BERKELEY HEIGHTS, N.J. - CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company, today announced a new commercial supply agreement with a leading mid-sized dialysis operator to provide DefenCath (taurolidine and heparin) to over 200 outpatient dialysis clinics across the United States. This contract aims to make DefenCath available to adult patients with kidney failure who are receiving hemodialysis through a central venous catheter (CVC).
DefenCath, which is designed to reduce the incidence of catheter-related bloodstream infections (CRBSI) in this patient population, received FDA approval on November 15, 2023, under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). The commercialization of DefenCath began for inpatient settings on April 15, 2024, and for outpatient settings in July 2024, following the Center for Medicare & Medicaid Services (CMS) reimbursement that took effect on July 1st.
Joseph Todisco, CEO of CorMedix, stated that the new contract, in conjunction with existing agreements, potentially expands DefenCath's availability to roughly 60% of outpatient dialysis centers in the U.S. The company expects to start shipping DefenCath under this new agreement within the fourth quarter of the year.
CorMedix emphasizes that DefenCath is indicated for a specific and limited patient population and should not be used in patients with known hypersensitivity to its components, including taurolidine, heparin, citrate excipient, or pork products, as well as those with heparin-induced thrombocytopenia (HIT). Any adverse reactions or safety concerns can be reported to CorMedix or the FDA.
The company plans to work closely with its new customer relationships to ensure operational steps are taken for the availability of DefenCath in their clinics in the upcoming months.
This article is based on a press release statement from CorMedix Inc. and does not contain any promotional content or endorsements. The information presented is intended to provide a factual report on the new supply agreement and the availability of DefenCath for patients requiring hemodialysis through a CVC.
In other recent news, CorMedix Inc. has announced a multi-year commercial supply agreement with a leading global healthcare provider for the distribution of DefenCath in the United States. The healthcare company plans to make DefenCath available for approximately 4,000 patients, prioritized by medical necessity. The company initiated its commercial launch for inpatient use of DefenCath, which is designed to reduce catheter-related bloodstream infections, in April 2024. Shipments under the new agreement are expected to commence in the fourth quarter of 2024.
In its second-quarter financial results for 2024, CorMedix reported its first revenue from the U.S. distribution of DefenCath, with net revenue of $0.8 million and a net loss of $14.2 million. The company anticipates reaching breakeven EBITDA by the end of 2024, with sales expected to rise in the fourth quarter. The company's cash and cash equivalents stand at $45.6 million, projected to fund operations for at least the next 12 months.
Clinical studies for DefenCath in different patient populations are planned, with enrollment starting in the first quarter of 2025. These are recent developments in the company's progress and will be updated in the next quarterly call in November.
InvestingPro Insights
CorMedix Inc.'s recent commercial supply agreement for DefenCath aligns with the company's strong market performance and growth potential. According to InvestingPro data, CorMedix has shown impressive revenue growth of 2107.4% in the last twelve months as of Q2 2024, reflecting the impact of DefenCath's commercialization. This growth trajectory is further supported by the stock's robust performance, with a 157.58% price return over the past year.
InvestingPro Tips highlight that CorMedix holds more cash than debt on its balance sheet, which could provide financial flexibility as the company expands DefenCath's availability to approximately 60% of outpatient dialysis centers in the U.S. Additionally, the stock is trading near its 52-week high, indicating investor confidence in the company's recent developments and future prospects.
It's worth noting that while CorMedix shows promising growth, it is not yet profitable. The company's gross profit margin is currently negative, which is not uncommon for biopharmaceutical companies in the early stages of product commercialization. Investors should consider that analysts do not anticipate the company to be profitable this year, as per another InvestingPro Tip.
For readers interested in a more comprehensive analysis, InvestingPro offers 16 additional tips for CorMedix, providing a deeper understanding of the company's financial health and market position.
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