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8-K - FORM 8-K - Chelsea Therapeutics International, Ltd.d8k.htm

Exhibit 99.1

 

LOGO   Press Release
     

Chelsea Therapeutics Reports Second Quarter 2011 Results

 

   

Northera (droxidopa) New Drug Application for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension On Track for Submission In Third Quarter 2011

 

   

Unblinded Interim Efficacy Data from CH-4051 Phase II Trial in Rheumatoid Arthritis Expected in September 2011

 

   

Company to Host Conference Call at 4:30 PM EDT

Charlotte, NC, July 26, 2011 – Chelsea Therapeutics International, Ltd. (NASDAQ: CHTP) today reported financial results for the second 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:

 

   

Reported significant benefit of droxidopa in rapidly improving symptoms of adult attention deficit hyperactivity disorder in investigator-led Phase II study

 

   

Completed Northera dedicated thorough QTc study showing no cardiac safety concerns including no prolongation of QTc interval

 

   

Opened enrollment in 3.0 mg dose arms of CH-4051 Phase II trial in rheumatoid arthritis after review of data from 0.3 mg and 1.0 mg arms confirmed safety

 

   

Presented new data from Northera Study 306A highlighting the reduction of falls associated with Northera treatment in patients with neurogenic orthostatic hypotension (NOH) associated with Parkinson’s disease (PD) during MDS 15th International Congress of Parkinson’s Disease and Movement Disorders

“During the second quarter of 2011, we made significant advancements toward our near-term objectives of completing our new drug application for Northera and reporting the first efficacy data for our novel-antifolate, CH-4051, in rheumatoid arthritis,” commented Dr. Simon Pedder, president and CEO of Chelsea. “Having completed our QTc study ahead of schedule and having completed enrollment for our interim RA analysis, we look forward to achieving both of these goals later this quarter.”

Financial Results for the Second Quarter


Chelsea reported a net loss for the quarter ended June 30, 2011 of $13.3 million or ($0.21) per share versus a net loss of $9.9 million or ($0.25) per share for the same period in 2010. For the first six months of 2011, Chelsea reported a net loss of $27.1 million or ($0.46) per share compared to a net loss of $16.2 million or ($0.43) per share for the first half of 2010.

Research and development (R&D) expenses for the second quarter 2011 were $10.7 million, compared to $8.4 million for the same period in 2010. The increase in R&D expense during the second quarter reflects increases in costs associated with the planned commercialization of Northera and included approximately $1.6 million related to the manufacturing and process validation of commercial drug product, $1.3 million related to the completion of a dedicated QTc study to support the application for marketing approval in the U.S. and approximately $0.9 million related to the preparation of the Northera new drug application (NDA). An overall decrease of approximately $2.0 million year-over-year in clinical trial expenses was further offset by the initiation of medical affairs planning that accounted for approximately $0.9 million during the quarter.

For the six months ended June 30, 2011, research and development expenses were $22.1 million versus $13.3 million for the comparable prior-year period. Similar to R&D expense for the quarter, R&D expense for the first half of 2011 was primarily driven by increased costs associated with the planned registration and anticipated launch of Northera in the first half of 2012 including approximately $3.8 million related to the manufacture of commercial drug product, $2.6 million related to the Northera QTc study and $0.9 million related to the implementation of a medical affairs program.

Selling, general and administrative (SG&A) expenses of $2.6 million for the three months ended June 30, 2011 increased from $1.6 million for the same period in 2010. This increase in SG&A is primarily related to increased compensation and related expenses as well as increases in market research, promotional activities such as conference sponsorships and presentations, and legal expenses related to our intellectual property. Similarly, for the six months ended June 30, 2011, SG&A expenses of $5.1 million reflect an increase from $3.0 million for the prior-year period reflecting an increase in compensation and related expenses to support the planned commercialization of Northera as well as an overall increase in costs associated with implementing pre-launch sales and marketing initiatives.

Chelsea ended the quarter with $67.1 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 $47 million and SG&A expenses continuing to ramp through commercialization with a 2011 total of approximately $17 million. 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

Chelsea will discuss its second quarter 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 855-859-2056 for domestic participants or 404-537-3406 for international participants and entering passcode 84867259 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. 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 June 30,     For the six months ended June 30,  
     2011     2010     2011     2010  

Operating expenses:

        

Research and development

   $ 10,681,032      $ 8,394,276      $ 22,139,974      $ 13,274,749   

Sales and marketing

     1,324,217        508,420        2,435,347        918,967   

General and administrative

     1,317,454        1,088,171        2,650,170        2,063,758   
                                

Total operating expenses

     13,322,703        9,990,867        27,225,491        16,257,474   
                                

Operating loss

     (13,322,703     (9,990,867     (27,225,491     (16,257,474

Interest income

     51,316        101,923        85,898        169,474   

Interest expense

     —          (35,381     —          (68,334
                                

Net loss

   $ (13,271,387   $ (9,924,325   $ (27,139,593   $ (16,156,334
                                

Net loss per basic and diluted share of common stock

   $ (0.21   $ (0.25   $ (0.46   $ (0.43
                                

Weighted average number of basic and diluted common shares outstanding

     61,847,065        40,200,406        58,373,101        37,831,345   
                                


CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY

Condensed Consolidated Balance Sheet Data

(unaudited)

 

     June 30,
2011
    December 31,
2010
 
     (in thousands)  

Cash and cash equivalents

   $ 10,967        47,593   

Short-term investments

     56,145        —     

Total assets

     68,250        48,374   

Total liabilities

     12,682        13,186   

Deficit accumulated during the development stage

     (160,013     (132,873

Stockholders’ equity

     55,567        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. We refer you to documents we file from time to time with the Securities and Exchange Commission.

***

 

Investors:   Media:
Kathryn McNeil   Lauren Tortorete
Chelsea Therapeutics   Hill & Knowlton
704-973-4231   212-885-0348
mcneil@chelseatherapeutics.com   lauren.tortorete@hillandknowlton.com
Nick Riehle  
Chelsea Therapeutics  
704-973-4201  
Riehle@chelseatherapeutics.com