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Letter Text
BIOMARIN PHARMACEUTICAL INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2025-06-13
BIOMARIN PHARMACEUTICAL INC
References: June 9, 2025
BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-10-03
BIOMARIN PHARMACEUTICAL INC
Summary
Generating summary...
BIOMARIN PHARMACEUTICAL INC
Response Received
12 company response(s)
High - file number match
SEC wrote to company
2007-12-20
BIOMARIN PHARMACEUTICAL INC
Summary
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Company responded
2008-01-03
BIOMARIN PHARMACEUTICAL INC
References: December 20, 2007
Summary
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Company responded
2008-01-10
BIOMARIN PHARMACEUTICAL INC
References: December 20, 2007
Summary
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Company responded
2008-01-18
BIOMARIN PHARMACEUTICAL INC
References: December 20, 2007 | January 10, 2008
Summary
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Company responded
2010-08-13
BIOMARIN PHARMACEUTICAL INC
References: July 30, 2010
Summary
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Company responded
2010-10-12
BIOMARIN PHARMACEUTICAL INC
References: August 13, 2010 | September 28, 2010
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Company responded
2012-04-02
BIOMARIN PHARMACEUTICAL INC
References: March 23, 2012
Summary
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Company responded
2012-05-03
BIOMARIN PHARMACEUTICAL INC
References: April 27, 2012
Summary
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Company responded
2013-05-20
BIOMARIN PHARMACEUTICAL INC
References: May 8, 2013
Summary
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Company responded
2021-12-20
BIOMARIN PHARMACEUTICAL INC
References: December 7, 2021
Summary
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Company responded
2022-02-23
BIOMARIN PHARMACEUTICAL INC
References: January 31, 2022
Summary
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Company responded
2023-04-06
BIOMARIN PHARMACEUTICAL INC
References: March 30, 2023
Summary
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Company responded
2024-09-16
BIOMARIN PHARMACEUTICAL INC
References: August 31, 2024
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-09-02
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-04-10
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-03-30
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-03-29
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-01-31
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2021-12-07
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2017-05-25
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-04-28
BIOMARIN PHARMACEUTICAL INC
Summary
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Company responded
2017-05-02
BIOMARIN PHARMACEUTICAL INC
References: April 28, 2017
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2016-07-26
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2016-06-24
BIOMARIN PHARMACEUTICAL INC
Summary
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Company responded
2016-07-08
BIOMARIN PHARMACEUTICAL INC
References: June 23, 2016
Summary
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BIOMARIN PHARMACEUTICAL INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2014-12-31
BIOMARIN PHARMACEUTICAL INC
References: December 22, 2014
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-05-23
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2013-05-09
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-05-15
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-04-27
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2012-03-23
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-10-13
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-09-28
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-07-30
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2008-11-06
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2008-10-07
BIOMARIN PHARMACEUTICAL INC
Summary
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Company responded
2008-10-16
BIOMARIN PHARMACEUTICAL INC
References: October 7, 2008
Summary
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Company responded
2008-11-04
BIOMARIN PHARMACEUTICAL INC
References: October 16, 2008 | October 7, 2008
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-01-31
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2005-07-14
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2005-07-14
BIOMARIN PHARMACEUTICAL INC
Summary
Generating summary...
BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2005-07-14
BIOMARIN PHARMACEUTICAL INC
Summary
Generating summary...
BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2005-07-11
BIOMARIN PHARMACEUTICAL INC
Summary
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BIOMARIN PHARMACEUTICAL INC
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2005-07-11
BIOMARIN PHARMACEUTICAL INC
Summary
Generating summary...
BIOMARIN PHARMACEUTICAL INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2005-05-19
BIOMARIN PHARMACEUTICAL INC
References: May 18, 2005
Summary
Generating summary...
BIOMARIN PHARMACEUTICAL INC
Orphan - no UPLOAD in window
1 company response(s)
Low - unmatched response
Company responded
2005-05-16
BIOMARIN PHARMACEUTICAL INC
References: May 12, 2005
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-13 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2024-10-03 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | 000-26727 | Read Filing View |
| 2024-09-16 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2024-09-02 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | 000-26727 | Read Filing View |
| 2023-04-10 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2023-04-06 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2023-03-30 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2022-03-29 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2022-02-23 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2022-01-31 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2021-12-20 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2021-12-07 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2017-05-25 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2017-05-02 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2017-04-28 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2016-07-26 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2016-07-08 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2016-06-24 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2014-12-31 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2013-05-23 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2013-05-20 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2013-05-09 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-05-15 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-05-03 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-04-27 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-04-02 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-03-23 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-10-13 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-10-12 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-09-28 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-08-13 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-07-30 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-11-06 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-11-04 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-10-16 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-10-07 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-31 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-18 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-10 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-03 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2007-12-20 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-14 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-14 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-14 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-11 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-11 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-05-19 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-05-16 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2024-10-03 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | 000-26727 | Read Filing View |
| 2024-09-02 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | 000-26727 | Read Filing View |
| 2023-04-10 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2023-03-30 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2022-03-29 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2022-01-31 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2021-12-07 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2017-05-25 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2017-04-28 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2016-07-26 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2016-06-24 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2013-05-23 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2013-05-09 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-05-15 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-04-27 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-03-23 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-10-13 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-09-28 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-07-30 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-11-06 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-10-07 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-31 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2007-12-20 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-14 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-14 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-14 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-11 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-07-11 | SEC Comment Letter | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-13 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2024-09-16 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2023-04-06 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2022-02-23 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2021-12-20 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2017-05-02 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2016-07-08 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2014-12-31 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2013-05-20 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-05-03 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2012-04-02 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-10-12 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2010-08-13 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-11-04 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-10-16 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-18 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-10 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2008-01-03 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-05-19 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
| 2005-05-16 | Company Response | BIOMARIN PHARMACEUTICAL INC | DE | N/A | Read Filing View |
2025-06-13 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm CORRESP BioMarin June 13, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Daniel Duchovny, Division of Corporation Finance, Office of Mergers & Acquisitions Re: BioMarin Pharmaceutical Inc. Inozyme Pharma, Inc. Schedule TO-T Filed June 2, 2025 File No. 005-91586 Dear Mr. Duchovny, This letter responds to the comment letter dated June 9, 2025, from the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the above-referenced Tender Offer Statement on Schedule TO (the “Schedule TO”) of BioMarin Pharmaceutical Inc. (“Parent”) and Incline Merger Sub, Inc., a wholly-owned subsidiary of Parent (“Purchaser”). Concurrently with our submission of this letter, Parent and Purchaser are filing an amendment to the Schedule TO, setting forth the changes described herein (the “TO Amendment”). Capitalized terms used but not defined herein have the meanings ascribed to them in the Schedule TO. For the convenience of the Staff, Parent and Purchaser have reproduced in italics the text of the Staff’s comments, with their response immediately following each comment. Schedule TO-T filed June 2, 2025 Offer to Purchase - Background of the Offer, page 28 1. Please revise your disclosure to describe the preliminary discussions Parent carried out in 2024 with Inozyme, including the individuals involved and the setting of such discussions. Response : Parent and Purchaser respectfully acknowledge the Staff’s comment and advise the Staff that the TO Amendment sets forth revised disclosure on page 28 of the Offer to Purchase in response to the Staff’s comment. 2. Describe the negotiations of the tender and support agreements. In addition, disclose the name of the shareholders with whom you negotiated the agreements and, if different, those with whom you entered into agreement. Response : Parent and Purchaser respectfully acknowledge the Staff’s comment and advise the Staff that the TO Amendment sets forth revised disclosure on pages 29 and 51 of the Offer to Purchase in response to the Staff’s comment. The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned or to Jamie Leigh, Cooley LLP at (415) 693-2190 or Ben Beerle, Cooley LLP at (415) 693-2192. Sincerely, /s/ G. Eric Davis G. Eric Davis Executive Vice President, Chief Legal Officer BioMarin Pharmaceutical Inc. cc: Jamie Leigh, Cooley LLP Ben Beerle, Cooley LLP
2024-10-03 - UPLOAD - BIOMARIN PHARMACEUTICAL INC File: 000-26727
October 3, 2024
Brian Mueller
Chief Financial Officer
BioMarin Pharmaceutical Inc.
770 Lindaro Street
San Rafael, California 94901
Re:BioMarin Pharmaceutical Inc.
Form 10-K for the fiscal year ended December 31, 2023
Filed February 26, 2024
Form 10-Q for the quarterly period ended June 30, 2024
Filed August 5, 2024
File No. 000-26727
Dear Brian Mueller:
We have completed our review of your filings. 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
cc:Eric Davis
2024-09-16 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP
1
filename1.htm
Document
BioMarin
September 16, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attn: Frank Wyman
Daniel Gordon
Re: BioMarin Pharmaceutical Inc.
Form 10-K for the Year Ended December 31, 2023
Filed February 26, 2024
Form 10-Q for the Quarter Ended June 30, 2024
Filed August 5, 2024
File No. 000-26727
Dear Messrs. Wyman and Gordon,
This letter is being submitted in response to the comment received from the staff (the Staff) of the United States Securities and Exchange Commission (the Commission) by letter dated August 31, 2024, addressed to Brian Mueller, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (the Company) with respect to our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the Annual Report) filed by the Company with the Commission on February 26, 2024 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 filed with the Commission on August 5, 2024 (the Quarterly Report). The Staff’s comment is restated above our response for convenience.
Form 10-Q for the quarterly period ended June 30, 2024
Notes to Condensed Consolidated Financial Statements
(10) Restructuring, page 16
1.Please provide a detailed description of your strategic portfolio assessment of research and development programs, particularly identification of terminated and advanced programs as well as the criteria for research and development programs that will meet “the high bar for advancement.” In this regard, you have now limited your breakdown of research and development expense to three broad categories in lieu of the detailed project-by-project expense breakdown provided in your Form 10-Q for the nine months ended September 30, 2023. Explain your basis for removing this information as well as corresponding discussion in the Business section, give the apparent impact of the strategic portfolio assessment on your future research and development activities. Revise your disclosures accordingly.
Response:
Please provide a detailed description of your strategic portfolio assessment of research and development programs, particularly identification of terminated and advanced programs as well as the criteria for research and development programs that will meet “the high bar for advancement.”
The Company periodically evaluates its research and development (R&D) portfolio to determine which programs the Company believes have the strongest combination of scientific merit, opportunity for
105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com
Page 2 of 4
commercial success and potential value creation for stockholders, based on the latest information available to the Company at the time of the assessment. Any programs determined not to have this same level of merit are considered for termination. The assessment is performed on both a program-by-program and overall portfolio basis using consistent financial and portfolio metrics to measure the merits of each asset individually and compare attributes across the portfolio. The financial and portfolio metrics include, but are not limited to:
•global market opportunities;
•competitive landscape and commercial potential;
•net present value and return on investment;
•probability of technical and regulatory success;
•unmet medical need;
•clinical development strategy, costs and timelines;
•manufacturing capabilities and required investment; and
•strategic fit.
The assessment results in recommendations regarding the business opportunity and scientific and technical feasibility for each program. An evaluation committee comprised of the Company’s senior executives and other internal key subject matter experts within the Company, uses the recommendations in a discussion of a program’s merits, risks and opportunities and final determination on continued development or program termination. As a result of their evaluation process, the committee decided to discontinue development of four programs: BMN 255; BMN 331; BMN 355; and BMN 365.
In this regard, you have now limited your breakdown of research and development expense to three broad categories in lieu of the detailed project-by-project expense breakdown provided in your Form 10-Q for the nine months ended September 30, 2023. Explain your basis for removing this information as well as corresponding discussion in the Business section, give the apparent impact of the strategic portfolio assessment on your future research and development activities.
The Company’s decision to revise the R&D expense disclosures within “Management’s Discussion and Analysis of Financial Conditions and Results of Operations” in the Annual Report, was not related to the strategic portfolio review, but rather a concerted effort to provide the readers of our financial statements with more meaningful information.
In preparing its Annual Report, the Company assessed the relative significance of its detailed development program disclosures given the Company’s transition to growing profitability driven by significant revenue growth, the composition of the existing R&D portfolio and evolving corporate strategic priorities. As a result of this assessment, the Company determined that none of its current R&D portfolio programs when considered individually was essential to its business as a whole, nor necessary to the execution of its business strategy and therefore, the presentation of R&D portfolio programs in the Business Section was revised to discuss its R&D portfolio as a whole to avoid projecting undue significance to any one of the programs.
Historically, the product-by-product detail provided the reader insight into our investment in each specific program, the Company recognized that there is not always a direct link between development activities, timing of expense recognition and program progression. As each phase of development carry different risks and value profiles the Company believes the revised presentation along with the related discussion is more meaningful to the reader as it provides a clearer picture of the status of the Company’s development pipeline and the progression of R&D programs through the various development phases in a single location, which the Company believes to be consistent with the disclosure requirements.
Revise your disclosures accordingly.
In response to the Staff’s comment, the Company plans to revise its disclosure in future filings, beginning with its quarterly report on Form 10-Q for the quarter ending September 30, 2024. Using the disclosure in the
Page 3 of 4
Quarterly Report for illustrative purposes, the Company intends to replace its existing disclosure under “Management’s Discussion and Analysis of Financial Condition and Results of Operations —Overview — Recent Developments” with disclosure in substantially the following form:
We continued to grow our commercial business and advance our product candidate pipeline during the first half of 2024. We believe that the combination of our internal research programs and partnerships will allow us to continue to develop and commercialize innovative therapies for people with serious and life-threatening rare diseases and medical conditions.
In the first half of 2024, we focused on value creation through working to accelerate growth, optimize efficiencies and drive operational excellence, including progress in executing on key strategic priorities first outlined in January 2024 accelerating and maximizing VOXZOGO, establishing the ROCTAVIAN opportunity, and focusing R&D activities on the assets management believes will be the most productive and accelerate earnings per share through expanding margins. We also completed a strategic portfolio assessment of R&D programs to determine which we believe have the strongest combination of scientific merit, opportunity for commercial success and potential value creation for stockholders. have the most transformative potential for patients and value creation for shareholders and have shifted focus and resources to those R&D programs that met our highest bar for prioritized advancement. We determined that The programs, namely BMN 333, a long-acting C-type natriuretic peptide for multiple growth disorders, BMN 349, a potential best-in-class, oral therapeutic for liver disease associated with Alpha-1 Antitrypsin Deficiency, and BMN 351, our next generation oligonucleotide for Duchenne Muscular Dystrophy, all met the highest bar criteria for advancement. Based on such strategic portfolio assessment, certain programs have also been discontinued. Further In addition, we initiated the execution of our financial and operational strategy that improved operating results and is expected to continue to improve our results of operations going forward. In August 2024, we announced our ROCTAVIAN strategy, which includes focusing on the United States, Germany, and Italy, where ROCTAVIAN is approved and reimbursed, and reducing additional investments in development and manufacturing, which that we anticipate will enable ROCTAVIAN to contribute to our long-term profitability.
Additionally, in response to the Staff’s comment, the Company plans to revise its disclosure in future filings beginning with its quarterly report on Form 10-Q for the quarter ending September 30, 2024. Using the disclosure in our Quarterly Report for illustrative purposes, the Company intends to replace its existing disclosure under Part I, Item 1 “Notes to Condensed Consolidated Financial Statements (Unaudited) — (10) Restructuring” with disclosure in substantially the following form:
(10) RESTRUCTURING
During the first half of 2024, the Company completed a strategic portfolio assessment of its research and development programs to determine which have it believes have the strongest combination of scientific merit, opportunity for commercial success and the most transformative potential for patients and potential value creation for shareholders stockholders. With the combined focus on patient impact and commercial opportunity, certain programs that met the highest bar for advancement have been prioritized. As a result of the assessment, the Company discontinued certain programs. have been discontinued.
During the second quarter of 2024, in connection with the discontinuation of certain research and development programs and an organizational redesign effort centered around our strategic priorities, including the acceleration and maximization of VOXZOGO, establishing the ROCTAVIAN opportunity, and focusing R&D activities on the assets management believes will be the most productive and accelerate earnings per share through expanding margins, the Company committed to a plan to reduce its global workforce by approximately 170 employees (representing approximately 5% of the Company’s global workforce). Workforce reductions are expected to be substantially completed by end of 2024.
The restructuring plan includes severance and employee-related costs, asset impairments, and other costs. The asset impairment charges were for abandoned assets-in-progress and a Right-of-Use asset (ROU Asset) related to leased office space the Company decided to exit and sub-lease. The Company utilized the
Page 4 of 4
discounted cash flow approach to determine the fair value of the ROU Asset. The ROU Asset impairment is the difference between the existing lease terms and rates and the expected sub-lease terms and rates available in the market. The Other category includes restructuring-related costs, which are expensed as incurred, as well as other obligations related to the leased office space that will be satisfied over the remainder of the lease term.
The restructuring charges and adjustments were included in Selling, General, and Administrative in the Condensed Consolidated Statements of Comprehensive Income. Restructuring expenses consisted of the following:
Three Months Ended
June 30,
Six Months Ended
June 30,
2024 2024
Severance and one-time employee benefits $ 23,837 $ 25,275
Asset Impairments 9,671 9,671
Other 5,519 7,519
$ 39,027 $ 42,465
The following unpaid balance as of June 30, 2024 was recorded to Accounts Payable and Accrued Liabilities on the Condensed Consolidated Balance Sheet:
Severance and related costs Other Total
Balance as of December 31, 2023
$ — $ — $ —
Charges and Adjustments 25,275 7,519 32,793
Payments (4,321) (2,000) (6,321)
Balance as of June 30, 2024
$ 20,954 $ 5,519 $ 26,472
The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned or Brian R. Mueller, Chief Financial Officer at (415) 506-6700 or to Jodie Bourdet, Cooley LLP at (415) 693-2054 or Julia Boesch, Cooley LLP at (415) 693-2326.
Sincerely,
/s/ G. Eric Davis
G. Eric Davis
Executive Vice President, General Counsel
BioMarin Pharmaceutical Inc.
cc: Brian R. Mueller, Executive Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc.
Jodie Bourdet, Cooley LLP
Julia Boesch, Cooley LLP
2024-09-02 - UPLOAD - BIOMARIN PHARMACEUTICAL INC File: 000-26727
August 31, 2024
Brian Mueller
Chief Financial Officer
BioMarin Pharmaceutical Inc.
770 Lindaro Street
San Rafael, California 94901
Re:BioMarin Pharmaceutical Inc.
Form 10-K for the fiscal year ended December 31, 2023
Filed February 26, 2024
Form 10-Q for the quarterly period ended June 30, 2024
Filed August 5, 2024
File No. 000-26727
Dear Brian Mueller:
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-Q for quarterly period ended June 30, 2024
Notes to Condensed Consolidated Financial Statements
(10) Restructuring , page 16
1.Please provide a detailed description of your strategic portfolio assessment of research
and development programs, particularly identification of terminated and advanced
programs as well as the criteria for research and development programs that will meet "the
highest bar for advancement." In this regard, you have now limited your breakdown of
research and development expense to three broad categories in lieu of a detailed project-
by-project expense breakdown as last provided in your Form 10-Q for the nine months
ended September 30, 2023. Explain your basis for removing this information as well as
corresponding discussion in the Business section, given the apparent impact of the
strategic portfolio assessment on your future research and development activities. Revise
your disclosures accordingly.
August 31, 2024
Page 2
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.
Please contact Frank Wyman at 202-551-3660 or Daniel Gordon at 202-551-3486 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Eric Davis
2023-04-10 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
United States securities and exchange commission logo
April 10, 2023
Brian R. Mueller
Executive Vice President, Finance & Chief Financial Officer
BioMarin Pharmaceutical Inc.
770 Lindaro Street
San Rafael, CA 94901
Re:BioMarin Pharmaceutical Inc.
Form 10-K for the Year Ended December 31, 2022
Filed February 27, 2023
File No. 000-26727
Dear Brian R. Mueller:
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
2023-04-06 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP
1
filename1.htm
Document
April 6, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attn: Mary Mast
Angela Connell
Re: BioMarin Pharmaceutical Inc.
Form 10-K for the Year Ended December 31, 2022
Filed February 27, 2023
Form 8-K dated February 27, 2023
File No. 000-26727
Dear Mses. Mast and Connell,
This letter is being submitted in response to the comment received from the staff (the Staff) of the United States Securities and Exchange Commission (the Commission) by letter dated March 30, 2023, addressed to Brian R. Mueller, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (we, our or the Company) with respect to our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by the Company with the Commission on February 27, 2023 and our earnings press release furnished as Exhibit 99.1 (the February Press Release) to the Form 8-K filed by the Company with the Commission on February 27, 2023. The numbering of the paragraphs below corresponds to the numbering of the comment letter, the text of which is incorporated into this response letter for convenience.
Form 8-K dated February 27, 2023
Exhibit 99.1
Non-GAAP Information, page 11
1.Please tell us why you believe your Reconciliation of Certain GAAP Reported Information to Non-GAAP information on page 11 is consistent with C&DI 102.10(a) through (c) or confirm how you will revise the presentation in future filings.
Response: The Company acknowledges the Staff’s comment and confirms the Company will revise its Reconciliation of Certain GAAP Reported Information to Non-GAAP Information in future filings to comply with Question 102.10 of the Commission’s Non-GAAP Financial Measures Compliance and Disclosure Interpretations (C&DI). We have historically provided the reconciliation of Non-GAAP financial measures in the form included on page 11 of the February Press Release because we believed it was useful to investors and did not violate the equal or greater prominence requirement, but we acknowledge the Staff’s comment with respect to the updated guidance published in December of 2022 and, in order to address the concerns raised by the Staff, in future earnings press releases the Company will replace in its entirety the current form of the table and reconciliation of Non-GAAP financial measures previously included on pages 10 and 11, respectively of the February Press Release with the reconciliation of Non-GAAP financial measures as substantially reflected in the attached Exhibit A.
We respectfully request the Staff’s assistance in completing the review of this response letter at its earliest convenience. The Company intends to use the presentation set forth in Exhibit A in connection with announcing its upcoming earnings for the first quarter of 2023, which is planned for April 26, 2023. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned or Brian R. Mueller,
105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com
Page 2 of 2
Chief Financial Officer at (415) 506-6700 or to Jodie Bourdet, Cooley LLP at (415) 693-2054 or Siana Lowrey, Cooley LLP at (415) 693-2150.
Sincerely,
/s/ G. Eric Davis
G. Eric Davis
Executive Vice President, General Counsel
BioMarin Pharmaceutical Inc.
cc: Brian R. Mueller, Executive Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc.
Jodie Bourdet, Cooley LLP
Siana Lowery, Cooley LLP
Exhibit A
The following reconciliation of certain GAAP reported information to Non-GAAP information provides the details of the effects of the Non-GAAP adjustments on certain components of the Company's operating results for each of the periods presented.
2023-03-30 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
United States securities and exchange commission logo
March 30, 2023
Brian R. Mueller
Executive Vice President, Finance & Chief Financial Officer
BioMarin Pharmaceutical Inc.
770 Lindaro Street
San Rafael, CA 94901
Re:BioMarin Pharmaceutical Inc.
Form 10-K for the Year Ended December 31, 2022
Filed February 27, 2023
Form 8-K dated February 27, 2023
File No. 000-26727
Dear Brian R. Mueller:
We have limited our review of your filings to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 8-K dated February 27, 2023
Exhibit 99.1
Non-GAAP Information, page 11
1.Please tell us why you believe your Reconciliation of Certain GAAP Reported
Information to Non-GAAP Information on page 11 is consistent with C&DI 102.10(a)
through (c) or confirm how you will revise the presentation in future filings.
FirstName LastNameBrian R. Mueller
Comapany NameBioMarin Pharmaceutical Inc.
March 30, 2023 Page 2
FirstName LastName
Brian R. Mueller
BioMarin Pharmaceutical Inc.
March 30, 2023
Page 2
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.
You may contact Mary Mast at 202-551-3613 or Angela Connell at 202-551-3426 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-03-29 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
United States securities and exchange commission logo
March 29, 2022
Brian Mueller
Executive Vice President, Chief Financial Officer
Biomarin Pharmaceutical, Inc.
770 Lindaro Street
San Rafael, California 94901
Re:Biomarin Pharmaceutical, Inc.
