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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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(Exact name of registrant as specified in its charter)
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Delaware
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32-0375147
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. employer identification number)
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Large Accelerated Filer
x
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Accelerated Filer
¨
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Non-Accelerated Filer
¨
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Smaller reporting company
¨
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(Do not check if a smaller reporting company)
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PART I.
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Page
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ITEM 1.
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ITEM 2.
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ITEM 3.
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ITEM 4.
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PART II.
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ITEM 1.
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ITEM 2.
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ITEM 6.
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2016 Form 10-Q
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1
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Three months ended
September 30, |
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Nine months ended
September 30, |
||||||||||||
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(in millions, except per share data)
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2016
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2015
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2016
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2015
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||||||||
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Net revenues
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$
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6,432
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$
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5,944
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$
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18,842
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$
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16,459
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||||||||
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Cost of products sold
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1,504
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1,167
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4,278
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3,025
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||||
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Selling, general and administrative
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1,381
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1,474
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4,202
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4,650
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||||
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Research and development
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1,106
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1,418
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3,176
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3,210
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||||
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Acquired in-process research and development
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80
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—
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160
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150
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||||
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Total operating costs and expenses
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4,071
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4,059
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11,816
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11,035
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||||
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Operating earnings
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2,361
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1,885
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7,026
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5,424
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Interest expense, net
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250
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197
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675
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487
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||||
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Net foreign exchange loss (gain)
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(4
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)
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13
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313
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191
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Other expense, net
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101
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28
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152
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25
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||||
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Earnings before income tax expense
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2,014
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1,647
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5,886
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4,721
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||||
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Income tax expense
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416
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408
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1,324
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1,094
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||||
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Net earnings
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$
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1,598
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$
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1,239
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$
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4,562
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$
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3,627
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Per share data
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Basic earnings per share
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$
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0.97
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$
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0.75
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$
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2.79
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$
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2.22
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Diluted earnings per share
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$
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0.97
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$
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0.74
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$
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2.78
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$
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2.21
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Cash dividends declared per common share
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$
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0.57
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$
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0.51
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$
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1.71
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$
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1.53
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Weighted-average basic shares outstanding
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1,632
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1,652
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1,624
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1,623
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Weighted-average diluted shares outstanding
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1,640
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1,664
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1,633
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1,635
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2016 Form 10-Q
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2
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Three months ended
September 30, |
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Nine months ended
September 30, |
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(in millions)
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2016
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2015
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2016
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2015
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||||||||
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Net earnings
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$
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1,598
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$
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1,239
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$
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4,562
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$
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3,627
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Foreign currency translation adjustments, net of tax (benefit) expense of $10 for the three months and $30 for the nine months ended September 30, 2016 and $10 for the three months and $(98) for the nine months ended September 30, 2015.
