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 [18][19] - 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-$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 anticipates a total addressable market of over $2 billion for Rezeo, aimed at immune-compromised patients undergoing antifungal prophylaxis [10][11] - The total addressable market for DefenCath in the prevention of CLABSI for TPN patients is estimated 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 portfolio [5][7] - The company is focusing on integrating operations and capturing approximately $30 million of projected synergies from the Melinta acquisition by the end of 2025 [5][21] - Future growth strategies include expanding DefenCath's utilization and engaging with Medicare Advantage payers [9][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustained future profitability, supported by a substantial tax benefit of $59.7 million [22] - The company is optimistic about the operational performance in Q4 2025, expecting significant cash generation and a year-end cash position of approximately $100 million [24] Other Important Information - The integration of CorMedix and Melinta operations is progressing faster than expected, with all functional areas fully integrated from a personnel standpoint [16][17] - The company is working on real-world evidence studies to demonstrate the effectiveness of DefenCath in reducing infection rates [16][40] Q&A Session Summary Question: Inventory stocking versus utilization for DefenCath in Q3 - Management indicated that smaller customers held an average of two to three weeks of inventory, while larger customers held three to four weeks [29] Question: Guidance for next year and potential seasonality - Management noted that there is no historic seasonality in hemodialysis, and they are still assessing the full-year outlook 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, which is not bound by post-TDAPA pricing [33] 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 emphasized that volume growth has offset these changes [56]

Financial Data and Key Metrics Changes - CorMedix reported record revenue of $104.3 million for Q3 2025, a year-over-year increase of $77.5 million, driven by strong performance from DefenCath and contributions from Melinta [6][18] - Net income for the quarter was $108.6 million, or $1.26 per diluted share, compared to a net loss of $2.8 million in Q3 2024 [20][21] - Adjusted EBITDA for Q3 2025 was $71.8 million, a significant improvement from a loss of $2 million in the same quarter last year [22] Business Line Data and Key Metrics Changes - DefenCath sales reached $88.8 million, contributing significantly to the overall revenue growth [18] - 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 raised its pro forma combined full-year revenue guidance from a minimum of $375 million to a range of $390-$410 million [6] - Pro forma fully synergized adjusted EBITDA guidance for 2025 was increased from $165-$185 million to a new range of $220-$240 million [7] Company Strategy and Development Direction - The acquisition of Melinta Therapeutics is seen as transformational, creating a diversified specialty pharmaceutical company with a broad portfolio [5] - The company is focusing on integrating operations and capturing approximately $30 million of projected synergies by the end of 2025 [5][20] - CorMedix is planning to expand DefenCath into new indications, including the prevention of CLABSI for patients receiving total parenteral nutrition [11] 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 realized in Q3 2025 [21] - The company anticipates significant cash generation in Q4 2025, projecting to end the year with approximately $100 million in cash and cash equivalents [24] - Management highlighted the importance of upcoming catalysts, including top-line data for Rezeo in Q2 2026 and the expansion of DefenCath [10][11] Other Important Information - The integration of Melinta's operations is progressing faster than expected, with all functional areas fully integrated from a personnel standpoint [16] - The company is actively engaging with Medicare Advantage payers to expand the utilization of DefenCath [32] Q&A Session Summary Question: Inventory stocking versus utilization for DefenCath in Q3 - Management indicated that smaller customers are holding an average of two to three weeks of inventory, while larger customers are at three to four weeks [28] Question: Guidance for next year and potential seasonality - Management noted that there is no historic seasonality for the DefenCath business, and they are still assessing the full-year outlook for 2026 [30] Question: Real-world evidence and pricing negotiations for TDAPA - Management clarified that real-world evidence will be most applicable for Medicare Advantage, which has flexibility in contracting [33] Question: Update on DefenCath utilization and patient demographics - Management reported that utilization is higher than the initial target of 6,000 patients, primarily among fee-for-service patients [39] Question: Pricing dynamics post-TDAPA - Management acknowledged expected price compression post-TDAPA and is awaiting final determinations from CMS [45] Question: Insights on Melinta transaction and its value - Management emphasized the stabilizing revenue from Melinta and the potential of Rezeo as a significant growth driver [63]

Summary of CorMedix Inc. Conference Call Company Overview - CorMedix Inc. is transitioning from a small-cap single-product company focused on DefenCath, an antimicrobial catheter lock solution, to a multi-product diversified specialty injectable hospital acute care platform following the acquisition of Millennium Therapeutics [3][4] Acquisition of Millennium Therapeutics - The acquisition is seen as transformational, providing CorMedix with seven commercial products, primarily anti-infectives and antifungals, and a stable revenue base of approximately $130 million [5][4] - The acquisition aligns with CorMedix's criteria for business development, including synergy with existing products, near-term accretion, and growth potential [4][5] Synergies and Growth Opportunities - Post-acquisition synergies are expected in both operating costs and revenue, with potential overlaps in hospital systems and accounts [7][6] - DefenCath's expansion into new indications, such as TPN and chemotherapy, is anticipated to align well with Millennium's existing deployment [8][10] Market Potential for Rezeo - The total addressable market for Rezeo in prophylaxis of fungal infections is estimated to exceed $2 billion, with peak annual sales projected over $200 million [12][11] - The current approved indication for invasive fungal infections has a smaller market opportunity of about $250 million, with challenges in hospital utilization [9][10] Dialysis Market Insights - The dialysis market is highly concentrated, with major players like DaVita and Fresenius controlling 90-95% of the market [16][17] - CorMedix has successfully onboarded large dialysis operators, which is crucial for the adoption of DefenCath [18][19] Clinical Trials and Future Milestones - A real-world evidence study with US Renal Care is underway, with interim results expected later this year [20][21] - Clinical trials for new indications of DefenCath are progressing, with hopes for approval by the end of 2027 [21][22] Future Business Development - CorMedix aims to pursue future business development opportunities that are synergistic and accretive, focusing on renal, hospital acute care, and oncology spaces [24][25] - The acquisition of Millennium Therapeutics is viewed as a significant step in mitigating risks associated with pricing uncertainties for DefenCath [25][26] Conclusion - The acquisition of Millennium Therapeutics is a pivotal move for CorMedix, enabling a shift to a multi-product company with diverse growth opportunities, particularly in the hospital acute care sector and the expansion of DefenCath [25][26]