CHARLOTTE, N.C., March 10, 2010 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the fourth quarter and full year 2009 and will host a conference call this afternoon at 4:30 PM ET to discuss these results and provide a quarterly update on the Company's development progress.
2009 Highlights
Droxidopa:
- Initiated Phase II trial of Droxidopa in fibromyalgia
- Reported statistically significant reduction (87.5%) in the number of patients requiring early termination of hemodialysis sessions in Phase II trial of Droxidopa in intradialytic hypotension and presented findings in late breaking clinical trials session at World Congress of Nephrology 2009
- Reported results from first Phase III pivotal Droxidopa study in neurogenic orthostatic hypotension showing statistically significant benefits across five clinically relevant assessment criteria and positive trends favoring Droxidopa on 16 of the 17 study endpoints
- Conducted subgroup analysis of 44 Parkinson's patients in Study 302 showing highly statistically significant benefits of Droxidopa therapy
- Granted approval to increase enrollment and change the primary endpoint in Droxidopa pivotal Study 301 to the OHQ composite score, a more comprehensive global assessment of the clinical benefit of Droxidopa
Metabolically Inert Antifolates:
- Demonstrated comparable efficacy of multiple doses of CH-1504 to methotrexate in head-to-head Phase II trial and presented detailed findings in platform presentation at 2009 American College of Rheumatology Annual Scientific Meeting
- Reported positive findings from Phase I trial of CH-4051 single and multiple ascending dose studies demonstrating that CH-4051 is safe and well tolerated up to a maximally tolerated dose of 7.5mg and presented safety, tolerability and pharmacokinetic data at 2009 American College of Rheumatology Annual Scientific Meeting
"During 2009, Chelsea's development programs generated an unprecedented amount of clinical data all clearly supporting the efficacy of our drug candidates in their target indications," commented Dr. Simon Pedder, President and CEO of Chelsea. "The combined results of these trials are of great value as we incorporate our findings from the past year, continue to advance our core pipeline of drug candidates and work toward the commercialization of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension."
Financial Results for the Fourth Quarter
Chelsea reported a net loss for the quarter ended December 31, 2009 of $6.0 million or ($0.18) per share versus a net loss of $9.0 million or ($0.30) per share for the comparable period in 2008. Net loss for the fourth quarter 2008 included a net charge of $0.7 million or $0.02 cents per share related to the valuation of auction rate securities.
Research and development expenses for the three months ended December 31, 2009 were $4.0 million, compared to $7.2 million for the same period in 2008. Total research and development expense decreased $3.2 million during the quarter compared to the same period a year ago due primarily to a decrease in research and development expenses related to Chelsea's clinical activity as several studies ongoing in 2008 reached conclusion in 2009.
Selling, general and administrative expenses were $2.0 million for the three months ended December 31, 2009 compared to $1.3 million for the same period in 2008. The increase resulted primarily from costs associated with certain market research initiatives.
Financial Results for the Year Ended December 31, 2009
Chelsea reported a net loss for the year ended December 31, 2009 of $25.8 million or ($0.82) compared to a net loss of $35.1 million or ($1.17) per share for the year ended December 31, 2008. The net loss for 2008 includes the recognition of other expense totaling approximately $4.4 million related to the valuation of auction rate securities, the full amount of which was recovered and recorded as other income in 2009.
Research and development expenses for the year ended December 31, 2009 were $24.0 million, compared to $27.1 million for the same period in 2008. This decrease of approximately $3.1 million was due primarily to decreased clinical trial and manufacturing costs as several studies ongoing in 2008 were concluded in 2009.
Selling, general and administrative expenses for the 12 months ended December 31, 2009 were $6.4 million compared to $5.3 million for the same period in 2008. The $1.1 million increase can be attributed to market research conducted in the fourth quarter and moderate increases in administrative costs in 2009.
Chelsea ended the year with $22.3 million in cash and cash equivalents. This compares to $21.5 million in cash and cash equivalents at December 31, 2008. Chelsea anticipates that the cash and cash equivalents at year-end combined with net proceeds of $16.8 million from the registered direct offering completed in March 2010 will fund the company's current development programs into the first quarter of 2011.
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 60600587 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, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan for the treatment of symptomatic orthostatic hypotension, freezing gait in Parkinson's disease and intradialytic hypotension, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan. 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 suggests superior safety and tolerability, as well as increased potency versus methotrexate (MTX), currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases including RA.
| CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY | ||||
| (A Development Stage Company) | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
|
For the three months ended December 31, |
For the years ended December 31, |
|||
| 2009 | 2008 | 2009 | 2008 | |
| (unaudited) | (unaudited) | |||
| Operating expenses: | ||||
| Research and development | $ 4,025,053 | $ 7,193,969 | $ 23,985,118 | $ 27,109,174 |
| Sales and marketing | 936,966 | 384,325 | 2,289,451 | 1,561,223 |
| General and administrative | 1,036,429 | 929,008 | 4,075,663 | 3,726,915 |
| Total operating expenses | 5,998,448 | 8,507,302 | 30,350,232 | 32,397,312 |
| Operating loss | (5,998,448) | (8,507,302) | (30,350,232) | (32,397,312) |
| Interest income | 72,926 | 213,308 | 336,850 | 1,706,568 |
| Interest expense | (40,900) | (4,920) | (149,019) | (4,920) |
| Other income (expense) | -- | (714,314) | 4,390,487 | (4,390,487) |
| Net loss | $ (5,966,422) | $ (9,013,228) | $ (25,771,914) | $ (35,086,151) |
|
Net loss per basic and diluted share of common stock |
$ (0.18) | $ (0.30) | $ (0.82) | $ (1.17) |
|
Weighted average number of basic and diluted common shares outstanding |
33,500,406 | 30,111,479 | 31,549,739 | 30,027,031 |
|
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY (A Development Stage Company) CONDENSED CONSOLIDATED BALANCE SHEET DATA (unaudited) |
||
| As of December 31, | ||
| 2009 | 2008 | |
| (in thousands) | ||
| Cash and cash equivalents | $ 22,295 | $ 21,533 |
| Short-term investments | 11,450 | 10,306 |
| Long-term investments | -- | 11,329 |
| Total assets | 34,349 | 44,130 |
| Line of credit payable | 11,466 | 7,277 |
| Total liabilities | 21,497 | 19,583 |
| Deficit accumulated during the development stage | (95,543) | (69,771) |
| Stockholders' equity | 12,852 | 24,548 |
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, |
|||
| 2009 | 2008 | 2009 | 2008 | |
| GAAP loss per share | $ (0.18) | $ (0.30) | $ (0.82) | $ (1.17) |
|
Net other expense related to investments in auction rate securities |
-- | 0.02 | (0.14) | 0.15 |
| Non-GAAP loss per share | $ (0.18) | $ (0.28) | $ (0.96) | $ (1.02) |
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, 2009 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-4051, 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.