e10vq
UNITED STATES SECURITIES AND
EXCHANGE COMMISSION
Washington, D.C.
20549
Form 10-Q
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(Mark One)
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þ
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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For the quarterly period ended
June 30, 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
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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14 Cambridge Center, Cambridge, MA 02142
(617) 679-2000
(Address, including zip code,
and telephone number, including
area code, of registrants principal executive
offices)
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days: Yes þ No o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, 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
(Do not check if a smaller reporting company)
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Smaller reporting
company o
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Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2
of the Exchange
Act): Yes o No þ
The number of shares of the registrants Common Stock,
$0.0005 par value, outstanding as of July 17, 2008,
was 290,254,475 shares.
BIOGEN
IDEC INC.
FORM 10-Q
Quarterly Report
For the
Quarterly Period Ended June 30, 2008
TABLE OF
CONTENTS
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Page
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Item 1.
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Financial Statements (unaudited)
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Consolidated Statements of Income
Three and Six Months Ended June 30, 2008 and 2007
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3
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Consolidated Balance Sheets
June 30, 2008 and December 31, 2007
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4
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Consolidated Statements of Cash Flows
Six Months Ended June 30, 2008 and 2007
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5
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Notes to Consolidated Financial Statements
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6
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Managements Discussion and Analysis of
Financial Condition and Results of Operations
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24
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Quantitative and Qualitative Disclosures About
Market Risk
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34
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Controls and Procedures
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34
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Legal Proceedings
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35
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Risk Factors
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35
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Unregistered Sales of Equity Securities and Use
of Proceeds
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46
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Submission of Matters to a Vote of Security
Holders
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46
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Exhibits
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47
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48
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EX-10.2 Amendment to Biogen, Inc. 1985 Non-Qualified Stock Option Plan dated April 18, 2008. |
EX-10.3 Amendment to Biogen, Inc. 1987 Scientific Board Stock Option Plan dated April 18, 2008. |
EX-10.4 Amendment to IDEC Pharmaceuticals Corporation 1988 Stock Option Plan dated April 18, 2008. |
EX-10.5 Amendment to IDEC Pharmaceuticals Corporation 1993 Non-Employee Directors Stock Option Plan dated April 18, 2008. |
EX-10.6 Amendment to Biogen Idec Inc. 2003 Omnibus Equity Plan dated April 18, 2008. |
EX-10.7 Amendment to Biogen Idec Inc. 2005 Omnibus Equity Plan dated April 18, 2008. |
EX-10.8 Amendment to Biogen Idec Inc. 2006 Non-Employee Directors Equity Plan dated April 18, 2008. |
EX-31.1 Section 302 Certification of CEO. |
EX-31.2 Section 302 Certification of CFO. |
EX-32.1 Section 906 Certification of CEO & CFO. |
2
PART I
FINANCIAL INFORMATION
BIOGEN
IDEC INC. AND SUBSIDIARIES
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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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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684,486
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$
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518,625
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$
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1,349,556
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$
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1,003,013
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Unconsolidated joint business
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278,822
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230,590
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526,045
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437,754
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Other revenues
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30,136
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23,961
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60,029
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48,319
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Total revenues
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993,444
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773,176
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1,935,630
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1,489,086
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Costs and expenses:
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Cost of sales, excluding amortization of acquired intangible
assets
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92,401
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84,063
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193,335
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166,013
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Research and development
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252,259
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218,149
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510,491
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409,598
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Selling, general and administrative
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245,689
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203,668
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461,518
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391,729
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Collaboration profit (loss) sharing
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33,429
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(105
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54,835
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(5,672
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Amortization of acquired intangible assets
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72,869
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60,961
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147,650
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120,881
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In-process research and development
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25,000
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18,405
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Total costs and expenses
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696,647
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566,736
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1,392,829
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1,100,954
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Income from operations
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296,797
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206,440
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542,801
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388,132
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Other income (expense), net
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(5,463
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31,586
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(5,093
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53,288
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Income before income tax expense
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291,334
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238,026
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537,708
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441,420
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Income tax expense
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84,706
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51,886
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167,983
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123,779
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Net income
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$
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206,628
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$
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186,140
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$
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369,725
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$
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317,641
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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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0.55
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$
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1.26
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$
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0.93
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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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0.54
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$
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1.24
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$
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0.92
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Weighted-average shares used in calculating:
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Basic earnings per share
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290,356
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340,315
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293,268
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340,312
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Diluted earnings per share
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293,476
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343,389
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296,554
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343,713
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See accompanying notes to the consolidated financial statements.
3
BIOGEN
IDEC INC. AND SUBSIDIARIES
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June 30,
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December 31,
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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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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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466,493
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$
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659,662
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Marketable securities
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234,515
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319,408
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Cash collateral received for loaned securities
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146,956
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208,209
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Accounts receivable, net
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482,797
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392,646
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Due from unconsolidated joint business
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184,221
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166,686
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Loaned securities
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191,244
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204,433
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Inventory
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255,028
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233,987
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Other current assets
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199,774
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183,376
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Total current assets
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2,161,028
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2,368,407
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Marketable securities
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691,044
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932,271
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Property, plant and equipment, net
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1,629,398
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1,497,383
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Intangible assets, net
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2,347,561
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2,492,354
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Goodwill
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1,139,597
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1,137,372
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Investments and other assets
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204,198
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201,028
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Total assets
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$
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8,172,826
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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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146,956
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$
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208,209
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Accounts payable
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116,755
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90,672
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Taxes payable
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138,871
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11,274
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Accrued expenses and other
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471,315
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367,885
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Current portion of notes payable
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11,544
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1,511,135
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Total current liabilities
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885,441
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2,189,175
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Notes payable
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1,038,086
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51,843
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Long-term deferred tax liability
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501,452
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521,525
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Other long-term liabilities
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224,916
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331,977
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Total liabilities
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2,649,895
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3,094,520
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Commitments and contingencies (Notes 10 and 12)
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Shareholders equity:
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Preferred stock, par value $0.001 per share
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Common stock, par value $0.0005 per share
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149
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147
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Additional paid-in capital
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5,979,200
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5,807,071
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Accumulated other comprehensive income
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121,115
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79,246
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Accumulated deficit
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(103,137
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)
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(352,169
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Treasury stock, at cost
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(474,396
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Total shareholders equity
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5,522,931
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5,534,295
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Total liabilities and shareholders equity
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$
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8,172,826
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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
CONSOLIDATED
STATEMENTS OF CASH FLOWS
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Six Months Ended
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June 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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369,725
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$
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317,641
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Adjustments to reconcile net income to net cash flows from
operating activities
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Depreciation and amortization of fixed & intangible
assets
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212,471
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181,275
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In-process research & development
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25,000
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18,405
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Minority interest in subsidiaries
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4,154
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Share-based compensation
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67,647
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59,419
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Non-cash interest expense
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12,151
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1,484
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Deferred income taxes
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(14,757
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)
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(18,172
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Realized gain on sale of marketable securities and strategic
investments
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(5,928
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)
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(6,999
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)
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Write-down of inventory to net realizable value
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9,838
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14,834
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Impairment of investments and other assets
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15,451
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|
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5,513
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Excess tax benefit from stock options
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(18,448
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)
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(9,840
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)
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Changes in assets and liabilities, net:
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Accounts receivable
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(86,302
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)
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(40,999
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)
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Due from unconsolidated joint business
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(17,535
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)
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|
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6,240
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Inventory
|
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(28,187
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)
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|
|
(52,081
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)
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Other assets
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|
|
(7,427
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)
|
|
|
(12,885
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)
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Accrued expenses and other liabilities
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|
|
105,154
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|
|
|
512
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|
|
|
|
|
|
|
|
|
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Net cash flows provided by operating activities
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|
|
643,007
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|
|
|
464,347
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Cash flows from investing activities:
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Purchases of marketable securities
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(1,060,159
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)
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|
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(1,868,371
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)
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Proceeds from sales and maturities of marketable debt securities
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|
|
1,391,949
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|
|
|
2,409,802
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Collateral received under securities lending
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|
|
61,253
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|
|
|
|
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Acquisitions, net of cash acquired
|
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(25,000
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)
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|
|
(42,289
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)
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Purchases of property, plant and equipment
|
|
|
(157,093
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)
|
|
|
(117,178
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)
|
Purchases of other investments
|
|
|
(11,611
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)
|
|
|
(15,818
|
)
|
Proceeds from the sale of a strategic equity investment
|
|
|
15
|
|
|
|
30,566
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|
|
|
|
|
|
|
|
|
|
Net cash flows provided by investing activities
|
|
|
199,354
|
|
|
|
396,712
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Purchase of treasury stock
|
|
|
(559,767
|
)
|
|
|
|
|
Proceeds from issuance of stock for share based compensation
arrangements
|
|
|
89,532
|
|
|
|
81,748
|
|
Change in cash overdrafts
|
|
|
873
|
|
|
|
(642
|
)
|
Excess tax benefit from stock options
|
|
|
18,448
|
|
|
|
9,840
|
|
Repurchase of senior notes
|
|
|
|
|
|
|
(6,563
|
)
|
Proceeds from borrowings, net of discounts and expenses
|
|
|
986,980
|
|
|
|
|
|
Repayments of borrowings
|
|
|
(1,512,474
|
)
|
|
|
(3,703
|
)
|
Obligations under securities lending
|
|
|
(61,253
|
)
|
|
|
|
|
Proceeds from line of credit
|
|
|
|
|
|
|
8,133
|
|
|
|
|
|
|
|
|
|
|
Net cash flow (used in) provided by financing activities
|
|
|
(1,037,661
|
)
|
|
|
88,813
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(195,300
|
)
|
|
|
949,872
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
2,131
|
|
|
|
332
|
|
Cash and cash equivalents, beginning of the period
|
|
|
659,662
|
|
|
|
661,377
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of the period
|
|
$
|
466,493
|
|
|
$
|
1,611,581
|
|
|
|
|
|
|
|
|
|
|
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 six months ended June 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 the three months ended June 30, 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):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Raw materials
|
|
$
|
47.3
|
|
|
$
|
46.4
|
|
Work in process
|
|
|
171.7
|
|
|
|
155.4
|
|
Finished goods
|
|
|
36.0
|
|
|
|
32.2
|
|
|
|
|
|
|
|
|
|
|
Total inventory
|
|
$
|
255.0
|
|
|
$
|
234.0
|
|
|
|
|
|
|
|
|
|
|
During the three months ended June 30, 2008 and 2007, we
wrote down $5.5 million and $8.1 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the six months ended June 30, 2008
and 2007, we wrote down $9.8 million and
$14.8 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 six months ended June 30,
2007, cost of sales was approximately $3.2 million and
$5.7 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 and 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
|
|
|
30.3
|
|
|
|
73.8
|
|
|
|
8.5
|
|
|
|
112.6
|
|
Adjustments relating to sales in prior periods
|
|
|
|
|
|
|
(1.6
|
)
|
|
|
|
|
|
|
(1.6
|
)
|
Payments/returns relating to sales in current period
|
|
|
(21.9
|
)
|
|
|
(33.6
|
)
|
|
|
|
|
|
|
(55.5
|
)
|
Payments/returns relating to sales in prior periods
|
|
|
(5.7
|
)
|
|
|
(36.3
|
)
|
|
|
(7.6
|
)
|
|
|
(49.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance, June 30, 2008
|
|
$
|
9.1
|
|
|
$
|
35.4
|
|
|
$
|
21.3
|
|
|
$
|
65.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The total reserves above were included in the consolidated
balance sheets as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Reduction of accounts receivable
|
|
$
|
31.4
|
|
|
$
|
28.5
|
|
Accrued expenses and other
|
|
|
34.4
|
|
|
|
31.4
|
|
|
|
|
|
|
|
|
|
|
Total reserves
|
|
$
|
65.8
|
|
|
$
|
59.9
|
|
|
|
|
|
|
|
|
|
|
Reserves for discounts, contractual adjustments and returns
reduced gross product revenues as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Three Months Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Discounts
|
|
$
|
15.9
|
|
|
$
|
10.0
|
|
|
$
|
30.3
|
|
|
$
|
20.5
|
|
Contractual adjustments
|
|
|
35.8
|
|
|
|
24.1
|
|
|
|
72.2
|
|
|
|
46.9
|
|
Returns
|
|
|
5.5
|
|
|
|
9.3
|
|
|
|
8.5
|
|
|
|
13.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total allowances
|
|
$
|
57.2
|
|
|
$
|
43.4
|
|
|
$
|
111.0
|
|
|
$
|
81.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross product revenues
|
|
$
|
741.7
|
|
|
$
|
565.2
|
|
|
$
|
1,460.6
|
|
|
$
|
1,087.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent of gross product revenues
|
|
|
7.7
|
%
|
|
|
7.7
|
%
|
|
|
7.6
|
%
|
|
|
7.4
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 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 June 30,
|
|
|
|
|
|
|
|
|
As of Dec. 31,
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
|
|
|
|
|
|
2007
|
|
|
|
|
|
|
Estimated
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
Life
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Cost
|
|
|
Amortization
|
|
|
Net
|
|
|
Out-licensed patents
|
|
|
12 years
|
|
|
$
|
578.0
|
|
|
$
|
(223.2
|
)
|
|
$
|
354.8
|
|
|
$
|
578.0
|
|
|
$
|
(199.1
|
)
|
|
$
|
378.9
|
|
Core/developed technology
|
|
|
15-20 years
|
|
|
|
3,006.7
|
|
|
|
(1,086.8
|
)
|
|
|
1,919.9
|
|
|
|
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
|
|
|
|
(0.8
|
)
|
|
|
2.2
|
|
|
|
3.0
|
|
|
|
(0.7
|
)
|
|
|
2.3
|
|
Assembled workforce
|
|
|
4 years
|
|
|
|
2.1
|
|
|
|
(1.0
|
)
|
|
|
1.1
|
|
|
|
2.1
|
|
|
|
(0.7
|
)
|
|
|
1.4
|
|
Distribution rights
|
|
|
2 years
|
|
|
|
13.3
|
|
|
$
|
(7.7
|
)
|
|
|
5.6
|
|
|
|
11.8
|
|
|
|
(3.8
|
)
|
|
|
8.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
|
|
|
|
$
|
3,667.1
|
|
|
$
|
(1,319.5
|
)
|
|
$
|
2,347.6
|
|
|
$
|
3,661.9
|
|
|
$
|
(1,169.5
|
)
|
|
$
|
2,492.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
|
Indefinite
|
|
|
$
|
1,139.6
|
|
|
$
|
|
|
|
$
|
1,139.6
|
|
|
$
|
1,137.4
|
|
|
$
|
|
|
|
$
|
1,137.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization expense was $72.9 million and
$61.0 million in the three months ended June 30, 2008
and 2007, respectively. Amortization expense was
$147.7 million and $120.9 million in the six months
ended June 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, Inc., or Conforma, pursuant to our acquisition of
Conforma Therapeutics 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 and non-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 June 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
|
|
|
|
June 30,
|
|
|
Active Markets
|
|
|
Observable Inputs
|
|
|
Inputs
|
|
Description
|
|
2008
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents
|
|
$
|
391.4
|
|
|
$
|
|
|
|
$
|
391.4
|
|
|
$
|
|
|
Marketable debt securities
|
|
|
1,116.8
|
|
|
|
|
|
|
|
1,116.8
|
|
|
|
|
|
Strategic investments
|
|
|
9.2
|
|
|
|
9.2
|
|
|
|
|
|
|
|
|
|
Venture capital investments
|
|
|
24.6
|
|
|
|
|
|
|
|
|
|
|
|
24.6
|
|
Derivative contracts
|
|
|
0.8
|
|
|
|
|
|
|
|
0.8
|
|
|
|
|
|
Plan assets for deferred compensation
|
|
|
15.4
|
|
|
|
|
|
|
|
15.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,558.2
|
|
|
$
|
9.2
|
|
|
$
|
1,524.4
|
|
|
$
|
24.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative contracts
|
|
|
22.8
|
|
|
|
|
|
|
|
22.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
22.8
|
|
|
$
|
|
|
|
$
|
22.8
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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):
|
|
|
|
|
Description
|
|
Fair Value
|
|
|
Balance at December 31, 2007
|
|
$
|
28.1
|
|
Total unrealized losses included in earnings
|
|
|
(4.8
|
)
|
Purchases, issuances, and settlements
|
|
|
1.3
|
|
|
|
|
|
|
Balance at June 30, 2008
|
|
$
|
24.6
|
|
|
|
|
|
|
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
|
|
June 30, 2008:
|
|
Value
|
|
|
Gains
|
|
|
Losses
|
|
|
Cost
|
|
|
Available-for-sale
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
$
|
96.6
|
|
|
$
|
0.4
|
|
|
$
|
|
|
|
$
|
96.2
|
|
Non-current
|
|
|
271.0
|
|
|
|
2.2
|
|
|
|
(0.1
|
)
|
|
|
268.9
|
|
U.S. Government securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
67.9
|
|
|
|
0.2
|
|
|
|
|
|
|
|
67.7
|
|
Non-current
|
|
|
179.7
|
|
|
|
2.1
|
|
|
|
|
|
|
|
177.6
|
|
Other interest bearing securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
110.1
|
|
|
|
|
|
|
|
|
|
|
|
110.1
|
|
Non-current
|
|
|
391.5
|
|
|
|
4.0
|
|
|
|
(4.1
|
)
|
|
|
391.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total available-for-sale securities
|
|
$
|
1,116.8
|
|
|
$
|
8.9
|
|
|
$
|
(4.2
|
)
|
|
$
|
1,112.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Strategic investments, non-current
|
|
$
|
9.2
|
|
|
$
|
0.6
|
|
|
$
|
(0.5
|
)
|
|
$
|
9.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 June 30, 2008 and 2007, we
recognized $2.9 million and $3.1 million in charges
for the impairment of available-for-sale securities that were
determined to be other-than-temporary following a decline in
value. In the six months ended June 30, 2008 and 2007, we
recognized $5.2 million and $5.5 million in charges
for the impairment of available-for-sale securities that were
determined to be other-than-temporary following a decline in
value.
