CorMedix Inc. Q1 FY2025 earnings call

• CorMedix has strong momentum with DefenCath's launch, with first quarter net sales of $39.1 million in line with pre-announced results and adjusted EBITDA slightly above pre-announcement.
• Steady utilization growth with existing anchor customer U.S. Renal Care, IRC, and DCI, and new utilization with smaller outpatient dialysis operators and inpatient hospitals. In April, inpatient hospital ordering accounted for over 6% of shipments.
• Updated net revenue guidance for DefenCath sales to existing customers for the first half of 2025 to a range of $62 million to $70 million, narrowing to approximately $70 million based on order trends and inventory tracking.
• Inpatient sales team is fully staffed, trained, and operational, and partnership with WSI for promotion to federal facilities is operational with first orders shipped to VA facilities in Q1.
• Phase 3 clinical study for reduction of CLABSIs in adult TPN patients began site selection in February, first site operational, first patient to be dosed soon. Submitted Orphan Drug status application for this indication. Goal to obtain FDA approval for expanded use of taurolidine and heparin catheter lock solution in late 2027 to early 2028 with peak sales potential $150M-$200M.
• Real-world evidence study with U.S. Renal Care has eclipsed 2,000 patients and will hit midpoint in July. Study of DefenCath in pediatric hemodialysis population to begin in Q3 2025. Expanded access program for high-risk populations is live.

The company's key product segment is DefenCath. In the first quarter of 2025, net sales of DefenCath were $39.1 million. Adjusted EBITDA for the first quarter was $23.6 million. DefenCath's revenue contribution is significant as it led to the company's profitability in the quarter.

• Revised net revenue guidance for DefenCath sales to existing customers for the first half of 2025 to approximately $70 million, narrowing the range toward the upper end.
• Anticipate order volumes from U.S. Renal Care to normalize starting in Q3 2025.
• Optimistic about achieving mid-year 2025 implementation start with a large dialysis operator customer, awaiting a definitive timeline from the customer.
• Goal to obtain FDA approval for expanded use of taurolidine and heparin catheter lock solution in late 2027 to early 2028 with peak sales potential $150M-$200M.

• Inventory lumpiness was largely caused by a customer's price incentive to move inventory earlier.
• Uncertainty in the timing of implementation by the large dialysis operator customer.
• Macro-level issues like tariffs or supply chain constraints not a major issue for the company but inventory lumpiness could still be affected by unforeseen customer actions.

Q: Gregory Renza from RBC Capital asked about the LDO partnership progress and inventory control.

A: Joe Todisco said the LDO partnership has seen heightened preparatory activity but nothing is set in stone, and inventory lumpiness was due to customer inventory moves, with no major macro issues affecting it.

Q: Roana Ruiz from Leerink Partners asked about drivers of 1Q revenue and updates on the LDO.

A: Joe Todisco said U.S. Renal was a large driver of 1Q revenue, and they have visibility into inventory and utilization, with optimism about the LDO partnership.

Q: Leszek Sulewski from Truist Securities asked about U.S. Renal start, reimbursement.

A: Joe Todisco discussed U.S. Renal's utilization runway, reimbursement negotiations with MA plans, and expected MA claim percentages.

Q: Serge Belanger from Needham & Company asked about the inpatient segment and TDAPA reimbursement.

A: Joe Todisco talked about the inpatient segment's opportunity and ongoing efforts to modify TDAPA reimbursement.

Q: Dan Ferry from audience asked about provider feedback on DefenCath.

A: Liz Hurlburt said customer feedback has been positive, with smooth implementation and helpful reimbursement support.