CorMedix Reaffirms FY26 Total Sales Guidance Of $325M-$345M; Anticipates That The DefenCath Add-On Will Decline Sequentially In Q2 2027, With A QoQ Increase In Q3 And/Or Q4

CorMedix announces unaudited cash and cash equivalents on hand as of September 30, 2026 of approximately $355 million.

 

CorMedix reaffirms its August 2026 total revenue guidance of between $325 million and $345 million for the full-year 2026.

 

On October 28, 2026, CMS released the 2027 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule, which provided for a post-TDAPA Add-on for DefenCath® (taurolidine and heparin) of $8.32 per dialysis session, for Q1 of 2027, as well as a new quarterly process for calculating Add-On adjustments. The Q1 2027 Add-on of $8.32 is within the Company’s previously guided range of 3x-5x higher than the current $2.37 in effect for the third and fourth quarters of 2026.

 

The Company is aware of statements made by a large dialysis organization (LDO) during its investor call about the quarterly trajectory of the 2027 DefenCath post-TDAPA Add-on payments following CMS’s publication of the 2027 ESRD PPS Final rule. CorMedix has not provided the LDO or any other party with past or forecasted utilization or pricing data that would be necessary to estimate future quarterly adjustments to the 2027 Add-on. We believe any third-party projections regarding future quarterly adjustments are subject to significant uncertainty without visibility into the relevant utilization and pricing data. Investors should not interpret third-party projections as guidance provided or endorsed by CorMedix.

 

Based on CorMedix evaluation of sales data and insights that the Company has in connection with DefenCath fee-for-service utilization, including terms of its contractual arrangements with customers, the Company anticipates that the DefenCath Add-on will decline in Q2 of 2027 compared to Q1, but increase in Q3 and/or Q4 of 2027 compared to Q2, subject to how CMS applies certain utilization data. In addition, CorMedix believes that the Add-on rate for all four quarters in 2027 will exceed the current rate of $2.37 and that the average Add-on rate for all four quarters in 2027 will equate to more than 2x the current rate of $2.37.

 

CorMedix expects to hold a conference call on November 12, 2026 to discuss its financial results and additional business updates at that time. The Company will provide more specifics about its third quarter earnings call approximately one week prior to the scheduled meeting.