CorMedix FY Conference Summary Company Overview - **Company**: CorMedix (NasdaqGM:CRMD) - **Industry**: Specialty Pharmaceuticals - **Focus**: Institutional settings of care, primarily injectable drugs used in hospitals and infusion centers [2][3] Financial Highlights - **Cash Position**: Approximately $150 million cash on hand, close to zero net debt [2][6] - **Revenue Guidance for 2026**: Expected to exceed $300 million, with EBITDA between $100-$125 million [3][5] - **2025 Revenue**: Exceeded $400 million, driven by DefendCath and Melinta acquisition [5][6] Key Products and Pipeline DefendCath - **Approval**: Approved in late 2023, launched mid-2024 [6][8] - **Indication**: Reduces risk of catheter-related bloodstream infections (CRBSIs) in hemodialysis patients [8][9] - **Market Size**: Total addressable market (TAM) of approximately $750 million [23] - **Reimbursement**: Under CMS's TDAPA, transitioning to post-TDAPA add-on period in July 2026 [10][11] - **Clinical Impact**: Phase 3 study showed a 71% reduction in CRBSI risk; real-world data from US Renal Care showed a 70% reduction in hospitalizations [12][13] Rezzayo - **Current Status**: In phase three clinical studies for prophylaxis of fungal infections in immunocompromised patients, with results expected in Q2 2026 [3][14] - **Market Potential**: TAM over $2 billion for prophylaxis of invasive fungal infections [21] Leadership and Team - **New Additions**: Mike Seckler as Chief Commercial Officer and Susan Blum as CFO, enhancing the leadership team [4] Strategic Initiatives - **Acquisition of Melinta**: Added $140 million in revenue and a portfolio of anti-infectious products [5][16] - **Future Growth**: Focus on expanding indications for existing products and pursuing strategic tuck-in business development [17][23] Market Position and Valuation - **Current Valuation**: Trading at a significant discount compared to peers (5x EBITDA vs. 12x for peers) [27] - **Investor Education**: Emphasis on improving communication regarding the value of Rezzayo and DefendCath for TPN [27][28] Upcoming Milestones - **Analyst Day**: Scheduled for February 10, 2026, to discuss growth trajectory and upcoming catalysts [24] - **Clinical Data Updates**: Expected for TPN study and Rezzayo sNDA submission in early 2027 [24][35] Regulatory and Competitive Landscape - **Legislative Risks**: Potential changes in TDAPA reimbursement structure could impact future revenue [35] - **Intellectual Property**: Strong IP protection for DefendCath and Rezzayo, with exclusivity extending into the 2030s [38][39] Conclusion - **Outlook**: CorMedix is positioned as a robust, diversified specialty pharmaceutical company with a strong financial profile and significant growth potential through its product pipeline and strategic initiatives [26]