CorMedix Inc. Q3 FY2024 earnings call

• DefenCath Launch: Third quarter was first full quarter of DefenCath shipments and outpatient utilization. Net revenue of $11.5M exceeded Street consensus, driven by U.S. Renal. New agreements with midsized and large dialysis operators, with purchases expected from new partners by end of Q4. DefenCath is protocolized by outpatient customers, patient conversion ramp quick once live but setup takes weeks to months.
• Inpatient Launch: Made progress in building champions and scheduling P&T meetings. Some hospitals with early P&T review have added DefenCath to formulary.
• Clinical Developments:
  • TPN: Received FDA supportive feedback, refining clinical protocol to submit by mid-November 2024, aiming for FDA approval late 2027-2028 with annual peak sales potential $150M-$200M. Study cost $10M-$12M over 2025-2026.
  • Real World Evidence Study: With U.S. Renal Care, evaluating ~2,000 patients over 24 months to generate data on cost, infection rates, etc. Data collection commenced.
  • Pediatric Hemodialysis Study: Post-marketing requirement, FDA concurrence on protocol, plan to begin patient enrollment early 2025, cost $4M-$6M over 5 years.
  • Expanded Access Program: For high-risk populations, cost <$750K/year, generate data for label expansion.
• Financials: Third quarter net loss $2.8M vs $9.7M in 2023. Operating expenses increased, but R&D decreased due to DefenCath approval. Cash and cash equivalents $46M as of Sept 30, 2024, expect to fund operations for at least 12 months.

The main product segment is DefenCath. In the third quarter, net revenue was $11.5 million. DefenCath was the driver, with initial anchor customer U.S. Renal contributing significantly. Revenue contribution from DefenCath is substantial as it's the newly launched product with commercial activities in the quarter.

• Fourth Quarter: Expect EBITDA positive. Revenue variability due to timing and scale of purchases from large dialysis operators and new customers. LDO customer expected to begin ordering in Dec, new MDO customers expected to begin orders in Nov.
• TPN: Anticipate submitting refined clinical protocol to FDA by mid-Nov 2024, aim for approval late 2027-2028.

• Revenue Variability: Timing of purchases from large dialysis operators and new customers can materially impact fourth quarter revenue.
• Inpatient Launch Complexity: Inpatient update process longer and ramp more consistent with traditional launches compared to outpatient.
• Manufacturing and Supply: While current finished dosage inventory is sufficient, need to ensure sufficient quantities for future demand, especially with new customers.

Q: Speak to use of product driven by individual doctors vs institutions, reimbursement dynamics, and 4Q expenses A: Outpatient use is top-down protocolization. Reimbursement balance seen with Medicare fee-for-service and Advantage. 4Q operating expenses expected to be in 15-17 range, with R&D uptick in 2025-2026.

Q: Stocking, macro impact, manufacturing for future demand A: Initial customers ship direct, LDO may hold 15-30 days inventory. Macro impact on Southeast clinics resolved. Manufacturing has sufficient quantities with two finished dosage manufacturers.

Q: Patient metrics, dialysis center access, inpatient contribution, ND Partners A: 3Q metrics not disclosed yet. 60% access to dialysis centers with potential for higher utilization. Inpatient contribution long-term. ND Partners milestone met, payment expected over coming year.

Q: Anchor customer U.S. Renal's sales percentage, TDAPA transition A: U.S. Renal accounted for >90% of 3Q sales. TDAPA transition to ASP not expected to impact ordering patterns drastically.

Q: Why no guidance, TPN FDA feedback, financing A: Variability in LDO customer purchases prevents guidance. TPN FDA feedback minor, protocol amended. Financing may consider ATM and business development dry powder.