CorMedix(US:CRMD)2025-11-12 14:30Financial 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]