424(b)(5)
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-158405
PROSPECTUS SUPPLEMENT
(To Prospectus dated May 27, 2009)
AMICUS THERAPEUTICS, INC.
4,946,524 Shares of Common Stock
Warrants
to Purchase up to 1,854,946
Shares of Common Stock
We are offering directly to selected investors 4,946,524 shares of our common stock and
warrants to purchase up to 1,854,946 shares of our common stock pursuant to this prospectus
supplement and the accompanying prospectus. The common stock and warrants will be sold in units,
with each unit consisting of one share of common stock and a warrant to purchase 0.375 of a share
of our common stock. The warrants will have an exercise price of $4.43 per share of our common
stock. Units will not be issued or certificated. The shares of common stock and warrants are
immediately separable and will be issued separately. The warrants will be exercisable on or after
the date that is six months after the date of issuance and will terminate on the fourth anniversary
of the date of issuance. For a more detailed description of the warrants, see the section entitled
Description of Warrants beginning on page S-14 of this prospectus supplement.
Our Chairman and Chief Executive Officer will purchase 11,898 units in this offering.
Our common stock is listed on the Global Market of The NASDAQ Stock Market, LLC, or NASDAQ, under
the symbol FOLD. On February 24, 2010, the closing bid price for our common stock on NASDAQ was
$3.69 per share.
We have retained Leerink Swann LLC to act as the placement agent to solicit offers to purchase
units in this offering. The placement agent has no obligation to buy any units, shares of our
common stock or warrants from us or to arrange for the purchase or sale of any specific number or
dollar amount of units, shares of our common stock or warrants. The placement agent is not
purchasing or selling any units, shares of our common stock or warrants in this offering. See Plan
of Distribution beginning on page S-11 of this prospectus supplement for more information
regarding these arrangements.
Investing in our securities involves a high degree of risk. See Risk Factors, beginning on page
S-8 of this prospectus supplement to read about factors you should consider before buying the
securities offered by this prospectus supplement.
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Per Unit |
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Total1 |
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Public offering price |
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3.74 |
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18,500,000 |
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Placement agency fee |
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$ |
0.21 |
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$ |
1,054,500 |
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Proceeds, before expenses, to us |
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$ |
3.53 |
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$ |
17,445,500 |
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(1) |
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Assumes all units offered in this offering are sold. |
We expect the total offering expenses, excluding the placement agency fee, to be approximately $0.2
million. Because there is no minimum offering amount required as a condition to the closing of this
offering, the actual public offering amount,
placement agency fee and proceeds to us are not presently determinable and may be substantially
less than the maximum amounts set forth above.
We expect delivery of the shares of our common stock and warrants will be made to purchasers on or
about March 2, 2010. The shares of our common stock will be delivered in book-entry form through
The Depository Trust Company, New York, New York. We will mail the warrants directly to the
purchasers at the respective addresses set forth in their purchase agreement with us. Purchaser
funds will be deposited into an escrow account and held until jointly released by us and the
placement agent on the date the shares of common stock and warrants are to be delivered to the
purchasers, unless other arrangements are made with our consent. All funds received in the escrow
account will be held in a non-interest bearing account.
You should carefully read this prospectus supplement and the accompanying prospectus, together with
the documents we incorporate by reference, before you invest in any of the securities offered by
this prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or
disapproved of these securities or determined if this prospectus supplement or the accompanying
prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
Leerink Swann
The date of this prospectus supplement is February 25, 2010.
TABLE OF CONTENTS
Prospectus Supplement
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S-1 |
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S-2 |
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S-7 |
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S-8 |
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S-8 |
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S-10 |
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S-11 |
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S-16 |
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S-16 |
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Prospectus
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About This Prospectus |
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The Company |
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Risk Factors |
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Forward-Looking Statements |
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Use of Proceeds |
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Ratio of Earnings to Combined Fixed Charges |
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Selling Stockholders |
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Plan of Distribution |
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General Description of Securities |
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Description of Our Common Stock |
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Description of Our Preferred Stock |
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Description of Our Warrants |
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Description of Our Debt Securities |
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Where You Can Find More Information |
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Legal Matters |
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Experts |
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ABOUT THIS PROSPECTUS SUPPLEMENT
This document is in two parts. The first part is this prospectus supplement, which describes
the terms of the offering of shares of our common stock and warrants and also adds to and updates
information contained in the accompanying prospectus and the documents incorporated by reference
into this prospectus supplement and the accompanying prospectus. The second part, the accompanying
prospectus, provides more general information about us and the securities offered hereby.
Generally, when we refer to this prospectus, we are referring to both parts of this document
combined together with all documents incorporated by reference. To the extent there is a conflict
between the information contained in this prospectus supplement or any free writing prospectus we
may authorize to be delivered to you, on the one hand, and the information contained in the
accompanying prospectus or any document incorporated by reference therein, on the other hand, you
should rely on the information in this prospectus supplement or such free writing prospectus, as
the case may be, provided that, if any statement in one of these documents is inconsistent with a
statement in another document having a later datefor example, a document incorporated by
reference in the accompanying prospectusthe statement in the document having the later date
modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants made by us in any agreement
that is filed as an exhibit to any document that is incorporated by reference in the accompanying
prospectus were made solely for the benefit of the parties to such agreement and the third-party
beneficiaries named therein, if any, including, in some
cases, for the purpose of allocating risk among the parties to such agreements, and should not be
deemed to be a representation, warranty or covenant to you. Moreover, such representations,
warranties or covenants were accurate only as of the date when made. Accordingly, such
representations, warranties and covenants should not be relied on as accurately representing the
current state of our affairs.
You should rely only on the information contained in this prospectus supplement, contained in
the accompanying prospectus or incorporated herein and therein by reference, and any free writing
prospectus we may authorize to be delivered to you. Neither we nor the placement agent have
authorized anyone to provide you with information that is different. We are offering to sell, and
seeking offers to buy, our securities only in jurisdictions where offers and sales are permitted.
The distribution of this prospectus supplement, the accompanying prospectus and the offering of our
securities in certain jurisdictions may be restricted by law. Persons outside the United States who
come into possession of this prospectus supplement and accompanying prospectus must inform
themselves about, and observe any restrictions relating to, the offering of our securities and the
distribution of this prospectus supplement and accompanying prospectus outside the United States.
This prospectus supplement and accompanying prospectus do not constitute, and may not be used in
connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by
this prospectus supplement and the accompanying prospectus by any person in any jurisdiction in
which it is unlawful for such person to make such an offer or solicitation. The information
contained, or incorporated by reference, in this prospectus supplement and contained, or
incorporated herein by reference, in the accompanying prospectus is accurate only as of the
respective dates thereof, regardless of the time of delivery of this prospectus supplement and the
accompanying prospectus, or of any sale of our securities. It is important for you to read and
consider all information contained in this prospectus supplement and the accompanying prospectus,
including the documents we have referred you to in the section entitled Where You Can Find More
Information below in the accompanying prospectus and any free writing prospectus we may
authorize to be delivered to you.
Unless the context otherwise requires, in this prospectus supplement the Company, we,
us, our and similar names refer to Amicus Therapeutics, Inc.
S-1
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights selected information about us, this offering and information appearing
elsewhere in this prospectus supplement and in the accompanying prospectus and in the documents we
incorporate by reference. This summary is not complete and does not contain all the information you
should consider before investing in shares of our common stock and warrants in this offering. You
should carefully read this entire prospectus supplement and the entire accompanying prospectus,
including the Risk Factors section beginning on page S-8 of this prospectus supplement and page 3
in the accompanying prospectus and the financial statements and the other information incorporated
by reference in this prospectus supplement and the accompanying prospectus, before making an
investment decision. If you invest in our securities, you are assuming a high degree of risk.
Overview
We are a biopharmaceutical company focused on the discovery, development and commercialization
of orally-administered, small molecule drugs known as pharmacological chaperones. Pharmacological
chaperones are a novel, first-in-class approach to treating a broad range of diseases including
lysosomal storage disorders and diseases of neurodegeneration. Our goal is to become a leading
biopharmaceutical company in this area. Our current strategic priorities are advancing:
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the Phase 3 development of our lead product candidate, Amigal for Fabry disease; |
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the preclinical and clinical development of pharmacological chaperone/enzyme replacement
therapy combination therapy; and |
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the preclinical evaluation of the use of pharmacological chaperones for diseases of
neurodegeneration. |
Our novel approach to the treatment of human genetic diseases consists of using
pharmacological chaperones that selectively bind to the target protein, increasing the stability of
the protein and helping it fold into the correct three-dimensional shape. This allows proper
trafficking of the protein within the cell, thereby increasing protein activity, improving cellular
function and potentially reducing cell stress. We have also demonstrated in preclinical studies
that pharmacological chaperones can further stabilize normal, or wild-type, proteins. This
stabilization could lead to a higher percentage of the target proteins folding correctly and more
stably, which can increase cellular levels and improve cellular function, making chaperones
potentially applicable to a wide range of diseases.
Our lead product candidate, Amigal (migalastat hydrochloride) for Fabry disease, is in Phase 3
development. Our other clinical stage product candidates are AT2220 (1-deoxynojirimycin HCl) for
Pompe disease, which is currently in Phase 1 testing and remains on partial clinical hold, and
Plicera (afegostat tartrate) for Gaucher disease, which we do not plan to advance into Phase 3
development at this time. We are conducting preclinical studies in diseases of neurodegeneration,
including Parkinsons and Alzheimers disease. Although Fabry, Gaucher and Pompe are relatively
rare diseases, they represent substantial commercial markets due to the severity of the symptoms
and the chronic nature of the diseases. The worldwide net product sales for the five currently
approved therapeutics to treat Fabry, Gaucher and Pompe disease were approximately $2.2 billion in
2008, as publicly reported by the companies that market these therapeutics.
Fabry and other lysosomal storage disorders are among certain human diseases that are caused
by mutations in specific genes that, in many cases, lead to the production of proteins with reduced
stability. Proteins with such mutations may not fold into their correct three-dimensional shape and
are generally referred to as misfolded or unstable proteins. Misfolded or unstable proteins are
often recognized by cells as having defects and, as a result, may be eliminated prior to reaching
their intended location in the cell. The reduced biological activity of these proteins leads to
impaired cellular function and ultimately to disease.
The current standard of treatment for Fabry, Gaucher and Pompe diseases is enzyme replacement
therapy, or ERT. This type of therapy compensates for the reduced level of activity of specific
enzymes through regular
infusions of recombinant forms of the enzyme. Instead of adding enzymes from an external
source by intravenous infusion, our approach uses orally-administered small molecule
pharmacological chaperones to improve the function of the enzyme that is made by the patients own
body. We believe our product candidates may have advantages over ERT relating to bio-distribution
and ease of use, potentially improving treatment of these diseases.
S-2
In addition, we have increasingly focused on the use of pharmacological chaperones in
combination with ERT, which we believe may address certain key limitations of ERT. The use of
pharmacological chaperones in combination with ERT may significantly enhance the safety and
efficacy of ERT by, among other effects, prolonging the half-life of infused enzymes in
circulation, increasing uptake of the infused enzymes into cells and tissues, and increasing enzyme
activity and substrate reduction in target tissues compared to that observed with ERT alone.
While our initial clinical efforts have focused on the use of pharmacological chaperones to
treat lysosomal storage diseases, we believe that our technology may be applicable to the treatment
of certain diseases of neurodegeneration. Our lead preclinical program in this area is focused on
Parkinsons disease and we have established initial proof-of-concept in animal models. Our second
preclinical program in this area is focused on Alzheimers disease. In 2010, we expect to complete
advanced preclinical proof-of-concept studies in Parkinsons disease and complete initial
proof-of-concept studies in Alzheimers disease.
Our Lead Product Candidate-Amigal for Fabry Disease
Our first key strategic priority is to advance our lead program, Amigal for Fabry disease. We
commenced a Phase 3 study of Amigal intended to support approval in the United States (Study 011)
in the second quarter of 2009, and treatment of the first patient began in the fourth quarter of
2009. We expect to complete enrollment by the end of 2010 and to have preliminary results from this
study in mid-2011. Study 011 is a 6-month, randomized, double-blind trial comparing Amigal to
placebo in approximately 60 subjects. The surrogate primary endpoint is the change in the amount of
kidney interstitial capillary GL-3, the substrate that accumulates in the cells of Fabry patients.
Subjects to be enrolled are Fabry patients who have never received ERT or who have not received ERT
for at least 6 months, and who have a mutation responsive to Amigal. We intend to seek Accelerated
Approval for Amigal according to Subpart H regulations. The key elements of this study design and
regulatory path were agreed to with the U.S. Food and Drug Administration (FDA) in the second
quarter of 2009.
In addition, we expect to commence a separate Phase 3 study (Study 012) during 2010 to support
approval of Amigal in the European Union. Study 012 will be an 18-month, randomized, open-label
study comparing Amigal to ERT in approximately 60 subjects. The primary outcome of efficacy will be
renal function as measured by glomerular filtration rate (GFR).
In February 2010, we presented preliminary data from our ongoing Phase 2 extension study of
Amigal, which is designed to evaluate the long-term safety and efficacy of Amigal. Among the
endpoints being evaluated are two measures of renal function, estimated glomerular filtration rate
(eGFR) and proteinuria. Preliminary data indicate that eGFR has remained stable out to 2-3 years
for all subjects in the extension study and the average annual rate of change in eGFR in subjects
identified as responders to Amigal, excluding hyperfiltrators, was +2.0 mL/min/1.73m2.
Additionally, trends of reduced proteinuria continued to be observed in subjects identified as
responders to Amigal. In addition, the data indicate that treatment with Amigal continues to be
generally well-tolerated, with no drug-related serious adverse events. Nineteen subjects continue
to receive treatment in the extension study. We previously reported in March 2009 that subjects
identified as responders to Amigal at the completion of the Phase 2 studies continued to maintain
elevated levels of the target enzyme (a-Gal A), as measured in white blood cells, and reduced
levels of the target substrate (kidney GL-3), as measured in urine. A reduction of GL-3 levels was
also observed in interstitial capillary cells from kidney biopsies.
Chaperone-ERT Combination Therapy
Another of our key strategic priorities is the advancement of the preclinical and clinical
development of pharmacological chaperone-ERT combination therapy. When used as a monotherapy,
pharmacological chaperones
are designed to selectively bind to target enzymes in patient cells, thereby increasing
protein stability and allowing for increased transport to lysosomes, where the enzyme performs its
natural function of degrading substrate. When used in combination with ERT, we believe that these
binding and stabilization properties may improve key characteristics of the infused enzymes used in
ERT, thereby increasing ERTs safety and efficacy. As previously reported, in 2009, we conducted
initial preclinical studies using pharmacological chaperones in combination with ERT. At several
scientific conferences, we presented data from these studies which demonstrated that the addition
of a pharmacological chaperone to ERT has the potential to address key limitations of ERT, such as
a lack of stability in circulation which can reduce safety and efficacy.
S-3
In February 2010, we presented new data from preclinical studies that evaluated the
combination of Amigal and an ERT, and another pharmacological chaperone, AT2220 (1-deoxynojirimycin
HC1) and a different ERT, in mouse models of Fabry and Pompe disease, respectively. Studies of
both combinations demonstrated that co-administration of the chaperone with ERT resulted in
prolonged half-life of the administered enzyme in circulation, increased enzyme activity in cells
and greater substrate reduction in target tissues compared to that seen with ERT alone.
We intend to initiate a Phase 2 study with Amigal in combination with ERT for Fabry disease
before the end of 2010. Additionally, we are evaluating options to advance chaperone-ERT
combination therapy programs for Pompe disease and Gaucher disease and are conducting pre-clinical
combination studies for the treatment of these diseases.
Diseases of Neurodegeneration
Our final key strategic priority is advancing our pharmacological chaperone technology to
develop treatments for diseases of neurodegeneration. We believe the knowledge we have gained from
exploring the use of pharmacological chaperones in rare genetic diseases can be applied to these
non-lysosomal storage disease applications, and that our small molecule approach may be especially
well-suited for treating diseases that affect the brain. For these applications, we believe
pharmacological chaperones may be used to further stabilize normal, or wild-type, proteins and
may therefore increase the cellular amounts and activities of specifically chosen target proteins
that may be important for the treatment of neurodegenerative diseases. In addition, recent
population genetics studies have established a link between being a Gaucher carrier and developing
Parkinsons disease. In particular, these studies demonstrate that Gaucher carriers have an
estimated five-fold increased risk for Parkinsons disease, and that carriers tend to develop
Parkinsons at an earlier age. Our lead pre-clinical program for Parkinsons disease is leveraging
the knowledge we have gained from our Gaucher program to advance the use of pharmacological
chaperones for the treatment of Parkinsons disease.
We have completed initial proof-of-concept studies in animal models of Parkinsons disease and
we recently presented data from preclinical studies that evaluated the chaperone AT2101 in
appropriate mouse models. These studies demonstrated that treatment with AT2101 increased the
activity of β-glucocerebrosidase (GCase), prevented accumulation
of α-synuclein in the brain and
improved motor function as assessed in various behavioral tests. We also reported that we have
developed new compounds that improve on the properties of AT2101 and expand the range of doses and
regimens that show motor improvement in mouse models of the disease. We expect to complete
advanced preclinical proof-of-concept studies in Parkinsons disease and report additional data
during 2010. Additionally, we recently announced that we have initiated a second preclinical
neurodegenerative disease program for Alzheimers disease. Our work in Alzheimers also builds on
the understanding of pharmacological chaperones we have developed over the past several years and
our work in Parkinsons disease. We expect to complete initial proof-of-concept studies in
Alzheimers disease and report data during 2010.
Our Pharmacological Chaperone Technology
In the human body, proteins are involved in almost every aspect of cellular function. Proteins
are linear strings of amino acids that fold and twist into specific three-dimensional shapes in
order to function properly. Certain human diseases result from mutations that cause changes in the
amino acid sequence of a protein, and these changes often reduce protein stability and may prevent
them from folding properly. The majority of genetic mutations that lead to the production of less
stable or misfolded proteins are called missense mutations. These
mutations result in the substitution of a single amino acid for another in the protein.
Because of this type of error, missense mutations often result in proteins that have a reduced
level of biological activity. In addition to missense mutations, there are also other types of
mutations that can result in proteins with reduced biological activity.
S-4
Proteins generally fold in a specific region of the cell known as the endoplasmic reticulum
(ER). The cell has quality control mechanisms that ensure that proteins are folded into their
correct three-dimensional shape before they can move from the ER to the appropriate destination in
the cell, a process generally referred to as protein trafficking. Misfolded proteins are often
eliminated by the quality control mechanisms after initially being retained in the ER. In certain
instances, misfolded or unstable proteins can accumulate in the ER before being eliminated.
The retention of misfolded proteins in the ER interrupts their proper trafficking, and the
resulting reduced biological activity can lead to impaired cellular function and ultimately to
disease. In addition, the accumulation of misfolded proteins in the ER may lead to various types of
stress on cells, which may also contribute to cellular dysfunction and disease.
We use pharmacological chaperones to selectively bind to a target protein and increase its
stability. The binding of the chaperone molecule helps the protein fold into its correct
three-dimensional shape. This allows the protein to be trafficked from the ER to the appropriate
location in the cell, thereby increasing cellular amounts and protein activity, improving cellular
function and potentially reducing cell stress.
Our proprietary approach to the discovery of pharmacological chaperone product candidates
involves the use of rapid molecular and cell-based screening methods combined with our
understanding of the intended biological function of proteins implicated in disease. We use this
knowledge to select and develop compounds with desirable properties. In many cases, we are able to
start with specific molecules and classes of compounds already known to interact with the target
protein but not used previously as therapies. This can greatly reduce the time and cost of the
early stages of drug discovery and development.
We believe our technology may be broadly applicable to a wide range of diseases for which
protein stabilization and improved folding may be beneficial.
Preliminary Financial Results for the Three and Twelve Months Ended December 31, 2009
The following information is preliminary and has been prepared by our management. Ernst &
Young LLP, our independent registered public accounting firm, has not completed any audit, review
or similar procedures with respect to the unaudited preliminary financial results presented in this
prospectus supplement. Accordingly, Ernst & Young LLP does not express an opinion or any other
form of assurance with respect to such preliminary financial results. We expect the audit of our
financial results and other financial statements for the year ended December 31, 2009 to be
completed immediately prior to the filing of our Annual Report on Form 10-K for the year ended
December 31, 2009.
During the course of the preparation of our complete, consolidated financial statements as of
and for the year ended December 31, 2009, the completion of our annual fiscal year-end closing
procedures and analyses and the completion of the audit of our financial statements, we may
identify items that would require us to make adjustments to the preliminary financial results
presented herein. The unaudited preliminary financial results presented in this prospectus
supplement are not necessarily indicative of the results to be expected for any future period.
Fourth Quarter 2009 and Full Year 2009 Financial Results Highlights
On February 16, 2010, we reported our unaudited preliminary financial results for the fourth
fiscal quarter and year ended December 31, 2009. Our cash spend for the quarter ended December 31,
2009 was $11.1 million. Our cash, cash equivalents and marketable securities were $78.2 million as
of December 31, 2009, and we reiterate our expectations that our cash spend will be $40 to $50
million in 2010.
S-5
Revenue for the quarter ended December 31, 2009 was $49.5 million, which represented revenue
received under our license and collaboration agreement with Shire Pharmaceuticals Ireland Ltd., or
Shire. Upon signing the collaboration agreement in 2007, Shire paid us an initial, non-refundable
license fee of $50.0 million that was being recognized as revenue on a straight-line basis over the
period of performance obligations under the collaboration agreement, or 18 years from the date of
such agreement. In connection with the mutual termination of the Shire collaboration agreement on
October 29, 2009, we recognized $44.7 million of previously deferred revenue on the upfront payment
from Shire. In addition, we received a $5.2 million termination payment from Shire as a full and
fair settlement of all development cost-sharing obligations, approximately $4.7 million of which
was recognized as research revenue during the quarter ended December 31, 2009, and $0.5 million was
applied to a receivable for reimbursable research and development costs incurred during the
previous quarter ended September 30, 2009.
Net income for the quarter ended December 31, 2009 was $33.0 million, or $1.45 per diluted
common share, compared to a net loss of $14.2 million, or $0.63 per diluted common share, for the
quarter ended December 31, 2008. Net loss for the year ended December 31, 2009 was $6.6 million, or
$0.29 per diluted common share, compared to net loss of $39.4 million, or $1.75 per diluted common
share for the year ended December 31, 2008. The variances between periods were attributable to
the termination of the Shire collaboration agreement and the resulting recognition of previously
deferred revenue discussed above.
Research and development expense for the quarter ended December 31, 2009 was $10.1 million,
representing a decrease of $3.7 million, or 27%, from $13.8 million for the quarter ended December
31, 2008. The decrease was due primarily to a $2.6 million non-recurring license fee incurred
during the quarter ended December 31, 2008 and a reduction in costs incurred in connection with the
development of AT2220 for the treatment of Pompe disease during the quarter ended December 31,
2009.
General and administrative expense for the quarter ended December 31, 2009 was $4.3 million,
representing a decrease of $0.7 million, or 14%, from $5.0 million for the quarter ended December
31, 2008. The decrease was due primarily to reduced consulting and personnel costs.
Restructuring charges incurred for the quarter ended December 31, 2009 in connection with our
corporate restructuring were approximately $1.5 million. The restructuring charges were
attributable to employment termination costs of approximately $0.9 million, consisting of one-time
severance payments and benefit continuation, and a charge for facility consolidation of
approximately $0.7 million, consisting of future minimum lease payments and a write-off of certain
fixed assets in a vacated facility.
Corporate Information
We were incorporated on February 4, 2002 under the laws of the State of Delaware. Our
principal executive offices are located at 6 Cedar Brook Drive, Cranbury, NJ 08512 and our
telephone number is (609) 662-2000. You can obtain more information regarding our business and
industry by reading our Annual Report on Form 10-K for the year ended December 31, 2008 filed with
the SEC on February 6, 2009 and the other reports we file with the Securities and Exchange
Commission, or SEC.
S-6
THE OFFERING
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Common stock offered by us pursuant to this
prospectus supplement
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4,946,524 |
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Common stock to be outstanding after this
offering (assumes all units offered in this
offering are sold)
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27,594,393 |
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Warrants
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Warrants to purchase up to
1,854,946 shares of common
stock will be offered in
this offering. Each
warrant may be exercised
at any time on or after
the date that is six
months after the date of
issuance until the fourth
anniversary of the
issuance of the warrants
at an exercise price of
$4.43 per share of common
stock. This prospectus
also relates to the
offering of the shares of
common stock issuable upon
exercise of the warrants. |
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Use of proceeds
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We intend to use the net
proceeds from the sale of
securities pursuant to
this offering to further
advance the development of
our lead product
candidate, Amigal,
including the initiation
of the Phase 3 study to
support registration in
the European Union and the
completion of certain
activities required for
the submission of a
license application
globally, as well as for
general corporate matters. |
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Risk factors
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See Risk Factors
beginning on page S-8 of
this prospectus
supplement, in our Annual
Report on Form 10-K for
the year ended December
31, 2008 and in our
Quarterly Reports on Form
10-Q for the quarters
ended June 30, 2009 and
September 30, 2009,
respectively, for a
discussion of factors you
should consider carefully
before deciding to invest
in shares of our common
stock. |
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Market for the common stock and warrants
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Our common stock is quoted
and traded on The NASDAQ
Global Market under the
symbol FOLD. However,
there is no established
public trading market for
the warrants and we do
not expect a market to
develop. In addition, we
do not intend to apply to
list the warrants on any
securities exchange. The
warrants are immediately
separable from the shares
of our common stock being
offered as part of the
units. |
The number of shares of our common stock to be outstanding after this offering is based on
22,647,869 shares of common stock outstanding as of September 30, 2009. Unless specifically stated
otherwise, the information in this prospectus supplement excludes:
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3,965,481 shares of our common stock issuable upon the exercise of
stock options outstanding as of September 30, 2009, at a weighted average
exercise price of $9.40 per share, of which options to purchase 1,948,081
shares of our common stock were then exercisable; |
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an aggregate of 1,216,140 shares of our common stock reserved for
future grants of stock options (or other similar equity instruments) under our
2007 Stock Option Plan and our 2007 Director Option Plan as of September 30,
2009; and |
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up to 1,854,946 shares of our common stock issuable upon the exercise of
warrants to be issued in this offering (assuming all units offered in this
offering are sold), at an exercise price of $4.43 per share. |
S-7
RISK FACTORS
Investing in our securities involves a high degree of risk and uncertainty. Please see the
risk factors under the heading Risk Factors in our Annual Report on Form 10-K for the year ended
December 31, 2008, as supplemented and updated by the risk factors in our Quarterly Reports on Form
10-Q for the quarters ended June 30, 2009 and September 30, 2009, respectively, as such discussions
may be amended or updated in subsequent reports filed by us with the SEC.
Before making an investment decision, you should carefully consider these risks as well as
other information we include or incorporate by reference in this prospectus supplement and the
accompanying prospectus. The risks and uncertainties we have described are not the only ones facing
our company. Additional risks and uncertainties not presently known to us or that we currently deem
to be immaterial may also affect our business operations. If any of such risks and uncertainties
actually occurs, our business, financial condition and results of operations could be severely
harmed. This could cause the trading price of our common stock to decline, and you could lose all
or part of your investment.
FORWARD-LOOKING STATEMENTS
This prospectus supplement, the accompanying prospectus and the documents that we incorporate
by reference herein and therein contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the
Securities Exchange Act of 1934, as amended, or the Exchange Act. Those statements are therefore
entitled to the protection of the safe harbor provisions of these laws. These forward-looking
statements, which are usually accompanied by words such as may, might, will, should,
could, intends, estimates, predicts, potential, continue, believes, anticipates,
plans, expects and similar expressions, involve risks and uncertainties, and relate to, without
limitation, statements about our product candidates, our market opportunities, our strategy, our
competition, our projected revenue, expense levels and cash spend and the adequacy of our available
cash resources. These statements are only predictions based on current expectations and projections
about future events. There are important factors that could cause our actual results, level of
activity, performance or achievements to differ materially from those expressed or forecasted in,
or implied by, such forward-looking statements, including those factors to which we refer you in
Risk Factors above.
S-8
Our business, financial condition, results of operations and prospects may change. Although
we believe that the expectations reflected in these forward-looking statements are based upon
reasonable assumptions, no assurance can be given that such expectations will be attained or that
any deviations will not be material. In light of these risks, uncertainties and assumptions, the
forward-looking events and circumstances discussed in this prospectus supplement, the accompanying
prospectus and the documents that we incorporate by reference herein and therein may not occur and
actual results could differ materially and adversely from those anticipated or implied in the
forward-looking statements. We disclaim any obligation or undertaking to disseminate any updates or
revision to any forward-looking statement to reflect any change in our expectations with regard
thereto or any change in events, conditions or circumstances on which any such statement is based.
You should read this prospectus supplement, the accompanying prospectus and the documents that
we incorporate by reference herein and therein, of which this prospectus supplement and the
accompanying prospectus are part, completely and with the understanding that our actual future
results may be materially different from what we expect. You should assume that the information
appearing in this prospectus supplement and the accompanying prospectus is accurate as of the date
on the front cover of this prospectus supplement and the accompanying prospectus, respectively,
only. We qualify all of the information presented in this prospectus supplement and the
accompanying prospectus, and particularly our forward-looking statements, by these cautionary
statements.
USE OF PROCEEDS
We estimate that our net proceeds from the sale of shares of our common stock and warrants
offered pursuant to this prospectus supplement will be approximately $17.2 million after deducting
the placement agency fee and estimated offering expenses that are payable by us. We intend to use
the net proceeds from the sale of shares of our common stock and warrants pursuant to this offering
to further advance the development of our lead product candidate, Amigal, including the initiation
of the Phase 3 study to support registration in the European Union and the completion of certain
activities required for the submission of a license application globally, as well as for general
corporate matters.
Consistent with our investment policy, we may invest the net proceeds temporarily in deposits
with major financial institutions, money market funds, notes issued by the United States
government, fixed income investments which can be readily purchased and sold using established
markets and United States bond funds which can be readily purchased and sold using established
markets until we use them for their intended purpose.
S-9
DILUTION
Purchasers of shares of our common stock included as part of the units offered by this
prospectus supplement and the accompanying prospectus will experience an immediate dilution in the
net tangible book value of their common stock from the public offering price of the units. The net
tangible book value of our common stock as of September 30, 2009 was $37.2 million, or $1.64 per
share. Net tangible book value per share of our common stock is equal to our net tangible assets
(tangible assets less total liabilities) divided by the number of shares of our common stock issued
and outstanding as of September 30, 2009.
Dilution per share represents the difference between the public offering price per share of
our common stock and the adjusted net tangible book value per share of our common stock included as
part of the units after giving effect to this offering. After reflecting the sale of 4,946,524
shares of our common stock offered by us at the public offering price of $3.74 per unit, less
placement agency fee and estimated offering expenses, our adjusted net tangible book value per
share of our common stock as of September 30, 2009 would have been $54.4 million or $1.97 per
share. The change represents an immediate increase in net tangible book value per share of our
common stock of $0.33 per share to existing stockholders and an immediate dilution of $1.77 per
share to new investors purchasing the shares of our common stock included as part of the units
offered in this offering. The following table illustrates this per share dilution:
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Public offering price per unit |
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$ |
3.74 |
|
Net tangible book value per share as of September 30, 2009 |
|
$ |
1.64 |
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|
Increase per share attributable to new investors |
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0.33 |
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Adjusted net tangible book value per share as of September 30, 2009 |
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1.97 |
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Dilution per share to new investors |
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$ |
1.77 |
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The foregoing calculations are based on 22,647,869 shares of our common stock outstanding as
of September 30, 2009 and do not take into account any of the following:
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3,965,481 shares of our common stock issuable upon the exercise of
stock options outstanding as of September 30, 2009, at a weighted average
exercise price of $9.40 per share, of which options to purchase 1,948,081
shares of our common stock were then exercisable; |
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|
an aggregate of 1,216,140 shares of our common stock reserved for
future grants of stock options (or other similar equity instruments) under our
2007 Stock Option Plan and our 2007 Director Option Plan as of September 30,
2009; and |
|
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|
up to 1,854,946 shares of our common stock issuable upon the exercise of
warrants to be issued in this offering (assuming all units offered in this
offering are sold), at an exercise price of $4.43 per share. |
S-10
PLAN OF DISTRIBUTION
We are offering the shares of our common stock and warrants through a placement agent.
