UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
x |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2015
Or
o |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File Number: 000-26727
BioMarin Pharmaceutical Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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68-0397820 |
(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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770 Lindaro Street, San Rafael, California |
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94901 |
(Address of principal executive offices) |
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(Zip Code) |
(415) 506-6700
(Registrant’s telephone number including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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x |
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Accelerated filer |
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o |
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Non-accelerated filer |
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o (Do not check if a smaller reporting company) |
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Smaller reporting company |
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o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.) Yes o No x
Applicable only to issuers involved in bankruptcy proceedings during the preceding five years:
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes o No o
Applicable only to corporate issuers:
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 160,336,762 shares of common stock, par value $0.001, outstanding as of April 24, 2015.
BIOMARIN PHARMACEUTICAL INC.
TABLE OF CONTENTS
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Page |
PART I. |
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FINANCIAL INFORMATION |
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Item 1. |
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Financial Statements |
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Condensed Consolidated Balance Sheets as of March 31, 2015 (Unaudited) and December 31, 2014 |
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3 |
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4 |
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5 |
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Notes to Condensed Consolidated Financial Statements (Unaudited) |
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6 |
Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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27 |
Item 3. |
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40 |
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Item 4. |
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40 |
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PART II. |
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40 |
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Item 1. |
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40 |
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Item 1A. |
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40 |
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Item 2. |
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61 |
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Item 3. |
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61 |
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Item 4. |
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61 |
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Item 5. |
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61 |
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Item 6. |
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62 |
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63 |
BioMarin®, Vimizim ®, Naglazyme®, Kuvan® and Firdapse® are our registered trademarks. Aldurazyme ® is a registered trademark of BioMarin/Genzyme LLC. All other brand names and service marks, trademarks and other trade names appearing in this report are the property of their respective owners.
2
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2015 and December 31, 2014
(In thousands of U.S. dollars, except per share amounts)
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March 31, |
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December 31, |
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2015 |
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2014(1) |
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ASSETS |
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(unaudited) |
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Current assets: |
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Cash and cash equivalents |
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$ |
900,570 |
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$ |
875,486 |
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Short-term investments |
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108,119 |
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69,706 |
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Accounts receivable, net (allowance for doubtful accounts: $489 and $490, at March 31, 2015 and December 31, 2014, respectively) |
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175,738 |
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144,472 |
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Inventory |
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222,833 |
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199,452 |
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Current deferred tax assets |
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31,203 |
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31,203 |
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Other current assets |
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84,265 |
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111,835 |
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Total current assets |
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1,522,728 |
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1,432,154 |
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Noncurrent assets: |
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Investment in BioMarin/Genzyme LLC |
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890 |
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1,039 |
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Long-term investments |
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223,920 |
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97,856 |
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Property, plant and equipment, net |
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538,117 |
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523,516 |
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Intangible assets, net |
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926,896 |
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156,578 |
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Goodwill |
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202,392 |
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54,258 |
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Long-term deferred tax assets |
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163,411 |
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159,771 |
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Other assets |
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80,332 |
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65,281 |
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Total assets |
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$ |
3,658,686 |
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$ |
2,490,453 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
230,212 |
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$ |
231,844 |
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Short-term contingent acquisition consideration payable |
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75,294 |
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3,895 |
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Total current liabilities |
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305,506 |
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235,739 |
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Noncurrent liabilities: |
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Long-term convertible debt |
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655,491 |
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657,976 |
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Long-term contingent acquisition consideration payable |
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39,052 |
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38,767 |
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Long-term deferred tax liabilities |
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193,202 |
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— |
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Other long-term liabilities |
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39,980 |
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30,077 |
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Total liabilities |
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1,233,231 |
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962,559 |
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Stockholders’ equity: |
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Common stock, $0.001 par value: 250,000,000 shares authorized at March 31, 2015 and December 31, 2014: 160,282,313 and 149,093,647 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively |
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161 |
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149 |
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Additional paid-in capital |
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3,308,137 |
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2,359,744 |
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Company common stock held by Nonqualified Deferred Compensation Plan |
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(9,391 |
) |
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(9,695 |
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Accumulated other comprehensive income |
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43,819 |
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27,466 |
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Accumulated deficit |
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(917,271 |
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(849,770 |
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Total stockholders’ equity |
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2,425,455 |
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1,527,894 |
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Total liabilities and stockholders’ equity |
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$ |
3,658,686 |
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$ |
2,490,453 |
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(1) |
December 31, 2014 balances were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the Securities and Exchange Commission (the SEC) on March 2, 2015. |
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
3
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
Three Months Ended March 31, 2015 and 2014
(In thousands of U.S. dollars, except per share amounts)
(Unaudited)
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2015 |
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2014 |
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REVENUES: |
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Net product revenues |
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$ |
201,312 |
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$ |
149,004 |
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Collaborative agreement revenues |
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376 |
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415 |
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Royalty, license and other revenues |
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1,576 |
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2,133 |
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Total revenues |
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203,264 |
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151,552 |
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OPERATING EXPENSES: |
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Cost of sales |
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32,813 |
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22,816 |
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Research and development |
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142,074 |
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86,166 |
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Selling, general and administrative |
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92,806 |
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60,069 |
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Intangible asset amortization and contingent consideration |
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1,431 |
