Correspondence
Meerie M.
Joung, Esq.
Direct Dial: (617) 951-8840
E-Mail: meerie.joung@bingham.com
March 30, 2009
VIA EDGAR AND FEDERAL EXPRESS
Jeffrey R. Riedler
Assistant Director
U.S. Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549-0404
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Re:
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Amicus Therapeutics, Inc. |
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Form 10-K |
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Filed February 8, 2008 |
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File No. 001-33497 |
Dear Mr. Riedler:
On behalf of our client, Amicus Therapeutics, Inc., a Delaware corporation (the Company or
Amicus), in connection with the Companys Annual Report on Form 10-K for the fiscal year ended
December 31, 2007 (the Form 10-K), set forth below are the responses of the Company to the
comments of the staff (the Staff) of the Securities and Exchange Commission (the Commission)
that were contained in your letter dated March 23, 2009 (the Comment Letter). For ease of
reference, each comment contained in the Comment Letter is printed below in bold and is followed by
the Companys response.
Comment
Compensation Discussion and Analysis
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We note your response to our comment requesting a comprehensive analysis supporting
your conclusion that disclosure of your corporate and individual goals would likely cause
you to suffer competitive harm. Please note that your analysis is not sufficiently
detailed for us to consider whether confidential treatment is appropriate. Please provide
a more detailed analysis. Your analysis should more clearly describe each goal and how
such information is likely to cause competitive harm, as opposed to conclusory statements
that the information is a trade secret. Please note, you may request confidential
treatment for information provided in your response letter pursuant to Rule 83. For
example, you have previously stated that individual objectives are based on a variety of
factors including company growth, leadership, clinical and regulatory process, development
and integration of departments, establishment of presences in the biopharmaceutical
community, and scientific advancement. |
U.S. Securities and Exchange Commission
Page 2 of 9
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How have these goals been defined? To what extent have they been quantified? |
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Was a specific objective set relating to company growth? If a specific target or
goal was set, please describe it. The description should be quantified to the extent
that the communicated goal was quantified. |
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What were the specific goals relating to clinical and regulatory progress? To the
extent that you believe the disclosure of these goals would cause competitive harm,
please describe the specific harm disclosure may cause. Please note that if you have
previously discussed your expectations relating to achievement of any of these
milestones in other contexts, confidential treatment may not be appropriate. |
Response: In response to the Staffs comment, the Company understands the Staffs request for
additional detail in support of the Companys position that disclosure of specific company and
individual goals and objectives should be properly excluded from the Form 10-K in accordance with
the exemption provided in Instruction 4 to Item 402(b) of Regulation S-K (Instruction 4). The
Company provides such additional detail below and simultaneously herewith is submitting a request
for confidential treatment of the specific portions of the descriptions of the company goals and
objectives which, if publicly disclosed, would cause competitive harm (the Confidential
Information). Pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, the Confidential
Information has been omitted from this letter being filed with the Commission via Edgar. A copy
of this letter indicating the Confidential Information has been filed separately with the
Commission pursuant to this request for confidential treatment.
Where portions of specific goals and objectives provide general information about the
Companys current overall direction, business and operations, then the Company has attempted to
isolate such portions and intends on a going forward basis to disclose such general information in
a manner which allows a reader to understand in detail how the Company determines appropriate
compensation for its named executive officers. However, if specific goals and objectives reveal
confidential clinical and regulatory pathway information, scientific discoveries or research
developments, therapeutic product strategies and other similar information which if disclosed
would provide the Companys competitors with information which the Company ordinarily takes
reasonable business measures to protect, then such specific goals and objectives should not and
would not be disclosed.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS
BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
U.S. Securities and Exchange Commission
Page 3 of 9
The issue of disclosure in this context presents an acute challenge for the Company. With
respect to corporate goals and objectives, this is true mostly
because the Company is, by definition, a clinical and research and development stage company.
Accordingly, with no marketed products, the organizational goals and objectives are focused
primarily on clinical and regulatory matters, scientific research and discovery information, and
other confidential drug development strategies. With respect to personal goals and objectives, as
previously explained to the Staff and as the Company has disclosed (and will continue to
disclose), the Companys chief executive officer (CEO), with input from the management team and
from any other source deemed appropriate, oversees the establishment of specific goals and
objectives for each named executive officer at the beginning of each year. The Compensation
Committee has no involvement in that individual goal-setting process. Because of the dynamic
nature of the business, the goals and objectives are fluid throughout the year and often are
adjusted depending upon data received, clinical trial information, scientific developments,
financial conditions and the like. The Company believes that it has disclosed the relevant
information related to individual executive performance that is considered by the Compensation
Committee in making its determinations on executive compensation, but is providing yet further
detailed information here to the extent possible.
