CorMedix Inc. Announces Commercial and Operational Updates

BERKELEY HEIGHTS, N.J., Jan. 08, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced several commercial and operational updates related to its business and anticipated launch of DefenCath.

Recent Updates:

• CorMedix formally submitted an HCPCS application for a J-Code to the Center for Medicare and Medicaid Services (CMS) on December 8, 2023 for DefenCath, and CMS has confirmed the application is under review. The Company continues to engage in discussions with CMS related to the appropriate outpatient reimbursement structure for DefenCath and remains committed to its pursuit of separate payment under Medicare Part B as the appropriate reimbursement mechanism for the product. CMS has not yet made a determination or provided a timeline for a final decision.

• The Company estimates the timing for DefenCath commercial availability at April 15, 2024 for the inpatient setting, and no sooner than July 1, 2024 for the outpatient setting, depending on a final determination from CMS related to outpatient reimbursement.

• The Company has received significant interest from providers since DefenCath’s November 2023 approval. Several large and medium sized health systems have committed to put DefenCath through their P&T formulary processes in 2024, a necessary first step toward obtaining utilization in the inpatient setting.

• To begin the P&T formulary process at hospitals and health systems, CorMedix may need to establish its list price for DefenCath prior to a final CMS determination on outpatient reimbursement. In such an instance, the Company expects to establish a list price based on the market dynamics for both inpatient contracting as well as a Transitional Drug Add-On Payment (TDAPA) framework for outpatient reimbursement. CorMedix would then subsequently revise the list price downward should CMS make a determination in favor of separate payment under Medicare Part B.

• CorMedix expects to provide further detail on the DefenCath market opportunity as we receive clarity from CMS regarding outpatient reimbursement.

• The Company believes it has sufficient cash, cash equivalents and available resources to fund the commercial launch.

Joseph Todisco, CorMedix CEO, commented, “I am very excited by the volume of inbound interest we have received over the last 45 days from inpatient health systems as well as outpatient dialysis operators interested in evaluating the use of DefenCath in their patients receiving hemodialysis through a central venous catheter. The company is working with providers on information needed for their respective formulary processes and expects to provide updates over the upcoming months. We have accelerated our staffing plans as communicated previously and expect to have a field team of approximately 30 Key Account Managers and Directors in place at the time of commercial launch.”