Correspondence
Julio E. Vega, Esq.
Direct Dial: (617) 951-8901
E-Mail: julio.vega@bingham.com
March 13, 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.
Form 10-K
Filed February 8, 2008
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 February 11, 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 responses to comments 1 and 2 and your statement that disclosure of
company and individual goals and objectives would result in competitive harm to your
company. Please present a comprehensive analysis supporting your conclusion that the
disclosure of this information would cause competitive harm. Additionally, when
information regarding targets and goals is not provided on the basis that disclosure would
cause competitive harm, you must discuss how difficult it will be for the executive or
how likely it will be for your company to achieve the undisclosed targets or goals.
Please see Instruction 4 to Item 402(b) of Regulation S-K. Alternatively, provide a more
specific discussion of the strategic, operational and individual goals and which goals
were attained and which were not attained. Regardless of which alternative presentation
is included
in the discussion, your discussion should help readers to understand how the Compensation
Committee determined that 100% of the Corporate multiplier was appropriate and how the
Committee determined each executives individual multiplier. |
U.S. Securities and Exchange Commission
Page 2 of 9
Response: In response to the Staffs comment on disclosure of specific company and individual
goals and objectives, the Company respectfully advises the Staff that such disclosure would
result in competitive harm to the Company. The Company believes that such information 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).
Set forth below is a comprehensive analysis supporting the Companys conclusion that disclosure of
the company and individual goals would cause competitive harm to the Company. The Company is also
providing proposed revisions to its prior disclosure to include a discussion of the degree of
difficulty in performing the company and individual goals and objectives. As previously submitted
and included in the Companys Proxy Statement filed with the Commission on April 25, 2008, the
Companys disclosure also includes a discussion of how the Companys Compensation Committee
determined that a Corporate multiplier of 100% and each executive individual multiplier were
appropriate. In instances where the Company does not disclose its specific company and individual
goals and objectives, the Company intends to provide similar disclosure in future periodic filings
with the Commission which require disclosure about executive compensation pursuant to Item 402 of
Regulation S-K.
Comprehensive Analysis of Competitive Harm
The confidential, internal goals and objectives set by the Company reflect proprietary
commercial and scientific information of the Company which has not been disclosed to the public
and is not known to our competitors. These goals as they relate to clinical development
strategies and timelines, clinical trial recruitment, specific areas of research focus and
regulatory strategy are highly confidential. Instruction 4 provides that registrants are not
required to disclose target levels with respect to specific quantitative or qualitative
performance-related factors if the disclosure would result in competitive harm to the registrant.
The standard used to determine competitive harm is the same standard that applies in confidential
treatment requests with respect to trade secrets or confidential commercial or financial
information, pursuant to Exchange Act Rule 24b-2 (17 C.F.R. § 240.24b-2) (Rule 24b-2). Pursuant
to Rule 24b-2, the registrant must provide a statement of the grounds for objection referring to,
and containing an
analysis of, the applicable exemption from disclosure under the Commission rules and regulations
adopted under the Freedom of Information Act, 5 U.S.C. § 552 (FOIA).
U.S. Securities and Exchange Commission
Page 3 of 9
The Company believes that disclosure of its company and individual goals and objectives is not
required based on the exemption from disclosure set forth in 17 C.F.R. § 200.80(b)(4) (a
subsection of the Commissions rule adopted under FOIA) (Exemption Four). Exemption Four
exempts from disclosure trade secrets and commercial or financial information obtained from a
person and privileged and confidential, contained in material filed with the Commission. To
satisfy Exemption Four, the relevant information must meet the following test: (1) the information
for which an exemption is sought must be a trade secret or such information must be commercial or
financial in character; (2) such information must be obtained from a person, which includes a
corporation; and (3) such information must be privileged or confidential.
The Company believes that its company and individual goals and objectives meet this standard and,
therefore, should be exempt from disclosure. The Company satisfies the second requirement because
it is a corporation submitting information to the Commission. As discussed in detail below, the
other requirements of this test are also satisfied because Amicus company and individual goals
and objectives constitute commercial or financial information that is privileged and
confidential within the meaning of Exemption Four.
Trade Secrets, Commercial and Financial Information
The term trade secrets has been broadly interpreted to encompass commercial and financial
information. Public Citizen Health Group v. Food and Drug Admin., 704 F.2d 1280, 1283 (D.C. Cir.
