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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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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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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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Large accelerated filer
x
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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Page
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PART I —
FINANCIAL INFORMATION
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Item 1.
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Financial Statements (unaudited)
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Item 2.
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Item 3.
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Item 4.
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PART II —
OTHER INFORMATION
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Item 1.
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Item 1A.
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Item 2.
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Item 6.
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•
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the anticipated amount, timing and accounting of revenues, contingent payments, milestone, royalty and other payments under licensing, collaboration or acquisition agreements, tax positions and contingencies, doubtful accounts, pre-approval inventory, cost of sales, research and development costs, compensation and other expenses, amortization of intangible assets, and foreign currency forward contracts;
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•
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the potential impact of increased product competition in the multiple sclerosis (MS) market, including competition from and growth of our own products and the possibility of future competition from biosimilars, generic versions or related prodrug derivatives;
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•
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the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to patents and other proprietary and intellectual property rights, tax audits, assessments and settlements, product liability and other matters;
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•
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the expected timing and financial impact of the final resolution of our dispute with the Italian National Medicines Agency relating to sales of TYSABRI;
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•
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the costs, timing, potential approval and therapeutic scope of the development and commercialization of our pipeline products;
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•
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the potential impact of healthcare reform in the U.S. and measures being taken worldwide designed to reduce healthcare costs to constrain the overall level of government expenditures, including the impact of pricing actions in Europe and elsewhere and reduced reimbursement for our products;
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•
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our ability to finance our operations and business initiatives and obtain funding for such activities;
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•
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the impact of new laws and accounting standards; and
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•
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the drivers for growing our business, including our plans to pursue business development and research opportunities, and competitive conditions.
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For the Three Months
Ended March 31, |
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2014
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2013
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Revenues:
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Product, net
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$
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1,742,765
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$
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1,095,779
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Unconsolidated joint business
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296,885
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264,606
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Other
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90,101
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54,711
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Total revenues
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2,129,751
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1,415,096
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Cost and expenses:
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Cost of sales, excluding amortization of acquired intangible assets
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279,245
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133,749
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Research and development
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528,884
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284,340
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Selling, general and administrative
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511,674
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352,598
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Amortization of acquired intangible assets
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143,258
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51,301
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Collaboration profit sharing
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—
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85,357
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(Gain) loss on fair value remeasurement of contingent consideration
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(799
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)
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2,277
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Total cost and expenses
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1,462,262
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909,622
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Gain on sale of rights
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3,859
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5,051
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Income from operations
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671,348
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510,525
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Other income (expense), net
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(5,601
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)
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(14,457
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)
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Income before income tax expense and equity in loss of investee, net of tax
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665,747
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496,068
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Income tax expense
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178,414
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65,508
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Equity in loss of investee, net of tax
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7,605
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3,811
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Net income
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479,728
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426,749
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Net income (loss) attributable to noncontrolling interests, net of tax
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(228
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)
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—
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Net income attributable to Biogen Idec Inc.
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$
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479,956
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$
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426,749
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Net income per share:
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Basic earnings per share attributable to Biogen Idec Inc.
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$
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2.03
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$
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1.80
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Diluted earnings per share attributable to Biogen Idec Inc.
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$
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2.02
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$
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1.79
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Weighted-average shares used in calculating:
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Basic earnings per share attributable to Biogen Idec Inc.
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236,786
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236,837
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Diluted earnings per share attributable to Biogen Idec Inc.
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237,849
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238,304
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For the Three Months
Ended March 31, |
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2014
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2013
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Net income attributable to Biogen Idec Inc.
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$
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479,956
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$
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426,749
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Other comprehensive income:
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Unrealized gains (losses) on securities available for sale, net of tax of $1,014 and $654
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1,725
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(1,117
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)
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Unrealized gains on foreign currency forward contracts, net of tax of $265 and $1,421
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5,791
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11,603
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Unrealized gains on pension benefit obligation
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817
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1,263
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Currency translation adjustment
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(2,944
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)
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(24,419
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)
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Total other comprehensive income (loss), net of tax
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5,389
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(12,670
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)
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Comprehensive income attributable to Biogen Idec Inc.
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485,345
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414,079
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Comprehensive income (loss) attributable to noncontrolling interests, net of tax
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(228
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)
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—
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Comprehensive income
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$
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485,117
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$
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414,079
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As of March 31,
2014 |
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As of December 31,
2013 |
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ASSETS
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|||||||
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Current assets:
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Cash and cash equivalents
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$
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828,601
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$
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602,562
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Marketable securities
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431,610
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620,167
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Accounts receivable, net
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1,018,487
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824,406
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Due from unconsolidated joint business, net
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278,316
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252,662
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Inventory
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672,750
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659,003
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Other current assets
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295,260
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226,134
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Total current assets
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3,525,024
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3,184,934
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Marketable securities
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724,272
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625,772
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Property, plant and equipment, net
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1,744,266
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1,750,710
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Intangible assets, net
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4,364,384
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4,474,653
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Goodwill
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1,232,916
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1,232,916
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Investments and other assets
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639,269
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594,350
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Total assets
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$
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12,230,131
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$
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11,863,335
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LIABILITIES AND EQUITY
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|||||||
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Current liabilities:
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||||
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Current portion of notes payable and line of credit
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$
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3,550
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$
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3,494
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Taxes payable
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161,045
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179,685
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|
||
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Accounts payable
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212,809
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219,913
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|
||
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Accrued expenses and other
|
1,216,843
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1,355,187
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|
||
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Total current liabilities
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1,594,247
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1,758,279
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||
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Notes payable
|
591,012
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592,433
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|
||
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Long-term deferred tax liability
|
200,901
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232,554
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|
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Other long-term liabilities
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702,908
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659,231
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|
||
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Total liabilities
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3,089,068
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3,242,497
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|
||
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Commitments and contingencies
|
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||
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Equity:
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|
||||
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Biogen Idec Inc. shareholders’ equity
|
|
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|
||||
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Preferred stock, par value $0.001 per share
|
—
|
|
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—
|
|
||
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Common stock, par value $0.0005 per share
|
128
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|
|
128
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|
||
|
Additional paid-in capital
|
4,054,774
|
|
|
4,023,651
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|
||
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Accumulated other comprehensive loss
|
(22,355
|
)
|
|
(27,745
|
)
|
||
|
Retained earnings
|
6,829,091
|
|
|
6,349,135
|
|
||
|
Treasury stock, at cost
|
(1,724,927
|
)
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(1,724,927
|
)
|
||
|
Total Biogen Idec Inc. shareholders’ equity
|
9,136,711
|
|
|
8,620,242
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|
||
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Noncontrolling interests
|
4,352
|
|
|
596
|
|
||
|
Total equity
|
9,141,063
|
|
|
8,620,838
|
|
||
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Total liabilities and equity
|
$
|
12,230,131
|
|
|
$
|
11,863,335
|
|
|
|
For the Three Months
Ended March 31, |
||||||
|
|
2014
|
|
2013
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net income
|
$
|
479,728
|
|
|
$
|
426,749
|
|
|
Adjustments to reconcile net income to net cash flows from operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
190,963
|
|
|
97,453
|
|
||
|
Share-based compensation
|
46,340
|
|
|
36,757
|
|
||
|
Deferred income taxes
|
(79,558
|
)
|
|
(66,525
|
)
|
||
|
Other
|
(71,476
|
)
|
|
(33,442
|
)
|
||
|
Changes in operating assets and liabilities, net:
|
|
|
|
||||
|
Accounts receivable
|
(197,685
|
)
|
|
(75,546
|
)
|
||
|
Inventory
|
(16,980
|
)
|
|
(60,809
|
)
|
||
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Accrued expenses and other current liabilities
|
(171,368
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)
|
|
(180,910
|
)
|
||
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Other changes in operating assets and liabilities, net
|
(75,338
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)
|
|
35,212
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|
||
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Net cash flows provided by operating activities
|
104,626
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|
|
178,939
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|
||
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Cash flows from investing activities:
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|
|
|
||||
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Proceeds from sales and maturities of marketable securities
|
757,512
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|
|
4,329,506
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|
||
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Purchases of marketable securities
|
(666,211
|
)
|
|
(1,160,680
|
)
|
||
|
Purchases of reverse repurchase agreements
|
—
|
|
|
(2,968,000
|
)
|
||
|
Purchases of property, plant and equipment
|
(54,306
|
)
|
|
(33,289
|
)
|
||
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Acquisitions of business, net of cash acquired
|
(25,000
|
)
|
|
—
|
|
||
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Other
|
(6,002
|
)
|
|
(11,596
|
)
|
||
|
Net cash flows provided by investing activities
|
5,993
|
|
|
155,941
|
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Purchase of treasury stock
|
—
|
|
|
(41,023
|
)
|
||
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Proceeds from issuance of stock for share-based compensation arrangements
|
22,363
|
|
|
21,817
|
|
||
|
Repayment of borrowings under senior notes
|
—
|
|
|
(450,000
|
)
|
||
|
Proceeds from borrowings under line of credit facility
|
—
|
|
|
200,000
|
|
||
|
Excess tax benefit from stock options
|
79,456
|
|
|
37,397
|
|
||
|
Other
|
13,056
|
|
|
(6,615
|
)
|
||
|
Net cash flows provided by (used in) financing activities
|
114,875
|
|
|
(238,424
|
)
|
||
|
Net increase (decrease) in cash and cash equivalents
|
225,494
|
|
|
96,456
|
|
||
|
Effect of exchange rate changes on cash and cash equivalents
|
545
|
|
|
(3,875
|
)
|
||
|
Cash and cash equivalents, beginning of the period
|
602,562
|
|
|
570,721
|
|
||
|
Cash and cash equivalents, end of the period
|
$
|
828,601
|
|
|
$
|
663,302
|
|
|
1.
|
Summary of Significant Accounting Policies
|
|
2.
|
Accounts Receivable
|
|
|
As of March 31, 2014
|
||||||||||
|
(In millions)
|
Current
Balance Included
within Accounts
Receivable, net
|
|
Non-Current
Balance Included
within Investments
and Other Assets
|
|
Total
|
||||||
|
Spain
|
$
|
47.3
|
|
|
$
|
8.1
|
|
|
$
|
55.4
|
|
|
Italy
|
$
|
82.3
|
|
|
$
|
0.9
|
|
|
$
|
83.2
|
|
|
Portugal
|
$
|
10.4
|
|
|
$
|
11.1
|
|
|
$
|
21.5
|
|
|
|
As of December 31, 2013
|
||||||||||
|
(In millions)
|
Current
Balance Included
within Accounts
Receivable, net
|
|
Non-Current
Balance Included
within Investments
and Other Assets
|
|
Total
|
||||||
|
Spain
|
$
|
113.3
|
|
|
$
|
6.8
|
|
|
$
|
120.1
|
|
|
Italy
|
$
|
76.1
|
|
|
$
|
2.4
|
|
|
$
|
78.5
|
|
|
Portugal
|
$
|
10.4
|
|
|
$
|
8.2
|
|
|
$
|
18.6
|
|
|
3.
|
Reserves for Discounts and Allowances
|
|
(In millions)
|
Discounts
|
|
Contractual
Adjustments
|
|
Returns
|
|
Total
|
||||||||
|
Balance, as of December 31, 2013
|
$
|
47.0
|
|
|
$
|
335.6
|
|
|
$
|
33.7
|
|
|
$
|
416.3
|
|
|
Current provisions relating to sales in current year
|
78.2
|
|
|
293.2
|
|
|
7.1
|
|
|
378.5
|
|
||||
|
Adjustments relating to prior years
|
(1.4
|
)
|
|
(2.1
|
)
|
|
4.4
|
|
|
0.9
|
|
||||
|
Payments/returns relating to sales in current year
|
(30.7
|
)
|
|
(91.4
|
)
|
|
(0.1
|
)
|
|
(122.2
|
)
|
||||
|
Payments/returns relating to sales in prior years
|
(41.2
|
)
|
|
(159.0
|
)
|
|
(8.3
|
)
|
|
(208.5
|
)
|
||||
|
Balance, as of March 31, 2014
|
$
|
51.9
|
|
|
$
|
376.3
|
|
|
$
|
36.8
|
|
|
$
|
465.0
|
|
|
(In millions)
|
As of March 31,
2014 |
|
As of December 31,
2013 |
||||
|
Reduction of accounts receivable
|
$
|
134.5
|
|
|
$
|
151.4
|
|
|
Component of accrued expenses and other
|
330.5
|
|
|
264.9
|
|
||
|
Total reserves
|
$
|
465.0
|
|
|
$
|
416.3
|
|
|
4.
|
Inventory
|
|
(In millions)
|
As of
March 31, 2014 |
|
As of
December 31, 2013 |
||||
|
Raw materials
|
$
|
122.7
|
|
|
$
|
115.0
|
|
|
Work in process
|
421.2
|
|
|
435.4
|
|
||
|
Finished goods
|
128.9
|
|
|
108.6
|
|
||
|
Total inventory
|
$
|
672.8
|
|
|
$
|
659.0
|
|
|
5.
|
Intangible Assets and Goodwill
|
|
|
|
|
As of March 31, 2014
|
|
As of December 31, 2013
|
||||||||||||||||||||
|
(In millions)
|
Estimated
Life
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net
|
|
Cost
|
|
Accumulated
Amortization
|
|
Net
|
||||||||||||
|
Out-licensed patents
|
13-23 years
|
|
$
|
543.3
|
|
|
$
|
(458.3
|
)
|
|
$
|
85.0
|
|
|
$
|
578.0
|
|
|
$
|
(450.8
|
)
|
|
$
|
127.2
|
|
|
Developed
technology
|
15-23 years
|
|
3,005.3
|
|
|
(2,224.3
|
)
|
|
781.0
|
|
|
3,005.3
|
|
|
(2,165.4
|
)
|
|
839.9
|
|
||||||
|
In-process research and development
|
Indefinite until commercialization
|
|
330.9
|
|
|
—
|
|
|
330.9
|
|
|
327.4
|
|
|
—
|
|
|
327.4
|
|
||||||
|
Trademarks and
tradenames
|
Indefinite
|
|
64.0
|
|
|
—
|
|
|
64.0
|
|
|
64.0
|
|
|
—
|
|
|
64.0
|
|
||||||
|
Acquired and in-licensed rights
and patents
|
6-17 years
|
|
3,269.6
|
|
|
(166.2
|
)
|
|
3,103.4
|
|
|
3,240.0
|
|
|
(123.8
|
)
|
|
3,116.2
|
|
||||||
|
Total intangible assets
|
|
|
$
|
7,213.1
|
|
|
$
|
(2,848.8
|
)
|
|
$
|
4,364.4
|
|
|
$
|
7,214.7
|
|
|
$
|
(2,740.0
|
)
|
|
$
|
4,474.7
|
|
|
(In millions)
|
As of March 31, 2014
|
||
|
2014 (remaining nine months)
|
$
|
316.3
|
|
|
2015
|
334.7
|
|
|
|
2016
|
319.9
|
|
|
|
2017
|
323.2
|
|
|
|
2018
|
324.3
|
|
|
|
2019
|
304.1
|
|
|
|
Total
|
$
|
1,922.5
|
|
|
(In millions)
|
As of
March 31, 2014 |
|
As of
December 31, 2013 |
||||
|
Goodwill, beginning of period
|
$
|
1,232.9
|
|
|
$
|
1,201.3
|
|
|
Increase to goodwill
|
—
|
|
|
35.7
|
|
||
|
Other
|
—
|
|
|
(4.1
|
)
|
||
|
Goodwill, end of period
|
$
|
1,232.9
|
|
|
$
|
1,232.9
|
|
|
6.
