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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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Emerging growth company
¨
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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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Item 1.
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Item 2.
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Item 6.
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2018 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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2018
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2017
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2018
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2017
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||||||||
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Net revenues
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$
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8,236
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$
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6,995
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$
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24,448
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$
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20,477
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||||||||
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Cost of products sold
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1,835
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1,616
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5,696
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4,761
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Selling, general and administrative
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1,919
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1,457
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5,470
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4,339
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||||
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Research and development
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1,268
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1,228
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3,834
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3,599
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||||
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Acquired in-process research and development
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55
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—
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124
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15
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||||
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Other expense
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—
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—
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500
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—
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Total operating costs and expenses
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5,077
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4,301
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15,624
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12,714
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Operating earnings
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3,159
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2,694
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8,824
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7,763
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Interest expense, net
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302
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252
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825
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752
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Net foreign exchange loss
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2
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9
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18
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28
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Other expense, net
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94
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338
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411
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449
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Earnings before income tax expense
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2,761
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2,095
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7,570
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6,534
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Income tax expense
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14
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464
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57
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1,277
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Net earnings
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$
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2,747
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$
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1,631
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$
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7,513
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$
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5,257
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Per share data
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Basic earnings per share
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$
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1.81
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$
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1.02
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$
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4.81
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$
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3.28
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Diluted earnings per share
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$
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1.81
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$
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1.01
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$
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4.79
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$
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3.27
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Weighted-average basic shares outstanding
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1,511
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1,597
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1,556
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1,596
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Weighted-average diluted shares outstanding
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1,515
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1,603
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1,561
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1,602
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2018 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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2018
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2017
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2018
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2017
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Net earnings
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$
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2,747
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$
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1,631
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$
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7,513
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$
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5,257
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Foreign currency translation adjustments, net of tax expense (benefit) of $3 for the three months and $(16) for the nine months ended September 30, 2018 and $7 for the three months and $40 for the nine months ended September 30, 2017
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30
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183
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(250
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)
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602
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Net investment hedging activities, net of tax expense (benefit) of $(9) for the three months and $22 for the nine months ended September 30, 2018 and $(52) for the three months and $(174) for the nine months ended September 30, 2017
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(32
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)
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(90
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)
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73
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(307
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)
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Pension and post-employment benefits, net of tax expense (benefit) of $8 for the three months and $24 for the nine months ended September 30, 2018 and $8 for the three months and $23 for the nine months ended September 30, 2017
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28
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8
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99
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21
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Marketable security activities, net of tax expense (benefit) of $— for the three months and $— for the nine months ended September 30, 2018 and $4 for the three months and $6 for the nine months ended September 30, 2017
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—
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(28
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(2
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(18
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)
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Cash flow hedging activities, net of tax expense (benefit) of $1 for the three months and $18 for the nine months ended September 30, 2018 and $(14) for the three months and $(29) for the nine months ended September 30, 2017
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54
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(138
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248
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(325
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)
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Other comprehensive income (loss)
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80
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(65
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)
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168
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(27
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)
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Comprehensive income
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$
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2,827
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$
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1,566
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$
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7,681
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$
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5,230
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2018 Form 10-Q
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3
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(in millions, except share data)
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September 30,
2018 |
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December 31,
2017 |
||||
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(unaudited)
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Assets
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Current assets
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Cash and equivalents
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$
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8,015
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$
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9,303
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Short-term investments
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770
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486
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Accounts receivable, net
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5,780
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5,088
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Inventories
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1,786
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1,605
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Prepaid expenses and other
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2,114
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4,741
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Total current assets
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18,465
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21,223
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Investments
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1,463
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2,090
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Property and equipment, net
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2,950
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2,803
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Intangible assets, net
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26,625
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27,559
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Goodwill
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15,718
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15,785
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Other assets
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943
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1,326
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Total assets
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$
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66,164
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$
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70,786
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||||
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Liabilities and Equity
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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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3,002
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$
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400
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Current portion of long-term debt and lease obligations
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1,019
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6,015
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Accounts payable and accrued liabilities
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11,366
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10,226
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Total current liabilities
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15,387
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16,641
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||||
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Long-term debt and lease obligations
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36,487
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30,953
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Deferred income taxes
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1,490
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2,490
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|
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Other long-term liabilities
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15,721
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15,605
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||||
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Commitments and contingencies
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||||
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Stockholders’ equity (deficit)
|
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|
||||
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Common stock, $0.01 par value, 4,000,000,000 shares authorized, 1,776,109,692 shares issued as of September 30, 2018 and 1,768,738,550 as of December 31, 2017
|
18
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|
|
18
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|
||
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Common stock held in treasury, at cost, 271,949,381 shares as of September 30, 2018 and 176,607,525 as of December 31, 2017
|
(21,849
|
)
|
|
(11,923
|
)
|
||
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Additional paid-in capital
|
14,680
|
|
|
14,270
|
|
||
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Retained earnings
|
6,789
|
|
|
5,459
|
|
||
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Accumulated other comprehensive loss
|
(2,559
|
)
|
|
(2,727
|
)
|
||
|
Total stockholders’ equity (deficit)
|
(2,921
|
)
|
|
5,097
|
|
||
|
|
|
|
|
||||
|
Total liabilities and equity
|
$
|
66,164
|
|
|
$
|
70,786
|
|
|
2018 Form 10-Q
|
|
4
|
|
|
Nine months ended
September 30, |
||||||
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(in millions) (brackets denote cash outflows)
|
2018
|
|
2017
|
||||
|
Cash flows from operating activities
|
|
|
|
||||
|
Net earnings
|
$
|
7,513
|
|
|
$
|
5,257
|
|
|
Adjustments to reconcile net earnings to net cash from operating activities:
|
|
|
|
||||
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Depreciation
|
349
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|
|
324
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|
||
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Amortization of intangible assets
|
974
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|
|
808
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|
||
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Change in fair value of contingent consideration liabilities
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432
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|
|
547
|
|
||
|
Stock-based compensation
|
351
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|
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288
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|
||
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Upfront costs and milestones related to collaborations
|
711
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|
|
85
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|
||
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Other, net
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423
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|
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(73
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)
|
||
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Changes in operating assets and liabilities:
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|
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|
||||
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Accounts receivable
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(806
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)
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|
(163
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)
|
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Inventories
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(367
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)
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|
(119
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)
|
||
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Prepaid expenses and other assets
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(426
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)
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|
(22
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)
|
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Accounts payable and other liabilities
|
881
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|
|
444
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|
||
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Cash flows from operating activities
|
10,035
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|
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7,376
|
|
||
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|
||||
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Cash flows from investing activities
|
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|
||||
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Acquisitions and investments
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(541
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)
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|
(180
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)
|
||
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Acquisitions of property and equipment
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(515
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)
|
|
(347
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)
|
||
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Purchases of investment securities
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(1,581
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)
|
|
(1,838
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)
|
||
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Sales and maturities of investment securities
|
1,914
|
|
|
1,890
|
|
||
|
Cash flows from investing activities
|
(723
|
)
|
|
(475
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)
|
||
|
|
|
|
|
||||
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Cash flows from financing activities
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|
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|
||||
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Net change in commercial paper borrowings
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(400
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)
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|
423
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|
||
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Proceeds from issuance of other short-term borrowings
|
3,002
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|
|
—
|
|
||
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Proceeds from issuance of long-term debt
|
5,963
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|
|
—
|
|
||
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Repayments of long-term debt and lease obligations
|
(5,021
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)
|
|
(18
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)
|
||
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Debt issuance costs
|
(34
|
)
|
|
—
|
|
||
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Dividends paid
|
(4,129
|
)
|
|
(3,077
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)
|
||
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Purchases of treasury stock
|
(9,956
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)
|
|
(905
|
)
|
||
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Proceeds from the exercise of stock options
|
66
|
|
|
214
|
|
||
|
Payments of contingent consideration liabilities
|
(78
|
)
|
|
(268
|
)
|
||
|
Other, net
|
16
|
|
|
47
|
|
||
|
Cash flows from financing activities
|
(10,571
|
)
|
|
(3,584
|
)
|
||
|
Effect of exchange rate changes on cash and equivalents
|
(29
|
)
|
|
29
|
|
||
|
Net change in cash and equivalents
|
(1,288
|
)
|
|
3,346
|
|
||
|
Cash and equivalents, beginning of period
|
9,303
|
|
|
5,100
|
|
||
|
|
|
|
|
||||
|
Cash and equivalents, end of period
|
$
|
8,015
|
|
|
$
|
8,446
|
|
|
2018 Form 10-Q
|
|
5
|
|
|
|
2018 Form 10-Q
|
|
6
|
|
|
|
Three months ended
September 30, 2018 |
|
Nine months ended
September 30, 2018 |
||||||||||||||||||||
|
(in millions, except per share data)
|
|
As Reported
|
|
Balances Without Adoption of
ASU 2014-09
|
|
Effect of Change Higher/(Lower)
|
|
As Reported
|
|
Balances Without Adoption of
ASU 2014-09
|
|
Effect of Change Higher/(Lower)
|
||||||||||||
|
Net revenues
|
|
$
|
8,236
|
|
|
$
|
8,270
|
|
|
$
|
(34
|
)
|
|
$
|
24,448
|
|
|
$
|
24,452
|
|
|
$
|
(4
|
)
|
|
Cost of products sold
|
|
1,835
|
|
|
1,851
|
|
|
(16
|
)
|
|
5,696
|
|
|
5,696
|
|
|
—
|
|
||||||
|
Income tax expense
|
|
14
|
|
|
16
|
|
|
(2
|
)
|
|
57
|
|
|
52
|
|
|
5
|
|
||||||
|
Net earnings
|
|
2,747
|
|
|
2,763
|
|
|
(16
|
)
|
|
7,513
|
|
|
7,522
|
|
|
(9
|
)
|
||||||
|
Diluted earnings per share
|
|
$
|
1.81
|
|
|
$
|
1.82
|
|
|
$
|
(0.01
|
)
|
|
$
|
4.79
|
|
|
$
|
4.80
|
|
|
$
|
(0.01
|
)
|
|
2018 Form 10-Q
|
|
7
|
|
|
|
2018 Form 10-Q
|
|
8
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Interest expense
|
|
$
|
339
|
|
|
$
|
293
|
|
|
$
|
968
|
|
|
$
|
851
|
|
|
Interest income
|
|
(37
|
)
|
|
(41
|
)
|
|
(143
|
)
|
|
(99
|
)
|
||||
|
Interest expense, net
|
|
$
|
302
|
|
|
$
|
252
|
|
|
$
|
825
|
|
|
$
|
752
|
|
|
(in millions)
|
September 30, 2018
|
|
December 31, 2017
|
||||
|
Finished goods
|
$
|
522
|
|
|
$
|
610
|
|
|
Work-in-process
|
1,054
|
|
|
822
|
|
||
|
Raw materials
|
210
|
|
|
173
|
|
||
|
Inventories
