corresp
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Brian J. Lane |
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Direct: 202.887.3646 |
December 15, 2010
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Fax: 202.530.9589 |
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BLane@gibsondunn.com |
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VIA EDGAR
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Client: C 12412-00001 |
Ms. Rose Zukin
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
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Re:
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BioCryst Pharmaceuticals, Inc. |
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Form 10-K for the year ended December 31, 2009 |
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Filed March 9, 2010 |
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Definitive Proxy Statement on Schedule 14A |
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Filed April 6, 2010 |
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File No. 000-23186 |
Dear Ms. Zukin:
On behalf of BioCryst Pharmaceuticals, Inc. (the Company) this responds to your letter of
November 16, 2010 with respect to the above-referenced filings. For ease of reference, the
numbered paragraphs below correspond to the numbered comments in your letter, with your comments
presented in bold followed by the related response.
Schedule 14A
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Please refer to your responses to comments 4, 5, and 6 in your response letter. Please note
that when we ask you to revise your disclosure, we request that you amend your Form 10-K for
the Fiscal Year Ended December 31, 2009 to include the requested disclosure. Accordingly, we
will not be able to clear your filing of comments until you have filed an amended Form 10-K
with the requested disclosure. |
The Company will file an amendment to its Form 10-K for the Fiscal Year Ended December 31,
2009 (the Amendment) to include the requested disclosure.
Form 10-K for the year ended December 31, 2009
Compensation Discussion and Analysis
Annual Incentive Compensation, page 24
United States Securities and Exchange Commission
December 15, 2010
Page 2
2. |
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We note your responses to Comments 4 and 5 and reissue the comments in part. Please expand
the proposed disclosure to be included in an amendment to your Form 10-K for the fiscal year
ended December 31, 2009 to disclose: |
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Specific examples of corporate and individual objectives that would increase the
understanding of the corporate and individual objectives, respectively, as you propose
to do in the future; |
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The evaluation by the Compensation Committee of the level of achievement by the
company of corporate goals and by each named executive officer of the individual
performance objectives applicable to them. |
Please note that it is not sufficient to disclose only the amounts awarded under the AIP in 2009
and the achievement of corporate objectives, instead of describing the Compensation Committees
assessment of the level of achievement of each individual performance objective. To the extent
that you are concerned about the release of our correspondence, you may request confidential
treatment pursuant to Rule 83. In order to do this, please file on EDGAR your supplemental
response requesting confidential treatment under Rule 83, redacting the information you request to
remain confidential. Please note that only those words, numbers and phrases for which
confidentiality is necessary should be redacted. Further, an unredacted copy of your supplemental
response requesting Rule 83 treatment must be mailed directly to the Staff.
Please note that in order to keep your performance metrics confidential pursuant to Instruction 4
to Item 402(b) of Regulation S-K you must submit an analysis supporting your conclusion that you
are likely to suffer competitive harm if the information is disclosed. We are generally only
willing to grant confidential treatment for performance goals if you can demonstrate how the
disclosure of these goals will allow your competitors to discover information about break even
points, cost structures relating to specific products or similarly sensitive information. In these
instances, you must submit a detailed analysis, identifying the competitively harmful information
and demonstrating how the information could be harmful to your company.
For the reasons detailed in the response letter sent on behalf of the Company dated September
9, 2010, the Company believes that disclosure of the specific corporate and individual objectives
would result in substantial competitive harm to the Company and that they are therefore not
required to be disclosed. However, the Company proposes to disclose in the Amendment the following
additional detail about the corporate and individual objectives in order to increase the
understanding of the objectives without providing competitively sensitive information:
United States Securities and Exchange Commission
December 15, 2010
Page 3
The corporate objectives established for 2009 were primarily related to the continued
progression of both our clinical and non-clinical programs. The corporate objectives fell into
four primary categories: clinical development objectives, licensing and financing objectives, early
stage project objectives, and functional support objectives. Clinical development objectives were
collectively weighted at 85% of the 2009 corporate objectives (of which 65% related to peramivir
and 20% related to forodesine and BCX4208, collectively). These objectives consisted of specific,
detailed goals with respect to the advancement of the Companys clinical programs with respect to
peramivir, forodesine and BCX4208, and focused on study initiation, progress and completion,
related support activities, and, in the case of peramivir, responding to the emergency use
authorization that was issued during the year. Licensing and financing objectives were
collectively weighted at 30% of the 2009 corporate objectives and related to potential partnering,
licensing or other alliance relationships with respect to the Companys products, maintenance of
existing partnerships, and the completion of a financing transaction. Early stage project
objectives were collectively weighted at 5% of the 2009 corporate objectives and related to the
development of various specific early-stage product candidates toward an investigational new drug
application or licensure and a review and prioritized plan and gap analysis with respect to the
Companys early-stage projects. Functional support objectives were collectively weighted at 5% of
the 2009 corporate objectives and related to increasing the Companys infrastructure development
through a web-based compliance training program and an integrated internal communications program.
