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, 2008
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OR
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Commission File Number 0-19311
BIOGEN IDEC INC.
(Exact name of registrant as
specified in its charter)
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Delaware
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33-0112644
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(State or other jurisdiction
of
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(I.R.S. Employer
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incorporation or
organization)
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Identification
No.)
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14 Cambridge Center, Cambridge, MA 02142
(617) 679-2000
(Address, including zip code,
and telephone number, including
area code, of registrants principal executive
offices)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days: Yes þ No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of
large accelerated filer, accelerated
filer and smaller reporting company in
Rule 12b-2
of the Exchange Act. (Check one):
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Large
accelerated
filer þ
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Accelerated
filer o
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Non-accelerated
filer o
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Smaller
reporting
company o
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(Do
not check if a smaller reporting company)
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,
$0.0005 par value, outstanding as of October 16, 2008,
was 291,752,825 shares.
BIOGEN
IDEC INC.
FORM 10-Q
Quarterly Report
For the Quarterly Period Ended September 30, 2008
TABLE OF
CONTENTS
2
PART I
FINANCIAL INFORMATION
BIOGEN
IDEC INC. AND SUBSIDIARIES
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2008
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2007
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2008
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2007
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In thousands, except per share amounts
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(Unaudited)
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Revenues:
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Product
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$
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758,260
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$
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529,581
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$
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2,107,816
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$
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1,532,594
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Unconsolidated joint business
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298,979
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234,637
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825,024
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672,391
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Other revenues
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35,725
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25,013
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95,754
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73,332
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Total revenues
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1,092,964
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789,231
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3,028,594
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2,278,317
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Costs and expenses:
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Cost of sales, excluding amortization of acquired intangible
assets
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107,493
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81,613
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300,828
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247,626
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Research and development
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268,800
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286,274
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779,291
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695,872
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Selling, general and administrative
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232,824
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190,644
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694,342
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582,373
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Collaboration profit (loss) sharing
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43,533
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5,842
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98,368
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170
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Amortization of acquired intangible assets
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94,464
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65,689
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242,114
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186,570
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In-process research and development
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29,959
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25,000
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48,364
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Total costs and expenses
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747,114
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660,021
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2,139,943
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1,760,975
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Income from operations
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345,850
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129,210
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888,651
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517,342
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Other income (expense), net
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(24,725
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)
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44,904
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(29,818
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)
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98,192
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Income before income tax expense
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321,125
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174,114
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858,833
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615,534
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Income tax expense
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114,337
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54,733
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282,320
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178,512
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Net income
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$
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206,788
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$
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119,381
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$
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576,513
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$
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437,022
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Basic earnings per share
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$
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0.71
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$
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0.41
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$
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1.97
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$
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1.35
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Diluted earnings per share
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$
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0.70
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$
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0.41
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$
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1.95
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$
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1.34
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Weighted-average shares used in calculating:
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Basic earnings per share
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291,408
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288,958
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292,613
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323,006
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Diluted earnings per share
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293,921
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293,396
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295,515
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326,743
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See accompanying notes to the consolidated financial statements.
3
BIOGEN
IDEC INC. AND SUBSIDIARIES
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September 30,
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December 31,
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2008
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2007
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(In thousands, except per
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share amounts)
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(Unaudited)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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1,010,701
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$
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659,662
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Marketable securities
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217,127
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319,408
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Cash collateral received for loaned securities
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178,129
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208,209
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Accounts receivable, net
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484,636
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392,646
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Due from unconsolidated joint business
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196,542
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166,686
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Loaned securities
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158,971
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204,433
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Inventory
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249,858
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233,987
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Other current assets
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143,116
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183,376
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Total current assets
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2,639,080
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2,368,407
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Marketable securities
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717,182
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932,271
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Property, plant and equipment, net
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1,579,938
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1,497,383
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Intangible assets, net
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2,250,766
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2,492,354
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Goodwill
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1,137,547
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1,137,372
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Investments and other assets
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210,695
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201,028
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Total assets
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$
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8,535,208
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$
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8,628,815
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LIABILITIES AND SHAREHOLDERS EQUITY
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Current liabilities:
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Collateral payable on loaned securities
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$
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178,129
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$
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208,209
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Accounts payable
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123,512
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90,672
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Taxes payable
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176,753
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11,274
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Accrued expenses and other
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497,263
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367,885
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Current portion of notes payable
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10,215
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1,511,135
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Total current liabilities
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985,872
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2,189,175
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Notes payable
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1,042,427
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51,843
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Long-term deferred tax liability
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440,164
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521,525
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Other long-term liabilities
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298,267
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331,977
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Total liabilities
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2,766,730
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3,094,520
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Commitments and contingencies (Notes 11 and 13)
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Shareholders equity:
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Preferred stock, par value $0.001 per share
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Common stock, par value $0.0005 per share
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149
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147
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Additional paid-in capital
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6,029,111
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5,807,071
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Accumulated other comprehensive income
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33,431
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79,246
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Retained Earnings (Accumulated deficit)
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75,361
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(352,169
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Treasury stock, at cost
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(369,574
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Total shareholders equity
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5,768,478
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5,534,295
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Total liabilities and shareholders equity
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$
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8,535,208
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$
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8,628,815
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See accompanying notes to the consolidated financial statements.
4
BIOGEN
IDEC INC. AND SUBSIDIARIES
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Nine Months Ended
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September 30,
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2008
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2007
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(In thousands)
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(Unaudited)
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Cash flows from operating activities:
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Net income
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$
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576,513
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$
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437,022
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Adjustments to reconcile net income to net cash flows from
operating activities Depreciation and amortization of
fixed & intangible assets
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340,042
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278,030
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In-process research & development
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25,000
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98,364
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Minority interest in subsidiaries
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5,167
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(25,045
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Share-based compensation
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104,339
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91,209
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Non-cash interest expense
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(11,288
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)
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84
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Deferred income taxes
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(57,591
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)
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(40,366
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)
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Realized loss (gain) on sale of marketable securities and
strategic investments
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3,774
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(17,667
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Write-down of inventory to net realizable value
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22,472
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19,579
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Impairment of investments and other assets
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31,502
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6,166
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Excess tax benefit from stock options
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(27,424
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)
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(31,400
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)
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Changes in assets and liabilities, net:
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Accounts receivable
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(95,337
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)
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(57,723
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)
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Due from unconsolidated joint business
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(29,856
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)
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7,436
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Inventory
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(34,376
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)
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(70,866
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)
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Other assets
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24,898
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(71,257
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)
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Accrued expenses and other current liabilities
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155,437
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42,311
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Other liabilities and taxes payable
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121,928
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8,896
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Net cash flows provided by operating activities
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1,155,200
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674,773
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Cash flows from investing activities:
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Purchases of marketable securities
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(1,801,056
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)
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(2,201,518
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)
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Proceeds from sales and maturities of marketable debt securities
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2,135,065
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2,702,841
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Collateral received under securities lending
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30,080
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Acquisitions, net of cash acquired
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(25,000
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)
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(92,289
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)
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Purchases of property, plant and equipment
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(221,961
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)
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(175,750
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)
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Proceeds from sale of property, plant, and equipment
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16
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16,812
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Purchases of other investments
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(17,260
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)
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(19,522
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)
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Proceeds from the sale of a strategic equity investment
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99,489
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Net cash flows provided by investing activities
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99,884
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|
330,063
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Cash flows from financing activities:
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Purchase of treasury stock
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(559,767
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)
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(2,991,183
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)
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Proceeds from issuance of stock for share based compensation
arrangements
|
|
|
167,032
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|
|
|
247,436
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Change in cash overdrafts
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|
|
18,052
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|
|
|
(10,215
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)
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Excess tax benefit from stock options
|
|
|
27,424
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|
|
|
31,400
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Proceeds from borrowings, net of discounts and expenses
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|
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986,980
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|
|
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1,512,296
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Repayments of borrowings
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(1,512,474
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)
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|
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(12,042
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)
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Obligations under securities lending
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|
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(30,080
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)
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|
|
|
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Repayment of long-term debt
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|
|
|
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(6,563
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)
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|
|
|
|
|
|
|
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|
Net cash flow (used in) provided by financing activities
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|
|
(902,833
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)
|
|
|
(1,228,871
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)
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|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
352,251
|
|
|
|
(224,035
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)
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
(1,212
|
)
|
|
|
(16
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)
|
Cash and cash equivalents, beginning of the period
|
|
|
659,662
|
|
|
|
661,377
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of the period
|
|
$
|
1,010,701
|
|
|
$
|
437,326
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the consolidated financial statements.
5
BIOGEN
IDEC INC. AND SUBSIDIARIES
(Unaudited)
Overview
Biogen Idec Inc. is a global biotechnology company that creates
new standards of care in therapeutic areas of high unmet medical
needs. We currently have four marketed products:
AVONEX®,
RITUXAN®,
TYSABRI®
and
FUMADERM®.
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, 2007. Our accounting
policies are described in the Notes to the Consolidated
Financial Statements in our 2007 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, but does not include 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, 2008 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.
In 2008, we reclassified amounts within the shareholders
equity section, resulting in an approximately $78 million
correction to Additional Paid-in Capital and Accumulated
Deficit, in connection with the reporting of the re-issuance of
treasury stock at a loss.
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. In accordance with FASB
Interpretation No. 46, Consolidation of Variable
Interest Entities, or FIN 46(R), we consolidate
variable interest 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 our
statement of income and our balance sheet for the ownership
interest of the minority owner. All material intercompany
balances and transactions have been eliminated in consolidation.
Inventories are stated at the lower of cost or market with cost
determined under the
first-in,
first-out, or FIFO, method. Included in inventory are raw
materials used in the production of pre-clinical and clinical
products, which are charged to research and development expense
when consumed.
6
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The components of inventory are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Raw materials
|
|
$
|
34.2
|
|
|
$
|
46.4
|
|
Work in process
|
|
|
168.8
|
|
|
|
155.4
|
|
Finished goods
|
|
|
46.9
|
|
|
|
32.2
|
|
|
|
|
|
|
|
|
|
|
Total inventory
|
|
$
|
249.9
|
|
|
$
|
234.0
|
|
|
|
|
|
|
|
|
|
|
During the three months ended September 30, 2008 and 2007,
we wrote down $12.6 million and $4.7 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the nine months ended September 30,
2008 and 2007, we wrote down $22.5 million and
$19.6 million, respectively, in unmarketable inventory,
which was charged to cost of sales.
During 2007, we had TYSABRI product on hand that had been
written down in 2005 due to the uncertainties surrounding the
TYSABRI suspension, but which was subsequently used to fill
orders in 2007. As a result, in 2007, we recognized lower than
normal cost of sales and, therefore, higher margins on our sales
of TYSABRI. For the three and nine months ended
September 30, 2007, cost of sales was approximately
$4.2 million and $10.0 million lower, respectively,
due to the sale of TYSABRI inventory that had been written down.
All TYSABRI inventory that had been previously written down was
shipped prior to December 31, 2007.
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; title and risk of loss
have passed to the customer; the sellers price to the
buyer is fixed or determinable; and collectibility is reasonably
assured.
Revenues from product sales are recognized when the criteria
described above have all been met, which is typically upon
delivery. However, 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.
Discounts
and Allowances
Revenues are recorded net of applicable allowances for
discounts, contractual adjustments and returns.
We establish reserves for these allowances and discounts, which
include trade term discounts and wholesaler incentives,
contractual adjustments, which include Medicaid rebates,
Veterans Administration rebates, managed care rebates and
other applicable allowances and product returns, which include
returns made by wholesalers. Such reserves are classified as
reductions of accounts receivable if the amount is payable to a
customer and has the effect of reducing the amount they are
required to pay us or as a liability if the amount is payable to
a party other than a customer.
7
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
An analysis of the amount of, and change in, reserves is as
follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual
|
|
|
|
|
|
|
|
|
|
Discounts
|
|
|
Adjustments
|
|
|
Returns
|
|
|
Total
|
|
|
Beginning balance, January 1, 2008
|
|
$
|
6.4
|
|
|
$
|
33.1
|
|
|
$
|
20.4
|
|
|
$
|
59.9
|
|
Current provisions relating to sales in current period
|
|
|
46.5
|
|
|
|
113.9
|
|
|
|
14.4
|
|
|
|
174.8
|
|
Adjustments relating to sales in prior periods
|
|
|
|
|
|
|
(1.6
|
)
|
|
|
|
|
|
|
(1.6
|
)
|
Payments/returns relating to sales in current period
|
|
|
(38.2
|
)
|
|
|
(64.7
|
)
|
|
|
|
|
|
|
(102.9
|
)
|
Payments/returns relating to sales in prior periods
|
|
|
(6.5
|
)
|
|
|
(33.1
|
)
|
|
|
(11.7
|
)
|
|
|
(51.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance, September 30, 2008
|
|
$
|
8.2
|
|
|
$
|
47.6
|
|
|
$
|
23.1
|
|
|
$
|
78.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total reserves above were included in the consolidated
balance sheets as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Reduction of accounts receivable
|
|
$
|
34.7
|
|
|
$
|
28.5
|
|
Accrued expenses and other
|
|
|
44.2
|
|
|
|
31.4
|
|
|
|
|
|
|
|
|
|
|
Total reserves
|
|
$
|
78.9
|
|
|
$
|
59.9
|
|
|
|
|
|
|
|
|
|
|
Reserves for discounts, contractual adjustments and returns
reduced gross product revenues as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Discounts
|
|
$
|
16.2
|
|
|
$
|
10.8
|
|
|
$
|
46.5
|
|
|
$
|
31.3
|
|
Contractual adjustments
|
|
|
40.1
|
|
|
|
24.7
|
|
|
|
112.3
|
|
|
|
71.6
|
|
Returns
|
|
|
5.9
|
|
|
|
4.0
|
|
|
|
14.4
|
|
|
|
17.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total allowances
|
|
$
|
62.2
|
|
|
$
|
39.5
|
|
|
$
|
173.2
|
|
|
$
|
120.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross product revenues
|
|
$
|
820.5
|
|
|
$
|
575.9
|
|
|
$
|
2,281.0
|
|
|
$
|
1,663.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of gross product revenues
|
|
|
7.6
|
%
|
|
|
6.9
|
%
|
|
|
7.6
|
%
|
|
|
7.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
|
Intangible
Assets and Goodwill
|
As of September 30, 2008 and December 31, 2007,
intangible assets and goodwill, net of accumulated amortization,
impairment charges and adjustments, are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30,
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
Estimated
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
Life
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Out-licensed patents
|
|
|
12 years
|
|
|
$
|
578.0
|
|
|
$
|
(238.0
|
)
|
|
$
|
340.0
|
|
|
$
|
578.0
|
|
|
$
|
(199.1
|
)
|
|
$
|
378.9
|
|
Core/developed technology
|
|
|
15-20 years
|
|
|
|
3,003.7
|
|
|
|
(1,163.5
|
)
|
|
|
1,840.2
|
|
|
|
3,003.0
|
|
|
|
(965.2
|
)
|
|
|
2,037.8
|
|
Trademarks & tradenames
|
|
|
Indefinite
|
|
|
|
64.0
|
|
|
|
|
|
|
|
64.0
|
|
|
|
64.0
|
|
|
|
|
|
|
|
64.0
|
|
In-licensed patents
|
|
|
14 years
|
|
|
|
3.0
|
|
|
|
(0.9
|
)
|
|
|
2.1
|
|
|
|
3.0
|
|
|
|
(0.7
|
)
|
|
|
2.3
|
|
Assembled workforce
|
|
|
4 years
|
|
|
|
2.1
|
|
|
|
(1.1
|
)
|
|
|
1.0
|
|
|
|
2.1
|
|
|
|
(0.7
|
)
|
|
|
1.4
|
|
Distribution rights
|
|
|
2 years
|
|
|
|
12.1
|
|
|
|
(8.6
|
)
|
|
|
3.5
|
|
|
|
11.8
|
|
|
|
(3.8
|
)
|
|
|
8.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
|
|
|
|
$
|
3,662.9
|
|
|
$
|
(1,412.1
|
)
|
|
$
|
2,250.8
|
|
|
$
|
3,661.9
|
|
|
$
|
(1,169.5
|
)
|
|
$
|
2,492.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
Indefinite
|
|
|
$
|
1,137.5
|
|
|
$
|
|
|
|
$
|
1,137.5
|
|
|
$
|
1,137.4
|
|
|
$
|
|
|
|
$
|
1,137.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense was $94.5 million and
$65.7 million in the three months ended September 30,
2008 and 2007, respectively. Amortization expense was
$242.1 million and $186.6 million in the nine months
ended September 30, 2008 and 2007, respectively. In the
first quarter of 2008, we recorded $25.0 million of
in-process research and development (IPR&D) charges related
to an HSP-90 related milestone payment made to the former
shareholders of Conforma Therapeutics, Inc., or Conforma,
pursuant to our acquisition of Conforma in 2006.
|
|
5.
|
Fair
Value Measurements
|
Effective January 1, 2008, we implemented Statement of
Financial Accounting Standard No. 157, Fair Value
Measurement, or SFAS 157, for our financial assets and
liabilities that are re-measured and reported at fair value at
each reporting period, and non-financial assets and liabilities
that are re-measured and reported at fair value at least
annually. In accordance with the provisions of FSP
No. FAS 157-2,
Effective Date of FASB Statement No. 157, we have
elected to defer implementation of SFAS 157 as it relates
to our non-financial assets and non-financial liabilities that
are recognized and disclosed at fair value in the financial
statements on a nonrecurring basis until January 1, 2009.
We are evaluating the impact, if any, this Standard will have on
our non-financial assets and liabilities.
The adoption of SFAS 157 for financial assets and
liabilities that are re-measured and reported at fair value at
least annually did not have an impact on our financial results.
9
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following tables present information about our assets and
liabilities that are measured at fair value on a recurring basis
as of September 30, 2008, and indicates the fair value
hierarchy of the valuation techniques we utilized to determine
such fair value. In general, fair values determined by
Level 1 inputs utilize quoted prices (unadjusted) in active
markets for identical assets or liabilities. Fair values
determined by Level 2 inputs utilize data points that are
observable such as quoted prices, interest rates and yield
curves. Fair values determined by Level 3 inputs are
unobservable data points for the asset or liability, and
includes situations where there is little, if any, market
activity for the asset or liability (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant
|
|
|
|
Balance at
|
|
|
Quoted Prices in
|
|
|
Significant Other
|
|
|
Unobservable
|
|
|
|
September 30,
|
|
|
Active Markets
|
|
|
Observable Inputs
|
|
|
Inputs
|
|
Description
|
|
2008
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
$
|
908.7
|
|
|
$
|
|
|
|
$
|
908.7
|
|
|
$
|
|
|
Marketable debt securities
|
|
|
1,093.3
|
|
|
|
|
|
|
|
1,093.3
|
|
|
|
|
|
Strategic investments
|
|
|
6.3
|
|
|
|
6.3
|
|
|
|
|
|
|
|
|
|
Venture capital investments
|
|
|
28.4
|
|
|
|
|
|
|
|
|
|
|
|
28.4
|
|
Derivative contracts
|
|
|
8.3
|
|
|
|
|
|
|
|
8.3
|
|
|
|
|
|
Plan assets for deferred compensation
|
|
|
14.1
|
|
|
|
|
|
|
|
14.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2,059.1
|
|
|
$
|
6.3
|
|
|
$
|
2,024.4
|
|
|
$
|
28.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative contracts
|
|
|
1.9
|
|
|
|
|
|
|
|
1.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1.9
|
|
|
$
|
|
|
|
$
|
1.9
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The fair values of our cash equivalents, marketable debt
securities, plan assets and derivative instruments are
determined through market, observable and corroborated sources.
Our strategic investments are investments in publicly traded
equity securities where fair value is readily determinable.
The following table is a roll forward of the fair value of our
venture capital investments, where fair value is determined by
Level 3 inputs (in millions):
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2008
|
|
Description
|
|
Fair Value
|
|
|
Fair Value
|
|
|
Beginning Balance
|
|
$
|
24.6
|
|
|
$
|
28.1
|
|
Total net unrealized gains (losses) included in earnings
|
|
|
2.2
|
|
|
|
(2.6
|
)
|
Purchases, issuances, and settlements
|
|
|
1.6
|
|
|
|
2.9
|
|
|
|
|
|
|
|
|
|
|
Ending Balance
|
|
$
|
28.4
|
|
|
$
|
28.4
|
|
|
|
|
|
|
|
|
|
|
The carrying value of the venture capital investments reflect
changes in the fair value of the underlying funds net
assets, which is calculated by employing various market, income
and cost approaches to determine fair value at each measurement
date. Gains and losses (realized and unrealized) included in
earnings for the period are reported in other income (expense),
net.
10
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Marketable
Securities, including Strategic Investments
The following is a summary of marketable securities and
investments (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Fair
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Amortized
|
|
September 30, 2008:
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
Available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$
|
98.8
|
|
|
$
|
0.1
|
|
|
$
|
|
|
|
$
|
98.7
|
|
Non-current
|
|
|
234.3
|
|
|
|
1.5
|
|
|
|
(0.1
|
)
|
|
|
232.9
|
|
U.S. Government securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
118.0
|
|
|
|
0.3
|
|
|
|
|
|
|
|
117.7
|
|
Non-current
|
|
|
218.1
|
|
|
|
3.0
|
|
|
|
|
|
|
|
215.1
|
|
Other interest bearing securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
55.6
|
|
|
|
|
|
|
|
|
|
|
|
55.6
|
|
Non-current
|
|
|
368.5
|
|
|
|
2.8
|
|
|
|
(0.4
|
)
|
|
|
366.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale securities
|
|
$
|
1,093.3
|
|
|
$
|
7.7
|
|
|
$
|
(0.5
|
)
|
|
$
|
1,086.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic investments, non-current
|
|
$
|
6.3
|
|
|
$
|
0.1
|
|
|
$
|
(0.4
|
)
|
|
$
|
6.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
Gross
|
|
|
|
|
|
|
Fair
|
|
|
Unrealized
|
|
|
Unrealized
|
|
|
Amortized
|
|
December 31, 2007:
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
Available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$
|
178.3
|
|
|
$
|
0.2
|
|
|
$
|
(0.3
|
)
|
|
$
|
178.4
|
|
Non-current
|
|
|
309.7
|
|
|
|
3.5
|
|
|
|
(0.1
|
)
|
|
|
306.3
|
|
U.S. Government securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
192.5
|
|
|
|
0.2
|
|
|
|
(0.1
|
)
|
|
|
192.4
|
|
Non-current
|
|
|
232.5
|
|
|
|
4.7
|
|
|
|
|
|
|
|
227.8
|
|
Other interest bearing securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
6.1
|
|
|
|
|
|
|
|
|
|
|
|
6.1
|
|
Non-current
|
|
|
537.0
|
|
|
|
5.2
|
|
|
|
(0.5
|
)
|
|
|
532.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale securities
|
|
$
|
1,456.1
|
|
|
$
|
13.8
|
|
|
$
|
(1.0
|
)
|
|
|
1,443.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic investments, non-current
|
|
$
|
16.8
|
|
|
$
|
2.9
|
|
|
$
|
(0.1
|
)
|
|
$
|
14.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The table above includes securities we loan from our portfolio
to other institutions, as described below.