Leerink Swann LLC, or Leerink Swann, has entered into a placement agency agreement with us pursuant
to which it has agreed to act as our placement agent in connection with this offering. Under the
placement agency agreement, Leerink Swann, whom we refer to as the placement agent, has agreed to
use its best efforts to arrange for the sale of 4,946,524 shares of our common stock and
warrants to purchase up to 1,854,946 shares of our common stock. The common stock and warrants
will be sold in units, with each unit consisting of one share of common stock and a warrant to
purchase 0.375 of a share of our common stock. The warrants will have an exercise price of $4.43
per share of our common stock.
The placement agent is not purchasing or selling any units, shares or warrants from us, nor is
it required to arrange for the purchase or sale of any specific number or dollar amount of the
units, shares or warrants. We will enter into subscription agreements directly with investors in
connection with this offering. The placement agency agreement provides that the obligations of the
placement agent and the investors are subject to certain conditions precedent, including the
absence of certain adverse changes in our business and the receipt of certain customary legal
opinions, letters and certificates.
This prospectus supplement will be distributed to the investors who agree to purchase units
and will inform the investors of the closing date as to such units. We currently anticipate that
closing of the sale of 4,946,524 units pursuant to this prospectus supplement will take place on or
about March 2, 2010. Investors will also be informed of the date and manner in which they must
transmit the purchase price for their shares. Investor funds will be deposited into an escrow
account set up at JPMorgan Chase Bank, N.A., as escrow agent, unless other arrangements are made
with the Companys consent. Before the closing date, the escrow agent will notify the placement
agent when funds to pay for the units have been received. We will deposit the shares of our common
stock with The Depository Trust Company upon receipt of notice from the placement agent that the
funds have been received. At the closing, The Depository Trust Company will credit the shares to
the respective accounts of the investors. We will mail warrants directly to the investors at the
respective addresses set forth in their purchase agreement with us. If the conditions to this
offering are not satisfied or waived, then all investor funds that were deposited into escrow will
be returned to investors and this offering will terminate.
We will pay the placement agent a fee equal to 5.7% of the gross proceeds of the sale of units
in this offering. The following table shows the per unit and total fee we will pay to the
placement agent in connection with the sale of units offered by this prospectus supplement,
assuming all of the units offered hereby are issued and sold by us.
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Placement Agency Fee |
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Per Unit |
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|
Total |
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Securities offered hereby |
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$ |
0.21 |
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$ |
1,054,500 |
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Because there is no minimum offering amount required as a condition to closing, the actual
total placement agency fee may be less than the maximum total placement agency fee set forth above.
We will also reimburse the placement agent for certain expenses, including legal fees and
expenses, incurred by the placement agent in connection with this offering. The estimated offering
expenses payable by us, in addition to the placement agency fee of
$1,054,500, are approximately
$0.2 million, which includes legal, accounting and printing costs and various other fees associated
with registering and listing shares of our common stock issued and sold in this offering. After
deducting certain fees due to the placement agent and our estimated offering expenses, we expect
the net proceeds from this offering to be approximately $17.2 million.
In no event will the total amount of compensation paid to Leerink Swann and any other member
of the Financial Industry Regulatory Authority upon completion of this offering exceed 8% of the
gross proceeds of this offering.
We, each of our directors and each of our executive officers and certain of our stockholders
have agreed that, without the prior written consent of Leerink Swann, they will not, during the
period ending 90 days, with respect to us, or 60 days, with respect to our directors, executive
officers and certain of our stockholders, after the
date of this prospectus supplement, sell, offer, contract or grant any option to sell
(including without limitation any short sale), pledge, transfer, establish an open put equivalent
position or liquidate or decrease a call equivalent position within the meaning of Rule 16a-1(h)
under the Exchange Act or otherwise dispose of or transfer (or enter into any transaction which is
designed to, or might reasonably be expected to, result in the disposition of), any shares of our
common stock, options to acquire shares of our common stock, or securities exchangeable or
exercisable for or convertible into shares of our common stock or publicly announce an intention to
do any of the foregoing.
S-11
In addition, during such 90-day restricted period, we will not file any registration statement
(other than on Form S-8) with the SEC relating to the offering of any shares of our common stock,
options to acquire shares of our common stock, any securities convertible into or exchangeable for
our common stock or other rights to purchase shares of our common stock or any other securities
that are substantially similar to our common stock.
The restrictions described above do not apply to:
with respect to us:
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the shares of our common stock and warrants to be sold in this offering; or |
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the issuance by us of shares of our common stock or options to purchase shares of our
common stock, or our common stock upon exercise of options, pursuant to our equity
incentive plans; |
with respect to our directors, executive officers and certain of our stockholders:
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transactions relating to shares of our common stock or other securities acquired in open
market transactions after the completion of this offering, provided that no filing under
Section 16(a) of the Exchange Act shall be required or shall be voluntarily made in
connection with subsequent sales of our common stock or other securities acquired in such
open market transactions; |
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transactions effected pursuant to any trading plan established pursuant to Rule 10b5-1
of the Exchange Act for the transfer of shares of our common stock that has been entered
into by the director, executive officer or stockholder prior to the date he or she entered
into the agreement regarding the 60-day restricted period; |
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transfers of shares of our common stock or any security convertible into our common
stock as a bona fide gift; or |
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transfers of shares of our common stock or any security convertible into our common
stock either during the directors, executive officers or stockholders lifetime or upon
death by will or intestate succession to the immediate family of the director, executive
officer or stockholder or to a trust the beneficiaries of which are exclusively the
director, executive officer or stockholder and/or a member or members of his or her
immediate family; provided that in the case of any transfer or distribution described in
this bullet or the immediately preceding bullet (i) each donee or distributee agrees in
writing to the same restrictions as set forth above and (ii) no filing under the Exchange
Act or other public announcement shall be required or shall be made voluntarily (other than
a filing on a Form 5 made after expiration of the 60-day restricted period) during the
60-day restricted period. |
The restricted period described above is subject to extension such that, in the event that
either (1) during the last 17 days of the restricted period, we issue an earnings release or
material news or a material event relating to us occurs or (2) prior to the expiration of the
restricted period, we announce that we will release earnings results during the 16-day period
beginning on the last day of the restricted period, the lock-up restrictions described above
will, subject to limited exceptions, continue to apply until the expiration of the 18-day period
beginning on the issuance of the earnings release or the occurrence of the material news or
material event.
The placement agent has informed us that it will not engage in over-allotment, stabilizing
transactions or syndicate covering transactions in connection with this offering.
S-12
We have agreed to indemnify the placement agent against certain liabilities, including
liabilities under the Securities Act, and liabilities arising from breaches of representations and
warranties contained in the placement agency agreement, or to contribute to payments the placement
agent may be required to make in respect of such liabilities.
The placement agency agreement with Leerink Swann will be filed as an exhibit to our Current
Report on Form 8-K that will be filed with the SEC in connection with this offering.
Delivery of the shares of our common stock and warrants issued and sold in this offering is
expected to be made on or about March 2, 2010, which will be the 3rd business day following the date
of pricing of the units. Under Rule 15c6-1 of the Exchange Act, trades in the secondary market
generally are required to settle in three business days unless the parties to any such trade
expressly agree otherwise. Accordingly, purchasers who wish to trade shares purchased in this
offering on the date of pricing will be required, by virtue of the fact that the shares purchased
in this offering initially will settle on the 3rd business day following the date of pricing of the
shares, to specify an alternate settlement cycle at the time of any such trade to prevent a failed
settlement. Purchasers of the shares in this offering who wish to trade the shares on the pricing
date should consult their own advisor.
The transfer agent for shares of our common stock to be issued in this offering is American
Stock Transfer and Trust Company, LLC located at 59 Maiden Lane, Plaza Level, New York, New York
10038.
S-13
DESCRIPTION OF OUR WARRANTS
The material terms and provisions of the warrants being offered pursuant to this prospectus
supplement are summarized below. The form of warrant will be provided to each investor in this
offering and will be filed as an exhibit to a Current Report on Form 8-K with the SEC in connection
with this offering.
Each investor that purchases units will receive, for each unit purchased, one share of our
common stock and a warrant to purchase 0.375 of a share of our common stock. The warrants will
have an exercise price of $4.43 per share of our common stock. The warrants are exercisable on or
after the date that is six months after the date of issuance and will terminate on the fourth
anniversary of the date of issuance. The exercise price and number of shares of common stock
issuable upon exercise is subject to appropriate adjustment in the event of stock dividends, stock
splits, reorganizations or similar events affecting our common stock and the exercise price.
There is no established public trading market for the warrants and we do not expect a market
to develop. We do not intend to apply to list the warrants on any securities exchange. Without an
active market, the liquidity of the warrants will be limited. In addition, in the event our common
stock price does not exceed the per share exercise price of the warrants during the period when the
warrants are exercisable, the warrants will not have any value.
Holders of the warrants may exercise their warrants to purchase shares of our common stock on
or before the termination date by delivering an exercise notice, appropriately completed and duly
signed, and payment of the exercise price for the number of shares for which the warrant is being
exercised. In the event that the registration statement relating to the shares of common stock is
not effective and another exemption from registration is not available or the fair market value (as
determined pursuant to the warrant) of a share of common stock is greater than the exercise price
of the warrant, a holder of warrants will have the right, in its sole discretion, to exercise its
warrants for a net number of warrant shares pursuant to the cashless exercise procedures specified
in the warrants. Warrants may be exercised in whole or in part, and any portion of a warrant not
exercised prior to the termination date shall be and become void and of no value. The absence of an
effective registration statement or applicable exemption from registration does not alleviate our
obligation to deliver common stock issuable upon exercise of a warrant.
Upon the holders exercise of a warrant, we will issue the shares of common stock issuable
upon exercise of the warrant within three trading days of our receipt of notice of exercise and
payment of the aggregate exercise price, subject to surrender of the warrant.
The shares of common stock issuable on exercise of the warrants are duly and validly
authorized and will be, when issued, delivered and paid for in accordance with the warrants, issued, fully paid and non-assessable. We will authorize and reserve at least that number of shares of
common stock equal to the number of shares of common stock issuable upon exercise of all
outstanding warrants.
If, at any time a warrant is outstanding, we consummate any fundamental transaction, as
described in the warrants and generally including any consolidation or merger into another
corporation, or the sale of all or substantially all of our assets, or other transaction in which
our common stock is converted into or exchanged for other securities or other consideration, the
holder of any warrants will thereafter receive upon exercise of the warrants, the securities or
other consideration to which a holder of the number of shares of common stock then deliverable upon
the exercise or conversion of such warrants would have been entitled upon such consolidation or
merger or other transaction.
The exercisability of the warrants may be limited in certain circumstances if, upon exercise,
the holder (together with the holders affiliates and any other persons or entities acting together
with the holder as a group) would hold more than 9.99% of our total common stock issued and
outstanding. The holder of a warrant has the ability, upon providing us not less than 61 days
prior written notice, to waive the foregoing limitation. The absence of an effective registration
statement relating to the common stock issuable upon exercise of a warrant will not provide the
holder with the right to net-settle the warrant in cash.
S-14
Amendments and waivers of the terms of the warrants require the written consent of the holders
of warrants representing at least two-thirds of the shares of common stock issuable upon the then
outstanding warrants, except that no such action may increase the exercise price of a warrant or
decrease the number of shares or class of stock obtainable upon exercise of a warrant without the
written consent of the holder.
THE HOLDER OF A WARRANT WILL NOT POSSESS ANY RIGHTS AS A STOCKHOLDER UNDER THAT WARRANT UNTIL
THE HOLDER EXERCISES THE WARRANT. THE WARRANTS MAY BE TRANSFERRED INDEPENDENT OF THE COMMON STOCK
WITH WHICH THEY WERE ISSUED, SUBJECT TO APPLICABLE LAWS.
S-15
LEGAL MATTERS
The validity of the securities we are offering will be passed upon by Pepper Hamilton LLP,
Philadelphia, Pennsylvania. Dechert LLP, Philadelphia, Pennsylvania, is counsel for the placement
agent.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2008, as set forth in their report, which is incorporated by reference in the accompanying
prospectus. Our consolidated financial statements are incorporated by reference in reliance on
Ernst & Young LLPs report, given on their authority as experts in accounting and auditing.
S-16
PROSPECTUS
AMICUS THERAPEUTICS, INC.
$92,430,000
Common Stock
Preferred Stock
Warrants
Debt Securities
1,000,000 Shares of Common Stock
Offered by
Selling Stockholders
We may offer to the public from time to time in one or more series or issuances:
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shares of our common stock; |
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shares of preferred stock; |
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warrants to purchase shares of our common stock, preferred stock and/or debt securities; |
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debt securities consisting of debentures, notes or other evidences of indebtedness; or |
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any combination of these securities. |
Selling stockholders may also offer shares of our common stock from time to time
in connection with this offering.
This prospectus provides a general description of the securities that we or the selling
stockholders may offer. Each time that securities are sold under this prospectus, we will provide
specific terms of the securities offered in a supplement to this prospectus. The prospectus
supplement may also add, update or change information contained in this prospectus. This prospectus
may not be used to consummate a sale of securities unless accompanied by the applicable prospectus
supplement. You should read both this prospectus and the applicable prospectus supplement together
with additional information described under the heading Where You Can Find More Information
before you make your investment decision.
Securities sold under this prospectus shall be sold directly to purchasers or through agents
on our behalf or on behalf of the selling stockholders or through underwriters or dealers as
designated from time to time. Each time a selling stockholder sells or disposes shares of common stock pursuant to this offering, the selling stockholder
is required to provide you with this prospectus and a prospectus supplement containing specific information about the selling stockholder and the terms of the
offering. If any agents or underwriters are involved in the sale of any of
these securities, the applicable prospectus supplement will provide the names of the agents or
underwriters and any applicable fees, commissions or discounts.
Our common stock is traded on the Nasdaq Global Market under the symbol FOLD. On May 11,
2009, the closing price of our common stock was $7.50.
As of March 23, 2009, the aggregate market value of our outstanding common stock held by
non-affiliates was approximately $106,307,120, based on 22,643,056 shares of outstanding common
stock, of which approximately 10,630,712 shares are held by non-affiliates, and a per share price
of $10.00 based on the closing sale price of our common stock on March 23, 2009. As of the date
hereof, we have not offered any securities pursuant to General Instruction I.B.6 of Form S-3 during
the prior 12 calendar month period that ends on and includes the date hereof.
Investing in our securities involves certain risks. Before investing, you should refer to the
risk factors on page 3 of this prospectus, included in our periodic reports, in prospectus
supplements and in other information filed by us with the Securities and Exchange Commission.
These securities have not been approved by the Securities and Exchange Commission or any state
securities commission, nor have these organizations determined that this prospectus is accurate or
complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is May 27, 2009.
TABLE OF CONTENTS
Prospectus
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ABOUT THIS PROSPECTUS
This prospectus is a part of a registration statement that we filed with the Securities and
Exchange Commission, or the SEC, using a shelf registration process. Under this shelf
registration process we may offer to sell any of the securities, or any combination of the
securities, described in this prospectus, in each case in one or more
offerings, up to a total dollar amount of $92,430,000 and the selling
stockholders may sell up to 1,000,000 shares of our common stock in
one or more offerings.
This prospectus provides you only with a general description of the securities we or the
selling stockholders may offer. Each time securities are sold under this shelf registration, we
will provide a prospectus supplement that will contain specific information about the terms of
those securities and the terms of that offering. The prospectus supplement may also add, update or
change information contained in this prospectus. You should read both this prospectus and any
prospectus supplement, including all documents incorporated herein by reference, together with the
additional information described under Where You Can Find More Information below.
The information contained in this prospectus is not complete and may be changed. You should
rely only on the information provided in or incorporated by reference in this prospectus or in any
prospectus supplement, or documents to which we otherwise refer you. We have not authorized anyone
else to provide you with different information.
We have not authorized any dealer, agent or other person to give any information or to make
any representation other than those contained or incorporated by reference in this prospectus and
any accompanying prospectus supplement. You must not rely upon any information or representation
not contained or incorporated by reference in this prospectus or an accompanying prospectus
supplement. This prospectus and the accompanying prospectus supplement, if any, do not constitute
an offer to sell or the solicitation of an offer to buy any securities other than the registered
securities to which they relate, nor do this prospectus and the accompanying prospectus supplement
constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction
to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. You
should not assume that the information contained in this prospectus and the accompanying prospectus
supplement, if any, is accurate on any date subsequent to the date set forth on the front of the
document or that any information we have incorporated by reference is correct on any date
subsequent to the date of the document incorporated by reference, even though this prospectus and
any accompanying prospectus supplement is delivered or securities are sold on a later date.
References in this prospectus to the terms the Company, Amicus, we, our and us or other
similar terms mean Amicus Therapeutics, Inc., unless we state otherwise or the context indicates
otherwise.
THE COMPANY
We are a clinical-stage biopharmaceutical company focused on the discovery, development and
commercialization of a new class of orally-administered, small molecule drugs, known as
pharmacological chaperones, for the treatment of a range of human genetic diseases. Our lead
product candidates in development are Amigal (migalastat hydrochloride) for Fabry disease, Plicera
(afegostat tartrate) for Gaucher disease and AT2220 (1-deoxynojirimycin HCl) for Pompe disease. We
completed our Phase 2 clinical trials of Amigal and are currently conducting Phase 2 clinical
trials of Plicera. We recently suspended a Phase 2 clinical trial of AT2220 and the IND is on
clinical hold pending FDA agreement to allow the Company to resume clinical development. Although
Fabry, Gaucher and Pompe are relatively rare diseases, they represent substantial commercial
markets due to the severity of the symptoms and the chronic nature of the diseases. The worldwide
net product sales for the five currently approved therapeutics to treat Fabry, Gaucher and Pompe
disease were approximately $2.2 billion in 2008, as publicly reported by the companies that market
these therapeutics.
Our goal is to become a leading biopharmaceutical company focused on the discovery,
development and commercialization of pharmacological chaperone therapies for the treatment of a
wide range of human diseases. Our initial clinical efforts are currently focused on developing
pharmacological chaperones for the treatment of lysosomal storage disorders, which are chronic
genetic diseases, such as Fabry, Gaucher and Pompe that frequently result in severe symptoms. We
also believe our technology may be broadly applicable to other diseases for which protein
stabilization and improved folding may be beneficial, including certain neurodegenerative and
genetically-based metabolic disorders.
Fabry, Gaucher and Pompe are among certain human diseases which result from mutations in
specific genes that, in many cases, lead to the production of proteins with reduced stability.
Proteins with such mutations may not fold into their correct three-dimensional shape and are
generally referred to as misfolded proteins. Misfolded proteins are often recognized by cells as
having defects and, as a result, may be eliminated prior to reaching their intended location in the
cell. The reduced biological activity of these proteins leads to impaired cellular function and
ultimately to disease.
Our novel approach to the treatment of human genetic diseases consists of using
pharmacological chaperones that selectively bind to the target protein; increasing the stability of
the protein and helping it fold into the correct three-dimensional shape. This allows proper
trafficking of the protein, thereby increasing protein activity, improving cellular function and
potentially reducing cell stress.
The current standard of treatment for Fabry, Gaucher and Pompe is enzyme replacement therapy
(ERT). This therapy compensates for the reduced level of activity of specialized proteins called
enzymes through regular infusions of recombinant enzyme. Instead of adding enzymes from an external
source by intravenous infusion, our approach uses small molecule, orally-administered
pharmacological chaperones to restore the function of the enzyme that is already made by the
patients own body. We believe our product candidates may have advantages relative to ERT relating
to bio-distribution and ease of use, potentially improving treatment of these diseases.
In order to further the development of our pharmacological chaperone therapies and share the
costs of such development, in November 2007, we entered into a strategic collaboration with Shire
Pharmaceuticals Ireland Ltd. (Shire), a subsidiary of Shire plc, to jointly develop our three lead
pharmacological chaperone compounds for lysosomal storage disorders. Shire will receive rights to
commercialize these products outside of the United States (U.S.). We retain all rights to
commercialize these products in the U.S.
Our principal executive offices are located at 6 Cedar Brook Drive, Cranbury, NJ 08512, and
our phone number is (609) 662-2000.
-2-
RISK FACTORS
Investing in our securities involves risk. The prospectus supplement applicable to each
offering of our securities will contain a discussion of the risks applicable to an investment in
us. Prior to making a decision about investing in our securities, you should carefully consider the
specific factors discussed under the heading Risk Factors in the applicable prospectus
supplement, together with all of the other information contained or incorporated by reference in
the prospectus supplement or appearing or incorporated by reference in this prospectus. You should
also consider the risks, uncertainties and assumptions discussed under the heading Risk Factors
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2008 filed on February 6,
2009, with the SEC, which is incorporated herein by reference, and may be amended, supplemented or
superseded from time to time by other reports we file with the SEC in the future. The risks and
uncertainties we have described are not the only ones we face. Additional risks and uncertainties
not presently known to us or that we currently deem immaterial may also affect our operations.
FORWARD-LOOKING STATEMENTS
This prospectus, any prospectus supplement and the other documents we have filed with the SEC
that are incorporated herein by reference contain forward-looking statements that involve
substantial risks and uncertainties. All statements, other than statements of historical facts,
regarding our strategy, future operations, future financial position, future revenues, projected
costs, prospects, plans, objectives of management or other financial items are forward-looking
statements. The words anticipate, believe, estimate, expect, intend, may, plan,
predict, project, will, would and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain these identifying
words.
We may not actually achieve the plans, intentions or expectations disclosed in our
forward-looking statements, and you should not place undue reliance on our forward-looking
statements. Actual results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we make. We have included important
factors in the cautionary statements included in this prospectus, particularly as set forth and
incorporated by reference in the Risk Factors section above, that we believe could cause actual
results or events to differ materially from the forward-looking statements that we make. Our
forward-looking statements do not reflect the potential impact of any future acquisitions, mergers,
dispositions, joint ventures, collaborations or investments we may make.
You should read this prospectus, any supplements to this prospectus and the documents that we
incorporate by reference in this prospectus completely and with the understanding that our actual
future results may be materially different from what we expect. We do not assume any obligation to
update any forward-looking statements.
-3-
USE OF PROCEEDS
Except as otherwise provided in the applicable prospectus supplement, we intend to use the net
proceeds from the sale of the securities covered by this prospectus for general corporate purposes,
which may include working capital, capital expenditures, research and development expenditures,
clinical trial expenditures, commercial expenditures, acquisitions of new technologies or
businesses, and investments. Additional information on the use of net proceeds from the sale of
securities covered by this prospectus may be set forth in the prospectus supplement relating to the
specific offering. We will not receive any of the proceeds from the sale of any securities offered
pursuant to this prospectus by any selling stockholder.
RATIO OF EARNINGS TO COMBINED FIXED CHARGES (1)
The following table sets forth our ratio of earnings to fixed charges on a historical basis
for the periods indicated. For purposes of this calculation, earnings consists of net loss from
continuing operations plus fixed charges. Fixed charges consist of the sum of interest expense
and the estimate of interest within rental expense.
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Years Ended December 31, |
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2004 |
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2005 |
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2006 |
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2007 |
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2008 |
Ratio of Earnings
to Fixed Charges
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Deficiency of
Earnings Available
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(in millions) |
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8.2 |
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$ |
19.6 |
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$ |
45.5 |
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$ |
40.2 |
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$ |
38.5 |
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(1) |
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For the years ended December 31, 2004, 2005, 2006, 2007 and 2008, earnings were insufficient
to cover fixed charges by $8.8 million, $20.0 million, $46.3 million, $41.2 million and $39.4
million, respectively. |
-4-
SELLING STOCKHOLDERS
This
prospectus also relates to the possible resale of up to an aggregate
of 1,000,000 shares of our common stock which were previously
acquired by certain persons through several private placements of our convertible preferred stock
completed by us prior to our initial public offering (IPO) in 2007, which were all converted to
shares of our common stock in connection with the IPO, and through private placements of our common
stock completed by us prior to the filing of the Registration Statement of which this prospectus is a
part. In connection with such private placements, these persons have registration rights with respect
to their shares as described further below under the heading Certain Relationships and Related Party
Transactions. Information about selling stockholders, if any, including their identities and the number
of shares of common stock to be registered on their behalf, will be set forth in a prospectus supplement,
in a post-effective amendment or in filings we make with the Securities and Exchange Commission under the
Securities Exchange Act of 1934, as amended, that are incorporated by reference into this prospectus.
Selling stockholders shall not sell any shares of our common stock pursuant to this prospectus until we
have identified such selling stockholders and the shares being offering for resale by such selling
stockholders in a subsequent prospectus supplement. However, the selling stockholders may sell or
transfer all or a portion of their shares of our common stock pursuant to any available exemption
from the registration requirements of the Securities Act of 1933, as amended.
Certain Relationships and Related Party Transactions
Investor Rights Agreement
Pursuant to a third amended and restated investor rights agreement, dated as of September 13,
2006, by and among entities who held our redeemable convertible preferred stock (which was
converted to common stock at our initial public offering) and us, we granted registration rights to
all such holders, to Mount Sinai School of Medicine of New York University, or MSSM, and to the
holder of a warrant which has since been exercised. Entities affiliated with Prospect Venture
Partners II, L.P., New Enterprise Associates, Frazier Healthcare Ventures, Canaan Equity, Quaker
BioVentures, CHL Medical Partners and Palo Alto Investors, LLC, each a holder of 5% or more of our
voting securities, and their affiliates are parties to this investor rights agreement.
Subject to certain limitations, these stockholders may demand that, on up to two occasions, we
register all or part of their securities for sale under the Securities Act as long as the aggregate
price to the public for the securities to be sold in each instance is $5,000,000 or more. If we
are eligible to register any of our common stock on Form S-3, these stockholders may make the same
demand; provided, however, that we will not be required to register their securities if (i) we have
already effected a registration within 90 days prior to the request or have effected two or more
registrations on Form S-3 within the preceding 12 month period, or (ii) if the aggregate price to
the public for the securities to be sold is less than $2,500,000. Additionally, if we believe that
such registration would have a materially detrimental effect on any material corporate event, we
may delay the request for up to three months, but not more than once in any twelve month period.
These stockholders may also request registration of their shares if we register any of our
common stock, either for our own account or for the account of other securityholders. In such an
event, these stockholders are entitled to notice of the registration and to include their shares of
common stock in such registration. In the case of an underwritten registration, we must use our
reasonable best efforts to obtain the permission of the underwriters to the inclusion of the
holders shares in the offering on the same terms.
With specified exceptions, a holders right to include shares in a registration is subject to
the right of the underwriters to limit the number of shares included in the offering. All fees,
costs and expenses of any registrations will generally be paid by us.
Mt. Sinai School of Medicine License Agreement
We acquired exclusive worldwide patent rights to develop and commercialize our lead products
and other pharmacological chaperones pursuant to a license agreement with MSSM. In connection with
this agreement, we issued 232,266 shares of our common stock to MSSM in April 2002. In October 2006
we issued MSSM an additional 133,333 shares of common stock and made a payment of $1.0 million in
consideration of an expanded field of use under that license. Under this agreement, to date we have
paid no upfront or annual license fees and we have no milestone or future payments other than
royalties on net sales. However, on October 31, 2008, we amended and restated this license
agreement to, among other items, provide us with the sole right to control the prosecution of
patent rights under such agreement and to clarify the portion of royalties and milestone payments
we receive from Shire Pharmaceuticals Ireland Ltd. that are payable to MSSM. In connection
therewith, we agreed to pay MSSM $2.6 million in connection with the $50 million upfront payment
that we received in November 2007 from Shire and an additional $2.6 million for the sole right to
and control over the prosecution of patent rights. This agreement expires upon expiration of the
last of the licensed patent rights, which will be in 2019 if a foreign patent is granted and 2018
otherwise, or later subject to any patent term extension that may be granted.
-5-
PLAN OF DISTRIBUTION
Amicus, and any selling stockholders and their successors, including their permitted
transferees, may sell the offered securities in any of the ways described below or in any
combination or any other way set forth in an applicable prospectus supplement from time to time:
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to or through underwriters or dealers; |
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through one or more agents; or |
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directly to purchasers or to a single purchaser. |
The distribution of the securities may be effected from time to time in one or more
transactions:
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at a fixed price, or prices, which may be changed from time to time; |
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at market prices prevailing at the time of sale; |
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at prices related to such prevailing market prices; or |
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at negotiated prices. |
Each prospectus supplement will describe the method of distribution of the securities and any
applicable restrictions.
The prospectus supplement with respect to the securities of a particular series will describe
the terms of the offering of the securities, including the following:
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the name or names of any underwriters, dealers or agents and the
amounts of securities underwritten or purchased by each of them; |
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the public offering price of the securities and the proceeds to us and
any discounts, commissions or concessions allowed or reallowed or paid
to dealers; and |
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any securities exchanges on which the securities may be listed. |
Any offering price and any discounts or concessions allowed or reallowed or paid to dealers
may be changed from time to time.
Only the agents or underwriters named in each prospectus supplement are agents or underwriters
in connection with the securities being offered thereby.
We may authorize underwriters, dealers or other persons acting as our agents to solicit offers
by certain institutions to purchase securities from us pursuant to delayed delivery contracts
providing for payment and delivery on the date stated in each applicable prospectus supplement.
Each contract will be for an amount not less than, and the aggregate amount of securities sold
pursuant to such contracts shall not be less nor more than, the respective amounts stated in each
applicable prospectus supplement. Institutions with whom the contracts, when authorized, may be
made include commercial and savings banks, insurance companies, pension funds, investment
companies, educational and charitable institutions and other institutions, but shall in all cases
be subject to our approval. Delayed delivery contracts will be subject only to those conditions set
forth in each applicable prospectus supplement, and each prospectus supplement will set forth any
commissions we pay for solicitation of these contracts.
Agents, underwriters and other third parties described above may be entitled to
indemnification by us or any selling stockholder against certain civil liabilities, including
liabilities under the Securities Act of 1933, or to contribution from us with respect to payments
which the agents, underwriters or other third parties may be required to make in respect thereof.
Agents, underwriters and such other third parties may be customers of, engage in transactions with,
or perform services for us in the ordinary course of business.
One or more firms, referred to as remarketing firms, may also offer or sell the securities,
if a prospectus supplement so indicates, in connection with a remarketing arrangement upon their
purchase. Remarketing firms will act as principals for their own accounts or as our agents. These
remarketing firms will offer or sell the securities in accordance with the terms of the securities.
Each prospectus supplement will identify and describe any remarketing firm and the terms of its
agreement, if any, with us and will describe the remarketing firms compensation. Remarketing firms
may be deemed to be underwriters in connection with the securities they remarket. Remarketing firms
may be entitled under agreements that may be entered into with us to indemnification by us against
-6-
certain civil liabilities, including liabilities under the Securities Act of 1933, and may be
customers of, engage in transactions with or perform services for us in the ordinary course of
business.
Certain underwriters may use this prospectus and any accompanying prospectus supplement for
offers and sales related to market-making transactions in the securities. These underwriters may
act as principal or agent in these transactions, and the sales will be made at prices related to
prevailing market prices at the time of sale.
The securities we or any selling stockholders offer may be new issues of securities and may
have no established trading market. The securities may or may not be listed on a securities
exchange. Underwriters may make a market in these securities, but will not be obligated to do so
and may discontinue any market making at any time without notice. We can make no assurance as to
the liquidity of, or the existence of trading markets for, any of the securities.
Certain persons participating in an offering may engage in overallotment, stabilizing
transactions, short covering transactions and penalty bids in accordance with rules and regulations
under the Securities Exchange Act of 1934. Overallotment involves sales in excess of the offering
size, which create a short position. Stabilizing transactions permit bids to purchase the
underlying security so long as the stabilizing bids do not exceed a specified maximum. Short
covering transactions involve purchases of the securities in the open market after the distribution
is completed to cover short positions. Penalty bids permit the underwriters to reclaim a selling
concession from a dealer when the securities originally sold by the dealer are purchased in a short
covering transaction to cover short positions. Those activities may cause the price of the
securities to be higher than it would otherwise be. If commenced, the underwriters may discontinue
any of the activities at any time.
We also may sell any of the securities through agents designated by us from time to time. We
will name any agent involved in the offer or sale of these securities and will list commissions
payable by us to these agents in the applicable prospectus supplement. These agents will be acting
on a best efforts basis to solicit purchases for the period of its appointment, unless stated
otherwise in the applicable prospectuses.
We or any selling stockholders may sell any of the securities directly to purchasers. In this
case, we or any selling stockholders will not engage underwriters or agents in the offer and sale
of these securities.
-7-
GENERAL DESCRIPTION OF SECURITIES
We may offer and sell, at any time and from time to time:
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Shares of our common stock; |
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Shares of our preferred stock; |
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Warrants to purchase shares of our common stock, preferred stock and/or debt
securities; |
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Debt securities consisting of debentures, notes or other evidences of indebtedness;
or |
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Any combination of these securities. |
The
selling stockholders may also offer shares of our common stock from time to
time. The terms of any securities we offer or offered by the selling stockholders will be
determined at the time of sale. We may issue debt securities that are exchangeable for and/or
convertible into common stock or any of the other securities that may be sold under this
prospectus. When particular securities are offered, a supplement to this prospectus will be filed
with the SEC, which will describe the terms of the offering and sale of the offered securities.
DESCRIPTION OF OUR COMMON STOCK
The following summary of the terms of our common stock is subject to and qualified in its
entirety by reference to our charter and by-laws, copies of which are on file with the SEC as
exhibits to previous SEC filings. Please refer to Where You Can Find More Information below for
directions on obtaining these documents.
As of May 11, 2009, we are authorized to issue 50,000,000 shares of common stock, $0.01 par
value per share. As of May 11, 2009, we had 22,643,334 shares of common stock outstanding.
General
Holders of our common stock are entitled to one vote for each share held on all matters
submitted to a vote of stockholders and do not have cumulative voting rights. An election of
directors by our stockholders shall be determined by a plurality of the votes cast by the
stockholders entitled to vote on the election. Holders of common stock are entitled to receive
proportionately any dividends as may be declared by our board of directors, subject to any
preferential dividend rights of any outstanding preferred stock.
In the event of our liquidation or dissolution, the holders of common stock are entitled to
receive proportionately all assets available for distribution to stockholders after the payment of
all debts and other liabilities and subject to the prior rights of any outstanding preferred stock.
Holders of common stock have no preemptive, subscription, redemption or conversion rights. The
rights, preferences and privileges of holders of common stock are subject to and may be adversely
affected by the rights of the holders of shares of any series of preferred stock that we may
designate and issue in the future.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is American Stock Transfer and Trust
Company.
The NASDAQ Global Market
Our common stock is listed on the Nasdaq Global Market under the symbol FOLD.
-8-
DESCRIPTION OF OUR PREFERRED STOCK
We are authorized to issue up to 10,000,000 shares of preferred stock, par value $0.01 per
share. As of May 11, 2009, there were no shares of our preferred stock outstanding.
Our board of directors may, without further action by our stockholders, from time to time,
direct the issuance of shares of preferred stock in series and may, at the time of issuance,
determine the rights, preferences and limitations of each series, including voting rights, dividend
rights and redemption and liquidation preferences. Satisfaction of any dividend preferences of
outstanding shares of our preferred stock would reduce the amount of funds available for the
payment of dividends on shares of our common stock. Holders of shares of our preferred stock may be
entitled to receive a preference payment in the event of any liquidation, dissolution or winding-up
of our Company before any payment is made to the holders of shares of our common stock. In some
circumstances, the issuance of shares of preferred stock may render more difficult or tend to
discourage a merger, tender offer or proxy contest, the assumption of control by a holder of a
large block of our securities or the removal of incumbent management. Upon the affirmative vote of
our board of directors, without stockholder approval, we may issue shares of preferred stock with
voting and conversion rights which could adversely affect the holders of shares of our common
stock.
If we offer a specific class or series of preferred stock under this prospectus, we will
describe the terms of the preferred stock in the prospectus supplement for such offering and will
file a copy of the certificate establishing the terms of the preferred stock with the SEC. To the
extent required, this description will include:
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the title and stated value; |
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the number of shares offered, the liquidation preference per share and the purchase
price; |
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the dividend rate(s), period(s) and/or payment date(s), or method(s) of calculation
for such dividends; |
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whether dividends will be cumulative or non-cumulative and, if cumulative, the date
from which dividends will accumulate; |
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the procedures for any auction and remarketing, if any; |
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the provisions for a sinking fund, if any; |
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the provisions for redemption, if applicable; |
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any listing of the preferred stock on any securities exchange or market; |
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whether the preferred stock will be convertible into our common stock, and, if
applicable, the conversion price (or how it will be calculated), the conversion period and
any other terms of conversion (including any anti-dilution provisions, if any); |
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whether the preferred stock will be exchangeable into debt securities, and, if
applicable, the exchange price (or how it will be calculated), the exchange period and any
other terms of exchange (including any anti-dilution provisions, if any); |
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voting rights, if any, of the preferred stock; |
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a discussion of any material U.S. federal income tax considerations applicable to the
preferred stock; |
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the relative ranking and preferences of the preferred stock as to dividend rights and
rights upon liquidation, dissolution or winding up of the affairs of the Company; |
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any material limitations on issuance of any class or series of preferred stock
ranking senior to or on a parity with the series of preferred stock as to dividend rights
and rights upon liquidation, dissolution or winding up of the Company; and |
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any other affirmative, negative or other covenants or contractual rights which might
be attendant with the specific class or series of preferred stock. |
The preferred stock offered by this prospectus, when issued, will not have, or be subject to,
any preemptive or similar rights.
Transfer Agent and Registrar
The transfer agent and registrar for any series or class of preferred stock will be set forth
in each applicable prospectus supplement.
-9-
DESCRIPTION OF OUR WARRANTS
We may issue warrants to purchase shares of our common stock, preferred stock and/or debt
securities in one or more series together with other securities or separately, as described in each
applicable prospectus supplement. Below is a description of certain general terms and provisions of
the warrants that we may offer. Particular terms of the warrants will be described in the
applicable warrant agreements and the applicable prospectus supplement for the warrants.
The applicable prospectus supplement will contain, where applicable, the following terms of
and other information relating to the warrants:
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the specific designation and aggregate number of, and the price at which we will
issue, the warrants; |
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the currency or currency units in which the offering price, if any, and the exercise
price are payable; |
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the designation, amount and terms of the securities purchasable upon exercise of the
warrants; |
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if applicable, the exercise price for shares of our common stock and the number of shares of common stock to be received upon exercise of the warrants; |
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if applicable, the exercise price for shares of our preferred stock, the number of
shares of preferred stock to be received upon exercise, and a description of that class or
series of our preferred stock; |
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if applicable, the exercise price for our debt securities, the amount of our debt
securities to be received upon exercise, and a description of that series of debt
securities; |
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the date on which the right to exercise the warrants will begin and the date on which
that right will expire or, if the warrants may not be continuously exercised throughout
that period, the specific date or dates on which the warrants may be exercised; |
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whether the warrants will be issued in fully registered form or bearer form, in
definitive or global form or in any combination of these forms, although, in any case, the
form of a warrant included in a unit will correspond to the form of the unit and of any
security included in that unit; |
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any applicable material U.S. federal income tax consequences; |
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the identity of the warrant agent for the warrants and of any other depositaries,
execution or paying agents, transfer agents, registrars or other agents; |
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the proposed listing, if any, of the warrants or any securities purchasable upon
exercise of the warrants on any securities exchange; |
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if applicable, the date from and after which the warrants and the common stock,
preferred stock and/or debt securities will be separately transferable; |
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if applicable, the minimum or maximum amount of the warrants that may be exercised at
any one time; |
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information with respect to book-entry procedures, if any; |
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the anti-dilution provisions of the warrants, if any; |
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any redemption or call provisions; |
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whether the warrants are to be sold separately or with other securities as parts of
units; and |
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any additional terms of the warrants, including terms, procedures and limitations
relating to the exchange and exercise of the warrants. |
Transfer Agent and Registrar
The transfer agent and registrar for any warrants will be set forth in the applicable
prospectus supplement.
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DESCRIPTION OF OUR DEBT SECURITIES
This section describes the general terms and provisions of the debt securities that we may
offer under this prospectus, any of which may be issued as convertible or exchangeable debt
securities. We will set forth the particular terms of the debt securities we offer in a prospectus
supplement. The extent, if any, to which the following general provisions apply to particular debt
securities will be described in the applicable prospectus supplement. The following description of
general terms relating to the debt securities and the indenture under which the debt securities
will be issued are summaries only and therefore are not complete. You should read the indenture and
the prospectus supplement regarding any particular issuance of debt securities.
We will issue any debt under an indenture to be entered into between us and the trustee
identified in the applicable prospectus supplement. The terms of the debt securities will include
those stated in the indenture and those made part of the indenture by reference to the Trust
Indenture Act of 1939, as in effect on the date of the indenture. We have filed or will file a copy
of the form of indenture as an exhibit to the registration statement in which this prospectus is
included. The indenture will be subject to and governed by the terms of the Trust Indenture Act of
1939.
We
may offer under this prospectus up to an aggregate principal amount
of $92,430,000 in debt
securities, or if debt securities are issued at a discount, or in a foreign currency, foreign
currency units or composite currency, the principal amount as may be sold for an initial public
offering price of up to $92,430,000. Unless otherwise specified in the applicable prospectus
supplement, the debt securities will represent direct, unsecured obligations of the Company and
will rank equally with all of our other unsecured indebtedness.
The following statements relating to the debt securities and the indenture are summaries,
qualified in their entirety by reference to the detailed provisions of the indenture and the final
form indenture as may be filed with a future prospectus supplement.
General
We may issue the debt securities in one or more series with the same or various maturities, at
par, at a premium, or at a discount. We will describe the particular terms of each series of debt
securities in a prospectus supplement relating to that series, which we will file with the SEC.
The prospectus supplement will set forth, to the extent required, the following terms of the
debt securities in respect of which the prospectus supplement is delivered:
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the title of the series; |
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the aggregate principal amount; |
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the issue price or prices, expressed as a percentage of the aggregate principal
amount of the debt securities; |
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any limit on the aggregate principal amount; |
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the date or dates on which principal is payable; |
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the interest rate or rates (which may be fixed or variable) or, if applicable, the
method used to determine such rate or rates; |
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the date or dates from which interest, if any, will be payable and any regular
record date for the interest payable; |
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the place or places where principal and, if applicable, premium and interest, is
payable; |
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the terms and conditions upon which we may, or the holders may require us to, redeem
or repurchase the debt securities; |
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the denominations in which such debt securities may be issuable, if other than
denominations of $1,000 or any integral multiple of that number; |
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whether the debt securities are to be issuable in the form of certificated
securities (as described below) or global securities (as described below); |
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the portion of principal amount that will be payable upon declaration of
acceleration of the maturity date if other than the principal amount of the debt
securities; |
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the currency of denomination; |
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the designation of the currency, currencies or currency units in which payment of
principal and, if applicable, premium and interest, will be made; |
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if payments of principal and, if applicable, premium or interest, on the debt
securities are to be made in one or more currencies or currency units other than the
currency of denomination, the manner in which the exchange rate with respect to such
payments will be determined; |
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if amounts of principal and, if applicable, premium and interest may be determined
by reference to an index based on a currency or currencies or by reference to a
commodity, commodity index, stock exchange index or financial index, then the manner in
which such amounts will be determined; |
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the provisions, if any, relating to any collateral provided for such debt
securities; |
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any addition to or change in the covenants and/or the acceleration provisions
described in this prospectus or in the indenture; |
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any events of default, if not otherwise described below under Events of Default; |
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the terms and conditions, if any, for conversion into or exchange for shares of our
common stock or preferred stock; |
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any depositaries, interest rate calculation agents, exchange rate calculation agents
or other agents; and |
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the terms and conditions, if any, upon which the debt securities shall be
subordinated in right of payment to other indebtedness of the Company. |
We may issue discount debt securities that provide for an amount less than the stated
principal amount to be due and payable upon acceleration of the maturity of such debt securities in
accordance with the terms of the indenture. We may also issue debt securities in bearer form, with
or without coupons. If we issue discount debt securities or debt securities in bearer form, we will
describe material U.S. federal income tax considerations and other material special considerations
which apply to these debt securities in the applicable prospectus supplement.
