CorMedix Announces New Commercial Agreement with Mid-Sized Dialysis Operator

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD) has announced a new commercial supply contract with a top-five mid-sized dialysis operator for DefenCath® (taurolidine and heparin) in the US. This agreement will provide DefenCath access to adult kidney failure patients receiving hemodialysis through a central venous catheter at over 200 outpatient dialysis clinics nationwide.

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 Q4.

CEO Joseph Todisco stated that this agreement, combined with existing customer agreements, allows CorMedix to make DefenCath available to patients at approximately 60% of US outpatient dialysis centers.

Positive

• New commercial supply contract with a top-five mid-sized dialysis operator
• Access to over 200 outpatient dialysis clinics across the US
• Potential to reach approximately 60% of US outpatient dialysis centers
• Outpatient reimbursement from CMS effective since July 1st
• Shipments under the new agreement expected to begin in Q4

Negative

• None.

Insights

Medical Research Analyst

This commercial agreement with a top-five mid-sized dialysis operator is a significant development for CorMedix. It expands DefenCath's potential reach to over 200 outpatient dialysis clinics across the US, representing approximately 60% of outpatient dialysis centers when combined with existing agreements. This broad market access is important for the product's commercial success.

The timing is strategic, following the July 1st implementation of CMS outpatient reimbursement for DefenCath. This reimbursement is vital for widespread adoption in outpatient settings. The company's ability to secure agreements with major dialysis operators suggests growing confidence in DefenCath's clinical value and market potential.

However, investors should note that while the agreement is in place, actual shipments are expected to begin in Q4. The implementation process and the rate of adoption across these clinics will be critical factors to monitor in the coming months. The impact on CorMedix's revenue and market penetration will become clearer in subsequent quarterly reports.

Financial Analyst

This agreement represents a significant commercial milestone for CorMedix, potentially expanding their market reach substantially. With a current market cap of $507,487,773, this deal could have a material impact on the company's financial performance.

Key financial considerations include:

• Potential revenue growth from increased market access
• Improved economies of scale in production and distribution
• Possible acceleration of break-even point and path to profitability

However, it's important to note that the agreement doesn't guarantee immediate revenue. The timeline for implementation and the rate of adoption will be critical. Investors should closely monitor upcoming quarterly reports for indications of revenue impact and any changes in cash burn rate or profitability projections.

While this news is positive, the stock's reaction may be tempered by the fact that actual shipments won't begin until Q4. The market will likely be looking for concrete financial results before significantly re-rating the stock.

BERKELEY HEIGHTS, N.J., Oct. 08, 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-five 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 200 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 fourth quarter.

“This new agreement, in combination with our existing customer agreements, gives CorMedix the opportunity to make DefenCath available to patients receiving hemodialysis though a CVC at roughly 60% of the outpatient dialysis centers in the US,” says CorMedix CEO, Joseph Todisco. “We are working closely with all of our new customer relationships on the operational steps needed to ensure DefenCath availability in their clinics in the coming months.”

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 for DefenCath (CRMD)?

CorMedix (CRMD) announced a new commercial supply contract with a top-five mid-sized dialysis operator for DefenCath, providing access to over 200 outpatient dialysis clinics across the United States.

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.

What percentage of US outpatient dialysis centers can CorMedix (CRMD) potentially reach with DefenCath?

According to the CEO, CorMedix (CRMD) can potentially make DefenCath available to patients at approximately 60% of US outpatient dialysis centers through this new agreement and existing customer agreements.