In the three months ended September 30, 2008 and 2007, we
recognized $14.1 million and $0.7 million in
impairment charges primarily related to mortgage and asset
backed securities classified as available-for-sale securities.
In the nine months ended September 30, 2008 and 2007, we
recognized $19.3 million and $6.2 million in
impairment charges primarily related to mortgage and asset
backed securities classified as available-for-sale securities.
11
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Unrealized losses relate to various debt securities, including
U.S. Government issues, corporate bonds and asset-backed
securities and strategic investments. We believe that these
unrealized losses are temporary. 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
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Proceeds from maturities and sales
|
|
$
|
743.2
|
|
|
$
|
293.0
|
|
|
$
|
2,135.1
|
|
|
$
|
2,702.8
|
|
Realized gains
|
|
$
|
0.9
|
|
|
$
|
1.2
|
|
|
$
|
11.6
|
|
|
$
|
3.2
|
|
Realized losses
|
|
$
|
10.6
|
|
|
$
|
0.4
|
|
|
$
|
15.4
|
|
|
$
|
4.2
|
|
The realized losses for the three and nine months ended
September 30, 2008 primarily relate to losses on the sale
of corporate debt securities.
The amortized cost and estimated fair value of securities
available-for-sale at September 30, 2008 by contractual
maturity are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
Estimated
|
|
|
Amortized
|
|
|
|
Fair Value
|
|
|
Cost
|
|
|
Due in one year or less
|
|
$
|
266.4
|
|
|
$
|
265.9
|
|
Due after one year through five years
|
|
|
458.4
|
|
|
|
454.0
|
|
Mortgage and other asset backed securities
|
|
|
368.5
|
|
|
|
366.2
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,093.3
|
|
|
$
|
1,086.1
|
|
|
|
|
|
|
|
|
|
|
The average maturity of our marketable securities as of
September 30, 2008 and December 31, 2007, was
13 months and 15 months, respectively.
Certain commercial paper and short-term debt securities with
original maturities of less than 90 days are included in
cash and cash equivalents on the accompanying balance sheet and
are not included in the table above. The commercial paper,
including accrued interest, has a fair and carrying value of
$268.6 million and $368.2 million and short-term debt
securities has a fair and carrying value of $640.1 million
and $195.1 million at September 30, 2008 and
December 31, 2007, respectively.
Strategic
Investments
We hold investments in equity securities of certain publicly
traded companies. In the three and nine months ended
September 30, 2008, we recognized $2.5 million and
$6.1 million, respectively, in charges for the impairment
of strategic investments that were deemed to be
other-than-temporary. In the nine months ended
September 30, 2007, we recognized no charges 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 and biotechnology oriented venture
capital investments. The carrying value of these investments as
of September 30, 2008 and December 31, 2007, was
$67.9 million and $52.4 million, respectively. These
investments are included in investments and other assets on the
accompanying consolidated balance sheets.
In the three months ended September 30, 2008, we recorded
$2.2 million in unrealized gains due to increases in the
fair value of the investments and $0.3 million in charges
for the impairment of investments
12
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
that were determined to be other-than-temporary. In the nine
months ended September 30, 2008, we recorded
$2.6 million in unrealized losses due to declines in the
fair value of the investments and $1.3 million in charges
for the impairment of investments that were determined to be
other-than-temporary. In the three and nine months ended
September 30, 2007, we recorded $0.5 million and
$0.9 million in impairment losses.
Securities
Lending
We loan certain securities from our portfolio to other
institutions. Such securities are classified as loaned
securities on the accompanying consolidated balance sheet.
Collateral for the loaned securities, consisting of cash or
other assets, is maintained at a rate of approximately 102% of
the market value of each loaned security. We held cash as
collateral in the amount of $178.1 million and
$208.2 million as of September 30, 2008 and
December 31, 2007, respectively. The cash collateral is
recorded as cash collateral received for loaned securities on
the consolidated balance sheet. We have a current obligation to
return the collateral, which is reflected as collateral payable
on loaned securities on the accompanying consolidated balance
sheet. Income received from lending securities is recorded in
other income (expense), net.
Forward
Contracts and Interest Rate Swaps
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, 2008 have durations of one to nine 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 accumulated 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), net.
The notional settlement amount of the foreign currency forward
contracts outstanding at September 30, 2008 was
approximately $132.8 million. These contracts had an
aggregate fair value of $5.7 million, representing an
unrealized gain, and were included in other current assets at
September 30, 2008. The notional settlement amount of the
foreign currency forward contracts outstanding at
December 31, 2007 was approximately $409.2 million.
These contracts had an aggregate fair value of
$6.4 million, representing an unrealized loss, and were
included in other current liabilities at December 31, 2007.
For our foreign currency forward contracts, in the three and
nine months ended September 30, 2008, there was
$1.3 million and $2.4 million, respectively,
recognized in earnings as a loss due to hedge ineffectiveness.
In the three and nine months ended September 30, 2007,
there was $2.0 million and $2.6 million recognized in
earnings as a loss due to hedge ineffectiveness. We recognized
$2.3 million and $20.0 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, 2008 as compared to $3.8 million and
$4.9 million in product revenue for the three and nine
months ended September 30, 2007. These settlements were
recorded in the same period the related forecasted transactions
affected earnings.
In connection with the issuance of our Senior Notes in March
2008, as described in Note 7, Indebtedness, we entered into
interest rate swaps at the issuance of the Senior Notes and
during the second quarter of 2008 with a total aggregate
notional amount of $550.0 million, which expire in March
2018. These interest rate swaps have been designated as fair
value hedges and are being used to manage our exposure to
changes in interest rates. These swaps have the effect of
changing $550.0 million of our fixed rate debt to variable
rate debt, as we receive a fixed rate and pay a floating rate.
In the three and nine months ended September 30, 2008, we
recognized a net gain of $1.3 million and a net loss of
$3.6 million, respectively, in earnings due to hedge
ineffectiveness. The fair value of these swaps at
September 30, 2008, which incorporates counter party credit
risk, is included in other assets and other liabilities was
$2.6 million and $1.9 million, respectively, net of
accrued interest.
13
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Notes payable consists of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
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
|
|
|
10.2
|
|
|
|
10.3
|
|
Other
|
|
|
|
|
|
|
0.6
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
10.2
|
|
|
$
|
1,511.1
|
|
|
|
|
|
|
|
|
|
|
Non-current portion:
|
|
|
|
|
|
|
|
|
6.000% Senior Notes due 2013
|
|
$
|
449.5
|
|
|
$
|
|
|
6.875% Senior Notes due 2018
|
|
|
550.1
|
|
|
|
|
|
Note payable to Fumedica
|
|
|
25.9
|
|
|
|
34.3
|
|
Credit line from Dompé
|
|
|
16.9
|
|
|
|
17.5
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,042.4
|
|
|
$
|
51.8
|
|
|
|
|
|
|
|
|
|
|
On March 4, 2008, we issued $450.0 million aggregate
principal amount of 6.0% Senior Notes due March 1,
2013 and $550.0 million aggregate principal amount of
6.875% Senior Notes due March 1, 2018 at 99.886% and
99.184% of par, respectively. The discount will be amortized as
additional interest expense over the period from issuance
through maturity. These notes are senior unsecured obligations.
Interest on the notes is payable March 1 and September 1 of each
year. The notes may be redeemed at our option at any time at
100% of the principal amount plus accrued interest and a
specified make-whole amount. The notes contain a change of
control provision that may require us to purchase the notes
under certain circumstances. There is also an interest rate
adjustment feature that requires us to increase the interest
rate on the notes if the rating on the notes declines below
investment grade. Offering costs of approximately
$8.0 million have been recorded as debt issuance costs on
our consolidated balance sheet and will be amortized as
additional interest expense using the effective interest rate
method over the period from issuance through maturity.
Additionally, in connection with this issuance, we entered into
interest rate swaps, as further described in Note 6,
Financial Instruments. The carrying value of the
6.875% Senior Notes due in 2018 has increased by
approximately $4.4 million related to the interest rate
swap.
We used the proceeds of this borrowing, along with cash and the
proceeds from the liquidation of marketable securities, to repay
the $1,500.0 million term loan facility we had entered into
in July 2007 in connection with the funding of our June 2007
common stock tender offer.
In June 2007, we entered into a five-year $400.0 million
Senior Unsecured Revolving Credit Facility, which we may use for
future working capital and general corporate purposes. The
bankruptcy of Lehman Brothers Holdings Inc. has eliminated their
$40 million portion of the credit facility, thereby
reducing the availability of the credit facility to
$360 million. This credit facility bears interest at a rate
of LIBOR plus 45 basis points. The terms of this revolving
credit facility include various covenants, including financial
covenants that require us to not exceed a maximum leverage ratio
and under certain circumstances, an interest coverage ratio. As
of September 30, 2008, we were in compliance with these
covenants and there were no borrowings under this credit
facility.
14
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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Net income
|
|
$
|
206.8
|
|
|
$
|
119.4
|
|
|
$
|
576.5
|
|
|
$
|
437.0
|
|
Translation adjustments
|
|
|
(101.8
|
)
|
|
|
25.8
|
|
|
|
(47.2
|
)
|
|
|
36.9
|
|
Unfunded status of pension and post retirement benefit plan
|
|
|
(0.2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains (losses) on available-for-sale marketable
securities, net of tax of $(0.7) million,
$2.6 million, $2.6 million and $2.0 million,
respectively
|
|
|
1.3
|
|
|
|
(4.7
|
)
|
|
|
(6.3
|
)
|
|
|
(3.2
|
)
|
Net unrealized gains (losses) on foreign currency forward
contracts, net of tax of $7.6 million, $3.0 million,
$4.5 million, and $4.3 million, respectively
|
|
|
13.0
|
|
|
|
(5.1
|
)
|
|
|
7.7
|
|
|
|
(7.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
$
|
119.1
|
|
|
$
|
135.4
|
|
|
$
|
530.7
|
|
|
$
|
463.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings per share are calculated as follows
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
206.8
|
|
|
$
|
119.4
|
|
|
$
|
576.5
|
|
|
$
|
437.0
|
|
Adjustment for net income allocable to preferred shares
|
|
|
(0.4
|
)
|
|
|
(0.2
|
)
|
|
|
(1.0
|
)
|
|
|
(0.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income used in calculating basic and diluted earnings per
share
|
|
$
|
206.4
|
|
|
$
|
119.2
|
|
|
$
|
575.5
|
|
|
$
|
436.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
|
|
|
291.4
|
|
|
|
289.0
|
|
|
|
292.6
|
|
|
|
323.0
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and ESPP
|
|
|
1.1
|
|
|
|
2.7
|
|
|
|
1.6
|
|
|
|
2.1
|
|
Restricted stock units
|
|
|
1.4
|
|
|
|
1.3
|
|
|
|
1.2
|
|
|
|
0.8
|
|
Performance-based restricted stock units
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.1
|
|
Restricted stock awards
|
|
|
|
|
|
|
0.4
|
|
|
|
0.1
|
|
|
|
0.5
|
|
Convertible promissory notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares
|
|
|
2.5
|
|
|
|
4.4
|
|
|
|
2.9
|
|
|
|
3.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted earnings per share
|
|
|
293.9
|
|
|
|
293.4
|
|
|
|
295.5
|
|
|
|
326.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
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,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income allocable to preferred shares
|
|
$
|
0.4
|
|
|
$
|
0.2
|
|
|
$
|
1.0
|
|
|
$
|
0.6
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
6.7
|
|
|
|
7.6
|
|
|
|
6.4
|
|
|
|
10.5
|
|
Time-vested restricted stock units
|
|
|
1.8
|
|
|
|
0.1
|
|
|
|
1.4
|
|
|
|
0.1
|
|
Convertible preferred stock
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
9.0
|
|
|
|
8.2
|
|
|
|
8.3
|
|
|
|
11.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three and nine months ended September 30, 2008 and
2007, share-based compensation expense reduced our results of
operations as follows (in millions, except for earnings per
share):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
Effect on
|
|
|
Effect on
|
|
|
|
Net Income
|
|
|
Net Income
|
|
|
Income before income taxes
|
|
$
|
36.7
|
|
|
$
|
31.8
|
|
|
$
|
104.3
|
|
|
$
|
91.2
|
|
Tax effect
|
|
|
(11.4
|
)
|
|
|
(9.9
|
)
|
|
|
(32.2
|
)
|
|
|
(27.8
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
25.3
|
|
|
$
|
21.9
|
|
|
$
|
72.1
|
|
|
$
|
63.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
0.09
|
|
|
$
|
0.08
|
|
|
$
|
0.25
|
|
|
$
|
0.20
|
|
Diluted earnings per share
|
|
$
|
0.09
|
|
|
$
|
0.07
|
|
|
$
|
0.24
|
|
|
$
|
0.19
|
|
Share-based compensation expense and cost in the three and nine
months ended September 30, 2008 and 2007 is as follows (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2008
|
|
|
Three Months Ended September 30, 2007
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
Research and development
|
|
$
|
2.4
|
|
|
$
|
11.6
|
|
|
$
|
14.0
|
|
|
$
|
3.5
|
|
|
$
|
9.7
|
|
|
$
|
13.2
|
|
Selling, general and administrative
|
|
|
5.5
|
|
|
|
19.0
|
|
|
|
24.5
|
|
|
|
6.0
|
|
|
|
13.7
|
|
|
|
19.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
7.9
|
|
|
$
|
30.6
|
|
|
$
|
38.5
|
|
|
$
|
9.5
|
|
|
$
|
23.4
|
|
|
$
|
32.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based compensation costs
|
|
|
|
|
|
|
|
|
|
|
(1.8
|
)
|
|
|
|
|
|
|
|
|
|
|
(1.1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
36.7
|
|
|
|
|
|
|
|
|
|
|
$
|
31.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, 2008
|
|
|
Nine Months Ended September 30, 2007
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
Stock
|
|
|
Restricted Stock
|
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
Options
|
|
|
and Restricted
|
|
|
|
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
& ESPP
|
|
|
Stock Units
|
|
|
Total
|
|
|
Research and development
|
|
$
|
6.2
|
|
|
$
|
39.6
|
|
|
$
|
45.8
|
|
|
$
|
9.5
|
|
|
$
|
27.3
|
|
|
$
|
36.8
|
|
Selling, general and administrative
|
|
|
12.7
|
|
|
|
51.3
|
|
|
|
64.0
|
|
|
|
17.5
|
|
|
|
40.1
|
|
|
|
57.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
18.9
|
|
|
$
|
90.9
|
|
|
$
|
109.8
|
|
|
$
|
27.0
|
|
|
$
|
67.4
|
|
|
$
|
94.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based compensation costs
|
|
|
|
|
|
|
|
|
|
|
(5.5
|
)
|
|
|
|
|
|
|
|
|
|
|
(3.2
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
104.3
|
|
|
|
|
|
|
|
|
|
|
$
|
91.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
Options
In February of 2008 and 2007, we made our annual awards of stock
options. Approximately one million stock options were awarded as
part of the annual award in each of February 2008 and 2007 at
exercise prices of $60.56 per share and $49.31 per share,
respectively.
The fair values of the stock option grants awarded in the nine
months ended September 30, 2008 and 2007 were estimated as
of the date of grant using a Black-Scholes option valuation
model that used the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Expected dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Expected stock price volatility
|
|
|
34.4
|
%
|
|
|
33.6
|
%
|
Risk-free interest rate
|
|
|
2.47
|
%
|
|
|
4.50
|
%
|
Expected option life in years
|
|
|
5.10
|
|
|
|
4.87
|
|
Per share grant-date fair value
|
|
$
|
21.12
|
|
|
$
|
18.36
|
|
Time-Vested
Restricted Stock Units
In February of 2008 and 2007, 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 each of February 2008 and 2007 at grant date fair values of
$60.56 per share and $49.31 per share, respectively.
Performance-Based
Restricted Stock Units
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. These tranches are subject to performance conditions
established at the time of grant. In February 2008, 27,000 of
the first tranche of RSUs vested and was converted into shares
of common stock, while the remaining 3,000 RSUs of the tranche
expired unvested. The total grant of 120,000 RSUs is being
recognized as compensation expense, adjusted as necessary, 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, or FIN 28.
Employee
Stock Purchase Plan
In the three months ended September 30, 2008 and 2007,
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, 2008
17
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
and 2007, 0.4 million and 0.4 million shares,
respectively, were issued under the ESPP. In the three months
ended September 30, 2008 and 2007, we recorded
approximately $3.0 million and $2.4 million,
respectively, of stock compensation charges related to the ESPP.
In the nine months ended September 30, 2008 and 2007, we
recorded approximately $4.6 million and $3.6 million,
respectively, of stock compensation charges related to the ESPP.
Tax
Rate
Our effective tax rate was 35.6% on pre-tax income for the three
months ended September 30, 2008, compared to 31.4% for the
comparable period in 2007. Our effective tax rate was 32.9% on
pre-tax income for the nine months ended September 30,
2008, compared to 29.0% for the comparable period in 2007. The
effective tax rate in 2008 was unfavorably impacted by a higher
proportion of income subject to US taxes and enactment of an
amendment to Massachusetts tax laws which will increase payments
on timing items which become taxable after January 1, 2009.
A reconciliation of the U.S. federal statutory tax rate to
the effective tax rate for the three and nine months ended
September 30, 2008 and 2007, respectively, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Statutory Rate
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
State Taxes
|
|
|
4.4
|
|
|
|
4.1
|
|
|
|
3.0
|
|
|
|
2.5
|
|
Foreign Taxes
|
|
|
(7.4
|
)
|
|
|
(7.7
|
)
|
|
|
(9.0
|
)
|
|
|
(7.7
|
)
|
Credits and net operating loss utilization
|
|
|
1.1
|
|
|
|
(2.3
|
)
|
|
|
0.1
|
|
|
|
(2.5
|
)
|
Other
|
|
|
(1.3
|
)
|
|
|
(0.6
|
)
|
|
|
(0.8
|
)
|
|
|
(2.6
|
)
|
Fair Value Adjustment
|
|
|
3.8
|
|
|
|
3.0
|
|
|
|
3.6
|
|
|
|
3.1
|
|
IPR&D
|
|
|
|
|
|
|
(0.1
|
)
|
|
|
1.0
|
|
|
|
1.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35.6
|
%
|
|
|
31.4
|
%
|
|
|
32.9
|
%
|
|
|
29.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingency
On September 12, 2006, we received a Notice of Assessment
from the Massachusetts Department of Revenue for
$38.9 million, including penalties and interest, with
respect to the 2001, 2002 and 2003 tax years. We believe that we
have meritorious defenses to the proposed adjustment and are
vigorously opposing the assessment. We believe that the
assessment does not impact the level of liabilities for income
tax contingencies. However, there is a possibility that we may
not prevail in all of our assertions. If this is resolved
unfavorably in the future, it could have a material impact on
our future effective tax rate and our results of operations in
the period the resolution occurs.
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 our consolidated federal
income tax returns for the fiscal years 2003 and 2004 and issued
an assessment. We subsequently paid amounts related to items
agreed to with the IRS and are appealing several items.
18
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
12. 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,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Interest income
|
|
$
|
16.8
|
|
|
$
|
18.8
|
|
|
$
|
55.0
|
|
|
$
|
80.1
|
|
Minority interest
|
|
|
(1.0
|
)
|
|
|
29.0
|
|
|
|
(5.2
|
)
|
|
|
25.0
|
|
Interest expense
|
|
|
(8.1
|
)
|
|
|
(19.6
|
)
|
|
|
(37.6
|
)
|
|
|
(21.9
|
)
|
Other, net
|
|
|
(32.4
|
)
|
|
|
16.7
|
|
|
|
(42.0
|
)
|
|
|
15.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
$
|
(24.7
|
)
|
|
$
|
44.9
|
|
|
$
|
(29.8
|
)
|
|
$
|
98.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2008, the principal
components of other, net, included losses on foreign currency of
$1.8 million and impairments of and net realized losses on
the sales of marketable securities of $23.8 million, as
further described in Note 6 Financial
Instruments. In the three months ended September 30,
2007, the principal components of other, net included gain on
sale of land of $7.1 million and net realized gains on
sales of strategic investments of $11.0 million, offset by
net realized losses on sales of marketable securities of
$0.7 million.
In the nine months ended September 30, 2008, the principal
components of other, net, included net impairments on strategic
investments of $10.7 million, losses on foreign currency of
$2.8 million and hedge ineffectiveness of
$2.5 million, impairments of and net realized losses on the
sale of marketable securities of $23.1 million, as further
described in Note 6 Financial Instruments. In
the nine months ended September 30, 2007, the principal
components of other, net, included net realized losses on sales
of marketable securities of $7.1 million, offset by net
realized gains on our strategic investments of
$19.0 million and gain on sale of land of $7.1 million.
We, along with William H. Rastetter, our former Executive
Chairman, James C. Mullen, our Chief Executive Officer,
Peter N. Kellogg, our former Chief Financial Officer, William R.
Rohn, our former Chief Operating Officer, Burt A. Adelman, our
former Executive Vice President, Portfolio Strategy, and Thomas
J. Bucknum, our former General Counsel are defendants in a
consolidated purported class action lawsuit, captioned Brown v
Biogen Idec., et al (Brown), first filed in the
U.S. District Court for the District of Massachusetts on
March 2, 2005. The action is purportedly brought on behalf
of all purchasers of our publicly-traded securities between
February 18, 2004 and February 25, 2005. 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 plaintiffs allege 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 plaintiffs allege that these
statements harmed the purported class by artificially inflating
our stock price during the purported class period and that our
insiders benefited personally from the inflated price by selling
our stock. The plaintiffs seek unspecified damages, as well as
interest, costs and attorneys fees. On September 14,
2007, the District Court entered an Order allowing the Motions
to Dismiss of all defendants. That decision was affirmed on
August 7, 2008 by the United Stated Court of Appeals for
the First Circuit. We do not anticipate further action in this
matter.
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, and that it has been advised the investigation is
both civil and criminal in nature. We are cooperating with the
19
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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 (the
Three County Actions) are the subject of
a Consolidated Complaint (Consolidated Complaint),
first filed on June 15, 2005 in the U.S. District Court for
the District of Massachusetts in Multi-District Litigation
No. 1456 (the MDL proceedings). 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. With respect to the MDL
proceedings, the defendants were successful in having some of
the plaintiffs claims dismissed, and the parties,
including Biogen Idec, have agreed to participate in mediation
with respect to the outstanding claims, which began on
July 1, 2008.
We have not formed an opinion that an unfavorable outcome is
either probable or remote in any of
these cases, and do not express an opinion at this time as to
their likely outcome or as to the magnitude or range of any
potential loss. We believe that we have good and valid defenses
to each of these complaints and are vigorously defending against
them.
