Cormedix Lifts 2026 Outlook After Q1 Beat, Sets H2 FDA Filing Plan for Rizzeo

Overview

• Cormedix reported Q1 net revenue of $127.4 million and adjusted EBITDA of $70 million, then raised full-year guidance to $325–$345 million in revenue and $115–$135 million in EBITDA.
• DefenCath demand remained strong on higher patient use and the full-quarter contribution from the Melinta brands, with management pointing to rising run rates at key dialysis customers.
• A non-recurring $9 million change in sales allowances lifted Q1 results, which management and analysts said could affect Q2 comparisons.
• The company plans an FDA submission for Rizzeo in the second half of 2026 for prophylaxis, with Mundy leading regulatory work and a potential 2027 launch under evaluation.
• Cormedix is seeking an FDA-approved change to widen enrollment in its TPN study and now guides to a 2028 timeline, while it courts Medicare Advantage plans and flags a June shelf stock adjustment as buyers prepare for a 2027 price step-up after Medicare’s temporary add-on for new dialysis products ends.