CorMedix combines DefenCath’s near-monopoly dialysis position, profitable Melinta diversification, and discounted valuation with meaningful CMS, customer-concentration, and pipeline-execution risk.
Overview
CorMedix is a commercial-stage U.S. specialty pharmaceutical company built around DefenCath, the first and only FDA-approved antimicrobial catheter lock solution, and a six-product acute-care anti-infective portfolio acquired from Melinta in August 2025. DefenCath’s LOCK-IT-100 Phase III trial reduced CRBSIs by 71% versus heparin, and agreements with all five leading dialysis organizations provide coverage of 100% of the top-tier market. **Financial momentum is strong:** Q2 2026 revenue rose 157% year over year to $101.93 million, including $66.10 million from DefenCath and $35.83 million from Melinta, while Adjusted EBITDA increased 162% to $58.74 million. GAAP net income was $25.99 million, or $0.29 per diluted share, beating the $0.24 consensus estimate. Management reaffirmed 2026 revenue guidance of $325 million-$345 million and DefenCath guidance of $175 million-$195 million, while raising Adjusted EBITDA guidance to $125 million-$140 million. Valuation remains compressed at approximately 1.8x trailing EV/EBITDA and 5.1x trough-year EV/EBITDA. Near-term catalysts include the REZZAYO prophylaxis sNDA, CMS’s 2027 post-TDAPA rate, fifth-LDO rollout, and real-world DefenCath outcomes.