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31
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(48
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)
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164
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(464
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)
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Pension and post-employment benefits, net of tax expense of $8 for the three months and $23 for the nine months ended September 30, 2016 and $10 for the three months and $28 for the nine months ended September 30, 2015.
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15
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23
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48
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91
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Unrealized gains (losses) on marketable equity securities, net of tax (benefit) expense of $1 for the three months and $(7) for the nine months ended September 30, 2016 and $3 for the three months and $2 for the nine months ended September 30, 2015.
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12
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(13
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)
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19
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(4
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)
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Hedging activities, net of tax expense (benefit) of $1 for the three months and $(3) for the nine months ended September 30, 2016 and $(5) for the three months and $(7) for the nine months ended September 30, 2015.
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(8
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)
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(87
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)
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(10
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(91
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)
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||||
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Other comprehensive income (loss)
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50
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(125
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)
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221
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(468
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)
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Comprehensive income
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$
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1,648
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$
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1,114
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$
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4,783
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$
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3,159
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|
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2016 Form 10-Q
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3
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(in millions, except share data)
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September 30,
2016 |
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December 31,
2015 |
||||
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(unaudited)
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||||
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Assets
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||||
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Current assets
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||||
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Cash and equivalents
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$
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6,218
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$
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8,399
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Short-term investments
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1,732
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8
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|
||
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Accounts receivable, net
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4,999
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4,730
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|
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Inventories
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1,630
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1,719
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|
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Prepaid expenses and other
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1,711
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1,458
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|
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Total current assets
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16,290
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16,314
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|
||
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||||
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Investments
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1,378
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|
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145
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|
||
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Property and equipment, net
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2,638
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2,565
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|
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Intangible assets, net
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29,113
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19,709
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|
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Goodwill
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15,657
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13,168
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|
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Other assets
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1,550
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1,149
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|
||
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Total assets
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$
|
66,626
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$
|
53,050
|
|
|
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||||
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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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Short-term borrowings
|
$
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—
|
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$
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406
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|
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Current portion of long-term debt and lease obligations
|
26
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|
|
2,025
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|
||
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Accounts payable and accrued liabilities
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9,077
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|
|
8,463
|
|
||
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Total current liabilities
|
9,103
|
|
|
10,894
|
|
||
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|
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|
|
||||
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Long-term debt and lease obligations
|
37,284
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|
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29,240
|
|
||
|
Deferred income taxes
|
6,124
|
|
|
5,276
|
|
||
|
Other long-term liabilities
|
7,646
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|
|
3,695
|
|
||
|
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|
|
||||
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Commitments and contingencies
|
|
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|
||
|
|
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|
||||
|
Stockholders’ equity
|
|
|
|
||||
|
Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,762,991,093 shares issued as of September 30, 2016 and 1,749,027,140 as of December 31, 2015.
|
18
|
|
|
17
|
|
||
|
Common stock held in treasury, at cost, 138,083,499 shares as of September 30, 2016 and 139,134,205 as of December 31, 2015.
|
(8,760
|
)
|
|
(8,839
|
)
|
||
|
Additional paid-in capital
|
13,540
|
|
|
13,080
|
|
||
|
Retained earnings
|
4,011
|
|
|
2,248
|
|
||
|
Accumulated other comprehensive loss
|
(2,340
|
)
|
|
(2,561
|
)
|
||
|
Total stockholders’ equity
|
6,469
|
|
|
3,945
|
|
||
|
|
|
|
|
||||
|
Total liabilities and equity
|
$
|
66,626
|
|
|
$
|
53,050
|
|
|
2016 Form 10-Q
|
|
4
|
|
|
Nine months ended
September 30, |
||||||
|
(in millions) (brackets denote cash outflows)
|
2016
|
|
2015
|
||||
|
Cash flows from operating activities
|
|
|
|
||||
|
Net earnings
|
$
|
4,562
|
|
|
$
|
3,627
|
|
|
Adjustments to reconcile net earnings to net cash from operating activities:
|
|
|
|
||||
|
Depreciation
|
307
|
|
|
296
|
|
||
|
Amortization of intangible assets
|
554
|
|
|
279
|
|
||
|
Change in fair value of contingent consideration
|
143
|
|
|
—
|
|
||
|
Stock-based compensation
|
278
|
|
|
229
|
|
||
|
Upfront costs and milestones related to collaborations
|
230
|
|
|
280
|
|
||
|
Devaluation loss related to Venezuela
|
298
|
|
|
—
|
|
||
|
Other, net
|
326
|
|
|
369
|
|
||
|
Changes in operating assets and liabilities, net of acquisitions:
|
|
|
|
||||
|
Accounts receivable
|
(129
|
)
|
|
(842
|
)
|
||
|
Inventories
|
28
|
|
|
(446
|
)
|
||
|
Prepaid expenses and other assets
|
(122
|
)
|
|
452
|
|
||
|
Accounts payable and other liabilities
|
(975
|
)
|
|
1,328
|
|
||
|
Cash flows from operating activities
|
5,500
|
|
|
5,572
|
|
||
|
|
|
|
|
||||
|
Cash flows from investing activities
|
|
|
|
||||
|
Acquisitions of businesses, net of cash acquired
|
(2,477
|
)
|
|
(11,488
|
)
|
||
|
Other acquisitions and investments
|
(172
|
)
|
|
(794
|
)
|
||
|
Acquisitions of property and equipment
