CRANBURY, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Amicus Therapeutics , a biopharmaceutical company developing small molecule, orally-active pharmacological chaperones for the treatment of human genetic diseases, today announced financial results for the third quarter of 2007. On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Amicus announced a net loss attributable to common stockholders per share of $0.46 for the three months ended September 30, 2007. On a non-GAAP basis, Amicus reported a net loss attributable to common stockholders per share of $0.41 for the three months ended September 30, 2007. As of September 30, 2007, cash, cash equivalents, and marketable securities totaled $119.4 million.
“We continue to be very pleased with the progress in all of our clinical programs and look forward to sharing the preliminary Phase II data from our lead programs for Amigal(TM) for Fabry disease and Plicera(TM) for Gaucher disease by yearend,” stated John F. Crowley, CEO of Amicus Therapeutics.
Financial Results
On a reported basis, the net loss attributable to common stockholders for the three months ended September 30, 2007 was $10.3 million as compared to $11.7 million for the same period in 2006. On a non-GAAP basis, the net loss for the three months ended September 30, 2007 was $9.2 million as compared to $10.6 million and the same period in 2006. The Company recorded no revenues during these periods.
On a non-GAAP basis, research and development expense for the three months ended September 30, 2007, was $7.1 million, an increase of $0.9 million from $6.2 million for the three months ended September 30, 2006.
On a non-GAAP basis, general and administrative expense for the three months ended September 30, 2007, was $3.3 million, a decrease of $0.1 million from $3.4 million from the three months ended September 30, 2006.
The differences between U.S. GAAP EPS, net loss, research and development expense and general and administrative expense and the corresponding non-GAAP amounts are itemized in table 2 and 3, and are primarily due to:
Our “non-GAAP net loss” and “non-GAAP diluted net loss per common share” financial measures are defined as reported, or GAAP, net loss and diluted net loss per common share excluding, for the reasons discussed below,
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has two product candidates in Phase II clinical trials, Amigal(TM) for the treatment of Fabry disease and Plicera(TM) for the treatment of Gaucher disease. The Company is also conducting Phase I clinical trials of AT2220 for the treatment of Pompe disease.
Forward-Looking Statements
Amicus cautions you that statements included in the press release that are not a description of historical facts are “forward-looking statements” within the meaning of Section 21E of the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “intend,” “plan,” “targets,” “likely,” “will,” “would,” “should” and “could” and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the potential progress and results of clinical trials, actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the respective Phase II clinical trials and data for Amigal(TM) and Plicera(TM), and the Phase I clinical trial for AT2220 may not proceed in the timeframes or in the manner Amicus expects or at all. Further, the results of earlier clinical trials may not be predictive of future results; Amicus and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks detailed in the public filings of Amicus with the Securities and Exchange Commission. You are cautioned no to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Amicus undertakes no obligation to revise or update this news to reflect events or circumstances after the date hereof.
Statement of Operations Information for Three Months Ended September 30, 2007
Statement of Operations Information for Three Months Ended September 30, 2006
CONTACT: Investors, Carney Noensie of Burns McClellan , +1-212-213-0006,
or media, Dan Budwick, of BMC Communications Group, +1-212-477-9007 ext.
14, both for Amicus Therapeutics
