CorMedix Therapeutics Announces Preliminary Fourth Quarter and Full Year 2025 Results and Provides Business Updates

Rhea-AI Summary

CorMedix (Nasdaq: CRMD) reported preliminary unaudited results for Q4 and FY 2025 and provided FY 2026 guidance and program updates. Key metrics: Q4 2025 net revenue ~$127M, FY 2025 net revenue ~$310M, FY 2025 pro forma net revenue ~$400M, Q4 2025 adjusted EBITDA $77M–$81M, and cash and short-term investments ~$148M as of Dec 31, 2025. Management introduced FY 2026 revenue guidance $300M–$320M (DefenCath $150M–$170M) and FY 2026 adjusted EBITDA $100M–$125M. Company expects REZZAYO Phase 3 prophylaxis topline in Q2 2026. DefenCath reimbursement will transition on Jul 1, 2026, which the company says will reduce net pricing in H2 2026; estimated higher 2027 pricing if CMS applies prior methodology. Analyst Day scheduled for Feb 10, 2026.

Positive

• Q4 2025 net revenue of approximately $127 million
• FY 2025 pro forma net revenue of approximately $400 million
• Preliminary cash and short-term investments of approximately $148 million
• Operationalized acquisition synergies of approximately $35 million
• FY 2026 adjusted EBITDA guidance of $100M–$125M

Negative

• Expected significant decline in DefenCath net pricing in Q3–Q4 2026
• FY 2026 revenue guidance ($300M–$320M) below FY 2025 pro forma ($400M)

News Market Reaction

-32.77% 4.9x vol

88 alerts

-32.77% News Effect

-32.4% Trough in 3 hr 45 min

-$429M Valuation Impact

$880M Market Cap

4.9x Rel. Volume

On the day this news was published, CRMD declined 32.77%, reflecting a significant negative market reaction. Argus tracked a trough of -32.4% from its starting point during tracking. Our momentum scanner triggered 88 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $429M from the company's valuation, bringing the market cap to $880M at that time. Trading volume was very high at 4.9x the daily average, suggesting heavy selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Q4 2025 adjusted EBITDA: $77–$81M FY 2026 revenue guidance: $300–$320M 2026 DefenCath revenue: $150–$170M +5 more

8 metrics

Q4 2025 adjusted EBITDA $77–$81M Expected range for Q4 2025 adjusted EBITDA

FY 2026 revenue guidance $300–$320M Company-wide FY 2026 revenue outlook

2026 DefenCath revenue $150–$170M FY 2026 revenue guidance for DefenCath

Estimated Melinta synergies $35M Full-year run-rate operating synergies from Melinta acquisition

FY 2026 operating expenses $145–$160M Guided FY 2026 operating expenses, ex non-cash and one-time items

FY 2026 Adjusted EBITDA $100–$125M Guided FY 2026 adjusted EBITDA range

FY 2027 DefenCath sales $100–$140M Estimated full-year 2027 DefenCath sales range

ReSPECT Phase 3 data timing Q2 2026 Expected topline data for REZZAYO ReSPECT prophylaxis study

Market Reality Check

Price: $7.69 Vol: Volume 2,473,060 is 0.87x...

normal vol

$7.69 Last Close

Volume Volume 2,473,060 is 0.87x the 20-day average 2,828,960, showing no pre-news volume spike. normal

Technical Shares at $11.17 are trading slightly below the 200-day MA of $11.29 and about 35.92% under the 52-week high.

Peers on Argus

CRMD slipped 0.8% pre-release while biotech peers showed mixed moves: ABUS +1.46...

CRMD slipped 0.8% pre-release while biotech peers showed mixed moves: ABUS +1.46%, QURE +3.92%, UPB +7.67%, MRVI -0.77%, VERV -0.09%. This points to stock-specific factors rather than a coordinated sector trade.