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. The unrealized losses on
these securities were primarily caused by a rise in interest
rates subsequent to purchase. We believe that these unrealized
losses are temporary, and we have the intent and ability to hold
these securities to recovery, which may be at maturity.
The proceeds from maturities and sales of marketable securities,
which were primarily reinvested, and resulting realized gains
and losses were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Proceeds from maturities and sales
|
|
$
|
473.9
|
|
|
$
|
1,606.1
|
|
|
$
|
1,391.9
|
|
|
$
|
2,409.8
|
|
Realized gains
|
|
$
|
1.1
|
|
|
$
|
1.5
|
|
|
$
|
10.7
|
|
|
$
|
2.0
|
|
Realized losses
|
|
$
|
0.5
|
|
|
$
|
3.5
|
|
|
$
|
4.8
|
|
|
$
|
3.8
|
|
The amortized cost and estimated fair value of securities
available-for-sale at June 30, 2008 by contractual maturity
are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
Estimated
|
|
|
Amortized
|
|
|
|
Fair Value
|
|
|
Cost
|
|
|
Due in one year or less
|
|
$
|
274.4
|
|
|
$
|
273.9
|
|
Due after one year through five years
|
|
|
450.8
|
|
|
|
446.5
|
|
Mortgage and other asset backed securities
|
|
|
391.6
|
|
|
|
391.7
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,116.8
|
|
|
$
|
1,112.1
|
|
|
|
|
|
|
|
|
|
|
The average maturity of our marketable securities as of
June 30, 2008 and December 31, 2007, was
18 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
$78.1 million and $368.2 million and short-term debt
securities has a fair and carrying value of $313.3 million
and $195.1 million at June 30, 2008 and
December 31, 2007, respectively.
Strategic
Investments
In the three and six months ended June 30, 2008, we
recognized $0.9 million and $3.6 million,
respectively, in charges for the impairment of strategic
investments that were deemed to be other-than-temporary. In the
six months ended June 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 or biotechnology oriented venture
capital investments. The carrying value of these strategic
investments as of June 30, 2008 and December 31, 2007,
was $60.3 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 June 30, 2008, we recorded
$1.2 million in unrealized losses due to declines in the
fair value of the investments and $1.0 million in charges
for the impairment of investments that were determined to be
other-than-temporary. There were no charges for realized losses
or impairments in the three months ended June 30, 2007. In
the six months ended June 30, 2008, we recorded
$4.8 million in unrealized
12
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
losses due to declines in the fair value of the investments and
$1.0 million in charges for the impairment of investments
that were determined to be other-than-temporary. In the six
months ended June 30, 2007, we recorded $0.4 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 securities, 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 $147.0 million and
$208.2 million as of June 30, 2008 and
December 31, 2007, respectively. We have access to other
securities as collateral in the amount of $48.1 million as
of June 30, 2008. 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 June 30,
2008 have durations of one to twelve 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 June 30, 2008 was approximately
$497.1 million. These contracts had an aggregate fair value
of $14.9 million, representing an unrealized loss, and were
included in other current liabilities at June 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 months
ended June 30, 2008, there was $0.5 million recognized
in earnings as a loss due to hedge ineffectiveness. There was no
loss recognized in the three months ended June 30, 2007 due
to hedge ineffectiveness. In the six months ended June 30,
2008 and 2007, there was $1.2 million and $0.6 million
recognized in earnings as a loss due to hedge ineffectiveness.
We recognized $10.1 million of losses in product revenue
for the settlement of certain effective cash flow hedge
instruments for the three months ended June 30, 2008 as
compared to $1.1 million in product revenue for the three
months ended June 30, 2007. We recognized
$17.7 million of losses in product revenue for the
settlement of certain effective cash flow hedge instruments for
the six months ended June 30, 2008 as compared to nominal
losses for the six months ended June 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 six months ended June 30, 2008, we
recognized a net loss of $3.7 million and
$5.0 million, respectively, in earnings due to hedge
ineffectiveness.
13
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The fair value of these swaps at June 30, 2008, which is
included in other assets and other liabilities was
$0.7 million and $9.3 million, respectively, net of
accrued interest.
Notes payable consists of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
June 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
|
|
|
11.5
|
|
|
|
10.3
|
|
Other
|
|
|
|
|
|
|
0.6
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
11.5
|
|
|
$
|
1,511.1
|
|
|
|
|
|
|
|
|
|
|
Non-current portion:
|
|
|
|
|
|
|
|
|
6.000% Senior Notes due 2013
|
|
$
|
449.5
|
|
|
$
|
|
|
6.875% Senior Notes due 2018
|
|
|
542.0
|
|
|
|
|
|
Note payable to Fumedica
|
|
|
27.7
|
|
|
|
34.3
|
|
Credit line from Dompé
|
|
|
18.9
|
|
|
|
17.5
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,038.1
|
|
|
$
|
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 been reduced by
approximately $3.6 million related to the interest rate
swap hedge.
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
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. 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 June 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
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Net income
|
|
$
|
206.6
|
|
|
$
|
186.1
|
|
|
$
|
369.7
|
|
|
$
|
317.6
|
|
Translation adjustments
|
|
|
(2.7
|
)
|
|
|
5.5
|
|
|
|
54.6
|
|
|
|
11.2
|
|
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 $3.5 million, $2.1 million,
$3.3 million and $(0.6) million, respectively
|
|
|
(6.1
|
)
|
|
|
(4.0
|
)
|
|
|
(7.6
|
)
|
|
|
1.5
|
|
Net unrealized gains (losses) on foreign currency forward
contracts, net of tax of ($3.8) million, $0.6 million,
$3.1 million, and $1.3 million, respectively
|
|
|
6.5
|
|
|
|
(1.0
|
)
|
|
|
(5.3
|
)
|
|
|
(2.3
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income
|
|
$
|
204.3
|
|
|
$
|
186.6
|
|
|
$
|
411.6
|
|
|
$
|
328.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted earnings per share are calculated as follows
(in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
206.6
|
|
|
$
|
186.1
|
|
|
$
|
369.7
|
|
|
$
|
317.6
|
|
Adjustment for net income allocable to preferred shares
|
|
|
(0.3
|
)
|
|
|
(0.2
|
)
|
|
|
(0.6
|
)
|
|
|
(0.4
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income used in calculating basic and diluted earnings per
share
|
|
$
|
206.3
|
|
|
$
|
185.9
|
|
|
$
|
369.1
|
|
|
$
|
317.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding
|
|
|
290.4
|
|
|
|
340.3
|
|
|
|
293.3
|
|
|
|
340.3
|
|
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and ESPP
|
|
|
1.9
|
|
|
|
1.9
|
|
|
|
2.0
|
|
|
|
1.9
|
|
Restricted stock units
|
|
|
1.2
|
|
|
|
0.6
|
|
|
|
1.2
|
|
|
|
0.6
|
|
Performance-based restricted stock units
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
0.1
|
|
Restricted stock awards
|
|
|
|
|
|
|
0.4
|
|
|
|
0.1
|
|
|
|
0.5
|
|
Convertible promissory notes
|
|
|
|
|
|
|
0.2
|
|
|
|
|
|
|
|
0.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive potential common shares
|
|
|
3.1
|
|
|
|
3.1
|
|
|
|
3.3
|
|
|
|
3.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in calculating diluted earnings per share
|
|
|
293.5
|
|
|
|
343.4
|
|
|
|
296.6
|
|
|
|
343.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income allocable to preferred shares
|
|
$
|
0.3
|
|
|
$
|
0.2
|
|
|
$
|
0.6
|
|
|
$
|
0.4
|
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
4.0
|
|
|
|
13.8
|
|
|
|
5.2
|
|
|
|
13.7
|
|
Time-vested restricted stock units
|
|
|
0.2
|
|
|
|
1.7
|
|
|
|
0.2
|
|
|
|
1.3
|
|
Convertible preferred stock
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
0.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
4.7
|
|
|
|
16.0
|
|
|
|
5.9
|
|
|
|
15.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2008 and 2007,
share-based compensation expense reduced our results of
operations as follows (in millions, except for earnings per
share):
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
Effect on
|
|
|
Effect on
|
|
|
|
Net Income
|
|
|
Net Income
|
|
|
Income before income taxes
|
|
$
|
(33.1
|
)
|
|
$
|
(29.9
|
)
|
Tax effect
|
|
|
10.0
|
|
|
|
9.1
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
(23.1
|
)
|
|
$
|
(20.8
|
)
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
(0.08
|
)
|
|
$
|
(0.06
|
)
|
Diluted earnings per share
|
|
$
|
(0.08
|
)
|
|
$
|
(0.06
|
)
|
In the six months ended June 30, 2008 and 2007, share-based
compensation expense reduced our results of operations as
follows (in millions, except for earnings per share):
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
Effect on
|
|
|
Effect on
|
|
|
|
Net Income
|
|
|
Net Income
|
|
|
Income before income taxes
|
|
$
|
(67.6
|
)
|
|
$
|
(59.4
|
)
|
Tax effect
|
|
|
20.8
|
|
|
|
18.3
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
(46.8
|
)
|
|
$
|
(41.1
|
)
|
|
|
|
|
|
|
|
|
|
Basic earnings per share
|
|
$
|
(0.16
|
)
|
|
$
|
(0.12
|
)
|
Diluted earnings per share
|
|
$
|
(0.16
|
)
|
|
$
|
(0.12
|
)
|
16
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Share-based compensation expense and cost in the three and six
months ended June 30, 2008 and 2007 is as follows (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2008
|
|
|
Three Months Ended June 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
|
|
$
|
1.4
|
|
|
$
|
12.8
|
|
|
$
|
14.2
|
|
|
$
|
3.0
|
|
|
$
|
9.9
|
|
|
$
|
12.9
|
|
Selling, general and administrative
|
|
|
3.8
|
|
|
|
17.0
|
|
|
|
20.8
|
|
|
|
5.3
|
|
|
|
12.7
|
|
|
|
18.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
5.2
|
|
|
$
|
29.8
|
|
|
$
|
35.0
|
|
|
$
|
8.3
|
|
|
$
|
22.6
|
|
|
$
|
30.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based compensation costs
|
|
|
|
|
|
|
|
|
|
|
(1.9
|
)
|
|
|
|
|
|
|
|
|
|
|
(1.0
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
33.1
|
|
|
|
|
|
|
|
|
|
|
$
|
29.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2008
|
|
|
Six Months Ended June 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
|
|
$
|
3.8
|
|
|
$
|
28.0
|
|
|
$
|
31.8
|
|
|
$
|
6.0
|
|
|
$
|
17.6
|
|
|
$
|
23.6
|
|
Selling, general and administrative
|
|
|
7.2
|
|
|
|
32.3
|
|
|
|
39.5
|
|
|
|
11.5
|
|
|
|
26.3
|
|
|
|
37.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
11.0
|
|
|
$
|
60.3
|
|
|
$
|
71.3
|
|
|
$
|
17.5
|
|
|
$
|
43.9
|
|
|
$
|
61.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalized share-based compensation costs
|
|
|
|
|
|
|
|
|
|
|
(3.7
|
)
|
|
|
|
|
|
|
|
|
|
|
(2.0
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
|
|
|
|
|
|
|
$
|
67.6
|
|
|
|
|
|
|
|
|
|
|
$
|
59.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 February 2008 at an exercise price
of $60.56 per share. Approximately one million stock options
were awarded as part of the annual award in February 2007 at an
exercise price of $49.31 per share.
The fair value of the stock option grants awarded in the six
months ended June 30, 2008 and 2007 was estimated as of the
date of grant using a Black-Scholes option valuation model that
uses the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
Expected dividend yield
|
|
|
0.0
|
%
|
|
|
0.0
|
%
|
Expected stock price volatility
|
|
|
34.4
|
%
|
|
|
33.6
|
%
|
Risk-free interest rate
|
|
|
2.46
|
%
|
|
|
4.51
|
%
|
Expected option life in years
|
|
|
5.10
|
|
|
|
4.87
|
|
Per share grant-date fair value
|
|
$
|
21.07
|
|
|
$
|
18.22
|
|
17
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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 February 2008 at a grant date fair value of $60.56 per share.
Approximately 2.3 million RSUs were awarded as part of the
annual grant in February 2007 at a grant date fair value of
$49.31 per share.
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 issuance. 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 June 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
six months ended June 30, 2008 and 2007, 0.3 million
and 0.3 million shares, respectively, were issued under the
ESPP. In the three months ended June 30, 2008 and 2007, we
recorded compensation charges of approximately $0.5 million
and $0.4 million, respectively, of stock compensation
charges related to the ESPP. In the six months ended
June 30, 2008 and 2007, we recorded compensation charges of
approximately $1.6 million and $1.2 million,
respectively, of stock compensation charges related to the ESPP.
Tax
Rate
Our effective tax rate was 29.1% on pre-tax income for the three
months ended June 30, 2008, compared to 21.8% for the
comparable period in 2007. Our effective tax rate was 31.2% on
pre-tax income for the six months ended June 30, 2008,
compared to 28.0% for the comparable period in 2007.
A reconciliation of the U.S. federal statutory tax rate to
the effective tax rate for the three and six months ended
June 30, 2008 and 2007, respectively, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Statutory Rate
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
State Taxes
|
|
|
1.6
|
|
|
|
1.7
|
|
|
|
2.2
|
|
|
|
1.9
|
|
Foreign Taxes
|
|
|
(11.2
|
)
|
|
|
(8.0
|
)
|
|
|
(10.1
|
)
|
|
|
(7.7
|
)
|
Credits and net operating loss utilization
|
|
|
0.5
|
|
|
|
(3.7
|
)
|
|
|
(0.5
|
)
|
|
|
(2.5
|
)
|
Other
|
|
|
(0.4
|
)
|
|
|
(6.8
|
)
|
|
|
(0.5
|
)
|
|
|
(3.4
|
)
|
Fair Value Adjustment
|
|
|
3.6
|
|
|
|
3.6
|
|
|
|
3.5
|
|
|
|
3.1
|
|
IPR&D
|
|
|
|
|
|
|
|
|
|
|
1.6
|
|
|
|
1.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29.1
|
%
|
|
|
21.8
|
%
|
|
|
31.2
|
%
|
|
|
28.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Contingency
On September 12, 2006, we received a Notice of Assessment
from the Massachusetts Department of Revenue for
$38.9 million, including penalties and interest, with
respect to the 2001, 2002 and 2003 tax years. We believe that we
have meritorious defenses to the proposed adjustment and 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.
|
|
12.
|
Other
Income (Expense), Net
|
Total other income (expense), net, consists of the following (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Interest income
|
|
$
|
15.3
|
|
|
$
|
32.1
|
|
|
$
|
38.2
|
|
|
$
|
61.2
|
|
Minority interest
|
|
|
(1.4
|
)
|
|
|
(1.9
|
)
|
|
|
(4.2
|
)
|
|
|
(4.0
|
)
|
Interest expense
|
|
|
(13.9
|
)
|
|
|
(1.9
|
)
|
|
|
(29.6
|
)
|
|
|
(2.3
|
)
|
Other, net
|
|
|
(5.5
|
)
|
|
|
3.3
|
|
|
|
(9.5
|
)
|
|
|
(1.6
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net
|
|
$
|
(5.5
|
)
|
|
$
|
31.6
|
|
|
$
|
(5.1
|
)
|
|
$
|
53.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2008, the principal
components of other, net were impairments on strategic
investments of $3.4 million and net realized losses on
sales of marketable securities of $2.2 million. In the
three months ended June 30, 2007, the principal components
of other, net were legal settlements of $1.6 million and
net realized gains on sales of strategic investments of
$8.1 million, offset by net realized losses on sales of
marketable securities of $5.0 million.
In the six months ended June 30, 2008, the principal
components of other, net were net impairments on strategic
investments of $10.2 million, losses on foreign currency of
$0.9 million and hedge ineffectiveness of
$1.2 million, offset by a VAT refund of $3.8 million.
In the six months ended June 30, 2007, the principal
components of other, net were net realized losses on sales of
marketable securities of $7.3 million, offset by net
realized gains on our strategic investments of $8.0 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
19
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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. On October 15, 2007, the
plaintiffs filed a notice of appeal to the U.S. Court of
Appeals for the First Circuit. 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 to vigorously defend
the case.
On October 4, 2004, Genentech, Inc. received a subpoena
from the U.S. Department of Justice requesting documents
related to the promotion of RITUXAN. We market RITUXAN in the
U.S. in collaboration with Genentech. Genentech has
disclosed that it is cooperating with the associated
investigation, which it has disclosed that it has been advised
is both civil and criminal in nature. We are cooperating with
the U.S. Department of Justice in its investigation of
Genentech. The potential outcome of this matter and its impact
on us cannot be determined at this time.
Along with several other major pharmaceutical and biotechnology
companies, Biogen, Inc. (now Biogen Idec MA, Inc., one of
our wholly-owned subsidiaries) or, in certain cases, Biogen Idec
Inc., was named as a defendant in lawsuits filed by the City of
New York and numerous Counties of the State of New York.
All of the cases except for cases filed by the
County of Erie, County of Oswego and County of Schenectady (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. The lawsuit was filed in the
Superior Court of the State of Arizona and transferred to the
MDL proceedings. The complaint, as amended on March 13,
2007, is 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
20
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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. On December 26, 2007, Biogen Idec and
other defendants agreed to participate in mediation. Informal
mediation has begun. 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 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 arbitration is in
the discovery stage. The hearing is scheduled to take place in
the fall of 2008. 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
21
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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.
