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Letter Text
BIOCRYST PHARMACEUTICALS INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
BIOCRYST PHARMACEUTICALS INC
Response Received
9 company response(s)
High - file number match
Company responded
2006-12-08
BIOCRYST PHARMACEUTICALS INC
References: November 15, 2006
↓
Company responded
2006-12-15
BIOCRYST PHARMACEUTICALS INC
References: November 15, 2005
↓
Company responded
2006-12-15
BIOCRYST PHARMACEUTICALS INC
References: November 15, 2006
↓
SEC wrote to company
2006-12-21
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2006-12-21
Generating summary...
↓
Company responded
2007-01-19
BIOCRYST PHARMACEUTICALS INC
References: December 15, 2006
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2007-01-19
Generating summary...
↓
Company responded
2007-02-05
BIOCRYST PHARMACEUTICALS INC
References: December 15, 2006 | November 15, 2006
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2007-02-05
Generating summary...
↓
Company responded
2010-09-09
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2010-09-09
Generating summary...
↓
Company responded
2010-11-30
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2010-11-30
Generating summary...
↓
Company responded
2010-12-15
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2010-12-15
Generating summary...
↓
Company responded
2022-01-14
BIOCRYST PHARMACEUTICALS INC
References: December 14, 2021
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2022-01-14
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-14
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2021-12-14
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2020-04-27
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2020-04-27
Generating summary...
↓
Company responded
2020-05-04
BIOCRYST PHARMACEUTICALS INC
References: April 27, 2020
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2020-05-04
Generating summary...
↓
Company responded
2020-05-12
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2020-05-12
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2017-12-08
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2017-12-08
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-05-17
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2017-05-17
Generating summary...
↓
Company responded
2017-06-08
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2017-06-08
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-03-07
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2016-03-07
Generating summary...
↓
Company responded
2016-04-14
BIOCRYST PHARMACEUTICALS INC
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2016-04-14
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2011-01-25
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2011-01-25
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-11-16
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2010-11-16
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-08-25
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2010-08-25
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-12-30
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2008-12-30
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-12-30
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2008-12-30
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2008-11-25
BIOCRYST PHARMACEUTICALS INC
References: October 31, 2008
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2008-11-25
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2008-09-02
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2008-09-02
Generating summary...
↓
Company responded
2008-09-29
BIOCRYST PHARMACEUTICALS INC
References: August 29, 2008
Filing - Correspondence from BIOCRYST PHARMACEUTICALS INC
CORRESP · 2008-09-29
Generating summary...
BIOCRYST PHARMACEUTICALS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2007-02-15
BIOCRYST PHARMACEUTICALS INC
Filing - SEC Comment Letter to BIOCRYST PHARMACEUTICALS INC
UPLOAD · 2007-02-15
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-16 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2022-01-18 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2022-01-14 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2021-12-14 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2020-05-04 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2020-04-27 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2017-12-08 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2017-06-08 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2017-05-17 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2016-04-14 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2016-03-07 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2011-01-25 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-12-15 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-11-30 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-11-16 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-09-09 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-08-25 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-12-30 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-12-30 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-11-25 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-09-29 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-09-02 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2007-02-15 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2007-02-05 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2007-01-19 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-21 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-15 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-15 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-08 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2022-01-18 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2021-12-14 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2020-04-27 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2017-05-17 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2016-03-07 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2011-01-25 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-11-16 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-08-25 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-12-30 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-12-30 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-09-02 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2007-02-15 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-21 | SEC Comment Letter | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-12-16 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2022-01-14 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2020-05-12 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2020-05-04 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2017-12-08 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2017-06-08 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2016-04-14 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-12-15 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-11-30 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2010-09-09 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-11-25 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2008-09-29 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2007-02-05 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2007-01-19 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-15 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-15 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
| 2006-12-08 | Company Response | BIOCRYST PHARMACEUTICALS INC | DE | N/A | Read Filing View |
2025-12-16 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP 1 filename1.htm December 16, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Lauren Hamill Re: BioCryst Pharmaceuticals, Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed December 15, 2025 File No. 333-291678 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, BioCryst Pharmaceuticals, Inc. hereby requests that the effective date of its Registration Statement on Form S-4 (File No. 333-291678) be accelerated by the Securities and Exchange Commission to December 18, 2025 at 9:00 a.m., Eastern Time, or as soon as practicable thereafter. Should you have any questions or comments regarding the foregoing, please contact Matthew T. Gehl of Covington & Burling LLP at (212) 841-1113. In addition, please notify Mr. Gehl by telephone when this request for acceleration has been granted. Sincerely, BIOCRYST PHARMACEUTICALS, INC. By: /s/ Jon P. Stonehouse Jon P. Stonehouse Chief Executive Officer cc: Alane Barnes, BioCryst Pharmaceuticals, Inc. Ben Harshbarger, Astria Therapeutics, Inc. Jack S. Bodner, Covington & Burling LLP Andrew W. Ment, Covington & Burling LLP Matthew T. Gehl, Covington & Burling LLP Charles A. Dobb, Covington & Burling LLP Rosemary G. Reilly, Sidley Austin LLP John H. Butler, Sidley Austin LLP Sally Wagner Partin, Sidley Austin LLP
2022-01-18 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
United States securities and exchange commission logo
January 18, 2022
Alane Barnes
Chief Legal Officer
BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
Re:BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed March 1, 2021
File No. 000-23186
Dear Ms. Barnes:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-01-14 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
1
filename1.htm
VIA EDGAR
January 14, 2022
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Kristin Lochhead and Brian Cascio
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed March 1, 2021
File No. 000-23186
Dear Ladies and Gentlemen:
On behalf of BioCryst Pharmaceuticals,
Inc. (the “Company”), set forth below is the Company’s response to the comment letter dated December 14, 2021
from the staff (the “Staff”) of the Securities and Exchange Commission in connection with the Staff’s review
of the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2020. For ease of reference, the numbered paragraph
below corresponds to the numbered comment in your letter, with your comment presented in bold followed by the related response.
Notes to Consolidated Financial Statements
Note 3. Royalty Monetizations, page 64
1. We see that you used level 3 inputs to determine the fair value of the ORLADEYO royalty financing obligation.
Please tell us where you provided all of the relevant disclosures required by ASC 820-10-50, including quantitative information about
the significant unobservable inputs used in the fair value measurement.
The Company acknowledges
the Staff’s comment and respectfully informs the Staff that the ORLADEYO® royalty financing obligation was recorded
at fair value as of the transaction date but is then recorded at its carrying value in subsequent periods. As the disclosure requirements
in ASC 820 are focused solely on fair value measurements recorded subsequent to the initial recognition, we determined the relevant disclosures
of ASC 820-10-50 are not applicable.
As disclosed in
Note 3, the Company recorded the ORLADEYO financing obligation at fair value at the time of the transaction (December 7, 2020) based on
estimated future royalties due, which were based on level 3 unobservable inputs. However, the financing obligation is subsequently recorded
at its carrying value in accordance with ASC 470 based on the application of the effective interest method. ASC 470 requires amounts recorded
as debt to be amortized under the interest method, and accordingly, the Company determines the effective interest rate based on future
royalty payments to be made to the counterparty. In applying the effective interest method, if there is a change in estimated cash flows
from future revenue, the Company utilizes the prospective method to periodically assess and adjust the carrying value based on estimated
future cash payments. At December 31, 2020, there were no changes to the estimated future cash royalty payments used in the initial estimate
to record the fair value as of the transaction date of December 7, 2020.
For clarity, the
Company will revise future filings to include the following enhanced disclosure relative to the ongoing accounting treatment:
The fair value
for the royalty financing obligation at the time of the transaction was based on the Company’s estimates of future royalties expected
to be paid to the counterparty over the life of the arrangement. The Company subsequently records the obligation at its carrying value
using the effective interest method. In order to amortize the royalty financing obligation, the Company utilizes the prospective method
to estimate the future royalties to be paid by the Company to the counterparty over the life of the arrangement. Under the prospective
method, a new effective interest rate is determined based on the revised estimate of remaining cash flows. The new rate is the discount
rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will
be used to recognize interest expense for the remaining periods. The Company periodically assesses the amount and timing of expected royalty
payments using a combination of internal projections and forecasts from external sources. To the extent such payments are greater or less
than our initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively
adjust the amortization of the royalty financing obligation and the effective interest rate.
If you have any additional
questions or comments or require further information with respect to the foregoing, please call the undersigned at (919) 859-7930 or Brian
Lane of Gibson, Dunn & Crutcher LLP at (202) 887-3646.
Very truly yours,
/s/ Alane Barnes
Alane Barnes
Chief Legal Officer
cc:
Brian Lane, Gibson, Dunn & Crutcher LLP
Mark Baxter, Ernst & Young LLP
2
2021-12-14 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
United States securities and exchange commission logo
December 14, 2021
Alane Barnes
Chief Legal Officer
BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
Re:BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed March 1, 2021
File No. 000-23186
Dear Ms. Barnes:
We have reviewed your filing and have the following comment. In our comment, we
may ask you to provide us with information so we may better understand your disclosure.
Please respond to this comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this comment, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2020
Notes to Consolidated Financial Statements
Note 3. Royalty Monetizations, page 64
1.We see that you used level 3 inputs to determine the fair value of the
ORLADEYO royalty financing obligation. Please tell us where you provided all of the
relevant disclosures required by ASC 820-10-50, including quantitative information about
the significant unobservable inputs used in the fair value measurement.
FirstName LastNameAlane Barnes
Comapany NameBioCryst Pharmaceuticals, Inc.
December 14, 2021 Page 2
FirstName LastName
Alane Barnes
BioCryst Pharmaceuticals, Inc.
December 14, 2021
Page 2
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
You may contact Kristin Lochhead at (202) 551-3664 or Brian Cascio, Accounting
Branch Chief, at (202) 551-3676 if you have questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2020-05-12 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
1
filename1.htm
BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
(919) 859-1302
May 12, 2020
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attn: Courtney Lindsay and Celeste Murphy
Re:
BioCryst Pharmaceuticals, Inc.
Registration Statement on Form S-3 (File No. 333-237820)
Filed April 24, 2020
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, BioCryst Pharmaceuticals, Inc., a Delaware corporation (the
“Company”), hereby respectfully requests that the effective time of the above referenced Registration Statement on Form S-3 filed by the Company (the “Registration Statement”) be accelerated to 4:00 p.m., Eastern Daylight Time, on May 14, 2020 or as
soon thereafter as practicable.
[Signature page follows]
Very truly yours,
BioCryst Pharmaceuticals, Inc.
/s/ Alane Barnes
Alane Barnes
Senior Vice President and Chief Legal Officer
cc: Robyn Zolman, Gibson, Dunn & Crutcher LLP
2020-05-04 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
1
filename1.htm
BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
(919) 859-1302
May 4, 2020
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549
Attn: Courtney Lindsay and Celeste Murphy
Re:
BioCryst Pharmaceuticals, Inc.
Registration Statement on
Form S-3
Filed April 24, 2020
File No. 333-237820
Dear Ladies and Gentlemen:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”), set forth below are the Company’s responses to the comment letter dated April 27, 2020 from the Staff (the “Staff”) of the Securities and
Exchange Commission (the “Commission”) in connection with the Staff’s review of the Company’s Registration Statement on Form S-3 (File No. 333-237820) (the “Registration Statement”). 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.
Risk Factors, page 2
1.
We note your disclosure on page 6 regarding the exclusive forum provision in your bylaws. Please include a risk factor on this exclusive forum provision that discusses the risks and implications of the
provision. In addition to any other material risks, please discuss any potential costs, unfavorable rulings, or uncertainty with regard to enforcement. In this regard, please refer to our comment below.
Company Response: In the future, the Company will include a risk factor addressing this provision and these limitations in the “Risk Factors” section of its periodic reports filed pursuant to the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). More specifically, in the Company’s quarterly report for the quarter ended March 31, 2020, the Company will include a risk factor in substantially the following form:
“Our Amended and Restated Bylaws provide that the Court of Chancery of the State of Delaware will be the sole and exclusive forum for certain litigation that may be
initiated by our stockholders, which may limit a stockholder’s ability to obtain a favorable judicial forum for such disputes with us or our directors, officers or employees.
Our Amended and Restated Bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any
derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, stockholders, employees or agents to us or our stockholders, (iii) any action asserting a
claim against us or any of our directors, officers, stockholders, employees or agents arising out of or relating to any provision of the General Corporation Law of Delaware or our Certificate of Incorporation or Amended and Restated Bylaws or (iv)
any action against us or any of our directors, officers, stockholders, employees or agents governed by the internal affairs doctrine of the State of Delaware. This exclusive forum provision does not apply to establish the Delaware Court of Chancery
as the forum for actions or proceedings brought to enforce a duty or liability created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.
This exclusive forum provision may limit a stockholder’s ability to choose its preferred judicial forum for disputes with us or our directors, officers, employees or agents, which may discourage the filing of lawsuits
with respect to such claims. If a court were to find this exclusive forum provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in another jurisdiction, which could adversely
affect our business and financial condition.”
Description of Common Stock, Preferred Stock and Depositary Shares, page 6
2.
We note that your forum selection provision discussed in your disclosure here and in Article 8 of your bylaws identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain
litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Exchange Act and the Securities Act. We note in this regard that Section 27 of the Exchange Act creates exclusive
federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules or regulations thereunder. If this provision does not apply to actions arising under the Exchange Act, please tell us how
you will inform investors in future filings that the provision does not apply to any actions arising under the Exchange Act. If you intend for this provision to apply to the Securities Act, please also revise your prospectus to state that
there is uncertainty as to whether a court would enforce such provision and that investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder.
Company Response: The forum selection provision in the Company’s Amended and Restated Bylaws does not apply to establish the Delaware Court of Chancery as the forum for actions or proceedings brought to enforce a duty or liability created
by the Securities Act of 1933, as amended, or the Exchange Act. Accordingly, when the Company files a prospectus supplement pursuant to Rule 424 under the Securities Act in connection with any future offering under the Registration Statement, it
will include in the base prospectus included therein the following disclosure under the heading “Description of Capital Stock”:
“Exclusive Forum for Certain Actions
Our Amended and Restated Bylaws provide that, unless we consent in writing to the selection of an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any
derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers, stockholders, employees or agents to us or our stockholders, (iii) any action asserting a
claim against us or any of our directors, officers, stockholders, employees or agents arising out of or relating to any provision of the General Corporation Law of Delaware or our Certificate of Incorporation or Amended and Restated Bylaws or (iv)
any action against us or any of our directors, officers, stockholders, employees or agents governed by the internal affairs doctrine of the State of Delaware. Our Bylaws provide that any person or entity purchasing or otherwise acquiring any
interest in shares of our common stock will be deemed to have notice of and to have consented to this choice of forum provision. This exclusive forum provision does not apply to establish the Delaware Court of Chancery as the forum for actions or
proceedings brought to enforce a duty or liability created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.
This exclusive forum provision may limit a stockholder’s ability to choose its preferred judicial forum for disputes with us or our directors, officers, employees or agents, which may discourage the filing of lawsuits
with respect to such claims. If a court were to find this exclusive forum provision to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in another jurisdiction, which could adversely
affect our business and financial condition.”
***
If you have any additional questions or comments or require further information with respect to the foregoing, please call the undersigned at (919) 859-7930 or Robyn Zolman of Gibson, Dunn & Crutcher LLP at (303)
298-5740.
Very truly yours,
Name:
/s/ Alane Barnes
Alane Barnes
Senior Vice President and Chief Legal Officer
cc:
Robyn Zolman, Gibson, Dunn & Crutcher LLP
2020-04-27 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
United States securities and exchange commission logo
April 27, 2020
Alane Barnes
Senior Vice President and Chief Legal Officer
BioCryst Pharmaceuticals, Inc.
4505 Emperor Boulevard, Suite 200
Durham, North Carolina 27703
Re:BioCryst Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed April 24, 2020
File No. 333-237820
Dear Ms. Barnes:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form S-3
Risk Factors, page 2
1.We note your disclosure on page 6 regarding the exclusive forum provision in your
bylaws. Please include a risk factor on this exclusive forum provision that discusses the
risks and implications of the provision. In addition to any other material risks, please
discuss any potential costs, unfavorable rulings, or uncertainty with regard to
enforcement. In this regard, please refer to our comment below.
Descriptio of Common Stock, Preferred Stock and Depositary Shares, page 6
2.We note that your forum selection provision discussed in your disclosure here and in
Article 8 of your bylaws identifies the Court of Chancery of the State of Delaware as the
exclusive forum for certain litigation, including any "derivative action." Please disclose
FirstName LastNameAlane Barnes
Comapany NameBioCryst Pharmaceuticals, Inc.
April 27, 2020 Page 2
FirstName LastName
Alane Barnes
BioCryst Pharmaceuticals, Inc.
April 27, 2020
Page 2
whether this provision applies to actions arising under the Exchange Act and the
Securities Act. We note in this regard that Section 27 of the Exchange Act creates
exclusive federal jurisdiction over all suits brought to enforce any duty or liability created
by the Exchange Act or the rules or regulations thereunder. If this provision does not
apply to actions arising under the Exchange Act, please tell us how you will inform
investors in future filings that the provision does not apply to any actions arising under the
Exchange Act. If you intend for this provision to apply to the Securities Act, please also
revise your prospectus to state that there is uncertainty as to whether a court would
enforce such provision and that investors cannot waive compliance with the federal
securities laws and the rules and regulations thereunder.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Courtney Lindsay at (202) 551-7237 or Celeste Murphy at (202) 551-3257
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2017-12-08 - CORRESP - BIOCRYST PHARMACEUTICALS INC
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BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
(919) 859-1302
December 8, 2017
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attn: Jeff Gabor
Re: BioCryst Pharmaceuticals, Inc.
Registration Statement on
Form S-3
Filed November 8, 2017
As Amended by Amendment No. 1
Filed December 4, 2017
File No. 333-221421
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under
the Securities Act of 1933, as amended, BioCryst Pharmaceuticals, Inc., a Delaware corporation (the “Company”), hereby
respectfully requests that the effective time of the above referenced Registration Statement on Form S-3 filed by the Company (the
“Registration Statement”) be accelerated to 4:00 p.m., Eastern Standard Time, on December 12, 2017 or as soon thereafter
as practicable.
[Signature page follows]
Very truly yours,
BioCryst Pharmaceuticals, Inc.
/s/ Alane Barnes
Alane Barnes
Vice President, General Counsel and Corporate Secretary
cc: Robyn Zolman, Gibson, Dunn & Crutcher LLP
2017-06-08 - CORRESP - BIOCRYST PHARMACEUTICALS INC
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BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
(919) 859-1302
June 8, 2017
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attn: Chris Edwards
Re: BioCryst Pharmaceuticals, Inc.
Registration Statement on
Form S-3
Filed May 10, 2017
File No. 333-217859
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under
the Securities Act of 1933, as amended, BioCryst Pharmaceuticals, Inc., a Delaware corporation (the “Company”), hereby
respectfully requests that the effective time of the above referenced Registration Statement on Form S-3 filed by the Company (the
“Registration Statement”) be accelerated to 4:00 p.m., Eastern Daylight Time, on June 12, 2017 or as soon thereafter
as practicable.
[Signature page follows]
Very truly yours,
BioCryst Pharmaceuticals, Inc.
/s/
Alane Barnes
Alane Barnes
Vice President, General Counsel and Corporate Secretary
cc: Robyn Zolman, Gibson, Dunn & Crutcher LLP
2017-05-17 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
May 17, 2017
Jon P. Stonehouse
President and Chief Executive Officer
BioCryst Pharmaceuticals, Inc.
4505 Emperor Blvd., Suite 200
Durham, North Carolina 27703
BioCryst Pharmaceuticals, Inc.
Registration Statement on Form S-3
Filed May 10, 2017
File No. 333-217859Re:
Dear Mr. Stonehouse:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at (202) 551-6761 with any questions.
Division of Corporation Finance
Office of Healthcare and
Insurance
cc: Robyn E. Zolman
2016-04-14 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP 1 filename1.htm BioCryst Pharmaceuticals, Inc. 4505 Emperor Blvd., Suite 200 Durham, North Carolina 27703 (919) 859-1302 April 14, 2016 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attn: Mary Beth Breslin Re: BioCryst Pharmaceuticals, Inc. Post-Effective Amendment No. 1 to Registration Statement on Form S-3 Filed February 26, 2016 (File No. 333-202466) Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, BioCryst Pharmaceuticals, Inc., a Delaware corporation (the “Company”), hereby respectfully requests that the effective time of the above referenced Post-Effective Amendment No. 1 to Registration Statement on Form S-3 filed by the Company (the “Registration Statement”) be accelerated to 4:00 p.m., Eastern Daylight Time, on April 18, 2016 or as soon thereafter as practicable. The Company hereby acknowledges that: · should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. [Signature page follows] Very truly yours, BioCryst Pharmaceuticals, Inc. /s/ Alane Barnes Alane Barnes Vice President, General Counsel and Corporate Secretary cc: Brian Lane, Gibson, Dunn & Crutcher LLP
2016-03-07 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
Mail Stop 4720 March 7, 2016 Jon P. Stonehouse President and Chief Executive Officer BioCryst Pharmaceuticals, Inc. 4505 Emperor Blvd., Suite 200 Durham, North Carolina 27703 Re: BioCryst Pharmaceuticals, Inc. Post-Effective Amendment No. 1 to Registration Statement on Form S-3 Filed February 26, 2016 File No. 333-202466 Dear Mr. Stonehouse : We have limited our review of your post-effective amendment to the issue addressed in our comment. Please respond to this letter by amending your registration statement or otherwise providing the requested information . If you do not believe our comment appl ies to yo ur facts and circumstances or do not believe an amendment is appropriate, please tell us why in a response. After reviewing any amendment to your registration statement and any information you provide in response to these comments, we may have additiona l comments. Incorporation of Certain Documents by Reference, page 17 1. We note that you incorporate by reference your Annual Report on Form 10 -K for the year ended December 31, 2015. However, the Form 10 -K incorporates by reference information from your definitive proxy statement that has not yet been filed. Please note that we will not be in a position to take your filing effective until you have amended the Form 10 -K to include Part III information or filed the definitive proxy statement. Please refer to Compliance and Disclosure Interpretations, Securities Act Forms, Question 123.01 and Regulation S -K, Question 117.05 for guidance. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Secur ities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made . Jon P. Stonehouse BioCryst Pharmaceuticals, Inc. March 7, 2016 Page 2 Notwithstanding our comment , before we can declare the amended registration statement effective, the company should provide us with a letter, acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company fr om its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under th e federal securities laws of the United States. Please contact Scot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Brian Lane, Esq.
2011-01-25 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
January 25, 2011 Mr. Jon P. Stonehouse President and Chief Executive Officer Biocryst Pharmaceuticals, Inc. 2190 Parkway Lane Drive Birmingham, AL 35244 Re: Biocryst Pharmaceuticals, Inc. Form 10- K for the year ended December 31, 2009 Filed March 9, 2010 Definitive Proxy Statement on Schedule 14A Filed April 6, 2010 File No. 000 -23186 Dear Mr. Stonehouse : We have completed our review of the above filing and have no further comments at this time. Sincerely, Jeffrey P. Riedler Assistant Director
2010-12-15 - CORRESP - BIOCRYST PHARMACEUTICALS INC
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corresp
Brian J. Lane
Direct: 202.887.3646
December 15, 2010
Fax: 202.530.9589
BLane@gibsondunn.com
VIA EDGAR
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
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Filed March 9, 2010
Definitive Proxy Statement on Schedule 14A
Filed April 6, 2010
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
1.
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.
