e10vq
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission File Number 0-19311
BIOGEN IDEC INC.
(Exact name of registrant as specified in its charter)
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Delaware
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33-0112644 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
14 Cambridge Center, Cambridge, MA 02142
(617) 679-2000
(Address, including zip code, and telephone number, including
area code, of registrants principal executive offices)
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one)
Large Accelerated Filer þ Accelerated Filer o Non-Accelerated Filer 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 þ
The number of shares of the registrants Common Stock, $0.0005 par value, outstanding as of August
1, 2006, was 343,593,569 shares.
BIOGEN IDEC INC.
FORM 10-Q Quarterly Report
For the Quarterly Period Ended June 30, 2006
TABLE OF CONTENTS
2
PART I
BIOGEN IDEC INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Revenues: |
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Product |
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$ |
436,081 |
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$ |
398,822 |
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$ |
842,600 |
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$ |
796,406 |
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Unconsolidated joint business |
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206,095 |
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184,934 |
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389,476 |
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345,387 |
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Royalty |
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18,286 |
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21,734 |
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38,847 |
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48,483 |
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Corporate partner |
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(421 |
) |
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144 |
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293 |
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3,160 |
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Total revenues |
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660,041 |
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605,634 |
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1,271,216 |
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1,193,436 |
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Costs and expenses: |
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Cost of product revenues, excluding amortization of
acquired intangible assets |
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77,060 |
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70,244 |
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143,452 |
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168,725 |
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Cost of royalty revenues |
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933 |
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849 |
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2,036 |
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1,976 |
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Research and development |
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161,985 |
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179,843 |
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307,877 |
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358,611 |
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Selling, general and administrative |
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170,289 |
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155,754 |
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324,680 |
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314,227 |
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Amortization of acquired intangible assets |
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76,260 |
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77,078 |
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146,967 |
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152,756 |
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Acquired in-process research and development |
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330,520 |
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330,520 |
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Facility impairments and loss on sale |
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(799 |
) |
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75,565 |
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(1,098 |
) |
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75,565 |
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Gain on settlement of license agreement |
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(34,192 |
) |
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(34,192 |
) |
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Total costs and expenses |
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782,056 |
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559,333 |
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1,220,242 |
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1,071,860 |
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Income (loss) from operations |
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(122,015 |
) |
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46,301 |
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50,974 |
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121,576 |
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Other income (expense), net |
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21,806 |
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6,051 |
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40,471 |
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(2,874 |
) |
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Income (loss) before income tax provision and cumulative
effect of accounting change |
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(100,209 |
) |
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52,352 |
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91,445 |
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118,702 |
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Income tax expense |
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70,404 |
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17,848 |
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142,868 |
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40,738 |
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Income (loss) before cumulative effect of accounting change |
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(170,613 |
) |
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34,504 |
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(51,423 |
) |
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77,964 |
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Cumulative effect of accounting change, net of income tax |
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3,779 |
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Net income (loss) |
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$ |
(170,613 |
) |
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$ |
34,504 |
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$ |
(47,644 |
) |
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$ |
77,964 |
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Basic earnings (loss) per share: |
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Income (loss) before cumulative effect of accounting change |
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$ |
(0.50 |
) |
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$ |
0.10 |
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$ |
(0.15 |
) |
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$ |
0.23 |
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Cumulative effect of accounting change, net of income tax |
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0.01 |
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Basic earnings (loss) per share |
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$ |
(0.50 |
) |
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$ |
0.10 |
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$ |
(0.14 |
) |
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$ |
0.23 |
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Diluted earnings (loss) per share: |
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Income (loss) before cumulative effect of accounting change |
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$ |
(0.50 |
) |
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$ |
0.10 |
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$ |
(0.15 |
) |
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$ |
0.23 |
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Cumulative effect of accounting change, net of income tax |
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0.01 |
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Diluted earnings (loss) per share |
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$ |
(0.50 |
) |
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$ |
0.10 |
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$ |
(0.14 |
) |
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$ |
0.23 |
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Shares used in calculating: |
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Basic earnings (loss) per share |
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342,375 |
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332,629 |
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341,742 |
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333,946 |
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Diluted earnings (loss) per share |
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342,375 |
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344,735 |
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341,742 |
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348,086 |
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See accompanying notes to the condensed consolidated financial statements.
3
BIOGEN IDEC INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
(unaudited)
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June 30, |
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December 31, |
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2006 |
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2005 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
345,104 |
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$ |
568,168 |
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Marketable securities |
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368,670 |
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282,585 |
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Accounts receivable, net |
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284,912 |
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265,742 |
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Due from unconsolidated joint business |
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164,862 |
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141,059 |
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Deferred tax assets |
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55,732 |
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41,242 |
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Inventory |
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147,024 |
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182,815 |
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Other current assets |
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74,033 |
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78,054 |
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Assets held for sale |
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9,403 |
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58,416 |
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Total current assets |
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1,449,740 |
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1,618,081 |
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Marketable securities |
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1,417,482 |
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1,204,378 |
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Property and equipment, net |
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1,227,296 |
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1,174,396 |
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Intangible assets, net |
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2,856,292 |
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2,975,601 |
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Goodwill |
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1,156,348 |
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1,130,430 |
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Investments and other assets |
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233,004 |
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264,061 |
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$ |
8,340,162 |
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$ |
8,366,947 |
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LIABILITIES AND SHAREHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
62,280 |
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$ |
99,780 |
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Deferred revenue |
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19,415 |
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16,928 |
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Taxes payable |
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|
165,594 |
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|
200,193 |
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Accrued expenses and other |
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252,693 |
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|
266,135 |
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Total current liabilities |
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499,982 |
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|
583,036 |
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Notes payable |
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44,526 |
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43,444 |
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Long-term deferred tax liability |
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|
691,395 |
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|
762,282 |
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Other long-term liabilities |
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|
95,668 |
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|
72,309 |
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Commitments
and contingencies (Notes 10 and 12) |
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Shareholders equity: |
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Convertible preferred stock, par value $0.001 per share |
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Common stock, par value $0.0005 per share |
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173 |
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|
173 |
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Additional paid-in capital |
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|
8,248,773 |
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8,206,911 |
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Accumulated other comprehensive income (loss) |
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(22,532 |
) |
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|
(13,910 |
) |
Deferred stock-based compensation |
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|
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|
(42,894 |
) |
Accumulated deficit |
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(1,104,681 |
) |
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|
(1,021,644 |
) |
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|
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|
7,121,733 |
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|
7,128,636 |
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Less treasury stock, at cost |
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113,142 |
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|
222,760 |
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Total shareholders equity |
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7,008,591 |
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|
6,905,876 |
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|
$ |
8,340,162 |
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|
$ |
8,366,947 |
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See accompanying notes to the condensed consolidated financial statements.
4
BIOGEN IDEC INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
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Six Months Ended |
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June 30, |
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|
2006 |
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|
2005 |
|
Cash flows from operating activities: |
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Net income (loss) |
|
$ |
(47,644 |
) |
|
$ |
77,964 |
|
Adjustments to reconcile net income (loss) to net cash flows from operating activities |
|
|
|
|
|
|
|
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Depreciation and amortization of fixed & intangible assets |
|
|
198,922 |
|
|
|
194,933 |
|
Acquisition of in process research & development |
|
|
330,520 |
|
|
|
|
|
Gain on settlement of license agreement |
|
|
(34,192 |
) |
|
|
|
|
Stock-based compensation |
|
|
65,625 |
|
|
|
16,629 |
|
Non-cash interest expense (income) and amortization of investment premium |
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|
(36 |
) |
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|
25,010 |
|
Deferred income taxes |
|
|
(46,098 |
) |
|
|
(99,560 |
) |
Realized loss on sale of marketable securities |
|
|
1,758 |
|
|
|
1,305 |
|
Write-down of inventory to net realizable value |
|
|
12,049 |
|
|
|
49,613 |
|
Impact of inventory step-up related to inventory sold |
|
|
4,921 |
|
|
|
8,078 |
|
Facility impairments and loss on sale |
|
|
(1,098 |
) |
|
|
81,788 |
|
Impairment of investments and other assets |
|
|
4,439 |
|
|
|
14,588 |
|
Tax benefit from stock options |
|
|
(10,241 |
) |
|
|
17,569 |
|
Other |
|
|
|
|
|
|
(1,996 |
) |
Changes in assets and liabilities, net: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(20,881 |
) |
|
|
19,132 |
|
Due from unconsolidated joint business |
|
|
(23,803 |
) |
|
|
(3,494 |
) |
Inventory |
|
|
(23,578 |
) |
|
|
(50,212 |
) |
Other assets |
|
|
3,308 |
|
|
|
15,593 |
|
Accrued expenses and other current liabilities |
|
|
(82,587 |
) |
|
|
69,643 |
|
Deferred revenue |
|
|
2,487 |
|
|
|
2,694 |
|
Other long-term liabilities |
|
|
5,754 |
|
|
|
2,300 |
|
|
|
|
|
|
|
|
Net cash flows provided by operating activities |
|
|
339,625 |
|
|
|
441,577 |
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
Purchases of marketable securities |
|
|
(1,329,022 |
) |
|
|
(495,724 |
) |
Proceeds from sales and maturities of marketable securities |
|
|
1,023,057 |
|
|
|
1,276,382 |
|
Proceeds from sale of Amevive |
|
|
59,800 |
|
|
|
|
|
Payments for acquisition of Fumapharm, net of cash acquired |
|
|
(215,468 |
) |
|
|
|
|
Payments for acquisition of Conforma, net of cash acquired |
|
|
(147,783 |
) |
|
|
|
|
Acquisitions of property, plant and equipment |
|
|
(79,722 |
) |
|
|
(156,216 |
) |
Proceeds from sale of property, plant and equipment |
|
|
35,857 |
|
|
|
408,130 |
|
Purchases of other investments |
|
|
(4,305 |
) |
|
|
(9,593 |
) |
|
|
|
|
|
|
|
Net cash flows provided by (used in) investing activities |
|
|
(657,586 |
) |
|
|
1,022,979 |
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
Purchase of treasury stock |
|
|
(366 |
) |
|
|
(322,590 |
) |
Issuance of treasury stock for stock-based compensation arrangements |
|
|
74,487 |
|
|
|
64,433 |
|
Change in cash overdrafts |
|
|
(5,303 |
) |
|
|
(31,122 |
) |
Tax benefit from stock options |
|
|
10,241 |
|
|
|
|
|
Repurchase of senior notes |
|
|
|
|
|
|
(746,415 |
) |
Loan proceeds from joint venture partner |
|
|
15,231 |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flow provided by (used in) financing activities |
|
|
94,290 |
|
|
|
(1,035,694 |
) |
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
(223,671 |
) |
|
|
428,862 |
|
Effect of exchange rate changes on cash & cash equivalents |
|
|
607 |
|
|
|
91 |
|
Cash and cash equivalents, beginning of the period |
|
|
568,168 |
|
|
|
209,447 |
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of the period |
|
$ |
345,104 |
|
|
$ |
638,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow disclosures: |
|
|
|
|
|
|
|
|
Cash paid during the period for tax liabilities |
|
$ |
204,392 |
|
|
$ |
29,734 |
|
|
|
|
|
|
|
|
Cash paid during the period for interest |
|
$ |
|
|
|
$ |
38,018 |
|
|
|
|
|
|
|
|
See accompanying notes to the condensed consolidated financial statements.
5
BIOGEN IDEC INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Business Overview and Summary of Significant Accounting Policies
Overview
Biogen Idec is an international biotechnology company that creates new standards of care in
oncology, neurology, and immunology. As a global leader in the development, manufacturing, and
commercialization of novel therapies, we transform scientific discoveries into advances in human
healthcare.
TYSABRI Status
TYSABRI® (natalizumab) was initially approved by the U.S. Food and Drug Administration, or
FDA, in November 2004 to treat relapsing forms of multiple sclerosis, or MS, to reduce the
frequency of clinical relapses. In February 2005, in consultation with the FDA, we and Elan
Corporation plc, or Elan, voluntarily suspended the marketing and commercial distribution of
TYSABRI, and we informed physicians that they should suspend dosing of TYSABRI until further
notification. In addition, we suspended dosing in clinical studies of TYSABRI in MS, Crohns
disease, and rheumatoid arthritis, or RA. These decisions were based on reports of cases of
progressive multifocal leukoencephalopathy, or PML, a rare brain infection that usually causes
death or severe disability, in patients treated with TYSABRI in clinical studies
In March 2006, we and Elan began an open-label, multi-center safety extension study of TYSABRI
monotherapy in the U.S. and internationally. On June 5, 2006, we and Elan announced the FDAs
approval of the supplemental Biologics License Application, or sBLA, for the reintroduction of
TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of disability
and reduce the frequency of clinical relapses. On June 29, 2006, we and Elan announced that the
European Agency for the Evaluation of Medicinal Products, or EMEA, had approved TYSABRI as a
similar treatment. In July 2006, we began to ship TYSABRI in both the United States and Europe.
Basis of Presentation
In the opinion of management, the accompanying unaudited condensed consolidated financial
statements include all adjustments, consisting of only normal recurring accruals, necessary for a
fair statement of our financial position, results of operations, and cash flows as well as those of
our subsidiaries. The information included in this quarterly report on Form 10-Q should be read in
conjunction with our consolidated financial statements and the accompanying notes included in our
Annual Report on Form 10-K for the year ended December 31, 2005. Our accounting policies are
described in the Notes to the Consolidated Financial Statements in our 2005 Annual Report on Form
10-K and updated, as necessary, in this Form 10-Q. The year-end condensed consolidated balance
sheet data was derived from audited financial statements, but does not include all disclosures
required by accounting principles generally accepted in the US. The results of operations for the
three and six months ended June 30, 2006 are not necessarily indicative of the operating results
for the full year or for any other subsequent interim period.
The preparation of the condensed consolidated financial statements in conformity with
generally accepted accounting principles requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements, and the reported amounts of revenues and
expenses during the reporting period. Actual results could differ from those estimates.
Principles of Consolidation
The condensed consolidated financial statements include our financial statements and those of
our wholly-owned subsidiaries, and joint ventures in Italy and Switzerland, in which we are the
primary beneficiary. We also consolidate a limited partnership investment, in which we are the
majority investor. All material intercompany balances and transactions have been eliminated.
6
Inventory
Inventories are stated at the lower of cost or market with cost determined under the first-in,
first-out, or FIFO, method. Included in inventory are raw materials used in the production of
pre-clinical and clinical products, which are charged to research and development expense when
consumed.
The components of inventory are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
42,698 |
|
|
$ |
44,417 |
|
Work in process |
|
|
87,195 |
|
|
|
107,987 |
|
Finished goods |
|
|
17,131 |
|
|
|
30,411 |
|
|
|
|
|
|
|
|
|
|
$ |
147,024 |
|
|
$ |
182,815 |
|
|
|
|
|
|
|
|
Capitalization of Inventory Costs
We capitalize inventory costs associated with our products prior to regulatory approval, when,
based on managements judgment, future commercialization is considered probable and the future
economic benefit is expected to be realized. We consider numerous attributes in evaluating whether
the costs to manufacture a particular product should be capitalized as an asset. We assess the
regulatory approval process and where the product stands in relation to that approval process
including any known constraints and impediments to approval, including safety, efficacy and
potential labeling restrictions. We evaluate our anticipated research and development initiatives
and constraints relating to the particular product and the indication in which it will be used. We
consider our manufacturing environment including our supply chain in determining logistical
constraints that could possibly hamper approval or commercialization. We consider the shelf life of
the product in relation to the expected timeline for approval and we consider patent related or
contract issues that may prevent or cause delay in commercialization. We are sensitive to the
significant commitment of capital to scale up production and to launch commercialization
strategies. We also base our judgment on the viability of commercialization, trends in the
marketplace and market acceptance criteria. Finally, we consider the reimbursement strategies that
may prevail with respect to the product and assess the economic benefit that we are likely to
realize. We would be required to expense previously capitalized costs related to pre-approval
inventory upon a change in such judgment, due to, among other potential factors, a denial or delay
of approval by necessary regulatory bodies.
As of June 30, 2006, $22.1 million and $0.1 million of TYSABRI inventory is included in work
in process and finished goods, respectively. As of December 31, 2005, there was no TYSABRI
inventory on our consolidated balance sheet. In the first quarter of 2006, in light of expectations
of the re-introduction of TYSABRI, we began a new manufacturing campaign. On June 5, 2006, the FDA
approved the reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow
the progression of disability and reduce the frequency of clinical relapses. On June 29, 2006, we
and Elan announced the EMEAs approval of TYSABRI as a similar treatment. In July 2006, we began to
ship TYSABRI in both the United States and Europe.
TYSABRI currently has an approved shelf life of up to 48 months. Based on our sales forecasts
for TYSABRI, we expect the carrying value of the TYSABRI inventory to be realized.
We manufactured TYSABRI during the first and second quarter of 2005 and completed our
scheduled production of TYSABRI during July 2005. Because of the uncertain future commercial
availability of TYSABRI at the time, and our inability to predict to the required degree of
certainty that TYSABRI inventory would be realized in commercial sales prior to the expiration of
its shelf life, we expensed $23.2 million of costs related to the manufacture of TYSABRI in the
first quarter of 2005 to cost of product revenues. At the time of production, the inventory was
believed to be commercially saleable. During 2005, as we worked with clinical investigators to
understand the possible risks of PML, we charged the costs related to the manufacture of TYSABRI to
research and development expense. As we sell TYSABRI, we will
recognize lower than normal cost of sales due to the amounts written-off.
Valuation of Inventory
We periodically review our inventories for excess or obsolete inventory and write-down
obsolete or otherwise unmarketable inventory to its estimated net realized value. If the actual
realizable value is less than that estimated by us, or if there are any further determinations that
inventory will not be marketable based on estimates of demand, additional inventory write-downs may
be required. This periodic review led to the expensing of costs associated with the manufacture of
TYSABRI during 2005, as described above, and may lead us to expense costs associated with the
manufacture of TYSABRI or other inventory in subsequent periods.
7
Our products are subject to strict quality control and monitoring throughout the manufacturing
process. Periodically, certain batches or units of product may no longer meet quality
specifications or may expire. As a result, included in cost of product revenues were write-downs of
commercial inventory that did not meet quality specifications or became obsolete due to dating
expiration, in all cases this product inventory was written-down to its net realizable value.
We wrote-down the following unmarketable inventory, which was charged to cost of product
revenues (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
AVONEX® |
|
$ |
3,380 |
|
|
$ |
738 |
|
|
$ |
3,634 |
|
|
$ |
9,545 |
|
AMEVIVE® |
|
|
|
|
|
|
7,125 |
|
|
|
2,433 |
|
|
|
14,288 |
|
ZEVALIN® |
|
|
3,177 |
|
|
|
678 |
|
|
|
3,177 |
|
|
|
2,580 |
|
TYSABRI® |
|
|
2,194 |
|
|
|
|
|
|
|
2,805 |
|
|
|
23,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,751 |
|
|
$ |
8,541 |
|
|
$ |
12,049 |
|
|
$ |
49,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The write-downs for the three and six months ended June 30, 2006 and 2005, respectively, were
the result of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
New components for alternative presentations |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
8,417 |
|
Failed quality specifications |
|
|
7,866 |
|
|
|
7,708 |
|
|
|
10,910 |
|
|
|
15,260 |
|
Excess and/or obsolescence |
|
|
885 |
|
|
|
833 |
|
|
|
1,139 |
|
|
|
2,736 |
|
Costs for voluntary suspension of TYSABRI |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,751 |
|
|
$ |
8,541 |
|
|
$ |
12,049 |
|
|
$ |
49,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible Assets and Goodwill
As of June 30, 2006 and December 31, 2005, intangible assets and goodwill, net of accumulated
amortization and impairment charges and adjustments, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
Historical |
|
|
Accumulated |
|
|
|
|
|
|
|
June 30, 2006: |
|
Life |
|
Cost |
|
|
Amortization |
|
|
Adjustments |
|
|
Net |
|
Out-licensed patents |
|
12 years |
|
$ |
578,000 |
|
|
$ |
126,839 |
|
|
$ |
|
|
|
$ |
451,161 |
|
Core/developed technology |
|
15 20 years |
|
|
3,001,370 |
|
|
|
664,284 |
|
|
|
|
|
|
|
2,337,086 |
|
Trademarks & tradenames |
|
Indefinite |
|
|
64,000 |
|
|
|
|
|
|
|
|
|
|
|
64,000 |
|
In-licensed patents |
|
14 years |
|
|
3,000 |
|
|
|
355 |
|
|
|
|
|
|
|
2,645 |
|
Assembled workforce |
|
4 years |
|
|
1,400 |
|
|
|
|
|
|
|
|
|
|
|
1,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
3,647,770 |
|
|
$ |
791,478 |
|
|
$ |
|
|
|
$ |
2,856,292 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
Indefinite |
|
$ |
1,150,935 |
|
|
$ |
|
|
|
$ |
5,413 |
|
|
$ |
1,156,348 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
Historical |
|
|
Accumulated |
|
|
|
|
|
|
|
December 31, 2005: |
|
Life |
|
Cost |
|
|
Amortization |
|
|
Adjustments |
|
|
Net |
|
Out-licensed patents |
|
12 years |
|
$ |
578,000 |
|
|
$ |
102,756 |
|
|
$ |
|
|
|
$ |
475,244 |
|
Core/developed technology |
|
15-20 years |
|
|
2,984,000 |
|
|
|
542,407 |
|
|
|
(7,993 |
) |
|
|
2,433,600 |
|
Trademarks & tradenames |
|
Indefinite |
|
|
64,000 |
|
|
|
|
|
|
|
|
|
|
|
64,000 |
|
In-licensed patents |
|
14 years |
|
|
3,000 |
|
|
|
243 |
|
|
|
|
|
|
|
2,757 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
$ |
3,629,000 |
|
|
$ |
645,406 |
|
|
$ |
(7,993 |
) |
|
$ |
2,975,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill |
|
Indefinite |
|
$ |
1,151,105 |
|
|
$ |
|
|
|
$ |
(20,675 |
) |
|
$ |
1,130,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As discussed in Note 2, Acquisitions, core/developed technology, goodwill and assembled workforce
increased by $26.4 million, $20.5 million, and $1.4 million, respectively, as a result of the
acquisition of entities in the second quarter of 2006.
8
Revenue Recognition
Product Revenues
We recognize revenue when all of the following criteria are met: persuasive evidence of an
arrangement exists; delivery has occurred or services have been rendered; the sellers price to the
buyer is fixed or determinable; collectibility is reasonably assured; and title and the risks and
rewards of ownership have transferred to the buyer.
Revenues from product sales are recognized when product is shipped and title and risk of loss
has passed to the customer, typically upon delivery. The timing of distributor orders and shipments
can cause variability in earnings. Revenues are recorded net of applicable allowances for returns,
patient assistance, trade term discounts, Medicaid rebates, Veterans Administration rebates,
managed care discounts and other applicable allowances. Included in our condensed consolidated
balance sheets at June 30, 2006 and December 31, 2005 are allowances for returns, rebates,
discounts and other allowances which totaled $65.1 million and $65.3 million, respectively.
At June
30, 2006, our allowance for product returns, which is a component of allowances for returns,
rebates, discounts, and other allowances, was $15.0 million. At June 30, 2006, total reserves for
discounts and allowances were approximately 4.5% of total current assets and less than 1% of total
assets. We prepare our estimates for sales returns and allowances, discounts and rebates quarterly
based primarily on historical experience updated for changes in facts and circumstances, as
appropriate.
During the three months ended June 30, 2006, we recorded a charge of $6.9 million related to our
allowance for expired products. The charge is included in our total
reductions in revenue for the three months of
$63.1 million and was calculated based on an analysis of our experience in relation to expired
products. Additionally, we recorded an increase to goodwill of
$5.4 million related to increasing reserve levels at the time
of our merger with Biogen Inc. in 2003. We determined an historical rate for returns based on volumes of returns and the amount
of credit granted to the returning distributor. Based on the analysis, we determined that the
charge of $6.9 million and the increase to goodwill were required to be added to existing reserve levels. The $6.9 million charge
relates largely to prior years and arises from applying higher return rates than we had historically
applied. We have determined that, in accordance with APB 28,
Interim Financial Reporting paragraph 29, that the
charge is an error but one that is not material to the current period
or current year.
Additionally, we have determined that
the error is not material to any prior year and that the error
associated with the increase to goodwill was not material.
Product returns, which is a component of allowances for returns, rebates, discounts, and other
allowances, were $4.0 million and $11.3 million for the three and six months ended June 30, 2006,
and $4.1 million and $16.1 million for the comparable periods in 2005. The decrease of product
returns in the first six months of 2006, as compared to the same period in 2005, is primarily a
result of $9.7 million included in the first six months of 2005 due to the voluntary suspension of
TYSABRI, offset by a higher number of replacement units and higher credit amounts on distributor
returns. Product returns in the three and six months ended June 30, 2006 included $2.8 million and $6.7 million, respectively,
related to product sales made
prior to 2006. Of these amounts, $1.6 million was in
reserves at December 31, 2005.
Under our agreement with Elan, we manufacture TYSABRI and, in the US (prior to its
suspension), sold TYSABRI to Elan who then distributed TYSABRI to third party distributors. Prior
to the suspension, we recorded revenue when TYSABRI was shipped from Elan to third party
distributors. As of March 31, 2005, under our revenue recognition policy, we deferred $14.0 million
in revenue from Elan related to sales of TYSABRI that had not yet been shipped by Elan. The amount
has been fully paid to us by Elan. The amount remained deferred at
June 30, 2006 and is expected to be recognized by the end of 2006, as the product expires.
As of June 30, 2006, Elan owed us $20.6 million, representing commercialization and
development expenses incurred by us. This is included in other current assets on our condensed
consolidated balance sheet.
Revenues from unconsolidated joint business
Revenues from unconsolidated joint business consist of our share of the pretax copromotion
profits generated from our copromotion arrangement with Genentech Inc. or Genentech, reimbursement
from Genentech of our RITUXAN-related sales force and development expenses, and royalties from
Genentech for sales of RITUXAN® (rituximab) outside the U.S. by F. Hoffman LaRoche., or Roche, and
Zenyaku Kogyo Co. Ltd., or Zenyaku. Under the copromotion arrangement, all U.S. sales of RITUXAN
and associated costs and expenses are recognized by Genentech and we record our share of the pretax
copromotion profits on a quarterly basis, as defined in our amended and restated collaboration
agreement with Genentech. Pretax copromotion profits under the copromotion arrangement are derived
by taking U.S. net sales of RITUXAN to third-party customers less cost of sales, third-party
royalty expenses, distribution, selling and marketing expenses, and joint development expenses
incurred by Genentech and us. We record royalty revenue on sales of RITUXAN outside the U.S. on a
cash basis.
Royalty Revenues
We receive royalty revenues under license agreements with a number of third parties that sell
products based on technology we have developed or to which we have rights. The license agreements
provide for the payment of royalties to us based on sales of the
9
licensed product. We record these revenues based on estimates of the sales that occurred
during the relevant period. The relevant period estimates of sales are based on interim data
provided by licensees and analysis of historical royalties we have been paid (adjusted for any
changes in facts and circumstances, as appropriate). We maintain regular communication with our
licensees in order to gauge the reasonableness of our estimates. Differences between actual royalty
revenues and estimated royalty revenues are reconciled and adjusted for in the period which they
become known, typically the following quarter. Historically, adjustments have not been material
based on actual amounts paid by licensees. There are no future performance obligations on our part
under these license agreements. To the extent we do not have sufficient ability to accurately
estimate revenue, we record it on a cash basis.
Research and Development Expenses
Research and development expenses consist of upfront fees and milestones paid to collaborators
and expenses incurred in performing research and development activities including salaries and
benefits, facilities expenses, overhead expenses, clinical trial and related clinical manufacturing
expenses, share-based compensation expense, contract services, and other outside expenses. Research
and development expenses are expensed as incurred. We have entered into certain research agreements
in which we share expenses with our collaborator. We have entered into other collaborations where
we are reimbursed for work performed on behalf of our collaborative partners. We record these
expenses as research and development expenses. If the arrangement is a cost-sharing arrangement and
there is a period during which we receive payments from the collaborator, we record payments by the
collaborator for their share of the development effort as a reduction of research and development
expense. If the arrangement is a reimbursement of research and development expenses, we record the
reimbursement as corporate partner revenue.
Acquired In-Process Research and Development
Acquired in-process research and development, or IPR&D, represents the estimated fair value
assigned to research and development projects that we acquire which have not been completed at the
date of acquisition and which have no future alternative use. Accordingly, the fair value of such
projects is charged to expense as of the acquisition date.
The value assigned to acquired IPR&D is determined by estimating the costs to develop the
acquired technology into commercially viable products, estimating the resulting net cash flows from
the projects, and discounting the net cash flows to present value. The revenue projections used to
value IPR&D were, as applicable, reduced based on the probability of developing a new drug.
Additionally, the projections considered the relevant market sizes and growth factors, expected
trends in technology, and the nature and expected timing of new product introductions by us and our
competitors. The resulting net cash flows from such projects are based on managements estimates of
cost of sales, operating expenses, and income taxes from such projects. The rates utilized to
discount the net cash flows to their present value were based on estimated cost of capital
calculations.
If these projects are not successfully developed, the sales and profitability of the company
may be adversely affected in future periods. Additionally, the value of other acquired intangible
assets may become impaired. We believed that the foregoing assumptions used in the IPR&D analysis
were reasonable at the time of the acquisition. No assurance can be given, however, that the
underlying assumptions used to estimate expected project sales, development costs or profitability,
or the events associated with such projects, will transpire as estimated.
Reclassification
Certain reclassifications of prior year amounts have been made to conform to current year
presentation.
Share-Based Payments
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123
(revised 2004) Share-Based Payment, or SFAS 123(R), which requires compensation cost relating to
share-based payment transactions to be recognized in the financial statements using a fair-value
measurement method. See Note 6, Share-Based Payments, for a complete discussion on accounting for
share-based payments.
Assets Held For Sale
We consider certain real property in Oceanside, CA and certain other miscellaneous assets as
held for sale, since they meet the criteria of held for sale under SFAS 144, Accounting for the
Impairment or Disposal of Long-Live Assets.
10
We sold the worldwide rights to AMEVIVE for $59.8 million, including inventory on hand, to
Astellas Pharma US, Inc., in April 2006. As of December 31, 2005, our AMEVIVE assets held for sale
included $8.0 million, net, related to intangible assets, and $5.4 million, for property, plant and
equipment, net, and were reported separately in current assets on the condensed consolidated
balance sheet. Additionally, approximately $43.7 million in
inventory was sold. The pre-tax gain on this sale was approximately
$2.8 million and is being deferred and recognized over the
period of a related supply contract.
In February 2006, we sold our NICO clinical manufacturing facility in Oceanside, California to
Genentech. The assets associated with the NICO clinical manufacturing facility were included in
assets held for sale on our condensed consolidated balance sheet as of December 31, 2005.
2. Acquisitions
During the three months ended June 30, 2006, we acquired two entities, Fumapharm AG, or
Fumapharm, and Conforma Therapeutics Corporation, or Conforma.
Fumapharm
On June 15, 2006, we completed the acquisition of 100% of the stock of Fumapharm, a privately
held pharmaceutical company based in Switzerland that develops therapeutics derived from fumaric
acid esters. As part of the acquisition, we acquired: FUMADERM®, a commercial product available in
Germany for the treatment of psoriasis, and BG-12, a clinical-stage compound being studied for the
treatment of MS and psoriasis that was being jointly developed by Fumapharm and us. The purpose of
this acquisition was to support our goal of developing innovative therapeutic options for people
living with MS.
As part of the acquisition, we agreed to pay $220.0 million, of which $218.0 million was paid
at closing and $2.0 million was retained and will
be paid upon satisfaction of customary representations and
warranties. We agreed to additional payments of: i) $15.0 million upon
achievement of certain regulatory approvals, and ii) up to an additional $300.0 million in the
event that annual and cumulative sales targets are achieved. The $2.0 million retention amount has
been accrued on our consolidated balance sheet as of June 30, 2006.
The acquisition was funded from our existing cash on hand and has been accounted for as a
business combination. Assets and liabilities assumed have been recorded at their fair values as of
the date of acquisition. The results of operations for Fumapharm are included from the date of
acquisition. We have completed our preliminary purchase price allocation for the acquisition as set
out below (in millions):
|
|
|
|
|
Purchase Price Allocation |
|
|
|
|
Current assets |
|
$ |
3.7 |
|
IPR&D |
|
|
207.4 |
|
Core technology |
|
|
16.9 |
|
Developed technology |
|
|
9.5 |
|
Goodwill |
|
|
20.5 |
|
Other assets |
|
|
1.2 |
|
Deferred tax liabilities |
|
|
(2.8 |
) |
Other liabilities |
|
|
(1.9 |
) |
|
|
|
|
|
|
$ |
254.5 |
|
|
|
|
|
Consideration and Gain |
|
|
|
|
Consideration |
|
$ |
220.0 |
|
Gain on settlement of license agreement |
|
|
34.2 |
|
Transaction costs |
|
|
0.3 |
|
|
|
|
|
|
|
$ |
254.5 |
|
|
|
|
|
The purchase price allocation is considered preliminary as we are currently evaluating certain
executory contracts to determine whether the contracted services will
be required. We expect to complete the purchase price allocation
during the third quarter of 2006.
The amount allocated to IPR&D projects relates to the development of BG-12. BG-12 recently
received positive results from a Phase II study of its efficacy and safety for patients with
relapsing-remitting MS. We expect to incur an additional $190 million to
11
complete the project. The estimated revenues from BG-12 are expected to be recognized
beginning in 2011. A discount rate of 12% was used to value the project which we believe to be
commensurate with the stage of development and the uncertainties in the economic estimates
described above. At the date of acquisition, the development of BG-12 had not yet
reached technological feasibility, and the research and development in progress had no alternative
future uses. Accordingly, the $207.4 million in IPR&D was expensed in the three months ended June
30, 2006.
The fair value of intangible assets was based on valuations using an income approach, with
estimates and assumptions provided by management. The core technology asset represents a
combination of Fumapharms processes and procedures related to the design and development of its
application products. The developed technology relates to processes and procedures related to
products that have reached technological feasibility. Core technology is being amortized over
approximately 12 years and the developed technology over approximately 3 years. The excess of
purchase price over tangible assets, identifiable intangible assets and assumed liabilities was
recorded as goodwill. None of the goodwill or intangible assets acquired are deductible for income
tax purposes. As a result, we recorded a deferred tax liability of $2.8 million, relating to the
tax effect of the amount of the acquired intangible assets other than goodwill.
In addition to the assets acquired, a gain of $34.2 million was recognized coincident with the
acquisition of Fumapharm in accordance with EITF 04-1, Accounting for Preexisting Relationships
between the Parties to a Business Combination. The gain related to the settlement of a preexisting
license agreement between Fumapharm and us. The license agreement in question had been entered into
in October 2003 and required us to make payments to Fumapharm of certain royalty amounts. The
market rate for such payments was determined to have increased due, principally, to the increased
technical feasibility of BG-12. The gain relates, principally, to the difference between i) the
royalty rates at the time the agreement was entered into as compared to ii) the royalty rates at
the time the agreement was effectively settled by virtue of our acquisition of Fumapharm.
Future
contingent consideration payments, if any, will be accounted for as increases to goodwill.
The total revenue, operating income (loss) and net income (loss) impact of the acquisition for
the three and six months ended June 30, 2006 and 2005 were not material.
Conforma
In May 2006, we completed the acquisition of 100% of the stock of Conforma, a privately-held
development stage biopharmaceutical company based in California that focused on the design and
development of drugs for the treatment of cancer. The goal of this acquisition was to enable us to
broaden our therapeutic opportunities in the field of oncology.
We acquired all of the issued and outstanding shares of the capital stock of Conforma for
$150.0 million, paid at closing. Of this amount, $15.0 million has been escrowed by the sellers
pending satisfaction of customary representations and warranties made by Conforma. Up to an
additional $100.0 million would be payable to the sellers upon the achievement of certain future
development milestones. Additionally, $0.5 million in transaction costs were incurred and loans of
approximately $2.3 million were made to certain non-officer employees of Conforma. Such loans are fully
collateralized and were made for the purpose of assisting the employees in meeting tax liabilities.
The acquisition was funded from our existing cash on hand and was accounted for as an asset
acquisition as Conforma is a development-stage company. As a result of the acquisition, we obtained
the rights to two compounds in Phase I clinical trials: CNF1010, a proprietary form of the
geldanamycin derivative 17-AAG; and CNF2024, a totally synthetic, orally bioavailable heat shock
protein 90 inhibitor.
The results of operations of Conforma are included from the date of acquisition. We have
completed our purchase price allocation for the acquisition as set out below (in millions):
|
|
|
|
|
Current assets |
|
$ |
2.5 |
|
Fixed assets |
|
|
0.8 |
|
Deferred tax asset |
|
|
24.0 |
|
Assembled workforce |
|
|
1.4 |
|
IPR&D |
|
|
123.1 |
|
Current liabilities |
|
|
(1.3 |
) |
|
|
|
|
|
|
$ |
150.5 |
|
|
|
|
|
12
The amount allocated to IPR&D relates to the development of CNF2024, which is in Phase I
clinical trials. We expect to incur an additional $80 million to complete the project.
The estimated revenues from CNF2024 are expected to be recognized
beginning in 2012. A discount
rate of 12% was used to value the project which we believe to be commensurate with the stage of
development and the uncertainties in the economic estimates described above. At the date
of acquisition, this compound had not reached technological feasibility and had no alternative
future use. Accordingly, the $123.1 million in IPR&D was expensed in the three months ended June
30, 2006.
Upon acquisition, we recognized a deferred tax asset of $24.0 million relating to US federal
and state net operating losses and tax credit carryforwards that we
acquired from Conforma. The amount allocated to deferred tax assets does not include certain tax attributes, such as
net operating losses and research credits, that may not be realized because they are subject to
annual limitations under the Internal Revenue Code due to a cumulative ownership change of more
than 50%.
Future
contingent consideration payments, if any, will be expensed to IPR&D.
In connection with this asset purchase, approximately $1.2 million of severance costs were
incurred and are recorded in the consolidated statement of operations. (See Note 16, Severance and
Other Restructuring Costs).
The total revenue, operating income (loss) and net income (loss) impact of the acquisition for
the three and six months ended June 30, 2006 and 2005 were not material.
3. Financial Instruments
We have foreign currency forward contracts to hedge specific forecasted transactions
denominated in foreign currencies. All foreign currency forward contracts have durations of three
to six months. These contracts have been designated as cash flow hedges and accordingly, to the
extent effective, any unrealized gains or losses on these foreign currency forward contracts are
reported in other comprehensive income. Realized gains and losses for the effective portion are
recognized with the underlying hedge transaction. The notional settlement amount of the foreign
currency forward contracts outstanding at June 30, 2006 was approximately $112.7 million. These
contracts had a fair value of $8.2 million, representing an unrealized loss, and were included in
other current liabilities at June 30, 2006. The notional settlement amount of the foreign currency
forward contracts outstanding at December 31, 2005 was approximately $214.0 million. These
contracts had a fair value of $0.9 million, representing an unrealized loss, and were included in
other current liabilities at December 31, 2005.
For the three and six months ended June 30, 2006, there was $0.2 million and $0.9 million,
respectively recognized in earnings due to hedge ineffectiveness. There were no material amounts in
the three and six months ended June 30, 2006 related to the discontinuance of cash flow hedge
accounting because it was no longer probable that the hedge forecasted transaction would occur. For
the three and six months ended June 30, 2005, we recognized $1.0 million of gains in earnings due
to hedge ineffectiveness and no significant amounts as a result of the discontinuance of cash flow
hedge accounting because it was no longer probable that the hedge forecasted transaction would
occur. We recognized approximately $2.9 million and $3.7 million of losses in product revenue for
the settlement of certain effective cash flow hedge instruments for the three and six months ended
June 30, 2006, respectively, as compared to approximately $0.4 million and $2.2 million of losses
for the three and six months ended June 30, 2005, respectively. We recognized no significant gains
or losses in royalty revenue for the settlement of effective cash flow hedge instruments for the
three and six months ended June 30, 2006, respectively, as compared to approximately $0.1 million
and $0.3 million of losses for the three and six months ended June 30, 2005, respectively. These
settlements were recorded in the same period as the related forecasted transactions affecting
earnings.
4. Comprehensive Income (Loss)
Our accumulated comprehensive income was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
June |
|
|
December |
|
|
|
30, 2006 |
|
|
31, 2005 |
|
Translation
adjustments, net of taxes |
|
$ |
9,665 |
|
|
$ |
(9,960 |
) |
Unrealized holding gains and losses on marketable securities and other investments, net of taxes |
|
|
(27,100 |
) |
|
|
(3,376 |
) |
Unrealized gains and losses on derivative instruments, net of taxes |
|
|
(5,097 |
) |
|
|
(574 |
) |
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
$ |
(22,532 |
) |
|
$ |
(13,910 |
) |
|
|
|
|
|
|
|
13
The activity in comprehensive income for the three and six months ended June 30, 2006, and
2005, was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Net income (loss) |
|
$ |
(170,613 |
) |
|
$ |
34,504 |
|
|
$ |
(47,644 |
) |
|
$ |
77,964 |
|
Translation adjustments |
|
|
14,829 |
|
|
|
(8,306 |
) |
|
|
19,625 |
|
|
|
(11,790 |
) |
Unrealized holding gains and losses on investments |
|
|
(39,087 |
) |
|
|
3,977 |
|
|
|
(23,725 |
) |
|
|
(5,768 |
) |
Unrealized gains and losses on derivative instruments |
|
|
(2,867 |
) |
|
|
5,324 |
|
|
|
(4,522 |
) |
|
|
12,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
$ |
(197,738 |
) |
|
$ |
35,499 |
|
|
$ |
(56,266 |
) |
|
$ |
72,481 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5. Earnings per Share
We calculate earnings per share in accordance with Statement of Financial Accounting Standards
No. 128, Earnings per Share, or SFAS 128, and EITF 03-06, Participating Securities and the
Two-Class Method Under SFAS 128, or EITF 03-06, SFAS 128 and EITF 03-06 together require the
presentation of basic earnings per share and diluted earnings per share.
Basic earnings per share is computed using the two-class method. Under the two-class method,
undistributed net income is allocated to common stock and participating securities based on their
respective rights to share in dividends. We have determined that our preferred shares meet the
definition of participating securities, and have allocated a portion of net income to our preferred
shares on a pro rata basis. Net income allocated to preferred shares is excluded from the
calculation of basic earnings per share. For basic earnings per share, net income available to
holders of common stock is divided by the weighted average number of shares of common stock
outstanding. For purposes of calculating diluted earnings per share, net income is adjusted for the
after-tax amount of interest associated with convertible debt and net income allocable to preferred
shares, and the denominator includes both the weighted average number of shares of common stock
outstanding and the potential dilutive shares of common stock from stock options, unvested
restricted stock awards, restricted stock units and other convertible securities, to the extent
they are dilutive.
Basic and diluted earnings (loss) per share are calculated as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before cumulative effect of accounting change |
|
$ |
(170,613 |
) |
|
$ |
34,504 |
|
|
$ |
(51,423 |
) |
|
$ |
77,964 |
|
Cumulative effect of accounting change |
|
|
|
|
|
|
|
|
|
|
3,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
(170,613 |
) |
|
|
34,504 |
|
|
|
(47,644 |
) |
|
|
77,964 |
|
Adjustment for net income (loss) allocable to preferred shares |
|
|
|
|
|
|
51 |
|
|
|
|
|
|
|
115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) used in calculating basic earnings per share |
|
|
(170,613 |
) |
|
|
34,453 |
|
|
|
(47,644 |
) |
|
|
77,849 |
|
Adjustment for interest, net of tax |
|
|
|
|
|
|
519 |
|
|
|
|
|
|
|
1,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) used in calculating diluted earnings per share |
|
$ |
(170,613 |
) |
|
$ |
34,972 |
|
|
$ |
(47,644 |
) |
|
$ |
78,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
342,375 |
|
|
|
332,629 |
|
|
|
341,742 |
|
|
|
333,946 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options |
|
|
|
|
|
|
2,282 |
|
|
|
|
|
|
|
4,124 |
|
Restricted stock awards |
|
|
|
|
|
|
1,871 |
|
|
|
|
|
|
|
1,674 |
|
Convertible promissory notes due 2019 |
|
|
|
|
|
|
7,953 |
|
|
|
|
|
|
|
8,342 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares |
|
|
|
|
|
|
12,106 |
|
|
|
|
|
|
|
14,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted earnings (loss) per share |
|
|
342,375 |
|
|
|
344,735 |
|
|
|
341,742 |
|
|
|
348,086 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following amounts were not included in the calculation of net income (loss) per share
because their effects were anti-dilutive (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Numerator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) allocable to preferred shares |
|
$ |
(245 |
) |
|
$ |
51 |
|
|
$ |
(69 |
) |
|
$ |
115 |
|
Adjustment for interest, net of tax |
|
|
|
|
|
|
1,397 |
|
|
|
|
|
|
|
5,409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(245 |
) |
|
$ |
1,448 |
|
|
$ |
(69 |
) |
|
$ |
5,524 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
493 |
|
|
|
493 |
|
|
|
493 |
|
|
|
493 |
|
Stock options |
|
|
19,022 |
|
|
|
26,774 |
|
|
|
19,563 |
|
|
|
16,355 |
|
Restricted stock awards |
|
|
860 |
|
|
|
|
|
|
|
811 |
|
|
|
|
|
Restricted stock units |
|
|
303 |
|
|
|
|
|
|
|
204 |
|
|
|
|
|
Convertible promissory notes due 2019 |
|
|
3,048 |
|
|
|
|
|
|
|
3,048 |
|
|
|
|
|
Convertible promissory notes due 2032 |
|
|
73 |
|
|
|
2,810 |
|
|
|
73 |
|
|
|
5,719 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
23,799 |
|
|
|
30,077 |
|
|
|
24,192 |
|
|
|
22,567 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6. Share-Based Payments
Fair Value Method Accounting
Our share-based compensation programs consist of share-based awards granted to employees
including stock options, restricted stock awards, and performance and time-vested restricted stock
units, as well as our employee stock purchase plan.
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123
(revised 2004), Share-Based Payment, or SFAS 123(R). This Statement requires compensation cost
relating to share-based payment transactions to be recognized in the financial statements using a
fair-value measurement method. Under the fair value method, the estimated fair value of awards is
charged against income over the requisite service period, which is generally the vesting period. We
selected the modified prospective method as prescribed in SFAS 123(R) and therefore, prior periods
were not restated. Under the modified prospective application, this Statement was applied to new
awards granted in 2006, as well as to the unvested portion of previously granted share-based awards
for which the requisite service had not been rendered as of December 31, 2005.
On December 6, 2005, our Board of Directors approved the acceleration of vesting of unvested
stock options then outstanding having an exercise price per share of $55.00 or higher, granted
under our stock option plans that were held by current employees, including executive officers.
Shares of common stock acquired by our executive officers upon the exercise of stock options whose
vesting was so accelerated generally are subject to transfer restrictions until such time as the
stock options otherwise would have vested. Options held by our non-employee directors were
excluded from this vesting acceleration. As a result, the vesting of options granted predominantly
from 2001 to 2005 with respect to approximately 4,518,809 shares of our common stock was
accelerated.
The purpose of this acceleration was to eliminate future compensation expense that we would
otherwise have recognized in our results of operation upon adoption of SFAS 123(R) in 2006. The
approximate future expense eliminated by the acceleration, based on a Black-Scholes calculation,
was estimated to be approximately $93.1 million between 2006 and 2009 on a pre-tax basis. The
acceleration did not result in any compensation expense in 2005.
In the second quarter of 2006, we recorded pre-tax share-based compensation expense associated
with the SFAS 123(R) adoption and the restricted stock units of $40.3 million. In the six months
ended June 30, 2006, we recorded pre-tax share-based compensation expense of $63.9 million. This
expense is net of a cumulative effect pre-tax adjustment of $5.6 million, or $3.8 million
after-tax, resulting from the application of an estimated forfeiture rate for current and prior
period unvested restricted stock awards. As a result of adopting SFAS 123R on January 1, 2006, our
net income before taxes and net income for the three and six months ended
June 30, 2006 is $13.7 million and $19.6 million lower
than if we continued to account for stock-based employee compensation under APB 25.
