CorMedix (NASDAQ:CRMD) reported lower third-quarter revenue as its DefenCath product entered a new reimbursement period, while management outlined plans to acquire substantially all of Heron Therapeutics’ assets and deferred 2027 guidance for the dialysis treatment.
Revenue fell to $54.5 million from $104.3 million a year earlier, and the company reported a net loss of $14.7 million, or $0.19 per share, compared with net income of $108.6 million in the prior-year quarter. Adjusted EBITDA declined to $3.1 million from $71.9 million.
Chairman and CEO Joe Todisco said the company’s largest dialysis customers largely maintained DefenCath utilization during the quarter despite a lower reimbursement add-on. CorMedix reaffirmed its 2026 revenue outlook of $325 million to $345 million and narrowed its adjusted EBITDA guidance to $130 million to $140 million, at the upper end of its prior range.
DefenCath reimbursement and 2027 outlook
DefenCath net sales were $17.2 million in the third quarter. CFO Susan Blum said the year-over-year decline in product revenue primarily reflected lower net pricing after DefenCath transitioned on July 1 to the post-TDAPA reimbursement period.
The quarterly figure included a $5 million favorable adjustment to estimates for Medicaid rebates and product returns. CorMedix excluded that adjustment from its adjusted EBITDA calculation. Asked whether roughly $12 million was an appropriate sales base for the fourth quarter, Todisco said it was tentatively the right way to look at it, though sales could be slightly higher.
The Centers for Medicare and Medicaid Services set an $8.32 post-TDAPA add-on payment for the first quarter of 2027 and adopted a methodology under which the payment will be reset quarterly. Todisco said CorMedix expects the full-year average to be below $8.32 but at least twice the current $2.37 rate. Management also expects each quarter’s add-on to exceed the current rate, subject to how CMS applies its methodology.
Todisco said the company expects the add-on to decline from the first quarter to the second, with a higher rate in the third and/or fourth quarter. He cautioned that outside projections of the quarterly path carry significant uncertainty because the calculations incorporate pricing and utilization data that CorMedix reports to CMS.
CorMedix is discussing pricing with customers to track the quarterly adjustments and is pursuing separate payment agreements with Medicare Advantage plans. Todisco said the company needs greater visibility into customer pricing, fee-for-service utilization and potential Medicare Advantage uptake before providing 2027 DefenCath guidance. It expects to update investors in early 2027.
Heron deal targets diversification
CorMedix expects its proposed acquisition of substantially all of Heron’s assets to close in the first quarter of 2027, subject to Heron stockholder approval, regulatory clearance and other customary conditions. Todisco said the transaction would diversify CorMedix’s revenue across acute care and hematology/oncology supportive care and reduce its reliance on DefenCath.
The Heron portfolio generated approximately $150 million in net product revenue over the trailing 12 months, and CorMedix expects the acquired products to contribute $125 million to $150 million in pro forma 2027 revenue. The company also projects $45 million to $60 million in annualized operating cost synergies by the end of 2027.
Up to $55 million of the transaction consideration depends on ZYNRELEF achieving 2028 net sales milestones. Todisco said additional contingent payments include a royalty above a sales threshold for CINVANTI, SUSTOL and products launched under a multi-product development agreement.
Pipeline and financial position
The Food and Drug Administration accepted a supplemental application for REZZAYO to prevent invasive fungal disease in certain adult bone marrow transplant patients, granting it priority review with a target action date in the first quarter of 2027. Todisco said CorMedix would expect to begin promotional efforts for the new indication in the second half of 2027 if it is approved.
Enrollment in a phase 3 study of DefenCath in total parenteral nutrition patients remains substantially behind the original timeline. Todisco said CorMedix is evaluating potential alternative pathways with the FDA if enrollment does not accelerate in the next one to two months and expects to decide on a strategy before its next quarterly update.
Blum noted that year-over-year comparisons were affected by the Melinta acquisition, which closed in August 2025: The latest quarter included three months of Melinta operations, versus one month a year earlier. CorMedix ended the quarter with $355.2 million in cash and cash equivalents and lowered and narrowed its full-year operating expense guidance to $140 million to $145 million, excluding non-cash items such as stock-based compensation.
About CorMedix (NASDAQ:CRMD)
CorMedix Inc. is a biopharmaceutical company focused on products for infectious and inflammatory diseases. Its lead product, DefenCath, is an antimicrobial catheter-lock solution containing taurolidine and heparin. The U.S. Food and Drug Administration approved it to reduce catheter-related bloodstream infections in adults with kidney failure who receive chronic hemodialysis through a central venous catheter. CorMedix expanded its business in 2024 by acquiring Melinta Therapeutics, adding marketed antibiotics to its portfolio.
