CorMedix (CRMD) The Citizens JMP Life Sciences Conference 2025 summary

Product overview and clinical data

• Lead product DefenCath launched mid-2024 as a catheter-lock solution combining taurolidine and heparin, targeting reduction of catheter-related bloodstream infections (CRBSI) in hemodialysis patients.

• Only FDA-approved catheter-lock solution with antimicrobial activity, addressing a critical unmet need with high infection and mortality rates in end-stage renal disease (ESRD) patients.

• Phase III LOCK-IT-100 study showed a 71% reduction in CRBSI risk versus standard of care; a second Phase III trial for total parenteral nutrition (TPN) patients is underway, aiming for 18 months duration.

• Expanded access program includes other disease states such as oncology and pediatric TPN.

Commercialization and market adoption

• Achieved profitability within 12 months of launch, with Q1 sales over $39 million and adjusted EBITDA over $23 million; maintains a debt-free balance sheet and strong cash position.

• Outpatient hemodialysis is the largest market, with five providers covering 90% of the market; U.S. Renal Care is the anchor customer with over 3,000 patients on DefenCath.

• Implementation with IRC and DCI (4th and 5th largest providers) is ongoing; progress with the two largest providers varies, with one showing increased engagement and the other expected to be a late adopter.

• Inpatient market is about 10% of total addressable market by volume but higher by dollar value; dedicated inpatient sales team launched in Q1 2024, with early signs of growth and a partnership targeting VA facilities.

Reimbursement and pricing dynamics

• Outpatient reimbursement is through the TDAPA program: first two years at government ASP, followed by price erosion in years 3-5; strategy will shift to focus on volume and direct Medicare Advantage contracting.

• Net selling price has remained stable, with some improvement in Q2 due to business mix and expiration of volume rebates; expected to align with Q1 levels in the second half of the year.

• Medicare covers about 90% of patients, split evenly between fee-for-service and Medicare Advantage, with the latter expected to grow to 70% in 3-4 years.

• Future contracting aims to negotiate fixed annual prevention investments with Medicare Advantage payers.