On August 31, 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 second quarter and six months ended June 30, 2021 and provided an update on recent developments (Press release, CorMedix, AUG 31, 2021, View Source [SID1234587038]).

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Recent Business Highlights:

CorMedix remains focused in its efforts to resolve the deficiencies sent to the third-party manufacturer in the Post-Application Action Letter and remains on schedule to re-submit the DefenCath New Drug Application in the fourth quarter of 2021.
CorMedix received approximately $1.3 million in net proceeds upon the closing of the sale of tax benefits pursuant to the New Jersey Technology Business Tax Certificate Transfer (NOL) program.
CorMedix has approximately $78.3 million in cash on hand and short-term investments as of June 30; we believe this is sufficient to fund operations at least through 2022.
Khoso Baluch, CorMedix CEO commented, "We are pleased with the progress we are making as we address the deficiencies identified by FDA at the third-party manufacturing facility. We remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters."

Second Quarter and Six Month 2021 Financial Highlights

For the second quarter 2021, CorMedix recorded a net loss of $4.6 million, or $0.12 per share, compared with a net loss of $3.8 million, or $0.14 per share, in the second quarter of 2020. The higher net loss recognized in 2021 compared with 2020 was due to increased personnel expenses and a lower tax benefit from the NJ NOL program, partially offset by raw materials purchased during 2Q of 2020. We recorded an increase in SG&A and a decrease in R&D expenses. We recognized a tax benefit of $1.3 million in 2021 from the sale of our NJ Net Operating Losses compared with a $5.2 million benefit recorded in 2020.

Operating expenses in the second quarter of 2021 decreased approximately 34% to $5.9 million, compared with $8.9 million in the second quarter of 2020. R&D expense decreased approximately 56% to $2.5 million, mainly due to a $3.4 million purchase of raw material during the second quarter of 2020 for the manufacturing of DefenCath prior to its potential marketing approval. SG&A expense increased approximately 4% to $3.4 million compared with $3.2 million in the second 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 as a result of additional hires, partially offset by a decrease in consulting fees.

For the six months ended June 30, 2021, CorMedix recorded a net loss of $11.8 million, or $0.32 per share, compared with a net loss of $9.3 million, or $0.36 per share, in the first half of 2020. Operating expenses in the first half of 2021 were $13.1 million, compared to $14.6 million in the first half of 2020, a decrease of approximately 10%. This decrease was primarily due to the raw material purchased in 2nd quarter of 2020 partially offset by higher SG&A expenses throughout the organization.

Total cash on hand and short-term investments as of June 30, 2021 was $78.3 million, excluding restricted cash of $0.2 million. The Company believes that, based on the Company’s cash resources at June 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, August 12, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information is as follows: