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CorMedix(CRMD) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - CorMedix reported first quarter net sales of $39.1 million, aligning with preannounced results, and achieved adjusted EBITDA of $23.6 million, slightly above earlier expectations [7][15] - The company recognized net income of $20.6 million or $0.32 per share, compared to a net loss of $14.5 million or $0.25 per share in the same quarter of the previous year [15] - Operating expenses increased approximately 9% to $17.4 million from $15.9 million year-over-year, with R&D expenses rising 281% to $3.2 million [16] Business Line Data and Key Metrics Changes - The majority of first quarter shipments (over 80%) came from U.S. Renal Care, with growth also noted in smaller outpatient dialysis operators and inpatient hospitals [31][32] - Inpatient hospital orders accounted for more than 6% of shipments in April, more than doubling from the first quarter [8] Market Data and Key Metrics Changes - The company anticipates net revenue guidance for DEFENCATH sales to existing customers in the first half of the year to be approximately $70 million, with a projected second quarter revenue of $23 million to $31 million [8] - The inpatient market is expected to grow as the dedicated sales team is now fully operational, and initial orders to VA facilities have been shipped [11] Company Strategy and Development Direction - CorMedix aims to expand DEFENCATH to new therapeutic indications and increase its customer base [18] - The company is optimistic about the implementation timeline with a large dialysis operator customer, targeting mid-year 2025 for the start [10] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the operational engagement with the large dialysis operator and noted that macro-level issues are not currently impacting inventory [25][26] - The company is focused on increasing utilization growth in the latter half of 2025 as new patients initiate therapy [10] Other Important Information - CorMedix has cash and cash equivalents of $77.5 million as of March 31, 2025, and expects cash operating expenses for 2025 to be between $72 million and $78 million [17] - The company is conducting a Phase 3 clinical study targeting the reduction of central line-associated bloodstream infections, with completion expected by late 2026 or early 2027 [12] Q&A Session Summary Question: Updates on the LDO partnership and operational engagement - Management noted increased preparatory activities with the large dialysis operator and remains cautiously optimistic about the timeline for implementation [22][23] Question: Drivers behind the first quarter revenue number - The majority of revenue was driven by U.S. Renal Care, with good growth also seen in smaller customers and hospitals [30][31] Question: Insights on U.S. Renal Care's patient pool and utilization tracking - Approximately 78% of first quarter revenue came from U.S. Renal Care, with good visibility into utilization versus inventory [42][43] Question: Reimbursement negotiations with Medicare Advantage - Management expects to enter negotiations with Medicare Advantage plans while TDAPA is still in force, with about 40% of claims currently from MA plans [44][46] Question: Inpatient segment opportunity and reimbursement process - The inpatient segment is expected to grow, but its overall percentage of business will depend on new customer onboarding and market dynamics [54][55]