On May 9, 2024 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported financial results for the first quarter ended March 31, 2024 and provided an update on its business (Press release, CorMedix, MAY 9, 2024, View Source [SID1234642985]).

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Recent Corporate Highlights:

On April 2, 2024, CMS published its HCPCS coding decision for DefenCath, establishing a new HCPCS Level II code for the product. CMS subsequently notified the Company on April 18th of its determination that DefenCath meets the criteria for a Transitional Drug Add-On Payment (TDAPA) and will be effective July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers.
On April 15, 2024, the Company commenced commercial launch of DefenCath in the inpatient setting, and remains on schedule to commence outpatient launch in July.
The Company announced in April that it entered into a 5-year commercial supply contract with ARC Dialysis, LLC, a Florida-based dialysis provider, for the supply of DefenCath.
The FDA granted the Company’s Type C meeting request to discuss an updated development plan for DefenCath in Total Parenteral Nutrition (TPN) and pediatric study requirements. The Company expects to receive feedback from the FDA by the end of the second quarter of 2024.
The Company submitted to FDA earlier this week a supplement to the CorMedix NDA adding Siegfried Hameln as an alternate finished dosage manufacturing site for DefenCath. Pending FDA review and approval, the Company anticipates approval of the supplement by the end of 2024.
Cash and short-term investments, excluding restricted cash, at March 31, 2024, amounted to $58.6 million.
Joe Todisco, CorMedix CEO, commented, "I am excited about the Company’s recent progress as we have officially transitioned to a commercial stage organization. In only a few weeks of inpatient deployment we have received meaningful interest in scheduling DefenCath for formulary review at various institutions, and we look forward to additional progress in the coming months. We are also focusing simultaneously on our upcoming outpatient launch and actively engaging with customers regarding the potential to implement DefenCath as a preventative measure to reduce the risk of CRBSI in their respective hemodialysis patients with CVCs."

First Quarter 2024 Financial Highlights

For the first quarter of 2024, CorMedix recorded a net loss of $14.5 million, or $0.25 per share, compared with a net loss of $10.6 million, or $0.24 per share, in the first quarter of 2023, an increase of $3.9 million, driven primarily by an increase in operating expenses, partially offset by the sale of New Jersey NOLs for $1.4 million.

Operating expenses in the first quarter 2024 were $15.9 million, compared with $11.0 million in the first quarter of 2023, an increase of approximately 44%.  The increase was driven by higher SG&A expenses which increased approximately 98% to $15.0 million, partially offset by a decrease in research and development expenses of approximately 75%. The increase in SG&A was primarily driven by the hiring of sales force, medical affairs and marketing personnel. Additionally, as a result of the post FDA approval commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized in selling, general and administrative expense during the three months ended March 31, 2024, as compared to the same period last year during which these items were recognized in R&D, which drove the decrease in R&D expenses for this period compared to the same period last year.

The Company reported cash and short-term investments of $58.6 million at March 31, 2024, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 9, 2024, at 8:30am Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Thursday, May 9th @ 8:30am ET

Domestic: 1-888-886-7786

International: 1-416-764-8658

Conference ID: 32817785

Webcast: Webcast Link