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 in the Superior Court of the
State of Arizona and transferred to the MDL proceedings. The
complaint, as amended on March 13, 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. Biogen Idec and other
defendants have filed a motion to dismiss the complaint, which
is pending. On December 26, 2007, Biogen Idec and other
defendants agreed to participate in mediation. Mediation is
underway. We have not formed an opinion that an unfavorable
outcome is either probable or remote,
and do 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. We believe that we have good and valid defenses
to the complaint and intend vigorously to defend the case.
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 U.S. District Court of the District of Maine. 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. The plaintiff alleges, among other things, that we
illegally marketed off-label uses of RITUXAN for treating
rheumatoid arthritis, provided illegal kickbacks to physicians
to promote off-label uses, 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
20
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
appropriate relief. On July 24, 2007, the District Court
granted Biogen Idecs motion to dismiss. Certain of the
plaintiffs claims against Genentech are still pending. The
District Court subsequently denied the plaintiffs motion
to allow an interlocutory appeal of the granting of Biogen
Idecs motion to dismiss. We have not formed an opinion
that an unfavorable outcome is either probable or
remote, and do 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. We believe that we have good and
valid defenses to the complaint and intend vigorously to defend
the case.
On June 17, 2006, Biogen Idec filed a Demand for
Arbitration against Genentech, Inc. with the American
Arbitration Association (AAA), which Demand was
amended on December 5, 2006 and on January 29, 2008.
In the Demand, 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. In its Answering
Statement, Genentech also asserted for the first time that the
November 2003 transaction in which Idec Pharmaceuticals acquired
Biogen and became Biogen Idec was a change of control 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. The hearing commenced
on September 15, 2008 and is scheduled to conclude in
December, 2008. We anticipate a decision during the first half
of 2009. We have not formed an opinion that an unfavorable
outcome is either probable or remote,
and do 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. We believe that we have good and valid defenses
to Genentechs allegations in the arbitration and intend
vigorously to defend against these allegations.
On August 10, 2004, Classen Immunotherapies, Inc. filed
suit against us, GlaxoSmithKline, Chiron Corporation,
Merck & Co., Inc., and Kaiser-Permanente, Inc. in the
U.S. District Court for the District of Maryland contending
that we induced infringement of U.S. Patent Nos, 6,420,139,
6,638,739, 5,728,383, and 5,723,283, all of which are directed
to various methods of immunization or determination of
immunization schedules. All counts asserted against us by
Classen were dismissed by the District Court. Classen filed an
appeal, which has been fully briefed and argued, but not yet
decided by the Court of Appeals. We have not formed an opinion
that an unfavorable outcome is either probable or
remote, and do 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. We believe that we have good and
valid defenses and intend vigorously to defend the case.
On September 12, 2006, the Massachusetts Department of
Revenue (DOR) issued a notice of assessment against
Biogen Idec MA, Inc. for $38.9 million of corporate excise
tax for 2002, which includes associated interest and penalties.
On December 6, 2006, we filed an abatement application with
the DOR, seeking abatements for
2001-2003.
The abatement application was denied on July 24, 2007. On
July 25, 2007, we filed a petition with the Massachusetts
Appellate Tax Board, seeking abatements of corporate excise tax
for
2001-2003
and adjustments in certain credits and credit carryforwards for
2001-2003.
Issues before the Board include the computation of Biogen Idec
MAs sales factor for
2001-2003,
computation of Biogen Idec MAs research credits for those
same years, and the availability of deductions for certain
expenses and partnership flow-through items. We intend to
contest this matter vigorously. We believe that the assessment
does not impact the level of liabilities for income tax
contingencies.
21
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In January 2008, the European Commission (EC) began
an industry-wide antitrust inquiry into competitive conditions
within the pharmaceutical sector. As part of the inquiry, the EC
issued detailed questionnaires to approximately
100 companies, including Biogen Idec. The first
questionnaire, which we received in April 2008, has been
followed by further interaction with the EC and we continue to
cooperate with the EC in its inquiry.
In addition, we are involved in product liability claims and
other legal proceedings generally incidental to our normal
business activities. While the outcome of any of these
proceedings cannot be accurately predicted, we do not believe
the ultimate resolution of any of these existing matters would
have a material adverse effect on our business or financial
conditions.
We operate in one business segment, which is the business of
discovery, development, manufacturing and commercialization of
innovative therapies for human health care. Our chief operating
decision maker manages our operations as a single operating
segment.
|
|
15.
|
New
Accounting Pronouncements
|
On December 12, 2007,
EITF 07-01,
Accounting for Collaborative Arrangements Related to the
Development and Commercialization of Intellectual Property,
or
EITF 07-01,
was issued.
EITF 07-01
prescribes the accounting for collaborations. It requires
certain transactions between collaborators to be recorded in the
income statement on either a gross or net basis when certain
characteristics exist in the collaboration relationship.
EITF 07-01
is effective for all of our collaborations existing after
January 1, 2009. We are evaluating the impact, if any, this
Standard will have on our financial statements.
On December 4, 2007, Statement of Financial Accounting
Standard No. 141(R), Business Combinations, or
SFAS 141(R), was issued. This Standard will require us to
measure all assets acquired and liabilities assumed, including
contingent considerations and all contractual contingencies, at
fair value as of the acquisition date when we acquire another
business. In addition, we will capitalize IPR&D when we
acquire another business and either amortize it over the life of
the product or write it off if the project is abandoned or
impaired. SFAS 141(R) is effective for transactions
occurring on or after January 1, 2009. We are evaluating
the impact, if any, this Standard will have on our financial
statements.
On December 4, 2007, Statement of Financial Accounting
Standard No. 160, Noncontrolling Interests in
Consolidated Financial Statements, an Amendment of ARB
No. 51, or SFAS 160, was issued. This Standard
changes the accounting for and reporting of noncontrolling
interests (formerly known as minority interests) in consolidated
financial statements. This Standard is effective January 1,
2009. When implemented, prior periods will be recast for the
changes required by SFAS 160. We do not expect the adoption
of this standard to have a material impact on our financial
statements or our results of operations.
On March 19, 2008, Statement of Financial Accounting
Standard No. 161, Disclosures About Derivative
Instruments and Hedging Activities, or SFAS 161, was
issued. This Standard enhances the disclosure requirements for
derivative instruments and hedging activities. This Standard is
effective January 1, 2009. Since SFAS No. 161
requires only additional disclosures concerning derivatives and
hedging activities, adoption of SFAS No. 161 will not
affect our financial condition, results of operations or cash
flows.
On May 5, 2008, Statement of Financial Accounting Standard
No. 162, The Hierarchy of Generally Accepted Accounting
Principles, or SFAS 162, was issued. This Standard
identifies the sources of accounting principles and the
framework for selecting the principles to be used in the
preparation of financial statements that are presented in
conformity with generally accepted accounting principles in the
U.S. We do not expect the adoption of this standard to have
a material impact on our financial statements or our results of
operations.
22
|
|
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. These
forward-looking statements do not relate strictly to historical
or current facts and they may be accompanied by such words as
anticipate, believe,
estimate, expect, forecast,
intend, plan, project,
target, may, will and other
words and terms of similar meaning. Reference is made in
particular to forward-looking statements regarding the
anticipated level of future product sales, royalty revenues,
expenses, contractual obligations, regulatory approvals, our
long-term growth, the development and marketing of additional
products, the impact of competitive products, the incidence or
anticipated outcome of pending or anticipated litigation,
patent-related proceedings, tax assessments and other legal
proceedings, our effective tax rate for future periods, our
ability to finance our operations and meet our manufacturing
needs, the completion of our manufacturing facility in Hillerod,
Denmark, liquidity, 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. Forward-looking statements, like
all statements in this report, speak only as of the date of this
report (unless another date is indicated). 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 beginning on
page 3 of this quarterly report on
Form 10-Q.
Overview
Biogen Idec Inc. (We, Biogen Idec or
the Company) is a global biotechnology company that
creates new standards of care in therapeutic areas with high
unmet medical needs.
We currently have four marketed products:
|
|
|
|
|
AVONEX®
(interferon beta-1a);
|
|
|
|
RITUXAN®
(rituximab);
|
|
|
|
TYSABRI®
(natalizumab); and,
|
|
|
|
FUMADERM®
(dimethylfumarate and monoethylfumarate salts).
|
Through December 2007, we recorded product revenues from sales
of
ZEVALIN®
(ibritumomab tiuxetan). In December 2007, we sold the
U.S. marketing, sales, and manufacturing and development
rights of ZEVALIN to Cell Therapeutics, Inc., or CTI. As part of
the overall agreement, we entered into a supply agreement with
CTI to manufacture and supply ZEVALIN product through 2014 and a
related services and security agreement under which CTI has
agreed to reimburse us for expenses incurred in an ongoing
randomized clinical trial for ZEVALIN with respect to aggressive
non-Hodgkins lymphoma, or NHL. Our supply of ZEVALIN to
CTI and our sales of ZEVALIN to Bayer Schering Pharma AG, or
Schering AG, for distribution in the EU will be recognized as
product revenue. We will continue to receive royalty revenues
from Schering AG on their sales of ZEVALIN in the EU.
Executive
Overview
Results for the first nine months of 2008 included total revenue
of $3,028.6 million, net income of $576.5 million and
diluted net income per share of $1.95. These results reflect
continued growth in TYSABRI revenue, an increase in RITUXAN
revenues from an unconsolidated joint business arrangement as
well as the impact of price increases on our AVONEX product. The
effect of the increase in revenue was partially offset by an
increase in research and development expense due to clinical
trials and other projects, and an increase in selling, general
and administrative expense related to increased personnel to
support the ongoing AVONEX
23
sales and TYSABRI growth and realized losses and impairments of
$24.7 million in our marketable securities portfolio
primarily related to mortgage and asset backed securities. In
July 2008, we disclosed two confirmed cases of progressive
multifocal leukoencephalopathy (PML), a known side effect, in
patients taking TYSABRI. These patients were the first two
confirmed cases of PML reported to us since the reintroduction
of TYSABRI in the U.S. and approval in the EU in July 2006.
We continue to monitor the growth of TYSABRI in light of these
results.
Results
of Operations
Revenues
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Product sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
380.5
|
|
|
|
34.9
|
%
|
|
$
|
297.4
|
|
|
|
37.7
|
%
|
|
$
|
1,084.8
|
|
|
|
35.8
|
%
|
|
$
|
883.8
|
|
|
|
38.8
|
%
|
Rest of world
|
|
|
377.7
|
|
|
|
34.6
|
%
|
|
|
232.2
|
|
|
|
29.4
|
%
|
|
|
1,023.0
|
|
|
|
33.8
|
%
|
|
|
648.8
|
|
|
|
28.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
|
758.2
|
|
|
|
69.5
|
%
|
|
|
529.6
|
|
|
|
67.1
|
%
|
|
|
2,107.8
|
|
|
|
69.6
|
%
|
|
|
1,532.6
|
|
|
|
67.3
|
%
|
Unconsolidated joint business
|
|
|
298.9
|
|
|
|
27.3
|
%
|
|
|
234.6
|
|
|
|
29.7
|
%
|
|
|
825.0
|
|
|
|
27.2
|
%
|
|
|
672.4
|
|
|
|
29.5
|
%
|
Royalties
|
|
|
35.2
|
|
|
|
3.2
|
%
|
|
|
23.5
|
|
|
|
3.0
|
%
|
|
|
87.3
|
|
|
|
2.9
|
%
|
|
|
69.2
|
|
|
|
3.0
|
%
|
Corporate partner
|
|
|
0.6
|
|
|
|
|
%
|
|
|
1.5
|
|
|
|
0.2
|
%
|
|
|
8.5
|
|
|
|
0.3
|
%
|
|
|
4.1
|
|
|
|
0.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
1,092.9
|
|
|
|
100.0
|
%
|
|
$
|
789.2
|
|
|
|
100.0
|
%
|
|
$
|
3,028.6
|
|
|
|
100.0
|
%
|
|
$
|
2,278.3
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Revenues (in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
AVONEX
|
|
$
|
573.5
|
|
|
|
75.6
|
%
|
|
$
|
454.9
|
|
|
|
85.9
|
%
|
|
$
|
1,636.8
|
|
|
|
77.7
|
%
|
|
$
|
1,365.4
|
|
|
|
89.1
|
%
|
TYSABRI
|
|
|
171.1
|
|
|
|
22.6
|
%
|
|
|
62.9
|
|
|
|
11.9
|
%
|
|
|
433.0
|
|
|
|
20.5
|
%
|
|
|
140.2
|
|
|
|
9.1
|
%
|
FUMADERM
|
|
|
11.1
|
|
|
|
1.5
|
%
|
|
|
7.4
|
|
|
|
1.4
|
%
|
|
|
32.8
|
|
|
|
1.6
|
%
|
|
|
12.5
|
|
|
|
0.8
|
%
|
ZEVALIN
|
|
|
2.5
|
|
|
|
0.3
|
%
|
|
|
4.4
|
|
|
|
0.8
|
%
|
|
|
5.0
|
|
|
|
0.2
|
%
|
|
|
14.2
|
|
|
|
0.9
|
%
|
AMEVIVE
|
|
|
|
|
|
|
|
%
|
|
|
|
|
|
|
|
%
|
|
|
0.2
|
|
|
|
|
%
|
|
|
0.3
|
|
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues
|
|
$
|
758.2
|
|
|
|
100.0
|
%
|
|
$
|
529.6
|
|
|
|
100.0
|
%
|
|
$
|
2,107.8
|
|
|
|
100.0
|
%
|
|
$
|
1,532.6
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of Sales, excluding Amortization of Intangibles (in
millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Cost of product revenues
|
|
$
|
106.3
|
|
|
|
98.8
|
%
|
|
$
|
80.6
|
|
|
|
98.8
|
%
|
|
$
|
297.2
|
|
|
|
98.8
|
%
|
|
$
|
244.6
|
|
|
|
98.8
|
%
|
Cost of royalty revenues
|
|
|
1.2
|
|
|
|
1.2
|
%
|
|
|
1.0
|
|
|
|
1.2
|
%
|
|
|
3.6
|
|
|
|
1.2
|
%
|
|
|
3.0
|
|
|
|
1.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, excluding amortization of intangibles
|
|
$
|
107.5
|
|
|
|
100.0
|
%
|
|
$
|
81.6
|
|
|
|
100.0
|
%
|
|
$
|
300.8
|
|
|
|
100.0
|
%
|
|
$
|
247.6
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three months ended September 30, 2008 and 2007,
we wrote-down $12.6 million and $4.7 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the nine months ended September 30,
2008 and 2007, we wrote-down $22.5 million and
$19.6 million, respectively, in unmarketable inventory,
which was charged to cost of sales.
24
AVONEX
Revenues from AVONEX in the three and nine months ended
September 30, 2008 and 2007 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
AVONEX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
321.9
|
|
|
|
56.1
|
%
|
|
$
|
266.4
|
|
|
|
58.6
|
%
|
|
$
|
935.9
|
|
|
|
57.2
|
%
|
|
$
|
806.1
|
|
|
|
59.0
|
%
|
Rest of World
|
|
|
251.6
|
|
|
|
43.9
|
%
|
|
|
188.5
|
|
|
|
41.4
|
%
|
|
|
700.9
|
|
|
|
42.8
|
%
|
|
|
559.3
|
|
|
|
41.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total AVONEX revenues
|
|
$
|
573.5
|
|
|
|
100.0
|
%
|
|
$
|
454.9
|
|
|
|
100.0
|
%
|
|
$
|
1,636.8
|
|
|
|
100.0
|
%
|
|
$
|
1,365.4
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, U.S. sales
of AVONEX increased $55.5 million, or 20.8%, due to price
increases, partially offset by decreased product demand. In the
nine months ended September 30, 2008, compared to the nine
months ended September 30, 2007, U.S. sales of AVONEX
increased $129.8 million, or 16.1%, due to price increases,
partially offset by a decreased product demand.
In the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, Rest of World
sales of AVONEX increased $63.1 million, or 33.5% primarily
due to increased unit shipments and the impact of exchange
rates. In the nine months ended September 30, 2008,
compared to the nine months ended September 30, 2007, Rest
of World sales of AVONEX increased $141.6 million, or
25.3%, due to increased unit shipments and the impact of
exchange rates.
We are facing increasing competition in the multiple sclerosis,
or MS, marketplace in both the U.S. and Rest of World from
existing and new MS treatments, including TYSABRI, which may
have a negative impact on sales of AVONEX. We expect future
sales of AVONEX to be dependent, to a large extent, on our
ability to compete successfully with the products of our
competitors.
TYSABRI
Revenues from TYSABRI for the three and nine months ended
September 30, 2008 and 2007 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
TYSABRI
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
56.2
|
|
|
|
32.8
|
%
|
|
$
|
28.1
|
|
|
|
44.7
|
%
|
|
$
|
144.0
|
|
|
|
33.3
|
%
|
|
$
|
67.4
|
|
|
|
48.1
|
%
|
Rest of World
|
|
|
114.9
|
|
|
|
67.2
|
%
|
|
|
34.8
|
|
|
|
55.3
|
%
|
|
|
289.0
|
|
|
|
66.7
|
%
|
|
|
72.8
|
|
|
|
51.9
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total TYSABRI revenues
|
|
$
|
171.1
|
|
|
|
100.0
|
%
|
|
$
|
62.9
|
|
|
|
100.0
|
%
|
|
$
|
433.0
|
|
|
|
100.0
|
%
|
|
$
|
140.2
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, sales of TYSABRI
increased $108.2 million, or 172.0%, and in the nine months
ended September 30, 2008, compared to the nine months ended
September 30, 2007, sales of TYSABRI increased
$292.8 million, or 208.8%. These increases are primarily
due to an increase in patients using TYSABRI in both the
U.S. and Rest of World. Net sales of TYSABRI from our
collaboration partner, Elan, to third-party customers in the
U.S. for the three months ended September 30, 2008 and
2007 were $121.5 million and $58.5 million,
respectively. Net sales of TYSABRI to third-party customers in
the U.S. for the nine months ended September 30, 2008
and 2007 were $307.0 million and $141.1 million,
respectively. We recognize revenue for sales of TYSABRI in the
U.S. upon Elans shipment of the product to third
party customers. We recognize revenue for sales of TYSABRI
outside the U.S. at the time of product delivery to our
customers. In July 2008, we disclosed two confirmed cases of
PML, a known side effect, in patients taking TYSABRI. These
patients were the first two confirmed cases of PML reported to
us since the reintroduction of TYSABRI in the U.S. and
approval in the EU in July 2006. We continue to monitor the
growth of TYSABRI in light of these results. During the three
months ended September 30, 2008, pursuant to our
collaboration agreement with Elan, Elan paid us a
$75 million milestone payment in order to maintain the
current profit sharing split. We will
25
recognize this $75 million as product revenue in our
consolidated statement of income over the term of our agreement
with Elan on a units of revenue method, whereby the revenue
recognized is based on the ratio of units shipped in the current
period over the total units expected to be shipped over the
collaboration. We have recognized $0.6 million of this
milestone as revenue in the three months ended
September 30, 2008. Based on the expected TYSABRI sales
levels for the fourth quarter of 2008, we anticipate that Elan
will have the option to pay us a second milestone payment of
$50M in the first quarter of 2009 in order to maintain the
current profit sharing split.
FUMADERM
In connection with our June 2006 acquisition of Fumapharm, we
began recognizing revenue on sales of FUMADERM to our
distributor, Fumedica, in July 2006. In December 2006, we
acquired the right to distribute FUMADERM in Germany from
Fumedica effective May 1, 2007. In connection with the
acquisition of the FUMADERM distribution rights in Germany, we
committed to the repurchase of any inventory Fumedica did not
sell by May 1, 2007. As a result of this provision, we
deferred the recognition of revenue on shipments made to
Fumedica through April 30, 2007. We resumed recognizing
revenue on sales of FUMADERM into the German market in May 2007.
Accordingly, we recognized no revenue of FUMADERM through
April 30, 2007. For the three months ended
September 30, 2008 and 2007, we recognized
$11.1 million and $7.4 million, respectively, of sales
of FUMADERM. For the nine months ended September 30, 2008
and 2007, we recognized $32.8 million and
$12.5 million, respectively, of sales of FUMADERM.
ZEVALIN
In the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, sales of ZEVALIN
decreased from $4.4 million to $2.5 million, due to
the sale of the rights to market, sell, manufacture and develop
ZEVALIN in the U.S. to CTI during the fourth quarter of
2007.
In the nine months ended September 30, 2008, compared to
the nine months ended September 30, 2007, sales of ZEVALIN
decreased from $14.2 million to $5.0 million,
primarily due to the sale of the rights to market, sell,
manufacture and develop ZEVALIN in the U.S. to CTI during
the fourth quarter of 2007.
Unconsolidated
Joint Business Revenue
Revenues from unconsolidated joint business, which consist of
our share of pre-tax copromotion profits pursuant to our
collaboration agreement with Genentech, Inc., or 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,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Copromotion profits
|
|
$
|
192.2
|
|
|
$
|
156.3
|
|
|
$
|
527.9
|
|
|
$
|
446.3
|
|
Reimbursement of selling and development expenses
|
|
|
16.7
|
|
|
|
15.3
|
|
|
|
45.4
|
|
|
|
44.4
|
|
Royalty revenue on sales of RITUXAN outside the U.S.
|
|
|
90.0
|
|
|
|
63.0
|
|
|
|
251.7
|
|
|
|
181.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
298.9
|
|
|
$
|
234.6
|
|
|
$
|
825.0
|
|
|
$
|
672.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits consist of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Nine Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
September 30,
|
|
|
September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Product revenues, net
|
|
$
|
655.4
|
|
|
$
|
572.4
|
|
|
$
|
1,910.8
|
|
|
$
|
1,689.2
|
|
Costs and expenses
|
|
|
182.3
|
|
|
|
181.6
|
|
|
|
586.1
|
|
|
|
560.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits
|
|
$
|
473.1
|
|
|
$
|
390.8
|
|
|
$
|
1,324.7
|
|
|
$
|
1,128.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biogen Idecs share of copromotion profits
|
|
$
|
192.2
|
|
|
$
|
156.3
|
|
|
$
|
527.9
|
|
|
$
|
446.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26
For the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, our share of
copromotion profits increased $35.9 million, or 23.0%, due
principally to higher sales of RITUXAN. For the nine months
ended September 30, 2008, compared to the nine months ended
September 30, 2007, our share of copromotion profits
increased $81.6 million, or 18.3%, due principally to
higher sales of RITUXAN. Effective October 1, 2008, the end
user price of RITUXAN increased 2.75%.
Our royalty revenue on sales of RITUXAN outside the U.S. is
based on net sales by F. Hoffman-LaRoche Ltd., or Roche, and
Zenyaku Kogyo Co. Ltd., or Zenyaku, to third-party customers and
is recorded on a cash basis. For the three months ended
September 30, 2008, compared to the three months ended
September 30, 2007, royalty revenue on sales of RITUXAN
outside the U.S. increased $27.0 million, or 42.9%,
due primarily to increased sales outside the U.S., reflecting
greater market penetration, as well as the impact of foreign
exchange. For the nine months ended September 30, 2008,
compared to the nine months ended September 30, 2007,
royalty revenue on sales of RITUXAN outside the
U.S. increased $70.0 million, or 38.5%, due primarily
to increased sales outside the U.S., reflecting greater market
penetration, as well as the impact of foreign exchange.
