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|
|
x
|
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2017
|
|
¨
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO
|
|
|
|
|
Delaware
|
|
22-0790350
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
|
|
|
|
|
|
PART I—FINANCIAL INFORMATION
|
|
|
|
Item 1.
|
|
|
|
|
|
Item 2.
|
|
|
|
Item 3.
|
|
|
|
Item 4.
|
|
|
|
PART II—OTHER INFORMATION
|
|
|
|
Item 1.
|
|
|
|
Item 1A.
|
|
|
|
Item 2.
|
|
|
|
Item 6.
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
EARNINGS
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net product sales
|
$
|
4,862
|
|
|
$
|
4,492
|
|
|
$
|
14,212
|
|
|
$
|
12,888
|
|
Alliance and other revenues
|
392
|
|
|
430
|
|
|
1,115
|
|
|
1,296
|
|
||||
Total Revenues
|
5,254
|
|
|
4,922
|
|
|
15,327
|
|
|
14,184
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Cost of products sold
|
1,572
|
|
|
1,305
|
|
|
4,393
|
|
|
3,563
|
|
||||
Marketing, selling and administrative
|
1,147
|
|
|
1,144
|
|
|
3,388
|
|
|
3,450
|
|
||||
Research and development
|
1,543
|
|
|
1,138
|
|
|
4,490
|
|
|
3,540
|
|
||||
Other (income)/expense
|
(191
|
)
|
|
(224
|
)
|
|
(1,377
|
)
|
|
(1,198
|
)
|
||||
Total Expenses
|
4,071
|
|
|
3,363
|
|
|
10,894
|
|
|
9,355
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Earnings Before Income Taxes
|
1,183
|
|
|
1,559
|
|
|
4,433
|
|
|
4,829
|
|
||||
Provision for Income Taxes
|
327
|
|
|
344
|
|
|
1,129
|
|
|
1,220
|
|
||||
Net Earnings
|
856
|
|
|
1,215
|
|
|
3,304
|
|
|
3,609
|
|
||||
Net Earnings/(Loss) Attributable to Noncontrolling Interest
|
11
|
|
|
13
|
|
|
(31
|
)
|
|
46
|
|
||||
Net Earnings Attributable to BMS
|
$
|
845
|
|
|
$
|
1,202
|
|
|
$
|
3,335
|
|
|
$
|
3,563
|
|
|
|
|
|
|
|
|
|
||||||||
Earnings per Common Share
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
0.52
|
|
|
$
|
0.72
|
|
|
$
|
2.02
|
|
|
$
|
2.13
|
|
Diluted
|
$
|
0.51
|
|
|
$
|
0.72
|
|
|
$
|
2.02
|
|
|
$
|
2.12
|
|
|
|
|
|
|
|
|
|
||||||||
Cash dividends declared per common share
|
$
|
0.39
|
|
|
$
|
0.38
|
|
|
$
|
1.17
|
|
|
$
|
1.14
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
COMPREHENSIVE INCOME
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net Earnings
|
$
|
856
|
|
|
$
|
1,215
|
|
|
$
|
3,304
|
|
|
$
|
3,609
|
|
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:
|
|
|
|
|
|
|
|
||||||||
Derivatives qualifying as cash flow hedges
|
(1
|
)
|
|
4
|
|
|
(61
|
)
|
|
(126
|
)
|
||||
Pension and postretirement benefits
|
18
|
|
|
72
|
|
|
74
|
|
|
(213
|
)
|
||||
Available-for-sale securities
|
22
|
|
|
(8
|
)
|
|
41
|
|
|
46
|
|
||||
Foreign currency translation
|
7
|
|
|
1
|
|
|
28
|
|
|
26
|
|
||||
Other Comprehensive Income/(Loss)
|
46
|
|
|
69
|
|
|
82
|
|
|
(267
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Comprehensive Income
|
902
|
|
|
1,284
|
|
|
3,386
|
|
|
3,342
|
|
||||
Comprehensive Income/(Loss) Attributable to Noncontrolling Interest
|
11
|
|
|
13
|
|
|
(31
|
)
|
|
46
|
|
||||
Comprehensive Income Attributable to BMS
|
$
|
891
|
|
|
$
|
1,271
|
|
|
$
|
3,417
|
|
|
$
|
3,296
|
|
ASSETS
|
September 30,
2017 |
|
December 31,
2016 |
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
4,644
|
|
|
$
|
4,237
|
|
Marketable securities
|
2,478
|
|
|
2,113
|
|
||
Receivables
|
5,922
|
|
|
5,543
|
|
||
Inventories
|
1,250
|
|
|
1,241
|
|
||
Prepaid expenses and other
|
754
|
|
|
570
|
|
||
Total Current Assets
|
15,048
|
|
|
13,704
|
|
||
Property, plant and equipment
|
5,014
|
|
|
4,980
|
|
||
Goodwill
|
6,865
|
|
|
6,875
|
|
||
