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
September 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
(State or other jurisdiction
of
incorporation or organization)
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33-0112644
(I.R.S. Employer
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,
$0.0005 par value, outstanding as of October 15, 2007,
was 293,369,248 shares.
BIOGEN
IDEC INC.
FORM 10-Q
Quarterly Report
For the Quarterly Period Ended September 30, 2007
TABLE OF
CONTENTS
2
PART I
FINANCIAL INFORMATION
BIOGEN
IDEC INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF INCOME
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2007
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2006
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2007
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2006
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(In thousands, except per share amounts)
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(Unaudited)
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Revenues:
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Product
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$
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529,581
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$
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475,096
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$
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1,532,594
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$
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1,317,696
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Unconsolidated joint business
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234,637
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203,820
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672,391
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593,296
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Other
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25,013
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24,576
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73,332
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63,716
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Total revenues
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789,231
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703,492
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2,278,317
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1,974,708
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Costs and expenses:
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Cost of sales, excluding amortization of acquired intangible
assets
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81,613
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66,792
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247,626
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212,280
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Research and development
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286,274
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211,033
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695,872
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518,910
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Selling, general and administrative
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190,644
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173,442
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582,373
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498,122
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Collaboration profit (loss) sharing
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5,842
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(5,289
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)
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170
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(5,289
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)
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Amortization of acquired intangible assets
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65,689
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60,011
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186,570
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206,978
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Acquired in-process research and development
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29,959
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48,364
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330,520
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Facility impairments and loss (gain) on sale
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175
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(923
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)
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Gain on settlement of license agreement
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(34,192
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)
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Total costs and expenses
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660,021
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506,164
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1,760,975
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1,726,406
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Income from operations
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129,210
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197,328
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517,342
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248,302
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Other income (expense), net
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44,904
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22,319
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98,192
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62,790
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Income before income tax provision and cumulative effect of
accounting change
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174,114
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219,647
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615,534
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311,092
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Income tax expense
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54,733
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63,048
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178,512
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205,916
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Income before cumulative effect of accounting change
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119,381
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156,599
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437,022
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105,176
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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
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$
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119,381
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$
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156,599
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$
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437,022
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$
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108,955
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Basic earnings per share:
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Income before cumulative effect of accounting change
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$
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0.41
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$
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0.46
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$
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1.35
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$
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0.31
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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 per share
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$
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0.41
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$
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0.46
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$
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1.35
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$
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0.32
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Diluted earnings per share:
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Income before cumulative effect of accounting change
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$
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0.41
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$
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0.45
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$
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1.34
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$
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0.30
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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 per share
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$
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0.41
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$
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0.45
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$
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1.34
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$
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0.31
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Weighted-average shares used in calculating:
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Basic earnings per share
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288,958
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338,021
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323,006
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339,527
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Diluted earnings per share
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293,396
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344,754
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326,743
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345,999
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See accompanying notes to the consolidated financial statements.
3
BIOGEN
IDEC INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
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September 30,
|
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December 31,
|
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2007
|
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2006
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|
(In thousands, except
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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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437,326
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$
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661,377
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Marketable securities
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234,021
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241,314
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Accounts receivable, net
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378,807
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317,353
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Due from unconsolidated joint business
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|
161,272
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168,708
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Inventory
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222,857
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169,102
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Other current assets
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|
186,187
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154,713
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|
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Total current assets
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1,620,470
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|
1,712,567
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Marketable securities
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921,994
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1,412,238
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Property, plant and equipment, net
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1,392,577
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1,280,385
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Intangible assets, net
|
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2,562,566
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|
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2,747,241
|
|
Goodwill
|
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|
1,136,858
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1,154,757
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Investments and other assets
|
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|
181,910
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245,620
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Total assets
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$
|
7,816,375
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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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$
|
92,336
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$
|
100,457
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Taxes payable
|
|
|
|
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145,529
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|
Accrued expenses and other
|
|
|
386,295
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|
|
|
336,869
|
|
Current portion of notes payable
|
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1,510,113
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|
|
|
|
|
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|
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Total current liabilities
|
|
|
1,988,744
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|
|
|
582,855
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|
|
|
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Notes payable
|
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|
50,113
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|
|
|
96,694
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|
Long-term deferred tax liability
|
|
|
558,743
|
|
|
|
643,645
|
|
Other long-term liabilities
|
|
|
226,076
|
|
|
|
79,836
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|
|
|
|
|
|
|
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Total liabilities
|
|
|
2,823,676
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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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|
|
|
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|
|
|
Common stock, par value $0.0005 per share
|
|
|
146
|
|
|
|
173
|
|
Additional paid-in capital
|
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|
5,497,506
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|
|
|
8,308,232
|
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Accumulated other comprehensive income
|
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|
48,127
|
|
|
|
21,855
|
|
Accumulated deficit
|
|
|
(553,080
|
)
|
|
|
(860,827
|
)
|
Treasury stock, at cost
|
|
|
|
|
|
|
(319,655
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)
|
|
|
|
|
|
|
|
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|
Total shareholders equity
|
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|
4,992,699
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|
|
|
7,149,778
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|
|
|
|
|
|
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Total liabilities and shareholders equity
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$
|
7,816,375
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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
CONSOLIDATED
STATEMENTS OF CASH FLOWS
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|
|
|
|
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|
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|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
(In thousands)
|
|
|
|
(Unaudited)
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
437,022
|
|
|
$
|
108,955
|
|
Adjustments to reconcile net income to net cash flows from
operating activities Depreciation and amortization of
fixed & intangible assets
|
|
|
278,030
|
|
|
|
288,653
|
|
Acquired in process research & development and license
|
|
|
98,364
|
|
|
|
330,520
|
|
Minority interest of subsidiaries
|
|
|
(25,045
|
)
|
|
|
6,092
|
|
Gain on settlement of license agreement
|
|
|
|
|
|
|
(34,192
|
)
|
Share-based compensation
|
|
|
91,209
|
|
|
|
102,059
|
|
Non-cash interest (income) expense
|
|
|
84
|
|
|
|
623
|
|
Deferred income taxes
|
|
|
(40,366
|
)
|
|
|
(79,777
|
)
|
Realized (gain) loss on sale of marketable securities and
strategic investment
|
|
|
(17,667
|
)
|
|
|
2,420
|
|
Write-down of inventory to net realizable value
|
|
|
19,579
|
|
|
|
12,608
|
|
Facility impairment and (gain) loss on sale, net
|
|
|
|
|
|
|
(923
|
)
|
Impairment of investments and other assets
|
|
|
6,166
|
|
|
|
5,021
|
|
Excess tax benefit from stock options
|
|
|
(31,400
|
)
|
|
|
(12,293
|
)
|
Changes in assets and liabilities, net:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(57,723
|
)
|
|
|
(18,845
|
)
|
Due from unconsolidated joint business
|
|
|
7,436
|
|
|
|
(16,260
|
)
|
Inventory
|
|
|
(70,866
|
)
|
|
|
(22,973
|
)
|
Other assets
|
|
|
(71,257
|
)
|
|
|
3,527
|
|
Accrued expenses and other current liabilities
|
|
|
23,565
|
|
|
|
(77,840
|
)
|
Other liabilities
|
|
|
27,642
|
|
|
|
2,088
|
|
|
|
|
|
|
|
|
|
|
Net cash flows provided by operating activities
|
|
|
674,773
|
|
|
|
599,463
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Purchases of marketable securities
|
|
|
(2,201,518
|
)
|
|
|
(1,597,263
|
)
|
Proceeds from sales and maturities of marketable debt securities
|
|
|
2,702,841
|
|
|
|
1,468,097
|
|
Proceeds from sale of Amevive
|
|
|
|
|
|
|
59,800
|
|
Acquisitions, net of cash acquired
|
|
|
(92,289
|
)
|
|
|
(363,251
|
)
|
Purchases of property, plant and equipment
|
|
|
(175,750
|
)
|
|
|
(133,840
|
)
|
Proceeds from sale of property, plant and equipment
|
|
|
16,812
|
|
|
|
35,942
|
|
Purchases of other investments
|
|
|
(19,522
|
)
|
|
|
(5,580
|
)
|
Proceeds from the sale of a strategic equity investment
|
|
|
99,489
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flows provided by (used in) investing activities
|
|
|
330,063
|
|
|
|
(536,095
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Purchase of common stock
|
|
|
(2,991,183
|
)
|
|
|
(320,268
|
)
|
Proceeds from issuance of stock for share based compensation
arrangements
|
|
|
247,436
|
|
|
|
86,838
|
|
Change in cash overdrafts
|
|
|
(10,215
|
)
|
|
|
(11,145
|
)
|
Excess tax benefit from stock options
|
|
|
31,400
|
|
|
|
12,293
|
|
Proceeds from borrowings
|
|
|
1,512,296
|
|
|
|
15,304
|
|
Repayments of borrowings
|
|
|
(12,042
|
)
|
|
|
|
|
Repayments of long-term debt
|
|
|
(6,563
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash flow used in financing activities
|
|
|
(1,228,871
|
)
|
|
|
(216,978
|
)
|
|
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents
|
|
|
(224,035
|
)
|
|
|
(153,610
|
)
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
(16
|
)
|
|
|
36
|
|
Cash and cash equivalents, beginning of the period
|
|
|
661,377
|
|
|
|
568,168
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of the period
|
|
$
|
437,326
|
|
|
$
|
414,594
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
5
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(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®.
In August 2007, we entered into an agreement to sell the
U.S. marketing, sales, manufacturing and development rights
of
ZEVALIN®
to Cell Therapeutics, Inc., or CTI for an upfront purchase price
of $10.0 million and up to an additional $20.0 million
in milestone payments. In addition, we also will receive royalty
payments on future sales of ZEVALIN. As part of the overall
arrangement, we have entered into a contract with CTI to supply
ZEVALIN product through 2014 and a related services and security
agreement under which CTI has agreed to reimburse us for costs
incurred in an ongoing randomized clinical trial for ZEVALIN
with respect to aggressive non-Hodgkins lymphoma. The
$10.0 million upfront payment will be recognized in our
results of operations over the term of the supply agreement. We
anticipate the sale will close in the fourth quarter of 2007.
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 nine months ended
September 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, 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. As a result of FASB Interpretation No. 46,
Consolidation of Variable Interest Entities, or
FIN 46R, we consolidate variable entities in which we are
the primary beneficiary. For such consolidated entities in which
we own less than a 100% interest, we record minority interest in
other income (expense) for the ownership interest of the
minority owner. All material intercompany balances and
transactions have been eliminated in consolidation.
6
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
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):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Raw materials
|
|
$
|
48.9
|
|
|
$
|
45.7
|
|
Work in process
|
|
|
142.9
|
|
|
|
105.3
|
|
Finished goods
|
|
|
31.1
|
|
|
|
18.1
|
|
|
|
|
|
|
|
|
|
|
Total inventory
|
|
$
|
222.9
|
|
|
$
|
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. As of
September 30, 2007, the approximate value of this product,
based on its original cost of manufacture, is $3.9 million.
As a result, until all of this inventory is sold, we are
recognizing lower than normal cost of sales and, therefore,
higher margins. We expect all of this product to be sold in
2007. For the three and nine months ended September 30,
2007, $4.2 million and $10.0 million, respectively, of
this product was used to fulfill orders. For the three and nine
months ended September 30, 2006, $0.6 million of this
product was used to fulfill orders.
During the three and nine months ended September 30, 2007,
we wrote down $4.7 million and $19.6 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the three and nine months ended
September 30, 2006, we wrote down $0.7 million and
$12.6 million, respectively, in unmarketable inventory,
which was 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.
7
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
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
|
|
|
31.3
|
|
|
|
73.3
|
|
|
|
12.4
|
|
|
|
117.0
|
|
Adjustments relating to sales in prior periods
|
|
|
|
|
|
|
(1.7
|
)
|
|
|
5.2
|
|
|
|
3.5
|
|
Payments/returns relating to sales in current period
|
|
|
(25.1
|
)
|
|
|
(41.7
|
)
|
|
|
(0.1
|
)
|
|
|
(66.9
|
)
|
Payments/returns relating to sales in prior periods
|
|
|
(12.6
|
)
|
|
|
(30.3
|
)
|
|
|
(16.6
|
)
|
|
|
(59.5
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance, September 30, 2007
|
|
$
|
6.3
|
|
|
$
|
30.1
|
|
|
$
|
18.7
|
|
|
$
|
55.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total reserves above were included in the consolidated
balance sheets as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Reduction of accounts receivable
|
|
$
|
29.0
|
|
|
$
|
30.2
|
|
Accrued expenses and other
|
|
|
26.1
|
|
|
|
30.8
|
|
|
|
|
|
|
|
|
|
|
Total reserves and accruals
|
|
$
|
55.1
|
|
|
$
|
61.0
|
|
|
|
|
|
|
|
|
|
|
Reserves for discounts, contractual adjustments and returns
reduced gross product revenues as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
Nine Months Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Discounts
|
|
$
|
10.8
|
|
|
$
|
24.7
|
|
|
$
|
31.3
|
|
|
$
|
77.9
|
|
Contractual adjustments
|
|
|
24.7
|
|
|
|
24.7
|
|
|
|
71.6
|
|
|
|
73.1
|
|
Returns
|
|
|
4.0
|
|
|
|
8.7
|
|
|
|
17.6
|
|
|
|
30.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total allowances
|
|
$
|
39.5
|
|
|
$
|
58.1
|
|
|
$
|
120.5
|
|
|
$
|
181.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross product revenues
|
|
$
|
575.9
|
|
|
$
|
536.7
|
|
|
$
|
1,663.3
|
|
|
$
|
1,504.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of gross product revenues
|
|
|
6.9
|
%
|
|
|
10.8
|
%
|
|
|
7.2
|
%
|
|
|
12.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
8
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
|
|
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 was 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 filed 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.
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 nine months ended September 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 $7.4 million to develop
long-acting Factor IX and an additional $1.3 million to
develop long-acting Factor VIII since the acquisition. We expect
to incur an additional $32.4 million to develop long-acting
Factor IX and an additional $41.2 million to develop
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 recorded 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
9
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
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 nine months ended
September 30, 2007 and 2006 were not material.
Cardiokine
In August 2007, our agreement with Cardiokine Biopharma LLC
became effective. The agreement is for the joint development of
lixivaptan, an oral compound for the potential treatment of
hyponatremia in patients with congestive heart failure expected
to enter a Phase III clinical trial in the fourth quarter
of 2007. We will be responsible for the global commercialization
of lixivaptan and Cardiokine Biopharma LLC has an option for
limited co-promotion in the United States.
Under the terms of the agreement, we paid a $50.0 million
upfront payment and will pay up to $170.0 million in
milestone payments for successful development and global
commercialization of lixivaptan, as well as royalties on
commercial sales. The $50.0 million is reflected as
research and development expense in the accompanying
consolidated statement of income. In accordance with
FIN 46, we have consolidated the results of Cardiokine
Biopharma LLC and recorded an IPR&D charge of approximately
$30 million. The amount allocated to IPR&D reflects
the value ascribed to lixivaptan in excess of the
$50.0 million paid by us, which is attributable to the
minority interest. As such, we have recorded a corresponding
minority interest credit, which is included in other income
(expense). At the effective date of the agreement, this compound
had not reached technological feasibility and had no alternative
future use. Through September 30, 2007, we have spent an
additional $10.3 million to develop lixivaptan since the
agreement became effective. We expect to incur approximately an
additional $260 million to develop lixivaptan for all
indications under development. The estimated revenues from
lixivaptan are expected to be recognized beginning in 2011. A
discount rate of 11% was used to value these projects, which we
believe to be commensurate with the stage of development of
lixivaptan and the uncertainties in the economic estimates
described above.
|
|
5.
|
Intangible
Assets and Goodwill
|
As of September 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 Sept. 30,
|
|
|
|
|
|
|
|
|
As of Dec. 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
|
|
2006
|
|
|
|
|
|
|
Estimated
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
Life
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Out-licensed patents
|
|
|
12 years
|
|
|
$
|
578.0
|
|
|
$
|
(187.0
|
)
|
|
$
|
391.0
|
|
|
$
|
578.0
|
|
|
$
|
(150.9
|
)
|
|
$
|
427.1
|
|
Core/developed technology
|
|
|
15-20 years
|
|
|
|
3,002.5
|
|
|
|
(908.0
|
)
|
|
|
2,094.5
|
|
|
|
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
|
|
|
|
(0.6
|
)
|
|
|
1.5
|
|
|
|
1.4
|
|
|
|
(0.2
|
)
|
|
|
1.2
|
|
Distribution rights
|
|
|
2 years
|
|
|
|
11.6
|
|
|
|
(2.4
|
)
|
|
|
9.2
|
|
|
|
11.1
|
|
|
|
|
|
|
|
11.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
$
|
3,661.2
|
|
|
$
|
(1,098.6
|
)
|
|
$
|
2,562.6
|
|
|
$
|
3,659.0
|
|
|
$
|
(911.8
|
)
|
|
$
|
2,747.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
Indefinite
|
|
|
$
|
1,136.9
|
|
|
$
|
|
|
|
$
|
1,136.9
|
|
|
$
|
1,154.8
|
|
|
$
|
|
|
|
$
|
1,154.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
In the nine months ended September 30, 2007, goodwill
decreased by $17.9 million primarily 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 $65.7 million and
$60.0 million in the three months ended September 30,
2007 and 2006, respectively. Amortization expense was
$186.6 million and $207.0 million for the nine months
ended September 30, 2007 and 2006, respectively.
Marketable
Securities, including Strategic Investments
The following is a summary of marketable securities and
investments (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Fair
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Amortized
|
|
September 30, 2007:
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
Available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$
|
120.2
|
|
|
$
|
0.1
|
|
|
$
|
(0.3
|
)
|
|
$
|
120.4
|
|
Non-current
|
|
|
294.0
|
|
|
|
1.9
|
|
|
|
(0.6
|
)
|
|
|
292.7
|
|
U.S. Government securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
111.4
|
|
|
|
0.1
|
|
|
|
(0.3
|
)
|
|
|
111.6
|
|
Non-current
|
|
|
141.4
|
|
|
|
1.2
|
|
|
|
|
|
|
|
140.2
|
|
Other interest bearing securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
2.5
|
|
|
|
|
|
|
|
|
|
|
|
2.5
|
|
Non-current
|
|
|
486.5
|
|
|
|
2.9
|
|
|
|
(0.7
|
)
|
|
|
484.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale securities
|
|
$
|
1,156.0
|
|
|
$
|
6.2
|
|
|
$
|
(1.9
|
)
|
|
$
|
1,151.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic investments, non-current
|
|
$
|
22.8
|
|
|
$
|
2.1
|
|
|
$
|
(9.1
|
)
|
|
$
|
29.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 nine months ended September 30, 2007, we
recognized $0.7 million and $6.2 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 nine months ended September 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 and strategic investments. 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.
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
|
|
|
Nine Months
|
|
|
|
Ended September 30,
|
|
|
Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Proceeds from maturities and sales
|
|
$
|
293.0
|
|
|
$
|
445.0
|
|
|
$
|
2,702.8
|
|
|
$
|
1,468.1
|
|
Realized gains
|
|
$
|
1.2
|
|
|
$
|
0.6
|
|
|
$
|
3.2
|
|
|
$
|
1.2
|
|
Realized losses
|
|
$
|
0.4
|
|
|
$
|
1.2
|
|
|
$
|
4.2
|
|
|
$
|
3.6
|
|
The amortized cost and estimated fair value of securities
available-for-sale at September 30, 2007 by contractual
maturity are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
Estimated
|
|
|
Amortized
|
|
|
|
Fair Value
|
|
|
Cost
|
|
|
Due in one year or less
|
|
$
|
250.9
|
|
|
$
|
251.3
|
|
Due after one year through five years
|
|
|
421.3
|
|
|
|
418.8
|
|
Mortgage and other asset backed securities
|
|
|
483.8
|
|
|
|
481.6
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,156.0
|
|
|
$
|
1,151.7
|
|
|
|
|
|
|
|
|
|
|
The average maturity of our marketable securities as of
September 30, 2007 and December 31, 2006, was
23 months and 18 months, respectively.
12
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
Strategic
Investments
In the nine months ended September 30, 2007, we recognized
no charges for the impairment of investments that were deemed to
be other than temporary. In June 2007, we sold a portion 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 a gain of
$9.1 million, resulting in a total gain of approximately
$17.2 million in 2007. In the three and nine months ended
September 30, 2006, we recognized $0.6 million and
$5.0 million in charges, respectively, for the impairment
of strategic 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 September 30, 2007, and December 31, 2006, was
$49.7 million and $32.6 million, respectively. These
investments are included in investments and other assets on the
accompanying consolidated balance sheets.
In the three and nine months ended September 30, 2007, we
recorded $0.5 million and $0.9 million, respectively,
in charges for the impairment of investments that were
determined to be other-than-temporary. In the nine months ended
September 30, 2006, we recorded no charges for the
impairment of investments that were determined to be
other-than-temporary.
Forward
Contracts and Other Agreements
We have foreign currency forward contracts to hedge specific
forecasted transactions denominated in foreign currencies. All
foreign currency forward contracts in effect at
September 30, 2007 have durations of 3 to 9 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 September 30, 2007 was
approximately $221.6 million. These contracts had an
aggregate fair value of $11.9 million, representing an
unrealized loss, and were included in other current liabilities
at September 30, 2007. The notional settlement amount of
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 three and nine months ended September 30, 2007,
there was $2.0 million and $2.6 million, respectively,
recognized in earnings as a loss due to hedge ineffectiveness.
In the three and nine months ended September 30, 2006, we
recognized no charge and $0.9 million, respectively, of
losses in earnings due to hedge ineffectiveness. We recognized
$3.8 million and $4.9 million of losses in product
revenue for the settlement of certain effective cash flow hedge
instruments for the three and nine months ended
September 30, 2007, respectively, as compared to
approximately $3.2 million and $6.9 million, of losses
for the three and nine months ended September 30, 2006,
respectively. These settlements were recorded in the same period
as the related forecasted transactions affecting earnings.
13
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
The activity in comprehensive income, net of income taxes, was
as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
|
|
Three Months Ended September 30,
|
|
|
Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Net income
|
|
$
|
119.4
|
|
|
$
|
156.6
|
|
|
$
|
437.0
|
|
|
$
|
109.0
|
|
Translation adjustments
|
|
|
25.8
|
|
|
|
(4.0
|
)
|
|
|
36.9
|
|
|
|
15.5
|
|
Net unrealized gains (losses) on available-for-sale marketable
securities, net of tax of $2.6 million,
($4.8) million, $2.0 million and $10.6 million,
respectively
|
|
|
(4.7
|
)
|
|
|
5.8
|
|
|
|
(3.2
|
)
|
|
|
(17.9
|
)
|
Net unrealized gains (losses) on foreign currency forward
contracts, net of tax of $3.0 million, ($1.7) million,
$4.3 million, and $1.0 million, respectively
|
|
|
(5.1
|
)
|
|
|
2.9
|
|
|
|
(7.4
|
)
|
|
|
(1.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
$
|
135.4
|
|
|
$
|
161.3
|
|
|
$
|
463.3
|
|
|
$
|
105.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings per share are calculated as follows
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
|
|
Three Months Ended September 30,
|
|
|
Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before cumulative effect of accounting change
|
|
$
|
119.4
|
|
|
$
|
156.6
|
|
|
$
|
437.0
|
|
|
$
|
105.2
|
|
Cumulative effect of accounting change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
119.4
|
|
|
|
156.6
|
|
|
|
437.0
|
|
|
|
109.0
|
|
Adjustment for net income allocable to preferred shares
|
|
|
0.2
|
|
|
|
0.2
|
|
|
|
0.6
|
|
|
|
0.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income used in calculating basic and diluted earnings per
share
|
|
$
|
119.2
|
|
|
$
|
156.4
|
|
|
$
|
436.4
|
|
|
$
|
108.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
|
|
|
289.0
|
|
|
|
338.0
|
|
|
|
323.0
|
|
|
|
339.5
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and ESPP
|
|
|
2.7
|
|
|
|
1.7
|
|
|
|
2.1
|
|
|
|
2.1
|
|
Restricted stock units
|
|
|
1.3
|
|
|
|
0.5
|
|
|
|
0.8
|
|
|
|
0.3
|
|
Performance-based restricted stock units
|
|
|
|
|
|
|
0.6
|
|
|
|
0.1
|
|
|
|
0.2
|
|
Restricted stock awards
|
|
|
0.4
|
|
|
|
0.9
|
|
|
|
0.5
|
|
|
|
0.8
|
|
Convertible promissory notes
|
|
|
|
|
|
|
3.1
|
|
|
|
0.2
|
|
|
|
3.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares
|
|
|
4.4
|
|
|
|
6.8
|
|
|
|
3.7
|
|
|
|
6.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted earnings per share
|
|
|
293.4
|
|
|
|
344.8
|
|
|
|
326.7
|
|
|
|
346.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
The following amounts were not included in the calculation of
net income per share because their effects were anti-dilutive
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income allocable to preferred shares
|
|
$
|
(0.2
|
)
|
|
$
|
(0.2
|
)
|
|
$
|
(0.6
|
)
|
|
$
|
(0.2
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
7.6
|
|
|
|
19.3
|
|
|
|
10.5
|
|
|
|
17.7
|
|
Time-vested restricted stock units
|
|
|
0.1
|
|
|
|
1.5
|
|
|
|
0.1
|
|
|
|
|
|
Convertible preferred stock
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
8.2
|
|
|
|
21.3
|
|
|
|
11.1
|
|
|
|
18.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As a result of the tender offer described in Note 15,
Tender Offer, earnings per share for the nine months
ended September 30, 2007 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
accordance with FASB Statement No. 150, Accounting for
Certain Financial Instruments with Characteristics of Both
Liabilities and Equity, or SFAS 150.
In the nine months ended September 30, 2007, we
reclassified amounts within the statement of shareholders
equity on the accompanying consolidated balance sheet resulting
in an approximately $48 million correction in the treasury
stock balance.
In the three months ended September 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
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
|
Effect on
|
|
|
Effect on
|
|
|
|
Net Income
|
|
|
Net Income
|
|
|
Income before income taxes
|
|
$
|
31.8
|
|
|
$
|
37.9
|
|
Tax effect
|
|
|
(9.9
|
)
|
|
|
(12.1
|
)
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
21.9
|
|
|
$
|
25.8
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
0.08
|
|
|
$
|
0.08
|
|
Diluted earnings per share
|
|
$
|
0.07
|
|
|
$
|
0.07
|
|
15
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
In the nine months ended September 30, 2007 and 2006,
share-based compensation expense reduced our results of
operations as follows (in millions, except for earnings per
share):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
|
Nine Months Ended September 30, 2006
|
|
|
|
Ended Sept. 30,
|
|
|
Impact Before
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
Cumulative Effect
|
|
|
Cumulative Effect
|
|
|
|
|
|
|
Effect on
|
|
|
of Accounting
|
|
|
of Accounting
|
|
|
Effect on Net
|
|
|
|
Net Income
|
|
|
Change
|
|
|
Change
|
|
|
Income
|
|
|
Income before income taxes
|
|
$
|
91.2
|
|
|
$
|
107.7
|
|
|
$
|
(5.6
|
)
|
|
$
|
102.1
|
|
Tax effect
|
|
|
(27.8
|
)
|
|
|
(34.0
|
)
|
|
|
1.8
|
|
|
|
(32.2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
63.4
|
|
|
$
|
73.7
|
|
|
$
|
(3.8
|
)
|
|
$
|
69.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
0.20
|
|
|
$
|
0.22
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.21
|
|
Diluted earnings per share
|
|
$
|
0.19
|
|
|
$
|
0.21
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.20
|
|
Share-based compensation expense and cost in the three months
ended September 30, 2007 and 2006 is as follows (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2007
|
|
|
Three Months Ended September 30, 2006
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
Research and development
|
|
$
|
3.5
|
|
|
$
|
9.7
|
|
|
$
|
13.2
|
|
|
$
|
5.3
|
|
|
$
|
9.4
|
|
|
$
|
14.7
|
|
Selling, general and administrative
|
|
|
6.0
|
|
|
|
13.7
|
|
|
|
19.7
|
|
|
|
7.8
|
|
|
|
16.1
|
|
|
|
23.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
9.5
|
|
|
$
|
23.4
|
|
|
$
|
32.9
|
|
|
$
|
13.1
|
|
|
$
|
25.5
|
|
|
$
|
38.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based compensation costs
|
|
|
|
|
|
|
|
|
|
|
(1.1
|
)
|
|
|
|
|
|
|
|
|
|
|
(0.7
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
31.8
|
|
|
|
|
|
|
|
|
|
|
$
|
37.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the nine months ended September 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.
16
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
Share-based compensation expense and cost for the nine months
ended September 30, 2007 and 2006 is as follows (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2007
|
|
|
Nine Months Ended September 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
|
|
$
|
9.5
|
|
|
$
|
27.3
|
|
|
$
|
36.8
|
|
|
$
|
16.7
|
|
|
$
|
26.8
|
|
|
$
|
43.5
|
|
Selling, general and administrative
|
|
|
17.5
|
|
|
|
40.1
|
|
|
$
|
57.6
|
|
|
|
24.6
|
|
|
|
42.0
|
|
|
|
66.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
27.0
|
|
|
$
|
67.4
|
|
|
$
|
94.4
|
|
|
$
|
41.3
|
|
|
$
|
68.8
|
|
|
$
|
110.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax cumulative effect
catch-up
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-tax effect of share-based compensation
|
|
|
|
|
|
|
|
|
|
$
|
94.4
|
|
|
|
|
|
|
|
|
|
|
$
|
104.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based compensation costs
|
|
|
|
|
|
|
|
|
|
|
(3.2
|
)
|
|
|
|
|
|
|
|
|
|
|
(2.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
91.2
|
|
|
|
|
|
|
|
|
|
|
$
|
102.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 at 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 at an exercise price of $44.24 per
share.
The fair value of the stock option grants awarded in the nine
months ended September 30, 2007 and 2006 was estimated as
of the date of grant using a Black-Scholes option valuation
model that uses the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
|
|
Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
Expected dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Expected stock price volatility
|
|
|
33.6
|
%
|
|
|
34.8
|
%
|
Risk-free interest rate
|
|
|
4.50
|
%
|
|
|
4.38
|
%
|
Expected option life in years
|
|
|
4.87
|
|
|
|
4.87
|
|
Per share grant-date fair value
|
|
$
|
18.36
|
|
|
$
|
16.88
|
|
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.
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
17
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
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 September 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
nine months ended September 30, 2007 and 2006,
0.4 million and 0.4 million shares, respectively, were
issued under the ESPP. In the three months ended
September 30, 2007 and 2006, we recorded compensation
charges of approximately $2.4 million and
$2.2 million, respectively, of stock compensation charges
related to the ESPP. In the nine months ended September 30,
2007 and 2006, we recorded compensation charges of approximately
$3.6 million and $7.0 million, respectively, of stock
compensation charges related to the ESPP.
Tax
Rate
Our effective tax rate was 31.4% on pre-tax income for the three
months ended September 30, 2007, compared to 28.7% for the
comparable period in 2006. Our effective tax rate was 29.0% on
pre-tax income for the nine months ended September 30,
2007, compared to 66.2% 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 nine months ended
September 30, 2007 and 2006, respectively, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Statutory Rate
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
State Taxes
|
|
|
4.1
|
|
|
|
1.6
|
|
|
|
2.5
|
|
|
|
3.5
|
|
Foreign Taxes
|
|
|
(7.7
|
)
|
|
|
(7.8
|
)
|
|
|
(7.7
|
)
|
|
|
(13.4
|
)
|
Credits and net operating loss utilization
|
|
|
(2.3
|
)
|
|
|
|
|
|
|
(2.5
|
)
|
|
|
(0.3
|
)
|
Other
|
|
|
(0.6
|
)
|
|
|
(1.1
|
)
|
|
|
(2.6
|
)
|
|
|
1.1
|
|
Fair Value Adjustment
|
|
|
3.0
|
|
|
|
1.0
|
|
|
|
3.1
|
|
|
|
7.0
|
|
IPR&D
|
|
|
(0.1
|
)
|
|
|
|
|
|
|
1.2
|
|
|
|
37.2
|
|
Gain on Settlement of Fumapharm License Agreement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3.9
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.4
|
%
|
|
|
28.7
|
%
|
|
|
29.0
|
%
|
|
|
66.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
18
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
We believe that we have meritorious defenses to the proposed
adjustment and will vigorously oppose the assessment. 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
|
|
|
16.2
|
|
Additions for tax positions of prior periods
|
|
|
72.4
|
|
Reductions for tax positions of prior periods
|
|
|
(69.6
|
)
|
Settlements
|
|
|
(18.7
|
)
|
|
|
|
|
|
Balance at September 30, 2007
|
|
$
|
197.1
|
|
|
|
|
|
|
Included in the balance of unrecognized tax benefits at
September 30, 2007 and January 1, 2007, are
$101.0 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 September 30, 2007 and 2006, we
recognized approximately $4.1 million and $2.5 million
in interest. During the nine months ended September 30,
2007 and 2006, we recognized approximately $10.2 million
and $7.7 million in interest. We had accrued approximately
$27.2 million and $20.3 million for the payment of
interest at September 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 Internal Revenue Service,
or 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 in its liabilities for income tax
contingencies 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.
19
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
|
|
11.
|
Other
Income (Expense), Net
|
Total other income (expense), net, consists of the following (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Interest income
|
|
$
|
18.8
|
|
|
$
|
26.0
|
|
|
$
|
80.1
|
|
|
$
|
75.7
|
|
Minority interest
|
|
|
29.0
|
|
|
|
(2.0
|
)
|
|
|
25.0
|
|
|
|
(6.1
|
)
|
Interest expense
|
|
|
(19.6
|
)
|
|
|
(0.1
|
)
|
|
|
(21.9
|
)
|
|
|
(0.5
|
)
|
Other net
|
|
|
16.7
|
|
|
|
(1.6
|
)
|
|
|
15.0
|
|
|
|
(6.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
$
|
44.9
|
|
|
$
|
22.3
|
|
|
$
|
98.2
|
|
|
$
|
62.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2007, the principal
components of other net, were gain on sale of land
($7.1 million), net realized gain on sales of strategic
investments ($11.0 million) and gains on foreign currency
($3.0 million), offset by realized losses on hedge
ineffectiveness ($2.0 million). In the three months ended
September 30, 2006, the principal components of other net,
were loss on foreign currency ($0.7 million) and realized
losses on sales of marketable securities ($0.7 million).
In the nine months ended September 30, 2007, the principal
components of other net, were gain on sale of land
($7.1 million), and net realized gains on sales of our
strategic investments ($19.0 million) offset by net
realized losses on sales of marketable securities
($7.1 million). In the nine months ended September 30,
2006, the principal components of other net, were legal
settlements ($4.0 million), realized losses on marketable
securities ($2.4 million), impairment charges on strategic
investments ($4.5 million), and hedge ineffectiveness
($1.0 million), offset by gains on foreign currency
($4.7 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 former
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 September 14, 2007, the District Court
Judge entered an Order allowing the Motions to Dismiss of all
defendants. On September 28, 2007, the plaintiffs filed a
Motion for Clarification of the Courts Order Allowing
Defendants Motion to Dismiss, in which they seek leave to
amend their complaint. On October 15, 2007, the plaintiffs
filed a notice of appeal to the United States Court of Appeals
for the First Circuit. We
20
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
believe that the motion and appeal are without merit and intend
to contest them vigorously. At this 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
whether the Committee will request additional information in the
future, but at the present time we consider this matter to be
closed.
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 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 joined in the amended Consolidated Complaint on
June 8, 2007. On September 17, 2007, the County of
Erie, County of Oswego and County of Schenectady cases were
remanded to state court in New York.
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 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. On April 2, 2007, the
defendants joint motion to dismiss the original
Consolidated Complaint and the County of Nassaus second
amended complaint were granted in part, but certain claims
against Biogen Idec remained. Biogen Idecs individual
motion to dismiss these complaints remains pending. Biogen Idec
intends to defend itself vigorously against all of the remaining
allegations and claims in all of 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,
21
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
2007, is 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 July 24, 2007, the
District Court granted Biogen Idecs motion to dismiss 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. Certain of plaintiffs claims
against Genentech are still pending. On August 14, 2007,
the plaintiff filed a motion requesting that the Court allow the
plaintiff to file an interlocutory appeal of the granting of
Biogen Idecs motion to dismiss. The court denied the
motion on October 22, 2007. 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. 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,
22
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
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. On
March 7, 2007, we filed our brief in response. The Court of
Appeals held oral argument on 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):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Current portion:
|
|
|
|
|
|
|
|
|
Term loan facility
|
|
$
|
1,500.0
|
|
|
$
|
|
|
20-year
subordinated convertible promissory notes, due 2019 at 5.5%
|
|
|
0.2
|
|
|
|
|
|
Note payable to Fumedica
|
|
|
9.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,510.1
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
Note payable to Fumedica
|
|
|
33.0
|
|
|
|
39.2
|
|
Credit line from Dompé
|
|
|
17.1
|
|
|
|
11.9
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
50.1
|
|
|
$
|
96.7
|
|
|
|
|
|
|
|
|
|
|
In June 2007, we 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. As of September 30, 2007, there were
no borrowings under this credit facility.
In June 2007, in connection with the tender offer described in
Note 15 Tender Offer, we entered into a
$1,500.0 million term loan facility. The term loan facility
has a term of 364 days and bears interest at a rate of
LIBOR plus 45 basis points, which was 5.52% at
September 30, 2007. On July 2, 2007, in connection
with the funding of the tender offer, we borrowed the full
$1,500.0 million under this facility.
23
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Continued)
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.
In January and July 2007, we issued from Treasury Stock
2.8 million and 0.2 million shares of common stock,
respectively, to the holders of our 2019 subordinated notes that
had elected to convert into our common stock. These conversions
represented $70.5 million and $4.5 million in face
value and $36.6 million and $2.4 million in carrying
value, respectively.
On June 27, 2007, pursuant to the terms of a modified
Dutch Auction tender offer, we accepted for payment
56,424,155 shares of our common stock at a price of $53.00
per share for a purchase price of $2,990.5 million. 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 was recognized as interest expense.
We funded the tender offer through existing cash and cash
equivalents of $1,490.5 million and $1,500.0 million
borrowed under our term loan facility as described in
Note 14, Indebtedness. We retired all of these
shares in July 2007. In connection with this retirement, in
accordance with our policy, we recorded an approximately
$2,991 million reduction in treasury stock and additional
paid-in-capital.
|
|
16.
|
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 us to choose to measure many financial instruments and
certain other items at fair value. It also 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. The Statement is effective January 1, 2008
for the company. We do not expect the implementation of
SFAS 157 to have a material impact on our financial
statements.
On June 27, 2007,
EITF 07-3
Accounting for Nonrefundable Advance Payments for Goods or
Services Received for Use in Future Research and Development
Activities, or
EITF 07-3,
was issued.
EITF 07-3
provides that nonrefundable advance payments made for goods or
services to be used in future research and development
activities should be deferred and capitalized until such time as
the related goods or services are delivered or are performed, at
which point the amounts would be recognized as an expense. This
standard is effective for new contracts entered into after
January 1, 2008. We are currently evaluating the potential
impact, if any, this standard will have on our financial
statements.
On October 12, 2007, we announced that our Board of
Directors had authorized management to evaluate whether third
parties would have an interest in acquiring the Company at a
price and on terms that would represent a better value for our
stockholders than having the Company continue to execute its
strategy on a stand-alone basis. This process has required that
we engage professional advisors to assist in reviewing and
evaluating transaction proposals and advising our Board of
Directors and management with respect thereto. We do not intend
to disclose further information regarding the status of this
evaluation until the process has been completed. We emphasize
that there can be no assurance that an acquisition of the
Company will occur.
24
|
|
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, our current evaluation of a potential acquisition of
the Company, 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, liquidity
and capital resources, 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 quarterly 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); and,
|
|
|
|
FUMADERM®
(dimethylfumarate and monoethylfumarate salts);
|
|
|
|
ZEVALIN®
(ibritumomab tiuxetan) In August 2007, as described below, we
entered into an agreement to sell the rights to market, sell,
manufacture and develop ZEVALIN in the United States to Cell
Therapeutics, Inc., or CTI. We expect this agreement to close in
the fourth quarter of 2007.
|
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 nine months of 2007 included total revenue
of $2,278.3 million, net income of $437.0 million and
diluted net income per share of $1.34. 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
personnel to support the re-launch of TYSABRI and AVONEX sales.
In August 2007, we entered into an agreement to sell the
U.S. marketing, sales, manufacturing and development rights
of
ZEVALIN®
to CTI for an upfront purchase price of $10.0 million and
up to an additional $20.0 million in milestone payments. In
addition, we will receive royalty payments on future sales of
ZEVALIN. As part of the overall arrangement, we entered into a
supply agreement with CTI to sell
25
ZEVALIN product through 2014 and a services and security
agreement under which CTI has agreed to reimburse us for costs
incurred in an ongoing randomized clinical trial for ZEVALIN
with respect to aggressive non-Hodgkins lymphoma. The
$10.0 million upfront payment will be recognized in our
results of operations over the term of the supply agreement. We
expect this agreement to close in the fourth quarter of 2007.
In August 2007, an agreement with Cardiokine Biopharma LLC
became effective under which we paid a $50.0 million
upfront fee that we recorded as research and development expense
and will pay up to an additional $170.0 million if certain
milestones are met. In accordance with FIN 46R, we recorded
a charge for acquired in-process research and development, or
IPR&D, of approximately $30 million pursuant to this
transaction offset by a corresponding credit to minority
interest. The amount allocated to IPR&D reflects the value
ascribed to lixivaptan in excess of the $50.0 million paid
by us.
In July 2007 we completed a tender offer in which we purchased
56,424,155 shares of our common stock for a purchase price
of $2,990.5 million. We funded the transaction in July 2007
through the liquidation of $1,490.5 million of cash and
marketable securities and obtaining a term loan for
$1,500.0 million. We retired all of these shares in July
2007.
In January 2007, we completed the acquisition of 100% of the
stock of Syntonix Pharmaceuticals, Inc. for total initial
consideration of $44.4 million, which is subject to
increase to as much as $124.4 million if certain milestones
are achieved. The financial statement impact resulting from the
purchase included recognition of a charge for IPR&D of
$18.4 million.
