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DefenCath's unique FDA-approved status and patent protection through 2033 support top-line growth.
CorMedix’s (CRMD - Free Report) lead product, DefenCath (taurolidine plus heparin), is the company’s primary source of revenues. DefenCath was approved in 2023 as the first and only antimicrobial catheter lock solution in the United States. The product is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure who receive chronic hemodialysis through a central venous catheter. CRBSIs can delay treatment and raise healthcare costs through extended hospital stays, intensive therapies and higher mortality. With DefenCath, CorMedix aims to meet this critical unmet medical need.
DefenCath was launched in 2024 in both the hospital inpatient and outpatient hemodialysis settings. The product holds a unique market position as the only FDA-approved therapy for a niche condition, supported by patent protection through 2033. CorMedix is also planning future potential label expansion of DefenCath into total parenteral nutrition to increase its customer base. DefenCath is expected to be a key top-line driver in the fourth quarter of 2025, like the previous three quarters.
In addition to DefenCath, CorMedix is benefiting from its $300 million acquisition of Melinta Therapeutics, which aims to diversify revenues and strengthen its presence in hospital acute care and infectious disease markets. The deal added seven approved products, including Rezzayo, now in late-stage trials for preventing invasive fungal infections. These acquired products from Melinta generated $12.8 million in revenues for CorMedix in the third quarter of 2025, reflecting a partial quarter of sales.
CorMedix recently reported preliminary fourth-quarter and full-year 2025 results, with unaudited net revenues of approximately $127 million and $310 million, respectively. The company expects adjusted EBITDA to be in the range of $77-$81 million in the fourth quarter of 2025.
The higher-than-expected utilization of DefenCath by outpatient dialysis customers is likely to have driven revenue growth in the fourth quarter.
Pro forma net revenues for full-year 2025 were around 400 million. As of Dec. 31, 2025, CorMedix reported cash and short-term investments of about $148 million, reflecting improved financial flexibility.
For full-year 2026, CorMedix expects total revenues of $300-$320 million, including $150-$170 million from DefenCath. Importantly, DefenCath’s 2026 revenue guidance is weighted toward the first half of the year and assumes modest growth in usage, which the company expects will partially offset price declines throughout 2026. CorMedix anticipates adjusted EBITDA to be in the range of $100 million to $125 million for full-year 2026.
CRMD’s Competition in the Target Market
While CorMedix is currently benefiting from DefenCath’s success, it faces strong competition from larger, established players in the heparin market.
DefenCath combines taurolidine, an antimicrobial agent, with heparin in a fixed-dose formulation, tailored for a specific subset of kidney failure patients. Although CorMedix currently holds a first-mover advantage in the United States with DefenCath, the broader competitive environment still poses risks. Major players such as Pfizer (PFE - Free Report) , Amphastar Pharmaceuticals (AMPH - Free Report) , B. Braun, Baxter and Fresenius Kabi USA already market heparin for multiple uses.
Given their stronger pipelines, larger manufacturing capabilities and greater financial resources, these companies could quickly become significant competitors if they decide to target CRBSI-related indications — a move that could challenge CorMedix’s market advantage and affect its long-term growth outlook.
Pfizer, which sells Heparin Sodium Injection across multiple indications such as dialysis, surgery and thrombosis, could leverage its global scale and expertise to enter the CRBSI prevention market.
Amphastar Pharmaceuticals, with end-to-end control over enoxaparin production, also has the efficiency and technical capabilities to pursue similar opportunities.
If either Pfizer or Amphastar Pharmaceuticals expands its anticoagulant portfolio into catheter-related infection prevention, CorMedix could encounter significant competitive pressure within its primary therapeutic space.
CRMD’s Stock Price, Valuation and Estimates
Shares of CorMedix have plunged 36.3% in the past six months against the industry’s growth of 21.1%. The stock has also underperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
Image Source: Zacks Investment Research
From a valuation standpoint, CorMedix is trading at a discount to the industry. Going by the price/book ratio, the company’s shares currently trade at 1.49, lower than 3.56 for the industry. The stock is also trading below its five-year mean of 3.37.
Image Source: Zacks Investment Research
Estimates for CorMedix’s 2025 earnings have increased from $2.57 to $2.85 per share in the past 60 days, while estimates for 2026 earnings have declined from $2.72 to $2.37 over the same timeframe.
Image Source: Zacks Investment Research
CRMD’s Zacks Rank
CorMedix currently carries a Zacks Rank #5 (Strong Sell).
