SEC Company Response from BIOMARIN PHARMACEUTICAL INC (BMRN) (CIK 0001048477) (BMRN) — Aug 13, 2010
BIOMARIN PHARMACEUTICAL INC (BMRN) (CIK 0001048477)
Date: Aug. 13, 2010 · CIK: 0001048477 · Accession: 0001193125-10-188801
AI Filing Summary & Sentiment
File numbers found in text: 000-26727
Referenced dates: July 30, 2010
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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