1983). The courts have construed commercial and financial information in accordance with its
plain meaning to broadly include information relating to pricing and technical designs, records
that reveal basic commercial operations, such as business sales statistics, profits and losses,
and inventories, and information relating to the income-producing aspects of a business. Id.;
Landfair v. United States Dept. of the Army, 645 F. Supp. 325, 327 (D.D.C. 1986).
The Companys internal company and individual goals and objectives relate to the core of the
Companys business, and reflect confidential clinical development, research and commercial
efforts, including clinical development strategies and timelines, clinical trial subject
enrollment, specific areas of research focus and regulatory strategy. The company and individual
goals and objectives reflect the Companys proprietary approach to conducting its business,
product and strategic development, research, and commercial efforts. Therefore, based on these
facts, the Companys internal goals and objectives clearly fall within the plain meaning of
commercial and financial information.
U.S. Securities and Exchange Commission
Page 4 of 9
Privileged and Confidential
Additionally, commercial or financial information is considered confidential if disclosure ... is
likely to ... cause substantial harm to the competitive position of the person from whom the
information was obtained. National Parks and Conservation Assn v. Morton, 498 F.2d 756, 770
(D.C. Cir. 1974). For purposes of Exemption Four, the Company must present specific evidence
revealing (1) actual competition and (2) a likelihood of substantial competitive injury to be
exempt from disclosure. Frazee v. U.S. Forest Service, 97 F.3d 367, 371 (9th Cir. 1996). In
considering the likelihood of substantial competitive harm, the decision maker shall exercise its
judgment in view of the nature of the material sought and the competitive circumstances of the
industry and shall also consider whether the information is typically disclosed to the public.
National Parks and Conservation Assn v. Kleppe, 547 F.2d 673, 683 (D.C. Cir. 1976); Morton, 498
F.2d at 770. Thus, exemption is appropriate depending on the competitive significance of
whatever information may be contained in the documents and, in making this determination, the
decision maker shall assess whether any non-public information contained in those documents is
completely sensitive. Occidental Petroleum Corporation v. Securities and Exchange Commission, 873
F.2d 325, 341 (D.C. Cir. 1989).
Amicus operates in an intensely competitive industry and, therefore, it is substantially likely
that, if disclosed, the Companys goals, objectives and strategies will be exploited and
manipulated by Amicus competitors to their advantage, which would result in competitive injury to
the Company.
Amicus is 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. The Company
participates in an industry that is characterized by rapidly advancing technologies and intense
competition, and which places a strong emphasis on proprietary products. The Companys potential
competitors include commercial pharmaceutical and biotechnology enterprises, academic
institutions, government agencies and private and public research institutions, among others.
Many of these competitors have significantly greater financial resources and expertise associated
with research and development, regulatory approvals and the marketing of approved products.
Additionally, the Company faces intense competition in recruiting and in retaining qualified
scientific and management personnel, enrolling subjects for clinical trials in rare diseases, as
well as acquiring technology complementary to, or necessary for, its programs. The Company is
developing medicines for rare diseases that affect only tens of thousands of patients worldwide.
If competitors gain knowledge with respect to the Companys goals and objectives, in terms of
research, clinical development and recruiting, the impact on the Company will be substantial.
Therefore, because of the unique nature of the Companys markets and the range and size of its
competitors, disclosure of proprietary, confidential goals and objectives would result in
significant competitive harm to Amicus.
U.S. Securities and Exchange Commission
Page 5 of 9
Disclosure of the company and individual goals and objectives related to clinical development,
research and commercial efforts would allow Amicus competitors to draw meaningful conclusions
about factors determining (i) the likelihood of the Company reaching certain clinical development
and regulatory milestones, (ii) clinical trial strategies, and (iii) areas of new scientific
research. In such a small and rapidly advancing industry, knowledge of such confidential
information would allow competitors to understand how aggressively the Company is pursuing
development of its products, clinical trial enrollment, research into new areas, and regulatory
filings, and would allow its competitors to strategize in a manner harmful to the Company.
Perhaps most importantly, disclosure of its goals and objectives would significantly impair the
Companys own efforts to achieve these goals and objectives.
