8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 5, 2009
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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71-0869350 |
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(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 |
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(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:
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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)) |
Item 2.02. Results of Operations and Financial Condition.
On August 5, 2009, Amicus Therapeutics, Inc. issued a press release announcing its
financial results for the quarter ended June 30, 2009. 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.
(c) Exhibits.
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99.1
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Press Release, dated August 5, 2009 |
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 5, 2009 |
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By: |
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/s/ GEOFFREY P. GILMORE |
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Name:
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Geoffrey P. Gilmore |
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Title:
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Senior Vice President and General Counsel |
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EXHIBIT INDEX
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Exhibit |
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No. |
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Description |
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99.1 |
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Press Release, dated August 5, 2009 |
Exhibit 99.1
Exhibit 99.1
Amicus Therapeutics Announces Second Quarter
2009 Financial Results
Company
Successfully Transitions into Late-Stage Development with Amigal for Fabry Disease
Entering Phase 3
CRANBURY, N.J., August 5, 2009 Amicus Therapeutics (Nasdaq: FOLD) today announced financial
results for the second quarter 2009.
On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles
(GAAP), Amicus announced a net loss attributable to common stockholders of $0.60 per share ($0.51
per share on a non-GAAP basis) for the three months ended June 30, 2009. As of June 30, 2009,
cash, cash equivalents, and marketable securities totaled $100.4 million.
John F. Crowley, President and CEO of Amicus stated, The second quarter was marked by a
significant achievement for Amicus with our lead program, Amigal for Fabry disease, entering Phase
3 development. Crowley continued, This is a major step for the Company as we have now
transitioned to a late-stage biopharmaceutical company and are one step closer to bringing to
market an important, novel treatment to patients who suffer with Fabry disease.
Clinical Program Updates
Amigal (migalastat hydrochloride) for the treatment of Fabry disease
In the second quarter of 2009, Amicus announced that the Company reached agreement with the U.S.
Food and Drug Administration (FDA) on the key protocol design elements of its pivotal trial,
including the use of the surrogate primary endpoint of the change in the amount of kidney
interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients. In
addition, the FDA is in agreement that the Company is eligible to seek Accelerated Approval for
Amigal according to Subpart H regulations. Amicus has begun submitting the Phase 3 protocol to
investigational sites worldwide and expects to begin the dosing of subjects in the second half of
this year.
As previously announced, the Phase 3 trial will evaluate the efficacy, safety and pharmacodynamics
of Amigal in males and females with Fabry disease. The trial will consist of a six-month
double-blind, randomized, placebo-controlled treatment stage and will enroll approximately 60
subjects who are naïve to enzyme replacement therapy (ERT) or who have not received ERT for at
least six months prior to the start of treatment with Amigal. The Amigal treatment arm dose and
regimen will be 150 mg every other day.
The primary endpoint will be the change in the amount of kidney interstitial capillary GL-3 as
measured in kidney biopsies using histology. Secondary endpoints will include safety and
tolerability, kidney GL-3 as measured in urine, and an assessment of renal function (including
glomerular filtration rate (GFR) and 24-hour urine protein).
Additionally, the FDA and Amicus reached agreement on an improved methodology for the histological
evaluation of GL-3 in the kidney biopsies. An analysis of the Phase 2 and Phase 2 extension study
biopsies using the improved methodology demonstrated that all of the evaluable baseline samples had
detectable interstitial capillary GL-3 and that reductions were observed in 8 of the 9 responders.
It is expected that approximately 30 clinical sites worldwide will participate in this trial.
Plicera (afegostat tartrate) for the treatment of Gaucher Disease
A Phase 2 clinical trial of the Companys investigational drug Plicera is ongoing. This 6-month
study is designed to evaluate safety, dosing, and preliminary efficacy, as measured by the standard
endpoints in Gaucher disease. The Company expects to report the results early in the fourth
quarter of 2009.
Amicus continues to work closely with its partner, Shire HGT, to prepare for Phase 3 development of
Plicera pending the results of the ongoing Phase 2 trial.
AT2220 (1-deoxynojirimycin HCl) for the treatment of Pompe Disease
As previously reported, the Company suspended enrollment for the Phase 2 clinical trial of its
investigational drug AT2220 for the treatment of Pompe Disease and received notice from the U.S.
Food and Drug Administration (FDA) that the trial is on clinical hold.