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8,957 |
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Total operating expenses |
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269,124 |
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178,008 |
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LOSS FROM OPERATIONS |
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(65,860 |
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(26,456 |
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Equity in the loss of BioMarin/Genzyme LLC |
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(150 |
) |
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(338 |
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Interest income |
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683 |
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1,123 |
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Interest expense |
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(9,462 |
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(9,106 |
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Debt conversion expense |
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(163 |
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— |
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Other income |
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249 |
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153 |
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LOSS BEFORE INCOME TAXES |
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(74,703 |
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(34,624 |
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Provision for (benefit from) income taxes |
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(7,202 |
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3,491 |
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NET LOSS |
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$ |
(67,501 |
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$ |
(38,115 |
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NET LOSS PER SHARE, BASIC |
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$ |
(0.43 |
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$ |
(0.26 |
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NET LOSS PER SHARE, DILUTED |
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$ |
(0.43 |
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$ |
(0.27 |
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Weighted average common shares outstanding, basic |
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157,612 |
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143,983 |
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Weighted average common shares outstanding, diluted |
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157,612 |
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144,157 |
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COMPREHENSIVE LOSS |
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$ |
(51,148 |
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$ |
(35,858 |
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The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
4
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Three Months Ended March 31, 2015 and 2014
(In thousands of U.S. dollars)
(Unaudited)
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2015 |
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2014 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
(67,501 |
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$ |
(38,115 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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14,397 |
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12,004 |
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Non-cash interest expense |
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7,000 |
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6,698 |
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Accretion of discount on investments |
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417 |
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1,900 |
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Stock-based compensation |
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23,714 |
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17,267 |
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Gain on termination of lease |
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— |
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(8,858 |
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Equity in the loss of BioMarin/Genzyme LLC |
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150 |
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338 |
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Deferred income taxes |
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(7,800 |
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(179 |
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Excess tax benefit from stock option exercises |
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(527 |
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(278 |
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Unrealized foreign exchange gain on forward contracts |
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(5,686 |
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1,323 |
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Non-cash changes in the fair value of contingent acquisition consideration payable |
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282 |
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8,151 |
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Debt conversion expense |
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163 |
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— |
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Other |
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(443 |
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— |
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Changes in operating assets and liabilities: |
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Accounts receivable, net |
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(26,789 |
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7,406 |
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Inventory |
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(23,946 |
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(13,870 |
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Other current assets |
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(3,522 |
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(927 |
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Other assets |
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330 |
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(920 |
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Accounts payable and accrued liabilities |
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(57,236 |
) |
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(19,020 |
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Other long-term liabilities |
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9,186 |
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587 |
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Net cash used in operating activities |
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(137,811 |
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(26,493 |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Purchases of property, plant and equipment |
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(43,832 |
) |
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(23,607 |
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Maturities and sales of investments |
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124,137 |
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69,391 |
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Purchase of available-for-sale investments |
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(288,431 |
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(84,306 |
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Purchase of promissory note |
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(3,326 |
) |
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— |
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Business acquisitions, net of cash acquired |
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(538,392 |
) |
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— |
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Other |
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(1,027 |
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— |
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Net cash used in investing activities |
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(750,871 |
) |
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(38,522 |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from exercises of stock options and Employee Stock Purchase Plan (the ESPP) |
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28,026 |
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19,712 |
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Taxes paid related to net share settlement of equity awards |
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(735 |
) |
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(473 |
) |
Proceeds from public offering of common stock, net |
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888,257 |
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117,464 |
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Excess tax benefit from stock option exercises |
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|
527 |
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278 |
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Payments for debt conversion |
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(163 |
) |
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— |
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Other |
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(1,121 |
) |
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(17 |
) |
Net cash provided by financing activities |
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914,791 |
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136,964 |
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Effect of exchange rate changes on cash |
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(1,025 |
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(952 |
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NET INCREASE IN CASH AND CASH EQUIVALENTS |
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25,084 |
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70,997 |
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Cash and cash equivalents: |
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Beginning of period |
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$ |
875,486 |
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$ |
568,781 |
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End of period |
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$ |
900,570 |
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$ |
639,778 |
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SUPPLEMENTAL CASH FLOW DISCLOSURES: |
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Cash paid for interest, net of interest capitalized into fixed assets |
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309 |
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1 |
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Cash paid for income taxes |
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1,358 |
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381 |
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Stock-based compensation capitalized into inventory |
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2,480 |
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2,053 |
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Depreciation capitalized into inventory |
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3,580 |
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2,924 |
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SUPPLEMENTAL CASH FLOW DISCLOSURES FROM INVESTING AND FINANCING ACTIVITIES: |
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Decrease in accounts payable and accrued liabilities related to fixed assets |
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(20,985 |
) |
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(9,171 |
) |
Conversion of convertible debt |
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8,133 |
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— |
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Deferred offering costs reclassified into additional paid-in-capital as a result of conversion of convertible debt |
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45 |
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— |
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Release of escrow balance for purchase of San Rafael Corporate Center |
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— |
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116,500 |
|
The accompanying notes are an integral part of these Condensed Consolidated Financial Statements.