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
22
BIOGEN
IDEC INC. AND SUBSIDIARIES
NOTES TO
CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
will be recast for the changes required by SFAS 160. We are
evaluating the impact, if any, this Standard will have on our
financial statements.
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, of 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 are evaluating the impact, if any, this Standard will
have on our financial statements.
23
|
|
Item 2.
|
Managements
Discussion and Analysis of Financial Condition and Results of
Operations
|
Forward-Looking
Information
In addition to historical information, this report contains
forward-looking statements that involve risks and uncertainties
that could cause actual results to differ materially from those
reflected in such forward-looking statements. You can identify
these forward-looking statements by their use of words such as
anticipate, believe,
estimate, expect, forecast,
intend, plan, project,
target, may, will and other
words and terms of similar meaning. You also can identify them
by the fact that they do not relate strictly to historical or
current facts. Reference is made in particular to
forward-looking statements regarding the anticipated level of
future product sales, royalty revenues, expenses, reserves and
profits, regulatory approvals, our long-term growth, the
development and marketing of additional products, the impact of
competitive products, the anticipated outcome of pending or
anticipated litigation, patent-related proceedings and tax
assessments, our ability to finance our operations and meet our
manufacturing needs, the completion of our manufacturing
facility in Hillerod, Denmark, the value of investments in
certain marketable securities, liquidity and capital resources,
and our plans to spend additional capital on external business
development and research opportunities. Risk factors which could
cause actual results to differ from our expectations and which
could negatively impact our financial condition and results of
operations are discussed in the section entitled Risk
Factors in Part II of this report and elsewhere in
this report. 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 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 six months of 2008 included total revenue
of $1,935.6 million, net income of $369.7 million and
diluted net income per share of $1.24. 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
24
selling, general and administrative expense related to increased
personnel to support the ongoing AVONEX sales and TYSABRI growth.
Results
of Operations
Revenues
(in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Product sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
352.2
|
|
|
|
35.5
|
%
|
|
$
|
295.2
|
|
|
|
38.2
|
%
|
|
$
|
702.2
|
|
|
|
36.3
|
%
|
|
$
|
586.4
|
|
|
|
39.4
|
%
|
Rest of world
|
|
|
332.3
|
|
|
|
33.4
|
%
|
|
|
223.4
|
|
|
|
28.9
|
%
|
|
|
647.4
|
|
|
|
33.4
|
%
|
|
|
416.6
|
|
|
|
28.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
|
684.5
|
|
|
|
68.9
|
%
|
|
|
518.6
|
|
|
|
67.1
|
%
|
|
|
1,349.6
|
|
|
|
69.7
|
%
|
|
|
1,003.0
|
|
|
|
67.4
|
%
|
Unconsolidated joint business
|
|
|
278.8
|
|
|
|
28.1
|
%
|
|
|
230.6
|
|
|
|
29.8
|
%
|
|
|
526.0
|
|
|
|
27.2
|
%
|
|
|
437.8
|
|
|
|
29.4
|
%
|
Royalties
|
|
|
28.1
|
|
|
|
2.8
|
%
|
|
|
22.6
|
|
|
|
2.9
|
%
|
|
|
52.1
|
|
|
|
2.7
|
%
|
|
|
45.6
|
|
|
|
3.1
|
%
|
Corporate partner
|
|
|
2.0
|
|
|
|
0.2
|
%
|
|
|
1.4
|
|
|
|
0.2
|
%
|
|
|
7.9
|
|
|
|
0.4
|
%
|
|
|
2.7
|
|
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
$
|
993.4
|
|
|
|
100.0
|
%
|
|
$
|
773.2
|
|
|
|
100.0
|
%
|
|
$
|
1,935.6
|
|
|
|
100.0
|
%
|
|
$
|
1,489.1
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Revenues (in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
AVONEX
|
|
$
|
527.2
|
|
|
|
77.0
|
%
|
|
$
|
461.6
|
|
|
|
89.0
|
%
|
|
$
|
1,063.3
|
|
|
|
78.8
|
%
|
|
$
|
910.4
|
|
|
|
90.8
|
%
|
TYSABRI
|
|
|
147.2
|
|
|
|
21.5
|
%
|
|
|
47.5
|
|
|
|
9.2
|
%
|
|
|
261.8
|
|
|
|
19.4
|
%
|
|
|
77.3
|
|
|
|
7.7
|
%
|
FUMADERM
|
|
|
10.0
|
|
|
|
1.5
|
%
|
|
|
5.2
|
|
|
|
1.0
|
%
|
|
|
21.7
|
|
|
|
1.6
|
%
|
|
|
5.2
|
|
|
|
0.5
|
%
|
ZEVALIN
|
|
|
|
|
|
|
|
%
|
|
|
4.3
|
|
|
|
0.8
|
%
|
|
|
2.5
|
|
|
|
0.2
|
%
|
|
|
9.9
|
|
|
|
1.0
|
%
|
AMEVIVE
|
|
|
0.1
|
|
|
|
0.0
|
%
|
|
|
|
|
|
|
|
%
|
|
|
0.3
|
|
|
|
0.0
|
%
|
|
|
0.2
|
|
|
|
0.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product revenues
|
|
$
|
684.5
|
|
|
|
100.0
|
%
|
|
$
|
518.6
|
|
|
|
100.0
|
%
|
|
$
|
1,349.6
|
|
|
|
100.0.
|
%
|
|
$
|
1,003.0
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of Sales, excluding Amortization of Intangibles (in
millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Cost of product revenues
|
|
$
|
91.2
|
|
|
|
98.7
|
%
|
|
$
|
83.2
|
|
|
|
98.9
|
%
|
|
$
|
190.9
|
|
|
|
98.8
|
%
|
|
$
|
164.0
|
|
|
|
98.8
|
%
|
Cost of royalty revenues
|
|
|
1.2
|
|
|
|
1.3
|
%
|
|
|
0.9
|
|
|
|
1.1
|
%
|
|
|
2.4
|
|
|
|
1.2
|
%
|
|
|
2.0
|
|
|
|
1.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales, excluding amortization of intangibles
|
|
$
|
92.4
|
|
|
|
100.0
|
%
|
|
$
|
84.1
|
|
|
|
100.0
|
%
|
|
$
|
193.3
|
|
|
|
100.0
|
%
|
|
$
|
166.0
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the three months ended June 30, 2008 and 2007, we
wrote-down $5.5 million and $8.1 million,
respectively, in unmarketable inventory, which was charged to
cost of sales. During the six months ended June 30, 2008
and 2007, we wrote-down $9.8 million and
$14.8 million, respectively, in unmarketable inventory,
which was charged to cost of sales.
25
AVONEX
Revenues from AVONEX in the three and six months ended
June 30, 2008 and 2007 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
AVONEX
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
305.6
|
|
|
|
58.0
|
%
|
|
$
|
269.6
|
|
|
|
58.4
|
%
|
|
$
|
614.0
|
|
|
|
57.7
|
%
|
|
$
|
539.6
|
|
|
|
59.3
|
%
|
Rest of World
|
|
|
221.6
|
|
|
|
42.0
|
%
|
|
|
192.0
|
|
|
|
41.6
|
%
|
|
|
449.3
|
|
|
|
42.3
|
%
|
|
|
370.8
|
|
|
|
40.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total AVONEX revenues
|
|
$
|
527.2
|
|
|
|
100.0
|
%
|
|
$
|
461.6
|
|
|
|
100.0
|
%
|
|
$
|
1,063.3
|
|
|
|
100.0
|
%
|
|
$
|
910.4
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, U.S. sales of AVONEX
increased $36.0 million, or 13.4%, due to price increases,
partially offset by decreased product demand resulting in lower
volume. In the six months ended June 30, 2008, compared to
the six months ended June 30, 2007, U.S. sales of
AVONEX increased $74.4 million, or 13.8%, due to price
increases, partially offset by a decreased product demand
resulting in lower volume.
In the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, Rest of World sales of
AVONEX increased $29.6 million, or 15.4% due to the impact
of exchange rates. In the six months ended June 30, 2008,
compared to the six months ended June 30, 2007, Rest of
World sales of AVONEX increased $78.5 million, or 21.2%,
due to increased unit shipments and the impact of exchange rates.
We are facing increasing competition in the multiple sclerosis,
or MS, marketplace in and outside the U.S. 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 six months ended
June 30, 2008 and 2007 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
TYSABRI
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S.
|
|
$
|
46.5
|
|
|
|
31.6
|
%
|
|
$
|
22.3
|
|
|
|
46.9
|
%
|
|
$
|
87.7
|
|
|
|
33.5
|
%
|
|
$
|
39.4
|
|
|
|
51.0
|
%
|
Rest of World
|
|
|
100.7
|
|
|
|
68.4
|
%
|
|
|
25.2
|
|
|
|
53.1
|
%
|
|
|
174.1
|
|
|
|
66.5
|
%
|
|
|
37.9
|
|
|
|
49.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total TYSABRI revenues
|
|
$
|
147.2
|
|
|
|
100.0
|
%
|
|
$
|
47.5
|
|
|
|
100.0
|
%
|
|
$
|
261.8
|
|
|
|
100.0
|
%
|
|
$
|
77.3
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, sales of TYSABRI
increased $99.7 million, or 209.9%, and in the six months
ended June 30, 2008, compared to the six months ended
June 30, 2007, sales of TYSABRI increased
$184.5 million, or 238.7%. 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 June 30, 2008 and 2007
was $99.3 million and $46.8 million, respectively. Net
sales of TYSABRI to third-party customers in the U.S. for
the six months ended June 30, 2008 and 2007 was
$185.6 million and $82.6 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.
