On November 10, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, reported financial results for the third quarter and nine months ended September 30, 2022 and provided an update on recent business events (Press release, CorMedix, NOV 10, 2022, View Source [SID1234623668]).

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Recent Corporate Highlights:

Earlier this week, CorMedix announced that the Center for Medicare & Medicaid Services (CMS) has published in the Federal Register a correction to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals New Technology Add on Payment (NTAP) reimbursement of DefenCath, increasing the maximum reimbursement per average hospital visit from $4,387.50 to $14,259.38.
CorMedix also announced the recent submission of a duplicate NTAP application to CMS, intended to take effect should the potential final approval of the DefenCath New Drug Application (NDA) by FDA occur after July 1st of 2023.
The Contract Manufacturing Organization (CMO) for the manufacture of DefenCath has informed the Company that it has implemented more than 95% of the corrective actions that resulted from a June FDA inspection, and that the CMO believes it is on track to close out remaining items during December.
As CorMedix executes on its plan to create alternative supply chain options for resubmission of the NDA for DefenCath, the Company is in the process of validating manufacturing at the CMO with heparin sourced from an alternative API supplier, as well as validating manufacturing at Alcami, an additional CMO, with heparin sourced from an alternative API supplier.
The Company’s target is to resubmit the DefenCath NDA by the end of the first quarter of 2023.
Cash and short-term investments, excluding restricted cash, at September 30, 2022 amounted to $59.0 million.
Joe Todisco, CorMedix CEO, commented, "the CorMedix team has made excellent progress on all fronts, working diligently in support of the CMO as it implements corrective actions to address deficiencies the CMO received from FDA during a June inspection of the manufacturing facility, as well as undertaking multiple steps to build out the team, processes and systems to be ready for commercialization as quickly as possible following a potential FDA approval. We have created parallel pathways to mitigate risk, with the goal of securing FDA approval of DefenCath in 2023. We look forward to providing additional updates as we aim to deliver on our commitment to patients receiving hemodialysis via central venous catheters."

Third Quarter and Nine Month 2022 Financial Highlights

For the third quarter of 2022, CorMedix recorded a net loss of $6.9 million, or $0.17 per share, compared with a net loss of $8.6 million, or $0.22 per share, in the third quarter of 2021. The lower net loss recognized during the third quarter of 2022 compared with 2021 was due to the net decrease in operating expenses.

Operating expenses in the third quarter of 2022 decreased approximately 19% to $7.0 million, compared with $8.6 million in the third quarter of 2021. R&D expense decreased approximately 51% to $2.3 million compared to $4.7 million in the third quarter of 2021, mainly due to a net decrease in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 21% to $4.6 million compared with $3.8 million in the third quarter of 2021. This increase was driven primarily by an increase in costs related to market research studies and pre-launch activities in preparation for the potential marketing approval of DefenCath.

For the nine months ended September 30, 2022, CorMedix recorded a net loss of $21.5 million, or $0.54 per share, compared with a net loss of $20.4 million, or $0.54 per share, in the first nine months of 2021. The increase in net loss in the first nine months of 2022 was driven primarily by a lower tax benefit from the NJ NOL program and an increase in operating expenses.

Operating expenses in the first nine months of 2022 were $22.3 million compared with $21.7 million during the comparable period in 2021, an increase of $0.6 million, or 3%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by lower costs related to the manufacturing of DefenCath prior to its potential marketing approval during the nine-month period of 2022.

Total cash on hand and short-term investments as of September 30, 2022 was $59.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2022, it has sufficient resources to fund operations at least through 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, November 10, 2022, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows: