e10vq
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-Q
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(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
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For the quarterly period ended
June 30, 2007
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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
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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
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(State or other jurisdiction
of
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(I.R.S. Employer
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incorporation or
organization)
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Identification
No.)
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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,
$0.0005 par value, outstanding as of July 13, 2007,
was 287,925,669 shares.
BIOGEN
IDEC INC.
FORM 10-Q
Quarterly Report
For the Quarterly Period Ended June 30, 2007
TABLE OF
CONTENTS
2
PART I
FINANCIAL INFORMATION
BIOGEN IDEC INC. AND SUBSIDIARIES
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2007
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2006
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2007
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2006
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(In thousands, except per share amounts)
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(Unaudited)
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Revenues:
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Product
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$
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518,625
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$
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436,081
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$
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1,003,013
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$
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842,600
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Unconsolidated joint business
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230,590
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206,095
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437,754
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389,476
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Other
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23,961
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17,865
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48,319
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39,140
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Total revenues
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773,176
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660,041
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1,489,086
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1,271,216
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Costs and expenses:
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Cost of sales, excluding
amortization of acquired intangible assets
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84,063
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77,993
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166,013
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145,488
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Research and development
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218,149
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161,985
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409,598
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307,877
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Selling, general and administrative
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203,668
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170,289
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391,729
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324,680
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Collaboration profit (loss) sharing
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(105
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)
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(5,672
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)
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Amortization of acquired
intangible assets
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60,961
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76,260
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120,881
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146,967
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Acquired in-process research and
development
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330,520
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18,405
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330,520
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Gain on sale of long lived assets
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(799
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(1,098
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Gain on settlement of license
agreement
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(34,192
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)
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(34,192
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)
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Total costs and expenses
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566,736
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782,056
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1,100,954
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1,220,242
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Income (loss) from operations
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206,440
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(122,015
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)
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388,132
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50,974
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Other income (expense), net
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31,586
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21,806
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53,288
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40,471
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Income (loss) before income tax
provision and cumulative effect of accounting change
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238,026
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(100,209
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)
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441,420
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91,445
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Income tax expense
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51,886
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70,404
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123,779
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142,868
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Income (loss) before cumulative
effect of accounting change
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186,140
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(170,613
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317,641
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(51,423
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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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$
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186,140
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$
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(170,613
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)
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$
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317,641
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$
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(47,644
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)
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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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$
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0.55
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$
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(0.50
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)
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$
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0.93
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$
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(0.15
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)
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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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$
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0.55
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$
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(0.50
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)
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$
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0.93
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$
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(0.14
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)
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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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$
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0.54
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$
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(0.50
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)
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$
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0.92
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$
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(0.15
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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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$
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0.54
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$
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(0.50
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)
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$
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0.92
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$
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(0.14
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)
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Shares used in calculating:
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Basic earnings (loss) per share
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340,315
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342,375
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340,312
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341,742
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Diluted earnings (loss) per share
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343,389
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342,375
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343,713
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341,742
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See accompanying notes to the consolidated financial statements.
3
BIOGEN
IDEC INC. AND SUBSIDIARIES
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June 30,
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December 31,
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2007
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2006
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(In thousands, except per share amounts)
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(Unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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1,611,581
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$
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661,377
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Marketable securities
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191,136
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241,314
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Accounts receivable, net
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359,518
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317,353
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Due from unconsolidated joint
business
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162,468
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168,708
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Inventory
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207,897
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169,102
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Other current assets
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161,406
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154,713
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Total current assets
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2,694,006
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1,712,567
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Marketable securities
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917,403
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1,412,238
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Property, plant and equipment, net
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|
1,330,899
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1,280,385
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Intangible assets, net
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2,626,838
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2,747,241
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Goodwill
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1,135,939
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1,154,757
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Investments and other assets
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230,630
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245,620
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Total assets
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$
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8,935,715
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$
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8,552,808
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LIABILITIES AND
SHAREHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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99,440
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$
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100,457
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Taxes payable
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17,106
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145,529
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Accrued expenses and other
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346,456
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336,869
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Tender obligation (Note 16)
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2,990,030
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Current portion of notes payable
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|
11,897
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|
|
|
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|
|
|
|
|
|
|
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Total current liabilities
|
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|
3,464,929
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|
582,855
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Notes payable
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|
51,348
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96,694
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Long-term deferred tax liability
|
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|
588,784
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|
643,645
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Other long-term liabilities
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|
193,955
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|
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79,836
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|
|
|
|
|
|
|
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Total liabilities
|
|
|
4,299,016
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|
|
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1,403,030
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|
|
|
|
|
|
|
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Commitments and contingencies
(Notes 4, 10 and 12)
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Shareholders equity:
|
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Preferred stock, par value $0.001
per share
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Common stock, par value $0.0005
per share
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|
172
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|
|
|
173
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|
Additional paid-in capital
|
|
|
8,286,958
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8,308,232
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Accumulated other comprehensive
income
|
|
|
32,167
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|
|
|
21,855
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|
Accumulated deficit
|
|
|
(666,955
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)
|
|
|
(860,827
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)
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Tender Offer Obligation (Note 16)
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(2,990,297
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)
|
|
|
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|
Treasury stock, at cost
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|
|
(25,346
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)
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|
|
(319,655
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)
|
|
|
|
|
|
|
|
|
|
Total shareholders equity
|
|
|
4,636,699
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|
|
|
7,149,778
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|
|
|
|
|
|
|
|
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Total liabilities and
shareholders equity
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|
$
|
8,935,715
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|
|
$
|
8,552,808
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|
|
|
|
|
|
|
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|
See accompanying notes to the consolidated financial statements.
4
BIOGEN
IDEC INC. AND SUBSIDIARIES
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
|
(Unaudited)
|
|
|
Cash flows from operating
activities:
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
317,641
|
|
|
$
|
(47,644
|
)
|
Adjustments to reconcile net income
(loss) to net cash flows from operating activities
|
|
|
|
|
|
|
|
|
Depreciation and amortization of
fixed & intangible assets
|
|
|
181,275
|
|
|
|
198,922
|
|
Acquired in process
research & development
|
|
|
18,405
|
|
|
|
330,520
|
|
Gain on settlement of license
agreement
|
|
|
|
|
|
|
(34,192
|
)
|
Stock-based compensation
|
|
|
59,419
|
|
|
|
65,625
|
|
Non-cash interest expense (income)
|
|
|
1,484
|
|
|
|
(36
|
)
|
Deferred income taxes
|
|
|
(18,172
|
)
|
|
|
(46,098
|
)
|
Realized (gain) loss on sale of
marketable securities and strategic investment
|
|
|
(6,999
|
)
|
|
|
1,758
|
|
Write-down of inventory to net
realizable value
|
|
|
14,834
|
|
|
|
12,049
|
|
Facility impairment and (gain) loss
on disposition, net
|
|
|
|
|
|
|
(1,098
|
)
|
Impairment of investments and other
assets
|
|
|
5,513
|
|
|
|
4,439
|
|
Excess tax benefit from stock
options
|
|
|
(9,840
|
)
|
|
|
(10,241
|
)
|
Changes in assets and liabilities,
net:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(40,999
|
)
|
|
|
(20,881
|
)
|
Due from unconsolidated joint
business
|
|
|
6,240
|
|
|
|
(23,803
|
)
|
Inventory
|
|
|
(52,081
|
)
|
|
|
(18,657
|
)
|
Other assets
|
|
|
(12,885
|
)
|
|
|
3,308
|
|
Accrued expenses and other current
liabilities
|
|
|
(693
|
)
|
|
|
(80,100
|
)
|
Other liabilities
|
|
|
1,205
|
|
|
|
5,754
|
|
|
|
|
|
|
|
|
|
|
Net cash flows provided by
operating activities
|
|
|
464,347
|
|
|
|
339,625
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities:
|
|
|
|
|
|
|
|
|
Purchases of marketable securities
|
|
|
(1,868,371
|
)
|
|
|
(1,329,022
|
)
|
Proceeds from sales and maturities
of marketable securities
|
|
|
2,409,802
|
|
|
|
1,023,057
|
|
Proceeds from sale of Amevive
|
|
|
|
|
|
|
59,800
|
|
Acquisitions, net of cash acquired
|
|
|
(42,289
|
)
|
|
|
(363,251
|
)
|
Purchases of property, plant and
equipment
|
|
|
(117,248
|
)
|
|
|
(79,722
|
)
|
Proceeds from sale of property,
plant and equipment
|
|
|
70
|
|
|
|
35,857
|
|
Purchases of other investments
|
|
|
(15,818
|
)
|
|
|
(4,305
|
)
|
Proceeds from the sale of a
strategic investment
|
|
|
30,566
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flows provided by (used
in) investing activities
|
|
|
396,712
|
|
|
|
(657,586
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities:
|
|
|
|
|
|
|
|
|
Purchase of treasury stock
|
|
|
|
|
|
|
(366
|
)
|
Proceeds from issuance of stock for
share based payment arrangements
|
|
|
81,748
|
|
|
|
74,487
|
|
Change in cash overdrafts
|
|
|
(642
|
)
|
|
|
(5,303
|
)
|
Excess tax benefit from stock
options
|
|
|
9,840
|
|
|
|
10,241
|
|
Repurchase of senior notes
|
|
|
(6,563
|
)
|
|
|
|
|
Proceeds of loan from joint venture
partner
|
|
|
|
|
|
|
15,231
|
|
Repayments of loan to joint venture
partner
|
|
|
(3,703
|
)
|
|
|
|
|
Proceeds from line of credit
|
|
|
8,133
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flow provided by financing
activities
|
|
|
88,813
|
|
|
|
94,290
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and
cash equivalents
|
|
|
949,872
|
|
|
|
(223,671
|
)
|
Effect of exchange rate changes on
cash and cash equivalents
|
|
|
332
|
|
|
|
607
|
|
Cash and cash equivalents,
beginning of the period
|
|
|
661,377
|
|
|
|
568,168
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of
the period
|
|
$
|
1,611,581
|
|
|
$
|
345,104
|
|
|
|
|
|
|
|
|
|
|
Non-cash financing transaction:
|
|
|
|
|
|
|
|
|
See Note 14
Indebtedness and Note 16 Tender
Offer for a discussion of non-cash financing transactions
that occurred during the six months ended June 30, 2007.
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
5
BIOGEN
IDEC INC. AND SUBSIDIARIES
(Unaudited)
Overview
Biogen Idec Inc. is an international biotechnology company that
creates new standards of care in oncology, neurology, immunology
and other specialty areas of unmet medical need. We currently
have five products:
AVONEX®,
RITUXAN®,
TYSABRI®,
FUMADERM®,
and
ZEVALIN®.
Basis
of Presentation
In the opinion of management, the accompanying unaudited
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. 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, 2006. Our accounting
policies are described in the Notes to the Consolidated
Financial Statements in our 2006 Annual Report on
Form 10-K
and updated, as necessary, in this
Form 10-Q.
The year-end consolidated balance sheet data presented for
comparative purposes was derived from audited financial
statements. This
Form 10-Q
does not contain all disclosures required by accounting
principles generally accepted in the U.S. The results of
operations for the three and six months ended June 30, 2007
are not necessarily indicative of the operating results for the
full year or for any other subsequent interim period.
The preparation of the 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 amounts and
results could differ from those estimates.
Principles
of Consolidation
The consolidated financial statements reflect our financial
statements and those of our wholly-owned subsidiaries and of our
joint ventures in Italy and Switzerland. We also consolidate a
limited partnership investment in which we are the majority
investor. All material intercompany balances and transactions
have been eliminated in consolidation.
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 millions):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Raw materials
|
|
$
|
54.7
|
|
|
$
|
45.7
|
|
Work in process
|
|
|
125.1
|
|
|
|
105.3
|
|
Finished goods
|
|
|
28.1
|
|
|
|
18.1
|
|
|
|
|
|
|
|
|
|
|
Total inventory
|
|
$
|
207.9
|
|
|
$
|
169.1
|
|
|
|
|
|
|
|
|
|
|
Included in inventory is TYSABRI inventory that was written off
in 2005, due to uncertainties surrounding the TYSABRI
suspension, but which is available to fill future orders. The
approximate value of this product, based on
6
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
its original cost of manufacture, is $13.8 million. As a
result, we are recognizing lower than normal cost of sales and,
therefore, higher margins.
During the three and six months ended June 30, 2007, we
wrote down $8.1 million and $14.8 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the three and six months ended
June 30, 2006, we wrote down $8.8 million and
$12.0 million, respectively, in unmarketable inventory,
which was also charged to cost of sales.
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.
Except for revenues from sales of TYSABRI in the U.S., revenues
from product sales are recognized when product is shipped and
title and risk of loss has passed to the customer, typically
upon delivery. Sales of TYSABRI in the U.S. are recognized
on the sell-through model, that is, upon shipment of
the product by our collaboration partner, Elan, to the customer.
Effective January 1, 2007, we changed the manner in which
we administer our patient assistance and patient replacement
goods programs. Prior to January 1, 2007, AVONEX product
shipped to administer these programs was invoiced and recorded
as gross product revenue. In addition, an offsetting provision
for discount and returns was recorded for expected credit
requests from the distributor that administers these programs on
our behalf. Effective January 1, 2007, we established a
consignment sales model. Under the new arrangement, gross
revenue is not recorded for product shipped to satisfy these
programs.
Discounts
and Allowances
Revenues are recorded net of applicable allowances for
discounts, contractual adjustments and returns.
We establish reserves for these discounts, which include trade
term discounts and wholesaler incentives, contractual
adjustments, which include Medicaid rebates, Veterans
Administration rebates and managed care, and returns, which
include returns made by wholesalers. Such reserves are
classified as reductions of accounts receivable (if the amount
is payable to a customer) or as a liability (if the amount is
payable to a party other than a customer).
