• Fourth Quarter Net Revenue: $31.2 million.
• Full Year Net Revenue: $43.5 million.
• Fourth Quarter Net Income: $13.5 million or $0.22 per share.
• Fourth Quarter Operating Expenses: Increased 9% to $17.1 million.
• Fourth Quarter R&D Expense: Decreased 26% to $1.7 million.
• Fourth Quarter Selling and Marketing Expense: Increased 1% to $8.3 million.
• Fourth Quarter G&A Expense: Increased 36% to $7.1 million.
• Full Year Operating Expenses: $62 million, a 28% increase from 2023.
• Full Year R&D Expense: Decreased 70% to $3.9 million.
• Full Year Selling and Marketing Expense: Increased 59% to $28.7 million.
• Full Year G&A Expense: Increased 69% to $30 million.
• Net Cash Used in Operations (2024): $50.6 million.
• Cash and Cash Equivalents (End of 2024): $51.7 million.
• Projected Cash and Cash Equivalents (End of Q1 2025): At least $75 million.
• 2025 Cash Operating Expenses Guidance: $72 million to $78 million.

• Warning! GuruFocus has detected 3 Warning Signs with CRMD.

Release Date: March 25, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Cormedix Inc (NASDAQ:CRMD) achieved its first profitable commercial quarter in Q4 2024 with a net income of $13.5 million.
• The company reported strong revenue growth, with Q4 2024 net revenue at $31.2 million and full-year 2024 revenue at $43.5 million, both exceeding Wall Street expectations.
• Cormedix Inc (NASDAQ:CRMD) has secured over $25 million in purchase orders for Q1 2025, indicating strong demand for DefenCath.
• The company is expanding its market presence with a new in-patient field team and partnerships with Syneos Health and WSI to enhance commercialization efforts.
• Cormedix Inc (NASDAQ:CRMD) is advancing its clinical pipeline with a Phase 3 study for reducing central line-associated bloodstream infections (CLABSIs) and has applied for orphan drug status for this indication.

Negative Points

• Net price erosion for DefenCath is expected to begin in Q2 2025, which may impact future revenue.
• The implementation of DefenCath by a large dialysis organization (LDO) customer has been delayed to 2025 due to operational resource constraints.
• Operating expenses increased by 9% in Q4 2024, driven by higher selling, marketing, and G&A expenses.
• The company is not providing full-year revenue guidance for 2025, creating uncertainty about future financial performance.
• There are challenges in expanding the customer base, particularly with large dialysis organizations, which could impact growth potential.

Q & A Highlights

Q: Can you provide details on the Syneos Health partnership and the inpatient sales team ramp-up for DefenCath? A: Joseph Todisco, CEO, explained that the inpatient segment was initially slow but is now gaining traction, with inpatient sales accounting for about 3% of unit volume and 4-5% of revenue in Q1. Erin Mistry, Chief Commercial Officer, added that the team will focus on large academic medical centers and VA medical centers, with training nearly complete and deployment expected in the next four to five weeks.

Q: What is the expected impact of net price erosion starting in Q2 2025? A: Joseph Todisco, CEO, noted that while exact percentages weren't provided, price erosion is anticipated due to discounts and rebates off government ASP. The company expects a shelf stock adjustment at the end of Q2, with the impact on revenue being factored into their guidance for the first half of 2025.

Q: Can you elaborate on the contracted LDO's process and your confidence in their upcoming orders? A: Joseph Todisco, CEO, stated that CorMedix is providing extensive support to the LDO, including training and reimbursement assistance. While hopeful for implementation by mid-year, the exact timing and scale of orders remain uncertain.

Q: How is CorMedix addressing potential new customers and smaller providers? A: Joseph Todisco, CEO, mentioned ongoing communication with another LDO and efforts to engage smaller providers and joint venture entities. The focus is on increasing order size and frequency from these smaller customers throughout 2025.

Q: What are the expectations for the TPN program and its patient population? A: Liz Hurlburt, EVP and Chief Clinical Strategy & Operations Officer, explained that the Phase 3 NutriGuard study targets adult TPN patients who have had a CLABSI in the past 12 months, as they are at higher risk for infections. These patients are similar to dialysis patients in terms of vulnerability but access their catheters daily.

Q: How has the change in CMMI policy impacted patient uptake in Q1? A: Joseph Todisco, CEO, noted that the policy change in November, which allowed TDAPA payments without penalties, led to a 15-20% increase in patient numbers, particularly with US Renal Care.

Q: What resources does CorMedix provide to help providers with reimbursement processing? A: Erin Mistry, Chief Commercial Officer, stated that CorMedix has partnered with a third-party hub, Prospectus, to assist with benefits verification, billing and coding expertise, and navigating payer policies and Medicaid challenges.

Q: How is CorMedix positioned in terms of manufacturing capacity and raw materials? A: Joseph Todisco, CEO, assured that CorMedix has more than a year's worth of finished dosage on hand and sufficient raw materials. The company can pivot to additional manufacturing capacity within a few months if needed.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.