For the three and six months ended June 30, 2006, share-based compensation expense reduced our
results of operations as follows (in thousands except for Earnings Per Share):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2006 |
|
|
Six months ended June 30, 2006 |
|
|
|
Effect before |
|
|
|
|
|
|
|
|
|
|
Effect before |
|
|
|
|
|
|
|
|
|
cumulative |
|
|
|
|
|
|
|
|
|
|
cumulative |
|
|
Cumulative |
|
|
|
|
|
|
effect of |
|
|
Cumulative effect |
|
|
|
|
|
|
effect of |
|
|
effect |
|
|
|
|
|
|
accounting |
|
|
of accounting |
|
|
Effect on net |
|
|
accounting |
|
|
of accounting |
|
|
Effect on net |
|
|
|
change |
|
|
change |
|
|
income (loss) |
|
|
change |
|
|
change |
|
|
income (loss) |
|
Income Before Income Taxes |
|
$ |
40,272 |
|
|
$ |
|
|
|
$ |
40,272 |
|
|
$ |
69,466 |
|
|
$ |
(5,574 |
) |
|
$ |
63,892 |
|
Tax effect |
|
|
(12,864 |
) |
|
|
|
|
|
|
(12,864 |
) |
|
|
(21,938 |
) |
|
|
1,795 |
|
|
|
(20,143 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
27,408 |
|
|
$ |
|
|
|
$ |
27,408 |
|
|
$ |
47,528 |
|
|
$ |
(3,779 |
) |
|
$ |
43,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic Earnings (Loss) Per Share: |
|
$ |
.08 |
|
|
$ |
|
|
|
$ |
.08 |
|
|
$ |
.14 |
|
|
$ |
(.01 |
) |
|
$ |
.13 |
|
Diluted Earnings (Loss) Per Share: |
|
$ |
.08 |
|
|
$ |
|
|
|
$ |
.08 |
|
|
$ |
.14 |
|
|
$ |
(.01 |
) |
|
$ |
.13 |
|
15
As a result of the adoption of SFAS 123(R), we recorded share-based compensation for the three
and six months ended June 30, 2006 as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2006 |
|
|
Six months ended June 30, 2006 |
|
|
|
|
|
|
|
Restricted Stock |
|
|
|
|
|
|
|
|
|
|
Restricted Stock |
|
|
|
|
|
|
Stock options |
|
|
and Restricted |
|
|
|
|
|
|
Stock options & |
|
|
and Restricted |
|
|
|
|
|
|
& ESPP |
|
|
Stock Units |
|
|
Total |
|
|
ESPP |
|
|
Stock Units |
|
|
Total |
|
Research and development |
|
$ |
6,411 |
|
|
$ |
10,946 |
|
|
$ |
17,357 |
|
|
$ |
11,324 |
|
|
$ |
17,345 |
|
|
$ |
28,669 |
|
Selling, general and administrative |
|
|
8,262 |
|
|
|
15,977 |
|
|
|
24,239 |
|
|
|
16,742 |
|
|
|
25,788 |
|
|
|
42,530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
14,673 |
|
|
$ |
26,923 |
|
|
$ |
41,596 |
|
|
$ |
28,066 |
|
|
$ |
43,133 |
|
|
$ |
71,199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax cumulative effect catch-up |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax effect of share-based compensation |
|
|
|
|
|
|
|
|
|
$ |
41,596 |
|
|
|
|
|
|
|
|
|
|
$ |
65,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three and six months ended June 30, 2006, we capitalized costs of $1.3 million and
$1.7 million associated with share-based compensation to inventory and fixed assets. We did not
capitalize stock based compensation cost in our pro forma footnotes under SFAS 123(R). For the
three and six months ended June 30, 2005, we recorded share-based compensation expense of
approximately $5.4 million and $11.3 million, which was primarily related to expenses for
restricted stock awards.
In
accordance with SFAS 123(R), tax benefits from benefits from stock
option exercises of $10.2
million were recorded as cash outflows from operating activities and cash inflows from financing
activities in our condensed consolidated statement of cash flows in the six months ended June 30,
2006. Cash received from the exercise of stock options in the three and six months ended June 30,
2006 was approximately $14.3 million and $66.4 million.
At June 30, 2006, unrecognized compensation costs relating to unvested share-based
compensation was approximately $170.4 million. We expect to recognize the cost of these non-vested
awards over a weighted average period of 1.1 years. In accordance with SFAS 123(R), deferred share
based compensation is no longer reflected as a separate component of shareholders equity in the
condensed consolidated balance sheet. As a result, we reclassified our deferred share based
compensation of $42.9 million at December 31, 2005 to additional paid in capital during the first
quarter of 2006.
Stock Based Compensation Plans
We have three share-based compensation plans pursuant to which
awards are currently being made: (i) our 2006 Non-Employee Directors Equity Plan, or the
2006 Directors Plan; (ii) our 2005 Omnibus Equity Plan, or the 2005 Omnibus Plan; and (iii) our 1995 Employee
Stock Purchase Plan, or ESPP. We have four share-based compensation plans pursuant to which outstanding
awards have been made, but from which no further awards can and will be made: (i) our
1993 Non-Employee Directors Stock Option Plan, or the 1993 Directors Plan; (ii) our 1998 Stock Option Plan; (iii) the Biogen, Inc. 1985
Non-Qualified Stock Option Plan; and (iv) the Biogen, Inc. 1987 Scientific Board Stock Option Plan. In addition, we have our 2003 Omnibus Equity Plan,
or the 2003 Omnibus Plan, pursuant to which outstanding awards have been made. We have not made any awards from the 2003 Omnibus Plan since our stockholders
approved the 2005 Omnibus Plan and do not intend to make any awards
from the 2003 Omnibus Plan in the future.
Directors Plan: In May 2006, our stockholders approved the 2006 Directors Plan for
share-based awards to our directors. Awards granted from the 2006 Directors Plan may include
options, shares of restricted stock, restricted stock units, stock appreciation rights and other
awards in such amounts and with such terms and conditions as may be determined by a committee of
our Board of Directors, subject to the provisions of the plan. We have reserved a total of 850,000
shares of common stock for issuance under the 2006 Directors Plan. The 2006 Directors Plan
provides that awards other than stock options and stock appreciation rights will be counted against
the total number of shares reserved under the plan in a 1.5-to-1 ratio.
Omnibus Plans: In June 2005, our stockholders approved the 2005 Omnibus Plan for share-based
awards to our employees. Awards granted from the 2005 Omnibus Plan may include options, shares of restricted
stock, restricted stock units, performance shares, shares of phantom stock, stock bonuses, stock
appreciation rights and other awards in such amounts and with such terms and conditions as may be
determined by a committee of our Board of Directors, subject to the provisions of the plan. Shares
of common stock available for issuance under the 2005 Omnibus Plan consist of 15.0 million shares
reserved for this purpose, plus shares of common stock that remained available for issuance under
the 2003 Omnibus Plan on the date that our stockholders approved the 2005 Omnibus Plan, plus shares
that are subject to awards under the 2003 Omnibus Plan which remain
16
unissued upon the cancellation, surrender, exchange or termination of such awards. The 2005
Omnibus Plan provides that awards other than stock options and stock appreciation rights will be
counted against the total number of shares available under the plan in a 1.5-to-1 ratio.
Stock options
All
stock option grants to employees are for a ten-year term and
generally vest one-fourth per year over four years on the
anniversary of the date of grant, provided the employee remains
continuously employed with us. Stock option grants to directors are
for ten-year terms and generally vest as follows: (i) grants
made on the date of a directors initial election to our Board
of Directors vest one-third per year over three years on the
anniversary of the date of grant, and (ii) grants made for
service on our Board of Directors vest on the first anniversary of
the date of grant, provided in each case that the director continues
to serve on our Board of Directors through the vesting date. Options granted under all plans
are exercisable at a price per share not less than the fair market value of the underlying common
stock on the date of grant. The estimated fair value of options, including the effect of estimated
forfeitures, is recognized over the options vesting periods. The fair value of the first and
second quarter 2006 stock option grants were estimated on the date of grant using a Black-Scholes
option valuation model that uses the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Q1 2006 |
|
Q2 2006 |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
34.8 |
% |
|
|
34.8 |
% |
Risk-free interest rate |
|
|
4.35 |
% |
|
|
5.03 |
% |
Expected option life in years |
|
|
4.87 |
|
|
|
4.87 |
|
Per share grant date fair value |
|
$ |
16.82 |
|
|
$ |
17.71 |
|
Expected volatility is based primarily upon implied volatility for our exchange-traded options
and other factors, including historical volatility. After assessing all available information on
either historical volatility, implied volatility, or both, we have concluded that a combination of
both historical and implied volatility provides the best estimate of expected volatility. The
expected term of options granted is derived using assumed exercise rates based on historical
exercise patterns and represents the period of time that options granted are expected to be
outstanding. The risk-free interest rate used is determined by the market yield curve based upon
risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have
maturities equal to the expected term. The dividend yield is based upon the fact that we have not
historically granted cash dividends, and do not expect to issue dividends in the foreseeable
future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair
value of those awards, using the Black-Scholes option pricing model, as previously calculated for
pro-forma disclosures under SFAS 123(R), Share-Based Payment.
A summary of stock option activity is presented in the following table (shares are in
thousands):
|
|
|
|
|
|
|
|
|
|
|
All Option Plans |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Exercise |
|
|
|
Shares |
|
|
Price |
|
Outstanding at December 31, 2005 |
|
|
31,306 |
|
|
$ |
45.71 |
|
Granted |
|
|
1,669 |
|
|
|
44.97 |
|
Exercised |
|
|
(2,081 |
) |
|
|
25.08 |
|
Cancelled |
|
|
(1,951 |
) |
|
|
53.12 |
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2006 |
|
|
28,943 |
|
|
$ |
46.66 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
192 |
|
|
|
45.95 |
|
Exercised |
|
|
(493 |
) |
|
|
28.78 |
|
Cancelled |
|
|
(642 |
) |
|
|
53.48 |
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2006 |
|
|
28,000 |
|
|
$ |
46.81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at June 30, 2006 |
|
|
22,777 |
|
|
$ |
47.92 |
|
|
|
|
|
|
|
|
|
17
The weighted average grant-date fair values of stock options granted during the quarters ended
June 30, 2006 and 2005 were $17.71 and $14.11, respectively. The
weighted average grant-date fair values of stock options granted during
the quarters ended March 31, 2006 and 2005, were $16.82 and
$26.32, respectively. The total intrinsic values of options
exercised for the three months ending June 30, 2006 and 2005,
were $9.0 million and $5.9 million, respectively. The total
intrinsic values of options exercised for the three months ended
March 31, 2006 and 2005 were $44.9 million and
$55.5 million, respectively. The weighted average remaining contractual
terms for options outstanding and exercisable at June 30, 2006 and 2005 were 6.2 and 6.7 years,
respectively.
Time-Vested Restricted Stock Units
Time-vested restricted stock units, or RSUs, awarded to employees vest one-third per year
over three years on the anniversary of the date of grant, provided the employee remains
continuously employed with us. Shares of our common stock will be delivered to the employee upon
vesting, subject to payment of applicable withholding taxes. Time-vested RSUs awarded to directors
vest as follows: (i) awards made on the date of a directors initial election to our Board of
Directors vest one-third per year over three years on the anniversary of the date of award, and
(ii) awards made for service on our Board of Directors vest on the first anniversary of the date of
award, provided in each case that the director continues to serve on our Board of Directors through
the vesting date. Shares of our common stock will be delivered to the director upon vesting. The
fair value of all time-vested RSUs is based on the market value of our stock on the date of grant.
Compensation expense, including the effect of forfeitures, is recognized over the applicable
service period. For the three and six months ended June 30, 2006, we recorded $8.8 million and
$12.0 million of stock compensation charges related to time-vested RSUs. A summary of time-vested
RSU activity is presented in the following table (shares are in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Shares |
|
|
Fair Value |
|
Unvested at December 31, 2005 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
2,311 |
|
|
|
44.27 |
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(29 |
) |
|
|
44.24 |
|
|
|
|
|
|
|
|
|
Unvested at March 31, 2006 |
|
|
2,282 |
|
|
$ |
44.27 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
85 |
|
|
|
47.37 |
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(60 |
) |
|
|
44.32 |
|
|
|
|
|
|
|
|
|
Unvested at June 30, 2006 |
|
|
2,307 |
|
|
$ |
44.38 |
|
|
|
|
|
|
|
|
|
The weighted average grant-date fair value of the time-vested RSUs granted during the quarter
ended June 30, 2006 was $47.37. The weighted average remaining contractual term for the time-vested
RSUs was 1.6 years as of June 30, 2006. There were no time-vested RSUs awarded in the three months
ended June 30, 2005.
Performance-Based Restricted Stock Units:
In the first quarter of 2006, our Board of Directors awarded 100,000 RSUs to our CEO, under
the 2005 Omnibus Plan, subject to certain 2006 financial performance criteria. If the performance
criteria are attained and our CEO is still in active employment in February 2007, up to 100,000
RSUs will vest and convert into shares of our common stock. No performance-based RSUs were awarded
in the second quarter of 2006. No performance-based RSUs have been awarded to our directors.
During the third quarter of 2005, we granted performance-based RSUs, to be settled in shares
of our common stock to a group of approximately 200 employees at the director-level and above
(excluding our CEO). The grants were made under the 2005 Omnibus Plan. The RSUs will convert into
shares of our common stock, subject to attainment of certain performance goals and the employees
continued employment. If the performance goals are attained and the employee is still in active
employment, 70% of the RSUs will vest and convert into shares on September 14, 2006 and the
remaining 30% of the RSUs will vest and convert into shares on March 14, 2007. Shares of our
common stock will be delivered to the employee upon vesting, subject to payment of applicable
withholding taxes. In the three and six months ended June 30, 2006, we recorded compensation
charges of approximately $10.2 million and $20.9 million. The fair value is based on the market
price of the Companys stock on the date of grant and assumes that the target payout level will be
achieved. Compensation cost is adjusted quarterly for subsequent changes in the outcome of
performance-related conditions until the vesting date.
18
A summary of performance-based RSU activity is presented in the following table (shares are in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Shares |
|
|
Fair Value |
|
Unvested at December 31, 2005 |
|
|
1,154 |
|
|
$ |
40.67 |
|
Granted |
|
|
100 |
|
|
|
44.59 |
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(38 |
) |
|
|
40.67 |
|
|
|
|
|
|
|
|
|
Unvested at March 31, 2006 |
|
|
1,216 |
|
|
$ |
40.99 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(12 |
) |
|
|
40.67 |
|
|
|
|
|
|
|
|
|
Unvested at June 30, 2006 |
|
|
1,204 |
|
|
$ |
41.00 |
|
|
|
|
|
|
|
|
|
No performance-based RSUs were granted during the quarter ended June 30, 2006. The weighted
average remaining contractual term for the performance-based RSUs was 0.4 years as of June 30,
2006. There were no performance-based RSUs awarded in the three months ended June 30, 2005.
Restricted Stock Awards:
In 2005 and 2004, we awarded restricted common stock to our employees under the 2005 Omnibus
Plan and the 2003 Omnibus Plan at no cost to the employees. We have not awarded restricted common
stock to our directors. The restricted stock will vest in full on the third anniversary of the
date of award, provided the employee remains continuously employed with us. During the vesting
period, the recipient of the restricted stock has full voting rights as a stockholder, even though
the restricted stock remains subject to transfer restrictions and will generally be forfeited upon
termination of employment by the recipient prior to vesting. For the three months ended June 30,
2006, we recorded $7.9 million of stock compensation charges related to restricted stock awards.
For the six months ended June 30, 2006, we recorded $10.3 million of stock compensation charges
related to restricted stock awards, prior to a first quarter pre-tax cumulative effect catch-up
credit of $5.6 million, or $3.8 million after-tax, resulting from the application of an estimated
forfeiture rate for prior period unvested restricted stock awards. A summary of restricted stock
award activity is presented in the following table (shares are in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Shares |
|
|
Fair Value |
|
Unvested at December 31, 2005 |
|
|
1,440 |
|
|
$ |
53.87 |
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(75 |
) |
|
|
55.76 |
|
|
|
|
|
|
|
|
|
Unvested at March 31, 2006 |
|
|
1,365 |
|
|
$ |
53.76 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
|
|
|
|
|
|
Forfeited |
|
|
(33 |
) |
|
|
54.74 |
|
|
|
|
|
|
|
|
|
Unvested at June 30, 2006 |
|
|
1,332 |
|
|
$ |
53.74 |
|
|
|
|
|
|
|
|
|
No restricted common stock was awarded in the three months ended June 30, 2006. The weighted
average remaining contractual term for the restricted stock was 1.0 years as of June 30, 2006. The
weighted average grant-date fair value of the restricted stock awarded during the quarter ended
June 30, 2005 was $38.07.
Employee Stock Purchase Plan:
Under the terms of the ESPP, employees can elect to have up to ten percent of their annual
compensation (subject to certain dollar limits) withheld to purchase shares of our common stock. The purchase price of the common
stock is equal to 85% of the lower of the fair market value of the common stock on the enrollment
or purchase date. During the three and six months ended June 30, 2006, 0.1 million and 0.3 million
shares, respectively, were issued under the ESPP. During the three and six months ended June 30,
2005, 0.1 million and 0.3 million shares, respectively, were issued under the ESPP. We utilize the
Black-Scholes model to calculate the fair value of these awards. The fair value plus the 15%
discount amount are recognized as compensation expense over the purchase period. In the three and
six months ended June 30, 2006, we recorded compensation charges of approximately $2.1 million and
$4.8 million, respectively.
19
Pro-forma Disclosure
The following table illustrates the effect on net income and earnings per share if we were to
have applied the fair-value based method to account for all stock-based awards for the three and
six months ended June 30, 2005 (in thousands, except per share amounts).
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2005 |
|
|
June 30, 2005 |
|
Net income, as reported |
|
$ |
34,504 |
|
|
$ |
77,964 |
|
Stock-based compensation expense included in net income, net of tax |
|
|
5,442 |
|
|
|
11,306 |
|
Pro forma stock compensation expense, net of tax |
|
|
(21,232 |
) |
|
|
(43,585 |
) |
|
|
|
|
|
|
|
Pro forma net income |
|
$ |
18,714 |
|
|
$ |
45,685 |
|
|
|
|
|
|
|
|
Reported basic earnings per share: |
|
$ |
.10 |
|
|
$ |
.23 |
|
|
|
|
|
|
|
|
Pro forma basic earnings per share: |
|
$ |
.06 |
|
|
$ |
.14 |
|
|
|
|
|
|
|
|
Reported diluted earnings per share: |
|
$ |
.10 |
|
|
$ |
.23 |
|
|
|
|
|
|
|
|
Pro forma diluted earnings per share: |
|
$ |
.06 |
|
|
$ |
.13 |
|
|
|
|
|
|
|
|
The pro-forma amounts and fair value of each option grant were estimated on the date of grant
using the Black-Scholes option pricing model with the following weighted-average assumptions used
for grants in the period:
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Six Months Ended |
|
|
Ended June 30, 2005 |
|
June 30, 2005 |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
35 |
% |
|
|
35 |
% |
Risk-free interest rate |
|
|
3.7 |
% |
|
|
4.1 |
% |
Expected option life in years |
|
|
5.4 |
|
|
|
5.4 |
|
7. Income Taxes
Our effective tax rate was (70.3%) on pre-tax losses for the three months ended June 30, 2006
and 156.2% on pre-tax income before the cumulative effect of accounting change, for the six months
ended June 30, 2006, compared to 34.1% and 34.3% for the
comparable periods in 2005. Our effective tax rate for the periods
ending June 30 differs from the U.S. federal statutory rate primarily
due to the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Statutory
Rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State Taxes |
|
|
(3.6) |
|
|
|
4.6 |
|
|
|
7.9 |
|
|
|
3.0 |
|
Foreign Taxes |
|
|
12.8 |
|
|
|
(22.7) |
|
|
|
(26.9) |
|
|
|
(15.8) |
|
Credits |
|
|
0.3 |
|
|
|
(4.7) |
|
|
|
(0.9) |
|
|
|
(3.3) |
|
Other |
|
|
(4.2) |
|
|
|
(1.0) |
|
|
|
6.5 |
|
|
|
(0.3) |
|
Fair Value
Adjustment |
|
|
(7.1) |
|
|
|
22.9 |
|
|
|
21.2 |
|
|
|
15.7 |
|
IPR&D |
|
|
(115.4) |
|
|
|
0.0 |
|
|
|
126.5 |
|
|
|
0.0 |
|
Gain on
Settlement of Fumapharm License Agreement |
|
|
11.9 |
|
|
|
0.0 |
|
|
|
(13.1) |
|
|
|
0.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(70.3) |
% |
|
|
34.1 |
% |
|
|
156.2 |
% |
|
|
34.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Our effective
tax rate for the three and six months ended June 30, 2006 varied from the normal statutory rate
primarily due to the pre-tax loss resulting from the write-off of non-deductible IPR&D in
connection with the acquisitions of Conforma and Fumapharm, the gain on settlement of the Fumapharm
license agreement, the impact of state taxes, and non-deductible items such as certain stock-based
compensation charges, partially offset by the new domestic manufacturing deduction.
Our effective tax rate for the three and six months ended June 30, 2005 was lower than the
normal statutory rate primarily due to the effect of lower income tax rates (less than 35% U.S.
statutory corporate rate) in certain non-U.S. jurisdictions in which we operate, tax credits
allowed for research and experimentation expenditures in the U.S., and the new manufacturing
deduction, offset by acquisition-related intangible amortization expenses arising from purchase
accounting related to foreign jurisdictions.
We have net operating loss carryforwards and tax credit carryforwards for federal and state
income tax purposes available to offset future taxable income. The utilization of our net operating
loss carryforwards and tax credits may be subject to an annual limitation under the Internal
Revenue Code due to a cumulative change of ownership of more than 50% in prior years. However,
other than for tax attributes acquired as part of the Conforma transaction, we anticipate that this
annual limitation will result only in a modest delay in the utilization of such net operating loss
and tax credits.
8. Other Income (Expense), Net
Total other income (expense), net, consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Interest income |
|
$ |
26,114 |
|
|
$ |
12,401 |
|
|
$ |
49,671 |
|
|
$ |
28,106 |
|
Interest expense |
|
|
(186 |
) |
|
|
(2,849 |
) |
|
|
(479 |
) |
|
|
(9,760 |
) |
Other expense, net |
|
|
(4,122 |
) |
|
|
(3,501 |
) |
|
|
(8,721 |
) |
|
|
(21,220 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
$ |
21,806 |
|
|
$ |
6,051 |
|
|
$ |
40,471 |
|
|
$ |
(2,874 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income totaled $26.1 million and $49.7 million, respectively, for the three and six
months ended June 30, 2006 compared to $12.4 million and $28.1 million, respectively, for the
comparable periods in 2005. The increase in interest income is primarily due
20
to higher cash levels and higher yields on our marketable securities portfolio. Interest
income levels that may be achieved in the future are, in part, dependent upon market conditions.
Interest expense
totaled $0.2 million and $0.5 million, respectively, for the three and six
months ended June 30, 2006 compared to $2.8 million and $9.8 million, respectively, for the
comparable period of 2005. The decrease in interest expense relates to the repurchase of our senior
notes in the second quarter of 2005.
For
the three months ended June 30, 2006, the principal components
of other expense, net, were realized losses on investments
($3.3 million), expenses related to legal settlements
($2.1 million) and minority interest expense ($2.1 million),
offset by gains on foreign currency ($3.6 million). For the
three months ended June 30, 2005, the principal components of
other expense, net, were losses on foreign exchange
($5.1 million), offset by gains on currency hedges
($1.3 million).
For
the six months ended June 30, 2006, the principal components of
other expense, net, were realized losses on investments
($6.2 million), minority interest expense ($4.1 million),
and expenses related to legal settlements ($3.6 million), offset by
gains on foreign currency ($5.4 million). For the six months
ended June 30, 2005, the principal components of other expense,
net, were realized losses on investments ($13.6 million) and
losses on foreign currency ($7.5 million).
