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CURIS INC
Response Received
1 company response(s)
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CURIS INC
Response Received
1 company response(s)
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CURIS INC
Response Received
1 company response(s)
High - file number match
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CURIS INC
Response Received
1 company response(s)
High - file number match
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CURIS INC
Awaiting Response
0 company response(s)
High
CURIS INC
Response Received
1 company response(s)
Medium - date proximity
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CURIS INC
Response Received
1 company response(s)
High - file number match
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CURIS INC
Response Received
1 company response(s)
High - file number match
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CURIS INC
Response Received
2 company response(s)
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CURIS INC
Response Received
1 company response(s)
High - file number match
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CURIS INC
Awaiting Response
0 company response(s)
High
CURIS INC
Response Received
10 company response(s)
High - file number match
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Company responded
2005-06-20
CURIS INC
References: June 7, 2005
Summary
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Company responded
2005-09-28
CURIS INC
References: August 22, 2005
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Company responded
2005-11-09
CURIS INC
References: November 1, 2005 | September 23, 2005
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Company responded
2005-11-28
CURIS INC
References: November 18, 2005 | November 9, 2005
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Company responded
2006-03-21
CURIS INC
References: December 7, 2005 | November 23, 2005
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Company responded
2009-09-18
CURIS INC
References: September 14, 2009
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Company responded
2009-10-02
CURIS INC
References: September 14, 2009
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Company responded
2009-10-02
CURIS INC
References: September 14, 2009
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Company responded
2009-10-16
CURIS INC
References: October 13, 2009
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CURIS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-10-13
CURIS INC
References: October 2, 2009 | September 14, 2009
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CURIS INC
Awaiting Response
0 company response(s)
High
CURIS INC
Awaiting Response
0 company response(s)
High
CURIS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2005-12-07
CURIS INC
References: November 18, 2005
Summary
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CURIS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2005-11-18
CURIS INC
References: November 1, 2005
Summary
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CURIS INC
Awaiting Response
0 company response(s)
High
CURIS INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2005-08-22
CURIS INC
References: June 7, 2005
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-14 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2025-08-13 | SEC Comment Letter | CURIS INC | DE | 333-289456 | Read Filing View |
| 2025-05-15 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2025-05-13 | SEC Comment Letter | CURIS INC | DE | 333-287014 | Read Filing View |
| 2025-01-03 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2024-12-31 | SEC Comment Letter | CURIS INC | DE | 333-284009 | Read Filing View |
| 2024-04-10 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2024-02-13 | SEC Comment Letter | CURIS INC | DE | 333-276950 | Read Filing View |
| 2024-01-03 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2023-12-21 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2023-12-12 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2018-05-15 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2018-05-14 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2016-12-15 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2016-12-14 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2015-08-31 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2015-08-12 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2015-07-08 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2015-04-29 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2015-04-23 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2009-11-13 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-16 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-13 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-02 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-02 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-09-18 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-09-14 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2006-04-19 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2006-03-21 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2006-03-21 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-12-07 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-28 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-18 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-09 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-01 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-09-28 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-08-22 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-06-20 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-06-07 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-13 | SEC Comment Letter | CURIS INC | DE | 333-289456 | Read Filing View |
| 2025-05-13 | SEC Comment Letter | CURIS INC | DE | 333-287014 | Read Filing View |
| 2024-12-31 | SEC Comment Letter | CURIS INC | DE | 333-284009 | Read Filing View |
| 2024-02-13 | SEC Comment Letter | CURIS INC | DE | 333-276950 | Read Filing View |
| 2024-01-03 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2023-12-12 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2018-05-14 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2016-12-14 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2015-07-08 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2015-04-23 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2009-11-13 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-13 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2009-09-14 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2006-04-19 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-12-07 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-18 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-01 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-08-22 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| 2005-06-07 | SEC Comment Letter | CURIS INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-14 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2025-05-15 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2025-01-03 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2024-04-10 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2023-12-21 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2018-05-15 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2016-12-15 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2015-08-31 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2015-08-12 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2015-04-29 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-16 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-02 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-10-02 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2009-09-18 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2006-03-21 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2006-03-21 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-28 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-11-09 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-09-28 | Company Response | CURIS INC | DE | N/A | Read Filing View |
| 2005-06-20 | Company Response | CURIS INC | DE | N/A | Read Filing View |
2025-08-14 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Document August 14, 2025 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Chris Edwards Re: Curis, Inc. Registration Statement on Form S-1 File No. 333-289456 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Curis, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333- 289456), so that it may become effective at 4:30 p.m., Eastern Time, on August 18, 2025, or as soon as practicable thereafter. Very truly yours, CURIS, INC. By: /s/ Diantha Duvall Name: Diantha Duvall Title: Chief Financial Officer 128 Spring Street | Building C – Suite 500 | Lexington, MA 02421-3112 | www.curis.com | Phone 617.503.6500
2025-08-13 - UPLOAD - CURIS INC File: 333-289456
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 13, 2025 James E. Dentzer President and Chief Executive Officer Curis, Inc. 128 Spring Street, Building C Suite 500 Lexington, MA 02421 Re: Curis, Inc. Registration Statement on Form S-1 Filed August 11, 2025 File No. 333-289456 Dear James E. Dentzer: 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. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Caroline Dotolo, Esq. </TEXT> </DOCUMENT>
2025-05-15 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Document May 15, 2025 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Tyler Howes Re: Curis, Inc. Registration Statement on Form S-3 File No. 333-287014 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Curis, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-287014), so that it may become effective at 4:30 p.m., Eastern Time, on May 19, 2025, or as soon as practicable thereafter. Very truly yours, CURIS, INC. By: /s/ Diantha Duvall Name: Diantha Duvall Title: Chief Financial Officer 128 Spring Street | Building C – Suite 500 | Lexington, MA 02421-3112 | www.curis.com | Phone 617.503.6500
2025-05-13 - UPLOAD - CURIS INC File: 333-287014
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 13, 2025 James Dentzer Chief Executive Officer Curis, Inc. 128 Spring Street, Building C Suite 500 Lexington, MA 02421 Re: Curis, Inc. Registration Statement on Form S-3 Filed May 7, 2025 File No. 333-287014 Dear James Dentzer: 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 Tyler Howes at 202-551-3370 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Caroline Dotolo, Esq. </TEXT> </DOCUMENT>
2025-01-03 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Document January 3, 2025 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance, Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Jessica Dickerson Re: Curis, Inc. Registration Statement on Form S-3 File No. 333-284009 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Curis, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-284009), so that it may become effective at 4:30 p.m., Eastern Time, on January 7, 2025, or as soon as practicable thereafter. Very truly yours, CURIS, INC. By: /s/ Diantha Duvall Name: Diantha Duvall Title: Chief Financial Officer
2024-12-31 - UPLOAD - CURIS INC File: 333-284009
December 31, 2024
James E. Dentzer
President and Chief Executive Officer
Curis, Inc.
128 Spring Street, Building C - Suite 500
Lexington, MA 02421
Re:Curis, Inc.
Registration Statement on Form S-3
Filed December 23, 2024
File No. 333-284009
Dear James E. Dentzer:
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 Jessica Dickerson at 202-551-8013 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Cynthia T. Mazareas, Esq.
2024-04-10 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Document April 10, 2024 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance, Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Jimmy McNamara Re: Curis, Inc. Registration Statement on Form S-3 File No. 333-276950 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Curis, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-276950), so that it may become effective at 4:30 p.m., Eastern Time, on April 12, 2024, or as soon as practicable thereafter. Very truly yours, CURIS, INC. By: /s/ Diantha Duvall Name: Diantha Duvall Title: Chief Financial Officer
2024-02-13 - UPLOAD - CURIS INC File: 333-276950
United States securities and exchange commission logo
February 13, 2024
Diantha Duvall
Chief Financial Officer
Curis Inc.
128 Spring Street, Building C – Suite 500
Lexington, MA 02421
Re:Curis Inc.
Registration Statement on Form S-3
Filed February 8, 2024
File No. 333-276950
Dear Diantha Duvall:
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 Jimmy McNamara at 202-551-7349 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Cynthia Mazareas
2024-01-03 - UPLOAD - CURIS INC
United States securities and exchange commission logo
January 3, 2024
Diantha Duvall
Chief Financial Officer
Curis, Inc.
128 Spring Street
Building C - Suite 500
Lexington, Massachusetts 02421
Re:Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2022
File No. 000-30347
Dear Diantha Duvall:
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
2023-12-21 - CORRESP - CURIS INC
CORRESP
1
filename1.htm
Document
December 21, 2023
By Electronic Submission
Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street, N.E.
Washington, DC 20549
Attention: Gary Newberry and Kevin Kuhar
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2022
Filed March 13, 2023
File No. 001-30347
Ladies and Gentlemen:
Curis, Inc. (the “Company” or “we”) is responding to the comments of the staff (the “Staff”) of the Securities and Exchange Commission contained in the Staff’s letter dated December 12, 2023 (the “Comment Letter”), relating to the above referenced Form 10-K for the fiscal year ended December 31, 2022. For convenience, the Company’s responses below are keyed to the numbering of the comment and heading used in the Comment Letter.
Form 10-K for the Fiscal Year ended December 31, 2022
Item 9A - Controls and Procedures, page 113
1. In an abbreviated amended filing for this Item 9A, please provide the disclosures required by Item 307 of Regulation S-K regarding the effectiveness of your disclosure controls and procedures. Refer to Rule 12b-15 of the Exchange Act and Question 161.01 of the Compliance and Disclosure Interpretations for Exchange Act Rules.
Response: The Company acknowledges the Staff’s comment and has provided the disclosures required by Item 307 of Regulation S-K regarding the effectiveness of the Company’s disclosure controls and procedures by filing an abbreviated Amendment No. 1 to its Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (617) 503-6602. Thank you for your assistance.
Securities and Exchange Commission
December 21, 2023
Page 2
Very truly yours,
/s/ Diantha Duvall
Diantha Duvall
Chief Financial Officer
cc: James E. Dentzer, Chief Executive Officer, Curis, Inc.
Cynthia Mazareas, Wilmer Cutler Pickering Hale and Dorr LLP
2023-12-12 - UPLOAD - CURIS INC
United States securities and exchange commission logo
December 12, 2023
Diantha Duvall
Chief Financial Officer
Curis, Inc.
128 Spring Street
Building C - Suite 500
Lexington, Massachusetts 02421
Re:Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2022
File No. 000-30347
Dear Diantha Duvall:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment.
Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to this letter, we may have additional comments.
Form 10-K for Fiscal Year Ended December 31, 2022
Item 9A - Controls and Procedures, page 113
1.In an abbreviated amended filing for this Item 9A, please provide the disclosures required
by Item 307 of Regulation S-K regarding the effectiveness of your disclosure controls and
procedures. Refer to Rule 12b-15 of the Exchange Act and Question 161.01 of the
Compliance and Disclosure Interpretations for Exchange Act Rules.
In closing, 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.
FirstName LastNameDiantha Duvall
Comapany NameCuris, Inc.
December 12, 2023 Page 2
FirstName LastName
Diantha Duvall
Curis, Inc.
December 12, 2023
Page 2
Please contact Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-551-3662 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2018-05-15 - CORRESP - CURIS INC
CORRESP 1 filename1.htm CORRESP Curis, Inc. 4 Maguire Road Lexington, MA 02421 May 15, 2018 Via EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Curis, Inc. Registration Statement on Form S-3 File No. 333-224627 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Curis, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-224627) (the “Registration Statement”), so that it may become effective at 4:30 p.m. Eastern time on May 17, 2018, or as soon thereafter as practicable. [The remainder of this page is intentionally left blank.] Very truly yours, Curis, Inc. By: /s/ Ali Fattaey Name: Title: Ali Fattaey, Ph.D. President and Chief Executive Officer
2018-05-14 - UPLOAD - CURIS INC
May 14, 2018
Ali Fattaey
President and Chief Executive Officer
Curis, Inc.
4 Maguire Road
Lexington, Massachusetts 02421
Re:Curis Inc.
Registration Statement on Form S-3
Filed May 3, 2018
File No. 333-224627
Dear Dr. Fattaey:
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 Irene Paik at 202-551-6553 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Cynthia T. Mazareas, Esq.
2016-12-15 - CORRESP - CURIS INC
CORRESP 1 filename1.htm CORRESP December 15, 2016 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Curis, Inc. Registration Statement on Form S-3 File No. 333-214899 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Curis, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-214899) (the “Registration Statement”), so that it may become effective at 4:00 p.m. Eastern time on December 16, 2016, or as soon thereafter as practicable. [The remainder of this page is intentionally left blank.] 4 Maguire Road, Lexington, MA 02421-3112 | www.curis.com | Phone 617.503.6500 | Fax 617.503.6501 Very truly yours, Curis, Inc. By: /s/ James E. Dentzer Name: Title: James E. Dentzer Chief Financial Officer and Chief Administrative Officer [Signature Page to Request for Acceleration]
2016-12-14 - UPLOAD - CURIS INC
Mail Stop 4565 December 14 , 2016 Ali Fattaey President and Chief Executive Officer Curis, Inc. 4 Maguire Road Lexington, Massachusetts 02421 Re: Curis , Inc. Registration Statement on Form S-3 Filed December 5 , 2016 File No. 333-214899 Dear Mr. Fattaey : 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 Johnny Gharib at (202) 551 -3170 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Cynthia T. Mazareas , Esq. Wilmer Cutler Pickering Hale and Dorr LLP
2015-08-31 - CORRESP - CURIS INC
CORRESP
1
filename1.htm
CORRESP
Curis, Inc.
4 Maguire Road
Lexington, MA 02421
August 31, 2015
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Curis, Inc.
Registration Statement on Form S-3
File No. 333-205460
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461
promulgated under the Securities Act of 1933, as amended, Curis, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-205460) (the “Registration
Statement”), so that it may become effective at 4:00 pm Eastern time on September 2, 2015, or as soon thereafter as practicable.
The Registrant hereby acknowledges that:
(i)
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;
(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and
accuracy of the disclosure in the Registration Statement; and
(iii)
the Registrant may not assert staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws
of the United States.
[Remainder of this page intentionally left blank]
Very truly yours,
CURIS, INC.
By:
/s/ Michael P. Gray
Name: Michael P. Gray
Title: Chief Financial
and Chief Business
Officer
[Signature Page to Curis, Inc. Acceleration Request]
-2-
2015-08-12 - CORRESP - CURIS INC
CORRESP
1
filename1.htm
Acceleration Request
Curis, Inc.
4 Maguire Road
Lexington, MA 02421
August 12, 2015
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Curis, Inc.
Registration Statement on Form S-3
File No. 333-205460
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461
promulgated under the Securities Act of 1933, as amended, Curis, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-205460) (the “Registration
Statement”), so that it may become effective at 4:00 pm Eastern time on August 14, 2015, or as soon thereafter as practicable.
The Registrant hereby acknowledges that:
(i)
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;
(ii)
the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and
accuracy of the disclosure in the Registration Statement; and
(iii)
the Registrant may not assert staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws
of the United States.
[Remainder of this page intentionally left blank]
Very truly yours,
CURIS, INC.
By:
/s/ Michael P. Gray
Name: Michael P. Gray
Title: Chief Financial
and Chief Business
Officer
[Signature Page to Curis, Inc. Acceleration Request]
-2-
2015-07-08 - UPLOAD - CURIS INC
July 8 , 2015 Via E-Mail Michael P. Gray Chief Business and Financial Officer Curis, Inc. 4 Maguire Road Lexington, Massachusetts 02421 Re: Curis, Inc. Registration Statement on Form S -3 Filed July 2 , 2015 File No. 333-205460 Dear Mr. Gray : We have limited our review of your registration statement to the resolution of your pending confidential treatment request. Please be advised that we will not be in a position to declare your registration statement effective until all outstanding comments, if any, on your request for confidential treatment have been cleared. 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 Securities 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 accu racy and adequacy of the disclosures they have made. Notwithstanding our comment , in the event you request acceleration of the effective date of the pending registration statement , please provide a written statement from the company 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 from 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 effe ctiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Michael P. Gray Curis, Inc. July 8 , 2015 Page 2 Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for accel eration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relat e to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact P reston Brewer at (202) 551 -3969 , Dan Greenspan at (202) 551 -3623 or me at (202) 551 -3715 with any questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -Mail Cynthia T. Mazareas , Esq. Wilmer Cutler Pickering Hale and Dorr LLP
2015-04-29 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Correspondence Curis, Inc. 4 Maguire Road Lexington, MA 02421 April 29, 2015 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Curis, Inc. Registration Statement on Form S-3 File No. 333-203480 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Curis, Inc. (the “Registrant”) hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-203480), as amended (the “Registration Statement”), so that it may become effective at 4:30 pm Eastern time on May 1, 2015, or as soon thereafter as practicable. The Registrant hereby acknowledges that: (i) 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; (ii) the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and (iii) the Registrant may not assert staff comments and the declaration of effectiveness of the Registration Statement as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. [Remainder of this page intentionally left blank] Very truly yours, CURIS, INC. By: /s/ Ali Fattaey Name: Ali Fattaey Title: President and Chief Executive Officer [Signature Page to Curis, Inc. Acceleration Request] -2-
2015-04-23 - UPLOAD - CURIS INC
April 23, 2015 Via E -mail Ali Fattaey President and Chief Executive Officer Curis, Inc. 4 Maguire Road Lexington, Massachusetts 02421 Re: Curis, Inc. Registration Statement on Form S-3 Filed April 1 7, 2015 File No. 333-203480 Dear Mr. Fattaey : We have reviewed your registration statement and have the following comment. If you do not believe this comment applies to your facts and circumstances, please tell us why in your response. After reviewing any information you provide in response to this comment, we may have additional comments. 1. We have limited our review of your registration statement to the resolution of your pending confidential treatment request. Please be advised that we will not be in a position to declare your registration statement effective until all outstanding comments , if any, on your request for confidential treatment have been cleared. 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 Securities 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. Notwithstand ing our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated au thority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; Ali Fattaey Curis, Inc. April 23, 2015 Page 2 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from 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 the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified i n the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Please contact Tara Keating Brooks at (202) 551 -8336 , Daniel Greenspan at (202) 551 - 3623 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Via E -mail Steven D. Singer , Esq. Wilmer Cutler Pickering Hale and Dorr LLP
2009-11-13 - UPLOAD - CURIS INC
Mail Stop 4720
November 13, 2009
Mr. Daniel R. Passeri President & Chief Executive Officer Curis, Inc. 45 Moulton Street Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Filed February 26, 2009
Schedule 14A filed April 17, 2009
File No. 000-30347
Dear Mr. Passeri:
We have completed our review of your Fo rm 10-K and related filings and have no
further comments at this time.
Sincerely,
Jeffrey Riedler Assistant Director
2009-10-16 - CORRESP - CURIS INC
CORRESP
1
filename1.htm
SEC Response Letter
October 16, 2009
BY EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Attention: Rose Zukin
Re:
Curis, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Filed February 26, 2009 (“Form 10-K”)
Schedule 14A filed April 17, 2009 (“Schedule 14A”)
File No. 000-30347
Dear Ms. Zukin:
On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the Company’s
responses to comments contained in a letter dated October 13, 2009 (the “Letter”) from Jeffrey Riedler, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to
Mr. Daniel R. Passeri, President and Chief Executive Officer of Curis, relating to the Company’s Form 10-K and Schedule 14A. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP
by the Company. The response is keyed to the numbering of the comments in the Letter and to the headings used in the Letter.
Form 10-K for
Fiscal Year Ended December 31, 2008
General
1.
Please refer to your response to Comment 1. Please note that we will not be in a position to clear outstanding comments on the 10-K until we have reviewed your revised
disclosure in the Form 10-K/A, to be filed.
Response:
We respectfully note your comment. As indicated in our conversation with Ms. Zukin on Friday, October 10, 2009, Curis intends to file its Form 10-K/A
immediately following the Staff’s confirmation that Curis has satisfied all of the Staff’s other comments with respect to its review of the Form 10-K and Schedule 14A.
Securities and Exchange Commission
October 16, 2009
Page 2
Item 1. Business
Intellectual Property, page 7
2.
Please refer to your response to Comment 3. Please provide us with an analysis supporting your determination that the license agreements are not material or significant
to your business. We note that the subject matter of these license agreements is the proprietary technology and data and resources relating to the Hedgehog Pathway. As this technology is the subject of your current, material collaboration agreement
with Genentech, it appears that these license agreements are material to your business. We reissue Comments 3 and 4.
Response:
In its Form 10-K, the Company disclosed that it was a party to various license agreements that give it rights to research, develop and commercialize various
technologies, particularly its Hedgehog pathway technologies, and that its most significant license agreements (collectively, the “License Agreements”) include:
•
license agreements dated February 9, 1995 and September 1, 2000 with the President and Fellows of Harvard University, each of which was
amended and restated effective June 10, 2003 (as restated, collectively, the “Harvard Agreement”);
•
a license agreement dated January 1, 1995, as subsequently amended, with The Trustees of the Columbia University, which has recently been
terminated;
•
a license agreement dated September 26, 1996, which was amended and restated effective June 1, 2003, with the Johns Hopkins University and
the University of Washington School of Medicine (as restated, the “JHU/WashU Agreement”);
•
a license agreement dated May 3, 2000 with the Johns Hopkins University; and
•
a license agreement dated February 12, 1996 with the Leland Stanford Junior University.
The License Agreements are Not Significant or Material
As further described below, although the License Agreements have historically been “significant” to Curis in its past research and development programs and
collaborations, as Curis’s business has evolved its material collaborations have been terminated or narrowed in focus and the importance of the License Agreements has substantially diminished such that Curis no longer considers these License
Agreements to be either “material” or “significant.” Specifically, these License Agreements do not currently provide for obligations that are material to and enforceable against Curis, or rights that are material to Curis and
enforceable against the other parties to such agreements.
Securities and Exchange Commission
October 16, 2009
Page 3
The Licensed Rights. The License Agreements generally grant to the Company exclusive, royalty-bearing licenses to third party intellectual property relating to
the Hedgehog signaling pathway (the “Licensed Rights”). The Hedgehog signaling pathway controls the development and growth of many kinds of tissues in the body by directly promoting cell division in specific cell types, and by activating
other secondary signaling pathways that control the synthesis of growth factors and angiogenic (blood vessel-forming) factors. Historically, Curis’s therapeutic approaches targeting the Hedgehog pathway have been aimed at developing molecules
that either amplify Hedgehog pathway cell signaling (“Hedgehog agonists”) or inhibit Hedgehog pathway cell signaling (“Hedgehog antagonists”).
Hedgehog Agonists. In the past, Curis was party to various collaboration agreements that related to Hedgehog agonist research and development, including:
(i) a July 2001 joint venture with affiliates of Elan Corporation, plc to research and develop Hedgehog agonists in neurology indications, which was terminated in May 2003; (ii) a January 2004 license and collaboration agreement with Wyeth
Pharmaceuticals for therapeutic applications of Hedgehog agonists in the treatment of neurological and other disorders, which was terminated effective May 2008; and (iii) a September 2005 license and collaboration agreement with
Procter & Gamble Corporation to evaluate and develop Hedgehog agonist compounds for hair growth regulation and other skin disorders, which was terminated effective November 2007.
The Company is no longer conducting research and development on Hedgehog agonists, either alone or in any material collaboration. Moreover, none of the Licensed Rights
included claims that were material to the lead Hedgehog agonists compounds that were under development during the time these collaborations were in effect. As such, to the extent that the License Agreements grant to the Company rights to Hedgehog
agonist intellectual property, such Licensed Rights were not, and are not, material to the Company.
Securities and Exchange Commission
October 16, 2009
Page 4
Hedgehog Antagonists. Curis also historically conducted research on Hedgehog antagonists, and in June 2003, Curis entered into a collaboration with Genentech,
Inc., a wholly-owned member of the Roche Group, to further research and develop Hedgehog antagonists. This collaboration is the only remaining Hedgehog-related research and development program in Curis’s development pipeline. The only drug
candidate currently being developed under this program is GDC-0449, a small molecule Hedgehog pathway antagonist. Genentech and Roche are responsible for the clinical development and commercialization of GDC-0449, and Curis is eligible to receive
payments under the collaboration assuming the successful achievement by Genentech of specified development and regulatory objectives, and is also eligible to receive royalty payments on product sales if GDC-0449 is successfully commercialized and
sold by Genentech or its sublicensee. GDC-0449 is currently being tested by Genentech and Roche in several Phase II clinical trials.
Although Curis has sublicensed to Genentech all of its rights under the License Agreements, none of the Licensed Rights include claims that cover GDC-0449 and, as such,
none of the License Agreements is material to this collaboration. To Curis’s knowledge, Genentech is not advancing into development any other program under the collaboration that is covered by the claims in the Licensed Rights, or otherwise.
Curis notes that under the Harvard Agreement and the JHU/WashU Agreement, it has an obligation to pay to the applicable licensor a portion of any royalty payments that
it receives from Genentech, notwithstanding that the Licensed Rights under the Harvard Agreement and the JHU/WashU Agreement do not specifically cover GDC-0449. After giving effect to royalty stacking provisions under these two License Agreements,
the total payment Curis is obligated to make under each of the Harvard Agreement and the JHU/WashU Agreement is 2.5%, respectively, of any payments that Curis may in the future receive from Genentech. In addition, Curis notes that under all of the
License Agreements, it has certain patent prosecution and maintenance cost obligations which in each of the last three years, and during the first half of 2009, equaled 1.1%, 2.3%, 1.9% and 1.9%, respectively, of Curis’s total operating
expenses. Curis does not view any of these financial obligations as material.
Securities and Exchange Commission
October 16, 2009
Page 5
The Agreements Are “Ordinary Course”
Curis also notes that the License Agreements, if made today, would be deemed by the Company to have been “made in the ordinary course of its business” and to
not be agreements upon which Curis’s business is “substantially dependant.” Accordingly, if these License Agreements were entered into today, Curis would not, for example, disclose these agreements on Form 8-K pursuant to item
1.01 thereto (and Item 601(b)(10)(ii)(B) of Regulation S-K). Curis is a life science company that is engaged in researching, developing and seeking to commercialize targeted cancer therapies. Curis believes that in-licenses of intellectual
property are one type of agreement that ordinarily accompanies the kind of business conducted by Curis and other life science companies. To this end, in the ordinary course of Curis’s business, it may from time to time enter into license
agreements pursuant to which it in-licenses intellectual property rights that are useful to its research and development programs, but that are not material to its business.
In summary, because these License Agreements, when viewed in the context of Curis’s current business, are both immaterial and ordinary course, Curis has determined
to revise its disclosure in future filings to omit references to the License Agreements and will update its Exhibit Index in its next Annual Report on Form 10-K to delete references to these agreements.
Please do not hesitate to contact the undersigned at (617) 526-6393 if you have any questions regarding this response letter or any related matters.
Very truly yours,
/s/ Cynthia T.
Mazareas
Cynthia T. Mazareas
Cc:
Daniel R. Passeri
2009-10-13 - UPLOAD - CURIS INC
Mail Stop 4720
October 13, 2009
Mr. Daniel R. Passeri President & Chief Executive Officer Curis, Inc. 45 Moulton Street Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Filed February 26, 2009 Schedule 14A filed April 17, 2009
File No. 000-30347
Dear Mr. Passeri:
We have reviewed your response letter dated October 2, 2009 to comments we
issued in a letter dated September 14, 2009 and have the following comments. Where the comments request you to revise disclosure, th e information you provide should show us
what the revised disclosure will look like a nd identify the annual or quarterly filing, as
applicable, in which you intend to first incl ude it. If you do not believe that revised
disclosure is necessary, e xplain the reason in your res ponse. 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 comment 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 Fiscal Year Ended December 31, 2008
General
1. Please refer to your response to Comment 1. Please note that we will not be in a
position to clear outstanding comments on the 10-K until we have reviewed your revised disclosure in the Form 10-K/A, to be filed.
Mr. Daniel R. Passeri
Curis, Inc.
October 13, 2009 Page 2
Item 1. Business
Intellectual Property, page 7
2. Please refer to your response to Comment 3. Please provide us with an analysis
supporting your determination that the lic ense agreements are not material or
significant to your business. We note th at the subject matte r of these license
agreements is the proprietary technology and data and resources relating to the Hedgehog Pathway. As this technology is the subject of your current, material collaboration agreement with Genentech, it appears that these license agreements are material to your business. We reissue Comments 3 and 4.
* * *
Please respond to these comments within 10 business days or tell us when you
will provide us with a response. Please provide us any requested information. Detailed cover letters greatly facilitate our review. Please file the letter on EDGAR under the form
type label CORRESP. We urge all persons who are responsi ble for the accuracy an d 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 comments, please provide, in writing, 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. Daniel R. Passeri
Curis, Inc. October 13, 2009 Page 3
Please do not hesitate to contact Rose Zukin at (202) 551-3239 or me at (202) 551-3715 if you have questions regarding th e comments and related matters.
Sincerely,
Jeffrey Riedler Assistant Director
2009-10-02 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Correspondence VIA FACSIMILE October 2, 2009 Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Attention: Rose Zukin, Esq. Re: Curis, Inc. Form 10-K for the Fiscal Year Ended December 31, 2008 Filed February 26, 2009 (“Form 10-K”) Schedule 14A filed April 17, 2009 File No. 000-30347 (“Schedule 14A”) Dear Ms. Zukin: On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the Company’s responses to comments contained in a letter dated September 14, 2009 (the “Letter”) from Jeffrey Riedler, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Daniel R. Passeri, President and Chief Executive Officer of Curis, relating to the Company’s Form 10-K and Schedule 14A. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The response is keyed to the numbering of the comments in the Letter and to the headings used in the Letter. Form 10-K for Fiscal Year Ended December 31, 2008 General 1. We note that your Form 10-K indicates that information related to “Securities Authorized for Issuance Under Equity Compensation Plans” may be found in your definitive proxy statement. However, this information is not contained in your definitive proxy statement. Please amend your filing to disclose the information required by Item 201(d) of Regulation S-K. Response: In response to this comment, the Company intends to file a Form 10-K/A in order to include the information required by Item 201(d) of Regulation S-K, “Securities Authorized for Issuance Under Equity Compensation Plans.” Securities and Exchange Commission October 2, 2009 Page 2 Item 1. Business Hedgehog Pathway Inhibitor Program, page 3 2. We note your disclosure on pages 4 and 5 that pursuant to your Genentech Hedgehog Pathway Inhibitor Collaboration, you will be eligible to receive future cash payments upon the achievement of additional specified clinical development and regulatory approval objectives, as well as royalties on product sales if any products are successfully developed and commercialized. Please expand your disclosure in this section to state the aggregate amount of milestone payments that you are entitled to receive under the collaboration agreement. In addition, please expand your disclosure to disclose the potential range of the percentage of royalty payments (for example, “low-single-digits” or “high-single-digits”). This information is considered material to an investor. Response: In response to this comment, the Company intends to expand the disclosure relating to its collaboration with Genentech in order to disclose the aggregate amount of milestone payments under the collaboration and the range of potential future royalty payments. The new disclosure is attached hereto as Schedule A. The Company intends to include this revised disclosure in its Quarterly Report on Form 10-Q for the quarter ended September 30, 2009. Intellectual Property, page 7 3. We note your disclosure on page 8 that you have entered into the following “significant” license agreements: • License Agreements dated February 9, 1995 and September 1, 2000 with the President and Fellows of Harvard University, each of which were amended and restated effective June 10, 2003; • License Agreement dated January 1, 1995 and as subsequently amended with The Trustees of the Columbia University; • License Agreement dated September 26, 1996, which was amended and restated effective June 1, 2003, with the Johns Hopkins University and the University of Washington School of Medicine; • License Agreement dated May 3, 2000 with the Johns Hopkins University; and • License Agreement dated February 12, 1996 with the Leland Stanford Junior University. Securities and Exchange Commission October 2, 2009 Page 3 Please expand your disclosure to provide a more specific description of each agreement. Your disclosure should include a discussion of the material terms of the agreement, including the subject of the agreement, each party’s obligations, rights to intellectual property, all amounts payable under the agreement including any aggregate amount of milestones and the potential range of the percent of royalty payments, all amounts already paid, and termination provisions. Response: We respectfully note the Staff’s comment. After a further analysis of these license agreements, the Company has concluded that none of the license agreements referenced in this section and filed as exhibits to the Company’s periodic reports continue to be material or significant to the Company’s business. In view of this determination, the Company will revise its disclosure to delete this discussion. The Company intends to include this revised disclosure in its Annual Report on Form 10-K for the year ended December 31, 2009 and will also update its Exhibit Index in such Annual Report on Form 10-K to delete references to these agreements. Exhibit Index 4. We note that you described the license agreement with The Johns Hopkins University, dated May 3, 2000, as “significant”; however, you have not filed the agreement as an exhibit. Please provide us with a legal analysis as to why the agreement need not be filed as an exhibit pursuant to Item 601(b)(10) of Regulation S-K. Response: Please refer to the Company’s response to comment No. 3. Because the Company has determined that the license agreement is no longer material or significant, the Company will revise its disclosure. Schedule 14A Executive and Director Compensation and Related Matters Compensation Discussion and Analysis, page 15 Benchmarking and Targeted Compensation Levels, page 16 5. We note your disclosure on page 16 that the compensation committee retains an independent third-party compensation consultant to review your executive officer compensation. Please identify this third-party compensation consultant, and confirm that you will identify the compensation consultant in future filings. Securities and Exchange Commission October 2, 2009 Page 4 Response: In response to this comment, the Company confirms that it will identify its compensation consultant in its “Compensation Discussion and Analysis” in future filings. The Company supplementally discloses to the Staff that the compensation consultant referred to in its Schedule 14A was Towers Perrin. Please do not hesitate to contact the undersigned at (617) 526-6393 if you have any questions regarding this response letter or any related matters. Very truly yours, /s/ Cynthia T. Mazareas Cynthia T. Mazareas cc: Daniel R. Passeri President and Chief Executive Officer Curis, Inc. Schedule A Our most advanced program is our Hedgehog pathway inhibitor program under collaboration with Genentech, Inc., a wholly-owned member of the Roche Group. The lead drug candidate being developed under this program is GDC-0449, a first-in-class orally-administered small molecule Hedgehog pathway inhibitor. Genentech and Roche are responsible for the clinical development and commercialization of GDC-0449. We are eligible to receive up to $115 million in contingent cash payments under the collaboration for the development of GDC-0449 or another small molecule assuming the successful achievement by Genentech and Roche of specified clinical development and regulatory objectives, of which we have received $18 million to date. In addition to these payments, we are also eligible for a royalty on sales of any Hedgehog pathway inhibitor products that are successfully commercialized by Genentech and Roche. For GDC-0449, we are entitled to a mid- to high-single digit royalty, which escalates within this range with increasing product sales. In certain specified circumstances, the royalty rate applicable to GDC-0449 may be decreased to a low- to mid-single digit royalty.
2009-10-02 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Correspondence CURIS, INC. 45 Moulton Street Cambridge, MA 02138 October 2, 2009 Via EDGAR SECURITIES AND EXCHANGE COMMISSION Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Rose Zukin, Esq. Re: Curis, Inc. (the “Company”) Form 10-K for the Fiscal Year Ended December 31, 2008 (“Form 10-K”) Filed February 26, 2009 Schedule 14A filed April 17, 2009 (“Schedule 14A”) File No. 000-30347 Dear Ms. Zukin: This letter is in response to a letter dated September 14, 2009 (the “Letter”) from Jeffrey Riedler, of the Staff of the Securities and Exchange Commission (the “Commission”) to Mr. Daniel R. Passeri, President and Chief Executive Officer of the Company relating to the Company’s Form 10-K and Schedule 14A. The Company hereby acknowledges that: • the Company is responsible for the adequacy and accuracy of the disclosure in the filings; • staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filings; 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, CURIS, INC. By: /s/ Daniel R. Passeri Name: Daniel R. Passeri Title: President and Chief Executive Officer
2009-09-18 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Correspondence VIA EDGAR TRANSMISSION September 18, 2009 Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Attention: Rose Zukin, Esq. Re: Curis, Inc. Form 10-K for the Fiscal Year Ended December 31, 2008 Filed February 26, 2009 and Schedule 14A filed April 17, 2009 File No. 000-30347 Dear Ms. Zukin: On behalf of Curis, Inc. (“Curis”), I am writing to confirm that Curis is preparing a response to the letter dated September 14, 2009 from Jeffrey Riedler, of the Staff of the Securities and Exchange Commission to Mr. Daniel R. Passeri, President and Chief Executive Officer of Curis relating to the Company’s Form 10-K and Schedule 14A (the “Letter”). As I indicated during our telephone conversation on September 17, 2009, the Company intends to submit its response to the Letter on or before October 2, 2009. Very truly yours, /s/ Cynthia T. Mazareas Cynthia T. Mazareas cc: Daniel R. Passeri
2009-09-14 - UPLOAD - CURIS INC
Mail Stop 4720
September 14, 2009
Mr. Daniel R. Passeri President & Chief Executive Officer Curis, Inc. 45 Moulton Street Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008
Filed February 26, 2009 Schedule 14A filed April 17, 2009
File No. 000-30347
Dear Mr. Passeri:
We have reviewed your filing and have the following comments. Where the
comments request you to revise disclosure, th e information you provide should show us
what the revised disclosure will look like a nd identify the annual or quarterly filing, as
applicable, in which you intend to first incl ude it. If you do not believe that revised
disclosure is necessary, e xplain the reason in your res ponse. 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 comment 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 Fiscal Year Ended December 31, 2008
General
1. We note that your Form 10-K indicates th at information related to “Securities
Authorized for Issuance Under Equity Compensation Plans” may be found in
your definitive proxy statement. However, this information is not contained in
your definitive proxy statement. Pleas e amend your filing to disclose the
information required by Item 201(d) of Regulation S-K.
Mr. Daniel R. Passeri
Curis, Inc.
September 14, 2009 Page 2
Item 1. Business
Hedgehog Pathway Inhibitor Program, page 3
2. We note your disclosure on pages 4 and 5 that pursuant to your Genentech
Hedgehog Pathway Inhibitor Collaboration, you will be eligible to receive future
cash payments upon the achievement of add itional specified clinical development
and regulatory approval objectives, as well as royalties on pro duct sales if any
products are successfully developed a nd commercialized. Please expand your
disclosure in this section to state the aggregate amount of milestone payments that
you are entitled to rece ive under the collaborati on agreement. In addition, please
expand your disclosure to disclose the poten tial range of the pe rcentage of royalty
payments (for example, “low-single-dig its” or “high-single-digits”). This
information is considered material to an investor.
Intellectual Property, page 7
3. We note your disclosure on page 8 that you have entered into the following
“significant” license agreements:
• License Agreements dated February 9, 1995 and September 1, 2000 with the President and Fellows of Harvard University, each of which
were amended and restated effective June 10, 2003;
• License Agreement dated January 1, 1995 and as subsequently amended with The Trustees of the Columbia University;
• License Agreement dated September 26, 1996, which was amended and restated effective June 1, 2003, w ith the Johns Hopkins University
and the University of Washington School of Medicine;
• License Agreement dated May 3, 2000 with the Johns Hopkins University; and
• License Agreement dated February 12, 1996 with the Leland Stanford Junior University.
Please expand your disclosure to provide a more specific description of each
agreement. Your disclosure should include a discussion of the material terms of
the agreement, including the subject of the agreement, each party’s obligations,
rights to intellectual prop erty, all amounts payable under the agreement including
any aggregate amount of milestones and the potential range of the percent of
royalty payments, all amounts already pa id, and termination provisions.
Mr. Daniel R. Passeri
Curis, Inc.
September 14, 2009 Page 3
Exhibit Index
4. We note that you described the license agreement with The Johns Hopkins University, dated May 3, 2000, as “significant”; however, you have not filed the
agreement as an exhibit. Please provide us with a legal analysis as to why the
agreement need not be filed as an exhi bit pursuant to Item 601(b)(10) of
Regulation S-K.
Schedule 14A
Executive and Director Compen sation and Related Matters
Compensation Discussion and Analysis, page 15
Benchmarking and Targeted Compensation Levels, page 16
5. We note your disclosure on page 16 that the compensation committee retains an
independent third-party compensation consultant to review your executive officer compensation. Please identify this third-party compensation consultant, and confirm that you will identify the compensa tion consultant in future filings.
* * *
Please respond to these comments within 10 business days or tell us when you
will provide us with a response. Please provide us any requested information. Detailed cover letters greatly facilitate our review. Please file the letter on EDGAR under the form
type label CORRESP. We urge all persons who are responsi ble for the accuracy an d 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 comments, please provide, in writing, 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
Mr. Daniel R. Passeri
Curis, Inc. September 14, 2009 Page 4
• 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. Please do not hesitate to contact Rose Zukin at (202) 551-3239 or me at (202) 551-3715 if you have questions regarding th e comments and related matters.
Sincerely,
Jeffrey Riedler Assistant Director
2006-04-19 - UPLOAD - CURIS INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Mail Stop 6010
Via Facsimile and U.S. Mail
April 19, 2006
Mr. Michael P. Gray
Vice President of Finance and
Chief Financial Officer
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
File No. 000-30347
Dear Mr. Gray:
We have completed our review of your Form 10-K and have no further
comments at this time.
Sincerely,
Joseph J. Roesler
Accounting Branch Chief
</TEXT>
</DOCUMENT>
2006-03-21 - CORRESP - CURIS INC
CORRESP 1 filename1.htm SEC Letter WILMERHALE Cynthia T. Mazareas +1 617 526 6393 (t) +1 617 526 5000 (f) cynthia.mazareas@wilmerhale.com VIA FACSIMILE March 21, 2006 Securities and Exchange Commission Division of Corporation Finance Judiciary Plaza 450 Fifth Street, N.W. Washington, DC 20549 Attention: Joseph Roesler Re: Curis, Inc. File No. 000-30347 Dear Mr. Roesler: In response to the March 20, 2006 telephone conversation between Mary Mast of the Staff of the Securities and Exchange Commission (the “Commission”) and Mr. Michael P. Gray, Vice President of Finance and Chief Financial Officer of Curis, Inc. (“Curis” or the “Company”), we are writing to you on behalf of Curis to advise you that the Audit Committee of the Board of Directors of Curis has determined that Curis will restate its financial results for 2003, 2004 and for the quarters ended March 31, 2005, June 30, 2005 and September 30, 2005. The scope of the restatement is set forth in the Form 12b-25 (Notification of Late Filing) filed by the Company with the Commission on March 17, 2006, a copy of which is attached hereto. If you require any additional information, please telephone the undersigned at the telephone number indicated above. Very truly yours, /s/ Cynthia T. Mazareas Cynthia T. Mazareas Cc: Michael P. Gray Wilmer Cutler Pickering Hale and Dorr LLP, 60 State Street, Boston, Massachusetts 02109 Baltimore Beijing Berlin Boston Brussels London Munich New York Northern Virginia Oxford Palo Alto Waltham Washington UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 12b-25 Commission File Number 000-30347 NOTIFICATION OF LATE FILING (Check One): x Form 10-K ¨ Form 20-F ¨ Form 11-K ¨ Form 10-Q ¨ Form 10-D ¨ Form N-SAR ¨ Form N-CSR For Period Ended: December 31, 2005 ¨ Transition Report on Form 10-K ¨ Transition Report on Form 10-Q ¨ Transition Report on Form 20-F ¨ Transition Report on Form N-SAR ¨ Transition Report on Form 11-K For the Transition Period Ended: ______________ Nothing in this form shall be construed to imply that the Commission has verified any information contained herein. If the notification relates to a portion of the filing checked above, identify the item(s) to which the notification relates: PART I REGISTRANT INFORMATION Full name of registrant: Curis, Inc. Former name if applicable: Not applicable. Address of principal executive office (Street and number): 61 Moulton Street City, state and zip code: Cambridge, MA 02138 PART II RULE 12b-25 (b) AND (c) If the subject report could not be filed without unreasonable effort or expense and the registrant seeks relief pursuant to Rule 12b-25(b), the following should be completed. (Check box if appropriate.) (a) The reasons described in reasonable detail in Part III of this form could not be eliminated without unreasonable effort or expense; x (b) The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, Form 11-K, Form N-SAR or Form N-CSR, or portion thereof, will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report or transition report on Form 10-Q or subject distribution report on Form 10-D, or portion thereof, will be filed on or before the fifth calendar day following the prescribed due date; and (c) The accountant’s statement or other exhibit required by Rule 12b-25(c) has been attached if applicable. A-1 PART III NARRATIVE State below in reasonable detail why Forms 10-K, 20-F, 11-K, 10-Q, 10-D, N-SAR, N-CSR, or the transition report or portion thereof, could not be filed within the prescribed time period. On March 16, 2006, the Audit Committee of the Board of Directors of Curis, Inc. (“Curis” or the “Company”) determined, following a routine review by the SEC of the Company’s Annual Report on Form 10-K for the year ended December 31, 2004 and Quarterly Report on Form 10-Q for the Quarter ended March 31, 2005, that Curis will restate its financial results for 2003, 2004 and for the quarters ended March 31, 2005, June 30, 2005, and September 30, 2005. The restatement primarily relates to the Company’s revenue recognition accounting for $7,509,000 in license and maintenance fee payments paid by Genentech as part of the June 2003 Hedgehog antagonist collaboration between the parties. From fiscal year 2003 through the third quarter of 2005, the Company had recognized $2,239,000 in license fee revenue related to these payments. Following discussions with the SEC, Curis has determined it should not have recognized any of this revenue. Instead, Curis will defer the $7,509,000 in license and maintenance fee payments and recognize it only when the Company can reasonably estimate when its contractual steering committee obligations will cease or after it no longer has contractual steering committee obligations under this agreement with Genentech. The contractual term of the Company’s steering committee obligations extends for as long as Hedgehog antagonist products subject to this collaboration are being developed or commercialized by either of the parties. Accordingly, the contractual term of the Company’s steering committee obligations is indefinite and the Company expects that it will not record any revenue related to these payments for at least several years. The Company had been recognizing revenue in connection with the $7,509,000 in payments over an eight-year period based on the Company’s estimate that its participation on the steering committees would become inconsequential after the first product was approved in each of the two programs covered under this collaboration, and would therefore no longer represent a performance obligation. During this same period from fiscal year 2003 through the third quarter of 2005, the Company recorded $345,000 as research and development expenses for the amortization of $410,000 in license fees that were payable by the Company to university licensors as a result of the June 2003 Genentech collaboration. The Company has determined that it should not have amortized this expense, but instead should have recognized the $410,000 immediately as expense in June 2003. In connection with the restatement, the Company will also correct other previously identified immaterial errors which had previously been corrected through a cumulative adjustment to the financial statements in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005. The restatement will allocate the adjustment among the correct periods. The Company expects that the effect to previously recorded license fee revenues, research and development expenses, and net income (loss) of the restatement, which is not yet complete and is subject to audit or review by the Company’s independent registered public accountants, PricewaterhouseCoopers LLP, will be as follows: (Unaudited) Nine Months Ended September 30, 2005 Year-ended December 31, 2004 2003 Decrease to license fee revenues $ (340,000 ) $ (1,229,000 ) $ (670,000 ) (Decrease)/increase to research and development expense (238,000 ) (84,000 ) 387,000 Increase to net loss (102,000 ) (1,145,000 ) (1,057,000 ) Previously reported net loss before adjustments (13,419,000 ) (13,904,000 ) (11,623,000 ) Percent variation from previously reported loss before adjustments 0.8 % 8.2 % 9.1 % A-2 (Unaudited) Quarter Ended March 31, 2005 June 30, 2005 September 30, 2005 (Decrease)/increase to license fee revenues $ (273,000 ) $ (273,000 ) $ 206,000 Decrease to research and development expense (12,000 ) (97,000 ) (129,000 ) (Increase)/decrease to net loss (261,000 ) (176,000 ) 335,000 Previously reported net loss before adjustments (5,113,000 ) (4,675,000 ) (3,631,000 ) Percent variation from previously reported loss before adjustments 5.1 % 3.8 % (9.2 %) (Unaudited) Quarter Ended March 31, 2004 June 30, 2004 September 30, 2004 December 31, 2004 Decrease to license fee revenues $ (310,000 ) $ (310,000 ) $ (311,000 ) $ (298,000 ) (Decrease)/increase to research and development expense (11,000 ) (93,000 ) 36,000 (16,000 ) Increase to net loss (299,000 ) (217,000 ) (347,000 ) (282,000 ) Previously reported net loss before adjustments (4,038,000 ) (4,301,000 ) (3,906,000 ) (1,659,000 ) Percent variation from previously reported loss before adjustments 7.4 % 5.0 % 8.9 % 17.0 % (Unaudited) Quarter Ended March 31, 2003 June 30, 2003 September 30, 2003 December 31, 2003 Decrease to license fee revenues N/A $ (13,000 ) $ (346,000 ) $ (310,000 ) (Decrease)/increase to research and development expense N/A 409,000 (12,000 ) (10,000 ) Increase to net loss N/A (422,000 ) (334,000 ) (300,000 ) Previously reported net loss before adjustments N/A (5,039,000 ) 4,550,000 (6,936,000 ) Percent variation from previously reported loss before adjustments N/A 8.4 % (7.3 %) 4.3 % A-3 The Company expects that, as an effect of the restatement, previously recorded deferred revenues in the Company’s consolidated balance sheets will change as set forth in the table below. The amounts below are subject to audit or review by PricewaterhouseCoopers LLP. (Unaudited) September 30, 2005 December 31, 2004 December 31, 2003 Increase (decrease) in deferred revenues $ 2,239,000 $ 408,000 $ (4,821,000 ) While the Company has worked diligently to complete the review of its revenue recognition accounting for the $7,509,000 received from Genentech and the restatement, the Company is unable timely to file its Form 10-K for the fiscal year ended December 31, 2005 without unreasonable effort or expense. The Company currently expects to complete its review and restatement and to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2005 on or before March 31, 2006. In the Company’s Annual Report on Form 10-K for the year ended December 31, 2004, filed on March 15, 2005, management concluded that the Company’s internal control over financial reporting was effective as of December 31, 2004. However, in consideration of the restatement described above, management is reevaluating its conclusion on the effectiveness of internal control over financial reporting as of December 31, 2004. In addition, management has not yet completed its evaluation of internal control over financial reporting as of December 31, 2005. As management completes its evaluation of internal control over financial reporting as of December 31, 2005 and its reevaluation of its conclusion on the effectiveness of internal control over financial reporting as of December 31, 2004, it is possible that one or more control deficiencies may individually, or in the aggregate, constitute one or more material weaknesses as of December 31, 2004 and/or December 31, 2005. The existence of one or more material weaknesses would preclude a conclusion by management that the Company’s internal control over financial reporting was effective as of the respective date. PART IV OTHER INFORMATION (1) Name and telephone number of person to contact in regard to this notification: Michael Gray, Vice President of Finance and Chief Financial Officer, 617-503-6500 (2) Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If the answer is no, identify report(s). x Yes ¨ No (3) Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof? x Yes ¨ No If so: attach an explanation of the anticipated change, both narratively and quantitatively, and, if appropriate, state the reasons why a reasonable estimate of the results cannot be made. A-4 The Company expects that the effect of the restatement on the results of operations, which is not yet complete and is subject to audit by the Company’s independent registered public accountants, PricewaterhouseCoopers LLP, will be as set forth above under “Part III – Narrative.” Curis, Inc. (Name of Registrant as Specified in Charter) Has caused this notification to be signed on its behalf by the undersigned thereunto duly authorized. Date March 17, 2006 By: /S/ MICHAEL P. GRAY Name: Title: Michael P. Gray Vice President of Finance and Chief Financial Officer
2006-03-21 - CORRESP - CURIS INC
CORRESP 1 filename1.htm SEC RESPONSE LETTER VIA FACSIMILE January 4, 2006 Securities and Exchange Commission Division of Corporation Finance Judiciary Plaza 450 Fifth Street, N.W. Washington, DC 20549 Attention: Joseph Roesler Re: Curis, Inc. Form 10-K for Fiscal Year Ended December 31, 2004 (“Form 10-K”) Form 10-Q for Quarter Ended March 31, 2005 (“Form 10-Q”) File No. 000-30347 Dear Mr. Roesler: On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the Company’s responses to comments contained in a letter dated December 7, 2005 (the “December Letter”) from Jim B. Rosenberg, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Michael P. Gray, Vice President of Finance and Chief Financial Officer of Curis relating to the Company’s Form 10-K and Form 10-Q. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The response is keyed to the numbering of the comments in the December Letter and to the headings used in the December Letter. Form 10-K for the year ended December 31, 2003 Genentech Collaboration Accounting 1. Refer to our comment number 3 and your response. Please revise your proposed disclosure to clearly state that if one milestone is not considered substantive, then the remaining milestones would also not be considered substantive. Response: In response to this comment, the Company has further revised its proposed disclosure in Note 1 (Revenue Recognition), which is attached hereto as Exhibit A. Please be advised that for purposes of the Company’s response to this comment as well as comment No. 2 below, the attached Exhibit A has been marked against the Exhibit A attached to the Company’s response letter to the Staff dated November 23, 2005. Securities and Exchange Commission January 4, 2006 Page 2 2. Refer to our comment number 4 and your response. We understood from previous discussions that the steering committee services were considered an obligation during the research and development period, but were considered a right after FDA approval. Please address the following in disclosure-type format: • Clarify why the steering committee services would not be considered an obligation during the research and development stage for all products developed, not just the two initial products or revise your policy to account for all steering committee services consistently as a separate obligation and deliverable under the contract. • Clarify whether or not a change in estimate for your period of revenue recognition would be made if you entered into new product development which included participation on a steering committee. • Clarify why the steering committee services become a right after FDA approval. • Clarify the term of the steering committee services, any parameters relating to your participation in the steering committee, and whether or not your obligation or participation differs for the initial two products vs. any other products developed during the life of the agreement. Response: In response to this comment, the Company has further revised its proposed disclosure in Note 4 (Research and Development Collaborations Entered into After January 1, 2005), which is attached hereto as Exhibit A. If you require any additional information, please telephone the undersigned at the telephone number indicated above. Very truly yours, /s/ Cynthia T. Mazareas / KJ Cynthia T. Mazareas Cc: Michael P. Gray Exhibit A (1) REVENUE RECOGNITION During the third quarter of 2005, the Company updated its disclosure relating to its revenue recognition policies that were previously presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. In addition, in the third quarter of 2005, the Company recorded adjustments identified during the preparation of the financial statements for the quarter to correct errors in recording the fair value of shares issued in connection with our collaborations with Genentech and Wyeth. The shares were valued using a price based on a trailing average of closing prices, pursuant to the terms of the stock purchase agreements. The Company has determined that it should have valued the shares using the quoted market price on the dates of issuance and, as a result, additional paid-in capital was understated and deferred revenues were overstated. The effects of these adjustments was to increase additional paid-in-capital by $1,629,000, decrease noncurrent deferred revenue by $1,169,000 and to reverse $460,000 of revenue in the third quarter of 2005 to correct for the cumulative overstatement of revenues from June 2003 through June 30, 2005. The impact of these errors, if recorded in the periods to which they related, would not effect the net loss per share previously reported by the Company for any prior year or quarter, nor otherwise have a material impact on previously reported financial information. In addition, the Company does not believe that the impact of these adjustments is material to the financial statements for the quarter ended September 30, 2005 or to the projected results of operations for the year ending December 31, 2005. The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s product candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development milestones and royalties on product sales. The Company follows the provisions of the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 104 (SAB No. 104), Revenue Recognition, Emerging Issues Task Force (EITF) Issue No. 00-21 (EITF 00-21), Accounting for Revenue Arrangements with Multiple Deliverables, EITF Issue No. 99-19 (EITF 99-19), Reporting Revenue Gross as a Principal Versus Net as an Agent, and EITF Issue No. 01-9 (EITF 01-9), Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products). Non-refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured and the Company has no further performance obligations under the license agreement. Multiple element arrangements, such as license and development arrangements are analyzed to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services can be separated or whether they must be accounted for as a single unit of accounting in accordance with EITF 00-21. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has standalone value and the fair value of the undelivered performance obligations, typically including research or steering committee A-1 services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have standalone value or (ii) have standalone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The Company recognizes revenue using the relative performance method provided that the Company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance. Revenue recognized under the relative performance method would be determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of substantive milestones, by the ratio of level of effort incurred to date to estimated total level of effort required to complete the Company’s performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement and the performance obligations are provided on a best-efforts basis, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period the Company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. In addition, if the Company is involved in a steering committee as part of a multiple element arrangement that is accounted for as a single unit of accounting, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. Collaboration agreements may also contain substantive milestone payments. Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: • the milestone payments are non-refundable; A-2 • achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • substantive effort is involved in achieving the milestone; • the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and, • a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. Determination as to whether a milestone meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone, and therefore the resulting payment would be considered part of the consideration for the single unit of accounting and be recognized as revenue as such performance obligations are performed under either the relative performance or straight-line methods, as applicable, and in accordance with these policies as described above. In addition, the determination that one such payment was not a substantive milestone would prevent the Company from concluding that subsequent milestone payments were substantive milestones and, as a result, any additional milestone payments would also be considered part of the consideration for the single unit of accounting and would be recognized as revenue as such performance obligations are performed under either the relative performance or straight-line methods, as applicable. Reimbursement of costs is recognized as revenue provided the provisions of EITF 99-19 are met, the amounts are determinable, and collection of the related receivable is reasonably assured. Royalty revenue is recognized upon the sale of the related products, provided that the royalty amounts are fixed or determinable, collection of the related receivable is reasonably assured and the Company has no remaining performance obligations under the arrangement. If royalties are received when the Company has remaining performance obligations, the royalty payments would be attributed to the services being provided under the arrangement and therefore would be recognized as such performance obligations are performed under either the relative performance or straight line methods, as applicable, and in accordance with these policies as described above. For revenue generating arrangements where the Company, as a vendor, provides consideration to a licensor or collaborator, as a customer, the Company applies the provisions of EITF 01-9. EITF 01-9 addresses the accounting for revenue arrangements where both the vendor and the customer make cash payments to each other for services and/or products. A payment to a customer is presumed to be a reduction of the selling price unless the Company receives an identifiable benefit for the payment and the Company can reasonably estimate the fair value of the benefit received. Payments to a customer that are deemed a reduction of selling price are recorded first as a reduction of revenue, to the extent of both cumulative revenue recorded to date and of probable future revenues, which include any unamortized deferred revenue balances, A-3 under all arrangements with such customer and then as an expense. Payments that are not deemed to be a reduction of selling price would be recorded as an expense. Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets. Amounts not expected to be recognized during the twelve-month period ended September 30, 2006 are classified as long-term deferred revenue. As of September 30, 2005, the Company has short- and long-term deferred revenue of $2,152,000 and $7,291,000, respectively, related to its collaborations. A-4 (4) RESEARCH AND DEVELOPMENT COLLABORATIONS ENTERED INTO PRIOR TO JANUARY 1, 2005 During the third quarter of 2005, the Company updated certain aspects of its disclosures related to its research and development collaborations entered into prior to January 1, 2005. The updated disclosures are presented within this Note and were previously presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. (a) GENENTECH, INC. JUNE 2003 COLLABORATION (i) Collaboration Summary In June 2003, the Company licensed its proprietary Hedgehog pathway technologies to Genentech for human therapeutic use. The primary focus of the collaborative research plan has been to develop molecules that inhibit, or antagonize, the Hedgehog pathway for the treatment of various cancers. The collaboration consists of two programs: the development of a small molecule Hedgehog antagonist formulated for the topical treatment for basal cell carcinoma; and the development of systemically administered small molecule and antibody Hedgehog antagonists for the treatment of certain other solid tumor cancers. Pursuant to the collaboration agreement, Genentech agreed to make specified cash payments, in
2005-12-07 - UPLOAD - CURIS INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
December 7, 2005
Mr. Michael P. Gray
Vice President of Finance and
Chief Financial Officer
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
Form 10-Q for Quarter Ended March 31, 2005
File No. 000-30347
Dear Mr. Gray:
We have reviewed your November 23, 2005 response to our
letter
dated November 18, 2005, and have the following comments. In our
comments, 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 review 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 year ended December 31, 2003
Genentech Collaboration Accounting
1. Refer to our comment number 3 and your response. Please revise
your proposed disclosure to clearly state that if one milestone is
not considered substantive, then the remaining milestones would
also
not be considered substantive.
2. Refer to our comment number 4 and your response. We understood
from previous discussions that the steering committee services
were
considered an obligation during the research and development
period,
but were considered a right after FDA approval. Please address
the
following in disclosure-type format:
* Clarify why the steering committee services would not be
considered
an obligation during the research and development stage for all
products developed, not just the two initial products or revise
your
policy to account for all steering committee services consistently
as
a separate obligation and deliverable under the contract.
* Clarify whether or not a change in estimate for your period of
revenue recognition would be made if you entered into new product
development which included participation on a steering committee.
* Clarify why the steering committee services become a right after
FDA approval.
* Clarify the term of the steering committee services, any
parameters
relating to your participation in the steering committee, and
whether
or not your obligation or participation differs for the initial
two
products vs. any other products developed during the life of the
agreement
* * * *
Please respond to the comments 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 comments and provides the
requested information. Detailed letters greatly facilitate our
review. Please file your letter on EDGAR under the form type
label
CORRESP.
You may contact Joseph Roesler, Staff Accountant, at (202)
551-
3628 or Mary Mast, Senior Accountant, at (202) 551-3613 if you
have
questions regarding the comments. In this regard, do not hesitate
to
contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
??
??
??
??
Michael P. Gray
Curis, Inc.
December 7, 2005
Page 2
</TEXT>
</DOCUMENT>
2005-11-28 - CORRESP - CURIS INC
CORRESP 1 filename1.htm SEC Response Letter Cynthia T. Mazareas VIA FACSIMILE 60 STATE STREET BOSTON, MA 02109 November 23, 2005 +1 617 526 6393 +1 617 526 5000 fax Securities and Exchange Commission cynthia.mazareas@wilmerhale.com Division of Corporation Finance Judiciary Plaza 450 Fifth Street, N.W. Washington, DC 20549 Attention: Joseph Roesler Re: Curis, Inc. Form 10-K for Fiscal Year Ended December 31, 2004 (“Form 10-K”) Form 10-Q for Quarter Ended March 31, 2005 (“Form 10-Q”) File No. 000-30347 Dear Mr. Roesler: On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the Company’s responses to comments contained in a letter dated November 18, 2005 (the “November Letter”) from Jim B. Rosenberg, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Michael P. Gray, Vice President of Finance and Chief Financial Officer of Curis relating to the Company’s Form 10-K and Form 10-Q. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The response is keyed to the numbering of the comments in the November Letter and to the headings used in the November Letter. Form 10-K for the year ended December 31, 2003 Genentech Collaboration Accounting 1. Refer to comment 1. We note you plan to revise your accounting in future periods. From our telephone conversations, we understood that the correction of this accounting policy had no impact on historical periods. Please tell us if our understanding is correct. Response: The Company confirms to the Staff that the revisions to its accounting policies discussed in Response No. 1 of the Company’s letter to the Staff dated November 9, 2005 have no impact on historical periods. BALTIMORE BEIJING BERLIN BOSTON BRUSSELS LONDON MUNICH NEW YORK NORTHERN VIRGINIA OXFORD PALO ALTO WALTHAM WASHINGTON Securities and Exchange Commission November 23, 2005 Page 2 2. We note that your proposed disclosure on page A-2 no longer addresses how you account for a multiple element arrangement that represents a single unit of accounting if that arrangement contains performance obligations that are not on a best efforts basis. If you enter into such arrangements, please revise your proposed accounting policy disclosure to address them. Response: The Company does not currently have any revenue-generating arrangements that contain performance obligations that are not on a best efforts basis and does not anticipate that it would have any such arrangements in future periods. Accordingly, the Company determined to eliminate such disclosure. However, if the Company were to enter into such an arrangement in a future period, the Company would modify the disclosures relating to its revenue recognition policy to address such arrangement. 3. Refer to the discussion of substantive milestones on page A-3. We understood from telephone discussions with you that if a performance bonus does not meet the conditions described on page A-3, then the resulting payment would not be considered a substantive milestone and therefore the resulting payment would be considered part of the consideration for the single unit of accounting and recognized over that unit’s performance period using either the relative performance or straight-line methods, as applicable, described on page A-2. We also understood from those telephone discussions that if an arrangement contained multiple performance bonuses and you determined that a performance bonus was not a substantive milestone, this determination would prevent you from concluding that subsequent performance bonuses were substantive milestones and as a result those performance bonuses would also be considered part of the consideration for the single unit of accounting. Please tell us if our understanding is correct and consider the need to clarify your proposed disclosure. Response: The Company confirms to the Staff its position that if a performance bonus does not meet the conditions described on page A-3, then the resulting payment would not be considered a substantive milestone and therefore the resulting payment would be considered part of the consideration for the single unit of accounting and recognized over that unit’s performance period using either the relative performance or straight-line methods. The Company has further clarified this accounting policy in Note 1 (Revenue Recognition) (“Note 1”), which is attached hereto as Exhibit A. The Company also confirms that if an arrangement contains performance bonus payments and one of the performance bonus Securities and Exchange Commission November 23, 2005 Page 3 payments is not deemed to be substantive milestone, then subsequent performance bonus payments would be considered part of the consideration for the single unit of accounting. 4. We note from the revised disclosure that you propose on page A-8 of your response that the performance period you use to recognize revenue (i.e. June 2003 through June 2011) only includes Curis’ steering committee performance obligations as they relate to the first product discovered for each of basal cell carcinoma and Hedgehog. However, we also note from the revised disclosure you propose that the Genentech June 2003 Collaboration is not limited to the first product discovered for each of basal cell and Hedgehog, but also covers other drugs and that Curis’ steering committee performance obligations extend beyond the first product discovered for each of basal cell and Hedgehog. Because Curis has asserted that its participation in the steering committee is a right to participate and not an obligation to participate only when a drug is in the manufacturing and selling phase, please clarify for us why the performance period would exclude Curis’ obligation to participate in the steering committee while research and development is ongoing under the arrangement subsequent to the first product approved in both the basal cell and Hedgehog. Response: The Company believes that its obligation to serve on the steering committee will constitute a substantive performance obligation until such time as the first product candidates based on the Hedgehog antagonist technology receive FDA approval. The Company currently estimates that FDA regulatory approval for its current Hedgehog antagonist product candidates under the collaboration will occur in June 2011, which is approximately eight years after the June 2003 initiation of the collaboration. The Company currently has two Hedgehog antagonist product candidates under development. The first is a topically-applied Hedgehog antagonist for the treatment of basal cell carcinoma, which is currently in phase I clinical trials. The Company is also currently developing a systemically-administered Hedgehog antagonist for the treatment of other solid tumors under the collaboration. This second compound is in pre-clinical development and the Company currently expects a Hedgehog antagonist for the treatment of other solid tumor cancers may enter clinical testing in 2006. Although the Company is contractually obligated to serve on the steering committee during any ongoing research and development, the Company believes that after the first two product candidates under the collaboration are FDA approved the Company’s steering committee service would be inconsequential or perfunctory and would therefore not constitute a substantive performance obligation. The Company believes that its Securities and Exchange Commission November 23, 2005 Page 4 involvement in the steering committees is presently a substantive performance obligation because the Company currently possesses greater knowledge and understanding of its Hedgehog antagonist technology than Genentech and Genentech is currently utilizing the steering committee process as a means to gain a fuller understanding of this technology. The Company believes that by June 2011, the estimated approval date for the first two product candidates, through the significant engagement of Genentech’s own resources in the development process, Genentech’s expertise in the Hedgehog antagonist technologies and the related clinical development of these technologies will be as substantial as, if not greater than, that of the Company. By June 2011, the Company believes Genentech will have the required knowledge to singly develop any Hedgehog antagonist product candidate without the need for Curis’ substantive involvement. Accordingly, the Company does not believe its service on the steering committee would thereafter constitute a substantive performance obligation. The Company cannot currently definitively conclude if there will be follow-on topical or systemic Hedgehog antagonist compounds after its estimated first FDA approvals in June 2011, or if thereafter Genentech will test the first topical or systemic Hedgehog antagonist compounds that receive regulatory approval in another cancer indication(s). However, as indicated above, the Company does not believe its steering committee service obligations with respect to such future product candidates would be substantive because Genentech could advance such compounds without Curis’ involvement. The Company has further revised its disclosures in Section 4(a)(ii) of Note 4 (Research and Development Collaborations Entered Into prior to January 1, 2005) (“Note 4”), which is attached hereto as Exhibit A, in order to clarify the basis for the estimates it has made with respect to the performance period. 5. Base on our telephone conversation, we confirm our understanding that you plan to further revise your disclosure to clarify the following points: a. See the last paragraph on page A-1. You will clarify that you analyze multiple element arrangements, such as license and development arrangements, to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services, can be separated or whether they must be account for as a single unit of accounting. b. See the last paragraph on page A-2. You will clarify that if the Company is involved in a steering committee as part of a multiple element arrangement that is Securities and Exchange Commission November 23, 2005 Page 5 accounted for as a single unit of accounting, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. c. See the first paragraph on page A-9. You will clarify that you believe the clinical development and drug approval milestones under the Genentech June 2003 collaboration are substantive milestones because they meet all of the conditions described in your policy. Response: In response to this comment, the Company has further revised its disclosures in Notes 1 and 4. The Company has attached such disclosures hereto as Exhibit A. Please be advised that for purposes of the Company’s response to this comment as well as comment Nos. 3 and 4 above, the attached Exhibit A has been marked against the Exhibit A attached to the Company’s response letter to the Staff dated November 9, 2005. The Company intends to include the revised Notes 1 and 4 in future filings. If you require any additional information, please telephone the undersigned at the telephone number indicated above. Sincerely, /s/ Cynthia T. Mazareas Cynthia T. Mazareas Cc: Michael P. Gray Exhibit A (1) REVENUE RECOGNITION During the third quarter of 2005, the Company updated its disclosure relating to its revenue recognition policies that were previously presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. In addition, in the third quarter of 2005, the Company recorded adjustments identified during the preparation of the financial statements for the quarter to correct errors in recording the fair value of shares issued in connection with our collaborations with Genentech and Wyeth. The shares were valued using a price based on a trailing average of closing prices, pursuant to the terms of the stock purchase agreements. The Company has determined that it should have valued the shares using the quoted market price on the dates of issuance and, as a result, additional paid-in capital was understated and deferred revenues were overstated. The effects of these adjustments was to increase additional paid-in-capital by $1,629,000, decrease noncurrent deferred revenue by $1,169,000 and to reverse $460,000 of revenue in the third quarter of 2005 to correct for the cumulative overstatement of revenues from June 2003 through June 30, 2005. The impact of these errors, if recorded in the periods to which they related, would not effect the net loss per share previously reported by the Company for any prior year or quarter, nor otherwise have a material impact on previously reported financial information. In addition, the Company does not believe that the impact of these adjustments is material to the financial statements for the quarter ended September 30, 2005 or to the projected results of operations for the year ending December 31, 2005. The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s product candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development milestones and royalties on product sales. The Company follows the provisions of the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 104 (SAB No. 104), Revenue Recognition, Emerging Issues Task Force (EITF) Issue No. 00-21 (EITF 00-21), Accounting for Revenue Arrangements with Multiple Deliverables, EITF Issue No. 99-19 (EITF 99-19), Reporting Revenue Gross as a Principal Versus Net as an Agent, and EITF Issue No. 01-9 (EITF 01-9), Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products). Non-refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured and the Company has no further performance obligations under the license agreement. Multiple element arrangements, such as license and development arrangements are analyzed to determine whether the deliverables, which often include a license and performance obligations such as research and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting in accordance with EITF 00-21. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has standalone value and the fair value of the undelivered performance obligations, A-1 typically including research or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have standalone value or (ii) have standalone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using e
2005-11-18 - UPLOAD - CURIS INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
November 18, 2005
Mr. Michael P. Gray
Vice President of Finance and
Chief Financial Officer
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
Form 10-Q for Quarter Ended March 31, 2005
File No. 000-30347
Dear Mr. Gray:
We have reviewed the above referenced filings and your
November
9, 2005 response to our letter dated November 1, 2005, and have
the
following comments. In our comments, 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 review 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 year ended December 31, 2003
Genentech Collaboration Accounting
1. Refer to comment 1. We note you plan to revise your accounting
in
future periods. From our telephone conversations, we understood
that the correction of this accounting policy had no impact on
historical periods. Please tell us if our understanding is
correct.
2. We note that your proposed disclosure on page A-2 no longer
addresses how you account for a multiple element arrangement that
represents a single unit of accounting if that arrangement
contains
performance obligations that are not on a best efforts basis. If
you
enter into such arrangements, please revise your proposed
accounting
policy disclosure to address them.
3. Refer to the discussion of substantive milestones on page A-3.
We
understood from telephone discussions with you that if a
performance
bonus does not meet the conditions described on page A-3, then the
resulting payment would not be considered a substantive milestone
and
therefore the resulting payment would be considered part of the
consideration for the single unit of accounting and recognized
over
that unit`s performance period using either the relative
performance
or straight-line methods, as applicable, described on page A-2.
We
also understood from those telephone discussions that if an
arrangement contained multiple performance bonuses and you
determined
that a performance bonus was not a substantive milestone, this
determination would prevent you from concluding that subsequent
performance bonuses were substantive milestones and as a result
those
performance bonuses would also be considered part of the
consideration for the single unit of accounting. Please tell us
if
our understanding is correct and consider the need to clarify your
proposed disclosure.
4. We note from the revised disclosure that you propose on page A-
8
of your response that the performance period you use to recognize
revenue (i.e. June 2003 through June 2011) only includes Curis`
steering committee performance obligations as they relate to the
first product discovered for each of basal cell carcinoma and
Hedgehog. However, we also note from the revised disclosure you
propose that the Genentech June 2003 Collaboration is not limited
to
the first product discovered for each of basal cell and Hedgehog,
but
also covers other drugs and that Curis` steering committee
performance obligations extend beyond the first product discovered
for each of basal cell and Hedgehog. Because Curis has asserted
that
its participation in the steering committee is a right to
participate
and not an obligation to participate only when a drug is in the
manufacturing and selling phase, please clarify for us why the
performance period would exclude Curis` obligation to participate
in
the steering committee while research and development is ongoing
under the arrangement subsequent to the first product approved in
both the basal cell and Hedgehog.
5. Based on our telephone conversation, we confirm our
understanding
that you plan to further revise your disclosure to clarify the
following points:
a. See the last paragraph on page A-1. You will clarify that you
analyze multiple element arrangements, such as license and
development arrangements, to determine whether the deliverables,
which often include a license and performance obligations such as
research and steering committee services, can be separated or
whether
they must be accounted for as a single unit of accounting.
b. See the last paragraph on page A-2. You will clarify that if
the
Company is involved in a steering committee as part of a multiple
element arrangement that is accounted for as a single unit of
accounting, the Company assesses whether its involvement
constitutes
a performance obligation or a right to participate.
c. See the first paragraph on page A-9. You will clarify that you
believe the clinical development and drug approval milestones
under
the Genentech June 2003 collaboration are substantive milestones
because they meet all of the conditions described in your policy.
* * * *
Please respond to the comments 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 comments and provides the
requested information. Detailed letters greatly facilitate our
review. Please file your letter on EDGAR under the form type
label
CORRESP.
You may contact Joseph Roesler, Staff Accountant, at (202)
551-
3628 or Mary Mast, Senior Accountant, at (202) 551-3613 if you
have
questions regarding the comments. In this regard, do not hesitate
to
contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
??
??
??
??
Michael P. Gray
Curis, Inc.
November 18, 2005
Page 3
</TEXT>
</DOCUMENT>
2005-11-09 - CORRESP - CURIS INC
CORRESP 1 filename1.htm SEC RESPONSE LETTER VIA FACSIMILE November 9, 2005 Securities and Exchange Commission Division of Corporation Finance Judiciary Plaza 450 Fifth Street, N.W. Washington, DC 20549 Attention: Joseph Roesler Re: Curis, Inc. Form 10-K for Fiscal Year Ended December 31, 2004 (“Form 10-K”) Form 10-Q for Quarter Ended March 31, 2005 (“Form 10-Q”) File No. 000-30347 Dear Mr. Roesler: On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the Company’s responses to comments contained in a letter dated November 1, 2005 (the “November Letter”) from Jim B. Rosenberg, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Michael P. Gray, Vice President of Finance and Chief Financial Officer of Curis relating to the Company’s Form 10-K and Form 10-Q. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The response is keyed to the numbering of the comments in the November Letter and to the headings used in the November Letter. Form 10-K for the year ended December 31, 2003 Genentech Collaboration Accounting 1. We have read your response to comment 1. For the reasons cited in our October 26, 2005 conference call we continue to believe the income classification guidance in EITF 01-9 cited in your September 28, 2005 response does not provide a sufficient basis to offset income statement debits against deferred revenue. Please provide revised disclosures in disclosure-type format so we may evaluate your proposed disclosures. Response: In response to this comment, the Company intends to revise its accounting in future periods under EITF 01-9 for revenue generating arrangements Securities and Exchange Commission November 9, 2005 Page 2 where the Company, as a vendor, provides consideration to a licensor or collaborator, as a customer. Accordingly, the Company intends to revise the related disclosures in the notes to its financial statements in future filings and, specifically, has attached to this letter as Exhibit A the proposed revised disclosures for Note 1 (Revenue Recognition) (“Note 1”) and Note 4 (Research and Development Collaborations Entered Into Prior to January 1, 2005) (“Note 4”). Specifically, the Company has further revised the second to last paragraph in Note 1 and has also included a similar disclosure in the last paragraph of the “Accounting Summary” section of Note 4(a). Please be advised that for purposes of the Company’s response to this comment as well as comment Nos. 2 and 5 below, the attached Exhibit A has been marked against the Exhibit A attached to the Company’s response letter to the Staff dated September 23, 2005. 2. We have read the proposed revenue recognition disclosures in your response to comment 6 and based on the October 26, 2005 conference call we understand you are drafting new disclosures on revenue recognition to better clarify in what circumstances you use the relative performance method, the straight line method, the deliverable method and the substantive milestone method. We will re-evaluate your policy once we receive your proposed disclosures. Response: In response to this comment, the Company has further revised its revenue recognition disclosures in Note 1. The Company has attached as Exhibit A the proposed revised disclosures to Note 1. 3. In your response to comment 4 you stated that you will provide us a SAB 99 analysis. We will evaluate your response and your proposed disclosures once we receive your SAB 99 analysis. Response: In response to this comment, the Company has supplementally provided to the Staff its SAB 99 analysis of the materiality of its error in recording $4.0 million in maintenance fees as receivables and deferred revenue at the outset of the Genentech collaboration in June 2003. 4. We have read your response to comment 5 and we are unable to concur with you that taking an approximately 37% discount of the quoted market price is appropriate. We believe the quoted market price of the common stock on the EITF 96-18 measurement date is the best evidence of the value of stock. We also believe that restrictions imposed do not provide a basis for valuing the stock at a price other than the quoted market price Securities and Exchange Commission November 9, 2005 Page 3 and we do not believe the example provided in your response is comparable to the fact pattern presented. Please advise. Response: After further consideration of the Staff’s comment and our discussion during the October 26, 2005 conference call, the Company has now determined that it will modify its accounting for the sale of common stock to Genentech and Wyeth so that it is based on the quoted market prices as of the respective transaction dates. As a result of this determination, the Company has supplementally provided to the Staff its SAB 99 analysis of the materiality of its errors in recording the common stock sales to Genentech and Wyeth based upon a trailing average closing price rather than the quoted market price on the date of sale. Also as a result of this determination, the Company intends to revise the related disclosures in the notes to its financial statements in future filings and, specifically, has revised the disclosures in Note 4(a)(i) and (ii) and 4(c)(i) and (ii) set forth in Exhibit A attached hereto 5. We have read the proposed disclosures in your response to comment 8. We refer to the Genentech accounting summary disclosures in which you state that the “second $2,000,000 maintenance payment was eliminated as part of an amendment.” The term “eliminated” seems to imply that the receivable was written-off when in fact it was replaced with another amount per the amendment. Please provide revised disclosure in disclosure-type format so we may evaluate your proposed disclosures. Response: In response to this comment, the Company has revised the disclosures in Note 4(b) to remove the word “eliminated” from its revenue recognition disclosure and to clarify that the second $2,000,000 maintenance payment due under the June 2003 arrangement was replaced by a $2,000,000 payment made to the Company for research services in December 2004 with no economic impact arising from the replacement f one payment for the other. The Company has attached the proposed revised disclosures for Note 4(b) to this letter as Exhibit A. If you require any additional information, please telephone the undersigned at the telephone number indicated above. Securities and Exchange Commission November 9, 2005 Page 4 Please be advised that it is the Company’s intention to include the updated disclosures set forth in Exhibit A and the other modifications to its financial statements in its Quarterly Report on Form 10-Q for the Quarter ended September 30, 2005, which the Company is required to file with the SEC on or before November 9, 2005. Accordingly, the Company would appreciate the opportunity to review any further comments or revisions with the Staff at its earliest convenience prior to such filing. Sincerely, /s/ CYNTHIA T. MAZAREAS Cynthia T. Mazareas Cc: Michael P. Gray Exhibit A (1) REVENUE RECOGNITION During the third quarter of 2005, the Company updated its disclosure relating to its revenue recognition policies that were previously presented in the Company’s Annual Report on Form 10-K for the year ended December 31, 2004. In addition, in the third quarter of 2005, the Company recorded adjustments identified during the preparation of the financial statements for the quarter to correct errors in recording the fair value of shares issued in connection with our collaborations with Genentech and Wyeth. The shares were valued using a price based on a trailing average of closing prices, pursuant to the terms of the stock purchase agreements. The Company has determined that it should have valued the shares using the quoted market price on the dates of issuance and, as a result, additional paid-in capital was understated and deferred revenues were overstated. The effects of these adjustments was to increase additional paid-in-capital by $1,629,000, decrease noncurrent deferred revenue by $1,169,000 and to reverse $460,000 of revenue in the third quarter of 2005 to correct for the cumulative overstatement of revenues from June 2003 through June 30, 2005. The impact of these errors, if recorded in the periods to which they related, would not effect the net loss per share previously reported by the Company for any prior year or quarter, nor otherwise have a material impact on previously reported financial information. In addition, the Company does not believe that the impact of these adjustments is material to the financial statements for the quarter ended September 30, 2005 or to the projected results of operations for the year ending December 31, 2005. The Company’s business strategy includes entering into collaborative license and development agreements with biotechnology and pharmaceutical companies for the development and commercialization of the Company’s product candidates. The terms of the agreements typically include non-refundable license fees, funding of research and development, payments based upon achievement of clinical development milestones and royalties on product sales. The Company follows the provisions of the Securities and Exchange Commission’s Staff Accounting Bulletin (SAB) No. 104 (SAB No. 104), Revenue Recognition, Emerging Issues Task Force (EITF) Issue No. 00-21 (EITF 00-21), Accounting for Revenue Arrangements with Multiple Deliverables, EITF Issue No. 99-19 (EITF 99-19), Reporting Revenue Gross as a Principal Versus Net as an Agent, and EITF Issue No. 01-9 (EITF 01-9), Accounting for Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendor’s Products). Non-refundable license fees are recognized as revenue when the Company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured and the Company has no further performance obligations under the license agreement. Multiple element arrangements, such as license and development arrangements are analyzed to determine whether the elements, the license and the performance obligations, can be separated or whether they must be accounted for as a single unit of accounting in accordance with EITF 00-21. The Company recognizes up-front license payments as revenue upon delivery of the license only if the license has standalone value and the fair value of the undelivered performance obligations, typically including research or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have standalone value or (ii) have standalone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The Company recognizes revenue using the relative performance method provided that the Company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Direct labor hours or full-time equivalents are typically used as the measure of performance. Revenue recognized under the relative performance method would be determined by multiplying the total payments under the contract, excluding royalties and payments contingent upon achievement of substantive milestones, by the ratio of level of effort incurred to date to estimated total level of effort required to complete the Company’s performance obligations under the arrangement. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the Company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement and the performance obligations are provided on a best-efforts basis, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period the Company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the Company is expected to complete its performance obligations under an arrangement. In addition, if the Company is involved in a steering committee under a research arrangement, the Company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are not inconsequential or perfunctory and that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the Company expects to complete its aggregate performance obligations. A-2 Collaboration agreements may also contain substantive milestones. Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: • the milestone payments are non-refundable; • achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; • substantive effort is involved in achieving the milestone; • the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and, • a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. Determination as to whether a milestone meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the milestone payment would not be considered a substantive milestone, and the resulting payment would be recognized as revenue as such performance obligations are performed under either the relative performance or straight-line methods, as applicable, and in accordance with these policies as described above. Reimbursement of costs is recognized as revenue provided the provisions of EITF 99-19 are met, the amounts are determinable, and collection of the related receivable is reasonably assured. Royalty revenue is recognized upon the sale of the related products, provided that the royalty amounts are fixed or determinable, collection of the related receivable is reasonably assured and the Company has no remaining performance obligations under the arrangement. If royalties are received when the Company has remaining performance obligations, the royalty payments would be attribute
2005-11-01 - UPLOAD - CURIS INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
November 1, 2005
Mr. Michael P. Gray
Vice President of Finance and
Chief Financial Officer
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
Form 10-Q for Quarter Ended March 31, 2005
File No. 000-30347
Dear Mr. Gray:
We have reviewed the above referenced filings and your
September
28, 2005 response to our August 22, 2005 letter, as well as our
teleconference call on October 26, 2005 and have the following
comments. In our comments, 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 review 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 year ended December 31, 2003
Genentech Collaboration Accounting
1. We have read your response to comment 1. For the reasons cited
in
our October 26, 2005 conference call we continue to believe the
income classification guidance in EITF 01-9 cited in your
September
28, 2005 response does not provide a sufficient basis to offset
income statement debits against deferred revenue. Please provide
revised disclosures in disclosure-type format so we may evaluate
your
proposed disclosures.
2. We have read the proposed revenue recognition disclosures in
your
response to comment 6 and based on the October 26, 2005 conference
call we understand you are drafting new disclosures on revenue
recognition to better clarify what circumstances you use the
relative
performance method, the straight line method, the deliverable
method
and the substantive milestone method. We will re-evaluate your
policy once we receive your proposed disclosures.
3. In your response to comment 4 you stated that you will provide
us
a SAB 99 analysis. We will evaluate your response and your
proposed
disclosures once we receive your SAB 99 analysis.
4. We have read your response to comment 5 and we are unable to
concur with you that taking an approximately 37% discount of the
quoted market price is appropriate. We believe the quoted market
price of the common stock on the EITF 96-18 measurement date is
the
best evidence of the value of stock. We also believe that
restrictions imposed do not provide a basis for valuing the stock
at
a price other than the quoted market price and we do not believe
the
example provided in your response is comparable to the fact
pattern
presented. Please advise.
5. We have read the proposed disclosures in your response to
comment
8. We refer to the Genentech accounting summary disclosures in
which
you state that the "second $2,000,000 maintenance payment was
eliminated as part of an amendment." The term "eliminated" seems
to
imply that the receivable was written-off when in fact it was
replaced with another amount per the amendment. Please provide
revised disclosure in disclosure-type format so we may evaluate
your
proposed disclosures.
* * * *
Please respond to the comments 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 comments and provides
requested information. Detailed letters greatly facilitate our
review. Please file your letter on EDGAR under the form type
label
CORRESP.
You may contact Joseph Roesler, Staff Accountant, at
(202)
551-3628 or Mary Mast, Senior Accountant, at (202) 551-3613 if you
have questions regarding the comments. In this regard, do not
hesitate to contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
??
??
??
??
Michael P. Gray
Curis, Inc.
November 1, 2005
Page 2
</TEXT>
</DOCUMENT>
2005-09-28 - CORRESP - CURIS INC
CORRESP
1
filename1.htm
Response Letter
WILMER CUTLER PICKERING
HALE AND DORR LLP
Cynthia T. Mazareas
60 STATE STREET
BOSTON, MA
02109
+1 617 526 6393
+1 617 526 5000 fax
cynthia.mazareas@wilmerhale.com
September 28, 2005
Pursuant to Regulation §200.83 (Rule 83) of the Freedom of Information Act, this letter omits confidential information included in the unredacted version of this
letter delivered to the Securities and Exchange Commission, Division of Corporation Finance. Asterisks denote such omissions.
BY ELECTRONIC SUBMISSION
Securities
and Exchange Commission
Division
of Corporation Finance
100
F Street, NE
Washington,
D.C. 20549
Attention:
Joseph Roesler
Re:
Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004 (“Form 10-K”)
Form 10-Q for Quarter Ended March 31, 2005 (“Form 10-Q”)
File No. 000-30347
Dear Mr. Roesler:
On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the responses to comments contained in a letter dated August 22, 2005
(the “August Letter”) from Jim B. Rosenberg, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Michael P. Gray, Vice President of Finance and Chief Financial
Officer of Curis relating to the Company’s Form 10-K and Form 10-Q. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The response is keyed to the numbering of the
comments in the August Letter and to the headings used in the August Letter.
Form 10-K for the year ended December 31, 2003
Genentech Collaboration Accounting
BALTIMORE
BEIJING
BERLIN
BOSTON
BRUSSELS
LONDON
MUNICH
NEW YORK
NORTHERN VIRGINIA
OXFORD
PALO ALTO
WALTHAM
WASHINGTON
Securities and Exchange Commission
September 28, 2005
Page 2
1.
We have evaluated your June 20, 2005 response 3 as it relates to your policy of charging the excess of costs incurred over cumulative revenues recognized against deferred
revenue. The effect of this policy appears to be to accelerate the timing of revenue recognition such that incurred costs have no impact on the income statement in the period in which they are incurred. It does not appear that the income
characterization guidance in EITF 01-9 provides a basis for changing the timing of revenue recognition. Please advise.
Response:
The
Company respectfully notes your comment and the additional factors discussed during the Company’s teleconferences with the Staff on August 9, 2005 and August 18, 2005.****************************************************
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The Company supplementally notes that the Company’s policy was not intended to accelerate revenue recognition. Rather, it was the Company’s
interpretation of the guidance in EITF 01-9 with respect to how a reduction in selling price, resulting from its payments to Genentech, should be reflected in its financial statements.
2.
In our telephone conferences on August 9, 2005 and August 18, 2005, you indicated that you recognize the $4 million in maintenance fees over the performance period. Please
help us understand why each of the maintenance fees does not represent a substantive milestone.
Securities and Exchange Commission
September 28, 2005
Page 3
Response:
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More specifically, the June 2003 Genentech agreement provided
for a $5 million up-front fee, two $2 million maintenance fee payments payable in June 2004 and June 2005, respectively, milestone payments on the achievement of specified clinical developmental and drug approval objectives and royalties on product
sales. The maintenance fee payments, while generally associated with the research and development services to be provided through 2005 and the steering committee obligations, are not specifically tied to the achievement of any developmental
objectives.
In addition, the maintenance fee payments were
contractually committed provided only that Genentech did not terminate the agreement during the first two years of the arrangement as the result of an uncured breach of any material term of the agreement by the Company (or due to the Company’s
insolvency). *****
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Securities and Exchange Commission
September 28, 2005
Page 4
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3.
Please analyze for us why it is appropriate to treat the December 2004 amendment as an arrangement separate and apart from the June 2003 arrangement rather than as a modification of
the June 2003 arrangement. We understand from our telephone conferences on August 9, 2005 and August 18, 2005 that the December 2004 amendment was not contemplated at the time the June 2003 arrangement was entered into and therefore given
the time elapsed between the June 2003 arrangement and its amendment you do not believe that the presumption in EITF 00-21, paragraph 2 has been met. However, we also note that the December 2004 amendment appears to change the rate per full time
equivalent implicit in the June 2003 arrangement through the acceleration of the $2 million cash payment originally due in June 2005. That is, the December 2004 amendment appears to modify the June 2003 arrangement rather than provide for
incremental services. In these circumstances, it is unclear why the December 2004 amendment is accounted for as a unit of accounting separate and apart from the June 2003 single unit of accounting. In addition, please clarify to us what role the
joint steering committee has in the additional eight full-time equivalents provided in the December 2004 amendment.
Response:
The
Company respectfully notes your comment. **********
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EITF 00-21 provides guidance relating to the separability of
deliverables included in an arrangement that obligates a vendor to provide more than one product or service (and that is not subject to the scope of other specific accounting literature). Paragraph 2 of EITF 00-21 states that “separate
contracts with the same entity or related parties that are entered into at or near the same time are presumed to have been negotiated as a package and should, therefore, be evaluated as a single arrangement in considering whether there are one or
more units of accounting. That presumption may be overcome if there is sufficient evidence to the contrary.”
Pursuant to the original June 2003 agreement, in exchange for the license and the research and steering committee services, Genentech paid a $5 million
up-front license payment and agreed to pay a total of $4 million in maintenance fees. ************
Securities and Exchange Commission
September 28, 2005
Page 5
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Pursuant to the terms of the June 2003 collaboration, during the initial two-year term of the research program, the Company agreed to assign no fewer than eight FTEs to the program. During the period from June 2003
until June 2004, the Company dedicated FTEs in excess of the minimum eight FTE requirement in order to build preclinical data that the Company expected would increase the likelihood of the successful preclinical development of the technology under
the collaboration. After the conclusion of the first year of the collaboration, the Company asked Genentech to pay for an additional eight FTEs, in return for which the Company would provide research services and xenograft tumor samples to Genentech
on a best-efforts basis (not subject to any acceptance criteria) through June 2005. These xenograft tumor samples are a by-product of the research services and consist of primary human tumor samples that have been implanted and grown in mouse
models. In anticipation of the execution of a formal written agreement, the Company committed an additional eight FTEs to the program beginning in June 2004. On December 20, 2004, the Company and Genentech entered into the expected amendment to
the June 2003 collaboration agreement. Genentech agreed to fund sixteen FTEs at a rate of $250,000 per year per FTE from June 2004 until June 2005, for a total of $4 million. Under the original agreement, during the second year of the collaboration,
the Company was obligated to dedicate 8 FTEs to the collaboration and Genentech would have paid the Company $2 million (which implies a per-FTE rate of $250,000 that is equal to the per-FTE rate included in the amendment). Genentech agreed to pay $2
million in December 2004 and eliminated the $2 million maintenance fee that was due in June 2005 under the original arrangement. In substance, the amendment provided an additional $2.1 million of funding to the Company (including $250,000 for each
of eight incremental FTEs plus $100,000 for the xenograft tumor samples) during the period of June 2004 through June 2005.
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Securities and Exchange Commission
September 28, 2005
Page 6
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The eight incremental FTEs are supporting the objectives of the research program under the direction of the steering
committee.
4.
In our telephone conferences on August 9, 2005 and August 18, 2005 you indicated that you recognized the right to receive $4 million in maintenance fees as a financial
asset on the date the June 2003 agreement was signed. You indicated that you believed these fees represented deferred payments contingent solely on the expiration of time because the contract did not explicitly link these fees to any particular
performance under the contract. You also indicated that if Curis failed to provide the services specified in the June 2003 arrangement that Curis would not be entitled to the $4 million maintenance fee notwithstanding the absence of an explicit link
between these performance provisions and the $4 million in maintenance fees. Under these circumstances, it is unclear why you believe the right to receive $4 million in maintenance fees represents a financial asset on the date the June 2003
agreement was signed. Please advise.
Response:
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5.
We note from your disclosures on page 70 of your December 31, 2004 Form 10-K that you sold 1,323,835 shares of common stock to Genentech for $3.5 million on
June 11, 2003 as partial consideration for the rights and licenses granted to Genentech under the Collaboration Agreement. We also understand from our telephone conference on August 9, 2005 that the $2.644 purchase price of the common
stock sold to Genentech was based on the average closing share price for 30 trading days preceding June 11, 2003, which you believe approximates fair value. Since the common stock was issued as part of a transaction to sell goods or services to
Genentech, it appears that such issuance should be measured and recognized in accordance with EITF 96-18 and classified in accordance with EITF 01-9. Please give us your analysis of both the requirement under EITF 96-18/Statement 123 to use the
quoted market price of the common stock if the common stock is more reliably measurable and the discussion prior to example 4 in EITF 01-9, Exhibit 01-9B. In your analysis, please reconcile the value you attributed to the common stock with the
quoted market price of the common stock on the EITF 96-18 measurement date. If you believe the difference between the $3.5 million value you attributed to the common stock and the fair value of that common stock dete
2005-08-22 - UPLOAD - CURIS INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
August 22, 2005
Mr. Michael P. Gray
Vice President of Finance and
Chief Financial Officer
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
Form 10-Q for Quarter Ended March 31, 2005
File No. 000-30347
Dear Mr. Gray:
We have reviewed the above referenced filings and your June
20,
2005 response to our letter dated June 7, 2005, as well as, our
teleconference calls on August 9, 2005 and August 18, 2005, and
have
the following comments. In our comments, 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 review 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 year ended December 31, 2003
Genentech Collaboration Accounting
1. We have evaluated your June 20, 2005 response 3 as it relates
to
your policy of charging the excess of costs incurred over
cumulative
revenues recognized against deferred revenue. The effect of this
policy appears to be to accelerate the timing of revenue
recognition
such that incurred costs have no impact on the income statement in
the period in which they are incurred. It does not appear that
the
income characterization guidance in EITF 01-9 provides a basis for
changing the timing of revenue recognition. Please advise.
2. In our telephone conferences on August 9, 2005 and August 18,
2005, you indicated that you recognize the $4 million in
maintenance
fees over the performance period. Please help us understand why
each
of the maintenance fees does not represent a substantive
milestone.
3. Please analyze for us why it is appropriate to treat the
December
2004 amendment as an arrangement separate and apart from the June
2003 arrangement rather than as a modification of the June 2003
arrangement. We understand from our telephone conferences on
August
9, 2005 and August 18, 2005 that the December 2004 amendment was
not
contemplated at the time the June 2003 arrangement was entered
into
and therefore given the time elapsed between the June 2003
arrangement and its amendment you do not believe that the
presumption
in EITF 00-21, paragraph 2 has been met. However, we also note
that
the December 2004 amendment appears to change the rate per full
time
equivalent implicit in the June 2003 arrangement through the
acceleration of the $2 million cash payment originally due in June
2005. That is, the December 2004 amendment appears to modify the
June 2003 arrangement rather than provide for incremental
services.
In these circumstances, it is unclear why the December 2004
amendment
is accounted for as a unit of accounting separate and apart from
the
June 2003 single unit of accounting. In addition, please clarify
to
us what role the joint steering committee has in the additional
eight
full-time equivalents provided in the December 2004 amendment.
4. In our telephone conferences on August 9, 2005 and August 18,
2005
you indicated that you recognized the right to receive $4 million
in
maintenance fees as a financial asset on the date the June 2003
agreement was signed. You indicated that you believed these fees
represented deferred payments contingent solely on the expiration
of
time because the contract did not explicitly link these fees to
any
particular performance under the contract. You also indicated
that
if Curis failed to provide the services specified in the June 2003
arrangement that Curis would not be entitled to the $4 million
maintenance fee notwithstanding the absence of an explicit link
between these performance provisions and the $4 million in
maintenance fees. Under these circumstances, it is unclear why
you
believe the right to receive $4 million maintenance fees
represents a
financial asset on the date the June 2003 agreement was signed.
Please advise.
5. We note from your disclosures on page 70 of your December 31,
2004
Form 10-K that you sold 1,323,835 shares of common stock to
Genentech
for $3.5 million on June 11, 2003 as partial consideration for the
rights and licenses granted to Genentech under the Collaboration
Agreement. We also understand from our telephone conference on
August 9, 2005 that the $2.644 purchase price of the common stock
sold to Genentech was based on the average closing share price for
30
trading days preceding June 11, 2003, which you believe
approximates
fair value. Since the common stock was issued as part of a
transaction to sell goods or services to Genentech, it appears
that
such issuance should be measured and recognized in accordance with
EITF 96-18 and classified in accordance with EITF 01-9. Please
give
us your analysis of both the requirement under EITF 96-
18/Statement
123 to use the quoted market price of the common stock if the
common
stock is more reliably measurable and the discussion prior to
example
4 in EITF 01-9, Exhibit 01-9B. In your analysis, please reconcile
the value you attributed to the common stock with the quoted
market
price of the common stock on the EITF 96-18 measurement date. If
you
believe the difference between the $3.5 million value you
attributed
to the common stock and the fair value of that common stock
determined using the quoted marked price of a share of the common
stock on the 96-18 measurement date is not material please provide
us
your SAB 99 analysis. In this regard, the apparent absence of any
disclosure about an identifiable benefit, as that term is used in
EITF 01-9, appears to suggest that the common stock issued
represents
a sales incentive. It also appears that the common stock is more
reliably measurable than the sales incentive given, but it appears
that the $3.5 million fair value is not based on the quoted market
price of the common stock on the EITF 96-18 measurement date.
6. See your revenue recognition policy in Note 1. Please clarify
in
your disclosure:
* How you distinguish between milestones and services in a single
unit of accounting.
* What "the remainder" is.
* How your accounting on the Genentech arrangement for the $4
million
maintenance fees ratably over the performance period reconciles
with
your accounting policy disclosure in Note 1 that indicates you
recognize such fees based on expected total labor hours for the
service.
7. In Note 1, you state that you assess proportional performance
of
services in some circumstances based on the ratio of costs
incurred
to date to total costs to be incurred under the related contract.
Please help us understand why you believe cost is an output
measure.
If cost is an input measure, please help us understand by
reference
to specific authoritative literature why you believe use of an
input
measure to assess proportional performance for a service contract
is
appropriate.
Disclosures
8. Based on our telephone conferences on August 9, 2005 and August
18, 2005 we believe additional disclosures are necessary to
provide
better transparency into your business. Please provide us the
following information in disclosure-type format to help us
evaluate
the adequacy of your disclosure:
* Separately present royalty revenue and license fee revenue on
the
face of the Consolidated Statement of Operations and Comprehensive
Loss.
* Disclose your accounting policy for characterizing in the income
statement sales incentives and other consideration given to your
customers. Refer to EITF 01-9.
* Ensure that the material facts of and accounting for each of the
collaborations disclosed in Note 4 are disclosed. For example, in
telephone conferences with us, you indicated that the $4 million
maintenance fees were recorded as financial assets on June 11,
2003.
You also indicated that in exchange for the exercise of the co-
development option, you gave up your right to certain US
milestones.
We are unable to locate disclosure to this effect in Note 4.
* Clarify why you believe it is appropriate in the Genentech
agreement to record the revenue over the period of the steering
committee services instead of the research and development period.
Clarify your obligations under the steering committee and the
composition of the steering committee.
* Clarify the reasons no accounting treatment was given to the
option
exercised in the June 2003 agreement. In this regard, we note
that
only Curis could exercise the option and that there was no
deliverable under EITF 00-21.
* For each collaboration agreement disclosed in Note 4, please
disclose the following:
* Whether the arrangement represents a single unit of accounting
or
multiple unit of accounting. If it is a single unit of
accounting,
identify the unique attributes of the collaboration that support
this
conclusion. If there are multiple units of accounting, identify
them. For each collaboration, ensure that it is clear from the
disclosure in Notes 1 and 4 how you are accounting for each unit
of
accounting.
* What the performance period is and how it was determined.
* Whether the milestones are substantive or whether they are
recognized proportionally.
* Whether consideration was given to the collaborator and if so,
how
you accounted for and characterized this consideration in the
income
statement.
Please provide to us your revised disclosures.
* * * *
Please respond to the comments 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 comments and provides
requested information. Detailed letters greatly facilitate our
review. Please file your letter on EDGAR under the form type
label
CORRESP.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings to be certain that the
filing includes all information required under the Securities and
Exchange Act of 1934 and that they have provided all information
investors require for an informed investment decision. 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.
You may contact Joseph Roesler, Staff Accountant, at (202)
551-
3628 or Mary Mast, Senior Accountant, at (202) 551-3613 if you
have
questions regarding the comments. In this regard, do not hesitate
to
contact me, at (202) 551-3679.
Sincerely,
For Jim B. Rosenberg
Senior Assistant Chief
Accountant
??
??
??
??
Michael P. Gray
Curis, Inc.
Page 1
</TEXT>
</DOCUMENT>
2005-06-20 - CORRESP - CURIS INC
CORRESP 1 filename1.htm Response Letter [LETTERHEAD OF WILMER CUTLER PICKERING HALE AND DORR LLP APPEARS HERE] VIA FACSIMILE June 20, 2005 Securities and Exchange Commission Division of Corporate Finance Judiciary Plaza 450 Fifth Street, N.W. Washington, DC 20549 Attention: Joseph Roesler Re: Curis, Inc. Form 10-K for Fiscal Year Ended December 31, 2004 (“Form 10-K”) Form 10-Q for Quarter Ended March 31, 2005 (“Form 10-Q”) File No. 000-30347 Dear Mr. Roesler: On behalf of Curis, Inc. (“Curis” or the “Company”), set forth below are the responses to comments contained in a letter dated June 7, 2005 (the “Letter”) from Jim B. Rosenberg, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Michael P. Gray, Vice President of Finance and Chief Financial Officer of Curis relating to the Company’s Form 10-K and Form 10-Q. The response contained herein is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. The response is keyed to the numbering of the comments in the Letter and to the headings used in the Letter. Form 10-K for the fiscal year ended December 31, 2004 Item 7. Management Discussion and Analysis of Financial Condition and Results of Operations Contractual Obligations, page 41 1. We note from your disclosures in Note 11(b) of your consolidated financial statements that you are obligated to pay license fees, royalties and milestones. Please assess whether these payments meet the criteria as a purchase obligation, and if these payments should be shown in the contractual obligations table pursuant to Item 303(a)(5) of Regulation S-K, tell us why you have neither included them in the table nor in a discussion in the liquidity and capital resource section of the MD&A. Please refer to Financial Reporting Release 72, section IV. Securities and Exchange Commission June 20, 2005 Page 2 Response: The Company does not have any fixed and determinable known material contractual obligations that constitute “purchase obligations” within the meaning of Item 305(a)(5) of Regulation S-K, other than any known contractual commitments that are currently disclosed. We note that the known contractually committed license payments that are referred to in footnote 11(b) of the Financial Statements have been set forth under the heading “Licensing Obligations” in “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Contractual Obligations” (the “Table”). The Company has determined to not include in the Table any milestone and royalty amounts that it may be required to pay to its licensees in future periods inasmuch as the amount and timing of any such payments, if any, is currently unknown. Such payments are contingent upon the achievement of specified research, development and commercialization objectives, the achievement of which is highly uncertain. The uncertain nature of any such future payments is due, in part, to the preclinical stage of development of each of the licensed technologies. In response to the Staff’s comment, in future filings the Company intends to include both a footnote to “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Contractual Obligations” and further discussion in the “Liquidity and Capital Resources” section to the effect that in the future the Company may owe royalties and other contingent payments to its licensees based on the achievement of developmental milestones, product sales and specified other objectives. Consolidated Financial Statements Notes to Consolidated Financial Statements (11) Commitments (b) License Agreements, page 79 2. Please tell us how recording an accrual for scientific and clinical milestones over the period that the work required to meet the milestone is completed is consistent with SFAS 5. It would appear that management’s best estimate of the accrual should be recorded at the point and time the milestone is probable and estimable. If the milestone relates to FDA approval, please tell us how management is able to determine that the milestone is probable. Response: In response to the Staff’s comment, in future filings the Company intends to revise this disclosure to state that expenses related to Securities and Exchange Commission June 20, 2005 Page 3 scientific and clinical milestones will be accrued at the point in which achievement of the milestone is probable and the amount can be estimated in accordance with SFAS 5, which is the Company’s policy as it relates to these expenses. All expenses incurred by the Company related to scientific and clinical milestones since its inception were recorded at the point in which the milestone became probable and the amount could be estimated. To date, the Company has not incurred any material milestone expenses related to either scientific or clinical development milestones. In response to the Staff’s comment regarding management’s ability to determine that milestone expenses are probable if such milestone is based on FDA approval, the Company notes that no milestone expenses have been incurred to date by the Company that have been tied to FDA approval. Further, should future milestone expenses be based on FDA approval, the Company expects that it would not consider such milestone probable until FDA approval had been obtained. Form 10-Q for the Quarter Ended March 31, 2005 Notes to Condensed Consolidated Financial Statements 3. Genentech Collaboration Accounting 3. We have the following comments related to your collaboration arrangement with Genentech: • Please tell us why you believe EITF 01-09 is the appropriate literature to account for the amount reimbursable to Genentech for research and development costs incurred by Genentech. • Please clarify to us why the excess of costs incurred over the cumulative revenues recognized is first charged against deferred revenue. It is not clear why incurring costs above the cumulative revenue recognized is the completion of the earning process. • Please tell us your consideration of EITF 99-19 and EITF 00-21 in regards to the arrangement with Genentech. In addressing EITF 99-19, please provide to us your analysis of each criteria within EITF 99-19, who the primary obligor is in this arrangement and who the customer is in the arrangement. In addressing EITF 00-21, please provide to us your evaluation of the separate units of accounting at inception and at the point that each item in the arrangement is delivered. Securities and Exchange Commission June 20, 2005 Page 4 Response: Set forth below is the corresponding response to each of the bulleted items in the Staff’s comment. • Paragraph 1 of EITF 01-09 states that it addresses the accounting for consideration given by a vendor to a customer and applies to vendors that derive revenue from sales of services or products. On June 11, 2003, the Company entered into a Collaborative Research, Development and License Agreement with Genentech (the “License Agreement”) pursuant to which the Company licensed its hedgehog (“Hh”) antagonist technologies to Genentech, agreed to provide research services for two years and also agreed to participate in a joint steering committee through the period of development of the technologies. The Company received $9 million from Genentech, which it has been recognizing over the performance period that it will be providing services to Genentech (see EITF 00-21 discussion below). Because the Company is deriving revenue from the sale of the license and services to Genentech, the Company has considered Genentech to be a customer. In January 2005, the Company exercised an option to co-develop with Genentech a basal cell carcinoma (“BCC”) product candidate that is based upon one of the Company’s Hh antagonist technologies. Pursuant to the co-development arrangment, the Company and Genentech will share equally in the U.S. costs and profits, if any, of the BCC product candidate. Other than the Company’s participation on the co-development steering committee, Genentech is managing all aspects of the BCC development program and is incurring all costs. Genentech subsequently invoices the Company for its equal share of these development costs and the Company has made payments to Genentech in satisfaction of these invoices. These payments were considered by the Company to be within the scope of EITF 01-09 because they are payments to a customer and did not meet any of the scope exceptions outlined in paragraph 7 of EITF 01-09. The Company considered the guidance in Issue 1 of EITF 01-09, specifically whether the benefit received by the Company from Genentech (i.e., the BCC development services provided by Genentech) was separable from the Hh antagonist license and services sold to Genentech and, if so, whether the fair value of those services provided by Genentech could be estimated, as discussed in paragraphs 9a and 9b of EITF 01-09. The Company concluded that the benefit received could not be separated from the license and services sold to Genentech. The Securities and Exchange Commission June 20, 2005 Page 5 benefit the Company will receive for paying 50% of Genentech’s development costs is a 50% share of the profits if and when the BCC technology is ultimately commercialized; such profits can not be separated from the BCC license that was sold to Genentech. Therefore, the amounts paid to Genentech under the co-development arrangement have been treated as a reduction of revenue. • By electing to fund 50% of Genentech’s BCC development costs, the Company believes it is effectively refunding the $9 million of up-front payments received from Genentech in order to fund the Company’s 50% share of the first $18 million of Genentech’s BCC development expenses. The Company believes that receiving $9 million in payments from Genentech and subsequently funding 50% of the first $18 million of Genentech’s development costs is economically the same as receiving no payments from Genentech; Genentech funding the first $18 million of BCC development costs; and then costs in excess of $18 million being split 50/50 between the Company and Genentech. In the latter situation, the Company would have recorded no revenue and would incur no expense until Genentech incurred in excess of $18 million of BCC development expenses; prior to which point the Company would have no obligations to provide funding of the BCC development. The Company believes its treatment of the amounts repaid to Genentech should result in the same accounting outcome on a cumulative basis. This is achieved by treating the payments to Genentech first as a reversal of previously recorded revenue and next as a reduction of any deferred revenue remaining from the payments received from Genentech. Once cumulative revenue is reduced to zero and the deferred revenue is eliminated, subsequent payments to Genentech should be recorded as research and development expense. The guidance in paragraph 18 of EITF 01-09 indicates that payments in excess of cumulative revenues could continue to be treated as contra-revenue if future revenues are probable. However, future revenues under the License Agreement are dependent upon successful clinical development and FDA approval. Because clinical development and FDA approval are highly uncertain, the Company believes these are not “probable” revenue streams as contemplated by paragraph 18, so payments to Genentech in excess of cumulative revenues and deferred revenue should be treated as expense. Securities and Exchange Commission June 20, 2005 Page 6 · Under the Company’s arrangement with Genentech, the Company sold a technology license to Genentech and employees of the Company are providing services to Genentech and, therefore, Genentech is viewed as a customer. The Company uses one subcontractor to provide research services in connection with the Genentech arrangement. The Company analyzed the following criteria of EITF 99-19 in determining whether it was appropriate to record revenues from Genentech on a gross basis. · Primary obligor: the Company is the primary obligor in the arrangement as it is responsible for managing the work done by the subcontractor and would be responsible for paying the subcontractor whether or not the Company is paid by Genentech. · Establishing price: the Company negotiated terms with Genentech and the subcontractor had no input in those negotiations. · Company performs part of the service: Company employees are providing the majority of the research services. · Supplier selection: the Company uses this subcontractor to provide medicinal chemistry services on the BCC program and other of the Company’s programs. The Company selected this subcontractor to perform services on these programs. · Determination of specifications: as noted above, the Company manages the work done by the subcontractor. · Credit risk: as noted above, the Company is obligated to pay the subcontractor whether or not Genentech pays the Company. Therefore, the Company bears the credit risk. · Inventory loss: not relevant. Based on its assessment of the criteria of EITF 99-19, the Company believed it was appropriate to record revenues from Genentech on a gross basis. Securities and Exchange Commission June 20, 2005 Page 7 As noted above, the arrangement with Genentech provided for the Company to grant to Genentech a license to its Hh antagonist technology, to provide research services for two years and to participate in the joint steering committee and co-development steering committee through the period of development of the technologies. In exchange, Genentech agreed to pay the Company $9 million. The Company viewed these as three deliverables under EITF 00-21 and assessed whether these items met the separability criteria of paragraph 9 of EITF 00-21. The Company concluded that the license was not separable from steering committee services as the Company has unique expertise in this field that Genentech needs to derive any benefit from the license arrangement and to continue to advance these programs. In addition, the fair value of the steering committee services could not be objectively and reliably determined. Those services involve senior members of the Company’s scientific team with expertise in this field and must be provided throughout the development period, which is expected to extend through June 2011. This is similar to example 6 in EITF 00-21. Because the license was not separable from the steering committee services and because the fair value of such services could not be determined, the contract has been accounted for as a single arrangement and the revenue is being recognized over the period that the Company provides steering committee services. We have also attached to this letter as Appendix A a written statement from the Company with respect to the matters set forth in the third to last paragraph of the Letter. If you require any additional information, please telephone the undersigned at the telephone number indicated above. Sincerely, /s/ Cynthia T. Mazareas Cynthia T. Mazareas Cc: Michael P. Gray Appendix A CURIS, INC. 61 Moulton Street Cambridge, MA 02138 June 20, 2005 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance Judiciary Plaza 450 Fifth Street, N.W. Washington, D.C. 20549 Attention: Joseph Roesler Re: Curis, Inc. (the “Company”) Form 10-K for Fiscal Year Ended December 31, 2004 (“Form 10-K”) Form 10-Q for Quarter Ended March 31, 2005 (“Form 10-Q”) File No. 000-30347 Dear Mr. Roesler: This letter is in response to a letter dated June 7, 2005 (the “Letter”) from Jim B. Rosenberg, of the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) to Mr. Michael P. Gray, Vice President of Finance and Chief Financial Officer of the Com
2005-06-07 - UPLOAD - CURIS INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
Via Facsimile and U.S. Mail
Mail Stop 6010
June 7, 2005
Mr. Michael P. Gray
Vice President of Finance and
Chief Financial Officer
Curis, Inc.
61 Moulton Street
Cambridge, MA 02138
Re: Curis, Inc.
Form 10-K for Fiscal Year Ended December 31, 2004
Form 10-Q for Quarter Ended March 31, 2005
File No. 000-30347
Dear Mr. Gray:
We have reviewed your filings and have the following
comments.
We have limited our review of the above referenced filings to only
those issues addressed. In our comments, we ask you to provide us
with supplemental information so we may better understand your
disclosure. After reviewing this information, we may or may not
raise additional comments.
Please understand that the purpose of our review 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, 2004
Item 7. Management Discussion and Analysis of Financial Condition
and Results of Operations
Contractual Obligations, page 41
1. We note from your disclosures in Note 11(b) of your
consolidated
financial statements that you are obligated to pay license fees,
royalties and milestones. Please assess whether these payments
meet
the criteria as a purchase obligation and, if these payments
should
be shown in the contractual obligations table pursuant to Item
303(a)(5) of Regulation S-K, tell us why you have neither included
them in the table nor in a discussion in the liquidity and capital
resource section of the MD&A. Please refer to Financial Reporting
Release 72, section IV.
Consolidated Financial Statements
Notes to Consolidated Financial Statements
(11) Commitments
(b) License Agreements, page 79
2. Please tell us how recording an accrual for scientific and
clinical milestones over the period that the work required to meet
the milestone is completed is consistent with SFAS 5. It would
appear that management`s best estimate of the accrual should be
recorded at the point and time the milestone is probable and
estimable. If the milestone relates to FDA approval, please tell
us
how management is able to determine that the milestone is
probable.
Form 10-Q for the Quarter Ended March 31, 2005
Notes to Condensed Consolidated Financial Statements
3. Genentech Collaboration Accounting
3. We have the following comments related to your collaboration
arrangement with Genentech:
* Please tell us why you believe EITF 01-09 is the appropriate
literature to account for the amount reimbursable to Genentech for
research and development costs incurred by Genentech.
* Please clarify to us why the excess of costs incurred over the
cumulative revenues recognized is first charged against deferred
revenue. It is not clear why incurring costs above the cumulative
revenue recognized is the completion of the earning process.
* Please tell us your consideration of EITF 99-19 and EITF 00-21
in
regards to the arrangement with Genentech. In addressing EITF 99-
19,
please provide to us your analysis of each criteria within EITF
99-
19, who the primary obligor is in this arrangement and who the
customer is in the arrangement. In addressing EITF 00-21, please
provide to us your evaluation of the separate units of accounting
at
inception and at the point that each item in the arrangement is
delivered.
* * * *
Please provide us a supplemental letter with detailed
explanations keyed to our comments within 10 business days of the
date of this letter or tell us when you will provide us with a
response. Please file your letter on EDGAR under the form type
label
CORRESP.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors 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.
In connection with responding to our comments, please
provide,
in writing, a statement from the company acknowledging that
* the company is responsible for the adequacy and accuracy of the
disclosure in the filings;
* staff comments or changes to disclosure in response to staff
comments in the filings reviewed by the staff 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 advised that the Division of Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in our review of your filing or in
response to our comments on your filing.
You may contact Joseph Roesler, Staff Accountant, at (202)
551-
3628 or Mary Mast, Senior Accountant, at (202) 551-3613 if you
have
questions regarding the comments. In this regard, do not hesitate
to
contact me, at (202) 551-3679.
Sincerely,
Jim B. Rosenberg
Senior Assistant Chief
Accountant
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Mr. Michael P. Gray
Curis, Inc.
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