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CorMedix Therapeutics Provides Business Update, Reaffirms 2026 Total Revenue Guidance, and Reports Third Quarter Cash Position

CMS set the Q1 2027 DefenCath add-on at $8.32 per dialysis session, compared with $2.37 for the final two quarters of 2026.

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CorMedix Therapeutics (CRMD) reaffirmed its full-year 2026 revenue guidance and outlined expectations for DefenCath’s dialysis reimbursement add-on payments.

Revenue guidance remains $325 million–$345 million; unaudited cash and cash equivalents were approximately $355 million at September 30, 2026. CMS set the Q1 2027 add-on at $8.32 per dialysis session, versus $2.37 for Q3 and Q4 2026, and introduced quarterly adjustments.

CorMedix expects the add-on to decline in Q2 2027, then increase in Q3 and/or Q4 versus Q2, subject to CMS’s application of certain utilization data. It expects every 2027 quarter’s rate to exceed $2.37 and the annual average to exceed twice that rate. Complete quarterly results are expected to be discussed on November 12, 2026.

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4 points · 0 major

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate pointDefenCath Q1 2027 add-on set at $8.32 per dialysis session, versus $2.37 for Q3–Q4 2026.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.CorMedix expects each 2027 quarterly rate above $2.37 and the annual average above twice that rate.
  • Minor point. Forward-looking: it has not happened yet and may not happen.Full-year 2026 revenue guidance reaffirmed at $325 million–$345 million.
  • Minor point. Forward-looking: it has not happened yet and may not happen.CorMedix expects a Q3 and/or Q4 2027 add-on increase versus Q2, subject to CMS’s utilization-data application.

Negative

  • Minor point. Forward-looking: it has not happened yet and may not happen.DefenCath add-on expected to decline in Q2 2027 compared with Q1.
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Details

Market Reaction – CRMD

$5.34 – $5.81 Day Range
$434.54M Mkt Cap at Last Price

On Nov 2, the day this news came out, the latest delayed price for CRMD is 2.11% below the previous close. Our momentum scanner has recorded 10 alerts for this stock so far that day. The latest delayed price is $5.58. Relative volume is exceptionally heavy at 8.6x what this stock usually trades by this time of day.

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Key Figures

Cash and cash equivalents: $355 million Total revenue guidance: $325 million–$345 million Post-TDAPA Add-on: $8.32 per dialysis session +2 more
Cash and cash equivalents
$355 million
Unaudited amount on hand at September 30, 2026
Total revenue guidance
$325 million–$345 million
Full-year 2026; reaffirmed
Post-TDAPA Add-on
$8.32 per dialysis session
Q1 2027 rate under the CMS final rule
Current Add-on rate
$2.37 per dialysis session
Rate in effect for Q3 and Q4 2026
Average 2027 Add-on rate
More than 2x the current rate
Company expectation for the average across all four quarters of 2027

Historical Context

1 past event · Latest: Aug 13
1 event
  1. Aug 13

    Q2 earnings report

    24h Move
    +14.7%

    Reported Q2 revenue of $101.9 million and maintained the same 2026 revenue guidance range.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

esrd pps, tdapa
2 terms
esrd pps regulatory
"2027 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule"
A Medicare payment system that pays a single, bundled per-treatment rate to dialysis facilities for care of patients with end-stage renal disease (ESRD). The ESRD Prospective Payment System (ESRD PPS) combines payment for dialysis sessions, certain drugs, laboratory tests and supplies into one standardized per-dialysis-unit payment that is adjusted for factors such as patient clinical characteristics (case mix), local wage levels, and qualifying outlier costs or low‑volume facilities; additional separate payments may still apply for items or services explicitly excluded by regulation.
tdapa regulatory
"post-TDAPA Add-on for DefenCath®"
A transitional drug add-on payment adjustment (TDAPA) is a temporary Medicare payment rule that gives hospitals higher reimbursement for newly available drugs or biologic treatments that are not yet reflected in standard outpatient payment rates. Think of it as a short-term price support that helps hospitals afford and use a new therapy while payers gather real-world cost and effectiveness data—important to investors because it can speed early adoption, stabilize initial revenue for the maker, and reduce commercial risk during the product’s launch.

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PARSIPPANY, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today provided a business update in advance of a conference call expected to be held on November 12, 2026 to discuss the Company’s complete quarterly financial performance.

Business Updates

  • 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.

About CorMedix

CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: www.cormedix.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; the 2027 post-TDAPA Add-on changes for DefenCath; and CorMedix’s forecasts and projections for the 2027 Add-on trajectory. CorMedix estimates for the 2027 Add-on are subject to several factors and assumptions, including known historical utilization and pricing data, DefenCath maintaining fee-for-service utilization in line with current trends, and the method by which CMS will apply certain utilization data in the Add-on calculations. Changes in customer utilization patterns, including fee-for-service utilization, changes in pricing, or differences between CMS’s application of its calculation methodology and the Company’s assumptions could cause the actual CMS-determined quarterly Add-on rates and the resulting full-year average to differ materially from CorMedix’s estimates. Increased reimbursement to dialysis facilities may not result in corresponding increases in CorMedix's realized pricing, product utilization or revenue. Additional risks include continued pricing pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; and the expiration or loss of intellectual property protection for certain of the Company's products and competition from generic and biosimilar products. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix does not adopt or endorse, and undertakes no obligation to comment on or correct, any projections, estimates or statements regarding its business or results of operations that are made by third parties, including analysts and customers, except as required by law. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576


FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What is CorMedix’s 2026 revenue guidance and latest cash position?

CorMedix reaffirmed full-year 2026 revenue guidance of $325 million to $345 million. Unaudited cash and cash equivalents were approximately $355 million as of September 30, 2026.

What DefenCath reimbursement add-on does CorMedix expect in 2027?

CMS set the Q1 2027 add-on at $8.32 per dialysis session. CorMedix expects a decline in Q2, followed by an increase in Q3 and/or Q4 compared with Q2, subject to how CMS applies certain utilization data. The company expects each quarter’s rate to exceed $2.37 and the annual average to exceed twice that rate.

Has CorMedix endorsed third-party forecasts for DefenCath’s 2027 quarterly add-on payments?

CorMedix has not endorsed third-party projections as its guidance. It has not provided the large dialysis organization or any other party with past or forecast utilization or pricing data needed to estimate future quarterly adjustments. The company considers third-party projections subject to significant uncertainty without those data.

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