CorMedix Inc. Q3 FY2025 earnings call

1. Completed the acquisition of Melinta Therapeutics, with integration progressing faster than initially expected. They aim to capture approximately $30 million of the projected $35 million to $45 million in total synergies by the end of 2025. 2. The company rebranded to CorMedix Therapeutics and adopted a new logo. 3. Achieved record financial results in the third quarter with record revenue, net income, and adjusted EBITDA. 4. Raised pro forma combined full year revenue guidance to a range of $390 million to $410 million and adjusted EBITDA guidance to $220 million to $240 million. 5. Closed a strategic minority investment in Talphera Inc., with a right-of-first negotiation to acquire Talphera following the announcement of Phase III results expected in the first half of 2026. 6. For DefenCath, it was pleased with the utilization in the outpatient hemodialysis initial phase of TDAPA and is planning for post-TDAPA add-on periods starting in July 2026. 7. Clinical updates: Enrollment for the global Phase III ReSPECT study for Rezzayo prophylaxis of fungal infections is complete, expecting top line results in Q2 2026; the Phase III Nutri-Guard study for DefenCath in CLABSI prevention for TPN patients is anticipated to complete by the end of 2026 or early 2027; the real-world evidence study with U.S. Renal Care is in the second year of data collection with interim results expected by the end of the year. 8. Integration progress: All functional areas have fully integrated personnel-wise. Systems integration is ongoing and expected to be completed in 2026. The legacy contracted hospital sales team for DefenCath will end service by the end of the year, and DefenCath promotion in the hospital setting will transition to the internal field organization in January 2026.

In the third quarter of 2025, CorMedix reported net revenue of $104.3 million. DefenCath sales accounted for $88.8 million, which is approximately 85.1% of the total revenue. The remaining revenue of around $15.5 million came from the Melinta portfolio, making up about 14.9% of the total. The quarter also saw record levels in net income ($108.6 million) and adjusted EBITDA ($71.8 million).

1. Raised pro forma combined full year revenue guidance from a minimum of $375 million to a range of $390 million to $410 million. 2. Increased pro forma fully synergized adjusted EBITDA guidance for 2025 from $165 million to $185 million to a new range of $220 million to $240 million. 3. Anticipates top line data for Rezzayo prophylaxis of invasive fungal infections in the second quarter of 2026. 4. Expects Phase III completion for DefenCath in CLABSI prevention for TPN patients as early as the end of 2026 or beginning of 2027.

1. Actual results may differ materially from forward-looking statements due to various factors such as regulatory uncertainties and market acceptance issues. 2. Uncertainty regarding TDAPA reimbursement calculations and its potential impact on DefenCath pricing. 3. Risks associated with the integration process, including systems integration challenges.

Q: On DefenCath, sense of inventory stocking versus utilization in 3Q and seasonality?

A: Smaller customers have on average about 2 to 3 weeks of inventory on hand, while LDO has between 3 to 4 weeks. The DefenCath business doesn't have historic seasonality related to hemodialysis patient times. For the Melinta portfolio, they aren't cough/cold type products, so no significant winter seasonality, though there may be a small amount of December stocking into January.

Q: Trends in DefenCath utilization and post TDAPA revenues?

A: LDO ordering and utilization have been faster than expected. Regarding post TDAPA revenues, there's price compression due to the shift from ASP method, and it depends on how CMS does the calculation for the post period, waiting for the final ESRD rule.

Q: Color on Melinta transaction misunderstanding?

A: Investors may not be crediting Melinta's stabilizing base business risk mitigation aspect and the potential of Rezzayo as a larger peak sales product with a over $2 billion total addressable market for immune compromised patients on prophylaxis.