On March 30, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on recent business developments (Press release, CorMedix, MAR 30, 2023, View Source [SID1234629585]).

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Recent Corporate Highlights:

CorMedix submitted a Type A meeting request to the U.S. Food and Drug Administration ("FDA"), in mid-March seeking guidance for resubmission of its DefenCath New Drug Application, and FDA subsequently granted the meeting request, with a date scheduled for mid-April.
CorMedix was informed by its primary contract manufacturing organization ("CMO") that all corrective actions stemming from the FDA’s June 2022 inspection have been completed, and the CMO has provided to FDA documentation showing effectiveness of the corrective actions. The FDA has acknowledged receipt of that close out report.
CorMedix was informed by its primary heparin active pharmaceutical ingredient ("API") supplier that it too has completed the implementation of corrective actions arising from the FDA’s June 2022 Warning Letter for a non-heparin API. In addition, CorMedix was informed that updates have been made to the Heparin API Drug Master file clarifying which activities take place at the site referenced in the warning letter and which activities take place at a different facility, which has been previously inspected by FDA.
CorMedix announced an agreement to validate manufacturing of DefenCath at Siegfried AG’s site in Hameln, Germany, which has previously been inspected by FDA. The Hameln site previously manufactured Neutrolin, which was sold in Europe as a medical device. The Company intends to utilize Siegfried as a back-up CMO.
CorMedix announced two promotions in January: Erin Mistry’s promotion to EVP and Chief Commercial Officer and Dr. Tushar Mukherjee’s promotion to SVP and Head of Technical Operations. In addition, the Company has made several key hires in commercial, medical affairs and legal to prepare the organization for the potential commercial launch of DefenCath.
Cash and short-term investments, excluding restricted cash, at December 31, 2022 amounted to $58.8 million.
Joe Todisco, CorMedix CEO, commented, "we are very pleased that FDA has granted our meeting request and classified the meeting as a Type A, allowing us to seek FDA’s guidance in mid-April. The CorMedix team has made solid progress on all fronts, working diligently in support of the primary CMO as it completed the corrective actions to address previously identified deficiencies, as well as continuing to build out the team, processes and systems to be ready for commercialization as quickly as possible following a potential FDA approval. We have further refined our parallel supply chain pathways to mitigate risk, with the goal of pursuing FDA approval of DefenCath in 2023. We look forward to providing additional updates as we aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous catheters, and potentially other therapeutic settings."

4th Quarter 2022 Financial Highlights

For the fourth quarter of 2022, CorMedix recorded a net loss of $8.2 million, or $0.20 per share, compared with a net loss of $7.8 million, or $0.20 per share, in the fourth quarter of 2021. The increase in net loss in the fourth quarter of 2022 compared with 2021 was primarily driven by increases in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath. Operating expenses during the fourth quarter of 2022 were $8.4 million, compared with $7.8 million in the fourth quarter of 2021, an increase of approximately $0.6 million.

Full Year 2022 Financial Highlights

For the year ended December 31, 2022, CorMedix recorded a net loss of $29.7 million, or $0.74 per share, compared with a net loss during the year ended December 31, 2021 of $28.2 million, or $0.75 per share. The increase in net loss was driven primarily by increases in operating expenses.

Operating expenses during the year ended December 31, 2022 amounted to $30.7 million compared with $29.5 million during the comparable period in 2021, an increase of $1.2 million, or 4%, due to a 22% increase in SG&A expense, offset by a 18% decrease in R&D expense.

Total cash on hand and short-term investments as of December 31, 2022 amounted to $58.8 million, excluding restricted cash of $0.2 million. CorMedix received approximately $7.2 million in net proceeds from ATM issuance during the first quarter of 2023. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of our Annual Report on Form 10-K.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, March 30, 2023, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows:

Thursday, March 30th @ 8:30am ET
Domestic: 1-877-423-9813
International: 1-201-689-8573
Conference ID: 13736467
Webcast: Webcast Link