An analysis of the amount of, and change in, reserves is as
follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual
|
|
|
|
|
|
|
|
|
|
Discounts
|
|
|
Adjustments
|
|
|
Returns
|
|
|
Total
|
|
|
Beginning balance, January 1,
2007
|
|
$
|
12.7
|
|
|
$
|
30.5
|
|
|
$
|
17.8
|
|
|
$
|
61.0
|
|
Current provisions relating to
sales in current period
|
|
|
20.5
|
|
|
|
47.7
|
|
|
|
8.4
|
|
|
|
76.6
|
|
Adjustments relating to sales in
prior periods
|
|
|
|
|
|
|
(0.8
|
)
|
|
|
5.2
|
|
|
|
4.4
|
|
Payments/returns relating to sales
in current period
|
|
|
(13.9
|
)
|
|
|
(19.1
|
)
|
|
|
|
|
|
|
(33.0
|
)
|
Payments/returns relating to sales
in prior periods
|
|
|
(12.6
|
)
|
|
|
(26.4
|
)
|
|
|
(13.4
|
)
|
|
|
(52.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance, June 30, 2007
|
|
$
|
6.7
|
|
|
$
|
31.9
|
|
|
$
|
18.0
|
|
|
$
|
56.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The total reserves above were included in the consolidated
balance sheets as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Reduction of accounts receivable
|
|
$
|
27.4
|
|
|
$
|
30.2
|
|
Accrued expenses and other
|
|
|
29.2
|
|
|
|
30.8
|
|
|
|
|
|
|
|
|
|
|
Total reserves
|
|
$
|
56.6
|
|
|
$
|
61.0
|
|
|
|
|
|
|
|
|
|
|
Reserves for discounts, contractual adjustments and returns
reduced gross product revenues as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Three Months Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Discounts
|
|
$
|
10.0
|
|
|
$
|
29.3
|
|
|
$
|
20.5
|
|
|
$
|
53.2
|
|
Contractual adjustments
|
|
|
24.1
|
|
|
|
19.4
|
|
|
|
46.9
|
|
|
|
48.4
|
|
Returns
|
|
|
9.3
|
|
|
|
14.6
|
|
|
|
13.6
|
|
|
|
22.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total allowances
|
|
$
|
43.4
|
|
|
$
|
63.3
|
|
|
$
|
81.0
|
|
|
$
|
123.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross product revenues
|
|
$
|
565.2
|
|
|
$
|
501.5
|
|
|
$
|
1,087.5
|
|
|
$
|
967.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of gross product revenues
|
|
|
7.7
|
%
|
|
|
12.6
|
%
|
|
|
7.4
|
%
|
|
|
12.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our product revenue reserves are based on estimates of the
amounts earned or to be claimed on the related sales. These
estimates take into consideration our historical experience,
current contractual and statutory requirements, specific known
market events and trends and forecasted customer buying
patterns. If actual results vary, we may need to adjust these
estimates, which could have an effect on earnings in the period
of the adjustment.
|
|
4.
|
Acquisitions
and Collaboration Agreements
|
Syntonix
Pharmaceuticals, Inc.
In January 2007, we acquired 100% of the stock of Syntonix
Pharmaceuticals, Inc., or Syntonix, a privately held
biopharmaceutical company based in Waltham, Massachusetts.
Syntonix focuses on discovering and developing long-acting
therapeutic products to improve treatment regimens for chronic
diseases, and is engaged in multiple pre-clinical programs in
hemophilia. The purchase price was $44.4 million, including
transaction costs, and is subject to increase to as much as
$124.4 million if certain development milestones with
respect to Syntonixs lead product, long-acting Factor IX
are achieved. The purpose of the acquisition was to enhance our
pipeline and to expand into additional specialized markets.
The acquisition was funded from our existing cash and was
accounted for as an asset acquisition as Syntonix is a
development-stage company. As a result of the acquisition we
obtained the rights to the in-process technology of the
Fc-fusion technology platform. Syntonix has two programs in
development using the Fc-fusion platform, long-acting Factor IX
and long-acting Factor VIII. Syntonixs lead product,
long-acting Factor IX, is a proprietary product for the
treatment of hemophilia B. Syntonix is expected to file an
investigational new drug application with the Food and Drug
Administration, or FDA, for long-acting Factor IX in 2007.
Long-acting Factor VIII is a product for the treatment of
hemophilia A and is approximately two years away from the filing
of an investigational new drug application with the FDA.
8
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The results of operations of Syntonix are included in our
consolidated results of operations from the date of acquisition.
We have completed our purchase price allocation for the
acquisition as set out below (in millions):
|
|
|
|
|
Current assets
|
|
$
|
0.3
|
|
Fixed assets
|
|
|
0.2
|
|
Deferred tax asset
|
|
|
27.8
|
|
Assembled workforce
|
|
|
0.7
|
|
In-process research and development
|
|
|
18.4
|
|
Current liabilities
|
|
|
(3.0
|
)
|
|
|
|
|
|
|
|
$
|
44.4
|
|
|
|
|
|
|
The purchase price included $2.0 million in loan
forgiveness and $0.7 million in transaction fees. In
addition, $0.3 million of severance charges were accrued in
the six months ended June 30, 2007, as a result of the
acquisition.
The amount allocated to in-process research and development, or
IPR&D, relates to the development of long-acting Factor IX
and long-acting Factor VIII, which are in a development stage.
We have spent an additional $4.8 million to complete
long-acting Factor IX and an additional $34.9 million to
complete long-acting Factor VIII since the acquisition. We
expect to incur an additional $0.6 million to complete
long-acting Factor IX and an additional $41.9 million to
complete long-acting Factor VIII. The estimated revenues from
long-acting Factor IX and long-acting Factor VIII are expected
to be recognized beginning in 2012 and 2014, respectively. A
discount rate of 13% was used to value these projects 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, these compounds had not reached
technological feasibility and had no alternative future use.
Accordingly, $18.4 million in IPR&D was expensed upon
acquisition.
Upon acquisition, we recognized a deferred tax asset of
$27.8 million relating, principally, to U.S. federal
net operating loss carryforwards that we obtained with the
acquisition of Syntonix. The deferred tax asset included
approximately $12.8 million of net operating loss and
research credit carryovers that will be utilized prior to
applicable expiration dates, as well as approximately
$15.3 million of other deferred tax assets primarily
related to
start-up and
research expenditures that have been capitalized for tax
purposes and will be amortized over the next several years.
Future contingent consideration payments, if ultimately payable,
will be expensed as research and development.
The total revenue, operating income (loss) and net income (loss)
impacts of the acquisition for the six months ended
June 30, 2007 and 2006 were not material.
Cardiokine,
Inc.
In June 2007, we entered into an agreement with Cardiokine,
Inc., a privately-held pharmaceutical company, for the joint
development of lixivapatan, an oral compound expected to enter a
Phase III clinical trial in the second half of 2007 for the
potential treatment of hyponatremia in patients with congestive
heart failure. The agreement is expected to become effective in
the third quarter of 2007, since it is subject to the
satisfaction of certain closing conditions and customary
approvals.
Under the terms of the agreement, we will pay a
$50.0 million upfront payment and up to $170.0 million
in additional milestone payments for successful development and
global commercialization of lixivapatan, as well as royalties
for commercial sales. We will be responsible for the global
commercialization of lixivapatan and Cardiokine, Inc. will have
an option for limited co-promotion in the United States.
9
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
5.
|
Intangible
Assets and Goodwill
|
As of June 30, 2007 and December 31, 2006, intangible
assets and goodwill, net of accumulated amortization, impairment
charges and adjustments, are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30,
|
|
|
|
|
|
|
|
|
As of Dec. 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
Estimated Life
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Out-licensed patents
|
|
|
12 years
|
|
|
$
|
578.0
|
|
|
$
|
(175.0
|
)
|
|
$
|
403.0
|
|
|
$
|
578.0
|
|
|
$
|
(150.9
|
)
|
|
$
|
427.1
|
|
Core/developed technology
|
|
|
15-20 years
|
|
|
|
3,001.5
|
|
|
|
(855.9
|
)
|
|
|
2,145.6
|
|
|
|
3,001.5
|
|
|
|
(760.2
|
)
|
|
|
2,241.3
|
|
Trademarks & tradenames
|
|
|
Indefinite
|
|
|
|
64.0
|
|
|
|
|
|
|
|
64.0
|
|
|
|
64.0
|
|
|
|
|
|
|
|
64.0
|
|
In-licensed patents
|
|
|
14 years
|
|
|
|
3.0
|
|
|
|
(0.6
|
)
|
|
|
2.4
|
|
|
|
3.0
|
|
|
|
(0.5
|
)
|
|
|
2.5
|
|
Assembled workforce
|
|
|
4 years
|
|
|
|
2.1
|
|
|
|
(0.5
|
)
|
|
|
1.6
|
|
|
|
1.4
|
|
|
|
(0.2
|
)
|
|
|
1.2
|
|
Distribution rights
|
|
|
2 years
|
|
|
|
11.1
|
|
|
|
(0.9
|
)
|
|
|
10.2
|
|
|
|
11.1
|
|
|
|
|
|
|
|
11.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
$
|
3,659.7
|
|
|
$
|
(1,032.9
|
)
|
|
$
|
2,626.8
|
|
|
$
|
3,659.0
|
|
|
$
|
(911.8
|
)
|
|
$
|
2,747.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
Indefinite
|
|
|
$
|
1,135.9
|
|
|
$
|
|
|
|
$
|
1,135.9
|
|
|
$
|
1,154.8
|
|
|
$
|
|
|
|
$
|
1,154.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the six months ended June 30, 2007, goodwill decreased
by $18.8 million as a result of certain tax adjustments.
Approximately $9.1 million of the adjustments related to
the adoption of FIN 48. (See Note 10 for discussion on
income taxes). Assembled workforce increased by
$0.7 million as a result of the acquisition of Syntonix.
Amortization expense was $61.0 million and
$76.3 million in the three months ended June 30, 2007
and 2006, respectively. Amortization expense was
$120.9 million and $147.0 million for the six months
ended June 30, 2007 and 2006, respectively.
10
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Marketable
Securities, including Strategic Investments
The following is a summary of marketable securities and
investments (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Fair
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Amortized
|
|
June 30, 2007:
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
Available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
Current
|
|
$
|
104.3
|
|
|
$
|
|
|
|
$
|
(0.4
|
)
|
|
$
|
104.7
|
|
Non-current
|
|
|
292.7
|
|
|
|
0.1
|
|
|
|
(1.1
|
)
|
|
|
293.7
|
|
U.S. Government securities
Current
|
|
|
83.4
|
|
|
|
|
|
|
|
(0.7
|
)
|
|
|
84.1
|
|
Non-current
|
|
|
81.4
|
|
|
|
|
|
|
|
(0.4
|
)
|
|
|
81.8
|
|
Other interest bearing securities
Current
|
|
|
3.4
|
|
|
|
|
|
|
|
|
|
|
|
3.4
|
|
Non-current
|
|
|
543.3
|
|
|
|
0.9
|
|
|
|
(1.1
|
)
|
|
|
543.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale securities
|
|
$
|
1,108.5
|
|
|
$
|
1.0
|
|
|
$
|
(3.7
|
)
|
|
$
|
1,111.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic investments, non-current
|
|
$
|
77.4
|
|
|
$
|
10.3
|
|
|
$
|
(3.0
|
)
|
|
$
|
70.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Fair
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Amortized
|
|
December 31, 2006:
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
Available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
Current
|
|
$
|
197.1
|
|
|
$
|
|
|
|
$
|
(0.7
|
)
|
|
$
|
197.8
|
|
Non-current
|
|
|
439.4
|
|
|
|
0.4
|
|
|
|
(3.2
|
)
|
|
|
442.2
|
|
U.S. Government securities
Current
|
|
|
40.1
|
|
|
|
|
|
|
|
(0.2
|
)
|
|
|
40.3
|
|
Non-current
|
|
|
270.3
|
|
|
|
0.3
|
|
|
|
(1.5
|
)
|
|
|
271.5
|
|
Other interest bearing securities
Current
|
|
|
4.2
|
|
|
|
|
|
|
|
(0.1
|
)
|
|
|
4.3
|
|
Non-current
|
|
|
702.5
|
|
|
|
1.6
|
|
|
|
(2.7
|
)
|
|
|
703.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale securities
|
|
$
|
1,653.6
|
|
|
$
|
2.3
|
|
|
$
|
(8.4
|
)
|
|
$
|
1,659.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic investments, non-current
|
|
$
|
116.9
|
|
|
$
|
8.6
|
|
|
$
|
|
|
|
$
|
108.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three and six months ended June 30, 2007, we
recognized $3.1 million and $5.5 million,
respectively, in charges for the impairment of
available-for-sale securities that were determined to be
other-than-temporary following a decline in value. In the three
and six months ended June 30, 2006, we recognized no
charges for the impairment of available for sale securities.
Unrealized losses relate to various debt securities, including
U.S. Government issues, corporate bonds and asset-backed
securities. The unrealized losses on these securities were
primarily caused by a rise in interest rates subsequent to
purchase. We believe that these unrealized losses are temporary,
and we have the intent and ability to hold these securities to
recovery, which may be at maturity.
11
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The proceeds from maturities and sales of marketable securities,
which were primarily reinvested, and resulting realized gains
and losses were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Proceeds from maturities and sales
|
|
$
|
1,606.1
|
|
|
$
|
665.2
|
|
|
$
|
2,409.8
|
|
|
$
|
1,023.1
|
|
Realized gains
|
|
$
|
1.5
|
|
|
$
|
0.3
|
|
|
$
|
2.0
|
|
|
$
|
0.6
|
|
Realized losses
|
|
$
|
3.5
|
|
|
$
|
1.3
|
|
|
$
|
3.8
|
|
|
$
|
2.3
|
|
The amortized cost and estimated fair value of securities
available-for-sale at June 30, 2007 by contractual maturity
are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
Estimated
|
|
|
Amortized
|
|
|
|
Fair Value
|
|
|
Cost
|
|
|
Due in one year or less
|
|
$
|
196.6
|
|
|
$
|
197.6
|
|
Due after one year through five
years
|
|
|
369.0
|
|
|
|
370.5
|
|
Mortgage and other asset backed
securities
|
|
|
542.9
|
|
|
|
543.1
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,108.5
|
|
|
$
|
1,111.2
|
|
|
|
|
|
|
|
|
|
|
The average maturity of our marketable securities as of
June 30, 2007 and December 31, 2006, was
22 months and 18 months, respectively.