Other intangible assets
|
1,213
|
|
|
1,385
|
|
||
Deferred income taxes
|
2,346
|
|
|
2,996
|
|
||
Marketable securities
|
2,526
|
|
|
2,719
|
|
||
Other assets
|
965
|
|
|
1,048
|
|
||
Total Assets
|
$
|
33,977
|
|
|
$
|
33,707
|
|
|
|
|
|
||||
LIABILITIES
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Short-term debt obligations
|
$
|
1,461
|
|
|
$
|
992
|
|
Accounts payable
|
1,699
|
|
|
1,664
|
|
||
Accrued liabilities
|
5,418
|
|
|
5,271
|
|
||
Deferred income
|
647
|
|
|
762
|
|
||
Income taxes payable
|
213
|
|
|
152
|
|
||
Total Current Liabilities
|
9,438
|
|
|
8,841
|
|
||
Deferred income
|
492
|
|
|
547
|
|
||
Income taxes payable
|
996
|
|
|
973
|
|
||
Pension and other liabilities
|
1,155
|
|
|
1,283
|
|
||
Long-term debt
|
6,982
|
|
|
5,716
|
|
||
Total Liabilities
|
19,063
|
|
|
17,360
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 17)
|
|
|
|
||||
|
|
|
|
||||
EQUITY
|
|
|
|
||||
Bristol-Myers Squibb Company Shareholders’ Equity:
|
|
|
|
||||
Preferred stock
|
—
|
|
|
—
|
|
||
Common stock
|
221
|
|
|
221
|
|
||
Capital in excess of par value of stock
|
1,845
|
|
|
1,725
|
|
||
Accumulated other comprehensive loss
|
(2,421
|
)
|
|
(2,503
|
)
|
||
Retained earnings
|
34,141
|
|
|
33,513
|
|
||
Less cost of treasury stock
|
(19,003
|
)
|
|
(16,779
|
)
|
||
Total Bristol-Myers Squibb Company Shareholders’ Equity
|
14,783
|
|
|
16,177
|
|
||
Noncontrolling interest
|
131
|
|
|
170
|
|
||
Total Equity
|
14,914
|
|
|
16,347
|
|
||
Total Liabilities and Equity
|
$
|
33,977
|
|
|
$
|
33,707
|
|
|
Nine Months Ended September 30,
|
||||||
|
2017
|
|
2016
|
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net earnings
|
$
|
3,304
|
|
|
$
|
3,609
|
|
Adjustments to reconcile net earnings to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization, net
|
592
|
|
|
260
|
|
||
Deferred income taxes
|
283
|
|
|
(500
|
)
|
||
Stock-based compensation
|
149
|
|
|
149
|
|
||
Impairment charges
|
223
|
|
|
75
|
|
||
Pension settlements and amortization
|
148
|
|
|
122
|
|
||
Divestiture gains and royalties
|
(546
|
)
|
|
(1,082
|
)
|
||
Asset acquisition charges
|
510
|
|
|
274
|
|
||
Other adjustments
|
108
|
|
|
(56
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Receivables
|
(539
|
)
|
|
(896
|
)
|
||
Inventories
|
7
|
|
|
(107
|
)
|
||
Accounts payable
|
63
|
|
|
(142
|
)
|
||
Deferred income
|
(91
|
)
|
|
445
|
|
||
Income taxes payable
|
400
|
|
|
(183
|
)
|
||
Other
|
(453
|
)
|
|
(353
|
)
|
||
Net Cash Provided by Operating Activities
|
4,158
|
|
|
1,615
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Sale and maturities of marketable securities
|
4,296
|
|
|
3,674
|
|
||
Purchase of marketable securities
|
(4,434
|
)
|
|
(2,248
|
)
|
||
Capital expenditures
|
(801
|
)
|
|
(844
|
)
|
||
Divestiture and other proceeds
|
526
|
|
|
1,193
|
|
||
Acquisition and other payments
|
(672
|
)
|
|
(311
|
)
|
||
Net Cash Provided by/(Used in) Investing Activities
|
(1,085
|
)
|
|
1,464
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Short-term debt obligations, net
|
1,198
|
|
|
102
|
|
||
Issuance of long-term debt
|
1,488
|
|
|
—
|
|
||
Repayment of long-term debt
|
(1,224
|
)
|
|
—
|
|
||
Repurchase of common stock
|
(2,220
|
)
|
|
(231
|
)
|
||
Dividends
|
(1,938
|
)
|
|
(1,912
|
)
|
||
Other
|
(29
|
)
|
|
(7
|
)
|
||
Net Cash Used in Financing Activities
|
(2,725
|
)
|
|
(2,048
|
)
|
||
Effect of Exchange Rates on Cash and Cash Equivalents
|
59
|
|
|
16
|
|
||
Increase in Cash and Cash Equivalents
|
407
|
|
|
1,047
|
|
||
Cash and Cash Equivalents at Beginning of Period
|
4,237
|
|
|
2,385
|
|
||
Cash and Cash Equivalents at End of Period
|
$
|
4,644
|
|
|
$
|
3,432
|
|
Accounting Standard Update
|
Effective Date
|
Recognition and Measurement of Financial Assets and Liabilities
|
January 1, 2018
|
Definition of a Business
|
January 1, 2018
|
Leases
|
January 1, 2019
|
Financial Instruments - Measurement of Credit Losses
|
January 1, 2020
|
Goodwill Impairment Testing
|
January 1, 2020
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Prioritized Brands
|
|
|
|
|
|
|
|
||||||||
Opdivo
|
$
|
1,265
|
|
|
$
|
920
|
|
|
$
|
3,587
|
|
|
$
|
2,464
|
|
Eliquis
|
1,232
|
|
|
884
|
|
|
3,509
|
|
|
2,395
|
|
||||
Orencia
|
632
|
|
|
572
|
|
|
1,817
|
|
|
1,640
|
|
||||
Sprycel
|
509
|
|
|
472
|
|
|
1,478
|
|
|
1,330
|
|
||||
Yervoy
|
323
|
|
|
285
|
|
|
975
|
|
|
789
|
|
||||
Empliciti
|
60
|
|
|
41
|
|
|
168
|
|
|
103
|
|
||||
Established Brands
|
|
|
|
|
|
|
|
||||||||
Hepatitis C Franchise
|
73
|
|
|
379
|
|
|
347
|
|
|
1,352
|
|
||||
Baraclude
|
264
|
|
|
306
|
|
|
819
|
|
|
896
|
|
||||
Sustiva Franchise
|
183
|
|
|
275
|
|
|
555
|
|
|
819
|
|
||||
Reyataz Franchise
|
174
|
|
|
238
|
|
|
555
|
|
|
706
|
|
||||
Other Brands
|
539
|
|
|
550
|
|
|
1,517
|
|
|
1,690
|
|
||||
Total Revenues
|
$
|
5,254
|
|
|
$
|
4,922
|
|
|
$
|
15,327
|
|
|
$
|
14,184
|
|
|
|
|
|
|
|
|
|
||||||||
Net product sales
|
$
|
4,862
|
|
|
$
|
4,492
|
|
|
$
|
14,212
|
|
|
$
|
12,888
|
|
Alliance revenues
|
334
|
|
|
402
|
|
|
957
|
|
|
1,229
|
|
||||
Other revenues
|
58
|
|
|
28
|
|
|
158
|
|
|
67
|
|
||||
Total Revenues
|
$
|
5,254
|
|
|
$
|
4,922
|
|
|
$
|
15,327
|
|
|
$
|
14,184
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Revenues from alliances:
|
|
|
|
|
|
|
|
||||||||
Net product sales
|
$
|
1,764
|
|
|
$
|
1,465
|
|
|
$
|
5,045
|
|
|
$
|
4,031
|
|
Alliance revenues
|
334
|
|
|
402
|
|
|
957
|
|
|
1,229
|
|
||||
Total Revenues
|
$
|
2,098
|
|
|
$
|
1,867
|
|
|
$
|
6,002
|
|
|
$
|
5,260
|
|
|
|
|
|
|
|
|
|
||||||||
Payments to/(from) alliance partners:
|
|
|
|
|
|
|
|
||||||||
Cost of products sold
|
$
|
678
|
|
|
$
|
572
|
|
|
$
|
1,969
|
|
|
$
|
1,543
|
|
Marketing, selling and administrative
|
(16
|
)
|
|
(3
|
)
|
|
(39
|
)
|
|
(10
|
)
|
||||
Research and development
|
(12
|
)
|
|
(7
|
)
|
|
(6
|
)
|
|
23
|
|
||||
Other (income)/expense
|
(151
|
)
|
|
(160
|
)
|
|
(545
|
)
|
|
(864
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Noncontrolling interest, pretax
|
4
|
|
|
3
|
|
|
9
|
|
|
13
|
|
Selected Alliance Balance Sheet information:
|
|
|
|
||||
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Receivables - from alliance partners
|
$
|
878
|
|
|
$
|
903
|
|
Accounts payable - to alliance partners
|
634
|
|
|
555
|
|
||
Deferred income from alliances
(a)
|
1,060
|
|
|
1,194
|
|
(a)
|
Includes unamortized upfront, milestone and other licensing proceeds, revenue deferrals attributed to
Atripla*
and undelivered elements of diabetes business divestiture proceeds. Amortization of deferred income (primarily related to alliances) was
$59 million
and
$193 million
for the
nine months ended September 30, 2017
and
2016
, respectively.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Interest expense
|
$
|
48
|
|
|
$
|
42
|
|
|
$
|
145
|
|
|
$
|
127
|
|
Investment income
|
(37
|
)
|
|
(32
|
)
|
|
(104
|
)
|
|
(81
|
)
|
||||
Provision for restructuring
|
28
|
|
|
19
|
|
|
207
|
|
|
41
|
|
||||
Litigation and other settlements
(a)
|
—
|
|
|
(1
|
)
|
|
(489
|
)
|
|
48
|
|
||||
Equity in net income of affiliates
|
(21
|
)
|
