BERKELEY HEIGHTS, N.J., Feb. 02, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced its Board of Directors has approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock. The repurchase program is authorized through December 31, 2027. “With a strong balance sheet, s ...

Core Insights - CorMedix Therapeutics announced interim results from a real-world evidence study of DefenCath, showing significant reductions in catheter-related bloodstream infections (CRBSI) and related hospitalizations in hemodialysis patients [1][3]. Company Overview - CorMedix is a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases, particularly through its product DefenCath, aimed at preventing CRBSI in adult hemodialysis patients [5][6]. - The company has expanded its portfolio following the acquisition of Melinta Therapeutics LLC, which includes various anti-infective products [5][6]. Study Details - The real-world evidence study, initiated in July 2024, aims to assess the impact of DefenCath on CRBSI rates and hospitalizations over a two-year period, with over 3,000 patients currently using the product monthly at U.S. Renal Care facilities [2][3]. - Preliminary analysis indicates a 72% reduction in CRBSI and a 70% reduction in hospitalizations due to CRBSI compared to historical controls, highlighting the potential cost savings for the healthcare system [3]. Economic Impact - The Centers for Medicare & Medicaid Services (CMS) spends over $3 billion annually on CRBSI-related costs in the end-stage renal disease (ESRD) patient population, with average hospitalization costs estimated at $63,000, potentially rising to $110,000 per incident [3]. - CorMedix aims to leverage these findings in discussions with payers, including Medicare Advantage, to enhance access to DefenCath and establish long-term reimbursement strategies [4]. Future Directions - The company is also assessing secondary data points such as missed treatment sessions and antibiotic utilization, with plans to release additional real-world evidence data in the future [4]. - CorMedix continues to conduct clinical studies for DefenCath in other patient populations and intends to develop it as a catheter lock solution [7].

Core Insights - CorMedix Inc. reported Q3 2025 net revenue of $104.3 million and pro forma net revenue of $130.8 million, primarily driven by increased utilization of DefenCath by outpatient dialysis customers [4] - The company raised its full-year 2025 pro forma net revenue guidance to a range of $390 to $410 million, with fourth quarter guidance set between $115 to $135 million [4] - CorMedix achieved a net income of $108.6 million for Q3 2025, significantly improving from a net loss of $2.8 million in Q3 2024, aided by a one-time tax benefit of $59.7 million [3][4] Financial Performance - Q3 2025 net revenue was $104.3 million, with DefenCath sales contributing $88.8 million [4] - Adjusted EBITDA for Q3 2025 was reported at $71.9 million, with basic and diluted EPS at $1.42 and $1.26, respectively [4][3] - Total operating expenses for Q3 2025 were $41.7 million, a 197% increase from $14.1 million in Q3 2024, driven by non-recurring costs related to the Melinta acquisition [5] Business Developments - CorMedix completed the acquisition of Melinta Therapeutics on August 29, 2025, with integration efforts proceeding faster than expected, estimating a synergy capture of approximately $30 million [4] - The company announced a rebranding to CorMedix Therapeutics, with all employees operating under the new name [4] - CorMedix completed enrollment in the Phase III ReSPECT study for Rezzayo in October 2025, expecting top-line data in Q2 2026 [4] Cash Position - As of September 30, 2025, CorMedix reported cash and short-term investments of $55.7 million, projecting year-end cash of approximately $100 million [6][4]

Core Insights - CorMedix Inc. reported preliminary unaudited net revenue for Q3 2025 exceeding $125 million, with DefenCath contributing more than $85 million to this total [1][4] - The company has raised its full-year 2025 pro forma net revenue guidance to at least $375 million, up from the previous range of $325-$350 million [1][4] - CorMedix anticipates achieving approximately $30 million in operating synergies on a go-forward run-rate basis before the end of 2025 [1][4] Financial Performance - Preliminary Q3 2025 unaudited net revenue is reported to be over $100 million, with DefenCath revenue growth driven by higher utilization from LDO customers and other clients [4] - The company expects adjusted EBITDA for Q3 2025 to be at least $70 million [4] - As of September 30, 2025, cash, cash equivalents, and short-term investments totaled approximately $56 million, with a projected year-end balance of around $100 million [4] Business Developments - CorMedix has made significant progress in integrating the recently acquired Melinta portfolio, with expected cost synergies of $30 million before Q4 2025 and an additional $5-$15 million targeted for 2026 [4] - The company has completed enrollment in the Phase III ReSPECT study for Rezzayo, aimed at preventing fungal infections in patients undergoing allogeneic blood and marrow transplants, with clinical data expected in Q2 2026 [4][6] - The total addressable market for prophylaxis is estimated to exceed $2 billion [4] Product Portfolio - CorMedix is focused on developing and commercializing therapeutic products for life-threatening conditions, including DefenCath for preventing catheter-related bloodstream infections [5] - Following the acquisition of Melinta Therapeutics, the company is also commercializing a range of anti-infective products, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV™, BAXDELA, and KIMYRSA [5]

Core Viewpoint - CorMedix Inc. has completed the acquisition of Melinta Therapeutics LLC, which is expected to enhance its revenue base and product portfolio, particularly in the hospital space, while providing significant growth opportunities [2][4]. Strategic and Financial Benefits - The acquisition is described as transformational, expanding CorMedix's commercial product portfolio with seven innovative drug products and a pipeline that has near-term revenue growth potential [4][5]. - Pro forma combined revenues for 2025 are now estimated to be between $325 million and $350 million, with synergized adjusted EBITDA projected to be between $165 million and $185 million [5][4]. - Melinta's portfolio generated total revenues of $120 million in 2024 and is expected to deliver between $125 million and $135 million for FY 2025 [5]. - The acquisition is anticipated to be accretive to earnings per share (EPS) with double-digit accretion expected in 2026 [1][5]. Product Portfolio and Growth Potential - The acquisition strengthens CorMedix's portfolio with multiple growth-driving assets, including marketed products such as MINOCIN, REZZAYO™, and VABOMERE, which will enhance revenue and reach in infectious disease [5]. - REZZAYO™ has ongoing Phase III studies that, if successful, could support a supplemental New Drug Application for expanded use, with peak annual sales potential exceeding $200 million [5]. - The combination is expected to achieve annual run-rate synergies of approximately $35 million to $45 million in the near term [5]. Leadership and Organizational Structure - The senior leadership team of the newly merged company will consist of executives from both CorMedix and Melinta, maintaining their current roles unless otherwise specified [4][11]. - The company plans to finalize a permanent commercial organization structure by the end of the year [6]. Acquisition Terms and Financing - CorMedix paid $300 million for the acquisition, consisting of $260 million in cash and $40 million in equity, funded through existing cash and a $150 million convertible debt financing [7]. - An additional regulatory milestone payment of up to $25 million is contingent upon FDA approval for REZZAYO™'s expanded indication [7].