Cormedix Stock Price, News & Analysis

CorMedix Inc. (NASDAQ: CRMD) reported Q2 and H1 2024 financial results and provided a business update. Key highlights include:

- Initial net sales of $0.8 million for Q2 2024, primarily from inpatient trade stocking

- Unaudited Q3 quarter-to-date net sales of $5.2 million as of August 13th, driven by outpatient setting orders

- Cash and short-term investments of $45.6 million as of June 30, 2024

- Net loss of $14.2 million ($0.25 per share) for Q2 2024, compared to $11.3 million ($0.25 per share) in Q2 2023

- Operating expenses increased 32% to $15.6 million in Q2 2024

- Company believes it has sufficient resources to fund operations for at least 12 months

CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company specializing in therapeutic products for life-threatening diseases, has announced its plan to release second quarter 2024 financial results on August 14, 2024, before the market opens. The company will also host a corporate update conference call at 8:30 AM Eastern Time on the same day.

Investors and interested parties can access the conference call through the following options:

• Domestic: 1-877-270-2148
• International: 1-412-902-6510
• Webcast: Available via provided link

This announcement indicates CorMedix's commitment to transparency and shareholder communication, providing an opportunity for stakeholders to gain insights into the company's financial performance and recent developments.

CorMedix Inc. (Nasdaq: CRMD) has announced the commercialization of DefenCath® (taurolidine and heparin) for outpatient dialysis centers and vascular access clinics. This launch, effective from July 1st, aligns with the Centers for Medicare & Medicaid Services (CMS) reimbursement for outpatient use.

DefenCath, approved by the FDA under the Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, initially launched for inpatient settings on April 15, 2024. The product is designed to reduce catheter-related bloodstream infections (CRBSI) in adults undergoing chronic hemodialysis through a central venous catheter.

CorMedix has begun shipping orders to dialysis operators, with additional customer agreements expected soon. The CEO, Joseph Todisco, expressed optimism about expanding access and the effective rollout by customers.

CorMedix (NASDAQ: CRMD) has received supportive feedback from the FDA regarding its plans to expand the use of DefenCath to adult Total Parenteral Nutrition (TPN) patients. The company plans to submit a complete clinical protocol by the third quarter of 2024 and aims to start the program by year-end. The FDA also requires a pediatric study under the Pediatric Research Equity Act. An independent market assessment shows a critical unmet need for DefenCath in TPN patients, with an estimated CLABSI rate over 25% and an addressable market of 5 million yearly infusions. Further details will be shared in CorMedix's Q2 earnings call in August.

CorMedix announced that CMS has granted pass-through status to DefenCath under the Out-Patient Prospective Payment System (OPPS). This status allows for separate Medicare Part B payments for DefenCath for at least two years, and up to three years, in outpatient settings. DefenCath, a combination of taurolidine and heparin, is used to reduce catheter-related bloodstream infections (CRBSI) in chronic hemodialysis patients using central venous catheters. The company estimates around 100,000 HD-CVC placements annually, highlighting the importance of reimbursement for DefenCath to prevent CRBSIs. However, DefenCath is contraindicated in patients with heparin-induced thrombocytopenia or hypersensitivity to any of its components.

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 Inc. (Nasdaq: CRMD) is set to participate in two upcoming investor conferences, the JMP Securities Life Sciences Conference on May 13-14, 2024, and the RBC Capital Markets Global Healthcare Conference on May 14-15, 2024. Management will engage in fireside chats and investor meetings during these events, with details provided for each. The events will be webcasted, and replays will be available on the company's investor relations website.

CorMedix Inc. reported financial results for Q1 2024, highlighting a net loss of $14.5 million. The company successfully launched DefenCath® and secured a commercial supply contract with ARC Dialysis. CMS approved a new HCPCS code for DefenCath, qualifying for TDAPA. The FDA granted a Type C meeting to discuss development plans. The company remains financially stable with $58.6 million in cash and short-term investments.

CorMedix Inc. (Nasdaq: CRMD) will report its financial results for the first quarter of 2024 on May 9, 2024. The company focuses on developing therapeutic products for life-threatening diseases. A corporate update conference call will follow the release.