5
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
(1) NATURE OF OPERATIONS AND BUSINESS RISKS
BioMarin Pharmaceutical Inc. (the Company or BioMarin), a Delaware corporation, develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. BioMarin selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company’s product portfolio is comprised of five approved products and multiple clinical and pre-clinical product candidates. The Company’s approved products are Vimizim (elosulfase alpha), Naglazyme (galsulfase), Kuvan (sapropterin dihydrochloride), Aldurazyme (laronidase) and Firdapse (amifampridine phosphate).
Through March 31, 2015, the Company had accumulated losses of approximately $917.3 million. The Company expects to continue to finance future cash needs that exceed its operating activities primarily through its current cash, cash equivalents, short-term and long-term investments, and to the extent necessary, through proceeds from equity or debt financings, loans and collaborative agreements with corporate partners. If the Company elects to increase its spending on development programs significantly above current long-term plans or enters into potential licenses and other acquisitions of complementary technologies, products or companies, the Company may need additional capital.
The Company is subject to a number of risks, including: the financial performance of Vimizim, Naglazyme, Kuvan, Aldurazyme and Firdapse; the potential need for additional financings; the Company’s ability to successfully commercialize its approved product candidates; the uncertainty of the Company’s research and development (R&D) efforts resulting in future successful commercial products; the Company’s ability to successfully obtain regulatory approval for new products; significant competition from larger organizations; reliance on the proprietary technology of others; dependence on key personnel; uncertain patent protection; dependence on corporate partners and collaborators; and possible restrictions on reimbursement from governmental agencies and healthcare organizations, as well as other changes in the health care industry.
(2) BASIS OF PRESENTATION
The accompanying Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the SEC for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by U.S. generally accepted accounting principles (U.S. GAAP) for complete financial statements. The Condensed Consolidated Financial Statements should therefore be read in conjunction with the Consolidated Financial Statements and Notes thereto for the fiscal year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K.
The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with U.S. GAAP, which requires management to make estimates and assumptions that affect amounts reported in the Condensed Consolidated Financial Statements and accompanying disclosures. Although these estimates are based on management’s best knowledge of current events and actions that the Company may undertake in the future, actual results may be different from those estimates. The Condensed Consolidated Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair presentation of results for these interim periods. The results of operations for the three months ended March 31, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015.
The Company has evaluated events and transactions subsequent to the balance sheet date. Based on this evaluation, the Company is not aware of any events or transactions that occurred subsequent to the balance sheet date but prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the Condensed Consolidated Financial Statements.
(3) SIGNIFICANT ACCOUNTING POLICIES
There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2015, as compared to the significant accounting policies disclosed in Note 3 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014.
Reclassifications
Certain items in the Company’s prior year Condensed Consolidated Financial Statements have been reclassified to conform to the current presentation.
6
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
(4) RECENT ACCOUNTING PRONOUNCEMENTS
There have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2015, as compared to the recent accounting pronouncements described in Note 4 of the Company’s Annual Report on Form 10-K for the year-ended December 31, 2014, that are of significance or potential significance to the Company.
(5) ACQUISITIONS
Prosensa Holding N.V.
On January 29 2015, the Company completed the acquisition of Prosensa Holding N.V. (Prosensa), a public limited liability company organized under the laws of the Netherlands, for a total purchase price of $751.5 million. In connection with the acquisition of Prosensa, the Company recognized transaction costs of $9.7 million, of which $2.7 million and $7.0 million, respectively, was recognized in the year ended December 31, 2014 and the three months ended March 31, 2015.
Prosensa was an innovative biotechnology company engaged in the discovery and development of ribonucleic acid (RNA)-modulating therapeutics for the treatment of genetic disorders. Prosensa’s primary focus was on rare neuromuscular and neurodegenerative disorders with a large unmet medical need, including subsets of patients with Duchenne muscular dystrophy (DMD), myotonic dystrophy and Huntington’s disease. Prosensa’s clinical portfolio of RNA-based product candidates was focused on the treatment of DMD. Each of Prosensa’s DMD compounds has been granted orphan drug status in the United States (the U.S.) and the European Union (the EU). Prosensa’s lead product, drisapersen, is currently under a rolling review as part of a rolling new drug application (NDA) with the Food and Drug Administration (the FDA). On April 27, 2015, the Company announced the completion of the rolling submission of the NDA to the FDA. The Company expects to file a marketing authorization application (MAA) for drisapersen with the European Medicines Agency (the EMA) in the summer of 2015.
In connection with its acquisition of Prosensa, the Company made cash payments totaling $680.1 million which were comprised of $620.7 million for approximately 96.8% of Prosensa’s ordinary shares (the Prosensa Shares), $38.6 million for the options that vested pursuant to the Company’s tender offer for the Prosensa Shares and $20.8 million to the remaining Prosensa shareholders that did not tender their shares under the tender offer. Additionally, for each Prosensa Share, the Company issued one non-transferable contingent value right (the CVR), which represents the contractual right to receive a cash payment of up to $4.14 per Prosensa Share, or approximately $160.0 million (undiscounted), upon the achievement of certain product approval milestones. The fair value of the CVRs and acquired in-process research and development (IPR&D) on the acquisition date was $71.4 million and $772.8 million, respectively. The acquisition date fair value of the CVRs and IPR&D was estimated by applying a probability-based income approach utilizing an appropriate discount rate. Key assumptions include a discount rate and various probability factors. See Note 15 to these Condensed Consolidated Financial Statements for additional discussion regarding fair value measurements of the CVRs which is included in contingent acquisition consideration payable.
7
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
The following table presents the allocation of the purchase consideration for the Prosensa acquisition, including the CVRs, based on fair value.
Cash and cash equivalents |
|
$ |
141,669 |
|
Trade accounts receivable |
|
|
3,086 |
|
Other current assets |
|
|
1,537 |
|
Property, plant and equipment |
|
|
2,683 |
|
Intangible assets |
|
|
497 |
|
Other assets |
|
|
104 |
|
Acquired IPR&D |
|
|
772,808 |
|
Total identifiable assets acquired |
|
|
922,384 |
|
Accounts payable and accrued expenses |
|
|
(68,799 |
) |
Debt assumed |
|
|
(57,053 |
) |
Deferred tax liability |
|
|
(193,202 |
) |
Total liabilities assumed |
|
|
(319,054 |
) |
Net identifiable assets acquired |
|
|
603,330 |
|
Goodwill |
|
|
148,134 |
|
Net assets acquired |
|
$ |
751,464 |
|
A substantial portion of the assets acquired consisted of IPR&D related to Prosensa’s product candidates drisapersen and exons PRO 044 and PRO 045, which are considered to be indefinite-lived assets until completion or abandonment of the associated research and development (R&D) efforts. The Company determined that the estimated acquisition-date fair value of the intangible assets related to drisapersen and Prosensa’s other primary product candidates, PRO 044 and PRO-045 was $731.8 million, $16.9 million and $24.1 million, respectively.
The deferred tax liability relates to the tax impact of future amortization or possible impairments associated with the identified intangible assets acquired, which are not deductible for tax purposes.
Prosensa’s results of operations prior to and since the acquisition date are insignificant to the Company’s Condensed Consolidated Financial Statements.
See Note 10 to these Condensed Consolidated Financial Statements for further discussion of the indefinite-lived intangible assets.
San Rafael Corporate Center
In March 2014, the Company completed the acquisition of the real estate commonly known as the San Rafael Corporate Center (SRCC), located in San Rafael, California. SRCC is a multi-building, commercial property where, prior to the acquisition, the Company was leasing a certain portion of the space for its headquarters and related operating activities. The purpose of this acquisition is to allow for future expansion of the Company’s corporate headquarters to accommodate anticipated headcount growth. The acquisition of SRCC has been accounted for as a business combination because the building and the in-place leases met the definition of a business in Accounting Standards Codification 805 (ASC 805), Business Combinations. The fair value of the consideration paid for SRCC was $116.5 million, all of which was paid in cash, which was held in escrow as of December 31, 2013.
8
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
The following table summarizes the estimated fair values of assets acquired as of the date of acquisition:
|
|
Estimated Fair Value |
|
|
Estimated Useful Lives |
|
Building and improvements |
|
$ |
94,414 |
|
|
50 years |
Land |
|
|
14,565 |
|
|
|
Land improvements |
|
|
3,616 |
|
|
10 years |
Intangible assets |
|
|
3,905 |
|
|
Remaining lease terms |
Total identifiable net assets |
|
$ |
116,500 |
|
|
|
The fair values assigned to tangible and identifiable intangible assets acquired are based on management’s estimates and assumptions using the information that was available as of the date of the acquisition. The Company believes that the information provides a reasonable basis for estimating the fair values of assets acquired.
The following table sets forth the fair value of the components of the identifiable intangible assets acquired by asset class as of the date of acquisition:
Above market leases |
|
$ |
351 |
|
In-place leases |
|
|
3,554 |
|
Total intangible assets subject to amortization |
|
$ |
3,905 |
|
The value of any in-place leases is estimated to be equal to the property owners’ avoidance of costs necessary to release the property for a lease term equal to the remaining primary in-place lease term and the value of investment-grade tenancy, which is derived by estimating, based on a review of the market, the cost to be borne by a property owner to replicate a market lease for the remaining in-place term. These costs consist of: (i) rent lost during downtime (e.g., assumed periods of vacancy), (ii) estimated expenses that would be incurred by the property owner during periods of vacancy, (iii) rent concessions (e.g., free rent), (iv) leasing commissions and (v) tenant improvement allowances. The Company determined these values using management’s estimates along with third-party appraisals. The Company will amortize the capitalized value of in-place lease intangible assets to expense over the remaining initial term of each lease. The Company will amortize the capitalized value of above market leases to expense over the remaining lives of the underlying leases.
