CorMedix Inc.

What they do

CorMedix develops and commercializes therapeutic products for life-threatening diseases and conditions. Its lead product, DefenCath (taurolidine and heparin), is an FDA-approved antimicrobial catheter lock solution indicated to reduce the incidence of catheter-related bloodstream infections in adult kidney failure patients receiving chronic hemodialysis through a central venous catheter. DefenCath launched in April 2024 in the inpatient setting and July 2024 in outpatient hemodialysis. On August 29, 2025, CorMedix acquired Melinta Therapeutics, adding six marketed hospital- and clinic-focused infectious disease products plus the cardiovascular product TOPROL-XL.

Revenue drivers

• DefenCath — The largest contributor to net sales; contributed $66.1 million of net revenue in Q2 2026. It is sold to dialysis organizations and reimbursed under Medicare ESRD PPS, with TDAPA add-on payments that began July 1, 2024.
• Melinta portfolio — Six marketed infectious disease products (REZZAYO, MINOCIN IV, VABOMERE, KIMYRSA, ORBACTIV, BAXDELA) plus TOPROL-XL; contributed $35.8 million in Q2 2026. Results are included in consolidated statements only from the August 29, 2025 closing date.
• Contracted dialysis customer base — Multi-year U.S. commercial supply agreements with a large and several mid-sized dialysis organizations that the company says represent roughly 60% of U.S. outpatient dialysis centers by addressable patient market.
• Development-stage pipeline — No revenue yet; includes expanded indications for DefenCath (CLABSI reduction in adult TPN patients) and REZZAYO prophylaxis of invasive fungal infections.

Recent performance

For Q2 2026, CorMedix reported consolidated revenue of $101.9 million, up from $39.7 million in Q2 2025, comprising $66.1 million of DefenCath sales and $35.8 million from the Melinta portfolio. Net income was $26.0 million and adjusted EBITDA was $58.7 million, with basic and fully diluted EPS of $0.33 and $0.29. Total operating expenses were $34.2 million versus $18.3 million a year earlier, driven mainly by a full quarter of Melinta operating expenses; R&D rose to $6.7 million from $2.4 million. For full-year 2025, revenue was $311.7 million, net income $163.1 million, diluted EPS $2.04, and operating cash flow $175.0 million. Cash and short-term investments excluding restricted cash were $256.7 million at June 30, 2026.

Strategy

Management's stated strategy is to maximize the value of the current portfolio, with promotional efforts focused on DefenCath, REZZAYO, MINOCIN IV and VABOMERE. The company is pursuing expanded indications for DefenCath (CLABSI reduction in adult TPN patients) and for REZZAYO (prophylaxis of invasive fungal infections in immunocompromised adults), and continues to evaluate synergistic business development. Integration of Melinta and cost optimization initiatives are a stated priority, alongside investments in commercial infrastructure and development activities. Management also cites a disciplined capital allocation strategy supported by the cash balance and an expanding DefenCath contract footprint.

Risks

• Dependence on DefenCath — The company states its ability to generate operating cash flow depends on continued successful commercialization of DefenCath, its largest product by revenue.
• Post-TDAPA reimbursement step-down — DefenCath's TDAPA reimbursement transitioned on July 1, 2026 into a post-TDAPA add-on payment phase set at $2.37 for Q3 and Q4 2026, which management expects will significantly reduce net pricing in those quarters.
• Melinta integration and comparability — Melinta results are included only from August 29, 2025, so reported periods are not comparable, and the company cites risks that integration may be more difficult, costly or disruptive than expected.
• Profitability history — Despite $163.1 million of net income in 2025, the company had an accumulated deficit of approximately $176.6 million as of December 31, 2025 and says it may incur net operating losses in future periods.

Outlook

Management maintains full-year 2026 consolidated revenue guidance of $325 to $345 million and raised full-year adjusted EBITDA guidance to $125 to $140 million, with cash OpEx guidance narrowed to $145 to $155 million. The company expects to submit an sNDA for the REZZAYO prophylaxis indication in Q3 2026, with anticipated FDA action in H1 2027 if accepted for review. Management expects the post-TDAPA reimbursement environment to pressure DefenCath net pricing in the second half of 2026, but estimates the 2027 add-on adjustment could be three to five times higher than the Q3/Q4 2026 level if CMS uses the same methodology.