|
Fair Value Measurements
|
|
(In millions)
|
As of
March 31, 2014 |
|
Quoted Prices
in Active
Markets
(Level 1)
|
|
Significant Other
Observable Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Cash equivalents
|
$
|
236.1
|
|
|
$
|
—
|
|
|
$
|
236.1
|
|
|
$
|
—
|
|
|
Marketable debt securities:
|
|
|
|
|
|
|
|
||||||||
|
Corporate debt securities
|
536.9
|
|
|
—
|
|
|
536.9
|
|
|
—
|
|
||||
|
Government securities
|
466.7
|
|
|
—
|
|
|
466.7
|
|
|
—
|
|
||||
|
Mortgage and other asset backed securities
|
152.2
|
|
|
—
|
|
|
152.2
|
|
|
—
|
|
||||
|
Marketable equity securities
|
13.8
|
|
|
13.8
|
|
|
—
|
|
|
—
|
|
||||
|
Venture capital investments
|
23.6
|
|
|
—
|
|
|
—
|
|
|
23.6
|
|
||||
|
Derivative contracts
|
2.6
|
|
|
—
|
|
|
2.6
|
|
|
—
|
|
||||
|
Plan assets for deferred compensation
|
32.9
|
|
|
—
|
|
|
32.9
|
|
|
—
|
|
||||
|
Total
|
$
|
1,464.8
|
|
|
$
|
13.8
|
|
|
$
|
1,427.4
|
|
|
$
|
23.6
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
|
Derivative contracts
|
$
|
19.1
|
|
|
$
|
—
|
|
|
$
|
19.1
|
|
|
$
|
—
|
|
|
Contingent consideration obligations
|
275.1
|
|
|
—
|
|
|
—
|
|
|
275.1
|
|
||||
|
Total
|
$
|
294.2
|
|
|
$
|
—
|
|
|
$
|
19.1
|
|
|
$
|
275.1
|
|
|
(In millions)
|
As of
December 31, 2013 |
|
Quoted Prices
in Active
Markets
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Cash equivalents
|
$
|
424.7
|
|
|
$
|
—
|
|
|
$
|
424.7
|
|
|
$
|
—
|
|
|
Marketable debt securities:
|
|
|
|
|
|
|
|
||||||||
|
Corporate debt securities
|
439.8
|
|
|
—
|
|
|
439.8
|
|
|
—
|
|
||||
|
Government securities
|
674.7
|
|
|
—
|
|
|
674.7
|
|
|
—
|
|
||||
|
Mortgage and other asset backed securities
|
131.4
|
|
|
—
|
|
|
131.4
|
|
|
—
|
|
||||
|
Marketable equity securities
|
11.2
|
|
|
11.2
|
|
|
—
|
|
|
—
|
|
||||
|
Venture capital investments
|
21.9
|
|
|
—
|
|
|
—
|
|
|
21.9
|
|
||||
|
Derivative contracts
|
3.8
|
|
|
—
|
|
|
3.8
|
|
|
—
|
|
||||
|
Plan assets for deferred compensation
|
22.7
|
|
|
—
|
|
|
22.7
|
|
|
—
|
|
||||
|
Total
|
$
|
1,730.2
|
|
|
$
|
11.2
|
|
|
$
|
1,697.1
|
|
|
$
|
21.9
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
||||||||
|
Derivative contracts
|
$
|
23.5
|
|
|
$
|
—
|
|
|
$
|
23.5
|
|
|
$
|
—
|
|
|
Contingent consideration obligations
|
280.9
|
|
|
—
|
|
|
—
|
|
|
280.9
|
|
||||
|
Total
|
$
|
304.4
|
|
|
$
|
—
|
|
|
$
|
23.5
|
|
|
$
|
280.9
|
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Fair value, beginning of period
|
$
|
21.9
|
|
|
$
|
20.3
|
|
|
Unrealized gains included in earnings
|
2.9
|
|
|
0.6
|
|
||
|
Unrealized losses included in earnings
|
(1.2
|
)
|
|
(1.4
|
)
|
||
|
Purchases
|
—
|
|
|
—
|
|
||
|
Settlements
|
—
|
|
|
(1.5
|
)
|
||
|
Fair value, end of period
|
$
|
23.6
|
|
|
$
|
18.0
|
|
|
|
As of March 31, 2014
|
|
As of December 31, 2013
|
||||||||||||
|
(In millions)
|
Fair
Value
|
|
Carrying
Value
|
|
Fair
Value
|
|
Carrying
Value
|
||||||||
|
Notes payable to Fumedica
|
$
|
17.5
|
|
|
$
|
16.1
|
|
|
$
|
17.5
|
|
|
$
|
15.8
|
|
|
6.875% Senior Notes due March 1, 2018
|
647.6
|
|
|
578.5
|
|
|
647.9
|
|
|
580.1
|
|
||||
|
Total
|
$
|
665.1
|
|
|
$
|
594.6
|
|
|
$
|
665.4
|
|
|
$
|
595.9
|
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Fair value, beginning of period
|
$
|
280.9
|
|
|
$
|
293.9
|
|
|
Additions
|
—
|
|
|
—
|
|
||
|
Changes in fair value
|
(0.8
|
)
|
|
2.3
|
|
||
|
Payments
|
(5.0
|
)
|
|
(2.5
|
)
|
||
|
Fair value, end of period
|
$
|
275.1
|
|
|
$
|
293.7
|
|
|
7.
|
Financial Instruments
|
|
As of March 31, 2014 (In millions)
|
Fair
Value
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Amortized
Cost
|
||||||||
|
Available-for-sale:
|
|
|
|
|
|
|
|
||||||||
|
Corporate debt securities
|
|
|
|
|
|
|
|
||||||||
|
Current
|
$
|
135.7
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
135.7
|
|
|
Non-current
|
401.2
|
|
|
0.5
|
|
|
(0.2
|
)
|
|
400.9
|
|
||||
|
Government securities
|
|
|
|
|
|
|
|
||||||||
|
Current
|
295.9
|
|
|
0.1
|
|
|
—
|
|
|
295.8
|
|
||||
|
Non-current
|
170.8
|
|
|
—
|
|
|
(0.1
|
)
|
|
170.9
|
|
||||
|
Mortgage and other asset backed securities
|
|
|
|
|
|
|
|
||||||||
|
Current
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
Non-current
|
152.2
|
|
|
0.1
|
|
|
(0.2
|
)
|
|
152.3
|
|
||||
|
Total marketable debt securities
|
$
|
1,155.8
|
|
|
$
|
0.7
|
|
|
$
|
(0.5
|
)
|
|
$
|
1,155.6
|
|
|
Marketable equity securities, non-current
|
$
|
13.8
|
|
|
$
|
11.4
|
|
|
$
|
(0.1
|
)
|
|
$
|
2.5
|
|
|
As of December 31, 2013 (In millions)
|
Fair
Value
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Amortized
Cost
|
||||||||
|
Available-for-sale:
|
|
|
|
|
|
|
|
||||||||
|
Corporate debt securities
|
|
|
|
|
|
|
|
||||||||
|
Current
|
$
|
100.7
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
100.7
|
|
|
Non-current
|
339.1
|
|
|
0.4
|
|
|
(0.1
|
)
|
|
338.8
|
|
||||
|
Government securities
|
|
|
|
|
|
|
|
||||||||
|
Current
|
519.5
|
|
|
—
|
|
|
—
|
|
|
519.5
|
|
||||
|
Non-current
|
155.2
|
|
|
—
|
|
|
(0.1
|
)
|
|
155.3
|
|
||||
|
Mortgage and other asset backed securities
|
|
|
|
|
|
|
|
||||||||
|
Current
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
Non-current
|
131.4
|
|
|
—
|
|
|
(0.1
|
)
|
|
131.5
|
|
||||
|
Total marketable debt securities
|
$
|
1,245.9
|
|
|
$
|
0.4
|
|
|
$
|
(0.3
|
)
|
|
$
|
1,245.8
|
|
|
Marketable equity securities, non-current
|
$
|
11.2
|
|
|
$
|
8.7
|
|
|
$
|
—
|
|
|
$
|
2.5
|
|
|
(In millions)
|
As of
March 31, 2014 |
|
As of
December 31, 2013 |
||||
|
Commercial paper
|
$
|
2.0
|
|
|
$
|
1.2
|
|
|
Overnight reverse repurchase agreements
|
44.1
|
|
|
22.4
|
|
||
|
Short-term debt securities
|
190.0
|
|
|
401.1
|
|
||
|
Total
|
$
|
236.1
|
|
|
$
|
424.7
|
|
|
|
As of March 31, 2014
|
|
As of December 31, 2013
|
||||||||||||
|
(In millions)
|
Estimated
Fair Value
|
|
Amortized
Cost
|
|
Estimated
Fair Value
|
|
Amortized
Cost
|
||||||||
|
Due in one year or less
|
$
|
431.6
|
|
|
$
|
431.5
|
|
|
$
|
620.2
|
|
|
$
|
620.2
|
|
|
Due after one year through five years
|
662.2
|
|
|
662.0
|
|
|
573.1
|
|
|
572.9
|
|
||||
|
Due after five years
|
62.0
|
|
|
62.1
|
|
|
52.6
|
|
|
52.7
|
|
||||
|
Total available-for-sale securities
|
$
|
1,155.8
|
|
|
$
|
1,155.6
|
|
|
$
|
1,245.9
|
|
|
$
|
1,245.8
|
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Proceeds from maturities and sales
|
$
|
757.5
|
|
|
$
|
4,329.5
|
|
|
Realized gains
|
$
|
0.2
|
|
|
$
|
6.3
|
|
|
Realized losses
|
$
|
(0.1
|
)
|
|
$
|
(2.0
|
)
|
|
8.
|
Derivative Instruments
|
|
|
Notional Amount
|
||||||
|
Foreign Currency: (In millions)
|
As of
March 31, 2014 |
|
As of
December 31, 2013 |
||||
|
Euro
|
$
|
819.0
|
|
|
$
|
636.3
|
|
|
Canadian dollar
|
27.5
|
|
|
34.0
|
|
||
|
British pound sterling
|
55.4
|
|
|
72.3
|
|
||
|
Total foreign currency forward contracts
|
$
|
901.9
|
|
|
$
|
742.6
|
|
|
For the Three Months Ended March 31,
|
||||||||||||||||||
|
Net Gains/(Losses)
Reclassified from AOCI into Net Income
(Effective Portion)
|
|
Net Gains/(Losses)
Recognized into Net Income
(Ineffective Portion)
|
||||||||||||||||
|
Location
|
|
2014
|
|
2013
|
|
Location
|
|
2014
|
|
2013
|
||||||||
|
Revenue
|
|
$
|
(4.7
|
)
|
|
$
|
1.1
|
|
|
Other income (expense)
|
|
$
|
(0.2
|
)
|
|
$
|
0.2
|
|
|
(In millions)
|
Balance Sheet Location
|
Fair Value As of March 31, 2014
|
||
|
Hedging Instruments:
|
|
|
||
|
Asset derivatives
|
Other current assets
|
$
|
1.3
|
|
|
|
Investments and other assets
|
$
|
0.1
|
|
|
Liability derivatives
|
Accrued expenses and other
|
$
|
(16.1
|
)
|
|
|
Other long-term liabilities
|
$
|
(2.2
|
)
|
|
Other Derivatives:
|
|
|
||
|
Asset derivatives
|
Other current assets
|
$
|
1.2
|
|
|
Liability derivatives
|
Accrued expenses and other
|
$
|
(0.7
|
)
|
|
|
|
|
||
|
(In millions)
|
Balance Sheet Location
|
Fair Value As of December 31, 2013
|
||
|
Hedging Instruments:
|
|
|
||
|
Asset derivatives
|
Other current assets
|
$
|
0.6
|
|
|
Liability derivatives
|
Accrued expenses and other
|
$
|
23.4
|
|
|
Other Derivatives:
|
|
|
||
|
Asset derivatives
|
Other current assets
|
$
|
3.2
|
|
|
Liability derivatives
|
Accrued expenses and other
|
$
|
0.1
|
|
|
9.
|
Indebtedness
|
|
10.
|
Equity
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Noncontrolling interests, beginning of period
|
$
|
0.6
|
|
|
$
|
2.3
|
|
|
Net income (loss) attributable to noncontrolling interests, net of tax
|
(0.2
|
)
|
|
—
|
|
||
|
Fair value of net assets and liabilities acquired and assigned to NCI
|
4.0
|
|
|
—
|
|
||
|
Deconsolidation of noncontrolling interest
|
—
|
|
|
(1.7
|
)
|
||
|
Noncontrolling interests, end of period
|
$
|
4.4
|
|
|
$
|
0.6
|
|
|
11.
|
Accumulated Other Comprehensive Income (Loss)
|
|
(In millions)
|
Unrealized Gains (Losses) on Securities Available for Sale
|
|
Unrealized Gains (Losses) on Foreign Currency Forward Contracts
|
|
Unfunded Status of Postretirement Benefit Plans
|
|
Translation Adjustments
|
|
Total
|
||||||||||
|
Balance, as of December 31, 2013
|
$
|
5.6
|
|
|
$
|
(23.7
|
)
|
|
$
|
(19.6
|
)
|
|
$
|
10.0
|
|
|
$
|
(27.7
|
)
|
|
Other comprehensive income (loss) before reclassifications
|
1.8
|
|
|
1.5
|
|
|
0.8
|
|
|
(2.9
|
)
|
|
1.2
|
|
|||||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
(0.1
|
)
|
|
4.3
|
|
|
—
|
|
|
—
|
|
|
4.2
|
|
|||||
|
Net current period other comprehensive income (loss)
|
1.7
|
|
|
5.8
|
|
|
0.8
|
|
|
(2.9
|
)
|
|
5.4
|
|
|||||
|
Balance, as of March 31, 2014
|
$
|
7.3
|
|
|
$
|
(17.9
|
)
|
|
$
|
(18.8
|
)
|
|
$
|
7.1
|
|
|
$
|
(22.4
|
)
|
|
(In millions)
|
Unrealized Gains (Losses) on Securities Available for Sale
|
|
Unrealized Gains (Losses) on Foreign Currency Forward Contracts
|
|
Unfunded Status of Postretirement Benefit Plans
|
|
Translation Adjustments
|
|
Total
|
||||||||||
|
Balance, as of December 31, 2012
|
$
|
4.2
|
|
|
$
|
(10.7
|
)
|
|
$
|
(21.7
|
)
|
|
$
|
(27.1
|
)
|
|
$
|
(55.3
|
)
|
|
Other comprehensive income (loss) before reclassifications
|
1.6
|
|
|
12.6
|
|
|
1.2
|
|
|
(24.4
|
)
|
|
(9.0
|
)
|
|||||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
(2.7
|
)
|
|
(1.0
|
)
|
|
—
|
|
|
—
|
|
|
(3.7
|
)
|
|||||
|
Net current period other comprehensive income (loss)
|
(1.1
|
)
|
|
11.6
|
|
|
1.2
|
|
|
(24.4
|
)
|
|
(12.7
|
)
|
|||||
|
Balance, as of March 31, 2013
|
$
|
3.1
|
|
|
$
|
0.9
|
|
|
$
|
(20.5
|
)
|
|
$
|
(51.5
|
)
|
|
$
|
(68.0
|
)
|
|
(In millions)
|
Income Statement Location
|
Amounts Reclassified from Accumulated Other Comprehensive Income
|
||||||
|
For the Three Months
Ended March 31, |
||||||||
|
2014
|
|
2013
|
||||||
|
Gains (losses) on securities available for sale
|
Other income (expense)
|
$
|
0.1
|
|
|
$
|
4.1
|
|
|
|
Income tax benefit (expense)
|
—
|
|
|
(1.4
|
)
|
||
|
|
|
|
|
|
||||
|
Gains (losses) on foreign currency forward contracts
|
Revenues
|
(4.7
|
)
|
|
1.1
|
|
||
|
|
Income tax benefit (expense)
|
0.4
|
|
|
(0.1
|
)
|
||
|
|
|
|
|
|
||||
|
Total reclassifications, net of tax
|
|
$
|
(4.2
|
)
|
|
$
|
3.7
|
|
|
12.
|
Earnings per Share
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Numerator:
|
|
|
|
||||
|
Net income attributable to Biogen Idec Inc.
|
$
|
480.0
|
|
|
$
|
426.7
|
|
|
Denominator:
|
|
|
|
||||
|
Weighted average number of common shares outstanding
|
236.8
|
|
|
236.8
|
|
||
|
Effect of dilutive securities:
|
|
|
|
||||
|
Stock options and employee stock purchase plan
|
0.1
|
|
|
0.4
|
|
||
|
Time-vested restricted stock units
|
0.6
|
|
|
0.8
|
|
||
|
Market stock units
|
0.3
|
|
|
0.3
|
|
||
|
Dilutive potential common shares
|
1.0
|
|
|
1.5
|
|
||
|
Shares used in calculating diluted earnings per share
|
237.8
|
|
|
238.3
|
|
||
|
13.
|
Share-based Payments
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Research and development
|
$
|
29.4
|
|
|
$
|
25.2
|
|
|
Selling, general and administrative
|
47.2
|
|
|
34.3
|
|
||
|
Subtotal
|
76.6
|
|
|
59.5
|
|
||
|
Capitalized share-based compensation costs
|
(2.6
|
)
|
|
(2.3
|
)
|
||
|
Share-based compensation expense included in total cost and expenses
|
74.0
|
|
|
57.2
|
|
||
|
Income tax effect
|
(22.3
|
)
|
|
(16.6
|
)
|
||
|
Share-based compensation expense included in net income attributable to Biogen Idec Inc.
|
$
|
51.7
|
|
|
$
|
40.6
|
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Stock options
|
$
|
—
|
|
|
$
|
0.3
|
|
|
Market stock units
|
14.9
|
|
|
8.5
|
|
||
|
Time-vested restricted stock units
|
29.2
|
|
|
27.1
|
|
||
|
Cash settled performance units
|
21.4
|
|
|
20.4
|
|
||
|
Performance units
|
6.3
|
|
|
—
|
|
||
|
Employee stock purchase plan
|
4.8
|
|
|
3.2
|
|
||
|
Subtotal
|
76.6
|
|
|
59.5
|
|
||
|
Capitalized share-based compensation costs
|
(2.6
|
)
|
|
(2.3
|
)
|
||
|
Share-based compensation expense included in total cost and expenses
|
$
|
74.0
|
|
|
$
|
57.2
|
|
|
|
For the Three Months
Ended March 31, |
||||
|
|
2014
|
|
2013
|
||
|
Market stock units
|
214,000
|
|
|
253,000
|
|
|
Cash settled performance shares
|
172,000
|
|
|
270,000
|
|
|
Performance units
|
50,000
|
|
|
—
|
|
|
Time-vested restricted stock units
|
392,000
|
|
|
638,000
|
|
|
14.
|
Income Taxes
|
|
|
For the Three Months
Ended March 31, |
||||
|
|
2014
|
|
2013
|
||
|
Statutory rate
|
35.0
|
%
|
|
35.0
|
%
|
|
State taxes
|
1.2
|
|
|
7.7
|
|
|
Taxes on foreign earnings
|
(8.4
|
)
|
|
(9.9
|
)
|
|
Credits and net operating loss utilization
|
(1.3
|
)
|
|
(3.3
|
)
|
|
Purchased intangible assets
|
1.5
|
|
|
1.1
|
|
|
Manufacturing deduction
|
(2.0
|
)
|
|
(22.7
|
)
|
|
Other permanent items
|
0.3
|
|
|
5.5
|
|
|
Other
|
0.5
|
|
|
(0.2
|
)
|
|
Effective tax rate
|
26.8
|
%
|
|
13.2
|
%
|
|
15.
|
Other Consolidated Financial Statement Detail
|
|
|
For the Three Months
Ended March 31, |
||||||
|
(In millions)
|
2014
|
|
2013
|
||||
|
Interest income
|
$
|
2.7
|
|
|
$
|
4.3
|
|
|
Interest expense
|
(7.6
|
)
|
|
(11.5
|
)
|
||
|
Impairments of investments
|
—
|
|
|
(0.3
|
)
|
||
|
Gain (loss) on investments, net
|
3.0
|
|
|
4.4
|
|
||
|
Foreign exchange gains (losses), net
|
(3.3
|
)
|
|
(2.6
|
)
|
||
|
Other, net
|
(0.4
|
)
|
|
(8.8
|
)
|
||
|
Total other income (expense), net
|
$
|
(5.6
|
)
|
|
$
|
(14.5
|
)
|
|
(In millions)
|
As of
March 31, 2014 |
|
As of
December 31, 2013 |
||||
|
Employee compensation and benefits
|
198.1
|
|
|
$
|
343.4
|
|
|
|
Revenue-related rebates
|
330.5
|
|
|
264.9
|
|
||
|
Deferred revenue
|
205.4
|
|
|
172.7
|
|
||
|
Royalties and licensing fees
|
131.3
|
|
|
160.7
|
|
||
|
Clinical development expenses
|
58.1
|
|
|
55.2
|
|
||
|
Current portion of contingent consideration obligations
|
21.0
|
|
|
29.0
|
|
||
|
Construction in progress accrual
|
14.1
|
|
|
25.0
|
|
||
|
Collaboration expenses
|
4.8
|
|
|
18.7
|
|
||
|
Other
|
253.5
|
|
|
285.6
|
|
||
|
Total accrued expenses and other
|
$
|
1,216.8
|
|
|
$
|
1,355.2
|
|
|
16.
|
Investments in Variable Interest Entities
|
|
17.
|
Collaborative and Other Relationships
|
|
18.
|
Litigation
|
|
19.
|
Commitments and Contingencies
|
|
|
|
Cumulative Sales Level
|
||||||||||||||
|
|
|
$1.0B
|
|
$2.0B
|
|
$3.0B
|
|
Each additional $1.0B up to $20.0B
|
||||||||
|
Prior 12 Month Sales
|
|
Payment Amounts (In Millions)
|
||||||||||||||
|
< $500 million
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$500 million - $1.0 billion
|
|
25.0
|
|
|
50.0
|
|
|
50.0
|
|
|
50.0
|
|
||||
|
$1.0 billion - $1.5 billion
|
|
50.0
|
|
|
100.0
|
|
|
100.0
|
|
|
100.0
|
|
||||
|
$1.5 billion - $2.0 billion
|
|
—
|
|
|
150.0
|
|
|
150.0
|
|
|
150.0
|
|
||||
|
$2.0 billion - $2.5 billion
|
|
—
|
|
|
200.0
|
|
|
200.0
|
|
|
200.0
|
|
||||
|
$2.5 billion - $3.0 billion
|
|
—
|
|
|
—
|
|
|
250.0
|
|
|
250.0
|
|
||||
|
> $3.0 billion
|
|
—
|
|
|
—
|
|
|
—
|
|
|
300.0
|
|
||||
|
20.
|
Segment Information
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except per share amounts and percentages)
|
2014 (1)
|
|
2013 (2)
|
|
Change %
|
|||||
|
Total revenues
|
$
|
2,129.8
|
|
|
$
|
1,415.1
|
|
|
50.5
|
%
|
|
Income from operations
|
$
|
671.3
|
|
|
$
|
510.5
|
|
|
31.5
|
%
|
|
Net income attributable to Biogen Idec Inc.
|
$
|
480.0
|
|
|
$
|
426.7
|
|
|
12.5
|
%
|
|
Diluted earnings per share attributable to Biogen Idec Inc.
|
$
|
2.02
|
|
|
$
|
1.79
|
|
|
12.7
|
%
|
|
(1)
|
Total revenues for the
three
months ended
March 31, 2014
includes 100% of net revenues related to sales of TYSABRI as a result of our acquisition of TYSABRI rights from Elan on April 2, 2013 and net revenues related to sales of TECFIDERA, our oral first-line treatment for people with relapsing forms of MS, which was approved by the U.S. Food and Drug Administration (FDA) in March 2013 and the European Commission (EC) in February 2014.
|
|
(2)
|
Our share of revenues from unconsolidated joint business reflects a charge of $41.5 million for damages and interest awarded to Hoechst GmbH (Hoechst) in Genentech Inc.'s arbitration with Hoechst for RITUXAN.
|
|
•
|
Worldwide AVONEX revenues totaled
$761.5 million
in the
first
quarter of
2014
, representing an increase of
2.1%
over the same period in
2013
.