26
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 June 30,
2008 and 2007, we recognized $10.0 million and
$5.2 million, respectively, of sales of FUMADERM. For the
six months ended June 30, 2008 and 2007, we recognized
$21.7 million and $5.2 million, respectively, of sales
of FUMADERM.
ZEVALIN
In the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, sales of ZEVALIN
decreased from $4.3 million to zero, 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 six months ended June 30, 2008, compared to the
three months ended June 30, 2007, sales of ZEVALIN
decreased from $9.9 million to $2.5 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
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Copromotion profits
|
|
$
|
177.7
|
|
|
$
|
153.5
|
|
|
$
|
335.7
|
|
|
$
|
290.0
|
|
Reimbursement of selling and development expenses
|
|
|
15.9
|
|
|
|
15.0
|
|
|
|
28.6
|
|
|
|
29.1
|
|
Royalty revenue on sales of RITUXAN outside the U.S.
|
|
|
85.2
|
|
|
|
62.1
|
|
|
|
161.7
|
|
|
|
118.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
278.8
|
|
|
$
|
230.6
|
|
|
$
|
526.0
|
|
|
$
|
437.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits consist of the following (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
|
|
|
Six Months
|
|
|
|
Ended
|
|
|
Ended
|
|
|
|
June 30,
|
|
|
June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Product revenues, net
|
|
$
|
650.9
|
|
|
$
|
581.9
|
|
|
$
|
1,255.5
|
|
|
$
|
1,116.8
|
|
Costs and expenses
|
|
|
206.6
|
|
|
|
198.3
|
|
|
|
403.8
|
|
|
|
379.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Copromotion profits
|
|
$
|
444.3
|
|
|
$
|
383.6
|
|
|
$
|
851.7
|
|
|
$
|
737.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biogen Idecs share of copromotion profits
|
|
$
|
177.7
|
|
|
$
|
153.5
|
|
|
$
|
335.7
|
|
|
$
|
290.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, our share of copromotion
profits increased $24.2 million, or 15.8%, due principally
to higher sales of RITUXAN. For the six months ended
June 30, 2008, compared to the six months ended
June 30, 2007, our share of copromotion profits increased
$45.7 million, or 15.8%, due principally to higher sales of
RITUXAN.
Our royalty revenue on sales of RITUXAN outside the U.S. is
based on net sales by Roche Holding AG, or Roche, and Zenyaku
Kogyo Co. Ltd., or Zenyaku, to third-party customers and is
recorded on a cash basis. For
27
the three months ended June 30, 2008, compared to the three
months ended June 30, 2007, royalty revenue on sales of
RITUXAN outside the U.S. increased $23.1 million, or
37.2%, due primarily to increased sales outside the U.S.,
reflecting greater market penetration, as well as the impact of
foreign exchange. For the six months ended June 30, 2008,
compared to the six months ended June 30, 2007, royalty
revenue on sales of RITUXAN outside the U.S. increased
$43.0 million, or 36.2%, 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 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%. |
28
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.
Other
Revenues
Other revenues for the three and six months ended June 30,
2008 and 2007 were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
Royalties
|
|
$
|
28.1
|
|
|
|
93.4
|
%
|
|
$
|
22.6
|
|
|
|
94.2
|
%
|
|
$
|
52.1
|
|
|
|
86.8
|
%
|
|
$
|
45.6
|
|
|
|
94.4
|
%
|
Corporate partner
|
|
|
2.0
|
|
|
|
6.6
|
%
|
|
|
1.4
|
|
|
|
5.8
|
%
|
|
|
7.9
|
|
|
|
13.2
|
%
|
|
|
2.7
|
|
|
|
5.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other revenues
|
|
$
|
30.1
|
|
|
|
100.0
|
%
|
|
$
|
24.0
|
|
|
|
100.0
|
%
|
|
$
|
60.0
|
|
|
|
100.0
|
%
|
|
$
|
48.3
|
|
|
|
100.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In the three months ended June 30, 2008, compared to the
three months ended June 30, 2007, royalties increased
$5.5 million, or 24.3%. Increased royalties of
$9.4 million were primarily related to increased sales of
products licensed by The Medicines Company, GlaxoSmithKline, and
Bayer Bioscience, as well as an increased royalty rate on
products licensed by Schering-Plough Corporation. These
increases were partially offset by a $3.9 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.
In the six months ended June 30, 2008, compared to the six
months ended June 30, 2007, royalties increased
$6.5 million, or 14.3%. Increased royalties of
$14.2 million were primarily related to increased sales of
products licensed by The Medicines Company, GlaxoSmithKline, and
Bayer Bioscience, as well as an increased royalty rate on
products licensed by Schering-Plough Corporation. These
increases were partially offset by a $7.7 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.
Research
and Development Expenses
Research and development expenses totaled $252.3 million
and $218.1 million in the three months ended June 30,
2008 and 2007, respectively, an increase of $34.2 million,
or 15.7%. The increase is due primarily to $13.0 million of
increases in Lixivaptan projects, $6.6 million of increases
in Baminercept Alpha projects, and $15.4 million of
increases in projects related to Anti-CD23, Aviptadil, Avonex,
BG-12, Daclizamab, HSP90, Volociximab and RITUXAN, partially
offset by a decrease in Tysabri and IGF-1R projects.
Research and development expenses totaled $510.5 million
and $409.6 million in the six months ended June 30,
2008 and 2007, respectively, an increase of $100.9 million,
or 24.6%. The increase is due primarily to $21.2 million of
increases in Lixivaptan projects, $17.1 million of
increases in Baminercept Alpha projects, $11.2 million of
increases related to our collaboration with Neurimmune,
$10.1 million of increases in RITUXAN projects, and
$28.9 million of increases in projects related to Adentri,
Anti-CD23, Aviptadil,
BG-12,
BIIB014, HSP90 and Volociximab programs, partially offset by a
decrease in IGF-1R, Tysabri and Zevalin projects.
29
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 six months ended June 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 June 30, 2008, research and development
expenditures related to in-process research and development
projects acquired in prior years are $30.6 million,
$37.9 million and $91.1 million related to Syntonix
Pharmaceuticals, Inc., or Syntonix, Conforma and Fumapharm,
respectively. In the six months ended June 30, 2007 we
recorded an IPR&D charge of $18.4 million, related to
the acquisition of Syntonix.
Selling,
General and Administrative Expenses
Selling, general and administrative expenses totaled
$245.7 million and $203.7 million in the three months
ended June 30, 2008 and 2007, respectively, an increase of
$42.0 million, or 20.6%. The increase reflects,
principally, a $17.2 million increase in international
sales and marketing activities, primarily for AVONEX and
TYSABRI, a $11.1 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
$461.5 million and $391.7 million in the six months
ended June 30, 2008 and 2007, respectively, an increase of
$69.8 million, or 17.8%. The increase reflects,
principally, a $34.8 million increase in international
sales and marketing activities, primarily for AVONEX and
TYSABRI, an $18.5 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.
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 of 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 June 30,
2008 and 2007, the collaboration profit (loss) sharing was
$33.4 million and ($0.1) million, respectively. For
the six months ended June 30, 2008 and 2007, the
collaboration profit (loss) sharing was $54.8 million and
($5.7) million, respectively. The
year-over-year
increase in the collaboration profit sharing for the three and
six months ended June 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 $14.6 million and $3.5 million for the
three months ended June 30, 2008 and 2007,
respectively, and $25.2 million and $5.3 million for
the six months ended June 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 $72.9 million for
the three months ended June 30, 2008, compared to
$61.0 million in the comparable period in 2007, an increase
of $11.9 million, or 19.5%. Amortization of intangible
assets totaled $147.7 million for the six months ended
June 30, 2008, compared to $120.9 million in the
comparable period in 2007, an increase of $26.8 million, or
22.2%. These changes are primarily due to the timing of 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 2007 and 2006.
Income
Tax Provision
Tax
Rate
Our effective tax rate was 29.1% on pre-tax income for the three
months ended June 30, 2008, compared to 21.8% for the
comparable period in 2007. Our effective tax rate was 31.2% on
pre-tax income for the six
30
months ended June 30, 2008, compared to 28.0% for the
comparable period in 2007. We expect our effective tax rate for
the full-year ending December 31, 2008 to be in a range of
31% to 33%, as our effective tax rates for the three and six
months ended June 30, 2008 were favorably impacted by the
restructuring of our operations in foreign jurisdictions in the
second quarter and other activities. Refer to Note 11,
Income Taxes, for a detailed income tax rate reconciliation for
the three and six months ended June 30, 2008 and 2007.