9. Unconsolidated Joint Business
Revenues from unconsolidated joint business arrangement consist of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Copromotion profits |
|
$ |
142,996 |
|
|
$ |
133,718 |
|
|
$ |
267,053 |
|
|
$ |
256,833 |
|
Reimbursement of selling and development expenses |
|
|
15,973 |
|
|
|
12,074 |
|
|
|
31,902 |
|
|
|
24,950 |
|
Royalty revenue on sales of RITUXAN outside the U.S. |
|
|
47,126 |
|
|
|
39,142 |
|
|
|
90,521 |
|
|
|
63,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
206,095 |
|
|
$ |
184,934 |
|
|
$ |
389,476 |
|
|
$ |
345,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our royalty revenue on sales of RITUXAN outside the U.S. is based on Roche and Zenyakus net
sales to third-party customers and is recorded on a cash basis.
Under the amended and restated collaboration agreement of June 2003, we will receive lower
royalty revenue from Genentech on sales by Roche and Zenyaku of any new anti-CD20 products, as
compared to royalty revenue received on sales of RITUXAN. The royalty period with respect to all
products is 11 years from the first commercial sale of such product on a country-by-country basis. For the majority of European countries, the first commercial sale of product occurred in the second
half of 1998.
10. Litigation
On March 2, 2005, we, along with William H. Rastetter, our former Executive Chairman, and
James C. Mullen, our Chief Executive Officer, were named as defendants in a purported class action
lawsuit, captioned Brown v. Biogen Idec Inc., et al., filed in the U.S. District Court for the
District of Massachusetts (the Court). The complaint alleges violations of Sections 10(b) and
20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. The action is
purportedly brought on behalf of all purchasers of our publicly-traded securities between February
18, 2004 and February 25, 2005. The plaintiff alleges that the defendants made materially false and
misleading statements regarding potentially serious side effects of TYSABRI in order to gain
accelerated approval from the FDA for the products distribution and sale. The plaintiff alleges
that these materially false and misleading statements harmed the purported class by artificially
inflating our stock price during the purported class period and that company insiders benefited
personally from the inflated price by selling our stock. The plaintiff seeks unspecified damages,
as well as interest, costs and attorneys fees. Substantially similar actions, captioned Grill v.
Biogen Idec Inc., et al. and Lobel v. Biogen Idec Inc., et al., were filed on March 10, 2005 and
April 21, 2005, respectively, in the same court by other purported class representatives. Those
actions have been assigned to District Judge Reginald C. Lindsay and Magistrate Judge Marianne C.
Bowler. On July 26, 2005, the three cases were consolidated and by Margin Order dated September 23,
2005, Magistrate Judge Bowler appointed lead plaintiffs and approved their selection of co-lead
counsel. An objection to the September 23, 2005 order was filed on October 7, 2005. The affected
plaintiffs objection is fully briefed and is pending with the Court. An amended, consolidated
complaint is to be filed no later than 30 days subsequent to the Courts resolution of such
objection. We believe that the actions are without merit and intend to contest them vigorously. At
this early stage of litigation, we cannot make any estimate of a potential loss or range of loss.
On March 9, 2005, two purported shareholder derivative actions, captioned Carmona v. Mullen, et al.
(Carmona) and Fink v. Mullen, et al. (Fink), were brought in the Superior Court of the State of
California, County of San Diego (the California Court), on our behalf, against us as nominal
defendant, our Board of Directors and our chief financial officer. The plaintiffs derivatively
claim breach of fiduciary duties, abuse of control, gross mismanagement, waste of corporate assets
and unjust enrichment against all
21
defendants. The plaintiffs also derivatively claim insider selling in violation of California
Corporations Code § 25402 and breach of fiduciary duty and misappropriation of information against
certain defendants who sold our securities during the period of February 18, 2004 to the date of
the complaints. The plaintiffs allege that the defendants caused and/or allowed us to issue, and
conspired, aided and abetted and acted in concert in concealing that we were issuing, false and
misleading press releases about the safety of TYSABRI and its financial prospects which resulted in
legal claims being asserted against us, irreparable harm to our corporate image, depression of our
stock price and impairment of our ability to raise capital. The plaintiffs also allege that
certain defendants sold personally owned shares of our stock while in possession of material,
undisclosed, adverse information. The plaintiffs seek unspecified damages, treble damages for the
purported insider trading in violation of California Corporate Code § 25402, equitable relief
including restriction of the defendants trading proceeds or other assets, restitution,
disgorgement and costs, including attorneys fees and expenses. Neither of the plaintiffs made
presuit demand on the Board of Directors prior to filing their respective actions. On May 11,
2005, the California Court consolidated the Carmona and Fink cases. On February 3, 2006,
plaintiffs filed an amended complaint which, among other amendments to the allegations, added our
former general counsel as a defendant. On March 6, 2006, defendants filed a demurrer. On April
28, 2006, the California Court sustained defendants demurrer with prejudice and entered final
judgment on May 9, 2006. On July 17, 2006, Plaintiffs filed a notice of appeal in the California
Court to the Court of Appeal, Fourth Appellate District, Division 1. These purported derivative
actions do not seek affirmative relief from the Company. We believe the plaintiffs claims lack
merit and intend to litigate the dispute vigorously. We are currently unable to determine whether
resolution of this matter will have a material adverse impact on our financial position or results
of operations, or reasonably estimate the amount of the loss, if any, that may result from
resolution of this matter.
On April 21, 2005, we received a formal order of investigation from the Boston District Office
of the SEC. The SEC is investigating whether any violations of the federal securities laws occurred
in connection with the suspension of marketing and commercial distribution of TYSABRI. We continue
to cooperate fully with the SEC in this investigation. We are unable to predict the outcome of this
investigation or the timing of its resolution at this time.
On June 9, 2005, we, along with numerous other companies, received a request for information
from the U.S. Senate Committee on Finance, or the Committee, concerning the Committees review of
issues relating to the Medicare and Medicaid programs coverage of prescription drug benefits. On
January 9, 2006, we, along with numerous other companies, received a further request for
information from the Committee. We filed a timely response to the request on March 6, 2006 and are
cooperating fully with the Committees information requests. We are unable to predict the outcome
of this review or the timing of its resolution at this time.
On October 4, 2004, Genentech, Inc. received a subpoena from the U.S. Department of Justice
requesting documents related to the promotion of RITUXAN. We market RITUXAN in the U.S. in
collaboration with Genentech. Genentech has disclosed that it is cooperating with the associated
investigation, which they disclosed that they have been advised is both civil and criminal in
nature. The potential outcome of this matter and its impact on us cannot be determined at this
time.
Along with several other major pharmaceutical and biotechnology companies, Biogen, Inc. (now
Biogen Idec MA, Inc., one of our wholly-owned subsidiaries) or, in certain cases, Biogen Idec,
Inc., was named as a defendant in lawsuits filed by the City of New York and numerous counties of
the State of New York. All of the cases, except for the County of Erie, County of Nassau, County of
Oswego and County of Schenectady cases, are the subject of a Consolidated Complaint (the
Consolidated Complaint), which was filed on June 15, 2005 in U.S. District Court for the District
of Massachusetts in Multi-District Litigation No. 1456. The County of Nassau, which originally
filed its complaint on November 24, 2004, filed an amended complaint on March 24, 2005 and that
case is also pending in the U.S. District Court for the District of Massachusetts. The County of
Erie, County of Oswego and County of Schenectady cases are currently pending in the Supreme Court
of the State of New York. All of the complaints allege that the defendants fraudulently reported
the Average Wholesale Price for certain drugs for which Medicaid provides reimbursement, also
referred to as Covered Drugs; marketed and promoted the sale of Covered Drugs to providers based on
the providers ability to collect inflated payments from the government and Medicaid beneficiaries
that exceeded payments possible for competing drugs; provided financing incentives to providers to
over-prescribe Covered Drugs or to prescribe Covered Drugs in place of competing drugs; and
overcharged Medicaid for illegally inflated Covered Drugs reimbursements. The complaints allege
violations of New York state law and advance common law claims for unfair trade practices, fraud,
and unjust enrichment. In addition, the Consolidated Complaint and the County of Nassau complaint
allege that the defendants failed to accurately report the best price on the Covered Drugs to the
Secretary of Health and Human Services pursuant to rebate agreements entered into with the
Secretary of Health and Human Services, and excluded from their reporting certain drugs offered at
discounts and other rebates that would have reduced the best price. We, along with the other
defendants, have filed a motion to dismiss the Consolidated Complaint and the complaints by the
County of Nassau and Couty of Erie. These motions are currently pending. We have not been served
with the complaints filed by the County of Oswego and County of Schenectady and, accordingly, we
have not yet filed our responses. We intend to defend ourselves vigorously
22
against all of the allegations and claims in these lawsuits. At this stage of the litigation,
we cannot make any estimate of a potential loss or range of loss.
We, along with several other major pharmaceutical and biotechnology companies, were named as a
defendant in a lawsuit filed by the Attorney General of Arizona. The lawsuit was filed in the
Superior Court of the State of Arizona on December 6, 2005. The complaint alleges that the
defendants fraudulently reported the Average Wholesale Price for certain drugs covered by the State
of Arizonas Medicare and Medicaid programs, and marketed these drugs to providers based on the
providers ability to collect inflated payments from the government and other third-party payors.
The complaint alleges violations of Arizona state law based on consumer fraud and racketeering. The
defendants have removed this case to federal court and the Joint Panel on Multi-District Litigation
has transferred the case to Multi-District Litigation No. 1456 pending in the U.S. District Court
for the District of Massachusetts. The Attorney General of Arizona has moved to remand the case
back to the Superior Court for the State of Arizona, and this motion is currently pending. We
intend to defend ourselves vigorously against all of the allegations and claims in this lawsuit. At
this stage of the litigation, we cannot make any estimate of a potential loss or range of loss.
On January 6, 2006, we were served with a lawsuit, captioned United States of America ex rel.
Paul P. McDermott v. Genentech, Inc. and Biogen-Idec, Inc., filed in the United States District
Court for the District of Maine. The lawsuit was filed by a former employee of our co-defendant
Genentech pursuant to the False Claims Act, 31 U.S.C. § 3729 et seq. On December 20, 2005, the U.S.
government elected not to intervene. On April 4, 2006, the plaintiff filed his first amended
complaint alleging, among other things, that we directly solicited physicians and their staff
members to illegally market off-label uses of RITUXAN for treating rheumatoid arthritis, provided
illegal kickbacks to physicians to promote off-label uses, trained our employees in methods of
avoiding the detection of these off-label sales and marketing activities, formed a network of
employees whose assigned duties involved off-label promotion of RITUXAN, intended and caused the
off-label promotion of RITUXAN to result in the submission of false claims to the government, and
conspired with Genentech to defraud the government. The plaintiff seeks entry of judgment on behalf
of the United States of America against the defendants, an award to the plaintiff as relator, and
all costs, expenses, attorneys fees, interest and other appropriate relief. On May 4, 2006, we
filed a motion to dismiss the first amended complaint on the grounds that the court lacks subject
matter jurisdiction, the complaint fails to state a claim and the claims were not pleaded with
particularity. We intend to defend ourselves vigorously against all of the allegations and claims
in this lawsuit. At this stage of the litigation, we cannot make any estimate of a potential loss
or range of loss. On February 28, 2006, the FDA approved the sBLA for use of RITUXAN, in
combination with methotrexate, for reducing signs and symptoms in adult patients with
moderately-to-severely active RA who have had an inadequate response to one or more TNF antagonist
therapies.
On February 24, 2006, a purported customer of TYSABRI in Louisiana commenced a Petition for
Redhibition in the U.S. District Court for the Eastern District of Louisiana, against Biogen Idec
and Elan, captioned as Jill Czapla v. Biogen Idec and Elan Pharmaceuticals, Civil Action No.
06-0945. The plaintiff filed this class action lawsuit on behalf of herself and all others
similarly situated, specifically all persons, natural and juridical, who purchased an infusion
drug TYSABRI (natalizumab) in Louisiana. The plaintiff seeks rescission of the sale, return of the
purchase price, expenses incidental to the sale, including all medical expenses related to the
infusion of TYSABRI in Louisiana, attorneys fees and interest, but excludes from the relief sought
any damages related to any personal injuries suffered because of the consumption of TYSABRI. Biogen
Idec and Elan were served with the lawsuit at the end of May 2006. Plaintiff also filed a Motion
to Certify the Class on May 25, 2006. A hearing on the motion
presently is set for September 14,
2006. Discovery has not yet begun in this matter, and a trial date has not been set. We intend to
defend ourselves vigorously against all of the allegations and claims in this lawsuit. At this
stage of the litigation, we cannot make any estimate of potential loss or range of loss.
In addition, we are involved in certain other legal proceedings generally incidental to our
normal business activities. While the outcome of any of these proceedings cannot be accurately
predicted, we do not believe the ultimate resolution of any of these existing matters would have a
material adverse effect on our business or financial condition.
11. Segment Information
We operate in one segment, which is the business of development, manufacturing and
commercialization of novel therapeutics for human health care. Our chief operating decision-makers
review our operating results on an aggregate basis and manage our operations as a single operating
segment. We currently have four products: AVONEX for the treatment of relapsing forms of MS,
RITUXAN for the treatment of certain B-cell non-Hodgkins lymphomas, or NHLs, and RA, ZEVALIN for
the treatment of a certain B-cell NHLs, and TYSABRI for treatment of relapsing forms of MS. We also
receive revenues from royalties on sales by our licensees of a number of products covered under
patents that we control including sales of RITUXAN outside the U.S.
23
12. Guarantees
We enter into indemnification provisions under our agreements with other companies in the
ordinary course of business, typically with business partners, contractors, clinical sites and
customers. Under these provisions, we generally indemnify and hold harmless the indemnified party
for losses suffered or incurred by the indemnified party as a result of our activities. These
indemnification provisions generally survive termination of the underlying agreement. The maximum
potential amount of future payments we could be required to make under these indemnification
provisions is unlimited. However, to date we have not incurred material costs to defend lawsuits or
settle claims related to these indemnification provisions. As a result, the estimated fair value of
these agreements is minimal. Accordingly, we have no liabilities recorded for these agreements as
of June 30, 2006.
In connection with the relocation from leased facilities to our research and corporate campus
in San Diego, California, we entered into a lease assignment, in January 2005, with Tanox West,
Inc., or Tanox, for a manufacturing facility in San Diego for which we have outstanding lease
obligations through September 2008. Under the lease assignment, Tanox was assigned all of our
rights, title, and interest in the amended lease and assumed all of the terms, covenants,
conditions and obligations required to be kept, performed and fulfilled under the amended lease,
including the making of all payments under the amended lease. However, if Tanox were to fail to
perform under the lease assignment we would be responsible for all obligations under the amended
lease through September 2008. At June 30, 2006, our estimate of the maximum potential of future
payments under the amended lease through September 2008 is $10.7 million. Under the lease
assignment, Tanox has agreed to indemnify and hold us harmless from and against any and all claims,
proceedings and demands and all costs, expenses and liabilities arising out of their performance or
failure to perform under the lease assignment.
13. Impairment of Long-Lived Assets
As
of March 31, 2005, after our voluntary suspension of TYSABRI, we
reconsidered our construction plans and determined that we would
proceed with the bulk manufacturing component of our large-scale
biologic manufacturing facility in Hillerod, Denmark. Additionally,
we added a labeling and packaging component to the project, and
determined that we would no longer proceed with the fill-finish
component of the large-scale biological manufacturing facility. As a
result, in the first quarter of 2005, we recorded an impairment
charge to facility impairments and loss on sale of approximately
$6.2 million of engineering costs related to the fill-finish
component that had previously been capitalized. Such charges are
included in research and development expenses.
14. Sale of AMEVIVE
In April 2006, we sold the worldwide rights to AMEVIVE to Astellas Pharma US, Inc., or
Astellas. We received $59.8 million in exchange for the worldwide rights to AMEVIVE and our
remaining assets related to AMEVIVE, including inventory, intangible, and fixed assets.
Additionally, we entered into an agreement with Astellas for us to continue to manufacture and
supply AMEVIVE to them for a period of approximately 11 years. The pre-tax gain on this sale was
approximately $2.8 million and is being deferred and recognized over the period of the related
supply contract.
15. Sale of Manufacturing Facilities
NICO
In February 2006, we sold our NICO clinical manufacturing facility in Oceanside, California,
known as NICO. The assets associated with the facility were included in assets held for sale on our
condensed consolidated balance sheet as of December 31, 2005. Total consideration for the sale was
$29.0 million. In the third and fourth quarters of 2005, we recorded impairment charges of $28.0
million to reduce the carrying value of NICO to its net realizable value. No additional loss
resulted from the completion of the sale.
Certain
reserve amounts established in connection with the sale were adjusted
during 2006, resulting in credit amounts being reflected in our
consolidated statement of operations.
NIMO
In June 2005, we sold our large-scale biologics manufacturing facility in Oceanside,
California, known as NIMO, along with approximately 60 acres of real property located in Oceanside,
California upon which NIMO is located, together with improvements, related property rights, and
certain personal property intangibles and contracts at or related to the real property. Total
consideration for the purchase was $408.1 million. A loss from this transaction of $75.6 million
was recognized, which consisted of an approximately $66.1 million write-down of NIMO to net selling
price and approximately $9.5 million of sales and transfer taxes and other associated transaction
costs.
24
16. Severance and Other Restructuring Costs
In accordance with our comprehensive strategic plan in 2005, we recorded restructuring
charges, which consisted primarily of severance and other employee termination costs, including
health benefits, outplacements, and bonuses. Other costs include write-downs of certain research
assets that will no longer be utilized, consulting costs in connection with the restructuring
effort, and costs related to the acceleration of restricted stock, offset by the reversal of
previously recognized compensation due to unvested restricted stock cancellations. The remaining
costs at June 30, 2006 are included in accrued expenses and other on our condensed consolidated
balance sheet.
Additionally, as discussed in Note 2, Acquisitions, approximately $1.2 million in severance
costs was incurred in connection with the acquisition of Conforma. Such costs are included in the
table below.
The components of the charges are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Costs |
|
|
Paid/Settled |
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
Liability at |
|
|
Incurred |
|
|
through |
|
|
Liability at |
|
|
Costs |
|
|
Paid/Settled |
|
|
Liability at |
|
|
|
December 31, |
|
|
During Q1 |
|
|
March 31, |
|
|
March 31, |
|
|
Incurred |
|
|
in Q2 |
|
|
June 30, |
|
|
|
2005 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
During Q2 2006 |
|
|
2006 |
|
|
2006 |
|
Severance and
employee
termination costs |
|
$ |
17,426 |
|
|
$ |
687 |
|
|
$ |
(8,571 |
) |
|
$ |
9,542 |
|
|
$ |
1,259 |
|
|
$ |
(3,306 |
) |
|
$ |
7,495 |
|
Other costs |
|
|
31 |
|
|
|
84 |
|
|
|
(53 |
) |
|
|
62 |
|
|
|
(3 |
) |
|
|
|
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,457 |
|
|
$ |
771 |
|
|
$ |
(8,624 |
) |
|
$ |
9,604 |
|
|
$ |
1,256 |
|
|
$ |
(3,306 |
) |
|
$ |
7,554 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We may have additional restructuring charges in future periods. The amounts of those charges
cannot be determined at this time.
17. New Accounting Pronouncements
In February 2006, the FASB issued FSP No. FAS 123(R) 4, Classification of Options and
Similar Instruments Issued as Employee Compensation That Allow for Cash Settlement upon the
Occurrence of a Contingent Event. This FSP addresses the classification of options and similar
instruments issued as employee compensation that allow for cash settlement upon the occurrence of a
contingent event. The guidance in this FSP amends SFAS 123(R), so that a cash settlement feature
that can be exercised only upon the occurrence of a contingent event that is outside the employees
control does not require the option or similar instrument to be classified as a liability, unless
it becomes probable that the event will occur. This FSP is effective in the first quarter of 2006,
the same period we are required to adopt SFAS 123(R). This FSP has not had any impact on our
results of operations for the three months ended March 31, 2006, nor do we expect it to have a
significant impact in future periods.
In November 2004, the FASB issued SFAS 151, Inventory Costs, an amendment of ARB No. 43,
Chapter 4, which amends the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to clarify the
accounting for abnormal amounts of idle facility expense, freight, handling costs, and wasted
material (spoilage). SFAS 151 clarifies that abnormal amounts of idle facility expense, freight,
handling costs, and wasted materials (spoilage) should be recognized as current-period charges. In
addition, SFAS 151 requires that allocation of fixed production overheads to the costs of
conversion be based on the normal capacity of the production facilities. The provisions of SFAS 151
were effective for inventory costs incurred during our fiscal year beginning on January 1, 2006. We
did not experience a significant impact on our results of operations in the second quarter of 2006
as a result of our adoption of SFAS 151. However, we may experience variability in future results
of operations due to abnormal amounts of idle facility expense, freight, handling costs, and wasted
material (spoilage).
In February 2006, the FASB issued SFAS 155, Accounting for Certain Hybrid Financial
Instruments, or SFAS 155, which amends both SFAS 133, Accounting for Derivative Instruments and
Hedging Activities, and SFAS 140, Accounting for Transfers and Servicing of Financial Assets and
Extinguishments of Liabilities. SFAS 155 allows the fair value remeasurement for any hybrid
financial instrument that contains an embedded derivative that would otherwise required
bifurcation. SFAS 155 will be effective for fiscal years beginning after September 15, 2006. We do
not expect this statement to have any impact on our results of operations.
The FASB issued SFAS 156, Accounting for Servicing of Financial Assets, which amends FASB
Statement No. 140, Accounting for Transfers and Servicing of Financial Assets and Extinguishments
of Liabilities, in March 2006. FASB 156 requires the recognition of a servicing asset or liability
during the undertaking of an obligation to service a financial asset through the creation of a
service contract. In addition, under SFAS 156, all recognized servicing assets and liabilities
should be recognized initially at fair
25
value and subsequently by either the amortization or fair value measurement method. SFAS 156
should be adopted for all fiscal years beginning after September 15, 2006. We do not expect SFAS
156 to have any impact on our results of operations.
On July 13, 2006, FASB Interpretation (FIN) No. 48, Accounting for Uncertainty in Income
Taxes An Interpretation of FASB Statement No. 109, was issued. FIN 48 clarifies the accounting
for uncertainty in income taxes recognized in an enterprises financial statements in accordance
with FASB Statement No. 109, Accounting for Income Taxes. FIN 48 also prescribes a recognition
threshold and measurement attribute for the financial statement recognition and measurement of a
tax position taken or expected to be taken in a tax return. The new FASB standard also provides
guidance on derecognition, classification, interest and penalties, accounting in interim periods,
disclosure, and transition and is effective for fiscal years beginning after December 15, 2006. We
are currently evaluating the impact of this standard on our financial statements.
26
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Forward-Looking Information
In addition to historical information, this report contains forward-looking statements that
involve risks and uncertainties that could cause actual results to differ materially from those
reflected in such forward-looking statements. You can identify these forward-looking statements by
their use of words such as anticipate, believe, estimate, expect, forecast, intend,
plan, project, target, will and other words and terms of similar meaning. You also can
identify them by the fact that they do not relate strictly to historical or current facts.
Reference is made in particular to forward-looking statements regarding the anticipated level of
future product sales, royalty revenues, expenses and profits, regulatory approvals, our long-term
growth, the development and marketing of additional products, the impact of competitive products,
the anticipated outcome of pending or anticipated litigation and patent-related proceedings, our
ability to meet our manufacturing needs, the value of investments in certain marketable securities,
and our plans to spend additional capital on external business development and research
opportunities. Risk factors which could cause actual results to differ from our expectations and
which could negatively impact our financial condition and results of operations are discussed in
the section entitled Risk Factors in Part II of this
report and elsewhere in this report. Unless required by law, we do not
undertake any obligation to publicly update any forward-looking statements.
Overview
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global
leader in the development, manufacturing, and commercialization of novel therapies, we transform
scientific discoveries into advances in human healthcare. We currently have four products:
AVONEX® (interferon beta-1a). AVONEX is approved for the treatment of relapsing forms of
multiple sclerosis, or MS.
RITUXAN® (rituximab). RITUXAN is approved worldwide for the treatment of relapsed or
refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkins lymphomas, or B-cell NHLs.
In February 2006, RITUXAN was approved by the U.S. Food and Drug Administration, or FDA, to treat
previously untreated patients with diffuse, large B-cell NHL in combination with
anthracycline-based chemotherapy regimens. In addition, in February 2006, the FDA approved the
supplemental Biologics License Application, or sBLA, for use of RITUXAN, in combination with
methotrexate, for reducing signs and symptoms in adult patients with moderately-to-severely active
rheumatoid arthritis, or RA, who have had an inadequate response to one or more TNF antagonist
therapies. We are working with Genentech Inc., or Genentech, and F. Hoffman-La Roche Ltd., or
Roche, on the development of RITUXAN in additional oncology and other indications.
TYSABRI® (natalizumab). TYSABRI was approved by the FDA in November 2004 to treat relapsing
forms of MS to reduce the frequency of clinical relapses. In February 2005, in consultation with
the FDA, we and Elan Corporation plc, or Elan, voluntarily suspended the marketing and commercial
distribution of TYSABRI, and we informed physicians that they should suspend dosing of TYSABRI
until further notification. On June 5, 2006, the FDA approved a sBLA for the reintroduction of
TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the progression of disability
and reduce the frequency of clinical relapses. On June 29, 2006, we and Elan announced that the
European Agency for the Evaluation of Medicinal Products, or EMEA, had approved TYSABRI as a
similar treatment. In July, 2006, we began to ship TYSABRI in both the United States and Europe.
ZEVALIN® (ibritumomab tiuxetan). The ZEVALIN therapeutic regimen, which features ZEVALIN, is
a radioimmunotherapy that is approved for the treatment of patients with relapsed or refractory
low-grade, follicular, or transformed B-cell NHL, including patients with RITUXAN relapsed or
refractory NHL.
Significant Events
The
significant events that occurred during the six months ended June 30, 2006 were as
follows:
|
|
|
Reintroduction of TYSABRI: TYSABRI was reapproved for sale in the United
States and approved for sale in Europe in June 2006. No revenue was recorded during the
three and six months ended June 30, 2006, but we expect to recognize revenue from TYSABRI
sales beginning in the third quarter of 2006. |
|
|
|
|
Acquisition of Fumapharm AG, or Fumapharm: In June 2006, we completed the acquisition of
Fumapharm. The most significant financial statement impact from the purchase was the
recognition of an acquired in-process research and |
27
|
|
|
development, or IPR&D, charge of approximately $207.4 million. The results of operations of
Fumapharm in the quarter were not significant. |
|
|
|
|
Acquisition of Conforma Therapeutics Corporation, or Conforma: In May 2006, we completed
the acquisition of Conforma. The most significant financial statement impact from the
purchase was the recognition of an IPR&D charge of approximately $123.1 million. The
results of operations of Conforma in the quarter were not significant. |
|
|
|
|
Sale of AMEVIVE: In April 2006, we sold the worldwide rights to AMEVIVE, including
inventory on-hand, to Astellas Pharma US, Inc., or Astellas. We will continue to
manufacture AMEVIVE and supply this product to Astellas for a period of 11 years. The
pre-tax gain on this sale was approximately $2.8 million and is being deferred and
recognized over the period of the related supply contract. |
Refer
to Note 2, Acquisitions, for discussion of the acquisition of
Fumapharm and Conforma.
Results of Operations
Revenues (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Product sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States |
|
$ |
265,825 |
|
|
$ |
242,867 |
|
|
$ |
505,890 |
|
|
$ |
497,464 |
|
Rest of world |
|
|
170,256 |
|
|
|
155,955 |
|
|
|
336,710 |
|
|
|
298,942 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
|
436,081 |
|
|
|
398,822 |
|
|
|
842,600 |
|
|
|
796,406 |
|
Unconsolidated joint business |
|
|
206,095 |
|
|
|
184,934 |
|
|
|
389,476 |
|
|
|
345,387 |
|
Royalties |
|
|
18,286 |
|
|
|
21,734 |
|
|
|
38,847 |
|
|
|
48,483 |
|
Corporate partner |
|
|
(421 |
) |
|
|
144 |
|
|
|
293 |
|
|
|
3,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
660,041 |
|
|
$ |
605,634 |
|
|
$ |
1,271,216 |
|
|
$ |
1,193,436 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Sales (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
AVONEX |
|
$ |
429,377 |
|
|
$ |
381,789 |
|
|
$ |
822,805 |
|
|
$ |
755,374 |
|
AMEVIVE |
|
|
2,460 |
|
|
|
12,457 |
|
|
|
10,738 |
|
|
|
24,473 |
|
ZEVALIN |
|
|
4,440 |
|
|
|
5,473 |
|
|
|
9,450 |
|
|
|
11,510 |
|
TYSABRI |
|
|
(196 |
) |
|
|
(897 |
) |
|
|
(393 |
) |
|
|
5,049 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
436,081 |
|
|
$ |
398,822 |
|
|
$ |
842,600 |
|
|
$ |
796,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
An analysis of the sales of AVONEX is as follows (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
AVONEX |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
260,643 |
|
|
$ |
229,524 |
|
|
$ |
492,694 |
|
|
$ |
462,372 |
|
Rest of world |
|
|
168,734 |
|
|
|
152,265 |
|
|
|
330,111 |
|
|
|
293,002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total AVONEX sales |
|
$ |
429,377 |
|
|
$ |
381,789 |
|
|
$ |
822,805 |
|
|
$ |
755,374 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, 2006, compared to the three months ended June 30, 2005, US
sales of AVONEX increased $31.1 million, or 13.6%, due, principally, to the impact of price
increases and a reduction in discounts associated with a change in
patient mix in connection with the introduction of
the Medicare Part D prescription drug benefit. For the six months ended June 30, 2006,
compared to the six months ended June 30, 2005, U.S. sales of AVONEX increased by $30.3 million, or
6.6%, due to the impact of a price increase and adjustments to rebate and discount levels offset
by slightly lower volume.
For the three months ended June 30, 2006, compared to the three months ended June 30, 2005,
international sales of AVONEX increased $16.5 million, or 10.8%, due to overall price increases
and, to a lesser extent, overall increases in volume. Foreign exchange accounted for a 4.5%
reduction in reported revenues; on a local currency basis, revenue increased 15.3%. For the six
months ended June 30, 2006, compared to the six months ended June 30, 2005, international sales of
AVONEX increased $37.1 million, or 12.7% due to overall increases in price and, to a lesser extent,
overall increases in volume. Foreign exchange accounted for a 5.9% reduction in reported revenues.
On a local currency basis, revenue increased 18.6%.
28
Product sales from AVONEX represented approximately 98.5% and 95.7% of our total product
revenues for the three months ended June 30, 2006 and 2005, respectively. We expect to face
increasing competition in the MS marketplace in and outside the U.S. from existing and new MS
treatments, including TYSABRI, which may impact sales of AVONEX. We expect future sales of AVONEX
to be dependent to a large extent on our ability to compete successfully.
For the three and six months ended June 30, 2006, AMEVIVE generated product sales of $2.5
million and $10.7 million, of which $0.9 million and $4.8 million was generated in the U.S. For the
three and six months ended June 30, 2005, AMEVIVE generated product sales of $12.5 million and
$24.5 million, of which $8.8 million and $19.2 million was generated in the U.S. The decrease in
current year amounts versus prior year amounts is due to the sale, in April 2006, of our worldwide
rights and infrastructure related to sales, production, and marketing of AMEVIVE.
The decrease in product sales for the three and six months ended June 30, 2006 versus June 30,
2005, related to ZEVALIN is attributable to lower sales volumes in the U.S. Product sales from
ZEVALIN represented 1.0% and 1.4% of our total product revenues in the three months ended June 30,
2006 and 2005, respectively.
In November 2004, TYSABRI was approved by the FDA as a treatment for relapsing forms of MS to
reduce the frequency of clinical relapses. In February 2005, in consultation with the FDA, we and
Elan voluntarily suspended the marketing and commercial distribution of TYSABRI, and we informed
physicians that they should suspend dosing of TYSABRI until further notification. In the US, prior
to the suspension, we sold TYSABRI to Elan who then distributed TYSABRI to third party distributors
and other customers. In the first quarter of 2005, our revenue associated with sales of TYSABRI was
$5.9 million, which consisted of revenue from sales that occurred prior to our voluntary
suspension. Sales from TYSABRI represent 1% of our total revenues in the first quarter of 2005. As
of March 31, 2005, and in connection with the voluntary suspension of TYSABRI, we recorded an
allowance for sales returns of approximately $9.0 million related to product sold in the first
quarter of 2005, which represented our best estimate of expected returns from our customers. On
June 5, 2006, the FDA approved a sBLA for the reintroduction of TYSABRI as a monotherapy treatment
for relapsing forms of MS to slow the progression of disability and reduce the frequency of
clinical relapses. On June 29, 2006, we and Elan announced that the European Agency for the
Evaluation of Medicinal Products, or EMEA, had approved TYSABRI as a similar treatment. In July,
2006, we began to ship TYSABRI in both the United States and Europe.
Additionally, as of March 31, 2005, we deferred $14.0 million in revenue related to sales to
Elan of TYSABRI. Although we have been paid for the shipments, under our revenue recognition policy
we have deferred revenue recognition as Elan had not shipped the product as of June 30, 2006.
See also the risks affecting revenues described in Risk Factors Our Revenues Rely
Significantly on a Limited Number of Products and Risk Factors Safety Issues with TYSABRI Could
Significantly Affect our Growth.
Reserves for discounts and allowances
At
June 30, 2006, our allowance for product returns was $15.0 million. This is a component of
our total allowance for returns, rebates, discounts, and other of
$65.1 million. At June 30, 2006,
our total allowance for returns, rebates, discounts, and other was
approximately 4.5% of total
current assets and less than 1% of total assets. On a quarterly basis, we analyze our estimates for
expected expense for returns, rebates, discounts and other quarterly, based primarily on historical
experience updated for changes in facts and circumstances, as appropriate.
During the three months ended June 30, 2006, we recorded a charge of $6.9 million related to our
allowance for expired products. The charge is included in our total
reductions in revenue for the three months of
$63.1 million and was calculated based on an analysis of our experience in relation to expired
products. Additionally, we recorded an increase to goodwill of
$5.4 million related to increasing reserve levels at the time
of our merger with Biogen Inc. in 2003. We determined an historical rate for returns based on volumes of returns and the amount
of credit granted to the returning distributor. Based on the analysis, we determined that the
charge of $6.9 million and the increase to goodwill were required to be added to existing reserve levels. The $6.9 million charge
relates largely to prior years and arises from applying higher return rates than we had historically
applied. We have determined that, in accordance with APB 28,
Interim Financial Reporting paragraph 29, that the
charge is an error but one that is not material to the current period
or current year.
Additionally, we have determined that
the error is not material to any prior year and that the error
associated with the increase to goodwill was not material.
For the three and six months ended June 30, 2006, we recorded $63.1 million and $121.9
million, respectively, in our condensed consolidated statements of income related to sales returns
and allowances, discounts, and rebates, compared to $54.2 million and $108.0 million, respectively,
for the comparable periods in 2005. In the three and six months ended June 30, 2006, the amount of
product returns was approximately 0.9% and 1.3%, respectively, of product revenue for all our
products, compared to 1.0% and 2.0%, respectively, for the comparable periods in 2005. Product
returns, which is a component of allowances for returns, rebates, discounts,
29
and other allowances, were $4.0 million and $11.3 million for the three and six months ended
June 30, 2006, respectively, compared to $4.1 million and $16.1 million for the comparable periods
in 2005.
Unconsolidated Joint Business Revenue
RITUXAN is currently marketed and sold worldwide for the treatment of certain B-cell NHLs. In
February 2006, RITUXAN was approved by the FDA to treat previously untreated patients with diffuse,
large B-cell NHL in combination with anthracycline-based chemotherapy regimens. In addition, in
February 2006, the FDA approved the sBLA for use of RITUXAN, in combination with methotrexate, for
reducing signs and symptoms in adult patients with moderately-to-severely active RA who have had an
inadequate response to one or more TNF antagonist therapies. We copromote RITUXAN in the U.S. in
collaboration with Genentech under a collaboration agreement between the parties. Under the
collaboration agreement, we granted Genentech a worldwide license to develop, commercialize and
market RITUXAN in multiple indications. In exchange for these worldwide rights, we have copromotion
rights in the U.S. and a contractual arrangement under which Genentech shares a portion of the
pretax U.S. copromotion profits of RITUXAN with us. This collaboration was created through a
contractual arrangement not through a joint venture or other legal entity. In June 2003, we amended
and restated our collaboration agreement with Genentech to include the development and
commercialization of one or more anti-CD20 antibodies targeting B-cell disorders, in addition to
RITUXAN, for a broad range of indications.
In the U.S., we contribute resources to selling and the continued development of RITUXAN.
Genentech is responsible for worldwide manufacturing of RITUXAN. Genentech also is responsible for
the primary support functions for the commercialization of RITUXAN in the U.S. including selling
and marketing, customer service, order entry, distribution, shipping and billing. Genentech also
incurs the majority of continuing development costs for RITUXAN. Under the arrangement, we have a
limited sales force as well as limited development activity.
Under the terms of separate sublicense agreements between Genentech and Roche,
commercialization of RITUXAN outside the U.S. is the responsibility of Roche, except in Japan where
Roche copromotes RITUXAN in collaboration with Zenyaku Kogyo Co. Ltd., or Zenyaku. There is no
direct contractual arrangement between us and Roche or Zenyaku.
Revenue from unconsolidated joint business consists of our share of pretax copromotion
profits, which is calculated by Genentech, and includes reimbursement of our RITUXAN-related sales
force and development expenses, and royalty revenue from sales of RITUXAN outside the U.S. by Roche
and Zenyaku. Copromotion profit consists of U.S. sales of RITUXAN to third-party customers net of
discounts and allowances and less the cost to manufacture RITUXAN, third-party royalty expenses,
distribution, selling and marketing expenses, and joint development expenses incurred by Genentech
and us.
Under the amended and restated collaboration agreement, our current pretax copromotion
profit-sharing formula for the U.S., is as follows:
|
|
|
|
|
Copromotion Operating Profits |
|
Biogen Idecs Share of Copromotion Profits |
First $50 million |
|
|
30 |
% |
Greater than $50 million |
|
|
40 |
% |
In both 2006 and 2005, the 40% threshold was met during the first quarter. For each calendar
year or portion thereof following the approval date of the first new anti-CD20 product, the pretax
copromotion profit-sharing formula for RITUXAN and other anti-CD20 products sold by us and
Genentech will change to the following:
|
|
|
|
|
|
|
Copromotion |
|
New Anti-CD20 U.S. |
|
Biogen Idecs Share |
Operating Profits |
|
Gross Product Sales |
|
of Copromotion Profits |
First $50 million (1)
|
|
N/A
|
|
|
30 |
% |
|
|
|
|
|
|
|
Greater than $50 million
|
|
Until such sales exceed $150
million in any calendar year(2)
|
|
|
38 |
% |
|
|
|
|
|
|
|
|
|
Or |
|
|
|
|
|
|
|
|
|
|
|
|
|
After such sales exceed $150
million in any calendar year
and until such sales exceed
$350 million in any calendar
year (3)
|
|
|
35 |
% |
|
|
|
|
|
|
|
|
|
Or |
|
|
|
|
|
|
|
|
|
|
|
|
|
After such sales exceed $350
million in any calendar year (4)
|
|
|
30 |
% |
30
|
|
|
(1) |
|
not applicable in the calendar year the first new anti-CD20 product is approved if $50
million in copromotion operating profits has already been achieved in such calendar year
through sales of RITUXAN. |
|
(2) |
|
if we are recording our share of RITUXAN copromotion profits at 40%, upon the approval date
of the first new anti-CD20 product, our share of copromotion profits for RITUXAN and the new
anti-CD20 product will be immediately reduced to 38% following the approval date of the first
new anti-CD20 product until the $150 million new product sales level is achieved. |
|
(3) |
|
if $150 million in new product sales is achieved in the same calendar year the first new
anti-CD20 product receives approval, then the 35% copromotion profit-sharing rate will not be
effective until January 1 of the following calendar year. Once the $150 million new product
sales level is achieved then our share of copromotion profits for the balance of the year and
all subsequent years (after the first $50 million in copromotion operating profits in such
years) will be 35% until the $350 million new product sales level is achieved. |
|
(4) |
|
if $350 million in new product sales is achieved in the same calendar year that $150
million in new product sales is achieved, then the 30% copromotion profit-sharing rate will
not be effective until January 1 of the following calendar year (or January 1 of the second
following calendar year if the first new anti-CD20 product receives approval and, in the same
calendar year, the $150 million and $350 million new product sales levels are achieved). Once
the $350 million new product sales level is achieved then our share of copromotion profits for
the balance of the year and all subsequent years will be 30%. |
Copromotion profits consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Product revenues, net |
|
$ |
525,369 |
|
|
$ |
450,348 |
|
|
$ |
1,002,347 |
|
|
$ |
890,897 |
|
Costs and expenses |
|
|
167,879 |
|
|
|
116,053 |
|
|
|
322,213 |
|
|
|
236,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits |
|
$ |
357,490 |
|
|
$ |
334,295 |
|
|
$ |
680,134 |
|
|
$ |
654,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biogen Idecs share of copromotion profits |
|
$ |
142,996 |
|
|
$ |
133,718 |
|
|
$ |
267,053 |
|
|
$ |
256,833 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amount of our share of copromotion profits for the three and six months ended June 30,
2006 was primarily due to higher sales for RITUXAN.
Revenues from unconsolidated joint business consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Biogen Idecs share of copromotion profits |
|
$ |
142,996 |
|
|
$ |
133,718 |
|
|
$ |
267,053 |
|
|
$ |
256,833 |
|
Reimbursement of selling and development expenses |
|
|
15,973 |
|
|
|
12,074 |
|
|
|
31,902 |
|
|
|
24,950 |
|
Royalty revenue on sales of RITUXAN outside the U.S. |
|
|
47,126 |
|
|
|
39,142 |
|
|
|
90,521 |
|
|
|
63,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
206,095 |
|
|
$ |
184,934 |
|
|
$ |
389,476 |
|
|
$ |
345,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of selling and development expenses increased for both the three and six months
of 2006 versus 2005, primarily due to the expansion of the oncology sales force and development
costs we incurred mainly related to the development of RITUXAN for RA.
Our royalty revenue on sales of RITUXAN outside the U.S. is based on Roche and Zenyakus net
sales to third-party customers and is recorded on a cash basis. Royalty revenues from sales of
RITUXAN outside the U.S. increased approximately $8.0 million and $26.9 million during the three
and six months ended June 30, 2006, which is primarily related to increased penetration of the
market. A $11.3 million royalty credit was claimed by Genentech in the three months ended March
31, 2005, which we have settled and have agreed to pay. This amount is accrued in our consolidated
balance sheet as of June 30, 2006.
31
Under the amended and restated collaboration agreement, we will receive lower royalty revenue
from Genentech on sales by Roche and Zenyaku of new anti-CD20 products, as compared to royalty
revenue received on sales of RITUXAN. The royalty period with respect to all products is 11 years
from the first commercial sale of such product on a country-by-country basis. For the majority of European countries, the first commercial sale of product occurred in the second
half of 1998.
Total unconsolidated joint business revenue represented 31.2% and 30.6% of our total revenues
for the three and six months ended June 30, 2006, respectively, as compared to 30.5% and 28.9% for
the comparable periods in 2005, respectively.
Royalty Revenue
We receive revenues from royalties on sales by our licensees of a number of products covered
under patents that we control. Our royalty revenues on sales of RITUXAN outside the U.S. are
included in Unconsolidated joint business. For the three and six months ended June 30, 2006, we
earned approximately $18.3 million and $38.8 million in royalty revenues, respectively, as compared
to approximately $21.7 million and $48.5 million in comparable periods in 2005. Royalty revenues
represent approximately 3% of total revenues for the three and six months ended June 30, 2006
compared to 4% of total revenues for the three and six months ended June 30, 2005.
Royalty revenues may fluctuate as a result of fluctuations in sales levels of products sold by
our licensees from quarter to quarter due to the timing and extent of major events such as new
indication approvals or government-sponsored programs.
Corporate Partner Revenues
Corporate partner revenues consist of contract revenues and license fees. Corporate partner
revenues totaled ($0.4) million and $0.3 million for the three and six months ended June 30, 2006,
which represented less than 1% of total revenues for the three and six months ended June 30, 2006.
Corporate partner revenue totaled $0.1 million and $3.2 million in the three and six months ended
June 30, 2005, representing less than 1% of total revenues for both periods.
Cost of Product Revenues, excluding Amortization of Intangibles
Cost of product revenues by product are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
Product |
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVONEX |
|
$ |
62,141 |
|
|
$ |
52,781 |
|
|
$ |
117,733 |
|
|
$ |
110,004 |
|
AMEVIVE |
|
|
2,020 |
|
|
|
15,334 |
|
|
|
9,807 |
|
|
|
28,561 |
|
ZEVALIN |
|
|
10,494 |
|
|
|
2,275 |
|
|
|
12,655 |
|
|
|
6,337 |
|
TYSABRI |
|
|
2,405 |
|
|
|
(146 |
) |
|
|
3,257 |
|
|
|
23,823 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues, excluding amortization of intangibles |
|
$ |
77,060 |
|
|
$ |
70,244 |
|
|
$ |
143,452 |
|
|
$ |
168,725 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
cost of product revenue for AVONEX increased $9.4 million, or
17.7%, from $52.8 million
for the three months ended June 30, 2005 to $62.1 million for the three months ended June 30, 2006,
in line with sales level. The cost of product revenue for AVONEX increased $7.7 million, or 7.0%,
from $110.0 million for the six months ended June 30, 2005 to $117.7 million for the six months
ended June 30, 2006, in line with sales level.
The cost of product revenue for AMEVIVE decreased $13.3 million, or 86.8% from $15.3 million
for the three months ended June 30, 2005 to $2.0 million for the three months ended June 30, 2006,
reflecting the decline in sales levels associated with the disposition of our worldwide rights in
April 2006. The cost of product revenue for AMEVIVE decreased $18.8 million, or 65.7% from $28.6
million for the six months ended June 30, 2005 to $9.8 million for the six months ended June 30,
2006, also reflecting the decline in sales levels associated with the disposition of our worldwide
rights in April 2006.
The cost of product revenue for ZEVALIN increased $8.2 million, or 361%, from $2.3 million for
the three months ended June 30, 2005 to $10.5 million for the three months ended June 30, 2006,
primarily due to failed production runs in 2006. The cost of product revenue for ZEVALIN increased
$6.3 million, or 99.7%, from $6.3 million for the six months ended June 30, 2005 to $12.7 million
for the six months ended June 30, 2006, primarily due to the failed production runs that occurred
in the second quarter of 2006.
32
TYSABRI
We capitalize inventory costs associated with our products prior to regulatory approval, when,
based on managements judgment, future commercialization is considered probable and the future
economic benefit is expected to be realized.
In the first quarter of 2006, in light of expectations of the re-introduction of TYSABRI, we
began a new manufacturing campaign. TYSABRI currently has an approved shelf life of up to 48
months. Based on our sales forecasts for TYSABRI, we fully expect the carrying value of the
TYSABRI inventory to be realized. As of June 30, 2006, $22.1 million and $0.1 million of TYSABRI
inventory is included in work in process and finished goods, respectively. As of December 31,
2005, there was no TYSABRI inventory on our condensed consolidated balance sheet.
We manufactured TYSABRI during the first and second quarter of 2005 and completed our
scheduled production of TYSABRI during July 2005. Because of the uncertain future commercial
availability of TYSABRI at the time, and our inability to predict to the required degree of
certainty that TYSABRI inventory would be realized in commercial sales prior to the expiration of
its shelf life, we expensed $23.2 million of costs related to the manufacture of TYSABRI in the
first quarter of 2005 to cost of product revenues. At the time of production, the inventory was
believed to be commercially saleable. During 2005, as we worked in the second quarter with clinical
investigators to understand the possible risks of PML, we charged the costs related to the
manufacture of TYSABRI to research and development expense. As we
sell TYSABRI, we will recognize lower than normal cost of sales due
to the amounts written-off.
