CHARLOTTE, N.C., March 11, 2008 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today presented a quarterly update on the Company's development progress, reported financial results for the fourth quarter and full year 2007 and will host a conference call this afternoon to discuss these results at 5:00 PM EDT.
2007 Highlights:
* Improved pharmacokinetics of CH-1504 and reported greater than
10-fold improvement in relative bioavailability
* Secured U.S. and EU Orphan Drug Designations for Droxidopa
* Reached agreement with the U.S. FDA on the clinical protocol for
its Phase III trials of Droxidopa in neurogenic orthostatic
hypotension
* Received IND approval from the FDA and initiated Phase II study
of Droxidopa in intradialytic hypotension
* Raised over $60 million
"Our goal in 2007 was to build out our clinical programs to deliver on both the near-term opportunities related to CH-1504 in rheumatoid arthritis and Droxidopa in neurogenic orthostatic hypotension while driving long-term value creation by expanding the potential indications for our pipeline," commented Dr. Simon Pedder, President and CEO of Chelsea. "Having successfully completed our reformulation of CH-1504 and secured FDA approval for our Phase III trials of Droxidopa in neurogenic orthostatic hypotension including an SPA agreement for study 301, we positioned ourselves to not only advance both these critical programs, but to do so from the strongest position possible to ensure the highest probability of success. In addition to advancements in our two lead indications, we also implemented development programs for Droxidopa in both intradialytic hypotension and fibromyalgia. As a result of these efforts, Chelsea has initiated three of our five planned clinical trials for 2008 with the remaining two on track to begin enrolling patients next quarter."
Financial Results for the Year Ended December 31, 2007
Chelsea reported a net loss for the year ended December 31, 2007 of $15.1 million or ($0.66) compared to a net loss of $8.7 million or ($0.46) per share for the year ended December 31, 2006. The increase in net loss was primarily attributable to an increase in research and development expenses related to expansion of Chelsea's pipeline.
Research and development expenses for the year ended December 31, 2007 were $12.3 million, compared to $6.9 million for the same period in 2006. This increase of approximately $5.4M was due primarily to increased clinical trial costs and manufacturing costs associated with Chelsea's expanded pipeline.
Selling, general and administrative expenses for the 12 months ended December 31, 2007 were $4.2 million compared to $2.7 million for the same period in 2006. The $1.5 million increase was mainly due to salaries and other expenses associated with increased headcount, including stock based compensation expense, as well as increased sales and marketing expenses related to our pre-launch activities for Droxidopa.
Chelsea ended the year with $62.7 million in cash and short-term investments consisting of $34 million in cash and cash equivalents and $28.6 million in short-term investments.
Financial Results for the Fourth Quarter
The Company reported a net loss for the quarter ended December 31, 2007 of $4.8 million or ($0.18) per share versus a net loss of $2.4 million or ($0.12) per share for the comparable period in 2006.
Research and development expenses for the three months ended December 31, 2007 were $4.4 million, compared to $2 million for the same period in 2006. Total research and development expense increased $2.4 million during the quarter compared to the same period a year ago due primarily to increased clinical trial expenses, headcount, and costs associated with the advancement of each of the three product candidates.
Selling, general and administrative expenses were $1.1 million for the three months ended December 31, 2007 compared to $0.7 million for the same period in 2006. The increase resulted primarily from costs associated with increased headcount and with the initiation of pre-launch activities for Droxidopa.
Conference Call Today at 5:00 PM EDT
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 5:00 PM Eastern Time. Those interested in hearing management's discussion can access the call directly by dialing 1-877-681-3373. International participants may access the call by dialing 719-325-4912. A replay will be available for one week following the call by dialing 1-888-203-1112 for domestic participants or 719-457-0820 for international participants and entering passcode 3194840 when prompted. Participants may also access both the live and archived webcast of the conference call through the investor relations section of Chelsea's web site at http://www.chelseatherapeutics.com. The webcast will remain available on the company's website until the next quarterly conference call.
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. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
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 reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.
CHELSEA THERAPEUTICS INTERNATIONAL, LTD. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
For the three months For the years
ended December 31, ended December 31,
-------------------------- --------------------------
2007 2006 2007 2006
------------ ------------ ------------ ------------
(unaudited) (unaudited)
Operating
expenses:
Research and
development $ 4,361,224 $ 1,989,386 $ 12,336,266 $ 6,864,357
Sales and
marketing 239,164 181,595 1,294,359 642,263
General and
administrative 840,330 475,930 2,874,762 2,027,564
------------ ------------ ------------ ------------
Total operating
expenses 5,440,718 2,646,911 16,505,387 9,534,184
------------ ------------ ------------ ------------
Operating loss (5,440,718) (2,646,911) (16,505,387) (9,534,184)
Interest income 601,296 226,208 1,423,842 862,808
Interest expense -- -- -- --
------------ ------------ ------------ ------------
Net loss $ (4,839,422) $ (2,420,703) $(15,081,545) $ (8,671,376)
============ ============ ============ ============
Net loss per
basic and
diluted share
of common
stock $ (0.18) $ (0.12) $ (0.66) $ (0.46)
============ ============ ============ ============
Weighted average
number of basic
and diluted
common shares
outstanding 26,785,120 19,707,129 22,936,780 18,780,638
============ ============ ============ ============
Chelsea Pharmaceuticals International, Ltd.
Condensed Consolidated Balance Sheet Data
(unaudited)
As of December 31,
-----------------------------
2007 2006
-------- --------
(in thousands)
Cash and cash equivalents $ 34,076 $ 3,111
Short-term investments * 28,638 12,786
Total assets 57,910 14,080
Total liabilities 63,163 16,171
Deficit accumulated during
the development stage (34,685) (19,604)
Stockholders' equity 57,967 14,137
* At December 31, 2007, the Company had investments of approximately $28.6 million in auction rate securities. These investments represent interests in collateralized debt obligations supported by pools of student loans.
To view the Notes to the Company's Financial Statements and Management's Discussion and Analysis, please see the Company's 2007 Annual Filings available on Chelsea's website at www.chelseatherapeutics.com