Under the weighting system described above, achievement of all of the corporate objectives would
have led to a corporate performance percentage of 125% of target.
Jon Stonehouse, the Companys Chief Executive Officer, is responsible for ensuring that the
corporate objectives are fully supported in order to progress the Company toward its achievement of
the corporate objectives, and his performance rating is that of the Company as a whole.
Accordingly, Mr. Stonehouse did not have his own individual objectives for 2009.
The individual objectives established for the other named executive officers for 2009 were
prepared in conjunction with the corporate objectives and were designed to promote the execution of
the corporate objectives. Achievement of all of the individual objectives would have led to an
individual performance percentage of 125% of target.
Stuart Grant, Chief Financial Officer, had objectives that consisted of managing the Companys
cash burn (weighted at 25%) and driving funding opportunities (weighted at 30%), integrating supply
chain activities (weighted at 30%), implementing an integrated external and internal communications
program (weighted at 10%), creating and maintaining an effective control environment (weighted at
10%), strengthening finance processes
United States Securities and Exchange Commission
December 15, 2010
Page 4
(weighted at 10%), and providing support from the finance organization to the Companys function
heads (weighted at 10%).
Dr. William Sheridan, the Companys Chief Medical Officer, had individual objectives that
consisted of goals related to the advancement of the Companys clinical programs with respect to
i.v. and i.m. peramivir (weighted at 35% and 20%, respectively), forodesine and BCX4208 (weighted
at 20%, collectively), and early stage pipeline candidates (weighted at 5%), supporting the
Companys partnering, corporate alliance and business development objectives (weighted at 35%) and
building the Companys clinical and regulatory capabilities (weighted at 10%).
David McCullough, VP of Strategy, Planning, Commercial and Business Development, had
objectives related to completing new licensing and other alliance relationships (weighted at 75%),
supporting the advancement of the Companys clinical programs with respect to peramivir (weighted
at 20%), maintaining existing partnerships (weighted at 15%), leading and completing the Companys
portfolio review process (weighted at 10%), and expanding his leadership role in the Company
(weighted at 5%).
Dr. Y.S. Babu, VP of Drug Discovery, had objectives related to advancing and supporting the
Companys clinical programs with respect to i.v. and i.m. peramivir (weighted at 30% and 25%,
respectively), forodesine and BCX4208 (weighted at 10%) and early stage pipeline candidates
(weighted at 30%), supporting the Companys partnering efforts (weighted at 25%) and expanding his
leadership role in the Company (weighted at 5%).
The Company proposes to disclose the following in the Amendment with respect to the evaluation
by the Compensation Committee of the level of achievement by the Company of the corporate
objectives and by the named executive officers of the individual performance objectives:
The Compensation Committee assessed the achievement of the corporate objectives for 2009 and
determined that the objectives were achieved at 93% of target. The Committee considered the
Companys performance under each of the four categories of corporate objectives and assessed a
rating for each category. The sum of the ratings constituted the corporate performance percentage.
In assessing performance under each category and assigning its performance rating, the Committee
considered the totality of the Companys performance with respect to the various objectives
contained within the category and used its discretion to assign the rating to the category.
Accordingly, specific performance objectives within each category were not weighted by the
Committee.
With respect to the clinical development objectives, the Committee rated the Companys
achievement at 65% out of 85% (55% out of 65% for peramivir and 10% out of 20% for forodesine and
BCX4208, collectively). With respect to peramivir, the Committee
United States Securities and Exchange Commission
December 15, 2010
Page 5
considered the Companys progress with respect to the clinical development of i.v. peramivir and
related support activities, and the receipt and delivery of the peramivir stockpiling order. The
Committee also considered the discontinuation of the i.m. peramivir program. With respect to
forodesine and BCX4208, the Committee considered the progress of the clinical development of those
products, and specifically the institution of a study of BCX4208 for the treatment of gout and the
fact that certain other studies were completed later than targeted, were not completed or were
cancelled. With respect to licensing and financing objectives, the Committee rated the Companys
achievement at 20% out of 30%. The Committee considered the Companys strengthening and
maintenance of its existing partnerships, the execution of partnerships for peramivir stockpiling
outside of the United States, and the completion of a successful equity financing. The Committee
also considered the fact that other partnering transactions were not completed. With respect to
early stage products, the Committee rated the Companys achievement at 3% out of 5%. The Committee
considered the rapid advancement of the development program with respect to certain products, the
filing of related patent applications, and the completion of a portfolio review with respect to
early stage products, leading to a prioritized plan and gap analysis. The Committee also
considered the postponement or delay of the development programs with respect to certain other
products. With respect to the functional support objectives, the Committee rated the Companys
achievement at 5% out of 5% because both the web-based compliance training program and the
integrated internal communications program were completed during the year.