Valuation of Inventory
We wrote-down the following unmarketable inventory, which was charged to cost of product
revenues (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
AVONEX |
|
$ |
3,380 |
|
|
$ |
738 |
|
|
$ |
3,634 |
|
|
$ |
9,545 |
|
AMEVIVE |
|
|
|
|
|
|
7,125 |
|
|
|
2,433 |
|
|
|
14,288 |
|
ZEVALIN |
|
|
3,177 |
|
|
|
678 |
|
|
|
3,177 |
|
|
|
2,580 |
|
TYSABRI |
|
|
2,194 |
|
|
|
|
|
|
|
2,805 |
|
|
|
23,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,751 |
|
|
$ |
8,541 |
|
|
$ |
12,049 |
|
|
$ |
49,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The write-downs for the three and six months ended June 30, 2006 and 2005, respectively, were
the result of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
New components for alternative presentations |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
8,417 |
|
Failed quality specifications |
|
|
7,866 |
|
|
|
7,708 |
|
|
|
10,910 |
|
|
|
15,260 |
|
Excess and/or obsolescence |
|
|
885 |
|
|
|
833 |
|
|
|
1,139 |
|
|
|
2,736 |
|
Costs for voluntary suspension of TYSABRI |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
8,751 |
|
|
$ |
8,541 |
|
|
$ |
12,049 |
|
|
$ |
49,613 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expenses
Research and development expenses totaled $162.0 million and $179.8 million in the three
months ended June 30, 2006 and 2005, respectively, a decrease of $17.8 million, or 10%. Of the
quarterly decrease, $18.1 million is a result of salary and benefits expense savings from our
comprehensive strategic plan initiated in the third quarter of 2005. An additional $16.2 million of
the decrease is due to reduced expenses for clinical trials, primarily those relating to TYSABRI
and AMEVIVE. These decreased expenses were offset by $5.6 million of increased expenses relating
to our joint development programs. For the three months ended June 30, 2006, approximately $17.4
million of share-based compensation is included in research and development expenses in connection
with the adoption of FAS 123(R) in 2006. For the three months ended June 30, 2006, share-based compensation expense included in research and development, computed under APB 25 was $11.3 million.
Research and development expenses totaled $307.9 million and $358.6 million in the six months
ended June 30, 2006 and 2005, respectively, a decrease of $50.7 million, or 14%. Of the decrease,
$35.7 million is a result of salary and benefits expense savings from our comprehensive strategic
plan. An additional $25.2 million of the decrease is due to reduced expenses for clinical trials,
primarily those relating to TYSABRI and AMEVIVE. These decreased expenses were offset by $10.8
million of increased expenses relating to our joint development programs. For the six months ended
June 30, 2006, approximately $28.7 million of share-based compensation is included in research and
development expenses in connection with the adoption of FAS 123(R) in
2006. For the six months ended June 30, 2006, share-based
compensation expense included in research and development, computed
under APB 25 was $18.3 million.
Included
in research and development expenses for the six months ended
June 30, 2005, was $6.2 million in asset impairment charges
related to the fill-finish component of our Hillerod manufacturing
facility.
33
Acquired In-Process Research and Development, or IPR&D
During the three months ended June 30, 2006, we recognized $330.5 million in expense related
to IPR&D. Of this amount, $207.4 million related to acquired IPR&D from the acquisition of
Fumapharm and $123.1 million related to acquired IPR&D from the acquisition of Conforma.
Selling, General and Administrative Expenses
Selling, general and administrative expenses totaled $170.3 million for the three months ended
June 30, 2006 compared to $155.8 million in the comparable period in 2005, an increase of $14.5
million, or 9%. Expenses increased $11.5 million due to international neurology sales and marketing
activities, primarily in the EU, as sales and marketing expenses related to TYSABRI grew, $5.1
million for increased rheumatology sales and marketing activities as we began building our sales
force for RITUXAN in RA, and $3.9 million for salary and benefits for general and administrative
personnel. This was offset by a $7.0 million decrease in immunology marketing and sales, primarily
due to the AMEVIVE divestiture. For the three months ended June 30, 2006, approximately $24.2
million of share-based compensation is included in selling, general and administrative expenses in
connection with the adoption of SFAS 123(R) in 2006. For the three
months ended June 30, 2006, share-based compensation expense included
in selling, general and administrative expense, computed under
APB 25 was $16.6 million.
Selling, general and administrative expenses totaled $324.7 million for the six months ended
June 30, 2006 compared to $314.2 million in the comparable period in 2005, an increase of $10.5
million, or 3%. Expenses increased $17.1 million due to international neurology sales and marketing
activities increasing, primarily in the EU, as sales and marketing expenses related to TYSABRI
grew, $10.0 million for increased rheumatology sales and marketing activities as we began building
our sales force for RITUXAN in RA, $5.6 million for salary and benefits for general and
administrative personnel, and $4.6 million due to increased legal expenses relating primarily to
stock-based compensation and TYSABRI. These increases were offset by an $11.8 million decrease in
immunology marketing and sales, primarily due to the AMEVIVE divestiture, $15.1 million for US
neurology sales and marketing expense related primarily to expense savings from our comprehensive
strategic plan. For the six months ended June 30, 2006, approximately $42.5 million of share-based
compensation is included in selling, general and administrative expenses in connection with the
adoption of FAS 123(R) in 2006. For the six
months ended June 30, 2006, share-based compensation expense included
in selling, general and administrative expense, computed under
APB 25 was $27.8 million.
We anticipate that total selling, general, and administrative expenses in 2006 will continue
to be higher than 2005 due to sales and marketing and other general and administrative expenses to
support AVONEX and TYSABRI, and legal expenses related to lawsuits, investigations and other
matters resulting from the suspension of TYSABRI.
Severance and Other Restructuring Costs
In accordance with our comprehensive strategic plan in 2005, we recorded restructuring
charges, which consist primarily of severance and other employee termination costs, including
health benefits, outplacements, and bonuses. Other costs include write-downs of certain research
assets that will no longer be utilized, consulting costs in connection with the restructuring
effort, and costs related to the acceleration of restricted stock, offset by the reversal of
previously recognized compensation due to unvested restricted stock cancellations. The remaining
costs at June 30, 2006 are included in accrued expenses and other on our condensed consolidated
balance sheet.
Additionally, as discussed in Note 2, Acquisitions, approximately $1.2 million in severance
costs was incurred in connection with the acquisition of Conforma. Such costs are included in the
table below.
The components of the charges are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
Costs |
|
|
Paid/Settled |
|
|
Remaining |
|
|
Costs |
|
|
|
|
|
|
Remaining |
|
|
|
Liability at |
|
|
Incurred |
|
|
through |
|
|
Liability at |
|
|
Incurred |
|
|
Paid/Settled |
|
|
Liability at |
|
|
|
December 31, |
|
|
During Q1 |
|
|
March 31, |
|
|
March 31, |
|
|
During Q2 |
|
|
in Q2 |
|
|
June 30, |
|
|
|
2005 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
Severance and
employee
termination costs |
|
$ |
17,426 |
|
|
$ |
687 |
|
|
$ |
(8,571 |
) |
|
$ |
9,542 |
|
|
$ |
1,259 |
|
|
$ |
(3,306 |
) |
|
$ |
7,495 |
|
Other costs |
|
|
31 |
|
|
|
84 |
|
|
|
(53 |
) |
|
|
62 |
|
|
|
(3 |
) |
|
|
|
|
|
|
59 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
17,457 |
|
|
$ |
771 |
|
|
$ |
(8,624 |
) |
|
$ |
9,604 |
|
|
$ |
1,256 |
|
|
$ |
(3,306 |
) |
|
$ |
7,554 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34
We may have additional restructuring charges in future periods. The amounts of those charges
cannot be determined at this time.
Amortization of Intangible Assets
For the three and six months ended June 30, 2006, we recorded amortization expense of $76.3
million and $147.0 million compared to $77.1 million and $152.8 million for the comparable period
in 2005 related to intangible assets.
We review our intangible assets for impairment periodically and whenever events or changes in
circumstances indicate that the carrying value of an asset may not be recoverable. If future events
or circumstances indicate that the carrying value of these assets may not be recoverable, we may be
required to record additional charges to our results of operations.
Facility Impairments and Loss on Sale
In June 2005, we sold our large-scale biologics manufacturing facility in Oceanside,
California, known as NIMO, along with approximately 60 acres of real property located in Oceanside,
California upon which NIMO is located, together with improvements, related property rights, and
certain personal property intangibles and contracts at or related to the real property. Total
consideration for the purchase was $408.1 million. A loss from this transaction of $75.6 million
was recognized, which consisted of an approximately $66.1 million write-down of NIMO to net selling
price and approximately $9.5 million of sales and transfer taxes and other associated transaction
costs.
As
of March 31, 2005, after our voluntary suspension of TYSABRI, we
reconsidered our construction plans and determined that we would
proceed with the bulk manufacturing component of our large-scale
biologic manufacturing facility in Hillerod, Denmark. Additionally,
we added a labeling and packaging component to the project, and
determined that we would no longer proceed with the fill-finish
component of the large-scale biological manufacturing facility. As a
result, in the first quarter of 2005, we recorded an impairment
charge to facility impairments and loss on sale of approximately
$6.2 million of engineering costs related to the fill-finish
component that had previously been capitalized. Such charges are
included in research and development expenses.
NICO
In February 2006, we sold our NICO clinical manufacturing facility in Oceanside, California,
known as NICO. The assets associated with the facility were included in assets held for sale on our
condensed consolidated balance sheet as of December 31, 2005. Total consideration for the sale was
$29.0 million. In the third and fourth quarters of 2005, we recorded impairment charges of $28.0
million to reduce the carrying value of NICO to its net realizable value. No additional loss
resulted from the completion of the sale.
Certain
reserve amounts established in connection with the sale were adjusted
during 2006, resulting in credit amounts being reflected in our
consolidated statement of operations.
Gain on Settlement of License Agreement
A gain of $34.2 million was recognized coincident with the acquisition of Fumapharm in
accordance with EITF 04-1, Accounting for Preexisting Relationships between the Parties to a
Business Combination. The gain related to the settlement of a previous collaboration agreement
between Fumapharm and us. The collaboration agreement in question had been entered into in October
2003 and required payments to Fumapharm of certain royalty amounts. The market rate for such
payments was determined to have increased due, principally, to the increased technical feasibility
of BG-12. The gain relates, principally, to the difference between the royalty rates at the time
the agreement was entered into as compared to the rates at the time the agreement was effectively
settled by virtue of our acquisition of Fumapharm.
Other Income (Expense), Net
Total other income (expense), net, consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Interest income |
|
$ |
26,114 |
|
|
$ |
12,401 |
|
|
$ |
49,671 |
|
|
$ |
28,106 |
|
Interest expense |
|
|
(186 |
) |
|
|
(2,849 |
) |
|
|
(479 |
) |
|
|
(9,760 |
) |
Other expense, net |
|
|
(4,122 |
) |
|
|
(3,501 |
) |
|
|
(8,721 |
) |
|
|
(21,220 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
$ |
21,806 |
|
|
$ |
6,051 |
|
|
$ |
40,471 |
|
|
$ |
(2,874 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income totaled $26.1 million and $49.7 million, respectively, for the three and six
months ended June 30, 2006 compared to $12.4 million and $28.1 million, respectively, for the
comparable periods in 2005. The increase in interest income is primarily due to higher cash levels
and higher yields on our marketable securities portfolio. Interest income levels that may be
achieved in the future are, in part, dependent upon market conditions.
Interest expense totaled $0.2 million and $0.5 million, respectively, for the three and six
months ended June 30, 2006 compared to $2.8 million and $9.8 million, respectively, for the
comparable period of 2005. The decrease in interest expense relates to the repurchase of our senior
notes in the second quarter of 2005.
Other
expense, net, for the three months ended June 30, 2006 versus
the prior year increased $0.6 million, principally reflecting a $8.6 million increase in gains on foreign exchange, offset
by a $3.6 million increase in losses on security sales, a $2.1 million increase in minority
interest expense, a $1.5 million increased loss on hedging, and a $2.1 million increase in expense
due to a legal settlement. Other expense, net, for the six months ended June 30, 2006 versus the
prior year decreased $12.5 million, principally reflecting a $12.8 million increase in gains on
foreign exchange and an $7.4 million increased gain on security sales, offset by a $4.1 million
increase in minority interest expense, a $2.2 million increased loss on hedging, and a $3.6 million
increase in expense due to a legal settlement.
35
Share-Based Payments
Our share-based compensation programs consist of share-based awards granted to employees
including stock options, restricted stock, performance share units and restricted stock units, or
RSUs, as well as our employee stock purchase plan, or ESPP.
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards No. 123
(revised 2004) Share-Based Payment, or SFAS 123(R). This Statement requires compensation cost
relating to share-based awards to be recognized in the financial statements using a fair-value
measurement method. Under the fair value method, the estimated fair value of awards is charged
against income over the requisite service period, which is generally the vesting period. We
selected the modified prospective method as prescribed in SFAS 123(R) and, therefore, prior periods
were not restated. Under the modified prospective method, this Statement was applied to new awards
granted in 2006, as well as to the unvested portion of previously granted equity-based awards for
which the requisite service had not been rendered as of December 31, 2005.
The fair value of performance based stock units is based on the market price of our stock on
the date of grant and assumes that the performance criteria will be met and the target payout level
will be achieved. Compensation expense is adjusted for subsequent changes in the outcome of
performance-related conditions until the vesting date. In the three and six months ended June 30,
2006, we recorded share-based compensation expense and cost associated with the SFAS 123(R)
adoption as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2006 |
|
|
Six months ended June 30, 2006 |
|
|
|
Stock options |
|
|
Restricted Stock |
|
|
|
|
|
|
Stock options & |
|
|
Restricted Stock |
|
|
|
|
|
|
& ESPP |
|
|
and RSUs |
|
|
Total |
|
|
ESPP |
|
|
and RSUs |
|
|
Total |
|
Research and development |
|
$ |
6,411 |
|
|
$ |
10,946 |
|
|
$ |
17,357 |
|
|
$ |
11,324 |
|
|
$ |
17,345 |
|
|
$ |
28,669 |
|
Selling, general and administrative |
|
|
8,262 |
|
|
|
15,977 |
|
|
|
24,239 |
|
|
|
16,742 |
|
|
|
25,788 |
|
|
|
42,530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
14,673 |
|
|
$ |
26,923 |
|
|
$ |
41,596 |
|
|
$ |
28,066 |
|
|
$ |
43,133 |
|
|
$ |
71,199 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax cumulative effect catch-up |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax effect of share-based compensation |
|
|
|
|
|
|
|
|
|
$ |
41,596 |
|
|
|
|
|
|
|
|
|
|
$ |
65,625 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For
the three and six months ended June 30, 2006, we capitalized
costs of $1.3 million and $1.7 million associated with
share-based compensation to inventory and fixed assets.
In the second quarter of 2006, we recorded pre-tax share-based compensation cost associated
with the SFAS 123(R) adoption and the restricted stock units of $41.6 million. In the six months
ended June 30, 2006, we recorded pre-tax share-based compensation cost and expense of $65.6
million. This expense is net of a cumulative effect pre-tax adjustment of $5.6 million, or $3.8
million after-tax, resulting from the application of an estimated forfeiture rate for current and
prior period unvested restricted stock awards.
For the current quarter, share-based compensation reduced diluted earnings per share by $0.08.
For the six months ended June 30, 2006, share-based compensation reduced diluted earnings per share
by $0.13. See Note 6, Share-Based Payments, for prior period pro-forma data and additional
discussion.
Income Tax Provision
Our effective tax rate was (70.3%) on pre-tax losses for the three months ended June 30, 2006
and 156.2% on pre-tax income before the effect of cumulative accounting change for the six months
ended June 30, 2006, compared to 34.1% and 34.3% for the
comparable periods in 2005. Our effective tax rate for the periods
ending June 30 differs from the U.S. federal statutory rate primarily
due to the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
|
2005 |
|
Statutory
Rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State Taxes |
|
|
(3.6) |
|
|
|
4.6 |
|
|
|
7.9 |
|
|
|
3.0 |
|
Foreign Taxes |
|
|
12.8 |
|
|
|
(22.7) |
|
|
|
(26.9) |
|
|
|
(15.8) |
|
Credits |
|
|
0.3 |
|
|
|
(4.7) |
|
|
|
(0.9) |
|
|
|
(3.3) |
|
Other |
|
|
(4.2) |
|
|
|
(1.0) |
|
|
|
6.5 |
|
|
|
(0.3) |
|
Fair Value
Adjustment |
|
|
(7.1) |
|
|
|
22.9 |
|
|
|
21.2 |
|
|
|
15.7 |
|
IPR&D |
|
|
(115.4) |
|
|
|
0.0 |
|
|
|
126.5 |
|
|
|
0.0 |
|
Gain on
Settlement of Fumapharm License Agreement |
|
|
11.9 |
|
|
|
0.0 |
|
|
|
(13.1) |
|
|
|
0.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(70.3) |
% |
|
|
34.1 |
% |
|
|
156.2 |
% |
|
|
34.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Our effective
tax rate for the three and six months ended June 30, 2006 varied from the normal statutory rate
primarily due to the pre-tax loss resulting from the write-off of non-deductible IPR&D in
connection with the acquisitions of Conforma and Fumapharm, the gain on settlement of the Fumapharm
license agreement, the impact of state taxes, and non-deductible items such as certain stock-based
compensation charges, partially offset by the new domestic manufacturing deduction.
Our effective tax rate for the three and six months ended June 30, 2005 was lower than then
normal statutory rate primarily due to the effect of lower income tax rates (less than 35% U.S.
statutory corporate rate) in certain non-U.S. jurisdictions in which we operate, tax credits
allowed for research and experimentation expenditures in the U.S., and the new manufacturing
deduction, offset by acquisition-related intangible amortization expenses arising from purchase
accounting related to foreign jurisdictions.
We have net operating loss carryforwards and tax credit carryforwards for federal and state
income tax purposes available to offset future taxable income. The utilization of our net operating
loss carryforwards and tax credits may be subject to an annual limitation under the Internal
Revenue Code due to a cumulative change of ownership of more than 50% in prior years. However,
other than for tax attributes acquired as part of the Conforma transaction, we anticipate that this
annual limitation will result only in a modest delay in the utilization of such net operating loss
and tax credits.
36
Liquidity and Capital Resources
Financial Condition
Our financial condition is summarized as follows (in thousands);
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Cash and Cash Equivalents |
|
$ |
345,104 |
|
|
$ |
568,168 |
|
Marketable Securities Short Term |
|
|
368,670 |
|
|
|
282,585 |
|
Marketable Securities Long Term |
|
|
1,417,482 |
|
|
|
1,204,378 |
|
|
|
|
|
|
|
|
|
|
|
2,131,256 |
|
|
|
2,055,131 |
|
|
|
|
|
|
|
|
|
|
Working Capital |
|
$ |
949,758 |
|
|
$ |
1,035,045 |
|
|
|
|
|
|
|
|
|
|
Outstanding Borrowings |
|
$ |
44,526 |
|
|
$ |
43,444 |
|
Until required for operations, we invest our cash reserves in bank deposits, certificates of
deposit, commercial paper, corporate notes, foreign and U.S. government instruments and other
readily marketable debt instruments in accordance with our investment policy.
Our
operating activities generated $339.6 million of cash for the six months ended June 30,
2006, as compared to $441.6 million for the six months ended June 30, 2005.
We have financed our operating and capital expenditures principally through cash flows from
our operations. We expect to finance our current and planned operating requirements principally
through cash from operations, as well as existing cash resources. We believe that these funds will
be sufficient to meet our operating requirements for the foreseeable future. However, we may, from
time to time, seek additional funding through a combination of new collaborative agreements,
strategic alliances and additional equity and debt financings or from other sources. Our working
capital and capital requirements will depend upon numerous factors, including:
|
|
|
the continued commercial success of AVONEX and RITUXAN and, to a lesser extent, ZEVALIN; |
|
|
|
|
the commercial success of TYSABRI; |
|
|
|
|
the timing and expense of obtaining regulatory approvals for products in development; |
|
|
|
|
the cost of launching new products, and the success of those products; |
|
|
|
|
funding and timing of payments related to several significant capital projects; |
|
|
|
|
the progress of our preclinical and clinical testing; |
|
|
|
|
fluctuating or increasing manufacturing requirements and research and development programs; |
|
|
|
|
levels of resources that we need to devote to the development of manufacturing, sales
and marketing capabilities, including resources devoted to the marketing of AVONEX,
RITUXAN, ZEVALIN, TYSABRI and future products; |
|
|
|
|
technological advances; |
|
|
|
|
status of products being developed by competitors; |
|
|
|
|
our ability to establish collaborative arrangements with other organizations; |
|
|
|
|
and working capital required to satisfy the options of holders of our senior notes and
subordinated notes who may require us to repurchase their notes on specified terms or upon
the occurrence of specified events. |
In connection with the strategic plan that we announced in September 2005, we intend to commit
significant additional capital to external research and development opportunities. To date, we
have financed our external growth initiatives through existing cash resources. We expect to
finance our future growth initiative requirements either through existing cash resources or a
combination of existing cash resources and debt financings.
Operating activities
The
cash provided by operations during the six months ended June 30,
2006 was $339.6 million,
compared to $441.6 million for the six months ended June 30, 2005. The decrease reflects higher
underlying earnings cash-based earnings reduced by uses of cash to finance higher working capital.
Specifically, although lower inventory balances were a use of funds
of $23.6 million, other working
capital changes were uses of funds: increased accounts receivable balances were a use of funds of
$20.9 million, increased joint venture receivables were a use of funds of $23.8 million and
reductions in accounts payable, current taxes payable and accrued liabilities were a use of cash of
$82.6 million.
37
Investing activities
Our
investing activities used cash of $657.6 million in the six months ended June 30, 2006
compared to generating $1,023.0 million in the six months ended June 30, 2005. This was due to the
net purchase of marketable securities and payments related to the acquisitions of Fumapharm
(approximately $215.5 million) and Conforma (approximately $147.8 million). In the prior year,
proceeds from investments had been a source of cash of $780.7 million and proceeds from sales of
property, plant and equipment were $408.1 million.
Financing activities
Cash generated from financing activities during the six months ended June 30, 2006 was $94.3
million compared to a use of cash of $1,035.7 million in the six months ended June 30, 2005 due to
the use of cash for the repurchase of senior notes in 2005 and significantly lower treasury
purchases in the current year.
Borrowings
As of June 30, 2006, our remaining indebtedness under our subordinated notes was approximately
$44.5 million.
Commitments
In August 2004, we restarted construction of our large-scale biologic manufacturing facility
in Hillerod, Denmark. In March 2005, after our voluntary suspension of TYSABRI, we reconsidered our
construction plans and determined that we would proceed with the bulk-manufacturing component of
our large-scale biologic manufacturing facility in Hillerod, Denmark. Additionally, we added a
labeling and packaging component to the project. We also determined that we would no longer proceed
with the fill-finish component of our large-scale biological manufacturing facility in Hillerod,
Denmark. The original cost of the project was expected to be $372.0 million. As of June 30, 2006,
we had committed approximately $234.8 million to the project, of which $208.6 million had been
paid. We expect the label and packaging facility to be substantially completed in 2006 and licensed
for operation in 2007.
The timing of the completion and anticipated licensing of the Hillerod facility is in part
dependent upon market acceptance of TYSABRI. See Risk Factors Safety Issues with TYSABRI Could
Significantly Affect our Growth. Now that TYSABRI has been approved we are in the process of
evaluating our requirements for TYSABRI inventory and additional manufacturing capacity in light of
the approved label and our judgment of the potential market acceptance of TYSABRI in MS, and the
probability of obtaining marketing approval of TYSABRI in additional indications in the US, EU and
other jurisdictions.
Share Repurchase Program
In October 2004, our Board of Directors authorized the repurchase of up to 20.0 million shares
of our common stock. The repurchased stock will provide us with treasury shares for general
corporate purposes, such as common stock to be issued under our employee equity and stock purchase
plans. This repurchase program will expire no later than
October 4, 2006. We did not repurchase a significant amount of
shares under this program for the six months ended June 30, 2006. Approximately 11.9 million shares
remain authorized for repurchase under this program at June 30, 2006.
Off-Balance Sheet Arrangements
We do not have any significant relationships with unconsolidated entities or financial
partnerships, such as entities often referred to as structured finance or special purpose entities,
which would have been established for the purpose of facilitating off-balance sheet arrangements or
other contractually narrow or limited purposes. As such, we are not exposed to any financing,
liquidity, market or credit risk that could arise if we had engaged in such relationships.
Legal Matters
Please
refer to Note 10, Litigation, for a discussion of legal matters as of June 30, 2006.
New Accounting Standards
Please
refer to Note 17, New Accounting Pronouncements, for a discussion of new accounting standards.