Image: Bigstock
Will DefenCath Continue to Aid CorMedix's Top Line in Q4 Earnings?
Key Takeaways
CorMedix’s (CRMD - Free Report) lead product, DefenCath (taurolidine plus heparin), is the company’s primary source of revenues. DefenCath was approved in 2023 as the first and only antimicrobial catheter lock solution in the United States. The product is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure who receive chronic hemodialysis through a central venous catheter. CRBSIs can delay treatment and raise healthcare costs through extended hospital stays, intensive therapies and higher mortality. With DefenCath, CorMedix aims to meet this critical unmet medical need.
DefenCath was launched in 2024 in both the hospital inpatient and outpatient hemodialysis settings. The product holds a unique market position as the only FDA-approved therapy for a niche condition, supported by patent protection through 2033. CorMedix is also planning future potential label expansion of DefenCath into total parenteral nutrition to increase its customer base. DefenCath is expected to be a key top-line driver in the fourth quarter of 2025, like the previous three quarters.
In addition to DefenCath, CorMedix is benefiting from its $300 million acquisition of Melinta Therapeutics, which aims to diversify revenues and strengthen its presence in hospital acute care and infectious disease markets. The deal added seven approved products, including Rezzayo, now in late-stage trials for preventing invasive fungal infections. These acquired products from Melinta generated $12.8 million in revenues for CorMedix in the third quarter of 2025, reflecting a partial quarter of sales.
CorMedix recently reported preliminary fourth-quarter and full-year 2025 results, with unaudited net revenues of approximately $127 million and $310 million, respectively. The company expects adjusted EBITDA to be in the range of $77-$81 million in the fourth quarter of 2025.
The higher-than-expected utilization of DefenCath by outpatient dialysis customers is likely to have driven revenue growth in the fourth quarter.
Pro forma net revenues for full-year 2025 were around 400 million. As of Dec. 31, 2025, CorMedix reported cash and short-term investments of about $148 million, reflecting improved financial flexibility.
For full-year 2026, CorMedix expects total revenues of $300-$320 million, including $150-$170 million from DefenCath. Importantly, DefenCath’s 2026 revenue guidance is weighted toward the first half of the year and assumes modest growth in usage, which the company expects will partially offset price declines throughout 2026. CorMedix anticipates adjusted EBITDA to be in the range of $100 million to $125 million for full-year 2026.
CRMD’s Competition in the Target Market
While CorMedix is currently benefiting from DefenCath’s success, it faces strong competition from larger, established players in the heparin market.
DefenCath combines taurolidine, an antimicrobial agent, with heparin in a fixed-dose formulation, tailored for a specific subset of kidney failure patients. Although CorMedix currently holds a first-mover advantage in the United States with DefenCath, the broader competitive environment still poses risks. Major players such as Pfizer (PFE - Free Report) , Amphastar Pharmaceuticals (AMPH - Free Report) , B. Braun, Baxter and Fresenius Kabi USA already market heparin for multiple uses.
Given their stronger pipelines, larger manufacturing capabilities and greater financial resources, these companies could quickly become significant competitors if they decide to target CRBSI-related indications — a move that could challenge CorMedix’s market advantage and affect its long-term growth outlook.
Pfizer, which sells Heparin Sodium Injection across multiple indications such as dialysis, surgery and thrombosis, could leverage its global scale and expertise to enter the CRBSI prevention market.
Amphastar Pharmaceuticals, with end-to-end control over enoxaparin production, also has the efficiency and technical capabilities to pursue similar opportunities.
If either Pfizer or Amphastar Pharmaceuticals expands its anticoagulant portfolio into catheter-related infection prevention, CorMedix could encounter significant competitive pressure within its primary therapeutic space.
CRMD’s Stock Price, Valuation and Estimates
Shares of CorMedix have plunged 36.3% in the past six months against the industry’s growth of 21.1%. The stock has also underperformed the sector and the S&P 500 index during the same time frame, as seen in the chart below.
Image Source: Zacks Investment Research
From a valuation standpoint, CorMedix is trading at a discount to the industry. Going by the price/book ratio, the company’s shares currently trade at 1.49, lower than 3.56 for the industry. The stock is also trading below its five-year mean of 3.37.
Image Source: Zacks Investment Research
Estimates for CorMedix’s 2025 earnings have increased from $2.57 to $2.85 per share in the past 60 days, while estimates for 2026 earnings have declined from $2.72 to $2.37 over the same timeframe.
Image Source: Zacks Investment Research
CRMD’s Zacks Rank
CorMedix currently carries a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.