Core Insights - CorMedix Therapeutics reported preliminary unaudited financial results for Q4 and FY 2025, with Q4 net revenue of approximately $127 million and FY 2025 net revenue of approximately $310 million, alongside a pro forma net revenue of approximately $400 million for FY 2025 [1][3] - The company expects Q4 2025 adjusted EBITDA to be between $77 million and $81 million, and reported unaudited cash and short-term investments of approximately $148 million as of December 31, 2025 [1][3] Financial Performance - Preliminary unaudited net revenue for Q4 2025 is approximately $127 million, while FY 2025 net revenue is approximately $310 million [1] - FY 2025 pro forma net revenue is approximately $400 million [1] - Expected Q4 adjusted EBITDA is between $77 million and $81 million [1] - As of December 31, 2025, unaudited cash and short-term investments are approximately $148 million [1] Business Updates - CorMedix anticipates clinical data from the Phase 3 ReSPECT study of REZZAYO® in Q2 2026 [1] - The ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients is expected to complete enrollment in early 2027 [1] - Strong utilization and patient growth for DefenCath® is noted among outpatient dialysis organization customers [1] Revenue Guidance - FY 2026 revenue guidance is set at $300 million to $320 million, including $150 million to $170 million for DefenCath [1] - DefenCath revenue guidance for 2026 is heavily weighted towards H1 2026, with expectations of modest utilization growth [1] - For FY 2027, CorMedix estimates DefenCath sales in the range of $100 million to $140 million, assuming maintenance of current outpatient dialysis utilization [1] Operational Synergies - The company has operationalized synergies of approximately $35 million on a full-year run rate basis related to the acquisition of Melinta [1] - Estimated FY 2026 operating expenses are projected to be between $145 million and $160 million, excluding non-cash items and one-time expenses [1] Future Events - CorMedix will hold an Analyst Day on February 10, 2026, to provide insights on its key pipeline assets and future strategic direction [2][3]

Core Insights - CorMedix Inc. has completed enrollment for the Phase III ReSPECT trial, which evaluates the efficacy of REZZAYO® (rezafungin) in preventing fungal infections in adult patients undergoing allogeneic blood and marrow transplantation (BMT) [1][2] - Topline results from the ReSPECT study are expected in the second quarter of 2026, which is a significant milestone towards seeking FDA approval for REZZAYO in this indication [2][5] - The ReSPECT trial is a multicenter, randomized, double-blind study comparing once-weekly rezafungin to a standard antimicrobial regimen, with the primary endpoint being fungal-free survival at day 90 [2][3] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, including antifungal treatments [4] - Following the acquisition of Melinta Therapeutics in August 2025, CorMedix is expanding its portfolio to include various anti-infective products alongside REZZAYO [4][5] - REZZAYO is already approved in the U.S. for treating candidemia and invasive candidiasis, with an estimated addressable market of approximately 130,000 patients for antifungal prophylaxis, translating to a total addressable market of over $2 billion [3][4] Product Details - REZZAYO (rezafungin) is a next-generation echinocandin indicated for patients with limited treatment options for candidemia and invasive candidiasis [3][7] - The drug has orphan drug exclusivity until 2035 and patent coverage until 2038 in the U.S., enhancing its market potential [3]