Historical Context

5 past events · Latest: Dec 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 18	Clinical data update	Positive	+4.1%	Interim real-world DefenCath data showing large CRBSI and hospitalization reductions.
Nov 12	Partner earnings link	Positive	+2.1%	Talphera financing led by CorMedix and trial progress, modestly benefiting sentiment.
Nov 12	Q3 earnings beat	Positive	+2.1%	Strong Q3 revenue, profitability and raised FY 2025 guidance after Melinta deal.
Oct 31	Earnings call notice	Neutral	-4.2%	Announcement of upcoming Q3 results call and brief business update timing.
Oct 23	Commercial milestone	Positive	+1.0%	Vizient Innovative Technology designation for DefenCath, reinforcing commercial positioning.

Pattern Detected

Recent CRMD news has usually seen positive price alignment, with only one notable divergence on a conference/earnings scheduling update.

Recent Company History

Over the past few quarters, CorMedix has reported strong revenue and profitability growth, driven largely by DefenCath and, more recently, the Melinta acquisition. Earnings updates on May 6, Aug 7, and Nov 12, 2025 highlighted rising net income, adjusted EBITDA, and upgraded guidance, generally followed by positive share reactions. Clinical and commercial milestones for DefenCath have also been well received. Today’s preliminary 2025 results and 2026 guidance extend this trajectory by updating revenue, EBITDA outlook, and pipeline timing into 2026–2027.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-07

An effective S-3ASR filed on 2025-10-07 registers up to 6,323,833 existing-holder shares for resale. These are selling stockholder shares, and the prospectus states CorMedix will receive no proceeds from their sale, though it incurred about $140,000 of related legal expenses.

Market Pulse Summary

The stock dropped -32.8% in the session following this news. A negative reaction despite constructiv...

Analysis

The stock dropped -32.8% in the session following this news. A negative reaction despite constructive preliminary results and detailed 2026 guidance would fit prior instances where news did not prevent downside, such as the Oct 31, 2025 divergence. With short interest at 15.09%, selling pressure could be amplified if investors focus on reimbursement headwinds for DefenCath or future dilution from previously issued securities. Historical data show that not every operational milestone has translated into durable upside.

Key Terms

adjusted EBITDA, phase 3, prophylaxis, total parenteral nutrition, +4 more

8 terms

adjusted EBITDA financial

"Expects Q4 Adjusted EBITDA of Between $77 million and $81 million"

Adjusted EBITDA is a way companies measure how much money they make from their core operations, like running a business, by removing certain costs or income that aren’t part of regular business activities. It helps investors see how well a company is doing without distractions from unusual expenses or gains, making it easier to compare companies or track performance over time.

phase 3 medical

"expects clinical data from the Phase 3 ReSPECT study of REZZAYO"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

prophylaxis medical

"REZZAYO ... in the prophylaxis of invasive fungal infection in adult patients"

Prophylaxis is a medical prevention strategy — a drug, vaccine, device, or procedure given to stop a disease or condition before it starts. For investors, prophylactic products matter because they can create steady, large markets and reduce long‑term healthcare costs; regulatory approval or broader adoption can change demand forecasts much like a new safety feature that becomes standard across an entire industry.

total parenteral nutrition medical

"Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients"

Total parenteral nutrition is a medical treatment that supplies all needed calories, fluids, vitamins and minerals directly into a patient’s bloodstream through an IV, bypassing the digestive tract — like a complete meal delivered by a drip. It matters to investors because TPN relies on specialized ingredients, preparation and delivery services with steady hospital and home-care demand, significant regulation and reimbursement exposure, and potential for durable revenue or risk from supply-chain or clinical issues.

allogeneic blood and marrow transplant medical

"adult patients undergoing allogeneic blood and marrow transplant in Q2 2026"

A medical procedure in which a patient’s diseased or damaged blood- and immune-forming cells are replaced with healthy cells from a genetically matched donor. Think of it like swapping out a faulty engine for one from another car: it can cure certain blood cancers and immune disorders but carries risks like rejection and infection, so outcomes, supply of donors, regulatory approvals, and costs are important to investors evaluating related therapies or services.

TDAPA regulatory

"DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment"

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.

