CHARLOTTE, N.C., Nov. 2, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the third quarter 2011 and presented a quarterly update on the Company's development progress. Chelsea's management team will host a conference call this afternoon at 4:30 PM EDT to discuss these results.
Recent Highlights:
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Reported unblinded interim safety data from ongoing Phase II trial of CH-4051 demonstrating that a daily 1.0 mg dose of CH-4051 achieved similar efficacy to 20.0 mg weekly dose of methotrexate (MTX) while maintaining better safety and tolerability in patients with an incomplete response to MTX;
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Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking Priority Review and approval to market NORTHERA™ (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure, dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy;
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Granted new patent related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications; and
- Achieved target enrollment in Phase II trial of droxidopa in fibromyalgia.
"People with symptomatic neurogenic orthostatic hypotension face extraordinary challenges every day," commented Dr. Simon Pedder, President and CEO of Chelsea. "The filing of our new drug application during the third quarter was a significant achievement that has been several years in the making and reflects our team's commitment to these patients. In reaching this goal, we believe we took a significant step toward making a meaningful new treatment option available to patients whose lives have been impacted by the symptoms of NOH. We are highly confident in the effectiveness of Northera, the strength of our filing and the abilities of our sales and marketing team and look forward toward an anticipated U.S. approval and launch of Northera next year."
Financial Results for the Third Quarter
Chelsea reported a net loss for the quarter ended September 30, 2011 of $10.9 million or ($0.18) per share versus a net loss of $8.8 million or ($0.22) per share for the same period in 2010. For the first nine months of 2011, Chelsea reported a net loss of $38.0 million or ($0.64) per share compared to a net loss of $24.9 million or ($0.65) per share for the nine months ended September 30, 2010.
Research and development (R&D) expenses of $7.4 million for the third quarter 2011 remained flat year-over-year. The R&D expenses for the quarter reflect a decrease in clinical expense offset by approximately $1.1 million related to medical affairs activities including the hiring, on a contract basis, of a team of Medical Science Liaisons and approximately $0.7 million related to the preparation and filing of the Northera NDA. For the nine months ended September 30, 2011, R&D expenses were $29.6 million versus $20.7 million for the comparable prior-year period. This year-over-year increase primarily reflects an increase in costs associated with the planned registration and anticipated launch of Northera including expenses related to the manufacturing of commercial drug product, the Northera QTc study and the preparation and filing of the Northera NDA.
Selling, general and administrative (SG&A) expenses of $3.5 million for the three months ended September 30, 2011 increased from $1.4 million for the same period in 2010. This increase of approximately $2.1 million reflects an increase in compensation related to the hiring of a marketing and sales leadership team, increased prelaunch market research and the implementation of key sales and marketing initiatives to support the planned commercialization of Northera in 2012. SG&A expenses of $8.6 million for the nine months ended September 30, 2011 compared to $4.4 for the prior-year period and, similar to third quarter expense, reflects an increase in compensation and costs related to market research, sales force strategy and planning, as well as planning for advertising and promotional campaigns.
Chelsea ended the quarter with $57.6 million in cash, cash equivalents and short-term investments compared to $47.6 million at December 31, 2010.
2011 Financial Guidance
Chelsea anticipates 2011 R&D expense to remain near current levels with full year R&D expenses of approximately $42 million and SG&A expenses continuing to ramp through commercialization with a 2011 total of approximately $16 million. Based on these expenses, Chelsea anticipates ending the year with approximately $35 – 40 million in cash, cash equivalents and short-term investments. The Company anticipates that available cash, cash equivalents and short-term investments should fund the company's current development programs and launch initiatives through anticipated commercialization of Northera in the second quarter of 2012.
Conference Call Today at 4:30 PM EDT
Interested investors may participate in the conference call by dialing 877-638-9567 (domestic) or 720-545-0009 (international). A replay will be available for one week following the call by dialing 855-859-2056 for domestic participants or 404-537-3406 for international participants and entering passcode 22815594 when prompted. Participants may also access both the live and archived webcast of the conference call on Chelsea's web site at www.chelseatherapeutics.com.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, NORTHERA™ (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | |||||
| (A Development Stage Company) | |||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||
| (unaudited) | |||||
| For the three months ended September 30, | For the nine months ended September 30, | ||||
| 2011 | 2010 | 2011 | 2010 | ||
| Operating expenses: | |||||
| Research and development | $ 7,417,477 | $ 7,424,682 | $ 29,557,451 | $ 20,699,430 | |
| Sales and marketing | 2,203,898 | 424,453 | 4,639,245 | 1,343,421 | |
| General and administrative | 1,278,085 | 954,540 | 3,928,255 | 3,018,299 | |
| Total operating expenses | 10,899,460 | 8,803,675 | 38,124,951 | 25,061,150 | |
| Operating loss | (10,899,460) | (8,803,675) | (38,124,951) | (25,061,150) | |
| Interest income | 45,222 | 19,003 | 131,120 | 188,478 | |
| Interest expense | -- | (2,055) | -- | (70,389) | |
| Net loss | $ (10,854,238) | $ (8,786,727) | $ (37,993,831) | $ (24,943,061) | |
|
Net loss per basic and diluted share of common stock |
$ (0.18) | $ (0.22) | $ (0.64) | $ (0.65) | |
|
Weighted average number of basic and diluted common shares outstanding |
61,847,700 | 40,316,699 | 59,544,028 | 38,668,900 | |
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | ||
| Condensed Consolidated Balance Sheet Data | ||
| (unaudited) | ||
| September 30, | December 31, | |
| 2011 | 2010 | |
| (in thousands) | ||
| Cash and cash equivalents | $ 37,104 | $ 47,593 |
| Short-term investments | 20,503 | -- |
| Total assets | 59,025 | 48,374 |
| Total liabilities | 13,644 | 13,186 |
| Deficit accumulated during the development stage | (170,867) | (132,873) |
| Stockholders' equity | 45,381 | 35,188 |
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder.