8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 7, 2007
AMICUS THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
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Delaware
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001-33497
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20-0422823 |
(State or Other Jurisdiction
of Incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.) |
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6 Cedar Brook Drive, Cranbury, NJ
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08512 |
(Address of Principal Executive Offices)
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(Zip Code) |
Registrants telephone number, including area code: (609) 662-2000
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4(c)) |
TABLE OF CONTENTS
Item 2.02. Results of Operations and Financial Condition.
On August 7, 2007, Amicus Therapeutics, Inc. issued a press release announcing its financial
results for the quarter ended June 30, 2007. A copy of this press release is attached hereto as
Exhibit 99.1.
In accordance with General Instruction B.2. of Form 8-K, the information in this Current
Report on Form 8-K, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to
the liability of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by
specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
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99.1 |
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Press Release, dated August 7, 2007 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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AMICUS THERAPEUTICS, INC. |
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Date: August 7, 2007
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By:
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/s/ DOUGLAS A. BRANCH |
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Name:
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Douglas A. Branch |
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Title:
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Vice President, General Counsel and Secretary
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1
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Press Release, dated August 7, 2007 |
EX-99.1
Exhibit 99.1
Amicus Therapeutics Announces Second Quarter 2007 Financial Results
Cranbury, NJ, August 2, 2007 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 second quarter of 2007. On a reported
basis, calculated in accordance with U.S. generally accepted accounting principals (GAAP), Amicus
announced a net loss attributable to common stockholders per share of $1.37 for the three months
ended June 30, 2007. On a non-GAAP basis, Amicus reported a net loss attributable to common
stockholders per share of $1.17 for the three months ended June 30, 2007. As of June 30, 2007,
cash, cash equivalents, and marketable securities totaled $125.7 million.
We
continue to remain very confident in the potential for pharmacological chaperones to treat a
range of human genetic diseases, beginning with the lysosomal storage disorders, stated John F.
Crowley, President and CEO of Amicus Therapeutics. We expect to deliver on three significant
clinical milestones by the end of 2007: Phase II data for Amigal for Fabry disease; preliminary
Phase II data in the 4-week Plicera switching study; and, complete Phase I data for AT2220 for
Pompe disease.
Quarterly Highlights:
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Amicus completed its IPO and sold a total of 5,000,000 shares of its common stock at a public
offering price of $15.00 per share. Gross proceeds to Amicus totaled $75.0 million and after
underwriting discounts and commissions and offering expenses, net proceeds totaled $68.1
million. |
Financial Results
On a reported basis, the net loss attributable to common stockholders for the three months ended
June 30, 2007 was $9.7 million as compared to $28.1 million for the same period in 2006. On a
Non-GAAP basis, the net loss for the three months ended June 30, 2007 and the three months ended
June 30, 2006 was $8.3 million, respectively. The Company recorded no revenues during these
periods.
On a Non-GAAP basis, research and development expense for the three months ended June 30, 2007, was
$6.4 million, an increase of $0.1 million from $6.3 million for the three months ended June 30,
2006.
On a Non-GAAP basis, general and administrative expense for the three months ended June 30, 2007,
was $2.6 million, an increase of $0.4 million from $2.2 million from the three months ended June
30, 2006.
The differences between U.S. GAAP EPS, net loss, research and development and general and
administrative and the corresponding non-GAAP amounts are itemized in table 2, and are due to:
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Pre-tax share-based compensation expense under SFAS 123R of $1.0 million (or $0.14 per share), primarily related to
employee stock option expense. |
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Pre-tax charge for a deemed dividend of $19.4 million in the second quarter of 2006. |
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Pre-tax charges for preferred stock accretion. |
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Pre-tax charges for changes in the fair value of warrant liability. |
Use of Non-GAAP Financial Measures
Our non-GAAP net income and non-GAAP diluted EPS financial measures are defined as reported, or
GAAP, net income and diluted EPS 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 Companys financial performance is enhanced as a result of our disclosing these non-GAAP
financial measures. Non-GAAP net income and diluted EPS should not be viewed in isolation or as a
substitute for reported, or GAAP, net income and diluted EPS.
(1) |
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Stock option expense Non-GAAP net income and diluted EPS 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. |
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Other items Non-GAAP net income and diluted EPS 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 income and diluted EPS 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 for the treatment of Fabry disease and Plicera 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 this 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, estimate, 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 release due to the risks and uncertainties inherent in the business of
Amicus, including, without limitation: the respective Phase II clinical trials for Amigal and
Plicera, 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 not 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 release to reflect events or circumstances after the date hereof. This caution is made
under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of
1995.
Contact:
Investors, Jim Dentzer or Corporate, Matthew Patterson, both of Amicus Therapeutics, +1-609-662-2000, or Media, Dan Budwick of BMC Communications Group for Amicus Therapeutics, +1-212-477-9007, ext. 14
Table 1
Amicus Therapeutics, Inc.