Liquidity
and Capital Resources
Financial
Condition
Our financial condition is summarized as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
Cash and cash equivalents
|
|
$
|
466.5
|
|
|
$
|
659.7
|
|
Marketable securities current and non-current
|
|
|
1,116.8
|
|
|
|
1,456.1
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and marketable securities
|
|
$
|
1,583.3
|
|
|
$
|
2,115.8
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$
|
1,275.6
|
|
|
$
|
179.2
|
|
Outstanding borrowings current and non-current
|
|
$
|
1,049.6
|
|
|
$
|
1,563.0
|
|
The decline in cash and marketable securities at June 30,
2008, as compared to December 31, 2007, primarily reflects
the net repayment of approximately $500 million of
indebtedness, as well as $559.8 million used to fund share
repurchases, partially offset by cash generated from operations.
In addition, during the six months ended June 30, 2008, we
paid approximately $36.0 million in milestone and other
payments pursuant to our research and development programs,
including $25.0 million of contingent purchase price in
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 readily marketable debt instruments in
accordance with our investment policy.
As of June 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,
and includes situations where there is little, if any, market
activity 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 using
market data including reportable trades, benchmark yields,
broker/dealer quotes, bids, offers, current spot rates, and
other industry and economic events. When necessary we validate
our valuation techniques by understanding the models used by
pricing sources, obtaining market values from other pricing
sources and challenging pricing data received from others.
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
June 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.
31
We have financed our operating and capital expenditures through
cash flows from our operations. We financed our 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 $643.0 million and
$464.3 million in the six months ended June 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.
Investing
activities
Cash provided by investing activities was $199.4 million
and $396.7 million in the six months ended June 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 $157.1 million in the six months ended
June 30, 2008, as compared to $117.2 million in the
six months ended June 30, 2007. Payments pursuant to
acquisitions and licenses were $25.0 million in the six
months ended June 30, 2008, which related to our 2006
acquisition of Conforma, and $42.3 million in the six
months ended June 30, 2007, which related to our
acquisition of Syntonix.
Financing
activities
Cash used in financing activities in the six months ended
June 30, 2008 was $1,037.7 million compared to cash
provided of $88.8 million in the six months ended
June 30, 2007. The increase in use of cash was due,
principally, to the repayment of our term loan facility of
$1.5 billion, a decrease in our securities lending
obligations of $61.3 million 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
$89.5 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. As of June 30, 2008, there were no borrowings
outstanding under this credit facility.
Working
capital
At June 30, 2008, our working capital, which we define as
current assets less current liabilities, was
$1,275.6 million, as compared to $179.2 million at
December 31, 2007, an increase of $1,096.4 million.
This
32
primarily reflects use of cash and cash equivalents and the
issuance of long-term debt to repay our short-term loan facility
of $1,500.0 million.
Commitments
As of June 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 June 30, 2008, we had
contractual commitments of approximately $264.9 million for
the second phase, of which approximately $197.3 million had
been paid. This second phase of the project is expected to be
licensed for commercial production in 2009.
The timing of the completion and anticipated licensing of the
bulk manufacturing facility is in part dependent upon market
acceptance of TYSABRI. See Risk Factors Our
near-term success depends on the market acceptance and
successful sales growth of TYSABRI. Now that TYSABRI has
been approved for the 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 six months ended June 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 June 30, 2008 of up to
approximately $24.7 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 June 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 June 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
|
|
$
|
111.2
|
|
|
$
|
13.5
|
|
|
$
|
47.0
|
|
|
$
|
32.2
|
|
|
$
|
18.5
|
|
Notes payable(1)
|
|
|
1,477.2
|
|
|
|
28.9
|
|
|
|
155.3
|
|
|
|
118.7
|
|
|
|
1,174.3
|
|
Other long-term obligations
|
|
|
10.7
|
|
|
|
4.8
|
|
|
|
5.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual cash obligations
|
|
$
|
1,599.1
|
|
|
$
|
47.2
|
|
|
$
|
208.2
|
|
|
$
|
150.9
|
|
|
$
|
1,192.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes estimated interest payable |
33
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 June 30,
2008, we have approximately $115 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 June 30, 2008.
New
Accounting Standards
Refer to Note 15, New Accounting Pronouncements, for a
discussion of new accounting standards.
Critical
Accounting Estimates
The discussion and analysis of our financial condition and
results of operations is based on our financial statements,
which have been prepared in accordance with accounting
principles generally accepted in the 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. There have been no
material changes in the first six months of 2008 to such risks
or to our management of such risks.
|
|
Item 4.
|
Controls
and Procedures
|
Disclosure
Controls and Procedures
We have carried out an evaluation, under the supervision and the
participation of our management, including our principal
executive officer and principal financial officer, of the
effectiveness of the design and operation of our disclosure
controls and procedures (as defined in
Rules 13a-15(e)
and
15d-15(e)
under the Securities Exchange Act of 1934, as amended, or the
Securities Exchange Act) as of June 30, 2008. Based upon
that evaluation, our principal executive officer and principal
financial officer concluded that, as of June 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
34
was required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
Changes
in Internal Control over Financial Reporting
We have not made any changes in our internal control over
financial reporting during the three months ended June 30,
2008 that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
Part II
OTHER INFORMATION
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Item 1.
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Legal
Proceedings
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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 82% of our total
revenues for the first half 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. Additional cases
of the known side effect progressive multifocal
leukoencephalopathy (PML) at a higher rate than indicated in the
prescribing information, or the occurrence of other unexpected
side effects could harm acceptance and limit TYSABRI sales. Any
significant lack of acceptance of TYSABRI by the medical
community or patients would materially and adversely affect our
growth and our plans for the future.
As a 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
35
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 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 and products in development
Even after we receive marketing approval for a product, adverse
event reports may have a negative impact on our
commercialization efforts. Our voluntary withdrawal of TYSABRI
from the market in February 2005 following reports of cases of
PML resulted in a significant reduction in expected revenues as
well as significant expense and management time required to
address the legal and regulatory issues arising from the
withdrawal, including revised labeling and enhanced risk
management programs. Later discovery of safety issues with our
products that were not known at the time of their approval by
the FDA could cause product liability events, additional
regulatory scrutiny and requirements for additional labeling,
withdrawal of products from the market and the imposition of
fines or criminal penalties. Any of these actions could result
in, among other things, material write-offs of inventory and
impairments of intangible assets, goodwill and fixed assets.
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.
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
36
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 copromote 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).
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
37
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.
If we
do not successfully execute our strategy of growth through the
acquisition, partnering and in-licensing of products,
technologies or companies, our future performance could be
adversely affected
In addition to the expansion of our pipeline through spending on
internal development projects, we plan to grow through external
growth opportunities, which include the acquisition, partnering
and in-licensing of products, technologies and companies or the
entry into strategic alliances and collaborations. If we are
unable to complete or manage these external growth opportunities
successfully, we will not be able to grow our business in the
way that we currently expect. The availability of high quality
opportunities is limited and we are not certain that we will be
able to identify suitable candidates or complete transactions on
terms that are acceptable to us. In addition, even if we are
able to successfully identify and complete acquisitions, we may
not be able to integrate them or take full advantage of them and
therefore may not realize the benefits that we expect. If we are
unsuccessful in our external growth program, we may not be able
to grow our business significantly and we may incur asset
impairment charges as a result of acquisitions that are not
successful.
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 plan on applying 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.
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If we cannot produce sufficient commercial requirements of bulk
product to meet demand, we would need to rely on third party
contract manufacturers, of which there are only a limited number
capable of manufacturing bulk products of the type we require.
We cannot be certain that we could reach agreement on reasonable
terms, if at all, with those manufacturers. Even if we were to
reach agreement, the transition of the manufacturing process to
a third party to enable commercial supplies could take a
significant amount of time. Our ability to supply products in
sufficient capacity to meet demand is also dependent upon third
party contractors to fill-finish, package and store such
products. Any prolonged interruption in the operations of our
existing manufacturing facilities could result in cancellations
of shipments or loss of product in the process of being
manufactured. Because our manufacturing processes are highly
complex and are subject to a lengthy FDA approval process,
alternative qualified production capacity may not be available
on a timely basis or at all.
We
rely on third parties to provide services in connection with the
manufacture of our products and, in some instances, the
manufacture of the product itself
We rely on Genentech for all RITUXAN manufacturing. Genentech
relies on a third party to manufacture certain bulk RITUXAN
requirements. If Genentech or any third party upon which it
relies does not manufacture or fill-finish RITUXAN in sufficient
quantities and on a timely and cost-effective basis, or if
Genentech or any third party does not obtain and maintain all
required manufacturing approvals, our business could be harmed.
We also source all of our fill-finish and the majority of our
final product storage operations, along with a substantial
portion of our packaging operations of the components used with
our products, to a concentrated group of third party
contractors. The manufacture of products and product components,
fill-finish, packaging and storage of our products require
successful coordination among 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.
