CorMedix pulls 2027 DefenCath outlook as Medicare add-on payment lapses weigh on pricing

CorMedix has withdrawn its 2027 outlook for DefenCath, its dialysis catheter-lock product, citing changes to the reimbursement framework run by the US Centers for Medicare & Medicaid Services (CMS). The company announced the move on 12 November alongside its third-quarter 2026 results. The material available does not describe what the framework changes are, and it gives no replacement outlook.

DefenCath net sales were $17.2M in the quarter. CorMedix links the lower pricing to the expiry of the product's transitional drug add-on payment adjustment (TDAPA) on 1 July 2026. Context: TDAPA is a temporary Medicare payment for certain new dialysis-related drugs, so its end can change what providers are paid for a product soon after launch.

Total third-quarter revenue was $54.5M, and the company reported a net loss of $14.7M and adjusted EBITDA of $3.1M. The material on file does not break down the revenue beyond the DefenCath figure, so the contribution of other products is not clear.

Two other items remain open. CorMedix has a pending acquisition of assets from Heron Therapeutics, backed by a term loan of up to $150M; the deal has not closed, so its effect on the portfolio depends on completion. Separately, the FDA is reviewing a supplemental new drug application (sNDA) for REZZAYO for preventing invasive fungal disease. The review is under Priority Review, with an agency action expected in the first quarter of 2027.