In conclusion, disclosure of the company and individual goals and objectives in the Form 10-K
would cause substantial economic harm to the Companys competitive position. The Company believes
that such competitive harm satisfies the standard of Exemption Four and, as a result, the Company
is eligible to use the exemption from disclosure as provided by Instruction 4. Moreover,
disclosure of specific goals and objectives is not necessary to protect stockholders. Investors
have been provided with information regarding annual cash incentive awards, the range of the
potential size of the awards and the factors that are considered in determining the awards, and
the Compensation Committees rationale for determining the awards, and with proposed revised
disclosure below, information regarding how difficult it was for the executive and the Company to
achieve the goals. The Company believes that this, along with a summary of goals, objectives and
accomplishments, provides investors with all the material information needed to assess the
Companys determination of executive compensation.
Likelihood of Achieving Targets or Goals
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 a discussion of the degree of
difficulty or likelihood of the executive officers and Company achieving the goals and objectives
in 2007. This revised disclosure also includes a discussion of how the Compensation Committee
determined that the corporate and individual multipliers were appropriate. The disclosure with
respect to the 2007 Bonus structure would have been expanded on page 19 of the Companys proxy
statement filed on April 25, 2008 as detailed below, with the additional revised disclosure
underlined in the text below; additional language added in response to the Staffs comments
received February 11, 2009 is further highlighted in bold and italics.
In future filings with the Commission, the Company will include similar disclosure in instances
when specific goals and objectives are not disclosed.
U.S. Securities and Exchange Commission
Page 6 of 9
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.
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. 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.
The Compensation Committee 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.
The 2007 annual cash incentive target for Mr. Crowley, the Companys chief executive
officer, was 50% of his salary, or $200,000. The Compensation Committee recognized Mr. Crowleys
extensive contributions leading our successful initial public offering, directing our transition
to a public company,
driving and completing the license and strategic collaboration agreement with Shire
Pharmaceuticals Ireland Ltd. to jointly develop the Companys three lead pharmacological chaperone
compounds for lysosomal storage disorders, and managing executive talent acquisition in clinical
and regulatory functions. In recognition of his 2007 achievements, the Compensation Committee
determined that Mr. Crowley exceeded performance expectations and used its discretion to set his
individual multiplier at 110%. Mr. Crowleys annual cash incentive payout was $220,000.
U.S. Securities and Exchange Commission
Page 7 of 9
Mr. Haydens 2007 annual cash incentive target was 50% of his salary, or $17,308. The
Compensation Committee recognized Mr. Hayden for effectively serving as interim chief executive
officer during Mr. Crowleys absence and for driving enhancements in the Companys administrative
infrastructure. Overall, the Compensation Committee determined that Mr. Hayden exceeded
performance expectations of an interim chief executive officer and used its discretion to set his
individual multiplier at 110%. Mr. Haydens annual cash incentive payout was $19,000.
Mr. Dentzers 2007 annual cash incentive target was 30% of his salary, or $84,840. The
Compensation Committee recognized Mr. Dentzer for driving and completing our initial public
offering, building the foundation of the companys investor relations function, and enhancing
finance and control capabilities, including his role in the recruitment of key finance personnel.
In recognition of his 2007 achievements, the Compensation Committee determined that Mr. Dentzer
exceeded performance expectations and used its discretion to set his individual multiplier at
110%. Mr. Dentzers annual cash incentive payout was $93,324.
Mr. Pattersons 2007 annual cash incentive target was 30% of his salary, or $94,050. The
Compensation Committee noted Mr. Pattersons efforts in the areas of talent acquisition in
clinical and regulatory functions, advancement of clinical development of our lead programs, and
expansion of the Companys presence in the physician and patient biopharmaceutical communities.
In considering Mr. Pattersons performance and individual multiplier, the Compensation Committee
also recognized Mr. Pattersons significant efforts and contributions in support of the Companys
successful initial public offering. Overall, the Compensation Committee determined that Mr.
Patterson exceeded performance expectations and used its discretion to set his individual
multiplier at 105%. Mr. Pattersons annual cash incentive payout was $98,753.