|
|
•
|
Worldwide TYSABRI revenues totaled
$441.0 million
in the
first
quarter of
2014
, representing an increase of
41.3%
over the same period in
2013
. The increase in revenue is primarily due to 100% of net U.S. revenue being recognized starting in April 2013 as a result of our acquisition of TYSABRI rights.
|
|
•
|
Worldwide TECFIDERA revenues totaled
$505.7 million
in the
first
quarter of
2014
.
|
|
•
|
Our share of RITUXAN and GAZYVA revenues totaled
$296.9 million
in the
first
quarter of
2014
, representing an increase of
12.2%
over the same period in
2013
.
|
|
•
|
Total cost and expenses increased
60.8%
in the
first
quarter of
2014
, compared to the same period in
2013
. This increase resulted from a
179.2%
increase in the amortization of acquired intangible assets, a
86.0%
increase in research and development expense, a
108.8%
increase in cost of sales, a 172.4% increase in income tax expense and a
45.1%
increase in selling, general and administrative expense, partially offset by a
100.0%
decrease in collaboration profit sharing compared with the same period in
2013
.
|
|
|
For the Three Months
Ended March 31, |
||||||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
||||||||||
|
Product revenues:
|
|
|
|
|
|
|
|
||||||
|
United States
|
$
|
1,170.2
|
|
|
54.9
|
%
|
|
$
|
604.9
|
|
|
42.7
|
%
|
|
Rest of world
|
572.6
|
|
|
26.9
|
%
|
|
490.9
|
|
|
34.7
|
%
|
||
|
Total product revenues
|
1,742.8
|
|
|
81.8
|
%
|
|
1,095.8
|
|
|
77.4
|
%
|
||
|
Unconsolidated joint business
|
296.9
|
|
|
13.9
|
%
|
|
264.6
|
|
|
18.7
|
%
|
||
|
Other revenues
|
90.1
|
|
|
4.2
|
%
|
|
54.7
|
|
|
3.9
|
%
|
||
|
Total revenues
|
$
|
2,129.8
|
|
|
100.0
|
%
|
|
$
|
1,415.1
|
|
|
100.0
|
%
|
|
|
For the Three Months
Ended March 31, |
||||||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
||||||||||
|
AVONEX
|
$
|
761.5
|
|
|
43.7
|
%
|
|
$
|
746.1
|
|
|
68.1
|
%
|
|
TYSABRI
|
441.0
|
|
|
25.3
|
%
|
|
312.2
|
|
|
28.5
|
%
|
||
|
TECFIDERA
|
505.7
|
|
|
29.0
|
%
|
|
—
|
|
|
—
|
%
|
||
|
Other product revenues
|
34.6
|
|
|
2.0
|
%
|
|
37.5
|
|
|
3.4
|
%
|
||
|
Total product revenues
|
$
|
1,742.8
|
|
|
100.0
|
%
|
|
$
|
1,095.8
|
|
|
100.0
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
United States
|
$
|
476.1
|
|
|
$
|
491.5
|
|
|
(3.1
|
)%
|
|
Rest of world
|
285.4
|
|
|
254.6
|
|
|
12.1
|
%
|
||
|
Total AVONEX revenues
|
$
|
761.5
|
|
|
$
|
746.1
|
|
|
2.1
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
United States
|
$
|
234.3
|
|
|
$
|
113.4
|
|
|
106.6
|
%
|
|
Rest of world
|
206.7
|
|
|
198.8
|
|
|
4.0
|
%
|
||
|
Total TYSABRI revenues
|
$
|
441.0
|
|
|
$
|
312.2
|
|
|
41.3
|
%
|
|
|
For the Three Months
Ended March 31, |
||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
||||
|
United States
|
$
|
459.8
|
|
|
$
|
—
|
|
|
**
|
|
Rest of world
|
45.9
|
|
|
—
|
|
|
**
|
||
|
Total TECFIDERA revenues
|
$
|
505.7
|
|
|
$
|
—
|
|
|
**
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
FAMPYRA
|
$
|
19.0
|
|
|
$
|
23.2
|
|
|
(18.1
|
)%
|
|
FUMADERM
|
15.6
|
|
|
14.3
|
|
|
9.1
|
%
|
||
|
Total other product revenues
|
$
|
34.6
|
|
|
$
|
37.5
|
|
|
(7.7
|
)%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Biogen Idec's share of profits in the U.S. for RITUXAN and GAZYVA (1)
|
$
|
273.3
|
|
|
$
|
281.3
|
|
|
(2.8
|
)%
|
|
Reimbursement of selling and development expenses in the U.S. for RITUXAN
|
1.4
|
|
|
0.5
|
|
|
180.0
|
%
|
||
|
Revenue on sales in the rest of world for RITUXAN
|
22.2
|
|
|
(17.2
|
)
|
|
(229.1
|
)%
|
||
|
Total unconsolidated joint business revenues
|
$
|
296.9
|
|
|
$
|
264.6
|
|
|
12.2
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Product revenues, net
|
$
|
876.2
|
|
|
$
|
864.5
|
|
|
1.4
|
%
|
|
Cost and expenses
|
184.4
|
|
|
148.6
|
|
|
24.1
|
%
|
||
|
Pre-tax profits in the U.S. for RITUXAN and GAZYVA
|
691.8
|
|
|
715.9
|
|
|
(3.4
|
)%
|
||
|
Biogen Idec's share of pre-tax profits in the U.S. for RITUXAN and GAZYVA
|
$
|
273.3
|
|
|
$
|
281.3
|
|
|
(2.8
|
)%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Royalty revenues
|
$
|
37.9
|
|
|
$
|
32.8
|
|
|
15.5
|
%
|
|
Corporate partner revenues
|
52.2
|
|
|
21.9
|
|
|
138.4
|
%
|
||
|
Total other revenues
|
$
|
90.1
|
|
|
$
|
54.7
|
|
|
64.7
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Discounts
|
$
|
76.8
|
|
|
$
|
27.0
|
|
|
184.4
|
%
|
|
Contractual adjustments
|
291.1
|
|
|
148.2
|
|
|
96.4
|
%
|
||
|
Returns
|
11.5
|
|
|
3.9
|
|
|
194.9
|
%
|
||
|
Total allowances
|
$
|
379.4
|
|
|
$
|
179.1
|
|
|
111.8
|
%
|
|
Gross product revenues
|
$
|
2,122.2
|
|
|
$
|
1,274.9
|
|
|
66.5
|
%
|
|
Percent of gross product revenues
|
17.9
|
%
|
|
14.0
|
%
|
|
|
|
||
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Cost of sales, excluding amortization of acquired intangible assets
|
$
|
279.2
|
|
|
$
|
133.7
|
|
|
108.8
|
%
|
|
Research and development
|
528.9
|
|
|
284.3
|
|
|
86.0
|
%
|
||
|
Selling, general and administrative
|
511.7
|
|
|
352.6
|
|
|
45.1
|
%
|
||
|
Amortization of acquired intangible assets
|
143.3
|
|
|
51.3
|
|
|
179.2
|
%
|
||
|
Collaboration profit sharing
|
—
|
|
|
85.4
|
|
|
(100.0
|
)%
|
||
|
(Gain) loss on fair value remeasurement of contingent consideration
|
(0.8
|
)
|
|
2.3
|
|
|
(135.1
|
)%
|
||
|
Total cost and expenses
|
$
|
1,462.3
|
|
|
$
|
909.6
|
|
|
60.8
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Product cost of sales
|
$
|
149.6
|
|
|
$
|
87.9
|
|
|
70.2
|
%
|
|
Royalty cost of sales
|
$
|
129.6
|
|
|
$
|
45.8
|
|
|
183.0
|
%
|
|
Total cost of sales
|
$
|
279.2
|
|
|
$
|
133.7
|
|
|
108.8
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Marketed products
|
$
|
78.5
|
|
|
$
|
43.7
|
|
|
79.6
|
%
|
|
Late stage programs
|
49.4
|
|
|
71.7
|
|
|
(31.1
|
)%
|
||
|
Early stage programs
|
50.3
|
|
|
25.6
|
|
|
96.5
|
%
|
||
|
Research and discovery
|
30.2
|
|
|
23.4
|
|
|
29.1
|
%
|
||
|
Other research and development costs
|
182.7
|
|
|
119.4
|
|
|
53.0
|
%
|
||
|
Milestone and upfront expenses
|
137.8
|
|
|
0.5
|
|
|
**
|
|
||
|
Total research and development
|
$
|
528.9
|
|
|
$
|
284.3
|
|
|
86.0
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Selling, general and administrative
|
$
|
511.7
|
|
|
$
|
352.6
|
|
|
45.1
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Amortization of acquired intangible assets
|
$
|
143.3
|
|
|
$
|
51.3
|
|
|
179.2
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Collaboration profit sharing
|
$
|
—
|
|
|
$
|
85.4
|
|
|
(100.0
|
)%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
(Gain) loss on fair value remeasurement of contingent consideration
|
$
|
(0.8
|
)
|
|
$
|
2.3
|
|
|
(135.1
|
)%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Gain on sale of rights
|
$
|
3.9
|
|
|
$
|
5.1
|
|
|
(23.6
|
)%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Other income (expense), net
|
$
|
(5.6
|
)
|
