CorMedix Inc. Announces New Commercial Agreement

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD) has announced a new commercial supply contract with a top-tier mid-sized dialysis operator in the US for DefenCath® (taurolidine and heparin). This agreement will provide DefenCath access to adult kidney failure patients receiving hemodialysis through central venous catheters at over 250 outpatient dialysis clinics across the country.

CorMedix received NDA approval for DefenCath on November 15, 2023, and began commercialization in the inpatient setting on April 15, 2024. Outpatient reimbursement from CMS took effect on July 1st, with shipments to outpatient facilities commencing in July. The company anticipates shipments under this new agreement to begin in early Q4 2024.

Positive

• New commercial supply contract with a top-tier mid-sized dialysis operator
• Access to over 250 outpatient dialysis clinics across the US
• Outpatient reimbursement from CMS effective July 1st, 2024
• Shipments to outpatient facilities commenced in July 2024
• Anticipated shipments under new agreement to begin in early Q4 2024

Negative

• None.

Financial Analyst

This new commercial agreement marks a significant milestone for CorMedix, potentially boosting its revenue stream and market presence. The contract with a top-tier mid-sized dialysis operator covering over 250 outpatient clinics across the US represents a substantial expansion of DefenCath's reach. This development is particularly noteworthy given that outpatient reimbursement from CMS only began on July 1st.

The timing of shipments starting in Q4 suggests we might see a positive impact on CorMedix's financial results as early as the upcoming quarter. However, investors should closely monitor the adoption rate and any potential challenges in implementation. The CEO's optimism about product utilization trajectory is encouraging, but concrete financial figures will be important to assess the real impact on the company's bottom line.

Medical Research Analyst

The commercial agreement for DefenCath represents a significant step in addressing catheter-related bloodstream infections (CRBSI) in hemodialysis patients. With DefenCath's unique combination of taurolidine and heparin, it offers a novel approach to reducing CRBSI incidence. The expansion to over 250 outpatient clinics could potentially benefit a large number of kidney failure patients receiving hemodialysis through central venous catheters.

However, it's important to note that DefenCath was approved under the Population Pathway, indicating its use for a specific patient group. The contraindications, including heparin-induced thrombocytopenia and hypersensitivity, highlight the importance of careful patient selection. As the product rolls out to more clinics, monitoring real-world efficacy and safety data will be essential for long-term success and potential broader applications.

Market Research Analyst

This agreement signifies CorMedix's growing foothold in the dialysis market. Partnering with a top-tier mid-sized operator not only expands DefenCath's reach but also validates its potential value in the healthcare ecosystem. The timing is strategic, capitalizing on the recent CMS outpatient reimbursement approval.

However, the dialysis market is highly competitive and dominated by large players. CorMedix's success will depend on DefenCath's performance against existing protocols and its ability to demonstrate clear cost-effectiveness. The population approval might restrict rapid market penetration, but it could also serve as a springboard for broader applications if real-world data proves compelling. Investors should watch for adoption rates, any expansion of indications and CorMedix's ability to secure agreements with other major dialysis providers in the coming months.

BERKELEY HEIGHTS, N.J., Sept. 19, 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 new commercial supply contract with a top-tier mid-sized dialysis operator for the supply of DefenCath^® (taurolidine and heparin) to dialysis clinics in the US. This new agreement will provide access to DefenCath for adult patients with kidney failure receiving hemodialysis through a central venous catheter at more than 250 outpatient dialysis clinics located across the United States.

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 15, 2024. Outpatient reimbursement of DefenCath from the Center for Medicare & Medicaid Services (CMS) took effect on July 1^st, and CorMedix subsequently commenced the shipment of orders to outpatient dialysis facilities in July. CorMedix anticipates shipments for DefenCath under this agreement to begin in the beginning of the fourth quarter.

“We’ve made great progress over the last few months in terms of operationalizing existing customers as well as signing new agreements with top-tier dialysis providers in the US,” says CorMedix CEO, Joseph Todisco. “I am excited by the trajectory we are seeing for product utilization with early adopters and optimistic about the potential for utilization under these new relationships.”

DefenCath^® (taurolidine and heparin)
IMPORTANT SAFETY INFORMATION

These highlights do not include all the information needed to use DefenCath safely and effectively. See full prescribing information for DefenCath.

LIMITED POPULATION: DefenCath is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

DefenCath is contraindicated and has warnings and precautions in patients with:

• Known heparin-induced thrombocytopenia (HIT).
• Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.

If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.

To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see the full Prescribing Information.

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 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 new commercial agreement announced by CorMedix (CRMD)?

CorMedix (CRMD) announced a new commercial supply contract with a top-tier mid-sized dialysis operator for DefenCath® supply to over 250 outpatient dialysis clinics across the US.

When did CorMedix (CRMD) receive NDA approval for DefenCath?

CorMedix (CRMD) received NDA approval for DefenCath under the Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023.

When did CorMedix (CRMD) begin commercialization of DefenCath in the inpatient setting?

CorMedix (CRMD) began commercialization of DefenCath in the inpatient setting on April 15, 2024.

When did outpatient reimbursement for DefenCath from CMS take effect for CorMedix (CRMD)?

Outpatient reimbursement for DefenCath from the Center for Medicare & Medicaid Services (CMS) took effect on July 1st, 2024 for CorMedix (CRMD).