CorMedix Inc. Announces Preliminary Third Quarter 2025 Results and Raises 2025 Net Revenue Guidance

Rhea-AI Summary

CorMedix (Nasdaq: CRMD) reported preliminary unaudited Q3 2025 results and raised 2025 pro forma net revenue guidance. Key figures include Q3 pro forma net revenue >$125M, DefenCath Q3 net revenue >$85M, and Q3 unaudited company net revenue >$100M. Management raised full‑year 2025 pro forma net revenue guidance to at least $375M and expects Q3 adjusted EBITDA ≥ $70M.

The company forecasts at least $30M of go‑forward operating synergies before year‑end 2025 from the Melinta integration, with an additional $5–$15M targeted in 2026. Cash and short‑term investments were approximately $56M on Sept 30, 2025, with a projected year‑end cash balance of ~$100M. Clinical update: Phase III ReSPECT enrollment complete; data expected 2Q 2026.

Positive

• Q3 pro forma net revenue >$125M
• Raised 2025 pro forma net revenue guidance to ≥ $375M
• Q3 adjusted EBITDA expected ≥ $70M
• Forecasted $30M run‑rate synergies before end of 2025
• Phase III ReSPECT enrollment complete; data due 2Q 2026

Negative

• Cash on Sept 30, 2025 approximately $56M
• Q3 cash impacted by Melinta acquisition payments and higher working capital

Insights

Commercial and Clinical Integration Analyst

Strong preliminary Q3 revenue, raised FY2025 pro forma guidance and sizeable near-term synergies—overall positive operational and financial momentum.

CorMedix reported preliminary unaudited pro forma Q3 2025 net revenue of more than $125 million and unaudited Company net revenue of more than $100 million, including at least $85 million from DefenCath. Management increased full-year 2025 pro forma net revenue guidance to at least $375 million and expects Q3 2025 adjusted EBITDA of at least $70 million. These figures show clear revenue strength and near-term profitability on a non‑GAAP basis.

The company forecasts cost synergies of at least $30 million on a go‑forward run‑rate basis before the end of Q4 2025, with another $5–$15 million targeted in CY 2026. Cash, cash equivalents and short‑term investments stood at approximately $56 million as of September 30, 2025, with guidance to approximately $100 million year‑end. The cash change reflects the Melinta acquisition payments, a strategic investment in Talphera, and higher working capital to support revenue growth.

Dependencies and risks remain explicit in the disclosures: figures are preliminary and unaudited and may adjust after quarter‑end review, adjusted EBITDA is a non‑GAAP metric pending reconciliation, and synergy capture timing splits across Q4 2025 and CY 2026. The company also notes completed enrollment in the Phase III ReSPECT study and expects to share clinical data in 2Q 2026; the prophylaxis addressable market is stated as more than $2 billion.

Concrete items to watch on the stated timelines include the finalized audited Q3 results and the adjusted EBITDA reconciliation in the upcoming earnings release, announced synergy captures by the end of Q4 2025, and the Phase III ReSPECT data expected in 2Q 2026. These milestones will validate the revenue guidance, the non‑GAAP profitability claim, and the integration progress.

‒ Q3 2025 Unaudited Pro Forma Net Revenue of more than $125 million ‒

‒ Q3 2025 Unaudited DefenCath Net Revenue of more than $85 million ‒

‒ Raising FY 2025 Pro Forma Net Revenue Guidance to at least $375 million ‒

‒ ~$30mm of operating synergy on a go-forward run-rate basis before year end 2025 ‒

BERKELEY HEIGHTS, N.J., Oct. 20, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced selected preliminary unaudited third quarter results and provided an update on its business. These include the following key updates:

• Preliminary Q3 2025 unaudited net revenue of more than $100 million, including at least $85 million for DefenCath, and preliminary pro forma Q3 2025 unaudited Company net revenue of more than $125 million⁽¹⁾. DefenCath revenue growth has been driven by stronger than projected utilization by the Company’s LDO customer as well as continued utilization growth with other customers.
  
  
• Based on the current sales trend for DefenCath as well as the performance of the recently acquired Melinta portfolio, CorMedix is increasing its full-year 2025 pro forma net revenue guidance from the previously announced range of $325-$350 million to at least $375 million⁽¹⁾.
  
  
• Company expects Q3 2025 adjusted EBITDA⁽²⁾ of at least $70 million.
  
  
• The Company has made significant progress on the integration of Melinta and management now forecasts cost synergy capture of at least $30 million on a go-forward run-rate basis before the end of the fourth quarter 2025, with the remaining targeted synergies of $5 – $15 million expected to be captured in CY 2026.
  
  
• CorMedix recently announced the completion of enrollment in the ongoing Phase III ReSPECT study of Rezzayo in prophylaxis of fungal infection in adult patients undergoing allogeneic blood and marrow transplant. The Company expects to be able to share clinical data in 2Q 2026 and believes that the total addressable market for prophylaxis is more than $2 billion.
  
  
• Cash, cash equivalents and short-term investments as of September 30, 2025 accounted for approximately $56 million, and the Company is guiding to a projected year end cash and cash equivalent balance of approximately $100 million.   The Company’s Q3 cash balance was impacted by cash payments made for the acquisition of Melinta and associated closing costs, the Company’s strategic investment in Talphera, as well as increased working capital requirements necessary to support revenue growth.
  

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 the quarterly review procedures of CorMedix’s third quarter 2025 financial statements.

1. Q3 2025 unaudited pro forma net revenue was prepared by combining the estimated financial results for CorMedix and Melinta for the full fiscal quarter ended September 30, 2025, as if the transaction had closed as of the first day of the fiscal quarter. Pro Forma 2025 Net Revenue guidance was prepared by combining the estimated financial results and guidance 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 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 third quarter 2025 financial results. Such reconciliation is not included in this release because the Company 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 Inc. 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), 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 and Pediatric patient 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, peak annual sales estimates, synergy estimates and timing, accretion estimates and Adjusted EBITDA estimates. 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 and in the Quarterly Report on Form 10-Q for the quarter ended, on June 30, 2025. 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. In addition, pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. 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 did CorMedix (CRMD) report for preliminary Q3 2025 net revenue?

CorMedix reported preliminary unaudited Q3 2025 net revenue of more than $100M and pro forma net revenue of more than $125M.

How much revenue did DefenCath generate in Q3 2025 for CRMD?

DefenCath net revenue in Q3 2025 was reported at more than $85M.

What is CorMedix's updated full‑year 2025 pro forma net revenue guidance (CRMD)?

CorMedix raised its 2025 pro forma net revenue guidance to at least $375M.

What synergy savings did CorMedix forecast from the Melinta integration?

Management forecasts at least $30M of go‑forward run‑rate synergies before year‑end 2025, with an additional $5–$15M targeted in 2026.

What cash balance did CorMedix report on Sept 30, 2025 and what is the year‑end projection?

Cash, cash equivalents and short‑term investments were about $56M on Sept 30, 2025, and the company projects approximately $100M at year‑end 2025.

When does CorMedix expect to report ReSPECT Phase III clinical data for Rezzayo?

The company expects to share Phase III ReSPECT clinical data in 2Q 2026.