CorMedix Inc. Announces Commercial Agreement With Top Tier Dialysis Provider
CorMedix (Nasdaq: CRMD) announced a multi-year commercial supply contract with a top-tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin). Approved under the LPAD pathway on November 15, 2023, DefenCath® started commercialization in inpatient settings on April 15 and will begin in outpatient dialysis clinics in July. The agreement covers over 500 dialysis facilities, providing thousands of patients access to the infection-reducing product. CEO Joseph Todisco emphasized the importance of broad patient access and the company's commitment to innovation and infection reduction.
- CorMedix secured a multi-year commercial supply contract.
- DefenCath® received NDA approval under the LPAD pathway.
- Commercialization in inpatient settings began on April 15, 2024.
- Expansion to outpatient dialysis clinics is expected in July 2024.
- The agreement covers over 500 dialysis facilities nationally.
- Thousands of patients at risk for catheter-related bloodstream infections will gain access to DefenCath®.
- Focus on innovation and infection reduction could improve long-term relationships with dialysis providers.
- No specific financial terms of the agreement were disclosed.
- The potential impact on revenue from the deal is unclear.
- Initial commercialization started relatively recently, in April 2024.
- Further commercial success is contingent upon the July 2024 expansion.
Insights
The signing of a multi-year commercial supply contract for DefenCath® highlights a significant milestone for CorMedix Inc. The product's approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) and subsequent commercialization in both inpatient and outpatient settings displays a robust trajectory.
DefenCath® combines taurolidine and heparin, which are known for their antibacterial and anticoagulant properties, respectively. Such a combination could significantly reduce the incidence of catheter-related bloodstream infections, a serious complication for dialysis patients. The endorsement by a top-tier dialysis provider further validates the potential efficacy and necessity of this product.
Scaling up to serve more than 500 dialysis facilities indicates a strategic move that could potentially shift industry standards for infection control in dialysis clinics. The company's commitment to innovation and long-term relationships with providers is a positive signal for stakeholders.
From a financial perspective, this agreement is noteworthy as it likely represents a substantial revenue stream for CorMedix Inc. By securing a contract with a leading dialysis provider, the company is not only ensuring steady demand for DefenCath® but also strengthening its market position in the dialysis sector.
Revenue generation from over 500 facilities is expected to enhance the company's financial stability and potentially lead to positive earnings forecasts. Additionally, the adoption of DefenCath® in both inpatient and outpatient settings reflects a comprehensive market approach, possibly leading to economies of scale and improved profit margins.
Investors should monitor the financial metrics in upcoming quarters to assess the impact of this deal on the company’s overall financial health, including any potential increases in cash flow and profitability.
The expansion of DefenCath® into outpatient dialysis clinics represents a important market penetration strategy for CorMedix Inc. The dialysis market is competitive and having a product that addresses a critical need—reducing catheter-related bloodstream infections—can significantly boost market share.
Entering more than 500 facilities nationwide gives CorMedix a substantial footprint. This could create a competitive advantage if DefenCath® proves to be effective and well-received. The company's focus on long-term relationships suggests a strategic intent to secure sustained market presence rather than short-term gains.
Understanding market reception and adoption rates of DefenCath® will be key. If the product garners positive feedback and demonstrates tangible benefits, it could lead to further contracts and expanded usage, solidifying CorMedix's position in the antibacterial and antifungal drug market.
BERKELEY HEIGHTS, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin).
CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and began commercialization of the product in the inpatient setting on April 15th. The Company expects to begin commercialization in outpatient dialysis clinics in July. CorMedix is committed to building meaningful long-term relationships with dialysis providers that are dedicated to innovation and infection reduction. This agreement will allow for patients to have access to DefenCath at more than 500 dialysis facilities located nationally.
“I am pleased with the progress we are making in our discussions with outpatient dialysis providers, and solidifying this agreement ensures that potentially thousands of patients at risk for a catheter related bloodstream infection will have access to DefenCath,” says CorMedix CEO, Joseph Todisco. “Utimately our goal is to ensure the broadest access possible to this important infection reduction mechanism.”
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 commercializing its lead product DefenCath®, which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and anticipates launch in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. 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. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects 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, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, 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 such forward-looking statements speak only as of the date of this press release. 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
What is the recent commercial agreement announced by CorMedix (CRMD)?
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When did CorMedix start commercialization of DefenCath® in inpatient settings?
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How many dialysis facilities will have access to DefenCath® under the new agreement?
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