The amount of third-party tenant revenue (included in the line item Royalty, License and Other Revenues) included in the Company’s Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2015, was $1.0 million, compared to $0.4 million for the three months ended March 31, 2014. The amount of net income/loss from third-party tenants for the three months ended March 31, 2015 and 2014, was insignificant to the Company’s Consolidated Statement of Comprehensive Loss.
SRCC’s results of operations prior to the acquisition were insignificant to the Company’s Condensed Consolidated Financial Statements.
Included in Selling, General and Administrative (SG&A) expenses during the three months ended March 31, 2014 are transaction costs incurred in connection with the acquisition of SRCC of $0.2 million. The Company recognized a gain of $8.8 million in the three months ended March 31, 2014, due to the early termination of the Company’s pre-existing lease and the realization of the remaining balance in deferred rent and the reversal of the related asset retirement obligation upon acquisition of the SRCC. $2.7 million and $6.1 million of the gain were included in SG&A and R&D expenses, respectively, which is consistent with the Company’s allocation practices for facility costs for this previously leased space.
(6) STOCKHOLDERS’ EQUITY
In January 2015, the Company sold 9,775,000 shares of its common stock at a price of $93.25 per share in an underwritten public offering pursuant to an effective registration statement previously filed with the SEC. The Company received net proceeds of approximately $888.3 million from this public offering after underwriter’s discount and offering costs.
9
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
(7) NET LOSS PER COMMON SHARE
Potentially issuable shares of common stock include shares issuable upon the exercise of outstanding employee stock option awards, common stock issuable under the Company’s Amended and Restated 2006 ESPP, unvested restricted stock, common stock held by the Company’s Nonqualified Deferred Compensation Plan (the NQDC) and contingent issuances of common stock related to convertible debt.
The following table sets forth the computation of basic and diluted earnings per common share (in thousands of common shares):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2015 |
|
|
2014 |
|
||
Numerator: |
|
|
|
|
|
|
|
|
Net loss, basic |
|
$ |
(67,501 |
) |
|
$ |
(38,115 |
) |
Gain on Company common stock issued to the NQDC |
|
|
— |
|
|
|
(374 |
) |
Net loss, diluted |
|
$ |
(67,501 |
) |
|
$ |
(38,489 |
) |
Denominator: |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, basic |
|
|
157,612 |
|
|
|
143,983 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
Common stock issued to the NQDC |
|
|
— |
|
|
|
174 |
|
Weighted-average common shares outstanding, diluted |
|
|
157,612 |
|
|
|
144,157 |
|
Net loss per common share, basic |
|
$ |
(0.43 |
) |
|
$ |
(0.26 |
) |
Net loss per common share, diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.27 |
) |
In addition to the equity instruments included in the table above, the table below presents potential shares of common stock that were excluded from the computation as they were anti-dilutive using the treasury stock method (in thousands of common shares):
|
|
Three Months Ended March 31, |
|
|||||
|
|
2015 |
|
|
2014 |
|
||
Options to purchase common stock |
|
|
11,109 |
|
|
|
12,444 |
|
Common stock issuable under the 2017 Notes |
|
|
1,567 |
|
|
|
3,047 |
|
Common stock issuable under the 2018 and 2020 Notes |
|
|
7,966 |
|
|
|
7,966 |
|
Unvested restricted stock units |
|
|
1,557 |
|
|
|
1,326 |
|
Potentially issuable common stock for ESPP purchases |
|
|
223 |
|
|
|
209 |
|
Common stock held by the NQDC |
|
|
213 |
|
|
|
— |
|
Total number of potentially issuable shares |
|
|
22,635 |
|
|
|
24,992 |
|
The effect of the Company’s 0.75% senior subordinated convertible notes due in 2018 (the 2018 Notes) and the Company’s 1.50% senior subordinated convertible notes due in 2020 (the 2020 Notes and together with the 2018 Notes, the Notes) was excluded from the diluted net loss per common share since they may be settled in cash or shares at the Company’s option and the Company’s current intention is to settle up to the principal amount of the converted notes in cash and any excess conversion value (conversion spread) in shares of the Company’s common stock. As a result, during the three months ended March 31, 2014 the 2018 Notes and the 2020 Notes had no effect on diluted net loss per share until the Company’s stock price exceeded the conversion price of $94.15 per share for the Notes. Although the Company’s stock price exceeded the conversion price at March 31, 2105, the potential shares issuable under the Notes were excluded from the calculation of diluted loss per share as they were anti-dilutive using the if-converted method.
