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CorMedix Therapeutics — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Unaudited cash and cash equivalents on hand as of September 30, 2026, were approximately $355 million.
    • No specific revenue, earnings, profit margins, or cash flow figures for the third quarter of 2026 were disclosed in this press release.
  • Guidance and Future Outlook:

    • Reaffirmed August 2026 total revenue guidance for the full year 2026 of between $325 million and $345 million.
    • Anticipates the DefenCath Add-on rate for all four quarters of 2027 will exceed the current rate of $2.37.
    • Expects the average Add-on rate for all four quarters in 2027 to equate to more than 2x the current rate of $2.37.
    • Projects the DefenCath Add-on will decline in Q2 2027 compared to Q1 2027, but increase in Q3 and/or Q4 2027 compared to Q2 2027, subject to CMS utilization data application.
  • Business Segments and Product Lines:

    • CMS released the 2027 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule on October 28, 2026.
    • The 2027 rule provides a post-TDAPA Add-on for DefenCath® (taurolidine and heparin) of $8.32 per dialysis session for Q1 2027.
    • 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 rate in effect for Q3 and Q4 2026.
    • A new quarterly process for calculating Add-On adjustments has been established under the 2027 rule.
  • Market and Competitive Landscape:

    • CorMedix notes statements made by a large dialysis organization (LDO) regarding the quarterly trajectory of 2027 DefenCath post-TDAPA Add-on payments.
    • The Company states it has not provided the LDO or any other party with past or forecasted utilization or pricing data necessary to estimate future quarterly adjustments.
    • CorMedix warns that third-party projections regarding future quarterly adjustments are subject to significant uncertainty without visibility into relevant utilization and pricing data.
  • Risks and Challenges:

    • Actual CMS-determined quarterly Add-on rates and resulting full-year averages may differ materially from estimates due to changes in customer utilization patterns, pricing changes, or differences in CMS's application of calculation methodology.
    • Increased reimbursement to dialysis facilities may not result in corresponding increases in CorMedix's realized pricing, product utilization, or revenue.
    • Risks include continued pricing pressures, impacts of governmental and private payer actions on pricing and reimbursement, and reporting obligations.
    • Potential risks include expiration or loss of intellectual property protection and competition from generic and biosimilar products.
  • Management Commentary and Tone:

    • Management expressed confidence that the Q1 2027 Add-on rate is within the previously guided range.
    • Management emphasized that investors should not interpret third-party projections as guidance provided or endorsed by CorMedix.
    • The Company anticipates holding a conference call on November 12, 2026, to discuss complete quarterly financial performance and additional business updates.
  • Other Key Points:

    • A conference call is scheduled for November 12, 2026, with more specifics to be provided approximately one week prior to the meeting.
    • CorMedix is a biopharmaceutical company focused on therapeutic products for life-threatening conditions in the US, with a field-based medical and commercial infrastructure in hospitals, clinics, and infusion centers.
    • The press release includes standard forward-looking statement disclaimers under the Private Securities Litigation Reform Act of 1995 and related securities laws.
Company
CORMEDIX INC
Sector
Healthcare
Industry
Biotechnology