Record Annual DEFENCATH Sales
DEFENCATH generated $258.8 million in net sales for 2025 (reported as "just under $260,000,000"), representing the company's largest single-product revenue contribution for the year.
Acquisition of Melinta and Achieved Synergies
Closed acquisition of Melinta Therapeutics (08/29/2025) and realized targeted annual synergies of $35,000,000 during 2025; Melinta contributed $37.4 million to Q4 2025 revenue.
Strong Quarterly and Pro Forma Revenue
Q4 2025 revenue was $128.6 million (DEFENCATH $91.2M; Melinta $37.4M). Pro forma full-year 2025 revenue (combined CorMedix + Melinta) was $401.3 million, in line with prior guidance.
Affirmed 2026 and 2027 Financial Guidance
Affirmed 2026 DEFENCATH guidance of $150M–$170M and 2027 DEFENCATH guidance of $100M–$125M. Company also affirmed full-year 2026 consolidated revenue guidance of $300M–$320M and adjusted EBITDA of $100M–$125M.
Strong Adjusted EBITDA and Net Income
Q4 adjusted EBITDA was $77.2 million (within guidance). CorMedix recognized net income of $14.0 million for 2025 and pre-tax Q4 income of $56.4 million (an increase of $43.0M vs. 2024).
Healthy Liquidity and Operating Cash Flow
Ended Q4 with $148.5 million in cash, cash equivalents, and short-term investments; operating cash flow in the quarter was nearly $100 million.
Clinical Milestones and Pipeline Value
Phase III RESPECT (RIZEAO prophylaxis) completed enrollment September 2025 with database lock expected March 2026 and top-line data anticipated in Q2 2026. Company estimates RIZEAO market opportunity at ~$2.5 billion across indications and DEFENCATH in TPN at $500M–$750M.
Progress on DEFENCATH TPN Program and NEUTROGUARD Enrollment
Phase III NEUTROGUARD (DEFENCATH for CLABSI prevention in TPN patients) is ~30% enrolled toward the minimum target of 90 patients; study completion anticipated in early 2027.
Workforce and Integration Progress
Headcount increased from ~100 to just under 200 employees post-merger (approximately 100% growth), reflecting integration and scaling to support commercial expansion. Management also initiated an active share repurchase program.