CHARLOTTE, N.C., March 11, 2014 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the fourth quarter and full year ended December 31, 2013.
"FDA approval of NORTHERA™ (droxidopa) this February for symptomatic neurogenic orthostatic hypotension is Chelsea Therapeutics' most important milestone to date," said Joseph G. Oliveto, President and CEO of Chelsea. "NORTHERA is the first new treatment option approved for this indication in nearly two decades, representing a significant market opportunity. We continue to pursue a dual path of actively assessing the Company's strategic alternatives and preparing for the commercial launch of NORTHERA."
Financial Results for the Fourth Quarter
For the quarter ended December 31, 2013, Chelsea reported a net loss of $5.3 million or ($0.07) per share versus a net loss of $2.2 million or ($0.03) per share for the same period in 2012. For the twelve months ended December 31, 2013, Chelsea reported a net loss of $16.4 million or ($0.24) per share compared to a net loss of $31.7 million of ($0.47) per share for the same period in 2012.
Research and development (R&D) expenses for the fourth quarter of 2013 were $3.9 million, compared to $0.9 million for the same period in 2012. For the twelve months ended December 31, 2013, research and development expenses were $10.4 million, versus $16.7 million for 2012. The reduction in R&D costs year over year is primarily due to the completion of multiple studies in both the droxidopa and antifolate development programs during 2012, contributing to significantly reduced R&D spending during the first three quarters of 2013.
Selling, general and administrative (SG&A) expenses were $1.4 million for the three months ended December 31, 2013, compared to $1.4 million for the same period in 2012. For the twelve months ended December 31, 2013, SG&A expenses were $6.1 million, compared to $12.9 million for the prior-year period. The reduction in SG&A expenses were primarily due to decreases in compensation and related costs associated with the reduction in force that occurred in July 2012. Costs incurred in 2013 included compensation and related expenses for continuing administrative and business development efforts, legal fees and other professional fees.
Chelsea ended the year with $45.3 million in cash and cash equivalents compared to $28.4 million, as of December 31, 2012. Plans for a NORTHERA™ launch are progressing while the Company continues to evaluate other strategic alternatives.
About NORTHERA
NORTHERA is indicated for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic NOH caused by primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.
Droxidopa was initially developed by Dainippon Sumitomo Pharma Co., Ltd. (DSP) and first commercialized in Japan in 1989.
Please see NORTHERA full Prescribing Information including Most Serious Side Effects for additional Important Safety Information at http://www.chelseatherapeutics.com.
For product information, or to report SUSPECTED ADVERSE REACTIONS, contact Chelsea Therapeutics, Inc. at 1-855-351-2879 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
About Chelsea Therapeutics
Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company that acquires, develops and commercializes innovative products for the treatment of a variety of human diseases, including central nervous system disorders. Chelsea acquired global development and commercialization rights to droxidopa (L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006, excluding Japan, Korea, China and Taiwan. For more information about the Company, visit www.chelseatherapeutics.com.
This press release contains forward-looking statements regarding future events including our intention to pursue the development of NORTHERA . These statements are subject to risks and uncertainties that could cause the actual events or results to differ materially. These include the risk that we are unable to successfully commercialize NORTHERA; the risks associated with fulfilling sales, marketing and distribution requirements; reliance on key personnel and our ability to attract and/or retain key personnel; the risk that FDA will not agree that our clinical trial results demonstrate the safety and effectiveness of droxidopa or fulfill the post marketing requirements to achieve full approval; the risk that our resources will not be sufficient to conduct any study of NORTHERA that will be acceptable to the FDA; the risk that we cannot complete Study 401 or any other additional study for NORTHERA without the need for additional capital; the risks and costs of drug development and that such development may take longer or be more expensive than anticipated; our need to raise additional operating capital in the future; our reliance on our lead drug candidate droxidopa; the risk that we will not be able to obtain regulatory approvals of droxidopa or our other drug candidates for additional indications; the risk of volatility in our stock price, related litigation, and analyst coverage of our stock; reliance on collaborations and licenses; intellectual property risks; our history of losses; competition; market acceptance for our products when approved for marketing.
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | ||||
| (A Development Stage Company) | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
| Period from | ||||
| April 3, 2002 | ||||
| For the years ended December 31, | (inception) through | |||
| 2013 | 2012 | 2011 | December 31, 2013 | |
| Operating expenses: | ||||
| Research and development | $ 10,367,757 | $ 16,744,423 | $ 37,270,138 | $ 172,872,603 |
| Sales and marketing | 1,089,053 | 7,221,800 | 8,067,709 | 25,335,429 |
| General and administrative | 4,977,546 | 5,679,485 | 5,276,146 | 35,880,704 |
| Restructuring | -- | 2,157,795 | -- | 2,157,795 |
| Total operating expenses | 16,434,356 | 31,803,503 | 50,613,993 | 236,246,531 |
| Operating loss | (16,434,356) | (31,803,503) | (50,613,993) | (236,246,531) |
| Interest income | 18,123 | 67,594 | 161,828 | 5,027,236 |
| Interest expense | -- | -- | -- | (258,348) |
| Net loss | $ (16,416,233) | $ (31,735,909) | $ (50,452,165) | $ (231,477,643) |
| Net loss per basic and diluted share of common stock | $ (0.24) | $ (0.47) | $ (0.84) | |
| Weighted average number of basic and diluted common shares outstanding | 68,825,944 | 66,892,982 | 60,136,326 | |
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | |||||
| (A Development Stage Company) | |||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||
| (unaudited) | |||||
| Period from | |||||
| April 3, 2002 | |||||
| For the three months ended December 31, | For the twelve months ended December 31, | (inception) to | |||
| 2013 | 2012 | 2013 | 2012 | December 31, 2013 | |
| Operating expenses: | |||||
| Research and development | $ 3,946,967 | $ 870,287 | $ 10,367,757 | $ 16,744,423 | $ 172,872,603 |
| Sales and marketing | 249,547 | 278,472 | 1,089,053 | 7,221,800 | 25,335,429 |
| General and administrative | 1,128,446 | 1,149,050 | 4,977,546 | 5,679,485 | 35,880,704 |
| Restructuring | -- | (60,552) | -- | 2,157,795 | 2,157,795 |
| Total operating expenses | 5,324,960 | 2,237,257 | 16,434,356 | 31,803,503 | 236,246,531 |
| Operating loss | (5,324,960) | (2,237,257) | (16,434,356) | (31,803,503) | (236,246,531) |
| Interest income | 4,514 | 9,150 | 18,123 | 67,594 | 5,027,236 |
| Interest expense | -- | -- | -- | -- | (258,348) |
| Net loss | $ (5,320,446) | $ (2,228,107) | $ (16,416,233) | $ (31,735,909) | $ (231,477,643) |
| Net loss per basic and diluted share of common stock | $ (0.07) | $ (0.03) | $ (0.24) | $ (0.47) | |
| Weighted average number of basic and diluted common shares outstanding | 73,868,309 | 67,058,174 | 68,825,944 | 66,892,982 | |
| See accompanying notes to condensed consolidated financial statements. | |||||
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | ||
| Condensed Consolidated Balance Sheet Data | ||
| (unaudited) | ||
| December 31, | December 31, | |
| 2013 | 2012 | |
| (in thousands) | ||
| Cash and cash equivalents | $ 45,323 | $ 28,425 |
| Total assets | 46,503 | 28,928 |
| Total liabilities | 3,247 | 3,011 |
| Deficit accumulated during the development stage | (231,478) | (215,061) |
| Stockholders' equity | 43,256 | 25,916 |