As requested and as discussed, our response below includes: (1) a description of the specific
Company goals for 2007 and an analysis of the competitive harm that would result from the
disclosure of portions of such goals, and (2) further information on specific individual goals and
objectives for 2007 in response to the Staffs request for more detail relevant to how the
Compensation Committee sets executive compensation for the named executive officers.
Companys 2007 Corporate Goals
The Companys Corporate Goals for 2007 included the following six items:
1. [***.]
2. [***.]
3. [***.]
4. Complete Stage 1 proof of concept studies in Parkinsons by third quarter.
5. [***.]
6. Establish corporate partnership that helps build significant value by second quarter.
The first three goals stated above relate to the timing of the Companys efforts to advance
the clinical development of the Companys lead programs [***]. These goals reflect an overall
strategy for the development of the Companys products and reveal the assumptions on what actions
will be needed to carry out that strategy. Disclosure of these goals would allow the Companys
competitors to draw meaningful conclusions about factors determining the likelihood of the Company
reaching certain clinical development and regulatory milestones and allow them to extrapolate the
Companys clinical and regulatory strategy. Understanding these elements would therefore allow
the Companys competitors to prepare counter strategies that could adversely affect the Company. For example, by knowing when and with what
types of studies the Company intends to approach regulatory authorities, competitors will be able
to prepare against competition from the Company in a more effective way by, for example,
initiating similar studies, preparing commercial counter-strategies, and developing medical
messaging around the Companys programs.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
U.S. Securities and Exchange Commission
Page 4 of 9
Additionally, in order to understand why the Company adjusted particular goals or did not
meet other goals, the Company may have to disclose in certain instances how it specifically
changed its development strategy. For example, in order to understand why the Company did not
meet its enrollment goal in one study, might require an explanation of how the Company changed its
strategic approach in a way that would require further disclosure of sensitive information. In
the Companys particular competitive context, where the Company is developing medicines for rare
diseases that affect only tens of thousands of patients and its major competitor has significantly
greater resources to compete in the market, disclosure of such information would harm the
Companys ability to compete.
With respect to the fifth goal, the Company has not publicly disclosed that it was conducting
research in the application of pharmacological chaperones to [***]. The particular targets that
the Company is pursuing in its early stage research are proprietary and confidential. Should
competitors learn that we are researching the application of pharmacological chaperones to
particular disease areas and, more specifically, certain targets within a disease area, they would
be able to focus their own research efforts in the same areas. This could result in the Company
losing opportunities for developing new applications for its technology and opportunities for
intellectual property protection for its research, which is one of the core aspects of the
Companys business model.
The Company does not request confidential treatment for the fourth and sixth goals and would
include those goals in its disclosure. In future filings with the Commission, the Company will
include and exclude similar disclosure when discussing corporate goals and objectives.
Individual Goals and Objectives
The Company believes that it has disclosed the relevant information related to individual
executive performance that is considered by the Compensation Committee in making its
determinations on executive compensation. As the Company has noted in its disclosure, the
Compensation Committee does not set the individual objectives of the named executive officers, and
does not review the performance of those officers against their objectives in making compensation
determinations. Rather, the Companys CEO, as part of his management responsibility, is
responsible for ensuring that objectives for each named executive officer are set and for reviewing the executives performance against those objectives. The
Compensation Committee largely bases its compensation determinations for a named executive officer
on the assessment by the CEO of that individuals key accomplishments in support of the Companys
goals. Therefore, disclosure of the specific individual goals and objectives of each named
executive officer is not relevant to an investors understanding of how the Compensation Committee
makes its compensation determinations because those goals are not reviewed by the Committee in
determining compensation.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
U.S. Securities and Exchange Commission
Page 5 of 9
In further response to the Staffs comment, the Company proposes revised disclosure for the
Form 10-K as set forth below. This proposed disclosure includes further clarification of how
individual objectives established at the beginning of the year are utilized by our chief executive
officer in making his recommendation to the Compensation Committee as to the appropriate
individual multiplier for each named executive officer, other than the chief executive officer
himself. The disclosure with respect to the individual multiplier would have been expanded on
page 19 of the Companys proxy statement filed on April 25, 2008 as detailed below, with the
additional proposed revised disclosure underlined in the text below. Yet further
additional language added in response to the Staffs most recent comments is further highlighted
in bold and italics.
In future filings with the Commission, the Company will include similar disclosure when
discussing individual objectives and the individual multiplier.
The Individual Multiplier
In addition, the plan provides for an individual multiplier that is determined based upon the
individual performance year end rating. The multiplier may typically range from 0%-120+%.
Individual multipliers for 2007 for named executive officers ranged from 100% to 120%. The
individual multiplier for each executive is determined after considering several factors including
achievement of individual objectives, departmental or organizational performance, and other
significant accomplishments.
Individual objectives are necessarily tied to the particular area of expertise of the
executive and are designed to support the Companys achievement of its corporate goals.
Individual objectives are based on a variety of factors, including the following categories:
company growth; leadership; clinical and regulatory progress; development and integration of
departments; establishment of presence in the biopharmaceutical community; and scientific
advancement. These objectives are set with the belief that full achievement will be difficult and
challenging, but attainable, so long as the officer is fully committed to their accomplishment
through significant effort and dedication to the Companys strategies, and an ability to quickly
adapt to a constantly evolving business environment. Achievement of these objectives is measured
relative to external forces, internal resources utilized and overall individual effort. Although the individual objectives serve as a meaningful
means of supporting the Companys goals and evaluating individual performance, their achievement
is not necessarily tied to the determination of each named executive officers individual
multiplier.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
U.S. Securities and Exchange Commission
Page 6 of 9
Our chief executive officers individual performance is measured by the Companys ability
to meet its corporate goals and is reviewed and approved by our Chairman of the Board and the
Compensation Committee. Individual performance objectives of our other named officers are
determined by the executive officer to whom each named executive officer reports, but are
neither reviewed or approved by the Compensation Committee. Rather, these objectives serve as a
measuring tool for our chief executive officer in formulating his recommendation to the
Compensation Committee as to the appropriate individual multiplier for each named executive
officer. During the annual review process, the Companys chief executive officer discusses with
the Compensation Committee his overall evaluation for each executive which includes each
executives performance and accomplishments as they relate to the Companys corporate goals,
departmental performance, and other significant accomplishments. However, this discussion does
not include a presentation to the Compensation Committee as to how each named executive officer
performed relative to his individual objectives. While the Compensation Committee relies heavily
on the chief executive officers evaluation of the other named execution officers, it also
considers the degree of difficulty in attaining the Companys goals and the executives
accomplishments. In considering the degree of difficulty, the Compensation Committee considers
factors such as the influence of external events, including unanticipated clinical events and
regulatory timelines, and the effort expanded by executives. The Compensation Committee reviews
and discusses their evaluation of the Companys chief executive officers performance and
accomplishments in executive session along with the Chairman of the Board and without the presence
of the chief executive officer.
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL
HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT
TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
U.S. Securities and Exchange Commission
Page 7 of 9
* * * *
Should you wish to discuss the contents of this letter at any time, please do not hesitate to
contact Meerie M. Joung at (617) 951-8840 of Bingham McCutchen LLP.
Very truly yours,
/s/
Meerie M. Joung
Meerie M. Joung, Esq.
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cc:
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Mike Rosenthall, U.S. Securities and Exchange Commission |
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John F. Crowley, Amicus Therapeutics, Inc. |
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Geoffrey Gilmore, Amicus Therapeutics, Inc. |
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Julio E. Vega, Esq., Bingham McCutchen LLP |
[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL
HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
AMICUS THERAPEUTICS, INC.
6 Cedar Brook Drive
Cranbury, NJ 08512
March 30, 2009
Jeffrey R. Riedler
Assistant Director
U.S. Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549-0404
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Re:
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Amicus Therapeutics, Inc. |
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Form 10-K |
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Filed February 8, 2008 |
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File No. 001-33497 |
Dear Mr. Riedler:
In connection with the response letter dated March 13, 2009 submitted on our behalf, Amicus
Therapeutics, Inc., a Delaware corporation (the Company), in response to the comments of
the staff of the U.S. Securities and Exchange Commission (the Commission) that were
contained in your letter March 23, 2009, the Company hereby acknowledges that:
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The Company is responsible for the adequacy and accuracy of the disclosure in the filing; |
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Staff comments or changes to disclosure in response to staff comments do not foreclose the
Commission from taking any action with respect to the filing; and |
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The Company may not assert staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States. |
Should you wish to discuss the foregoing at any time, please do not hesitate to contact Julio
E. Vega at (617) 951-8901 of Bingham McCutchen LLP or the undersigned, the Chief Executive Officer
of the Company, at (609) 662-2000.
Very truly yours,
/s/ John F. Crowley
John F. Crowley
Chief Executive Officer
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cc:
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Mike Rosenthall, U.S. Securities and Exchange Commission |
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James E. Dentzer, Amicus Therapeutics, Inc. |
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Geoffrey Gilmore, Amicus Therapeutics, Inc. |
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Julio E. Vega, Esq., Bingham McCutchen LLP |
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Meerie M. Joung, Esq., Bingham McCutchen LLP |