Under our collaboration agreement with Genentech, 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
|
%
|
In 2008 and 2007, 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 |
27
|
|
|
|
|
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 our collaboration agreement with Genentech, 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.
Therefore, we expect a significant decrease in royalty revenues
on sales of RITUXAN outside the US beginning in the latter half
of 2009.
Other
Revenues
Other revenues for the three and nine months ended
September 30, 2008 and 2007 were as follows
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Royalties
|
|
$
|
35.1
|
|
|
|
98.3
|
%
|
|
$
|
23.5
|
|
|
|
94.0
|
%
|
|
$
|
87.3
|
|
|
|
91.1
|
%
|
|
$
|
69.2
|
|
|
|
94.4
|
%
|
Corporate partner
|
|
|
0.6
|
|
|
|
1.7
|
%
|
|
|
1.5
|
|
|
|
6.0
|
%
|
|
|
8.5
|
|
|
|
8.9
|
%
|
|
|
4.1
|
|
|
|
5.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues
|
|
$
|
35.7
|
|
|
|
100.0
|
%
|
|
$
|
25.0
|
|
|
|
100.0
|
%
|
|
$
|
95.8
|
|
|
|
100.0
|
%
|
|
$
|
73.3
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended September 30, 2008, compared to
the three months ended September 30, 2007, royalties
increased $11.6 million, or 49.4%. Increased royalties of
$14.8 million were primarily related to increased sales of
products licensed by The Medicines Company and GlaxoSmithKline,
as well as an increased royalty rate on products licensed by
Schering-Plough Corporation. These increases were partially
offset by a $3.2 million decrease, which was primarily due
to the expiration of a license agreement with Plant Genetics, as
well as decreased sales on products licensed by Merck and Co.,
Inc.
In the nine months ended September 30, 2008, compared to
the nine months ended September 30, 2007, royalties
increased $18.1 million, or 26.2%. Increased royalties of
$26.2 million were primarily related to increased sales of
products licensed by The Medicines Company and GlaxoSmithKline,
as well as an increased royalty rate on products licensed by
Schering-Plough Corporation. These increases were partially
offset by a $8.1 million decrease, which was primarily due
to the expiration of a license agreement with Shionogi and Co.,
Ltd., as well as decreased sales on products licensed by Merck
and Co., Inc.
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.
28
Research
and Development Expenses
Research and development expenses totaled $268.8 million
and $286.3 million in the three months ended
September 30, 2008 and 2007, respectively, a decrease of
$17.5 million, or 6.1%. The decrease is primarily due to
lower Lixivaptan expenses of $46.5 million because of a
$50.0 million upfront collaboration payment made to
Cardiokine in Q3 2007. This decrease was offset by
$29.0 million increase driven primarily by the BG-12,
Anti-CD23 and Adentri programs.
Research and development expenses totaled $779.3 million
and $695.9 million in the nine months ended
September 30, 2008 and 2007, respectively, an increase of
$83.4 million, or 12.0%. The net increase is primarily due
to $22.4 million increase for BG-12, $17.7 million
increase for Anti CD23, $14.9 million increase for our BART
collaboration with Neurimmune and a $11.5 million increase
for Adentri. The balance of the net increase related to other
R&D programs including Rituxan, HSP90, Avonex, Baminercept
and BIIB014. These increases were offset by a decrease in
expense for Lixivaptan, Tysabri and Zevalin projects.
We anticipate that Research and development expenses in 2008
will continue to be higher than in 2007.
In-Process
Research and Development, or IPR&D
In the nine months ended September 30, 2008, we recorded an
IPR&D charge of $25.0 million related to a
HSP90-related milestone payment made to the former shareholders
of Conforma, pursuant to our acquisition of Conforma in 2006.
Through September 30, 2008, research and development
expenditures related to in-process research and development
projects acquired in prior years are $36.3 million,
$54.5 million and $135.9 million related to Syntonix
Pharmaceuticals, Inc., or Syntonix, Conforma and Fumapharm,
respectively. In the nine months ended September 30, 2007
we recorded an 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.
Selling,
General and Administrative Expenses
Selling, general and administrative expenses totaled
$232.8 million and $190.6 million in the three months
ended September 30, 2008 and 2007, respectively, an
increase of $42.2 million, or 22.1%. The increase reflects,
principally, a $19.8 million increase in international
sales and marketing activities, primarily for AVONEX and
TYSABRI, a $10.5 million increase in salaries and benefits
related to general and administrative personnel and increases in
fees and services, including fees related to our proxy contest.
Selling, general and administrative expenses totaled
$694.3 million and $582.4 million in the nine months
ended September 30, 2008 and 2007, respectively, an
increase of $111.9 million, or 19.2%. The increase
reflects, principally, a $54.6 million increase in
international sales and marketing activities, primarily for
AVONEX and TYSABRI, an $34.7 million increase in salaries
and benefits related to general and administrative personnel and
increases in fees and services, including fees related to our
proxy contest.
We anticipate that total selling, general, and administrative
expenses in 2008 will continue to be higher than 2007 due to
sales and marketing and other general and administrative
expenses to support global expansion of AVONEX sales and TYSABRI
sales growth.
Collaboration
profit (loss) sharing
Payments to or from Elan for their share of collaboration net
operating profits or losses, including reimbursement for our
portion of third-party royalties Elan pays on behalf of the
collaboration, relating to sales outside of the U.S. to
effect an equal sharing of operating profit are reflected in the
collaboration profit (loss) sharing line in our consolidated
statement of income. For the three months ended
September 30, 2008 and 2007, the collaboration profit
(loss) sharing was $43.5 million and 5.8 million,
respectively. For the nine months ended September 30, 2008
and 2007, the collaboration profit (loss) sharing was
$98.4 million and 0.2 million, respectively. The
year-over-year increase in the collaboration profit sharing for
the three and nine months ended September 30, 2008 was due
to the growth in TYSABRI sales outside the U.S. and the
resulting growth in the third-party royalties Elan paid on
behalf of the collaboration, which were $16.8 million and
29
$5.2 million for the three months ended September 30,
2008 and 2007, respectively, and $42.0 million and
$10.5 million for the nine months ended September 30,
2008 and 2007, respectively. In the prior year, operating costs
were greater than profit on sales of TYSABRI outside the U.S.
Amortization
of Intangible Assets
Amortization of intangible assets totaled $94.5 million for
the three months ended September 30, 2008, compared to
$65.7 million in the comparable period in 2007, an increase
of $28.8 million, or 43.8%. Amortization of intangible
assets totaled $242.1 million for the nine months ended
September 30, 2008, compared to $186.6 million in the
comparable period in 2007, an increase of $55.5 million, or
29.7%. These changes are primarily due to the changes in the
estimate of the future revenue of AVONEX, which serves as the
basis for the calculation of economic consumption for core
technology that occurred as part of our annual reassessment of
amortization expense in the third quarters of 2008 and 2007. The
change in the estimate of the future revenue of AVONEX is
attributable to the expected impact of competitor products,
including our own internal pipeline product candidates.
Income
Tax Provision
Tax
Rate
Our effective tax rate was 35.6% on pre-tax income for the three
months ended September 30, 2008, compared to 31.4% for the
comparable period in 2007. Our effective tax rate was 32.9% on
pre-tax income for the nine months ended September 30,
2008, compared to 29.0% for the comparable period in 2007. The
effective tax rate in the three and nine months ended
September 30, 2008 was unfavorably impacted by a higher
proportion of income subject to US taxes and enactment of an
amendment to Massachusetts tax laws which will increase payments
on timing items which become taxable after January 1, 2009.
We expect our effective tax rate for the full-year ending
December 31, 2008 to be in a range of 31% to 33%, which
includes an approximate 1% reduction due to the extension of the
federal R&D tax credit enacted into law on October 3,
2008. Additionally, we intend to reorganize our current legal
structure and move certain organizational functions prior to
2009. This restructuring will impact our amounts subject to
taxation in Denmark and Switzerland. We anticipate these changes
in the Massachusetts tax laws and our international structure
will have a modest unfavorable impact on our effective tax rate
for 2009 and beyond. Future changes in federal, state and
international tax laws will likely impact our tax rate. Refer to
Note 11, Income Taxes, for a detailed income tax rate
reconciliation for the three and nine months ended
September 30, 2008 and 2007.
Liquidity
and Capital Resources
Financial
Condition
Our financial condition is summarized as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Cash and cash equivalents
|
|
$
|
1,010.7
|
|
|
$
|
659.7
|
|
Marketable securities current and non-current
|
|
|
1,093.2
|
|
|
|
1,456.1
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and marketable securities
|
|
$
|
2,103.9
|
|
|
$
|
2,115.8
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$
|
1,653.2
|
|
|
$
|
179.2
|
|
Outstanding borrowings current and non-current
|
|
$
|
1,052.6
|
|
|
$
|
1,563.0
|
|
Our cash and marketable securities at September 30, 2008,
are consistent with the balances at December 31, 2007.
However, there were several significant cash flow activities
including the net repayment of approximately $500 million
of indebtedness, as well as $559.8 million used to fund
share repurchases and the net impairment of $19.3 million
of marketable securities, offset by cash generated from
operations of $1.16 billion. In addition, during the nine
months ended September 30, 2008, we paid approximately
$41.5 million in milestone and other payments pursuant to
our research and development programs, including
$25.0 million of contingent purchase price in
30
connection with our Conforma acquisition and $8.0 million
related to the development of the
Beta-Amyloid
antibody under our arrangement with Neurimmune Therapeutics AG.
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 interest bearing marketable debt
instruments in accordance with our investment policy. The value
of these securities may be adversely affected by the instability
of the global financial markets which could adversely impact our
financial position and our overall liquidity.
As of September 30, 2008, we have certain financial assets
and liabilities recorded at fair value. In accordance with
Statement of Financial Accounting Standards No. 157,
Fair Value Measurement, or SFAS 157, we have
classified our financial assets and liabilities as Level 1,
2 or 3 within the fair value hierarchy. Fair values determined
by Level 1 inputs utilize quoted prices (unadjusted) in
active markets for identical assets or liabilities that we have
the ability to access. Fair values determined by Level 2
inputs utilize data points that are observable such as quoted
prices, interest rates and yield curves. Fair values determined
by Level 3 inputs are unobservable data points for the
asset or liability.
As noted in Note 5, Fair Value Measurements, a majority of
our financial assets and liabilities have been classified as
Level 2. These assets and liabilities have been initially
valued at the transaction price and subsequently valued
utilizing third party pricing services. The pricing services use
many inputs to determine value, including reportable trades,
benchmark yields, credit spreads, broker/dealer quotes, bids,
offers, current spot rates, and other industry and economic
events. We validate the prices provided by our third party
pricing services by understanding the models used, obtaining
market values from other pricing sources and challenging pricing
data in certain instances.
Excluding cash equivalents, the largest portion of our
marketable debt securities is comprised of investments that may
be sensitive to changes in economic factors such as interest
rates or credit spreads. These risks are further described in
Part II, Item 1A, Risk Factors of this
Form 10-Q.
The only assets where we used Level 3 inputs to determine
the fair value are our venture capital investments, which
represent approximately 0.3% of the total assets at
September 30, 2008. The underlying assets in these funds
are initially measured at transaction prices and subsequently
valued using the pricing of recent financing
and/or by
reviewing the underlying economic fundamentals and liquidation
value of the companies.
We have financed our operating and capital expenditures through
cash flows from our operations. We financed our common stock
tender offer in July 2007 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 adversely affect 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 $1,155.2 million and
$674.8 million in the nine months ended September 30,
2008 and 2007, respectively. The increase is due to higher
earnings, offset by lower non-cash charges and a higher
investment in working capital.
31
Investing
activities
Cash provided by investing activities was $99.9 million and
$330.1 million in the nine months ended September 30,
2008 and 2007, respectively. This decrease was primarily due to
a reduction in net proceeds from our sales and purchases of
marketable securities. Purchases of property, plant and
equipment totaled $221.9 million in the nine months ended
September 30, 2008, as compared to $175.8 million in
the nine months ended September 30, 2007. Payments pursuant
to acquisitions and licenses were $25.0 million in the nine
months ended September 30, 2008, which related to our 2006
acquisition of Conforma, and $92.3 million in the nine
months ended September 30, 2007, which related to our
acquisition of Syntonix and agreement with Cardiokine Biopharma
LLC.
Financing
activities
Cash used in financing activities in the nine months ended
September 30, 2008 was $902.8 million compared to cash
provided of $1,228.9 million in the nine months ended
September 30, 2007. The increase in use of cash was due,
principally, to the repayment of our term loan facility of
$1.5 billion, and the purchase of our common stock of
$559.8 million, offset in part by the issuance of long-term
debt, net, of $987.0 million, and proceeds of
$167.0 million relating to the exercise of stock options
and purchases of our stock under our employee stock purchase
plan.
Borrowings
On March 4, 2008, we issued $450.0 million aggregate
principal amount of 6.0% Senior Notes due March 1,
2013 and $550.0 million aggregate principal amount of
6.875% Senior Notes due March 1, 2018 for proceeds of
$987.0 million, net of issuance costs. Additionally, in
connection with the note issuance, we entered into interest rate
swaps which are further described in Note 6, Financial
Instruments.
We used the proceeds of this offering, along with cash and the
proceeds from the liquidation of marketable securities, to repay
the $1.5 billion term loan facility we had entered into in
July 2007 in connection with the funding of our June 2007 tender
offer.
In June 2007, we also entered into a five-year
$400.0 million Senior Unsecured Revolving Credit Facility,
which we may use for working capital and general corporate
purposes. The bankruptcy of Lehman Brothers Holdings Inc. in
September 2008 has eliminated their $40 million portion of
the credit facility, thereby reducing the availability of the
credit facility to $360 million. As of September 30,
2008, there were no borrowings outstanding under this credit
facility.
Working
capital
At September 30, 2008, our working capital, which we define
as current assets less current liabilities, was
$1,653.2 million, as compared to $179.2 million at
December 31, 2007, an increase of $1,474 million. This
primarily reflects use of cash and cash equivalents and the
issuance of long-term debt to repay our short-term loan facility
of $1.5 billion.
Commitments
As of September 30, 2008, we have completed the first phase
of construction of our large-scale biologic manufacturing
facility in Hillerod, Denmark, which included partial completion
of a bulk manufacturing component, a labeling and packaging
component, and installation of major equipment. We are
proceeding with the second phase of the project, including the
completion of the large scale bulk manufacturing component and
construction of a warehouse. As of September 30, 2008, we
had contractual commitments of approximately $240.4 million
for the second phase, of which approximately $227 million
had been paid. This second phase of the project is expected to
be in commercial production in 2010.
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 sales growth of TYSABRI. Now that TYSABRI has
been approved for the
32
treatment of relapsing forms of MS in the U.S. and other
countries, 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.
Share
Repurchase Program
In the nine months ended September 30, 2008, we repurchased
approximately 9.0 million shares of our common stock for
$559.8 million under the share repurchase program that our
Board of Directors authorized in October 2006.
Contractual
Obligations and Off-Balance Sheet Arrangements
We have funding commitments as of September 30, 2008 of up
to approximately $26.6 million as part of our investment in
biotechnology-oriented venture capital investments. 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 or commercial
milestones. Because the achievement of these milestones had not
occurred as of September 30, 2008, 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 entities falling within the scope of FIN 46(R)
if we are the primary beneficiary.
The following summarizes our contractual obligations (excluding
funding and contingent milestone payments as described above and
construction commitments disclosed above under
Commitments) as of September 30, 2008,
including debt issued in March 2008, and the effects such
obligations are expected to have on our liquidity and cash flows
in future periods (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period
|
|
|
|
|
|
|
Remainder of
|
|
|
2009-
|
|
|
2011-
|
|
|
After
|
|
|
|
Total
|
|
|
2008
|
|
|
2010
|
|
|
2012
|
|
|
2012
|
|
|
Non-cancellable operating leases
|
|
$
|
104.5
|
|
|
$
|
6.8
|
|
|
$
|
47.0
|
|
|
$
|
32.2
|
|
|
$
|
18.5
|
|
Notes payable(1)
|
|
|
1,469.1
|
|
|
|
15.0
|
|
|
|
154.1
|
|
|
|
121.6
|
|
|
|
1,178.4
|
|
Other long-term obligations
|
|
|
8.3
|
|
|
|
2.4
|
|
|
|
5.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations
|
|
$
|
1,581.9
|
|
|
$
|
24.2
|
|
|
$
|
207.0
|
|
|
$
|
153.8
|
|
|
$
|
1,196.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes estimated interest payable |
This table also excludes any liabilities pertaining to uncertain
tax positions, as we cannot make a reliable estimate of the
period of cash settlement with the respective taxing
authorities. In connection with the adoption of FASB
Interpretation No. 48, Accounting for Uncertainty in
Income Taxes an Interpretation of FASB Statement
No. 109, or FIN 48, we reclassified approximately
$113 million in reserves for uncertain tax positions from
current taxes payable to long-term liabilities. At
September 30, 2008, we have approximately $129 million
of long-term liabilities associated with uncertain tax positions.
Legal
Matters
Refer to Note 13, Litigation, for a discussion of legal
matters as of September 30, 2008.
New
Accounting Standards
Refer to Note 15, New Accounting Pronouncements, for a
discussion of new accounting standards.
33
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 U.S. 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, fair value, fair value hierarchies, 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 year ended December 31, 2007 for a discussion of
the Companys critical accounting estimates.
|
|
Item 3.
|
Quantitative
and Qualitative Disclosures about Market Risk
|
Our market risks, and the ways we manage them, are summarized in
Item 7A of our Annual Report on
Form 10-K
for the year ended December 31, 2007. In response to the
instability in the global financial markets, we have regularly
reviewed our marketable securities holdings and reduced
investments deemed to have increased risk. Apart from such
adjustments to our investment portfolio, there have been no
material changes in the first nine months of 2008 to our market
risks or to 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, 2008. Based
upon that evaluation, our principal executive officer and
principal financial officer concluded that, as of
September 30, 2008, 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, 2008 that have materially affected, or are
reasonably likely to materially affect, our internal control
over financial reporting.
34
Part II
OTHER INFORMATION
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Item 1.
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Legal
Proceedings
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Refer to Note 13, Litigation, in Notes to
Consolidated Financial Statements in Part I of this
quarterly report on
Form 10-Q,
which 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 81% of our total
revenues for the first nine months of 2008. Any significant
negative developments relating to these two products, such as
safety or efficacy issues, the introduction or greater
acceptance of competing products (including greater than
anticipated substitution of TYSABRI for AVONEX) or adverse
regulatory or legislative developments, would have a material
adverse effect on our results of operations. Although we have
developed and continue to develop additional products for
commercial introduction, we expect to be substantially dependent
on sales from these two products for many years. A decline in
sales from either of these two products would adversely affect
our business.
Our
near-term success depends on the market acceptance and
successful sales growth of TYSABRI
A substantial portion of our growth in the near-term is
dependent on anticipated sales of TYSABRI. TYSABRI is expected
to 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.
Achievement of anticipated sales growth of TYSABRI 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. In July 2008, we
disclosed two confirmed cases of progressive multifocal
leukoencephalopathy (PML), a known side effect, in patients
taking TYSABRI. These patients were the first two confirmed
cases of PML reported to us since the reintroduction of TYSABRI
in the U.S. and approval in the EU in July 2006. The
occurrence of PML or the occurrence of other side effects could
harm acceptance and limit TYSABRI sales. Any significant lack or
diminution 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 relatively new entrant to a maturing multiple sclerosis
(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.
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. 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.
Conducting clinical trials is a complex, time-consuming and
expensive process. Our ability to complete our clinical trials
in a timely fashion depends in large part on a number of key
factors including protocol
35
design, regulatory and institutional review board approval, the
rate of patient enrollment in clinical trials, and compliance
with extensive current good clinical practice requirements. We
have recently opened clinical sites and are enrolling patients
in a number of new countries where our experience is more
limited, and we are in many cases using the services of
third-party contract clinical trial providers. If we fail to
adequately manage the design, execution and regulatory aspects
of our large, complex and diverse clinical trials, our studies
and ultimately our regulatory approvals may be delayed or we may
fail to gain approval for our product candidates altogether.
Adverse
safety events can negatively affect our assets, product sales,
operations, products in development and stock
price
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. In
addition, the reporting of adverse safety events involving our
products and public rumors about such events could cause our
stock price to decline or experience periods of volatility.
If we
fail to compete effectively, our business and market position
would suffer
The biotechnology and pharmaceutical industry is intensely
competitive. We compete in the marketing and sale of our
products, the development of new products and processes, the
acquisition of rights to new products with commercial potential
and the hiring and retention of personnel. We compete with
biotechnology and pharmaceutical companies that have a greater
number of products on the market, greater financial and other
resources and other technological or competitive advantages. We
cannot be certain that one or more of our competitors will not
receive patent protection that dominates, blocks or adversely
affects our product development or business, will not benefit
from significantly greater sales and marketing capabilities, or
will not develop products that are accepted more widely than
ours. The introduction of alternatives to our products that
offer advantages in efficacy, safety or ease of use could
negatively affect our revenues and reduce the value of our
product development efforts. In addition, potential governmental
action in the future could provide a means for competition from
developers of follow-on biologics, which could compete on price
and differentiation with products that we now or could in the
future market.
In addition to competing directly with products that are
marketed by substantial pharmaceutical competitors, AVONEX,
RITUXAN and TYSABRI 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.
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 order to pursue such
opportunities, we may require significant additional financing,
which may not be available to us on favorable terms, if at all.
The availability of such financing is limited by the recent
tightening of the global credit markets and the reduction of our
revolving credit facility from
36
$400 million to $360 million as a result of the
bankruptcy of Lehman Brothers Holdings Inc. 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.
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 the U.S., at both the federal and state levels, the
government regularly proposes legislation to reform healthcare
and its cost, any of which may impact our ability to
successfully commercialize our products. In the last few years,
there have been a number of legislative changes that have
affected the reimbursement for our products, including, but not
limited to, the Medicare Prescription Drug Improvement and
Modernization Act of 2003 and most recently, the Deficit
Reduction Act of 2005. The Deficit Reduction Act made
significant changes to the Medicaid prescription drug provisions
of the Social Security Act, including changes that impose the
monthly reporting of price information and that may have an
impact on the Medicaid rebates we pay. 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.
Pricing pressures in the U.S. may increase as a result of
the Medicare Prescription Drug Improvement and Modernization Act
of 2003. Managed care organizations as well as Medicaid and
other government health administration authorities continue to
seek price discounts. Government efforts to reduce Medicaid
expenses may continue to increase the use of managed care
organizations. This may result in managed care organizations
influencing prescription decisions for a larger segment of the
population and a corresponding constraint on prices and
reimbursement for our products. In addition, some states have
implemented and other states are considering price controls or
patient-access constraints under the Medicaid program and some
states are considering price-control regimes that would apply to
broader segments of their populations that are not Medicaid
eligible. Other matters also could be the subject of
U.S. federal or state legislative or regulatory action that
could adversely affect our business, including the importation
of prescription drugs that are marketed outside the
U.S. and sold at lower prices as a result of drug price
limitations imposed 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.
