CorMedix Inc. Announces Commercial and Operational Updates
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Insights
The strategic efforts by CorMedix to secure a J-Code for DefenCath and their engagement with CMS for an appropriate outpatient reimbursement structure are pivotal for the product's commercial success. The company's proactive approach in discussions with CMS is indicative of the importance of reimbursement rates in the biopharmaceutical sector, as they significantly influence provider adoption and patient access. The anticipation of a list price adjustment based on CMS's final decision reflects a flexible pricing strategy that can adapt to regulatory outcomes, which is crucial in maintaining competitive advantage in the market.
Furthermore, the commitment from health systems to include DefenCath in their P&T formulary processes signals a strong initial acceptance within the industry, potentially leading to widespread utilization in the inpatient setting. This early interest from providers is a positive indicator of market demand and could lead to a successful product launch, assuming favorable reimbursement conditions are established. As CorMedix prepares for commercial availability, the company's financial position, with sufficient cash and resources to fund the launch, is reassuring for stakeholders and may impact the stock positively if the market's response remains optimistic.
The timeline for commercial availability of DefenCath, with a targeted inpatient launch in April 2024 and outpatient launch no sooner than July 2024, sets a clear roadmap for investors. This timeline, however, is contingent on CMS's determination regarding outpatient reimbursement, which introduces a degree of uncertainty in the company's revenue projections. Investors should closely monitor CMS's decision as it will have a direct impact on CorMedix's revenue potential and market penetration strategy.
The company's decision to possibly establish a list price before CMS's final determination suggests a confident approach to market entry, yet it also carries the risk of needing to revise pricing strategies post-launch. The mention of a potential list price revision should CMS favor separate payment under Medicare Part B could lead to market volatility, as investors react to the implications on long-term profitability. The clarity provided by CorMedix on its financial readiness to support the commercial launch is a critical element in investor confidence, as it mitigates concerns about the need for imminent fundraising which could dilute shareholder value.
The process of obtaining a J-Code for DefenCath from CMS is a regulatory hurdle that, once cleared, can greatly facilitate billing and reimbursement for healthcare providers. This process is a testament to the intricate relationship between healthcare policy and business strategy within the biopharmaceutical industry. The company's engagement with CMS to secure separate payment under Medicare Part B showcases the complexity of reimbursement mechanisms and their influence on a product's market adoption.
The Transitional Drug Add-On Payment (TDAPA) framework mentioned is particularly relevant as it provides temporary additional payments for new drugs and devices, which can be instrumental in the initial phases of product launch. The company's strategic planning around this framework indicates a nuanced understanding of the regulatory environment. The potential for CorMedix to revise its list price in response to CMS's determinations could serve as a catalyst for policy discussions on the impact of reimbursement structures on drug pricing and accessibility.
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.”
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
FAQ
When is DefenCath expected to be commercially available?
What updates did CorMedix provide regarding DefenCath?
How many Key Account Managers and Directors does CorMedix expect to have in place at the time of commercial launch?