Form 10-K for the fiscal year ended December 31, 2020
Filed February 26, 2021
File No. 000-26727
Dear Mr. Mueller:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-02-23 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm CORRESP February 23, 2022 VIA EDGAR *FOIA Confidential Treatment Request* Confidential Treatment Requested by BioMarin Pharmaceutical Inc. in connection with comments relating to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 (File No. 000-26727) United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street N.E. Washington, D.C. 20549 Attn: Frank Wyman Dan Gordon Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2020 Filed February 26, 2021 File No. 000-26727 Dear Messrs. Wyman and Gordon, This letter is being submitted in response to the comment received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) by letter dated January 31, 2022, addressed to Brian Mueller, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (“we,” “our” or the “Company”) with respect to our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by the Company with the Commission on February 26, 2021 (“2020 Annual Report”). The numbering of the paragraphs below corresponds to the numbering of the comment letter, the text of which is incorporated into this response letter for convenience. Confidential Treatment Request Because of the commercially sensitive nature of the information contained herein, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has filed a separate copy of this letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. §200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days’ advance notice of any intended release so that the Company may, if it deems it to be necessary or appropriate, pursue any remedies available to it. In such event, we request that you telephone the undersigned at (415) 506-6307 rather than rely on the US mail for such notice. Form 10-K for the Fiscal Year Ended December 31, 2020 Notes to Consolidated Financial Statements (18) Income Taxes, page 128 1. We acknowledge the information provided in your response but continue to have difficulty in understanding the basis for your accounting treatment. Please provide us with the following information: [***] Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. § 200.83. 105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com Page 2 of 8 Response • Describe the nature of intellectual property rights transferred to your Irish subsidiary, the products and manufacturing processes that they support, and the consideration paid by your Irish subsidiary for the transferred intellectual property. On September 30, 2020, our Irish subsidiary, BioMarin International Ltd. (“BIL”) purchased from our subsidiary, BioMarin Commercial Ltd. (“BCL”), substantially all of the intellectual property (“IP”) rights associated with the research, development, manufacture and commercialization of five pharmaceutical products—Brineura, Kuvan, Palynziq, Vimizim, and Voxzogo (fka vosoritide)—for a purchase price of $[***] billion. The consideration was based on the full fair market value of the IP on the date of transfer. The IP acquired essentially entitled BIL to control and enjoy the global benefits of the research and development, manufacturing and commercialization of the four approved pharmaceutical products plus Voxzogo which was subsequently approved in 2021. Such rights specifically included patents, patent applications and invention disclosures, trademarks, copyrights and copyrightable works in any technical information or data, research and development information, manufacturing and operating information, process characterization data, technical scientific and medical information, ideas, trade secrets, confidential information, proprietary techniques, business models, processes, methods, applications, disclosures, design rights, unpublished research and development information, manufacturing and operating information, technical data, process characterization data, technical scientific and medical information, knowledge, know-how, and inventions. • Explain how these intellectual property rights now align with your manufacturing and commercial operations domiciled in Ireland and describe the specific benefits resulting from these rights subsequent to their transfer to your Irish subsidiary that were not previously available. We are a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare diseases and medical conditions. Our products help to address unmet medical needs around the world. Most of our global revenues are outside of the United States (“US”), led by sales in our European market. Therefore, it was natural to align our manufacturing and commercial operations to be in the same geographic regions and time zones as our customers and patients. A large component of this alignment was the purchase of a manufacturing facility in Ireland in 2011, which began commercial manufacturing in 2014. Our regional commercial office in Ireland opened in 2013 and houses substantial executive leadership and respective support operations. Prior to the purchase of the IP, BIL had licensed the manufacturing and distribution rights from BCL to the IP relating to the above five products. Under this structure, BIL was guaranteed a limited risk distribution margin pursuant to the license arrangement. By 2020, BIL had the infrastructure and skills considered necessary to manage the economic risks associated with the monetization of IP and could maximize the future profits associated with these products. BIL had built a commercial team, fully staffed manufacturing facility, distribution channel and supply chain operation. The management team had become more experienced in the launch and commercialization of our products. With the alignment of the IP ownership BIL can earn higher margins commensurate with the additional risks it now bears. Further, by consolidating the IP into BIL, it created operational efficiencies by eliminating a separate management and control structure for BCL with respect to the five products for which the IP relates. • Describe the legislative changes and effective dates for Irish tax law, governing the transfer of these rights and supporting your recognition of the $835.1 million tax benefit and your conclusion that a valuation allowance was not necessary. [***] Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. § 200.83. 2 Page 3 of 8 At the time of the transaction, BCL was a company incorporated in Ireland but not subject to Irish taxation because its management and control were located in the Bahamas. Instead of being subject to Irish taxation, BIL’s tax residency was in the Bahamas as a “non-resident” Irish corporation. Under the 2014 Ireland Finance Act, Ireland eliminated this “non-resident” structure with delayed effective dates described below, and provided that, upon the effective date of the change, a company incorporated in Ireland would be treated as resident in Ireland for tax purposes unless it is resident in a country with which Ireland has a double taxation treaty. For companies incorporated before January 1, 2015, the law included a grandfather period of five years with the effective date of the change January 1, 2021. Because BCL was incorporated prior to January 1, 2015 and Ireland does not have a double taxation agreement with the Bahamas, BCL was set to be treated as a resident Irish corporation beginning January 1, 2021. The Company transferred the IP in 2020 before the effective date of the law change. If BCL had not sold the IP to BIL, BCL would have been subject to Irish tax, or if the transaction had not occurred before January 1, 2021, the transaction would have been subject to Irish tax. The law change did not create a deferred tax asset. BIL purchased the IP assets, thus creating amortizable tax basis in IP under existing and longstanding Irish tax law. The IP transferred were internally developed intangible assets, with a cost basis of zero in the consolidated financial statements of the Company and with a tax basis equal to the fair value at the time of the intra-entity transaction resulting in a deferred tax asset of $835.1 million. Therefore, we recorded a deferred tax asset pursuant to ASC 740-10-25-2 and 740-10-30-5(c). The transfer of the IP rights gave rise to tax basis equal to the value of the IP, $[***] billion, pursuant to Irish tax law. The IP can be amortized over 15 years and the amortization is deductible. For Irish income tax purposes, net operating losses can be carried forward indefinitely. ASC 740-10-30-5(e) requires that deferred tax assets be reduced “by a valuation allowance if, based on the weight of available evidence, it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized.” The guidance requires an analysis of the positive and negative evidence and cumulative income is very strong positive evidence to support not setting up a valuation allowance. As of December 31, 2020, BIL was in a cumulative income position (we note that there is no discontinued operations and other comprehensive income or loss and immaterial permanent differences for the periods included in the analysis) of approximately $[***] million for the prior three-year period, or an average annual pretax income of approximately $[***] million. As discussed below, we have also provided BIL’s income combined with BCL’s income for the same period, as Pro-forma Adjusted Income, which shows a cumulative income position of approximately $[***] million for the prior three-year period, or an average annual pretax income of $[***] million as follows: YEAR BIL Income Pro-forma Adjusted Income 2018 $[***] $[***] 2019 $[***] $[***] 2020 $[***] $[***] Total $[***] $[***] Average $[***] $[***] [***] Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. § 200.83. 3 Page 4 of 8 BIL’s standalone cumulative income during this period was based on its limited risk distribution functions. This analysis is not complete because it does not reflect how BIL will operate in the future because the IP and its related income was not in BIL before the transfer. Accordingly, the Company believes that for the historical results to be representative of what the historical results would have been had the IP always been in BIL, pro-forma adjustments should be made to the historical amounts to include the earnings of the IP while it was held by BCL. Based on the table above, the Company determined that BIL, on a standalone and adjusted basis, does not have a “cumulative loss in recent years”. We also considered other examples of negative evidence included in ASC 740-10-30-21 and determined that none applies to BIL: a history of operating losses or tax credit carryforward expiring unused; losses expected in early future years; unsettled circumstances that, if unfavorably resolved, would adversely affect future operations and profit levels on a continuing basis in future years; and a carryback, carryforward period that is so brief that it would limit realization of tax benefits if a significant deductible temporary difference is expected to reverse in a single year or the entity operates in a traditionally cyclical business. Accordingly, we concluded that there was no negative evidence as related to BIL. Because BIL has positive cumulative earnings, ASC 740-10-30-18 allows the use of future taxable income to support the deferred tax asset. The projected total average annual future profit of BIL was $[***] million based on the valuation report as of the purchase date on September 30, 2020. The projected annual future profit of $[***] million was larger than the Pro-forma Adjusted Income of $[***] million due to several factors. The Pro-forma Adjusted Income was more conservative because it did not fully account for future revenue and profit from Voxzogo, which had not yet been approved, or projected increasing revenue and profit from Vimizim, Palynziq and Brineura. In particular, we had only recently launched Brineura and Palynziq and expected to launch Voxzogo, subsequently approved in 2021, which we believed would result in significant additional revenue in the future. For example, our largest product in the transfer, Vimizim, had a solid financial result since launch. It continued to grow annually, unfettered by competition in the niche MPS market, bolstered by a first mover advantage as well as complex manufacturing requirements that present high barriers to entry for any competitor. Brineura and Palynziq were recently launched large molecule products. As such, there was an anticipated ramp up period inherent for the products, and afterwards we anticipated [***] growth within the next five years. All three products are considered large molecules and we anticipated these products would enjoy a longer life cycle. In addition, we believed that Voxzogo, once approved, would enjoy a significant uplift of revenue and profit in the launch years. If this projection was used, then BIL would not have any net operating losses and the tax amortization of the IP would be realized as it was expected to reduce future income as the deductions are taken on the tax return. However, we acknowledge that this projection still includes growth rates and other assumptions that were based on management’s judgment. See response to bullet number 5, “Quantify the interquartile range for your valuation of intellectual property rights transferred to the Irish subsidiary. Include a description and quantification of key assumptions, including associated products, projected revenue and profit by product, number of years constituting “long term market potential,” discount rates, competitive factors and royalty charges by license agreement.” for further discussion on molecule types and anticipated competition under the headings “Financial Projections” and “Valuation Horizon and Competitive Factors.” Based on above analysis, management concluded that a valuation allowance was not required for the Irish deferred tax asset related to the transferred IP as of December 31, 2020. [***] Certain confidential information contained in this document, marked by bracketed asterisks, has been omitted and filed separately with the Commission pursuant to 17 C.F.R. § 200.83. 4 Page 5 of 8 • Identify the “owner” of your Irish subsidiary, which is a Disregarded Entity for US tax purposes but also a wholly owned subsidiary. Given this apparent inconsistency, explain your basis for disregarding this transfer of intellectual property for US tax reporting purposes. BioMarin Pharmaceutical Inc. (“BPI”) is a US corporation, incorporated in Delaware. BPI owned 100% of the stock of BCL at the time of the transaction and continues to own 100% today. For US tax purposes, BCL is tr
2022-01-31 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
United States securities and exchange commission logo
January 31, 2022
Brian Mueller
Executive Vice President, Chief Financial Officer
Biomarin Pharmaceutical, Inc.
770 Lindaro Street
San Rafael, California 94901
Re:Biomarin Pharmaceutical, Inc.
Form 10-K for the fiscal year ended December 31, 2020
Filed February 26, 2021
File No. 000-26727
Dear Mr. Mueller:
We have reviewed your December 20, 2021 response to our comment letter and have the
following comment. In our comment, we may ask you to provide us with information so we may
better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the fiscal year ended December 31, 2020 filed February 26, 2021
Notes to Consolidated Financial Statements
(18) Income Taxes, page 128
1.We acknowledge the information provided in your response but continue to have
difficulty in understanding the basis for your accounting treatment. Please provide us the
following information.
•Describe the nature of intellectual property rights transferred to your Irish
subsidiary, the products and manufacturing processes that they support and the
consideration paid by your Irish subsidiary for the transferred intellectual property.
•Explain how these intellectual property rights now align with your manufacturing and
commercial operations domiciled in Ireland and describe the specific benefits
resulting from these rights subsequent to their transfer to your Irish subsidiary that
were not previously available.
•Describe legislative changes and effective dates for Irish tax law, governing the
FirstName LastNameBrian Mueller
Comapany NameBiomarin Pharmaceutical, Inc.
January 31, 2022 Page 2
FirstName LastName
Brian Mueller
Biomarin Pharmaceutical, Inc.
January 31, 2022
Page 2
transfer of these rights and supporting your recognition of the $835.1 million tax
benefit and your conclusion that a valuation allowance was not necessary.
•Identify the "owner" of your Irish subsidiary, which is a Disregarded Entity for US
tax purposes but also a wholly-owned subsidiary. Given this apparent inconsistency,
explain your basis for disregarding this transfer of intellectual property for US tax
reporting purposes.
•Quantify the interquartile range for your valuation of intellectual property rights
transferred to the Irish subsidiary. Include a description and quantification of key
assumptions, including associated products, projected revenue and profit by product,
number of years constituting "long term market potential," discount rates,
competitive factors and royalty charges by license agreement.
You may contact Frank Wyman at 202-551-3660 or Dan Gordon at 202-551-3486, if you
have questions regarding the comment.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2021-12-20 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP
1
filename1.htm
Document
December 20, 2021
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attn: Frank Wyman
Dan Gordon
Re: BioMarin Pharmaceutical Inc.
Form 10-K for the Fiscal Year Ended December 31, 2020
Filed February 26, 2021
File No. 000-26727
Dear Messrs. Wyman and Gordon,
This letter is being submitted in response to the comment received from the staff (the Staff) of the United States Securities and Exchange Commission (the Commission) by letter dated December 7, 2021, addressed to Brian Mueller, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (we, our or the Company) with respect to our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed by the Company with the Commission on February 26, 2021 (2020 Annual Report). The numbering of the paragraphs below corresponds to the numbering of the comment letter, the text of which is incorporated into this response letter for convenience.
Form 10-K for the Fiscal Year Ended December 31, 2020
Notes to Consolidated Financial Statements
(18) Income Taxes, page 128
1.In 2020, you completed an intra-entity transfer of intellectual property rights to an Irish subsidiary that resulted in a $835.1 tax benefit. Please explain your basis for not recognizing a corresponding US taxable gain in 2020 and the expected US tax impact in future periods. Refer us to the technical guidance upon which you relied. In addition, describe and quantify the methods and key assumptions used to determine the fair value of these transferred intellectual rights. Revise your disclosures accordingly.
Response
Please explain your basis for not recognizing a corresponding US taxable gain in 2020 and the expected US tax impact in future periods. Refer us to the technical guidance upon which you relied.
The transaction was an intra-entity transfer of intellectual property (IP) rights from a wholly owned foreign subsidiary to its wholly owned Irish subsidiary completed in the third quarter of 2020. The foreign subsidiary is a controlled foreign corporation (CFC) for United States (U.S.) corporate income tax purposes. The Irish subsidiary is a disregarded entity (DRE) for U.S. corporate income tax purposes, and therefore its assets, liabilities, income and deductions are treated as belonging to its owner. As a result, the intra-entity IP transfer from the CFC to its Irish DRE is disregarded for U.S. tax purposes and as such, there was no taxable gain in 2020 and no tax basis in the IP for U.S. corporate income tax purposes.
Accordingly, the transaction has no impact on the Company’s U.S. taxes in future periods. For Irish corporate income tax purposes, the IP tax basis will give rise to amortization that will reduce the Irish subsidiary’s future Irish taxable income. This, in turn, will reduce the future amount of creditable foreign taxes, and therefore there is a potential indirect impact to the U.S. Global Intangible Low-taxed Income (GILTI) calculation resulting from the Irish tax deduction and corresponding foreign tax credit. As we have elected to treat GILTI as a period cost, there is no corresponding deferred tax impact to the U.S. federal income tax calculation.
105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com
Page 2 of 3
The guidance we relied upon is Accounting Standards Codification (ASC) 740-10-25-2, which provides that an entity must recognize deferred tax assets and deferred tax liabilities for taxable or deductible temporary difference unless an exception applies. ASC 740-10-20 defines a temporary difference as “a difference between the tax basis of an asset or liability computed pursuant to the requirements in Subtopic 740-10 for tax positions, and its reported amount in the financial statements that will result in taxable or deductible amounts in future years when the reported amount of the asset or liability is recovered or settled, respectively.” As this transaction relates to the transfer of IP and not inventory, the exception in ASC 740-10-25-3(e) does not apply. The IP transferred are internally developed intangible assets, with a cost basis of zero in the consolidated financial statements with a tax basis equal to the fair value at the time of the intra-entity transaction resulting in a deferred tax asset of $835.1 million. Therefore, we recorded a deferred tax asset pursuant to ASC 740-10-25-2. Additionally, ASC 740-10-30-5(e) requires that deferred tax assets be reduced “by a valuation allowance if, based on the weight of available evidence, it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized.” Pursuant to ASC 740-10-30-23, the weight given to positive and negative evidence should be commensurate with the extent to which it can be objectively verified. Expected realization of deferred tax assets must meet the more-likely-than-not standard to be recorded in the financial statements without a valuation allowance. We determined that there was sufficient positive evidence that the Irish subsidiary would more-likely-than-not realize the benefit of the deferred tax asset associated with the IP, and therefore no valuation allowance was recorded.
In addition, describe and quantify the methods and key assumptions used to determine the fair value of these transferred intellectual property rights.
We engaged third party experts to assist the Company in determining the fair value of the transferred intellectual property rights using the income approach specified in the Organisation for Economic Co-operation and Development (OECD) Transfer Pricing Guidelines for Multinational Enterprises and Tax Administrations 2017. The key assumptions in the valuation included probability adjusted product-specific revenue projections, selection of appropriate discount rates, the determination of the terminal value for each product depending on molecule type, long term market potential, competitive factors and revenue and profit trends. The projections utilized in the valuation were also used for group planning purposes, including strategic planning, product pricing, tax and accounting purposes. We also considered comparable transactions in the marketplace to generate arm’s length royalty charges for existing license agreements. Given the various model parameters, the Company then selected the median value in that resulting interquartile range.
Revise your disclosures accordingly.
Additionally, in response to Staff’s comment, we propose to include the following disclosure in our notes to financial statements for our annual report on Form 10-K for the year ended December 31, 2021 expected to be filed with the SEC in February 2022.
“In the third quarter of 2020, the Company completed an intra-entity transfer of certain intellectual property rights from a wholly owned foreign corporation to its wholly owned Irish subsidiary. The rights were transferred to the Company’s Irish subsidiary where its ex-U.S. regional headquarters are located and has significant manufacturing and commercial operations, to better align ownership of intellectual property rights with how the business operates. The intra-entity transfer did not result in a taxable gain in 2020 in any jurisdiction including the U.S. as the transaction was disregarded for U.S. tax purposes. The transaction did create a step-up in the tax basis in the transferred intellectual property rights and the Company’s Irish subsidiary recognized a deferred tax asset for the book and tax basis difference of the transferred intellectual property rights. As a result, the Company recognized a deferred tax asset of $835.1 million and related tax benefit on its Consolidated Financial Statements based on the fair value of the transferred intellectual property rights. The fair value of the transferred intellectual property rights was determined utilizing the income approach which relied on projections of product-specific revenues and the inclusion or exclusion of a terminal value for each product.
The tax deductions related to the amortization of these transferred intellectual property rights will be recognized in the future and any amortization not deducted for tax purposes will be carried forward indefinitely under Irish tax laws. The Company expects to be able to realize the deferred tax asset resulting from this transaction and has not recorded a valuation allowance as of December 31, 2020.”
Page 3 of 3
We respectfully request the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned or Brian Mueller, Chief Financial Officer at (415) 506-6700 or to Jodie Bourdet, Cooley LLP, (415) 693-2054.
Sincerely,
/s/ G. Eric Davis
G. Eric Davis
Executive Vice President, General Counsel
BioMarin Pharmaceutical Inc.
cc: Brian Mueller, Executive Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc.
Jodie Bourdet, Cooley LLP
2021-12-07 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
United States securities and exchange commission logo
December 7, 2021
Brian Mueller
Executive Vice President, Chief Financial Officer
Biomarin Pharmaceutical, Inc.
770 Lindaro Street
San Rafael, California 94901
Re:Biomarin Pharmaceutical, Inc.
Form 10-K for the fiscal year ended December 31, 2020
Filed February 26, 2021
File No. 000-26727
Dear Mr. Mueller:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-K for the fiscal year ended December 31, 2020 filed February 26, 2021
Notes to Consolidated Financial Statements
(18) Income Taxes, page 128
1.In 2020, you completed an intra-entity transfer of intellectual property rights to an Irish
subsidiary that resulted in a $835.1 tax benefit. Please explain your basis for not
recognizing a corresponding US taxable gain in 2020 and the expected US tax impact in
future periods. Refer us to the technical guidance upon which you relied. In addition,
describe and quantify the methods and key assumptions used to determine the fair value of
these transferred intellectual property rights. Revise your disclosures accordingly.
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 LastNameBrian Mueller
Comapany NameBiomarin Pharmaceutical, Inc.
December 7, 2021 Page 2
FirstName LastName
Brian Mueller
Biomarin Pharmaceutical, Inc.
December 7, 2021
Page 2
You may contact Frank Wyman at 202-551-3660 or Dan Gordon at 202-551-3486 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2017-05-25 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Mail Stop 4546 May 25, 2017 Via E -mail Mr. Daniel Spiegelman Executive Vice President and Chief Financial Officer BioMarin Pharmaceutical, Inc. 770 Lindaro Street San Rafael, CA 94901 Re: BioMarin Pharmaceutical, Inc. Form 10-K for Fiscal Year Ended December 31, 2016 Filed February 27, 2017 File No. 001 -26727 Dear Mr. Spiegelman : We have completed our review of your filing s. We remind you that the company and its management are responsible for the accuracy and adequacy of the ir disclosure s, notwithstanding any review, comments, action or absence of action by the staff . Sincerely, /s/ Angela M. Connell Angela M. Connell Accounting Branch Chief Office of Healthcare and Insurance
2017-05-02 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm bmrn-corresp.htm May 2, 2017 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant Office of Healthcare and Insurance Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2016 Filed February 27, 2017 File No. 0-26727 Dear Mr. Rosenberg, This letter is being submitted in response to the comment received from the staff (the Staff) of the United States Securities and Exchange Commission (the Commission) by letter dated April 28, 2017, addressed to Daniel Spiegelman, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (we, our or the Company) with respect to our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed by the Company with the Commission on February 27, 2017 (2016 Annual Report). The numbering of the paragraphs below corresponds to the numbering of the comment letter, the text of which is incorporated into this response letter for convenience. Form 10-K for the Fiscal Year Ended December 31, 2016 Management’s Discussion and Analysis of Financial Condition and Results of Operations Impairment of Long-Lived Assets, page 61 1. You disclose that in the fourth quarter of 2016 you assessed the qualitative factors such as “industry and market conditions and other entity specific factors” and determined that the goodwill of $148 million from your Prosensa Holding N.V. acquisition, at December 31, 2016, was not impaired. Please explain to us the specific factors that you considered in reaching this conclusion and specifically how the $599.1 million impairment charge recognized in the 2nd Quarter 2016 related to the IPR&D acquired with the Prosensa acquisition impacted your assessment. Further, please explain how you considered the guidance in ASC 350-20-35-33 through 35-38 in identifying only a single reporting unit for purposes of your goodwill impairment testing. Response The Company confirms to the Staff that it has a single reporting unit for the development and commercialization of innovative biopharmaceutical therapies. Upon an acquisition and related purchase price allocation, the Company records goodwill to its existing reporting unit. Our management team assesses whether our reporting unit should change if there are changes to the business and any internal or external reporting or management changes that result in discrete financial information being available and reviewed by the chief decision maker. 105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com Page 2 of 3 As further discussed below, we have identified one reporting unit consistent with the guidance of the Financial Accounting Standards Board’s Accounting Standards Codification (ASC) 350-20-35. Accordingly, in performing our annual impairment review, goodwill is analyzed as a whole at the entity level. Using that analysis, as discussed below, we determined that, based on the significant fair value of the Company’s market capitalization as compared to goodwill as of June 30, 2016 and December 31, 2016, goodwill was not impaired. Single Reporting Unit Determination In evaluating whether the Company has more than one reporting unit, our management team focused on the guidance in ASC 280-10-50-1a–c, which outlines the following characteristics of operating segments: a. It engages in business activities from which it may earn revenues and incur expenses; b. Its operating results are regularly reviewed by the Company’s chief operating decision maker to make decisions about the allocation of resources and to assess its performance; c. Its discrete financial information is available. The Company’s sole business activities include the development and commercialization of innovative therapies for people with serious and life-threatening rare diseases and medical conditions, which primarily include revenues earned from the Company’s commercial products and expenses incurred to support the Company’s manufacturing, development and commercialization activities and general and administrative support. The allocation of resources results from the Company’s annual budgeting and periodic forecasting processes. Our management team generates budget drivers based on the Company’s overall corporate goals, milestones to achieve the goals and estimated time for completion. The budget drivers are used to estimate costs and create a consolidated budget that allocates resources to research and development activities, manufacturing, sales and marketing and general and administrative support for all of the Company’s business activities. Ultimately, the Company’s annual operating plan and budget for its single operating segment and reporting unit are approved by the Company’s Chief Executive Officer (CEO) and Board of Directors (Board). Once the Company’s annual operating plan is approved, performance targets are developed for the Company’s corporate bonus plan. The key performance targets typically include company–wide revenue and operating expense targets as well as potential regulatory milestones of the Company, such as the commencement of a clinical trial, the submission of filings to regulatory agencies or new product approvals. The corporate bonus plan is approved by the Company’s Board. In addition to participating in the corporate bonus plan, executive officers also may receive performance based equity awards which are earned based on achieving defined revenue targets for the Company’s commercial products. Although the budget drivers for individual development programs and products are developed by various members of management, the Company’s CEO has the ultimate decision making power as to how the Company’s resources are allocated, and the CEO does this on the basis of a single consolidated business. The Company’s commercial, manufacturing, research and development and selling, general and administration operations all contribute to the Company’s commercial product and research and development programs and these functions are managed as a single operational unit for which resources are moved among these operating activities based on the Company’s goals. There is no review of discrete financial information, fiscal responsibility or decision authority at these lower functional management levels below the Company’s CEO. Page 3 of 3 The CEO receives financial results on a monthly basis consisting of comparative balance sheets, statements of operations, revenues by product and detailed operating expenses, all of which are prepared at the consolidated level. The CEO also receives financial results on a quarterly basis consisting of a quarterly financial results package and a forecast for the remainder of the fiscal year. The quarterly financial results package is also prepared at the consolidated level and includes highlights of significant development programs and commercial net products sales results, as well as key drivers of consolidated financial and operating performance. Based on the CEO’s review of the business and finances of the Company at the consolidated level, management has concluded that the CEO is the Company’s Chief Decision Maker. Resource allocations are not reviewed at a level lower than the Company’s global consolidated business. No Goodwill Impairment at Operating Unit Management’s reviews for impairment during 2016 were based on qualitative factors, including those described in ASC 350-20-35-3a through 35-3g, applied to goodwill at the entity level. Management identified no macroeconomic conditions or industry or market considerations, and no cost factors, financial performance or other entity specific events that indicated that our goodwill was impaired. Because the Company evaluates goodwill for impairment at its single consolidated entity level, the Company compares the carrying value of its single reporting unit, including goodwill, to the total fair value of the reporting unit, as evidenced by the Company’s market capitalization. The carrying value of our single reporting unit was $2.8 billion, compared to our market capitalization of $14.3 billion as of December 31, 2016. As of June 30, 2016, the Company’s market capitalization was $13.5 billion, compared to the carrying value of our single reporting unit of $1.9 billion, subsequent to when the acquired Prosensa Holding N.V. (Prosensa) intangible assets were fully impaired. Specifically considering the $599.1 million impairment of intangible assets recognized during the three months ended June 30, 2016, which included both the Prosensa intangible assets and the termination of the Company’s cerliponase alfa development program, the Company experienced a decrease in its market valuation resulting from the abandonment of those programs; however, based on the significant fair value of the Company’s market capitalization as compared to the carrying value of its single reporting unit as of June 30, 2016 and December 31, 2016, the Company determined that goodwill was not impaired. The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned at (415) 506-6700 or to Jodie Bourdet, Cooley LLP, (415) 693-2054. Sincerely, /s/ G. Eric Davis G. Eric Davis Executive Vice President, General Counsel BioMarin Pharmaceutical Inc. cc: Daniel Spiegelman, Executive Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc. Jodie Bourdet, Cooley LLP
2017-04-28 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Mail Stop 4546 April 28, 2017 Via E -mail Mr. Daniel Spiegelman Executive Vice President and Chief Financial Officer BioMarin Pharmaceutical, Inc. 770 Lindaro Street San Rafael, CA 94901 Re: BioMarin Pharmaceutical, Inc. Form 10-K for Fis cal Year Ended December 31, 2016 Filed February 27 , 2017 File No. 0 -26727 Dear Mr. Spiegelman : We have reviewed your filing and have the following comment. In our c omment , we may ask you to provide us with information so we may better understand your disclosure. Please respond to the comme nt within ten busine ss days by providing the requested information or advis e us as soon as possible when you will respond. If you do not believe our comme nt appl ies to your facts and circumstances, please tell us why in your response. After reviewing your response to the comment , we may have additional comments. Management’s Discussion and Analysis of Financial Cond ition and Results of Operatio ns Impairment of Long -Lived Assets, page 61 1. You disclose that in the fourth quarter of 2016 you assessed qualitative factors such as “industry and market considerations and other entity specific factors” and determined that the goodwill of $148 million from your Prosensa Holding N.V. acquisition, at December 31, 2016, was not impaired. Please explain to us the specific factors that you considered in reaching this conclusion and specifically how the $599.1 million impairment charge recognized in the 2nd Quarter 2016 related to IPR&D acquired with the Prosensa acquisition impacted your assessment. Further, please explain how you considered the guidance in ASC 350 -20-35-33 through 35 -38 in identifying only a single reporting unit for purposes of your goodwill impairment testing. We remind you that t he 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. Mr. Daniel Spiegelman BioMarin Pharmaceutical, Inc. April 28, 2017 Page 2 You may contact Senior Staff Accountants Frank Wyman at (202) 551 -3660 or Ibolya Ignat at (202) 551-3636 with any questions . In this regard, do not hesitate to contact me at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant Office of Healthcare and Insurance
2016-07-26 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Mail Stop 4546 July 26, 2016 VIA E -mail Mr. Daniel Spiegelman Chief Financial Officer Biomarin Pharmaceutical Inc. 770 Lindaro Street San Rafael, CA 94901 Re: Biomarin Pharmaceuticals Inc. Form 10-K for Fis cal Year Ended December 31, 2015 Filed February 29 , 2016 File No. 0-26727 Dear Mr. Spiegelman : We have completed our review of your filing. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing and the company may not asser t staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be ce rtain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Angela M. Connell Angela M. Connell Accounting Branch Chief Office of Healthcare and Insurance
2016-07-08 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm CORRESP July 8, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549 Attn: Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2015 Filed February 29, 2016 File No. 0-26727 Dear Mr. Rosenberg, This letter is being submitted in response to comments received from the staff (the Staff) of the United States Securities and Exchange Commission (the Commission) by letter dated June 23, 2016, addressed to Daniel Spiegelman, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (we, our or the Company) with respect to the Annual Report on Form 10-K for the fiscal year ended December 31, 2015 filed by the Company with the Commission on February 29, 2016 (2015 Annual Report). The numbering of the paragraphs below corresponds to the numbering in the comment letter, the text of which is incorporated into this response letter for convenience. Form 10-K for the Fiscal Year ended December 31, 2015 Notes to the Consolidated Financial Statements (3) Summary of Significant Accounting Policies Revenue Recognition Net Product Revenues, page F-11 1. You state on page F-13 that due to the significant role you play in the operations of Aldurazyme and Kuvan, you elected not to classify the Aldurazyme and Kuvan royalties earned as royalty, license and other revenues and instead include them as a component of net product revenues. Please provide us a detailed analysis with reference to the authoritative literature to which you rely as to why classification of royalties earned as net product revenues is appropriate, excluding the portion attributed to product transfer revenue. Response The Company acknowledges the Staff’s comment and, as background and for context, respectfully advises the Staff that although there are two contractual payment streams associated with each of its Aldurazyme and Kuvan products, one for product transfer and a second based on a percentage of net sales by the applicable commercial partner, Genzyme Corporation (Genzyme) and Ares Trading S.A. (Merck Serono), respectively, the payment streams together represent a single economic transaction. The timing of revenue recognition creates a separation because the product transfer revenue is recognized when the Company’s delivery obligations are fulfilled, whereas the timing of the percentage of sales revenue is dependent upon the third party sales by Genzyme and Merck Serono. For both products, when entering into the contractual relationships with Genzyme and Merck Serono, both the Company and the respective counterparty recognized that the transfer price represented less than the fully burdened cost of producing and delivering the product, which standing in isolation, would not represent a commercially reasonable transaction. However, the parties believed that the initial transfer payment was appropriate to minimize the carrying cost of producing a product over a year before the ultimate sale to an end user, with the understanding that the incremental sales-based payment would compensate the Company for the loss on the initial transfer and provide for a reasonable profit margin on the product sale. The product transfer revenue alone would not provide any economic rationale for the transactions. 105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com The Company understands that the relevant authoritative literature does not contain specific definitions of revenue types, and instead provides guidance on grouping and separating types of revenue sources based on their similar or dissimilar characteristics. In determining the classification of Aldurazyme and Kuvan revenues as net product revenues, the Company considered the following guidance, which it believes supports the Company’s revenue presentation (emphasis added): a) Rule 5-03(b)(1) of Regulation S-X (Rule 5-03(b)(1)) Net sales and gross revenues. State separately: (a) Net sales of tangible products (gross sales less discounts, returns and allowances); (b) operating revenues of public utilities or others; (c) income from rentals; (d) revenues from services; and (e) other revenues. b) Financial Accounting Standards Board (FASB) Statement of Financial Accounting Concepts No. 5 (As Amended), Recognition and Measurement in Financial Statements of Business Enterprises (Concepts Statement No. 5), paragraph 20: Classification in financial statements facilitates analysis by grouping items with essentially similar characteristics and separating items with essentially different characteristics. Analysis aimed at objectives such as predicting amounts, timing and uncertainty of future cash flows requires financial information segregated into reasonably homogeneous groups. For example, components of financial statements that consist of items that have similar characteristics in one or more respects, such as continuity of recurrence, stability and reliability, are likely to have more predictive value than if their characteristics are dissimilar. Rule 5-03(b)(1) Application The Company believes that the payments based on net sales amounts constitute part of the sale of tangible product by the Company consistent with clause (a) of Rule 5-03(b)(1), and that presenting these amounts in combination with the product transfer revenue is more useful to readers of the Company’s financial statements and is more representative of the operations and economics of the arrangements with Genzyme and Merck Serono. Conversely, the Company believes that to separate the two items and to present the percentage of net sales separately as “other revenues” pursuant to clause (e) of Rule 5-03(b)(1) would imply to investors that the income is passive in nature, which the Company believes could misrepresent the substantive role the Company plays in generating such revenues. The Company reports as “net product revenues” those revenues associated with the sale of tangible goods developed and manufactured by or on behalf of the Company. The sale of tangible goods is, unlike sources of passive income, highly dependent on substantial operational activities retained by the Company. Although described as “royalties” in the Company’s third party agreements, the revenue received by the Company based on net sales of Aldurazyme and, for periods through 2015, for Kuvan (excluding the initial consideration for the product transfer) by Genzyme and Merck Serono, respectively, is similar to direct product sales because the revenue is highly dependent on substantial operational activities performed by the Company, including exclusive performance of complex manufacturing processes and responsibility for global pharmaceutical product regulatory compliance. These responsibilities, and the operational risk that could reduce or eliminate the Company’s receipt of these percentage of net sales amounts, are similar to many of the responsibilities and risks associated with the Company’s direct sales of other commercial products. The Company’s role with respect to both the Aldurazyme and Kuvan products is more substantive and fundamentally different from its role with respect to other product rights that the Company licensed and has substantially divested to third parties and relies substantially on the efforts of others including manufacturing, distribution and regulatory compliance. The Company includes revenues derived from these license arrangements in the separate revenue line item “royalty, license and other revenues.” Concepts Statement No. 5 Application In presenting the Company’s Aldurazyme and Kuvan net product revenues, the Company has applied Concepts Statement No. 5 to “group items with essentially similar characteristics” by combining the revenue received by the Company based on net sales amounts of Aldurazyme and Kuvan by Genzyme and Merck Serono, respectively, with the product transfer revenues as components of net product revenues on its Consolidated Statements of Operations because the Company believes that its arrangements with respect to these products share the same operational characteristics as the Company’s direct sale of other commercial products. The Company believes such classification is more accurate and useful to readers of the Company’s financial statements than classification of these amounts as “royalty, license and other revenues.” As noted above, the product transfer revenue only represents the approximate manufacturing cost without any profit element and does not represent a standalone transaction. The Company reports as “royalty, license and other revenues” those revenues derived primarily or exclusively from ongoing operational activities of third parties to which the Company has licensed full product rights and responsibilities and as to which the Company maintains no ongoing direct involvement in the manufacturing, regulatory process or distribution of the licensed product. Historical examples under these types of arrangements include royalties earned by the Company from Orapred and a compound similar to Kuvan, which the company does not manufacture. Finally, the Company respectfully advises the Staff that, on January 1, 2016, the Company completed the acquisition from Merck Serono of certain rights and other assets with respect to Kuvan, and BioMarin now possesses all global rights to Kuvan, except in Japan. As a result, beginning in fiscal year 2016, Merck Serono no longer sells Kuvan, except for certain markets during a brief transition period, and the Company’s net product revenues with respect to Kuvan no longer include amounts received based on net sales by Merck Serono. The Company respectfully refers to the October 16, 2008 response provided to the Staff’s comment letter of October 7, 2008 (specifically comment number 4) (the Prior Response). Although the comment related only to Aldurazyme at that time, the Company believes its combination of the product transfer revenues and amounts earned as a percentage of sales for each of Aldurazyme and Kuvan, respectively, is in principle consistent with the Prior Response. The Company acknowledges that: The Company is responsible for the adequacy and accuracy of the disclosure in the filing; Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing: and The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned at (415) 506-6700 or to Jodie Bourdet, Cooley LLP, 415-693-2054. Sincerely, /s/ G. Eric Davis G. Eric Davis Executive Vice President, General Counsel BioMarin Pharmaceutical Inc. cc: Daniel Spiegelman, Executive Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc. Jodie Bourdet, Cooley LLP
2016-06-24 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Mail Stop 4720
June 23, 2016
VIA E -mail
Mr. Daniel Spiegelman
Chief Financial Officer
Biomarin Pharmaceutical Inc.
770 Lindaro Street
San Rafael, CA 94901
Re: Biomarin Pharmaceuticals Inc.
Form 10-K for Fis cal Year Ended December 31, 2015
Filed February 29 , 2016
File No. 0-26727
Dear Mr. Spiegelman :
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment , we ask you to provide us with
information so we may better understand your disclosure.
Please respond to th e comment within ten business days by providing the requested
information or advise us as soon as pos sible when you will respond. If you do not believe the
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment , we may have additional comments.
Notes to Consolidated Financi al Statements
(3) Summary of Significant Accounting Policies
Revenue Recognition
Net Product Revenues, page F -11
1. You state on page F-13 that due to the significant role you play in the operations of
Aldurazyme and Kuvan , you elected not to classify the Aldurazyme and Kuvan royalties
earned as royalty, license and other revenues and instead include them as a component of
net product revenues. Please provide us a detailed analysis with reference to the
authoritative liter ature to which you rely as to why classification of royalties earned as
net product revenues is appropriate , excluding the portion attribu ted to product transfer
revenue .
Mr. Daniel Spiegelman
Biomarin Pharmaceuticals Inc
June 23, 2016
Page 2
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules 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 responding to our comment, please provide a written statement from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.
You may contact Senior Staff Accountant Mary Mast at (202) 551 -3613 with any
questions . In this regard, do not hesitate to contact me at (20 2) 551 -3679.
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance
2014-12-31 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP
1
filename1.htm
CORRESP
JONES DAY
3161 MICHELSON DRIVE Ÿ SUITE 800 Ÿ IRVINE, CALIFORNIA 92612.4408
TELEPHONE: +1.949.851.3939 Ÿ FACSIMILE: +1.949.553.7539
Direct Number: (949) 553-7509
kbespinola@jonesday.com
December 31, 2014
VIA EDGAR AND
COURIER
Christina Chalk
Senior Special Counsel
Office of Mergers and Acquisitions
U.S. Securities and Exchange
Commission
Division of Corporate Finance
100 F Street, N.E.
Washington, D.C. 20549-3628
Re:
Prosensa Holding N.V.
Schedule TO-T filed
December 12, 2014 by BioMarin Pharmaceutical Inc. et al.
File No. 005-87624
Dear Ms. Chalk:
On behalf of our clients,
BioMarin Pharmaceutical Inc., BioMarin Falcons B.V. and BioMarin Giants B.V. (collectively, the “Filers”), set forth below are the responses of the Filers to the comment letter from the Staff of the Securities and Exchange Commission (the
“Staff”), dated December 22, 2014, concerning the Schedule TO-T (the “Schedule TO-T”), filed on December 12, 2014 (File No. 005-87624), under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), by the Filers.
The responses contained herein are based on information provided to Jones Day by the Filers. To facilitate the
Staff’s review, we have included in this letter the headings and numbered comments in bold text and have provided the Filers’ response immediately following each of the numbered comments.
The Filers are submitting, via EDGAR, Amendment No. 2 to the Schedule TO-T (the “Schedule TO-T/A”) containing changes made in
response to the Staff’s comments, copies of which are enclosed herewith. Capitalized terms used but not defined in this letter have the meanings given to them in the Schedule TO-T.
Schedule TO
1.
Please revise to use the current version of Schedule TO, which includes a box to check indicating reliance on the cross-border exemption for
third-party tender offers. See Rule 14d-1(d). If you are relying on Rule 14d-1(d), please check the
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MEXICO
CITY Ÿ MIAMI
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December 31, 2014
Page
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box and describe in your response letter the facts that you believe support your reliance on the exemption.
Pursuant to the Staff’s request, the Schedule TO-T/A includes the boxes to indicate reliance on exemptions for cross-border tender offers.
The Filers are not relying on such exemptions and, as such, have not checked the boxes.
Exhibit (a)(1)(A) - Offer to Purchase
General
2.
You have not registered the issuance of the CVRs in connection with this tender Offer. In your response letter, please provide your analysis as to why the issuance of the CVRs in this Offer is not a registerable
event under Section 5 of the Securities Act of 1933. Please cite to applicable precedent, including staff no-action letters, and analyze the relevant features of these CVRs that relate to their status as securities.
We do not believe that the contractual contingent value rights (the “CVRs”) as described in the Offer to Purchase are registerable
because it is our view that they are not “securities” under the Securities Act of 1933 (the “Securities Act”), and treating the CVRs as securities would be inconsistent with the position consistently taken by the Staff in
no-action letters under which the Staff has not recommended enforcement action in connection with the issuance, without registration, of contingent deferred payment rights bearing the same essential characteristics as the CVRs.
Pursuant to the CVR Agreement, the CVRs will give former holders of Shares the contractual right to receive cash payments of up to $4.14 per
Share in the aggregate upon the achievement of the product approval milestones described in the Offer to Purchase included in the Schedule TO-T.
The Staff has consistently taken the position that it would not recommend enforcement action if, in connection with a proposed merger or tender
offer, contingent deferred payment rights, having the same essential characteristics as the CVRs, were not registered under the Securities Act. The Staff has noted the following factors when granting such no-action relief:
(i)
the rights are an integral part of the consideration to be received in the merger or tender offer and will be granted pro-rata;
(ii)
the rights do not represent any ownership or equity interest and do not carry voting or dividend rights or bear a stated rate of interest;
(iii)
the rights are non-transferable, except by operation of law or by will or intestacy;
December 31, 2014
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3
(iv)
the rights will not be evidenced by any form of certificate or instrument; and
(v)
any amount ultimately paid to the selling stockholders does not depend on the operating results of the surviving company or any constituent company to the merger.
(See, e.g., Lorimar, Inc. (November 4, 1985); Slater Development Corporation (April 7, 1988); Essex Communications Corp. (June
28, 1988); Minnesota Mining and Manufacturing Company (October 13, 1988); First Boston, Inc. (December 2, 1988); GID/TL, Inc. (March 21, 1989); Genentech Clinical Partners III (April 28, 1989); Quanex Corporation (July 28, 1989); Marriott Residence
Inn Limited Partnership (February 20, 2002) and Marriott Residence Inn Limited Partnership II (May 8, 2002).)
These criteria are
well-established and have been relied on in recent transactions involving contractual contingent payment rights that were not registered under the Securities Act, including contingent payment rights payable upon achievement of regulatory approval
similar to those that determine payment under the CVRs. Several recent examples include:
•
Forest Laboratories, Inc.’s 2013 acquisition of Furiex Pharmaceuticals, Inc., in which Forest Laboratories agreed to pay for each share of Furiex Pharmaceuticals, $95 plus one non-transferable contingent value
right to receive up to an additional $30 per share, payable upon the achievement of certain regulatory milestones related to FDA approval of new drug applications.
•
Echo Pharma Acquisition Limited’s, 2013 tender offer for all of outstanding shares of Elan Corporation, plc., in which Echo Pharma Acquisition Limited agreed to pay, for each share of Elan Corporation, $13 plus one
non-transferable contingent value right, which entitled the holder to receive up to an additional $2.50 per share, payable upon the achievement of certain regulatory and commercial milestones. The first contingent payment was payable upon FDA
approval of certain additions to the label for Elan Corporation’s Tysabri product. The second and third contingent payments were payable if the worldwide net sales of Tysabri for certain periods were in excess of certain net sales thresholds.
•
Forest Laboratories, Inc.’s 2011 tender offer for all of the outstanding shares of Clinical Data, Inc., in which Forest Laboratories agreed to pay, for each share of Clinical Data, $30 plus a non-transferable
contingent value right that entitled the holder thereof to up to $6.00 per share if the aggregate net sales of Viibryd and other products containing vilazadone hydrochloride exceeded certain net sales thresholds.
December 31, 2014
Page
4
•
ViroPharma Inc.’s October 2008 acquisition of Lev Pharmaceuticals, in which ViroPharma agreed to pay for each share of Lev Pharmaceuticals stock an upfront cash payment, a fraction of a share of ViroPharma common
stock and a non-transferable contingent value right entitling the holder to receive up to two contingent payments in cash, payable upon the achievement of certain regulatory and commercial milestones. The first contingent payment was payable upon
approval by the FDA of Lev’s Cinryze product and the second contingent payment was payable when Cinryze reached at least $600 million in cumulative net product sales within a specified time period.
•
Endo Pharmaceuticals Holdings Inc.’s March 2009 acquisition of Indevus Pharmaceuticals, Inc., in which the merger consideration included an upfront cash payment and a non-transferable contingent right to receive up
to an additional $3.00 per share for certain milestones relating to a given product, Nebido. The first contingent payment was payable upon FDA approval of the product, with the amount of payment depending on whether the product was subject to a
“boxed warning” label. The full amount of this payment would be payable either upon FDA approval without the boxed warning label, or if the product was subject to a boxed warning label, upon achievement of a specified sales target for the
product. The second contingent payment will become payable if an additional specified product is approved by the FDA within a given time period.
The CVRs described in the Offer to Purchase have the same five essential characteristics the Staff has identified in the no-action letters
cited above and were present in the transactions described above:
•
The CVRs are an integral part of the consideration to be received by tendering shareholders of Prosensa in the Offer because they will be issued in partial consideration of the Shares at the same time as the Cash
Consideration is paid. Additionally, as discussed in Section 8 of the Offer to Purchase, the addition of CVRs to the consideration payable in the transaction allowed Parent to increase the price it was willing to pay to tendering holders of the
Shares, because the Filers will only be obligated to pay cash in respect of the CVRs if Parent or its affiliates are successful in achieving applicable product approval milestones. The CVRs will be granted pro rata to each tendering shareholder of
Prosensa (see pages i-vi, x-xi, 1-3, 13-15, 27-30 and 45-49 of the Offer to Purchase);
•
The CVRs will not represent any ownership interest in BioMarin Falcons B.V., Parent or their subsidiaries and will not have any voting, liquidation or dividend rights, nor will the CVRs bear any interest (see pages iv
and 46 of the Offer to Purchase);
December 31, 2014
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5
•
The CVRs will not be assignable or transferable except (1) upon death by will or intestacy or by instrument to an inter vivos or testamentary trust in which the CVRs are to be passed to beneficiaries upon the death
of the trustee, (2) pursuant to a court order, (3) by operation of law (including a consolidation or merger) or without consideration in connection with the dissolution, liquidation or termination of any corporation, limited liability
company, partnership or other entity, (4) in the case of CVRs payable to a nominee, from a nominee to a beneficial owner (and, if applicable, through an intermediary) or from such nominee to another nominee for the same beneficial owner, in
each case as allowable by the Depository Trust Company, (5) to Parent, BioMarin Falcons or their affiliates, or (6) upon abandonment by the holder. (see page 46 of the Offer to Purchase);
•
The CVRs will not be evidenced by any certificate or other instrument (see page 46 of the Offer to Purchase); and
•
The CVRs represent only the contractual right to receive the contingent payments described above, and accordingly, any payment obligations to CVR holders depend only on receipt of the applicable regulatory approval, not
the operating results of BioMarin or Prosensa (see pages 45-46 of the Offer to Purchase).
On the basis of the foregoing, we
respectfully submit that the CVRs are not “securities” within the meaning of the Securities Act and, accordingly, registration of the CVRs under the Securities Act is not required.
3.
Please advise how you are complying with the prompt payment requirements of Rule 14e-1(c) in connection with the issuance of the CVRs. In this regard, tell us whether, under applicable law of the Netherlands, the
rights that tendering Prosensa security holders receive are enforceable as of the close of the tender Offer. We may have further comments.
The Filers believe that the Offer satisfies the prompt payment rule set forth in Rule 14e-1(c). The consideration to be received by a tendering
shareholder of Prosensa will be cash and CVRs, and, as disclosed on page 8 of the Offer to Purchase under the heading, “Acceptance for Payment and Payment of Shares,” Purchaser will pay for all Shares validly tendered and not
withdrawn following the acceptance of Shares pursuant to the Offer by prompt payment of cash and the CVRs. Each CVR represents the immediate contractual right to receive up to an additional $4.14 in cash payments upon the occurrence of the product
approval milestones described on page 1 of the Offer to Purchase (each a “Milestone”). Accordingly, the component of consideration represented by the CVRs will in fact be paid in compliance with the prompt payment rule because the CVRs are
not a deferred cash payment to shareholders of Prosensa, but rather the contractual right to
December 31, 2014
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receive additional cash payments if and only if product approval Milestones are achieved in accordance with the terms of the CVR Agreement, and the CVRs will be delivered concurrently with the
Cash Consideration. With respect to the CVR, the consideration is not the cash itself that might be paid in the future, but instead the right to receive the Milestone payments in cash if and only if the Milestones are achieved. As such, the payment
of the Offer Price is complete at the time a tendering shareholder of Prosensa receives the Cash Consideration and the CVR.
On numerous
occasions, the Staff has either granted no action relief or did not object to the payment of consideration in a tender offer that included the contractual right to receive an additional payment at a future point in time upon the occurrence of a
specified event. For example, in Boston Scientific’s tender offer to acquire all outstanding shares of common stock of Rubicon Medical Corporation, Boston Scientific agreed to pay an “Additional Payment” to tendering shareholders if
certain milestones related to FDA approval of a medical device and net sales of certain products were achieved, with no further action required on the part of the holders. In response to a similar SEC comment, Boston Scientific responded that,
“the component of consideration represented by the Additional Payments will in fact be paid in compliance with the prompt payment rule, because the consideration is not the cash itself that might be paid in the future, but instead the right to
receive the Additional Payments in cash if and only if certain milestones are achieved. Tendering shareholders will obtain the right to receive the Additional Payments precisely at the same time as the cash component of the consideration is paid to
the stockholder in compliance with Rule 14e-1(c).” Boston Scientific subsequently accepted for payment, and paid for, shares of Rubicon in the tender offer, and the consideration paid included the contractual right to receive the Additional
Payments in the event the applicable milestones were achieved. The CVRs that are a component of the consideration in the Offer are substantially similar to the Additional Payments offered by Boston Scientific in its tender offer for Rubicon Medical
Corporation. Like the right to receive Additional Payments, the CVRs are the right to receive cash if and only if a Milestone is achieved, with no further action required on the part of the CVR holders. The CVRs will be obtained by tendering
shareholders of Prosensa at the same time as the Cash Consideration is paid to such shareholders, as noted on page 1 of the Offer to Purchase. Accordingly, we share the view expressed by
2013-05-23 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
May 22, 2013 Via E -mail Mr. Daniel Spiegelman Executive Vice President and Chief Financial Officer BioMarin Pharmaceutical Inc. 770 Lindaro Street San Rafael, CA 94901 Re: BioMarin Pharmaceutical Inc. Form 10 -K for the Fiscal Year Ended December 31, 2012 Filed February 26, 2013 File No. 000-26727 Dear Mr. Spiegelman : We have completed our re view of your filing s. We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or the filing [s] 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. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing [s] to be certain that the filing [s] include [s] the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2013-05-20 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm CORRESP May 20, 2013 VIA EDGAR AND OVERNIGHT MAIL United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549-8561 Attn: Mr. Jim B. Rosenberg, Senior Assistant Chief Accountant Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2012 Filed February 26, 2013 Form 10-Q for the Quarterly Period Ended March 31, 2013 Filed April 29, 2013 File No. 000-26727 Dear Mr. Rosenberg, This letter is being submitted in response to comments received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) by letter dated May 8, 2013, addressed to Daniel Spiegelman, Executive Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (“we”, “our” or the “Company”) with respect to the Annual Report on Form 10-K for the fiscal year ended December 31, 2012 filed by the Company with the Commission on February 26, 2013 (“2012 Annual Report”) and the Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2013 filed by the Company with the Commission on April 29, 2013 (March 2013 Quarterly Report). The number of the paragraphs below corresponds to the numbering in the comment letter, the text of which is incorporated into this response letter for convenience. STAFF COMMENTS AND COMPANY RESPONSES Form 10-Q for the Quarterly Period ended March 31, 2013 Notes to the Consolidated Financial Statements Note 10. Inventory, page 11 1. Please provide us proposed revised disclosure to be included in future periodic reports indicating revisions to your accounting policy regarding capitalization of inventory costs prior to regulatory approval that specifically states the point during the FDA approval process that you determine a probable future benefit exists and the status of the FDA’s consideration of the safety and efficacy of the drug/system and evaluation of the manufacturing process at that point. Disclose how you apply the lower of cost or market principle to your pre-launch inventory. 105 Digital Drive . Novato, CA 94949 . Tel 415.506.6700 . Fax 415.382.7889 . www.BMRN.com Response: The Company proposes to include disclosures substantially similar to the following in future periodic reports for our accounting policy regarding capitalization of inventory costs prior to regulatory approval: Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Estimates Inventory We value inventory at the lower of cost or net realizable value and determine the cost of inventory using the average-cost method. Inventories consist of currently marketed products and may contain certain products awaiting regulatory approval. In evaluating the recoverability of inventories produced in preparation for product launches, we consider the likelihood that revenue will be obtained from the future sale of the related inventory together with the status of the product within the regulatory approval process. We analyze our inventory levels quarterly and write down inventory that has become obsolete, or has a cost basis in excess of its expected net realizable value and inventory quantities in excess of expected requirements. In applying the lower of cost or net realizable value to pre-launch inventory, we estimate a range of likely commercial prices based on our comparable commercial products. Expired inventory is disposed of and the related costs are recognized as Cost of Sales in the Consolidated Statements of Operations. Inventories Produced in Preparation for Product Launches We capitalize inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that we believe are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and we have determined it is probable that these capitalized costs will provide future economic benefit in excess of capitalized costs. The factors considered by us in evaluating these uncertainties include the receipt and analysis of positive Phase III clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the compilation of the regulatory application. We closely monitor the status of each respective product within the regulatory approval process, including all relevant communication with regulatory authorities. We also consider our historical experience with manufacturing and commercializing similar products and the relevant product candidate. If we are aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however in evaluating whether to capitalize pre-launch inventory production costs, we consider the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. 2 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Inventory The Company values inventory at the lower of cost or net realizable value and determines the cost of inventory using the average-cost method. Inventories consist of currently marketed products and may contain certain products awaiting regulatory approval. In evaluating the recoverability of inventories produced in preparation for product launches, the Company considers the likelihood that revenue will be obtained from the future sale of the related inventory together with the status of the product within the regulatory approval process. The Company analyzes its inventory levels quarterly and writes down inventory that has become obsolete, or has a cost basis in excess of its expected net realizable value and inventory quantities in excess of expected requirements. In applying the lower of cost or net realizable value to pre-launch inventory, the Company estimates a range of likely commercial prices based on its comparable commercial products. Expired inventory is disposed of and the related costs are recognized as Cost of Sales in the Consolidated Statements of Operations. Inventories Produced in Preparation for Product Launches The Company capitalizes inventories produced in preparation for product launches sufficient to support estimated initial market demand. Typically, capitalization of such inventory begins when positive results have been obtained for the clinical trials that the Company believes are necessary to support regulatory approval, uncertainties regarding ultimate regulatory approval have been significantly reduced and the Company has determined it is probable that these capitalized costs will provide some future economic benefit in excess of capitalized costs. The material factors considered by the Company in evaluating these uncertainties include the receipt and analysis of positive Phase III clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, and the compilation of the regulatory application. The Company closely monitors the status of each respective product within the regulatory approval process, including all relevant communication with regulatory authorities. The Company also considers its historical experience with manufacturing and commercializing similar products and the relevant product candidate. If the Company is aware of any specific material risks or contingencies other than the normal regulatory review and approval process or if there are any specific issues identified relating to safety, efficacy, manufacturing, marketing or labeling, the related inventory would generally not be capitalized. For inventories that are capitalized in preparation of product launch, anticipated future sales, expected approval date and shelf lives are evaluated in assessing realizability. The shelf life of a product is determined as part of the regulatory approval process; however in evaluating whether to capitalize pre-launch inventory production costs, the Company considers the product stability data of all of the pre-approval production to date to determine whether there is adequate expected shelf life for the capitalized pre-launch production costs. 3 Note 10 – INVENTORY Inventory consisted of the following: March 31, December 31, 2013 2012 Raw materials $ 13,314 $ 11,943 Work-in process 75,543 71,443 Finished goods 46,965 45,309 Total inventory $ 135,822 $ 128,695 Inventory as of March 31, 2013 and December 31, 2012 included $5.1 million and $0, respectively, of raw materials purchased for use in the pre-launch Vimizim manufacturing campaign. The Company believes that all material uncertainties related to the ultimate regulatory approval of Vimizim for commercial sale have been significantly reduced based on positive data from Phase III clinical trial results, successful pre-filing meetings with the Food and Drug Administration (FDA) for the Biologics License Application (BLA), the filing of the BLA with the FDA in the first quarter of 2013, and the filing of the Marketing Authorization Application (MAA) filed with the European Medicines Agency (EMA) in April 2013. In its evaluation, the Company also considered its historical experience with developing and commercially producing similar products. Inventory as of March 31, 2013 and December 31, 2012 also included $7.4 million and $12.0 million, respectively, of product manufactured using certain process and specification changes that have not yet received regulatory approval. Although the products have been approved by various regulatory agencies, the process and specification changes must also be approved before product produced with the alternate processes and specifications can be sold commercially. The Company expects to receive regulatory approval and has determined that it is probable that the Company will realize the future economic benefit associated with the costs of these inventories through future sales. 2. In addition, please provide us proposed revised disclosure to be included in future periodic reports that discusses the overall FDA approval process; the description should meaningfully relate to your accounting policy for pre-launch inventory. For each product with significant costs capitalized in inventory prior to the regulatory approval, discuss the following: • The current status of the approval process, including any contingencies needed to be resolved prior to obtaining FDA approval, the risks affecting the probability of obtaining FDA approval, and the estimated timing of obtaining approval. • The specific nature of any safety and efficacy, manufacturing, and marketing or labeling issues outstanding and why you do not believe those issues affect its probable future benefit conclusion. • The remaining shelf life of each product, as of each balance sheet date presented, and why you believe you will be able to realize the inventory prior to the expiration of the shelf life. • The risks and uncertainties surrounding market acceptance of the product once approved and how this will affect the realization of the asset. 4 Response: The Company has provided a detailed discussion of the FDA approval process included in Item 1 Business, under the caption “FDA Approval Process” on page 10 of the Company’s 2012 Annual Report. The Company believes this detailed description of the FDA approval process, along with our proposed revised accounting policy disclosures provided in response to Staff Comment 1, provide a meaningful link between the FDA approval process, timing, and inherent risks to the accounting policy followed by the Company. The Company provides the following in response to each of the bulleted points raised by the Staff above: • The Company believes the proposed revised disclosures of its accounting policies provided in response to Staff Comment 1, as well as additional proposed disclosures regarding the current status of the regulatory approval of Vimizim in Note 10 above, provide adequate disclosure of the current status of the approval process, including the contingencies needed to be resolved prior to obtaining FDA approval. Additionally, in response to the Staff’s comment regarding risks affecting the probability of obtaining FDA approval, and the estimated timing of obtaining approval, the Company references the following Risk Factor disclosure in Item 1A, page 37 of our March 2013 Quarterly Report. The Company believes this Risk Factor disclosure adequately discusses risks and uncertainties affecting the probability of obtaining FDA approval and the estimated timing of obtaining approval. • If we fail to obtain or maintain regulatory approval to commercially market and sell our drugs, or if approval is delayed, we will be unable to generate revenue from the sale of these products, our potential for generating positive cash flow will be diminished, and the capital necessary to fund our operations will be increased. We must obtain and maintain regulatory approval to market and sell our drug products in the U.S. and in jurisdictions outside of the U.S. In the U.S., we must obtain FDA approval for each drug that we intend to commercialize. The FDA approval process is typically lengthy and expensive, and approval is never certain. Products distributed abroad are also subject to government regulation by international regulatory authorities. Naglazyme, Aldurazyme and Kuvan have received regulatory approval to be commercially marketed and sold in the U.S., EU and other countries. Firdapse has received regulatory approval to be commercially marketed only in the EU. Although we announced in November 2012 that our Phase 3 study of Vimizim™, an enzyme replacement therapy for patients with MPS IVA (Morquio Syndrome), had met its primary endpoint, Vimizim has not received regulatory approval in the U.S., EU or any other jurisdiction and may never receive approval. Also, even if we receive priority review timelines from the FDA for Vimizim, there is no assurance that the FDA will comply with such timelines and there may be delays and ultimately the FDA may decide not to approve Vimizim. As part of the recent reauthorization of PDUFA, new biologics are included in a new product review program intended to enhance FDA-sponsor communications to lead to greater first-cycle approval decisions. As part of this program, applications for new biologics are subject to either a 12-month standard or 8-month priority 5 review period that begins from the date of application submission. However, since this is a new product review program and no products have completed this new review process, the priority review period may take longer than eight months and the standard review period may take longer than 12 months. Similarly, although the EMA has an accelerated approval process, the timelines mandated by the regulations are subject to the possibility of substantial delays. In addition, the FDA and its international equivalents have substantial discretion over the approval process for pharmaceutical products. As such, these regu
2013-05-09 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
May 8, 201 3 Via E -mail Mr. Daniel Spiegelman Executive Vice President and Chief Financial Officer BioMarin Pharmaceutical Inc. 770 Lindaro Street San Rafael, CA 94901 Re: BioMarin Pharmaceutical Inc. Form 10 -K for the Fiscal Year Ended December 3 1, 2012 Filed February 26 , 2013 Form 10 -Q for the Quarterly Period ended March 31, 2013 Filed April 29, 2013 File No. 000-26727 Dear Mr. Spiegelman : We have reviewed your filing s and have the following comment s. In our comment s, we ask you to provide us with information so we may better understand your disclosure . Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your response s to our comment s. After reviewing the information you provide in response to th ese comment s, we may have additional comments and/or request that you amend your filing s. Form 10 -Q for the Quarterly Period ended March 31, 2013 Notes to the Consolidated Financial Statements. Note 10. Inventory, page 11 1. Please provide us proposed revised disclosure to be included in future periodic reports indicating revisions to your accounting policy rega rding capitalization of inventory costs prior to regulatory approval that specifically states the point during the FDA approval process that you determine a probable future benefit exists and the status of the FDA’s consideration of the safety and efficacy of the drug/system and evaluation of the manufacturing process at that point. Disclose how you apply the lower of cost or market principle to your pre -launch inventory. Mr. Daniel Spiegelman BioMarin Pharmaceutical Inc. May 8, 201 3 Page 2 2. In addition, please provide us proposed revised disclosure to be included in future periodic reports that discusses the overall FDA approval process; the description should meaningfully relate to your accounting policy for pre -launch inventory. For each product with significant costs capitalized in inventory prior to regulatory approval, discuss the following: The current status of the approval process, including any contingencies needed to be resolved prior to obtaining FDA approval, the risks affecting the probability of obtaining FDA approval, and the estimated timing of obtaining ap proval. The specific nature of any safety and efficacy, manufacturing, and marketing or labeling issues outstanding and why you do not believe those issues affect its probable future benefit conclusion. The remaining shelf life of each product, as of each balance sheet date presented, and why you believe you will be able to realize the inventory prior to the expiration of the shelf life. The risks and uncertainties surrounding market acceptance of the product once approved and how this will affect the real ization of the asset. We urge all persons who are responsible for the accuracy and a dequacy of the disclosure in the filing s to be certain that the filing s include the information the Securities Exchange Act of 1934 and all applicable Exchange 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 a dequacy of the disclosures they have made. In responding to our comment s, please provide a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing s; staff comments o r changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to th e filing s; 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. You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Lisa Vanjoske , Assistant Chief Accountant , at (202) 551 -3614 if you have questions . In this regard, do not hesitate to contact me a t (202) 551 -3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2012-05-15 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
May 14, 2012 Via E-mail Mr. Jeffrey H. Cooper Senior Vice President and Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 22, 2012 File No. 000-26727 Dear Mr. Cooper: We have completed our review of your f iling. We remind you that our comments or changes to disclosure in res ponse to our comments do not for eclose the Commission from taking any action with respect to the company or th e filing and the company may not assert staff comments as a defense in any proceeding ini tiated by the Commission or any person under the federal securities laws of the United States. We urge all pers ons who are responsible for the accuracy and adequacy of the disclosure in the fi ling to be certain that the filing includes the information the Securities Exchange Act of 1934 and all applicable rules require. Sincerely, /s/ Joel Parker Joel Parker Accounting Branch Chief
2012-05-03 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence May 3, 2012 VIA EDGAR AND OVERNIGHT MAIL United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549-8561 Attn: Mr. Jim B. Rosenberg, Senior Chief Accountant Re: BioMarin Pharmaceutical Inc. Form 10-K for the fiscal year ended December 31, 2011 Filed February 22, 2012 File No. 000-26727 Dear Mr. Rosenberg, This letter is being submitted in response to comments received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) by letter dated April 27, 2012, addressed to Jeffrey H. Cooper, Senior Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (“we”, “our” or the “Company”). The Staff issued the comment letter in response to our letter to the Staff, dated April 2, 2012, pertaining to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011 (the “Form 10-K”), filed by the Company with the Commission on February 22, 2012 (“2011 Annual Report”). The numbering of the paragraphs below corresponds to the numbering in the comment letter, the text of which is incorporated into this response letter for convenience. STAFF COMMENTS AND COMPANY RESPONSES Form 10-K for the fiscal year ended December 31, 2011 Management’s Discussion and Analysis Provision for Income Taxes, page 57 1. With regard to your response to comment three, please consider providing disclosure to explain in greater detail the impact on your effective income tax rates and obligations of certain foreign entities being profitable and incurring foreign current income tax expense and certain foreign entities incurring significant amounts of research and development expense and report significant losses in jurisdictions which do not have loss carryforwards and thus no tax benefit. It appears that separately discussing the foreign effective tax rates is important information necessary to understanding your results of operations. Response: The Company will expand the foreign income tax discussion in future annual filings to give the reader a better understanding of the impact of its foreign operations on its overall effective tax rate. (21) Revenue and Credit Concentrations, page F-39 2. Please refer to your response to our comment two. We believe disclosure of the information in your response would be useful to readers of your financial statements and should be made. Response: The Company hereby confirms that it will disclose the information requested by the Staff in future periodic reports if amounts past due from Italy, Spain, Portugal and Greece are a significant portion of the Company’s total receivables. The Company included such information in its Quarterly Report on Form 10-Q, filed on April 30, 2012. (22) Income Taxes, page F-40 3. You state “The Company has also elected to treat certain foreign entities as disregarded entities for U.S. tax purposes, which results in their net income or loss being recognized currently in the Company’s U.S. tax returns.” Provide us proposed disclosure to be included in future periodic reports identifying the countries in which disregarded entities are located and quantify the amount of net income or loss of the disregarded entities in each year. Response: At the end of 2011, the Company had two disregarded entities that will be included in the Company’s U.S. tax returns. The first disregarded entity is a Canadian entity that is dormant and had no income or loss for 2011 or the prior three years. The second entity is an Irish entity, which became a disregarded entity in November 2011, with a GAAP loss of ($669,342). This entity is being liquidated in 2012. Therefore, given the status of the Canadian entity and the immaterial impact of the Irish entity on the U.S. tax provision, we propose removing this statement going forward unless we have additional active disregarded entities that generate net income or loss. ********* The Company acknowledges that: The Company is responsible for the adequacy and accuracy of the disclosure in the filing; Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. ********* The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned at (415) 506-6700 or edavis@bmrn.com. Sincerely, /s/ G. Eric Davis G. Eric Davis Senior Vice President, General Counsel BioMarin Pharmaceutical Inc. cc: Jeffrey H. Cooper, Senior Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc. Thomas R. Pollock, Esq., Paul Hastings LLP
2012-04-27 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
April 27, 2012 Via E-mail Mr. Jeffrey H. Cooper Senior Vice President and Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 22, 2012 File No. 000-26 727 Dear Mr. Cooper: We have reviewed your April 2, 2012 respons e to our March 23, 2012 letter and have the following comments. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information you provide in response to these comments, we may have additional comments and/or request that you amend your filings. Management’s Discussion and Analysis Provision for Income Taxes, page 57 1. With regard to your response to comment thr ee, please consider providing disclosures to explain in greater detail the impact on your e ffective income tax rates and obligations of certain foreign entities being profitable and incurring foreign current income tax expense and certain foreign entities incurring significant amounts of research and development expense and report significant losses in jurisdictions which do not have loss carryforwards and thus no tax benefit. It a ppears that separately discussing the foreign effective income tax rates is important information necessary to understanding your results of operations. Mr. Jeffrey H. Cooper BioMarin Pharmaceutical Inc. April 27, 2012 Page 2 Financial Statements (21) Revenue and Credit Concentrations, page F-39 2. Please refer to your response to our comment two. We believe disclosure of the information in your response would be useful to readers of your financial statements and should be made. (22) Income Taxes, page F-40 3. You state “The Company has also elected to treat certain foreign entities as disregarded entities for U.S. tax purposes, which results in their net income or loss being recognized currently in the Company’s U.S. tax return.” Provide us proposed disclosure to be included in future periodic re ports identifying the countries in which disregarded entities are located and quantify the am ount of net income or loss of the disregarde d entities in each year. You may contact Lisa Vanjoske , Assistant Chief Accountant, at (202) 551-3614 or Joel Parker, Accounting Branch Chief, at (202) 551-3651 if you have quest ions regarding these comments. In this regard, do not hesita te to contact me at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2012-04-02 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence April 2, 2012 VIA EDGAR AND OVERNIGHT MAIL United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549-8561 Attn: Mr. Jim B. Rosenberg, Senior Chief Accountant Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 22, 2012 File No. 000-26727 Dear Mr. Rosenberg, This letter is being submitted in response to comments received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) by letter dated March 23, 2012, addressed to Jeffrey H. Cooper, Senior Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (“we”, “our” or the “Company”) with respect to the Annual Report on Form 10-K for the fiscal year ended December 31, 2011 filed by the Company with the Commission on February 22, 2012 (“2011 Annual Report”). The numbering of the paragraphs below corresponds to the numbering in the comment letter, the text of which is incorporated into this response letter for convenience. STAFF COMMENTS AND COMPANY RESPONSES Form 10-K for the Fiscal Year Ended December 31, 2011 Management’s Discussion and Analysis Provision for Income Taxes, page 57 1. You indicate here that the 2011 provision for income taxes relates to foreign and state income taxes yet page F-41 shows the majority of 2011 income tax expense was federal. Please provide us proposed disclosure to be included in future periodic reports reconciling these two disclosures or tell us why you believe no revision is necessary. Also explain why a provision for current federal income tax is required when you are utilizing net operating loss carryforwards. Response: In Management’s Discussion and Analysis (“MD&A”), the Company agrees that the disclosure of the components of the 2011 income tax provision could have more clearly identified that both the current and deferred expense included “federal” amounts. To aid the comparison of the MD&A discussion to the amounts disclosed in the notes to the consolidated financial statements in future periodic reports, the Company will provide discussion categorized by the current and deferred tax expense categories separately, with more detailed discussion about the federal, state and foreign components of the separate items of current and deferred expense as appropriate based on materiality. With respect to the Company’s recognition of federal current tax expense when we are utilizing net operating loss carryforwards, the majority of the current federal amount shown on page F-41 was related to Alternative Minimum Tax (“AMT”). Current AMT payments also generated an equal tax credit benefit in the deferred taxes whereby the net impact on the consolidated tax provision was $0. Financial Statements (21) Revenue and Credit Concentrations, page F-39 2. Please provide us proposed disclosure to be included in future periodic reports that discloses the amount of accounts receivable that is past due by country related to Italy, Spain, Portugal and Greece and the number of days past due. Disclose the portion of each of these countries that is due directly from the government or funded by the government. Tell us the amount of allowance for doubtful accounts at December 31, 2011 related to receivables in each of these countries and why you consider that amount to be adequate. Response: In our 2011 Annual Report, we disclosed the portion of our net product sales and outstanding receivables from Italy, Spain, Portugal and Greece in both note 21 to the consolidated financial statements and in the risk factor regarding our business being affected by macroeconomic conditions appearing on page 35. We did not disclose additional detail by country due to relative immateriality of each country individually, but have included this information below for the Staff’s information. The following table summarizes the accounts receivable by country that was past due related to Italy, Spain, Portugal and Greece as of December 31, 2011, the number of days past due and the total allowance for doubtful accounts related to each of these countries at December 31, 2011 (in thousands): Days Past Due < 180 Days 180 –360 Days > 360 Days Total Amount Past Due Allowance for Doubtful Accounts Italy $ — $ — $ — $ — $ — Spain 2,940 703 686 4,329 — Portugal 739 — — 739 — Greece — 466 346 812 474 Total $ 3,679 $ 1,169 $ 1,032 $ 5,880 $ 474 All of the Company’s past due accounts receivable in Italy, Spain, Portugal, and Greece are related to entities that are either government-owned or government-funded. The Company has not historically experienced a significant level of uncollected receivables and has received continued payments from the more aged accounts represented above. Also, the payment trends for our receivables from Italy, Spain and Portugal, including timeliness, have not changed 2 materially since the European debt crisis and are similar to historical patterns and thus we do not believe any allowance is necessary on those accounts. With respect to Greece, while the amounts are not material, the payment trend has changed in that we accepted Greek government debt in exchange for a portion of our receivables and, as noted above, we have recorded a reserve against a portion of the remaining accounts receivable in Greece to reflect our expected collections. The Company believes that the allowances for doubtful accounts from the countries above is adequate based on its analysis of the specific business circumstances and expectations of collection for each of the underlying accounts in these regions. We will continue to monitor the materiality of our accounts receivable exposure in each of these countries going forward, including the payment trends, and will disclose such detail in our future periodic reports if material. (22) Income Taxes, page F-40 3. Please provide us proposed disclosure to be included in future periodic reports explaining why you are recognizing foreign current income tax expense when you show losses before income tax from non-U.S. sources for all three years. Also disclose why the losses from non-U.S. sources do not appear to be reported as foreign net operating loss carryforwards. Tell us why the losses increased greatly in 2010 and 2011. Response: The Company proposes to include disclosure substantially similar to the following in future periodic reports to explain why we recognize foreign current income tax expense when we show losses before income tax from non-U.S. sources and why the losses from non-U.S. sources do not generate net operating loss carryforwards: Non-U.S. source losses represent the consolidated U.S. GAAP loss of all the Company’s foreign subsidiaries. In accordance with ASC 740, the Company calculates its tax provision on an entity-by-entity and jurisdiction-by-jurisdiction basis as adjusted for differences between book-basis income and tax-basis income, which results in certain foreign entities being profitable and incurring foreign current income tax expense. Certain foreign entities incur significant amounts of research and development expense and report significant losses that, on a consolidated basis, offset the income reported by the profitable foreign entities. The majority of the foreign losses are incurred in jurisdictions that do not have net operating loss carry forward provisions and there will be no future benefit to support a deferred tax asset related to loss carryforwards. The losses increased greatly in 2010 and 2011 due to significantly increased research and development expenses in certain entities that do not yet have revenues from product sales and therefore incur higher net losses as the related research and development activities increase. As disclosed on the Consolidated Statement of Operations, the Company’s total research and development expense on a consolidated basis increased by $67.1 million in 2011 as compared to 2010. The Company notes that in its MD&A in the 2011 Annual Report the Company discloses the change in research and development expenses from 2010 to 2011 and the principal reasons therefore. 4. You disclose “Based on projected U.S. taxable income and other key operating factors, the Company concluded in 2010 that it is more likely than not that a significant portion of the benefit of its deferred tax assets would be realized. As a result, the amount of the valuation allowance related to the deferred tax assets expected to be realized was reversed, resulting in a net tax benefit in 2010 of $230.6 million, which was recorded as a tax benefit in the Company’s 3 consolidated statements of operations in 2010.” Please provide us with a detailed analysis to support your conclusion that no additional valuation allowance was warranted. Your response should address both the positive and negative evidence you considered in making this determination in accordance with ASC 740. Response: Management’s assessment included consideration of the four sources of taxable income that may be available under the tax law to realize a portion or all of a tax benefit for deductible temporary differences and carryforwards. Management concluded that there were: (1) no significant future reversals of existing taxable temporary differences (DTL’s); (2) no significant ability to carryback net operating losses or credits for recovery of previous taxes paid; and (3) no viable tax planning strategies were currently planned. Accordingly the Company looked to the fourth possible source of future taxable income exclusive of reversing temporary differences and carryforwards. The Company concluded, on a more likely than not basis, that there was adequate evidence to support the existence of sufficient amounts of the fourth source of taxable income to support the realization of the majority of the Company’s deferred tax assets. The following is a summary of the significant positive, neutral and negative evidence evaluated in making this determination: Positive Evidence: a) Cumulative earnings history – The Company had generated cumulative pretax U.S. book income for the three-year period preceding the valuation allowance reversal. b) Character of future income – The Company compared the character of its future taxable income projections (e.g., ordinary income) to the character of its deferred tax assets (e.g., net operating loss carryforwards, or “NOLs”) and concluded that most of the future income was of the appropriate character to realize the deferred tax assets, most of which are NOLs and research and development tax credits. In cases where the Company’s income projections were not of the appropriate character to realize certain types of deferred tax such as capital loss carryforwards, the valuation allowance was not reversed. c) Long carryback/carryforward periods – Portions of the Company’s carryforwards begin to expire in the near future, however the level of projected taxable income is adequate to utilize those carryforwards, and in general the Company’s carryforward periods are long in duration. d) Trends support earnings expected in future years – Despite consolidated GAAP net losses, the Company’s U.S. pretax income trends support earnings expected in future years. e) Demonstrated ability to reasonably project future results of operations – Over time, the Company has consistently demonstrated its ability to predict financial results on a short-term and long-term basis within the materiality parameters required by the deferred tax asset valuation allowance analysis. f) Proven record of developing significant and successful new products – The Company has a proven record of successfully developing and commercializing new products evidenced by three internally developed commercial drugs that are approved and commercialized in the U.S. and globally. g) Absence of known loss contingencies or unsettled circumstances – The Company does not have any material loss contingencies and for purposes of the deferred tax asset valuation allowance analysis is not aware of any circumstances that could adversely affect future operations and taxable income in future years. 4 Neutral Evidence: a) Modest history of using all operating loss and tax credit carryforwards before they expire – Only de minimus amounts of loss carryforwards and credits in certain states and foreign countries have expired prior to utilization. b) Lack of significant existing contracts or firm sales backlog that are expected to produce taxable income – The Company does not have long-term contracts but does have orphan drug and patent protection around its products. c) Company’s competitive position in industry – The Company generally has less specific competition with its products and programs than its industry peers, however the biotech industry in general is highly competitive. With respect to resources, the Company has significantly greater resources than certain of its competitors, but significantly less resources than several larger competitors. d) Growth stage of industry – The biotech industry is in a continued growth stage, however the uncertainty of research and development efforts and general competition with respect to product innovation are significant obstacles to long-term success in the biotech industry. e) Financial ratios and sensitivity to external economic factors – The measurement and predictability of the Company’s success is not highly sensitive to financial ratio analysis, and although external economic factors affect the Company, the Company’s income projections are not highly sensitive to such factors within all material respects. f) Availability of tax-planning strategies – No material tax-planning strategies were identified to accelerate or delay taxable or deductible amounts. Negative Evidence: a) Industry stability – The biotech industry is not significantly cyclical, however the industry involves significant uncertainty with respect to drug development efforts and long-term product market protection. b) Ability to carryback current taxes – Except for AMT, taxes have not been paid in the current or prior years and carryback is not available. c) Timing of reversal of taxable amounts – The reversal of differences in the future could generate minimal taxable income for the Company. In accordance with ASC 740, the Company carefully considered each of the above factors, giving greater weight to the more objective factors. Some of the most compelling positive evidence reviewed by management was the Company’s positive earnings history, its proven ability to forecast income and the long carryover period of most of the deferred tax assets. Based upon analysis of these and all other factors, the Company believes that the evidence supporting its projections of future taxable income is sufficient to conclude that it is more likely than not that the Company will realize most of its deferred tax assets. ********* The Company acknowledges that: The Company is responsible for the adequacy and accuracy of the disclosure in the filing; Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. ********* 5 The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned at (415) 506-6700 or to Thomas R. Pollock, Esq. at (415) 856-7047. Sincerely, /s/ G. Eric Davis
2012-03-23 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
March 23, 2012 Via E-mail Mr. Jeffrey H. Cooper Senior Vice President and Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2011 Filed February 22, 2012 File No. 000-26727 Dear Mr. Cooper: We have limited our review to only your fina ncial statements and related disclosures and do not intend to expand our review to other porti ons of your document. In our comments, we ask you to provide us with information so we may better understa nd your disclosure. Please respond to this letter within 10 business days by providing the requested information or by advising us when you will provide the requested response. If you do not believe a comment applies to your facts and circ umstances, please tell us why in your response. Please furnish us a letter on EDGAR under the fo rm type label CORRESP that keys your responses to our comments. After reviewing the information you provide in response to these comments, we may have additional comments and/or request that you amend your filing. Management’s Discussion and Analysis Provision for Income Taxes, page 57 1. You indicate here that the 2011 provision for income taxes relates to foreign and state income taxes yet page F-41 shows the majority of 2011 income tax expense was federal. Please provide us proposed disclosure to be included in future periodic reports reconciling these two disclosures or tell us why you believe no revision is necessary. Also explain why a provision for current fe deral income tax is required when you are utilizing net operating loss carryforwards. Mr. Jeffrey H. Cooper BioMarin Pharmaceutical Inc. March 23, 2012 Page 2 Financial Statements (21) Revenue and Credit Concentrations, page F-39 2. Please provide us proposed disclosure to be included in future periodic reports that discloses the amount of accounts receivable th at is past due by count ry related to Italy, Spain, Portugal and Greece and the number of days past due. Disclose the portion in each of these countries that is due directly fr om the government or funded by the government. Tell us the amount of allowance for doubtfu l accounts at December 31, 2011 related to receivables in each of these countries and w hy you consider that amount to be adequate. (22) Income Taxes, page F-40 3. Please provide us proposed disclosure to be in cluded in future periodic reports explaining why you are recognizing foreign current in come tax expense when you show losses before income tax from non-U.S. sources for a ll three years. Also disclose why the losses from non-U.S. sources do not appear to be reported as foreign net operating loss carryforwards. Tell us why the losses increased greatly in 2010 and 2011. 4. You disclose “Based on projected U.S. taxa ble income and other key operating factors, the Company concluded in 2010 that it is more likely than not that a significant portion of the benefit of its deferred tax assets would be realized. As a result, the amount of the valuation allowance related to the deferred tax assets expected to be realized was reversed, resulting in a net tax benefit in 2010 of $230.6 million, which was recorded as a tax benefit in the Company's consolidated statement of operations in 2010.” Please provide us with a detailed analysis to suppor t your conclusion that no additional valuation allowance was warranted. Your response s hould address both the positive and negative evidence you considered in making this determination in accordance with ASC 740. We urge all persons who are responsible for th e accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Mr. Jeffrey H. Cooper BioMarin Pharmaceutical Inc. March 23, 2012 Page 3 You may contact Lisa Vanjoske , Assistant Chief Accountant, at (202) 551-3614 or Joel Parker, Accounting Branch Chief, at (202) 551-3651 if you have quest ions regarding these comments. In this regard, do not hesita te to contact me at (202) 551-3679. Sincerely, /s/ Jim B. Rosenberg Jim B. Rosenberg Senior Assistant Chief Accountant
2010-10-13 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
October 13, 2010 Jeffrey H. Cooper Senior Vice President, Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2009 Filed February 26, 2010 Proxy Statement on Schedule 14A Filed March 26, 2010 File Number: 000-26727 Dear Mr. Cooper: We have completed our review of your fili ngs and do not have any further comments at this time. Sincerely, Melissa Rocha Accounting Branch Chief
2010-10-12 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence Letter October 12, 2010 VIA EDGAR AND OVERNIGHT MAIL United States Securities and Exchange Commission Division of Corporate Finance 100 F Street N.E. Washington, D.C. 20549-8561 Attn: Ms. Dana Hartz, Staff Accountant Mr. Don Abbot, Senior Staff Accountant Re: BioMarin Pharmaceutical Inc. Form 10-K for the fiscal year ended December 31, 2009 Filed February 26, 2010 Form 8-K Filed March 24, 2010 Proxy Statement on Schedule 14A Filed March 26, 2010 File No. 000-26727 Dear Ms. Hartz and Mr. Abbott, This letter is being submitted in response to comments received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) by letter dated September 28, 2010, addressed to Jeffrey H. Cooper, Senior Vice President, Chief Financial Officer of BioMarin Pharmaceutical Inc. (“we”, “our” or the “Company”). The Staff issued the comment letter in response to our letter to the Staff, dated August 13, 2010, pertaining to our Annual Report on Form 10-K for the fiscal year ended December 31, 2009 (the “Form 10-K”), our Form 8-K filed by the Company with the Commission on March 24, 2010 (the “Form 8-K”) and our Proxy Statement on Schedule 14A filed by the Company with the Commission on March 26, 2010 (the “Proxy Statement”). The numbering of the paragraphs below corresponds to the numbering in the comment letter, the text of which is incorporated into this response letter for convenience. STAFF COMMENTS AND COMPANY RESPONSES Form 10-K for the fiscal year ended December 31, 2009 Commercial Products, page 3 1. We note your response to our prior comment 2. To the extent you continue to describe your exclusive license agreement with Asubio Pharma Co., Ltd. and list the agreement as an exhibit in future filings, we ask that you include all material information regarding the agreement including the total potential milestone payments to be made and a more narrow range of royalties within a ten percent range. Please confirm your understanding that this information should be included in future disclosure. Response: The Company confirms that to the extent we include our license agreement with Asubio Pharma Co., Ltd. as a material contract in an exhibit to a future filing, we will include all material information regarding the license agreement including the total potential milestone payments to be made and a more narrow range of royalties within a ten percent range. Consolidated Financial Statements Notes to Consolidated Financial Statements Note 11. Convertible Debt, page F-30 2. Please refer to your response to prior comment five. It appears under Section 4.07(a)(3) of the First Supplement Indenture dated March 29, 2006 that if you issue any rights or warrants to all or substantially all holders of your outstanding Common Stock entitling them to subscribe for or purchase shares of Common Stock (or securities convertible into Common Stock) at a price per share (or having a Conversion Price per share) less than the Current Market Price per share of Common Stock, the Conversion Rate in effect immediately prior thereto shall be increased based on the terms in the agreement. Please tell us how you determined that this embedded conversion feature was indexed to your own stock and therefore not an embedded derivative requiring separate liability classification under ASC 815-40-15. Response: In concluding that the embedded conversion feature of our convertible debt is indexed to our own stock in light of Section 4.07(a)(3) of the First Supplement Indenture, we note that this provision would operate to adjust for the dilution to the debt holder resulting from the occurrence of a specified dilutive event; a future rights offering to all or substantially all holders of our common stock at a price below market. We believe this provision is consistent with Example 17 illustrated in ASC 815-10-65-3. The adjustment to the conversion rate is based upon a mathematical calculation that determines the direct effect that such dilutive events would have on the price of the underlying shares. We note that it does not adjust for the actual change in the market price of the underlying shares upon the occurrence of those events. As a result, we concluded that this conversion feature was not an embedded derivative requiring separate liability classification under ASB 15-40-15. Definitive Proxy Statement on Schedule 14A Compensation Disclosure and Analysis Cash Bonus, page 34 3. We note your response to our prior comment 8 and your analysis as to why you believe disclosure of your 2009 corporate goals would cause competitive harm to the company. We disagree with your conclusion as it relates to the Net Operating Income and product specific sales goals. We also believe that disclosure of your non-financial goals in general terms would not cause competitive harm to the company. Therefore, please confirm that to the extent the company has analogous goals for the 2010 fiscal year, you will disclose such information in the Compensation Discussion and Analysis section of your next annual filing. 2 Response: The Company hereby confirms that to the extent it has analogous goals for the 2010 fiscal year, it will disclose the information requested by the Staff in the Compensation Discussion and Analysis section of our next annual filing, including any financial and product specific sales goals and a general description of any non-financial goals. ********* The Company acknowledges that: the Company is responsible for the adequacy and accuracy of the disclosure in the filing; Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and The Company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States ********* The Company respectfully requests the Staff’s assistance in completing the review of this response letter at its earliest convenience. Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response to the undersigned at (415) 506-6700 or to Thomas R. Pollock, Esq. at (415) 856-7047. Sincerely, /s/ G. Eric Davis G. Eric Davis Senior Vice President, General Counsel BioMarin Pharmaceutical Inc. cc: Jeffrey H. Cooper, Senior Vice President, Chief Financial Officer, BioMarin Pharmaceutical Inc. Thomas R. Pollock, Esq., Paul Hastings, Janofsky & Walker LLP 3
2010-09-28 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
September 28, 2010 Jeffrey H. Cooper Senior Vice President, Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2009 Filed February 26, 2010 Proxy Statement on Schedule 14A Filed March 26, 2010 File Number: 000-26727 Dear Mr. Cooper: We have reviewed your August 13, 2010 respon se to our July 30, 2010 letter and have the following comments. In our comments, we as k you to provide us with information to better understand your disclosure. Please respond to this letter within te n business days by providing the requested information or by advising us when you will provid e the requested response. Please furnish us a letter on EDGAR under the form type label CORRESP that keys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filings. Form 10-K for the fiscal year ended December 31, 2009 Commercial Products, page 3 1. We note your response to our prior comment 2. To the extent you continue to describe your exclusive license agreement with Asubio Ph arma Co., Ltd. and list the agreement as an exhibit in future filings, we ask that you in clude all material information regarding the agreement including the total potential milestone payments to be made and a more narrow range of royalties within a te n percent range. Please confirm your understanding that this information should be included in future disclosure. Jeffrey H. Cooper BioMarin Pharmaceutical Inc. September 28, 2010 Page 2 Consolidated Financial Statements Notes to Consolidated Financial Statements Note 11. Convertible Debt, page F-30 2. Please refer to your response to prior comment five. It appears under Section 4.07(a)(3) of the First Supplement Indenture dated March 29, 2006 that if you issue any rights or warrants to all or substantially all holders of your outstanding Common Stock entitling them to subscribe for or purchase shar es of Common Stock (or securi ties convertible into Common Stock) at a price per share (or having a Conve rsion Price per share) less than the Current Market Price per share of Common Stock, the Conversion Rate in e ffect immediately prior thereto shall be increased based on the terms in the agreement. Please tell us how you determined that this embedded conversion feature was indexed to your own stock and therefore not an embedded derivative requiring separate liability classification under ASC 815-40-15. Definitive Proxy Statement on Schedule 14A Compensation Discussion and Analysis Cash Bonus, page 34 3. We note your response to our prior comment 8 and your analysis as to why you believe disclosure of your 2009 corporate goals would ca use competitive harm to the company. We disagree with your conclusion as it relates to the Net Operating Income and product specific sales goals. We also believe that disclosure of your non-financial goals in general terms would not cause competitive harm to the compa ny. Therefore, please confirm that to the extent the company has analogous goals for th e 2010 fiscal year you will disclose such information in the Compensation Discussion and Analysis section of your next annual filing. You may contact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Don Abbott, Senior Staff Accountant, at (202) 551-3608 if you have a ny questions regarding the processing of your response as well as any questions regarding co mments on the financial statements and related matters. You may contact Laura Cr otty, Staff Attorne y, at (202) 551-3563 with questions on any of the other comments. In this regard, do not hesitate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2010-08-13 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence with the SEC [BioMarin Letterhead] [Confidential Treatment Requested] [Redacted Portions Noted with *** and Brackets] August 13, 2010 VIA EDGAR AND OVERNIGHT MAIL United States Securities and Exchange Commission Division of Corporation Finance 100 F Street N.E. Washington, D.C. 20549-8561 Attention: Ms. Dana Hartz, Staff Accountant Mr. Don Abbott, Senior Staff Accountant Re: BioMarin Pharmaceutical Inc. Form 10-K for the fiscal year ended December 31, 2009 Filed February 26, 2010 Form 8-K Filed March 24, 2010 Proxy Statement on Schedule 14A Filed March 26, 2010 File No. 000-26727 Dear Ms. Hartz and Mr. Abbott: This letter is being submitted in response to comments received from the staff (the “Staff”) of the United States Securities and Exchange Commission (the “Commission”) by letter dated July 30, 2010 with respect to: (i) the Annual Report on Form 10-K for the fiscal year ended December 31, 2009 filed by BioMarin Pharmaceutical Inc. (the “Company”) with the Commission on February 26, 2010 (the “Form 10-K”), (ii) the Form 8-K filed by the Company with the Commission on March 24, 2010 (the “Form 8-K”), and (iii) the Proxy Statement on Schedule 14A filed by the Company with the Commission on March 26, 2010 (the “Proxy Statement”). The numbering of the paragraphs below corresponds to the numbering in the comment letter, the text of which is incorporated into this response letter for convenience. FOIA CONFIDENTIAL TREATMENT REQUEST We request, pursuant to 17 C.F.R. §200.83 (“Rule 83”) confidential treatment for portions of our response to Comment Nos. 7 and 8 as indicated below. We request that the indicated portions of this letter be maintained in confidence, not be made part of any public record, and not be disclosed to any person. Two copies of this letter are provided: a redacted version with confidential information labeled “BMRN No. 1” (the “Confidential Information”) in brackets and replaced by asterisks, and a version with the same information in brackets and highlighted. We are submitting only the redacted version on EDGAR. We respectfully request that the Confidential Information be withheld from public disclosure, along with (a) any memoranda, notes, correspondence, or other writings made by any member or employee of the Commission relating to the Confidential [Confidential Treatment Requested] [Redacted Portions Noted with *** and Brackets] Information, or any conference or telephone call with respect thereto; and (b) any copies or extracts of any of the foregoing. In accordance with Rule 83 subparagraph (d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect the Confidential Information or any correspondence, memorandum, or notes related thereto, we ask that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days advance notice of any intended release so that we may, if deemed necessary or appropriate, pursue any remedies available to us. In such an event, we respectfully request that you telephone the undersigned directly at (415) 506-6307 in addition to sending such notice via United States mail. As required by Rule 83 subparagraph (a)(3), our address is 105 Digital Drive, Novato, California 94949. STAFF COMMENTS AND COMPANY RESPONSES Form 10-K for the fiscal year ended December 31, 2009 Item 1, Business, page 1 1. We note your discussion of various license and collaboration agreements throughout this section of the filing. Please revise your disclosure to include a summary of the duration and termination provisions of each material agreement. The Company has noted the Staff’s comments and believes it has provided this information in appropriate sections of its public filings, specifically summarizing such provisions in Commission filings as set forth on EXHIBIT A and filing such agreements as exhibits to its public filings without redaction of these provisions, as well as noting the termination provisions of the Genzyme and Merck Serono relationships in Item 1A of the Form 10-K. However, the Company will in future filings comply with this request subject to any request for confidential treatment that is approved by the Staff covering the requested information and the Company not providing such information where the contract itself is not material to the Company (disclosed elsewhere in the public filing). Commercial Products, page 3 2. We note the discussion of your exclusive license agreement with Asubio Pharma Co., Ltd. on page 4 of the filing. Please revise your disclosure to quantify the total potential milestone payments due under the agreement and to provide a more narrow range of royalties paid within ten percentage points. The exclusive license agreement with Asubio Pharma Co., Ltd. is not material to the Company. The Company only disclosed this exclusive license agreement because in the fiscal quarter in which the first milestone payment of $1.5M was received the Company’s earnings were near break even and the payment was material. Although the Company expects to receive in future periods approximately $1-2 million in revenue per year from this license, these future 2 [Confidential Treatment Requested] [Redacted Portions Noted with *** and Brackets] amounts are no longer material as compared to the Company’s total expected annual revenues of nearly $400 million and accordingly the Company believes its disclosure relating to this contract is sufficient and appropriate. Patents and Proprietary Rights, page 9 3. Please revise your disclosure on page 9 to include the expiration year of each of your material patents. The Company believes its disclosure relating to patents is appropriate. The Company notes that this information is already public record with the U.S. Patent and Trademark Office. However, in future filings the Company will add to its disclosure the expiration year of each of its material patents. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 4. You disclose, on page 4, that the granted orphan drug status and the related seven years of market exclusivity in the U.S. for Aldurazyme expires in 2010. In addition, you disclose that sales of Aldurazyme make up over 22% of your total net sales for the year ended December 31, 2009. Please revise your disclosure to discuss the expected impact that the expiration of the exclusive right in the U.S. will have on your future results of operations and liquidity. Although orphan drug status and the related seven years of market exclusivity in the U.S. for Aldurazyme does expire this year, Aldurazyme, patent number 6,426,208, is under patent protection until November 12, 2019. Accordingly, the Company does not anticipate any significant impact on its future results of operations and liquidity from the expiration of orphan drug status for Aldurazyme in the U.S. However, in future filings, the Company will note the patent protection for its products in its discussion of orphan status. Consolidated Financial Statements Notes to Consolidated Financial Statements Note 11. Convertible Debt, page F-30 5. You disclose that the conversion price is subject to adjustment in certain circumstances. Please disclose the circumstances that would result in an adjustment to the conversion price and tell us how you determined that the conversion feature was not an embedded derivative under ASC 815-15-25 which would require fair value accounting under ASC 470-20-25. Holders of the Company’s Senior Subordinated Convertible Notes due 2017 (the “2017 Notes”) and the Company’s Senior Subordinated Convertible Notes due 2013 (the “2013 Notes” and together with 2017 Notes, the “Notes”) may convert, at any time before maturity, any outstanding 2013 Notes and 2017 Notes into shares of the Company’s common stock at an initial conversion rate of 60.3318 and 49.1171, respectively, per $1,000 principal amount of Notes 3 [Confidential Treatment Requested] [Redacted Portions Noted with *** and Brackets] subject to anti-dilution adjustment as described below. Both classes of Notes have identical adjustment provisions to the conversion price except as noted below. As outlined in the “Adjustment of Conversion Rate” section of: (a) the prospectus supplement for the 2017 Notes, dated April 17, 2007 and filed with the Commission on April 18, 2007 (the “2017 Notes Supplement”), and (b) the prospectus supplement for the 2013 Notes, dated March 23, 2006 and filed with the Commission on March 24, 2006 (the “2013 Notes Supplement”), the conversion prices for both the 2017 Notes and the 2013 Notes are subject to adjustment in the following fundamental change circumstances: (i) if a person or group becomes the beneficial owner of 50% or more of the total voting power of all classes of the Company’s voting stock; (ii) if the Company consolidates with, or merges into, another person or any person consolidates or merges with or into the Company or the Company conveys, transfers, leases or otherwise disposes of all or substantially all of its assets to another person, subject to certain exceptions; and (iii) if the Company’s stockholders approve a plan of liquidation or dissolution (each of the above, a “Fundamental Change”). If the Company undergoes a Fundamental Change: (1) the Company will pay a make-whole premium on the Notes converted in connection with a fundamental change by increasing the conversion rate on such Notes, which amount, if any, will be based on the Common Stock price and the effective date of the fundamental change, and (2) each holder of the Notes will have the option to require the Company to repurchase all or any portion equal to $1,000 or a whole multiple of $1,000 of such holder’s Notes at a repurchase price of 100% of the principal amount of the Notes to be repurchased plus accrued and unpaid interest, if any. The tables in the “Make-Whole Premium Upon a Fundamental Change” sections of the 2017 Notes Supplement and the 2013 Notes Supplement show what the make-whole premium would be for various hypothetical stock prices and effective dates expressed as additional shares of common stock per $1,000 principal amount of Notes. The conversion prices for both the 2017 Notes and the 2013 Notes are also subject to adjustment in the following dilution causing circumstances: (i) if the Company pays a dividend or makes a distribution to all holders of outstanding common stock in shares of common stock; (ii) if the Company subdivides its outstanding common stock into a greater number of shares or combines its outstanding common stock into a smaller number of shares; (iii) if the Company issues any rights or warrants to all or substantially all holders of its common stock entitling them to subscribe for or purchase shares of common stock at a price less than the market price; (iv) if the Company distributes to all or substantially all holders of its common stock shares of any class of capital stock of the Company or evidences of its indebtedness, cash or other assets, subject to certain exceptions; (v)(a) with respect to the 2013 Notes, if the Company has a rights plan in effect for the 2013 Notes and the rights have separated from the common stock prior to conversion of the 2013 Notes, and (b) with respect to the 2017 Notes, if the Company has a rights plan in effect for the 2017 Notes and the rights have separated from the common stock prior to conversion of the 2017 Notes; (vi) if the Company distributes cash to all or substantially all holders of its common stock; and (vii) if a tender or exchange offer made by the Company or any of its subsidiaries for all or any portion of the common stock is about to expire (each of the above, a “Dilution Event”). In the event of a Dilution Event, the conversion rate is proportionately adjusted to reflect the amount of dilution caused by the Dilution Event. 4 [Confidential Treatment Requested] [Redacted Portions Noted with *** and Brackets] We considered the guidance in ASC 815-15-25-15 which states that an embedded derivative indexed to an entity’s own stock that would be classified in stockholders’ equity if freestanding, is not considered a derivative for purposes of ASC Sub-topic 815-10 if it meets the requirements of paragraphs 815-40-25-7 through 25-35 and 815-40-55-2 through 55-6. The guidance further states that these requirements do not apply if the contract is a conventional convertible debt instrument. A conventional convertible debt instrument is one in which the holder may only realize the value of the conversion option by exercising the option and receiving the entire proceeds in a fixed number of shares or the equivalent amount of cash (at the discretion of the issuer). As the make-whole provision described above calls for certain additional share payments to the debt holder in the event of a fundamental change, we concluded that this is not a conventional convertible debt instrument and therefore considered the requirements of paragraph 815-40-25-7 through 25-35 and 815-40-55-2 through 55-6 as discussed below: ASC 815-40 Conditions Company Assessment 25-7 to 9. Contracts that include any provision that could require net cash settlement cannot be accounted for as equity of the entity. Condition satisfied, net cash settlement is not permitted. Further, any provision that could result in a cash payment is in the control of the Company. 25-10a. The contract permits the entity to settle in unregistered shares. Condition satisfied, the convertible note offering was a registered transaction and qualifies for the Section 3(a)(9) exemption from the 1933 Act, therefore delivery of registered shares is within the Company’s control and the contract cannot be settled on a net-cash basis. 25-10b. The entity has sufficient authorized and unissued shares available to settle the contract after considering all other commitments that may require the issuance of stock during the maximum period the derivative instrument could remain outstanding. Condition satisfied, as the Company has sufficient authorized and unissued shares available to settle shares issuable under terms of the Notes. 25-10c. The contract contains an explicit limit on the number of shares to be delivered in a share settlement. Condition satisfied, as the shares issuable under the terms of the Notes are limited. 25-10d. There are no required cash payments to the counterparty in the event the entity fails to make timely filings with the Commission. Condition satisfied, as there is no clause in the Notes that would require cash settlement in the event of untimely Commission filings. 5 [Confidential Treatment Requested] [Redacted Portions Noted with *** and Brackets] 25-10e. There are no cash settled top-off or make-whole provisions. We considered the guidance in 25-30 and noted the maximum number of shares that could be required to be delivered under the make whole provision is fixed and there are sufficient authorized shares to cover the make-whole provision in the event there is a fundamental change. As of the 2007 issuance, approximately 26,360,634 shares of common stock would be required to settle conversions of all the outstanding convertible notes at the current conversion price. The make-whole provision could increase this number by a maximum of approximately 6,452,290 shares. At that time, we had approximately 54,343,820 shares authorized and unissued. Additional commitments potentially requiring issuance of stock include outstanding stock options, warrants and the employee stock purchase plan totaling commitments of up to approximately 12,530,632 shares. Hence at the time of issuance we had ample shares ava
2010-07-30 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
July 30, 2010 Jeffrey H. Cooper Senior Vice President, Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2009 Filed February 26, 2010 Form 8-K Filed March 24, 2010 Proxy Statement on Schedule 14A Filed March 26, 2010 File Number: 000-26727 Dear Mr. Cooper: We have reviewed your filings and have th e following comments. In our comments, we ask you to provide us with information so we may better underst and your disclosure. Please respond to this letter within te n business days by providing the requested information, or by advising us when you will provide the requested response. Where a comment requests you to revise disclosu re, the information you provide s hould show us what the revised disclosure will look like and identify the annual or quarterly filing, as applicable, in which you intend to first include it. If you do not be lieve a comment applies to your facts and circumstances, please tell us why in your res ponse. Please furnish us a letter on EDGAR under the form type label CORRESP that ke ys your responses to our comments. After reviewing the information provided, we may raise additional comments and/or request that you amend your filings. Form 10-K for the fiscal year ended December 31, 2009 Item 1. Business, page 1 1. We note your discussion of various license and collaboration agreements throughout this section of the filing. Please revise your disc losure to include a summary of the duration and termination provisions of each material agreement. Jeffrey H. Cooper BioMarin Pharmaceutical Inc. July 30, 2010 Page 2 Commercial Products, page 3 2. We note the discussion of your exclusive license agreement with Asubio Pharma Co., Ltd. on page 4 of the filing. Please revise your disc losure to quantify the to tal potential milestone payments due under the agreement and to provi de a more narrow range of royalties paid within ten percentage points. Patents and Proprietary Rights, page 9 3. Please revise your disclosure on page 9 to in clude the expiration year of each of your material patents. Item 7. Management’s Discussion and Analys is of Financial Condition and Results of Operations 4. You disclose, on page 4, that the granted orpha n drug status and the re lated seven years of market exclusivity in the U.S. for Aldurazyme expires in 2010. In a ddition, you disclose that sales of Aldurazyme make up over 22% of your total net sales for the year ended December 31, 2009. Please revise your disclosure to discus s the expected impact that the expiration of the exclusive right in the U.S. will have on your future results of operations and liquidity. Consolidated Financial Statements Notes to Consolidated Financial Statements Note 11. Convertible Debt, page F-30 5. You disclose that the conversion price is subjec t to adjustment in certain circumstances. Please disclose the circumstances that would re sult in an adjustment to the conversion price and tell us how you determined that the conve rsion feature was not an embedded derivative under ASC 815-15-25 which would require fa ir value accounting under ASC 470-20-25. Note 14. Income Taxes, page F-35 6. Please revise your disclosure to clarify what is included in the permanent items line item of the tax reconciliation on page F-36 and explain the major changes in this line item for the periods presented. Form 8-K filed March 24, 2010 7. In your response to several of the statements and assertions made by Mr. Klein in his Resignation Letter and the Company’s posit ion on the circumstances surrounding Mr. Klein’s resignation you disclose a disagreem ent regarding how to conduct an ongoing Jeffrey H. Cooper BioMarin Pharmaceutical Inc. July 30, 2010 Page 3 investigation regarding a serious matter. Please tell us the nature of the matter being investigated by the Audit Committee a nd status of this investigation. Definitive Proxy Statement on Schedule 14A Compensation Discussion and Analysis Cash Bonus, page 34 8. We note the following statement beginning on pa ge 34 of your defini tive proxy statement: “We have not disclosed the spec ific corporate goals as they are based on various strategic elements, each of which is confidential a nd the Compensation Committee has determined that disclosure of the goals can result in competitive harm to us.” Please provide us with an analysis supporting your determination that disc losure of the specific corporate goals would result in competitive harm to the company. To avoid the disclosure of the sensitive information in the analysis when our comment letters are released publicly, you may submit a confidential treatment reque st pursuant to Rule 83. Ot herwise, please provide draft disclosure to be includ ed in your next annual filing whic h discloses the specific corporate goals and the threshold, target and maximum leve ls of performance which must be achieved to reach the payout levels described in the firs t full paragraph on page 36. To the extent the goals are quantifiable, your discus sion should also be quantified. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules requir e. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In responding to our comments, please provi de a written statement from the company acknowledging that: • the company is responsible for the adequacy and accuracy of the 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 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. Jeffrey H. Cooper BioMarin Pharmaceutical Inc. July 30, 2010 Page 4 You may contact Dana Hartz, Staff Accountant, at (202) 551-3648 or Don Abbott, Senior Staff Accountant, at (202) 551-3608 if you have a ny questions regarding the processing of your response as well as any questions regarding co mments on the financial statements and related matters. You may contact Laura Cr otty, Staff Attorne y, at (202) 551-3563 with questions on any of the other comments. In this regard, do not hesitate to contact me, at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2008-11-06 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Via Facsimile and U.S. Mail Mail Stop 6010 November 6, 2008 Mr. Jeffrey H. Cooper Senior Vice President, Chief Financial Officer BioMarin Pharmaceutical Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2007 File No. 0-26727 Dear Mr. Cooper: We have completed our review of your Form 10-K and have no further comments at this time. Sincerely, Gustavo A. Rodriguez Branch Chief
2008-11-04 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Securities and Exchange Commission Letter November 4, 2008 Via Edgar and Facsimile Mr. Jim B. Rosenberg Senior Assistant Chief Accountant Securities and Exchange Commission 450 5th Street N.W. Washington, D.C. 20549-1103 Re: BioMarin Pharmaceutical Inc. Form 10-Q for the Quarterly Period Ended June 30, 2008 File No. 0-26727 Dear Mr. Rosenberg: We are writing in response to oral comments received from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), by teleconference on October 30, 2008 (the “Staff Comments”), with respect to BioMarin Pharmaceutical Inc.’s (the “Company”) Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 (the “Form 10-Q”). These comments are further comments based on the comments originally made by the Commission by letter dated October 7, 2008 (the “Comment Letter”) and the Company’s responses to those comments made by letter dated October 16, 2008. Set forth below are the Company’s responses to the Staff Comments. We have recited the Staff Comments as provided to us on the teleconference in italicized, bold type and have followed each comment with the Company’s response thereto. Page 2 of 10 Form 10-Q For the quarterly period ended June 30, 2008 1. We acknowledge your response to our previous comment No. 2. It is evident that you recorded your sales tax adjustment in the second quarter of 2008. Please confirm that you identified the error in the same quarter or tell us when you identified the error. In addition, you believe that it was immaterial to all periods presented. Please explain your consideration for not recording the corrected entry given the impact of the error would reverse over time due to depreciation and product sales and presumably would be immaterial to future periods. Response In response to Staff’s comment, we identified the error related to sales taxes associated with inventory and property, plant and equipment on May 7, 2008. The specific circumstance that led to the discovery was a meeting between certain members of our accounting department regarding the Company’s chart of accounts. After completing the analysis set forth in our response to your comment No. 2 in the Comment Letter, we concluded that the misstatement due to the erroneous expense recognition of sales tax related to inventory and fixed assets to be immaterial for all prior periods and for the projected financial results for the full year ending December 31, 2008, and that revision of the prior period financial statements was not required. As a result of this analysis and our conclusion regarding the materiality of the error, the Company considered not recording the adjustment. However, after further consideration of the fact that the financial statement misstatement would have carried on each quarter for several years resulting in proposed adjustments by our auditors, plus in the interest of full disclosure and presenting accurate financial statements going forward, the Company concluded that it was appropriate to correct the error. 2. We acknowledge your response to our previous comment No. 3. As previously requested, please revise your MD&A to discuss the impact of this adjustment on your results of operations for the three and six month periods ending June 30, 2008. Response In response to Staff’s comment, we propose to include the following disclosure in our MD&A for our quarterly report on Form 10-Q for the third quarter of 2008 to be filed with the SEC by no later than November 10, 2008. The Company believes that it is appropriate to include the revised disclosure for this item and the other proposed revised disclosures in the Form 10-Q for the third quarter as opposed to filling a 10-Q/A for the second quarter. For the reasons that were articulated in our response to comment No. 1, we chose to correct the sales tax error in the second quarter of 2008 even though our conclusion was that that amount was immaterial to prior periods, the three and six months ended June 30, 2008 and to the projected results for 2008. Therefore, we believe that filing a 10-Q/A filing would give undue importance to the adjustment and has the potential for causing overreaction. However, in the interest of providing additional disclosure on a prospective basis, the Company believes that it is appropriate to include the revised disclosures in the Form 10-Q for the third quarter of 2008. The third quarter 10-Q filing will be made in the next 7 days and, as it is the disclosure for the most recent quarter, investors will be reviewing the MD&A carefully, insuring that the additional disclosure is properly disseminated to investors. We have underlined text that has been specifically added in response to your comment. We believe that this disclosure provides investors with a full and complete understanding of the impact of this adjustment to our results of operation for the three and six month periods ending June 30, 2008 and for the nine month period ending September 30, 2008. Page 3 of 10 Results of Operations Net Income (Loss) Our net income for the three and nine months ended September 30, 2008 was $0.8 million and $6.3 million, respectively, as compared to a net loss of $5.2 million and $18.4 million for the three and nine months ended September 30, 2007, respectively. Net income for the three and nine months ended September 30, 2008 increased $6.0 million and $24.7 million primarily as a result of the following (in millions): Three Months Ended September 30, Nine Months Ended September 30, Net loss for the period ended 2007 $ (5.2 ) $ (18.4 ) Increased Naglazyme gross profit 10.2 30.1 Increased Kuvan gross profit 13.6 29.3 Increased Aldurazyme gross profit 14.8 39.8 Increased research and development expense (8.9 ) (13.3 ) Increased selling, general and administrative expenses (9.4 ) (25.3 ) Increased losses from BioMarin/Genzyme LLC (9.0 ) (22.9 ) Decreased collaborative agreement revenues (0.7 ) (3.4 ) Absence of Orapred milestone revenue — (4.0 ) Increased Orapred gross profit 0.4 1.1 Decreased interest income (4.5 ) (5.4 ) Sales tax error correction recorded in Q2 2008 — 0.8 Increased interest expense — (2.1 ) Other, net (0.5 ) — Net income for the period ended 2008 $ 0.8 $ 6.3 The increase in Naglazyme gross profit during the third quarter and first nine months of 2008 as compared to the same periods of 2007 is the result of additional patients initiating Naglazyme therapy, primarily outside of the U.S., as well as the favorable impact of foreign currency exchange rates on Naglazyme sales from customers based outside of the U.S. The increase in Kuvan gross profit during the third quarter and first nine months of 2008 as compared to the same periods in 2007 is due to the December 2007 marketing approval for Kuvan in the U.S. The increase in Aldurazyme gross profit during the third quarter and first nine months of 2008 as compared to the same periods of 2007 is the result of the restructuring of the joint venture with Genzyme and is partially offset by increased losses from BioMarin/Genzyme LLC, also due to the restructuring. The year-to-date decrease in collaborative agreement revenues primarily relates to lower reimbursable Kuvan development expenses. The increase in selling, general and administrative expense was primarily due to the continued international expansion of Naglazyme and commercialization of Kuvan in the U.S. The increase in research and development expense was primarily due to increases in development expenses for GALNS, a Duchenne Muscular Dystrophy licensed product, and other early stage programs. See below for additional information related to the primary net loss fluctuations presented above, including details of our operating expense fluctuations. The sales tax error correction recorded during the second quarter of 2008 relates to the out of period adjustment to correct inventory and property, plant and equipment balances for sales taxes associated with purchases made between April 2007 and March 2008 that were erroneously expensed at the time of purchase. The correction of the error, which was discovered in May 2008, Page 4 of 10 reduced operating expenses by $1.2 million during the second quarter of 2008, and also increased net income for the period by the same amount. The adjustment reduced operating expenses for the six months ended June 30, 2008 by $0.8 million and increased net income for the period by the same amount. The adjustment did not affect the consolidated statement of operations for the three months ended September 30, 2008, and increased net income during the nine months ended September 30, 2008 by $0.8 million. We believe that the adjustment is immaterial to the results of operations for the second quarter of 2008 when considering the $64.2 million of total revenues and $59.6 million of total operating expenses that contributed to the net income for the second quarter of 2008. For similar reasons, we believe that it is immaterial for the nine months ended September 30, 2008. Further, we determined that the impact of the adjustment was not material to prior periods or to the expected results for the year ending December 31, 2008, and as such the adjustment was recorded in the second quarter of 2008 under the provisions of Accounting Principles Board Opinion (APB) No. 28, Interim Financial Reporting. Note 4: Joint Venture 3. Please revise your disclosure in note 4 or in the MD&A to explain the business purpose for restructuring the Joint Venture with Genzyme consistent with your response to our previous comment No. 4A. In this regard, please ensure that you include the concept of sharing in 50% of Genzyme’s inefficiencies and receiving only 50% of the benefit of improving your own efficiencies. Response In response to Staff’s comment, we intend to include the following disclosure under Note 4 to the consolidated financial statements to be provided in our quarterly report on Form 10-Q for the third quarter of 2008. We propose to include the disclosure in the Form 10-Q for the third quarter for the reasons noted in response to comment No. 2. Further, the Company notes that this disclosure has substantially been made to the market through the Company’s press release related to the restructuring transaction issued in January 2008.We have underlined text that has been specifically added in response to your comment. (4) JOINT VENTURE Effective January 2008, the Company and Genzyme restructured BioMarin/Genzyme LLC. Under the revised structure, the operational responsibilities for BioMarin and Genzyme did not significantly change, as Genzyme continues to globally market and sell Aldurazyme and BioMarin continues to manufacture Aldurazyme. The restructuring had two significant business purposes. First, since each party now has full control over its own operational responsibilities, without the need to obtain the approval of the other party, and the parties do not need to review and oversee the activities of the other, it reduces management’s time and effort and therefore improves overall efficiencies. Second, since each party will realize 100% of the benefit of their own increased Page 5 of 10 operational efficiencies, it increases the incentives to identify and implement cost saving measures. Under the previous 50/50 structure, each company shared 50% of the expense associated with the other’s inefficiencies and only received 50% of the benefit of its own efficiencies. Specifically, the Company will be able to realize the full benefit of any manufacturing cost reductions and Genzyme will be able to realize the full benefit of any sales and marketing efficiencies. As of January 1, 2008, instead of sharing all costs and profits equally through the 50/50 joint venture, Genzyme records sales of Aldurazyme to third party customers and pays BioMarin a tiered payment ranging from approximately 39.5 to 50% of worldwide net product sales depending on sales volume, which is recorded by BioMarin as product revenue. The Company recognizes a portion of the royalty as product transfer revenue when product is shipped to Genzyme. The product transfer revenue represents the fixed amount per unit of Aldurazyme that Genzyme is required to pay if the product remains unsold by Genzyme. The amount of product transfer revenue is deducted from the calculated royalty amount when the product is sold by Genzyme. Certain research and development activities and intellectual property related to Aldurazyme continues to be managed in the joint venture with the costs shared equally by BioMarin and Genzyme. Pursuant to the terms of the joint venture restructuring, the Company received distributions of $16.7 million of cash and $26.8 million of inventory from the joint venture in the first quarter of 2008. 4. Also in your response to our previous comment No. 4A, you indicate your intention to provide in your MD&A an analysis of the impact of your Joint Venture restructuring on your liquidity. Please revise your MD&A to provide this analysis. In your response, please ensure you address cash inflows and outflows and impact of quarterly payments from Genzyme on your days sales outstanding receivables. Response In response to Staff’s comment, we intend to include the following disclosure under the “Liquidity and Capital Resources” section of our MD&A in our quarterly report on Form 10-Q for the third quarter of 2008. We propose to include the disclosure in the Form 10-Q for the third quarter for the reasons similar to those noted in response to comment No. 2. Further, the Company notes that this disclosure has substantially been made to the market through the Company’s press release related to its results of operations for the quarter ended March 31, 2008 and the investor conference call related thereto. We have underlined text that has been specifically added in response to your comment. Page 6 of 10 Liquidity and Capital Resources Cash and Cash Flow As of September 30, 2008, our combined cash, cash equivalents and short-term investments totaled $563.0 million, a decrease of $22.6 million compared to $585.6 million at December 31, 2007. During the nine months ended September 30, 2008, we financed our operations primarily through net product sales and available cash, cash equivalents and short-term investments and the related interest income earned thereon. The decrease in cash, cash equivalents, and short-term investments during the first nine months of 2008 was $22.6 million, which was $4.2 million more than the net decrease in cash, cash equivalents, and short-term investments during the first nine months of 2007 of $18.4 million, excluding net offering proceeds of $316.4 million. The primary items contributing to the decrease in net cash outflow in the first nine months of 2008 were as follows (in millions): Net decrease in cash and short-term investments for the first nine months of 2007 $ (18.4 ) Net decrease in operating spend 17.5 Increased capital asset purchases (32.0 ) Increased cash flows from BioMarin/Genzyme LLC 1.2 Investment in Summit Corporation plc (5.7 ) Cash received from settlement of foreign currency forward contracts 1.4 Increased proceeds from stock option exercises and ESPP 15.2 Other (1.8 ) Net decrease in cash and short-term investments for the first nine months of 2008 $ (22.6 ) The decreased net operating spend includes increases in cash receipts from net revenues offset by increases in cash payments made for operating activities, such as research and development and sales and marketing efforts, as discussed in “Results of Operations” above. Increased capital asset purchases include the purchase of our facility at Page 7 of 10 300 Bel Marin Keys Drive, Novato, California. Increased cash flows from BioMarin/Genzym
2008-10-16 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence October 16, 2008 Via EDGAR and Facsimile Mr. Jim B. Rosenberg Senior Assistant Chief Accountant Securities and Exchange Commission 450 5th Street N.W. Washington, D.C. 20549-1103 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 31, 2007 Form 10-Q for the Quarterly Period Ended June 30, 2008 File No. 0-26727 Dear Mr. Rosenberg: We are writing in response to comments received from the Staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), by letter dated October 7, 2008 (the “Comment Letter”), with respect to BioMarin Pharmaceutical Inc.’s (the “Company”) Annual Report on Form 10-K for the year ended December 31, 2007 (the “Form 10-K”) and Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 (the “Form 10-Q”). Set forth below are the Company’s responses to the Staff’s comments. We have recited the comments set forth in the Comment Letter in italicized, bold type and have followed each comment with the Company’s response thereto. Our responses have been numbered to correspond to the numbers assigned to each of the Staff’s comments in the Comment Letter. Form 10-K For the Fiscal Year Ended December 31, 2007 Exhibits 31: Certifications 1. Please represent to us that you will revise your certifications in all future filings to provide the wording exactly as require by Item 601(b)(31) of Regulation S-K. In this regard, please remove the officer’s title from your introductory sentence. Response In response to the Staff’s comment, the Company will revise its certifications in all future filings to provide the wording exactly as required by Item 601(b)(31) of Regulation S-K. Form 10-Q For the quarterly period ended June 30, 2008 Financial Statements Note 2(o) Reclassifications and Adjustments Page 1 2. You disclose the correction of an error recorded in the second quarter of 2008 related to sales taxes associated with inventory and property, plant and equipment purchased between April 2007 and March 2008. You indicate that you improperly expensed a total of $1.2 million of these sales taxes at the time of purchase and that the impact of the correcting adjustment to capitalize these taxes was not material to prior periods or to the expected results for the year ended December 31, 2008. Please provide us your analysis of the materiality of this adjustment by period. Please ensure that this analysis addresses both quantitative and qualitative factors, such as analyst consensus expectations as indentified in SAB Topic 1:M1. Response In response to the Staff’s comment, our analysis of the materiality of the sales tax expense correction to the historical periods and the projected full year ending December 31, 2008 included the following: Quantitative Factors (in thousands): Historical Period Overstatement of Operating Expenses* Percentage of Net Income (Loss)* Percentage of Total Revenues Percentage of Total Operating Expenses Percentage of Total Assets Q2 2007 $ 255 (6.6 %) 0.9 % 0.6 % 0.03 % Q3 2007 $ 258 (4.9 %) 1.0 % 0.6 % 0.06 % Q4 2007 $ 277 10.8 % 0.6 % 0.5 % 0.1 % 2007 $ 790 (5.0 %) 0.7 % 0.4 % 0.1 % Q1 2008 $ 385 22.8 % 0.6 % 0.6 % 0.14 % 2008 Projected $ 790 2.6 % 0.3 % 0.3 % N/A * The effect of the adjustment on basic and diluted earnings (loss) per share was less than $0.01 for all periods presented. Based on the disproportionate amounts of net income to the gross income statement components for certain periods above and the second quarter of 2008, the Company believes that net income alone is not the most appropriate basis under which to evaluate materiality, and total revenues and total operating expenses more accurately reflect the magnitude of the error correction in proportion to the income statement on the whole. Also, as the historical errors also affected the balance sheet amounts of inventory and fixed assets, the Company also analyzed the amount of the misstatements as compared to total assets. Qualitative Factors: SAB Topic 1: M1 Factors Company Assessment for All Periods Noted Above Whether the misstatement arises from an item capable of precise measurement or whether it arises from an estimate and, if so, the degree of imprecision inherent in the estimate. The amount does not require judgment or estimation. Whether the misstatement masks a change in earnings or other trends. No, the misstatement does not mask a change in earnings or other trends due to relatively small size of the adjustment as compared to the Company’s total revenue and expenses as well as net income. Page 2 Whether the misstatement hides a failure to meet analysts’ consensus expectations for the enterprise. No, the misstatements due to the sales tax correction did not hide a failure to meet analyst’s consensus expectations for the periods included above. For all periods discussed above where the Company’s actual results met or exceeded analyst consensus expectations, adjusting for the effect of the sales tax error in any of those periods would only serve to further exceed these consensus expectations. With respect to the full year ending December 31, 2008 projected results, the Company does not expect the sales tax error correction to hide a failure to meet analyst consensus expectations. Whether the misstatement changes a loss into income or vice versa. No. Whether the misstatement concerns a segment or other portion of the registrant’s business that has been identified as playing a significant role in the registrant’s operations or profitability. Not applicable due to the Company operating in a single segment and the nature of the error being of an administrative nature. Whether the misstatement affects the registrant’s compliance with regulatory requirements. No. Whether the misstatement affects the registrant’s compliance with loan covenants or other contractual requirements. No, the Company has no such loan covenants or contractual requirements. Whether the misstatement has the effect of increasing management’s compensation – for example, by satisfying requirements for the award of bonuses or other forms of incentive compensation. The misstatement had no effect on management compensation for 2007. In 2008, the Company’s corporate incentive compensation plan includes a variable component if operating income exceeds the corporate target, up to a certain limit. Due to this variable component of the incentive compensation plan and the fact that the adjustment affected operating income, the correction of the error in 2008 may increase management compensation, however the amount is de minimus. Whether the misstatement involves concealment of an unlawful transaction. No. Based on the analysis above, the Company concluded that the misstatement due to the erroneous expense recognition of sales tax related to inventory and fixed assets to be immaterial for all prior periods (using both the rollover and iron curtain approaches) and for the projected financial results for the full year ending December 31, 2008, and that revision of the prior period financial statements was not required. This conclusion was discussed with KPMG’s National Office who concurred. 3. Although your adjustment to correct the sales tax error may not be material to your expected results for 2008, the adjustment appears to be material to your operating results for the interim periods of 2008. Please revise your MD&A to discuss the impact of this adjustment on your results of operations for the three-and six-month periods ended June 30, 2008. In addition, please confirm to us that if the recorded adjustment proves to be material to actual full-year 2008 results of operations that you will revise your 2007 and 2008 financial statements to record the errors in the correct interim/annual periods. Page 3 In response to the Staff’s comment, in the Company’s quantitative materiality analysis of the sales tax error correction to the 2008 interim periods, the Company acknowledges that it was near break-even and therefore also considered the gross amounts of revenues and expenses during the period, as represented in the following table (in millions): Line Item Q1 2008 Q2 2008 Six Months Ended June 30, 2008 Total Revenues $ 60.4 $ 64.2 $ 124.6 Total Operating Expenses $ 59.6 $ 59.6 $ 119.2 Net Income $ 1.7 $ 3.8 $ 5.5 Understatement (Overstatement) of Net Income Due Sales Tax Error and Related Correction $ 0.4 $ (1.2 ) $ (0.8 ) Related Misstatement as a Percentage of: Total Revenues 0.6 % 1.8 % 0.6 % Total Operating Expenses 0.6 % 2.0 % 0.7 % Net Income 22.8 % 30.8 % 14.4 % As noted in the Company’s response to the Staff’s comment #2 above, the Company believes that net income alone is not the most appropriate basis under which to evaluate materiality, and total revenues and total operating expenses more accurately reflect the magnitude of the error correction in proportion to the income statement and the Company’s operations on the whole. The Company acknowledges that without the increase to net income during the second quarter of 2008 due to the $1.2 million sales tax error, the Company’s earnings would have been $0.5 million less than the analyst consensus expectations. However, management believes that the Company’s quarterly net income is not the primary area of focus for investors due to the net income volatility experienced from quarter to quarter based on the variable timing of the Company’s research and development activities. For the aforementioned reasons, the Company does not believe that the amount of the sales tax error correction was material to the second quarter of 2008. However, the Company acknowledged that the absolute amount of the $1.2 million correction as compared to the $3.8 million of net income for the second quarter of 2008 could be perceived to be material and accordingly the Company disclosed the correction in the footnotes to the financial statements under APB 28. The Company acknowledges the size of the correction as a percentage of net income for each quarter but notes that the percentage of the expected results for the year ending December 31, 2008 is only 2.6%. This conclusion was also discussed with KPMG’s National Office who concurred. With respect to the impact of the adjustment on the Company’s results of operations for the three and six months ended June 30, 2008, the Company did not include specific discussion of the sales tax adjustment in Management’s Discussion and Analysis (“MD&A”) in its Form 10-Q for the second quarter of 2008 due to the immateriality of the adjustment within the operational reporting format of the Company’s MD&A, whereby key fluctuations are presented by product, development program and significant business events. The Company presents noteworthy fluctuations in comparable period net income/loss in a table at the beginning of the “Results of Operations” in order to give a high-level analysis of the key fluctuations affecting net income. These changes are presented in the form of Page 4 revenue by product and primary income statement line item. Although the sales tax adjustment was presented as a $1.2 million overstatement of net income for the three and six months ended June 30, 2008 in the footnotes to the consolidated financial statements, for purposes of MD&A, the adjustment was presented within the increased amounts provided in the related income statement line item (i.e., research and development expense and selling, general and administrative expense). The effects of the sales tax adjustment on the MD&A net income/loss fluctuations that were presented in the Form 10-Q for the second quarter of 2008 are included in the following tables (in thousands): Net Income (Loss) As Reported Effect of Adjustment Adjusted Net loss for the three months ended June 30, 2007 $ (3.9 ) $ — $ (3.9 ) Increased Naglazyme gross profit 12.0 — 12.0 Increased Kuvan gross profit 10.6 — 10.6 Increased Aldurazyme gross profit 12.0 — 12.0 Decreased collaborative agreement revenues (1.0 ) — (1.0 ) Absence of Orapred milestone revenue (4.0 ) — (4.0 ) Increased Orapred gross profit 0.8 — 0.8 Increased research and development expense (4.6 ) — (4.6 ) Increased selling, general and administrative (7.9 ) (1.2 ) (9.1 ) Increased losses from BioMarin/Genzyme LLC (7.1 ) — (7.1 ) Decreased interest income (2.8 ) — (2.8 ) Increased interest expense (0.4 ) — (0.4 ) Sales tax error correction — 1.2 1.2 Other, net 0.1 — 0.1 Net income for three months ended June 30, 2008 $ 3.8 $ — $ 3.8 As Reported Effect of Adjustment Adjusted Net loss for the six months ended June 30, 2007 $ (13.2 ) $ — $ (13.2 ) Increased Naglazyme gross profit 19.9 — 19.9 Increased Kuvan gross profit 15.7 — 15.7 Increased Aldurazyme gross profit 25.1 — 25.1 Decreased collaborative agreement revenues (2.7 ) — (2.7 ) Absence of Orapred milestone revenue (4.0 ) — (4.0 ) Increased Orapred gross profit 0.7 — 0.7 Increased research and development expense (4.0 ) (0.3 ) (4.3 ) Increased selling, general and administrative (15.3 ) (0.5 ) (15.8 ) Increased losses from BioMarin/Genzyme LLC (13.8 ) — (13.8 ) Decreased interest income (0.9 ) — (0.9 ) Increased interest expense (2.1 ) — (2.1 ) Sales tax error correction — 0.8 0.8 Other, net 0.1 — 0.1 Net income for six months ended June 30, 2008 $ 5.5 $ — $ 5.5 Page 5 With respect to the specific discussion of the research and development and selling, general and administrative fluctuations within the “Results of Operations” section of MD&A, the Company believes that the most effective presentation format for such fluctuations is from a product and development program perspective. As such, portions of the sales tax correction are divided among the detailed line item fluctuations and accordingly the Company did not separately present the effect of the sales tax adjustment. When considering each product independently, the impact of the sales tax adjustment related to any one product is immaterial compared to the overall product expenses. Based on the above context of the presentation and perspective of the Company’s MD&A and the relative materiality of the sales tax adjustment to the consolidated financial statements and MD&A on the whole, the Company does not believe that the effects of the sales tax adjustments on these line items was material for purposes of special mention within MD&A, and respectfully requests that the Staff agree that revision of the MD&A for the relevant periods is not necessary. Lastly, the Company does confirm to the Staff that if the recorded adjustment proves to be material to the actual full-year 2008 results of operations that the Company will revise its 2007 and 2008 financial statements to record the errors in the correct interim/annual periods. Note 4: Joint Venture 4. You disclose that you restructured your Aldurazyme joint venture with Genzyme effective January 1, 2008. You indicate that the operational responsibilities for you and Genzyme did not significantly change as a result of the revised joint venture structure; you manufacture Aldurazyme while Genzyme markets and distributes it. In your January 3, 2008 press release announcing the joint venture restructuring you indicated that the payments under the revised structure are projected to result in both you and Genzyme receiving approximately the same profit as under the original joint venture structure. In this note you disclose that instead of sharing all costs and profits equally with Genzyme through the 50/50 joint venture, Genzyme records sales of Aldurazyme to third party customers and pays you a tiered royalty. In addition, you recognize product transfer revenue when product is ship
2008-10-07 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Via Facsimile and U.S. Mail Mail Stop 6010
October 7, 2008
Mr. Jean-Jacques Bienaimé Chief Executive Officer
BioMarin Pharmaceutical Inc.
105 Digital Drive
Novato, CA 94949
Re: BioMarin Pharmaceutical Inc.
Form 10-K for the Fiscal Year Ended December 31, 2007
Form 10-Q for the Quarterly Period Ended June 30, 2008
File No. 0-26727
Dear Mr. Bienaimé:
We have reviewed your filing and have the following comments. We have
limited our review to only your financial stat ements and related disclosures and do not
intend to expand our review to other portions of your documents. In our comments, we
ask you to provide us with information to better understand your disclosure. Where a
comment requests you to revise disclosure, the 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 comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter.
Form 10-K for the fiscal year ended December 31, 2007
Exhibits 31: Certifications
1. Please represent to us that you will revise your certifications in al l future filings to
provide the wording exactly as required by Item 601(b)(31) of Regulation S-K. In
this regard, please remove the officer’s title from your introductory sentence.
Mr. Jean-Jacques Bienaimé
BioMarin Pharmaceutical Inc.
October 7, 2008
Page 2
Form 10-Q for the quarterly period ended June 30, 2008
Financial Statements
Note 2(o): Reclassifi cations and Adjustments
2. You disclose the correction of an error recorded in the second quarter of 2008
related to sales taxes associated with inventory and property, plant and equipment
purchased between April 2007 and Ma rch 2008. You indicate that you
improperly expensed a total of $1.2 million of these sales taxes at the time of
purchase and that the impact of the corre cting adjustment to capitalize these taxes
was not material to prior periods or to the expected results for the year ended
December 31, 2008. Please provide us your an alysis of the materiality of this
adjustment by period. Please ensure that this analysis addres ses both quantitative
and qualitative factors, such as analyst consensus expectations as identified in
SAB Topic 1:M1.
3. Although your adjustment to correct the sa les tax error may not be material to
your expected results for 2008, the adjustme nt appears to be material to your
operating results for the interim periods of 2008. Please revise your MD&A to
discuss the impact of this adjustment on your results of operations for the three-
and six-month periods ended June 30, 2008. In addition, please confirm to us that
if the recorded adjustment proves to be material to act ual full-year 2008 results of
operations that you will re vise your 2007 and 2008 financial statements to record
the errors in the correct interim/annual periods.
Note 4: Joint Venture
4. You disclose that you restructured your Aldurazyme joint venture with Genzyme effective January 1, 2008. You indicate that the operational responsibilities for
you and Genzyme did not significantly change as a result of the revised joint
venture structure; you ma nufacture Aldurazyme while Genzyme markets and
distributes it. In your January 3, 2008 press release announcing the joint venture
restructuring you indicated that the pa yments under the revised structure are
projected to result in both you and Ge nzyme receiving approximately the same
profit as under the original jo int venture structure. In this note you disclose that
instead of sharing all costs and profits equally with Genzyme through the 50/50
joint venture, Genzyme records sales of Aldurazyme to third party customers and
pays you a tiered royalty. In addition, you recognize product transfer revenue
when product is shipped to Genzyme and ultimately deduct this amount from
royalties earned when product is sold by Genzyme. Pl ease address the following:
a. Please explain to us the business purpos e for restructuring your joint venture
with Genzyme when the operational respons ibilities of both pa rties appears to
have remained substantially unchanged and when you expect to receive approximately the same profit as under the original joint venture structure. In
Mr. Jean-Jacques Bienaimé
BioMarin Pharmaceutical Inc.
October 7, 2008
Page 3
addition, please explain to us whether and how the restructured arrangement
with Genzyme impacts your liquidity. In this regard, please clarify whether
the revised arrangement changes the timing and/or amount of cash flows
related to inventory pro duction and product sales.
b. Please explain to us your revenue recognition methodology for your
Aldurazyme revenues and reference the au thoritative litera ture you rely upon
to support your accounting. In your response please ensure you address the following issues:
i. Please explain the physical flow of Aldurazyme goods from your
manufacturing facility to the ultimat e consumer. Based on disclosure in
Note A to the joint venture’s financia l statements filed as Exhibit 99.1 to
your December 31, 2007 Form 10-K, you manufactured Aldurazyme, but
either Genzyme or third-parties comple ted final packaging of the product.
Please explain whether Genzyme still performs final pa ckaging and how
this impacts the transfer of title to the product. Please clarify whether
Genzyme takes physical possession of Aldurazyme at any point in the
process.
ii. Although you now indicate that you recognize product transfer revenues
when product is shipped to Genzyme, please explain to us whether and
how you recognized revenue related to product shipments prior to the
January 2008 restructuring.
iii. Although you indicate that you recogni ze product transfer revenues when
product is shipped to Genzyme, it app ears from your MD&A disclosure on
page 25 that you had no product transfer revenue in the second quarter of
2008 and $7.7 million for the first six m onths of 2008. Please explain why
you had only $7.7 million in product tran sfer revenue for the first six
months of 2008 when you had $9.5 million in the first quarter as reported
on page 21 of your March 31, 2008 Form 10-Q.
iv. In your revenue recognition policy note on page 8 you indicate that the
$7.7 million in product transfer revenue for the first six months of 2008 is
unbilled. Please explain to us whether and when you bill this revenue. If
you do not bill this revenue as you will ultimately r eceive royalty
payments from Genzyme, please expl ain how this amount was determined
and why it is appropriate to recognize this revenue prior to ultimate sale
by Genzyme. Please explain whether Genzyme is obligated to pay you for
product shipments if it ultimately is unable to sell the product.
v. Please explain whether, and if so, to what extent Genzyme and/or its
customers may return product to you.
vi. Please explain when Genzyme is oblig ated to pay the Aldurazyme royalty
to you and the payment terms.
c. You indicate that in 2008 you classify your Aldurazyme revenues with your
net product revenues of Naglazyme and K uvan, products you appear to market
using your own sales force and commercial organization. Please explain to us
why you do not classify your Aldurazyme royalty revenues with your royalty
and license revenues of your Orapred products or why you do not classify
Mr. Jean-Jacques Bienaimé
BioMarin Pharmaceutical Inc.
October 7, 2008
Page 4
your Aldurazyme product transfer revenues with product revenues and your
Aldurazyme royalty revenues with your other royalty revenues.
Please respond to these comments within 10 business days or tell us when you
will provide us with a response. Please s ubmit a letter that keys your responses to our
comments and provides the requested information. Detailed letters greatly facilitate our
review. Please furnish your letter to us via EDGAR under the form type label
CORRESP.
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filing to be certain that the filing includes all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United
States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
If you have any questions, please co ntact Mark Brunhofer , Senior Staff
Accountant, at (202) 551-3638. In this regard, do not hesita te to contact me, at (202)
551-3679.
Sincerely,
Jim B. Rosenberg Senior Assistant Chief
Accountant
2008-01-31 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Via Facsimile and U.S. Mail Mail Stop 6010 January 31, 2008 Mr. Jeffrey H. Cooper Chief Financial Officer BioMarin Pharmaceutical, Inc. 105 Digital Drive Novato, CA 94949
Re: BioMarin Pharmaceutical, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2006 Form 10-Q for the quarterly p eriod ended September 30, 2007
File No. 000-26727
Dear Mr. Cooper:
We have completed our review of your Form 10-K and related filings and have no further
comments at this time.
S i n c e r e l y ,
J i m A t k i n s o n Accounting Branch Chief
2008-01-18 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence Letter January 18, 2008 Via EDGAR and Facsimile Mr. Jim B. Rosenberg Senior Assistant Chief Accountant Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549-6010 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 30, 2006 Form 10-Q for the Quarterly Period Ended September 30, 2007 File No. 000-26727 Dear Mr. Rosenberg: Further to our letter dated January 10, 2008, in response to comments received from the Staff of the Securities and Exchange Commission (the “Staff”), by letter dated December 20, 2007, with respect to BioMarin Pharmaceutical Inc.’s (the “Company”) Form 10-K for the fiscal year ended December 30, 2006 and Form 10-Q for the quarterly period ended September 30, 2007, the Company hereby acknowledges the following: • the Company is responsible for the adequacy and accuracy of the disclosures in the Company’s filings required under the Securities Exchange Act of 1934; • Staff comments or changes to disclosure in response to Staff comments do not foreclose the Securities and Exchange Commission (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 federal securities laws of the United States. We appreciate the Staff’s courtesy and cooperation in this process. If you have any questions, please contact me by telephone at (415) 506-6388. Very Truly Yours, /s/ Jeffrey H. Cooper Jeffrey H. Cooper Senior Vice President, Chief Financial Officer
2008-01-10 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence Letter January 10, 2008 Via EDGAR and Facsimile Mr. Jim B. Rosenberg Senior Assistant Chief Accountant Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549-6010 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 30, 2006 Form 10-Q for the Quarterly Period Ended September 30, 2007 File No. 000-26727 Dear Mr. Rosenberg: We are writing in response to comments received from the Staff of the Securities and Exchange Commission (the “Staff”), by letter dated December 20, 2007 (the “Comment Letter”), with respect to BioMarin Pharmaceutical Inc.’s (the “Company”) Form 10-K for the fiscal year ended December 30, 2006 (the “2006 Form 10-K”) and Form 10-Q for the quarterly period ended September 30, 2007. Set forth below are the Company’s responses to the Staff’s comments. Our responses have been numbered to correspond to the numbers assigned to each of the Staff’s comments in the Comment Letter. Item 9A. Controls and Procedures, page 50 Evaluation of Disclosure Controls and Procedures, page 50 1. You state that your CEO and CFO have concluded that your disclosure controls are “sufficiently effective.” The use of terminology other than effective raises the question if you are attempting to state that disclosure controls and procedures met some standard lower than effective. Please revise your disclosure. Refer to Item 307 of Regulation S-K. Response In response to the Staff’s comment, the language was not intended to mean that the controls met a lower standard. The Company’s conclusion was that the controls and procedures met the effectiveness standards of Item 307 of Regulation S-K. The use of sufficient was intended to mean “enough to meet the needs of the situation.” The Company will remove the “sufficiently” adverb in future filings that require the Item 307 disclosure and because of the inadvertent use of the word “sufficiently” does not believe amending its prior filings is required. Financial Statements – December 31, 2006 (2) Summary of Significant Accounting Policies, page F-9 (s) Reclassifications, page F-17 2. Please explain to us why you classified cash outflows for property, plant and equipment within cash flows from operations instead of investing activities. Response In response to the Staff’s comment, in the Form 10-K for the year ended December 31, 2006, all of our cash outflows for property, plant and equipment are included within the cash flows from investing activities (in the line item “Purchase of property, plant and equipment”) and not within cash flows from operations for the three years presented. The Company notes that Footnote 2(s) discusses a reclassification of immaterial amounts for property, plant and equipment that were inappropriately included within the accounts payable and accrued liabilities line item of previously filed statements of cash flows for 2004 and 2005. Our consolidated statements of cash flows prior to December 31, 2006 presented our purchases of property, plant and equipment for statement of cash flow purposes on an accrual basis, i.e., the balances for accounts payable and accrued liabilities used to calculate the changes for purposes of operating cash flows included unpaid amounts related to purchases of property, plant and equipment. In December 2006 we determined that the inclusion of such amounts in the accounts payable and accrued liabilities line item of the statement of cash flows was not appropriate and recorded the prior year reclassifications discussed in the footnote. Depending on the relative size of unpaid amounts related to property, plant and equipment purchases that were included in the opening and closing balance sheets for any given period, the reclassification may increase or decrease cash flows from operations. As such, the footnote discloses that cash outflows from operations were decreased as a result of the reclassification for the year ended December 31, 2004 and were increased as a result of the reclassification for the year ended December 31, 2005. It does not mean that the actual cash flows for purchases of property, plant and equipment are being included in cash flows used in operations. We believe that the reclassifications of the unpaid acquisitions of property, plant and equipment are immaterial qualitatively and quantitatively to the consolidated statements of cash flows and consolidated financial statements for the years ended December 31, 2004 and 2005, and therefore we did not restate the financial statements for those periods. However, we disclosed the nature and amounts of the reclassifications in the footnotes to the consolidated financial statements for the year ended December 31, 2006 to assist readers of our financial statements with reconciling the previous and revised presentation. Beginning with the consolidated statement of cash flows for the year ended December 31, 2006 and for the interim financial statements for 2007, we have and will continue in the future to classify the actual cash payments for purchases of property, plant and equipment as cash flows from investing activities. Form 10-Q – September 30, 2007 (2) Summary of Significant Accounting Policies, page 6 (c) Revenue Recognition, page 7 Royalty and license revenues, page 9 3. Please explain to us why you believe that the milestone payment received related to the “one-year anniversary” of FDA approval recorded in the current period represented a substantive milestone, as its receipt is based solely on the passage of time from FDA approval. Response In response to the Staff’s comment, we recognized the revenue associated with the milestone payment received during the second quarter of 2007 related to the one-year anniversary of FDA approval because prior to that period we determined that all of the Staff Accounting Bulletin No. 104: Revenue Recognition (“SAB 104”) criteria were not met as they related to this payment, specifically the requirement that the seller’s price to the buyer be fixed or determinable within the meaning of SAB 104. For background on the overall transaction, in March 2006 we sublicensed the North American rights to the Orapred product line to Alliant Pharmaceuticals, Inc. (“Alliant”), which was subsequently acquired by Sciele Pharma, Inc. in June 2007 (“Sciele”). The sublicense agreement provided for a total of $18.0 million in upfront and milestone payments, including the final $4.0 million payment due one year after the FDA approval of Orapred ODT that we received and recorded as revenue in the second quarter of 2007. The first $14.0 million of payments provided for under the arrangement were payable within five days after the achievement of the applicable milestone event, and the final $4.0 million payment was the only payment required under the license that had payment terms one year after a milestone event. In analyzing whether the final $4.0 million payment under our license arrangement was fixed or determinable, the Company considered Footnote 5 of SAB 104, which refers to the consideration of paragraphs 26 – 33 of SOP 97-2: Software Revenue Recognition (“SOP 97-2”). Footnote 5 of SAB 104 notes that paragraphs 27 – 29 of SOP 97-2 specifically consider software transactions and other sales transactions in which the risk of technological obsolescence is high. Since the licensed Orapred ODT product was not subject to significant technological obsolescence through the payment date of the $4.0 million, the Company’s analysis focused on paragraphs 26 and 30-33 of SOP 97-2. Paragraph 30 of SOP 97-2 describes factors for considering whether the fixed or determinable and collectibility criteria for revenue recognition are met, including the following that were relevant in our analysis: a) Consideration of the seller’s business practices and other factors indicating that a payment is contingent on the customer’s success; b) The age, capitalization and financial situation of the customer in considering their ability to honor commitments to make fixed or determinable payments until they collect cash from their customers; and c) Uncertainties about the amount of future sales of the licensed product Normally, we recognize milestone revenue when the milestone event is achieved and the company has no further performance obligations related to that payment. However, with respect to the final $4.0 million payment from Alliant, we noted that the factors described in SOP 97-2 were relevant given our lack of experience with Alliant and their relative size as a company, together with the extended payment term of the $4.0 million of greater than one year from the agreement date. As such, after applying the guidance in SOP 97-2 to the Company’s situation and the following facts and circumstances, the Company concluded that the $4.0 million should have been recognized as it became due. The primary reason for the one year payment term was that Alliant’s ability to make the $4.0 million payment was contingent on Alliant’s ability to generate sufficient revenue to make the payment. Based on Alliant’s liquidity as of the execution of the license, although it had the ability to make the first $14.0 million of payments, it did not have the ability, without additional revenue, to make the final $4.0 million payment. In fact, although the entire $4.0 million was received in June 2007, Alliant was delinquent in making the full $4.0 million payment by the due date. Further, Orapred ODT was a new product, for which future sales were uncertain; and if sales of the licensed product were less than expected over the twelve-month period, there was not adequate evidence to overcome the presumption the amount would have been renegotiated and reduced. Alliant, and subsequently Sciele, had the ability to terminate the license agreement at its option upon notice to the Company. If the sales of Orapred ODT were significantly below expectations, Alliant or Sciele could have threatened to exercise this right in order to renegotiate the milestone. The Company did not believe that recognizing the payment during the twelve-month period following approval was appropriate as the fee was not considered to be fixed or determinable until the due and payable date based on the analysis above. We expect that the financial statements included with our Form 10-K for the year ended December 31, 2007 will provide additional footnote disclosures regarding our revenue recognition for this milestone consistent with generally accepted accounting principles requirements for audited financial statements. We appreciate the Staff’s courtesy and cooperation in this process. If you have any questions, please contact me by telephone at (415) 506-6388. Very Truly Yours, /s/ Jeffrey H. Cooper Jeffrey H. Cooper Senior Vice President, Chief Financial Officer
2008-01-03 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm Correspondence Letter January 3, 2008 Via EDGAR and Facsimile Mr. Jim B. Rosenberg Senior Assistant Chief Accountant Securities and Exchange Commission 100 F Street, NE Washington, D.C. 20549-6010 Re: BioMarin Pharmaceutical Inc. Form 10-K for the Fiscal Year Ended December 30, 2006 Form 10-Q for the Quarterly Period Ended September 30, 2007 File No. 000-26727 Dear Mr. Rosenberg: We are writing to request a ten (10) business day extension to respond to comments received from the Staff of the Securities and Exchange Commission (the “Staff”), by letter dated December 20, 2007 (the “Comment Letter”), with respect to BioMarin Pharmaceutical Inc.’s (the “Company”) Form 10-K for the fiscal year ended December 30, 2006 and Form 10-Q for the quarterly period ended September 30, 2007. Due to the Company shutdown during the Christmas and New Year’s holidays, the Company respectfully requests an extension through January 16, 2008 to respond to the Comment Letter. We appreciate the Staff’s courtesy and cooperation in this process. If you have any questions, please contact me by telephone at (415) 506-6307. Very Truly Yours, /s/ G. Eric Davis G. Eric Davis Vice President, General Counsel and Secretary
2007-12-20 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
Via Facsimile and U.S. Mail Mail Stop 6010 December 20, 2007 Mr. Jeffrey H. Cooper Chief Financial Officer BioMarin Pharmaceutical, Inc. 105 Digital Drive Novato, CA 94949 Re: BioMarin Pharmaceutical, Inc. Form 10-K for the Fiscal Year Ended December 31, 2006 Form 10-Q for the quarterly p eriod ended September 30, 2007 File No. 000-26727 Dear Mr. Cooper: We have reviewed your filing and have the following comments. We have limited our review to your financial statements a nd related disclosures and do not intend to expand our review to other portions of your document. In our comments, we ask you to provide us with information to better unde rstand your disclosure. Where a comment requests you to revise disclosure, the info rmation you provide should show us what the revised disclosure will look like and identify the annual or quarterly filing, as applicable, in which you intend to first include it. If you do not believe that revised disclosure is necessary, explain the reason in your response. After reviewing the information provided, we may raise additional comments and/or request that you amend your filing. Please understand that the purpose of our re view process is to assist you in your compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or any other aspect of our review. Feel free to call us at the telephone numbers listed at the end of this letter. Item 9A. Controls and Procedures, page 50 Evaluation of Disclosure Cont rols and Procedures, page 50 1. You state that your CEO and CFO have c oncluded that your di sclosure controls are “sufficiently effective.” The use of terminology other than effective raises the question if you are attempting to state that disclosure controls and procedures met Mr. Jeffrey H. Cooper BioMarin Pharmaceutical, Inc. December 20, 2007 Page 2 some standard lower than effective. Please revise your disclosure. Refer to Item 307 of Regulation S-K. Financial Statements – December 31, 2006 (2) Summary of Significant Accounting Policies, page F-9 (s) Reclassifications, page F-17 2. Please explain to us why you classified cash outflows for property, plant and equipment within cash flows from operati ons instead of inve sting activities. Form 10-Q – September 30, 2007 (2) Summary of Significant Accounting Policies, page 6 (c) Revenue Recognition, page 7 Royalty and license revenues, page 9 3. Please explain to us why you believe that the milestone payment received related to the “one-year anniversary” of FDA a pproval recorded in the current period represented a substantive mile stone, as its receipt is base d solely on the passage of time from FDA approval. *************************** Please respond to these comments within 10 business days or tell us when you will provide us with a response. Please furnish a letter that keys your response to our comments and provide the requested information. Detailed letters gr eatly facilitate our review. Please furnish the letter to us via EDGAR under the form type label CORRESP. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes all in formation required under the Securities Exchange Act of 1934 and th at they have provided all information investors require for an informed invest ment decision. Since the company and its management are in possession of all facts re lating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In connection with responding to our co mments, please provide, in your letter, a statement from the company acknowledging that: the company is responsible for the adequacy and accuracy of the disclosure in the filing; staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and the company may not assert staff comments as a defense in any proceeding initiated Mr. Jeffrey H. Cooper BioMarin Pharmaceutical, Inc. December 20, 2007 Page 3 by the Commission or any person under the federal securities laws of the United States. In addition, please be advise d that the Division of Enfo rcement has access to all information you provide to the staff of the Divi sion of Corporation Fi nance in our review of your filing or in response to our comments on your filing. You may contact Sasha Pa rikh, Staff Accountant, at (202) 551-3627 or Jim Atkinson, Accounting Branch Chief, at (202) 551-3674 if you have questions regarding the comments. In this regard, do not he sitate to contact me at (202) 551-3679. Sincerely, Jim B. Rosenberg Senior Assistant Chief Accountant
2005-07-14 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
<DOCUMENT> <TYPE>LETTER <SEQUENCE>1 <FILENAME>filename1.txt <TEXT> Postal Code 20549-0303 May 13, 2005 By Facsimile 646.848.4887 and U.S. Mail Stephen Besen, Esq. Shearman & Sterling LLP 599 Lexington Avenue New York, NY 10022-6069, RE: BioMarin Pharmaceutical, Inc. Preliminary Proxy Statement on Schedule 14A Filed: May 4, 2005 by Caduceus Capital Master Fund Limited et al. SEC File No.: 0-26727 Dear Mr. Besen: We have the following comments on your filing. General 1. Please characterize each statement or assertion of opinion or belief as such, and ensure that a reasonable basis for each such opinion or belief exists. Support for each statement or assertion of opinion or belief must be self-evident, disclosed in the proxy materials, or provided to the staff on a supplemental basis. We cite the following non-exhaustive examples of statements or assertions that, at a minimum, must be supported on a supplemental basis or, at a maximum, require both supplemental support and recharacterization as statements of belief or opinion: * The Glyko acquisition "offered no economic benefit to BioMarin;" * BioMarin`s "excessive burn rate" and "proposed financing which could dilute the value of the stock held by the existing stockholders;" * "the election of [Caduceus] Nominees would not constitute a change of control under the Company`s 3.5% convertible subordinated notes;" * Mr. Klein "received excerpts from BioMarin`s proxy statement and provided comments on such excerpts to BioMarin;" and * The assertion that the only means by which security holders will have the ability to influence BioMarin`s future will be if they vote for the Caduceus Nominees, as indicated by the statement "IN ORDER FOR YOUR VIEWS TO BE REPRESENTED AT THE ANNUAL MEETING..." Ownership of Participants 2. Explain to us, with a view toward revised disclosure, how the filing parties complied with Item 5(b) to Schedule 14A. For example, advise us why the information required by Item 5(b)(1) (vi)-(ix) does not appear to have been provided with respect to Fund Entities. In addition, advise us of the basis for the apparent belief that there has been compliance with Item 5(b)(vi) of Schedule 14A. Please revise to include any omitted information, including with respect to Item 5(b)(vii) as applicable. Election of Directors 3. Revise to affirmatively state that no assurance can be given that the Board nominees will serve with any of the Caduceus nominees. See Rule 14a-4(d)(iv) of Regulation 14A. Disclose how any vacancies on the Board would be filled in the event the Caduceus nominees are elected and whether or not security holders will be afforded the opportunity to vote to fill any such vacancies. 4. Advise us, with a view toward revised disclosure, whether or not any indemnification or other arrangements or understandings exist between the Caduceus nominees and the Caduceus Group. See Item 401(a) of Regulation S-K. 5. Disclose, if true, that each of the Caduceus nominees has consented to being named in the proxy statement. See Rule 14a-4(d)(4) of Regulation 14A. Revocation of Proxies 6. Revise to remove the implication that the only manner in which a proxy statement may be revoked will be by executing the blue proxy card. For example, balance the disclosure by indicating the executed proxies may also be revoked by delivering a later dated, duly executed proxy irrespective of color, by appearing at the meeting and voting in person, or otherwise delivering written notice of revocation. See Item 2 of Schedule 14A. Cost and Method of Solicitation 7. Advise us, with a view toward revised disclosure, why the filing persons believe that they have complied with Item 4(b)(4) and Item 4(b)(5) of Schedule 14A. Form of Proxy 8. Although the proxy statement cover sheet may have a check in the box next to "Preliminary Proxy Statement," the checked box is not sufficient to comply with Rule 14a-6(e)(1) of Regulation 14A. Revise the form of proxy and proxy statement to clearly identify it as being preliminary. Please clearly label both the form of proxy and the proxy statement as being preliminary. 9. We note your efforts to fully comply with Rule 14a-4(d). This rule, however, provides that a person shall not be deemed to be a bona fide nominee and shall not be named in the proxy statement unless he has consented to being so named. Because the company nominees have not provided you with their consent, the proxy statement must be amended to delete the names of the company`s nominees for whom the proxy holder will vote and list only the names of the company`s nominees for whom the proxy holder will not vote. Closing Comment Please amend the Schedule 14A promptly to comply with our comments. Include a cover letter with your response to each comment, and note the location of any change in the revised material. If you do not agree with a comment, please tell us why in your response. File your response via EDGAR, tagged as "CORRESP." We may have additional comments based on our review of the revised material and your response to our comments. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing reviewed by the staff to be certain that they have provided all information investors require for an informed decision. Since the filing persons are in possession of all facts relating to the 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 each of the filing persons acknowledging that: * the filing persons are 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 filing persons 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. Please direct any questions to me at (202) 551-3266. Sincerely, Nicholas P. Panos Special Counsel Office of Mergers and Acquisitions </TEXT> </DOCUMENT>
2005-07-11 - UPLOAD - BIOMARIN PHARMACEUTICAL INC
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
May 12, 2005
Via U.S. mail and facsimile 888.329.2995
Greg Smith, Esq.
Skadden, Arps, Slate, Meagher & Flom
525 University Avenue, Suite 1100
Palo Alto, CA 94301
Re: BioMarin Pharmaceutical, Inc.
Preliminary Proxy Statement on Schedule 14A
Filed May 2, 2005
File No. 0-26727
Dear Mr. Smith,
We have reviewed your filing and have the following
comments. Where indicated, we think you should revise your document
in response to these comments. If you disagree, we will consider
your explanation as to why a comment is inapplicable or a revision
is unnecessary. Please be as detailed as necessary in your
explanation. In some of our comments, we may 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 any other aspect
of our review. Feel free to call us at the telephone number listed
at the end of this letter.
Schedule 14A
General
1. As discussed by telephone, Edgar does not, at present, reflect
the receipt of a filing made in connection with a solicitation in
opposition. Please contact Ms. Teresa Brach in the Office of
Edgar and Information Analysis by facsimile at 202.772.9216 to
Request guidance on changing the errant PRE_14A header tag to the
appropriate PREC14A header tag. If BioMarin is successful in its
request to correct the Edgar header tag filing oversight, the next
Edgar header tag used by BioMarin on a proxy statement should be
PRER14A.
2. We note BioMarin expects to pay approximately $150,000 to
Morrow & Co. Notwithstanding this disclosure, please direct the
staff to the disclosure BioMarin has provided in its Schedule 14A to
comply with Item 4(b) of Schedule 14A, or provide comprehensive
revisions in the next amendment.
Quorum; Abstentions; Broker Non-Votes
3. Now that a solicitation in opposition has been filed on EDGAR,
advise us, with a view toward disclosure, what consideration
BioMarin has given to disclosing whether or not brokers will have
discretion to vote securities for which they have not received
instructions. In addition, to the extent brokers do retain discretion
to vote the securities they hold on behalf of beneficial holders,
advise us, with a view toward revised disclosure, what consideration
has been given to disclosing the date by when brokers must receive
instructions in order to have the votes reflect security holder
selections.
4. Please confirm that BioMarin does not reserve the right, and
otherwise does not intend, to adjourn the meeting for the purpose
of soliciting additional proxies.
Solicitation of Proxies
5. We note that proxies may be solicited by telephone, facsimile
and by email. We remind you to file, on the date of first use, all
written soliciting materials under the cover of Schedule 14A.
Refer to Rules 14a-6(b) and 14a-12. Please confirm your understanding
on a supplemental basis. Also confirm, if true, that proxies will not
be solicited via the internet, such as internet chat rooms or
postings on web sites.
6. Advise us whether not proxies may be voted by telephone. If
proxies may be voted by telephone, provide us with a legal
analysis as to whether Nasdaq rules permit the voting of proxies by
phone and, if applicable, the internet, in contested matters in which
a counter solicitation is being undertaken.
Possible Dissident Shareholder Solicitation
7. In view of the fact a solicitation in opposition has been
filed, it appears that the title to this section should be amended.
In addition, disclose the basis for the assertion that, "A change of
control will occur if at any time at least a majority of the
Company`s directors are not a majority of the existing Board or
nominated by a majority of the existing Board." For example,
revise to indicate whether or not "change of control" is expressly
defined in the indenture, and, if not, whether the representation
above is BioMarin`s interpretation based upon an opinion of counsel.
Annex A
8. Instruction 3(a)(ii) to Item 4 of Schedule 14A plainly states
that directors of the registrant are participants. Delete the "may
be deemed" language found in the opening paragraphs to this section.
Closing Comments
Please file a revised proxy statement in response to these
comments. In addition, provide a letter keying your responses to
the comments, and provide any requested supplemental information.
If you believe complying with these comments is not appropriate, tell
us why in your letter. The response letter should be uploaded to EDGAR,
with the form type label "CORRESP" and linked to the Exchange Act
file number. We may have comments after reviewing revised
materials and your responses.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filing reviewed by the staff to
be certain that they have provided all information investors require
for an informed 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.
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 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. Please direct any
questions to me at 202.551.3266. You may also contact us by facsimile
at 202.772.9203. Direct all correspondence to the following ZIP
code: 20549-0303.
Sincerely,
Nicholas P. Panos
Special Counsel
Office of Mergers and Acquisitions
</TEXT>
</DOCUMENT>
2005-05-19 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm SEC Correspondence DIRECT DIAL 650-470-4590 DIRECT FAX 650-470-4570 EMAIL ADDRESS grsmith@skadden.com May 18, 2005 Nicholas P. Panos, Esq. Special Counsel Office of Mergers & Acquisitions U.S. Securities and Exchange Commission Division of Corporation Finance 450 Fifth Street, N.W. Mail Stop 4-6 Washington, D.C. 20549 Re: BioMarin Pharmaceutical Inc. – Revised Preliminary Proxy Statement on Schedule 14A Filed May 19, 2005 (File No. 0-26727) Dear Mr. Panos: We are writing on behalf of our client, BioMarin Pharmaceutical Inc., a Delaware corporation (the “Company” or “BioMarin”), in response to the letter of comments from the Staff of the Securities and Exchange Commission to the Company dated May 18, 2005 (the “Comment Letter”) with respect to the Company’s Revised Preliminary Proxy Statement on Schedule 14A filed May 16, 2005 (the “Proxy Statement”). The Company is filing concurrently herewith via EDGAR a revised Preliminary Proxy Statement on Schedule 14A (the “Revised Proxy Statement”), marked to indicate changes from the Proxy Statement as last filed. The changes reflected in the Revised Proxy Statement include those made in response to the comments of the Staff set forth in the Comment Letter. A courtesy copy of the Revised Proxy Statement marked to indicate changes from the Proxy Statement as last filed is enclosed. Set forth below are the Company’s responses to the comments raised in the Comment Letter. For the convenience of the Staff, we have numbered each of the responses to correspond to the numbered paragraphs in the Comment Letter. Additionally, the text of each of the numbered comments in the Comment Letter has been duplicated in bold type to precede each of the Company’s responses. Capitalized terms used and not defined herein have the meanings ascribed to each such term in the Proxy Statement. Nicholas P. Panos, Esq. U.S. Securities and Exchange Commission May 19, 2005 Page 2 Schedule 14A Dissident Shareholder Solicitation 1. Provide us with the basis for the assertion that Mr. Klein elected not to comment upon the relevant portions of the Company’s proxy statement or delete the reference. For example, describe the nature and extent to which Mr. Klein had discussions or communications following his receipt of the portions of the proxy statement with any Company representative on this matter. Response The Company has no record of receiving any response, written or verbal, from Mr. Klein with respect to the proxy statement. In response to the Staff’s concern, the Company has nonetheless deleted the referenced disclosure. 2. Please reconcile the April 15 and April 18 dates cited in this section. For example, April 15 is designated as the date upon which notice was received but April 18 is the date upon which the Company is deemed to have been so notified. Response The correction has been made. 3. Provide us with the basis for the assertion that the Committee was influenced by an “apparent lack of candor” exhibited by Mr. Klein, or delete the reference. For example, confirm, if true, that the Committee was unaware that Mr. Klein was nominated by the Caduceus Entities and/or was otherwise of the belief that his interests were not aligned with those of the Caduceus Entities. Response The basis for the Company’s belief was set forth in the Preliminary Proxy. In response to the Staff’s concern, the Company has nonetheless deleted the referenced disclosure. Nicholas P. Panos, Esq. U.S. Securities and Exchange Commission May 19, 2005 Page 3 If you have any questions with respect to the foregoing, please contact the undersigned at (650) 470-4590. Very truly yours, /s/ Gregory C. Smith Gregory C. Smith cc: G. Eric Davis Vice President, Corporate Counsel and Assistant Secretary BioMarin Pharmaceutical Inc.
2005-05-16 - CORRESP - BIOMARIN PHARMACEUTICAL INC
CORRESP 1 filename1.htm SEC Letter [BioMarin Letterhead] May 16, 2005 Mr. Nicholas P. Panos Division of Mergers and Acquisitions U.S. Securities and Exchange Commission Division of Corporation Finance Mail Stop 4-6 Washington, D.C. 20549 Re: BioMarin Pharmaceutical Inc. - Preliminary Proxy Statement on Schedule 14A Filed May 2, 2005 (File No. 0-26727) Dear Mr. Panos: BioMarin Pharmaceutical Inc., a Delaware corporation (the “Company”), is writing to the Staff of the Securities and Exchange Commission (the “Staff”) in response to the Closing Statements contained in the letter of comments from the Staff dated May 12, 2005 (the “Comment Letter”) with respect to the Company’s Preliminary Proxy Statement on Schedule 14A (the “filing” or the “Proxy Statement”). Capitalized terms used and not defined herein have the meanings ascribed to each such term in the Proxy Statement. Set forth below is the statement of the Company requested by the Staff in the Closing Statements of the Proxy Statement: • the Company acknowledges that it is responsible for the adequacy and accuracy of the disclosure in the filing; • the Company acknowledges that 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 acknowledges that it may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. If you have any questions with respect to the foregoing, please contact the undersigned at (415) 506-6307 or Gregory C. Smith of Skadden, Arps, Slate, Meagher & Flom LLP at (650) 470-4590. Nicholas P. Panos, Esq. U.S. Securities and Exchange Commission May 16, 2005 Page 2 Very truly yours, /s/ G. Eric Davis Name: G. Eric Davis Title: Vice President, Corporate Counsel and Assistant Secretary cc: Gregory C. Smith (Skadden, Arps, Slate, Meagher & Flom LLP) 2