, while the acquisition had not yet closed during the comparable period a year earlier.
- Operating expenses were $34.2 million, compared with $18.3 million a year earlier.
- Research and development expense was $6.7 million, up from $2.4 million.
- Selling and marketing expense increased to $12.4 million from $6.4 million.
- General and administrative expense increased to $15.1 million from $9.5 million.
- Net income was $26.0 million, or $0.33 per basic share and $0.29 per diluted share, compared with $19.8 million a year earlier.
- The company ended the quarter with $256.7 million in cash and cash equivalents.
Blum said second-quarter general and administrative expense included $4.2 million in insurance reimbursements related to legal fees, including $2.7 million associated with costs incurred in prior periods. She said the reimbursement made the reported expense level appear lower than the underlying run rate.
CorMedix reaffirmed full-year 2026 consolidated revenue guidance of $325 million to $345 million, including DefenCath revenue of $175 million to $195 million. The company raised its adjusted EBITDA outlook to $125 million to $140 million. It also narrowed cash operating expense guidance to $145 million to $155 million.
REZZAYO Filing Planned for Third Quarter
CorMedix said it expects its partner, Mundipharma, to submit a supplemental new drug application during the third quarter for REZZAYO as prophylaxis for invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and marrow transplant.
The planned filing follows preliminary top-line results from the Phase III ReSPECT trial, which met its primary endpoint of fungal-free survival at day 90 by demonstrating non-inferiority to the standard antifungal regimen. Hurlburt said the study also showed a favorable profile across secondary endpoints, including treatment-emergent adverse events that led to dose reduction, interruption or withdrawal of study drugs, and study discontinuation.
CorMedix said that, assuming a timely submission and FDA acceptance, it anticipates potential agency action in the first half of 2027. The company expects to add 15 to 20 commercial and medical positions during the second half of 2026 as it prepares for a potential launch. Those planned investments are included in its cash operating expense outlook.
Management said detailed ReSPECT data are expected to be presented at one or more medical conferences in the fourth quarter. Todisco said the company has not yet conducted robust market research with potential prescribers because the full data set has not been released.
DefenCath TPN Study Continues
CorMedix also provided an update on its Phase III study of DefenCath in total parenteral nutrition. Hurlburt said the company submitted a protocol amendment to the FDA that narrows certain exclusion criteria and has activated additional trial sites. The company continues to expect completion of the study in 2028.
Todisco said CorMedix generated $277.8 million of adjusted EBITDA over the trailing 12 months and had $267 million of combined cash and investments at quarter-end, positioning the company to fund pipeline development and pursue business-development opportunities.
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.
