CorMedix (CRMD) 25th Annual Needham Virtual Healthcare Conference summary

Company overview and recent developments

• Diversified specialty pharmaceutical portfolio focused on institutional injectable drugs, with a transformative year following the acquisition of Melinta and expansion beyond a single product focus.

• Melinta acquisition added a portfolio of products and REZZAYO, a key pipeline asset with a completed phase III study and imminent data readout in Q2.

REZZAYO: Current status and future potential

• REZZAYO (rezafungin) is FDA-approved for invasive Candida infections, with commercialization starting in early 2024 and a modest $250M–$350M market, mainly in hospitals.

• The larger opportunity lies in prophylaxis for immunocompromised patients, with a phase III trial in bone marrow transplant patients fully enrolled (~660–680 patients), primary endpoint is fungal-free survival at day 90.

• Standard of care for prophylaxis has toxicity and discontinuation issues; REZZAYO aims to differentiate on safety and efficacy.

• Label expansion and pricing will depend on FDA discussions and trial results; pricing for prophylaxis will remain anchored to the current WAC.

• Commercialization for prophylaxis would require a small incremental build in sales force, targeting hematology clinics.

DefenCath: Market dynamics and reimbursement

• DefenCath launched in July 2024 for CRBSI reduction in hemodialysis, with rapid revenue ramp post-TDAPA implementation.

• TDAPA reimbursement shifts in July 2026 to a bundled adjustment, with a two-quarter stub period of lower reimbursement before rebounding in 2027.

• Volume growth depends on onboarding a large customer or expanding into Medicare Advantage, which now covers over 50% of ESRD patients.

• Real-world study with U.S. Renal Care to publish final results after June 2024, with interim data showing reduced infections and hospitalizations.

• Legislative and CMS rulemaking efforts are ongoing to improve TDAPA terms, with hopes for changes that better align reimbursement with patient utilization.