Cormedix Stock Earnings Reports

CorMedix reported strong Q1 2026 results with net revenue of $127.4M (DefenCath $97.5M; Melinta portfolio $29.9M) and adjusted EBITDA of $70M. Management raised full-year 2026 guidance: net revenue to $325M–$345M (previously $300M–$320M) and adjusted EBITDA to $115M–$135M (previously $100M–$125M). DefenCath guidance was raised to $175M–$195M for 2026; however, management expects variability in H2 2026 tied to the expiration of TDAPA on June 30 and the transition to post-TDAPA add-on reimbursement, which will compress revenue in Q3–Q4 but is expected to produce higher net selling price per unit in 2027. The company reported a one‑time $9M favorable change in estimate impacting Q1 DefenCath sales. CorMedix announced positive top-line ReSPECT Phase III results for REZZAYO (met primary endpoint: non-inferiority for 90-day fungal-free survival; favorable safety profile), plans a pre-NDA meeting and expects to submit an sNDA in H2 2026 targeting a potential 2027 U.S. launch. The NUTRI-GAURD (TPN) Phase III study is enrolling slower than expected and now trends toward completion in 2028; management plans to open additional sites and seek a protocol amendment to broaden inclusion criteria. The Melinta acquisition is contributing materially to revenues and costs; operating expenses increased (Q1 OpEx $41.5M) and management expects incremental commercial/medical hires (15–20) in H2. Cash position: $178.1M at quarter-end; operating cash flow generated $42.4M and the company repurchased ~$11.1M of stock in Q1. Key near-term milestones: monitoring DefenCath utilization through reimbursement transition, pre-NDA meeting and sNDA filing for REZZAYO in H2 2026, enrollment acceleration and protocol amendment for TPN study, and additional commercial investments ahead of potential REZZAYO launch.