We may issue debt securities denominated in or payable in a foreign currency or currencies or
a foreign currency unit or units. If we do, we will describe the restrictions, elections, and
general tax considerations relating to the debt securities and the foreign currency or currencies
or foreign currency unit or units in the applicable prospectus supplement.
Exchange and/or Conversion Rights
We may issue debt securities which can be exchanged for or converted into shares of our common
stock or preferred stock. If we do, we will describe the terms of exchange or conversion in the
prospectus supplement relating to these debt securities.
Transfer and Exchange
We may issue debt securities that will be represented by either:
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book-entry securities, which means that there will be one or more global securities
registered in the name of a depositary or a nominee of a depositary; or |
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certificated securities, which means that they will be represented by a certificate
issued in definitive registered form. |
We will specify in the prospectus supplement applicable to a particular offering whether the
debt securities offered will be book-entry or certificated securities.
Certificated Debt Securities
If you hold certificated debt securities issued under an indenture, you may transfer or
exchange such debt securities in accordance with the terms of the indenture. You will not be
charged a service charge for any transfer or exchange of certificated debt securities but may be
required to pay an amount sufficient to cover any tax or other governmental charge payable in
connection with such transfer or exchange.
Global Securities
The debt securities of a series may be issued in the form of one or more global securities
that will be deposited with a depositary or its nominees identified in the prospectus supplement
relating to the debt securities. In such a case, one or more global securities will be issued in a
denomination or aggregate denominations equal to the portion of the aggregate principal amount of
outstanding debt securities of the series to be represented by such global security or securities.
Unless and until it is exchanged in whole or in part for debt securities in definitive
registered form, a global security may not be registered for transfer or exchange except as a whole
by the depositary for such global security to a nominee of the depositary and except in the
circumstances described in the prospectus supplement relating to the debt securities. The specific
terms of the depositary
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arrangement with respect to a series of debt securities will be described in the prospectus
supplement relating to such series.
No Protection in the Event of Change of Control
Any indenture that governs our debt securities covered by this prospectus may not have any
covenant or other provision providing for a put or increased interest or otherwise that would
afford holders of our debt securities additional protection in the event of a recapitalization
transaction, a change of control of the Company, or a highly leveraged transaction. If we offer any
covenants or provisions of this type with respect to any debt securities covered by this
prospectus, we will describe them in the applicable prospectus supplement.
Covenants
Unless otherwise indicated in this prospectus or the applicable prospectus supplement, our
debt securities may not have the benefit of any covenant that limits or restricts our business or
operations, the pledging of our assets or the incurrence by us of indebtedness. We will describe in
the applicable prospectus supplement any material covenants in respect of a series of debt
securities.
Consolidation, Merger and Sale of Assets
We may agree in any indenture that governs the debt securities of any series covered by this
prospectus that we will not consolidate with or merge into any other person or convey, transfer,
sell or lease our properties and assets substantially as an entirety to any person, unless such
person and such proposed transaction meets various criteria, which we will describe in detail in
the applicable prospectus supplement.
Defaults and Notice
The debt securities of any series will contain events of default to be specified in the
applicable prospectus supplement, which may include, without limitation:
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failure to pay the principal of, or premium or make-whole amount, if any, on any
debt security of such series when due and payable (whether at maturity, by call for
redemption, through any mandatory sinking fund, by redemption at the option of the
holder, by declaration or acceleration or otherwise); |
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failure to make a payment of any interest on any debt security of such series when
due; |
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our failure to perform or observe any other covenants or agreements in the indenture
with respect to the debt securities of such series; |
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certain events relating to our bankruptcy, insolvency or reorganization; and |
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certain cross defaults, if and as applicable. |
If an event of default with respect to debt securities of any series shall occur and be
continuing, we may agree that the trustee or the holders of at least 25% in aggregate principal
amount of the then outstanding debt securities of such series may declare the principal amount (or,
if the debt securities of such series are issued at an original issue discount, such portion of the
principal amount as may be specified in the terms of the debt securities of such series) of all
debt securities of such series or such other amount or amounts as the debt securities or
supplemental indenture with respect to such series may provide, to be due and payable immediately.
Any provisions pertaining to events of default and any remedies associated therewith will be
described in the applicable prospectus supplement.
Any indenture that governs our debt securities covered by this prospectus may require that the
trustee under such indenture shall, within 90 days after the occurrence of a default, give to
holders of debt securities of any series notice of all uncured defaults with respect to such series
known to it. However, in the case of a default that results from the failure to make any payment of
the principal of, premium or make-whole amount, if any, or interest on the debt securities of any
series, or in the payment of any mandatory sinking fund installment with respect to debt securities
of such series, if any, the trustee may withhold such notice if it in good faith determines that
the withholding of such notice is in the interest of the holders of debt securities of such series.
Any terms and provisions relating to the foregoing types of provisions will be described in
further detail in the applicable prospectus supplement.
Any indenture that governs our debt securities covered by this prospectus will contain a
provision entitling the trustee to be indemnified by holders of debt securities before proceeding
to exercise any trust or power under the indenture at the request of such holders. Any such
indenture may provide that the holders of at least a majority in aggregate principal amount of the
then outstanding debt securities of any series may direct the time, method and place of conducting
any proceedings for any remedy available to the trustee, or of exercising any trust or power
conferred upon the trustee with respect to the debt securities of such series. However, the
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trustee under any such indenture may decline to follow any such direction if, among other
reasons, the trustee determines in good faith that the actions or proceedings as directed may not
lawfully be taken, would involve the trustee in personal liability or would be unduly prejudicial
to the holders of the debt securities of such series not joining in such direction.
Any indenture that governs our debt securities covered by this prospectus may endow the
holders of such debt securities to institute a proceeding with respect to such indenture, subject
to certain conditions, which will be specified in the applicable prospectus supplement and which
may include, that the holders of at least a majority in aggregate principal amount of the debt
securities of such series then outstanding make a written request upon the trustee to exercise its
power under the indenture, indemnify the trustee and afford the trustee reasonable opportunity to
act. Even so, such holders may have an absolute right to receipt of the principal of, premium or
make-whole amount, if any, and interest when due, to require conversion or exchange of debt
securities if such indenture provides for convertibility or exchangeability at the option of the
holder and to institute suit for the enforcement of such rights. Any terms and provisions relating
to the foregoing types of provisions will be described in further detail in the applicable
prospectus supplement.
Modification of the Indenture
We and the trustee may modify any indenture that governs our debt securities of any series
covered by this prospectus with or without the consent of the holders of such debt securities,
under certain circumstances to be described in a prospectus supplement.
Defeasance; Satisfaction and Discharge
The prospectus supplement will outline the conditions under which we may elect to have certain
of our obligations under the indenture discharged and under which the indenture obligations will be
deemed to be satisfied.
Regarding the Trustee
We will identify the trustee and any relationship that we may have with such trustee, with
respect to any series of debt securities, in the prospectus supplement relating to the applicable
debt securities. You should note that if the trustee becomes a creditor of Amicus, the indenture
and the Trust Indenture Act of 1939 limit the rights of the trustee to obtain payment of claims in
certain cases, or to realize on certain property received in respect of any such claim, as security
or otherwise. The trustee and its affiliates may engage in, and will be permitted to continue to
engage in, other transactions with us and our affiliates. If, however, the trustee acquires any
conflicting interest within the meaning of the Trust Indenture Act of 1939, it must eliminate
such conflict or resign.
Governing Law
The law governing the indenture and the debt securities will be identified in the prospectus
supplement relating to the applicable indenture and debt securities.
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WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information with the
SEC. You may read and copy information filed by us with the SEC at the SECs public reference
section, 100 F Street, N.E., Washington, D.C. 20549. Information regarding the operation of the
public reference section can be obtained by calling 1-800-SEC-0330. The SEC also maintains an
Internet site at http://www.sec.gov that contains reports, statements and other information about
issuers, such as us, who file electronically with the SEC. We maintain an Internet site at
http://www.amicustherapeutics.com. However, the information on our Internet site is not
incorporated by reference in this prospectus and any prospectus supplement and you should not
consider it a part of this prospectus or any accompanying prospectus supplement.
The SEC allows us to incorporate by reference into this prospectus the information in other
documents that we file with it. This means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is considered to be a
part of this prospectus, and information in documents that we file later with the SEC will
automatically update and supersede information contained in documents filed earlier with the SEC or
contained in this prospectus. We incorporate by reference in this prospectus the documents listed
below and any future filings that we may make with the SEC under Sections 13(a), 13(c), 14, or
15(d) of the Securities Exchange Act of 1934, as amended, prior to the termination of the offering
under this prospectus; provided, however, that we are not incorporating, in each case, any
documents or information deemed to have been furnished and not filed in accordance with SEC rules:
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Our Annual Report on Form 10-K for the year ended December 31, 2008 (File
No. 001-33497) and our Quarterly Report for the period ended March 31, 2009 (File No. 001-33497); |
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Our Current Reports on Form 8-K filed on January 8, 2009, February 18, 2009 and
February 27, 2009 (excluding any information furnished in such reports under exhibit 99.1
thereto); and |
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The description of our common stock contained in our registration statement on Form
8-A (File No. 001-33497) filed May 23, 2007, under the Exchange Act, including any
amendment or report filed for the purpose of updating such description. |
You may obtain a copy of any or all of the documents referred to above which may have been or
may be incorporated by reference into this prospectus, except for exhibits to those documents
(unless the exhibits are specifically incorporated by reference into those documents) at no cost to
you by writing or telephoning us at the following address: Office of the Corporate Secretary,
Amicus Therapeutics, Inc., 6 Cedar Brook Drive, Cranbury, NJ 08512, telephone (609)-662-2000.
LEGAL MATTERS
The validity of the issuance of the securities offered hereby will be passed upon for us by
Bingham McCutchen LLP, Boston, Massachusetts. As appropriate, legal counsel representing the
selling stockholders, underwriters, dealers or agents will be named in the accompanying prospectus
supplement and may opine to certain legal matters.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2008, as set forth in their report, which is incorporated by reference in the prospectus and
elsewhere in this registration statement. Our consolidated financial statements are incorporated by
reference in reliance on Ernst & Young LLPs report, given on their authority as experts in
accounting and auditing.
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