10
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
(8) INVESTMENTS
All investments were classified as available-for-sale at March 31, 2015 and December 31, 2014. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale securities by major security type at March 31, 2015 and December 31, 2014 are summarized in the tables below:
|
|
Amortized Cost |
|
|
Gross Unrealized Holding Gains |
|
|
Gross Unrealized Holding Losses |
|
|
Aggregate Fair Value at March 31, 2015 |
|
||||
Certificates of deposit |
|
$ |
69,871 |
|
|
$ |
1 |
|
|
$ |
— |
|
|
$ |
69,872 |
|
Corporate debt securities |
|
|
147,537 |
|
|
|
129 |
|
|
|
— |
|
|
|
147,666 |
|
Commercial paper |
|
|
21,354 |
|
|
|
— |
|
|
|
— |
|
|
|
21,354 |
|
U.S. government agency securities |
|
|
93,012 |
|
|
|
31 |
|
|
|
— |
|
|
|
93,043 |
|
Greek government-issued bonds |
|
|
50 |
|
|
|
54 |
|
|
|
— |
|
|
|
104 |
|
Total |
|
$ |
331,824 |
|
|
$ |
215 |
|
|
$ |
— |
|
|
$ |
332,039 |
|
|
|
Amortized Cost |
|
|
Gross Unrealized Holding Gains |
|
|
Gross Unrealized Holding Losses |
|
|
Aggregate Fair Value at December 31, 2014 |
|
||||
Certificates of deposit |
|
$ |
72,302 |
|
|
$ |
1 |
|
|
$ |
— |
|
|
$ |
72,303 |
|
Corporate debt securities |
|
|
95,478 |
|
|
|
— |
|
|
|
(342 |
) |
|
|
95,136 |
|
Greek government-issued bonds |
|
|
50 |
|
|
|
73 |
|
|
|
— |
|
|
|
123 |
|
Total |
|
$ |
167,830 |
|
|
$ |
74 |
|
|
$ |
(342 |
) |
|
$ |
167,562 |
|
The Company has two investments in marketable equity securities measured using quoted prices in their respective active markets and certain interest in non-marketable equity securities that are collectively considered strategic investments. As of March 31, 2015, the fair value of the Company’s marketable equity securities was $41.8 million, which included an unrealized gain of $29.3 million. The carrying cost of the non-marketable securities was $3.1 million at March 31, 2015. As of December 31, 2014, the fair value of the Company’s marketable equity securities was $30.8 million, which included an unrealized gain of $18.3 million. These investments are recorded in Other Assets in the Company’s Condensed Consolidated Balance Sheets.
The fair values of available-for-sale securities by contractual maturity were as follows:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Maturing in one year or less |
|
$ |
108,119 |
|
|
$ |
69,706 |
|
Maturing after one year through five years |
|
|
223,920 |
|
|
|
97,856 |
|
Total |
|
$ |
332,039 |
|
|
$ |
167,562 |
|
Impairment assessments are made at the individual security level each reporting period. When the fair value of an investment is less than its cost at the balance sheet date, a determination is made as to whether the impairment is other-than-temporary and, if it is other-than-temporary, an impairment loss is recognized in earnings equal to the difference between the investment’s amortized cost and fair value at such date. As of March 31, 2015, some of the Company’s investments were in an unrealized loss position. However, the Company has the ability and intent to hold all investments that have been in a continuous loss position until maturity or recovery, thus no other-than-temporary impairment is deemed to have occurred.
See Note 15 to these Condensed Consolidated Financial Statements for additional discussion regarding the fair value of the Company’s available-for-sale securities.
11
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
(9) GOODWILL
Goodwill is tested for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in the circumstances that would indicate a reduction in the fair value of the goodwill below its carrying amount.
The following table represents the changes in goodwill for the three months ended March 31, 2015:
Balance at December 31, 2014 |
|
$ |
54,258 |
|
Addition of goodwill related to the acquisition of Prosensa |
|
|
148,134 |
|
Balance at March 31, 2015 |
|
$ |
202,392 |
|
(10) INTANGIBLE ASSETS
Intangible assets consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Intangible assets: |
|
|
|
|
|
|
|
|
Finite-lived intangible assets |
|
$ |
123,836 |
|
|
$ |
123,365 |
|
Indefinite-lived intangible assets |
|
|
847,238 |
|
|
|
74,430 |
|
Gross intangible assets: |
|
|
971,074 |
|
|
|
197,795 |
|
Less: Accumulated amortization |
|
|
(44,178 |
) |
|
|
(41,217 |
) |
Net carrying value |
|
$ |
926,896 |
|
|
$ |
156,578 |
|
Indefinite-Lived Intangible Assets
IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated R&D efforts. During the period the assets are considered indefinite-lived, they will not be amortized but will be tested for impairment on an annual basis and between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate a reduction in the fair value of the IPR&D assets below their respective carrying amounts. If and when development is complete, which generally occurs if and when regulatory approval to market a product is obtained, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time.
See Note 6 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 for additional information related to the Company’s Intangible Assets.
