CorMedix (CRMD) Q1 2025 earnings summary

Executive summary

• Achieved profitability in Q1 2025 with net sales of $39.1 million and net income of $20.6 million, driven by strong DefenCath sales in both inpatient and outpatient settings.

• DefenCath, the first FDA-approved antimicrobial catheter lock solution for hemodialysis, launched in April 2024 (inpatient) and July 2024 (outpatient), with rapid market uptake and broad reimbursement approvals including NTAP, TDAPA, and pass-through status.

• Signed multi-year supply agreements with large and mid-sized dialysis organizations, covering about 60% of the U.S. outpatient dialysis market; U.S. Renal Care accounted for 78% of Q1 revenue.

• Inpatient hospital shipments doubled from Q1 to April, now representing over 6% of shipments, with a dedicated sales team fully operational.

• Initiated Phase 3 clinical study for CLABSI in TPN patients, with first site operational and patient dosing imminent.

Financial highlights

• Q1 2025 revenue was $39.1 million, up from $0 in Q1 2024, reflecting the first full quarter of DefenCath sales.

• Net income for Q1 2025 was $20.6 million ($0.32 per share), versus a net loss of $14.5 million ($0.25 per share) in Q1 2024.

• Gross profit was $37.5 million, with cost of revenue at $1.6 million and gross margin of approximately 96%.

• Operating expenses rose 9% year-over-year to $17.4 million, mainly from increased R&D and G&A costs.

• Net cash provided by operations was $19.7 million, compared to net cash used of $17.3 million in Q1 2024; cash and cash equivalents stood at $77.5 million as of March 31, 2025.

Outlook and guidance

• Net revenue guidance for DefenCath sales to existing customers for H1 2025 narrowed to approximately $70 million, at the upper end of the prior $62–$70 million range.

• Q2 2025 net revenue expected to be $23–$31 million, with sequential decline due to shipment timing; normalization expected in Q3.

• Anticipates utilization growth in H2 2025 as new patients initiate therapy and new customers are added; full-year outlook depends on timing and scale of large dialysis operator uptake.

• Management expects sufficient resources to fund operations for at least twelve months from March 31, 2025, supported by cash on hand, receivables, and ATM program capacity.

• 2025 cash operating expenses guided to $72–$78 million, mainly due to increased R&D spending.