Strategic
Investments
In the three and six months ended June 30, 2007, we
recognized no charges for the impairment of investments that
were deemed to be other than temporary. In June 2007, we sold
49% of our share in one strategic investment for
$48.2 million, which resulted in an $8.1 million gain.
In July 2007, we sold the remaining portion of this
strategic investment for $50.7 million, which resulted in an
additional gain of approximately $9.1 million. In the three
and six months ended June 30, 2006, we recognized
$2.3 million and $4.4 million in charges,
respectively, for the impairment of investments that were deemed
to be other than temporary.
Non-Marketable
Securities
We hold investments in equity securities of certain privately
held biotechnology companies or biotechnology oriented venture
capital funds. The carrying value of these strategic investments
at June 30, 2007, and December 31, 2006, was
$46.6 million and $32.6 million, respectively.
In the six months ended June 30, 2007, we recorded
$0.4 million in charges for the impairment of investments
that were determined to be other-than-temporary. In the three
and six months ended June 30, 2006, we recorded no charges
for the impairment of investments that were determined to be
other-than-temporary.
Forward
Contracts
We have foreign currency forward contracts to hedge specific
forecasted transactions denominated in foreign currencies. All
foreign currency forward contracts in effect at June 30,
2007 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 completion of the
underlying hedge transaction. To the extent ineffective, hedge
transaction gains and losses are reported in other income
(expense).
The notional settlement amount of the foreign currency forward
contracts outstanding at June 30, 2007 was approximately
$162.1 million. These contracts had an aggregate fair value
of $3.8 million, representing an unrealized loss, and were
included in other current liabilities at June 30, 2007. The
notional settlement amount of
12
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
the foreign currency forward contracts outstanding at
December 31, 2006 was approximately $293.2 million.
These contracts had an aggregate fair value of
$0.2 million, representing an unrealized loss, and were
included in other current liabilities at December 31, 2006.
In the six months ended June 30, 2007, there was
$0.6 million recognized in earnings as a loss due to hedge
ineffectiveness. In the three and six months ended June 30,
2006, we recognized $0.2 million and $0.9 million,
respectively, of losses in earnings due to hedge
ineffectiveness. $1.1 million and $1.1 million was
recognized in product revenue for the settlement of certain
effective cash flow hedge instruments for the three and six
months ended June 30, 2007, respectively, as compared to
approximately $2.9 million and $3.7 million, of losses
for the three and six months ended June 30, 2006,
respectively. These settlements were recorded in the same period
as the related forecasted transactions affecting earnings.
The activity in comprehensive income, net of income taxes, was
as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Net income (loss)
|
|
$
|
186.1
|
|
|
$
|
(170.6
|
)
|
|
$
|
317.6
|
|
|
$
|
(47.6
|
)
|
Translation adjustments
|
|
|
5.5
|
|
|
|
14.8
|
|
|
|
11.2
|
|
|
|
19.6
|
|
Net unrealized gains (losses) on
available-for-sale marketable securities, net of tax of
$2.1 million, $24.3 million, ($0.6) million and
$15.3 million, respectively
|
|
|
(4.0
|
)
|
|
|
(39.1
|
)
|
|
|
1.5
|
|
|
|
(23.7
|
)
|
Net unrealized losses on foreign
currency forward contracts, net of tax of $0.6 million,
$1.7 million, $1.3 million, and $2.7 million,
respectively
|
|
|
(1.0
|
)
|
|
|
(2.8
|
)
|
|
|
(2.3
|
)
|
|
|
(4.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss)
|
|
$
|
186.6
|
|
|
$
|
(197.7
|
)
|
|
$
|
328.0
|
|
|
$
|
(56.2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Basic and diluted earnings per share are calculated as follows
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before cumulative
effect of accounting change
|
|
$
|
186.1
|
|
|
$
|
(170.6
|
)
|
|
$
|
317.6
|
|
|
$
|
(51.4
|
)
|
Cumulative effect of accounting
change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
186.1
|
|
|
|
(170.6
|
)
|
|
|
317.6
|
|
|
|
(47.6
|
)
|
Adjustment for net income (loss)
allocable to preferred shares
|
|
|
0.2
|
|
|
|
|
|
|
|
0.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) used in
calculating basic and diluted earnings per share
|
|
$
|
185.9
|
|
|
$
|
(170.6
|
)
|
|
$
|
317.2
|
|
|
$
|
(47.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding
|
|
|
340.3
|
|
|
|
342.4
|
|
|
|
340.3
|
|
|
|
341.7
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and ESPP
|
|
|
1.9
|
|
|
|
|
|
|
|
1.9
|
|
|
|
|
|
Restricted Stock Units
|
|
|
0.6
|
|
|
|
|
|
|
|
0.6
|
|
|
|
|
|
Performance-based restricted stock
units
|
|
|
|
|
|
|
|
|
|
|
0.1
|
|
|
|
|
|
Restricted stock awards
|
|
|
0.4
|
|
|
|
|
|
|
|
0.5
|
|
|
|
|
|
Convertible promissory notes due
2019
|
|
|
0.2
|
|
|
|
|
|
|
|
0.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares
|
|
|
3.1
|
|
|
|
|
|
|
|
3.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted
earnings (loss) per share
|
|
|
343.4
|
|
|
|
342.4
|
|
|
|
343.7
|
|
|
|
341.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following amounts were not included in the calculation of
net income per share because their effects were anti-dilutive
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) allocable to
preferred shares
|
|
$
|
0.2
|
|
|
$
|
(0.2
|
)
|
|
$
|
0.4
|
|
|
$
|
(0.1
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
13.8
|
|
|
|
19.0
|
|
|
|
13.7
|
|
|
|
19.6
|
|
Time-vested restricted stock units
|
|
|
1.7
|
|
|
|
0.3
|
|
|
|
1.3
|
|
|
|
0.2
|
|
Restricted Stock Awards
|
|
|
|
|
|
|
0.9
|
|
|
|
|
|
|
|
0.8
|
|
Convertible Promissory note due
2019
|
|
|
|
|
|
|
3.0
|
|
|
|
|
|
|
|
3.0
|
|
Convertible Promissory note due
2032
|
|
|
|
|
|
|
0.1
|
|
|
|
|
|
|
|
0.1
|
|
Convertible preferred stock
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
16.0
|
|
|
|
23.8
|
|
|
|
15.5
|
|
|
|
24.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As a result of the tender offer described in Note 16,
Tender Offer, earnings per share reflects on a
weighted average basis the repurchase of 56,424,155 shares
as of June 27, 2007, the date the obligation was incurred,
in
14
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
accordance with FASB Statement No. 150, Accounting for
Certain Financial Instruments with Characteristics of Both
Liabilities and Equity, or SFAS 150.
In the three months ended June 30, 2007, we reclassified
amounts within the statement of shareholders equity on the
accompanying balance sheet resulting in a $48 million
correction in the treasury stock balance.
In the three months ended June 30, 2007 and 2006,
share-based compensation expense reduced our results of
operations as follows (in millions, except for earnings per
share):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Three Months Ended
|
|
|
|
June 30, 2007
|
|
|
June 30, 2006
|
|
|
|
Effect on
|
|
|
Effect on Net
|
|
|
|
Net Income
|
|
|
Income
|
|
|
Income before income taxes
|
|
$
|
29.9
|
|
|
$
|
40.3
|
|
Tax effect
|
|
|
(9.1
|
)
|
|
|
(12.9
|
)
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
20.8
|
|
|
$
|
27.4
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
0.06
|
|
|
$
|
0.08
|
|
Diluted earnings per share
|
|
$
|
0.06
|
|
|
$
|
0.08
|
|
In the six months ended June 30, 2007 and 2006, share-based
compensation expense reduced our results of operations as
follows (in millions, except for earnings per share):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
|
|
|
Ended June 30,
|
|
|
|
|
|
|
2007
|
|
|
Six Months Ended June 30, 2006
|
|
|
|
|
|
|
Impact Before
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative Effect
|
|
|
Cumulative Effect
|
|
|
|
|
|
|
Effect on
|
|
|
of Accounting
|
|
|
of Accounting
|
|
|
Effect on Net
|
|
|
|
Net Income
|
|
|
Change
|
|
|
Change
|
|
|
Income
|
|
|
Income before income taxes
|
|
$
|
59.4
|
|
|
$
|
69.5
|
|
|
$
|
(5.6
|
)
|
|
$
|
63.9
|
|
Tax effect
|
|
|
(18.3
|
)
|
|
|
(22.0
|
)
|
|
|
1.8
|
|
|
|
(20.2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
41.1
|
|
|
$
|
47.5
|
|
|
$
|
(3.8
|
)
|
|
$
|
43.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
|
0.12
|
|
|
$
|
0.14
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.13
|
|
Diluted earnings per share
|
|
|
0.12
|
|
|
$
|
0.14
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.13
|
|
Share-based compensation expense and cost in the three months
ended June 30, 2007 and 2006 is as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2007
|
|
|
Three Months Ended June 30, 2006
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
|
|
|
Restricted Stock
|
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
Stock Options
|
|
|
and Restricted
|
|
|
|
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
Research and development
|
|
$
|
3.0
|
|
|
$
|
9.9
|
|
|
$
|
12.9
|
|
|
$
|
6.4
|
|
|
$
|
10.9
|
|
|
$
|
17.3
|
|
Selling, general and administrative
|
|
|
5.3
|
|
|
|
12.7
|
|
|
|
18.0
|
|
|
|
8.3
|
|
|
|
16.0
|
|
|
|
24.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
8.3
|
|
|
$
|
22.6
|
|
|
$
|
30.9
|
|
|
$
|
14.7
|
|
|
$
|
26.9
|
|
|
$
|
41.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based payment
costs
|
|
|
|
|
|
|
|
|
|
|
(1.0
|
)
|
|
|
|
|
|
|
|
|
|
|
(1.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
29.9
|
|
|
|
|
|
|
|
|
|
|
$
|
40.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In the six months ended June 30, 2006, the expense is net
of a cumulative pre-tax adjustment of $5.6 million
resulting from the application of an estimated forfeiture rate
for prior period unvested restricted stock awards.
Share-based compensation expense and cost for the six months
ended June 30, 2007 and 2006 is as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2007
|
|
|
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
|
|
$
|
6.0
|
|
|
$
|
17.6
|
|
|
$
|
23.6
|
|
|
$
|
11.4
|
|
|
$
|
17.3
|
|
|
$
|
28.7
|
|
Selling, general and administrative
|
|
|
11.5
|
|
|
|
26.3
|
|
|
$
|
37.8
|
|
|
|
16.7
|
|
|
|
25.8
|
|
|
|
42.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
17.5
|
|
|
$
|
43.9
|
|
|
$
|
61.4
|
|
|
$
|
28.1
|
|
|
$
|
43.1
|
|
|
$
|
71.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax cumulative effect
catch-up
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax effect of share-based
compensation
|
|
|
|
|
|
|
|
|
|
$
|
61.4
|
|
|
|
|
|
|
|
|
|
|
$
|
65.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based payment
costs
|
|
|
|
|
|
|
|
|
|
|
(2.0
|
)
|
|
|
|
|
|
|
|
|
|
|
(1.7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
59.4
|
|
|
|
|
|
|
|
|
|
|
$
|
63.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
options
In February of 2007 and 2006, we made our annual awards of stock
options. Approximately 1.0 million stock options were
awarded as part of the annual award in February 2007 and bore an
exercise price of $49.31 per share. Approximately
0.9 million stock options were awarded as part of the
annual grant in February 2006 and bore an exercise price of
$44.24 per share.
The fair value of the stock option grants awarded in the six
months ended June 30, 2007 and 2006 were estimated as of
the date of grant using a Black-Scholes option valuation model
that uses the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
Expected dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Expected stock price volatility
|
|
|
33.6
|
%
|
|
|
34.8
|
%
|
Risk-free interest rate
|
|
|
4.51
|
%
|
|
|
4.42
|
%
|
Expected option life in years
|
|
|
4.87
|
|
|
|
4.87
|
|
Per share grant-date fair value
|
|
$
|
18.22
|
|
|
$
|
16.93
|
|
Time-Vested
Restricted Stock Units
In February of 2007 and 2006, we made our annual awards of
time-vested restricted stock units, or RSUs. Approximately
2.3 million RSUs were awarded as part of the annual grant
in February 2007 at a grant date fair value of $49.31 per share.
Approximately 2.2 million RSUs were awarded as part of the
annual grant in February 2006 at a grant date fair value of
$44.24 per share.
16
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Performance-Based
Restricted Stock Units
On March 14, 2007, 258,000 performance-based RSUs vested
and were converted into shares of common stock. The shares had
been earned by employees pursuant to the terms of the awards
granted in September 2005. The amounts that vested represented
83% of the remaining 30% of the total shares issued under the
program that had not already vested in September 2006.
In addition, in February 2007, 100,000 performance-based
RSUs, granted to our CEO in February 2006, vested and were
converted into shares of common stock.
In June 2006, we committed to grant 120,000 performance-based
RSUs to an executive. The first tranche of 30,000 RSUs was
granted in January 2007 and the remaining 90,000 were granted in
June 2007. This tranche, and subsequent tranches, are subject to
performance conditions established at the time of issuance. The
total grant of 120,000 RSUs is being recognized as compensation
expense over the requisite service period of four years as if it
were multiple awards, in accordance with FASB Interpretation
No. 28, Accounting for Stock Appreciation Rights and
Other Variable Stock Options or Award Plans.
Employee
Stock Purchase Plan
In the three months ended June 30, 2007 and 2006,
0.1 million and 0.1 million shares, respectively, were
issued under the employee stock purchase plan, or ESPP. In the
six months ended June 30, 2007 and 2006, 0.3 million
and 0.3 million shares, respectively, were issued under the
ESPP. In the three months ended June 30, 2007 and 2006, we
recorded compensation charges of approximately $0.4 million
and $2.1 million, respectively, of stock compensation
charges related to the ESPP. In the six months ended
June 30, 2007 and 2006, we recorded compensation charges of
approximately $1.2 million and $4.8 million,
respectively, of stock compensation charges related to the ESPP.
Tax
Rate
Our effective tax rate was 21.8% on pre-tax income for the three
months ended June 30, 2007, compared to (70.3)% for the
comparable period in 2006. Our effective tax rate was 28.0% on
pre-tax income for the six months ended June 30, 2007,
compared to 156.2% for the comparable period in 2006.
A reconciliation of the U.S. federal statutory tax rate to
the effective tax rate for the three and six months ended
June 30, 2007 and 2006, respectively, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Statutory Rate
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
State Taxes
|
|
|
1.7
|
|
|
|
(3.6
|
)
|
|
|
1.9
|
|
|
|
7.9
|
|
Foreign Taxes
|
|
|
(8.0
|
)
|
|
|
12.8
|
|
|
|
(7.7
|
)
|
|
|
(26.9
|
)
|
Credits and net operating loss
utilization
|
|
|
(3.7
|
)
|
|
|
0.3
|
|
|
|
(2.5
|
)
|
|
|
(0.9
|
)
|
Other
|
|
|
(6.8
|
)
|
|
|
(4.2
|
)
|
|
|
(3.4
|
)
|
|
|
6.5
|
|
Fair Value Adjustment
|
|
|
3.6
|
|
|
|
(7.1
|
)
|
|
|
3.1
|
|
|
|
21.2
|
|
IPR&D
|
|
|
|
|
|
|
(115.4
|
)
|
|
|
1.6
|
|
|
|
126.5
|
|
Gain on Settlement of Fumapharm
License Agreement
|
|
|
|
|
|
|
11.9
|
|
|
|
|
|
|
|
(13.1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21.8
|
%
|
|
|
(70.3
|
)%
|
|
|
28.0
|
%
|
|
|
156.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Contingency
On September 12, 2006, we received a Notice of Assessment
from the Massachusetts Department of Revenue for
$38.9 million, including penalties and interest, with
respect to the 2001, 2002 and 2003 tax years. We believe that we
have meritorious defenses to the proposed adjustment and will
vigorously oppose the assessment. We believe that the assessment
does not impact the level of our liabilities for income tax
contingencies. However, there is a possibility that we may not
prevail in all of our assertions. If this is resolved
unfavorably in the future, it could have a material impact on
our future effective tax rate and our results of operations in
the period in which the resolution occurs.
Adoption
of FASB Interpretation No. 48
Effective January 1, 2007, we adopted FASB Interpretation
No. 48, Accounting for Uncertainty in Income Taxes,
or FIN 48. 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 each tax position taken or expected to be taken
in a tax return. As a result of the adoption of FIN 48, we
recognized a reduction in the liability for unrecognized tax
benefits of $14.2 million, which was recorded as a
$1.8 million reduction to the January 1, 2007 balance
of our accumulated deficit, a $9.1 million reduction in
goodwill and a $3.3 million increase in our deferred tax
liability.
A reconciliation of the beginning and ending amount of
unrecognized tax benefits is as follows (in millions):
|
|
|
|
|
Balance at January 1, 2007
|
|
$
|
196.8
|
|
Additions based on tax positions
related to the current period
|
|
|
12.1
|
|
Additions for tax positions of
prior periods
|
|
|
51.4
|
|
Reductions for tax positions of
prior periods
|
|
|
(69.1
|
)
|
Settlements
|
|
|
(18.7
|
)
|
|
|
|
|
|
Balance at June 30, 2007
|
|
$
|
172.5
|
|
|
|
|
|
|
Included in the balance at June 30, 2007 and
January 1, 2007, are $77.9 million and
$98.2 million (net of the federal benefit on state issues),
respectively, of unrecognized tax benefits that, if recognized,
would affect the effective income tax rate in any future periods.
We recognize interest and penalties accrued related to
unrecognized tax benefits in income tax expense. During the
three months ended June 30, 2007 and 2006, we recognized
approximately $0.9 million and $1.9 million in
interest. Additionally, during the three months ended
June 30, 2007, we reduced interest expense by
$1.0 million due to the completion of an IRS examination as
described below. During the six months ended June 30, 2007
and 2006, we recognized approximately $6.1 million and
$5.2 million in interest. We had accrued approximately
$26.4 million and $20.3 million for the payment of
interest at June 30, 2007 and January 1, 2007,
respectively.
We file income tax returns in the U.S. federal
jurisdiction, and various states and foreign jurisdictions. With
few exceptions, we are no longer subject to U.S. federal,
state and local, or
non-U.S. income
tax examinations by tax authorities for years before 2001.
During the second quarter of 2007, the IRS completed its
examination of Biogen Idec Inc.s consolidated federal
income tax returns for the fiscal years 2003 and 2004 and issued
an assessment. We subsequently paid amounts related to issues
agreed to with the IRS and are appealing several issues. As a
result of this examination activity, Biogen Idec Inc. reassessed
its liability for income tax contingencies to reflect the IRS
findings and recorded a $14.7 million reduction during the
second quarter of 2007.
In connection with the adoption of FIN 48, we reclassified
approximately $113 million in reserves for uncertain tax
positions from current taxes payable to long-term liabilities.
18
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
11. Other
Income (Expense), Net
Total other income (expense), net, consists of the following (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Interest income
|
|
$
|
32.1
|
|
|
$
|
26.1
|
|
|
$
|
61.2
|
|
|
$
|
49.7
|
|
Interest expense
|
|
|
(1.9
|
)
|
|
|
(0.2
|
)
|
|
|
(2.3
|
)
|
|
|
(0.5
|
)
|
Other income/(expense), net
|
|
|
1.4
|
|
|
|
(4.1
|
)
|
|
|
(5.6
|
)
|
|
|
(8.7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
$
|
31.6
|
|
|
$
|
21.8
|
|
|
$
|
53.3
|
|
|
$
|
40.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2007, the principal
components of other income (expense), net, were minority
interest expense ($1.9 million), and net realized losses on
sales of marketable securities ($5.0 million) offset by
income related to legal settlements ($1.6 million), and net
realized gains on sales of strategic investments
($8.1 million). In the three months ended June 30,
2006, the principal components of other income (expense), net,
were realized losses on investments ($0.9 million),
expenses related to legal settlements ($2.1 million), net
realized losses on our strategic investments
($2.3 million), and minority interest expense
($2.1 million), offset by gains on foreign currency
($3.6 million).
In the six months ended June 30, 2007, the principal
components of other income (expense), net, were minority
interest expense ($4.0 million), and net realized losses on
sales of marketable securities ($7.3 million) offset by net
realized gains on our strategic investments ($8.0 million).
In the six months ended June 30, 2006, the principal
components of other income (expense), net, were realized losses
on investments ($1.8 million), minority interest expense
($4.1 million), net realized losses on our strategic
investments ($4.4 million), and expenses related to legal
settlements ($3.6 million), offset by gains on foreign
currency ($5.4 million).
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.
(Brown), 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 consolidated with the Brown case. On
October 13, 2006, the plaintiffs filed an amended
consolidated complaint which, among other amendments to the
allegations, adds as defendants Peter N. Kellogg, our Chief
Financial Officer, William R. Rohn, our former Chief Operating
Officer, Burt A. Adelman, our Executive Vice President,
Portfolio Strategy, and Thomas J. Bucknum, our former General
Counsel. On November 15, 2006, we and all the other
defendants who had been served as of that date filed a motion to
dismiss the amended consolidated complaint. The plaintiffs
opposition to our Motion to Dismiss was filed on
December 18, 2006 and a hearing on the Motion to Dismiss
was held before a Magistrate Judge on March 12, 2007. On
June 28, 2007, prior to any further action by the
Magistrate Judge on the Motion to Dismiss, the District Court
Judge withdrew the referral to the Magistrate Judge, and ordered
that the Motion to Dismiss be argued before the District Court
Judge on September 11, 2007. We
19
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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 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 have cooperated 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. Genentech has reported
further that the government has called and is expected to call
former and current Genentech employees to appear before a grand
jury in connection with this investigation. We are cooperating
with the U.S. Department of Justice in its investigation of
Genentech. 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 cases filed by the County of
Erie, County of Nassau, County of Oswego and County of
Schenectady are the subject of a Consolidated
Complaint (Consolidated Complaint), which was filed
on June 15, 2005, and amended on June 8, 2007, in the
U.S. District Court for the District of Massachusetts in
Multi-District Litigation No. 1456 (the MDL
proceedings). The County of Nassau filed an original
complaint on November 23, 2004 and a second amended
complaint on January 6, 2006 in the MDL proceedings.
Thereafter, the County of Nassau joined in the amended
Consolidated Complaint filed on June 8, 2007 in the MDL
proceedings. The County of Erie, County of Oswego and County of
Schenectady cases have been removed and transferred to the MDL
proceedings, and are currently subject to motions to remand
these cases to state court.
All of the complaints in these cases allege that the defendants
(i) fraudulently reported the Average Wholesale Price for
certain drugs for which Medicaid provides reimbursement
(Covered Drugs); (ii) 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; (iii) provided financing incentives to
providers to over-prescribe Covered Drugs or to prescribe
Covered Drugs in place of competing drugs; and
(iv) overcharged Medicaid for illegally inflated Covered
Drugs reimbursements. Among other things, 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 amended Consolidated Complaint alleges 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, and excluded from
their reporting certain discounts and other rebates that would
have reduced the best price.
On April 2, 2007, the defendants joint motion to
dismiss the original Consolidated Complaint and the County of
Nassaus second amended complaint was granted in part, but
certain claims against Biogen Idec remained. Biogen Idecs
individual motion to dismiss these complaints remains pending.
The defendants filed a joint motion to dismiss the amended
Consolidated Complaint on June 22, 2007. That motion has
not yet been decided. On September 7, 2006, a New York
State court granted in part and denied in part Biogen
Idecs motion to dismiss the County of Erie complaint.
Biogen Idec subsequently answered the complaints filed by the
Counties of Erie, Oswego and Schenectady. Biogen Idec intends to
defend itself vigorously 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.
Along with several other major pharmaceutical and biotechnology
companies, we were also 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 and transferred to the
MDL proceedings. The complaint, as amended on March 13,
2007, is
20
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
brought on behalf of Arizona consumers and other payors for
drugs, and alleges that the defendants violated the state
consumer fraud statute by fraudulently reporting the Average
Wholesale Price for certain drugs covered by various private and
public insurance mechanisms and by marketing these drugs to
providers based on the providers ability to collect
inflated payments from third-party payors. Motions to dismiss
the complaint have not yet been filed and briefed. 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 of the
District of Maine (Court). The lawsuit was filed
under seal on July 29, 2005 by a former employee of our
co-defendant Genentech pursuant to the False Claims Act,
31 U.S.C. section 3729 et. seq. On December 20,
2005, the U.S. government elected not to intervene, and the
complaint was subsequently unsealed and served. 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. On December 14, 2006, the Magistrate Judge
recommended that the Court dismiss the case based on our and
Genentechs Motion to Dismiss. The Plaintiff filed
objections to this recommendation and the matter awaits decision
by the District Court Judge. At this stage of the litigation, we
cannot make any estimate of a potential loss or range of loss.
On June 17, 2006, Biogen Idec filed a Demand for
Arbitration against Genentech, Inc. with the American
Arbitration Association (AAA). In the Demand for
Arbitration, Biogen Idec alleged that Genentech breached the
parties Amended and Restated Collaboration Agreement dated
June 19, 2003 (the Collaboration Agreement), by
failing to honor Biogen Idecs contractual right to
participate in strategic decisions affecting the parties
joint development and commercialization of certain
pharmaceutical products, including humanized anti-CD20
antibodies. The original Demand for Arbitration filed by Biogen
Idec focused primarily on Genentechs unilateral
development of an anti-CD20 product known as a second generation
anti-CD20 molecule to treat Neuromyelitis Optica
(NMO), a relatively rare disorder of the central
nervous system. Genentech filed an Answering Statement in
response to Biogen Idecs Demand in which Genentech denied
that it had breached the Collaboration Agreement and alleged
that Biogen Idec had breached the Collaboration Agreement.
Genentech also asserted for the first time that the November
2003 transaction in which Idec acquired Biogen and became Biogen
Idec was a change of control of our company under the
Collaboration Agreement, a position with which we disagree
strongly. It is our position that the Biogen Idec merger did not
constitute a change of control under the Collaboration Agreement
and that, even if it did, Genentechs rights under the
change of control provision, which must be asserted within
ninety (90) days of the change of control event, have long
since expired. We intend to vigorously assert that position if
Genentech persists in making this claim. On December 5,
2006, Biogen Idec filed an Amended Demand for Arbitration with
the AAA to make clear that the parties dispute also
includes a disagreement over Genentechs unilateral
development of another collaboration product a third
generation anti-CD20 molecule to treat certain oncology
indications. A three-member arbitration panel has been selected
to decide this matter. The arbitration is in an early stage and
we cannot make a determination as to the likely outcome.
On August 10, 2004, Classen Immunotherapies, Inc. filed
suit against us, GlaxoSmithKline, Chiron Corporation,
Merck & Co., Inc., and Kaiser-Permanente, Inc. in the
U.S. District Court for the District of Maryland contending
that we induced infringement of U.S. Patent Nos, 6,420,139,
6,638,739, 5,728,383, and 5,723,283, all of which are directed
to various methods of immunization or determination of
immunization schedules. All Counts asserted against us by
Classen were dismissed by the Court upon various motions filed
by the Parties. In early December 2006, Classen filed its
initial appeal brief with the United States Court of Appeals for
the Federal Circuit.
21
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In that brief, Classen argues for the first time that Biogen
Idec has no reporting duties and no activities related to FDA
reporting regarding Hepatitis B vaccines and hence can have no
claim to a safe harbor protection under Section 271(e)1.
Classen asserts, however, that we are inducing infringement by
having users consider risk prior to choosing an immunization
schedule. On March 7, 2007, we filed our brief in response.
We argued that Classen has waived this argument by not raising
it in the District Court and, moreover, that the argument lacks
merit because Biogen Idec cannot induce infringement if there
has been no actual infringement. The Court of Appeals has
scheduled oral argument for August 8, 2007. We are unable
to predict the outcome of this appeal.