(11) PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment, net consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Leasehold improvements |
|
$ |
40,733 |
|
|
$ |
39,297 |
|
Building and improvements |
|
|
339,161 |
|
|
|
335,991 |
|
Manufacturing and laboratory equipment |
|
|
129,348 |
|
|
|
124,564 |
|
Computer hardware and software |
|
|
99,879 |
|
|
|
97,032 |
|
Furniture and equipment |
|
|
14,874 |
|
|
|
13,717 |
|
Land improvements |
|
|
4,106 |
|
|
|
4,106 |
|
Land |
|
|
29,357 |
|
|
|
29,358 |
|
Construction-in-progress |
|
|
120,971 |
|
|
|
108,340 |
|
|
|
|
778,429 |
|
|
|
752,405 |
|
Less: Accumulated depreciation |
|
|
(240,312 |
) |
|
|
(228,889 |
) |
Total property, plant and equipment, net |
|
$ |
538,117 |
|
|
$ |
523,516 |
|
12
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
Depreciation expense for the three months ended March 31, 2015 and 2014 was $11.5 million and $9.6 million, respectively, of which $3.6 million and $2.9 million, respectively, was capitalized into inventory.
Capitalized interest related to the Company’s property, plant and equipment purchases for each of the three months ended March 31, 2015 and 2014 was insignificant.
(12) SUPPLEMENTAL BALANCE SHEET INFORMATION
Inventory consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Raw materials |
|
$ |
21,690 |
|
|
$ |
22,488 |
|
Work-in-process |
|
|
124,192 |
|
|
|
114,393 |
|
Finished goods |
|
|
76,951 |
|
|
|
62,571 |
|
Total inventory |
|
$ |
222,833 |
|
|
$ |
199,452 |
|
Other Current Assets consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Prepaid expenses |
|
|
39,159 |
|
|
|
35,390 |
|
Short-term forward currency exchange contract assets |
|
|
18,337 |
|
|
|
10,513 |
|
Promissory notes receivable, net |
|
|
3,326 |
|
|
|
46,946 |
|
Restricted investments |
|
|
7,131 |
|
|
|
2,354 |
|
Convertible promissory note conversion option |
|
|
— |
|
|
|
2,386 |
|
Other receivables |
|
|
10,983 |
|
|
|
9,733 |
|
Other |
|
|
5,329 |
|
|
|
4,513 |
|
Total other current assets |
|
$ |
84,265 |
|
|
$ |
111,835 |
|
Other Assets consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Deposits |
|
|
11,045 |
|
|
|
12,021 |
|
Deferred debt offering costs |
|
|
10,911 |
|
|
|
11,763 |
|
Strategic investments |
|
|
44,918 |
|
|
|
30,811 |
|
Long-term forward foreign currency exchange contract assets |
|
|
7,391 |
|
|
|
5,387 |
|
Other |
|
|
6,067 |
|
|
|
5,299 |
|
Total other assets |
|
$ |
80,332 |
|
|
$ |
65,281 |
|
13
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
Accounts payable and accrued liabilities consisted of the following:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2015 |
|
|
2014 |
|
||
Accounts payable |
|
$ |
23,606 |
|
|
$ |
32,779 |
|
Accrued accounts payable |
|
|
106,462 |
|
|
|
98,490 |
|
Accrued compensation expense |
|
|
32,461 |
|
|
|
45,479 |
|
Accrued vacation expense |
|
|
15,871 |
|
|
|
12,540 |
|
Accrued rebates payable |
|
|
17,173 |
|
|
|
14,859 |
|
Accrued royalties payable |
|
|
7,207 |
|
|
|
9,050 |
|
Value added taxes payable |
|
|
5,730 |
|
|
|
5,479 |
|
Other accrued operating expenses |
|
|
8,721 |
|
|
|
8,244 |
|
Other |
|
|
12,981 |
|
|
|
4,924 |
|
Total accounts payable and accrued liabilities |
|
$ |
230,212 |
|
|
$ |
231,844 |
|
(13) CONVERTIBLE DEBT
The following table summarizes information regarding the Company’s convertible debt:
|
|
March 31, 2015 |
|
|
December 31, 2014 |
|
||
Convertible Notes due 2020, net of unamortized discount of $74,214 and $77,045, at March 31, 2015 and December 31, 2014, respectively |
|
$ |
300,786 |
|
|
$ |
297,955 |
|
Convertible Notes due 2018, net of unamortized discount of $52,193 and $55,537, at March 31, 2015 and December 31, 2014, respectively |
|
|
322,807 |
|
|
|
319,463 |
|
Convertible Notes due 2017 |
|
|
31,898 |
|
|
|
40,558 |
|
Total convertible debt, net of unamortized discount |
|
$ |
655,491 |
|
|
$ |
657,976 |
|
|
|
|
|
|
|
|
|
|
Fair value of fixed rate convertible debt |
|
|
|
|
|
|
|
|
Convertible Notes due in 2020 (1) |
|
$ |
568,444 |
|
|
$ |
456,360 |
|
Convertible Notes due in 2018 (1) |
|
|
555,994 |
|
|
|
442,448 |
|
Convertible Notes due in 2017 (1) |
|
|
195,370 |
|
|
|
180,984 |
|
Total |
|
$ |
1,319,808 |
|
|
$ |
1,079,792 |
|
(1) |
The fair value of the Company’s fixed rate convertible debt is based on open market trades and is classified as Level 1 in the fair value hierarchy. |
Interest expense on the Company’s convertible debt was comprised of the following:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2015 |
|
|
2014 |
|
||
Coupon interest |
|
$ |
2,462 |
|
|
$ |
2,408 |
|
Amortization of issuance costs |
|
|
826 |
|
|
|
843 |
|
Accretion of debt discount |
|
|
6,174 |
|
|
|
5,855 |
|
Total interest expense on convertible debt |
|
$ |
9,462 |
|
|
$ |
9,106 |
|