For Mr. Stonehouse, as discussed above, the corporate objectives constituted 100% of his bonus
opportunity, and therefore he received an AIP payment of 93% of target, or $208,506.
With respect to each of the other named executive officers, the Committee assessed the
performance of the officer against his individual objectives. The Committee also evaluated the
executives performance against the Companys six core competencies: accountability for results,
business judgment, focus, teamwork, technical skills, and leadership. In determining the final
individual achievement percentage, the Committee considered the individuals performance against
his objectives; the significance of the objectives that were met or exceeded versus those that were
partially met or not met; in the case of exceptional performance, how substantially the objectives
were exceeded; and the results of its core competency assessment, and then used its discretion to
set an individual achievement percentage. The individual performance percentage was then
multiplied against the corporate performance percentage to result in the AIP payment as a
percentage of the individuals target.
With respect to Mr. Grant, the Committee determined that he substantially exceeded the
significant objectives of managing the Companys cash burn and integrating supply chain
United States Securities and Exchange Commission
December 15, 2010
Page 6
activities; met the objectives with respect to driving funding opportunities, implementing an
integrated external and internal communications program, creating and maintaining an effective
control environment, and strengthening finance processes; and partially met the objective of
providing support from the finance organization to the Companys function heads. Mr. Grant also
met or exceeded all of the Companys core competencies. In light of this evaluation, and in
consideration of the significance of the objectives that Mr. Grant exceeded and the number of
objectives that he met, the Committee determined that his individual objectives were met at a level
of 108%, which, when multiplied against the corporate performance percentage of 93%, led to an AIP
payment of 100% of his target, or $122,250.
With
respect to Dr. Sheridan, the Committee determined that he exceeded the objectives of
supporting the Companys partnering and alliance objectives and advancing the Companys clinical
program objectives with respect to i.v. peramivir; met the objectives of advancing the Companys
clinical program objectives with respect to BCX4208 and supporting the Companys business
development objectives; partially met the objectives of advancing the Companys clinical program
objectives with respect to i.m. peramivir and forodesine and building the Companys clinical and
regulatory capabilities; and did not meet the objective of advancing the Companys clinical
programs with respect to early stage pipeline candidates. Dr. Sheridan also met or exceeded all of
the Companys core competencies. In light of this evaluation, and in consideration of the number
and significance of the objectives that Dr. Sheridan exceeded, the Committee determined that his
individual objectives were met at a level of 103%, which, when multiplied against the corporate
performance percentage of 93%, led to an AIP payment of 96% of his target, or $92,894.
With respect to Mr. McCullough, the Committee determined that he exceeded the objectives of
supporting the advancement of the Companys clinical programs with respect to peramivir and leading
and completing the Companys portfolio review process; met the objectives of maintaining existing
partnerships and expanding his leadership role in the Company; and partially met the significant
objective of completing new licensing and other alliance relationships. Mr. McCullough also met or
exceeded all of the Companys core competencies. In light of this evaluation, the Committee
determined that his individual objectives were met at a level of 93%, which, when multiplied
against the corporate performance percentage of 93%, led to an AIP payment of 87% of his target, or
$68,900.
With respect to Dr. Babu, the Committee determined that he exceeded the significant objectives
of supporting the advancement of the Companys clinical programs with respect to i.v. peramivir and
early stage pipeline candidates; met the objective of expanding his leadership role; and partially
met the objectives of supporting the advancement of the Companys clinical programs with respect to
i.m. peramivir, forodesine and BCX4208 and
United States Securities and Exchange Commission
December 15, 2010
Page 7
supporting the Companys partnering efforts. Dr. Babu also exceeded, met or was making progress
with respect to the Companys core competencies. In light of this evaluation, the Committee
determined that his individual objectives were met at a level of 103%, which, when multiplied
against the corporate performance percentage of 93%, led to an AIP payment of 96% of his target, or
$75,734.
I have conferred with the Company and am authorized to represent and acknowledge on its behalf
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. |
If you have any questions please do not hesitate to contact me at (202) 887-3646.
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Sincerely,
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/s/ Brian J. Lane
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Brian J. Lane |
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BJL/rez
cc: Alane Barnes, General Counsel, BioCryst Pharmaceuticals, Inc.