Results
of Operations
Revenues
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Product sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
297.4
|
|
|
|
37.7
|
%
|
|
$
|
288.8
|
|
|
|
41.0
|
%
|
|
$
|
883.8
|
|
|
|
38.8
|
%
|
|
$
|
795.3
|
|
|
|
40.3
|
%
|
Rest of world
|
|
|
232.2
|
|
|
|
29.4
|
%
|
|
|
186.3
|
|
|
|
26.5
|
%
|
|
|
648.8
|
|
|
|
28.5
|
%
|
|
|
522.4
|
|
|
|
26.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
|
529.6
|
|
|
|
67.1
|
%
|
|
|
475.1
|
|
|
|
67.5
|
%
|
|
|
1,532.6
|
|
|
|
67.3
|
%
|
|
|
1,317.7
|
|
|
|
66.7
|
%
|
Unconsolidated joint business
|
|
|
234.6
|
|
|
|
29.7
|
%
|
|
|
203.8
|
|
|
|
29.0
|
%
|
|
|
672.4
|
|
|
|
29.5
|
%
|
|
|
593.3
|
|
|
|
30.0
|
%
|
Royalties
|
|
|
23.5
|
|
|
|
3.0
|
%
|
|
|
21.9
|
|
|
|
3.1
|
%
|
|
|
69.2
|
|
|
|
3.0
|
%
|
|
|
60.7
|
|
|
|
3.1
|
%
|
Corporate partner
|
|
|
1.5
|
|
|
|
0.2
|
%
|
|
|
2.7
|
|
|
|
0.4
|
%
|
|
|
4.1
|
|
|
|
0.2
|
%
|
|
|
3.0
|
|
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
789.2
|
|
|
|
100
|
%
|
|
$
|
703.5
|
|
|
|
100
|
%
|
|
$
|
2,278.3
|
|
|
|
100
|
%
|
|
$
|
1,974.7
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Revenues (in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
AVONEX
|
|
$
|
454.9
|
|
|
|
85.9
|
%
|
|
$
|
445.2
|
|
|
|
93.7
|
%
|
|
$
|
1,365.4
|
|
|
|
89.1
|
%
|
|
$
|
1,268.0
|
|
|
|
96.2
|
%
|
TYSABRI
|
|
|
62.9
|
|
|
|
11.9
|
%
|
|
|
18.7
|
|
|
|
3.9
|
%
|
|
|
140.2
|
|
|
|
9.1
|
%
|
|
|
18.3
|
|
|
|
1.4
|
%
|
FUMADERM
|
|
|
7.4
|
|
|
|
1.4
|
%
|
|
|
6.4
|
|
|
|
1.4
|
%
|
|
|
12.5
|
|
|
|
0.8
|
%
|
|
|
6.4
|
|
|
|
0.5
|
%
|
ZEVALIN
|
|
|
4.4
|
|
|
|
0.8
|
%
|
|
|
4.4
|
|
|
|
0.9
|
%
|
|
|
14.2
|
|
|
|
0.9
|
%
|
|
|
13.9
|
|
|
|
1.1
|
%
|
AMEVIVE
|
|
|
|
|
|
|
|
%
|
|
|
0.4
|
|
|
|
0.1
|
%
|
|
|
0.3
|
|
|
|
0.1
|
%
|
|
|
11.1
|
|
|
|
0.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues
|
|
$
|
529.6
|
|
|
|
100
|
%
|
|
$
|
475.1
|
|
|
|
100
|
%
|
|
$
|
1,532.6
|
|
|
|
100
|
%
|
|
$
|
1,317.7
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26
Cost
of Sales, excluding Amortization of Intangibles (in
millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Cost of product revenues
|
|
$
|
80.6
|
|
|
|
98.8
|
%
|
|
$
|
65.7
|
|
|
|
98.4
|
%
|
|
$
|
244.6
|
|
|
|
98.8
|
%
|
|
$
|
209.2
|
|
|
|
98.5
|
%
|
Cost of royalty revenues
|
|
|
1.0
|
|
|
|
1.2
|
%
|
|
|
1.1
|
|
|
|
1.6
|
%
|
|
|
3.0
|
|
|
|
1.2
|
%
|
|
|
3.1
|
|
|
|
1.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, excluding amortization of intangibles
|
|
$
|
81.6
|
|
|
|
100
|
%
|
|
$
|
66.8
|
|
|
|
100
|
%
|
|
$
|
247.6
|
|
|
|
100
|
%
|
|
$
|
212.3
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three and nine months ended September 30, 2007,
we wrote-down $4.7 million and $19.6 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the three and nine months ended
September 30, 2006, we wrote-down $0.7 million and
$12.6 million, respectively, in unmarketable inventory,
which was also charged to cost of sales.
AVONEX
Revenues from AVONEX in the three and nine months ended
September 30, 2007 and 2006 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
AVONEX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S
|
|
$
|
266.4
|
|
|
|
58.6
|
%
|
|
$
|
268.3
|
|
|
|
60.3
|
%
|
|
$
|
806.1
|
|
|
|
59.0
|
%
|
|
$
|
761.0
|
|
|
|
60.0
|
%
|
Rest of World
|
|
|
188.5
|
|
|
|
41.4
|
%
|
|
|
176.9
|
|
|
|
39.7
|
%
|
|
|
559.3
|
|
|
|
41.0
|
%
|
|
|
507.0
|
|
|
|
40.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total AVONEX revenues
|
|
$
|
454.9
|
|
|
|
100
|
%
|
|
$
|
445.2
|
|
|
|
100
|
%
|
|
$
|
1,365.4
|
|
|
|
100
|
%
|
|
$
|
1,268.0
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2007, compared to
the three months ended September 30, 2006, U.S. sales
of AVONEX decreased $1.9 million, or 0.7%, principally due
to decreased product demand resulting in lower volume, offset by
the impact of a price increase in August 2007. In the nine
months ended September 30, 2007, compared to the nine
months ended September 30, 2006, U.S. sales of AVONEX
increased $45.1 million, or 5.9%, principally due to the
impact of price increases offset by decreased product demand
resulting in lower volume.
In the three months ended September 30, 2007, compared to
the three months ended September 30, 2006, international
sales of AVONEX increased $11.6 million, or 6.6%, due to
the impact of exchange rates. In the nine months ended
September 30, 2007, compared to the nine months ended
September 30, 2006, international sales of AVONEX increased
$52.3 million, or 10.3%, 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.
27
TYSABRI
Revenues from TYSABRI for the three and nine months ended
September 30, 2007 and 2006 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
TYSABRI
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S
|
|
$
|
28.1
|
|
|
|
44.7
|
%
|
|
$
|
15.9
|
|
|
|
85.0
|
%
|
|
$
|
67.4
|
|
|
|
48.1
|
%
|
|
$
|
15.5
|
|
|
|
84.7
|
%
|
Rest of World
|
|
|
34.8
|
|
|
|
55.3
|
%
|
|
|
2.8
|
|
|
|
15.0
|
%
|
|
|
72.8
|
|
|
|
51.9
|
%
|
|
|
2.8
|
|
|
|
15.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total TYSABRI revenues
|
|
$
|
62.9
|
|
|
|
100
|
%
|
|
$
|
18.7
|
|
|
|
100
|
%
|
|
$
|
140.2
|
|
|
|
100
|
%
|
|
$
|
18.3
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In July 2006, we began to ship TYSABRI in both the U.S. and
Europe in connection with the re-launch.
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 September 30, 2007,
the approximate value of this product, based on its original
cost of manufacture, is $3.9 million. As a result, until
all of this inventory is sold, we are recognizing lower than
normal cost of sales and therefore, higher margins. We expect
all of this product to be sold in 2007. For the three and nine
months ended September 30, 2007, $4.2 million and
$10.0 million of this product, respectively, was used to
fulfill orders. For the three and nine months ended
September 30, 2006, $0.6 million of this product,
respectively, was used to fulfill orders.
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. For the three months ended
September 30, 2006, we recognized $6.4 million of
sales of FUMADERM. 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 resumed recognizing revenue on sales of FUMADERM into
the German market in May 2007. For the three and nine months
ended September 30, 2007, we recognized $7.4 million
and $12.5 million of sales of FUMADERM, respectively.
ZEVALIN
In the three months ended September 30, 2007, compared to
the three months ended September 30, 2006, sales of ZEVALIN
were unchanged. In the nine months ended September 30,
2007, compared to the nine months ended September 30, 2006,
sales of ZEVALIN increased 2.2%, due to higher international
sales offset by lower domestic sales. In August 2007 we entered
into an agreement to sell the rights to market, sell,
manufacture and develop ZEVALIN in the United States to CTI. We
expect this agreement to close in the fourth quarter of 2007.
28
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
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Copromotion profits
|
|
$
|
156.3
|
|
|
$
|
138.6
|
|
|
$
|
446.3
|
|
|
$
|
405.6
|
|
Reimbursement of selling and development expenses
|
|
|
15.3
|
|
|
|
13.7
|
|
|
|
44.4
|
|
|
|
45.7
|
|
Royalty revenue on sales of RITUXAN outside the U.S
|
|
|
63.0
|
|
|
|
51.5
|
|
|
|
181.7
|
|
|
|
142.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
234.6
|
|
|
$
|
203.8
|
|
|
$
|
672.4
|
|
|
$
|
593.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits consist of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Product revenues, net
|
|
$
|
572.4
|
|
|
$
|
508.9
|
|
|
$
|
1,689.2
|
|
|
$
|
1,511.2
|
|
Costs and expenses
|
|
|
181.6
|
|
|
|
162.4
|
|
|
|
560.9
|
|
|
|
484.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits
|
|
$
|
390.8
|
|
|
$
|
346.5
|
|
|
$
|
1,128.3
|
|
|
$
|
1,026.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biogen Idecs share of copromotion profits
|
|
$
|
156.3
|
|
|
$
|
138.6
|
|
|
$
|
446.3
|
|
|
$
|
405.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended September 30, 2007, compared to
the three months ended September 30, 2006, our share of
copromotion profits increased $17.7 million, or 12.8%, due,
principally, to higher sales of RITUXAN. For the nine months
ended September 30, 2007, compared to the nine months ended
September 30, 2006, our share of copromotion profits
increased $40.7 million, or 10.0%, due, principally, to
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 September 30, 2007, compared to
the three months ended September 30, 2006, royalty revenue
on sales of RITUXAN outside the U.S. increased
$11.5 million, or 22.3%, due, principally, to increased
sales outside the U.S., reflecting greater market penetration.