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:
•
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;
•
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 Committee’s
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 Company’s 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 Company’s 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
Company’s early-stage projects. Functional support objectives were collectively weighted at 5% of
the 2009 corporate objectives and related to increasing the Company’s 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 Company’s 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 Company’s
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 Company’s function
heads (weighted at 10%).
Dr. William Sheridan, the Company’s Chief Medical Officer, had individual objectives that
consisted of goals related to the advancement of the Company’s 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
Company’s partnering, corporate alliance and business development objectives (weighted at 35%) and
building the Company’s 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 Company’s clinical programs with respect to peramivir (weighted
at 20%), maintaining existing partnerships (weighted at 15%), leading and completing the Company’s
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
Company’s 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 Company’s 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
Company’s 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 Company’s 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 Company’s
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 Company’s 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 Company’s
achievement at 20% out of 30%. The Committee considered the Company’s 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 Company’s 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 Company’s
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
executive’s performance against the Company’s 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 individual’s 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 individual’s target.
With respect to Mr. Grant, the Committee determined that he substantially exceeded the
significant objectives of managing the Company’s 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 Company’s function heads. Mr. Grant also
met or exceeded all of the Company’s 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 Company’s partnering and alliance objectives and advancing the Company’s clinical
program objectives with respect to i.v. peramivir; met the objectives of advancing the Company’s
clinical program objectives with respect to BCX4208 and supporting the Company’s business
development objectives; partially met the objectives of advancing the Company’s clinical program
objectives with respect to i.m. peramivir and forodesine and building the Company’s clinical and
regulatory capabilities; and did not meet the objective of advancing the Company’s clinical
programs with respect to early stage pipeline candidates. Dr. Sheridan also met or exceeded all of
the Company’s 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
2010-11-30 - CORRESP - BIOCRYST PHARMACEUTICALS INC
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Robyn Zolman
November 30, 2010
Direct: 303.298.5740
Fax: 303.313.2830
RZolman@gibsondunn.com
Client: C 12412-00001
VIA EDGAR
Ms. Rose Zukin
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Filed March 9, 2010
Definitive Proxy Statement on Schedule 14A
Filed April 6, 2010
File No. 000-23186
Dear Ms. Zukin:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”) this letter confirms that as discussed
with you today, the Company will respond to the Staff’s November 16, 2010 letter to the Company on
or before December 15, 2010.
Sincerely,
/s/ Robyn Zolman
Robyn Zolman
REZ/rez
cc:
Alane Barnes, BioCryst Pharmaceuticals, Inc.
Brian Lane, Gibson, Dunn & Crutcher LLP
2010-11-16 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
November 16, 2010 Mr. Jon P. Stonehouse President and Chief Executive Officer Biocryst Pharmaceuticals, Inc. 2190 Parkway Lane Drive Birmingham, AL 35244 Re: Biocryst Pharmaceuticals, Inc. Form 10-K for the year ended December 31, 2009 Filed March 9, 2010 Definitive Proxy Statement on Schedule 14A Filed April 6, 2010 File No. 000-23186 Dear Mr. Stonehouse: We have reviewed your September 9, 2010 re sponse to our August 25, 2010 letter and have the following comments. Please respond to this letter within ten business days by providing us the requested information or by advising us when you will provid e the requested response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may have additional comments. Schedule 14A 1. Please refer to your responses to comments 4, 5, and 6 in your respons e letter. Pease note that when we ask you to revise your disclosu re, 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. Form 10-K for the year ended December 31, 2009 Compensation Discussion and Analysis Annual Incentive Compensation, page 24 2. 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: Mr. Jon P. Stonehouse Biocryst Pharmaceuticals, Inc. November 16, 2010 Page 2 • Specific examples of corporate and indivi dual objectives that would increase the understanding of the corporat e and individual objectives , respectively, as you propose to do in the future; • The evaluation by the Compensation Committ ee 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 disc lose only the amounts awarded under the AIP in 2009 and the achievement of corporate objectives, instead of describing the Compensation Committee’s assessment of the le vel of achievement of each individual performance objective. To the extent that you are concerned about the release of our correspondence, you may request co nfidential treatment pursuant to Rule 83. In order to do this, please file on EDGAR your supplem ental response reque sting confidential treatment under Rule 83, redac ting 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 pe rformance metrics conf idential pursuant to Instruction 4 to Item 402(b) of Regulation S-K you must submit an analysis supporting your conclusion that you are li kely to suffer competitive harm if the information is disclosed. We are generally onl y 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 brea k even points, cost structures relating to specific products or similarly sensitive info rmation. 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. You may contact Rose Zukin, Staff Attorney at (202) 551-3239 with questions on the comments. In this regard, do not hes itate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2010-09-09 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
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corresp
Confidential Treatment Requested
by BioCryst Pharmaceuticals, Inc.
Brian J. Lane
FOIA Confidential Treatment Request
Direct: 202.887.3646
Fax: 202.530.9589
September 9, 2010
BLane@gibsondunn.com
Client: C 12412-00001
VIA EDGAR
Mr. Jim Rosenberg
Division of Corporation Finance
United States Securities and Exchange Commission
100 F Street, NE
Washington, D.C. 20549
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the year ended December 31, 2009
Filed March 9, 2010
Definitive Proxy Statement on Schedule 14A
Filed April 6, 2010
File No. 000-23186
Dear Jim:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”) this responds to your letter of August
25, 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.
Pursuant to 17 C.F.R. § 200.83, the Company is requesting confidential treatment for portions of
the response to comment 4. The Company requests that these portions, as indicated by [***], be
maintained in confidence, not be made part of any public record and not be disclosed to any person
as they contain confidential information, disclosure of which would cause the Company competitive
harm. In the event that the Staff receives a request for access to the confidential portions
herein, whether pursuant to the Freedom of Information Act (“FOIA”) or otherwise, the Company
respectfully requests that it be notified immediately so that it may further substantiate this
request for confidential treatment. Please address any notification of a request for access to such
documents to the office of the General Counsel at the Company.
Form 10-K for the year ended December 31, 2009
Management’s Discussion and Analysis of Financial Condition and Results of Operations
2009 Corporate Highlights
Peramivir, page 40
Mr. Jim Rosenberg
Confidential Treatment Requested
September 9, 2010
by BioCryst Pharmaceuticals, Inc.
Page 2
1.
Refer to your disclosure that “We have determined that there is an excess of up to $5.0
million of peramivir active pharmaceutical ingredient (“API”) manufactured under the contract
with HHS. This excess API is beyond the amount necessary to support U.S. regulatory
approval...We are evaluating whether additional quantities of peramivir API are needed by the
Company, and if so, the acquisition process to obtain the API from HHS.” Please provide us
proposed disclosure to include in your September 30, 2010 Form 10-Q that provides a chronology
and description of events leading up to and subsequent to your determination of the excess.
Also include in the proposed disclosure the effects and expected effects of the excess on your
results of operations and financial position, and clarify why you are evaluating whether
additional quantities are needed if there is an excess. Finally, include in the proposed
disclosure how you have accounted for the excess in your financial statements.
In its Annual Report on Form 10-K for the year ended December 31, 2009, the Company described
its contract with the Department of Health and Human Services (“HHS”) as follows: In
January 2007, the Company was awarded a contract from HHS for the advanced development of its
influenza neuraminidase inhibitor, peramivir, for the treatment of seasonal and life-threatening
influenza. The contract was awarded at an amount of $102.6 million to support manufacturing,
process validation, clinical studies, and other development activities for peramivir. In
September 2009, the contract was modified to award the Company an additional $77.2 million in order
to perform Phase 3 studies and other development activities for intravenous peramivir. The
Company’s advanced development contract with HHS is a cost-plus-fixed-fee contract. That is, the
Company is entitled to receive reimbursement for all costs incurred in accordance with the contract
provisions that are related to the development of peramivir plus a fixed fee, or profit.
To address the Staff’s question regarding the issue of excess API manufactured under the
contract with HHS, the Company plans to provide the following disclosure in its Quarterly Report on
Form 10-Q for the quarterly period ended September 30, 2010:
“Under the defined scope of work in the contract with HHS for the development of peramivir, a
process was undertaken to validate a U.S.-based manufacturer and the related method for producing
commercial batches of peramivir active pharmaceutical ingredient (“API”). As a required outcome of
this validation process, large quantities of peramivir API were produced. In accordance with its
accounting practices, the Company recorded all costs associated with this validation process as R&D
expenses in its Statements of Operations. Simultaneously, revenue from the HHS contract was also
recorded in the Company’s Statement of Operations. HHS subsequently reimbursed the Company for
these costs and upon reimbursement from HHS, the associated peramivir API became property of the
U.S. government.
Mr. Jim Rosenberg
Confidential Treatment Requested
September 9, 2010
by BioCryst Pharmaceuticals, Inc.
Page 3
Under the terms of the contract, if the Company determines the amount of API produced under
the contract is in excess of what is necessary to complete the contract, the Company can acquire
any excess peramivir API at cost to use for its own purposes. The Company believes that as a
result of the manufacturing campaign described above, more peramivir API has been produced than is
required to support U.S. regulatory approval. Therefore, the Company determined that there was an
excess of up to $5.0 million of peramivir API manufactured under this validation process. HHS is
reviewing the Company’s estimate calculation, but has acknowledged that at least half of the amount
in the Company’s estimate is indeed excess to the requirements of the HHS contract. The Company is
evaluating whether any of the excess peramivir API will be needed by the Company to support other
contracts, partners, or activities, and if so, the acquisition process to obtain the excess API
from HHS. Acquisition of a portion or all of the excess peramivir API from HHS will impact the
Company’s financial statements.”
Schedule 14A filed April 6, 2010
2.
We note that you have not included any disclosure in response to Item 402(s) of Regulation
S-K. Please advise us of the basis for your conclusion that disclosure is not necessary and
describe the process you undertook to reach that conclusion.
During the Company’s proxy preparation process in the first quarter of 2010, management of the
Company, together with the Company’s compensation consultant and outside counsel and Compensation
Committee, examined the Company’s compensation program and discussed whether any elements of the
program created risks that were reasonably likely to have a material adverse effect on the Company.
Following this analysis, management concluded that the elements of the Company’s compensation
program did not create risks that are reasonably likely to have a material adverse effect on the
Company, and therefore that disclosure under Item 402(s) was not required.
In its analysis, management considered a number of factors, including primarily: (1) the total
value of the payments made under the Company’s compensation program for the prior year and (2) that
any corporate actions that would potentially lead to achievement of individual or corporate
performance objectives would require approval by the Company’s Board of Directors, which provides a
check on the ability of any individual to take risks that could have a material adverse effect on
the Company in an effort to achieve a certain performance objective.
Mr. Jim Rosenberg
Confidential Treatment Requested
September 9, 2010
by BioCryst Pharmaceuticals, Inc.
Page 4
Corporate Governance
Board Leadership Structure, page 18
3.
We note that the company has chosen to separate the principal executive officer and board
chairman positions. Please confirm that in future filings, you will expand your disclosure to
discuss why the company believes that this board leadership structure is the most appropriate
structure for the company at the time of filing. Please refer to Item 407(h) of Regulation
S-K.
The Company confirms that in applicable future filings it will explicitly state why the
Company has determined that the leadership structure of the Board is the most appropriate in light
of the circumstances that exist at that time.
Compensation Discussion and Analysis
Annual Incentive Compensation, page 24
4.
You disclose on page 24 that overall funding for annual incentive compensation is based on
your performance against the current year corporate objectives. On page 25, you state that
the Committee approved an AIP pool equal to 93% of the target incentive amount. Please
provide us proposed disclosure to be included in an amendment to your Form 10-K for the year
ended December 31, 2009 to identify the corporate objectives used by the Committee to
determine the potential size of the pool allocated for annual incentive compensation. In
addition, please discuss how the level of achievement of each corporate objective corresponded
to the Committee’s determination that the AIP pool would be equal to 93% of the target
incentive amount.
The Company omitted disclosure of the corporate objectives used by the Compensation Committee
to determine the potential size of the pool allocated for annual incentive compensation because it
believes that, based on established case law standards, such objectives constitute confidential
commercial information, the disclosure of which would cause competitive harm, and that therefore
such objectives would be entitled to confidential treatment. Instruction 4 to Item 402(b) of
Regulation S-K provides that registrants are not required to disclose any factors or criteria
involving confidential commercial information, the disclosure of which would result in competitive
harm for the registrant.
Mr. Jim Rosenberg
Confidential Treatment Requested
September 9, 2010
by BioCryst Pharmaceuticals, Inc.
Page 5
[*** Redacted***]
The Company will provide additional disclosure in its applicable future filings with respect
to the overall nature of the corporate objectives, including more specific examples that would
increase the understanding of the objectives without providing competitively sensitive information.
The Company will also provide additional disclosure in applicable future filings about the process
used by the Compensation Committee to determine the size of the pool for annual incentive
compensation.
As an illustration, the Company would propose to disclose the following with respect to the
corporate objectives in its 2011 Proxy Statement:
“The corporate objectives established for 2010 were primarily related to the continued
progression of both our clinical and non-clinical programs. The corporate objectives fell into
three primary categories: (1) clinical development objectives, which constituted a substantial
majority of the 2010 corporate objectives and consisted of specific, detailed goals with respect to
the advancement of the Company’s clinical programs; (2) licensing and financing objectives, which
related to potential partnering, licensing and other alliance relationships related to the
Company’s current product candidates and the development of new product candidates, as well as
management of the Company’s cash position and expenses; and (3) early stage project objectives,
which related to the development of various specific early-stage product candidates.”
5.
We note that the NEOs achieved 2009 bonus payments based on the achievement of corporate
objectives and individual objectives. Your Compensation Discussion and Analysis does not
disclose the corporate nor individual objectives used to determine these executive officers’
annual performance-based bonus. Please provide us proposed disclosure to be included in an
amendment to your Form 10-K for the year ended December 31, 2009 to provide the following:
•
The corporate and individual performance objectives;
•
The portion of the bonus attributable to the achievement of corporate objectives
and individual objectives; and
•
A discussion of how the level of achievement of each objective affected the actual
bonuses to be paid.
To the extent that the objectives are quantitative, the discussion should also be
quantitative. Please also disclose the level of achievement of these objectives.
Mr. Jim Rosenberg
Confidential Treatment Requested
September 9, 2010
by BioCryst Pharmaceuticals, Inc.
Page 6
As discussed in the response to comment 4 with respect to corporate objectives, the Company
omitted disclosure of the corporate objectives used by the Committee because it believes that,
based on established case law standards, such objectives constitute confidential commercial
information, the disclosure of which would cause competitive harm, and that therefore such
objectives would be entitled to confidential treatment. The Company disclosed in the Proxy
Statement that the individual objectives were prepared in conjunction with the corporate objectives
and were designed to promote the execution of the corporate objectives. Because the individual
objectives are of a similar nature as the corporate objectives, the Company believes that the
individual objectives constitute confidential commercial information and that disclosure of the
individual objectives would cause the Company competitive harm, for the same reasons detailed in
the response to comment 4. It therefore believes that disclosure of the individual objectives
would result in substantial competitive harm to the Company and that they are therefore not
required to be disclosed.
The Company will provide additional disclosure in its applicable future filings with respect
to the overall nature of the corporate and individual objectives, including more specific examples
that would increase the understanding of the objectives without providing competitively sensitive
information.
With respect to the portion of the bonus attributable to the achievement of corporate and
individual objectives for 2009, the Company disclosed in the Proxy Statement that the corporate
objectives are used to determine the overall funding for the AIP pool, and that the allocation of
the pool is determined based on the achievement of the individual objectives. The Company will
clarify in applicable future filings the way the corporate objectives and individual objectives
work together to result in a final bonus determination. For 2009, the corporate objectives
essentially acted as a multiplier applied to the achievement of the individual objectives (as an
example, if an executive achieved 95% of individual objectives, and the corporate objectives were
achieved at 50%, the executive would receive 45% of the target incentive amount). The disclosure
of both the amounts awarded under the AIP in 2009 in the Proxy Statement, and the AIP pool equal to
93% of target provided all of the information needed to determine the achievement of each
individual’s objectives.
As an illustration, the Company would propose to disclose the following with respect to the
individual objectives (assuming the named executive officers for 2010 will be the same as those for
2009) and the interaction between the individual objectives and the corporate objectives in its
2011 Proxy Statement:
“The individual objectives established for the named exe
2010-08-25 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
August 25, 2010 Mr. Jon P. Stonehouse President and Chief Executive Officer Biocryst Pharmaceuticals, Inc. 2190 Parkway Lane Drive Birmingham, AL 35244 Re: Biocryst Pharmaceuticals, Inc. Form 10-K for the year ended December 31, 2009 Filed March 9, 2010 Definitive Proxy Statement on Schedule 14A Filed April 6, 2010 File No. 000-23186 Dear Mr. Stonehouse: We have limited our review of your filings to those issues we have addressed in our comments. In some of our comments, we ask you to provide us with information so we may better understand your disclosure. Please respond to this letter within ten business days by providing us the requested information or by advising us when you will provid e the requested response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. If you do not believe a commen t applies to your facts and circumstances , please tell us why in your response. After reviewing the information provided, we may have additional comments. Form 10-K for the year ended December 31, 2009 Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations 2009 Corporate Highlights Peramivir, page 40 1. Refer to your disclosure that “We have determ ined that there is an excess of up to $5.0 million of peramivir active pharmaceutical ingredient (“API”) manufactured under the contract with HHS. This excess API is beyond the amount necessary to support U.S. regulatory approval…We are evaluating whether additional quantities of peramivir API are needed by the Company, and if so, the acquisiti on process to obtain the API from HHS.” Please provide us proposed disclosure to incl ude in your September 30, 2010 Form 10-Q that provides a chronology and description of even ts leading up to and subsequent to your determination of the excess. Also include in the proposed disclosure the effects and expected Mr. Jon P. Stonehouse Biocryst Pharmaceuticals, Inc. August 25, 2010 Page 2 effects of the excess on your re sults of operations and financ ial position, and clarify why you are evaluating whether additional quantities are need ed if there is an excess. Finally, include in the proposed disclosure how you have accounted for the excess in your financial statements. Schedule 14A filed April 6, 2010 2. We note that you have not included any disclosure in response to Item 402(s) of Regulation S-K. Please advise us of the basis for your c onclusion that disclosure is not necessary and describe the process you undertook to reach that conclusion. Corporate Governance Board Leadership Structure, page 18 3. We note that the company has chosen to separa te the principal executive officer and board chairman positions. Please confirm that in fu ture filings, you will expa nd your disclosure to discuss why the company believes th at this board leadership stru cture is the most appropriate structure for the company at the time of filing. Pl ease refer to Item 407(h) of Regulation S-K. Compensation Discussion and Analysis Annual Incentive Compensation, page 24 4. You disclose on page 24 that overall fundi ng for annual incentive compensation is based on your performance against the cu rrent year corporate objectives . On page 25, you state that the Committee approved an AIP pool equal to 93 % of the target incentive amount. Please provide us proposed disclosure to be included in an amendm ent to your Form 10-K for the year ended December 31, 2009 to identify the co rporate objectives used by the Committee to determine the potential size of the pool allocated for annua l incentive compensation. In addition, please discuss how the level of achievement of each corporate objective corresponded to the Committee’s determination th at the AIP pool would be equal to 93% of the target incentive amount. 5. We note that the NEOs achieved 2009 bonus payments based on the achievement of corporate objectives and indivi dual objectives. Your Compensation Discussion and Analysis does not disclose the corporate nor individual objectiv es used to determine these executive officers’ annual performance-based bonus. Plea se provide us proposed disclosure to be included in an amendment to your Form 10-K for the year ended December 31, 2009 to provide the following: • The corporate and individua l performance objectives; • The portion of the bonus attributable to th e achievement of corporate objectives and individual objectives; and Mr. Jon P. Stonehouse Biocryst Pharmaceuticals, Inc. August 25, 2010 Page 3 paid. • A discussion of how the level of achie vement of each objective affected the actual bonuses to be To the extent that the objectives are qu antitative, the discussion should also be quantitative. Please also disclose the le vel of achievement of these objectives. Long-Term Equity Incentive Awards, page 26 6. We note that Messrs. Stonehouse, Grant, and McCullough, as well as Dr. Babu, achieved long-term equity incentive awards in 2009. Acco rding to page 26, these awards were based, in part, on a review of the performance of each NEO. Please provide us proposed disclosure to be included in an amendment to your Form 10-K for the year ended December 31, 2009 to identify the material factors that the Compen sation Committee considered in awarding these long-term equity incentive awards. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the disclo sure in the filing; • 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 • the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federa l securities laws of the United States. You may contact Christine Allen, Staff Accountant at (202) 551-3652 or Lisa Vanjoske, Assistant Chief Accountant at (202) 551-3614 if you have questions regarding the processing of your response as well as any questions regarding comments on the financial statements and related matters. Please contac t Rose Zukin, Staff Attorney at (202) 551-3239 with questions on any of the other comments. In this regard, do not hesitate to cont act me, at (202) 551-3679. Sincerely, Jim Rosenberg Senior Assistant Chief Accountant
2008-12-30 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
Via Facsimile and U.S. Mail Mail Stop 6010 December 30, 2008 Mr. Stuart Grant Chief Financial Officer 2190 Parkway Lake Drive Birmingham, Alabama 35244 Re: Biocryst Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2007 Form 10-Q for the quarter ended March 31, 2008 Form 10-Q for the quarter ended June 30, 2008 File No. 0-23186 Dear Mr. Grant: We have completed our review of your Form 10-K and related filings and have no further comments at this time. S i n c e r e l y , G u s R o d r i g u e z A c c o u n t i n g B r a n c h C h i e f
2008-11-25 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
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CORRESPONDENCE
[BioCryst Letterhead]
Mr. Jim Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities & Exchange Commission
100 F Street, NW
Washington, DC 20001-2016
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2007
File No. 0-23186; Form 10-Q for the Quarter Ended March 31, 2008;
Form 10-Q for
the Quarter Ended June 30, 2008
Dear Mr. Rosenberg:
This letter responds to your letter dated October 31, 2008 in connection with the above referenced
file. To facilitate your review, we have reproduced your comments in bold below and have provided
our response immediately following your comment.
Form 10-K for the Fiscal Year Ended December 31, 2007
1.
We note your response to our prior comment 1 and the proposed changes to the
disclosure that will be included in future filings. Please expand your disclosure to also
discuss the following information:
•
In your discussion of the Mundipharma corporate alliance, please disclose the
percentage range of royalties (i.e., single digits, low teens, high teens, etc.).
•
In your discussion of the AECOM and IRL academic alliance, please disclose the
aggregate potential milestone payments, the annual license
fee, the percentage range of royalties on future sales of any resulting product, and
each party’s other rights and obligations.
•
In your discussions of the UAB and Emory academic alliances, please disclose the
percentage range of royalties.
In response to your comment, we have further revised our disclosure and have included the
information you requested above. Exhibit A is a sample of our revised disclosure, which
has been redlined for convenience to show the information added since our last Form 10-K filing.
Form 10-Q for the quarter ended June 30, 2008
2.
We noted your response to our comment 8. Please tell us how you are accounting for
the remaining portion of the revenue related to this contract (HHS). It would appear that
the company’s ability to estimate revenues related to the remaining portion of the HHS
contract would be diminished as a result of HHS’s change in reimbursable costs structure.
The Company’s contract with HHS is a cost-plus-fixed-fee contract. That is, we are entitled to
receive reimbursement for all reasonable and allowable costs incurred in accordance with the
contract provisions that are related to the development of peramivir plus a fixed fee, or profit.