|
(365
|
)
|
|
(387
|
)
|
||
|
Purchases of investment securities
|
(4,520
|
)
|
|
(851
|
)
|
||
|
Sales and maturities of investment securities
|
1,579
|
|
|
881
|
|
||
|
Cash flows from investing activities
|
(5,955
|
)
|
|
(12,639
|
)
|
||
|
|
|
|
|
||||
|
Cash flows from financing activities
|
|
|
|
||||
|
Net change in short-term borrowings
|
(406
|
)
|
|
335
|
|
||
|
Proceeds from issuance of long-term debt
|
7,771
|
|
|
16,660
|
|
||
|
Repayments of long-term debt and lease obligations
|
(2,006
|
)
|
|
(15
|
)
|
||
|
Debt issuance cost
|
(52
|
)
|
|
(179
|
)
|
||
|
Dividends paid
|
(2,784
|
)
|
|
(2,454
|
)
|
||
|
Purchases of treasury stock
|
(4,209
|
)
|
|
(6,342
|
)
|
||
|
Proceeds from the exercise of stock options
|
207
|
|
|
123
|
|
||
|
Other, net
|
53
|
|
|
55
|
|
||
|
Cash flows from financing activities
|
(1,426
|
)
|
|
8,183
|
|
||
|
Effect of exchange rate changes on cash and equivalents
|
(300
|
)
|
|
(241
|
)
|
||
|
Net increase (decrease) in cash and equivalents
|
(2,181
|
)
|
|
875
|
|
||
|
Cash and equivalents, beginning of period
|
8,399
|
|
|
8,348
|
|
||
|
|
|
|
|
||||
|
Cash and equivalents, end of period
|
$
|
6,218
|
|
|
$
|
9,223
|
|
|
Supplemental schedule of non-cash investing and financing activities
|
|
|
|
||||
|
Issuance of common shares associated with acquisitions of businesses
|
$
|
3,923
|
|
|
$
|
8,405
|
|
|
2016 Form 10-Q
|
|
5
|
|
|
|
2016 Form 10-Q
|
|
6
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Interest expense
|
$
|
271
|
|
|
$
|
207
|
|
|
$
|
731
|
|
|
$
|
511
|
|
|
Interest income
|
(21
|
)
|
|
(10
|
)
|
|
(56
|
)
|
|
(24
|
)
|
||||
|
Interest expense, net
|
$
|
250
|
|
|
$
|
197
|
|
|
$
|
675
|
|
|
$
|
487
|
|
|
(in millions)
|
September 30, 2016
|
|
December 31, 2015
|
||||
|
Finished goods
|
$
|
315
|
|
|
$
|
469
|
|
|
Work-in-process
|
1,184
|
|
|
1,081
|
|
||
|
Raw materials
|
131
|
|
|
169
|
|
||
|
Inventories
|
$
|
1,630
|
|
|
$
|
1,719
|
|
|
2016 Form 10-Q
|
|
7
|
|
(in millions)
|
September 30, 2016
|
|
December 31, 2015
|
||||
|
Property and equipment, gross
|
$
|
7,710
|
|
|
$
|
7,334
|
|
|
Less accumulated depreciation
|
(5,072
|
)
|
|
(4,769
|
)
|
||
|
Property and equipment, net
|
$
|
2,638
|
|
|
$
|
2,565
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions, except per share information)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Basic EPS
|
|
|
|
|
|
|
|
||||||||
|
Net earnings
|
$
|
1,598
|
|
|
$
|
1,239
|
|
|
$
|
4,562
|
|
|
$
|
3,627
|
|
|
Earnings allocated to participating securities
|
8
|
|
|
7
|
|
|
23
|
|
|
18
|
|
||||
|
Earnings available to common shareholders
|
$
|
1,590
|
|
|
$
|
1,232
|
|
|
$
|
4,539
|
|
|
$
|
3,609
|
|
|
Weighted-average basic shares outstanding
|
1,632
|
|
|
1,652
|
|
|
1,624
|
|
|
1,623
|
|
||||
|
Basic earnings per share
|
$
|
0.97
|
|
|
$
|
0.75
|
|
|
$
|
2.79
|
|
|
$
|
2.22
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Diluted EPS
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
Net earnings
|
$
|
1,598
|
|
|
$
|
1,239
|
|
|
$
|
4,562
|
|
|
$
|
3,627
|
|
|
Earnings allocated to participating securities
|
8
|
|
|
7
|
|
|
23
|
|
|
18
|
|
||||
|
Earnings available to common shareholders
|
$
|
1,590
|
|
|
$
|
1,232
|
|
|
$
|
4,539
|
|
|
$
|
3,609
|
|
|
Weighted-average shares of common stock outstanding
|
1,632
|
|
|
1,652
|
|
|
1,624
|
|
|
1,623
|
|
||||
|
Effect of dilutive securities
|
8
|
|
|
12
|
|
|
9
|
|
|
12
|
|
||||
|
Weighted-average diluted shares outstanding
|
1,640
|
|
|
1,664
|
|
|
1,633
|
|
|
1,635
|
|
||||
|
Diluted earnings per share
|
$
|
0.97
|
|
|
$
|
0.74
|
|
|
$
|
2.78
|
|
|
$
|
2.21
|
|
|
2016 Form 10-Q
|
|
8
|
|
|
|
(in millions)
|
|
||
|
Cash
|
$
|
1,883
|
|
|
Fair value of AbbVie common stock
|
3,923
|
|
|
|
Contingent consideration
|
620
|
|
|
|
Total consideration
|
$
|
6,426
|
|
|
(in millions)
|
|
||
|
Assets acquired and liabilities assumed
|
|
||
|
Accounts receivable
|
$
|
1
|
|
|
Prepaid expenses and other
|
7
|
|
|
|
Property and equipment
|
17
|
|
|
|
Intangible assets - Indefinite-lived research and development
|
6,100
|
|
|
|
Accounts payable and accrued liabilities
|
(31
|
)
|
|
|
Deferred income taxes
|
(1,975
|
)
|
|
|
Other long-term liabilities
|
(7
|
)
|
|
|
Total identifiable net assets
|
4,112
|
|
|
|
Goodwill
|
2,314
|
|
|
|
Total assets acquired and liabilities assumed
|
$
|
6,426
|
|
|
2016 Form 10-Q
|
|
9
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions, except per share information)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Net revenues
|
$
|
6,432
|
|
|
$
|
5,947
|
|
|
$
|
18,845
|
|
|
$
|
16,468
|
|
|
Net earnings
|
$
|
1,579
|
|
|
$
|
1,206
|
|
|
$
|
4,515
|
|
|
$
|
3,427
|
|
|
Basic earnings per share
|
$
|
0.97
|
|
|
$
|
0.70
|
|
|
$
|
2.72
|
|
|
$
|
2.03
|
|
|
Diluted earnings per share
|
$
|
0.96
|
|
|
$
|
0.70
|
|
|
$
|
2.71
|
|
|
$
|
2.02
|
|
|
2016 Form 10-Q
|
|
10
|
|
(in millions)
|
|
||
|
Cash
|
$
|
595
|
|
|
Deferred consideration payable
|
18
|
|
|
|
Contingent consideration
|
3,365
|
|
|
|
Total consideration
|
$
|
3,978
|
|
|
(in millions)
|
|
||
|
Assets acquired
|
|
||
|
Identifiable intangible assets - Indefinite-lived research and development
|
$
|
3,890
|
|
|
Goodwill
|
88
|
|
|
|
Total assets acquired
|
$
|
3,978
|
|
|
2016 Form 10-Q
|
|
11
|
|
(in millions)
|
|
||
|
Cash
|
$
|
12,365
|
|
|
Fair value of AbbVie common stock
|
8,405
|
|
|
|
Total consideration
|
$
|
20,770
|
|
|
(in millions)
|
|
||
|
Assets acquired and liabilities assumed
|
|
||
|
Cash and equivalents
|
$
|
877
|
|
|
Short-term investments
|
11
|
|
|
|
Accounts receivable
|
106
|
|
|
|
Inventories
|
492
|
|
|
|
Other assets
|
212
|
|
|
|
Intangible assets
|
|
||
|
Definite-lived developed product rights
|
4,590
|
|
|
|
Definite-lived license agreements
|
6,780
|
|
|
|
Indefinite-lived research and development
|
7,180
|
|
|
|
Accounts payable and accrued liabilities
|
(381
|
)
|
|
|
Deferred income taxes
|
(6,453
|
)
|
|
|
Other long-term liabilities
|
(254
|
)
|
|
|
Total identifiable net assets
|
13,160
|
|
|
|
Goodwill
|
7,610
|
|
|
|
Total assets acquired and liabilities assumed
|
$
|
20,770
|
|
|
2016 Form 10-Q
|
|
12
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||
|
(in millions, except per share information)
|
2015
|
|
2015
|
||||
|
Net revenues
|
$
|
5,944
|
|
|
$
|
16,815
|
|
|
Net earnings
|
$
|
1,332
|
|
|
$
|
3,780
|
|
|
Basic earnings per share
|
$
|
0.81
|
|
|
$
|
2.23
|
|
|
Diluted earnings per share
|
$
|
0.80
|
|
|
$
|
2.22
|
|
|
|
|
2016 Form 10-Q
|
|
13
|
|
|
|
(in millions)
|
|
||
|
Balance as of December 31, 2015
|
$
|
13,168
|
|
|
Additions (see Note 4)
|
2,402
|
|
|
|
Foreign currency translation adjustments
|
87
|
|
|
|
Balance as of September 30, 2016
|
$
|
15,657
|
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||||
|
(in millions)
|
Gross
carrying amount |
|
Accumulated
amortization |
|
Net
carrying amount |
|
Gross
carrying amount |
|
Accumulated
amortization |
|
Net
carrying amount |
||||||||||||
|
Definite-lived intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Developed product rights
|
$
|
16,481
|
|
|
$
|
(4,155
|
)
|
|
$
|
12,326
|
|
|
$
|
9,103
|
|
|
$
|
(3,944
|
)
|
|
$
|
5,159
|
|
|
License agreements
|
7,806
|
|
|
(1,009
|
)
|
|
6,797
|
|
|
8,000
|
|
|
(1,023
|
)
|
|
6,977
|
|
||||||
|
Total definite-lived intangible assets
|
24,287
|
|
|
(5,164
|
)
|
|
19,123
|
|
|
17,103
|
|
|
(4,967
|
)
|
|
12,136
|
|
||||||
|
Indefinite-lived research and development
|
9,990
|
|
|
—
|
|
|
9,990
|
|
|
7,573
|
|
|
—
|
|
|
7,573
|
|
||||||
|
Total intangible assets, net
|
$
|
34,277
|
|
|
$
|
(5,164
|
)
|
|
$
|
29,113
|
|
|
$
|
24,676
|
|
|
$
|
(4,967
|
)
|
|
$
|
19,709
|
|
|
2016 Form 10-Q
|
|
14
|
|
(in billions)
|
2016
|
|
2017
|
|
2018
|
|
2019
|
|
2020
|
||||||||||
|
Anticipated annual amortization expense
|
$
|
0.8
|
|
|
$
|
1.1
|
|
|
$
|
1.3
|
|
|
$
|
1.6
|
|
|
$
|
1.8
|
|
|
|
|
(in millions)
|
|
||
|
Accrued balance as of December 31, 2015
|
$
|
148
|
|
|
2016 restructuring charges
|
35
|
|
|
|
Payments and other adjustments
|
(93
|
)
|
|
|
Accrued balance as of September 30, 2016
|
$
|
90
|
|
|
|
|
2016 Form 10-Q
|
|
15
|
|
|
Fair value –
Derivatives in asset position |
|
Fair value –
Derivatives in liability position |
||||||
|
(in millions)
|
Balance sheet caption
|
Amount
|
|
Balance sheet caption
|
Amount
|
||||
|
Foreign currency forward exchange contracts —
|
|
|
|
|
|
||||
|
Hedging instruments
|
Prepaid expenses and other
|
$
|
41
|
|
|
Accounts payable and accrued liabilities
|
$
|
10
|
|
|
Hedging instruments
|
Other long-term assets
|
3
|
|
|
Other long-term liabilities
|
1
|
|
||
|
Others not designated as hedges
|
Prepaid expenses and other
|
11
|
|
|
Accounts payable and accrued liabilities
|
20
|
|
||
|
Interest rate swaps designated as fair value hedges
|
Other long-term assets
|
250
|
|
|
Other long-term liabilities
|
1
|
|
||
|
Total derivatives
|
|
$
|
305
|
|
|
|
$
|
32
|
|
|
|
Fair value –
Derivatives in asset position |
|
Fair value –
Derivatives in liability position |
||||||
|
(in millions)
|
Balance sheet caption
|
Amount
|
|
Balance sheet caption
|
Amount
|
||||
|
Foreign currency forward exchange contracts —
|
|
|
|
|
|
||||
|
Hedging instruments
|
Prepaid expenses and other
|
$
|
33
|
|
|
Accounts payable and accrued liabilities
|
$
|
—
|
|
|
Others not designated as hedges
|
Prepaid expenses and other
|
28
|
|
|
Accounts payable and accrued liabilities
|
21
|
|
||
|
Interest rate swaps designated as fair value hedges
|
Other long-term assets
|
9
|
|
|
Other long-term liabilities
|
81
|
|
||
|
Total derivatives
|
|
$
|
70
|
|
|
|
$
|
102
|
|
|
2016 Form 10-Q
|
|
16
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Unrealized gain/(loss)
|
$
|
(4
|
)
|
|
$
|
2
|
|
|
$
|
13
|
|
|
$
|
78
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions) (brackets denote losses)
|
Statement of earnings caption
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Foreign currency forward exchange contracts —
|
|
|
|
|
|
|
|
|
||||||||
|
Designated as cash flow hedges
|
Cost of products sold
|
$
|
4
|
|
|
$
|
89
|
|
|
$
|
23
|
|
|
$
|
171
|
|
|
Not designated as hedges
|
Net foreign exchange loss
|
(15
|
)
|
|
(5
|
)
|
|
(122
|
)
|
|
(170
|
)
|
||||
|
Non-designated treasury rate lock agreements
|
Other expense, net
|
—
|
|
|
—
|
|
|
(12
|
)
|
|
—
|
|
||||
|
Interest rate swaps designated as fair value hedges
|
Interest expense, net
|
(49
|
)
|
|
235
|
|
|
321
|
|
|
236
|
|
||||
|
·
|
Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets that the company has the ability to access;
|
|
·
|
Level 2 – Valuations based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-based valuations in which all significant inputs are observable in the market; and
|
|
·
|
Level 3 – Valuations using significant inputs that are unobservable in the market and include the use of judgment by the company’s management about the assumptions market participants would use in pricing the asset or liability.
|
|
2016 Form 10-Q
|
|
17
|
|
|
|
|
Basis of fair value measurement
|
||||||||||||
|
(in millions)
|
Total
|
|
Quoted prices in active markets for identical
assets (Level 1) |
|
Significant
other observable inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
||||||||
|
Assets
|
|
|
|
|
|
|
|
||||||||
|
Cash and equivalents
|
$
|
6,218
|
|
|
$
|
991
|
|
|
$
|
5,227
|
|
|
$
|
—
|
|
|
Time deposits
|
1,500
|
|
|
—
|
|
|
1,500
|
|
|
—
|
|
||||
|
Debt securities
|
1,476
|
|
|
—
|
|
|
1,476
|
|
|
—
|
|
||||
|
Equity securities
|
93
|
|
|
93
|
|
|
—
|
|
|
—
|
|
||||
|
Interest rate hedges
|
250
|
|
|
—
|
|
|
250
|
|
|
—
|
|
||||
|
Foreign currency contracts
|
55
|
|
|
—
|
|
|
55
|
|
|
—
|
|
||||
|
Total assets
|
$
|
9,592
|
|
|
$
|
1,084
|
|
|
$
|
8,508
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
|
Interest rate hedges
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
Foreign currency contracts
|
31
|
|
|
—
|
|
|
31
|
|
|
—
|
|
||||
|
Contingent consideration
|
4,128
|
|
|
—
|
|
|
—
|
|
|
4,128
|
|
||||
|
Total liabilities
|
$
|
4,160
|
|
|
$
|
—
|
|
|
$
|
32
|
|
|
$
|
4,128
|
|
|
|
|
|
Basis of fair value measurement
|
||||||||||||
|
(in millions)
|
Total
|
|
Quoted prices in active markets for identical
assets (Level 1) |
|
Significant
other observable inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
||||||||
|
Assets
|
|
|
|
|
|
|
|
||||||||
|
Cash and equivalents
|
$
|
8,399
|
|
|
$
|
798
|
|
|
$
|
7,601
|
|
|
$
|
—
|
|
|
Time deposits
|
8
|
|
|
—
|
|
|
8
|
|
|
—
|
|
||||
|
Equity securities
|
111
|
|
|
111
|
|
|
—
|
|
|
—
|
|
||||
|
Interest rate hedges
|
9
|
|
|
—
|
|
|
9
|
|
|
—
|
|
||||
|
Foreign currency contracts
|
61
|
|
|
—
|
|
|
61
|
|
|
—
|
|
||||
|
Total assets
|
$
|
8,588
|
|
|
$
|
909
|
|
|
$
|
7,679
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
|
Interest rate hedges
|
$
|
81
|
|
|
$
|
—
|
|
|
$
|
81
|
|
|
$
|
—
|
|
|
Foreign currency contracts
|
21
|
|
|
—
|
|
|
21
|
|
|
—
|
|
||||
|
Total liabilities
|
$
|
102
|
|
|
$
|
—
|
|
|
$
|
102
|
|
|
$
|
—
|
|
|
2016 Form 10-Q
|
|
18
|
|
(in millions)
|
|
||
|
Fair value as of December 31, 2015
|
$
|
—
|
|
|
Additions
|
3,985
|
|
|
|
Change in fair value recognized in net earnings
|
143
|
|
|
|
Fair value as of September 30, 2016
|
$
|
4,128
|
|
|
|
|
|
|
Basis of fair value measurement
|
||||||||||||||
|
(in millions)
|
Book Value
|
Approximate fair value
|
|
Quoted prices in
active markets for identical assets
(Level 1) |
|
Significant
other
observable
inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
||||||||||
|
Assets
|
|
|
|
|
|
|
|
|
||||||||||
|
Investments
|
$
|
41
|
|
$
|
42
|
|
|
$
|
—
|
|
|
$
|
5
|
|
|
$
|
37
|
|
|
Total assets
|
$
|
41
|
|
$
|
42
|
|
|
$
|
—
|
|
|
$
|
5
|
|
|
$
|
37
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
||||||||||
|
Current portion of long-term debt and lease obligations
|
$
|
26
|
|
$
|
26
|
|
|
$
|
—
|
|
|
$
|
26
|
|
|
$
|
—
|
|
|
Long-term debt and lease obligations, excluding fair value hedges
|
37,035
|
|
38,426
|
|
|
36,358
|
|
|
2,068
|
|
|
—
|
|
|||||
|
Total liabilities
|
$
|
37,061
|
|
$
|
38,452
|
|
|
$
|
36,358
|
|
|
$
|
2,094
|
|
|
$
|
—
|
|
|
2016 Form 10-Q
|
|
19
|
|
|
|
|
|
Basis of fair value measurement
|
||||||||||||||
|
(in millions)
|
Book Value
|
Approximate fair value
|
|
Quoted prices in
active markets for identical assets
(Level 1) |
|
Significant
other
observable
inputs (Level 2) |
|
Significant
unobservable inputs (Level 3) |
||||||||||
|
Assets
|
|
|
|
|
|
|
|
|
||||||||||
|
Investments
|
$
|
34
|
|
$
|
37
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
37
|
|
|
Total assets
|
$
|
34
|
|
$
|
37
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
37
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
||||||||||
|
Short-term borrowings
|
$
|
406
|
|
$
|
406
|
|
|
$
|
—
|
|
|
$
|
406
|
|
|
$
|
—
|
|
|
Current portion of long-term debt and lease obligations
|
2,025
|
|
2,016
|
|
|
—
|
|
|
2,016
|
|
|
—
|
|
|||||
|
Long-term debt and lease obligations, excluding fair value hedges
|
29,312
|
|
29,143
|
|
|
27,061
|
|
|
2,082
|
|
|
—
|
|
|||||
|
Total liabilities
|
$
|
31,743
|
|
$
|
31,565
|
|
|
$
|
27,061
|
|
|
$
|
4,504
|
|
|
$
|
—
|
|
|
|
Amortized Cost
|
|
Gross unrealized
|
|
Fair Value
|
||||||||||
|
(in millions)
|
|
Gains
|
|
Losses
|
|
||||||||||
|
Asset backed securities
|
$
|
670
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
671
|
|
|
Corporate debt securities
|
726
|
|
|
2
|
|
|
—
|
|
|
728
|
|
||||
|
Other debt securities
|
77
|
|
|
—
|
|
|
—
|
|
|
77
|
|
||||
|
Equity securities
|
19
|
|
|
74
|
|
|
—
|
|
|
93
|
|
||||
|
Total
|
$
|
1,492
|
|
|
$
|
77
|
|
|
$
|
—
|
|
|
$
|
1,569
|
|
|
2016 Form 10-Q
|
|
20
|
|
2016 Form 10-Q
|
|
21
|
|
|
|
|
Defined
benefit plans |
|
Other post-
employment plans |
||||||||||||||||||||||||||||
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||||||||||||||
|
(in millions)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||||||||||
|
Service cost
|
$
|
52
|
|
|
$
|
57
|
|
|
$
|
158
|
|
|
$
|
171
|
|
|
$
|
6
|
|
|
$
|
7
|
|
|
$
|
19
|
|
|
$
|
19
|
|
|
Interest cost
|
50
|
|
|
54
|
|
|
151
|
|
|
164
|
|
|
6
|
|
|
6
|
|
|
18
|
|
|
18
|
|
||||||||
|
Expected return on plan assets
|
(88
|
)
|
|
(81
|
)
|
|
(266
|
)
|
|
(244
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
|
Amortization of actuarial losses and prior service costs
|
22
|
|
|
31
|
|
|
64
|
|
|
95
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
||||||||
|
Net periodic benefit cost
|
$
|
36
|
|
|
$
|
61
|
|
|
$
|
107
|
|
|
$
|
186
|
|
|
$
|
12
|
|
|
$
|
13
|
|
|
$
|
37
|
|
|
$
|
38
|
|
|
|
|
2016 Form 10-Q
|
|
22
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Cost of products sold
|
$
|
6
|
|
|
$
|
6
|
|
|
$
|
19
|
|
|
$
|
17
|
|
|
Research and development
|
6
|
|
|
24
|
|
|
161
|
|
|
87
|
|
||||
|
Selling, general and administrative
|
35
|
|
|
25
|
|
|
141
|
|
|
125
|
|
||||
|
Total
|
$
|
47
|
|
|
$
|
55
|
|
|
$
|
321
|
|
|
$
|
229
|
|
|
(options in thousands, aggregate intrinsic value in millions)
|
Options
|
|
Weighted-
average exercise
price
|
|
Weighted-
average remaining life (in years) |
|
Aggregate
intrinsic value |
|||||
|
Outstanding as of December 31, 2015
|
23,569
|
|
|
$
|
30.64
|
|
|
3.0
|
|
$
|
674
|
|
|
Granted
|
1,143
|
|
|
54.99
|
|
|
|
|
|
|||
|
Granted in acquisition
|
1,076
|
|
|
12.85
|
|
|
|
|
|
|||
|
Exercised
|
(7,672
|
)
|
|
26.50
|
|
|
|
|
|
|||
|
Lapsed
|
(106
|
)
|
|
23.62
|
|
|
|
|
|
|||
|
Outstanding as of September 30, 2016
|
18,010
|
|
|
$
|
32.48
|
|
|
3.8
|
|
$
|
543
|
|
|
Exercisable as of September 30, 2016
|
14,857
|
|
|
$
|
30.49
|
|
|
2.8
|
|
$
|
484
|
|
|
2016 Form 10-Q
|
|
23
|
|
(share units in thousands)
|
Share units
|
|
Weighted-
average
grant date
fair value
|
|||
|
Outstanding as of December 31, 2015
|
12,490
|
|
|
$
|
51.66
|
|
|
Granted
|
5,480
|
|
|
55.17
|
|
|
|
Vested
|
(6,418
|
)
|
|
46.13
|
|
|
|
Lapsed
|
(644
|
)
|
|
56.90
|
|
|
|
Outstanding as of September 30, 2016
|
10,908
|
|
|
$
|
56.36
|
|
|
2016
|
|
2015
|
||||||||||||
|
Date Declared
|
|
Payment Date
|
|
Dividend Per Share
|
|
Date Declared
|
|
Payment Date
|
|
Dividend Per Share
|
||||
|
10/28/16
|
|
02/15/17
|
|
$
|
0.64
|
|
|
10/30/15
|
|
02/16/16
|
|
$
|
0.57
|
|
|
09/09/16
|
|
11/15/16
|
|
$
|
0.57
|
|
|
09/11/15
|
|
11/16/15
|
|
$
|
0.51
|
|
|
06/16/16
|
|
08/15/16
|
|
$
|
0.57
|
|
|
06/18/15
|
|
08/14/15
|
|
$
|
0.51
|
|
|
02/18/16
|
|
05/16/16
|
|
$
|
0.57
|
|
|
02/19/15
|
|
05/15/15
|
|
$
|
0.51
|
|
|
2016 Form 10-Q
|
|
24
|
|
(shares in millions, repurchase amounts in billions)
|
|
|
|
|||||||
|
Execution date
|
Purchase amount
|
|
Initial delivery of shares
|
|
Final delivery of shares
|
Related acquisition
|
||||
|
05/26/15
|
$
|
5.0
|
|
|
68.1
|
|
|
5.0
|
|
Pharmacyclics
|
|
06/01/16
|
$
|
3.8
|
|
|
54.4
|
|
|
5.4
|
|
Stemcentrx
|
|
(in millions)
|
Foreign
currency translation adjustments |
|
Pension
and post-
employment benefits |
|
Unrealized
gains on marketable equity
securities
|
|
Hedging
activities |
|
Total
|
||||||||||
|
Balance as of December 31, 2015
|
$
|
(1,270
|
)
|
|
$
|
(1,378
|
)
|
|
$
|
47
|
|
|
$
|
40
|
|
|
$
|
(2,561
|
)
|
|
Other comprehensive income before reclassifications
|
164
|
|
|
7
|
|
|
23
|
|
|
13
|
|
|
207
|
|
|||||
|
Net losses (gains) reclassified from accumulated other comprehensive loss
|
—
|
|
|
41
|
|
|
(4
|
)
|
|
(23
|
)
|
|
14
|
|
|||||
|
Net current-period other comprehensive income (loss)
|
164
|
|
|
48
|
|
|
19
|
|
|
(10
|
)
|
|
221
|
|
|||||
|
Balance as of September 30, 2016
|
$
|
(1,106
|
)
|
|
$
|
(1,330
|
)
|
|
$
|
66
|
|
|
$
|
30
|
|
|
$
|
(2,340
|
)
|
|
2016 Form 10-Q
|
|
25
|
|
(in millions)
|
Foreign
currency translation adjustments |
|
Pension
and post-
employment benefits |
|
Unrealized
gains on marketable equity
securities
|
|
Hedging
activities |
|
Total
|
||||||||||
|
Balance as of December 31, 2014
|
$
|
(603
|
)
|
|
$
|
(1,608
|
)
|
|
$
|
3
|
|
|
$
|
177
|
|
|
$
|
(2,031
|
)
|
|
Other comprehensive income before reclassifications
|
(464
|
)
|
|
23
|
|
|
—
|
|
|
78
|
|
|
(363
|
)
|
|||||
|
Net losses (gains) reclassified from accumulated other comprehensive loss
|
—
|
|
|
68
|
|
|
(4
|
)
|
|
(169
|
)
|
|
(105
|
)
|
|||||
|
Net current-period other comprehensive
income (loss)
|
(464
|
)
|
|
91
|
|
|
(4
|
)
|
|
(91
|
)
|
|
(468
|
)
|
|||||
|
Balance as of September 30, 2015
|
$
|
(1,067
|
)
|
|
$
|
(1,517
|
)
|
|
$
|
(1
|
)
|
|
$
|
86
|
|
|
$
|
(2,499
|
)
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions) (brackets denote gains)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Pension and post-employment benefits
|
|
|
|
|
|
|
|
||||||||
|
Amortization of actuarial losses and prior service costs
(a)
|
$
|
22
|
|
|
$
|
31
|
|
|
$
|
64
|
|
|
$
|
96
|
|
|
Less tax benefit
|
(8
|
)
|
|
(10
|
)
|
|
(23
|
)
|
|
(28
|
)
|
||||
|
Total reclassifications, net of tax
|
$
|
14
|
|
|
$
|
21
|
|
|
$
|
41
|
|
|
$
|
68
|
|
|
Hedging activities
|
|
|
|
|
|
|
|
||||||||
|
(Gains) on designated cash flow hedges
(b)
|
$
|
(2
|
)
|
|
$
|
(89
|
)
|
|
$
|
(21
|
)
|
|
$
|
(171
|
)
|
|
Less tax expense (benefit)
|
(2
|
)
|
|
—
|
|
|
(2
|
)
|
|
2
|
|
||||
|
Total reclassifications, net of tax
|
$
|
(4
|
)
|
|
$
|
(89
|
)
|
|
$
|
(23
|
)
|
|
$
|
(169
|
)
|
|
|
|
2016 Form 10-Q
|
|
26
|
|
|
|
2016 Form 10-Q
|
|
27
|
|
2016 Form 10-Q
|
|
28
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
HUMIRA
|
$
|
4,060
|
|
|
$
|
3,647
|
|
|
$
|
11,786
|
|
|
$
|
10,295
|
|
|
IMBRUVICA
|
501
|
|
|
304
|
|
|
1,321
|
|
|
411
|
|
||||
|
VIEKIRA
|
378
|
|
|
469
|
|
|
1,211
|
|
|
1,085
|
|
||||
|
Lupron
|
193
|
|
|
201
|
|
|
602
|
|
|
591
|
|
||||
|
Synagis
|
96
|
|
|
93
|
|
|
460
|
|
|
474
|
|
||||
|
Synthroid
|
188
|
|
|
188
|
|
|
558
|
|
|
561
|
|
||||
|
Creon
|
187
|
|
|
161
|
|
|
517
|
|
|
447
|
|
||||
|
AndroGel
|
174
|
|
|
177
|
|
|
501
|
|
|
500
|
|
||||
|
Kaletra
|
137
|
|
|
168
|
|
|
416
|
|
|
515
|
|
||||
|
Sevoflurane
|
102
|
|
|
122
|
|
|
327
|
|
|
366
|
|
||||
|
Duodopa
|
74
|
|
|
61
|
|
|
215
|
|
|
169
|
|
||||
|
All other
|
342
|
|
|
353
|
|
|
928
|
|
|
1,045
|
|
||||
|
Total net revenues
|
$
|
6,432
|
|
|
$
|
5,944
|
|
|
$
|
18,842
|
|
|
$
|
16,459
|
|
|
2016 Form 10-Q
|
|
29
|
|
2016 Form 10-Q
|
|
30
|
|
•
|
In April 2016, AbbVie acquired all rights to risankizumab (BI 655066), an anti-IL-23 monoclonal biologic antibody in Phase 3 development for psoriasis, from BI pursuant to a global collaboration agreement. AbbVie is also evaluating the potential of this biologic therapy in Crohn’s disease, psoriatic arthritis, and asthma. In addition to risankizumab, AbbVie also gained rights to an anti-CD40 antibody, BI 655064, currently in Phase 1 development.
|
|
•
|
In May 2016, the European Medicines Agency (EMA) granted approval for HUMIRA for the treatment of pediatric patients aged six years or older, with moderate to severely active Crohn’s disease.
|
|
•
|
In June 2016, HUMIRA received both U.S. Food and Drug Administration (FDA) and EMA approval to treat adults with non-infectious intermediate, posterior and panuveitis. HUMIRA is now the first and only FDA-approved non-corticosteroid therapy available for adults with non-infectious intermediate, posterior and panuveitis. This approval marks the 10
th
approved indication for HUMIRA in the United States for immune-mediated disease and the 14
th
approved indication in all geographies.
