On November 9, 2021 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 third quarter and nine months ended September 30, 2021 and provided an update on recent developments (Press release, CorMedix, NOV 9, 2021, View Source [SID1234595056]).
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Recent Corporate and Regulatory Highlights:
As noted previously, there was a delay as a result of issues at the third-party manufacturer, or CMO, unrelated to the manufacture of DefenCath. Together with our CMO, we have been able to resume manufacturing activities and are continuing to complete the work that is required to address the deficiencies identified at the manufacturing facility.
CorMedix continues to work diligently toward the resubmission of the DefenCath NDA and plans to provide an update when we have clarity on the submission timeline.
CorMedix announced in October that its Board had appointed Matt David M.D., CorMedix’s EVP and Chief Financial Officer, as interim Chief Executive Officer. In addition, CorMedix expanded the responsibilities of Phoebe Mounts, Ph.D., Esq., EVP, General Counsel, and Head of Regulatory, Compliance, and Legal to include leadership of the Technical Operations group.
CorMedix presented three abstracts at industry conferences including the Association of Managed Care Pharmacy (AMCP) Nexus conference in October and the American Society of Nephrology (ASN) conference in November. The presentations highlighted retrospective analyses that were conducted to better understand the incidence of and mortality related to CRBSIs and economic costs related to these infections.
Cash and short-term investments, excluding restricted cash, at September 30, 2021 amounted to $72.0 million.
Dr. Matt David, CorMedix interim CEO, commented, "We are pleased that we have been able to resume manufacturing activities at our CMO and look forward to providing updates over the coming months. As the recent industry conference presentations have highlighted, catheter related bloodstream infections are common in patients receiving hemodialysis via central venous catheters and are associated with significant morbidity and mortality. We remain steadfast in our commitment to these patients as we seek to bring DefenCath to market upon its approval."
Third Quarter and Nine Month 2021 Financial Highlights
For the third quarter of 2021, CorMedix recorded a net loss of $8.6 million, or $0.22 per share, compared with a net loss of $6.6 million, or $0.22 per share, in the third quarter of 2020. The higher net loss recognized during the third quarter of 2021 compared with 2020 was due to the net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval.
Operating expenses in the third quarter of 2021 increased approximately 30% to $8.6 million, compared with $6.6 million in the third quarter of 2020. R&D expense increased approximately 62% to $4.7 million compared to $2.9 million in the third quarter of 2020, mainly due to net increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 4% to $3.8 million compared with $3.7 million in the third quarter of 2020. This increase was driven primarily by an increase in non-cash charges for stock-based compensation and an increase in personnel expenses, partially offset by decreases in costs related to market research studies in preparation for the potential marketing approval of DefenCath and in consulting fees.
For the nine months ended September 30, 2021, CorMedix recorded a net loss of $20.4 million, or $0.54 per share, compared with a net loss of $15.9 million, or $0.58 per share, in the first nine months of 2020. The increase in net loss in the first nine months of 2021 was driven primarily by a lower tax benefit from the New Jersey NOL program.
Operating expenses in the first nine months of 2021 were $21.7 million compared with $21.2 million during the comparable period in 2020, an increase of $0.5 million, or 2%. This increase was primarily due to higher SG&A expenses throughout the organization, partially offset by a net decrease in costs related to the manufacturing of DefenCath prior to its potential marketing approval.
Total cash on hand and short-term investments as of September 30, 2021 was $72.0 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at September 30, 2021, it has sufficient resources to fund operations at least through 2022, after taking into consideration the costs for re-submission of the NDA and initial preparations for the commercial launch for DefenCath.
Conference Call Information
The management team of CorMedix will host a conference call and webcast today, November 9, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows: