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SEC Comment Letter for BIOMARIN PHARMACEUTICAL INC (BMRN) (CIK 0001048477) (BMRN) — Oct 7, 2008

BIOMARIN PHARMACEUTICAL INC (BMRN) (CIK 0001048477)
Date: Oct. 7, 2008 · CIK: 0001048477 · Accession: 0000000000-08-050463

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
October 7, 2008
Author
Jim B. Rosenberg
Form
UPLOAD
Company
BIOMARIN PHARMACEUTICAL INC (BMRN) (CIK 0001048477)

Letter

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

Show Raw Text
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