Detailed narrative
DefenCath Commercial Strategy and Post-TDAPA Performance
CorMedix has successfully secured commercial supply agreements with all five top U.S. dialysis providers for DefenCath, including a new multi-year agreement with an additional large dialysis organization (LDO) that initiated a pilot in Q3 FY26. The company is actively pursuing Medicare Advantage contracting, which represents a significant long-term growth avenue, although no contribution is assumed in 2026 guidance due to lengthy contracting cycles.
DefenCath order volumes in July tracked consistent with post-TDAPA forecasts, demonstrating durable underlying utilization.
Rezzayo Phase 3 ReSPECT Study and Regulatory Pathway
The Phase 3 ReSPECT study for Rezzayo in the prophylaxis of invasive fungal disease (IFD) met its primary endpoint of fungal-free survival at day 90, showing non-inferiority versus standard antifungal regimen. The study also demonstrated a favorable safety profile. CorMedix is collaborating with Mundipharma on the sNDA submission in Q3 FY26, with anticipated FDA action in H1 2027.
Additional data from the ReSPECT study is expected to be published at medical conferences in Q4 FY26.
Financial Performance and Outlook
CorMedix reported strong Q2 FY26 consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million, significantly higher year-over-year due to the Melinta acquisition. The company reaffirmed its full-year 2026 consolidated revenue guidance of $325 million to $345 million and raised its adjusted EBITDA guidance to $125 million to $140 million.
The company ended the quarter with $256.7 million in cash and cash equivalents, highlighting a strong balance sheet and cash generation.
Pipeline Advancement for DefenCath in TPN
Progress continues on the Phase 3 TPN study for DefenCath. A protocol amendment was recently submitted to the FDA to narrow certain exclusion criteria, aiming to increase enrollment in the coming months⏳. Additional study sites have been activated, and the company maintains its expectation for study completion in 2028. This represents a meaningful expansion opportunity for DefenCath beyond its current dialysis indication.
Real-World Evidence and Data Presentations
A growing body of real-world evidence continues to support DefenCath's clinical and pharmacoeconomic value. Final results from the U.S. Renal Care study, showing meaningful impact on infection-related hospitalizations and catheter-related bloodstream infections, are expected to be published in Q4 FY26. Two other external studies will highlight DefenCath's efficacy with chlorhexidine caps and its clinical/economic benefits in outpatient hemodialysis, including reduction in tPA use.
Operating Expenses and Cost Management
Operating expenses increased to $34.2 million in Q2 FY26, primarily due to the Melinta acquisition. R&D expenses rose to $6.7 million due to higher personnel and clinical trial services for ongoing programs. Sales and marketing expenses increased to $12.4 million due to a larger product portfolio.
G&A expenses included a $4.2 million reduction from expected insurance reimbursement for legal fees, making the reported figure artificially low. The company's narrowed cash OPEX guidance reflects disciplined investment.