The Company continues to work closely with the FDA to determine appropriate next steps for
advancing the development of AT2220 and expects to provide guidance on this progress over the
upcoming months.
Additionally, Amicus continues to be encouraged with its preclinical studies with AT2220 in
combination with ERT. As previously announced, the Company expects to report additional data from
these activities throughout the remainder of 2009.
Preclinical Chaperone Programs
Amicus continues to invest in research to assess the potential for applying its versatile chaperone
technology platform to the treatment of a broad range of human genetic diseases. As part of this
effort, Amicus continues to conduct preclinical studies in Parkinsons disease and is investing in
new research aimed at evaluating disease targets for other neurodegenerative and genetic disorders.
Appointment of New Director
The Company announced today the election of James Barrett, Ph.D., to its Board of Directors. Dr.
Barrett currently serves as General Partner of New Enterprise Associates (NEA), the Companys
single largest shareholder, where he specializes in biotechnology and works with members of NEAs
healthcare investment group on medical devices, healthcare information systems and healthcare
services companies. Prior to joining NEA in 2001, Dr. Barrett served as Founder, Chairman and CEO
of Sensors for Medicine and Science (1997 2001) where he remains Chairman. Prior to that, he led
three NEA-funded companies, serving as Chairman and CEO of Genetic Therapy, Inc. (1987 1995),
President and CEO of Life Technologies (1985 1987), and President and CEO of Bethesda Research
Labs (1982 1983). He currently serves on the Board of Directors for several life sciences
companies including Inhibitex, Inc. (NASDAQ: INHX) and Targacept, Inc. (NASDAQ: TRGT).
Dr. Barrett received a Ph.D. in Biochemistry at the University of Tennessee, his MBA from the
University of Santa Clara, and a BS in Chemistry from Boston College.
Shire HGT Collaboration
In November 2007, Amicus entered into a strategic collaboration with Shire Human Genetic Therapies,
Inc., a wholly-owned subsidiary of Shire plc, to jointly develop Amicus three lead pharmacological
chaperone compounds for lysosomal storage disorders, Amigal, Plicera and AT2220. Under the terms of
the collaboration Shire will pay development and sales milestones up to a maximum of $390 million,
and will also pay tiered, double-digit royalties on net sales of the products. Shire also
reimburses world-wide development costs on a 50/50 basis, and in return Shire received rights to
commercialize these products outside of the U.S. while Amicus retains all rights to commercialize
these products in the U.S. In addition, Amicus leads development operations through the end of
Phase 2 clinical trials. The companies then share responsibility for Phase 3 clinical trial
development leveraging Shires significant ex-US regulatory and clinical experience as well as its
commercial infrastructure.
Additional Financial Results & Notes
On a reported basis, the net loss attributable to common stockholders for the three months ended
June 30, 2009, was $13.6 million as compared to $9.3 million for the same period in 2008. On a
non-GAAP basis, the net loss for the three months ended June 30, 2009, was $11.5 million as
compared to $7.4 million in the same period in 2008.
Amicus recorded revenue during the second quarter of 2009 representing two different revenue
streams from the Shire agreement. Upon signing the agreement, Amicus received an upfront payment
of $50 million that will be recognized as revenue on a straight-line basis over 18 years from the
date of the agreement. In the second quarter of 2009, Amicus recognized $0.7 million of the Shire
upfront payment and $4.7 million of research revenue on reimbursed research and development costs.
The differences between U.S. GAAP and non U.S. GAAP financial results are itemized in Tables 2 and
3 and are primarily due to pre-tax stock compensation expense.
Use of Non-GAAP Financial Measures
Amicus 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 certain
items further discussed below. Amicus management uses these non-GAAP financial measures to
establish financial goals and to gain an understanding of the comparative financial performance of
Amicus from year to year and quarter to quarter. Accordingly, Amicus believes investors
understanding of Amicus financial performance is enhanced as a result of 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.
(1) |
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Stock option expense Non-GAAP net loss and diluted net loss per common share exclude the
impact of the stock option expense recorded in accordance with SFAS No. 123R. Amicus believes
that excluding the impact of expensing stock options better reflects the recurring economic
characteristics of its business. |
Conference Call and Webcast
We will host a conference call to discuss financial and operational results for the second quarter
2009, today, August 5, 2009 at 5 p.m. EDT. Interested participants and investors may access the
conference call by dialing 877-591-4949 (U.S./Canada) or 719-325-4889 (international). A telephonic
replay of the call will be available for seven days beginning at 8 p.m. EDT. Access numbers for
this replay are 888-203-1112 (U.S./Canada) and 719-457-0820 (international); participant code
4035217.
