CorMedix (CRMD) 2025 Conference Transcript

CorMedix (CRMD) Conference Call Summary Company Overview - CorMedix is a commercial stage biotech company focused on the launch of DefendCath, a catheter lock solution primarily for dialysis but with broader potential applications [1][4] - The product combines a proprietary new chemical entity, tyrolidine, with heparin to reduce catheter-related bloodstream infections (CRBSI) in patients undergoing hemodialysis [4][5] Financial Performance - First quarter sales for 2025 were over $39 million, with adjusted EBITDA exceeding$23 million [6][7] - Achieved profitability within twelve months of product launch, maintaining a clean balance sheet with no debt [7] Market Opportunity - The initial indication targets end-stage renal disease (ESRD) patients with high infection rates exceeding 25%, leading to significant mortality [8][11] - DefendCath is the only FDA-approved catheter lock solution with antimicrobial activity, addressing a critical unmet medical need [9] Clinical Data - Phase three clinical study (LACA100) showed a 71% reduction in CRBSI risk compared to standard care (heparin) [9] - A second phase three study is underway for an expanded label in patients receiving total parenteral nutrition (TPN) [10] Customer Adoption - US Renal Care is the largest customer, with over 3,000 patients currently using DefendCath [12][13] - The company is working to onboard additional mid-sized providers, with potential for significant patient conversion [14] Reimbursement Dynamics - The net selling price is expected to slightly decline due to government ASP erosion, with the first quarter at $2.45 and projected to decrease to$2.41 in the second quarter [18][19] - The TDAPA program incentivizes innovation in the ESRD setting, with reimbursement structured over five years [21][22] Medicare Advantage Insights - Approximately 90% of patients are Medicare, with a growing share in Medicare Advantage, which is expected to reach 70% in a few years [25] - Medicare Advantage payers are seen as more incentivized to invest in infection prevention due to their financial responsibility for treatment costs [25] Inpatient Market Strategy - The inpatient market represents about 10% of the total addressable market, with a focus on building a dedicated inpatient sales team [28][29] - Initial traction has been observed, with an increase in inpatient unit shipments from 3% to 6% in April [30] Future Growth and Strategy - The total addressable market for TPN is estimated between $500 million and$750 million, with peak sales potential of $150 to$200 million [38] - The company is exploring business development opportunities to complement DefendCath, focusing on adjacent markets [43][44] Metrics for Success - Revenue and profitability are primary metrics for gauging success, along with tracking inpatient progress and new account additions in outpatient hemodialysis [46][47] Additional Considerations - The company is generating data to support the pharmacoeconomic value of DefendCath, tracking metrics such as hospitalization rates and antibiotic use [26] - A partnership with WSI for dedicated sales reps targeting VA facilities has begun yielding orders [36]