Amicus Therapeutics Announces Third Quarter 2007 Financial Results
CRANBURY, N.J., Oct 31, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Amicus Therapeutics (Nasdaq: FOLD), 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:
-- Pre-tax share-based compensation expense under SFAS No. 123R of $1.1
million (or $0.05 per share) for the three months ended September 30,
2007, primarily related to employee stock option expense.
-- Pre-tax charges for preferred stock accretion.
-- Pre-tax charges for changes in the fair value of warrant liability.
Use of Non-GAAP Financial Measures
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,
(1) Stock option expense and the cumulative effect of an accounting
change relating to the initial adoption of SFAS No. 123R and (2)
other items. Our management uses these non-GAAP financial measures to
establish financial goals and to gain an understanding of the
comparative financial performance of the Company from year to year
and quarter to quarter. Accordingly, we believe investors'
understanding of the Company's financial performance is enhanced as a
result of our disclosing these non-GAAP financial measures. Non-GAAP
net loss and diluted net loss per common share should not be viewed
in isolation or as a substitute for reported, or GAAP net loss and
diluted net loss per common share.
(2) Stock option expense - Non-GAAP net loss and diluted net loss per
common share exclude the impact of our stock option expense recorded
in accordance with SFAS No. 123R. We believe that excluding the
impact of expensing stock options better reflects the recurring
economic characteristics of our business.
(3) Other items - Non-GAAP net loss and diluted net loss per common
share exclude other unusual or non-recurring items that are evaluated
on an individual basis. Our evaluation of whether to exclude an item
for purposes of determining our non-GAAP financial measures considers
both the quantitative and qualitative aspects of the item, including,
among other things (i) its size and nature, (ii) whether or not it
relates to our ongoing business operations, and (iii) whether or not
we expect it to occur as part of our normal business on a regular
basis. Items excluded for purposes of determining non-GAAP net loss
and diluted net loss per common share include deemed dividends,
preferred stock accretion, and changes in the fair value of warrant
liability.
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.
Table 1
Amicus Therapeutics, Inc.
(a development stage company)
Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
Period from
February 4, 2002
Three Months Nine Months (inception)to
Ended September 30, Ended September 30, September 30,
2006 2007 2006 2007 2007
Operating Expenses:
Research and
development $6,725 $7,537 $19,444 $21,404 $80,208
General and
administrative 3,783 3,954 8,247 9,994 32,786
Impairment of
leasehold
improvements - - - - 1,030
Depreciation and
amortization 245 315 661 924 2,481
In-process research
and development - - - - 418
Total operating
expenses 10,753 11,806 28,352 32,322 116,923
Loss from
operations (10,753) (11,806) (28,352) (32,322) (116,923)
Other income
(expenses):
Interest income 519 1,593 1,204 3,346 6,154
Interest expense (75) (90) (200) (269) (1,351)
Change in fair value
of warrant
liability (154) - (27) (149) (454)
Other expense (1,180) - (1,180) - (1,182)
Loss before tax
benefit (11,643) (10,303) (28,555) (29,394) (113,756)
Income tax benefit - - - - 695
Net loss (11,643) (10,303) (28,555) (29,394) (113,061)
Deemed dividend - - (19,424) - (19,424)
Preferred stock
accretion (41) - (122) (351) (802)
Net loss
attributable to
common
stockholders $(11,684) $(10,303) $(48,101) $(29,745) $(133,287)
Net loss
attributable
to common
stockholders per
common share
- basic and
diluted $(15.01) (0.46) (70.72) $(2.92)
Weighted-average
common shares
outstanding -
basic and
diluted 778,561 22,291,832 680,114 10,177,449
See accompanying notes to consolidated financial statements
Table 2
Amicus Therapeutics, Inc.
Statement of Operations Information for Three Months Ended September 30, 2007
(In thousands, except share and per share amounts)
Change in
Fair
Value of Preferred
Warrant Stock Stock GAAP as
Non-GAAP Liability Accretion Compensation Reported
Income Statement
Classifications:
Research and
development $(7,090) $ - $ - $(447) $(7,537)
General and
administrative (3,293) (661) (3,954)
Depreciation
and amortization (315) (315)
Interest income 1,593 1,593
Interest expense (90) (90)
Summary:
Loss before income
taxes: (9,195) (1,108) (10,303)
Net loss: $(9,195) $ - $ - $(1,108) $(10,303)
Net loss per
share - basic and
diluted: $(0.41) $ - $ - $(0.05) $(0.46)
Weighted
average number
of shares
outstanding: 22,291,832 22,291,832
Table 3
Amicus Therapeutics, Inc.
Statement of Operations Information for Three Months Ended September 30, 2006
(In thousands, except share and per share amounts)
Change in
Fair
Value of Preferred
Warrant Stock Stock GAAP as
Non-GAAP Liability Accretion Compensation Reported
Income Statement
Classifications:
Research and
development $(6,239) $ - $ - $(486) $(6,725)
General and
administrative (3,368) (415) (3,783)
Depreciation and
amortization (245) (245)
Interest income 519 519
Interest expense (75) (75)
Change in fair
value of
warrant
liability - (154) (154)
Other expense (1,180) (1,180)
Preferred stock
accretion - (41) (41)
Summary:
Loss before
income taxes: (10,588) (154) (41) (901) (11,684)
Net loss: $(10,588) $ (154) $ (41) $(901) $(11,684)
Net loss per
share - basic
and diluted: $(13.60) $(0.20) $(0.05) $(1.16) $(15.01)
Weighted average
number of shares
outstanding: 778,561 778,561
SOURCE Amicus Therapeutics
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