Chelsea Therapeutics Reports Fourth Quarter And Full-Year 2012 Results

Financial Results for the Fourth Quarter

For the quarter ended December 31, 2012, Chelsea reported a net loss of $2.2 million or ($0.03) per share versus a net loss of $12.5 million or ($0.20) per share for the same period in 2011.  For the twelve months ended December 31, 2012, Chelsea reported a net loss of $31.7 million or ($0.47) per share compared to a net loss of $50.5 million or ($0.84) per share for the same period in 2011.

Research and development (R&D) expenses for the fourth quarter of 2012 were $0.9 million, compared to $7.7 million for the same period in 2011.  For the twelve months ended December 31, 2012, research and development expenses were $16.7 million, versus $37.3 million for the comparable prior-year period.  The reduction in R&D costs is primarily due to the completion of multiple studies in both the droxidopa and antifolate development programs.

Selling, general and administrative (SG&A) expenses were $1.4 million for the three months ended December 31, 2012, compared to $4.8 million for the same period in 2011.  For the twelve months ended December 31, 2012, SG&A expenses were $12.9 million, compared to $13.3 million for the prior-year period.  The period to period changes in SG&A costs are primarily related to our significant spending on Northera commercialization and launch preparation activities that occurred during the latter half of 2011 and the first half of 2012. By the end of the second quarter of 2012, the majority of these activities had been brought to a close as related vendor contracts were cancelled and projects were finalized subsequent to receipt of the Complete Response Letter from the FDA in March 2012.

Chelsea ended the year with $28.4 million in cash and cash equivalents compared to $45.6 million, including short-term investments, as of December 31, 2011.  Chelsea anticipates that its cash and cash equivalents on hand should fund the Company's operations into the third quarter of 2014.  While details for a future clinical trial for Northera are yet to be determined, this projection assumes a new trial would commence dosing in the fourth quarter of 2013. In addition to the initial costs of a new trial, assumptions underlying this guidance cover costs related to the NDA re-submission. This current forecast does not include material activities related to an NDA approval or the commercialization of Northera.

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