CorMedix Inc. (NASDAQ:CRMD) is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions. The company's primary focus is on the commercialization of its lead product, DefenCath, in the United States.

Product Overview

DefenCath is an antimicrobial catheter lock solution indicated to reduce the incidence of catheter-related bloodstream infections (CRBSIs) in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter. It is the first and only FDA-approved antimicrobial catheter lock solution in the U.S. and was shown to reduce the risk of CRBSI by up to 71% in a Phase 3 clinical study.

Financials

CorMedix reported a net loss of $14,466,123 for the first quarter of 2024, compared to a net loss of $10,567,226 in the same period of 2023. The company's annual net income for the fiscal year 2023 was -$46,339,227, and it did not generate any revenue during the year. The company's annual operating cash flow and free cash flow for 2023 were -$38,409,480 and -$38,736,780, respectively.

In the first quarter of 2024, CorMedix's cost of revenues was $818,539, reflecting indirect fixed costs related to the manufacturing and distribution of DefenCath. Research and development expenses decreased by 75% to $837,445, while selling, general, and administrative expenses increased by 98% to $15,048,252, primarily due to the hiring of sales force, medical affairs, and marketing personnel, as well as increased costs related to medical affairs and certain personnel expenses that had been previously recognized in R&D.

Liquidity

The company's cash, cash equivalents, and short-term investments as of March 31, 2024, were $58,552,000, excluding restricted cash of $179,000. CorMedix expects its operating expenses, especially SG&A, to remain at increased levels to support the commercial infrastructure and the ongoing launch of DefenCath. The company anticipates 2024 quarterly operating expenses to range from $15 million to $18 million.

Recent Developments

CorMedix announced the commercial launch of DefenCath in the inpatient setting in the second quarter of 2024. The company's field team has met with more than half of its targeted institutions, and as of the announcement, roughly 50 key accounts representing more than 200 individual hospitals have recommended DefenCath for formulary review. However, the company does not expect material inpatient sales in the second quarter, as the inpatient process to obtain formulary inclusion and facility adoption can span several months.

On the outpatient front, CorMedix is on track to commence outpatient commercialization in July 2024. The company was pleased that the Centers for Medicare and Medicaid Services (CMS) approved its Transitional Drug Add-On Payment Adjustment (TDAPA) application, ensuring that Medicare fee-for-service reimbursement claims submitted by outpatient providers beginning July 1, 2024, will be reimbursed by CMS.

CorMedix also announced its first outpatient procurement contract with ARC Dialysis, one of the largest regional dialysis providers in the Southeast U.S. The company is currently engaged in commercial discussions with 8 of the top 10 U.S. dialysis providers to secure additional procurement contracts over the next few months.

Label Expansion Plans

Regarding the company's plans for label expansion, CorMedix has submitted a Type C meeting request to the FDA to discuss a pathway for additional indications, including the use of DefenCath as a catheter lock solution to reduce CRBSIs in total parenteral nutrition patients and certain oncology patients. The company expects to receive feedback from the FDA by the end of the second quarter of 2024.

Manufacturing Diversification

CorMedix is also taking steps to derisk its reliance on a single finished dose manufacturer. The company has submitted a supplement to its New Drug Application (NDA), adding Siegfried Hameln as an alternate manufacturing site for DefenCath. Pending FDA approval, the company anticipates Siegfried coming online as a manufacturer as early as the end of 2024.

Financial Flexibility

To provide additional financial flexibility, CorMedix has announced a Letter of Intent with a large U.S.-based lender for a revolving credit facility of up to $25 million. The company has also filed to renew its expiring shelf registration statement and replace the expired at-the-market (ATM) facility, allowing it to make cost-of-capital-based decisions between equity and debt, should any additional capital be required in the future.

Conclusion

In summary, CorMedix is focused on the successful commercialization of DefenCath in both the inpatient and outpatient settings. The company has made significant progress in its launch efforts, securing its first outpatient procurement contract and engaging with key stakeholders in the inpatient and outpatient markets. CorMedix is also taking steps to diversify its manufacturing capabilities and strengthen its financial position to support the ongoing launch and potential future growth opportunities.