Chelsea Therapeutics announces financial results for fourth quarter 2009

Mar 11 2010

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) reported financial results for the fourth quarter and full year 2009 and will host a conference call 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 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 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.

Source: http://chelseatherapeutics.com/