An audio webcast can also be accessed via the investor section of the Amicus Therapeutics Web site
at www.amicustherapeutics.com under Investors: Events and Presentations. Web participants
are encouraged to go to the Web site 15 minutes prior to the start of the call to register,
download and install any necessary software. After the live webcast, an audio webcast replay will
remain available in the Investors section of the Amicus Therapeutics Web site for 30 days.
Amicus
press releases are available at www.amicustherapeutics.com.
About NEA
New Enterprise Associates, Inc. (NEA) is a leading venture capital firm focused on helping
entrepreneurs create and build major new enterprises that use technology to improve the way we
live, work and play. Since its founding in 1978, the firm has followed the same core principles:
supporting its entrepreneurs, providing an excellent return to its limited partners, and practicing
its profession with the highest standards and respect. Through its affiliated funds, NEA focuses on
investments at all stages of a companys development, from seed stage through IPO. With
approximately $8.5 billion in committed capital, NEAs experienced management team has invested in
over 650 companies, of which more than 160 have gone public and more than 250 have been acquired.
NEA has U.S. offices in Chevy Chase, Maryland; Menlo Park, California; and Baltimore, Maryland. In
addition, New Enterprise Associates (India) Pvt. Ltd. has offices in Bangalore and Mumbai, India and New Enterprise Associates (Beijing), Ltd.
has offices in Beijing and Shanghai, China. For additional information, visit www.nea.com.
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 a strategic collaboration with Shire Human Genetic Therapies, Inc., a wholly-owned
subsidiary of Shire Limited, to develop and commercialize Amicus three lead pharmacological
chaperone compounds for lysosomal storage disorders. Under the agreement, Shire received commercial
rights outside of the United States. Amicus retains all U.S. rights.
Forward-Looking Statements
This press release contains and the accompanying conference call will contain forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995 relating to
preclinical and clinical development of Amicus candidate drug products, the timing and reporting
of results from preclinical studies and clinical trial evaluating Amicus candidate drug products,
and the timing of updates on the interactions with the FDA on the AT2220 program. 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 goals, progress, timing and outcomes of ongoing discussions with regulatory authorities and the
potential goals, progress, timing and results of preclinical studies and 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 potential
inability to reach final agreement with regulatory agencies on the lifting of the clinical hold on
the AT2220 program,; the potential that results of clinical or pre-clinical studies indicate that
the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll
patients in our clinical trials; the potential that preclinical and clinical studies could be
delayed because we identify serious side effects or other safety issues; and, our dependence on
third parties in the conduct of our clinical studies. Further, the results of earlier preclinical
studies and/or clinical trials may not be predictive of future results. Additionally, with respect
to statements regarding projections of the Companys cash position and expected use of cash during
2009, actual results may differ based on market factors, the companys ability to execute its
operational and budget plans, and its achievement of milestones and receipt of milestone payments
from Shire. Additionally, all forward looking statements are subject to other risks detailed in our
Annual Report on Form 10-K for the year ended December 31, 2008, and our other public filings 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:
Jenene Thomas
Director, Investor Relations
Amicus Therapeutics
609-662-5084
FOLD -G
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 from |
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February 4, |
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2002 |
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(inception) |
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Three Months |
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Six Months |
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to |
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Ended June 30, |
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Ended June 30, |
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June 30, |
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2008 |
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2009 |
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2008 |
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2009 |
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2009 |
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Revenue: |
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Research revenue |
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$ |
3,113 |
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$ |
4,667 |
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$ |
5,579 |
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$ |
8,580 |
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$ |
22,143 |
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Collaboration revenue |
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694 |
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694 |
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1,389 |
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1,389 |
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4,576 |
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Total revenue |
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3,807 |
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5,361 |
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6,968 |
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9,969 |
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26,719 |
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Operating Expenses: |
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Research and development |
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8,848 |
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13,470 |
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15,789 |
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25,345 |
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152,987 |
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General and administrative |
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5,118 |
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5,223 |
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10,305 |
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10,419 |
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68,154 |
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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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332 |
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519 |
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653 |