|
$
|
1,786
|
|
|
$
|
1,605
|
|
|
(in millions)
|
September 30, 2018
|
|
December 31, 2017
|
||||
|
Property and equipment, gross
|
$
|
8,449
|
|
|
$
|
8,071
|
|
|
Accumulated depreciation
|
(5,499
|
)
|
|
(5,268
|
)
|
||
|
Property and equipment, net
|
$
|
2,950
|
|
|
$
|
2,803
|
|
|
|
|
2018 Form 10-Q
|
|
9
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions, except per share data)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Basic EPS
|
|
|
|
|
|
|
|
|
||||||||
|
Net earnings
|
|
$
|
2,747
|
|
|
$
|
1,631
|
|
|
$
|
7,513
|
|
|
$
|
5,257
|
|
|
Earnings allocated to participating securities
|
|
12
|
|
|
8
|
|
|
34
|
|
|
26
|
|
||||
|
Earnings available to common shareholders
|
|
$
|
2,735
|
|
|
$
|
1,623
|
|
|
$
|
7,479
|
|
|
$
|
5,231
|
|
|
Weighted-average basic shares outstanding
|
|
1,511
|
|
|
1,597
|
|
|
1,556
|
|
|
1,596
|
|
||||
|
Basic earnings per share
|
|
$
|
1.81
|
|
|
$
|
1.02
|
|
|
$
|
4.81
|
|
|
$
|
3.28
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Diluted EPS
|
|
|
|
|
|
|
|
|
||||||||
|
Net earnings
|
|
$
|
2,747
|
|
|
$
|
1,631
|
|
|
$
|
7,513
|
|
|
$
|
5,257
|
|
|
Earnings allocated to participating securities
|
|
12
|
|
|
8
|
|
|
34
|
|
|
26
|
|
||||
|
Earnings available to common shareholders
|
|
$
|
2,735
|
|
|
$
|
1,623
|
|
|
$
|
7,479
|
|
|
$
|
5,231
|
|
|
Weighted-average shares of common stock outstanding
|
|
1,511
|
|
|
1,597
|
|
|
1,556
|
|
|
1,596
|
|
||||
|
Effect of dilutive securities
|
|
4
|
|
|
6
|
|
|
5
|
|
|
6
|
|
||||
|
Weighted-average diluted shares outstanding
|
|
1,515
|
|
|
1,603
|
|
|
1,561
|
|
|
1,602
|
|
||||
|
Diluted earnings per share
|
|
$
|
1.81
|
|
|
$
|
1.01
|
|
|
$
|
4.79
|
|
|
$
|
3.27
|
|
|
|
|
2018 Form 10-Q
|
|
10
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
United States - Janssen's share of profits (included in cost of products sold)
|
|
$
|
377
|
|
|
$
|
268
|
|
|
$
|
978
|
|
|
$
|
727
|
|
|
International - AbbVie's share of profits (included in net revenues)
|
|
160
|
|
|
114
|
|
|
455
|
|
|
306
|
|
||||
|
Global - AbbVie's share of other costs (included in respective line items)
|
|
81
|
|
|
75
|
|
|
232
|
|
|
209
|
|
||||
|
|
|
(in millions)
|
|
||
|
Balance as of December 31, 2017
|
$
|
15,785
|
|
|
Foreign currency translation adjustments
|
(67
|
)
|
|
|
Balance as of September 30, 2018
|
$
|
15,718
|
|
|
2018 Form 10-Q
|
|
11
|
|
|
September 30, 2018
|
|
December 31, 2017
|
||||||||||||||||||||
|
(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
|
$
|
15,877
|
|
|
$
|
(5,394
|
)
|
|
$
|
10,483
|
|
|
$
|
16,138
|
|
|
$
|
(4,982
|
)
|
|
$
|
11,156
|
|
|
License agreements
|
7,865
|
|
|
(1,713
|
)
|
|
6,152
|
|
|
7,822
|
|
|
(1,409
|
)
|
|
6,413
|
|
||||||
|
Total definite-lived intangible assets
|
23,742
|
|
|
(7,107
|
)
|
|
16,635
|
|
|
23,960
|
|
|
(6,391
|
)
|
|
17,569
|
|
||||||
|
Indefinite-lived research and development
|
9,990
|
|
|
—
|
|
|
9,990
|
|
|
9,990
|
|
|
—
|
|
|
9,990
|
|
||||||
|
Total intangible assets, net
|
$
|
33,732
|
|
|
$
|
(7,107
|
)
|
|
$
|
26,625
|
|
|
$
|
33,950
|
|
|
$
|
(6,391
|
)
|
|
$
|
27,559
|
|
|
|
|
(in millions)
|
|
||
|
Accrued balance as of December 31, 2017
|
$
|
86
|
|
|
Restructuring charges
|
34
|
|
|
|
Payments and other adjustments
|
(33
|
)
|
|
|
Accrued balance as of September 30, 2018
|
$
|
87
|
|
|
|
|
2018 Form 10-Q
|
|
12
|
|
|
Fair value –
Derivatives in asset position |
|
Fair value –
Derivatives in liability position |
||||||||||||
|
(in millions)
|
Balance sheet caption
|
September 30,
2018 |
December 31, 2017
|
|
Balance sheet caption
|
September 30,
2018 |
December 31, 2017
|
||||||||
|
Foreign currency forward exchange contracts
|
|
|
|
|
|
|
|
||||||||
|
Designated as cash flow hedges
|
Prepaid expenses and
other
|
$
|
95
|
|
$
|
1
|
|
|
Accounts payable and accrued liabilities
|
$
|
2
|
|
$
|
120
|
|
|
Designated as cash flow hedges
|
Other assets
|
3
|
|
—
|
|
|
Other long-term liabilities
|
—
|
|
—
|
|
||||
|
Not designated as hedges
|
Prepaid expenses and
other
|
17
|
|
22
|
|
|
Accounts payable and accrued liabilities
|
14
|
|
29
|
|
||||
|
Interest rate swaps designated as fair value hedges
|
Prepaid expenses and other
|
—
|
|
—
|
|
|
Accounts payable and accrued liabilities
|
7
|
|
8
|
|
||||
|
Interest rate swaps designated as fair value hedges
|
Other assets
|
—
|
|
—
|
|
|
Other long-term liabilities
|
700
|
|
393
|
|
||||
|
Total derivatives
|
|
$
|
115
|
|
$
|
23
|
|
|
|
$
|
723
|
|
$
|
550
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Foreign currency forward exchange contracts
|
|
$
|
1
|
|
|
$
|
(114
|
)
|
|
$
|
122
|
|
|
$
|
(253
|
)
|
|
2018 Form 10-Q
|
|
13
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
Statement of earnings caption
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Foreign currency forward exchange contracts
|
|
|
|
|
|
|
|
|
|
||||||||
|
Designated as cash flow hedges
|
Cost of products sold
|
|
$
|
(54
|
)
|
|
$
|
38
|
|
|
$
|
(144
|
)
|
|
$
|
101
|
|
|
Not designated as hedges
|
Net foreign exchange loss
|
|
22
|
|
|
(17
|
)
|
|
91
|
|
|
(88
|
)
|
||||
|
Interest rate swaps designated as fair value hedges
|
Interest expense, net
|
|
(63
|
)
|
|
11
|
|
|
(306
|
)
|
|
43
|
|
||||
|
Debt designated as hedged item in fair value hedges
|
Interest expense, net
|
|
63
|
|
|
(11
|
)
|
|
306
|
|
|
(43
|
)
|
||||
|
•
|
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.
|
|
|
|
|
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
|
$
|
8,015
|
|
|
$
|
653
|
|
|
$
|
7,362
|
|
|
$
|
—
|
|
|
Time deposits
|
559
|
|
|
—
|
|
|
559
|
|
|
—
|
|
||||
|
Debt securities
|
1,591
|
|
|
—
|
|
|
1,591
|
|
|
—
|
|
||||
|
Equity securities
|
5
|
|
|
5
|
|
|
—
|
|
|
—
|
|
||||
|
Foreign currency contracts
|
115
|
|
|
—
|
|
|
115
|
|
|
—
|
|
||||
|
Total assets
|
$
|
10,285
|
|
|
$
|
658
|
|
|
$
|
9,627
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
|
Interest rate hedges
|
$
|
707
|
|
|
$
|
—
|
|
|
$
|
707
|
|
|
$
|
—
|
|
|
Foreign currency contracts
|
16
|
|
|
—
|
|
|
16
|
|
|
—
|
|
||||
|
Contingent consideration
|
4,866
|
|
|
—
|
|
|
—
|
|
|
4,866
|
|
||||
|
Total liabilities
|
$
|
5,589
|
|
|
$
|
—
|
|
|
$
|
723
|
|
|
$
|
4,866
|
|
|
2018 Form 10-Q
|
|
14
|
|
|
|
|
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
|
$
|
9,303
|
|
|
$
|
849
|
|
|
$
|
8,454
|
|
|
$
|
—
|
|
|
Debt securities
|
2,524
|
|
|
—
|
|
|
2,524
|
|
|
—
|
|
||||
|
Equity securities
|
4
|
|
|
4
|
|
|
—
|
|
|
—
|
|
||||
|
Foreign currency contracts
|
23
|
|
|
—
|
|
|
23
|
|
|
—
|
|
||||
|
Total assets
|
$
|
11,854
|
|
|
$
|
853
|
|
|
$
|
11,001
|
|
|
$
|
—
|
|
|
Liabilities
|
|
|
|
|
|
|
|
||||||||
|
Interest rate hedges
|
$
|
401
|
|
|
$
|
—
|
|
|
$
|
401
|
|
|
$
|
—
|
|
|
Foreign currency contracts
|
149
|
|
|
—
|
|
|
149
|
|
|
—
|
|
||||
|
Contingent consideration
|
4,534
|
|
|
—
|
|
|
—
|
|
|
4,534
|
|
||||
|
Total liabilities
|
$
|
5,084
|
|
|
$
|
—
|
|
|
$
|
550
|
|
|
$
|
4,534
|
|
|
|
|
Nine months ended
September 30, |
||||||
|
(in millions)
|
|
2018
|
|
2017
|
||||
|
Beginning balance
|
|
$
|
4,534
|
|
|
$
|
4,213
|
|
|
Change in fair value recognized in net earnings
|
|
432
|
|
|
547
|
|
||
|
Milestone payments
|
|
(100
|
)
|
|
(305
|
)
|
||
|
Ending balance
|
|
$
|
4,866
|
|
|
$
|
4,455
|
|
|
2018 Form 10-Q
|
|
15
|
|
|
|
|
|
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) |
||||||||||
|
Liabilities
|
|
|
|
|
|
|
|
|
||||||||||
|
Short-term borrowings
|
$
|
3,002
|
|
$
|
3,002
|
|
|
$
|
—
|
|
|
$
|
3,002
|
|
|
$
|
—
|
|
|
Current portion of long-term debt and lease obligations, excluding fair value hedges
|
1,026
|
|
1,025
|
|
|
999
|
|
|
26
|
|
|
—
|
|
|||||
|
Long-term debt and lease obligations, excluding fair value hedges
|
37,187
|
|
36,392
|
|
|
36,320
|
|
|
72
|
|
|
—
|
|
|||||
|
Total liabilities
|
$
|
41,215
|
|
$
|
40,419
|
|
|
$
|
37,319
|
|
|
$
|
3,100
|
|
|
$
|
—
|
|
|
|
|
|
|
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
|
$
|
48
|
|
$
|
48
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
48
|
|
|
Total assets
|
$
|
48
|
|
$
|
48
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
48
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
||||||||||
|
Short-term borrowings
|
$
|
400
|
|
$
|
400
|
|
|
$
|
—
|
|
|
$
|
400
|
|
|
$
|
—
|
|
|
Current portion of long-term debt and lease obligations, excluding fair value hedges
|
6,023
|
|
6,034
|
|
|
4,004
|
|
|
2,030
|
|
|
—
|
|
|||||
|
Long-term debt and lease obligations, excluding fair value hedges
|
31,346
|
|
32,846
|
|
|
32,763
|
|
|
83
|
|
|
—
|
|
|||||
|
Total liabilities
|
$
|
37,769
|
|
$
|
39,280
|
|
|
$
|
36,767
|
|
|
$
|
2,513
|
|
|
$
|
—
|
|
|
2018 Form 10-Q
|
|
16
|
|
|
Amortized cost
|
|
Gross unrealized
|
|
Fair value
|
||||||||||
|
(in millions)
|
|
Gains
|
|
Losses
|
|
||||||||||
|
Asset backed securities
|
$
|
447
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
445
|
|
|
Corporate debt securities
|
1,050
|
|
|
3
|
|
|
(3
|
)
|
|
1,050
|
|
||||
|
Other debt securities
|
97
|
|
|
—
