CorMedix DefenCath Sales Collapse After Post-TDAPA Pricing
Consolidated revenue was $54.5 million in the third quarter, above street consensus of $51.2 million, as DefenCath net revenue fell to $17.2 million.
CorMedix Therapeutics (CRMD) reported $54.5 million of consolidated revenue for the third quarter ended September 30, 2026, as DefenCath’s July 1 transition to the post-TDAPA period cut net pricing. The figure exceeded street consensus of $51.2 million.
DefenCath (taurolidine and heparin) net revenue was $17.2 million, down from $66.1 million in the second quarter. The company said large outpatient dialysis customers largely maintained utilization and that a $5.0 million favorable change in estimate related to certain sales allowances contributed to the DefenCath figure.
The remaining portfolio contributed $37.3 million of total revenue and grant income, up from $35.8 million in the second quarter.
GAAP results swung to a net loss of $14.7 million, or $(0.19) a share, from net income of $26.0 million in the second quarter. The loss included $11.5 million of non-cash expense from remeasurement of contingent consideration tied to the Melinta acquisition. Adjusted EBITDA was $3.1 million; the 2026 calculation also excluded the $5.0 million favorable sales-allowance change.
Total operating expenses were $36.6 million, up from $34.2 million in the second quarter. Research and development expenses were $7.0 million. Selling and marketing expense was $11.7 million. General and administrative expenses were $17.9 million.
Cash and short-term investments, excluding restricted cash, totaled $355.2 million at September 30, 2026, up from $256.7 million at June 30. For the first nine months of 2026, net cash provided by operating activities was $218.3 million. The company said it believes it has sufficient resources to fund operations for at least twelve months from the issuance of its Form 10-Q.
The company maintained full-year 2026 consolidated revenue guidance of $325 million to $345 million, narrowed full-year adjusted EBITDA guidance to $130 million to $140 million from $125 million to $140 million, and reduced cash-based OpEx guidance to $140 million to $145 million from $145 million to $155 million.
On November 9, 2026, CorMedix announced a definitive asset purchase agreement to acquire substantially all assets of Heron Therapeutics. Closing is anticipated in the first quarter of 2027, subject to Heron stockholder approval, regulatory clearance and other customary conditions. The company said the transaction is expected to be immediately accretive to earnings and free cash flow upon closing and to contribute $125 million to $150 million of full-year 2027 revenue, effectively doubling non-DefenCath annual product revenue. In connection with the deal it entered a term loan of up to $150 million, expecting to use $75 million at closing.
The FDA accepted for review the sNDA for an expanded indication of REZZAYO for prophylaxis of invasive fungal disease, with Priority Review and a PDUFA date in the first quarter of 2027. The company anticipates agency action in the first quarter of 2027 and, if approved, plans promotional efforts in the second half of 2027.
In light of recently announced changes to the CMS reimbursement framework, CorMedix suspended any previously issued 2027 DefenCath revenue guidance and deferred future guidance until early 2027, the timeframe when it expects better visibility into 2027 utilization and pricing and any potential upside from Medicare Advantage contracting.