On January, 30, 2007, the Estate of Thaddeus Leoniak commenced a
civil lawsuit in the Court of Common Pleas, Philadelphia County,
Pennsylvania, against Biogen Idec, the Fox Chase Cancer Center
and three physicians. The Complaint alleges that Thaddeus
Leoniak died as a result of taking the drug ZEVALIN, and seeks
to hold Biogen Idec strictly liable for placing an allegedly
unreasonably dangerous product in the stream of
commerce without proper warnings. The Complaint also seeks to
hold the Company liable for alleged negligence in the design,
manufacture, advertising, marketing, promoting, distributing,
supplying and selling of ZEVALIN. The lawsuit seeks damages for
pecuniary losses suffered by the decedents survivors and
for compensatory damages for decedents pain and suffering,
loss of earnings and deprivation of normal activities, all in an
amount in excess of $50,000. On January 31,
2007, the Plaintiffs counsel demanded $7.0 million to
settle the lawsuit. Biogen Idec has not formed an opinion that
an unfavorable outcome is either probable or
remote and does not express an opinion at this time
as to the likely outcome of the matter or as to the magnitude or
range of any potential loss. The Company believes that it has
good and valid defenses to the Complaint and intends to
vigorously defend the case.
We operate in one business segment, which is the business of
development, manufacturing and commercialization of novel
therapeutics for human health care. Our chief operating
decision-maker manages our operations as a single operating
segment.
Notes payable consists of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Current portion:
|
|
|
|
|
|
|
|
|
20-year
subordinated convertible promissory notes, due 2019 at 5.5%
|
|
$
|
2.6
|
|
|
$
|
|
|
Note payable to Fumedica
|
|
|
9.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
11.9
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Non-current portion:
|
|
|
|
|
|
|
|
|
30-year
senior convertible promissory notes, due 2032 at 1.75%
|
|
$
|
|
|
|
$
|
6.5
|
|
20-year
subordinated convertible promissory notes, due 2019 at 5.5%
|
|
|
|
|
|
|
39.1
|
|
Credit line from Dompé
|
|
|
12.2
|
|
|
|
11.9
|
|
Note payable to Fumedica
|
|
|
31.0
|
|
|
|
39.2
|
|
Line of credit
|
|
|
8.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
51.3
|
|
|
$
|
96.7
|
|
|
|
|
|
|
|
|
|
|
In January 2007, we issued from treasury stock 2.8 million
shares of common stock for $70.5 million in face value and
$36.6 million in carrying value of our 2019 subordinated
notes that the holders had elected to convert into our common
stock.
In May 2007, we paid $6.6 million to note holders of the
2032 senior notes that had exercised their right to put the
senior notes back to us. These senior notes had a face value of
$10.1 million.
22
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In June 2007, in connection with the tender offer described in
Note 16 Tender Offer, we entered into a
$1,500 million term loan facility. The term loan facility
has a term of 364 days and bears interest of LIBOR plus
45 basis points, which was 5.77% at June 30, 2007. As
of June 30, 2007 we had no borrowings under this facility.
On July 2, 2007, in connection with the funding of the
tender offer, we borrowed the full $1,500 million under
this facility. We expect to repay this term loan facility in
2007 with proceeds from a long-term financing agreement.
In June 2007, we also entered into a five year $400 million
Senior Unsecured Revolving Credit Facility, which we may use for
future working capital and general corporate purposes. This
credit facility bears interest at a rate of LIBOR plus
45 basis points, which was 5.77% at June 30, 2007. As
of June 30, 2007, we had not borrowed any funds against
this credit facility.
|
|
15.
|
New
Accounting Pronouncements
|
On February 15, 2007, FASB Statement No. 159, The
Fair Value Option for Financial Assets and Financial
Liabilities, including an amendment of FASB Statement
No. 115, or SFAS 159, was issued. This Statement
permits companies to choose to measure many financial
instruments and certain other items at fair value that are not
currently required to be measured at fair value and establishes
presentation and disclosure requirements. This Statement is
effective January 1, 2008 for the company. We are currently
evaluating the impact, if any, this standard will have on our
financial statements.
On September 6, 2006, FASB Statement No. 157 Fair
Value Measurement, or SFAS 157, was issued. This
Statement defines fair value, establishes a framework for
measuring fair value in generally accepted accounting
principles, or GAAP, and expands disclosures about fair value
measurements. This Statement applies to other accounting
pronouncements that require or permit fair value measurements.
This Statement does not require any new fair value measurements.
The Statement is effective January 1, 2008 for the company.
We are currently evaluating the impact, if any, this standard
will have on our financial statements.
On May 30, 2007, we commenced a modified Dutch
Auction tender offer to purchase up to
56,603,773 shares of our outstanding stock at a price
between $47.00 and $53.00 per share, for an aggregate purchase
price of up to $3,000.0 million. On June 27, 2007, we
accepted for payment an aggregate of 56,424,155 shares of
our common stock at a price of $53.00 per share. As the
obligation of $2,990.5 million was incurred on
June 27, 2007 and funded on July 2, 2007, pursuant to
SFAS 150, we recorded the present value of the obligation
of $2,988.2 million on June 27, 2007, and the
$2.3 million difference between the present value of the
obligation and funded amount will be recognized as interest
expense through July 2, 2007. The amount recorded as tender
offer obligation within the shareholders equity section of
the accompanying balance sheet is the $2,988.2 million
present value of the obligation as of June 27, 2007, as
well as costs and fees incurred to effect the tender offer. As
of June 30, 2007, the obligation to settle the tender offer
of $2,990.0 million is recorded as a current liability in
the accompanying balance sheet. On July 2, 2007, we funded
the tender offer through existing cash and cash equivalents of
approximately $1,490 million and approximately
$1,500 million in funding by our term loan facility as
described in Note 14, Indebtedness.
23
|
|
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.
The following discussion should be read in conjunction with our
consolidated financial statements and related notes appearing
elsewhere in this Report on
Form 10-Q,
beginning on page 3.
Overview
Biogen Idec Inc. is an international biotechnology company that
creates new standards of care in oncology, neurology, immunology
and other speciality areas of unmet medical need.
We currently have five products:
|
|
|
|
|
AVONEX®
(interferon beta-1a);
|
|
|
|
RITUXAN®
(rituximab);
|
|
|
|
TYSABRI®
(natalizumab);
|
|
|
|
FUMADERM®
(dimethylfumarate and monoethylfumarate salts); and,
|
|
|
|
ZEVALIN®
(ibritumomab tiuxetan). During the third quarter of 2006, we
began executing a plan to divest our ZEVALIN product line.
|
Additionally, through April 2006, we recorded product revenues
from sales of
AMEVIVE®
(alefacept). In April 2006, we sold the worldwide rights to this
product to Astellas Pharma US, Inc., or Astellas. We will
continue to manufacture and supply this product to Astellas for
a period of up to 11 years.
Executive
Overview
Results for the first six months of 2007 included total revenue
of $1,489.1 million, net income of $317.6 million and
diluted net income per share of $0.92. These results reflect an
increase in revenue primarily attributable to the impact of
price increases as well as the re-launch of TYSABRI in July
2006. The effect of the increase in revenue was partially offset
by an increase in research and development expense due to new
clinical trials and other projects, and an increase in selling
general and administrative expense related to increased
headcount to support the
re-launch of
TYSABRI and AVONEX sales.
In June 2007 we completed a tender offer in which we purchased
56,424,155 shares of our common stock for an aggregate
purchase price of approximately $2,990 million. We funded
the transaction in July 2007 through the liquidation of
approximately $1,490 million of cash and marketable
securities and obtaining a term loan for approximately
$1,500 million.
In January 2007, we completed the acquisition of 100% of the
stock of Syntonix Pharmaceuticals, Inc. for total initial
consideration of $44.4 million and contingent payments of
up to $124.4 million if certain milestones are
24
achieved. The financial statement impact resulting from the
purchase included recognition of a charge for acquired
in-process research and development, or IPR&D, of
approximately $18.4 million.
Results
of Operations
Revenues
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Product sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
295.2
|
|
|
|
38.2
|
%
|
|
$
|
265.8
|
|
|
|
40.3
|
%
|
|
$
|
586.4
|
|
|
|
39.4
|
%
|
|
$
|
505.9
|
|
|
|
39.8
|
%
|
Rest of world
|
|
|
223.4
|
|
|
|
28.9
|
%
|
|
|
170.3
|
|
|
|
25.8
|
%
|
|
|
416.6
|
|
|
|
28.0
|
%
|
|
|
336.7
|
|
|
|
26.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
|
518.6
|
|
|
|
67.1
|
%
|
|
|
436.1
|
|
|
|
66.1
|
%
|
|
|
1,003.0
|
|
|
|
67.4
|
%
|
|
|
842.6
|
|
|
|
66.3
|
%
|
Unconsolidated joint business
|
|
|
230.6
|
|
|
|
29.8
|
%
|
|
|
206.1
|
|
|
|
31.2
|
%
|
|
|
437.8
|
|
|
|
29.4
|
%
|
|
|
389.5
|
|
|
|
30.6
|
%
|
Royalties
|
|
|
22.6
|
|
|
|
2.9
|
%
|
|
|
18.2
|
|
|
|
2.8
|
%
|
|
|
45.6
|
|
|
|
3.1
|
%
|
|
|
38.8
|
|
|
|
3.1
|
%
|
Corporate partner
|
|
|
1.4
|
|
|
|
0.2
|
%
|
|
|
(0.4
|
)
|
|
|
(0.1
|
)%
|
|
|
2.7
|
|
|
|
0.1
|
%
|
|
|
0.3
|
|
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
773.2
|
|
|
|
100
|
%
|
|
$
|
660.0
|
|
|
|
100
|
%
|
|
$
|
1,489.1
|
|
|
|
100
|
%
|
|
$
|
1,271.2
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Revenues (in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
AVONEX
|
|
$
|
461.6
|
|
|
|
89.0
|
%
|
|
$
|
429.4
|
|
|
|
98.4
|
%
|
|
$
|
910.4
|
|
|
|
90.8
|
%
|
|
$
|
822.8
|
|
|
|
97.7
|
%
|
TYSABRI
|
|
|
47.5
|
|
|
|
9.2
|
%
|
|
|
(0.2
|
)
|
|
|
0.0
|
%
|
|
|
77.3
|
|
|
|
7.7
|
%
|
|
|
(0.4
|
)
|
|
|
0.0
|
%
|
AMEVIVE
|
|
|
|
|
|
|
|
%
|
|
|
2.5
|
|
|
|
0.6
|
%
|
|
|
0.2
|
|
|
|
0.0
|
%
|
|
|
10.7
|
|
|
|
1.2
|
%
|
ZEVALIN
|
|
|
4.3
|
|
|
|
0.8
|
%
|
|
|
4.4
|
|
|
|
1.0
|
%
|
|
|
9.9
|
|
|
|
1.0
|
%
|
|
|
9.5
|
|
|
|
1.1
|
%
|
FUMADERM
|
|
|
5.2
|
|
|
|
1.0
|
%
|
|
|
|
|
|
|
|
%
|
|
|
5.2
|
|
|
|
0.5
|
%
|
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues
|
|
$
|
518.6
|
|
|
|
100
|
%
|
|
$
|
436.1
|
|
|
|
100
|
%
|
|
$
|
1,003.0
|
|
|
|
100
|
%
|
|
$
|
842.6
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
Sales, excluding Amortization of Intangibles (in
millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Cost of product revenues
|
|
$
|
83.2
|
|
|
|
98.9
|
%
|
|
$
|
77.1
|
|
|
|
98.8
|
%
|
|
$
|
164.0
|
|
|
|
98.8
|
%
|
|
$
|
143.5
|
|
|
|
98.6
|
%
|
Cost of royalty revenues
|
|
|
0.9
|
|
|
|
1.1
|
%
|
|
|
0.9
|
|
|
|
1.2
|
%
|
|
|
2.0
|
|
|
|
1.2
|
%
|
|
|
2.0
|
|
|
|
1.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, excluding
amortization of intangibles
|
|
$
|
84.1
|
|
|
|
100
|
%
|
|
$
|
78.0
|
|
|
|
100
|
%
|
|
$
|
166.0
|
|
|
|
100
|
%
|
|
$
|
145.5
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three and six months ended June 30, 2007, we
wrote-down $8.1 million and $14.8 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the three and six months ended
June 30, 2006, we wrote-down $8.8 million and
$12.0 million, respectively, in unmarketable inventory,
which was also charged to cost of sales.
25
AVONEX
Revenues from AVONEX in the three and six months ended
June 30, 2007 and 2006 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
AVONEX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
269.6
|
|
|
|
58.4
|
%
|
|
$
|
260.6
|
|
|
|
60.7
|
%
|
|
$
|
539.6
|
|
|
|
59.3
|
%
|
|
$
|
492.7
|
|
|
|
59.9
|
%
|
Rest of World
|
|
|
192.0
|
|
|
|
41.6
|
%
|
|
|
168.8
|
|
|
|
39.3
|
%
|
|
|
370.8
|
|
|
|
40.7
|
%
|
|
|
330.1
|
|
|
|
40.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total AVONEX revenues
|
|
$
|
461.6
|
|
|
|
100
|
%
|
|
$
|
429.4
|
|
|
|
100
|
%
|
|
$
|
910.4
|
|
|
|
100
|
%
|
|
$
|
822.8
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, U.S. sales of AVONEX
increased $9.0 million, or 3.5%, principally due to the
impact of price increases. In the six months ended June 30,
2007, compared to the six months ended June 30, 2006,
U.S. sales of AVONEX increased $46.9 million, or 9.5%,
principally due to the impact of price increases.
In the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, international sales of
AVONEX increased $23.2 million, or 13.7%, due to the impact
of higher volume and exchange rates. In the six months ended
June 30, 2007, compared to the six months ended
June 30, 2006, international sales of AVONEX increased
$40.7 million, or 12.3%, principally due to the impact of
exchange rates and higher volume.
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 with the products
of our competitors.
TYSABRI
Revenues from TYSABRI for the three and six months ended
June 30, 2007 and 2006 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
TYSABRI
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
22.3
|
|
|
|
46.9
|
%
|
|
$
|
(0.2
|
)
|
|
|
100
|
%
|
|
$
|
39.4
|
|
|
|
51.0
|
%
|
|
$
|
(0.4
|
)
|
|
|
100
|
%
|
Rest of World
|
|
|
25.2
|
|
|
|
53.1
|
%
|
|
|
|
|
|
|
0.0
|
%
|
|
|
37.9
|
|
|
|
49.0
|
%
|
|
|
|
|
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total TYSABRI revenues
|
|
$
|
47.5
|
|
|
|
100
|
%
|
|
$
|
(0.2
|
)
|
|
|
100
|
%
|
|
$
|
77.3
|
|
|
|
100
|
%
|
|
$
|
(0.4
|
)
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In July 2006, we began to ship TYSABRI in both the U.S. and
Europe in connection with the re-launch.
In the three and six months ended June 30, 2006, no sales
were made but certain amounts were recognized related to the
amortization of intangible assets, giving rise to negative
revenue of $196,000 and $393,000, respectively.
We have product on hand that was previously written off due to
uncertainties surrounding the TYSABRI suspension in 2005, but is
available to fill future orders. As of June 30, 2007, the
approximate value of this product, based on its original cost of
manufacture, is $13.8 million. We expect this product to be
utilized in 2007. For the three and six months ended
June 30, 2007, $3.2 million and $5.7 million of
this product, respectively, was used to fulfill orders.
ZEVALIN
In the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, sales of ZEVALIN
decreased 2.3%, due to lower domestic sales offset by higher
international sales. In the six months ended June 30, 2007,
compared to the six months ended June 30, 2006, sales of
ZEVALIN increased 4.2%, due to higher
26
international sales offset by lower domestic sales. We expect
future domestic sales of ZEVALIN to decline due to decreased
commercial effort as a result of our planned divestiture of this
product line.
FUMADERM
In connection with our June 2006 acquisition of Fumapharm, we
began recognizing revenue on sales of FUMADERM to our
distributor, Fumedica, in July 2006. In December 2006, we
acquired the right to distribute FUMADERM in Germany from
Fumedica effective May 1, 2007. In connection with the
acquisition of the FUMADERM distribution rights in Germany, we
committed to the repurchase of any inventory Fumedica did not
sell by May 1, 2007. As a result of this provision, we
deferred the recognition of revenue on shipments made to
Fumedica through April 30, 2007. We began recognizing
revenue on sales of FUMADERM into the German market in May 2007
and, in the three months ended June 30, 2007, we recognized
$5.2 million of sales of FUMADERM.
Unconsolidated
Joint Business Revenue
Revenues from unconsolidated joint business, which consist of
our share of pre-tax copromotion profits generated from our
copromotion agreement with Genentech and reimbursement by
Genentech of our Rituxan related expenses as well as royalty
revenue, consist of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended June 30,
|
|
|
Ended June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Copromotion profits
|
|
$
|
153.5
|
|
|
$
|
143.0
|
|
|
$
|
290.0
|
|
|
$
|
267.1
|
|
Reimbursement of selling and
development expenses
|
|
|
15.0
|
|
|
|
16.0
|
|
|
|
29.1
|
|
|
|
31.9
|
|
Royalty revenue on sales of
RITUXAN outside the U.S.
|
|
|
62.1
|
|
|
|
47.1
|
|
|
|
118.7
|
|
|
|
90.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
230.6
|
|
|
$
|
206.1
|
|
|
$
|
437.8
|
|
|
$
|
389.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits consist of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months Ended
|
|
|
|
Ended June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Product revenues, net
|
|
$
|
581.9
|
|
|
$
|
525.4
|
|
|
$
|
1,116.8
|
|
|
$
|
1,002.3
|
|
Costs and expenses
|
|
|
198.3
|
|
|
|
167.9
|
|
|
|
379.3
|
|
|
|
322.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits
|
|
$
|
383.6
|
|
|
$
|
357.5
|
|
|
$
|
737.5
|
|
|
$
|
680.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biogen Idecs share of
copromotion profits
|
|
$
|
153.5
|
|
|
$
|
143.0
|
|
|
$
|
290.0
|
|
|
$
|
267.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, our share of copromotion
profits increased $10.5 million, or 7.3%, due, principally,
to price increases, as well as higher sales of RITUXAN, as a
result of the approval of RITUXAN for treatment of rheumatoid
arthritis, or RA, in February 2006. For the six months ended
June 30, 2007, compared to the six months ended
June 30, 2006, our share of copromotion profits increased
$22.9 million, or 8.6%, due, principally, to price
increases, as well as higher sales of RITUXAN, as a result of
the approval of RITUXAN for treatment of rheumatoid arthritis,
or RA, in February 2006.
Our royalty revenue on sales of RITUXAN outside the U.S. is
based on Roches and Zenyakus net sales to
third-party customers and is recorded on a cash basis.
For the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, royalty revenue on sales
of RITUXAN outside the U.S. increased $15.0 million,
or 31.8%, due, principally to increased sales outside the U.S.,
reflecting greater market penetration. For the six months ended
June 30, 2007, compared to the six months ended
June 30, 2006, royalty revenue on sales of RITUXAN outside
the U.S. increased $28.2 million, or 31.2%, due,
principally to increased sales outside the U.S. reflecting
greater market penetration.
27
Under the amended and restated collaboration agreement, our
current pretax copromotion profit-sharing formula, which resets
annually, is as follows:
|
|
|
|
|
|
|
Biogen Idecs Share of
|
Copromotion Operating Profits
|
|
Copromotion Profits
|
|
First $50 million
|
|
|
30
|
%
|
Greater than $50 million
|
|
|
40
|
%
|
In 2007 and 2006, 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:
|
|
|
|
|
|
|
|
|
New Anti-CD20 U.S.
|
|
Biogen Idecs Share
|
|
Copromotion 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 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
|
%
|
|
|
|
(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%. |
Currently, we record our share of expenses incurred for the
development of new anti-CD20 products in research and
development expense until such time as a new product is
approved, at which time we will record our share of pretax
copromotion profits related to the new product in revenues from
unconsolidated joint business. We record our royalty revenue on
sales of RITUXAN outside the U.S. on a cash basis.
Under the amended and restated collaboration agreement, we will
receive a lower royalty percentage of revenue from Genentech on
sales by Roche and Zenyaku of new anti-CD20 products, as
compared to the royalty percentage of revenue 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 RITUXAN occurred in the second half of 1998.
28
Other
Revenue
Other revenue for the three and six months ended June 30,
2007 and 2006 was as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Royalties
|
|
$
|
22.6
|
|
|
|
94.2
|
%
|
|
$
|
18.2
|
|
|
|
102.2
|
%
|
|
$
|
45.6
|
|
|
|
94.4
|
%
|
|
$
|
38.8
|
|
|
|
99.2
|
%
|
Corporate partner
|
|
|
1.4
|
|
|
|
5.8
|
%
|
|
|
(0.4
|
)
|
|
|
(2.2
|
)%
|
|
|
2.7
|
|
|
|
5.6
|
%
|
|
|
0.3
|
|
|
|
0.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenue
|
|
$
|
24.0
|
|
|
|
100
|
%
|
|
$
|
17.8
|
|
|
|
100
|
%
|
|
$
|
48.3
|
|
|
|
100
|
%
|
|
$
|
39.1
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2007, compared to the
three months ended June 30, 2006, royalties increased
$4.4 million, or 24.2%, due, principally, to higher
royalties on sales of product licensed by The Medicines Company.
In the six months ended June 30, 2007, compared to the six
months ended June 30, 2006, royalties increased
$6.8 million, or 17.5%, due, principally, to higher
royalties on sales of product licensed by The Medicines Company.
Royalty revenues may fluctuate as a result of 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, government-sponsored programs, or loss of patent
protection.
Corporate partner revenues consist of contract revenues and
license fees.
Research
and Development Expenses
Research and development expenses totaled $218.1 million
and $162.0 million in the three months ended June 30,
2007 and 2006, respectively, an increase of $56.1 million,
or 34.6%. The increase reflects, principally, a
$31.3 million increase in clinical trial activity (notably
BG-12, Adentri, Anti-CD80, and TYSABRI), a $16.0 million
increase due to increased manufacturing of molecules for
clinical supply (notably
Anti-CD23
and IGF-1R), and $4.7 million of research and development
costs related to Syntonix.
Research and development expenses totaled $409.6 million
and $307.9 million in the six months ended June 30,
2007 and 2006, respectively, an increase of $101.7 million,
or 33.0%. The increase reflects, principally, a
$56.6 million increase in clinical trial activity (notably
BG-12, Anti-CD23, Anti-CD80, HSP90, and LTBR), a
$29.5 million increase due to increased manufacturing of
molecules for clinical supply (notably Anti-CD23 and IGF-1R),
and $7.3 million of research and development costs related
to Syntonix.
We anticipate that research and development expenses in 2007
will continue to be higher than 2006.
Acquired
In-Process Research and Development, or IPR&D
In the six months ended June 30, 2007, we recorded an
acquired IPR&D charge of $18.4 million related to the
acquisition of Syntonix. See Note 4 of the consolidated
financial statements, Acquisitions and Collaborations, for
details on future expenditures with respect to the IPR&D.
Research and development expenditures related to in-process
research and development projects acquired in the prior year are
$18.0 million for Fumapharm and $11.6 million for
Conforma. In the six months ended June 30, 2006, we
recorded $330.5 million of IPR&D related to the
acquisitions of Fumapharm and Conforma.
Since completing the acquisition in January of 2007, we have
spent approximately $7.4 million related to the in-process
technology of Syntonix. Those expenses are included in research
and development expenses in the accompanying consolidated
statement of income.
Selling,
General and Administrative Expenses
Selling, general and administrative expenses totaled
$203.7 million and $170.3 million in the three months
ended June 30, 2007 and 2006, respectively, an increase of
$33.4 million, or 19.6%. The increase reflects,
principally, a $14.5 million increase in sales and
marketing activities for TYSABRI, primarily in international
sales
29
and marketing, a $9.0 million increase in salaries and
benefits related to increased headcount in general and
administrative personnel, and a $9.1 million increase in
fees and services related to general and administrative costs.
Selling, general and administrative expenses totaled
$391.7 million and $324.7 million in the six months
ended June 30, 2007 and 2006, respectively, an increase of
$67.0 million, or 20.6%. The increase reflects,
principally, a $34.6 million increase in sales and
marketing activities for TYSABRI, primarily in international
sales and marketing, a $14.1 million increase in salaries
and benefits related to increased headcount in general and
administrative personnel, and a $13.5 million increase in
fees and services related to general and administrative costs.
These increases were offset by a $4.9 million decrease in
sales and marketing activities related to ZEVALIN.
We anticipate that total selling, general, and administrative
expenses in 2007 will continue to be higher than 2006 due to
sales and marketing and other general and administrative
expenses to support AVONEX and TYSABRI growth.
Amortization
of Intangible Assets
Amortization of intangible assets totaled $61.0 million for
the three months ended June 30, 2007 compared to
$76.3 million in the comparable period in 2006, a decrease
of $15.3 million, or 20.1%. Amortization of intangible
assets totaled $120.9 million for the six months ended
June 30, 2007 compared to $147.0 million in the
comparable period in 2006, a decrease of $26.1 million, or
17.8%. The decrease is due, principally, to a change in estimate
in the calculation of economic consumption for core technology
that occurred as part of our annual reassessment of amortization
expense in the third quarter of 2006.
Income
Tax Provision
Tax
Rate
Our effective tax rate was 21.8% on pre-tax income for the three
months ended June 30, 2007, compared to (70.3)% for the
comparable period in 2006. Our effective tax rate was 28.0% on
pre-tax income for the six months ended June 30, 2007,
compared to 156.2% for the comparable period in 2006. The change
in the effective tax rate for the three and six months ended
June 30, 2007, is primarily attributable to the prior year
non deductible acquisition related IPR&D.
Liquidity
and Capital Resources
Financial
Condition
Our financial condition is summarized as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Cash and cash equivalents
|
|
$
|
1,611.6
|
|
|
$
|
661.4
|
|
Marketable securities
short term
|
|
|
191.1
|
|
|
|
241.3
|
|
Marketable securities
long term
|
|
|
917.4
|
|
|
|
1,412.2
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and
marketable securities
|
|
$
|
2,720.1
|
|
|
$
|
2,314.9
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$
|
(770.9
|
)
|
|
$
|
1,129.7
|
|
Outstanding borrowings
convertible notes
|
|
$
|
2.6
|
|
|
$
|
45.6
|
|
Outstanding borrowings
other
|
|
$
|
60.6
|
|
|
$
|
51.1
|
|
Until required for use in the business, 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.
We have financed our operating and capital expenditures
principally through cash flows from our operations. We financed
the tender offer through the use of debt and existing cash. 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
30
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;
|
|
|
|
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, FUMADERM,
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.
|
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
Cash provided by operations was $464.3 million and
$339.6 million in the six months ended June 30, 2007
and 2006, respectively, an increase of $124.7 million, or
36.7%. The increase is due to higher earnings and a lower
investment in working capital. Specifically, cash used to
finance movements in working capital asset and liability
accounts gave rise to a use of funds in the current period of
approximately $99.2 million versus a use of funds of
$134.4 million in the prior year. The current year includes
an increase in net income of approximately $365.3 million
as well as a decrease in non-cash charges. The principal
component of non-cash charges for the six months ended
June 30, 2007 and 2006 was acquired in-process research and
development of $18.4 million and $330.5 million,
respectively. Additionally, deferred income taxes represented a
use of funds of $18.2 million during the six months ended
June 30, 2007 versus a use of funds of $46.1 million
in 2006. These increases were offset by a decrease in non-cash
charges relating to depreciation and amortization which declined
by $17.6 million to $181.3 million for the six months
ended June 30, 2007 from $198.9 million for the six
months ended June 30, 2006.