|
|
2016 Form 10-Q
|
|
31
|
|
•
|
In July 2016, following an evaluation of data for the development of ABT-122, a dual-variable domain (DVD) immunoglobulin targeting TNF and IL-17 in Phase 2 trials for rheumatoid arthritis and psoriatic arthritis, AbbVie determined that further development of ABT-122 will not be pursued. While the trial data demonstrated that the DVD platform worked well, with clear evidence of biologic activity, the decision was based on a lack a differentiation from other candidates in AbbVie’s development pipeline.
|
|
•
|
In October 2016, AbbVie opted not to exercise an option to license vobarilizumab, an anti-IL-6R Nanobody, from Ablynx NV based on results of a Phase 2 study in rheumatoid arthritis. AbbVie retains an option to license vobarilizumab based on results of an on-going Phase 2 study in systemic lupus erythematosus.
|
|
•
|
In April 2016, the FDA granted accelerated approval of Venclexta (venetoclax) tablets for patients diagnosed with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy. Additionally, in January 2016, the FDA granted two additional breakthrough therapy designations for venetoclax: (i) in combination with rituximab for the treatment of patients with relapsed/refractory CLL, including patients with chromosome 17p deletion; and (ii) in combination with hypomethylating agents for the treatment of patients with untreated (treatment-naïve) acute myeloid leukemia who are ineligible to receive standard induction therapy (high-dose chemotherapy). In February 2016, AbbVie announced that the EMA granted Orphan Drug Designation to venetoclax for the treatment of acute myeloid leukemia. The FDA also recently granted venetoclax orphan drug designation for the treatment of patients with acute myeloid leukemia. In October 2016, AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the EMA granted a positive opinion for VENCLEXTO for patients with relapsed/refractory CLL with chromosome 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or in patients without the 17p deletion or TP53 mutations who have failed both chemotherapy and a B-cell pathway inhibitor.
|
|
•
|
In July 2016, AbbVie announced the initiation of a Phase 3 clinical trial to study the safety and efficacy of venetoclax in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or naive to proteasome inhibitors and have received one to three prior lines of therapy. The combination of venetoclax, bortezomib and dexamethasone will be compared to treatment with bortezomib, dexamethasone and placebo.
|
|
•
|
In February 2016, AbbVie announced that the FDA granted IMBRUVICA orphan drug designation for the treatment of patients with extranodal marginal zone lymphoma. In September 2016, AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the FDA for IMBRUVICA to treat patients with marginal zone lymphoma (MZL). MZL is a slow-growing form of non-Hodgkin's lymphoma.
|
|
•
|
In March 2016, AbbVie announced that the FDA approved IMBRUVICA as a first-line treatment for patients with CLL. The approval was based on data from the Phase 3 RESONATE™-2 trial, which evaluated efficacy and safety of IMBRUVICA versus traditional chemotherapy, chlorambucil, in treatment-naïve patients with CLL or small lymphocytic leukemia. This is the first FDA-approved chemotherapy-free treatment option for first-line CLL patients and the 5th approved treatment indication for IMBRUVICA. In May 2016, AbbVie announced that the EMA approved IMBRUVICA as a first-line treatment option for adult patients with CLL. IMBRUVICA is now available to treat all lines of CLL in the European Union (EU). This is the fifth treatment indication in the EU for IMBRUVICA.
|
|
•
|
In May 2016, AbbVie announced that the FDA updated the IMBRUVICA Prescribing Information to include new data from two Phase 3 trials supporting expanded use in patients with CLL and small lymphocytic lymphoma. The label now includes overall survival results in previously-untreated CLL/small lymphocytic lymphoma patients from the Phase 3 RESONATE-2 trial. The IMBRUVICA label has also been updated with safety and efficacy data from the Phase 3 HELIOS trial assessing the use of IMBRUVICA in combination with bendamustine and rituximab versus placebo plus rituximab in relapsed/refractory patients with CLL/small lymphocytic lymphoma. Additionally, the FDA approved a new IMBRUVICA indication to include the treatment of patients with small lymphocytic lymphoma with or without the deletion of chromosome 17p.
|
|
•
|
In June 2016, AbbVie announced that the FDA granted IMBRUVICA breakthrough therapy designation for chronic graft-versus-host-disease after failure of one or more lines of systemic therapy, a rare condition with limited treatment options. The FDA additionally granted IMBRUVICA orphan drug designation for this condition. This is the fourth breakthrough therapy designation for IMBRUVICA.
|
|
2016 Form 10-Q
|
|
32
|
|
•
|
In May 2016, Bristol-Myers Squibb Company (BMS) and AbbVie announced that the EMA approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid® (lenalidomide) and dexamethasone in adult patients who have received at least one prior therapy. Empliciti is now the first and only immunostimulatory antibody approved for multiple myeloma in the EU.
|
|
•
|
In June 2016, AbbVie acquired Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T) currently in registrational trials for small cell lung cancer (SCLC). Rova-T is a novel bio-marker-specific therapy that is derived from cancer stem cells and targets delta-like protein 3 (DLL3) that is expressed in more than 80% of SCLC patient tumors and is not present in healthy tissue. Registrational trials for third-line SCLC are expected to complete enrollment by the end of 2016. AbbVie recently began enrollment of a Phase 1 eight-arm "basket study" in neuroendocrine tumors and a Phase 1/2 regimen selection study as a first-line treatment for SCLC. Beyond Rova-T, Stemcentrx has four novel compounds in clinical trials across several solid tumor indications and has additional pre-clinical compounds.
|
|
•
|
In July 2016, BMS and AbbVie announced a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Rova-T in combination with BMS’ Opdivo (nivolumab) and Opdivo + Yervoy (ipilimumab) regimen as a treatment for relapsed extensive stage SCLC. The Phase 1/2 clinical program will explore the potential of combining BMS’ immune-oncology agents in conjunction with Rova-T to drive improved and sustained efficacy and tolerability above the current standard of care.
|
|
•
|
In June 2016, AbbVie exercised its right to end its global collaboration with Infinity Pharmaceuticals, Inc. (Infinity), which it entered into in September 2014 to develop and commercialize duvelisib (IPI-145) for the treatment of patients with cancer. Pursuant to the terms of the global collaboration agreement, the worldwide rights to duvelisib reverted to Infinity.
|
|
•
|
In February 2016, AbbVie announced that (CHMP) granted a positive opinion for the use of VIEKIRA (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) without ribavirin (RBV) in chronic HCV infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A). In April 2016, AbbVie announced that the FDA approved VIEKIRA PAK (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without RBV in patients with GT1b chronic HCV infection and compensated cirrhosis. In July 2016, AbbVie announced that the FDA approved a New Drug Application (NDA) for VIEKIRA XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. VIEKIRA XR is a once-daily, extended-release co-formulation of the active ingredients in VIEKIRA PAK (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) HCV, including those with compensated cirrhosis (Child-Pugh A).
|
|
•
|
In October 2016, AbbVie announced that the FDA granted breakthrough therapy designation for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for the treatment of patients with HCV who failed previous therapy with direct-acting antivirals in genotype 1, including therapy with an NS5A inhibitor and/or protease inhibitor.
|
|
•
|
In May 2016, Biogen and AbbVie announced that the FDA approved ZINBRYTA (daclizumab) for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS). ZINBRYTA is a once-monthly, self-administered, subcutaneous injection. Biogen and AbbVie will co-promote ZINBRYTA in the United States. In July 2016, Biogen and AbbVie announced that the EMA granted a marketing authorization for ZINBRYTA for the treatment of adult patients with RMS. ZINBRYTA launched in the the third quarter of 2016.
|
|
•
|
In January 2016, AbbVie announced the initiation of the first of two planned Phase 3 studies evaluating the safety and efficacy of elagolix in the treatment of patients with uterine fibroids. AbbVie made a milestone payment of $15 million to Neurocrine Biosciences, Inc., AbbVie’s collaboration partner, upon enrollment of the first patient. Elagolix is also in Phase 3 development for endometriosis.
