CorMedix Inc. Announces New Commercial Agreement

Rhea-AI Summary

CorMedix Inc. (Nasdaq: CRMD) has announced a multi-year commercial supply contract with a major global healthcare company for DefenCath® (taurolidine and heparin). The agreement targets up to 4,000 patients in over 2,000 US clinics. DefenCath, approved by the FDA on November 15, 2023, began commercialization in inpatient settings on April 15, 2024. Outpatient reimbursement from CMS took effect on July 1st, with shipments commencing in July. CorMedix expects shipments under this new agreement to start in Q4 2024. CEO Joseph Todisco expressed excitement about providing access to DefenCath for thousands of adult patients at risk for catheter-related bloodstream infections, building on recent progress with smaller customers.

Positive

• Multi-year commercial supply contract secured with a major global healthcare company
• Potential to reach up to 4,000 patients across 2,000+ US clinics
• Outpatient reimbursement from CMS effective since July 1st, 2024
• Shipments under the new agreement expected to begin in Q4 2024

Negative

• None.

Financial Analyst

This commercial agreement marks a significant milestone for CorMedix, potentially boosting its revenue and market presence. The contract with a major healthcare provider targeting up to 4,000 patients nationally represents a substantial market opportunity. The timing is crucial, following DefenCath's NDA approval in November 2023 and the commencement of outpatient reimbursement from CMS in July 2024.

Investors should note the phased approach to implementation, starting with inpatient settings in April and expanding to outpatient settings. This strategy could lead to gradual revenue growth in the coming quarters. The Q4 shipment timeline suggests potential impact on CorMedix's financial performance starting this fiscal year, with more significant effects likely in 2025.

While promising, it's important to consider potential challenges such as adoption rates, competition and any unforeseen regulatory hurdles. The $CRMD stock may see increased volatility as the market assesses the long-term impact of this agreement on the company's financial health.

Medical Research Analyst

The commercial agreement for DefenCath represents a significant advancement in catheter-related bloodstream infection (CRBSI) prevention. The product's unique combination of taurolidine and heparin offers a novel approach to reducing infection risks in hemodialysis patients.

The target of up to 4,000 patients is substantial, potentially providing valuable real-world data on DefenCath's efficacy and safety. This could lead to expanded indications or increased adoption in the future. However, it's important to monitor for any adverse events or unexpected complications as the product reaches a broader patient population.

The Population Pathway for Antibacterial and Antifungal Drugs (LPAD) approval highlights both the product's potential and the need for continued vigilance. As DefenCath moves from clinical trials to widespread use, its performance in diverse patient populations will be critical for long-term success and potential label expansions.

Market Research Analyst

This agreement positions CorMedix strategically in the growing market for CRBSI prevention in hemodialysis patients. With over 2,000 clinics under the partner's network, there's significant potential for expansion beyond the initial 4,000 patient target. The U.S. hemodialysis market, with approximately 500,000 patients, presents a substantial opportunity for DefenCath.

The phased rollout - from inpatient to outpatient settings - allows for controlled market penetration and potential refinement of marketing strategies. The CMS reimbursement approval is crucial, as it removes a significant barrier to adoption in the price-sensitive healthcare market.

Competitors in the CRBSI prevention space may respond with increased marketing efforts or price adjustments. CorMedix should be prepared for potential market share battles. The company's ability to secure similar agreements with other healthcare providers will be a key indicator of DefenCath's long-term market potential and CorMedix's growth trajectory.

BERKELEY HEIGHTS, N.J., Sept. 09, 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 multi-year commercial supply contract with a global healthcare company for the supply of DefenCath^® (taurolidine and heparin) to its facilities in the US.

The company, which provides healthcare services to more than 2,000 clinics in the United States, expects to initially target the utilization of DefenCath in up to 4,000 patients nationally, that would be prioritized based upon medical need. 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 in July. CorMedix anticipates shipments for DefenCath under this agreement to begin in the fourth quarter.

“I am very excited that this agreement with one of the premier healthcare services providers in the U.S. will provide access to DefenCath for thousands of adult patients at risk for catheter related bloodstream infections, and it builds upon the progress we have made with smaller customers over the last few months,” says CorMedix CEO, Joseph Todisco. “CorMedix remains committed to our goal of ensuring broad access to this important infection reduction mechanism.”

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 began outpatient commercialization on July 1^st following the effectiveness of outpatient reimbursement from CMS. 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 multi-year commercial supply contract with a global healthcare company to supply DefenCath® to its facilities in the US, targeting up to 4,000 patients across more than 2,000 clinics.

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

CorMedix (CRMD) received FDA 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?

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 1, 2024, for CorMedix (CRMD).

When does CorMedix (CRMD) expect to begin shipments of DefenCath under the new agreement?

CorMedix (CRMD) anticipates shipments for DefenCath under the new agreement to begin in the fourth quarter of 2024.