CRITICAL ACCOUNTING ESTIMATES
We incorporate by reference the section Managements Discussion and Analysis of Financial
Condition and Results of Operation Critical Accounting Estimates of our Annual Report on Form
10-K for the fiscal year ended December 31, 2005. Significant judgments and/or updates to the
policies since December 31, 2005 are included below.
Share-Based Payments
Our share-based compensation programs consist of share-based awards granted to employees
including stock options, restricted stock, performance share units and restricted stock units, as
well as our ESPP.
38
As discussed in Note 6, Share-Based Payments, effective January 1, 2006, we adopted Statement
of Financial Accounting Standards No. 123 (revised 2004) Share-Based Payment, or SFAS 123(R).
This Statement requires compensation cost relating to share-based payment transactions to be
recognized in the financial statements using a fair-value measurement method. Prior to January 1,
2006, we accounted for stock options using the intrinsic value method. This method measures
share-based compensation expense as the amount by which the market price of the stock on the date
of grant exceeds the exercise price. We had not recognized any significant share-based compensation
expense under this method related to stock options in recent years because we granted stock options
at the market price as of the date of grant.
The estimated fair value of options, including the effect of estimated forfeitures, is
recognized over the options vesting periods. The fair value of all time vested restricted units
and restricted stock is based on the market value of our stock on the date of grant. Compensation
expense for restricted stock and restricted stock units, including the effect of forfeitures, is
recognized over the applicable service period. The fair value of performance based stock units is
based on the market price of the Companys stock on the date of grant and assumes that the
performance criteria will be met and the target payout level will be achieved. Compensation cost is
adjusted for subsequent changes in the outcome of performance-related conditions until the vesting
dates. If actual forfeitures differ significantly from our estimated forfeitures, there could be a
significant impact on our results of operations. Additionally, future changes to our assumptions to
the success of achieving the performance criteria for restricted stock units could significantly
impact our future results of operations.
The fair value of the first and second quarters of 2006 stock option grants were estimated on
the date of grant using a Black-Scholes option valuation model that uses the following
weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Q1 2006 |
|
Q2 2006 |
Expected dividend yield |
|
|
0 |
% |
|
|
0 |
% |
Expected stock price volatility |
|
|
34.8 |
% |
|
|
34.8 |
% |
Risk-free interest rate |
|
|
4.35 |
% |
|
|
5.03 |
% |
Expected option life in years |
|
|
4.87 |
|
|
|
4.87 |
|
Per share grant date fair value |
|
$ |
16.82 |
|
|
$ |
17.71 |
|
Expected volatility is based primarily upon implied volatility for our exchange traded options
and other factors, including historical volatility. After assessing all available information on
either historical volatility, implied volatility, or both, we have concluded that a combination of
both historical and implied volatility provides its best estimate of expected volatility. The
expected term of options granted is derived from using assumed exercise rates based on historical
exercise patterns, and represents the period of time that options granted are expected to be
outstanding. The risk-free interest rate used is determined by the market yield curve based upon
the risk-free interest rates established by the Federal Reserve, or non-coupon bonds that have
maturities equal to the expected term. The dividend yield is based upon the fact that we have not
historically granted cash dividends, and do not expect to issue dividends in the foreseeable
future. Stock options granted prior to January 1, 2006 were valued based on the grant date fair
value of those awards, using the Black-Scholes option pricing model, as previously calculated for
pro-forma disclosures under SFAS 123 Accounting for Stock-based Compensation. Alternative
estimates and judgements could yield materially different results.
Inventory
Capitalization of Inventory Costs
We capitalize inventory costs associated with our products prior to regulatory approval, when,
based on managements judgment, future commercialization is considered probable and the future
economic benefit is expected to be realized. We consider numerous attributes in evaluating whether
the costs to manufacture a particular product should be capitalized as an asset. We assess the
regulatory approval process and where the product stands in relation to that approval process
including any known constraints and impediments to approval, including safety, efficacy and
potential labeling restrictions. We evaluate our anticipated research and development initiatives
and constraints relating to the particular product and the indication in which it will be used. We
consider our manufacturing environment including our supply chain in determining logistical
constraints that could possibly hamper approval or commercialization. We consider the shelf life of
the product in relation to the expected timeline for approval and we consider patent related or
contract issues that may prevent or cause delay in commercialization. We are sensitive to the
significant commitment of capital to scale up production and to launch commercialization
strategies. We also base our judgment on the viability of commercialization, trends in the
marketplace and market acceptance criteria. Finally, we consider the reimbursement strategies that
may prevail with respect to the product and assess the economic benefit that we are likely to
realize. We would be required to expense previously capitalized costs related to pre-approval
inventory upon a change in such judgment, due to, among other potential factors, a denial or delay
of approval by necessary regulatory bodies.
Valuation of Inventory
We periodically review our inventories for excess or obsolete inventory and write-down
obsolete or otherwise unmarketable inventory to its estimated net realized value. If the actual
realizable value is less than that estimated by us, or if there are any further determinations that
inventory will not be marketable based on estimates of demand, additional inventory write-downs may
be required. This periodic review led to the expensing of costs associated with the manufacture of
TYSABRI during 2005, as described above, and may lead us to expense costs associated with the
manufacture of TYSABRI or other inventory in subsequent periods.
Our products are subject to strict quality control and monitoring throughout the manufacturing
process. Periodically, certain batches or units of product may no longer meet quality
specifications or may expire. As a result, included in cost of product revenues were write-downs of
commercial inventory that did not meet quality specifications or became obsolete due to dating
expiration, in all cases this product inventory was written-down to its net realizable value.
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Item 3. Quantitative and Qualitative Disclosure about Market Risk
Our market risks, and the ways we manage them, are summarized in our Annual Report on Form
10-K for the fiscal year ended December 31, 2005. There have been no material changes in the first
six months of 2006 to such risks or our management of such risks.
Item 4. Controls and Procedures.
Disclosure Controls and Procedures
We have carried out an evaluation, under the supervision and the participation of our
management, including our principal executive officer and principal financial officer, of the
effectiveness of the design and operation of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the
Securities Exchange Act) as of June 30, 2006. Based upon that evaluation, our principal executive
officer and principal financial officer concluded that, as of June 30, 2006, our disclosure
controls and procedures are effective in providing reasonable assurance that (a) the information
required to be disclosed by us in the reports that we file or submit under the Securities Exchange
Act is recorded, processed, summarized and reported within the time periods specified in the SECs
rules and forms, and (b) such information is accumulated and communicated to our management,
including our principal executive officer and principal financial officer, as appropriate to allow
timely decisions regarding required disclosure. In designing and evaluating our disclosure controls
and procedures, our management recognized that any controls and procedures, no matter how well
designed and operated, can provide only reasonable assurance of achieving the desired control
objectives, and our management necessarily was required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
Changes in Internal Control over Financial Reporting
We have not made any changes in our internal control over financial reporting during the
second quarter of 2006 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
Part II OTHER INFORMATION
Item 1. Legal Proceedings.
The section entitled Litigation in Notes to Condensed Consolidated Financial Statements in
Part I of this report is incorporated into this item by reference.
Item 1A. Risk Factors
Risk factors which could cause actual results to differ from our expectations and which could
negatively impact our financial condition and results of operations are discussed below and
elsewhere in this report. You should understand that it is not possible to predict or identify all
risk factors. Consequentially, you should not consider the risks listed below to be a complete set
of all potential risks or uncertainties. Although we believe that the risks described below
represent all material risks currently applicable to our business, additional risks and
uncertainties not presently known to us or that are currently not believed to be significant to our
business may also affect our actual results and could harm our business, financial condition and
results of operations.
Several of the risks described below have been updated to reflect our receipt in June 2006 of
marketing authorization for TYSABRI in the United States and Europe and the associated changes in
the risks relating to TYSABRI. Changes to the descriptions of the risks should not be considered
an admission by us that any particular change was or was not material.
Our Revenues Rely Significantly on a Limited Number of Products.
Our current and future revenues depend substantially upon continued sales of our commercial
products. Revenues related to sales of two of our products, AVONEX and RITUXAN, represented
approximately 96% of our total revenues in three months ended June 30, 2006. We cannot assure you
that AVONEX or RITUXAN will continue to be accepted in the U.S. or in any foreign markets or that
sales of either of these products will not decline in the future. A number of factors may affect
market acceptance of AVONEX, RITUXAN and our other products, including:
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the perception of physicians and other members of the health care community of their safety and
efficacy relative to that of competing products; |
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patient and physician satisfaction with these products; |
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the effectiveness of our sales and marketing efforts and those of our marketing partners
and licensees in the U.S., the EU and other foreign markets; |
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the size of the markets for these products; |
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unfavorable publicity concerning these products or similar drugs; |
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the introduction, availability and acceptance of competing treatments, including TYSABRI; |
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the availability and level of third party reimbursement; |
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adverse event information relating to any of these products; |
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changes to product labels to add significant warnings or restrictions on use; |
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the success of ongoing development work on RITUXAN and new anti-CD20 product candidates; |
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the continued accessibility of third parties to vial, label, and distribute these products on acceptable terms; |
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the unfavorable outcome of patent litigation related to any of these products; |
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the ability to manufacture commercial lots of these products successfully and on a timely basis; and |
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regulatory developments related to the manufacture or continued use of these products. |
Any material adverse developments with respect to the commercialization of these products may
cause our revenue to grow at a slower than expected rate, or even decrease, in the future. In
addition, the successful development and commercialization of new anti-CD20 product candidates in
our collaboration with Genentech (which also includes RITUXAN) will adversely affect our
participation in the operating profits from such collaboration (including as to RITUXAN) in such a
manner that, although overall collaboration revenue might ultimately increase as the result of the
successful development and commercialization of any such product candidate, our share of the
operating profits will decrease.
Safety Issues with TYSABRI Could Significantly Affect our Growth.
TYSABRI was approved by the FDA in November 2004 to treat relapsing forms of MS to reduce the
frequency of clinical relapses. In February 2005, in consultation with the FDA, we and Elan
voluntarily suspended the marketing and commercial distribution of TYSABRI. We also suspended
dosing in all clinical trials of TYSABRI. These decisions were based on reports of cases of
progressive multifocal leukoencephalopathy, or PML, an opportunistic viral infection of the brain
that usually leads to death or severe disability in patients treated with TYSABRI in clinical
studies. We and Elan conducted a safety evaluation of patients treated with TYSABRI in MS, Crohns
disease and RA clinical studies. The safety evaluation included the review of any reports of
potential PML in MS patients receiving TYSABRI in the commercial setting. In October 2005, we
completed the safety evaluation and found no new confirmed cases of PML. Three confirmed cases of
PML were previously reported, two of which were fatal.
In June 2006, the FDA approved a supplemental Biologics License Application, or sBLA, for the
reintroduction of TYSABRI as a monotherapy treatment for relapsing forms of MS to slow the
progression of disability and reduce the frequency of clinical relapses. The FDA granted approval
for reintroduction based on a review of TYSABRI clinical trial data; revised labeling with enhanced
safety warnings; and a risk management plan (TOUCH Prescribing Program) designed to inform
physicians and patients of the benefits and risks of TYSABRI treatment and minimize the potential
risk of PML. Because of the increased risk of PML, TYSABRI monotherapy is generally recommended
for patients who have had an inadequate response to, or are unable to tolerate, alternate MS
therapies. Elements of the TOUCH Prescribing Program include:
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revised labeling with a prominent boxed warning of the risk of PML; and warnings
against concurrent use of TYSABRI with chronic immunosuppressant or immunomodulatory
therapies, and patients who are immunocompromised due to HIV, hematological malignancies,
organ transplants or immunosuppressive therapies; |
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mandatory enrollment for all prescribers, central pharmacies, infusion centers and
patients who wish to prescribe, distribute, infuse, or receive, respectively, TYSABRI; |
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controlled, centralized distribution only to authorized infusion centers; |
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mandatory FDA-reviewed educational tools for patients and physicians, including a
patient medication guide, TOUCH enrollment form and a monthly pre-infusion checklist; |
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ongoing assessment of PML risk and overall safety; and |
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a 5,000 patient cohort observational study over five years. |
In June 2006, we and Elan also received approval from the European Commission to market
TYSABRI as a treatment for relapsing remitting MS to delay the progression of disability and reduce
the frequency of relapses. TYSABRI is indicated as a single disease modifying therapy in highly
active relapsing remitting MS for patients with high disease activity despite treatment with a
beta-interferon or in patients with rapidly evolving severe relapsing remitting MS.
The success of any reintroduction into the U.S. market and launch in the EU will depend upon
acceptance of TYSABRI by the medical community and patients, which cannot be certain given the
significant restrictions on use and the significant safety warnings in the label. Any significant
lack of acceptance of TYSABRI by the medical community or patients would materially affect our
growth and impact various aspects of our business and our plans for the future. This could result
in, among other things, material write-offs of inventory, intangible assets or goodwill, impairment
of capital assets, and additional reductions in our workforce.
Our Long-Term Success Depends Upon the Successful Development and Commercialization of Other
Products from Our Research and Development Activities and External Growth Opportunities.
Our long-term viability and growth will depend upon the successful development and
commercialization of other products from our research and development activities and external
growth opportunities. We, along with Genentech, continue to expand our development efforts related
to RITUXAN and we are independently expanding development efforts around other potential products
in our pipeline. The expansion of our pipeline may include increases in spending on internal
projects, and is expected to include an increase in spending on external growth opportunities, such
as the acquisition and license of third party technologies or products, collaborations with other
companies and universities, the acquisitions of companies with commercial products and/or products
in their pipelines, and other types of investments. Product development and commercialization
involve a high degree of risk. Only a small number of research and development programs result in
the commercialization of a product. In addition, competition for collaborations and the acquisition
and in-license of third party technologies and products in the biopharmaceutical industry is
intense. We cannot be certain that we will be able to enter into collaborations or agreements for
desirable and compatible technologies or products on acceptable terms or at all. Many important
factors affect our ability to successfully develop and commercialize other products, including the
ability to:
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obtain and maintain necessary patents and licenses; |
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demonstrate safety and efficacy of drug candidates at each stage of the clinical trial process; |
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enroll patients in our clinical trials and complete clinical trials; |
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overcome technical hurdles that may arise; |
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manufacture successfully products in sufficient quantities to meet demand; |
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meet applicable regulatory standards; |
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obtain reimbursement coverage for the products; |
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receive required regulatory approvals; |
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produce drug candidates in commercial quantities at reasonable costs; |
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compete successfully against other products and market products
successfully; |
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enter into agreements for desirable and compatible technologies or products on acceptable terms; |
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anticipate accurately the costs associated with any acquisition; |
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prevent the potential loss of key employees of any acquired business; |
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acquire a supplier base for the materials associated with any new product opportunity; |
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hire additional employees to operate effectively any acquired business, including employees with specialized knowledge; |
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mitigate risks associated with entering into new markets in which we have no or limited prior experience; and |
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manage successfully any significant collaborations and/or integrate any significant acquisitions. |
Success in early stage clinical trials or preclinical work does not ensure that later stage or
larger scale clinical trials will be successful. Even if later stage clinical trials are
successful, the risk exists that unexpected concerns may arise from additional data or analysis or
that obstacles may arise or issues may be identified in connection with review of clinical data
with regulatory authorities or that regulatory authorities may disagree with our view of the data
or require additional data or information or additional studies.
Competition in Our Industry and in the Markets for Our Products is Intense.
The biotechnology industry is intensely competitive. We compete in the marketing and sale of
our products, the development of new products and processes, the acquisition of rights to new
products with commercial potential and the hiring of personnel. We compete with biotechnology and
pharmaceutical companies that have a greater number of products on the market, greater financial
and other resources and other technological or competitive advantages. We cannot be certain that
one or more of our competitors will not receive patent protection that dominates, blocks or
adversely affects our product development or business; will not benefit from significantly greater
sales and marketing capabilities; or will not develop products that are accepted more widely than
ours.
AVONEX competes with three other products:
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REBIF, which is co-promoted by Serono, Inc. and Pfizer Inc. in the U.S. and sold by Serono AG in the EU; |
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BETASERON, sold by Berlex in the U.S. and sold under the name BETAFERON by Schering A.G. in the EU; and |
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COPAXONE, sold by Teva in the U.S. and co-promoted by Teva and Aventis Pharma in the EU. |
In addition, a number of companies, including us, are working to develop products to treat MS
that may in the future compete with AVONEX. TYSABRI will compete with the products listed above,
including AVONEX. AVONEX also faces competition from off-label uses of drugs approved for other
indications. Some of our current competitors are also working to develop alternative formulations
for delivery of their products, which may in the future compete with AVONEX.
RITUXAN is typically used after patients fail to respond or relapse after treatment with
traditional radiation therapy or standard chemotherapy regimes, such as CVP and CHOP. ZEVALIN is
typically used after patients fail to respond or relapse following treatment with RITUXAN. ZEVALIN
received designation as an Orphan Drug from the FDA for the treatment of relapsed or refractory low
grade, follicular, or transformed B-cell non-Hodgkins lymphoma, including patients with RITUXAN
refractory follicular NHL. Marketing exclusivity resulting from this Orphan Drug designation
expires in February 2009. ZEVALIN competes with BEXXAR, a radiolabeled molecule developed by Corixa
Corporation, which is now being developed and commercialized by GlaxoSmithKline. BEXXAR received
FDA approval in June 2003 to treat patients with CD20, follicular, NHL, with and without
transformation, whose disease is refractory to RITUXAN and has relapsed following chemotherapy. A
number of other companies, including us, are working to develop products to treat B-cell NHLs and
other forms of non-Hodgkins lymphoma that may ultimately compete with RITUXAN and ZEVALIN.
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In February 2006, the FDA approved the sBLA for use of RITUXAN, in combination with
methotrexate, for reducing signs and symptoms in adult patients with moderately-to-severely active
RA who have had an inadequate response to one or more TNF antagonist therapies. RITUXAN will
compete with several different types of therapies in the RA market, including:
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traditional therapies for RA, including disease-modifying
anti-rheumatic drugs, such as steroids, methotrexate and cyclosporine,
and pain relievers such as acetaminophen; |
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anti-TNF therapies, such as REMICADE, a drug sold worldwide by
Centocor, Inc., a subsidiary of Johnson & Johnson, HUMIRA, a drug sold
by Abbott Laboratories, and ENBREL, a drug sold by Amgen,Inc. and
Wyeth Pharmaceuticals, Inc.; |
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ORENCIA, a drug developed by Bristol-Myers Squibb Company, which was
approved by the FDA to treat moderate-to-severe RA in December 2005; |
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drugs in late-stage development for RA; and |
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drugs approved for other indications that are used to treat RA. |
In addition, a number of other companies, including us, are working to develop products to
treat RA that may ultimately compete with RITUXAN in the RA marketplace.
We are Subject to Risks Related to the Products that We Manufacture
We manufacture and expect to continue to manufacture our own commercial requirements of bulk
AVONEX, and TYSABRI and the ZEVALIN bulk antibody. Our inability to manufacture successfully bulk
product and to maintain regulatory approvals of our manufacturing facilities would harm our ability
to produce timely sufficient quantities of commercial supplies of AVONEX, ZEVALIN and TYSABRI to
meet demand. Problems with manufacturing processes could result in product defects or
manufacturing failures, which could require us to delay shipment of products, recall, or withdraw
products previously shipped, or impair our ability to expand into new markets or supply products in
existing markets. Any such problem would be exacerbated by unexpected demand for our products. In
June 2005, we sold our large-scale manufacturing facility in Oceanside, California to Genentech.
We previously had planned to use the Oceanside facility to manufacture TYSABRI and other commercial
products. We currently manufacture TYSABRI at our manufacturing facility in Research Triangle
Park, North Carolina, or RTP. We are proceeding with construction of the bulk manufacturing
component of our large-scale biologic manufacturing facility in Hillerod, Denmark and have added a
labeling and packaging component to the project. Our plans with respect to the Hillerod
large-scale manufacturing facility are, in part, dependent upon the market acceptance of TYSABRI.
See Risk Factors Safety Issues with TYSABRI Could Significantly Affect our Growth. We expect
that we will be able to meet foreseeable manufacturing needs for TYSABRI from our large-scale
manufacturing facility in RTP.
If we cannot produce sufficient commercial requirements of bulk product to meet demand, we
would need to rely on third party manufacturers, of which there are only a limited number capable
of manufacturing bulk products of the type we require as contract suppliers. We cannot be certain
that we could reach agreement on reasonable terms, if at all, with those manufacturers. Even if we
were to reach agreement, the transition of the manufacturing process to a third party to enable
commercial supplies could take a significant amount of time. Our ability to supply products in
sufficient capacity to meet demand is also dependent upon third party contractors to fill-finish,
package and store such products. For a discussion of the risks associated with using third parties
to perform manufacturing-related services for our products, see Risk Factors We Rely to a Large
Extent on Third Parties in the Manufacturing of Our Products. In the past, we have had to write
down and incur other charges and expenses for products that failed to meet specifications. Similar
charges may occur in the future. Any prolonged interruption in the operations of our existing
manufacturing facilities could result in cancellations of shipments or loss of product in the
process of being manufactured. Because our manufacturing processes are highly complex and are
subject to a lengthy FDA approval process, alternative qualified production capacity may not be
available on a timely basis or at all.
We Rely to a Large Extent on Third Parties in the Manufacturing of Our Products.
We rely on Genentech for all RITUXAN manufacturing. Genentech relies on a third party to
manufacture certain bulk RITUXAN requirements. If Genentech or any third party upon which it relies
does not manufacture or fill/finish RITUXAN in sufficient quantities and on a timely and
cost-effective basis, or if Genentech or any third party does not obtain and maintain all required
manufacturing approvals, our business could be harmed. We also rely heavily upon third party
manufacturers and suppliers to manufacture and supply significant portions of the product
components of ZEVALIN other than the bulk antibody.
We also source all of our fill-finish and the majority of our final product storage
operations, along with a substantial portion of our packaging operations of the components used
with our products, to a concentrated group of third party contractors. The manufacture
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of products and product components, fill-finish, packaging and storage of our products require
successful coordination among ourselves and multiple third party providers. Our inability to
coordinate these efforts, the lack of capacity available at the third party contractor or any other
problems with the operations of these third party contractors could require us to delay shipment of
saleable products, recall products previously shipped or impair our ability to supply products at
all. This could increase our costs, cause us to lose revenue or market share, and damage our
reputation. Any third party we use to fill-finish, package or store our products to be sold in the
U.S. must be licensed by the FDA. As a result, alternative third party providers may not be readily
available on a timely basis.
Due to the unique nature of the production of our products, there are several single source
providers of raw materials. We make every effort to qualify new vendors and to develop contingency
plans so that production is not impacted by short-term issues associated with single source
providers. Nonetheless, our business could be materially impacted by long term or chronic issues
associated with single source providers.
The Manufacture of Our Products is Subject to Government Regulation.
We and our third party providers are generally required to maintain compliance with current
Good Manufacturing Practice, or cGMP, and are subject to inspections by the FDA or comparable
agencies in other jurisdictions to confirm such compliance. Any changes of suppliers or
modifications of methods of manufacturing require amending our application to the FDA and ultimate
amendment acceptance by the FDA prior to release of product to the market place. Our inability or
the inability of our third party service providers to demonstrate ongoing cGMP compliance could
require us to withdraw or recall product and interrupt commercial supply of our products. Any
delay, interruption or other issues that arise in the manufacture, fill-finish, packaging, or
storage of our products as a result of a failure of our facilities or the facilities or operations
of third parties to pass any regulatory agency inspection could significantly impair our ability to
develop and commercialize our products. This could increase our costs, cause us to lose revenue or
market share and damage our reputation.
Royalty Revenues Contribute to Our Overall Profitability and Are Not Within Our Control.
Royalty revenues contribute to our overall profitability. Royalty revenues may fluctuate as a
result of disputes with licensees, collaborators and partners, future patent expirations and other
factors such as pricing reforms, health care reform initiatives, other legal and regulatory
developments and the introduction of competitive products that may have an impact on product sales
by our licensees and partners. In addition, sales levels of products sold by our licensees,
collaborators and partners may fluctuate from quarter to quarter due to the timing and extent of
major events such as new indication approvals or government-sponsored programs. Since we are not
involved in the development or sale of products by our licensees, collaborators and partners, we
cannot be certain of the timing or potential impact of factors which may affect their sales. In
addition, the obligation of licensees to pay us royalties generally terminates upon expiration of
the related patents.
