CorMedix (CRMD) RBC Capital Markets Global Healthcare Conference 2026 summary

REZZAYO clinical data and regulatory plans

• Preliminary top-line data show comparable efficacy to standard of care in antifungal prophylaxis for bone marrow transplant patients, with differentiation on safety endpoints like discontinuations and drug interactions.

• The goal is to secure a broad FDA label covering Candida, Aspergillus, and Pneumocystis, not limited to bone marrow transplant patients.

• Secondary endpoints are important for both payers and clinicians, especially regarding cost offsets and improved safety.

• sNDA submission is planned for the second half of the year, following a pre-NDA meeting with the FDA and in coordination with Mundipharma for global filings.

• Modest headcount increase and redeployment are underway to prepare for the prophylaxis launch, with new clinician stakeholders to engage.

Commercial strategy and portfolio updates

• REZZAYO's current treatment market may see a halo effect from the prophylaxis data, with new promotional tactics expected to drive growth.

• MINOCIN and VABOMERE are achieving low single-digit growth with minimal sales expense, while KIMYRSA and ORBACTIV are expected to contract short-term due to generic competition but may rebound next year.

• Plans are in place for a potential promotional relaunch of KIMYRSA in infusion clinics as generic competition impact wanes.

DefenCath performance, reimbursement, and expansion

• Increased 2024 guidance for DefenCath based on higher utilization and a one-time accrual adjustment; focus remains on maintaining therapy through reimbursement changes in Q3 and Q4.

• Expectation of higher CMS bundle adjustment in 2027, supporting better net pricing and revenue, with guidance provided for that year.

• High customer concentration (top three account for 93%-95% of business); maintaining these relationships is key.

• Constructive discussions with a potential new large customer and ongoing efforts to contract with Medicare Advantage plans, emphasizing pharmacoeconomic benefits.

• Real-world data from major customers show significant infection rate reductions, with more data and economic analyses expected later this year.