For the nine months ended September 30, 2007, compared to
the nine months ended September 30, 2006, royalty revenue
on sales of RITUXAN outside the U.S. increased
$39.7 million, or 28.0%, due, principally, to increased
sales outside the U.S. reflecting greater market
penetration.
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
|
|
Copromotion Operating Profits
|
|
Profits
|
|
|
First $50 million
|
|
|
30
|
%
|
Greater than $50 million
|
|
|
40
|
%
|
29
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:
|
|
|
|
|
|
|
|
|
|
|
Biogen Idecs
|
|
|
|
|
|
Share of
|
|
|
|
New Anti-CD20 U.S.
|
|
Copromotion
|
|
Copromotion Operating Profits
|
|
Gross Product Sales
|
|
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.
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.
30
Other
Revenue
Other revenue for the three and nine months ended
September 30, 2007 and 2006 was as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
Royalties
|
|
$
|
23.5
|
|
|
|
94.0
|
%
|
|
$
|
21.9
|
|
|
|
89.0
|
%
|
|
$
|
69.2
|
|
|
|
94.4
|
%
|
|
$
|
60.7
|
|
|
|
95.3
|
%
|
Corporate partner
|
|
|
1.5
|
|
|
|
6.0
|
%
|
|
|
2.7
|
|
|
|
11.0
|
%
|
|
|
4.1
|
|
|
|
5.6
|
%
|
|
|
3.0
|
|
|
|
4.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenue
|
|
$
|
25.0
|
|
|
|
100
|
%
|
|
$
|
24.6
|
|
|
|
100
|
%
|
|
$
|
73.3
|
|
|
|
100
|
%
|
|
$
|
63.7
|
|
|
|
100
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2007, compared to
the three months ended September 30, 2006, royalties
increased $1.6 million, or 7.3%. Increased royalties of
$7.0 million, primarily related to increased sales of
products licensed by The Medicines Company and Bayer BioScience,
were off-set by a $5.4 million decrease in royalties
primarily due to the expiration of license agreements with
Shionogi and Genetics Institute.
In the nine months ended September 30, 2007, compared to
the nine months ended September 30, 2006, royalties
increased $8.5 million, or 14.0%. Increased royalties of
$15.8 million, primarily related to increased sales of
products licensed by The Medicines Company, Bayer BioScience,
and Merck, were off-set by a $7.3 million decrease in
royalties primarily due to the expiration of license agreements
with Shionogi and Genetics Institute and a reduction in
royalties from Schering-Plough due to a lower royalty rate in
effect during the period.
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 $286.3 million
and $211.0 million in the three months ended
September 30, 2007 and 2006, respectively, an increase of
$75.3 million, or 35.7%. The increase reflects,
principally, approximately $60 million of expense for the
development of lixivaptan (including a $50.0 million
upfront payment to Cardiokine Biopharma LLC), a
$36.2 million increase in clinical trial activity (notably
Anti-CD23, Anti-CD80, LTBR, HSP90, M200, Adentri, Tysabri, and
BG-12), and $4.6 million of research and development costs
related to Syntonix, offset by the upfront $30 million
payment to UCB made in 2006.
Research and development expenses totaled $695.9 million
and $518.9 million in the nine months ended
September 30, 2007 and 2006, respectively, an increase of
$177.0 million, or 34.1%. The increase reflects,
principally, approximately $60 million of expense for the
development of lixivaptan (including a $50.0 million
upfront payment to Cardiokine Biopharma LLC), a
$92.8 million increase in clinical trial activity (notably
BG-12, Anti-CD23, Anti-CD80, LTBR, HSP90, Adentri, Tysabri, M200
and projects with Sunesis), a $30.0 million increase due to
increased manufacturing of molecules for clinical supply
(notably Anti-CD23 and IGF-1R), and $12.0 million of
research and development costs related to Syntonix, offset by
the upfront $30 million payment to UCB made in 2006.
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 nine months ended September 30, 2007, we recorded an
acquired IPR&D charge of $18.4 million related to the
acquisition of Syntonix and approximately $30 million
related to our collaboration with Cardiokine Biopharma LLC. See
Note 4 of the consolidated financial statements,
Acquisitions and Collaboration Agreements, 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
$1.5 million
31
for Fumapharm and $12.2 million for Conforma. In the nine
months ended September 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 $12.0 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
$190.6 million and $173.4 million in the three months
ended September 30, 2007 and 2006, respectively, an
increase of $17.2 million, or 9.9%. The increase reflects,
principally, a $16.3 million increase in sales and
marketing activities for TYSABRI, primarily in international
sales and marketing, a $6.2 million increase in salaries
and benefits related to increased headcount in general and
administrative personnel, offset by a $2.7 million decrease
in sales and marketing activities for ZEVALIN due to decreased
commercial efforts due to the planned divestiture of this
product line.
Selling, general and administrative expenses totaled
$582.4 million and $498.1 million in the nine months
ended September 30, 2007 and 2006, respectively, an
increase of $84.3 million, or 16.9%. The increase reflects,
principally, a $52.9 million increase in sales and
marketing activities for TYSABRI, primarily in international
sales and marketing, a $20.3 million increase in salaries
and benefits related to increased headcount in general and
administrative personnel, and a $18.1 million increase in
fees and services related to general and administrative expense.
These increases were offset by a $8.1 million decrease in
sales and marketing activities related to ZEVALIN resulting from
decreased commercial efforts due to the planned divestiture of
this product line.
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 $65.7 million for
the three months ended September 30, 2007 compared to
$60.0 million in the comparable period in 2006, an increase
of $5.7 million, or 9.5%. Amortization of intangible assets
totaled $186.6 million for the nine months ended
September 30, 2007 compared to $207.0 million in the
comparable period in 2006, a decrease of $20.4 million, or
9.9%. These changes are due, principally to the timing of
changes 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 quarters of
2007 and 2006.
Income
Tax Provision
Tax
Rate
Our effective tax rate was 31.4% on pre-tax income for the three
months ended September 30, 2007, compared to 28.7% for the
comparable period in 2006. Our effective tax rate was 29.0% on
pre-tax income for the nine months ended September 30,
2007, compared to 66.2% for the comparable period in 2006. The
change in the effective tax rate for the nine months ended
September 30, 2007, is primarily attributable to the prior
year non deductible acquisition-related IPR&D.
32
Liquidity
and Capital Resources
Financial
Condition
Our financial condition is summarized as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2007
|
|
|
2006
|
|
|
Cash and cash equivalents
|
|
$
|
437.3
|
|
|
$
|
661.4
|
|
Marketable securities current and non-current
|
|
|
1,156.0
|
|
|
|
1,653.5
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and marketable securities
|
|
$
|
1,593.3
|
|
|
$
|
2,314.9
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$
|
(368.3
|
)
|
|
$
|
1,129.7
|
|
Outstanding borrowings current and non-current
|
|
$
|
1,560.2
|
|
|
$
|
96.7
|
|
The decline in cash and investments at September 30, 2007
as compared to December 31, 2006, primarily reflects
payments made to fund our tender offer as discussed in
Note 15, Tender Offer, offset by cash generated
from operations.
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 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.
See Part II, Item 1A, Risk Factors of this
form 10-Q
for risk factors that could negatively impact our cash position
and ability to fund future operations.
Operating
activities
Cash provided by operating activities is primarily driven by our
net income. On an ongoing basis, we expect cash provided from
operating activities will continue to be our primary source of
funds to finance operating needs and capital expenditures. Cash
provided by operations was $674.8 million and
$599.5 million in the nine months ended September 30,
2007 and 2006, respectively. The increase is due to higher
earnings, offset by lower non-cash charges and a higher
investment in working capital. A principal component of
non-cash
charges for the nine months ended September 30, 2007 was
acquired in-process research and development and licenses of
$18.4 million relating to our acquisition of Syntonix and
approximately $80 million relating to our collaboration
with Cardiokine Biopharma LLC. The principal component of
non-cash charges for the nine months ended September 30,
2006 was acquired in-process research and development of
$330.5 million relating to our acquisitions of Fumapharm
and Conforma.
Investing
activities
Cash provided by investing activities was $330.1 million
compared to cash used in investing activities of
$536.1 million in the nine months ended September 30,
2007 and 2006, respectively. The increase in cash provided by
investing activities primarily reflects the sale of marketable
securities to fund the tender offer described in Note 15,
Tender Offer. Purchases of plant, property, and
equipment totaled $175.8 million in the nine months ended
September 30, 2007 as compared to $133.8 million in
the nine months ended September 30, 2006. Payments made for
acquisitions and licenses were $92.3 million in 2007, which
related to our acquisition of Syntonix and agreement with
Cardiokine Biopharma LLC, and $363.3 million in 2006, which
related to our acquisitions of Fumapharm and Conforma.
Additionally, in 2007 we sold our position in a strategic equity
investment for $99.5 million.