|
(19
|
)
|
|
(59
|
)
|
|
(65
|
)
|
||||
Divestiture (gains)/losses
|
1
|
|
|
(21
|
)
|
|
(126
|
)
|
|
(574
|
)
|
||||
Royalties and licensing income
(b)
|
(209
|
)
|
|
(158
|
)
|
|
(1,093
|
)
|
|
(579
|
)
|
||||
Transition and other service fees
|
(12
|
)
|
|
(57
|
)
|
|
(32
|
)
|
|
(184
|
)
|
||||
Pension charges
|
22
|
|
|
19
|
|
|
91
|
|
|
66
|
|
||||
Intangible asset impairments
|
—
|
|
|
—
|
|
|
—
|
|
|
15
|
|
||||
Equity investment impairment
|
—
|
|
|
—
|
|
|
—
|
|
|
45
|
|
||||
Loss on debt redemption
|
—
|
|
|
—
|
|
|
109
|
|
|
—
|
|
||||
Other
|
(11
|
)
|
|
(16
|
)
|
|
(26
|
)
|
|
(57
|
)
|
||||
Other (income)/expense
|
$
|
(191
|
)
|
|
$
|
(224
|
)
|
|
$
|
(1,377
|
)
|
|
$
|
(1,198
|
)
|
(a)
|
Includes BMS's share of a patent-infringement litigation settlement of
$481 million
related to Merck's PD-1 antibody
Keytruda*
in the
nine months ended September 30, 2017
.
|
(b)
|
Includes upfront licensing fees of
$470 million
from Biogen and Roche in the
nine months ended September 30, 2017
.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Employee termination costs
|
$
|
18
|
|
|
$
|
17
|
|
|
$
|
190
|
|
|
$
|
32
|
|
Other termination costs
|
10
|
|
|
2
|
|
|
17
|
|
|
9
|
|
||||
Provision for restructuring
|
28
|
|
|
19
|
|
|
207
|
|
|
41
|
|
||||
Accelerated depreciation
|
64
|
|
|
15
|
|
|
216
|
|
|
42
|
|
||||
Asset impairments
|
1
|
|
|
—
|
|
|
144
|
|
|
—
|
|
||||
Other shutdown costs
|
—
|
|
|
6
|
|
|
3
|
|
|
13
|
|
||||
Total charges
|
$
|
93
|
|
|
$
|
40
|
|
|
$
|
570
|
|
|
$
|
96
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Cost of products sold
|
$
|
1
|
|
|
$
|
7
|
|
|
$
|
131
|
|
|
$
|
15
|
|
Research and development
|
64
|
|
|
14
|
|
|
232
|
|
|
40
|
|
||||
Other (income)/expense
|
28
|
|
|
19
|
|
|
207
|
|
|
41
|
|
||||
Total charges
|
$
|
93
|
|
|
$
|
40
|
|
|
$
|
570
|
|
|
$
|
96
|
|
|
Nine Months Ended September 30,
|
||||||
Dollars in Millions
|
2017
|
|
2016
|
||||
Liability at January 1
|
$
|
114
|
|
|
$
|
125
|
|
Charges
|
233
|
|
|
48
|
|
||
Change in estimates
|
(26
|
)
|
|
(7
|
)
|
||
Provision for restructuring
|
207
|
|
|
41
|
|
||
Foreign currency translation
|
17
|
|
|
2
|
|
||
Spending
|
(179
|
)
|
|
(88
|
)
|
||
Liability at September 30
|
$
|
159
|
|
|
$
|
80
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Earnings Before Income Taxes
|
$
|
1,183
|
|
|
$
|
1,559
|
|
|
$
|
4,433
|
|
|
$
|
4,829
|
|
Provision for Income Taxes
|
327
|
|
|
344
|
|
|
1,129
|
|
|
1,220
|
|
||||
Effective Tax Rate
|
27.6
|
%
|
|
22.1
|
%
|
|
25.5
|
%
|
|
25.3
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Amounts in Millions, Except Per Share Data
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net Earnings Attributable to BMS used for Basic and Diluted EPS Calculation
|
$
|
845
|
|
|
$
|
1,202
|
|
|
$
|
3,335
|
|
|
$
|
3,563
|
|
|
|
|
|
|
|
|
|
||||||||
Weighted-average common shares outstanding – basic
|
1,639
|
|
|
1,671
|
|
|
1,648
|
|
|
1,670
|
|
||||
Incremental shares attributable to share-based compensation plans
|
6
|
|
|
8
|
|
|
7
|
|
|
9
|
|
||||
Weighted-average common shares outstanding – diluted
|
1,645
|
|
|
1,679
|
|
|
1,655
|
|
|
1,679
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Earnings per Common Share:
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
0.52
|
|
|
$
|
0.72
|
|
|
$
|
2.02
|
|
|
$
|
2.13
|
|
Diluted
|
$
|
0.51
|
|
|
$
|
0.72
|
|
|
$
|
2.02
|
|
|
$
|
2.12
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||||||
Dollars in Millions
|
Level 1
|
|
Level 2
|
|
Level 1
|
|
Level 2
|
||||||||