|
$
|
(14.5
|
)
|
|
61.3
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Effective tax rate on pre-tax income
|
26.8
|
%
|
|
13.2
|
%
|
|
103.0
|
%
|
||
|
Income tax expense
|
$
|
178.4
|
|
|
$
|
65.5
|
|
|
172.4
|
%
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
|||||
|
Equity in loss of investee, net of tax
|
$
|
7.6
|
|
|
$
|
3.8
|
|
|
99.6
|
%
|
|
|
For the Three Months
Ended March 31, |
||||||||
|
(In millions, except percentages)
|
2014
|
|
2013
|
|
Change %
|
||||
|
Net income (loss) attributable to noncontrolling interests, net of tax
|
$
|
(0.2
|
)
|
|
$
|
—
|
|
|
**
|
|
(In millions, except percentages)
|
As of
March 31, 2014 |
|
As of
December 31, 2013 |
|
Change %
|
|||||
|
Financial assets:
|
|
|
|
|
|
|||||
|
Cash and cash equivalents
|
$
|
828.6
|
|
|
$
|
602.6
|
|
|
37.5
|
%
|
|
Marketable securities — current
|
431.6
|
|
|
620.2
|
|
|
(30.4
|
)%
|
||
|
Marketable securities — non-current
|
724.3
|
|
|
625.8
|
|
|
15.7
|
%
|
||
|
Total cash, cash equivalents and marketable securities
|
$
|
1,984.5
|
|
|
$
|
1,848.5
|
|
|
7.4
|
%
|
|
Borrowings:
|
|
|
|
|
|
|||||
|
Current portion of notes payable and line of credit
|
$
|
3.6
|
|
|
$
|
3.5
|
|
|
2.9
|
%
|
|
Notes payable
|
591.0
|
|
|
592.4
|
|
|
(0.2
|
)%
|
||
|
Total borrowings
|
$
|
594.6
|
|
|
$
|
595.9
|
|
|
(0.2
|
)%
|
|
Working capital:
|
|
|
|
|
|
|||||
|
Current assets
|
$
|
3,525.0
|
|
|
$
|
3,184.9
|
|
|
10.7
|
%
|
|
Current liabilities
|
(1,594.2
|
)
|
|
(1,758.3
|
)
|
|
(9.3
|
)%
|
||
|
Total working capital
|
$
|
1,930.8
|
|
|
$
|
1,426.6
|
|
|
35.3
|
%
|
|
•
|
$91.3 million
in net proceeds received on sales and maturities of marketable securities;
|
|
•
|
$198.8 million
in total payments for income taxes;
|
|
•
|
$54.3 million
used for purchases of property, plant and equipment;
|
|
•
|
$120.0 million
used for upfront payments in collaborative arrangements; and
|
|
•
|
$25.0 million
used for contingent consideration payment to Fumapharm shareholders.
|
|
•
|
net sales of securities of $3,168.8 million offset by the purchase of a reverse repurchase agreement of
$2,968.0 million
in anticipation of our acquisition of TYSABRI rights from Elan;
|
|
•
|
$200.0 million
in proceeds from borrowings under our credit facility;
|
|
•
|
$450.0 million
used for the repayment of the aggregate principal amount of our 6.0% Senior Notes;
|
|
•
|
$72.2 million in total payments for income taxes;
|
|
•
|
$41.0 million
used for share repurchases; and
|
|
•
|
$33.3 million
used for purchases of property, plant and equipment.
|
|
|
|
For the Three Months
Ended March 31, |
|||||||||
|
(In millions, except percentages)
|
|
2014
|
|
2013
|
|
% Change
|
|||||
|
Net cash flows provided by operating activities
|
|
$
|
104.6
|
|
|
$
|
178.9
|
|
|
(41.5
|
)%
|
|
Net cash flows provided by investing activities
|
|
$
|
6.0
|
|
|
$
|
155.9
|
|
|
(96.2
|
)%
|
|
Net cash flows provided by (used in) financing activities
|
|
$
|
114.9
|
|
|
$
|
(238.4
|
)
|
|
(148.2
|
)%
|
|
•
|
Non-cash operating items such as depreciation and amortization, impairment charges and share-based compensation charges;
|
|
•
|
Changes in operating assets and liabilities which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations; and
|
|
•
|
Changes associated with the fair value of contingent milestones associated with our acquisitions of businesses and payments related to collaborations.
|
|
|
|
Cumulative Sales Level
|
||||||||||||||
|
|
|
$1.0B
|
|
$2.0B
|
|
$3.0B
|
|
Each additional $1.0B up to $20.0B
|
||||||||
|
Prior 12 Month Sales
|
|
Payment Amount (In Millions)
|
||||||||||||||
|
< $500 million
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$500 million - $1.0 billion
|
|
25.0
|
|
|
50.0
|
|
|
50.0
|
|
|
50.0
|
|
||||
|
$1.0 billion - $1.5 billion
|
|
50.0
|
|
|
100.0
|
|
|
100.0
|
|
|
100.0
|
|
||||
|
$1.5 billion - $2.0 billion
|
|
—
|
|
|
150.0
|
|
|
150.0
|
|
|
150.0
|
|
||||
|
$2.0 billion - $2.5 billion
|
|
—
|
|
|
200.0
|
|
|
200.0
|
|
|
200.0
|
|
||||
|
$2.5 billion - $3.0 billion
|
|
—
|
|
|
—
|
|
|
250.0
|
|
|
250.0
|
|
||||
|
> $3.0 billion
|
|
—
|
|
|
—
|
|
|
—
|
|
|
300.0
|
|
||||
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
|
Item 4.
|
Controls and Procedures
|
|
•
|
intense competition in the increasingly crowded MS market, including the possibility of future competition from generic versions of TECFIDERA or related prodrug derivatives or from off-label use by physicians of therapies indicated for other conditions to treat MS patients;
|
|
•
|
our significant reliance on third parties to manufacture TECFIDERA, including the risks these third parties may not be able to supply TECFIDERA in a timely and cost-effective manner or in compliance with applicable regulations or otherwise fail to have sufficient aggregate manufacturing capacity to satisfy demand;
|
|
•
|
our sales and marketing efforts may not result in product revenues that meet the investment community's expectations for TECFIDERA;
|
|
•
|
additional risks associated with our anticipated launches of TECFIDERA in the E.U., including the impact of delays and the effects of a slower rollout of TECFIDERA across European countries over an extended number of months, the impact of competitive oral MS therapies approved in the E.U. prior to TECFIDERA, and our ability to obtain appropriate pricing and reimbursement for TECFIDERA in countries throughout the E.U.;
|
|
•
|
damage to our sales and reputation, and physician and patient confidence in TECFIDERA relating to any adverse experiences or events that may occur with patients treated with TECFIDERA, including any PML cases that may develop in patients previously treated with TYSABRI that switch to therapy with TECFIDERA; and
|
|
•
|
the other risks related to commercialization of new products described throughout these “Risk Factors”.
|
|
•
|
the medical community's acceptance of the product and the confidence of patients in the product;
|
|
•
|
the effectiveness of our sales force and marketing efforts;
|
|
•
|
the size of the patient population and our ability to identify new patients;
|
|
•
|
pricing and the extent of reimbursement from third party payors;
|
|
•
|
the ability to obtain and maintain data or market exclusivity for our products in the relevant indication(s);
|
|
•
|
our ability to offer products that have convenient dosing and delivery methods;
|
|
•
|
the availability or introduction of competing treatments that are deemed more effective, safer, more convenient, or less expensive;
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•
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manufacturing the product in a timely and cost-effective manner; and
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•
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compliance with complex regulatory requirements.