|
|
|
(1
|
)
|
|
96
|
|
||||
|
Total
|
$
|
1,594
|
|
|
$
|
3
|
|
|
$
|
(6
|
)
|
|
$
|
1,591
|
|
|
|
Amortized cost
|
|
Gross unrealized
|
|
Fair value
|
||||||||||
|
(in millions)
|
|
Gains
|
|
Losses
|
|
||||||||||
|
Asset backed securities
|
$
|
930
|
|
|
$
|
1
|
|
|
$
|
(3
|
)
|
|
$
|
928
|
|
|
Corporate debt securities
|
1,451
|
|
|
4
|
|
|
(2
|
)
|
|
1,453
|
|
||||
|
Other debt securities
|
144
|
|
|
—
|
|
|
(1
|
)
|
|
143
|
|
||||
|
Equity securities
|
4
|
|
|
2
|
|
|
(2
|
)
|
|
4
|
|
||||
|
Total
|
$
|
2,529
|
|
|
$
|
7
|
|
|
$
|
(8
|
)
|
|
$
|
2,528
|
|
|
2018 Form 10-Q
|
|
17
|
|
|
|
|
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)
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||||||||||
|
Service cost
|
$
|
70
|
|
|
$
|
59
|
|
|
$
|
214
|
|
|
$
|
176
|
|
|
$
|
7
|
|
|
$
|
6
|
|
|
$
|
20
|
|
|
$
|
19
|
|
|
Interest cost
|
57
|
|
|
52
|
|
|
171
|
|
|
153
|
|
|
6
|
|
|
6
|
|
|
18
|
|
|
18
|
|
||||||||
|
Expected return on plan assets
|
(109
|
)
|
|
(96
|
)
|
|
(330
|
)
|
|
(286
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
|
Amortization of actuarial losses and prior service costs
|
38
|
|
|
27
|
|
|
114
|
|
|
80
|
|
|
—
|
|
|
1
|
|
|
1
|
|
|
1
|
|
||||||||
|
Net periodic benefit cost
|
$
|
56
|
|
|
$
|
42
|
|
|
$
|
169
|
|
|
$
|
123
|
|
|
$
|
13
|
|
|
$
|
13
|
|
|
$
|
39
|
|
|
$
|
38
|
|
|
2018 Form 10-Q
|
|
18
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Cost of products sold
|
|
$
|
7
|
|
|
$
|
7
|
|
|
$
|
23
|
|
|
$
|
20
|
|
|
Research and development
|
|
32
|
|
|
30
|
|
|
139
|
|
|
127
|
|
||||
|
Selling, general and administrative
|
|
36
|
|
|
34
|
|
|
189
|
|
|
141
|
|
||||
|
Pre-tax compensation expense
|
|
75
|
|
|
71
|
|
|
351
|
|
|
288
|
|
||||
|
Tax benefit
|
|
13
|
|
|
20
|
|
|
61
|
|
|
85
|
|
||||
|
After-tax compensation expense
|
|
$
|
62
|
|
|
$
|
51
|
|
|
$
|
290
|
|
|
$
|
203
|
|
|
2018
|
|
2017
|
||||||||||||
|
Date Declared
|
|
Payment Date
|
|
Dividend Per Share
|
|
Date Declared
|
|
Payment Date
|
|
Dividend Per Share
|
||||
|
11/02/18
|
|
02/15/19
|
|
$
|
1.07
|
|
|
10/27/17
|
|
02/15/18
|
|
$
|
0.71
|
|
|
09/07/18
|
|
11/15/18
|
|
$
|
0.96
|
|
|
09/08/17
|
|
11/15/17
|
|
$
|
0.64
|
|
|
06/14/18
|
|
08/15/18
|
|
$
|
0.96
|
|
|
06/22/17
|
|
08/15/17
|
|
$
|
0.64
|
|
|
02/15/18
|
|
05/15/18
|
|
$
|
0.96
|
|
|
02/16/17
|
|
05/15/17
|
|
$
|
0.64
|
|
|
2018 Form 10-Q
|
|
19
|
|
(in millions)
|
Foreign
currency translation adjustments |
|
Net investment hedging activities
|
|
Pension
and post-
employment benefits |
|
Marketable
security activities
|
|
Cash flow hedging
activities |
|
Total
|
||||||||||||
|
Balance as of December 31, 2017
|
$
|
(439
|
)
|
|
$
|
(203
|
)
|
|
$
|
(1,919
|
)
|
|
$
|
—
|
|
|
$
|
(166
|
)
|
|
$
|
(2,727
|
)
|
|
Other comprehensive income (loss) before reclassifications
|
(250
|
)
|
|
73
|
|
|
7
|
|
|
(6
|
)
|
|
110
|
|
|
(66
|
)
|
||||||
|
Net losses reclassified from accumulated other comprehensive loss
|
—
|
|
|
—
|
|
|
92
|
|
|
4
|
|
|
138
|
|
|
234
|
|
||||||
|
Net current-period other comprehensive income (loss)
|
(250
|
)
|
|
73
|
|
|
99
|
|
|
(2
|
)
|
|
248
|
|
|
168
|
|
||||||
|
Balance as of September 30, 2018
|
$
|
(689
|
)
|
|
$
|
(130
|
)
|
|
$
|
(1,820
|
)
|
|
$
|
(2
|
)
|
|
$
|
82
|
|
|
$
|
(2,559
|
)
|
|
(in millions)
|
Foreign
currency translation adjustments |
|
Net investment hedging activities
|
|
Pension
and post-
employment benefits |
|
Marketable
security activities
|
|
Cash flow hedging
activities |
|
Total
|
||||||||||||
|
Balance as of December 31, 2016
|
$
|
(1,435
|
)
|
|
$
|
140
|
|
|
$
|
(1,513
|
)
|
|
$
|
46
|
|
|
$
|
176
|
|
|
$
|
(2,586
|
)
|
|
Other comprehensive income (loss) before reclassifications
|
602
|
|
|
(307
|
)
|
|
(37
|
)
|
|
31
|
|
|
(229
|
)
|
|
60
|
|
||||||
|
Net losses (gains) reclassified from accumulated other comprehensive loss
|
—
|
|
|
—
|
|
|
58
|
|
|
(49
|
)
|
|
(96
|
)
|
|
(87
|
)
|
||||||
|
Net current-period other comprehensive income (loss)
|
602
|
|
|
(307
|
)
|
|
21
|
|
|
(18
|
)
|
|
(325
|
)
|
|
(27
|
)
|
||||||
|
Balance as of September 30, 2017
|
$
|
(833
|
)
|
|
$
|
(167
|
)
|
|
$
|
(1,492
|
)
|
|
$
|
28
|
|
|
$
|
(149
|
)
|
|
$
|
(2,613
|
)
|
|
2018 Form 10-Q
|
|
20
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions) (brackets denote gains)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Pension and post-employment benefits
|
|
|
|
|
|
|
|
|
||||||||
|
Amortization of actuarial losses and other
(a)
|
|
$
|
38
|
|
|
$
|
28
|
|
|
$
|
115
|
|
|
$
|
81
|
|
|
Tax benefit
|
|
(8
|
)
|
|
(8
|
)
|
|
(23
|
)
|
|
(23
|
)
|
||||
|
Total reclassifications, net of tax
|
|
$
|
30
|
|
|
$
|
20
|
|
|
$
|
92
|
|
|
$
|
58
|
|
|
Cash flow hedging activities
|
|
|
|
|
|
|
|
|
||||||||
|
Losses (gains) on designated cash flow hedges
(b)
|
|
$
|
54
|
|
|
$
|
(38
|
)
|
|
$
|
144
|
|
|
$
|
(101
|
)
|
|
Tax expense (benefit)
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
5
|
|
||||
|
Total reclassifications, net of tax
|
|
$
|
54
|
|
|
$
|
(38
|
)
|
|
$
|
138
|
|
|
$
|
(96
|
)
|
|
|
|
2018 Form 10-Q
|
|
21
|
|
|
|
2018 Form 10-Q
|
|
22
|
|
2018 Form 10-Q
|
|
23
|
|
2018 Form 10-Q
|
|
24
|
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
|
|
|
||||||||||||||
|
(in millions)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Immunology
|
|
|
|
|
|
|
|
|
||||||||
|
HUMIRA
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
3,546
|
|
|
$
|
3,151
|
|
|
$
|
10,070
|
|
|
$
|
9,048
|
|
|
International
|
|
1,578
|
|
|
1,550
|
|
|
4,948
|
|
|
4,487
|
|
||||
|
Total
|
|
$
|
5,124
|
|
|
$
|
4,701
|
|
|
$
|
15,018
|
|
|
$
|
13,535
|
|
|
Hematologic Oncology
|
|
|
|
|
|
|
|
|
||||||||
|
IMBRUVICA
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
812
|
|
|
$
|
574
|
|
|
$
|
2,129
|
|
|
$
|
1,559
|
|
|
Collaboration revenues
|
|
160
|
|
|
114
|
|
|
455
|
|
|
306
|
|
||||
|
Total
|
|
$
|
972
|
|
|
$
|
688
|
|
|
$
|
2,584
|
|
|
$
|
1,865
|
|
|
VENCLEXTA
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
69
|
|
|
$
|
25
|
|
|
$
|
157
|
|
|
$
|
60
|
|
|
International
|
|
27
|
|
|
8
|
|
|
63
|
|
|
18
|
|
||||
|
Total
|
|
$
|
96
|
|
|
$
|
33
|
|
|
$
|
220
|
|
|
$
|
78
|
|
|
HCV
|
|
|
|
|
|
|
|
|
||||||||
|
MAVYRET
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
444
|
|
|
$
|
60
|
|
|
$
|
1,206
|
|
|
$
|
60
|
|
|
International
|
|
395
|
|
|
35
|
|
|
1,413
|
|
|
35
|
|
||||
|
Total
|
|
$
|
839
|
|
|
$
|
95
|
|
|
$
|
2,619
|
|
|
$
|
95
|
|
|
VIEKIRA
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
3
|
|
|
$
|
64
|
|
|
International
|
|
23
|
|
|
181
|
|
|
132
|
|
|
605
|
|
||||
|
Total
|
|
$
|
23
|
|
|
$
|
181
|
|
|
$
|
135
|
|
|
$
|
669
|
|
|
Other Key Products
|
|
|
|
|
|
|
|
|
||||||||
|
Creon
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
239
|
|
|
$
|
215
|
|
|
$
|
667
|
|
|
$
|
596
|
|
|
Lupron
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
173
|
|
|
$
|
161
|
|
|
$
|
530
|
|
|
$
|
488
|
|
|
International
|
|
41
|
|
|
40
|
|
|
126
|
|
|
117
|
|
||||
|
Total
|
|
$
|
214
|
|
|
$
|
201
|
|
|
$
|
656
|
|
|
$
|
605
|
|
|
Synthroid
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
192
|
|
|
$
|
191
|
|
|
$
|
567
|
|
|
$
|
576
|
|
|
Synagis
|
|
|
|
|
|
|
|
|
||||||||
|
International
|
|
$
|
97
|
|
|
$
|
116
|
|
|
$
|
462
|
|
|
$
|
456
|
|
|
AndroGel
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
135
|
|
|
$
|
147
|
|
|
$
|
393
|
|
|
$
|
437
|
|
|
Duodopa
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
19
|
|
|
$
|
16
|
|
|
$
|
57
|
|
|
$
|
44
|
|
|
International
|
|
87
|
|
|
78
|
|
|
260
|
|
|
211
|
|
||||
|
Total
|
|
$
|
106
|
|
|
$
|
94
|
|
|
$
|
317
|
|
|
$
|
255
|
|
|
Sevoflurane
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
18
|
|
|
$
|
19
|
|
|
$
|
54
|
|
|
$
|
56
|
|
|
International
|
|
68
|
|
|
81
|
|
|
251
|
|
|
255
|
|
||||
|
Total
|
|
$
|
86
|
|
|
$
|
100
|
|
|
$
|
305
|
|
|
$
|
311
|
|
|
Kaletra
|
|
|
|
|
|
|
|
|
||||||||
|
United States
|
|
$
|
16
|
|
|
$
|
16
|
|
|
$
|
42
|
|
|
$
|
54
|
|
|
International
|
|
72
|
|
|
69
|
|
|
210
|
|
|
256
|
|
||||
|
Total
|
|
$
|
88
|
|
|
$
|
85
|
|
|
$
|
252
|
|
|
$
|
310
|
|
|
All other
|
|
$
|
25
|
|
|
$
|
148
|
|
|
$
|
253
|
|
|
$
|
689
|
|
|
Total net revenues
|
|
$
|
8,236
|
|
|
$
|
6,995
|
|
|
$
|
24,448
|
|
|
$
|
20,477
|
|
|
2018 Form 10-Q
|
|
25
|
|
|
|
2018 Form 10-Q
|
|
26
|
|
•
|
In January 2018, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designation for upadacitinib, an investigational oral JAK1-selective inhibitor, in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
|
|
•
|
In April 2018, AbbVie announced that top-line results from the Phase 3 SELECT-COMPARE clinical trial evaluating upadacitinib met all primary and ranked secondary endpoints in patients with moderate to severe rheumatoid arthritis (RA) who are on a stable background of methotrexate and who have an inadequate response. The safety profile of upadacitinib was consistent with previously reported clinical trials and no new safety signals were detected.