|
|
2016 Form 10-Q
|
|
33
|
|
|
Three months ended
September 30, |
|
Percent change
|
|
Nine months ended
September 30, |
|
Percent change
|
||||||||||||||||||||
|
|
|
At actual
currency rates |
|
At constant
currency rates |
|
|
At actual
currency rates |
|
At constant
currency rates |
||||||||||||||||||
|
(dollars in millions)
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||||||||||
|
United States
|
$
|
4,081
|
|
|
$
|
3,690
|
|
|
10.6
|
%
|
|
10.6
|
%
|
|
$
|
11,695
|
|
|
$
|
9,710
|
|
|
20.4
|
%
|
|
20.4
|
%
|
|
International
|
2,351
|
|
|
2,254
|
|
|
4.3
|
%
|
|
5.9
|
%
|
|
7,147
|
|
|
6,749
|
|
|
5.9
|
%
|
|
10.0
|
%
|
||||
|
Net revenues
|
$
|
6,432
|
|
|
$
|
5,944
|
|
|
8.2
|
%
|
|
8.8
|
%
|
|
$
|
18,842
|
|
|
$
|
16,459
|
|
|
14.5
|
%
|
|
16.1
|
%
|
|
2016 Form 10-Q
|
|
34
|
|
|
Three months ended
September 30, |
|
Percent change
|
|
Nine months ended
September 30, |
|
Percent change
|
||||||||||||||||||||
|
|
|
At actual
currency rates |
|
At constant
currency rates |
|
|
At actual
currency rates |
|
At constant
currency rates |
||||||||||||||||||
|
(dollars in millions)
|
2016
|
|
2015
|
|
|
2016
|
|
2015
|
|
||||||||||||||||||
|
HUMIRA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
2,647
|
|
|
$
|
2,268
|
|
|
16.7
|
%
|
|
16.7
|
%
|
|
$
|
7,554
|
|
|
$
|
6,073
|
|
|
24.4
|
%
|
|
24.4
|
%
|
|
International
|
1,413
|
|
|
1,379
|
|
|
2.4
|
%
|
|
4.5
|
%
|
|
4,232
|
|
|
4,222
|
|
|
0.2
|
%
|
|
4.4
|
%
|
||||
|
Total
|
$
|
4,060
|
|
|
$
|
3,647
|
|
|
11.3
|
%
|
|
12.1
|
%
|
|
$
|
11,786
|
|
|
$
|
10,295
|
|
|
14.5
|
%
|
|
16.2
|
%
|
|
IMBRUVICA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
437
|
|
|
$
|
267
|
|
|
63.6
|
%
|
|
63.6
|
%
|
|
$
|
1,146
|
|
|
$
|
364
|
|
|
>100.0
|
%
|
|
>100.0
|
%
|
|
Collaboration revenues
|
64
|
|
|
37
|
|
|
70.6
|
%
|
|
70.6
|
%
|
|
175
|
|
|
47
|
|
|
>100.0
|
%
|
|
>100.0
|
%
|
||||
|
Total
|
$
|
501
|
|
|
$
|
304
|
|
|
64.5
|
%
|
|
64.5
|
%
|
|
$
|
1,321
|
|
|
$
|
411
|
|
|
>100.0
|
%
|
|
>100.0
|
%
|
|
VIEKIRA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
76
|
|
|
$
|
242
|
|
|
(68.8
|
)%
|
|
(68.8
|
)%
|
|
$
|
288
|
|
|
$
|
607
|
|
|
(52.5
|
)%
|
|
(52.5
|
)%
|
|
International
|
302
|
|
|
227
|
|
|
32.5
|
%
|
|
30.9
|
%
|
|
923
|
|
|
478
|
|
|
92.8
|
%
|
|
95.0
|
%
|
||||
|
Total
|
$
|
378
|
|
|
$
|
469
|
|
|
(19.6
|
)%
|
|
(20.4
|
)%
|
|
$
|
1,211
|
|
|
$
|
1,085
|
|
|
11.6
|
%
|
|
12.6
|
%
|
|
Lupron
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
155
|
|
|
$
|
158
|
|
|
(2.7
|
)%
|
|
(2.7
|
)%
|
|
$
|
485
|
|
|
$
|
464
|
|
|
4.3
|
%
|
|
4.3
|
%
|
|
International
|
38
|
|
|
43
|
|
|
(9.4
|
)%
|
|
(8.7
|
)%
|
|
117
|
|
|
127
|
|
|
(7.4
|
)%
|
|
(2.2
|
)%
|
||||
|
Total
|
$
|
193
|
|
|
$
|
201
|
|
|
(4.1
|
)%
|
|
(3.9
|
)%
|
|
$
|
602
|
|
|
$
|
591
|
|
|
1.8
|
%
|
|
2.9
|
%
|
|
Synagis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
International
|
$
|
96
|
|
|
$
|
93
|
|
|
2.5
|
%
|
|
(2.4
|
)%
|
|
$
|
460
|
|
|
$
|
474
|
|
|
(3.0
|
)%
|
|
1.8
|
%
|
|
Synthroid
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
188
|
|
|
$
|
188
|
|
|
(0.3
|
)%
|
|
(0.3
|
)%
|
|
$
|
558
|
|
|
$
|
561
|
|
|
(0.5
|
)%
|
|
(0.5
|
)%
|
|
Creon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
187
|
|
|
$
|
161
|
|
|
16.6
|
%
|
|
16.6
|
%
|
|
$
|
517
|
|
|
$
|
447
|
|
|
15.7
|
%
|
|
15.7
|
%
|
|
AndroGel
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
174
|
|
|
$
|
177
|
|
|
(2.1
|
)%
|
|
(2.1
|
)%
|
|
$
|
501
|
|
|
$
|
500
|
|
|
0.2
|
%
|
|
0.2
|
%
|
|
Kaletra
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
27
|
|
|
$
|
39
|
|
|
(30.6
|
)%
|
|
(30.6
|
)%
|
|
$
|
90
|
|
|
$
|
123
|
|
|
(26.9
|
)%
|
|
(26.9
|
)%
|
|
International
|
110
|
|
|
129
|
|
|
(14.7
|
)%
|
|
(9.0
|
)%
|
|
326
|
|
|
392
|
|
|
(16.7
|
)%
|
|
(9.4
|
)%
|
||||
|
Total
|
$
|
137
|
|
|
$
|
168
|
|
|
(18.4
|
)%
|
|
(14.1
|
)%
|
|
$
|
416
|
|
|
$
|
515
|
|
|
(19.1
|
)%
|
|
(13.5
|
)%
|
|
Sevoflurane
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
19
|
|
|
$
|
21
|
|
|
(9.9
|
)%
|
|
(9.9
|
)%
|
|
$
|
58
|
|
|
$
|
59
|
|
|
(1.8
|
)%
|
|
(1.8
|
)%
|
|
International
|
83
|
|
|
101
|
|
|
(17.4
|
)%
|
|
(13.8
|
)%
|
|
269
|
|
|
307
|
|
|
(12.4
|
)%
|
|
(7.4
|
)%
|
||||
|
Total
|
$
|
102
|
|
|
$
|
122
|
|
|
(16.1
|
)%
|
|
(13.1
|
)%
|
|
$
|
327
|
|
|
$
|
366
|
|
|
(10.7
|
)%
|
|
(6.5
|
)%
|
|
Duodopa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
$
|
10
|
|
|
$
|
3
|
|
|
>100.0
|
%
|
|
>100.0
|
%
|
|
$
|
26
|
|
|
$
|
6
|
|
|
>100.0
|
%
|
|
>100.0
|
%
|
|
International
|
64
|
|
|
58
|
|
|
11.7
|
%
|
|
12.1
|
%
|
|
189
|
|
|
163
|
|
|
16.3
|
%
|
|
17.8
|
%
|
||||
|
Total
|
$
|
74
|
|
|
$
|
61
|
|
|
21.0
|
%
|
|
21.4
|
%
|
|
$
|
215
|
|
|
$
|
169
|
|
|
27.1
|
%
|
|
28.6
|
%
|
|
All other
|
$
|
342
|
|
|
$
|
353
|
|
|
(2.2
|
)%
|
|
(1.3
|
)%
|
|
$
|
928
|
|
|
$
|
1,045
|
|
|
(11.1
|
)%
|
|
(9.9
|
)%
|
|
Total net revenues
|
$
|
6,432
|
|
|
$
|
5,944
|
|
|
8.2
|
%
|
|
8.8
|
%
|
|
$
|
18,842
|
|
|
$
|
16,459
|
|
|
14.5
|
%
|
|
16.1
|
%
|
|
2016 Form 10-Q
|
|
35
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||||||||
|
(dollars in millions)
|
2016
|
|
2015
|
|
% change
|
|
2016
|
|
2015
|
|
% change
|
||||||||||
|
Gross margin
|
$
|
4,928
|
|
|
$
|
4,777
|
|
|
3
|
%
|
|
$
|
14,564
|
|
|
$
|
13,434
|
|
|
8
|
%
|
|
as a % of net revenues
|
77
|
%
|
|
80
|
%
|
|
|
|
77
|
%
|
|
82
|
%
|
|
|
||||||
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||||||||
|
(dollars in millions)
|
2016
|
|
2015
|
|
% change
|
|
2016
|
|
2015
|
|
% change
|
||||||||||
|
Selling, general, and administrative
|
$
|
1,381
|
|
|
$
|
1,474
|
|
|
(6
|
)%
|
|
$
|
4,202
|
|
|
$
|
4,650
|
|
|
(10
|
)%
|
|
as a % of net revenues
|
21
|
%
|
|
25
|
%
|
|
|
|
22
|
%
|
|
28
|
%
|
|
|
||||||
|
2016 Form 10-Q
|
|
36