Medicare Advantage regulatory

"upside from new outpatient dialysis customers, increased utilization due to anticipated Medicare Advantage contracting"

Medicare Advantage is a type of health insurance plan offered by private companies that covers services traditionally provided by government-run Medicare. Think of it as a bundled package that combines hospital, doctor, and other medical care into one plan, often with added benefits. For investors, it matters because the popularity and profitability of these plans can influence healthcare companies and the broader health insurance industry.

central venous catheter medical

"hemodialysis via a central venous catheter"

A central venous catheter is a thin, flexible tube placed into a large vein near the neck, chest, or groin to deliver medications, fluids, nutrition, or to measure pressures inside the body. For investors it matters because demand, safety, infection risk, and regulatory changes around these devices and the procedures to place them can affect hospital spending, device makers’ sales, and liability or reimbursement trends—think of it as a dedicated shipping lane for critical medical treatments.

AI-generated analysis. Not financial advice.

‒ Q4 2025 Unaudited Net Revenue of Approximately $127 million ‒

‒ FY 2025 Unaudited Pro Forma Net Revenue of Approximately $400 million ‒

‒ Expects Q4 Adjusted EBITDA of Between $77 million and $81 million ‒

‒ Unaudited Cash and Short-term Investments of Approximately $148 million ‒  

BERKELEY HEIGHTS, N.J., Jan. 08, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announces its preliminary unaudited fourth quarter 2025 and full-year 2025 results, and provides guidance and an update on its business. These include the following key updates:

• CorMedix announces preliminary, unaudited financial results for Q4 and FY 2025, including net revenue of approximately $127 million and $310 million, for Q4 2025 and FY 2025, respectively, FY 2025 Pro Forma net revenue⁽¹⁾ of approximately $400 million, and Q4 2025 adjusted EBITDA⁽²⁾ in the range of $77 million to $81 million.
  
  
• The Company reports preliminary unaudited cash and short-term investments, as of December 31, 2025, of approximately $148 million.
  
  
• CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO® (rezafungin for injection) in the prophylaxis of invasive fungal infection in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in early 2027.
  
  
• The Company continues to see strong utilization and patient growth for DefenCath® (taurolidine and heparin) by its outpatient dialysis organization customers. On July 1, 2026, DefenCath’s TDAPA reimbursement transitions into a post-TDAPA Add-On Adjustment, the calculation of which is determined by CMS. As a result of the methodology utilized by CMS, the level of reimbursement provided to institutions treating dialysis patients will significantly decline, and as a result, CorMedix expects a corresponding reduction to its net pricing for DefenCath in Q3 and Q4 of 2026. If CMS utilizes the same methodology to calculate the 2027 post-TDAPA Add-On Adjustment, which will be effective on January 1, 2027, CorMedix estimates the value of the Add-On Adjustment will be 3x – 5x higher than that granted for Q3 and Q4 of 2026, which the Company expects would result in higher DefenCath sales prices in 2027 relative to H2 2026.
  
  
• CorMedix is introducing FY 2026 Revenue guidance of $300 million to $320 million, which includes $150 million to $170 million for DefenCath.   2026 DefenCath revenue guidance is heavily weighted toward H1 2026 and assumes modest utilization growth, which the Company expects will offset some of the price erosion over the course of the year. Based on the assumption of a higher net selling price in 2027 relative to H2 2026, the Company currently estimates full-year 2027 DefenCath sales in the range of $100 million to $140 million. DefenCath guidance for 2026 and 2027 assumes the maintenance of its current outpatient dialysis utilization run-rate with existing customers, and excludes any potential upside from new outpatient dialysis customers, increased utilization due to anticipated Medicare Advantage contracting, or any change in reimbursement due to pending TDAPA legislation.
  
  
• In addition, management has operationalized synergies of approximately $35 million, on a full-year run rate basis, related to the acquisition of Melinta and is now focused on driving growth strategies for the business. The Company is estimating FY 2026 operating expenses of $145 million to $160 million, excluding non-cash items and one-time expenses, with the upper end of the spending range contingent upon positive Phase 3 data related to the ReSPECT study and a potential acceleration of enrollment in the DefenCath TPN study. Based on these estimates, CorMedix estimates FY 2026 Adjusted EBITDA in the range of $100 million to $125 million.
  