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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
$648 million. We anticipate that the facility will be ready
for commercial production in 2009. 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/or the
imposition of civil or criminal sanctions.
A portion of our business is conducted in currencies other than
our reporting currency, the U.S. dollar. We recognize
foreign currency gains or losses arising from our operations in
the period in which we incur
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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
operating results are subject to significant
fluctuations
Our quarterly revenues, expenses and net income (loss) have
fluctuated in the past and are likely to fluctuate significantly
in the future due to the timing of charges and expenses that we
may take. In recent periods, for instance, we have recorded
charges that include:
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acquired in-process research and development at the time we make
an acquisition;
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impairments that we are required to take with respect to
investments;
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impairments that we are required to take with respect to fixed
assets, including those that are recorded in connection with the
sale of fixed assets;
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inventory write-downs for failed quality specifications, charges
for excess
and/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
42
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.
Uncertainty
over intellectual property in the biotechnology industry has
been the source of litigation, which is inherently costly and
unpredictable
We are aware that others, including various universities and
companies working in the biotechnology field, have filed patent
applications and have been granted patents in the U.S. and
in other countries claiming subject matter potentially useful to
our business. Some of those patents and patent applications
claim only specific products or methods of making such products,
while others claim more general processes or techniques useful
or now used in the biotechnology industry. There is considerable
uncertainty within the biotechnology industry about the
validity, scope and enforceability of many issued patents in the
U.S. and elsewhere in the world, and, to date, there is no
consistent policy regarding the breadth of claims allowed in
biotechnology patents. We cannot currently determine the
ultimate scope and validity of patents which may be granted to
third parties in the future or which patents might be asserted
to be infringed by the manufacture, use and sale of our products.
There has been, and we expect that there may continue to be,
significant litigation in the industry regarding patents and
other intellectual property rights. Litigation and
administrative proceedings concerning patents and other
intellectual property rights may be protracted, expensive and
distracting to management. Competitors may sue us as a way of
delaying the introduction of our products. Any litigation,
including any interference proceedings to determine priority of
inventions, oppositions to patents in foreign countries or
litigation against our partners, may be costly and time
consuming and could harm our business. We expect that litigation
may be necessary in some instances to determine the validity and
scope of certain of our proprietary rights. Litigation may be
necessary in other instances to determine the validity, scope
and/or
noninfringement of certain patent rights claimed by third
parties to be pertinent to the manufacture, use or sale of our
products. Ultimately, the outcome of such litigation could
adversely affect the validity and scope of our patent or other
proprietary rights, or, conversely, hinder our ability to
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
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
43
adversely affected by increases in interest rates, downgrades in
the corporate bonds 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.
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 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.
44
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.
Several
aspects of our corporate governance and our collaboration
agreements may discourage a third party from attempting to
acquire us
Several factors might discourage a takeover attempt that could
be viewed as beneficial to stockholders who wish to receive a
premium for their shares from a potential bidder. For example:
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we are subject to Section 203 of the Delaware General
Corporation Law, which provides that we may not enter into a
business combination with an interested stockholder for a period
of three years after the date of the transaction in which the
person became an interested stockholder, unless the business
combination is approved in the manner prescribed in
Section 203;
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our stockholder rights plan is designed to cause substantial
dilution to a person who attempts to acquire us on terms not
approved by our board of directors;
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our board of directors has the authority to issue, without a
vote or action of stockholders, up to 8,000,000 shares of
preferred stock and to fix the price, rights, preferences and
privileges of those shares, each of which could be superior to
the rights of holders of common stock;
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our 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. Recently, in an arbitration
proceeding brought by Biogen Idec relating to the collaboration
agreement, Genentech alleged for the first time that the
November 2003 transaction in which Idec 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 intend to vigorously
assert our position if Genentech persists in making this claim.
If the arbitrators decide this issue in favor of Genentech, or
if a change of control were to occur in the future and Genentech
were to present an offer for the RITUXAN rights, we must either
accept Genentechs offer or purchase Genentechs
rights to RITUXAN on the same terms as its offer. If Genentech
presents such an offer, then they will be deemed concurrently to
have exercised a right, in exchange for a share in the
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45
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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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A summary of our stock repurchase activity for the three months
ended June 30, 2008 is set forth in the table below:
Issuer
Purchases of Equity Securities
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Total Number of
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Shares Purchased as
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Number of Shares
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Total Number of
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Average Price
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Part of Publicly
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that may yet be
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Shares Purchased
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Paid per Share
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Announced Program
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Purchased Under Our
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Period
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(#)
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($)
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(#)(a)
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Program (#)(a)
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Apr-08
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4,971,804
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64.27
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4,971,804
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11,000,000
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Total
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4,971,804
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$
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64.27
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4,971,804
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11,000,000
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(a) |
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On October 13, 2006 the Board of Directors authorized the
repurchase of up to 20.0 million shares of our common
stock. The repurchased stock will provide us with authorized
shares for general corporate purposes, such as common stock to
be issued under our employee equity and stock purchase plans.
This repurchase program does not have an expiration date. We
publicly announced the repurchase program in our press release
dated October 31, 2006, which was furnished to the SEC as
Exhibit 99.1 of our Current Report on
Form 8-K
filed on October 31, 2006. |
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Item 4.
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Submission
of Matters to a Vote of Security Holders
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On June 19, 2008, we held our Annual Meeting of
Stockholders. On July 9, 2008, the independent inspector of
election for the meeting certified that our stockholders took
the following actions:
(a) Our stockholders elected Stelios Papadopoulos, Cecil B.
Pickett, Lynn Schenk and Phillip A. Sharp as directors to serve
for a three year term ending at the 2011 Annual Meeting of
Stockholders and until their successors are duly elected and
qualified. None of the individuals nominated by entities
affiliated with Carl Icahn were elected as directors at the
annual meeting. The votes cast with respect to each nominee are
set forth below.
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Biogen Idec Nominees
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Votes For
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Votes Withheld
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Stelios Papadopoulos
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164,860,678
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3,781,180
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Cecil B. Pickett
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165,216,921
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3,424,937
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Lynn Schenk
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163,985,671
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4,656,187
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Phillip A. Sharp
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218,285,006
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3,732,585
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Icahn Nominees
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Alexander J. Denner
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53,170,703
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205,030
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Richard C. Mulligan
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53,174,324
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201,409
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Anne B. Young
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53,175,439
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200,294
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In addition, the terms of office of each of the following
directors continued after the meeting:
Lawrence C. Best, Marijn E. Dekkers, Alan B.
Glassberg, Nancy L. Leaming, James C. Mullen, Robert W. Pangia,
Bruce R. Ross and William D. Young.
46
(b) Our stockholders ratified the selection of
PricewaterhouseCoopers LLP as our independent registered public
accounting firm for the year ending December 31, 2008, with
216,423,327 votes for, 3,356,894 votes against and 2,237,369
abstentions.
(c) Our stockholders approved the Biogen Idec Inc. 2008
Omnibus Equity Plan, with 157,370,764 votes for, 61,975,665
votes against and 2,671,161 abstentions.
(d) Our stockholders approved the Biogen Idec Inc. 2008
Performance-Based Management Incentive Plan, with 169,115,404
votes for, 50,213,514 votes against and 2,688,672 abstentions.
(e) Our stockholders did not approve a proposal from
certain entities affiliated with Carl Icahn to amend our Amended
and Restated Bylaws to fix the size of the Board of Directors at
12 members and remove the Boards ability to change the
size of the Board, with 53,665,293 votes for, 165,371,172 votes
against and 2,981,125 abstentions.
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.
47
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
July 22, 2008
48
EXHIBIT INDEX
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Exhibit
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Number*
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Description of Exhibit
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10
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.1
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Biogen Idec Inc. 2008 Omnibus Equity Plan. Filed as Appendix A
to Biogen Idecs Definitive Proxy Statement on Schedule 14A
filed on May 8, 2008.
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10
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.2+
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Amendment to Biogen, Inc. 1985 Non-Qualified Stock Option Plan
dated April 18, 2008.
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10
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.3+
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Amendment to Biogen, Inc. 1987 Scientific Board Stock Option
Plan dated April 18, 2008.
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10
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.4+
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Amendment to IDEC Pharmaceuticals Corporation 1988 Stock Option
Plan dated April 18, 2008.
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10
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.5+
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Amendment to IDEC Pharmaceuticals Corporation 1993 Non-Employee
Directors Stock Option Plan dated April 18, 2008.
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10
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.6+
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Amendment to Biogen Idec Inc. 2003 Omnibus Equity Plan dated
April 18, 2008.
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10
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.7+
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Amendment to Biogen Idec Inc. 2005 Omnibus Equity Plan dated
April 18, 2008.
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10
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.8+
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Amendment to Biogen Idec Inc. 2006 Non-Employee Directors Equity
Plan dated April 18, 2008.
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10
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.9
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Biogen Idec Inc. 2008 Performance-Based Management Incentive
Plan. Filed as Appendix B to Biogen Idecs Definitive
Proxy Statement on Schedule 14A filed on May 8, 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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Filed herewith |
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Furnished herewith |