CHARLOTTE, N.C., March 2, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the fourth quarter and full year 2010 and will host a conference call this afternoon at 4:30 PM ET to discuss these results and provide an update on the Company's development progress.
2010 Highlights
- Met primary endpoint, achieving highly significant improvement OHQ composite scores (p=0.003) in pivotal Phase III Northera Study 301 in neurogenic orthostatic hypotension (NOH)
- Reported data from Northera NOH Study 303 confirming safety, sustained improvements in blood pressure and statistically significant 3.2 unit improvement in OHQ composite scores (p<0.001) following three months of open label treatment
- Reported results from Northera 24-hour blood pressure monitoring Study 305 in which no patients reported consecutive SBP measurements >180 mmHg for more than 3.5 hours at any time during the study
- Reached agreement with FDA to file Northera new drug application (NDA) in symptomatic neurogenic orthostatic hypotension based on efficacy data from Studies 301 & 302
- Reported positive interim analysis of Phase II trial evaluating novel droxidopa/carbidopa combination therapy in fibromyalgia in which data monitoring committee saw meaningful efficacy in multiple treatment arms
- Supported initiation of investigator-sponsored Phase II trials of droxidopa in both adult attention deficit hyperactivity disorder (ADHD) and chronic fatigue syndrome (CFS)
- Initiated Phase II trial designed to compare the efficacy and tolerability of CH-4051, a novel metabolically inert antifolate, against methotrexate (MTX) in rheumatoid arthritis (RA) patients who show an inadequate response to MTX
"Following the robust data generated by our Phase III clinical program and the success of our recent financing, we believe Chelsea is well positioned to seek approval to market Northera in the U.S. for the treatment of symptomatic neurogenic orthostatic hypotension and well funded for a U.S. launch early next year," commented Dr. Simon Pedder, President and CEO of Chelsea. "In the coming months, I look forward to having the opportunity to report data from multiple Phase II trials of droxidopa in new indications, get our first look at the efficacy of CH-4051 in RA patients and file our first new drug application for Northera."
Financial Results for the Fourth Quarter
Chelsea reported a net loss for the quarter ended December 31, 2010 of $12.4 million or ($0.25) per share versus a net loss of $6.0 million or ($0.18) per share for the comparable period in 2009.
Research and development expenses for the three months ended December 31, 2010 were $10.2 million, compared to $4.0 million for the same period in 2009. The increase in research and development expense was primarily driven by increased clinical activity, specifically expenses associated with the Northera registration program, Study 306, the Phase II trial of CH-4051 in rheumatoid arthritis along with expenses for the initial manufacturing and validation work of the active pharmaceutical ingredient of Northera.
Selling, general and administrative expenses were $2.3 million for the three months ended December 31, 2010 compared to $2.0 million for the same period in 2009.
Financial Results for the Year Ended December 31, 2010
Chelsea reported a net loss for the year ended December 31, 2010 of $37.3 million or ($0.91) per share compared to a net loss of $25.8 million or ($0.82) per share for the year ended December 31, 2009.
Research and development expenses for the year ended December 31, 2010 were $30.9 million, compared to $24.0 million for the same period in 2009. This increase of approximately $6.9 million was due primarily to increased clinical activity associated with the Northera Phase III registration program, Chelsea's Phase II trial of droxidopa in fibromyalgia and Phase II trial of CH-4051 in rheumatoid arthritis as well as the costs of manufacturing, packaging and labeling appropriate clinical trial material for these trials and manufacturing validation material for Northera commercialization.
Selling, general and administrative expenses for the 12 months ended December 31, 2010 were $6.6 million compared to $6.4 million for the same period in 2009. The overall increase in SG&A in 2010 reflects increases in compensation and related expenses and promotional costs that include conference sponsorships.
Chelsea ended the year with $47.6 million in cash and cash equivalents. This compares to $22.3 million in cash and cash equivalents at December 31, 2009. Chelsea anticipates that the cash and cash equivalents at year-end combined with net proceeds of $37.8 million from the public offering completed in February 2011 and the proceeds of $8.4 million resulting from the exercise of expiring warrants in February 2011 will fund the company's current development programs and launch initiatives through commercialization and into the second quarter of 2012.
Conference Call Today at 4:30 PM ET
Chelsea will discuss its fourth quarter and full year financial results and provide an update on its clinical development programs in a conference call today at 4:30 PM Eastern Time. 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 800-642-1687 for domestic participants or 706-645-9291 for international participants and entering passcode 47922805 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 December 31, | For the years ended December 31, | |||
| 2010 | 2009 | 2010 | 2009 | |
| Operating expenses: | ||||
| Research and development | $ 10,171,696 | $ 4,025,053 | $ 30,871,125 | $ 23,985,118 |
| Sales and marketing | 1,133,073 | 936,966 | 2,476,494 | 2,289,451 |
| General and administrative | 1,136,645 | 1,036,429 | 4,154,944 | 4,075,663 |
| Total operating expenses | 12,441,414 | 5,998,448 | 37,502,563 | 30,350,232 |
| Operating loss | (12,441,414) | (5,998,448) | (37,502,563) | (30,350,232) |
| Interest income | 54,405 | 72,926 | 242,883 | 336,850 |
| Interest expense | -- | (40,900) | (70,389) | (149,019) |
| Other income | -- | -- | -- | 4,390,487 |
| Net loss | $ (12,387,009) | $ (5,966,422) | $ (37,330,069) | $ (25,771,914) |
|
Net loss per basic and diluted share of common stock |
$ (0.25) | $ (0.18) | $ (0.91) | $ (0.82) |
|
Weighted average number of basic and diluted common shares outstanding |
48,649,758 | 33,500,406 | 41,184,623 | 31,549,739 |
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | ||
| (A Development Stage Company) | ||
| Condensed Consolidated Balance Sheet Data | ||
| (unaudited) | ||
| As of December 31, | ||
| 2010 | 2009 | |
| (in thousands) | ||
| Cash and cash equivalents | $ 47,593 | $ 22,295 |
| Short-term investments | -- | 11,450 |
| Long-term investments | -- | -- |
| Total assets | 48,374 | 34,349 |
| Line of credit payable | -- | 11,466 |
| Total liabilities | 13,186 | 21,497 |
| Deficit accumulated during the development stage | (132,873) | (95,543) |
| Stockholders' equity | 35,188 | 12,852 |
| A reconciliation of GAAP to non-GAAP loss per share is as follows: | ||||
|
For the three months ended December 31, |
For the year ended December 31, |
|||
| 2010 | 2009 | 2010 | 2009 | |
| GAAP loss per share | $ (0.25) | $ (0.18) | $ (0.91) | $ (0.82) |
|
Other income related to investments in auction rate securities |
-- | -- | -- | (0.14) |
| Non-GAAP loss per share | $ (0.25) | $ (0.18) | $ (0.91) | $ (0.96) |
To view the Notes to the Company's Financial Statements and Management's Discussion and Analysis, please see the Company's Annual Report on Form 10-K for the year ended December 31, 2010 available on Chelsea's website at www.chelseatherapeutics.com
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-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder.