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 has announced changes in its executive leadership, with CEO Joseph Todisco extending his contract and taking on the role of Chairman of the Board, succeeding Myron Kaplan, who will become the Lead Independent Director [1][2][3] Leadership Changes - Joseph Todisco's extended contract reflects his long-term commitment to CorMedix, and his transition to Chairman is seen as a strategic move to strengthen the company for future success [1][2] - Mike Seckler has been appointed as EVP & Chief Commercial Officer, bringing extensive experience in hematology and oncology, previously serving as CEO of Evome Medical Technologies Inc. [2][3] Company Overview - CorMedix is focused on developing and commercializing therapeutic products for life-threatening conditions, including its product DefenCath, which is aimed at preventing catheter-related bloodstream infections in hemodialysis patients [4] - Following the acquisition of Melinta Therapeutics LLC in August 2025, CorMedix is also commercializing a range of anti-infective products, including MINOCIN, REZZAYO, VABOMERE, ORBACTIV™, BAXDELA, and KIMYRSA [4] Clinical Developments - CorMedix has ongoing clinical studies for DefenCath in Total Parenteral Nutrition and Pediatric Hemodialysis populations, with plans to develop it as a catheter lock solution for other patient groups [5] - REZZAYO is currently approved for treating candidemia and invasive candidiasis in adults, with a Phase III study ongoing for prophylaxis of invasive fungal disease in patients undergoing allogeneic bone marrow transplantation, with topline results expected in Q2 2026 [5]

Core Insights - CorMedix Inc. is addressing a significant unmet medical need in preventing dialysis-related bloodstream infections through its catheter lock solution, DefenCath, which has shown promising clinical results [2][3] Group 1: Product Development and Clinical Results - DefenCath has demonstrated a 72% reduction in catheter-related bloodstream infections and a 70% reduction in related hospitalizations based on real-world evidence from a study ongoing since mid-2024 [3] - The adoption of DefenCath is exceeding expectations, with utilization rates well above the target of 6,000 patients [4] Group 2: Financial Performance and Growth Opportunities - CorMedix reported approximately $13 million in sales from Melinta Therapeutics' portfolio in September, indicating potential for significant synergies and growth opportunities outside the hemodialysis space [5] - The company is finalizing supply pricing under existing contracts and aims to boost utilization among Medicare Advantage users in the upcoming months [5] Group 3: Future Prospects - CorMedix is preparing for add-on periods beginning in summer 2026 and anticipates Phase III trial data for its other leading candidate, REZZAYO, in early 2026 [6]

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].

Financial Data and Key Metrics Changes - The company reported record revenue of $104.3 million for Q3 2025, a significant increase of $77.5 million year-over-year [7][18] - Net income reached $108.6 million, translating to $1.26 per diluted share, a substantial improvement from a net loss of $2.8 million in Q3 2024 [21][22] - Adjusted EBITDA for Q3 2025 was $71.8 million, up from a loss of $2 million in the same quarter last year [22][23] - The company raised its full-year revenue guidance from a minimum of $375 million to a range of $390 million-$410 million [7][8] Business Line Data and Key Metrics Changes - DefenCath sales accounted for $88.8 million of the total revenue, reflecting strong performance and utilization growth [18][19] - The Melinta portfolio contributed approximately $15.5 million in revenue for September 2025, with $12.8 million from Melinta portfolio sales [19] Market Data and Key Metrics Changes - The company is focusing on expanding DefenCath's utilization in the outpatient hemodialysis segment and planning for post-TDAPA add-on periods starting July 2026 [9][10] - The total addressable market for REZZAYO, aimed at immune-compromised patients, is estimated to exceed $2 billion [10][11] - The anticipated market for DefenCath in preventing CLABSI for patients receiving total parenteral nutrition is projected at up to $750 million [11] Company Strategy and Development Direction - The acquisition of Melinta Therapeutics is seen as transformational, creating a diversified specialty pharmaceutical company with a broad product portfolio [5][6] - The company is rebranding as CorMedix Therapeutics to reflect its commitment to developing novel therapies [6] - The integration of operations is progressing faster than expected, with projected synergies of approximately $30 million expected to be realized by the end of 2025 [5][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future profitability, supported by a substantial tax benefit of $59.7 million [22] - The company is optimistic about capturing synergies from the Melinta acquisition and expects significant cash generation in Q4 2025 [24][25] - Management highlighted the importance of real-world evidence data in negotiations with Medicare Advantage payers for future growth [33][46] Other Important Information - The company is expanding clinical study sites for the Nutri-Guard clinical study in Turkey to expedite enrollment timelines [15][16] - The integration of personnel across all functional areas is complete, with systems integration expected to finish in 2026 [17] Q&A Session Summary Question: Inventory stocking versus utilization in Q3 for DefenCath - Management indicated that smaller customers are holding about two to three weeks of inventory, while larger customers are at three to four weeks [29] Question: Guidance for next year and potential seasonality - Management noted that there is no historic seasonality in hemodialysis and that they are still assessing the full year for 2026 [30][31] Question: Real-world evidence and pricing negotiations for post-TDAPA - Management clarified that real-world evidence will be most applicable for Medicare Advantage and that traditional Medicare has limited negotiation opportunities [33][34] Question: Utilization and patient demographics for LDO - Management reported that utilization is higher than the initial target of 6,000 patients, primarily among fee-for-service patients [38] Question: Pricing dynamics for DefenCath in Q3 - Management acknowledged slight price erosion quarter-over-quarter but noted significant volume growth offsetting this [56] Question: Legislation affecting TDAPA reimbursement - Management mentioned a bipartisan bill proposing changes to TDAPA, which could incentivize innovation and extend the ASP-based pricing period [58]

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. announced that its product DefenCath has received an Innovative Technology designation from Vizient, indicating its potential impact on patient care and healthcare operations [1][4] - DefenCath is the first FDA-approved antimicrobial catheter lock solution in the U.S., specifically designed to reduce catheter-related bloodstream infections in adult patients undergoing chronic hemodialysis [3][5] - In clinical studies, DefenCath demonstrated a 71% reduction in the risk of developing catheter-related bloodstream infections compared to control [3] Company Overview - CorMedix is a biopharmaceutical company 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 LLC in August 2025, CorMedix is also commercializing a portfolio of anti-infective products [5] - The company has ongoing clinical studies for DefenCath in various patient populations and intends to expand its applications [6] Industry Context - Vizient, the organization granting the Innovative Technology designation, represents a diverse client base with approximately $156 billion in annual purchasing volume, including academic medical centers and community hospitals [4] - The Innovative Technology designation is awarded based on evaluations by healthcare experts for products that enhance clinical care and improve business operations [2]