Dr. Lockharts 2007 annual cash incentive target was 30% of his salary, or $89,040. The
Compensation Committee noted Dr. Lockharts efforts leading to the enhancement of the Companys
scientific organization and improved collaboration of science and clinical operations. In
considering Dr. Lockharts performance and individual multiplier, the Compensation Committee also
recognized Dr. Lockharts key scientific contributions to the Companys successful initial public
offering as well as his leadership of the Companys scientific diligence effort related to the
strategic collaboration with Shire Pharmaceuticals Ireland Ltd. Overall, the
Compensation Committee determined that Dr. Lockhart significantly exceeded performance
expectations and used its discretion to set his individual multiplier at 120%. Dr. Lockharts
annual cash incentive payout was $106,848.
Dr. Licholais 2007 annual cash incentive target was 25% of his salary, or $58,415. The
Compensation Committee recognized Dr. Licholais leadership efforts expanding the Companys
presence in the physician and patient biopharmaceutical communities, identifying new clinical
trial sites, and establishing and managing key medical relationships, including management of all
medical communications. Overall, the Compensation Committee determined that Dr. Licholai exceeded
performance expectations and used its discretion to set his individual multiplier at 110%. Dr.
Licholais annual cash incentive payout was $64,257.
U.S. Securities and Exchange Commission
Page 8 of 9
The Compensation Committee applies a corporate multiplier based upon a determination of how
the Company performed against the previously agreed corporate goals and the other significant
corporate activities that occurred during the year. This corporate multiplier may range from 0% to
150%.
On an annual basis, the Board works with management to set Company goals and objectives
that reflect a high degree of difficulty and acceleration of execution of the Companys strategies
commensurate with our short and long-term business plan. The Companys internal goals and
objectives reflect complex assumptions based on internal analyses and projections, and are
intended to encourage the Company to pursue its business plan in an expedited, aggressive manner.
Once the Companys goals and objectives have been developed, they are reviewed and approved by the
Compensation Committee and finally approved by the full Board.
At the time the goals and objectives are set, the Compensation Committee believes that
their full attainment will be extremely difficult and may not be reached, despite great effort,
due in part to internal and external factors, many of which may be out of the Companys control.
The objectives are set with the understanding that the Company is in its development stage and the
recognition that some objectives, especially those tied to timing of events, may need to be
altered as events throughout the course of the year shape the best path for the development of the
Companys products. However, while total achievement of all goals and objectives set at the
beginning of the year may not be expected, the Compensation Committee demands that management
significantly advance the Companys general business objectives throughout the year in order to
achieve a 100% corporate multiplier. For 2007, our corporate objectives are summarized as follows:
(1) advance the clinical development of our three lead pharmacological chaperone compounds for
lysosomal storage disorders, (2) advance the development of pre-clinical program targets in
certain other diseases, and (3) establish a corporate partnership.
In reaching its recommendation on the corporate multiplier, the Compensation Committee
reviewed the Companys performance relating to the goals and objectives as a whole.
This review included recognition of accomplishments by the Company that were not necessarily
anticipated at the beginning of the year. Additionally, the Compensation Committee does not apply
a weighting to the Companys goals and objectives.
U.S. Securities and Exchange Commission
Page 9 of 9
In the 2007 plan year, the Company achieved some of its 2007 corporate goals and made
significant progress towards the achievement of others; however, not all targets were completely
met. Objectives that were not fully met in 2007 included delays in (i) completing regulatory
meetings for one program, (ii) patient enrollment in clinical trials for one program, and (iii)
filing clinical protocols with regulatory authorities. However, the Compensation Committee
determined that the Companys successful completion of the initial public offering and the
execution of the License and Collaboration Agreement with Shire Pharmaceuticals Ireland, Ltd., the
combination of which significantly reduced financial risk to investors, along with substantial
clinical progress in three programs and continued overall scientific progress, more than offset
areas in which goals were not met completely. As such, the Compensation Committee
recommended a composite 100% corporate multiplier in recognition of the 2007 achievements.
This recommendation was approved by the full Board of Directors.
* * * *
Should you wish to discuss the contents of this letter at any time, please do not hesitate to
contact Julio E. Vega at (617) 951-8901 of Bingham McCutchen LLP.
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Very truly yours, |
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/s/ Julio E. Vega |
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Julio E. Vega, 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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Meerie M. Joung, Esq., Bingham McCutchen LLP |
AMICUS THERAPEUTICS, INC.
6 Cedar Brook Drive
Cranbury, NJ 08512
March 13, 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 dated February 11, 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.
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Very truly yours, |
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/s/ John F. Crowley |
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John F. Crowley |
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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 |