Our Operating Results Are Subject to Significant Fluctuations.
Our quarterly revenues, expenses and net income have fluctuated in the past and are likely to
fluctuate significantly in the future. Fluctuation may result from a variety of factors, including:
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demand and pricing for our products; |
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physician and patient acceptance of our products; |
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amount and timing of sales orders for our products; |
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our achievement of product development objectives and milestones; |
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research and development and manufacturing expenses; |
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clinical trial enrollment and expenses; |
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our manufacturing performance and capacity and that of our partners; |
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percentage of time that our manufacturing facilities are utilized for commercial versus clinical manufacturing; |
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rate and success of product approvals; |
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costs related to obtain product approvals, launching new products and maintaining market
acceptance for existing products; |
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timing of regulatory approval, if any, of competitive products and the rate of market penetration of competing products; |
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new data or information, positive or negative, on the benefits and risks of our products or products under development; |
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expenses related to protecting our intellectual property; |
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expenses related to litigation and settlement of litigation; |
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payments made to acquire new products or technology; |
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write downs and write offs of inventories, intangible assets, goodwill or investments; |
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impairment of assets, such as buildings and manufacturing facilities; |
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government or private healthcare reimbursement policies; |
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collaboration obligations and copromotion payments we make or receive; |
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timing and nature of contract manufacturing and contract research and development payments and receipts; |
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interest rate fluctuations; |
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changes in our effective tax rate; |
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foreign currency exchange rates; and |
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overall economic conditions. |
Our operating results during any one quarter do not necessarily suggest the anticipated
results of future quarters.
Our Revenues Depend on Payment and Reimbursement from Third Party Payors, and, to the Extent
that Payment or Reimbursement for Our Products Is Reduced, this Could Negatively Impact Our Product Sales and Revenue.
Sales of our products are dependent, in large part, on the availability and extent of reimbursement from government health administration authorities, private
health insurers and other organizations. U.S. and foreign government regulations mandating price controls and limitations on patient access to our products impact our business and our future results
could be adversely affected by changes in such regulations.
In the U.S., many of our products are subject to increasing pricing pressures. Such pressures may increase as a result of the Medicare Prescription Drug Improvement and Modernization Act of 2003.
Managed care organizations as well as Medicaid and other government health administration authorities continue to seek price discounts. Government efforts to reduce Medicaid expenses may continue to increase the use of managed care organizations. This may result in managed care organizations influencing prescription decisions for a larger segment of the population and a corresponding constraint on prices and reimbursement for our products. In addition,
some states have implemented and other states are considering price
controls or patient-access constraints under the Medicaid program and some states are considering price-control regimes that would apply to broader segments of their populations that are not Medicaid eligible. Other matters also could be the subject of U.S. federal or state legislative or regulatory
action that could adversely affect our business, including the importation of prescription drugs that are marketed outside the U.S. and sold at lower prices as a result of drug price regulations by the governments of various foreign countries.
We encounter similar regulatory and legislative issues in most other countries. In the EU and some other international markets, the government provides health care at low cost to consumers and regulates pharmaceutical prices, patient eligibility or reimbursement levels to control costs for the government-sponsored
health care system. This international patchwork of price regulations may lead to inconsistent prices and some third party trade in our products from markets with lower
prices thereby undermining our sales in some markets with higher prices.
When a new medical product is approved, the availability of government and private reimbursement for that product is uncertain, as is the amount for which that product will be reimbursed. We cannot predict the availability or amount of reimbursement for our product candidates.
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We May Be Unable to Adequately Protect or Enforce Our Intellectual Property Rights or Secure Rights
to Third Party Patents.
We have filed numerous patent applications in the U.S. and various other countries seeking
protection of inventions originating from our research and development, including a number of our
processes and products. Patents have been issued on many of these applications. We have also
obtained rights to various patents and patent applications under licenses with third parties, which
provide for the payment of royalties by us. The ultimate degree of patent protection that will be
afforded to biotechnology products and processes, including ours, in the U.S. and in other
important markets remains uncertain and is dependent upon the scope of protection decided upon by
the patent offices, courts and lawmakers in these countries. There is no certainty that our
existing patents or others, if obtained, will afford us substantial protection or commercial
benefit. Similarly, there is no assurance that our pending patent applications or patent
applications licensed from third parties will ultimately be granted as patents or that those
patents that have been issued or are issued in the future will prevail if they are challenged in
court.
A substantial number of patents have already been issued to other biotechnology and
biopharmaceutical companies. Competitors may have filed applications for, or have been issued
patents and may obtain additional patents and proprietary rights that may relate to products or
processes competitive with or similar to our products and processes. Moreover, the patent laws of
the U.S. and foreign countries are distinct and decisions as to patenting, validity of patents and
infringement of patents may be resolved differently in different countries. In general, we obtain
licenses to third party patents, which we deem necessary or desirable for the manufacture, use and
sale of our products. We are currently unable to assess the extent to which we may wish or be
required to acquire rights under such patents and the availability and cost of acquiring such
rights, or whether a license to such patents will be available on acceptable terms or at all. There
may be patents in the U.S. or in foreign countries or patents issued in the future that are
unavailable to license on acceptable terms. Our inability to obtain such licenses may hinder our
ability to market our products.
We are aware that others, including various universities and companies working in the
biotechnology field, have filed patent applications and have been granted patents in the U.S. and
in other countries claiming subject matter potentially useful to our business. Some of those
patents and patent applications claim only specific products or methods of making such products,
while others claim more general processes or techniques useful or now used in the biotechnology
industry. There is considerable uncertainty within the biotechnology industry about the validity,
scope and enforceability of many issued patents in the U.S. and
elsewhere in the world, and, to date, there is no consistent policy regarding the breadth of claims allowed in
biotechnology patents. We cannot currently determine the ultimate scope and validity of patents
which may be granted to third parties in the future or which patents might be asserted to be
infringed by the manufacture, use and sale of our products.
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There has been, and we expect that there may continue to be significant litigation in the
industry regarding patents and other intellectual property rights. Litigation, including our
current patent litigation with Classen Immunotherapies, and other proceedings concerning patents
and other intellectual property rights may be protracted, expensive and distracting to management.
Competitors may sue us as a way of delaying the introduction of our products. Any litigation,
including any interference proceedings to determine priority of inventions, oppositions to patents
in foreign countries or litigation against our partners, may be costly and time consuming and could
harm our business. We expect that litigation may be necessary in some instances to determine the
validity and scope of certain of our proprietary rights. Litigation may be necessary in other
instances to determine the validity, scope and/or noninfringement of certain patent rights claimed
by third parties to be pertinent to the manufacture, use or sale of our products. Ultimately, the
outcome of such litigation could adversely affect the validity and scope of our patent or other
proprietary rights, or, conversely, hinder our ability to market our products.
Legislative or Regulatory Changes Could Harm Our Business.
Our business is subject to extensive government regulation and oversight. As a result, we may
become subject to governmental actions which could adversely affect our business, operations or
financial condition, including:
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new laws, regulations or judicial decisions, or new interpretations of existing laws,
regulations or decisions, related to health care availability, method of delivery and
payment for health care products and services; |
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changes in the FDA and foreign regulatory approval processes that may delay or prevent
the approval of new products and result in lost market opportunity; |
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new laws, regulations and judicial decisions affecting pricing or marketing; and |
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changes in the tax laws relating to our operations. |
Failure to Comply with Government Regulations Regarding Our Products Could Harm Our Business.
Our activities, including the sale and marketing of our products, are subject to extensive
government regulation and oversight, including regulation under the federal Food, Drug and Cosmetic
Act and other federal and state statutes. Pharmaceutical and biotechnology companies have been the
target of lawsuits and investigations alleging violations of government regulation, including
claims asserting antitrust violations and violations of the Prescription Drug Marketing Act, or
other violations related to environmental matters. Violations of governmental regulation may be
punishable by criminal and civil sanctions, including fines and civil monetary penalties. We cannot
predict with certainty the eventual outcome of any litigation in this area. If we were to be
convicted of violating laws regulating the sale and marketing of our products, our business could
be materially harmed.
Some of Our Activities may Subject Us to Risks under Federal and State Laws Prohibiting Kickbacks
and False or Fraudulent Claims.
We are subject to the provisions of a federal law commonly known as the Medicare/Medicaid
anti-kickback law, and several similar state laws, which prohibit payments intended to induce
physicians or others either to purchase or arrange for or recommend the purchase of healthcare
products or services. While the federal law applies only to products or services for which payment
may be made by a federal healthcare program, state laws may apply regardless of whether federal
funds may be involved. These laws constrain the sales, marketing and other promotional activities
of manufacturers of drugs and biologicals, such as us, by limiting the kinds of financial
arrangements, including sales programs, with hospitals, physicians, and other potential purchasers
of drugs and biologicals. Other federal and state laws generally prohibit individuals or entities
from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid,
or other third party payors that are false or fraudulent, or are for items or services that were
not provided as claimed. Anti-kickback and false claims laws prescribe civil and criminal penalties
for noncompliance that can be substantial, including the possibility of exclusion from federal
healthcare programs (including Medicare and Medicaid).
48
Pharmaceutical and biotechnology companies have been the target of lawsuits and investigations
alleging violations of government regulation, including claims asserting violations of the federal
False Claim Act, the federal anti-kickback statute, and other violations in connection with
off-label promotion of products and Medicare and/or Medicaid reimbursement, or related to claims
under state laws, including state anti-kickback and fraud laws. For example, we and a number of
other major pharmaceutical and biotechnology companies are named defendants in certain Average
Wholesale Price litigation pending in the U.S. District Court for the District of Massachusetts
alleging, among other things, violations in connection with Medicaid reimbursement. See Legal
Proceedings for a description of this litigation. While we continually strive to comply with these
complex requirements, interpretations of the applicability of these laws to marketing practices is
ever evolving and even an unsuccessful challenge could cause adverse publicity and be costly to
respond to, and thus could have a material adverse effect on our business, results of operations
and financial condition.
Failure to Prevail in Litigation or Satisfactorily Resolve a Third Party Investigation Could Harm
Our Business.
Pharmaceutical and biotechnology companies have been the target of lawsuits relating to
product liability claims and disputes over intellectual property rights (including patents). See
Risk Factors We May Be Unable to Adequately Protect or Enforce Our Intellectual Property Rights
or Secure Rights to Third Party Patents. Additionally, the administration of drugs in humans,
whether in clinical studies or commercially, can result in lawsuits with product liability claims
whether or not the drugs are actually at fault in causing an injury. Our products or product
candidates may cause, or may appear to have caused, injury or dangerous drug interactions that we
may not learn about or understand until the product or product candidate has been administered to
patients for a prolonged period of time. For example, we may face lawsuits with product liability
and other related claims by patients treated with TYSABRI or related to TYSABRI, including lawsuits
filed by patients who have developed PML or other serious adverse events while using TYSABRI.
Public companies may also be the subject of certain other types of claims, including those
asserting violations of securities laws and derivative actions. For example, we face class action
lawsuits related to our announcement of the suspension of marketing and commercial distribution of
TYSABRI in February 2005. In April 2005, we received a formal order of investigation from the
Boston District Office of the SEC. The SEC is investigating whether any violations of the federal
securities laws occurred in connection with the suspension of marketing and commercial distribution
of TYSABRI. We continue to cooperate fully with the SEC in this investigation.
We cannot predict with certainty the eventual outcome of any pending litigation or third party
investigation. We may not be successful in defending ourselves or asserting our rights in the
litigation or investigation to which we are currently subject, or in new lawsuits, investigations
or claims brought against us, and, as a result, our business could be materially harmed. These
lawsuits, investigations or claims may result in large judgments or settlements against us, any of
which could have a negative effect on our financial performance and business. Additionally,
lawsuits and investigations can be expensive to defend, whether or not the lawsuit or investigation
has merit, and the defense of these actions may divert the attention of our management and other
resources that would otherwise be engaged in running our business.
We maintain product liability and director and officer insurance that we regard as reasonably
adequate to protect us from potential claims, however we cannot be certain that it will. Also, the
costs of insurance have increased dramatically in recent years, and the availability of coverage
has decreased. As a result, we cannot be certain that we will be able to maintain our current
product liability insurance at a reasonable cost, or at all.
Our Business Involves Environmental Risks.
Our business and the business of several of our strategic partners, including Genentech and
Elan, involve the controlled use of hazardous materials, chemicals, biologics and radioactive
compounds. Biologics manufacturing is extremely susceptible to product loss due to microbial or
viral contamination, material equipment failure, or vendor or operator error. Although we believe
that our safety procedures for handling and disposing of such materials comply with state and
federal standards, there will always be the risk of accidental contamination or injury. In
addition, microbial or viral contamination may cause the closure of a manufacturing facility for an
extended period of time. By law, radioactive materials may only be disposed of at state-approved
facilities. We currently store radioactive materials from our California operation on-site because
the approval of a disposal site in California for all California-based companies has been delayed
indefinitely. If and when a disposal site is approved, we may incur substantial costs related to
the disposal of these materials. If we were to become liable for an accident, or if we were to
suffer an extended facility shutdown, we could incur significant costs, damages and penalties that
could harm our business.
49
We Rely Upon Key Personnel.
Our success will depend, to a great extent, upon the experience, abilities and continued
services of our executive officers and key scientific personnel. If we lose the services of any of
these individuals, our business could be harmed. We currently have an employment agreement with
James C. Mullen, our Chief Executive Officer and President. Our success also will depend upon our
ability to attract and retain other highly qualified scientific, managerial, sales and
manufacturing personnel and our ability to develop and maintain relationships with qualified
clinical researchers. Competition to obtain the services of these personnel and relationships is
intense and we compete with numerous pharmaceutical and biotechnology companies as well as with
universities and non-profit research organizations. We may not be able to continue to attract and
retain qualified personnel or develop and maintain relationships with clinical researchers. One
effect of recent workforce reductions is the loss of research, development and other personnel that
could have contributed to our future growth. It remains to be seen whether the loss of such
personnel will have an adverse effect on our ability to accomplish our research, development and
external growth objectives.
Future Transactions May Harm Our Business or the Market Price of Our Stock.
We regularly review potential transactions related to technologies, products or product rights
and businesses complementary to our business. These transactions could include:
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mergers; |
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acquisitions: |
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strategic alliances; |
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licensing and collaboration agreements; and |
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copromotion agreements. |
We may choose to enter into one or more of these transactions at any time, which may cause
substantial fluctuations to the market price of our stock. Moreover, depending upon the nature of
any transaction, we may experience a charge to earnings, which could also harm the market price of
our stock.
We are Subject to Market Risk.
We have exposure to financial risk in several areas including changes in foreign exchange
rates and interest rates. We attempt to minimize our exposures to such risks by using certain
financial instruments, for purposes other than trading, in accordance with our overall risk
management guidelines. See Critical Accounting Estimates in Managements Discussion and Analysis
of Financial Condition and Results of Operations for information regarding our accounting policies
for financial instruments and disclosures of financial instruments.
Our Financial Position, Results of Operations and Cash Flows can be Affected by Fluctuations in
Foreign Currency Exchange Rates.
We have operations in Europe, Japan, Australia and Canada in connection with the sale of
AVONEX. We also receive royalty revenues based on worldwide product sales by our licensees and
through Genentech on sales of RITUXAN outside of the U.S. As a result, our financial position,
results of operations and cash flows can be affected by fluctuations in foreign currency exchange
rates (primarily Euro, Swedish krona, British pound, Japanese yen, Canadian dollar and Swiss
franc).
We are Exposed to Risk of Interest Rate Fluctuations.
The fair value of our cash, cash equivalents and marketable securities are subject to change
as a result of potential changes in market interest rates.
50
Volatility of Our Stock Price.
The market prices for our common stock and for securities of other companies engaged primarily
in biotechnology and pharmaceutical development, manufacture and distribution are highly volatile.
For example, the selling price of our common stock fluctuated between $70.00 per share and $33.18
per share during 2005. The market price of our common stock likely will continue to fluctuate due
to a variety of factors, including:
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material public announcements; |
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the announcement and timing of new product introductions by us or others; |
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material developments relating to TYSABRI; |
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events related to our other products or those of our competitors, including the
withdrawal or suspension of products from the market; |
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technical innovations or product development by us or our competitors; |
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regulatory approvals or regulatory issues; |
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availability and level of third party reimbursement; |
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developments relating to patents, proprietary rights and Orphan Drug status; |
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results of late-stage clinical trials with respect to our products under development or those of our competitors; |
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new data or information, positive or negative, on the benefits and risks of our products or products under development; |
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political developments or proposed legislation in the pharmaceutical or healthcare industry; |
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economic and other external factors, disaster or crisis; |
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period-to-period fluctuations in our financial results or results which do not meet or exceed analyst expectations; and |
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market trends relating to or affecting stock prices throughout our industry, whether or
not related to results or news regarding us or our competitors. |
We Have Adopted Several Anti-takeover Measures As Well As Other Measures to Protect Certain Members
of Our Management Which May Discourage or Prevent a Third Party From Acquiring Us.
A number of factors pertaining to our corporate governance discourage a takeover attempt that
might be viewed as beneficial to stockholders who wish to receive a premium for their shares from a
potential bidder. For example:
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we are subject to Section 203 of the Delaware General Corporation Law, which provides
that we may not enter into a business combination with an interested stockholder for a
period of three years after the date of the transaction in which the person became an
interested stockholder, unless the business combination is approved in the manner prescribed
in Section 203; |
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our stockholder rights plan is designed to cause substantial dilution to a person who
attempts to acquire us on terms not approved by our board of directors; |
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our board of directors has the authority to issue, without a vote or action of
stockholders, up to 8,000,000 shares of preferred stock and to fix the price, rights,
preferences and privileges of those shares, each of which could be superior to the rights of
holders of common stock; |
51
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our amended and restated collaboration agreement with Genentech provides that, in the
event we undergo a change of control, Genentech may present an offer to us to purchase our
rights to RITUXAN. We must then accept Genentechs offer or purchase Genentechs rights to
RITUXAN. If Genentech presents such an offer, then they will be deemed concurrently to have
exercised a right, in exchange for a share in the operating profits or net sales in the U.S.
of any other anti CD-20 products developed under the agreement, to purchase our interest in
each such product. The rights of Genentech described in this paragraph may limit our
attractiveness to potential acquirers; |
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our collaboration agreement with Elan provides Elan with the option to buy the rights to
TYSABRI in the event that we undergo a change of control, which may limit our attractiveness
to potential acquirers; |
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our directors are elected to staggered terms, which prevents the entire board from being
replaced in any single year; |
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advance notice is required for nomination of candidates for election as a director and
for proposals to be brought before an annual meeting of stockholders; and |
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our bylaws provide that, until November 12, 2006, the affirmative vote of at least 80% of
our board of directors (excluding directors who are serving as an officer or employee) is
required to remove James C. Mullen as our Chief Executive Officer and President. |
52
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
A summary of our stock repurchase activity for the three and six months ended June 30, 2006 is set
forth in the table below:
Issuer Purchases of Equity Securities
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Total number of |
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shares purchased as |
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Number of shares |
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Total number of |
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part of publicly |
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that may yet be |
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shares purchased |
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Average price paid |
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announced program |
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purchased under our |
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Period |
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(#)(a) |
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per share ($) |
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(#)(a) |
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program (#) |
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Q1 |
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8,040 |
(b) |
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$ |
45.56 |
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8,040 |
(b) |
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11,908,360 |
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Q2 |
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$ |
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11,908,360 |
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Total six months
ended 30 June 2006 |
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8,040 |
(b) |
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$ |
45.56 |
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8,040 |
(b) |
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11,908,360 |
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(a) |
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In October 2004, our Board of Directors authorized the repurchase of up to 20 million shares
of our common stock. This repurchase program will expire no later than October 4, 2006. We
publicly announced the repurchase program in our press release dated October 27, 2004 which
was furnished to (and not filed with) the SEC as Exhibit 99.1 of our Current Report of Form
8-K filed on October 27, 2004. |
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(b) |
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All of these shares are shares that were used by certain employees to pay the exercise price
of their stock options in lieu of paying cash or utilizing our cashless option exercise
program. |
Item 4. Submission of Matters to Vote of Security Holders
We held our Annual Meeting of Stockholders on May 25, 2006. The following proposals were voted
upon at the meeting:
(a) A proposal to elect Lawrence C. Best, Alan B. Glassberg, Robert W. Pangia and William D.
Young as directors to serve for a three year term ending in 2009 and until their successors
are duly elected and qualified was approved with the following vote:
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Director |
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For |
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Withheld |
Lawrence C. Best
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291,406,165 |
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8,367,938 |
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Alan B. Glassberg
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290,158,168 |
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9,615,935 |
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Robert W. Pangia
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295,143,569 |
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4,630,534 |
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William D. Young
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260,968,612 |
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38,805,491 |
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(b) A proposal to ratify the selection of PricewaterhouseCoopers LLP as the Companys
independent registered public accounting firm for the fiscal year ending December 31, 2006 was
approved with 294,849,418 votes for, 3,259,208 votes against, and 1,665,477 abstentions. There
were no broker non-votes for this proposal.
(c) A proposal to approve the Companys 2006 Non-Employee Directors Equity Plan was approved
with 179,542,711 votes for, 68,198,612 votes against, 2,021,462 abstentions, and 50,011,318 broker
non-votes.
Item 6. Exhibits
31.1 |
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Certification of the Chief Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of the Chief Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
53
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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August 9, 2006 |
BIOGEN IDEC INC.
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/s/ Peter N. Kellogg
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Peter N. Kellogg |
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Executive Vice President, Finance and Chief
Financial Officer |
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54
exv31w1
EXHIBIT 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James C. Mullen, certify that:
1. |
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I have reviewed this quarterly report of Biogen Idec Inc.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
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4. |
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The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have: |
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a) |
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designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b) |
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designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
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c) |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
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d) |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and |
5. |
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The registrants other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions): |
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a) |
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all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
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b) |
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any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
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Date: August 9, 2006 |
/s/ James C. Mullen
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James C. Mullen |
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Chief Executive Officer
and President |
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exv31w2
EXHIBIT 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Peter N. Kellogg, certify that:
1. |
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I have reviewed this quarterly report of Biogen Idec Inc.; |
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2. |
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Based on my knowledge, this report does not contain any untrue statement of a material fact
or omit to state a material fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not misleading with respect to the period
covered by this report; |
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3. |
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Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of
operations and cash flows of the registrant as of, and for, the periods presented in this
report; |
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4. |
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The registrants other certifying officer(s) and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and
15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and have: |
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a. |
|
designed such disclosure controls and procedures, or caused such disclosure controls
and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being
prepared; |
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b. |
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designed such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to provide
reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with generally accepted
accounting principles; |
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c. |
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evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls
and procedures, as of the end of the period covered by this report based on such
evaluation; and |
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d. |
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disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the
registrants fourth fiscal quarter in the case of an annual report) that has materially
affected, or is reasonably likely to materially affect, the registrants internal control
over financial reporting; and |
5. |
|
The registrants other certifying officer(s) and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or persons performing the equivalent
functions): |
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a. |
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all significant deficiencies and material weaknesses in the design or operation of
internal control over financial reporting which are reasonably likely to adversely affect
the registrants ability to record, process, summarize and report financial information;
and |
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b. |
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any fraud, whether or not material, that involves management or other employees who
have a significant role in the registrants internal control over financial reporting. |
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Date: August 9, 2006 |
/s/ Peter N. Kellogg
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Peter N. Kellogg |
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Executive Vice President, Finance
and Chief Financial Officer |
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exv32w1
EXHIBIT 32.1
CERTIFICATION
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section
1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Biogen Idec
Inc., a Delaware corporation (the Company), does hereby certify, to such officers knowledge,
that:
The Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 (the Form 10-Q) of the
Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange
Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material
respects, the financial condition and results of operations of the Company.
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Dated: August 9, 2006 |
/s/ James C. Mullen
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James C. Mullen |
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Chief Executive Officer
and President
[principal executive officer] |
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Dated: August 9, 2006 |
/s/ Peter N. Kellogg
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Peter N. Kellogg |
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Executive Vice President Finance
and Chief Financial Officer
[principal financial officer] |
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A signed original of this written statement required by Section 906 has been provided to the
Company and will be retained by the Company and furnished to the Securities and Exchange Commission
or its staff upon request.