  
• CorMedix is excited to announce that it will hold an Analyst Day on February 10, 2026, during which it will provide significant background on the medical need and the market potential for its key pipeline assets of REZZAYO in prophylaxis and DefenCath in TPN, as well as insights on the future strategic direction for the business. Details will be forthcoming.
  
  

Joseph Todisco, CorMedix Therapeutics CEO, commented, “I’m proud to announce our preliminary Q4 and FY 2025 results today, including surpassing our guidance for 2025. 2025 was a transformational year for CorMedix, as we evolved beyond a single-product company to an organization with multiple growth drivers and pipeline assets. We closed 2025 in a strong cash position, which we expect to further bolster over the coming year, providing the Company with financial flexibility to drive value for shareholders. With our new leadership team in place and multiple near-term pipeline catalysts, I am excited about the long-term potential for CorMedix Therapeutics.”

The preliminary financial information presented in this press release is based on CorMedix’s current expectations and may be adjusted as a result of, among other things, the completion of our internal review process and the completion of customary annual audit procedures.

(1)

FY 2025 Unaudited Pro Forma Net Revenue was prepared by combining the estimated financial results and for CorMedix and Melinta for the full fiscal year ended December 31, 2025, without further adjustment, as if the transaction had closed on January 1, 2025.

(2)

Adjusted EBITDA is a non-GAAP financial measure and excludes non-cash items such as depreciation, amortization and stock-based compensation, and certain non-recurring items. The Company expects to provide a reconciliation of Adjusted EBITDA to the most comparable GAAP measure in its earnings release relating to the fourth quarter and full year 2025 financial results. Such reconciliation is not included in this release because CorMedix is currently finalizing certain amounts that would be required to be included in the U.S. GAAP measure or the individual adjustments for such reconciliation.

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. CorMedix is commercializing DefenCath® (taurolidine and heparin) for the prevention of catheter-related bloodstream infections in adult patients undergoing hemodialysis via a central venous catheter. Following its August 2025 acquisition of Melinta Therapeutics LLC, CorMedix is also commercializing a portfolio of anti-infective products, including MINOCIN® (minocycline) for Injection, REZZAYO® (rezafungin), VABOMERE® (meropenem and vaborbactam), ORBACTIV™ (oritavancin), BAXDELA® (delafloxacin), and KIMYRSA® (oritavancin), as well as TOPROL-XL® (metoprolol succinate).

CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition (TPN) and Pediatric Hemodialysis populations and also intends to develop DefenCath as a catheter lock solution for use in other patient populations. REZZAYO is currently approved for the treatment of candidemia and invasive candidiasis in adults, with an ongoing Phase III study for the prophylaxis of IFD in adult patients undergoing allogeneic BMT. Topline results of the Phase III study for REZZAYO are expected in Q2 2026. For more information visit: www.cormedix.com or www.melinta.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, and Section 21E of the Exchange, 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,” “will,” “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 guidance, sales, revenue and operating expense estimates, expectations regarding product utilization, product reimbursement rates, synergy estimates and timing, expectations and timing regarding clinical studies and development and expectations of CorMedix’s product pipeline, results of the real-world study, expectations regarding implementation and perceived benefits of CorMedix’s 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, 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 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

What were CorMedix (CRMD) preliminary Q4 2025 results?

CorMedix reported Q4 2025 net revenue of ~$127M and adjusted EBITDA of $77M–$81M (unaudited, preliminary).

When will CorMedix (CRMD) release REZZAYO Phase 3 prophylaxis topline data?

Topline results from the REZZAYO Phase 3 prophylaxis study are expected in Q2 2026.

How does the Jul 1, 2026 TDAPA transition affect DefenCath pricing for CRMD?

CorMedix says the TDAPA transition on July 1, 2026 will cause CMS methodology-driven reimbursement declines, reducing DefenCath net pricing in H2 2026.

What is CorMedix (CRMD) revenue and DefenCath guidance for FY 2026?

CorMedix provided FY 2026 revenue guidance of $300M–$320M, including $150M–$170M for DefenCath.

When is CorMedix's Analyst Day and what will be covered?

Analyst Day is scheduled for February 10, 2026; the company will review REZZAYO and DefenCath market potential and strategy.