Cash and cash equivalents - Money market and other securities
|
$
|
—
|
|
|
$
|
3,915
|
|
|
$
|
—
|
|
|
$
|
3,532
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
Certificates of deposit
|
—
|
|
|
176
|
|
|
—
|
|
|
27
|
|
||||
Commercial paper
|
—
|
|
|
977
|
|
|
—
|
|
|
750
|
|
||||
Corporate debt securities
|
—
|
|
|
3,725
|
|
|
—
|
|
|
3,947
|
|
||||
Equity funds
|
—
|
|
|
119
|
|
|
—
|
|
|
101
|
|
||||
Fixed income funds
|
—
|
|
|
7
|
|
|
—
|
|
|
7
|
|
||||
Derivative assets
|
—
|
|
|
31
|
|
|
—
|
|
|
75
|
|
||||
Equity investments
|
90
|
|
|
—
|
|
|
24
|
|
|
—
|
|
||||
Derivative liabilities
|
—
|
|
|
(63
|
)
|
|
—
|
|
|
(30
|
)
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
Dollars in Millions
|
Amortized Cost
|
|
Gross Unrealized
|
|
|
|
Amortized Cost
|
|
Gross Unrealized
|
|
|
||||||||||||||||||||
|
Gains
|
|
Losses
|
|
Fair Value
|
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|||||||||||||||||||
Certificates of deposit
|
$
|
176
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
176
|
|
|
$
|
27
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
27
|
|
Commercial paper
|
977
|
|
|
—
|
|
|
—
|
|
|
977
|
|
|
750
|
|
|
—
|
|
|
—
|
|
|
750
|
|
||||||||
Corporate debt securities
|
3,713
|
|
|
15
|
|
|
(3
|
)
|
|
3,725
|
|
|
3,945
|
|
|
10
|
|
|
(8
|
)
|
|
3,947
|
|
||||||||
Equity investments
|
57
|
|
|
34
|
|
|
(1
|
)
|
|
90
|
|
|
31
|
|
|
—
|
|
|
(7
|
)
|
|
24
|
|
||||||||
|
$
|
4,923
|
|
|
$
|
49
|
|
|
$
|
(4
|
)
|
|
$
|
4,968
|
|
|
$
|
4,753
|
|
|
$
|
10
|
|
|
$
|
(15
|
)
|
|
$
|
4,748
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Financial assets measured using the fair value option
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Equity and fixed income funds
(a)
|
|
|
|
|
|
|
126
|
|
|
|
|
|
|
|
|
108
|
|
||||||||||||||
Total
|
|
|
|
|
|
|
$
|
5,094
|
|
|
|
|
|
|
|
|
$
|
4,856
|
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Current marketable securities
|
$
|
2,478
|
|
|
$
|
2,113
|
|
Non-current marketable securities
(b)
|
2,526
|
|
|
2,719
|
|
||
Other assets
(c)
|
90
|
|
|
24
|
|
||
Total
|
$
|
5,094
|
|
|
$
|
4,856
|
|
(a)
|
The fair value option for financial assets was elected for investments in equity and fixed income funds and are included in current marketable securities.
|
(b)
|
All non-current marketable securities mature within five years as of
September 30, 2017
and
December 31, 2016
.
|
(c)
|
Includes equity investments.
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
Asset
(a)
|
|
Liability
(b)
|
|
Asset
(a)
|
|
Liability
(b)
|
||||||||||||||||||||||||
Dollars in Millions
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
||||||||||||||||
Derivatives designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Interest rate swap contracts
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
755
|
|
|
$
|
(3
|
)
|
|
$
|
750
|
|
|
$
|
1
|
|
|
$
|
755
|
|
|
$
|
(3
|
)
|
Forward starting interest rate swap contracts
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
500
|
|
|
8
|
|
|
250
|
|
|
(11
|
)
|
||||||||
Foreign currency forward contracts
|
1,351
|
|
|
25
|
|
|
548
|
|
|
(28
|
)
|
|
967
|
|
|
66
|
|
|
198
|
|
|
(9
|
)
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Derivatives not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Foreign currency forward contracts
|
322
|
|
|
6
|
|
|
1,183
|
|
|
(32
|
)
|
|
106
|
|
|
—
|
|
|
360
|
|
|
(7
|
)
|
(a)
|
Included in prepaid expenses and other and other assets.
|
(b)
|
Included in accrued liabilities and pension and other liabilities.