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•
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the hemophilia treatment market is highly competitive, with current treatments marketed by companies that have substantially greater financial resources and marketing expertise, and we may have difficulty penetrating this highly
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•
|
other companies, including those currently offering hemophilia products, may introduce longer-lasting or more efficacious, safer, cheaper or more convenient treatments than our current and potential therapies;
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|
•
|
we do not have marketing experience within the hemophilia treatment market or well-established relationships with the associated medical and scientific community;
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|
•
|
filing of our planned marketing authorization applications with the EMA requires the submission of positive pediatric data from our ongoing global pediatric studies with our applications, and there can be no assurance that we will receive such positive data; and
|
|
•
|
several companies are working to develop additional treatments for hemophilia and may obtain marketing approval of their treatments in the E.U. before we do, which has the potential to bar our application with the EMA under operation of the EMA’s Orphan Medicines Regulation.
|
|
•
|
Our revenues related to RITUXAN and GAZYVA are dependent on the efforts of Genentech and the Roche Group. Their interests may not always be aligned with our interests and they may not market RITUXAN or GAZYVA in the same manner or to the same extent that we would, which could adversely affect our RITUXAN or GAZYVA revenues.
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•
|
Under our collaboration agreement with Genentech, the successful development and commercialization of GAZYVA and certain other anti-CD20 products will decrease our percentage of the collaboration's co-promotion profits.
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•
|
Any failure on the part of our collaborators to comply with applicable laws and regulatory requirements in the sale, marketing and maintenance of the market authorization of our products or to fulfill any responsibilities they may have to protect and enforce any intellectual property rights underlying our products could have an adverse effect on our revenues as well as involve us in possible legal proceedings.
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|
•
|
Collaborations often require the parties to cooperate, and failure to do so effectively could have an adverse impact on product sales by our collaborators, and could adversely affect the clinical development or regulatory approvals of products under joint control.
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|
•
|
The process of manufacturing biologics is extremely susceptible to product loss due to contamination, oxidation, equipment failure or improper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply
|
|
•
|
We rely on third party suppliers and manufacturers for, among other things, manufacturing of RITUXAN and GAZYVA, the majority of our clinical and commercial requirements for TECFIDERA and other small molecule products and product candidates, raw materials and supplies for production of products we manufacture, fill-finish operations, the majority of our final product storage, and a substantial portion of our packaging operations. In addition, due to the unique manner in which our products are manufactured, we rely on single source providers of several raw materials and manufacturing supplies. These third parties are independent entities subject to their own unique operational and financial risks that are outside of our control. These third parties may not perform their obligations in a timely and cost-effective manner or in compliance with applicable regulations, and they may be unable or unwilling to increase production capacity commensurate with demand for our existing or future products. Finding alternative providers could take a significant amount of time and involve significant expense due to the specialized nature of the services and the need to obtain regulatory approval of any significant changes to our suppliers or manufacturing methods. We cannot be certain that we could reach agreement with alternative providers or that the FDA or other regulatory authorities would approve our use of such alternatives.
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•
|
We rely on our manufacturing facilities in Cambridge, Massachusetts, Research Triangle Park, North Carolina (RTP) and Hillerød, Denmark for the production of drug substance for certain of our large molecule products and product candidates, including AVONEX, TYSABRI, ALPROLIX AND ELOCTATE. Our global bulk supply of these products and product candidates depends on the uninterrupted and efficient operation of these facilities, which could be adversely affected by equipment failures, labor shortages, natural disasters, power failures and numerous other factors.
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|
•
|
We and our third party providers are generally required to maintain compliance with current Good Manufacturing Practices and other stringent requirements and are subject to inspections by the FDA and comparable agencies in other jurisdictions to confirm such compliance. 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. Significant noncompliance could also result in the imposition of monetary penalties or other civil or criminal sanctions and damage our reputation.
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|
•
|
new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to health care availability, pricing or marketing practices, compliance with wage and hour laws and other employment practices, method of delivery, payment for health care products and services, compliance with health information and data privacy and security laws and regulations, tracking and reporting payments and other transfers of value made to physicians and teaching hospitals, and extensive anti-bribery and anti-corruption prohibitions;
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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;
|
|
•
|
requirements that may provide for increased transparency of clinical trial results and quality data, which, if implemented,
|
|
•
|
changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products.
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|
•
|
the inability to obtain necessary foreign regulatory or pricing approvals of products in a timely manner;
|
|
•
|
collectability of accounts receivable;
|
|
•
|
fluctuations in currency exchange rates;
|
|
•
|
difficulties in staffing and managing international operations;
|
|
•
|
the imposition of governmental controls;
|
|
•
|
less favorable intellectual property or other applicable laws;
|
|
•
|
increasingly complex standards for complying with foreign laws and regulations that may differ substantially from country to country and may conflict with corresponding U.S. laws and regulations;
|
|
•
|
the emergence of far-reaching anti-bribery and anti-corruption legislation in the U.K., including passage of the U.K. Bribery Act 2010, and elsewhere and escalation of investigations and prosecutions pursuant to such laws;
|
|
•
|
compliance with complex import and export control laws;
|
|
•
|
restrictions on direct investments by foreign entities and trade restrictions;
|
|
•
|
greater political or economic instability; and
|
|
•
|
changes in tax laws and tariffs.
|
|
•
|
the cost of restructurings;
|
|
•
|
impairments with respect to investments, fixed assets and long-lived assets, including in-process research and development and other intangible assets;
|
|
•
|
inventory write-downs for failed quality specifications, charges for excess or obsolete inventory and charges for inventory write downs relating to product suspensions, expirations or recalls;
|
|
•
|
bad debt expenses and increased bad debt reserves;
|
|
•
|
outcomes of litigation and other legal proceedings, regulatory matters and tax matters;
|
|
•
|
milestone payments under license and collaboration agreements; and
|
|
•
|
payments in connection with acquisitions and other business development activity.
|
|
Period
|
Total Number of
Shares Purchased
(#)
|
|
Average Price
Paid per Share
($)
|
|
Total Number of
Shares Purchased
as Part of Publicly
Announced Programs
(#)
|
|
Maximum
Number of Shares
That May Yet Be
Purchased Under
Our Programs (#)
|
||||
|
January 2014
|
—
|
|
|
—
|
|
|
—
|
|
|
4,185,526
|
|
|
February 2014
|
—
|
|
|
—
|
|
|
—
|
|
|
4,185,526
|
|
|
March 2014
|
—
|
|
|
—
|
|
|
—
|
|
|
4,185,526
|
|
|
Total
|
—
|
|
|
—
|
|
|
|
|
|
||
|
|
|
BIOGEN IDEC INC.
|
|
|
|
/s/ Paul J. Clancy
|
|
Paul J. Clancy
|
|
Executive Vice President and
|
|
Chief Financial Officer
|
|
(principal financial officer)
|
|
Exhibit
Number
|
|
Description of Exhibit
|
|
|
|
|
|
10.1+*
|
|
Biogen Idec Inc. Amended and Restated 2008 Omnibus Equity Plan
|
|
10.2+*
|
|
Form of performance unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan (2014 form)
|
|
10.3+*
|
|
Form of market stock unit award agreement under the Biogen Idec Inc. 2008 Omnibus Equity Plan (2014 form)
|
|
31.1+
|
|
Certification of the Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
31.2+
|
|
Certification of the Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
32.1++
|
|
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
|
101++
|
|
The following materials from Biogen Idec Inc.’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statements of Income, (ii) the Condensed Consolidated Statements of Comprehensive Income, (iii) the Condensed Consolidated Balance Sheets, (iv) the Condensed Consolidated Statements of Cash Flows, and (v) Notes to Condensed Consolidated Financial Statements.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|