33
Financing
activities
Cash used in financing activities in the nine months ended
September 30, 2007 was $1,228.9 million compared to
cash used of $217.0 million in the nine months ended
September 30, 2006. The increase was due, principally, to
the purchase of common stock via tender offer of
$3.0 billion, which was partially funded with cash proceeds
from a loan facility of $1.5 billion. This transaction is
more fully described in Note 15, Tender Offer.
Additionally, we received proceeds of $247.4 million
relating to the exercise of stock options.
Borrowings
At September 30, 2007, we have a note payable of
approximately $42.9 million relating to the acquisition of
distribution rights of FUMADERM. Additionally, one of our
international joint ventures maintains a loan that has a
carrying value of $17.1 million as of September 30,
2007.
In July 2007, we issued 0.2 million shares of common stock
for $4.5 million in face value and $2.4 million in
carrying value of our 2019 subordinated notes to the holders
that elected to convert into common stock.
In June 2007, in connection with the tender offer described in
Note 15, Tender Offer, we entered into a
$1.5 billion term loan facility, which is due in June 2008.
The loan has an effective interest rate of 5.52%. On
July 2, 2007, in connection with the funding of the tender
offer, we borrowed the full $1.5 billion available under
this facility.
In June 2007, we also entered into a five year $400 million
Senior Unsecured Revolving Credit Facility, which we may use for
working capital and general corporate purposes. As of
September 30, 2007, there were no borrowings outstanding
under this credit facility. The terms of this revolving credit
facility include various covenants, including financial
covenants that require us to meet a maximum leverage ratio and
under certain circumstances, an interest coverage ratio. As of
September 30, 2007, we were in compliance with these
covenants.
Tender
Offer
On June 27, 2007, pursuant to the terms of a modified
Dutch Auction tender offer, we accepted for payment
56,424,155 shares of our common stock at a price of $53.00
per share for a purchase price of $2,990.5 million. We
funded the tender offer through existing cash and cash
equivalents of $1,490.5 million and $1,500.0 million
in funding by our term loan facility as described in
Note 14, Indebtedness. All of the shares
repurchased were retired in July 2007.
Working
capital
At September 30, 2007, our working capital was
$(368.3) million, as compared to $1,129.7 million at
December 31, 2006, a decrease of $1,498.0 million.
This primarily reflects use of cash and cash equivalents and our
term loan facility of $1,500.0 million used to finance a
portion of the tender offer.
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. We also determined
that we would no longer proceed with the fill-finish component
of that facility. Additionally, we added a labeling and
packaging component to the project. As of September 30,
2007, we have substantially completed this phase of the project.
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
September 30, 2007, we had committed approximately
$203 million to the second phase, of which
$72.3 million had been paid.
34
The second phase of the project is expected to be ready for
commercial production in 2009.
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 August 2007, our agreement with Cardiokine Biopharma, LLC
became effective. The agreement is for the joint development of
lixivaptan, an oral compound expected to enter a Phase III
clinical trial in the fourth quarter of 2007 for the potential
treatment of hyponatremia in patients with congestive heart
failure. Under the terms of the agreement, we paid a
$50.0 million upfront payment in the third quarter 2007,
and may pay up to $170.0 million in potential milestone
payments for successful development and global commercialization
of lixivaptan, as well as royalties for commercial sales.
As announced on October 12, 2007, our Board of Directors
has authorized management to evaluate whether third parties
would have an interest in acquiring the Company at a price and
on terms that would represent better value for its stockholders
than having the Company continue to execute its strategy on a
stand-alone basis. The process has required that we engage
professional advisors to assist in reviewing and evaluating
transaction proposals that may be received and advising our
Board of Directors and management with respect thereto.
Share
Repurchase Program
In the nine months ended September 30, 2007, we did not
repurchase any shares of our common stock under our share
repurchase program that our Board of Directors authorized in
October 2006. See Note 15 for a discussion of our tender
offer.
Contractual
Obligations and Off-Balance Sheet Arrangements
The disclosure of payments we have committed to make under our
contractual obligations is set forth under the heading
Contractual Obligations and Off-Balance Sheet
Arrangements as included in Item 7 Managements
Discussion and Analysis of Financial Condition and Results of
Operation in our 2007
Form 10-K.
Excluding the items noted Borrowings and
Commitments above, there have been no material
changes to our contractual obligations since December 31,
2006.
We have funding commitments as of September 30, 2007 up to
approximately $32 million as part of our investment in
biotechnology oriented venture capital funds. In addition, we
have committed to make potential future milestone payments to
third-parties as part of our various collaborations including
licensing and development programs. Payments under these
agreements generally become due and payable only upon
achievement of certain developmental, regulatory
and/or
commercial milestones. Because the achievement of these
milestones had not occurred as of September 30, 2007, such
contingencies have not been recorded in our financial statements.
We do not have any significant relationships with 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. We
consolidate entites falling within the scope of FIN 46(R)
if we are deemed to be the primary beneficiary.
35
Legal
Matters
Refer to Note 12 of the consolidated financial statements
in Part I of this quarterly report on
Form 10-Q,
Litigation, for a discussion of legal matters as of
September 30, 2007.
New
Accounting Standards
Refer to Note 16 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.
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 $3.3 million increase in our deferred tax
liability.
A reconciliation of the beginning and ending amount of
unrecognized tax benefits is as follows (in millions):
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Balance at January 1, 2007
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$
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196.8
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Additions based on tax positions related to the current period
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16.2
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Additions for tax positions of prior periods
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72.4
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Reductions for tax positions of prior periods
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(69.6
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)
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Settlements
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(18.7
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Balance at September 30, 2007
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$
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197.1
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Included in the balance of unrecognized tax benefits at
September 30, 2007 and January 1, 2007, are
$101.0 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.
36
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Item 3.
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Quantitative
and Qualitative Disclosures about Market Risk
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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 nine 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 September 30, 2007. Based
upon that evaluation, our principal executive officer and
principal financial officer concluded that, as of
September 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
September 30, 2007 that have materially affected, or are
reasonably likely to materially affect, our internal control
over financial reporting.
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
quarterly 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 and approximately 89% of our total revenues for
the nine months ended September 30, 2007. 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.
37
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.
The
outcome of our current evaluation of a potential acquisition of
the Company by a third party is uncertain and this process
entails numerous risks and uncertainties
Our Board of Directors has authorized management to evaluate
whether third parties would have an interest in acquiring the
Company at a price and on terms that would represent better
value for its stockholders than having the Company continue to
execute its strategy on a stand-alone basis. The evaluation
process entails numerous risks and uncertainties, including the
following:
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the process is time-consuming and may disrupt our operations and
divert managements and our employees attention;
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perceived uncertainties as to our future direction may result in
the loss of, or our inability to attract and retain, key
employees or business partners;
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the rights of Genentech and Elan to buy from us certain rights
to RITUXAN and TYSABRI in the event we undergo a change of
control (as more fully described below in the fourth bullet
point to the last risk factor on page 47 of this
Form 10-Q)
may limit our attractiveness to potential acquirers;
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our announcement that we are engaged in the evaluation process
and any announcement that we may make regarding the results of
the evaluation process may increase the volatility of the market
price of our common stock;
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the process will increase expenditures for professional advisors
that we engage to assist in reviewing and evaluating transaction
proposals that may be received and advising our Board of
Directors and management with respect thereto; and
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38
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we may not be able to identify in the near term an acquisition
transaction that our Board of Directors determines is the best
means reasonably available to achieve and enhance stockholder
value, as compared to other alternatives available to the
Company, including continuing to execute our current stand-alone
strategy.
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The Company does not intend to disclose further information
regarding the status of its evaluation until the process has
been completed and there can be no assurance that an acquisition
of the Company will occur.
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. 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.
If we are not successful in growing sales of TYSABRI, that 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
39
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 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
40
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.
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
41
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. 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
42
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 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
In August 2004, we restarted construction of our large-scale
biologic manufacturing facility in Hillerod, Denmark. As of
September 30, 2007, we have substantially completed the
first phase of the project.
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
September 30, 2007, we had committed approximately
$203 million to the second phase of the project, of which
$72.3 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.
43
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.
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.
44
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.
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
46
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
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47
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 months
ended September 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
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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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Paid per Share
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Announced Program
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Purchased Under Our
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Period
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(#)
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($)
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(#)(a)
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Program (#)(a)
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Jul-07
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56,424,155
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(c)
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$
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53.00
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20,000,000
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1,231
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(b)
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54.76
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20,000,000
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Sep-07
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12,897
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(b)
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66.53
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20,000,000
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Total
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56,438,283
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$
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53.00
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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. No
purchases have been made under this plan. We publicly announced
the repurchase program in our press release dated
October 31, 2006, which was furnished to the SEC as
Exhibit 99.1 of our Current Report on
Form 8-K
filed on October 31, 2006. |
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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 15, 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 announced on
May 29, 2007 whereby we repurchased 56,424,155 shares
of our common stock at a price of $53.00 per share. |
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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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48
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.
Paul J. Clancy
Executive Vice President and Chief
Financial Officer
October 23, 2007
49