CorMedix (NASDAQ:CRMD) executives said 2025 was a “transformational” year, highlighted by DefenCath reaching peak sales of “just under $260 million,” the acquisition of Melinta Therapeutics, and the completion of targeted cost synergies by the fourth quarter. On the company’s fourth-quarter and full-year 2025 earnings call, management also reiterated its outlook for 2026 and provided initial guidance for 2027 as DefenCath transitions out of its Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement period in outpatient hemodialysis.
DefenCath reimbursement transition and guidance
Chief Executive Officer Joseph Todisco said the key near-term focus is DefenCath’s strategy in outpatient hemodialysis as TDAPA reimbursement transitions on July 1 from a buy-and-bill format to a bundled add-on mechanism. He said CorMedix has held “multiple conversations” with top customers and is finalizing supply pricing for the second half of 2026 as well as for 2027.
- 2026 DefenCath revenue: $150 million to $170 million
- 2027 DefenCath revenue: $100 million to $125 million
Management expects 2026 DefenCath revenue to be “front loaded” in the first half, with price erosion anticipated in the third and fourth quarters as the post-TDAPA dynamics take effect. Todisco also said that, assuming the Centers for Medicare & Medicaid Services (CMS) uses the same methodology to calculate the 2027 bundle adjustment, CorMedix expects a “meaningful increase” in traditional Medicare provider reimbursement in 2027, which the company expects to translate into a higher net selling price in 2027 compared with the second half of 2026.
Todisco said the company issued 2027 DefenCath guidance to provide a baseline based on existing patient utilization rates and current estimates for net selling prices, and that it does not include potential upside from new customers or Medicare Advantage contracting.
Melinta acquisition integration and portfolio commentary
CorMedix said it announced and closed the Melinta Therapeutics acquisition in the third quarter of 2025 and achieved its target synergy of $35 million during the fourth quarter. Todisco described the integration effort as a “monumental achievement” that reflects the organization’s operational execution.
On the call, management highlighted REZZAYO as a key growth asset, while pointing to MINOCIN and VABOMERE as durable inpatient products expected to provide a stable revenue base as the company works toward future growth opportunities. In the Q&A, Todisco said MINOCIN is “closing in at around $50 million in sales,” while VABOMERE is “just under $30 million.” He added that the company has “a little bit of promotional efforts” behind those products and expects “a couple percentage points of growth” in 2026, while noting the products are not “promotionally sensitive the way a launch product would be.”
Clinical and pipeline updates: REZZAYO prophylaxis and DefenCath in TPN
Chief Operating Officer Liz Hurlburt provided updates on two key development programs. For REZZAYO, CorMedix said enrollment for the global Phase III ReSPECT study in prophylaxis of fungal infections in adult allogeneic bone marrow transplant patients completed in September. The trial is being conducted by Mundipharma, and management said all sites have completed participation and a database lock is expected later this month. CorMedix said it expects to announce top-line ReSPECT data in the second quarter of 2026.
Hurlburt said top-line results are expected to include multiple endpoints and safety data, including:
- Primary efficacy outcome of fungal-free survival at day 90
- Discontinuation due to toxicity or intolerance
- All-cause mortality and attributable mortality with invasive fungal disease (as determined by the Data Review Committee)
- Cumulative incidence of invasive fungal disease at day 90 (by the Data Review Committee and by Azole CHOICE)
- Safety data including overall adverse events, treatment-emergent adverse events, and serious adverse events
In response to an analyst question on how the company might use the Phase III dataset, Todisco and Hurlburt said the commercial implications will depend in part on the pathogens observed in the top-line results, as well as discontinuation outcomes versus standard of care. Hurlburt said the company sees an opportunity to discuss with payers an option without the drug-drug interactions associated with azoles and other therapies, and she referenced the possibility of fewer hospitalizations and supporting patients staying on their anticancer regimens, while emphasizing that the approach will be “data dependent.”
For DefenCath’s expansion into Total Parenteral Nutrition (TPN), Hurlburt said the Phase III Nutriguard trial, evaluating prevention of central line-associated bloodstream infections (CLABSI) in adult TPN patients with central venous catheters, is approximately 30% enrolled toward a minimum target of 90 patients. CorMedix said it is working to increase enrollment rates in 2026 with new sites in Turkey, and it continues to anticipate study completion in early 2027. Hurlburt added the adaptive design allows 90 to 200 participants depending on CLABSI incidence, with an interim assessment after 15 participants have a CLABSI event.
Financial results: revenue growth, profitability, and cash generation
Chief Financial Officer Susan Blum said the fourth quarter of 2025 was the first full reporting period reflecting the Melinta acquisition, which closed on Aug. 29, 2025. For the fourth quarter, CorMedix reported net revenue of $128.6 million, driven by $91.2 million from DefenCath and $37.4 million from the Melinta portfolio. Blum compared that with net revenue of $31.2 million in the fourth quarter of 2024, which included only DefenCath.
On a pro forma basis for full-year 2025—including revenue for both the CorMedix and Melinta businesses—total revenue was $401.3 million, which Blum said was in line with previously established guidance. DefenCath generated $258.8 million in net sales for 2025.
Fourth-quarter operating expenses were $48.2 million, up from $17.1 million in the prior-year period, reflecting the combined organization’s cost structure, merger-related costs including severance, and increased investment in DefenCath expanded indications, including the Phase III TPN program. Blum also said headcount increased from about 100 employees a year ago to “just under 200” employees.
CorMedix reported fourth-quarter net income of $14 million, which Blum said was impacted by a $42.4 million tax expense that was “majority non-cash” related to utilization of deferred tax assets established in the third quarter of 2025. Pre-tax income for the quarter was $56.4 million, up $43 million year over year. Adjusted EBITDA for the fourth quarter was $77.2 million, which management said was within prior guidance and excluded one-time acquisition and reorganization costs, stock-based compensation, and tax benefits and expenses recognized during the year.
CorMedix ended the quarter with $148.5 million in cash, cash equivalents, and short-term investments, driven by “almost $100 million” of operating cash flow in the quarter and working capital optimization. In Q&A, management said Adjusted EBITDA can be a proxy for cash flow for the year, while noting potential 2026 impacts including inventory needs tied to technology transfers and payment of accrued rebates early in the year.
Looking ahead, CorMedix reaffirmed full-year 2026 financial guidance of $300 million to $320 million in revenue and Adjusted EBITDA of $100 million to $125 million. Todisco said the company is in active discussions with Medicare Advantage providers and potential new DefenCath customers in both inpatient and outpatient settings, and it will evaluate whether to update guidance as 2026 progresses.
Management also said it recently announced a share repurchase program and has been active repurchasing shares during the first quarter, with plans to continue subject to blackout periods, volume restrictions, and other business needs.
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.
