On August 11, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the second quarter and six months ended June 30, 2022 and provided an update on recent business events (Press release, CorMedix, AUG 11, 2022, View Source [SID1234618212]).

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Recent Corporate Highlights:

CorMedix announced on August 8th that a second Complete Response Letter (CRL) was received from the FDA stating that the DefenCath NDA cannot be approved until deficiencies conveyed to the contract manufacturing organization (CMO) and the supplier of the active pharmaceutical ingredient (API) heparin during inspections are resolved to the satisfaction of FDA.
CorMedix has supported the efforts of the CMO to compile robust responses and corrective action plans to inspectional observations the CMO received during the FDA’s recent pre-approval inspection of the CMO for the DefenCath NDA. The CMO is engaging external consultants who are experienced in FDA’s requirements for CGMP compliance to accelerate the implementation of corrective actions.
The FDA conducted a recent inspection unrelated to DefenCath at the facility of the company’s heparin supplier, which culminated in the API supplier receiving a warning letter as a result of manufacturing deficiencies for a non-heparin API. The Company’s heparin supplier has advised CorMedix that it has retained an independent CGMP consultant to expedite the implementation of corrective actions and resolve the warning letter as quickly as possible.
CorMedix announced that it has entered into an agreement with Alcami Corporation, a US based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products, which will serve as a manufacturing site for DefenCath. The Company has been working with Alcami over the past several months to transfer the manufacturing process for DefenCath into an Alcami site, and CorMedix expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023.
On August 1st, the Center for Medicare & Medicaid Services (CMS) published in the Federal Register the conditional New Technology Add on Payment (NTAP) reimbursement. The NTAP is conditioned upon the NDA obtaining final FDA approval prior to July 1, 2023, and would take effect in the first calendar quarter following such FDA approval of the NDA. The Company intends to submit a duplicate NTAP application in October of this year with the expectation of preserving eligibility for NTAP should final NDA approval occur after July 1, 2023.
Cash and short-term investments, excluding restricted cash, at June 30, 2022 amounted to $64.6 million.
Joe Todisco, CorMedix CEO, commented, "While I am disappointed that we will not receive FDA approval on our PDUFA date, I remain confident in our pathway forward to an FDA approval, once either our existing CMO and API supplier obtain compliance clearance, or we are able to obtain regulatory approval for manufacturing with Alcami. We have sufficient cash on hand to fund operations through at least the next four quarters, and the team is focused on obtaining FDA approval of the DefenCath NDA as quickly as possible. We look forward to providing additional updates as we aim to deliver on our commitment to these patients."

Second Quarter and Six Month 2022 Financial Highlights

For the second quarter 2022, CorMedix recorded a net loss of $7.6 million, or $0.19 per share, compared with a net loss of $4.6 million, or $0.12 per share, in the second quarter of 2021, an increase of $3.0 million or 65%. The higher net loss recognized in 2022 compared with 2021 included an increase in both SG&A expenses and R&D expenses versus the 2nd quarter of 2021. CorMedix recognized a tax benefit of $0.6 million in the second quarter of 2022 from the sale of our NJ Net Operating Losses compared with a $1.3 million benefit recorded in 2nd quarter of 2021.

Operating expenses in the second quarter of 2022 increased approximately 41% to $8.3 million, compared with $5.9 million in the second quarter of 2021. R&D expense increased approximately 28% to $3.2 million compared with $2.5 million in the second quarter of 2021, mainly due to an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 50% to $5.1 million compared with $3.4 million in the second quarter of 2021. This increase was driven primarily by an increase in in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath, and an increase in legal fees mainly due to the securities litigation.

For the six months ended June 30, 2022, CorMedix recorded a net loss of $14.6 million, or $0.38 per share, compared with a net loss of $11.8 million, or $0.32 per share, in the first half of 2021. Operating expenses in the first half of 2022 were $15.3 million, compared to $13.1 million in the first half of 2021, an increase of approximately 17%. This increase was primarily due to costs related to the manufacturing of DefenCath prior to its potential marketing approval, legal fees mainly due to the securities litigation, and personnel expenses.

The Company reported cash and short-term investments of $64.6 million at June 30, 2022, excluding restricted cash. The Company believes that it has sufficient resources to fund operations at least through the third quarter of 2023.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, August 11, 2022, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: