CorMedix beats, ups guidance, DefenCath resilient post-TDAPA, secures all 5 top US dialysis providers

 

CorMedix beats Q2 estimates and raises EBITDA guidance as DefenCath stays resilient post-TDAPA, secures all 5 top U.S. dialysis providers

• Q2 revenue $101.9M, up from $39.7M (+157% YoY), driven by DefenCath and Melinta.
• Q2 results beat analyst estimates, and the company raised full-year adjusted EBITDA guidance.
• DefenCath revenue $66.1M; Melinta portfolio $35.8M, first full comparable quarter post-acquisition.
• Net income $26.0M (diluted EPS $0.29) versus $19.8M (EPS $0.28) last year.
• Adjusted EBITDA $58.7M versus $22.4M YoY; full-year EBITDA guidance raised to $125–$140M.
• Full-year 2026 revenue guidance maintained at $325–$345M; DefenCath $175–$195M, trending mid-to-high end.
• New multi-year DefenCath deal secures all 5 top U.S. dialysis providers; pilot starts Q3 2026.
• Post-TDAPA, large-provider DefenCath volumes stable with expected attrition among smaller sites; July orders tracking forecasts.
• Rezzayo prophylaxis Phase 3 met non-inferiority primary endpoint with favorable safety; sNDA filing targeted for Q3 2026.
• DefenCath TPN Phase 3 enrollment boosted via protocol amendment; completion still expected in 2028.
• Gross margin: not disclosed; operating margin: not disclosed; strong cash position with $256.7M cash and equivalents.
• Main concern: Long-term DefenCath growth depends on evolving reimbursement (ESRD rule, Medicare Advantage) and successful Medicare Advantage contracting.
• Strong quarter, driven by resilient DefenCath utilization post-TDAPA and growing contribution from the Melinta portfolio.

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