CorMedix NASDAQ: CRMD reported sharply higher first-quarter 2026 revenue and profit, driven by continued adoption of DefenCath and the addition of products from its Melinta acquisition, while management raised its full-year financial outlook and outlined key pipeline developments.
Chairman and Chief Executive Officer Joseph Todisco said the company entered 2026 with “strong momentum” across its main priorities: growing DefenCath utilization, advancing pipeline opportunities and generating profitability and cash flow. CorMedix reported first-quarter net revenue of $127.4 million, compared with $39.1 million in the prior-year period. Adjusted EBITDA was $70 million, up from $23.6 million a year earlier.
CorMedix Raises 2026 Revenue and EBITDA Guidance
Following the first-quarter results, CorMedix increased its full-year 2026 net revenue guidance to a range of $325 million to $345 million, up from its prior outlook of $300 million to $320 million. The company also raised adjusted EBITDA guidance to $115 million to $135 million, compared with its previous range of $100 million to $125 million.
Todisco said the higher guidance reflects strong first-quarter execution and continued confidence in demand trends, while also accounting for expected variability in DefenCath sales in the second half of the year. That variability is tied to the expiration of DefenCath’s initial TDAPA reimbursement period and the transition to a post-TDAPA add-on reimbursement phase under the Centers for Medicare & Medicaid Services.
The company also raised its full-year DefenCath revenue guidance to $175 million to $195 million, from its earlier range of $150 million to $170 million. Todisco said the updated outlook is based on existing customer run rates and does not include potential upside from new customers or from successful contracting with Medicare Advantage plans.
During the question-and-answer portion of the call, Todisco said DefenCath utilization increased from the fourth quarter to the first quarter. He said most current DefenCath patients are in Medicare fee-for-service, which he described as “the overwhelming majority” and likely more than 90% of patients. He identified Medicare Advantage as a longer-term opportunity.
DefenCath Revenue Lifted by Demand and One-Time Benefit
Chief Financial Officer Susan Blum said first-quarter revenue included $97.5 million from DefenCath and $29.9 million from the Melinta portfolio. The year-over-year increase was driven primarily by sustained DefenCath demand, sales to the company’s largest dialysis customer onboarded in mid-2025, and the addition of Melinta revenue.
Blum said DefenCath sales in the quarter benefited from a non-recurring $9 million favorable change in estimate related to certain sales allowances, primarily Medicaid rebates and product returns. She added that net revenue still exceeded consensus expectations even excluding that adjustment.
Operating expenses totaled $41.5 million, including $7.2 million in research and development, $12.5 million in selling and marketing, and $21.7 million in general and administrative expenses. Blum attributed the year-over-year increase to the larger combined company, including higher personnel costs, expanded commercial and IT infrastructure, greater development activity across the portfolio, branded prescription fees and continued investment in DefenCath for the total parenteral nutrition indication.
CorMedix reported net income of $38.6 million, or $0.48 per basic share and $0.43 per diluted share, compared with net income of $20.6 million, or $0.32 per basic share and $0.30 per diluted share, in the first quarter of 2025. Blum said earnings per share were affected by approximately $25 million in non-operating expenses tied to routine quarterly mark-to-market adjustments for marketable equity securities and contingent consideration, as well as income tax expense under U.S. GAAP.
The company ended the quarter with $178.1 million in cash and cash equivalents, excluding restricted cash. CorMedix generated $42.4 million in cash from operating activities during the quarter and used $11.1 million to repurchase shares under its stock buyback program, resulting in a $33.3 million increase in cash during the period.
TDAPA Transition Expected to Affect DefenCath Sales Timing
Management said the second half of 2026 will reflect reimbursement changes after DefenCath’s initial TDAPA period expires on June 30. Todisco said the company expects a “significant increase” in the post-TDAPA add-on amount in 2027 compared with the second half of 2026, which would result in a higher net selling price per unit next year than current estimates for the third and fourth quarters of 2026.
For the third and fourth quarters, Todisco said the company’s main goal is to maintain or grow existing patient utilization heading into 2027. In response to an analyst question, he said the second quarter is effectively a “two-month quarter” because the company expects to take a shelf stock adjustment in June ahead of the July 1 pricing change. He said CorMedix is currently accruing for about four weeks of stock, which he said is typical for its largest customer, and expects second-quarter DefenCath revenue to be around $60 million, give or take a couple million.
Todisco also said the company is using real-world data and public comments from customers in discussions with Medicare Advantage plans. He cited U.S. Renal Care’s published real-world evidence, public information from IRC, and comments from Fresenius about DefenCath’s value in clinics.
REZZAYO Prophylaxis Data Supports Planned sNDA
Chief Operating Officer Liz Hurlburt reviewed preliminary top-line results from the ReSPECT study, a Phase 3 trial evaluating REZZAYO for prophylaxis of invasive fungal disease in adult immunosuppressed patients undergoing allogeneic bone and marrow transplant. The study met its FDA primary endpoint of fungal-free survival at day 90, demonstrating non-inferiority versus the standard antifungal regimen. Fungal-free survival was 60.7% for REZZAYO compared with 59% for the standard regimen.
Hurlburt said the top-line results showed comparable efficacy against invasive fungal infections from Candida, Aspergillus and Pneumocystis, as well as a favorable profile on several secondary endpoints, including treatment-emergent adverse events leading to dose reduction, interruption or withdrawal, and study discontinuation.
CorMedix and its global partner Mundipharma expect to hold a pre-NDA meeting with the FDA in the coming weeks and submit a supplemental new drug application in the second half of 2026. Todisco said the company is preparing for a potential commercial launch in 2027, including 15 to 20 additional employees across commercial and medical functions. The expected spending is included in the company’s 2026 cash operating expense guidance of $145 million to $160 million.
TPN Study Timeline Moves Toward 2028
Hurlburt said enrollment in the Phase 3 Nutri-Guard study of DefenCath in patients receiving total parenteral nutrition remains at about one-third of the 90 patients needed for an interim analysis. She said infections have been lower than pre-study estimates, affecting statistical projections for the trial timeline. Based on current enrollment and infection trends, study completion is now trending into 2028.
The company is seeking to accelerate the study by opening additional clinical sites and submitting a protocol amendment to the FDA that could broaden enrollment criteria if approved. Hurlburt said CorMedix is adding U.S. sites and expects five additional sites in Turkey to be activated over the next 45 days.
Todisco closed the call by saying DefenCath continues to exceed expectations despite the pending TDAPA expiration, while REZZAYO prophylaxis and DefenCath in TPN could expand the company’s long-term revenue opportunity. He said the company’s profitability and cash generation provide flexibility to reinvest in growth and repurchase shares.
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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