CorMedix (NYSE: CRMD) reported mixed second quarter results after the bell. Revenue failed to beat estimates, while earnings came in better-than-expected. Last month, the biopharma firm reported that it has completed the Phase 3 trials for LOCK-IT-100 and is encouraged by the response from the US Food and Drug Administration (FDA). 

Revenue improved to $35,266 compared to $7,551 reported last year while loss per share came in at 3 cents compared to 52 cents reported last year. Analysts were estimating revenue of $130,000 and loss per share of 21 cents. CorMedix also received $5.1 million through the sale of its New Jersey NOL through the Technology Business Tax Certificate program.

Operating expenses decreased 35% primarily due to reduction in Research & Development (R&D) expenses. R&D expenses were down 55% due to reduction of clinical trial expenses, while SG&A expenses rose 32% due to increased staffing and compliance expenses.

Commenting on the Neutrolin trial update, CEO Khoso Baluch said, “We have made significant progress on our goal of bringing Neutrolin to the U.S. market as a catheter lock solution for hemodialysis. Our focus now turns to making sure that we have all of the data and information required to file an NDA and obtain marketing approval.”

Phase 3 Trial Update

CorMedix focuses on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The company’s lead product candidate Neutrolin has completed its Phase 3 trials in the US. If the company gets positive feedback from FDA, it expects Neutrolin to get market approval in 2020.

The LOCK-IT-100 Phase 3 trial studies the effectiveness of Neutrolin to be used as a catheter lock solution compared to heparin for the prevention of catheter-related bloodstream infection (CRBSI) for patients who are undergoing hemodialysis.

Currently, FDA is reviewing all the data submitted for the Phase 3 trial. For now, the regulator hasn’t mentioned anything on whether there would be a need for CorMedix to conduct one more trial.

The company also plans to continue its discussions with the FDA relating to the chemistry, manufacturing and controls (CMC) data. It’s worth noting that the CMC data feedback from the regulator is important before the company can initiate pre-new drug application meeting during the fourth quarter of 2019.

Looking Ahead

For the third quarter, the Wall Street is expecting sales to touch $320,000 and loss per share of 24 cents. When it comes to fiscal 2019 estimates, analysts are anticipating revenue of $850,000 and loss per share of 94 cents.

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