Investing
activities
Cash provided by investing activities was $396.7 million
compared to cash used in investing activities of
$657.6 million in the six months ended June 30, 2007
and 2006, respectively. The increase in cash provided by
investing activities reflects the sale of marketable securities
to fund the tender offer described in Note 16, Tender
Offer. Purchases of plant, property, and equipment totaled
$117.2 million in the six months ended June 30, 2007
as compared to $79.7 million in the six months ended
June 30, 2006. Payments made for acquisitions were
$42.3 million in 2007 and $363.3 million in 2006.
31
Financing
activities
Cash provided by financing activities in the six months ended
June 30, 2007 was $88.8 million compared to cash
provided of $94.3 million in the six months ended
June 30, 2006. The decrease was due, principally, to the
repurchase of senior notes and lower proceeds from loans offset
by an increase in proceeds from the issuance of stock for share
based payment arrangements.
Borrowings
As of June 30, 2007, our remaining indebtedness under our
subordinated notes was approximately $2.6 million with a
face value of $4.9 million. On May 1, 2007, we paid
$6.6 million to note holders of the 2032 senior notes that
had exercised their right to put the notes back to us. These
notes had a face value of $10.1 million.
At June 30, 2007 we have a note payable of approximately
$40.3 million relating to the acquisition of distribution
rights of FUMADERM. Additionally, one of our international joint
ventures maintained a loan that had a carrying value of
$12.2 million as of June 30, 2007 and a line of credit
with an outstanding balance of $8.1 million. See
Note 14, Indebtedness, for a description of a
line of credit and term loan agreement entered into in June 2007.
Tender
Offer
On May 30, 2007, we commenced a modified Dutch
Auction tender offer to purchase up to
56,603,773 shares of our outstanding stock at a price
between $47.00 and $53.00 per share, for an aggregate purchase
price of up to $3,000.0 million. On June 27, 2007, we
accepted for payment an aggregate of 56,424,155 shares of
our common stock at a price of $53.00 per share. As the
obligation of $2,990.5 million was incurred on
June 27, 2007 and funded on July 2, 2007, pursuant to
SFAS 150, we recorded the present value of the obligation
of $2,988.2 million on June 27, 2007, and the
$2.3 million difference between the present value of the
obligation and funded amount will be recognized as interest
expense through July 2, 2007. The amount recorded as tender
offer obligation within the shareholders equity section of
the accompanying balance sheet is the $2,988.2 million
present value of the obligation as of June 27, 2007, as
well as costs and fees incurred to effect the tender offer. As
of June 30, 2007, the obligation to settle the tender offer
of $2,990.0 million is recorded as a current liability in
the accompanying balance sheet. On July 2, 2007, we funded
the tender offer through existing cash and cash equivalents of
approximately $1,490 million and approximately
$1,500 million in funding by our term loan facility as
described in Note 14, Indebtedness.
Working
capital
At June 30, 2007, our working capital was
$(770.9) million, as compared to $1,129.7 million at
December 31, 2006, a decrease of $1,900.6 million.
This reflects the classification of the $2,990.0 million
tender offer obligation as a current liability. We expect to
repay the $1,500.0 million term loan used to partially
satisfy this obligation with proceeds from the issuance of long
term debt.
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 that facility. As of June 30, 2007, we had
committed approximately $278.0 million to the project, of
which approximately $275.9 million had been paid.
We are proceeding with the second phase of the project, a
large-scale bulk manufacturing facility. In October 2006,
our Board of Directors approved this phase of the project, which
is expected to cost an additional $225.0 million. As of
June 30, 2007, we had committed approximately
$188.7 million to the second phase, of which approximately
$33.7 million had been paid.
The second phase of the project is expected to be ready for
commercial production in 2009.
32
The timing of the completion and anticipated licensing of the
bulk manufacturing facility is in part dependent upon market
acceptance of TYSABRI. See Risk Factors Our
near-term success depends on the market acceptance and
successful launch of our third product TYSABRI. 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 U.S., EU and other
jurisdictions.
In June 2007, we entered into an agreement with Cardiokine,
Inc., a privately-held pharmaceutical company, for the joint
development of lixivapatan, an oral compound expected to enter a
Phase III clinical trial in the second half of 2007 for the
potential treatment of hyponatremia in patients with congestive
heart failure. Under the terms of the agreement, we will pay a
$50.0 million upfront payment expected to be paid in the
third quarter 2007, and up to $170.0 million in additional
milestone payments for successful development and global
commercialization of lixivapatan, as well as royalties for
commercial sales.
Share
Repurchase Program
We did not repurchase any shares of our common stock under our
authorized share repurchase program in the three and six months
ended June 30, 2007. Please see Note 16, Tender
Offer, for a description of our share repurchase completed
in July.
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
Refer to Note 12 of the consolidated financial statements
in Part I of this report on
Form 10-Q,
Litigation, for a discussion of legal matters as of
June 30, 2007.
New
Accounting Standards
Refer to Note 15 of the consolidated financial statements
in Part I of this report on
Form 10-Q,
New Accounting Pronouncements, for a discussion of new
accounting standards.
Critical
Accounting Estimates
The discussion and analysis of our financial condition and
results of operations is based on our financial statements,
which have been prepared in accordance with accounting
principles generally accepted in the United States of
America. The preparation of these financial statements requires
us to make estimates and assumptions that affect the reported
amounts of assets and liabilities and the 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. On an ongoing basis, management
evaluates its critical estimates and judgments, including, among
others, those related to revenue recognition, investments,
purchase accounting, goodwill impairment, income taxes, and
stock-based compensation. Those critical estimates and
assumptions are based on our historical experience, our
observance of trends in the industry, and various other factors
that are believed to be reasonable under the circumstances and
form the basis for making judgments about the carrying values of
assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under
different assumptions or conditions. Refer to
Item 7 Managements Discussion and
Analysis of Financial Condition and Results of Operations
in the Companys Annual Report on
Form 10-K
for the fiscal year ended December 31, 2006 for a
discussion of the Companys critical accounting estimates.
33
Adoption
of FASB Interpretation No. 48
Effective January 1, 2007, we adopted FASB Interpretation
No. 48, Accounting for Uncertainty in Income Taxes,
or FIN 48. 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 each tax position taken or expected to be taken
in a tax return. As a result of the adoption of FIN 48, we
recognized a reduction in the liability for unrecognized tax
benefits of $14.2 million, which was recorded as a
$1.8 million reduction to the January 1, 2007 balance
of our accumulated deficit, a $9.1 million reduction in
goodwill and a $3.3 million increase in our deferred tax
liability.
A reconciliation of the beginning and ending amount of
unrecognized tax benefits is as follows (in millions):
|
|
|
|
|
Balance at January 1, 2007
|
|
$
|
196.8
|
|
Additions based on tax positions
related to the current period
|
|
|
12.1
|
|
Additions for tax positions of
prior periods
|
|
|
51.4
|
|
Reductions for tax positions of
prior periods
|
|
|
(69.1
|
)
|
Settlements
|
|
|
(18.7
|
)
|
|
|
|
|
|
Balance at June 30, 2007
|
|
$
|
172.5
|
|
|
|
|
|
|
Included in the balance at June 30, 2007 and
January 1, 2007, are $77.9 million and
$98.2 million (net of the federal benefit on state issues),
respectively, of unrecognized tax benefits that, if recognized,
would affect the effective income tax rate in any future periods.
|
|
Item 3.
|
Quantitative
and Qualitative Disclosures 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, 2006. There have
been no material changes in the first six months of 2007 to such
risks or our management of such risks.
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Item 4.
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Controls
and Procedures
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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, 2007. Based upon
that evaluation, our principal executive officer and principal
financial officer concluded that, as of June 30, 2007, 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 three months ended June 30,
2007 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
34
Part II
OTHER INFORMATION
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Item 1.
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Legal
Proceedings
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The section entitled Litigation in Notes to
Consolidated Financial Statements in Part I of this
report on
Form 10-Q
is incorporated into this item by reference.
We are
substantially dependent on revenues from our two principal
products
Our current and future revenues depend substantially upon
continued sales of our two principal products, AVONEX and
RITUXAN, which represented approximately 94% of our total
revenues in 2006. Any significant negative developments relating
to these two products, such as safety or efficacy issues, the
introduction or greater acceptance of competing products
(including greater than anticipated substitution of TYSABRI for
AVONEX) or adverse regulatory or legislative developments, would
have a material adverse effect on our results of operations.
Although we have developed and continue to develop additional
products for commercial introduction, we expect to be
substantially dependent on sales from these two products for
many years. A decline in sales from either of these two products
would adversely affect our business.
Our
long-term success depends upon the successful development and
commercialization of other products from our research and
development activities
Our long-term viability and growth will depend upon the
successful development and commercialization of other products
from our research and development activities. We, along with
Genentech, continue to expand our development efforts related to
additional uses for RITUXAN and follow on anti-CD20 product
candidates, and we are independently expanding development
efforts around other potential products in our pipeline. Product
development and commercialization are very expensive and involve
a high degree of risk. Only a small number of research and
development programs result in the commercialization of a
product. 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 remains 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.
If we are unable to introduce new products to the market
successfully or are unable to expand the indicated uses of
approved products such as RITUXAN and TYSABRI, our results of
operations would be adversely affected.
Adverse
safety events can negatively affect our assets, product sales,
operations and products in development
Even after we receive marketing approval for a product, adverse
event reports may have a negative impact on our
commercialization efforts. Our voluntary withdrawal of TYSABRI
from the market in February 2005 following reports of cases of
PML resulted in a significant reduction in expected revenues as
well as significant expense and management time required to
address the legal and regulatory issues arising from the
withdrawal, including revised labeling and enhanced risk
management programs. Later discovery of safety issues with our
products that were not known at the time of their approval by
the FDA could cause product liability events, additional
regulatory scrutiny and requirements for additional labeling,
withdrawal of products from the market and the imposition of
fines or criminal penalties. Any of these actions could result
in, among other things, material write-offs of inventory and
impairments of intangible assets, goodwill and fixed assets.
Our
near-term success depends on the market acceptance and
successful launch of our third product TYSABRI
A substantial portion of our growth in the near-term is
dependent on anticipated sales of TYSABRI. We received
regulatory approval to market TYSABRI in the U.S. and the
EU for relapsing forms of MS in June of 2006.
35
We re-introduced TYSABRI in the U.S. and launched TYSABRI
for the first time in Europe in the second half of 2006. TYSABRI
is expected to meaningfully diversify our product offerings and
revenues, and to drive additional revenue growth over the next
several years. Failure to launch the drug successfully would
result in a significant reduction in diversification and
expected revenues, and adversely affect our business.
The success of the reintroduction of TYSABRI into the
U.S. market and launch in the EU will depend upon its
acceptance by the medical community and patients, which cannot
be certain given the significant restrictions on use and the
significant safety warnings in the label. Additional cases of
the known side effect PML at a higher rate than indicated in the
prescribing information, or the occurrence of other unexpected
side effects could harm acceptance and limit TYSABRI sales. Any
significant lack of acceptance of TYSABRI by the medical
community or patients would materially and adversely affect our
growth and our plans for the future.
As a new entrant to a relatively mature MS market, TYSABRI sales
may be more sensitive to additional new competing products. A
number of such products are expected to be approved for use in
MS in the coming years. If these products have a similar or more
attractive overall profile in terms of efficacy, convenience and
safety, future sales of TYSABRI could be limited.
If we
do not successfully execute our strategy of growth through the
acquisition, partnering and in-licensing of products,
technologies or companies, our future performance could be
adversely affected
In addition to the expansion of our pipeline through spending on
internal development projects, we plan to grow through external
growth opportunities, which include the acquisition, partnering
and in-licensing of products, technologies and companies or the
entry into strategic alliances and collaborations. If we are
unable to complete or manage these external growth opportunities
successfully, we will not be able to grow our business in the
way that we currently expect. The availability of high quality
opportunities is limited and we are not certain that we will be
able to identify suitable candidates or complete transactions on
terms that are acceptable to us. In addition, even if we are
able to successfully identify and complete acquisitions, we may
not be able to integrate them or take full advantage of them and
therefore may not realize the benefits that we expect. If we are
unsuccessful in our external growth program, we may not be able
to grow our business significantly and we may incur asset
impairment charges as a result of acquisitions that are not
successful.
If we
fail to compete effectively, our business and market position
would suffer
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 and retention
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. The introduction of
alternatives to our products that offer advantages in efficacy,
safety or ease of use could negatively affect our revenues and
reduce the value of our product development efforts. In
addition, potential governmental action in the future could
provide a means for competition from developers of follow-on
biologics, which could compete on price and differentiation with
products that we now or could in the future market.
In addition to competing directly with products that are
marketed by substantial pharmaceutical competitors, both AVONEX
and RITUXAN also face 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
ours.
We
depend on collaborators for both product and royalty revenue and
the clinical development of future collaboration products, two
important parts of our business outside of our full
control
Collaborations between companies on products or programs are a
common business practice in the biotechnology industry.
Out-licensing typically allows a partner to collect up front
payments and future milestone payments, share the costs of
clinical development and risk of failure at various points, and
access sales and
36
marketing infrastructure and expertise in exchange for certain
financial rights to the product or program going to the
in-licensing partner. In addition, the obligation of
in-licensees to pay royalties or share profits generally
terminates upon expiration of the related patents. We have a
number of collaborators and partners, and have both in-licensed
and out-licensed several products and programs. These
collaborations include several risks:
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we are not fully in control of the royalty or profit sharing
revenues we receive from collaborators, and we cannot be certain
of the timing or potential impact of factors including patent
expirations, pricing or health care reforms, other legal and
regulatory developments, failure of our partners to comply with
applicable laws and regulatory requirements, the introduction of
competitive products, and new indication approvals which may
affect the sales of collaboration products;
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where we co-promote and co-market products with our
collaboration partners, any failure on their part to comply with
applicable laws in the sale and marketing of our products could
have an adverse effect on our revenues as well as involve us in
possible legal proceedings;
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collaborations often require the parties to cooperate, and
failure to do so effectively could have an impact on product
sales by our collaborators and partners, as well as an impact on
the clinical development of shared products or programs under
joint control.