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||||||||
|
(dollars in millions)
|
2016
|
|
2015
|
|
% change
|
|
2016
|
|
2015
|
|
% change
|
||||||||||
|
Research and development
|
$
|
1,106
|
|
|
$
|
1,418
|
|
|
(22
|
)%
|
|
$
|
3,176
|
|
|
$
|
3,210
|
|
|
(1
|
)%
|
|
as a % of net revenues
|
17
|
%
|
|
24
|
%
|
|
|
|
17
|
%
|
|
20
|
%
|
|
|
||||||
|
Acquired in-process research and development
|
$
|
80
|
|
|
$
|
—
|
|
|
100
|
%
|
|
$
|
160
|
|
|
$
|
150
|
|
|
6
|
%
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Interest expense
|
$
|
271
|
|
|
$
|
207
|
|
|
$
|
731
|
|
|
$
|
511
|
|
|
Interest income
|
(21
|
)
|
|
(10
|
)
|
|
(56
|
)
|
|
(24
|
)
|
||||
|
Interest expense, net
|
$
|
250
|
|
|
$
|
197
|
|
|
$
|
675
|
|
|
$
|
487
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net foreign exchange loss (gain)
|
$
|
(4
|
)
|
|
$
|
13
|
|
|
$
|
313
|
|
|
$
|
191
|
|
|
Other expense, net
|
101
|
|
|
28
|
|
|
152
|
|
|
25
|
|
||||
|
2016 Form 10-Q
|
|
37
|
|
|
Nine months ended
September 30, |
||||||
|
(in millions)
|
2016
|
|
2015
|
||||
|
Cash flows provided by/(used in):
|
|
|
|
||||
|
Operating activities
|
$
|
5,500
|
|
|
$
|
5,572
|
|
|
Investing activities
|
(5,955
|
)
|
|
(12,639
|
)
|
||
|
Financing activities
|
(1,426
|
)
|
|
8,183
|
|
||
|
2016 Form 10-Q
|
|
38
|
|
2016 Form 10-Q
|
|
39
|
|
2016 Form 10-Q
|
|
40
|
|
|
September 30, 2016
|
|
December 31, 2015
|
||||||||||||||||||
|
(dollars in millions)
|
Contract
amount |
|
Weighted
average exchange rate |
|
Fair and
carrying value receivable / (payable) |
|
Contract
amount |
|
Weighted
average exchange rate |
|
Fair and
carrying value receivable / (payable) |
||||||||||
|
Receive primarily U.S. dollars in exchange for the following currencies:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
|
Euro
|
$
|
5,751
|
|
|
1.127
|
|
|
$
|
23
|
|
|
$
|
5,880
|
|
|
1.103
|
|
|
$
|
34
|
|
|
Japanese yen
|
921
|
|
|
101.6
|
|
|
(2
|
)
|
|
853
|
|
|
120.9
|
|
|
(2
|
)
|
||||
|
British pound
|
698
|
|
|
1.338
|
|
|
17
|
|
|
163
|
|
|
1.496
|
|
|
1
|
|
||||
|
All other currencies
|
1,984
|
|
|
N/A
|
|
|
(14
|
)
|
|
1,387
|
|
|
N/A
|
|
|
8
|
|
||||
|
Total
|
$
|
9,354
|
|
|
|
|
$
|
24
|
|
|
$
|
8,283
|
|
|
|
|
$
|
41
|
|
||
|
2016 Form 10-Q
|
|
41
|
|
2016 Form 10-Q
|
|
42
|
|
Period
|
(a) Total
Number of Shares
(or Units)
Purchased |
|
(b) Average
Price Paid per Share (or Unit) |
|
(c) Total Number
of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs |
|
(d) Maximum
Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs |
|
||
|
July 1, 2016 – July 31, 2016
|
31,554
|
|
(1)
|
$57.48
|
(1)
|
—
|
|
|
$2,127,160,135
|
(2)
|
|
August 1, 2016 – August 31, 2016
|
10,319
|
|
(1)
|
$44.68
|
(1)
|
—
|
|
|
$2,127,160,135
|
(2)
|
|
September 1, 2016 – September 30, 2016
|
5,406,908
|
|
(1)/(3)
|
$70.28
|
(1)/(3)
|
5,406,908
|
|
(3)
|
$2,127,160,135
|
(2)
|
|
Total
|
5,448,781
|
|
(1)/(3)
|
$70.16
|
(1)/(3)
|
5,406,908
|
|
(3)
|
$2,127,160,135
|
(2)
|
|
1.
|
In addition to AbbVie shares repurchased on the open market under a publicly announced program, if any, these shares included the shares deemed surrendered to AbbVie to pay the exercise price in connection with the exercise of employee stock options – 12,074 in July; 10,319 in August; and zero in September, with average exercise prices of $45.51 in July and $44.68 in August.
|
|
2.
|
On October 20, 2014, AbbVie announced that its board of directors authorized the purchase of up to $5.0 billion of its common stock. The board of directors authorized increases to this repurchase program of $5.0 billion In March 2015 and $4.0 billion in April 2016 in anticipation of executing accelerated share repurchase agreements (ASRs) in connection with the acquisitions of Pharmacyclics, Inc. and Stemcentrx, Inc. Purchases of AbbVie shares under this program may be made from time to time at management’s discretion. The program has no time limit and can be discontinued at any time.
|
|
3.
|
On June 1, 2016, AbbVie entered into and executed a $3.8 billion ASR pursuant to which AbbVie received an initial delivery of approximately 54.4 million shares of AbbVie’s common stock on June 2, 2016, which represented approximately 90% of the total shares expected to be delivered under the agreement. The 2016 ASR transaction was completed on September 28, 2016, resulting in the receipt of an additional 5.4 million shares. The ASR had an average repurchase price of $63.50 per share.
|
|
2016 Form 10-Q
|
|
43
|
|
|
|
ABBVIE INC.
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ William J. Chase
|
|
|
|
William J. Chase
|
|
|
|
Executive Vice President,
|
|
|
|
Chief Financial Officer
|
|
2016 Form 10-Q
|
|
44
|
|
Exhibit No.
|
Exhibit Description
|
|
|
|
|
|
|
|
12.1
|
Ratio of Earnings to Fixed Charges
|
|
|
|
|
12.2
|
Computation of Ratio of Earnings to Fixed Charges
|
|
|
|
|
31.1
|
Certification of Chief Executive Officer Required by Rule 13a-14(a) (17 CFR 240.13a-14(a)).
|
|
|
|
|
31.2
|
Certification of Chief Financial Officer Required by Rule 13a-14(a) (17 CFR 240.13a-14(a)).
|
|
|
|
|
32.1
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
32.2
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
|
101
|
The following financial statements and notes from the AbbVie Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed on November 7, 2016, formatted in XBRL: (i) Condensed Consolidated Statements of Earnings; (ii) Condensed Consolidated Statements of Comprehensive Income; (iii) Condensed Consolidated Balance Sheets; (iv) Condensed Consolidated Statements of Cash Flows; and (v) the Notes to Condensed Consolidated Financial Statements.
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
Customers
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|