|
|
•
|
In June 2018, AbbVie announced that top-line results from the Phase 3 SELECT-EARLY clinical trial evaluating upadacitinib versus methotrexate in adult patients with moderate to severe RA who were methotrexate-naïve met all primary and ranked secondary endpoints. The safety profile of upadacitinib was consistent with previously reported clinical trials and no new safety signals were detected.
|
|
•
|
In July 2018, AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of upadacitinib in subjects with moderate to severe atopic dermatitis.
|
|
•
|
In September 2018, AbbVie initiated a Phase 3 clinical trial to evaluate the efficacy and safety of upadacitinib in subjects with moderate to severe ulcerative colitis.
|
|
•
|
In January 2018, AbbVie initiated two Phase 3 clinical trials to evaluate the efficacy and safety of risankizumab, an investigational interleukin-23 (IL-23) inhibitor, versus placebo during induction therapy in subjects with moderately to severely active Crohn’s disease.
|
|
•
|
In February 2018, AbbVie announced that top-line results from two Phase 3 clinical trials evaluating risankizumab with 12-week dosing compared to ustekinumab met ranked additional secondary endpoints for the treatment of patients with moderate to severe chronic plaque psoriasis. The initial results from these clinical trials were previously announced in October 2017. The safety profile was consistent with all previously reported studies, and there were no new safety signals detected across the two studies.
|
|
2018 Form 10-Q
|
|
27
|
|
•
|
In April 2018, AbbVie submitted a Biologics License Application (BLA) to the FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for risankizumab for the treatment of plaque psoriasis in adults.
|
|
•
|
In May 2018, AbbVie initiated a Phase 2b/3 clinical trial to evaluate the efficacy and safety of risankizumab versus placebo in subjects with moderately to severely active ulcerative colitis.
|
|
•
|
In April 2018, AbbVie initiated a Phase 3 clinical trial to evaluate the safety and efficacy of IMBRUVICA in combination with VENCLEXTA versus chlorambucil plus GAZYVA (obinutuzumab) for the first-line treatment of subjects with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
|
|
•
|
In May 2018, AbbVie announced that results from the Phase 3 iLLUMINATE study evaluating IMBRUVICA in combination with GAZYVA in previously untreated CLL/SLL met its primary endpoint.
|
|
•
|
In June 2018, AbbVie announced that results from an interim analysis of the Phase 3 iNNOVATE study evaluating IMBRUVICA plus Rituxan (rituximab) in previously untreated and relapsed/refractory (R/R) patients with Waldenström’s macroglobulinemia (WM) met its primary endpoint.
|
|
•
|
In July 2018, AbbVie announced that results from a Phase 3 study evaluating the addition of IMBRUVICA to a chemotherapy regimen consisting of five different agents used in combination did not meet its primary endpoint in a subset of untreated diffuse large B-cell lymphoma patients identified to have the non-germinal center B-cell or activated B-cell subtypes of this disease.
|
|
•
|
In August 2018, the FDA approved IMBRUVICA, in combination with Rituxan, for the treatment of adult patients with WM.
|
|
•
|
In October 2018, the FDA accepted for priority review AbbVie's supplemental New Drug Application (sNDA) for IMBRUVICA in combination with GAZYVA in patients with previously untreated CLL/SLL.
|
|
•
|
In January 2018, AbbVie submitted an sNDA to the FDA for VENCLEXTA monotherapy in patients with CLL who are refractory to or have relapsed B-cell receptor pathway inhibitors.
|
|
•
|
In June 2018, the FDA approved VENCLEXTA in combination with Rituxan for the treatment of patients with CLL/SLL, with or without 17p deletion, who have received at least one prior therapy. VENCLEXTA plus Rituxan is the first oral-based, chemotherapy-free combination in CLL that allows patients an option for fixed treatment duration.
|
|
•
|
In July 2018, AbbVie submitted an sNDA to the FDA for VENCLEXTA in combination with a hypomethylating agent or in combination with low dose cytarabine for treatment of newly diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy. In August, AbbVie was granted priority review for VENCLEXTA by the FDA.
|
|
•
|
In September 2018, the FDA expanded the label for VENCLEXTA in combination with Rituxan to include information about patients with previously-treated CLL who achieved minimal residual disease (MRD)-negativity in the Phase 3 MURANO trial.
|
|
•
|
In October 2018, the European Commission approved the type-II variation application for VENCLYXTO in combination with Rituxan for the treatment of patients with R/R CLL who have received at least one prior therapy.
|
|
•
|
In October 2018, AbbVie announced that the results from the Phase 3 CLL14 study comparing the efficacy and safety of VENCLEXTA plus obinutuzumab versus obinutuzumab plus chlorambucil in previously untreated patients with CLL and coexisting medical conditions met its primary endpoint.
|
|
2018 Form 10-Q
|
|
28
|
|
•
|
In March 2018, AbbVie announced top-line results from the Phase 2 TRINITY study evaluating rovalpituzumab tesirine (Rova-T) for third-line R/R small cell lung cancer (SCLC). Although Rova-T demonstrated single agent responses in advanced SCLC patients, after consulting with the FDA, based on the magnitude of effect across multiple parameters in this single-arm study, the company will not seek accelerated approval for Rova-T in third-line R/R SCLC. Ongoing Phase 3 studies will continue to investigate Rova-T in first- and second-line SCLC.
|
|
•
|
In August 2018, Bristol-Myers Squibb Company (BMS) announced that the FDA accepted for priority review its supplemental Biologics License Application (sBLA) for Empliciti (elotuzumab) in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior therapies. This submission followed the BMS announcement in June 2018 that results from the Phase 2 ELOQUENT-3 study evaluating the combination of Empliciti with pomalidomide/dexamethasone in RRMM patients met its primary endpoint. BMS and AbbVie are co-developing Empliciti, with BMS solely responsible for commercial activities.
|
|
•
|
In March 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of marketing authorizations for ZINBRYTA, a prescription medicine used to treat adults with relapsing forms of multiple sclerosis.
|
|
•
|
In February 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-I study evaluating elagolix, an investigational, orally administered gonadotropin-releasing hormone (GnRH) antagonist, being investigated in combination with low-dose hormone (add-back) therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints.
|
|
•
|
In March 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-II study evaluating elagolix in combination with low-dose hormone (add-back) therapy for uterine fibroids met its primary efficacy endpoint and all ranked secondary endpoints.
|
|
•
|
In July 2018, the FDA approved ORILISSA (elagolix) for the management of moderate to severe pain associated with endometriosis.
|
|
•
|
In August 2018, AbbVie announced that top-line results from the Phase 3 ELARIS UF-EXTEND study evaluating elagolix in combination with low-dose hormone therapy for uterine fibroids were consistent with findings observed in the ELARIS UF-I and ELARIS UF-II Phase 3 studies.