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1,024 |
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5,311 |
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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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14,298 |
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19,212 |
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26,747 |
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36,788 |
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227,900 |
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Loss from operations |
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(10,491 |
) |
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(13,851 |
) |
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(19,779 |
) |
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(26,819 |
) |
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(201,181 |
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Other income (expenses): |
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Interest income |
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1,331 |
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269 |
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3,034 |
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795 |
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13,555 |
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Interest expense |
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(59 |
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(41 |
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(129 |
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(71 |
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(1,718 |
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Change in fair value of
warrant liability |
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(454 |
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Other expense |
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(1,180 |
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Loss before tax benefit |
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(9,219 |
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(13,623 |
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(16,874 |
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(26,095 |
) |
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(190,978 |
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(Provision for)/benefit from
income taxes |
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(75 |
) |
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(150 |
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695 |
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Net loss |
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(9,294 |
) |
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(13,623 |
) |
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(17,024 |
) |
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(26,095 |
) |
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(190,283 |
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Deemed dividend |
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(19,424 |
) |
Preferred stock accretion |
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(802 |
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Net loss attributable to common
stockholders |
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$ |
(9,294 |
) |
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$ |
(13,623 |
) |
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$ |
(17,024 |
) |
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$ |
(26,095 |
) |
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$ |
(210,509 |
) |
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Net loss attributable to common
stockholders per
common share basic and
diluted |
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$ |
(0.41 |
) |
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$ |
(0.60 |
) |
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$ |
(0.76 |
) |
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$ |
(1.15 |
) |
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Weighted-average common shares
outstanding
basic and diluted |
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22,467,198 |
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22,618,026 |
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22,439,893 |
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22,615,951 |
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Table 2
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended June 30, 2009
(Unaudited)
(In thousands, except share and per share amounts)
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Stock |
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GAAP as |
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Non-GAAP |
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Compensation |
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Reported |
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Income Statement
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Classifications: |
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Revenue |
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$ |
5,361 |
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$ |
5,361 |
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|
Research and development |
|
|
(12,628 |
) |
|
$ |
(842 |
) |
|
|
(13,470 |
) |
General and administrative |
|
|
(3,968 |
) |
|
|
(1,255 |
) |
|
|
(5,223 |
) |
Depreciation and amortization |
|
|
(519 |
) |
|
|
|
|
|
|
(519 |
) |
Interest income |
|
|
269 |
|
|
|
|
|
|
|
269 |
|
Interest expense |
|
|
(41 |
) |
|
|
|
|
|
|
(41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss: |
|
$ |
(11,526 |
) |
|
$ |
(2,097 |
) |
|
$ |
(13,623 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic
and diluted: |
|
$ |
(0.51 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.60 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding: |
|
|
22,618,026 |
|
|
|
|
|
|
|
22,618,026 |
|
|
|
|
|
|
|
|
|
|
|
|
Table 3
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended June 30, 2008
(Unaudited)
(In thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
GAAP as |
|
|
|
Non-GAAP |
|
|
Compensation |
|
|
Reported |
|
Income Statement
|
|
|
|
|
|
|
|
|
|
|
|
|
Classifications: |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
3,807 |
|
|
|
|
|
|
$ |
3,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(8,151 |
) |
|
$ |
(697 |
) |
|
|
(8,848 |
) |
General and administrative |
|
|
(3,959 |
) |
|
|
(1,159 |
) |
|
|
(5,118 |
) |
Depreciation and amortization |
|
|
(332 |
) |
|
|
|
|
|
|
(332 |
) |
Interest income |
|
|
1,331 |
|
|
|
|
|
|
|
1,331 |
|
Interest expense |
|
|
(59 |
) |
|
|
|
|
|
|
(59 |
) |
(Provision for)/benefit from
income taxes |
|
|
(75 |
) |
|
|
|
|
|
|
(75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Summary: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss: |
|
$ |
(7,438 |
) |
|
$ |
(1,856 |
) |
|
$ |
(9,294 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic
and diluted: |
|
$ |
(0.33 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding: |
|
|
22,467,198 |
|
|
|
|
|
|
|
22,467,198 |
|
|
|
|
|
|
|
|
|
|
|
|
Source: FOLD -G