CorMedix Inc. Q4 FY2024 earnings call

DefenCath Commercial Performance - Fourth quarter had continued growth with existing and new customers in the outpatient segment, driving strong revenue and profit. - Began 2025 first quarter with over $25 million of purchase orders from existing customers. ### Inpatient Segment - Started to see utilization increase, partnered with Syneos Health to build dedicated inpatient field team, nearly fully staffed and expected to be active in 4 - 5 weeks; partnered with WSI to promote DefenCath to VA facilities. ### Clinical Developments - Began site selection for Phase 3 clinical study for reduction of CLABSIs in TPN patients, expect patient enrollment in second quarter; submitted orphan drug status application for TPN indication; goal is to obtain FDA approval for expanded use of taurolidine and heparin catheter lock solution in late 2027 to early 2028 with annual peak sales potential of $150 - $200 million; real - world evidence study with US Renal Care has commenced data collection; pediatric hemodialysis study to begin in third quarter 2025, spanning 3 - 5 years; expanded access program for high - risk populations commenced.

The fourth quarter saw net revenue of $31.2 million, and the full year had net revenue of $43.5 million. The fourth quarter was the first profitable commercial quarter with net income of $13.5 million and adjusted EBITDA of $15.3 million. The fourth quarter results were driven by strong uptake at US Renal Care, ramping implementation at IRC and DCI, and utilization by other small outpatient dialysis customers. For the full year 2024, total net revenue was $43.5 million. DefenCath was the primary driver of revenue and profit results, with the outpatient segment being the key contributor.

Revenue Guidance - Currently estimate net revenue from existing purchasing customers for first six months of 2025 to be in range of $50 million to $60 million, with more than $33 million expected in first quarter. - Expect DefenCath net price erosion to begin in second quarter of 2025. ### Inpatient Team - New inpatient team expected to be active in the field in next 4 - 5 weeks. ### TPN - Goal is to obtain FDA approval for expanded use of taurolidine and heparin catheter lock solution in late 2027 to early 2028, estimating annual peak sales potential of $150 million to $200 million.

Policy and Reimbursement - Proposed changes from new administration may pose risks, but DefenCath may present opportunities related to cost - cutting in government spend and promoting health. ### LDO Implementation - Contracted LDO customer implementation was pushed into 2025 due to operational resource constraints, which is a risk. ### Price Erosion - Expectation of net price erosion starting in second quarter 2025 is a risk. ### Clinical Study - Clinical study progress, such as enrollment delays or study results not meeting expectations, is a risk.

Q: What are your first steps for the Syneos Health partnership - built inpatient sales team once they're fully launched and what's the ramp look like in the inpatient setting for DefenCath over time?

A: Inpatient is currently about 3% of unit volume and 4% - 5% of dollars in first quarter. Team is nearly fully staffed, training near complete, and expected to be in field in next 4 - 5 weeks; aiming to move toward 10% unit volume of overall market opportunity by 2026.

Q: Can you give more color about the process that the contracted LDO is going through and your interactions that reinforce confidence they will begin ordering in next couple of months?

A: We've been very supportive, provided information requests around support services, staff available to them, and hopeful to stick with midyear implementation timeline.

Q: On TDAPA, how should we be thinking about patient applicability and trends in coverage such as Medicare Advantage over next two to three years and key levers to maximize uptake?

A: Initially 100% fee for service claims, then saw trend toward Medicare Advantage, currently 40% of claims are Medicare Advantage and others; real - world evidence study to utilize for direct contract negotiation with EMA plans to maximize uptake.

Q: Can you provide updates on DefenCath manufacturing capacity and filling open purchase orders to Q1?

A: Have more than a year's worth of finished dosage on hand at current run rate, well situated to fill open purchase orders.