|
|
•
|
In October 2018, AbbVie announced that it will assume full development and commercial responsibility for its collaboration with Galapagos to discover and develop new therapies to treat cystic fibrosis (CF). Under a revised agreement, AbbVie will assume full development and commercial responsibility over the investigational program comprising several clinical and pre-clinical compounds originally discovered and developed jointly by AbbVie and Galapagos. Galapagos will not pursue further research and development in CF, but is eligible for future milestones and royalties on commercialized programs.
|
|
2018 Form 10-Q
|
|
29
|
|
|
|
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)
|
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||||||||
|
United States
|
|
$
|
5,597
|
|
|
$
|
4,586
|
|
|
22.0
|
%
|
|
22.0
|
%
|
|
$
|
15,836
|
|
|
$
|
13,284
|
|
|
19.2
|
%
|
|
19.2
|
%
|
|
International
|
|
2,639
|
|
|
2,409
|
|
|
9.6
|
%
|
|
11.7
|
%
|
|
8,612
|
|
|
7,193
|
|
|
19.7
|
%
|
|
15.3
|
%
|
||||
|
Net revenues
|
|
$
|
8,236
|
|
|
$
|
6,995
|
|
|
17.8
|
%
|
|
18.5
|
%
|
|
$
|
24,448
|
|
|
$
|
20,477
|
|
|
19.4
|
%
|
|
17.8
|
%
|
|
2018 Form 10-Q
|
|
30
|
|
|
|
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)
|
|
2018
|
|
2017
|
|
|
2018
|
|
2017
|
|
||||||||||||||||||
|
Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
HUMIRA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
3,546
|
|
|
$
|
3,151
|
|
|
12.5
|
%
|
|
12.5
|
%
|
|
$
|
10,070
|
|
|
$
|
9,048
|
|
|
11.3
|
%
|
|
11.3
|
%
|
|
International
|
|
1,578
|
|
|
1,550
|
|
|
1.8
|
%
|
|
4.2
|
%
|
|
4,948
|
|
|
4,487
|
|
|
10.3
|
%
|
|
5.9
|
%
|
||||
|
Total
|
|
$
|
5,124
|
|
|
$
|
4,701
|
|
|
9.0
|
%
|
|
9.8
|
%
|
|
$
|
15,018
|
|
|
$
|
13,535
|
|
|
11.0
|
%
|
|
9.5
|
%
|
|
Hematologic Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
IMBRUVICA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
812
|
|
|
$
|
574
|
|
|
41.5
|
%
|
|
41.5
|
%
|
|
$
|
2,129
|
|
|
$
|
1,559
|
|
|
36.6
|
%
|
|
36.6
|
%
|
|
Collaboration revenues
|
|
160
|
|
|
114
|
|
|
40.1
|
%
|
|
40.1
|
%
|
|
455
|
|
|
306
|
|
|
48.5
|
%
|
|
48.5
|
%
|
||||
|
Total
|
|
$
|
972
|
|
|
$
|
688
|
|
|
41.3
|
%
|
|
41.3
|
%
|
|
$
|
2,584
|
|
|
$
|
1,865
|
|
|
38.5
|
%
|
|
38.5
|
%
|
|
VENCLEXTA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
69
|
|
|
$
|
25
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
$
|
157
|
|
|
$
|
60
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
International
|
|
27
|
|
|
8
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
63
|
|
|
18
|
|
|
>100.0%
|
|
|
>100.0%
|
|
||||
|
Total
|
|
$
|
96
|
|
|
$
|
33
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
$
|
220
|
|
|
$
|
78
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
HCV
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
MAVYRET
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
444
|
|
|
$
|
60
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
$
|
1,206
|
|
|
$
|
60
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
International
|
|
395
|
|
|
35
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
1,413
|
|
|
35
|
|
|
>100.0%
|
|
|
>100.0%
|
|
||||
|
Total
|
|
$
|
839
|
|
|
$
|
95
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
$
|
2,619
|
|
|
$
|
95
|
|
|
>100.0%
|
|
|
>100.0%
|
|
|
VIEKIRA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
—
|
|
|
$
|
—
|
|
|
n/m
|
|
|
n/m
|
|
|
$
|
3
|
|
|
$
|
64
|
|
|
(96.3
|
)%
|
|
(96.3
|
)%
|
|
International
|
|
23
|
|
|
181
|
|
|
(87.0
|
)%
|
|
(86.1
|
)%
|
|
132
|
|
|
605
|
|
|
(78.1
|
)%
|
|
(78.9
|
)%
|
||||
|
Total
|
|
$
|
23
|
|
|
$
|
181
|
|
|
(87.1
|
)%
|
|
(86.2
|
)%
|
|
$
|
135
|
|
|
$
|
669
|
|
|
(79.8
|
)%
|
|
(80.6
|
)%
|
|
Other Key Products
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
Creon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
239
|
|
|
$
|
215
|
|
|
11.3
|
%
|
|
11.3
|
%
|
|
$
|
667
|
|
|
$
|
596
|
|
|
11.8
|
%
|
|
11.8
|
%
|
|
Lupron
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
173
|
|
|
$
|
161
|
|
|
7.6
|
%
|
|
7.6
|
%
|
|
$
|
530
|
|
|
$
|
488
|
|
|
8.7
|
%
|
|
8.7
|
%
|
|
International
|
|
41
|
|
|
40
|
|
|
1.5
|
%
|
|
7.2
|
%
|
|
126
|
|
|
117
|
|
|
7.4
|
%
|
|
6.9
|
%
|
||||
|
Total
|
|
$
|
214
|
|
|
$
|
201
|
|
|
6.4
|
%
|
|
7.5
|
%
|
|
$
|
656
|
|
|
$
|
605
|
|
|
8.4
|
%
|
|
8.3
|
%
|
|
Synthroid
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
192
|
|
|
$
|
191
|
|
|
0.7
|
%
|
|
0.7
|
%
|
|
$
|
567
|
|
|
$
|
576
|
|
|
(1.5
|
)%
|
|
(1.5
|
)%
|
|
Synagis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
International
|
|
$
|
97
|
|
|
$
|
116
|
|
|
(16.2
|
)%
|
|
(14.1
|
)%
|
|
$
|
462
|
|
|
$
|
456
|
|
|
1.3
|
%
|
|
(2.2
|
)%
|
|
AndroGel
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
135
|
|
|
$
|
147
|
|
|
(8.3
|
)%
|
|
(8.3
|
)%
|
|
$
|
393
|
|
|
$
|
437
|
|
|
(10.1
|
)%
|
|
(10.1
|
)%
|
|
Duodopa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
19
|
|
|
$
|
16
|
|
|
18.7
|
%
|
|
18.7
|
%
|
|
$
|
57
|
|
|
$
|
44
|
|
|
30.0
|
%
|
|
30.0
|
%
|
|
International
|
|
87
|
|
|
78
|
|
|
10.8
|
%
|
|
12.2
|
%
|
|
260
|
|
|
211
|
|
|
22.8
|
%
|
|
15.6
|
%
|
||||
|
Total
|
|