(a development stage company)
Consolidated Statements of Operations
(Unaudited)
(in thousands, except share and per share amounts)
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Period |
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from |
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February |
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4, |
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2002 |
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Three Months |
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Six Months |
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(inception) |
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Ended June 30, |
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Ended June 30, |
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to June 30, |
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2006 |
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2007 |
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2006 |
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2007 |
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2007 |
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Operating Expenses: |
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Research and development |
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$ |
6,691 |
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$ |
6,783 |
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$ |
12,719 |
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$ |
13,867 |
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$ |
72,671 |
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General and administrative |
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2,563 |
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3,189 |
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4,464 |
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6,040 |
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28,832 |
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Impairment of leasehold
Improvements |
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1,030 |
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Depreciation and amortization |
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217 |
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312 |
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416 |
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609 |
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2,166 |
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In-process research and
Development |
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418 |
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Total operating expenses |
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9,471 |
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10,284 |
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17,599 |
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20,516 |
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105,117 |
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Loss from operations |
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(9,471 |
) |
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(10,284 |
) |
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(17,599 |
) |
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(20,516 |
) |
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(105,117 |
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Other income (expenses): |
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Interest income |
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448 |
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1,060 |
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686 |
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1,753 |
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4,560 |
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Interest expense |
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(74 |
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(86 |
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(125 |
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(179 |
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(1,261 |
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Change in fair value of warrant
Liability |
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471 |
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(86 |
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127 |
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(149 |
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(454 |
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Other expense |
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2 |
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(1 |
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(1,181 |
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Loss before tax benefit |
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(8,624 |
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(9,396 |
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(16,912 |
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(19,091 |
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(103,453 |
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Income tax benefit |
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695 |
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Net loss |
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(8,624 |
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(9,396 |
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(16,912 |
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(19,091 |
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(102,758 |
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Deemed dividend |
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(19,424 |
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(19,424 |
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(19,424 |
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Preferred stock accretion |
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(41 |
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(310 |
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(81 |
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(351 |
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(802 |
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Net loss attributable to common
stockholders |
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$ |
(28,089 |
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$ |
(9,706 |
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$ |
(36,417 |
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$ |
(19,442 |
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$ |
(122,984 |
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Net loss attributable to common
stockholders per
common share basic and diluted |
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$ |
(39.04 |
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$ |
(1.37 |
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$ |
(57.78 |
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$ |
(4.80 |
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Weighted-average common shares
outstanding
basic and diluted |
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719,556 |
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7,083,748 |
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630,230 |
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4,051,709 |
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See accompanying notes to consolidated financial statements
Table 2
Amicus Therapeutics, Inc
Statement of Operations Information for 3 months
ending June 30, 2007
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Change in Fair |
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Value of |
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Preferred |
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Warrant |
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Stock |
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Stock |
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GAAP as |
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Non-GAAP |
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Liability |
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Accretion |
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Compensation |
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Reported |
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Income Statement Classifications: |
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Research and development |
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(6,361 |
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(422 |
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(6,783 |
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General and administrative |
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(2,607 |
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(582 |
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(3,189 |
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Depreciation and amortization |
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(312 |
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(312 |
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Interest income |
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1,060 |
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1,060 |
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Interest expense |
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(86 |
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(86 |
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Change in fair value of warrant
liability |
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(86 |
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(86 |
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Preferred stock accretion |
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(310 |
) |
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(310 |
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Summary: |
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Income (loss) before income taxes: |
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(8,306 |
) |
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(86 |
) |
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(310 |
) |
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(1,004 |
) |
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(9,706 |
) |
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Net income (loss): |
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(8,307 |
) |
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|
(86 |
) |
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|
(310 |
) |
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|
(1,004 |
) |
|
|
(9,707 |
) |
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Net income (loss) per share
basic and diluted: |
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(1.17 |
) |
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(0.01 |
) |
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(0.04 |
) |
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(0.14 |
) |
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(1.37 |
) |
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Weighted average number of shares
outstanding: |
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7,083,748 |
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7,083,748 |
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Table 2
Amicus Therapeutics, Inc
Statement of Operations Information for 3 months
ending June 30, 2006
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Change in |
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Fair Value |
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Preferred |
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of Warrant |
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Stock |
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Deemed |
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Stock |
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GAAP as |
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Non-GAAP |
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Liability |
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Accretion |
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Dividend |
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Compensation |
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Reported |
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Income Statement Classifications: |
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Research and development |
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(6,295 |
) |
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(396 |
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(6,691 |
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General and administrative |
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(2,202 |
) |
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(361 |
) |
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(2,563 |
) |
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Depreciation and amortization |
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(217 |
) |
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(217 |
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Interest income |
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448 |
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448 |
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Interest expense |
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(73 |
) |
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(73 |
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Change in fair value of warrant
liability |
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(0 |
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471 |
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471 |
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Other |
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2 |
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2 |
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Deemed dividend |
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(19,424 |
) |
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(19,424 |
) |
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Preferred stock accretion |
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(41 |
) |
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(41 |
) |
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Summary: |
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Income (loss) before income taxes: |
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(8,338 |
) |
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471 |
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(41 |
) |
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(19,424 |
) |
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(757 |
) |
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(28,089 |
) |
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Net income (loss): |
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(8,338 |
) |
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471 |
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(41 |
) |
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(19,424 |
) |
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(757 |
) |
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(28,089 |
) |
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Net income (loss) per share
basic and diluted: |
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(11.59 |
) |
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0.65 |
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(0.06 |
) |
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(26.99 |
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(1.05 |
) |
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(39.04 |
) |
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Weighted average number of shares
outstanding: |
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719,556 |
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719,556 |
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