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Commercial paper
|
$
|
799
|
|
|
$
|
—
|
|
Bank drafts and short-term borrowings
|
662
|
|
|
243
|
|
||
Current portion of long-term debt
|
—
|
|
|
749
|
|
||
Total
|
$
|
1,461
|
|
|
$
|
992
|
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Principal Value
|
$
|
6,834
|
|
|
$
|
6,261
|
|
Adjustments to Principal Value:
|
|
|
|
||||
Fair value of interest rate swap contracts
|
(3
|
)
|
|
(2
|
)
|
||
Unamortized basis adjustment from swap terminations
|
234
|
|
|
287
|
|
||
Unamortized bond discounts and issuance costs
|
(83
|
)
|
|
(81
|
)
|
||
Total
|
$
|
6,982
|
|
|
$
|
6,465
|
|
|
|
|
|
||||
Current portion of long-term debt
|
$
|
—
|
|
|
$
|
749
|
|
Long-term debt
|
6,982
|
|
|
5,716
|
|
Dollars in Millions
|
2017
|
||
Principal Value:
|
|
||
1.600% Notes due 2019
|
$
|
750
|
|
3.250% Notes due 2027
|
750
|
|
|
Total
|
$
|
1,500
|
|
|
|
||
Proceeds net of discount and deferred loan issuance costs
|
$
|
1,488
|
|
Dollars in Millions
|
2017
|
||
Principal amount
|
$
|
337
|
|
Carrying value
|
366
|
|
|
Debt redemption price
|
474
|
|
|
Loss on debt redemption
(a)
|
109
|
|
(a)
|
Including acceleration of debt issuance costs, gain on previously terminated interest rate swap contracts and other related fees.
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Trade receivables
|
$
|
4,564
|
|
|
$
|
3,948
|
|
Less charge-backs and cash discounts
|
(184
|
)
|
|
(126
|
)
|
||
Less bad debt allowances
|
(48
|
)
|
|
(48
|
)
|
||
Net trade receivables
|
4,332
|
|
|
3,774
|
|
||
Alliance receivables
|
878
|
|
|
903
|
|
||
Prepaid and refundable income taxes
|
334
|
|
|
627
|
|
||
Other
|
378
|
|
|
239
|
|
||
Receivables
|
$
|
5,922
|
|
|
$
|
5,543
|
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Finished goods
|
$
|
380
|
|
|
$
|
310
|
|
Work in process
|
956
|
|
|
988
|
|
||
Raw and packaging materials
|
224
|
|
|
264
|
|
||
Total inventories
|
$
|
1,560
|
|
|
$
|
1,562
|
|
|
|
|
|
||||
Inventories
|
$
|
1,250
|
|
|
$
|
1,241
|
|
Other assets
|
310
|
|
|
321
|
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Land
|
$
|
105
|
|
|
$
|
107
|
|
Buildings
|
5,188
|
|
|
4,930
|
|
||
Machinery, equipment and fixtures
|
3,034
|
|
|
3,287
|
|
||
Construction in progress
|
938
|
|
|
849
|
|
||
Gross property, plant and equipment
|
9,265
|
|
|
9,173
|
|
||
Less accumulated depreciation
|
(4,251
|
)
|
|
(4,193
|
)
|
||
Property, plant and equipment
|
$
|
5,014
|
|
|
$
|
4,980
|
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Licenses
|
$
|
564
|
|
|
$
|
564
|
|
Developed technology rights
|
2,357
|
|
|
2,357
|
|
||
Capitalized software
|
1,339
|
|
|
1,441
|
|
||
IPRD
|
32
|
|
|
107
|
|
||
Gross other intangible assets
|
4,292
|
|
|
4,469
|
|
||
Less accumulated amortization
|
(3,079
|
)
|
|
(3,084
|
)
|
||
Other intangible assets
|
$
|
1,213
|
|
|
$
|
1,385
|
|
Dollars in Millions
|
|
September 30,
2017 |
|
December 31,
2016 |
||||
Rebates and returns
|
|
$
|
1,901
|
|
|
$
|
1,680
|
|
Employee compensation and benefits
|
|
702
|
|
|
818
|
|
||
Research and development
|
|
689
|
|
|
718
|
|
||
Dividends
|
|
639
|
|
|
660
|
|
||
Branded Prescription Drug Fee
|
|
251
|
|
|
234
|
|
||
Royalties
|
|
249
|
|
|
246
|
|
||
Restructuring
|
|
121
|
|
|
90
|
|
||
Pension and postretirement benefits
|
|
41
|
|
|
44
|
|
||
Litigation and other settlements
|
|
35
|
|
|
43
|
|
||
Other
|
|
790
|
|
|
738
|
|
||
Accrued liabilities
|
|
$
|
5,418
|
|
|
$
|
5,271
|
|
|
Common Stock
|
|
Capital in Excess
of Par Value
of Stock
|
|
Accumulated Other Comprehensive Loss
|
|
Retained
Earnings
|
|
Treasury Stock
|
|
Noncontrolling
Interest
|
||||||||||||||||||
Dollars and Shares in Millions
|
Shares
|
|
Par Value
|
|
Shares
|
|
Cost
|
|
|||||||||||||||||||||
Balance at January 1, 2016
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,459
|
|
|
$
|
(2,468
|
)
|
|
$
|
31,613
|
|
|
539
|
|
|
$
|
(16,559
|
)
|
|
$
|
158
|
|