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In addition, the successful development and commercialization of
new anti-CD20 product candidates in our collaboration with
Genentech (which also includes RITUXAN) will decrease our
participation in the operating profits from the collaboration
(including as to RITUXAN).
We
depend, to a significant extent, on reimbursement from third
party payors and a reduction in the extent of reimbursement
could negatively affect 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 addition,
states may more aggressively seek Medicaid rebates as a result
of legislation enacted in 2006, which rebate activity could
adversely affect our results of operations.
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.
Within the EU and other countries some third party trade in our
products occurs from markets with lower prices
thereby undermining our sales in some markets with higher
prices. Additionally, certain countries reference the prices in
other countries where our products are marketed. Thus, inability
to secure adequate prices in a particular country may also
impair our ability to obtain acceptable prices in existing and
potential new markets. This may create the opportunity for the
third party cross border trade previously mentioned or our
decision not to sell the product thus affecting our geographic
expansion plans.
37
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.
Our
business is subject to extensive governmental regulation and
oversight and changes in laws could adversely affect our
revenues and profitability
Our business is in a highly regulated industry. As a result,
governmental actions may 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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changes in FDA and foreign regulations that may require
additional safety monitoring after the introduction of our
products to market, which could increase our costs of doing
business and adversely affect the future permitted uses of
approved products;
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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.
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The enactment in the U.S. of the Medicare Prescription Drug
Improvement and Modernization Act of 2003, possible legislation
which could ease the entry of competing follow-on biologics in
the marketplace, and importation of lower-cost competing drugs
from other jurisdictions are examples of changes and possible
changes in laws that could adversely affect our business.
If we
fail to comply with the extensive legal and regulatory
requirements affecting the healthcare industry, we could face
increased costs, penalties and a loss of business
Our activities, including the sale and marketing of our
products, are subject to extensive government regulation and
oversight, including regulation under the U.S. Food, Drug
and Cosmetic Act and other federal and state statutes and
similar laws in foreign jurisdictions. 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 and exclusion from
participation in government programs. Whether or not we have
complied with the law, an investigation into alleged unlawful
conduct could increase our expenses, damage our reputation,
divert management time and attention and adversely affect our
business.
The Medicare/Medicaid anti-kickback law, and several similar
state laws, prohibit payments intended to induce physicians or
others either to purchase or arrange for or recommend the
purchase of healthcare products or services. 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).
Manufacturing
problems could result in our inability to deliver products,
inventory shortages, product recalls and increased
costs
We manufacture and expect to continue to manufacture our own
commercial requirements of bulk AVONEX and TYSABRI. Our products
are difficult to manufacture and problems in our manufacturing
processes can occur.
38
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 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. 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.
We currently manufacture TYSABRI at our manufacturing facility
in Research Triangle Park, North Carolina, or RTP. Although 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, we currently rely exclusively on our
RTP facility for the manufacture of TYSABRI.
If we cannot produce sufficient commercial requirements of bulk
product to meet demand, we would need to rely on third party
contract manufacturers, of which there are only a limited number
capable of manufacturing bulk products of the type we require.
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. 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 on third parties to provide services in connection with the
manufacture of our products and, in some instances, the
manufacture of the product itself
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 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 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 a 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.
If we
fail to meet the stringent requirements of governmental
regulation in the manufacture of our products, we could incur
substantial remedial costs and a reduction in
sales
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
acceptance of the change by the FDA prior to release of product
to the marketplace. Our inability, or the inability of our third
party service providers, to demonstrate ongoing cGMP
39
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 non-compliance could increase our costs,
cause us to lose revenue or market share and damage our
reputation.
We are
committing to a significant investment in the expansion of a
manufacturing facility the success of which relies upon
continued demand for our products
The first phase of our large-scale biologic manufacturing
facility in Hillerod, Denmark, is expected to be completed by
the end of the third quarter. As of June 30, 2007, we had
committed approximately $278.0 million to this phase of the
project, of which approximately $275.9 million had been
paid.
We are proceeding with the second phase of the facility and our
Board of Directors has authorized an additional
$225.0 million to be spent on this phase of the project in
addition to amounts spent for the first phase. As of
June 30, 2007, we had committed approximately
$188.7 million to the second phase of the project, of which
approximately $33.7 million had been paid.
In the event that we fail to manage the projects, or other
unforeseen events occur, we may incur additional costs to
complete the project. Additionally, any costs incurred may not
be recoverable in the event that projection of the demand for
future manufacturing volumes, including the demand for TYSABRI,
are not achieved.
If we
are unable to attract and retain qualified personnel and key
relationships, the growth of our business could be
harmed
Our success will depend, to a great extent, upon our ability to
attract and retain qualified scientific, manufacturing, sales
and marketing and executive personnel and our ability to develop
and maintain relationships with qualified clinical researchers
and key distributors. Competition for these people and
relationships is intense and we compete with numerous
pharmaceutical and biotechnology companies as well as with
universities and non-profit research organizations. Any
inability we experience to continue to attract and retain
qualified personnel or develop and maintain key relationships
could have an adverse effect on our ability to accomplish our
research, development and external growth objectives.
Our
operating results are subject to significant
fluctuations
Our quarterly revenues, expenses and net income (loss) have
fluctuated in the past and are likely to fluctuate significantly
in the future due to the timing of charges and expenses that we
may take. In recent periods, for instance, we have recorded
charges that include:
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acquired in-process research and development at the time we make
an acquisition;
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impairments that we are required to take with respect to
investments;
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impairments that we are required to take with respect to fixed
assets, including those that are recorded in connection with the
sale of fixed assets;
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the cost of restructurings.
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Additionally, net income may fluctuate due to the impact of
charges we may be required to take with respect to foreign
currency hedge transactions. In particular, we may incur higher
charges from hedge ineffectiveness than we expect or from the
termination of a hedge relationship.
These examples are only illustrative and other risks, including
those discussed in these Risk Factors, could also
cause fluctuations in our reported earnings. In addition, our
operating results during any one quarter do not necessarily
suggest the anticipated results of future quarters.
40
If we
are unable to adequately protect and enforce our intellectual
property rights, our competitors may take advantage of our
development efforts or our acquired technology
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. Our
patents may not afford us substantial protection or commercial
benefit. Similarly, our pending patent applications or patent
applications licensed from third parties may not ultimately be
granted as patents and we may not prevail if patents that have
been issued to us are challenged in court. If we are unable to
protect our intellectual property rights and prevent others from
exploiting our inventions, we will not derive the benefit from
them that we currently expect.
If our
products infringe the intellectual property rights of others, we
may incur damages and be required to incur the expense of
obtaining a license
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 that 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.
Uncertainty
over intellectual property in the biotechnology industry has
been the source of litigation, which is inherently costly and
unpredictable
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.
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 and
administrative 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.
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Pending
and future product liability claims may adversely affect our
business and our reputation
The administration of drugs in humans, whether in clinical
studies or commercially, carries the inherent risk of product
liability claims whether or not the drugs are actually the cause
of an injury. Our products or product candidates may cause, or
may appear to have caused, injury or dangerous drug interactions
and we may not learn about or understand those effects 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 already filed by patients who have had serious adverse
events while using TYSABRI.
We cannot predict with certainty the eventual outcome of any
pending or future litigation. We may not be successful in
defending ourselves in the litigation and, as a result, our
business could be materially harmed. These lawsuits may result
in large judgments or settlements against us, any of which could
have a negative effect on our financial condition and business.
Additionally, lawsuits can be expensive to defend, whether or
not they have 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
have recently incurred substantial indebtedness that could
adversely affect our business and limit our ability to plan for
or respond to changes in our business.
We have recently incurred a substantial amount of indebtedness
and we may also incur additional debt in the future. This
indebtedness could have important consequences to our business,
for example, it could:
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increase our vulnerability to general adverse economic and
industry conditions;
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require us to dedicate a substantial portion of our cash flow
from operations to payments on our indebtedness, thereby
reducing the availability of our cash flow for other purposes,
including business development efforts and mergers and
acquisitions; and
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limit our flexibility in planning for, or reacting to, changes
in our business and the industry in which we operate, thereby
placing us at a competitive disadvantage compared to our
competitors that may have less debt.
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Our
business involves environmental risks, which include the cost of
compliance and the risk of contamination or injury
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.
Our
international sales and operations are subject to the risks of
doing business abroad
We are increasing our presence in international markets, which
subjects us to many risks, such as:
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economic problems that disrupt foreign healthcare payment
systems;
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fluctuations in currency exchange rates;
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the imposition of governmental controls;
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less favorable intellectual property or other applicable laws;
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the inability to obtain any necessary foreign regulatory or
pricing approvals of products in a timely manner;
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restrictions on direct investments by foreign entities and trade
restrictions;
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changes in tax laws and tariffs;
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difficulties in staffing and managing international
operations; and
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longer payment cycles.
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Our operations and marketing practices are also subject to
regulation and scrutiny by the governments of the other
countries in which we operate. In addition, the Foreign Corrupt
Practices Act, or FCPA, prohibits U.S. companies and their
representatives from offering, promising, authorizing or making
payments to foreign officials for the purpose of obtaining or
retaining business abroad. In many countries, the healthcare
professionals we regularly interact with meet the definition of
a foreign official for purposes of the FCPA. Additionally, we
are subject to other U.S. laws in our international
operations. Failure to comply with domestic or foreign laws
could result in various adverse consequences, including possible
delay in approval or refusal to approve a product, recalls,
seizures, withdrawal of an approved product from the market,
and/or the
imposition of civil or criminal sanctions.
A portion of our business is conducted in currencies other than
our reporting currency, the U.S. dollar. We recognize
foreign currency gains or losses arising from our operations in
the period in which we incur those gains or losses. As a result,
currency fluctuations among the U.S. dollar and the
currencies in which we do business have caused foreign currency
transaction gains and losses in the past and will likely do so
in the future. Because of the number of currencies involved, the
variability of currency exposures and the potential volatility
of currency exchange rates, we may suffer significant foreign
currency transaction losses in the future due to the effect of
exchange rate fluctuations.
Our
investments in marketable securities are significant and are
subject to interest and credit risk that may reduce their
value
We maintain a significant portfolio of investments in marketable
securities. Our earnings may be adversely affected by changes in
the value of this portfolio. In particular, the value of our
investments may be adversely affected by increases in interest
rates, downgrades in the corporate bonds included in the
portfolio and by other than temporary declines in value. Each of
these events may cause us to record charges to reduce the
carrying value of our investment portfolio.
We may
incur liabilities to tax authorities in excess of amounts that
have been accrued
The preparation of our financial statements requires estimates
of the amount of tax that will become payable in each of the
jurisdictions in which we operate. Accordingly, we determine our
estimated liability for Federal, state and local taxes (in the
U.S.) and in connection with our tax liability in several
overseas jurisdictions. We may be challenged by any of these
taxing authorities and, in the event that we are not able to
defend our position, we may incur liabilities with respect to
the taxing authority and such amounts could be significant.
Several
aspects of our corporate governance and our collaboration
agreements may discourage a third party from attempting to
acquire us
Several factors might discourage a takeover attempt that could
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;
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our amended and restated collaboration agreement with Genentech
provides that, in the event we undergo a change of control,
within ninety (90) days Genentech may present an offer to
us to purchase our rights to RITUXAN. Recently, in an
arbitration proceeding brought by Biogen Idec relating to the
collaboration agreement, Genentech alleged for the first time
that the November 2003 transaction in which Idec acquired Biogen
and became Biogen Idec constituted such a change of control, an
assertion with which we strongly disagree. It is our position
that the Biogen Idec merger did not constitute a change of
control under our agreement with Genentech and that, even if it
did, Genentechs rights under the change of control
provision have long since expired. We intend to vigorously
assert our position if Genentech persists in making this claim.
If the arbitrators decide this issue in favor of Genentech, or
if a change of control were to occur in the future and Genentech
were to present an offer for the RITUXAN rights, we must either
accept Genentechs offer or purchase Genentechs
rights to RITUXAN on the same terms as its offer. 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;
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; and
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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 stock holders.
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Item 2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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A summary of our stock repurchase activity for the three and six
months ended June 30, 2007 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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Average Price Paid
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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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per Share
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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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($)
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(#)(a)
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Program (#)
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March 2007
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8,041
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(b)
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$
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44.99
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20,000,000
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April 2007
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747
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(b)
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$
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44.91
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20,000,000
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Total(c)
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8,788
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$
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44.98
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20,000,000
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(a) |
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On October 13, 2006 the Board of Directors authorized the
repurchase of up to 20.0 million shares of our common
stock. The repurchased stock will provide us with authorized
shares for general corporate purposes, such as common stock to
be issued under our employee equity and stock purchase plans.
This repurchase program does not have an expiration date. |
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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. |
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(c) |
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As more fully described in Note 16, Tender
Offer, in the accompanying notes to consolidated financial
statements in Part I of this report on Form 10-Q, in
July 2007 we consummated a tender offer whereby we repurchased
56,424,155 shares of our common stock at a price of $53.00
per share. |
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Item 4.
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Submission
of Matters to a Vote of Security Holders
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We held our Annual Meeting of Stockholders on May 31, 2007.
The following proposals were voted upon at the meeting:
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(a) |
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A proposal to elect Marijn E. Dekkers, James C. Mullen, and
Bruce R. Ross as directors to serve for a three year term ending
in 2010 and until their successors are duly elected and
qualified was approved with the following results: |
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Director
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For
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Withheld
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Marijn E. Dekkers
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295,847,571
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11,238,219
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James C. Mullen
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295,111,164
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11,974,626
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Bruce R. Ross
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296,088,593
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10,997,197
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(b) |
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A proposal to ratify the selection of PricewaterhouseCoopers LLP
as the Companys independent registered public accounting
firm for the fiscal year ending December 31, 2007 was
approved with 304,259,520 votes for, 1,102,477 votes against,
and 1,723,793 abstentions. There were no broker non-votes for
this proposal. |
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31
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.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
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.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
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.1
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Certification Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002.
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45
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.
BIOGEN IDEC INC.
Peter N. Kellogg
Executive Vice President, Finance and Chief
Financial Officer
July 24, 2007
46