37
We
depend on collaborators for both product and royalty revenue and
the clinical development of future collaboration products, which
are 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; and
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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).
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. In
addition, the Food and Drug Administration Amendments Act of
2007 included new authorization for the FDA to require
post-market safety monitoring, along with a clinical trials
registry, and expanded authority for FDA to impose civil
monetary penalties on companies that fail to meet certain
commitments.
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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 both in the U.S. and in foreign jurisdictions.
Pharmaceutical and biotechnology companies have been the target
of lawsuits and investigations alleging violations of government
regulation, including claims asserting submission of incorrect
pricing information, impermissible off-label promotion of
pharmaceutical products, causing false claims to be submitted
for government reimbursement as well as antitrust violations, 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. In addition
to penalties for violation of laws and regulations, we could be
required to repay amounts we received from government payors, or
pay additional rebates and interest if we are found to have
miscalculated the pricing information we have submitted to the
government.
Whether or not we have complied with the law, an investigation
into alleged unlawful conduct could increase our expenses,
damage our reputation, divert management time and attention and
adversely affect our business.
The federal Medicare/Medicaid anti-kickback law prohibits
payments intended to induce any entity either to purchase,
order, or arrange for or recommend the purchase of healthcare
products or services paid for under federal health care
programs. There are similar laws in a number of states. These
laws constrain the sales, marketing and other promotional
activities of manufacturers of drugs and biologics, such as us,
by limiting the kinds of financial arrangements, including sales
programs, with hospitals, physicians, and other potential
purchasers of drugs and biologics. Other federal and state laws
generally prohibit individuals or entities from knowingly
presenting, or causing to be presented, claims for payment from
federal health care programs, including 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).
Problems
with manufacturing or with inventory planning could result in
our inability to deliver products, inventory shortages or
surpluses, 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 successfully manufacture
bulk product and to obtain and 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 that could require us to delay shipment of products or
recall or withdraw products previously shipped, which could
result in inventory write-offs and 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. In addition, lower than
expected demand for our products, including suspension of sales,
or a change in product mix may result in less than optimal
utilization of our manufacturing facilities and lower inventory
turnover, which could result in abnormal manufacturing variance
charges, facility impairment charges and charges for excess and
obsolete inventory.
We rely solely on our manufacturing facility in Research
Triangle Park, North Carolina, or RTP, for the production of
TYSABRI. We have applied to the FDA and the European Medicines
Agency, or the EMEA, for approval of a production process, known
as a second generation high-titer process, which has higher
yields of TYSABRI than the process we currently use. If we do
not obtain approval for that process, to meet anticipated demand
for TYSABRI we would need to increase our capital spending to
add capacity at our RTP manufacturing facility and at the
Hillerod, Denmark facility we are completing. Such an increase
in capital spending would affect our business, cash position and
results of operations.
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
39
bulk products of the type we require. We cannot be certain that
we could reach agreement on reasonable terms, if at all, with
those manufacturers. Even if we were to reach agreement, the
transition of the manufacturing process to a third party to
enable commercial supplies could take a significant amount of
time. Our ability to supply products in sufficient capacity to
meet demand is also dependent upon third party contractors to
fill-finish, package and store such products. Any prolonged
interruption in the operations of our existing manufacturing
facilities could result in cancellations of shipments or loss of
product in the process of being manufactured. Because our
manufacturing processes are highly complex and are subject to a
lengthy FDA approval process, alternative qualified production
capacity may not be available on a timely basis or at all.
We
rely on third parties to provide services in connection with the
manufacture of our products and, in some instances, the
manufacture of the product itself
We rely on Genentech for all RITUXAN manufacturing. Genentech
relies on a third party to manufacture certain bulk RITUXAN
requirements. If Genentech or any third party upon which it
relies does not manufacture or fill-finish RITUXAN in sufficient
quantities and on a timely and cost-effective basis, or if
Genentech or any third party does not obtain and maintain all
required manufacturing approvals, our business could be harmed.
We also source all of our fill-finish and the majority of our
final product storage operations, along with a substantial
portion of our packaging operations of the components used with
our products, to a concentrated group of third party
contractors. The manufacture of products and product components,
fill-finish, packaging and storage of our products require
successful coordination among us 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, diminish our profitability 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.
The
current credit and financial market conditions may exacerbate
certain risks affecting our business.
Sales of our products are dependent, in large part, on
reimbursement from government health administration authorities,
private health insurers, distribution partners and other
organizations. As a result of the current credit and financial
market conditions, these organizations may be unable to satisfy
their reimbursement obligations or may delay payment. In
addition, federal and state health authorities may reduce
Medicare and
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Medicaid reimbursements, and private insurers may increase their
scrutiny of claims. A reduction in the availability or extent of
reimbursement could negatively affect our product sales and
revenue.
In addition, we rely on third parties for several important
aspects of our business. For example, we source portions of our
product manufacturing to a concentrated group of third-party
contractors, we depend upon collaborators for both product and
royalty revenue and the clinical development of future
collaboration products, we use third-party contract research
organizations for many of our clinical trials, and we rely upon
several single source providers of raw materials for our
products. Due to the recent tightening of global credit and the
disruption in the financial markets, there may be a disruption
or delay in the performance of our third-party contractors,
suppliers or collaborators. If such third parties are unable to
satisfy their commitments to us, our business would be adversely
affected.
Our
investments in marketable securities are significant and are
subject to market, 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, instability in the global financial markets that
reduces the liquidity of securities included in the portfolio,
declines in the value of collateral underlying the mortgage- and
asset-backed securities included in the portfolio, and by other
factors which may result in other than temporary declines in
value of the investments. Each of these events may cause us to
record charges to reduce the carrying value of our investment
portfolio or sell investments for less than our acquisition
cost. We attempt to mitigate these risks with the assistance of
our investment advisors by investing in high quality securities
and continuously monitoring the overall risk profile of our
portfolio.
We
have made a significant investment in constructing a
manufacturing facility the success of which depends upon the
completion and licensing of the facility and continued demand
for our products
We are building a large-scale biologic manufacturing facility in
Hillerod, Denmark, in which we have invested approximately
$611.0 million. We anticipate that the facility will be
ready for commercial production in 2010. If we fail to manage
the project, or other unforeseen events occur, we may incur
additional costs to complete the project. Depending on the
timing of the completion and licensing of the facility, and our
other estimates and assumptions regarding future product sales,
the carrying value of all or part of the manufacturing facility
or other assets may not be fully recoverable and could result in
the recognition of an impairment in the carrying value at the
time that such effects are identified. The recognition of
impairment in the carrying value, if any, could have a material
and adverse affect on our results of operations. For example, if
the anticipated demand for TYSABRI does not materialize, the
carrying values of our Hillerod, Denmark facility could be
impaired, which would negatively impact our results of
operations.
If we
are unable to attract and retain qualified personnel and key
relationships, the growth of our business could be
harmed
Our success will depend, to a great extent, upon our ability to
attract and retain qualified scientific, manufacturing, sales
and marketing and executive personnel and our ability to develop
and maintain relationships with qualified clinical researchers
and key distributors. Competition for these people and
relationships is intense and we compete with numerous
pharmaceutical and biotechnology companies as well as with
universities and non-profit research organizations. Any
inability we experience to continue to attract and retain
qualified personnel or develop and maintain key relationships
could have an adverse effect on our ability to accomplish our
research, development and external growth objectives.
Our
sales and operations are subject to the risks of doing business
internationally
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
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 will affect our operating
results, often in unpredictable ways.
Our
business could be negatively affected as a result of the actions
of activist shareholders
During the first half of 2008, we defended against a proxy
contest waged by Icahn Partners and certain of its affiliates
that nominated three individuals for election to our Board of
Directors at our 2008 Annual Meeting of Stockholders. Although
we were successful in having our Boards nominees elected
as directors, the proxy contest was disruptive to our operations
and caused us to incur substantial costs. If Icahn Partners or
any other activist shareholders wage a subsequent proxy context,
our business could be adversely affected because:
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Responding to proxy contests and other actions by activist
shareholders can be costly and time-consuming, disrupting our
operations and diverting the attention of management and our
employees;
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Perceived uncertainties as to our future direction may result in
the loss of potential acquisitions, collaborations or
in-licensing opportunities, and may make it more difficult to
attract and retain qualified personnel and business
partners; and
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If individuals are elected to our board of directors with a
specific agenda, it may adversely affect our ability to
effectively and timely implement our strategic plan and create
additional value for our stockholders.
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These actions could cause our stock price to experience periods
of volatility.
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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42
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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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inventory write-downs for failed quality specifications, charges
for excess or obsolete inventory and charges for inventory write
downs relating to product suspensions; and
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the cost of restructurings.
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Our quarterly revenues are also subject to foreign exchange rate
fluctuations due to the global nature of our operations.
Although we have foreign currency forward contracts to hedge
specific forecasted transactions denominated in foreign
currencies, our efforts to reduce currency exchange losses may
not be successful. As a result, changes in currency exchange
rates may have an adverse impact on our future operating results
and financial condition. Additionally, our 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. In addition, pending
legislation to reform the patent system could also reduce our
ability to enforce our patents. We do not know when, or if,
changes to the U.S. patent system will become law. 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 manufacture and market our
products.
43
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 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
manufacture and 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, lawsuits have been filed by patients who have had
serious adverse events while using TYSABRI, and we may face
lawsuits with other product liability and related claims by
patients treated with TYSABRI or other products.
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 managing our business.
Our
effective tax rate may fluctuate and we may incur liabilities to
tax authorities in excess of amounts that have been
accrued
As a global biotechnology company, we are subject to taxation in
numerous countries, states and other jurisdictions. As a result,
our effective tax rate is derived from a combination of
applicable tax rates in the various countries, states and other
jurisdictions in which we operate. In preparing our financial
statements, we estimate the amount of tax that will become
payable in each of the countries, states and other jurisdictions
in which we operate. Our effective tax rate, however, may be
lower or higher than those experienced in the past due to
numerous factors, including a change in the mix of our business
from country to country, the cessation or termination of
agreements we have with various taxing authorities, recently
enacted and future changes in tax laws in jurisdictions in which
we operate, unfavorable results of audits of our tax filings,
and changes in accounting for income taxes. Any of these factors
could cause us to experience an effective tax rate
44
significantly different from previous periods or our current
expectations and we may incur significant liabilities to tax
authorities in excess of amounts that have been accrued in our
financial statements, which could have an adverse effect on our
business and results of operations.
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 significant 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 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
laboratory
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. Biologics manufacturing
also requires permits from government agencies for water supply
and wastewater discharge. If we do not obtain appropriate
permits, or permits for sufficient quantities of water and
wastewater, we could incur significant costs and limits on our
manufacturing volumes that could harm our business.
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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45
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our collaboration agreement with Elan provides Elan with the
option to buy the rights to TYSABRI in the event that we undergo
a change of control, which may limit our attractiveness to
potential acquirers;
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our amended and restated collaboration agreement with Genentech
provides that, in the event we undergo a change of control,
within 90 days Genentech may present an offer to us to
purchase our rights to RITUXAN. In an arbitration proceeding
brought by Biogen Idec relating to the collaboration agreement,
Genentech alleged that the November 2003 transaction in which
Idec Pharmaceuticals 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 continue to vigorously assert this
position. 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.
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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 stockholders.
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Item 2.
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Unregistered
Sales of Equity Securities and Use of Proceeds
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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. 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. We did not repurchase any shares
pursuant to this program during the three months ended
September 30, 2008.
The exhibits listed on the Exhibit Index immediately
preceding such exhibits, which is incorporated herein by
reference, are filed or furnished as part of this Quarterly
Report on
Form 10-Q.
46
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
BIOGEN IDEC INC.
Paul J. Clancy
Executive Vice President and Chief
Financial Officer
October 21, 2008
47
EXHIBIT INDEX
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Exhibit
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Number*
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Description of Exhibit
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3
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.1+
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Second Amended and Restated Bylaws
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10
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.1+
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Annual Retainer Summary for Board of Directors
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10
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.2
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Form of restricted stock unit award agreement under the Biogen
Idec Inc. 2008 Omnibus Equity Plan. Filed as Exhibit 10.1
to Biogen Idecs Current Report on
Form 8-K
filed on August 1, 2008.
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10
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.3
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Form of nonqualified stock option award agreement under the
Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as
Exhibit 10.2 to Biogen Idecs Current Report on
Form 8-K
filed on August 1, 2008.
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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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* |
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Unless otherwise indicated, exhibits were previously filed with
the Securities and Exchange Commission under Commission File
Number 0-19311 and are incorporated herein by reference. |
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+ |
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Filed herewith |
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Furnished herewith |
exv3w1
Exhibit 3.1
SECOND AMENDED AND RESTATED
BYLAWS
OF
BIOGEN IDEC INC.
(Adopted as of October 13, 2008)
TABLE OF CONTENTS
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Page |
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ARTICLE 1 Offices |
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1 |
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1.1 Registered Office |
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1 |
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1.2 Other Offices |
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1 |
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ARTICLE 2 Meeting of Stockholders |
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1 |
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2.1 Place of Meeting |
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1 |
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2.2 Annual Meeting |
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1 |
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2.3 Special Meetings |
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4 |
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2.4 Notice of Meetings |
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4 |
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2.5 List of Stockholders |
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5 |
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2.6 Organization and Conduct of Business |
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5 |
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2.7 Quorum |
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5 |
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2.8 Adjournments |
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6 |
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2.9 Voting Rights |
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6 |
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2.10 Majority Vote |
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6 |
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2.11 Record Date for Stockholder Notice, Voting, Payment and Written Consent |
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6 |
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2.12 Proxies |
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7 |
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2.13 Inspectors of Election |
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7 |
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2.14 Inspectors of Written Consent |
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8 |
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ARTICLE 3 Directors |
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8 |
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3.1 Number, Election, Tenure and Qualifications |
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8 |
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3.2 Enlargement and Vacancies |
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11 |
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3.3 Resignation and Removal |
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12 |
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3.4 Powers |
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12 |
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3.5 Place of Meetings |
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12 |
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3.6 Organizational Meetings |
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12 |
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3.7 Regular Meetings |
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12 |
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3.8 Special Meetings |
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12 |
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3.9 Quorum, Action at Meeting, Adjournments |
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13 |
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3.10 Action Without Meeting |
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13 |
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3.11 Telephone Meetings |
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13 |
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3.12 Committees |
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13 |
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3.13 Fees and Compensation of Directors |
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14 |
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3.14 Rights of Inspection |
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14 |
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3.15 Lead Director |
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14 |
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ARTICLE 4 Officers |
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14 |
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4.1 Officers Designated |
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14 |
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4.2 Appointment |
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15 |
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TABLE OF CONTENTS
(continued)
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4.3 Tenure |
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15 |
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4.4 Chairman and Vice Chairman |
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15 |
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4.5 The Chief Executive Officer |
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15 |
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4.6 The President |
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16 |
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4.7 The Vice President |
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16 |
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4.8 The Secretary |
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16 |
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4.9 The Assistant Secretary |
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16 |
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4.10 The Chief Financial Officer |
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17 |
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4.11 The Treasurer and Assistant Treasurers |
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17 |
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4.12 Bond |
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17 |
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ARTICLE 5 Notices |
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17 |
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5.1 Delivery |
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17 |
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5.2 Waiver of Notice |
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18 |
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ARTICLE 6 Indemnification and Insurance |
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18 |
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6.1 Indemnification |
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18 |
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6.2 Advance Payment |
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22 |
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6.3 Non-Exclusivity and Survival of Rights; Amendments |
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22 |
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6.4 Insurance |
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22 |
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6.5 Severability |
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22 |
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6.6 Definitions |
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23 |
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6.7 Notices |
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24 |
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ARTICLE 7 Capital Stock |
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25 |
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7.1 Certificates for Shares |
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25 |
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7.2 Signatures on Certificates |
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25 |
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7.3 Transfer of Stock |
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26 |
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7.4 Registered Stockholders |
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26 |
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7.5 Lost, Stolen or Destroyed Certificates |
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26 |
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ARTICLE 8 General Provisions |
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26 |
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8.1 Dividends |
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26 |
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8.2 Dividend Reserve |
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27 |
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8.3 Checks |
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27 |
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8.4 Fiscal Year |
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27 |
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8.5 Corporate Seal |
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27 |
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8.6 Execution of Corporate Contracts and Instruments |
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27 |
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8.7 Representation of Shares of Other Corporations |
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27 |
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ARTICLE 9 Amendments |
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28 |
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- ii -
SECOND AMENDED AND RESTATED
BYLAWS
OF
BIOGEN IDEC INC.
(Adopted as of October 13, 2008)
ARTICLE 1
Offices
1.1 Registered Office
The registered office of the corporation shall be set forth in the certificate of
incorporation of the corporation.
1.2 Other Offices
The corporation may also have offices at such other places, either within or without the State
of Delaware, as the Board of Directors (the Board) may from time to time designate or the
business of the corporation may require.
ARTICLE 2
Meeting of Stockholders
2.1 Place of Meeting
Meetings of stockholders may be held at such place, either within or without of the State of
Delaware, as may be designated by or in the manner provided in these bylaws, or, if not so
designated, as determined by the Board.
2.2 Annual Meeting
Annual meetings of stockholders shall be held each year at such place, date and time as shall
be designated from time to time by the Board and stated in the notice of the meeting. At each such
annual meeting, the stockholders shall elect by a plurality vote the number of directors equal to
the number of directors of the class whose term expires at such meeting (or, if fewer, the number
of directors properly nominated and qualified for election) to hold office until the third
succeeding annual meeting of stockholders after their election and until their successors are duly
elected and qualified or until their earlier resignation, removal from office, death or incapacity.
- 1 -
The stockholders shall also transact such other business as may properly be brought before the
meeting.
To be properly brought before the annual meeting, nominations of persons for election to the
Board must be made in accordance with the procedures set forth in Section 3.1.
To be properly brought before the annual meeting, business other than nominations of persons
for election to the Board must be (a) specified in the notice of meeting (or any supplement
thereto) given by or at the direction of the Board or the Chairman of the Board or the Chief
Executive Officer, (b) otherwise properly brought before the meeting by or at the direction of the
Board (or any committee thereof) or the Chairman of the Board or the Chief Executive Officer, or
(c) otherwise properly brought before the meeting by a stockholder of record of the corporation at
the time the notice provided for in this Section 2.2 is delivered to the Secretary of the
corporation, who is entitled to vote at the meeting and who otherwise complies with this
Section 2.2. For any proposed business to be properly brought before an annual meeting by
a stockholder pursuant to clause (c) above of this paragraph, the proposed business must constitute
a proper matter for stockholder action. Any such stockholder may propose business to be brought
before a meeting only if such stockholder has given timely notice to the Secretary of the
corporation in proper written form of the stockholders intent to propose such business. To be
timely, the stockholders notice must be delivered by a nationally recognized courier service or
mailed by first class United States mail, postage or delivery charges prepaid, and received at the
principal executive offices of the corporation addressed to the attention of the Secretary of the
corporation not less than ninety (90) days nor more than one hundred twenty (120) days in advance
of the date the corporations proxy statement was released to the stockholders in connection with
the previous years annual meeting of stockholders; provided, however, that in the event that no
annual meeting was held in the previous year or the date of the annual meeting has been changed by
more than thirty (30) days from the date contemplated at the time of the previous years proxy
statement, notice by the stockholder must be received by the Secretary of the corporation not
earlier than the close of business on the one hundred twentieth (120th) day prior to such annual
meeting and not later than the close of business on the later of (x) the ninetieth (90th) day prior
to such annual meeting and (y) the tenth (10th) day following the day on which public announcement
of the date of such meeting is first made. For the purposes of these bylaws, public announcement
shall mean disclosure in a press release reported by the Dow Jones News Service, Associated Press
or a comparable national news service or in a document publicly filed by the corporation with the
Securities and Exchange Commission. In no event shall the public announcement of an adjournment or
postponement of an annual meeting commence a new time period (or extend any time period) for the
giving of stockholders notice as described above. A stockholders notice to the Secretary shall
set forth as to each matter the stockholder proposes to bring before the annual meeting (i) a brief
description of the business desired to be brought before the annual meeting, the text of the
proposal or business (including the text of any resolutions proposed for consideration and in the
event that such business includes a proposal to amend these bylaws, the language of the proposed
amendment), and the reasons for conducting such business at the annual meeting, (ii) the name and
record address of the stockholder proposing such business and the beneficial owner, if any, on
whose behalf the proposal is made, (iii) the class, series and number of shares of the corporation
that are owned beneficially and of record by the stockholder and such beneficial owner and a
representation that the stockholder will notify the corporation in writing of the class and number
of such shares
- 2 -
owned beneficially and of record as of the record date for the meeting promptly following the
later of the record date or the date notice of the record date is first publicly disclosed, (iv)
any option, warrant, convertible security, stock appreciation right, or similar right with an
exercise or conversion privilege or a settlement payment or mechanism at a price related to any
class or series of shares of the corporation or with a value derived in whole or in part from the
value of any class or series of shares of the corporation, whether or not such instrument or right
shall be subject to settlement in the underlying class or series of capital stock of the
corporation or otherwise (a Derivative Instrument) directly or indirectly owned beneficially by
such stockholder and any other direct or indirect opportunity to profit or share in any profit
derived from any increase or decrease in the value of shares of the corporation and a
representation that the stockholder will notify the corporation in writing of any such Derivative
Instrument in effect as of the record date for the meeting promptly following the later of the
record date or the date notice of the record date is first publicly disclosed, (v) a description of
any agreement, arrangement or understanding with respect to the proposal of business between or
among such stockholder and such beneficial owner, any of their respective affiliates or associates,
and any others acting in concert with any of the foregoing and a representation that the
stockholder will notify the corporation in writing of any such agreements, arrangements or
understandings in effect as of the record date for the meeting promptly following the later of the
record date or the date notice of the record date is first publicly disclosed, (vi) a description
of any material interest of the stockholder and the beneficial owner, if any, on whose behalf the
proposal is made, in such business, (vii) a representation that the stockholder is a holder of
record of stock of the corporation entitled to vote at such meeting and intends to appear in person
or by proxy at the meeting to propose such business, (viii) a representation whether the
stockholder or the beneficial owner, if any, intends or is part of a group which intends (a) to
deliver a proxy statement and/or form of proxy to holders of at least the percentage of the
corporations outstanding capital stock required to approve or adopt the proposal and/or (b)
otherwise to solicit proxies from stockholders in support of such proposal and (ix) any other
information that is required to be provided by the stockholder pursuant to Section 14 of the
Securities Exchange Act of 1934 and the rules and regulations promulgated thereunder (collectively,
the 1934 Act) in such stockholders capacity as a proponent of a stockholder proposal.
