DefenCath® (taurolidine and heparin) catheter lock solution is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

CORMEDIX INC. ANNOUNCES COMMERCIAL AND OPERATIONAL UPDATES

January 8, 2024

Berkeley Heights, NJ – January 8, 2024 – 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.”    

 

About CorMedix 

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. DefenCath was approved by the FDA on November 15, 2023 and the Company has indicated an estimated initial launch in 1Q 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  For more information visit: www.cormedix.com. 

Forward-Looking Statements 

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, the commercial launch of DefenCath, including the timing of availability of DefenCath for inpatient and outpatient settings and the ability to staff a field team in time for commercial launch, the interest in DefenCath by health systems, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations, including the commercial launch of DefenCath, should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including:  the risks and uncertainties related to the ability to have sufficient DefenCath available for commercial launch, CorMedix’s ability to contract with health systems for the use of DefenCath, market conditions, CorMedix’s ability to manage its cash resources and the impact on current, planned or future research. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. 

 Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com 
(617) 430-7576