BERKELEY HEIGHTS, N.J., Dec. 18, 2025 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced interim results for the Company’s ongoing real-world evidence study being conducted in conjunction with U.S. Renal Care’s (USRC) use of DefenCath in adult hemodialysis patients with central venous catheters. CorMedix and USRC commenced the real-world evidence stu ...

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]