$
|
106
|
|
|
$
|
94
|
|
|
12.1
|
%
|
|
13.3
|
%
|
|
$
|
317
|
|
|
$
|
255
|
|
|
24.0
|
%
|
|
18.1
|
%
|
|
Sevoflurane
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
18
|
|
|
$
|
19
|
|
|
(2.8
|
)%
|
|
(2.8
|
)%
|
|
$
|
54
|
|
|
$
|
56
|
|
|
(2.8
|
)%
|
|
(2.8
|
)%
|
|
International
|
|
68
|
|
|
81
|
|
|
(15.7
|
)%
|
|
(12.2
|
)%
|
|
251
|
|
|
255
|
|
|
(1.5
|
)%
|
|
(2.8
|
)%
|
||||
|
Total
|
|
$
|
86
|
|
|
$
|
100
|
|
|
(13.2
|
)%
|
|
(10.4
|
)%
|
|
$
|
305
|
|
|
$
|
311
|
|
|
(1.7
|
)%
|
|
(2.7
|
)%
|
|
Kaletra
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
|
United States
|
|
$
|
16
|
|
|
$
|
16
|
|
|
(2.9
|
)%
|
|
(2.9
|
)%
|
|
$
|
42
|
|
|
$
|
54
|
|
|
(21.4
|
)%
|
|
(21.4
|
)%
|
|
International
|
|
72
|
|
|
69
|
|
|
5.3
|
%
|
|
8.2
|
%
|
|
210
|
|
|
256
|
|
|
(18.1
|
)%
|
|
(19.0
|
)%
|
||||
|
Total
|
|
$
|
88
|
|
|
$
|
85
|
|
|
3.7
|
%
|
|
6.0
|
%
|
|
$
|
252
|
|
|
$
|
310
|
|
|
(18.7
|
)%
|
|
(19.5
|
)%
|
|
All other
|
|
$
|
25
|
|
|
$
|
148
|
|
|
(82.7
|
)%
|
|
(82.0
|
)%
|
|
$
|
253
|
|
|
$
|
689
|
|
|
(63.1
|
)%
|
|
(73.8
|
)%
|
|
Total net revenues
|
|
$
|
8,236
|
|
|
$
|
6,995
|
|
|
17.8
|
%
|
|
18.5
|
%
|
|
$
|
24,448
|
|
|
$
|
20,477
|
|
|
19.4
|
%
|
|
17.8
|
%
|
|
2018 Form 10-Q
|
|
31
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||||||||
|
(dollars in millions)
|
|
2018
|
|
2017
|
|
% change
|
|
2018
|
|
2017
|
|
% change
|
||||||||||
|
Gross margin
|
|
$
|
6,401
|
|
|
$
|
5,379
|
|
|
19
|
%
|
|
$
|
18,752
|
|
|
$
|
15,716
|
|
|
19
|
%
|
|
as a % of net revenues
|
|
78
|
%
|
|
77
|
%
|
|
|
|
77
|
%
|
|
77
|
%
|
|
|
||||||
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||||||||
|
(dollars in millions)
|
|
2018
|
|
2017
|
|
% change
|
|
2018
|
|
2017
|
|
% change
|
||||||||||
|
Selling, general and administrative
|
|
$
|
1,919
|
|
|
$
|
1,457
|
|
|
32
|
%
|
|
$
|
5,470
|
|
|
$
|
4,339
|
|
|
26
|
%
|
|
as a % of net revenues
|
|
23
|
%
|
|
21
|
%
|
|
|
|
22
|
%
|
|
21
|
%
|
|
|
||||||
|
2018 Form 10-Q
|
|
32
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||||||||
|
(dollars in millions)
|
|
2018
|
|
2017
|
|
% change
|
|
2018
|
|
2017
|
|
% change
|
||||||||||
|
Research and development
|
|
$
|
1,268
|
|
|
$
|
1,228
|
|
|
3
|
%
|
|
$
|
3,834
|
|
|
$
|
3,599
|
|
|
7
|
%
|
|
as a % of net revenues
|
|
15
|
%
|
|
18
|
%
|
|
|
|
16
|
%
|
|
18
|
%
|
|
|
||||||
|
Acquired in-process research and development
|
|
$
|
55
|
|
|
$
|
—
|
|
|
n/m
|
|
|
$
|
124
|
|
|
$
|
15
|
|
|
>100%
|
|
|
|
|
Three months ended
September 30, |
|
Nine months ended
September 30, |
||||||||||||
|
(in millions)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
|
Interest expense
|
|
$
|
339
|
|
|
$
|
293
|
|
|
$
|
968
|
|
|
$
|
851
|
|
|
Interest income
|
|
(37
|
)
|
|
(41
|
)
|
|
(143
|
)
|
|
(99
|
)
|
||||
|
Interest expense, net
|
|
$
|
302
|
|
|
$
|
252
|
|
|
$
|
825
|
|
|
$
|
752
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Net foreign exchange loss
|
|
$
|
2
|
|
|
$
|
9
|
|
|
$
|
18
|
|
|
$
|
28
|
|
|
Other expense, net
|
|
94
|
|
|
338
|
|
|
411
|
|
|
449
|
|
||||
|
2018 Form 10-Q
|
|
33
|
|
|
Nine months ended
September 30, |
||||||
|
(in millions)
|
2018
|
|
2017
|
||||
|
Cash flows provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
10,035
|
|
|
$
|
7,376
|
|
|
Investing activities
|
(723
|
)
|
|
(475
|
)
|
||
|
Financing activities
|
(10,571
|
)
|
|
(3,584
|
)
|
||
|
2018 Form 10-Q
|
|
34
|
|
2018 Form 10-Q
|
|
35
|
|
|
|
2018 Form 10-Q
|
|
36
|
|
|
|
2018 Form 10-Q
|
|
37
|
|
|
|
|
|
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, 2018 – July 31, 2018
|
1,157
|
|
(1)
|
$96.23
|
(1)
|
—
|
|
|
$2,500,000,000
|
|
|
August 1, 2018 – August 31, 2018
|
10,392,841
|
|
(1)
|
$96.23
|
(1)
|
10,391,816
|
|
|
$1,500,000,050
|
|
|
September 1, 2018 – September 30, 2018
|
1,145
|
|
(1)
|
$93.73
|
(1)
|
—
|
|
|
$1,500,000,050
|
|
|
Total
|
10,395,143
|
|
(1)
|
$96.23
|
(1)
|
10,391,816
|
|
|
$1,500,000,050
|
|
|
1.
|
In addition to AbbVie shares repurchased on the open market under a publicly announced program, if any, these shares also included the shares purchased on the open market for the benefit of participants in the AbbVie Employee Stock Purchase Plan – 1,157 in July; 1,025 in August; and 1,145 in September.
|
|
2018 Form 10-Q
|
|
38
|
|
|
|
Exhibit No.
|
|
Exhibit Description
|
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
|
||
|
|
|
|
|
101
|
|
The following financial statements and notes from the AbbVie Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, filed on November 7, 2018, formatted in XBRL: (i) Condensed Consolidated Statements of Earnings; (ii) Condensed Consolidated Statements of Comprehensive Income; (iii) Condensed Consolidated Balance Sheets; (iv) Condensed Consolidated Statements of Cash Flows; and (v) the Notes to Condensed Consolidated Financial Statements.
|
|
2018 Form 10-Q
|
|
39
|
|
|
|
ABBVIE INC.
|
|
|
|
|
|
|
|
|
|
|
By:
|
/s/ Robert A. Michael
|
|
|
|
Robert A. Michael
|
|
|
|
Senior Vice President,
|
|
|
|
Chief Financial Officer
|
|
2018 Form 10-Q
|
|
40
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
Customers
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|