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,563
|
|
|
—
|
|
|
—
|
|
|
46
|
|
||||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(267
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Cash dividends declared
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,904
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock repurchase program
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4
|
|
|
(231
|
)
|
|
—
|
|
||||||
Stock compensation
|
—
|
|
|
—
|
|
|
191
|
|
|
—
|
|
|
—
|
|
|
(6
|
)
|
|
(5
|
)
|
|
—
|
|
||||||
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(36
|
)
|
||||||
Balance at September 30, 2016
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,650
|
|
|
$
|
(2,735
|
)
|
|
$
|
33,272
|
|
|
537
|
|
|
$
|
(16,795
|
)
|
|
$
|
168
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Balance at December 31, 2016
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,725
|
|
|
$
|
(2,503
|
)
|
|
$
|
33,513
|
|
|
536
|
|
|
$
|
(16,779
|
)
|
|
$
|
170
|
|
Accounting change - cumulative effect
(a)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(787
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Adjusted balance at January 1, 2017
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,725
|
|
|
$
|
(2,503
|
)
|
|
$
|
32,726
|
|
|
536
|
|
|
$
|
(16,779
|
)
|
|
$
|
170
|
|
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,335
|
|
|
—
|
|
|
—
|
|
|
28
|
|
||||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
82
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Cash dividends declared
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,920
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock repurchase program
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
40
|
|
|
(2,226
|
)
|
|
—
|
|
||||||
Stock compensation
|
—
|
|
|
—
|
|
|
120
|
|
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
2
|
|
|
—
|
|
||||||
Variable interest entity
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(59
|
)
|
||||||
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8
|
)
|
||||||
Balance at September 30, 2017
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,845
|
|
|
$
|
(2,421
|
)
|
|
$
|
34,141
|
|
|
571
|
|
|
$
|
(19,003
|
)
|
|
$
|
131
|
|
(a)
|
Refer to "—Note
1
. Basis of Presentation and Recently Issued Accounting Standards" for additional information.
|
|
2017
|
|
2016
|
||||||||||||||||||||
|
Pretax
|
|
Tax
|
|
After tax
|
|
Pretax
|
|
Tax
|
|
After tax
|
||||||||||||
Three Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Derivatives qualifying as cash flow hedges:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized losses
|
$
|
(28
|
)
|
|
$
|
12
|
|
|
$
|
(16
|
)
|
|
$
|
(14
|
)
|
|
$
|
4
|
|
|
$
|
(10
|
)
|
Reclassified to net earnings
(a)
|
21
|
|
|
(6
|
)
|
|
15
|
|
|
21
|
|
|
(7
|
)
|
|
14
|
|
||||||
Derivatives qualifying as cash flow hedges
|
(7
|
)
|
|
6
|
|
|
(1
|
)
|
|
7
|
|
|
(3
|
)
|
|
4
|
|
||||||
Pension and postretirement benefits:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Actuarial gains/(losses)
|
(5
|
)
|
|
2
|
|
|
(3
|
)
|
|
72
|
|
|
(26
|
)
|
|
46
|
|
||||||
Amortization
(b)
|
19
|
|
|
(11
|
)
|
|
8
|
|
|
20
|
|
|
(7
|
)
|
|
13
|
|
||||||
Curtailments and settlements
(c)
|
21
|
|
|
(8
|
)
|
|
13
|
|
|
19
|
|
|
(6
|
)
|
|
13
|
|
||||||
Pension and postretirement benefits
|
35
|
|
|
(17
|
)
|
|
18
|
|
|
111
|
|
|
(39
|
)
|
|
72
|
|
||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gains/(losses)
|
28
|
|
|
(5
|
)
|
|
23
|
|
|
(8
|
)
|
|
4
|
|
|
(4
|
)
|
||||||
Realized gains
(c)
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|
(4
|
)
|
|
—
|
|
|
(4
|
)
|
||||||
Available-for-sale securities
|
27
|
|
|
(5
|
)
|
|
22
|
|
|
(12
|
)
|
|
4
|
|
|
(8
|
)
|
||||||
Foreign currency translation
|
(10
|
)
|
|
17
|
|
|
7
|
|
|
(2
|
)
|
|
3
|
|
|
1
|
|
||||||
|
$
|
45
|
|
|
$
|
1
|
|
|
$
|
46
|
|
|
$
|
104
|
|
|
$
|
(35
|
)
|
|
$
|
69
