CorMedix Inc. (Nasdaq: CRMD) has announced preliminary unaudited financial results for the fourth quarter of 2024, showcasing significant revenue growth and strategic expansions. The company, focused on developing and commercializing therapeutic products for life-threatening diseases, anticipates exceeding its breakeven guidance for the year. These results highlight the increasing adoption of DefenCath and strategic initiatives to broaden its application.
Financial Highlights
CorMedix reported preliminary net revenue of approximately $31 million for Q4 2024 and $43 million for the full year. The company expects adjusted EBITDA to exceed $12 million for the quarter. As of December 31, 2024, CorMedix holds approximately $52 million in cash and short-term investments.
"I'm proud to announce our preliminary Q4 results today, including surpassing our guidance of becoming breakeven by year-end 2024," said Joe Todisco, CEO of CorMedix. "CorMedix continues to execute well on our key objectives particularly around our outpatient launch, and I am pleased with the implementation efforts we have seen thus far from key customers in the outpatient segment."
DefenCath Expansion and Clinical Studies
DefenCath (taurolidine and heparin), approved by the FDA on November 15, 2023, is currently being shipped to all three of CorMedix's midsized dialysis operator (MDO) customers, with continuous ordering of increasing size observed throughout the quarter. The company reports over $25 million in existing open purchase orders scheduled for delivery in the first quarter of 2025.
CorMedix is actively collaborating with a Large Dialysis Operator (LDO) customer to initiate DefenCath implementation in the first half of 2025, aiming for a patient utilization target of 4,000 patients in the second half of the year. Furthermore, the company is expanding its focus to the inpatient hospital segment, partnering with Syneos Health to establish a dedicated field sales team for DefenCath promotion within hospitals and health systems, commencing in Q1 2025.
Clinical development of DefenCath is also progressing, with a final study protocol submitted to the FDA for use in Total Parenteral Nutrition (TPN) patients. Patient enrollment is anticipated to begin in the first half of 2025. A pediatric study for DefenCath in pediatric hemodialysis is expected to commence in the second half of 2025.
Operating Expense Guidance
CorMedix anticipates that the expanded inpatient deployment and internal commercial realignment will be cost-neutral regarding overall sales and marketing expenses in 2025. Preliminary operating expense guidance for FY 2025 is projected to be between $72 million and $78 million, excluding non-cash and one-time items. The increase in spending compared to 2024 is primarily attributed to R&D investments in previously announced clinical initiatives.