Notwithstanding anything in these bylaws to the contrary, no business shall be conducted at
the annual meeting except in accordance with the procedures set forth in this Section 2.2,
and no nominations shall be considered at an annual or special meeting of stockholders except in
accordance with the procedures set forth in Section 3.1 below; provided, however, that the
foregoing notice requirements of this Section 2.2 shall be deemed satisfied by a
stockholder with respect to business other than a nomination if the stockholder has notified the
corporation of his, her or its intention to present a proposal at an annual meeting in compliance
with applicable rules and regulations promulgated under the 1934 Act and such stockholders
proposal has been included in a proxy statement that has been prepared by the corporation to
solicit proxies for such annual meeting.
Except as otherwise provided by law, the Chairman of the Board (or such other person presiding
at the meeting in accordance with these bylaws) shall, if the facts warrant, determine and declare
to the meeting that business was not properly brought before the meeting in accordance with the
provisions of this Section 2.2 (including whether the stockholder or beneficial owner, if
any, on whose behalf the proposal is made solicited (or is part of a group
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which solicited) or did not so solicit, as the case may be, proxies in support of such
stockholders proposal in compliance with such stockholders representation as required by clause
(viii) above of this Section 2.2), and if he or she should so determine, he or she shall so
declare to the meeting and any such business not properly brought before the meeting shall not be
transacted. Notwithstanding the foregoing provisions of this Section 2.2, unless otherwise
required by law, if the stockholder (or a qualified representative of the stockholder) does not
appear at the annual or special meeting of stockholders of the corporation to present proposed
business, such proposed business shall not be transacted, notwithstanding that proxies in respect
of such proposed business may have been received by the corporation. For purposes of this
Section 2.2, to be considered a qualified representative of the stockholder, a person must
be a duly authorized officer, manager or partner of such stockholder or must be authorized by a
writing executed by such stockholder or an electronic transmission delivered by such stockholder to
act for such stockholder as proxy at the meeting of stockholders and such person must produce such
writing or electronic transmission, or a reliable reproduction of the writing or electronic
transmission, at the meeting of stockholders.
Notwithstanding the foregoing provisions of this Section 2.2 or Section 3.1, a
stockholder shall also comply with all applicable requirements of the 1934 Act and the rules and
regulations thereunder with respect to the matters set forth in this Section 2.2 or
Section 3.1; provided however, that any references in these bylaws to the 1934 Act or the
rules promulgated thereunder are not intended to and shall not limit any requirements applicable to
nominations or proposals as to any other business to be considered pursuant to this Section 2.2 or
Section 3.1 (including clause (c) of the third paragraph hereof, clause (c) of the third
paragraph of Section 3.1 and the sixth paragraph of Section 3.1), and compliance
with clause (c) of the third paragraph of this Section 2.2, clause (c) of the third
paragraph of Section 3.1 or the sixth paragraph of Section 3.1 shall be the
exclusive means for a stockholder to make nominations or submit other business (other than, as
provided in the fourth paragraph of this Section 2.2, matters brought properly under and in
compliance with Rule 14a-8 of the 1934 Act, as may be amended from time to time). Nothing in this
Section 2.2 shall be deemed to affect any rights of stockholders to request inclusion of
proposals in the corporations proxy statement pursuant to applicable rules and regulations
promulgated under the 1934 Act.
2.3 Special Meetings
Special meetings of the stockholders may be called for any purpose or purposes, unless
otherwise prescribed by statute or by the certificate of incorporation, by the Secretary only at
the request of the Chairman of the Board, the Chief Executive Officer or by a resolution duly
adopted by the affirmative vote of a majority of the Board. Such request shall state the purpose
or purposes of the proposed meeting. Business transacted at any special meeting shall be limited
to matters relating to the purpose or purposes stated in the notice of meeting.
2.4 Notice of Meetings
Except as otherwise provided by law, written notice of each meeting of stockholders, annual or
special, stating the place, if any, date and time of the meeting, the means of remote
communications, if any, by which stockholders and proxy holders may be deemed to be present in
person and vote at such meeting, and, in the case of a special meeting, the purpose or purposes
for which such special meeting is called, shall be given to each stockholder entitled to vote
at such meeting not less than ten (10) nor more than sixty (60) days before the date of the
meeting.
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When a meeting is adjourned to another place, date or time, notice need not be given of the
adjourned meeting if the place, date and time thereof are announced at the meeting at which the
adjournment is taken; provided, however, that if the date of any adjourned meeting is more than
thirty (30) days after the date for which the meeting was originally noticed, or if a new record
date is fixed for the adjourned meeting, written notice of the place, if any, date, time and means
of remote communications, if any, of the adjourned meeting shall be given in conformity herewith.
At any adjourned meeting, any business may be transacted that might have been transacted at the
original meeting.
2.5 List of Stockholders
The officer in charge of the stock ledger of the corporation or the transfer agent shall
prepare and make, at least ten (10) days before every meeting of stockholders, a complete list of
the stockholders entitled to vote at the meeting, arranged in alphabetical order, and showing the
address of each stockholder and the number of shares registered in the name of each stockholder.
Such list shall be open to the examination of any stockholder, for any purpose germane to the
meeting, for a period of at least ten (10) days prior to the meeting, (i) on a reasonably
accessible electronic network, provided that the information required to gain access to such list
is provided with the notice of the meeting, or (ii) during ordinary business hours, at the
principal place of business of the corporation. If the meeting is to be held at a place, then the
list shall also be produced and kept at the time and place of the meeting during the whole time
thereof, and may be inspected by any stockholder who is present. If the meeting is to be held
solely by means of remote communication, then the list shall also be open to the examination of any
stockholder during the whole time of the meeting on a reasonably accessible electronic network, and
the information required to gain access to such list shall be provided with the notice of the
meeting.
2.6 Organization and Conduct of Business
The Chairman of the Board or, in his or her absence, the Chief Executive Officer or President
of the corporation or, in their absence, such person as the Board may have designated or, in the
absence of such a person, such person as may be chosen by the holders of a majority of the shares
entitled to vote who are present, in person or by proxy, shall call to order any meeting of the
stockholders and act as chairman of the meeting. In the absence of the Secretary of the
corporation, the secretary of the meeting shall be such person as the chairman of the meeting
appoints.
The chairman of any meeting of stockholders shall determine the order of business and the
procedure at the meeting, including such regulation of the manner of voting and the conduct of
discussion as seems to him or her in order.
2.7 Quorum
Except where otherwise provided by law or the certificate of incorporation of the corporation
or these bylaws, the holders of a majority of the stock issued and outstanding and
entitled to vote, present in person or represented in proxy, shall constitute a quorum at all
meetings of the stockholders.
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2.8 Adjournments
Any meeting of stockholders may be adjourned from time to time to any other time and to any
other place at which a meeting of stockholders may be held under these bylaws, which time and place
shall be announced at the meeting, by either the Chairman of the Board or a majority of the
stockholders present in person or represented by proxy at the meeting and entitled to vote, whether
or not a quorum is present, without notice other than announcement at the meeting. At such
adjourned meeting at which a quorum shall be present or represented, any business may be transacted
which might have been transacted at the original meeting. If the adjournment is for more than
thirty days, or if after the adjournment a new record date is fixed for the adjourned meeting, a
notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at
the meeting.
2.9 Voting Rights
Unless otherwise provided in the certificate of incorporation of the corporation, each
stockholder shall at every meeting of the stockholders be entitled to one vote for each share of
the capital stock having voting power held by such stockholder.
2.10 Majority Vote
When a quorum is present at any meeting, the vote of the holders of a majority of the stock
having voting power present in person or represented by proxy shall decide any question brought
before such meeting, unless the question is one upon which by express provision of statute or of
the certificate of incorporation of the corporation or of these bylaws, a different vote is
required in which case such express provision shall govern and control the decision of such
question.
2.11 Record Date for Stockholder Notice, Voting, Payment and Written Consent
(a) For purposes of determining the stockholders entitled to notice of, or to vote at, any
meeting of stockholders or any adjournment thereof, or entitled to receive payment of any dividend
or other distribution or allotment of any rights, or entitled to exercise any right in respect of
any change, conversion or exchange of stock or for the purpose of any other lawful action (other
than the taking of action by written consent of the stockholders without a meeting which is
governed by Section 2.11(b) below), the Board may fix, in advance, a record date, which
shall not be more than sixty (60) days nor less than ten (10) days before the date of any such
meeting nor more than sixty (60) days before any other action to which the record date relates. A
determination of stockholders of record entitled to notice of or to vote at a meeting of
stockholders shall apply to any adjournment of the meeting; provided, however, that the Board may
fix a new record date for the adjourned meeting. If the Board does not so fix a record date, then:
(i) the record date for determining stockholders entitled to notice of or to vote at a meeting of
stockholders shall be at the close of business on the business day next preceding the day on which
notice is given or, if notice is waived, at the close of business on the business day next
preceding the day on which the meeting is held; and (ii) the record date for determining
stockholders for any other purpose shall be at the close of business on the day on which the
Board adopts the resolution relating to such purpose.
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(b) For purposes of determining the stockholders entitled to consent to corporate action in
writing without a meeting, the Board may fix a record date, which record date shall not precede the
date upon which the resolution fixing the record date is adopted by the Board, and which date shall
not be more than ten (10) days after the date upon which the resolution fixing the record date is
adopted by the Board. Any stockholder of record seeking to have the stockholders authorize or take
corporate action by written consent shall, by written notice to the Secretary, request the Board to
fix a record date. The Board shall, within ten (10) days after the date on which such written
notice is received, adopt a resolution fixing the record date. If no record date has been fixed by
the Board within ten (10) days after receipt of such written notice, when no prior action by the
Board is required by applicable law, the record date for determining stockholders entitled to
consent to corporate action in writing without a meeting shall be the first date on which a signed
written consent setting forth the action taken or proposed to be taken is delivered to the
corporation by delivery to its registered office in the State of Delaware, its principal place of
business or an officer or agent of the corporation having custody of the book in which proceedings
of meetings of stockholders are recorded, to the attention of the Secretary. Delivery shall be by
hand or by certified or registered mail, return receipt requested. If no record date has been
fixed by the Board and prior action by the Board is required by applicable law, the record date for
determining stockholders entitled to consent to corporate action in writing without a meeting shall
be at the close of business on the day on which the Board adopts the resolution taking such prior
action.
2.12 Proxies
Each stockholder entitled to vote at a meeting of stockholders may authorize another person or
persons to act for such stockholder by proxy, but no such proxy shall be voted or acted upon after
three (3) years from its date unless the proxy provides for a longer period. All proxies must be
filed with the Secretary of the corporation at the beginning of each meeting in order to be counted
in any vote at the meeting. Subject to the limitation set forth in the last clause of the first
sentence of this Section 2.12, a duly executed proxy that does not state that it is
irrevocable shall continue in full force and effect unless (i) revoked by the person executing it,
before the vote pursuant to that proxy, by a writing delivered to the corporation stating that the
proxy is revoked or by a subsequent proxy executed by, or attendance at the meeting and voting in
person by, the person executing the proxy, or (ii) written notice of the death or incapacity of the
maker of that proxy is received by the corporation before the vote pursuant to that proxy is
counted.
2.13 Inspectors of Election
The corporation shall, in advance of any meeting of stockholders, appoint one or more
inspectors of election to act at the meeting and make a written report thereof. The corporation
may designate one or more persons to act as alternate inspectors to replace any inspector who fails
to act. If no inspector or alternate is able to act at a meeting of stockholders, the person
presiding at the meeting shall appoint one or more inspectors to act at the meeting. Each
inspector, before entering upon the discharge of his or her duties, shall take and sign an oath
faithfully to execute the duties of inspector with strict impartiality and according to the
best of his or her ability.
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2.14 Inspectors of Written Consent
In the event of the delivery, in the manner prescribed by law or in these bylaws, to the
corporation of the requisite written consent or consents to take corporate action or any related
revocations thereof, the corporation may designate one or more persons for the purpose of promptly
performing a ministerial review of the validity of such consents and revocations. The corporation
may designate one or more persons to act as alternate inspectors to replace any inspector who fails
to act. Each inspector, before discharging his or her duties, shall take and sign an oath
faithfully to execute the duties of inspector with strict impartiality and according to the best of
his or her ability. For the purpose of permitting the inspectors to perform such review, no action
by written consent without a meeting shall be effective until such date as the independent
inspectors certify to the corporation that the consents delivered to the corporation in accordance
with applicable law and these bylaws represent at least the minimum number of votes that would be
necessary to take the corporate action. Nothing contained in this Section 2.14 shall
affect the right of the Board or any stockholder to contest the validity of any consent or
revocation thereof, whether before or after such certification by the independent inspectors, or to
take any other action (including, without limitation, the commencement, prosecution or defense of
any litigation with respect thereto, and the seeking of injunctive relief in such litigation).
ARTICLE 3
Directors
3.1 Number, Election, Tenure and Qualifications
The number of directors that shall constitute the entire Board initially shall be twelve (12);
provided, however, that the number of directors that shall constitute the entire Board shall be
fixed from time to time by resolution adopted by a majority of the entire Board. The classes of
directors that shall constitute the entire Board shall be as provided in the certificate of
incorporation of the corporation.
The directors shall be elected at the annual meetings of the stockholders, except as otherwise
provided in Section 3.2 below, and each director elected shall hold office until such
directors successor is elected and qualified, unless sooner displaced.
Subject to the rights of holders of any class or series of preferred stock, nominations of
persons for election to the Board by or at the direction of the Board may be made (a) pursuant to
the corporations notice of meeting (or any supplement thereto), (b) by or at the direction of the
Board or any committee thereof, or (c) by any stockholder of the corporation who was a stockholder
of record at the time the notice provided for in this Section 3.1 is delivered to the
Secretary of the corporation, who is entitled to vote for the election of directors at the
applicable meeting and who complies with the notice procedures set forth in this Section
3.1. Such nominations, other than those made by or at the direction of the Board, shall be
made pursuant to timely notice in writing to the Secretary of the corporation. To be timely, a
stockholders notice
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shall be delivered by a nationally recognized courier service or mailed by first class United
States mail, postage or delivery charges prepaid, and received at the principal executive offices
of the corporation addressed to the attention of the Secretary of the corporation not less than
ninety (90) days nor more than one hundred twenty (120) days in advance of the date the
corporations proxy statement was released to the stockholders in connection with the previous
years annual meeting of stockholders; provided, however, that in the event that no annual meeting
was held in the previous year or the date of the annual meeting has been changed by more than
thirty (30) days from the date contemplated at the time of the previous years proxy statement,
notice by the stockholder must be received by the Secretary of the corporation not earlier than the
close of business on the one hundred twentieth (120th) day prior to such annual meeting and not
later than the close of business on the later of (x) the ninetieth (90th) day prior to such annual
meeting and (y) the tenth (10th) day following the day on which public announcement of the date of
such meeting is first made. In no event shall the public announcement of an adjournment or
postponement of an annual meeting commence a new time period (or extend any time period) for the
giving of a stockholders notice as described above. Such stockholders notice to the Secretary
shall set forth (a) as to each person whom the stockholder proposes to nominate for election or
reelection as a director, (i) the name, age, business address and residence address of the person,
(ii) the principal occupation or employment of the person, (iii) the class, series and number of
shares of capital stock of the corporation that are owned beneficially and of record by the person,
(iv) a statement as to the persons citizenship, (v) the completed and signed representation and
agreement described below, (vi) any other information relating to the person that is required to be
disclosed in solicitations for proxies for election of directors pursuant to Section 14 of the 1934
Act, and (vii) such persons written consent to being named in the proxy statement as a nominee and
to serving as a director if elected, and (b) as to the stockholder giving the notice and the
beneficial owner, if any, on whose behalf the nomination is made, (i) the name and record address
of the stockholder and of such beneficial owner, if any, (ii) the class, series and number of
shares of capital stock of the corporation that are owned beneficially and of record by the
stockholder and such beneficial owner and a representation that the stockholder will notify the
corporation in writing of the class and number of such shares owned beneficially and of record as
of the record date for the meeting promptly following the later of the record date or the date
notice of the record date is first publicly disclosed, (iii) any Derivative Instrument directly or
indirectly owned beneficially by such stockholder and any other direct or indirect opportunity to
profit or share in any profit derived from any increase or decrease in the value of shares of the
corporation and a representation that the stockholder will notify the corporation in writing of any
such Derivative Instrument in effect as of the record date for the meeting promptly following the
later of the record date or the date notice of the record date is first publicly disclosed, (iv) a
description of any agreement, arrangement or understanding with respect to the nomination between
or among such stockholder and such beneficial owner, any of their respective affiliates or
associates, and any others acting in concert with any of the foregoing and a representation that
the stockholder will notify the corporation in writing of any such agreements, arrangements or
understandings in effect as of the record date for the meeting promptly following the later of the
record date or the date notice of the record date is first publicly disclosed, (v) a representation
that the stockholder is a holder of record of stock of the corporation entitled to vote at such
meeting and intends to appear in person or by proxy at the meeting to propose such nomination, and
(vi) a representation whether the stockholder or the beneficial owner, if any, intends or is part
of a
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group which intends (a) to deliver a proxy statement and/or form of proxy to holders of at
least the percentage of the corporations outstanding capital stock required to elect the nominee
and/or (b) otherwise to solicit proxies from stockholders in support of such nomination. The
corporation may require any proposed nominee to furnish such other information as may reasonably be
required by the corporation to determine the eligibility of such proposed nominee to serve as
director of the corporation.
To be eligible to be a nominee for election or reelection as a director of the corporation, a
person must deliver (in accordance with the time periods prescribed for delivery of notice under
this Section 3.1) to the Secretary of the corporation at the principal executive offices of
the corporation a written representation and agreement (in the form provided by the Secretary upon
written request) that such person (i) is not and will not become a party to (A) any agreement,
arrangement or understanding with, and has not given any commitment or assurance to, any person or
entity as to how such person, if elected as a director of the corporation, will act or vote on any
issue or question (a Voting Commitment) that has not been disclosed to the corporation or (B) any
Voting Commitment that could limit or interfere with such persons ability to comply, if elected as
a director of the corporation, with such persons fiduciary duties under applicable law, (ii) is
not and will not become a party to any agreement, arrangement or understanding with any person or
entity other than the corporation with respect to any direct or indirect compensation,
reimbursement or indemnification in connection with service or action as a director that has not
been disclosed therein, and (iii) in such persons individual capacity and on behalf of any person
or entity on whose behalf the nomination is being made, would be in compliance, if elected as a
director of the corporation, and will comply with, applicable law and all applicable publicly
disclosed corporate governance, conflict of interest, confidentiality and stock ownership and
trading policies and guidelines of the corporation.
Notwithstanding anything in the third sentence of the third paragraph of this Section 3.1
to the contrary, in the event that the number of directors to be elected to the Board is
increased effective at the annual meeting and there is no public announcement by the corporation
naming the nominees for the additional directorships at least one hundred (100) days prior to the
first anniversary of the date the corporations proxy statement was released to the stockholders in
connection with the previous years annual meeting of stockholders, a stockholders notice required
by this Section 3.1 shall also be considered timely, but only with respect to nominees for
the additional directorships, if it shall be delivered to the Secretary at the principal executive
offices of the Corporation not later than the close of business on the tenth (10th) day following
the day on which such public announcement is first made by the Corporation.
Nominations of persons for election to the Board may be made at a special meeting of
stockholders at which directors are to be elected pursuant to the corporations notice of meeting
(1) by or at the direction of the Board or any committee thereof or (2) provided that the Board
has determined that directors shall be elected at such meeting, by any stockholder of the
corporation who is a stockholder of record at the time the notice provided for in this Section
3.1 is delivered to the Secretary of the corporation, who is entitled to vote at the meeting
and upon such election and who complies with the notice procedures set forth in this Section
3.1. In the
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event the corporation calls a special meeting of stockholders for the purpose of electing one
or more directors to the Board, any such stockholder entitled to vote in such election of directors
may nominate a person or persons (as the case may be) for election to such position(s) as specified
in the corporations notice of meeting, if the stockholders notice required by the third paragraph
of this Section 3.1 shall be delivered to the Secretary at the principal executive offices of the
corporation not earlier than the close of business on the one hundred twentieth (120th) day prior
to such special meeting and not later than the close of business on the later of the ninetieth
(90th) day prior to such special meeting or the tenth (10th) day following the day on which public
announcement is first made of the date of the special meeting and of the nominees proposed by the
Board to be elected at such meeting. In no event shall the public announcement of an adjournment
or postponement of a special meeting commence a new time period (or extend any time period) for the
giving of a stockholders notice as described above.
No person shall be eligible for election as a director of the corporation unless nominated in
accordance with the procedures set forth herein.
In connection with any annual meeting of the stockholders (or, if and as applicable, any
special meeting of the stockholders), the Chairman of the Board (or such other person presiding at
such meeting in accordance with these bylaws) shall, if the facts warrant, determine and declare to
the meeting that a nomination was not made in accordance with the foregoing procedure (including
whether the stockholder or beneficial owner, if any, on whose behalf the nomination is made
solicited (or is part of a group which solicited) or did not so solicit, as the case may be,
proxies in support of such stockholders nominee in compliance with such stockholders
representation as required by clause (vi) above of this Section 3.1), and if he or she
should so determine, he or she shall so declare to the meeting and the defective nomination shall
be disregarded. Notwithstanding the foregoing provisions of this Section 3.1, unless
otherwise required by law, if the stockholder (or a qualified representative of the stockholder)
does not appear at the annual or special meeting of stockholders of the corporation to present a
nomination, such nomination shall be disregarded, notwithstanding that proxies in respect of such
vote may have been received by the corporation. For purposes of this Section 3.1, to be
considered a qualified representative of the stockholder, a person must be a duly authorized
officer, manager or partner of such stockholder or must be authorized by a writing executed by such
stockholder or an electronic transmission delivered by such stockholder to act for such stockholder
as proxy at the meeting of stockholders and such person must produce such writing or electronic
transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting
of stockholders.
3.2 Enlargement and Vacancies
The number of members of the Board may be increased at any time as provided in Section
3.1 above. Sole power to fill vacancies and newly created directorships resulting from any
increase in the authorized number of directors shall be vested in the Board, and each director so
chosen shall hold office until the next annual election at which the term of the class to which
they have been elected expires and until such directors successor is duly elected and qualified or
until such directors earlier resignation, removal from office, death or incapacity. If there are
no directors in office, then an election of directors may be held in the manner provided by
statute.
In the event of one or more vacancies in the Board, the remaining directors, except as
otherwise provided by law or these bylaws, may exercise the powers of the full board until the
vacancies are filled.
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3.3 Resignation and Removal
Any director may resign at any time upon written notice to the corporation at its principal
place of business or to the Chief Executive Officer or the Secretary. Such resignation shall be
effective upon receipt of such notice unless the notice specifies such resignation to be effective
at some other time or upon the happening of some other event. Any director or the entire Board may
be removed, but only for cause, by the holders of a majority of the shares then entitled to vote at
an election of directors, unless otherwise specified in the certificate of incorporation of the
corporation.
