CorMedix Inc. (“CorMedix”) (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, today announced its financial results for the year ended December 31, 2010.
Fourth Quarter 2010 Developments:
During the fourth quarter of 2010, CorMedix's key achievements included:
Financial Results for the Year Ended December 31, 2010
- Manufacturing the first trial batch of CRMD003 Neutrolin ® and beginning stability testing;
- Commencing the application process for submitting a CE Mark in Europe for CRMD003 Neutrolin ®;
- Filing an Investigational Device Exemption application with the FDA for CRMD003 Neutrolin ® for the prevention of Catheter Related Bloodstream Infection (“CRBI”) and Maintenance of Catheter Patency in Hemodialysis Patients;
- Continuing to advance patient enrollment in the Phase II Clinical Trial of CRMD001 Deferiprone for the prevention of Contrast Induced Nephropathy (“CIN”) with 8 active sites recruiting patients, and
- Receiving two federal grants totaling $0.5 million from the Qualifying Therapeutic Discovery Project Program.
The net loss for the year ended December 31, 2010 was $10.9 million, or ($1.15) per diluted share, compared to a net loss of $8.1 million, or ($9.48) per diluted share, for the year ended December 31, 2009. The increase in net loss was primarily attributable to an increase in Research and Development (“”R&D”) expense and General and Administrative (“G&A”) expense. R&D expense was $5.5 million for the year ended December 31, 2010, an increase of $0.6 million, from $4.9 million for the year ended December 31, 2009. The increase was primarily attributable to our issuance of 0.8 million shares of our common stock on March 30, 2010, of which 0.1 million shares are held in escrow, to our licensors valued at $3.125 per share, or $2.2 million, as a result of anti-dilution adjustments in connection with the conversion of our outstanding convertible debt to common stock upon the closing of our initial public offering (“IPO”), which anti-dilution provisions have expired. The increase in R&D expense was partially offset by higher stock-based licensor expenses in 2009 versus 2010, as a result of our issuance of 0.1 million shares of common stock to Shiva Biomedical, LLC at $32.05 per share in exchange for Shiva surrendering its rights to our Series B-F Common Stock, resulting in $3.2 million of R&D expense in 2009. The increase in R&D expense in 2010 compared to 2009 was also attributable to stock-based compensation expense of $0.5 million related to all stock options granted to our Chief Medical Officer and a portion of the stock options granted to our Chief Executive Officer in connection with the IPO. Also contributing to the higher R&D expense in 2010 were the clinical development costs related to our Phase II clinical trial of CRMD001 Deferiprone that began in June 2010, higher manufacturing costs related the development of CRMD003 Neutrolin
and costs related to the hiring of two employees in the areas of clinical operations and product development during the third quarter of 2010.
G&A expense was $3.0 million for the year ended December 31, 2010, an increase of $1.8 million from $1.2 million for the year ended December 31, 2009. The increase was primarily attributable to stock-based compensation expense of $0.7 million related to a portion of the stock options granted to our Chief Executive Officer and all of the stock options granted to our Chief Financial Officer and Board members in connection with the IPO, in addition to the issuance of 4,059 shares of our common stock to a consultant valued at $32.05 per share in February 2010, resulting in $0.1 million of G&A expense. The increase in G&A expense also reflects the increased costs of operating as a publicly-traded company following the IPO in March 2010, which include filing fees related to the listing of our common stock, as well as increased legal, accounting, investor relations consulting fees and increased compensation expense as a result of our hiring a Chief Financial Officer in February 2010.