During the three months ended March 31, 2015, the Company entered into separate agreements with three existing holders of its senior subordinated convertible notes due in 2017 (the 2017 Notes) pursuant to which such holders converted $8.1 million in aggregate principal amount of the 2017 Notes into 399,469 shares of the Company’s common stock. In addition to issuing the requisite number of shares of the Company’s common stock, the Company also made varying cash payments to the holder totaling
14
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
$0.2 million in aggregate, of which $0.2 million was recognized in total as Debt Conversion Expense on the Condensed Consolidated Statement of Comprehensive Loss for the three months ended March 31, 2015.
See Note 13 to the Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 for additional information related to the Company’s Convertible Debt.
(14) DERIVATIVE INSTRUMENTS AND HEDGING STRATEGIES
The Company uses forward foreign currency exchange contracts to hedge certain operational exposures resulting from potential changes in foreign currency exchange rates. Such exposures result from portions of the Company’s forecasted revenues and operating expenses being denominated in currencies other than the U.S. dollar, primarily the Euro, the British Pound and the Brazilian Real.
The Company designates certain of these forward foreign currency exchange contracts as hedging instruments and enters into some forward foreign currency exchange contracts that are considered to be economic hedges that are not designated as hedging instruments. Whether designated or undesignated, these forward foreign currency exchange contracts protect against the reduction in value of forecasted foreign currency cash flows resulting from product revenues, royalty revenues, operating expenses and asset or liability positions designated in currencies other than the U.S. dollar. The fair values of forward foreign currency exchange contracts are estimated using current exchange rates and interest rates, and take into consideration the current creditworthiness of the counterparties or the Company, as applicable. Details of the specific instruments used by the Company to hedge its exposure to foreign currency exchange rate fluctuations are discussed below. See Note 15 to these Condensed Consolidated Financial Statements for additional discussion regarding the fair value of forward foreign currency exchange contracts.
At March 31, 2015, the Company had 94 forward foreign currency exchange contracts outstanding to sell a total of 131.6 million Euros and seven forward foreign currency exchange contracts outstanding to purchase 20.0 million Euros with expiration dates ranging from April 2015 through March 2018. These hedges were entered into in order to protect against the fluctuations in revenue associated with Euro-denominated product sales and operating expenses. The Company has formally designated these forward foreign currency exchange contracts as cash flow hedges and expects them to be highly effective in offsetting fluctuations in revenues denominated in Euros related to changes in foreign currency exchange rates.
The Company also enters into forward foreign currency exchange contracts that are not designated as hedges for accounting purposes. The changes in fair value of these forward foreign currency exchange contracts are included as a part of SG&A expense in the Company’s Condensed Consolidated Statements of Comprehensive Loss. At March 31, 2015, the Company had one outstanding forward foreign currency exchange contract to sell 42.1 million Euros and one outstanding forward foreign currency exchange contract to sell 6.4 million British Pounds, both of which were not designated as a hedge for accounting purposes and matured on April 30, 2015.
The maximum length of time over which the Company is hedging its exposure to the reduction in value of forecasted foreign currency revenues through forward foreign currency exchange contracts is through March 2018. Over the next twelve months, the Company expects to reclassify $18.9 million from accumulated other comprehensive income to earnings as the forecasted revenue transactions occur.
15
BIOMARIN PHARMACEUTICAL INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS – (Continued)
(In thousands of U.S. dollars, except per share amounts or as otherwise disclosed)
The fair value carrying amounts of the Company’s derivative instruments were as follows:
|
|
Asset Derivatives |
|
|
Liability Derivatives |
|
||||||
|
|
March 31, 2015 |
|
|
March 31, 2015 |
|
||||||
|
|
Balance Sheet Location |
|
Fair Value |
|
|
Balance Sheet Location |
|
Fair Value |
|
||
Derivatives designated as hedging instruments: |
|
|
|
|
|
|
|
|
|
|
|
|
Forward foreign currency exchange contracts |
|
Other current assets |
|
$ |
18,171 |
|
|
Accounts payable and accrued liabilities |