3.4 Powers
The business of the corporation shall be managed by or under the direction of the Board, which
may exercise all such powers of the corporation and do all such lawful acts and things as are not
by statute or by the certificate of incorporation of the corporation or by these bylaws directed or
required to be exercised or done by the stockholders.
3.5 Place of Meetings
The Board may hold meetings, both regular and special, either within or without the State of
Delaware.
3.6 Organizational Meetings
There shall be an organizational meeting of the Board each year for the purposes of
organization, the appointment of officers and the transaction of other business. Organizational
meetings shall be held at such time and place as may be determined from time to time by the Board.
3.7 Regular Meetings
Regular meetings of the Board may be held without notice at such time and place as may be
determined from time to time by the Board; provided that any director who is absent when such a
determination is made shall be given prompt notice of such determination.
3.8 Special Meetings
Special meetings of the Board may be called by the Chairman of the Board, the Lead Director
(if any), the Chief Executive Officer or the President, or by the Secretary on the written request
of two or more directors, or by one director in the event that there is only one director in
office. Notice of the time and place, if any, of special meetings shall be delivered personally or
by telephone to each director, or sent by first-class mail or commercial delivery service,
facsimile transmission, or by electronic mail or other electronic means, charges prepaid, to such
directors business or home address as they appear upon the records of the corporation. In case
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such notice is mailed, at least two (2) days notice shall be provided to each director prior
to the time of holding of the meeting. In case such notice is delivered personally or by telephone
or by commercial delivery service, facsimile transmission, or electronic mail or other electronic
means, at least forty-eight (48) hours notice shall be provided to each director prior to the time
of the holding of the meeting. A notice or waiver of notice of a meeting of the Board need not
specify the purposes of the meeting.
3.9 Quorum, Action at Meeting, Adjournments
At all meetings of the Board, a majority of directors then in office, but in no event less
than one-third (1/3) of the entire Board, shall constitute a quorum for the transaction of business
and the act of a majority of the directors present at any meeting at which there is a quorum shall
be the act of the Board, except as may be otherwise specifically provided by law or by the
certificate of incorporation of the corporation. For purposes of this Section 3.9, the
term entire Board shall mean the number of directors last fixed by directors in accordance with
these bylaws; provided, however, that if fewer than all the number of directors so fixed have been
elected (by the stockholders or the Board), the entire Board shall mean the greatest number of
directors so elected to hold office at any one time pursuant to such authorization. If a quorum
shall not be present at any meeting of the Board, a majority of the directors present thereat may
adjourn the meeting from time to time, without notice other than announcement at the meeting, until
a quorum shall be present.
3.10 Action Without Meeting
Unless otherwise restricted by the certificate of incorporation of the corporation or these
bylaws, any action required or permitted to be taken at any meeting of the Board or of any
committee thereof may be taken without a meeting, if all members of the Board or committee, as the
case may be, consent thereto in writing or by electronic transmission, and the writings or
electronic transmissions are filed with the minutes of proceedings of the Board or committee.
3.11 Telephone Meetings
Unless otherwise restricted by the certificate of incorporation of the corporation or these
bylaws, any member of the Board or any committee thereof may participate in a meeting of the Board
or of any committee, as the case may be, by means of conference telephone or by any form of
communications equipment by means of which all persons participating in the meeting can hear each
other, and such participation in a meeting shall constitute presence in person at the meeting.
3.12 Committees
The Board may, by resolution passed by a majority of the whole Board, designate one or more
committees, each committee to consist of one or more of the directors of the corporation. The
Board may designate one or more directors as alternate members of any committee, who may replace
any absent or disqualified member at any meeting of the committee. In the absence or
disqualification of a member of a committee, the member or members present at any meeting and not
disqualified from voting, whether or not the member or members present constitute a quorum, may
unanimously appoint another member of the Board to act at the meeting in the
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place of any such absent or disqualified member. Any such committee, to the extent provided
in the resolution of the Board, shall have and may exercise all the powers and authority of the
Board in the management of the business and affairs of the corporation, and may authorize the seal
of the corporation to be affixed to all papers which may require it; but no such committee shall
have the power or authority in reference to (i) approving or adopting, or recommending to the
stockholders, any action or matter expressly required by the General Corporation Law of the State
of Delaware (the DGCL) to be submitted to stockholders for approval or (ii) adopting, amending or
repealing any of these bylaws. Any such committee shall have such name as may be determined from
time to time by resolution adopted by the Board. Each committee shall keep regular minutes of its
meetings and make such reports to the Board as the Board may request. Except as the Board may
otherwise determine, any committee may make rules for the conduct of its business, but unless
otherwise provided by the directors or in such rules, its business shall be conducted as nearly as
possible in the same manner as is provided in these bylaws for the conduct of its business by the
Board.
3.13 Fees and Compensation of Directors
Unless otherwise restricted by the certificate of incorporation of the corporation or these
bylaws, the Board shall have the authority to fix the compensation of directors. The directors may
be paid their expenses, if any, of attendance at each meeting of the Board and may be paid a fixed
sum for attendance at each meeting of the Board or a stated salary as director, or such other
compensation as may be determined by the Board. No such payment shall preclude any director from
serving the corporation in any other capacity and receiving compensation therefor. Members of
special or standing committees may be allowed like compensation for attending committee meetings.
3.14 Rights of Inspection
Any director shall have the right to examine the corporations stock ledger, a list of its
stockholders and its other books and records for a purpose reasonably related to his or her
position as a director.
3.15 Lead Director
The Board may designate a Lead Director from among its members from time to time, who shall be
a independent director, with such duties and authority as determined by the Board.
ARTICLE 4
Officers
4.1 Officers Designated
The officers of the corporation shall be chosen by the Board and shall include a Chief
Executive Officer, a Secretary and a Chief Financial Officer or Treasurer. The Board may elect
from among its members a Chairman of the Board and a Vice Chairman of the Board. The Board may
also choose a President, one or more Vice Presidents, one or more assistant
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Secretaries or assistant Treasurers and such other officers as the Board deems appropriate
from time to time. Any number of offices may be held by the same person, unless the certificate of
incorporation of the corporation or these bylaws otherwise provide.
4.2 Appointment
The Board at its organizational meeting shall choose a Chief Executive Officer, a President, a
Secretary and a Chief Financial Officer or Treasurer. Other officers may be appointed by the Board
at such meeting, at any other meeting, or by written consent, or in such other manner as is
determined by the Board.
4.3 Tenure
Each officer of the corporation shall hold office until such officers successor is appointed
and qualified, unless a different term is specified in the vote choosing or appointing such
officer, or until such officers earlier death, resignation, removal or incapacity. Any officer
may be removed with or without cause at any time by the affirmative vote of a majority of the Board
or a committee duly authorized to do so. Any vacancy occurring in any office of the corporation
may be filled by the Board, at its discretion. Any officer may resign by delivering such officers
written resignation to the corporation at its principal place of business or to the Chief Executive
Officer or the Secretary. Such resignation shall be effective upon receipt unless it is specified
to be effective at some other time or upon the happening of some other event.
4.4 Chairman and Vice Chairman
The Chairman of the Board, if any, shall preside at all meetings of the Board and of the
stockholders at which he or she shall be present. The Chairman of the Board shall have and may
exercise such powers as are, from time to time, assigned to him or her by the Board and as may be
provided by law. In the absence of the Chairman of the Board, the Vice Chairman of the Board, if
any, shall preside at all meetings of the Board and of the stockholders at which he or she shall be
present. The Vice Chairman of the Board shall have and may exercise such powers as are, from time
to time, assigned to him or her by the Board and as may be provided by law.
4.5 The Chief Executive Officer
Subject to such supervisory powers, if any, as may be given by the Board to the Chairman of
the Board, the Chief Executive Officer (who may also be designated by the title of President
unless a separate President shall be appointed) shall preside at all meetings of the stockholders
and the Board in the absence of the Chairman of the Board or if there be none, shall have general
and active management of the business of the corporation and shall see that all orders and
resolutions of the Board are carried into effect. He or she shall execute bonds, mortgages and
other contracts requiring a seal, under the seal of the corporation, except where required or
permitted by law to be otherwise signed and executed and except where the signing and execution
thereof shall be expressly delegated by the Board to some other officer or agent of the
corporation.
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4.6 The President
The President, if any, shall, in the event there be no Chief Executive Officer or in the
absence of the Chief Executive Officer or in the event of his or her disability or refusal to act,
perform the duties of the Chief Executive Officer, and when so acting, shall have the powers of and
be subject to all the restrictions upon the Chief Executive Officer. The President shall perform
such other duties and have such other powers as may from time to time be prescribed for such person
by the Board, the Chairman of the Board, the Chief Executive Officer or these bylaws.
4.7 The Vice President
The Vice President (or in the event there be more than one, the Vice Presidents in the order
designated by the directors, or in the absence of any designation, in the order of their
appointment), shall, in the absence of the President or in the event of his or her disability or
refusal to act, perform the duties of the President, and when so acting, shall have the powers of
and be subject to all the restrictions upon the President. The Vice President(s) shall perform
such other duties and have such other powers as may from time to time be prescribed for them by the
Board, the Chairman of the Board, the Chief Executive Officer, the President or these bylaws.
4.8 The Secretary
The Secretary shall attend all meetings of the Board and the stockholders and record all votes
and the proceedings of the meetings in a book to be kept for that purpose and shall perform like
duties for the standing committees, when required. The Secretary shall give, or cause to be given,
notice of all meetings of stockholders and special meetings of the Board, and shall perform such
other duties as may from time to time be prescribed by the Board, the Chairman of the Board, the
Chief Executive Officer, the President or these bylaws. The Secretary shall have custody of the
seal of the corporation, and the Secretary, or an Assistant Secretary, shall have authority to
affix the same to any instrument requiring it, and, when so affixed, the seal may be attested by
his or her signature or by the signature of such Assistant Secretary. The Board may give general
authority to any other officer to affix the seal of the corporation and to attest the affixing
thereof by his or her signature. The Secretary shall keep, or cause to be kept, at the principal
executive office or at the office of the corporations transfer agent or registrar, as determined
by resolution of the Board, a share register, or a duplicate share register, showing the names of
all stockholders and their addresses, the number and classes of shares held by each, the number and
date of certificates, if any, issued for the same and the number and date of cancellation of every
certificate surrendered for cancellation.
4.9 The Assistant Secretary
The Assistant Secretary, or if there be more than one, any Assistant Secretaries in the order
designated by the Board (or in the absence of any designation, in the order of their appointment)
shall assist the Secretary in the performance of his or her duties and, in the absence of the
Secretary or in the event of his or her inability or refusal to act, perform the duties and
exercise the powers of the Secretary and shall perform such other duties and have such other
powers as may from time to time be prescribed by the Board, the Chairman of the Board, the
Chief Executive Officer, the President or these bylaws.
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4.10 The Chief Financial Officer
The Chief Financial Officer (who may also be designated by the separate title of Treasurer
unless a separate Treasurer is appointed) shall consider the adequacy of, and make recommendations
concerning, the capital resources available to the corporation to meet it projected obligations and
business plans; report periodically to the Chief Executive Officer and the Board on financial
results and trends affecting the business; have custody of the corporate funds and deposit and pay
out such funds from time to time in such manner as may be prescribed by, or in accordance with the
direction of, the Board; and shall perform such other duties and have such other powers as may from
time to time be prescribed by the Board, the Chairman of the Board, the Chief Executive Officer,
the President or these bylaws.
4.11 The Treasurer and Assistant Treasurers
The Treasurer (if one is appointed) shall, (i) if a Chief Financial Officer is appointed, have
such duties as may be specified by the Chief Financial Officer to assist the Chief Financial
Officer in the performance of his or her duties, and (ii) otherwise perform such duties and have
other powers as may from time to time be prescribed by the Board, the Chairman of the Board, the
Chief Executive Officer, the President or these bylaws. It shall be the duty of any Assistant
Treasurers to assist the Treasurer in the performance of his or her duties and to perform such
other duties and have other powers as may from time to time be prescribed by the Board, the
Chairman of the Board, the Chief Executive Officer, the President or these bylaws.
4.12 Bond
If required by the Board, any officer shall give the corporation a bond in such sum and with
such surety or sureties and upon such terms and conditions as shall be satisfactory to the Board,
including without limitation a bond for the faithful performance of the duties of such officers
office and for the restoration to the corporation of all books, papers, vouchers, money and other
property of whatever kind in such officers possession or under such officers control and
belonging to the corporation.
ARTICLE 5
Notices
5.1 Delivery
Whenever, under the provisions of law, or of the certificate of incorporation of the
corporation or these bylaws, written notice is required to be given to any director or stockholder,
it shall not be construed to mean personal notice, but: (a) such notice may be given by mail,
addressed to such director or stockholder, at such persons address as it appears on the records of
the corporation, with postage thereon prepaid, and such notice shall be deemed to be given at the
time when the same shall be deposited in the United States mail or delivered to a nationally
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recognized courier service; and (b) unless written notice by mail is required by law, such
notice may also be given by commercial delivery service, facsimile transmission, electronic means
or similar means addressed to such director or stockholder at such persons address as it appears
on the records of the corporation, in which case such notice shall be deemed to be given when
delivered into the control of the persons charged with effecting such transmission, the
transmission charge to be paid by the corporation or the person sending such notice and not by the
addressee. Oral notice or other in-hand delivery, in person or by telephone, shall be deemed given
at the time it is actually given.
5.2 Waiver of Notice
Whenever any notice is required to be given under the provisions of law or of the certificate
of incorporation of the corporation or of these bylaws, a waiver thereof in writing, signed by the
person or persons entitled to said notice, whether before or after the time stated therein, shall
be deemed equivalent thereto. In addition to the foregoing, notice of a meeting need not be given
to any director who signs a waiver of notice or a consent, or electronically transmits the same, to
holding the meeting or an approval of the minutes thereof, whether before or after the meeting, or
who attends the meeting without protesting, prior thereto or at its commencement, the lack of
notice to such director. All such waivers, consents and approvals shall be filed with the
corporate records or made a part of the minutes of the meeting.
ARTICLE 6
Indemnification and Insurance
6.1 Indemnification
(a) Each person who was or is made a party or is threatened to be made a party to or is
involved in (as a witness or otherwise) any action, suit, arbitration, alternate dispute resolution
mechanism, investigation, inquiry, administrative hearing or any other proceeding, whether civil,
criminal, administrative or investigative in nature (hereinafter a proceeding), by reason of the
fact that he or she or a person of whom he or she is the legal representative (in the event of
death or disability of such person) is or was a director or officer of the corporation (or any
predecessor) or is or was serving at the request of the corporation (or any predecessor) as a
director, officer, employee, fiduciary, representative, partner or agent of another corporation or
of a partnership, joint venture, trust, employee benefit plan sponsored or maintained by the
corporation, or other enterprise (or any predecessor of any of such entities), whether the basis of
such proceeding is alleged action or inaction in an official capacity as a director, officer,
employee, fiduciary, representative, partner or agent or in any other capacity while serving as a
director, officer, employee, fiduciary, representative, partner or agent, shall be indemnified and
held harmless by the corporation to the fullest extent authorized by the DGCL, as the same exists
or may hereafter be amended (but, in the case of any such amendment, only to the extent that such
amendment permits the corporation to provide broader indemnification rights than said law permitted
the corporation to provide prior to such amendment), against all expense, liability and loss
(including attorneys fees, judgments, fines, ERISA excise taxes or penalties, and amounts paid or
to be paid in settlement) reasonably incurred or suffered by such person in connection therewith;
provided, however, that except as provided in Section 6.1(c) below, the corporation
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shall indemnify any such person seeking indemnification in connection with a proceeding (or
part thereof) initiated by such person only if such proceeding (or part thereof) was authorized by
the Board. The right to indemnification conferred in this Section 6.1 shall be a contract
right subject to the terms and conditions of this Article 6.
(b) To obtain indemnification under this Section 6.1, a claimant shall submit to the
corporation a written request, including therein or therewith such documentation and information as
is reasonably available to the claimant and is reasonably necessary to determine whether and to
what extent the claimant is entitled to indemnification. provided, however, that the failure of a
claimant to so notify the corporation shall not relieve the corporation of any obligation which it
may have to the claimant under this Section 6.1 or otherwise except to the extent that any
delay in such notification actually and materially prejudices the corporation. Upon written
request by a claimant for indemnification pursuant to the preceding sentence, a determination, if
required by applicable law, with respect to the claimants entitlement thereto shall be made as
follows: (i) if requested by the claimant, by Independent Counsel (as hereinafter defined), or (ii)
if no request is made by the claimant for a determination by Independent Counsel, (A) by the Board
by a majority vote of the Disinterested Directors (as hereinafter defined), even though less than a
quorum, or (B) by a committee of Disinterested Directors designated by majority vote of the
Disinterested Directors, even though less than a quorum, or (C) if there are no Disinterested
Directors or the Disinterested Directors so direct, by Independent Counsel in a written opinion to
the Board, a copy of which shall be delivered to the claimant, or (D) if a quorum of Disinterested
Directors so directs, by the stockholders of the corporation.
In the event the determination of entitlement to indemnification is to be made by Independent
Counsel at the request of the claimant, the Independent Counsel shall be selected by the Board
unless there shall have occurred within two years prior to the date of the commencement of the
proceeding for which indemnification is claimed a Change of Control (as hereinafter defined), in
which case Independent Counsel shall be selected by the claimant unless the claimant shall request
that such selection be made by the Board. In either event, the claimant or the corporation, as the
case may be, shall give written notice to the other advising it of the identity of the Independent
Counsel so selected. The party so notified may, within ten (10) days after such written notice of
selection shall have been given, deliver to the corporation or to the claimant, as the case may be,
a written objection to such selection; provided, however, that such objection may be asserted only
on the ground that the Independent Counsel so selected does not meet the requirements of
Independent Counsel as defined in Section 6.6, and the objection shall set forth with
particularity the factual basis of such assertion. If such written objection is so made and
substantiated, the Independent Counsel so selected may not serve as Independent Counsel unless and
until such objection is withdrawn or a court has determined that such objection is without merit.
If, within thirty (30) days after submission by the claimant of a written request for
indemnification pursuant to Section 6.1(b), no Independent Counsel shall have been selected
and not objected to, either the corporation or the claimant may petition the Court of Chancery of
the State of Delaware for resolution of any objection which shall have been made by the corporation
or the claimant to the others selection of Independent Counsel or for the appointment as
Independent Counsel of a person selected by the Court or by such other person as the Court shall
designate, and the person with respect to whom all objections are so resolved or the person so
appointed shall act as Independent Counsel hereunder. The corporation shall pay any and all fees
and expenses of Independent Counsel reasonably incurred in
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connection with acting pursuant to Section 6.1(b), and the corporation shall pay all
reasonable fees and expenses incident to the procedures of Section 6.1(b), regardless of
the manner in which such Independent Counsel was selected or appointed. Upon the due commencement
of any judicial proceeding pursuant to Section 6.1(c), Independent Counsel shall be
discharged and relieved of any further responsibility in such capacity (subject to the applicable
standards of professional conduct then prevailing).
If the person, persons or entity empowered or selected under this Section 6.1(b) to
determine whether the claimant is entitled to indemnification shall not have made a determination
within ninety (90) days after receipt by the corporation of the request therefor, the requisite
determination of entitlement to indemnification shall be deemed to have been made and the claimant
shall be entitled to such indemnification, absent (i) a misstatement by the claimant of a material
fact, or an omission of a material fact necessary to make the claimants statement(s) not
materially misleading, in connection with the request for indemnification or (ii) a prohibition of
such indemnification under applicable law.
If it is determined that the claimant is entitled to indemnification, the corporation shall
pay the claimant within twenty (20) business days after such determination any then known amounts
with respect to which it has been so determined that the claimant is entitled to indemnification
hereunder and will pay any other amounts thereafter incurred for which Indemnitee is entitled to
indemnification within twenty (20) business days of the corporations receipt of reasonably
detailed invoices for such amounts.
(c) In the event that (i) a determination is made pursuant to Section 6.1(b) that the
claimant is not entitled to indemnification, (ii) advancement of Expenses is not timely made
pursuant to Section 6.2 or (iii) a claim for the indemnification under Section 6.1
is not paid in full by the corporation within twenty (20) business days after a determination has
been made that the claimant is entitled to indemnification, the claimant may at any time thereafter
bring suit against the corporation to determine his entitlement to such indemnification or
advancement of Expenses and, if successful in whole or in part, the claimant shall be entitled to
be paid also the expense of prosecuting such claim. If a Change of Control shall have occurred, in
any judicial proceeding commenced pursuant to this Section 6.1(c), the corporation shall
have the burden of proving that the claimant is not entitled to indemnification. It shall be a
defense to any such action (other than an action brought to enforce a claim for expenses incurred
in defending any proceeding in advance of its final disposition where the required undertaking, if
any is required, has been tendered to the corporation) that the claimant has not met the standard
of conduct that makes it permissible under the DGCL for the corporation to indemnify the claimant
for the amount claimed, but the burden of proving such defense shall be on the corporation.
Neither the failure of the corporation (including the Board, Independent Counsel or stockholders)
to have made a determination prior to the commencement of such action that indemnification of the
claimant is proper in the circumstances because he or she has met the applicable standard of
conduct set forth in the DGCL, nor the fact that the corporation (including the Board, Independent
Counsel or stockholders) has determined that the claimant has not met such applicable standard of
conduct, shall be a defense to the action or create a presumption that the claimant has not met the
applicable standard of conduct. The termination of any action, suit or proceeding by judgment,
order, settlement, conviction, or upon a plea of nolo contendere or its
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equivalent, shall not, of itself, create a presumption that the claimant has not met the
applicable standard of conduct.
(d) If a determination shall have been made pursuant to this Section 6.1 that the
claimant is entitled to indemnification, the corporation shall be bound by such determination in
any judicial proceeding commenced pursuant to Section 6.1(c) above, absent (i) a
misstatement by the claimant of a material fact, or an omission of a material fact necessary to
make the claimants statements not materially misleading in connection with a request for
indemnification or (ii) a prohibition of such indemnification under applicable law. The
corporation shall be precluded from asserting in any judicial proceeding commenced pursuant to
Section 6.1(c) above that the procedures and presumptions of this Article 6 are not
valid, binding and enforceable and shall stipulate in such proceeding that the corporation is bound
by all the provisions of this Article 6.
