CorMedix (CRMD) investor relations material

Pipeline and clinical development

• REZZAYO is in a phase III trial for prophylaxis of fungal infections in immunocompromised patients, with data expected later in Q2; primary endpoint is non-inferiority in 90-day fungal-free survival compared to standard of care.

• The trial targets allogeneic bone marrow transplant patients, with secondary endpoints focused on safety, hepatotoxicity, and drug-drug interactions.

• Total addressable market (TAM) for prophylaxis in bone marrow transplant is estimated at $500 million, with broader prophylaxis TAM exceeding $2 billion, including solid organ transplant patients.

• DefenCath is in a phase III study for prevention of CLABSI in IV nutrition therapy, with TPN study completion targeted for early 2027; interim analysis may allow for early completion if efficacy is clear.

• Expansion into new indications and patient populations is planned, with ongoing studies and real-world evidence supporting efficacy and safety.

Commercial strategy and market access

• Recent acquisition of Melinta has diversified the portfolio, adding stable revenue and growth potential with products like Vabomere, Minocin, and Rocephin.

• Commercial infrastructure includes about 35 key account managers, 12 in market access, and a total commercial team of around 80, with plans to add 15-20 incremental heads as needed.

• DefenCath's launch in hemodialysis has been strong, with most revenue front-loaded due to reimbursement structure; 2027 revenue guidance provided based on expected price adjustments.

• Over 95% of DefenCath's current business is Medicare fee-for-service, but Medicare Advantage is seen as a major growth opportunity as its share of ESRD patients increases.

• Engagement with payers emphasizes cost savings from reduced hospitalizations, with a 70% reduction in hospitalizations observed in real-world data.

Financial outlook and operational approach

• Operational spend (OpEx) is guided at $145-$160 million, with scaling of infrastructure contingent on phase III data for REZZAYO.

• The company maintains a lean operational philosophy, avoiding overbuilding until clinical milestones are met.

• The Melinta acquisition added $150 million in stable base revenue, helping to offset reimbursement fluctuations for DefenCath.

• Future business development will focus on smaller, synergistic tuck-in acquisitions using cash and potential debt, rather than large equity deals.

• Success for 2026 is defined as achieving beat-and-raise performance, with guidance to be revisited after Q1 results.