CorMedix secures supply contract for DefenCath

BERKELEY HEIGHTS, N.J. - CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company, has announced a multi-year commercial supply agreement with a leading global healthcare provider to supply DefenCath® (taurolidine and heparin) for use in the United States. The healthcare company, serving over 2,000 U.S. clinics, plans to make DefenCath available for approximately 4,000 patients, prioritized by medical necessity.

DefenCath received FDA approval on November 15, 2023, under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD), and CorMedix initiated its commercial launch for inpatient use on April 15, 2024. Following the CMS's approval for outpatient reimbursement starting July 1, CorMedix began shipping orders that month. Shipments under the new agreement are expected to commence in the fourth quarter of 2024.

The product is designed to reduce catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure who are undergoing chronic hemodialysis via a central venous catheter (CVC). DefenCath is contraindicated for patients with known hypersensitivity to its components, including heparin, taurolidine, citrate excipient, or pork products, and for those with heparin-induced thrombocytopenia (HIT).

CorMedix CEO Joseph Todisco expressed enthusiasm about the agreement, highlighting its potential to provide access to DefenCath for thousands of patients at risk of infections. The company remains focused on broadening access to this infection prevention product.

CorMedix, committed to the development and commercialization of therapeutic products for the treatment of life-threatening diseases, aims to expand the use of DefenCath as a catheter lock solution for other patient populations beyond the current indication.

This news is based on a press release statement. The safety and effectiveness information for DefenCath, including its indication for a limited population, can be found in the full prescribing information provided by CorMedix. For safety concerns or adverse reactions, CorMedix can be contacted directly.

In other recent news, CorMedix Inc. reported its second-quarter financial results for 2024, generating its first revenue from the U.S. distribution of DefenCath. The company reported net revenue of $0.8 million and a net loss of $14.2 million, attributed to increased operating expenses from the commercial launch of DefenCath. Despite the loss, CorMedix has a positive outlook for the future, expecting sales to rise in the fourth quarter.

The company's cash and cash equivalents stand at $45.6 million, which is 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. CorMedix is currently in discussions with top dialysis providers for commercial supply agreements.

The company anticipates reaching breakeven EBITDA by the end of 2024. DefenCath sales are ramping up, with inpatient sales expected to increase as the product is added to hospital formularies. These are recent developments in the company's progress and will be updated in the next quarterly call in November.

InvestingPro Insights

As CorMedix Inc. (NASDAQ:CRMD) forges ahead with its commercial supply agreement for DefenCath®, analysts and investors are closely monitoring the company's financial health and stock performance. With a market capitalization of $315.33 million, CorMedix stands out with its significant revenue growth over the last twelve months, boasting an impressive 2107.4% increase. Despite this growth, the company faces challenges, evidenced by a negative gross profit margin of -64.79%, which indicates that it has been spending more on production than it has been able to recoup through sales.

Investors are also keeping an eye on the company's stock price volatility. CorMedix has experienced substantial price movements, with a 50.79% increase in the past month and a 56.52% uptick over the last six months. This volatility is a double-edged sword, presenting opportunities for gains while also posing risks for those invested in the company's shares. The current price, at the previous close, was $5.76 USD, which is 80.57% of its 52-week high, reflecting a significant recovery after a recent decline of 7.69% over the last week.

According to InvestingPro Tips, CorMedix holds more cash than debt on its balance sheet, which is a positive sign for financial stability. Additionally, three analysts have revised their earnings estimates upwards for the upcoming period, suggesting a more optimistic outlook for the company's financial performance. However, it's important to note that these analysts do not anticipate CorMedix will be profitable this year, and the company has been quickly burning through cash. For a more comprehensive understanding of CorMedix's financial position and future prospects, InvestingPro offers a total of 15 InvestingPro Tips, which can be further explored for detailed analysis and insights.

For those interested in a deeper dive into CorMedix's financial metrics and stock performance, additional tips and real-time data can be found on InvestingPro.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.