(e) With respect to any proceeding for which indemnification is sought hereunder, so long as
there shall not have occurred a Change in Control, the corporation, in its sole discretion, will be
entitled to participate in such proceeding at its own expense and, except as provided below, to
assume the defense of, and to settle, such proceeding. After notice from the corporation to the
claimant of its election so to assume the defense thereof, the corporation will not be liable to
the claimant under this Article 6 for any legal or other Expenses subsequently incurred by
the claimant in connection with the defense thereof other than reasonable costs of investigation or
as otherwise provided below. The claimant shall have the right to employ its counsel in such
proceeding but the fees and Expenses of such counsel incurred after notice from the corporation of
its assumption of the defense thereof shall be at the expense of the claimant unless (i) the
employment of counsel by the claimant has been authorized by the corporation, (ii) the claimant
shall have reasonably concluded that there may be a conflict of interest between the corporation
and the claimant in the conduct of the defense of such proceeding or (iii) the corporation shall
not in fact have employed counsel to assume the defense of such proceeding, in each of which cases
the fees and Expenses of counsel shall be at the expense of the corporation. The corporation shall
not be entitled to assume the defense of any proceeding brought by or on behalf of the corporation
or as to which the claimant shall have made the conclusion provided for in clause (ii) of the
immediately preceding sentence. The claimant shall not compromise or settle any claim or
proceeding, release any claim, or make any admission of fact, law, liability or damages with
respect to any losses for which indemnification is sought hereunder without the prior written
consent of the corporation, which consent shall not be unreasonably withheld (subject to the terms
and conditions of this Article 6, including any determination required by Section
6.1(b) or by applicable law). The corporation shall not be liable for any amount paid by the
claimant in settlement of any proceeding or any claim therein, unless the corporation has consented
to such settlement or unreasonably withholds consent to such settlement.
(f) If the claimant is a party to or involved in a proceeding with any other person(s) for
whom the corporation is required to indemnify or advance Expenses with respect to such proceeding,
the corporation shall not be required to indemnify against or advance Expenses for more than one
law firm to represent collectively the claimant and such other person(s) in respect of the same
matter unless the representation of the claimant and such other person(s) gives rise to an actual
or potential conflict of interest.
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6.2 Advance Payment
The right to indemnification under this Article 6 shall include the right to be paid
by the corporation the expenses incurred in defending any such proceeding in advance of its final
disposition, such advances to be paid by the corporation within twenty (20) business days after the
receipt by the corporation of a statement or statements from the claimant requesting and reasonably
evidencing such advance or advances from time to time; provided, however, that if the DGCL
requires, the payment of such expenses incurred by a director or officer in his or her capacity as
a director or officer (and not in any other capacity in which service was or is rendered by such
person while a director or officer, including, without limitation, service to an employee benefit
plan) in advance of the final disposition of a proceeding, shall be made only upon delivery to the
corporation of an undertaking by or on behalf of such director or officer to repay all amounts so
advanced if it shall ultimately be determined that such director or officer is not entitled to be
indemnified under Section 6.1 above or otherwise.
6.3 Non-Exclusivity and Survival of Rights; Amendments
The right to indemnification and the payment of expenses incurred in defending a proceeding in
advance of its final disposition conferred in this Article 6 shall not be deemed exclusive
of any other right which any person may have or hereafter acquire under any statute, provision of
the certificate of incorporation of the corporation, bylaws, agreement, vote of stockholders or
Disinterested Directors or otherwise, both as to action in such persons official capacity and as
to action in another capacity while holding such office, and shall continue as to a person who has
ceased to be a director, officer, employee or agent of the corporation and shall inure to the
benefit of the heirs, executors and administrators of such a person. Any repeal or modification of
the provisions of this Article 6 shall not in any way diminish or adversely affect the
rights or protections of any director, officer, employee or agent of the corporation hereunder in
respect of any proceeding (regardless of when such proceeding is first threatened, commenced or
completed) arising out of, or related to, any act or omission occurring prior to the time of such
repeal or modification.
6.4 Insurance
The corporation may purchase and maintain insurance on behalf of any person who is or was a
director, officer, employee or agent of the corporation, or is or was serving at the request of the
corporation as a director, officer, employee or agent of another corporation, partnership, joint
venture, trust, employee benefit plan or other enterprise against any expense, liability or loss
asserted against such person and incurred by such person in any such capacity, or arising out of
such persons status as such, whether or not the corporation would have the power to indemnify such
person against such liability under the provisions of the DGCL.
6.5 Severability
If any word, clause, provision or provisions of this Article 6 shall be held to be
invalid, illegal or unenforceable for any reason whatsoever: (i) the validity, legality and
enforceability of the remaining provisions of this Article 6 (including, without
limitation, each portion of any section or paragraph of this Article 6 containing any such
provision held to be invalid, illegal or
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unenforceable, that is not itself held to be invalid, illegal or unenforceable) shall not in
any way be affected or impaired thereby; and (ii) to the fullest extent possible, the provisions of
this Article 6 (including, without limitation, each such portion of any section or
paragraph of this Article 6 containing any such provision held to be invalid, illegal or
unenforceable) shall be construed so as to give effect to the intent manifested by the provision
held invalid, illegal or unenforceable.
6.6 Definitions
For the purpose of this Article 6:
Change of Control shall mean:
(1) the acquisition by any individual, entity or group (within the meaning of Section
13(d)(3) or 14(d)(2) of the 1934 Act (a Person)), directly or indirectly, of beneficial
ownership (within the meaning of Rule 13d-3 promulgated under the 1934 Act) of 20% or more
of either (i) the then outstanding shares of common stock of the corporation (the
Outstanding Corporation Common Stock) or (ii) the combined voting power of the then
outstanding voting securities of the corporation entitled to vote generally in the election
of directors (the Outstanding Corporation Voting Securities); provided, however, that for
purposes of this part (1), the following acquisitions shall not constitute a Change of
Control: (i) any acquisition directly from the corporation or any acquisition from other
stockholders where (A) such acquisition was approved in advance by the Board and (B) such
acquisition would not constitute a Change of Control under part (2) or part (4) of this
definition, (ii) any acquisition by the corporation, (iii) any acquisition by any employee
benefit plan (or related trust) sponsored or maintained by the corporation or any
corporation controlled by the corporation, or (iv) any acquisition by any corporation
pursuant to a transaction that complies with clauses (i), (ii) and (iii) of part (4) of this
definition; or
(2) the acquisition by any Person, directly or indirectly, of beneficial ownership
(within the meaning of Rule 13d-3 promulgated under the 1934 Act) of 50% or more of either
(i) the Outstanding Corporation Common Stock or (ii) the Outstanding Corporation Voting
Securities; or
(3) individuals who, as of the date hereof, constitute the Board (the Incumbent
Board) cease for any reason to constitute at least a majority of the Board; provided,
however, that any individual becoming a director subsequent to the date hereof whose
election, or nomination for election by the stockholders, was approved by a vote of at least
a majority of the directors then comprising the Incumbent Board (or such committee thereof
that shall then have the authority to nominate persons for election as directors) shall be
considered as though such individual were a member of the Incumbent Board, but excluding,
for this purpose, any such individual whose initial assumption of office occurs as a result
of an actual or threatened election contest with respect to the election or removal of
directors or other actual or threatened solicitation of proxies of consents by or on behalf
of a Person other than the Board; or
- 23 -
(4) consummation of a reorganization, merger or consolidation or sale or other
disposition of all or substantially all of the assets of the corporation (a Business
Combination), in each case, unless, immediately following such Business Combination, (i)
all or substantially all of the individuals and entities who were the beneficial owners,
respectively, of the Outstanding Corporation Common Stock and Outstanding Corporation Voting
Securities immediately prior to such Business Combination beneficially own, directly or
indirectly, more than 50% of, respectively, the then outstanding shares of common stock and
the combined voting power of the then outstanding voting securities entitled to vote
generally in the election of directors, as the case may be, of the corporation resulting
from such Business Combination (including, without limitation, a corporation that as a
result of such transaction owns the corporation or all or substantially all of the
corporations assets either directly or through one or more subsidiaries) in substantially
the same proportions as their ownership, immediately prior to such Business Combination of
the Outstanding Corporation Common Stock and Outstanding Corporation Voting Securities, as
the case may be, (ii) no Person (excluding any corporation resulting from such Business
Combination or any employee benefit plan (or related trust) of the corporation or such
corporation resulting from such Business Combination) beneficially owns, directly or
indirectly, 20% or more of, respectively, the then outstanding shares of common stock of the
corporation resulting from such Business Combination or the combined voting power of the
then outstanding voting securities of such corporation except to the extent that such
ownership existed prior to the Business Combination, and (iii) at least a majority of the
members of the board of directors of the corporation resulting from such Business
Combination were members of the Incumbent Board at the time of the execution of the initial
agreement, or of the action of the Board, providing for such Business Combination; or
(5) approval by the stockholders of a complete liquidation or dissolution of the
corporation.
Disinterested Director shall mean a director of the corporation who is not and was not a
party to the matter in respect of which indemnification is sought by the claimant.
Independent Counsel shall mean a law firm, a member of a law firm, or an independent
practitioner, that is experienced in matters of corporation law and neither presently is, nor in
the past five years has been, retained to represent: (i) the corporation or the claimant in any
matter material to any such party, or (ii) any other party to the proceeding giving rise to a claim
for indemnification hereunder. Notwithstanding the foregoing, the term Independent Counsel shall
not shall include any person who, under the applicable standards of professional conduct then
prevailing, would have a conflict of interest in representing either the corporation or the
claimant in an action to determine the claimants rights under this Article 6.
6.7 Notices
Any notice, request or other communication required or permitted to be given to the
corporation under this Article 6 shall be in writing and either delivered in person or sent
by telecopy or other electronic transmission, overnight mail or courier service, or certified or
registered mail, postage or charges prepaid, return copy requested, to the Secretary of the
corporation and shall be effective only upon receipt by the Secretary.
- 24 -
ARTICLE 7
Capital Stock
7.1 Certificates for Shares
The shares of stock of the corporation shall be represented by certificates or, where approved
by the Board and permitted by law, shall be uncertificated. Certificates representing shares of
stock shall be signed by, or in the name of the corporation by, the Chairman of the Board, the
Chief Executive Officer, the President or a Vice President and by the Chief Financial Officer, the
Treasurer or an Assistant Treasurer, or the Secretary or an Assistant Secretary of the corporation.
Certificates or uncertificated shares may be issued for partly paid shares and in the case of
certificated shares, upon the face or back of the certificates issued to represent any such partly
paid shares, the total amount of the consideration to be paid therefor, and the amount paid thereon
shall be specified.
If the corporation shall be authorized to issue more than one class of stock or more than one
series of any class, the powers, designations, preferences and relative, participating, optional or
other special rights of each class of stock or series thereof and the qualifications, limitations
or restrictions of such preferences or rights shall be set forth in full or summarized on the face
or back of the certificate which the corporation shall issue to represent such class or series of
stock, provided that, except as otherwise provided in Section 202 of the DGCL, in lieu of the
foregoing requirements, there may be set forth on the face or back of the certificate which the
corporation shall issue to represent such class or series of stock, a statement that the
corporation will furnish without charge to each stockholder who so requests the powers,
designations, preferences and relative, participating, optional or other special rights of each
class of stock or series thereof and the qualifications, limitations or restrictions of such
preferences or rights.
Within a reasonable time after the issuance or transfer of uncertificated stock, the
corporation shall send to the registered owner thereof a written notice containing the information
required by the DGCL or a statement that the corporation will furnish without charge to each
stockholder who so requests the powers, designations, preferences and relative participating,
optional or other special rights of each class of stock or series thereof and the qualifications,
limitations or restrictions of such preferences or rights.
7.2 Signatures on Certificates
Any or all of the signatures on a certificate may be a facsimile. In case any officer,
transfer agent or registrar who has signed or whose facsimile signature has been placed upon a
certificate shall have ceased to be such officer, transfer agent or registrar before such
certificate is issued, it may be issued by the corporation with the same effect as if he or she
were such officer, transfer agent or registrar at the date of issue.
- 25 -
7.3 Transfer of Stock
Upon surrender to the corporation or the transfer agent of the corporation of a certificate of
shares duly endorsed or accompanied by proper evidence of succession, assignation or authority to
transfer, it shall be the duty of the corporation to issue a new certificate to the person entitled
thereto, cancel the old certificate and record the transaction upon its books. Upon receipt of
proper transfer instructions from the registered owner of uncertificated shares, such
uncertificated shares shall be canceled and issuance of new equivalent uncertificated shares or
certificated shares shall be made to the person entitled thereto and the transaction shall be
recorded upon the books of the corporation.
7.4 Registered Stockholders
The corporation shall be entitled to recognize the exclusive right of a person registered on
its books as the owner of shares to receive dividends, and to vote as such owner, and to hold
liable for calls and assessments a person registered on its books as the owner of shares, and shall
not be bound to recognize any equitable or other claim to or interest in such share or shares on
the part of any other person, whether or not it shall have express or other notice thereof, except
as otherwise provided by the laws of Delaware.
7.5 Lost, Stolen or Destroyed Certificates
The corporation may direct that a new certificate or certificates or uncertificated shares be
issued to replace any certificate or certificates theretofore issued by the corporation alleged to
have been lost, stolen or destroyed, upon the making of an affidavit of that fact by the person
claiming the certificate of stock to be lost, stolen or destroyed and on such terms and conditions
as the corporation may require. When authorizing the issue of a new certificate or certificates,
the corporation may, in its discretion and as a condition precedent to the issuance thereof,
require the owner of the lost, stolen or destroyed certificate or certificates, or his or her legal
representative, to advertise the same in such manner as it shall require, to indemnify the
corporation in such manner as it may require, and to give the corporation a bond or other adequate
security in such sum as it may direct as indemnity against any claim that may be made against the
corporation with respect to the certificate alleged to have been lost, stolen or destroyed.
ARTICLE 8
General Provisions
8.1 Dividends
Dividends upon the capital stock of the corporation, subject to any restrictions contained in
the DGCL or the provisions of the certificate of incorporation of the corporation, if any, may be
declared by the Board at any regular or special meeting or by unanimous written consent. Dividends
may be paid in cash, in property or in shares of capital stock, subject to the provisions of the
certificate of incorporation of the corporation. The Board may fix any record date for
purposes of determining the stockholders entitled to receive payment of any dividend as set
forth in Section 2.11 above.
- 26 -
8.2 Dividend Reserve
Before payment of any dividend, there may be set aside out of any funds of the corporation
available for dividends such sum or sums as the directors from time to time, in their absolute
discretion, think proper as a reserve or reserves to meet contingencies, or for equalizing
dividends, or for repairing or maintaining any property of the corporation, or for such other
purpose as the directors shall think conducive to the interest of the corporation, and the
directors may modify or abolish any such reserve in the manner in which it was created.
8.3 Checks
All checks or demands for money and notes of the corporation shall be signed by such officer
or officers or such other person or persons as the Board may from time to time designate.
8.4 Fiscal Year
The fiscal year of the corporation shall be fixed by resolution of the Board.
8.5 Corporate Seal
The Board may, by resolution, adopt a corporate seal. The corporate seal shall have inscribed
thereon the name of the corporation, the year of its organization and the words Corporate Seal,
Delaware. The seal may be used by causing it or a facsimile thereof to be impressed or affixed or
otherwise reproduced. The seal may be altered from time to time by the Board.
8.6 Execution of Corporate Contracts and Instruments
The Board, except as otherwise provided in these bylaws, may authorize any officer or
officers, or agent or agents, to enter into any contract or execute any instrument in the name of
and on behalf of the corporation; such authority may be general or confined to specific instances.
Unless so authorized or ratified by the Board or within the agency power of an officer, no officer,
agent or employee shall have any power or authority to bind the corporation by any contract or
engagement or to pledge its credit or to render it liable for any purpose or for any amount.
8.7 Representation of Shares of Other Corporations
Each of the Chief Executive Officer, the President or any Vice President, the Chief Financial
Officer or the Treasurer or any Assistant Treasurer, or the Secretary or any Assistant Secretary of
the corporation is authorized to vote, represent and exercise on behalf of the corporation all
rights incident to any and all shares of any corporation or corporations standing in the name of
the corporation. The authority herein granted to said officers to vote or represent on behalf of
the corporation any and all shares held by the corporation in any other corporation or
corporations may be exercised either by such officers in person or by any other person
authorized so to do by proxy or power of attorney duly executed by said officers.
- 27 -
ARTICLE 9
Amendments
These bylaws may be altered, amended or repealed, in whole or in part, or new bylaws may be
adopted by the stockholders or by the Board; provided, however, that notice of such alteration,
amendment, repeal or adoption of new bylaws be contained in the notice of such meeting of the
stockholders or the Board, as the case may be. Any such alteration, amendment, repeal or adoption
must be approved by either the vote of the holders of a majority of the stock issued and
outstanding and entitled to vote thereon or by a majority of the entire Board.
- 28 -
exv10w1
Exhibit 10.1
M E M O R A N D U M
|
|
|
To:
|
|
Board of Directors |
From:
|
|
Bob Licht |
Date:
|
|
July 15, 2008 |
Subject:
|
|
Director Fees and Expenses |
The following is a summary of the retainers and meeting fees payable to directors effective July 1,
2008.
Retainers and Fees
Annual Retainers
|
|
|
|
|
$ |
35,000 |
|
|
Board retainer |
$ |
20,000 |
|
|
additional annual retainer for chair of Finance and Audit Committee |
$ |
5,000 |
|
|
additional annual retainer for members of Finance and Audit Committee (other than Chair) |
$ |
15,000 |
|
|
additional annual retainer for chairs of Corporate Governance Committee, Compensation and
Management Development Committee and
Transaction Committee |
$ |
60,000 |
|
|
additional annual retainer for Chairman of the Board |
Annual retainers will be paid in four equal quarterly installments.
Meeting Fees
|
|
|
|
|
$ |
2,500 |
|
|
each Board meeting attended (in person or by videoconference) |
$ |
1,500 |
|
|
each Board meeting attended (by teleconference) |
$ |
1,500 |
|
|
each committee meeting attended (in person or by teleconference) |
Meeting fees will be paid for attendance at formal meetings of the Board or its committees, i.e.,
those for which meeting minutes are prepared. Meeting fees will not be paid for informal
gatherings of directors.
Special Service Fee (extraordinary)
|
|
|
|
|
$ |
1,000 |
|
|
each full day of service |
The special service fee is for a full day of service, excluding services (and travel) relating to
Board or committee meetings, at the request of the Board or the Company and which involves
extensive travel by a director. It is expected that situations for which a special service fee is
due will be infrequent.
Retainers and fees will be paid shortly following the end of each calendar quarter (or, with
respect to the fourth calendar quarter, by the end of the year). Each payment will be accompanied
by a schedule explaining how the payment was calculated. Retainers are calculated on the basis of
the position held at the beginning of the calendar quarter for which payment is to be made.
Payments of retainers and fees will be reported to the IRS on Form 1099 as income, unless the
payments are made to qualifying deferred compensation accounts previously established by directors.
Expenses
The Company will reimburse directors for all reasonable out-of-pocket expenses associated with
their duties as directors, including travel to and from Board and committee meetings. The expenses
of spouses and significant others will be reimbursed when directors spouses and significant others
are invited to attend Company events with directors.
Expenses will be reimbursed when submitted. Expense reports, including receipts or other
supporting documentation, should be sent to the Companys accounts payable department (attn.
Drew Gollerkeri). If you would like to fax the expense report to expedite the approval process,
please fax it to Bob Licht at 866-819-5288.
Reimbursement for directors expenses usually will not be reported to the IRS as income.
Reimbursement for travel expenses of others will be reported to the IRS as income, and
reimbursement for certain other expenses (for example a program that does not meet IRS guidelines)
may also be reportable as income.
Questions
Questions about retainers, fees and expenses may be addressed to the following individuals:
Bob Licht (retainers and fees, including special service fee)
Vice President, Chief Corporation Counsel
Biogen Idec Inc.
14 Cambridge Center
Cambridge, MA 02142
Tel. (617) 679-3662
E-mail: bob.licht@biogenidec.com
Drew Gollerkeri (expenses)
Associate Director, Accounts Payable
Biogen Idec Inc.
14 Cambridge Center
Cambridge, MA 02142
Tel. (617) 679-3818
E-mail: drew.gollerkeri@biogenidec.com
- 2 -
exv31w1
EXHIBIT 31.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, James C. Mullen, certify that:
1. I have reviewed this quarterly report of Biogen Idec
Inc.;
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and
other financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as of,
and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I
are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act
Rules 13a-15(e)
and
15d-15(e))
and internal control over financial reporting (as defined in
Exchange Act Rules
13a-15(f)
and
15d-15(f))
for the registrant and have:
a) designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being prepared;
b) designed such internal control over financial reporting,
or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c) Evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d) disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting; and
5. The registrants other certifying officer(s) and I
have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrants
auditors and the audit committee of the registrants board
of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in
the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and
report financial information; and
b) any fraud, whether or not material, that involves
management or other employees who have a significant role in the
registrants internal control over financial reporting.
James C. Mullen
Chief Executive Officer and President
Date: October 21, 2008
exv31w2
EXHIBIT 31.2
CERTIFICATION
OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Paul J. Clancy, certify that:
1. I have reviewed this quarterly report of Biogen Idec
Inc.;
2. Based on my knowledge, this report does not contain any
untrue statement of a material fact or omit to state a material
fact necessary to make the statements made, in light of the
circumstances under which such statements were made, not
misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and
other financial information included in this report, fairly
present in all material respects the financial condition,
results of operations and cash flows of the registrant as of,
and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I
are responsible for establishing and maintaining disclosure
controls and procedures (as defined in Exchange Act
Rules 13a-15(e)
and
15d-15(e))
and internal control over financial reporting (as defined in
Exchange Act Rules
13a-15(f)
and
15d-15(f))
for the registrant and have:
a. designed such disclosure controls and procedures, or
caused such disclosure controls and procedures to be designed
under our supervision, to ensure that material information
relating to the registrant, including its consolidated
subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is
being prepared;
b. designed such internal control over financial reporting,
or caused such internal control over financial reporting to be
designed under our supervision, to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrants
disclosure controls and procedures and presented in this report
our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by
this report based on such evaluation; and
d. disclosed in this report any change in the
registrants internal control over financial reporting that
occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an
annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal
control over financial reporting; and
5. The registrants other certifying officer(s) and I
have disclosed, based on our most recent evaluation of internal
control over financial reporting, to the registrants
auditors and the audit committee of the registrants board
of directors (or persons performing the equivalent functions):
a. all significant deficiencies and material weaknesses in
the design or operation of internal control over financial
reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and
report financial information; and
b. any fraud, whether or not material, that involves
management or other employees who have a significant role in the
registrants internal control over financial reporting.
Paul J. Clancy
Executive Vice President and Chief Financial Officer
Date: October 21, 2008
exv32w1
EXHIBIT 32.1
CERTIFICATION
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF
2002
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002
(subsections (a) and (b) of section 1350,
chapter 63 of title 18, United States Code), each of
the undersigned officers of Biogen Idec Inc., a Delaware
corporation (the Company), does hereby certify, to
such officers knowledge, that:
The Quarterly Report on
Form 10-Q
for the quarter ended September 30, 2008 (the
Form 10-Q)
of the Company fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of
1934, and the information contained in the
Form 10-Q
fairly presents, in all material respects, the financial
condition and results of operations of the Company.
James C. Mullen
Chief Executive Officer and President
[principal executive officer]
Dated: October 21, 2008
Paul J. Clancy
Executive Vice President and Chief Financial Officer
[principal financial officer]
Dated: October 21, 2008
A signed original of this written statement required by
Section 906 has been provided to the Company and will be
retained by the Company and furnished to the Securities and
Exchange Commission or its staff upon request.