As outlined in Staff Accounting Bulletin No. 104, Revenue Recognition, and Accounting Research
Bulletin No. 43, Chapter 11, Section A, Government Contracts, Cost-Plus-Fixed-Fee Contracts, the
Company has and continues to recognize revenue as reimbursable costs are incurred under the
contract with HHS. The Company does not estimate revenues based on percentage of contract
completion or any other method of revenue recognition.
As disclosed in our initial response, the Company announced in January 2008 that the development
plan for peramivir had changed and that HHS would only fund certain elements of the revised
program. This decision by HHS did not change or alter the reimbursable cost structure of the
Company’s contract or the Company’s accounting related to the contract. The Company is currently
executing the development plan for peramivir that has been approved by HHS. We will only recognize
revenue related to this approved development plan and only up to the specified limits of the
contract. We have not recognized revenue in excess of the contract amount of $102.6 million.
* * *
The Company acknowledges that it is responsible for the adequacy and accuracy of the disclosure in
the filing; 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 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 contact our outside corporate counsel, Brian Lane of Gibson, Dunn
& Crutcher LLP at (202) 887-3646.
Sincerely,
/s/ Stuart Grant
Stuart Grant
Senior Vice President & Chief Financial Officer
Cc:
Jon Stonehouse
Mike Darwin
Alane Barnes
Brian Lane
Mike Mills
EXHIBIT A
Collaboration and In-License Relationships
We seek to enter into collaborations with leading pharmaceutical and biotechnology companies
when we feel it is advantageous to leverage these companies’ resources to develop and commercialize
our drug candidates on a global basis. This allows us to remain focused on our strength of early
stage discovery and development of drug candidates. To date, we have two major collaborations for
the development and commercialization of our lead PNP inhibitors and two collaborations for the
development and commercialization of peramivir in certain countries outside the U.S. In addition,
in January 2007, we announced that HHS had awarded the Company a $102.6 million, four-year contract
for the advanced development of peramivir for U.S. licensure.
Another important component of our strategy is to augment our internal discovery programs through
the selective in-licensing of potential drug development targets or early stage compounds for these
specific targets. For example, our PNP inhibitors were in-licensed from AECOM and IRL in June 2000.
Corporate Alliances
Roche. In November 2005, we entered into an exclusive license with Roche for the development
and commercialization of our second generation PNP inhibitor, BCX-4208, for the prevention of acute
rejection in transplantation and for the treatment of autoimmune diseases. Under the terms of the
agreement, Roche obtained worldwide rights to BCX-4208 in exchange for an up-front payment of $30
million, which included a payment as reimbursement for a limited supply of material during the
first 24 months of the collaboration. The license also provided for future milestone event payments
for achieving specified development, regulatory and commercial milestones (including sales level
milestones following a product’s launch) for certain indications. In addition, the license provided
for the Company to receive royalties based on a percentage of net product sales, which varies
depending upon when certain indications receive New Drug Application (“NDA”) approval in a major
market country and can vary by country depending on the patent coverage or sales of generic
compounds in a particular country. We licensed this compound and other PNP inhibitors from AECOM
and IRL and will owe sublicense payments to these third parties on any upfront payment, future
event payments and royalties received by us for the sublicense of these inhibitors.
Roche has a right of first negotiation, under certain conditions, on existing backup PNP
inhibitors we develop through Phase IIb in transplant rejection and autoimmune diseases, but any
new PNP inhibitors are exempt from this agreement and we retain all rights to such compounds. We
retain the right to co-promote BCX-4208 in the U.S. for certain indications. Roche has certain
obligations under the terms of the agreement to use commercially reasonable efforts to develop,
manufacture and commercialize the licensed product. The agreement may be terminated by either party
following an uncured material breach by the other party or may be either fully or partially
terminated by Roche without cause under certain conditions and all rights, data, materials,
products and other information would be transferred to the Company. For termination without cause,
the effective date of termination is 180 days from the date of notice.
In May 2008 the Company received notice that Roche was exercising the “no cause” termination
right under the license agreement for BCX-4208. Upon termination, the Company will recognize the
remaining deferred revenue and deferred expense related to the license agreement, which are $27.3
million and $8.4 million, respectively, as of March 31, 2008.
Mundipharma. In February 2006, the Company entered into an exclusive, royalty bearing right
and license in the specified territory (primarily Europe, Asia and Australia) with Mundipharma for
the development and commercialization of our lead PNP inhibitor, forodesine HCl, for use in
oncology. Under the terms of the agreement, Mundipharma obtained oncology rights to forodesine HCl
in the specified territory in exchange for a $10 million up-front payment. Mundipharma will share
50% of the documented third party development costs incurred by us in respect of our current and
planned trials as of the effective date of the agreement provided that Mundipharma’s maximum
contribution to these trials shall be $10 million. In addition, Mundipharma will conduct
additional clinical trials at their own cost up to a maximum of
$15 million. The license provides
for possibility of future event payments totaling $155 million for achieving specified development,
regulatory and commercial events (including certain sales level amounts following a product’s
launch) for certain indications. In addition, the agreement provides that we will receive
royalties (ranging from single digits to mid teens) based on a percentage of net product sales,
which varies depending upon when certain indications receive NDA approval in a major market country
and can vary by country depending on the patent coverage or sales of generic compounds in a
particular country. Generally, all payments under the agreement are nonrefundable and
non-creditable, but they are subject to audit. We licensed this compound and other PNP inhibitors
from AECOM and IRL and will owe sublicense payments to these third parties on the upfront payment,
future event payments and royalties received by us for the sublicense of these inhibitors.
Within five years of the effective date of the agreement, Mundipharma has a right of first
negotiation on existing backup PNP inhibitors we develop through Phase IIb in oncology, but any new
PNP inhibitors are exempt from this agreement and we retain all rights to such compounds. We retain
the rights to forodesine HCl in the U.S. and Mundipharma is obligated by the terms of the agreement
to use commercially reasonable efforts to develop the licensed product in the territory specified
by the agreement. The agreement will continue for the commercial life of the licensed products, but
may be terminated by either party following an uncured material breach by the other party or in the
event the pre-existing third party license with AECOM and IRL expires. It may be terminated by
Mundipharma upon 60 days written notice without cause or under certain other conditions as
specified in the agreement and all rights, data, materials, products and other information would be
transferred to us at no cost. In the event we terminate the agreement for material default or
insolvency, we could have to pay Mundipharma 50% of the costs of any independent data owned by
Mundipharma in accordance with the terms of the agreement.
Shionogi. In March 2007, the Company entered into an exclusive license agreement with Shionogi
to develop and commercialize the Company’s lead influenza neuraminidase inhibitor, peramivir, in
Japan for the treatment of seasonal and potentially life-threatening human influenza. Under the
terms of the agreement, Shionogi obtained rights to injectable formulations of peramivir in Japan
in exchange for a $14 million up-front payment. The license provides for potential future milestone
event payments (up to $21 million) and commercial event milestone payments (up to $95 million) in
addition to double digit (between 10 and 20% range) royalty payments on product sales of peramivir.
In December 2007, the Company received a $7 million milestone payment from Shionogi for their
initiation of a Phase II clinical trial with i.v. peramivir. Generally, all payments under the
agreement are nonrefundable and non-creditable, but they are subject to audit. Shionogi will be
responsible for all development, regulatory and marketing costs in Japan. The term of the
agreement is from February 28, 2007 until terminated by either party in accordance with the license
agreement. Either party may terminate in the event of an uncured breach. Shionogi has the right
of without cause termination. In the event of termination all license and rights granted to
Shionogi shall terminate and shall revert back to the Company. The Company developed peramivir
under a license from UAB and will owe sublicense payments to them on the upfront payment and any
future event payments and/or royalties received by the Company from Shionogi. The Company retains
all rights to commercialize peramivir in North America, Europe, and other countries outside of
Korea and Japan.
Green Cross Corporation (“Green Cross”). In June 2006, the Company entered into an agreement
with Green Cross to develop and commercialize peramivir in Korea. Under the terms of the agreement,
Green Cross will be responsible for all development, regulatory, and commercialization costs in
Korea. The Company received a one-time license fee of $250,000. Total future milestone payments
would be equally modest. The license also provides that the Company will share in profits
resulting from the sale of peramivir in Korea, including the sale of peramivir to the Korean
government for stockpiling purposes. Furthermore, Green Cross will pay the Company a premium over
its cost to supply peramivir for development and any future marketing of peramivir products in
Korea. Both parties have the right to terminate in the event of an uncured material breach. In the
event of termination all rights, data, materials, products and other information would be
transferred to the Company.
Academic Alliances Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd, New
Zealand. In June 2000, we licensed a series of potent inhibitors of PNP from AECOM and IRL. The
lead drug candidates from this collaboration are forodesine HCl and BCX-4208. We have obtained
worldwide exclusive rights to develop and ultimately distribute these compounds or any other drug
candidates that might arise from research on these inhibitors. We have the option to expand the
Agreement to include other inventions in the field made by the investigators or employees of AECOM
and IRL. We have agreed to use commercially reasonable efforts to develop these drugs. In
addition, we have agreed to pay certain milestone payments for each licensed product (which range
in the aggregate from $1.4 million to almost $4 million per indication) for future development of
these inhibitors, single digit royalties on net sales of any resulting product made by us, and to
share approximately one quarter of future payments received from other third-party partners, if
any. In addition, we have agreed to pay annual license fees which can range from $150,000 to
$500,000 depending on stage of development of products that is non-refundable, but is creditable
against actual royalties and other payments due to AECOM and IRL. This agreement may be terminated
by us at any time by giving 60 days advance notice or in the event of material uncured breach by
AECOM and/or IRL.
The University of Alabama at Birmingham. We have had a close relationship with UAB since our
formation. Our former Chairman, Dr. Charles E. Bugg, was the previous Director of the UAB Center
for Macromolecular Crystallography, and our Chief Operating Officer, Dr. J. Claude Bennett, was the
former President of UAB, the former Chairman of the Department of Medicine at UAB and a former
Chairman of the Department of Microbiology at UAB. Several of our early programs originated at UAB.
We currently have agreements with UAB for influenza neuraminidase and comple
2008-09-29 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
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SEC CORRESPONDENCE LETTER
September 29, 2008
VIA EDGAR AND OVERNIGHT MAIL
Mr. Jim Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities & Exchange Commission
100 F Street, NW
Washington, DC 20001-2016
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2007
File No. 0-23186; Form 10-Q for the Quarter Ended March 31, 2008;
Form 10-Q for the Quarter Ended June 30, 2008
Dear Mr. Rosenberg:
This letter responds to your letter dated August 29, 2008 in connection with the above referenced
file. To facilitate your review, we have reproduced your comments in bold below and have provided
our response immediately following your comment.
1.
To the extent not already disclosed, please include the following information in
the discussion of each of your corporate alliances, academic alliances and
government contracts:
•
each party’s rights and obligations under the agreement
•
the percentage range of royalties;
•
the aggregate potential milestone payments; and
•
the expiration and termination provisions.
RESPONSE:
We believe the Company has disclosed the principal aspects of its material alliances. In certain
cases, some of the details of the agreements have been afforded confidential treatment by the Staff
under Rule 24b-2. Nevertheless, in response to your comment, we have reviewed the disclosure
contained in our recent 10-K and have determined to make the disclosure more robust in the future
by including information which had been disclosed in previous SEC filings. Exhibit A is a
sample of such disclosure, which has been redlined for convenience.
2.
Please tell us why it was appropriate under GAAP to defer $2.3 million in
pre-contract costs incurred in 2006 and expense these costs in 2007.
RESPONSE:
The Company’s contract with the U.S. Department of Health and Human Services (“HHS”), which was
awarded on January 3, 2007, is a cost-plus-fixed-fee (“CPFF”) contract. That is, the Company is
entitled to receive reimbursement for all costs incurred related to the development of peramivir
plus a fixed fee, or profit. The Company incurred $2.3 million of costs in 2006, which were
directly associated with the contract and were incurred in anticipation of a contract award from
HHS. These costs were required to meet the delivery schedule of the proposed contract, and based
on discussions with the Contracting Officer and in accordance with the provisions of Federal
Acquisition Regulation 31.205-32, the costs were eligible for reimbursement.
Chapter 3.10 of the American Institute of Certified Public Accountants (“AICPA”) Audit and
Accounting Guide for Government Contractors, states that pre-contract costs should be accounted for
in conformity with paragraph 75a of AICPA Statement of Position No. 81-1, Accounting for
Performance of Construction-Type and Certain Production-Type Contracts. This guidance states that
costs incurred for a specific anticipated contract may be deferred if the costs are directly
associated with that contract and recoverability from the contract is probable. Therefore, the
Company deferred the $2.3 million of costs incurred during the fourth quarter of 2006 and prior to
the contract award date of January 3, 2007. The $2.3 million in costs were expensed in January 2007
and revenue in an equal amount plus the applicable fixed fee was recognized concurrently.
3.
Please explain in expanded disclosure why you had such a significant receivable
($36.5 million) from HHS at December 31, 2007. Explain why revenue
recognition in 2007 was appropriate. Page 41 indicates that you bill HHS monthly.
RESPONSE:
The Company invoices HHS for expenses incurred relative to work done within each calendar month.
The internal and external process of generating these invoices is time consuming and results in the
Company billing on average of 60 days after the period ends. The process of HHS reviewing these
invoices involves multiple layers of review and approval which results in payment on average of in
excess of 60 days beyond the date of invoice submission. As disclosed in the Company’s 10-K for
the year ended December 31, 2007, the Company had approximately $36.5 million due from HHS, of
which $23.1 million was related to billed receivables and $13.4 million was related to unbilled
receivables. The billed receivables represent the costs incurred and applicable fee for the months
of July, August, September and October. The unbilled receivables represent the costs incurred and
applicable fee for the months of November and December. All of these factors contributed to a
build-up of receivables at December 31, 2007. As of the date of this letter, all but $351,000 has
been paid or is expected to be paid by HHS.
In accordance with Staff Accounting Bulletin No. 104, Revenue Recognition (“SAB 104”), and
Accounting Research Bulletin No. 43, Chapter 11, Section A, Government Contracts,
Cost-Plus-Fixed-Fee Contracts, the Company recognizes revenue as reimbursable costs are incurred
under the contract with HHS. Based on this guidance, the Company recognized revenue equal to the
amount of reimbursable costs (both internal and external) incurred through December 31, 2007, plus
the applicable fixed fee.
4.
Please clarify for us in your disclosure the accounting for sublicense payments
and maintenance payments and your basis of accounting for these payments.
Provide the nature of costs deferred and why you believe deferral is appropriate.
RESPONSE:
The Company expenses sublicense payments as incurred unless they are related to revenues that have
been deferred, in which case the expenses are deferred and recognized over the related revenue
recognition period. The Company expenses maintenance payments as incurred.
The Company’s accounting for deferred sublicense payments related to revenues that have been
deferred is based on the guidance in SAB 104. SAB 104 states that the incremental direct costs
incurred related to the acquisition or origination of a contract in a transaction that results in
the deferral of revenue may either be expensed as incurred or accounted for in accordance with
paragraph 4 of Financial Accounting Standards Board (“FASB”) Technical Bulletin 90-1, Accounting
for Separately Priced Extended Warranty and Product Maintenance Costs (“FTB 90-1”). At December
31, 2007, the Company had deferred collaboration expenses of approximately $12.3 million. These
deferred expenses were sub-license payments, paid to our academic partners upon our receipt of
consideration from various commercial partners. These deferred expenses would not have been
incurred without receipt of such payments from our commercial partners and are being expensed in
proportion to the related revenue being recognized. We believe that this accounting treatment
appropriately matches expenses with the associated revenue.
5.
Provide the disclosures specified in paragraph 14b of FAS 68 or tell us why they
are not required.
RESPONSE:
Of the relationships outlined in Note 10 to the financial statements included in the Company’s 2007
Form 10-K, the Company believes that only the contracts with HHS and Mundipharma contain
obligations for the Company to perform research and development. The other relationships are
license agreements under which the Company has no obligation to perform contractual research and
development for others.
FASB Statement No. 68, Research and Development Arrangements (“FAS 68”), specifically exempts
government contracts from its scope. Accordingly, we do not believe that the disclosure
requirements of FAS 68 apply to the HHS contract.
However, the Company recognizes that certain aspects of FAS 68 appear to apply to the relationship
between Mundipharma and the Company. In previous filings the Company has included much of the
required disclosure in paragraph 14 of FAS 68. The terms of significant agreements under the
research and development arrangement with Mundipharma are disclosed in Notes 1 and 10.
Furthermore, the amount of revenue recognized related to our contract with Mundipharma also has
been disclosed in Note 1. In order to fully satisfy the disclosure requirement, in future filings
we also will separately disclose the costs incurred by the Company related to the contract with
Mundipharma, which are currently reported in research and development expenses in the statement of
operations.
6.
It appears that you have not filed as an exhibit to your filing a copy of your
agreement with Green Cross Corporation. Please file this agreement as an
exhibit to your filing or, alternatively, please provide us with a supplemental
analysis supporting your determination that you are not substantially dependent
on this agreement.
RESPONSE:
The Company has not filed a copy of the agreement with Green Cross as an exhibit as we do not
believe this is a material agreement, nor is the Company substantially dependent on this
collaboration. Therefore, we are not required to file a copy of the agreement under Item
601(b)(10) of Regulation S-K. Under the terms of the agreement, which had an effective date of
June 12, 2006, Green Cross paid BioCryst a one time license fee of $250,000. Total future
milestone payments by Green Cross would be equally modest. Finally, while it is possible that at
some point in the future we may receive royalties, we do not believe that those payments will be
significant. Therefore, we do not believe that this contract will be of material significance to
the Company in the foreseeable future.
7.
Please tell us what the impact, if any, of adopting FAS 159 had on your financial
statements. Explain why the disclosure of adopting the standard was not warranted.
RESPONSE:
At January 1, 2008, the Company adopted FASB Statement No. 159, The Fair Value Option for Financial
Assets and Liabilities (“FAS 159”) but did not elect to change the accounting for its financial
instruments. Therefore no disclosure regarding FAS 159, was made in the 1Q 2008 and 2Q 2008 Form
10-Qs. In future filings we will disclose that the Company did adopt FAS 159, but did not elect
to apply fair value accounting to any financial instruments that were not already accounted for at
fair value under existing guidance.
8.
You reversed $4.9 million of revenues related to your contract with HHS in the
quarter ended June 30, 2008. Please explain why you believed it was appropriate
under GAAP to recognize these revenues in an earlier period, that is, why you believed
these Phase III costs were reimbursable under the contract. We note in January 2008
you announced that development costs would exceed the amount of the contract and
HHS indicated they would fund certain elements of the revised program.
RESPONSE:
The contract we have with HHS requires them to reimburse all costs associated with the development
of peramivir, including wind down costs for our Phase III program. As such, all costs have been
recorded properly as reimbursable. In January BioCryst announced that the total costs of the
peramivir program would exceed the original contract amount of 102.6 million. We have not exceeded
the total contract amount.
Also in January, we announced our development plan for peramivir had changed and that HHS would
fund certain elements of the revised program. We further announced that HHS would play a more
active role in the program and in reviewing related spending under this contract. The Company
further disclosed that upon consideration of various factors and several discussions with HHS, the
Company would not continue the phase III program. During the last quarter of 2007 and the first
quarter of 2008, the Company recorded revenues related to the execution of the phase III program in
accordance with the contract with HHS. During the first quarter of 2008, the Company also recorded
revenue related to the wind-down costs associated with terminating the phase III program. Under
the terms of the HHS contract, the Company believed and continues to believe that these costs are
reimbursable by HHS.
At the end of the first quarter, we determined that it was probable that HHS would reimburse us for
the costs incurred under the phase III program including reasonable wind down costs and that no
reserve against revenue was necessary, as we believed these costs were reimbursable under the
contract . However, the Company recognized that some of the costs incurred could be subject to
different interpretation by HHS and that it was possible that some portion of the costs would not
be reimbursed. Accordingly, the Company disclosed the risk associated with revenue recorded in our
Form 10-Q for the quarter ended March 31, 2008.
For the first time, in July 2008, HHS verbally indicated that it did not intend to reimburse the
Company for all of the costs incurred related to the terminated Phase III program. Therefore,
under FAS 5, the Company determined that it was probable that a loss would occur and the loss could
be reasonably estimated. Therefore, during the second quarter of 2008, the Company recorded a
reserve against revenue for amounts the Company previously expected to receive from HHS related to
the peramivir phase III program. As previously mentioned, the contract with HHS is as a CPFF
contract and revenue is recorded as described in Item 3 of this letter.
* * *
The Company acknowledges that it is responsible for the adequacy and accuracy of the disclosure in
the filing; 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 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 contact our outside corporate counsel, Brian Lane of Gibson, Dunn
& Crutcher LLP at (202) 887-3646.
Sincerely,
/s/ Stuart Grant
Stuart Grant
Senior Vice President & Chief Financial Officer
Cc:
Jon Stonehouse
Mike Darwin
Alane Barnes
Brian Lane
Mike Mills
EXHIBIT A
Collaboration and In-License Relationships
We seek to enter into collaborations with leading pharmaceutical and biotechnology companies
when we feel it is advantageous to leverage these companies’ resources to develop and commercialize
our drug candidates on a global basis. This allows us to remain focused on our strength of early
stage discovery and development of drug candidates. To date, we have two major collaborations for
the development and commercialization of our lead PNP inhibitors and two collaborations for the
development and commercialization of peramivir in certain countries outside the U.S. In addition,
in January 2007, we announced that HHS had awarded the Company a $102.6 million, four-year contract
for the advanced development of peramivir for U.S. licensure.
Another important component of our strategy is to augment our internal discovery programs through
the selective in-licensing of potential drug development targets or early stage compounds for these
specific targets. For example, our PNP inhibitors were in-licensed from AECOM and IRL in June 2000.
Corporate Alliances
Roche. In November 2005, we entered into an exclusive license with Roche for the development
and commercialization of our second generation PNP inhibitor, BCX-4208, for the prevention of acute
rejection in transplantation and for the treatment of autoimmune diseases. Under the terms of the
agreement, Roche obtained worldwide rights to BCX-4208 in exchange for an up-front payment of $30
million, which included a payment as reimbursement for a limited supply of material during the
first 24 months of the collaboration, ff he license also provided for future
milestone event
2008-09-02 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
Via Facsimile and U.S. Mail Mail Stop 6010 August 29, 2008 Mr. Stuart Grant Chief Financial Officer 2190 Parkway Lake Drive Birmingham, Alabama 35244 Re: Biocryst Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2007 File No. 0-23186 Dear Mr. Grant: We have reviewed your filing and have the following comments. In our comments, we ask you to provide us with information to better understand your disclosure. Where it requests you to revi se disclosure, the information you provide should show us what the revised disclosure will look like and identify the annual or quarterly filing, as applicable, in which you intend to first include it. If you do not believe that revised disclosure is necessary, explain the reason in your response. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Form 10-K for the Fiscal Year Ended December 31, 2007 Item 1. Business Collaboration and In-License Relationships, page 12 1. To the extent not already disclosed, pl ease include the following information in the discussion of each of your corpor ate alliances, academic alliances and government contracts: • each party’s rights and obliga tions under the agreement; Mr. Stuart Grant Biocryst Pharmaceuticals, Inc. August 29, 2008 Page 2 • the percentage range of royalties; • the aggregate potential m ilestone payments; and • the expiration and termination provisions. Results of Operations Year ended December 31, 2007 compared with the year ended December 31, 2006, page 38 2. Please tell us why it was appropriate under GAAP to defer $2.3 million in pre- contract costs incurred in 2006 a nd expense these costs in 2007. Note 1. Significant Accounting Policies Receivables from Collaborations, page 53 3. Please explain in expanded disclosure why you had such a significant receivable ($36.5 million) from HHS at Decem ber 31, 2007. Explain why revenue recognition in 2007 was appropriate. Pa ge 41 indicates that you bill HHS monthly Research and Development expense, page 55 4. Please clarify for us in your disclosure the accounting for sublicense payments and maintenance payments and your basis of accounting for these payments. Provide the nature of cost s deferred and why you believe deferral is appropriate. Note 10. Collaborative and Other Research and Development C ontracts, page 64 5. Provide the disclosures specified in paragr aph 14b of FAS 68 or tell us why they are not required. Item 15. Exhibits and Financia l Statement Schedules, page 73 6. It appears that you have not filed as an exhibit to your filing a copy of your agreement with Green Cross Corporation. Pl ease file this agreement as an exhibit to your filing or, alternatively, please pr ovide us with a supplemental analysis supporting your determination that you are not substantially dependent on this agreement. Form 10-Q for the quarter ended March 31, 2008 Marketable Securities, page 5 7. Please tell us what the impact, if any, of adopting FAS 159 had on your financial statements. Explain why the disclosure of adopting the standard was not warranted. Mr. Stuart Grant Biocryst Pharmaceuticals, Inc. August 29, 2008 Page 3 Form 10-Q for the quarter ended June 30, 2008 8. You reversed $4.9 million of revenues relate d to your contract with HHS in the quarter ended June 30, 2008. Please expl ain why you believed it was appropriate under GAAP to recognize these revenues in an earlier period, that is, why you believed these Phase III costs were reim bursable under the contract. We note in January 2008 you announced that development costs would exceed the amount of the contract and HHS indicated they woul d fund certain elements of the revised program. *************************** Please respond to these comments within 10 business days or tell us when you will provide us with a response. Please furnish a letter that keys your response to our comments and provide the requested information. Detailed letters gr eatly facilitate our review. Please furnish the letter to us via EDGAR under the form type label CORRESP. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; 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 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. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comments on your filing. Mr. Stuart Grant Biocryst Pharmaceuticals, Inc. August 29, 2008 Page 4 Please contact Sasha Parikh, Staff Acc ountant, at (202) 551-3627 or Lisa Vanjoske, Assistant Chief Accountant, at ( 202) 551-3614 if you have questions regarding the processing of our response as well as any questions regarding comments on the financial statements and related matters. You may contact Sebastian Gomez-Abero, Staff Attorney, at (202) 551-3621 or Suzanne Haye s, Legal Branch Chief at (202) 551-3675 with questions on any other comm ents. In this regard, do not hesitate to contact me at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2007-02-15 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
Via Facsimile and U.S. Mail
Mail Stop 6010
February 15, 2007
Mr. Charles E. Bugg, Ph.D.
Chairman and Chief Executive Officer
BioCryst Pharmaceuticals, Inc.
2190 Parkway Lake Drive
Birmingham, AL 35244
Re: BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Bugg:
We have completed our review of your Form 10-K and have no further comment
at this time.
S i n c e r e l y ,
Jim Atkinson
Accounting Branch Chief
2007-02-05 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
1
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corresp
[LETTERHEAD OF HOLME ROBERTS & OWEN LLP]
December 15, 2006
Via EDGAR and Overnight Courier
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D. C. 20549-6010
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Rosenberg:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”), please find the responses and the
supplemental information requested by the Staff of the Securities and Exchange Commission (the
“Staff”) in its letter dated November 15, 2006 to Charles E. Bugg, Ph.D., Chairman and Chief
Executive Officer of the Company, which the Company received on December 4, 2006 (the “Comment
Letter”), with respect to the above-referenced Annual Report on Form 10-K of the Company. The
responses and supplemental information provided herein in response to the Comment Letter are based
upon conferences with representatives of the Company and other information supplied by its
advisors. We have not independently verified the accuracy and completeness of such information.
The full text of the comment contained in the Comment Letter has been reproduced below,
followed by the Company’s response.
Mr. Jim B. Rosenberg
December 15, 2006
Page 2
Form 10-K for the Fiscal Year Ended December 31, 2005
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,
page 34
Overview, Page 34
1.
We note your detailed discussion of the status of each of your significant project in the
business section. To further supplement the usefulness of that information, please provide to
us in disclosure type format the following information for each of your major research and
development projects identified:
a)
The costs incurred during each period presented and to date on the project;
b)
The nature, timing and estimated costs of the efforts necessary to complete
the project;
c)
The anticipated completion dates;
d)
The risks and uncertainties associated with completing development on
schedule, and the consequences to operations, financial position and liquidity if the
project is not completed timely; and finally
e)
The period in which material net cash inflows from significant projects are
expected to commence.
To the extent that information requested above is not known or estimable, disclose that
fact and the reason why it is not known.
As requested, the Company hereby supplementally provides the Staff with the information in
disclosure type format enclosed herewith as Exhibit A, which details the costs incurred
during each of the years ended December 31, 2005, 2004 and 2003 for each major product development
program identified in the Business section of the Form 10-K. The enclosed disclosure also sets
forth the risks and uncertainties associated with completing development of each program. However,
determination of the costs incurred to date are not disclosed, due to the fact that the information
is not readily available.
Mr. Jim B. Rosenberg
December 15, 2006
Page 3
To disclose such information would require substantial assumptions without adequate basis.
Further, based on the Company’s current development status of these projects, we would not expect
the presentation of historical costs to be important to investors.
The Company hereby advises the Staff that at this time it cannot predict the anticipated
completion date of or the period in which material net cash inflows are expected to commence from
each project. As described in the enclosed disclosure, completion dates and material net cash
inflows from the Company’s research and development programs are subject to a number of risks and
uncertainties, including the availability of capital, the development progress of existing or
potential future partnerships for its drug candidates, the progress and results of the Company’s
current and proposed clinical trials for its drug candidates and the allocation of resources among
programs.
Other
In connection with responding to the Staff’s comments, and as requested in the Comment Letter,
enclosed with the letter is a statement from the Company acknowledging that:
•
the Company is responsible for the adequacy and accuracy of the disclosure
in the filing;
•
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
•
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.
Mr. Jim B. Rosenberg
December 15, 2006
Page 4
If you would like to discuss the responses above or any other matter, please contact the
undersigned at (303) 866-0583 or Jennifer D’Alessandro at (303) 866-0635.
Sincerely,
/s/ Richard R. Plumridge
Richard R. Plumridge
cc:
Kei Ino
Jim Atkinson
Charles E. Bugg, Ph.D.
Michael A. Darwin
Exhibit A
Supplemental Disclosure on Research and Development Expenses
Research and Development Expenses
Major components of R&D expenses consist of personnel costs, including salaries and benefits,
manufacturing costs, clinical, regulatory, and toxicology services performed by contract research
organizations (CRO’s), materials and supplies, and overhead allocations consisting of various
administrative and facilities related costs. We charge these costs to expense when incurred,
consistent with Statement of Financial Accounting Standards No. 2, Accounting for Research and
Development Costs. These costs are a significant component of R&D expenses. Most of our
manufacturing and our clinical and preclinical studies are performed by third-party CRO’s. We
accrue costs for studies performed by CRO’s over the service periods specified in the contracts and
adjust our estimates, if required, based upon our on-going review of the level of services actually
performed. We expense both our internal and external research and development costs as incurred.
Additionally, we have license agreements with third parties, such as AECOM and IRL that
require maintenance fees or fees related to sublicense agreements. These fees are generally
expensed as incurred unless they are related to revenues that have been deferred in which case the
expenses will be deferred and recognized over the related revenue recognition period.
We group our R&D expenses into two major categories: direct external expenses and all other
R&D expenses. Direct external expenses consist of costs of outside parties to conduct laboratory
studies, to develop manufacturing processes and manufacture the product candidate, to conduct and
manage clinical trials and similar costs related to our clinical and preclinical studies. These
costs are accumulated and tracked by program. All other R&D expenses consist of costs to compensate
personnel, to purchase lab supplies and services, to maintain our facility, equipment and overhead
and similar costs of our research and development efforts. These costs apply to work on our
clinical and preclinical candidates as well as our discovery research efforts. These costs have not
been charged directly to each program historically because the number of product candidates and
projects in research and development may vary from period to period and because we utilize internal
resources across multiple projects at the same time.
The following table summarizes our R&D expenses for the periods indicated:
Year Ended December 31,
2005
2004
2003
Direct external R&D expenses by program:
PNP Inhibitor (Fodosine™)
9,256,417
8,031,922
3,223,202
PNP Inhibitor (BCX-4208)
3,563,966
2,815,773
—
Neuraminidase Inhibitor (peramivir)
1,454,738
27,059
160,489
Hepatitis C Polymerase Inhibitor
446,828
205,741
255,581
Tissue Factor/Factor VIIa Inhibitor
25,072
472,633
597,039
Other
21,167
19,451
22,361
All other R&D Expenses
8,874,189
7,295,533
7,263,310
Total R&D Expenses
$
23,642,377
$
18,868,112
$
11,521,982
At this time, due to the risks inherent in the clinical trial process and given the
stages of our various product development programs, we are unable to estimate with any certainty
the costs we will incur in the continued development of our drug candidates for potential
commercialization. While we are currently focused on advancing each of our product development
programs, our future R&D expenses will depend on the determinations we make as to the scientific
and clinical success of each drug candidate, as well as ongoing assessments as to each drug
candidate’s commercial potential. As such, we are unable to predict how we will allocate available
resources among our product development programs in the future. In addition, we cannot forecast
with any degree of certainty the development progress of our existing partnerships for our drug
candidates, which drug candidates will be subject to future collaborations, when such arrangements
will be secured, if at all, and to what degree such arrangements would affect our development plans
and capital requirements.
The successful development of our drug candidates is uncertain and subject to a number of
risks. We cannot be certain that any of our drug candidates will prove to be safe and effective or
will meet all of the applicable regulatory requirements needed to receive and maintain marketing
approval. Data from preclinical studies and clinical trials are susceptible to varying
interpretations that could delay, limit or prevent regulatory clearance. We, the FDA or other
regulatory authorities may suspend clinical trials at any time if we or they believe that the
subjects participating in such trials are being exposed to unacceptable risks or if such regulatory
agencies find deficiencies in the conduct of the trials or other problems with our products under
development. Delays or rejections may be encountered based on additional governmental regulation,
legislation, administrative action or changes in FDA or other regulatory policy during development
or the review process. Other risks associated with our product development programs are described
in Risk Factors in Part I, Item 1A of this Annual Report on Form 10-K, as updated from time to time
in our subsequent periodic reports and current reports filed with the SEC. Due to these uncertainties, accurate and meaningful estimates of the ultimate cost to
bring a product to market, the timing of completion of any of our product development programs and
the period in which material net cash inflows from any of our product development programs will
commence are unavailable.
[LETTERHEAD OF HOLME ROBERTS & OWEN LLP]
January 19, 2007
Via EDGAR and Overnight Courier
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D. C. 20549-6010
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Rosenberg:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”), please find the responses and the
supplemental information requested orally by the Staff of the Securities and Exchange Commission
(the “Staff”) in a telephone conversation on January 9, 2007 (the “Jan. 9 Comment”), with respect
to the above-referenced Annual Report on Form 10-K of the Company. The responses and supplemental
information provided herein in response to the Jan. 9 Comment are based upon conferences with
representatives of the Company and other information supplied by its advisors. We have not
independently verified the accuracy and completeness of such information.
As requested, the Company has revised the supplemental tabular disclosure previously provided
to the Staff in the response letter dated December 15, 2006 (the “Dec. 15 Response Letter”), to
quantify the categories of costs incurred under the “All other R&D expenses” category. The revised
supplemental tabular disclosure is enclosed herewith as Exhibit B. The Company undertakes
to include disclosure of the type enclosed with the Dec. 15 Response Letter as Exhibit A,
as modified in accordance with
Mr. Jim B. Rosenberg
January 19, 2007
Page 2
Exhibit B enclosed herewith, in its Management’s Discussion and Analysis for future
reporting periods, commencing with the Company’s Annual Report on Form 10-K for the year ended
December 31, 2006.
If you would like to discuss the responses above or any other matter, please contact the
undersigned at (303) 866-0583 or Jennifer D’Alessandro at (303) 866-0635.
Sincerely,
/s/ Richard R. Plumridge
Richard R. Plumridge
cc:
Kei Ino
Jim Atkinson
Jon P. Stonehouse
Michael A. Darwin
Exhibit B
Supplemental Disclosure on Research and Development Expenses
Year Ended December 31,
2005
2004
2003
Direct external R&D expenses by program:
PNP Inhibitor (Fodosine™)
$
9,256,417
$
8,031,922
$
3,223,202
PNP Inhibitor (BCX-4208)
3,563,966
2,815,773
—
Neuraminidase Inhibitor (peramivir)
1,454,738
27,059
160,489
Hepatitis C Polymerase Inhibitor
446,828
205,741
255,581
Tissue Factor/Factor VIIa Inhibitor
25,072
472,633
597,039
Other
21,167
19,451
22,361
All other R&D expenses:
Compensation and fringe benefits
3,813,281
3,115,231
2,792,416
Supplies and services
572,056
88,515
695,449
Maintenance, depreciation, and amortization
984,680
1,227,117
1,434,000
Overhead allocation and other
3,504,172
2,864,670
2,341,445
Total R&D Expenses
$
23,642,377
$
18,868,112
$
11,521,982
2007-01-19 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
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DENVER
BOULDER
COLORADO SPRINGS
LONDON
LOS ANGELES
MUNICH
SALT LAKE CITY
SAN FRANCISCO
January 19, 2007
Via EDGAR and Overnight Courier
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D. C. 20549-6010
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Rosenberg:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”), please find the responses and the
supplemental information requested orally by the Staff of the Securities and Exchange Commission
(the “Staff”) in a telephone conversation on January 9, 2007 (the “Jan. 9 Comment”), with respect
to the above-referenced Annual Report on Form 10-K of the Company. The responses and supplemental
information provided herein in response to the Jan. 9 Comment are based upon conferences with
representatives of the Company and other information supplied by its advisors. We have not
independently verified the accuracy and completeness of such information.
As requested, the Company has revised the supplemental tabular disclosure previously provided
to the Staff in the response letter dated December 15, 2006 (the “Dec. 15 Response Letter”), to
quantify the categories of costs incurred under the “All other R&D expenses” category. The revised
supplemental tabular disclosure is enclosed herewith as Exhibit B. The Company undertakes
to include disclosure of the type enclosed with the Dec. 15 Response Letter as Exhibit A,
as modified in accordance with Exhibit B enclosed herewith, in its Management’s Discussion
and Analysis for future reporting periods, commencing with the Company’s Annual Report on Form 10-K
for the year ended December 31, 2006.
Richard R. Plumridge 303.866.0583 rich.plumridge@hro.com
1700 Lincoln Street, Suite 4100 Denver, Colorado 80203-4541 tel 303.861.7000 fax 303.866.0200
Mr. Jim B. Rosenberg
January 19, 2007
Page 2
Please note that confidential treatment of the enclosed Exhibit B is requested under
the Freedom of Information Act (“FOIA”). Accordingly, we have marked the enclosed Exhibit B with the legend “FOIA Confidential Treatment Requested.”
If you would like to discuss the responses above or any other matter, please contact the
undersigned at (303) 866-0583 or Jennifer D’Alessandro at (303) 866-0635.
Sincerely,
/s/ Richard R. Plumridge
Richard R. Plumridge
cc:
Kei Ino
Jim Atkinson
Jon P. Stonehouse
Michael A. Darwin
2006-12-21 - UPLOAD - BIOCRYST PHARMACEUTICALS INC
Via Facsimile and U.S. Mail
Mail Stop 6010
November 15, 2006
Mr. Charles E. Bugg, Ph.D.
Chairman and Chief Executive Officer
BioCryst Pharmaceuticals, Inc.
2190 Parkway Lake Drive
Birmingham, AL 35244
Re: BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Bugg:
We have reviewed your filing and have the following comment. We have limited
our review to only your financia l statements and related disclosures and do not intend to
expand our review to other portions of your document. In our comment, we ask you to
provide us with information so we may better understand your disclosure. After
reviewing this information, we may raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-K for the Fiscal Year Ended December 31, 2005
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of
Operations, page 34
Overview, page 34
1. We note your detailed discussion of the status of each of your significant project in the business section. To further supplement the usefulness of that information,
please provide to us in disclosure type format the following information for each
of your major research and de velopment projects identified:
Mr. Charles E. Bugg, Ph.D.
BioCryst Pharmaceuticals, Inc.
November 15, 2006 Page 2
a) The costs incurred during each period presented and to date on the project;
b) The nature, timing and estimated costs of the efforts necessary to complete the
project;
c) The anticipated completion dates;
d) The risks and uncertainties associated with completing development on schedule, and the consequences to oper ations, financial position and liquidity
if the project is not completed timely; and finally
e) The period in which material net cash in flows from significant projects are
expected to commence.
To the extent that information request ed above is not known or estimable,
disclose that fact and th e reason why it is not known.
* * * *
Please respond to this comment within 10 business days or tell us when you will
provide us with a response. Please furnish a letter that keys your responses to our
comment and provide the request ed information. Detailed le tters greatly facilitate our
review. Please file your letter on E DGAR under the form type label CORRESP.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
• 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
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities laws of the
United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
Mr. Charles E. Bugg, Ph.D.
BioCryst Pharmaceuticals, Inc.
November 15, 2006 Page 3
You may contact Kei Ino, Staff Accountan t, at (202) 551-3659 or Jim Atkinson,
Accounting Branch Chief, at (202) 551- 3622 if you have questions regarding the
comments. In this regard, do not hes itate to contact me at (202) 551-3674.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
2006-12-15 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
1
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BIOCRYST PHARMACEUTICALS, INC.
2190 Parkway Lake Drive
Birmingham, AL 35244
December 15, 2006
Via EDGAR and Overnight Courier
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D. C. 20549-6010
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Rosenberg:
This letter includes the acknowledgement requested by the Staff of the Securities and Exchange
Commission in its letter dated November 15, 2005 to Charles E. Bugg, Ph.D. with respect to the
above-referenced Annual Report on Form 10-K.
In connection with responding to the Staff’s comments, and as requested in the Comment Letter,
the Company hereby acknowledges that:
•
the Company is responsible for the adequacy and accuracy of the disclosure in the
filing;
•
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
•
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.
Very truly yours,
/s/ Michael A. Darwin
Michael A. Darwin
cc:
Kei Ino
Jim Atkinson
Charles E. Bugg, Ph.D.
Richard R. Plumridge, Esq.
2006-12-15 - CORRESP - BIOCRYST PHARMACEUTICALS INC
CORRESP
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DENVER
BOULDER
COLORADO SPRINGS
LONDON
LOS ANGELES
MUNICH
SALT LAKE CITY
SAN FRANCISCO
December 15, 2006
Via EDGAR and Overnight Courier
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D. C. 20549-6010
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Rosenberg:
On behalf of BioCryst Pharmaceuticals, Inc. (the “Company”), please find the responses and the
supplemental information requested by the Staff of the Securities and Exchange Commission (the
“Staff”) in its letter dated November 15, 2006 to Charles E. Bugg, Ph.D., Chairman and Chief
Executive Officer of the Company, which the Company received on December 4, 2006 (the “Comment
Letter”), with respect to the above-referenced Annual Report on Form 10-K of the Company. The
responses and supplemental information provided herein in response to the Comment Letter are based
upon conferences with representatives of the Company and other information supplied by its
advisors. We have not independently verified the accuracy and completeness of such information.
The full text of the comment contained in the Comment Letter has been reproduced below,
followed by the Company’s response.
Richard R. Plumridge 303.866.0583 rich.plumridge@hro.com
1700 Lincoln Street, Suite 4100 Denver, Colorado 80203-4541 tel 303.861.7000 fax 303.866.0200
Mr. Jim B. Rosenberg
December 15, 2006
Page 2
Form 10-K for the Fiscal Year Ended December 31, 2005
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,
page 34
Overview, Page 34
1.
We note your detailed discussion of the status of each of your significant project in the
business section. To further supplement the usefulness of that information, please provide to
us in disclosure type format the following information for each of your major research and
development projects identified:
a)
The costs incurred during each period presented and to date on the project;
b)
The nature, timing and estimated costs of the efforts necessary to complete
the project;
c)
The anticipated completion dates;
d)
The risks and uncertainties associated with completing development on
schedule, and the consequences to operations, financial position and liquidity if the
project is not completed timely; and finally
e)
The period in which material net cash inflows from significant projects are
expected to commence.
To the extent that information requested above is not known or estimable, disclose that
fact and the reason why it is not known.
As requested, the Company hereby supplementally provides the Staff with the information in
disclosure type format enclosed herewith as Exhibit A, which details the costs incurred
during each of the years ended December 31, 2005, 2004 and 2003 for each major product development
program identified in the Business section of the Form 10-K. The enclosed disclosure also sets
forth the risks and uncertainties associated with completing development of each program. However,
determination of the costs incurred to date are not disclosed, due to the fact that the information
is not readily available. To
Mr. Jim B. Rosenberg
December 15, 2006
Page 3
disclose such information would require substantial assumptions without adequate basis.
Further, based on the Company’s current development status of these projects, we would not expect
the presentation of historical costs to be important to investors.
The Company hereby advises the Staff that at this time it cannot predict the anticipated
completion date of or the period in which material net cash inflows are expected to commence from
each project. As described in the enclosed disclosure, completion dates and material net cash
inflows from the Company’s research and development programs are subject to a number of risks and
uncertainties, including the availability of capital, the development progress of existing or
potential future partnerships for its drug candidates, the progress and results of the Company’s
current and proposed clinical trials for its drug candidates and the allocation of resources among
programs.
Please note that confidential treatment of the enclosed Exhibit A is requested under
the Freedom of Information Act (“FOIA”). Accordingly, we have marked the enclosed Exhibit
A with the legend “FOIA Confidential Treatment Requested.”
Other
In connection with responding to the Staff’s comments, and as requested in the Comment Letter,
enclosed with the letter is a statement from the Company acknowledging that:
•
the Company is responsible for the adequacy and accuracy of the disclosure
in the filing;
•
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
•
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.
Mr. Jim B. Rosenberg
December 15, 2006
Page 4
If you would like to discuss the responses above or any other matter, please contact the
undersigned at (303) 866-1583 or Jennifer D’Alessandro at (303) 866-0635.
Sincerely,
/s/ Richard R. Plumridge
Richard R. Plumridge
cc:
Kei Ino
Jim Atkinson
Charles E. Bugg, Ph.D.
Michael A. Darwin
2006-12-08 - CORRESP - BIOCRYST PHARMACEUTICALS INC
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BIOCRYST PHARMACEUTICALS, INC.
2190 Parkway Lake Drive
Birmingham, AL 35244
December 8, 2006
Via EDGAR
Mr. Jim B. Rosenberg
Senior Assistant Chief Accountant
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F Street, N.E.
Washington, D. C. 20549-6010
Re:
BioCryst Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2005
Filed March 9, 2006
File No. 000-23186
Dear Mr. Rosenberg:
In connection with the letter from the Staff of the Securities and Exchange Commission (the
“Staff”) dated November 15, 2006 to Charles E. Bugg, Ph.D., Chairman and Chief Executive Officer of
BioCryst Pharmaceuticals, Inc. (“the Company”), which the Company received on December 4, 2006 (the
“Comment Letter”), and as you requested in a telephone conversation with the undersigned earlier
today, the Company hereby advises the Staff that it will provide the responses and supplemental
information requested in the Comment Letter to the Staff no later than December 15, 2006.
Very truly yours,
/s/ Michael A. Darwin
Michael A. Darwin
cc:
Kei Ino
Jim Atkinson
Charles E. Bugg, Ph.D.
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