CorMedix (NasdaqGM:CRMD) FY Conference Transcript

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]