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Nine Months Ended September 30,
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Derivatives qualifying as cash flow hedges:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized losses
|
$
|
(81
|
)
|
|
$
|
31
|
|
|
$
|
(50
|
)
|
|
$
|
(199
|
)
|
|
$
|
66
|
|
|
$
|
(133
|
)
|
Reclassified to net earnings
(a)
|
(11
|
)
|
|
—
|
|
|
(11
|
)
|
|
12
|
|
|
(5
|
)
|
|
7
|
|
||||||
Derivatives qualifying as cash flow hedges
|
(92
|
)
|
|
31
|
|
|
(61
|
)
|
|
(187
|
)
|
|
61
|
|
|
(126
|
)
|
||||||
Pension and postretirement benefits:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Actuarial losses
|
(40
|
)
|
|
17
|
|
|
(23
|
)
|
|
(453
|
)
|
|
160
|
|
|
(293
|
)
|
||||||
Amortization
(b)
|
57
|
|
|
(22
|
)
|
|
35
|
|
|
56
|
|
|
(19
|
)
|
|
37
|
|
||||||
Curtailments and settlements
(c)
|
96
|
|
|
(34
|
)
|
|
62
|
|
|
66
|
|
|
(23
|
)
|
|
43
|
|
||||||
Pension and postretirement benefits
|
113
|
|
|
(39
|
)
|
|
74
|
|
|
(331
|
)
|
|
118
|
|
|
(213
|
)
|
||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gains
|
49
|
|
|
(7
|
)
|
|
42
|
|
|
29
|
|
|
(13
|
)
|
|
16
|
|
||||||
Realized (gains)/losses
(c)
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
|
30
|
|
|
—
|
|
|
30
|
|
||||||
Available-for-sale securities
|
48
|
|
|
(7
|
)
|
|
41
|
|
|
59
|
|
|
(13
|
)
|
|
46
|
|
||||||
Foreign currency translation
|
(8
|
)
|
|
36
|
|
|
28
|
|
|
20
|
|
|
6
|
|
|
26
|
|
||||||
|
$
|
61
|
|
|
$
|
21
|
|
|
$
|
82
|
|
|
$
|
(439
|
)
|
|
$
|
172
|
|
|
$
|
(267
|
)
|
(a)
|
Included in cost of products sold
|
(b)
|
Included in cost of products sold, research and development and marketing, selling and administrative expenses
|
(c)
|
Included in other (income)/expense
|
Dollars in Millions
|
September 30,
2017 |
|
December 31, 2016
|
||||
Derivatives qualifying as cash flow hedges
|
$
|
(23
|
)
|
|
$
|
38
|
|
Pension and other postretirement benefits
|
(2,023
|
)
|
|
(2,097
|
)
|
||
Available-for-sale securities
|
34
|
|
|
(7
|
)
|
||
Foreign currency translation
|
(409
|
)
|
|
(437
|
)
|
||
Accumulated other comprehensive loss
|
$
|
(2,421
|
)
|
|
$
|
(2,503
|
)
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Service cost – benefits earned during the year
|
$
|
7
|
|
|
$
|
6
|
|
|
$
|
19
|
|
|
$
|
19
|
|
Interest cost on projected benefit obligation
|
48
|
|
|
45
|
|
|
142
|
|
|
145
|
|
||||
Expected return on plan assets
|
(104
|
)
|
|
(104
|
)
|
|
(308
|
)
|
|
(314
|
)
|
||||
Amortization of prior service credits
|
(1
|
)
|
|
(1
|
)
|
|
(3
|
)
|
|
(3
|
)
|
||||
Amortization of net actuarial loss
|
20
|
|
|
22
|
|
|
61
|
|
|
62
|
|
||||
Curtailments and settlements
|
22
|
|
|
19
|
|
|
91
|
|
|
66
|
|
||||
Special termination benefits
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
||||
Net periodic benefit cost/(credit)
|
$
|
(8
|
)
|
|
$
|
(13
|
)
|
|
$
|
2
|
|
|
$
|
(24
|
)
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions, except per share data
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Total Revenues
|
$
|
5,254
|
|
|
$
|
4,922
|
|
|
$
|
15,327
|
|
|
$
|
14,184
|
|
|
|
|
|
|
|
|
|
||||||||
Diluted Earnings Per Share
|
|
|
|
|
|
|
|
||||||||
GAAP
|
0.51
|
|
|
0.72
|
|
|
2.02
|
|
|
2.12
|
|
||||
Non-GAAP
|
0.75
|
|
|
0.77
|
|
|
2.32
|
|
|
2.20
|
|
Product
|
Date
|
Approval
|
Opdivo
|
September 2017
|
FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib.
|
September 2017
|
Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono.
|
|
August 2017
|
FDA approval for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
|
|
June 2017
|
EC approval for the treatment of patients with previously treated locally advanced unresectable or metastatic urothelial carcinoma, a type of bladder cancer, in adults after failure of platinum-containing therapy.
|
|
April 2017
|
EC approval for the treatment of SCCHN in adults progressing on or after platinum-based therapy.
|
|
March 2017
|
Approval in Japan for the treatment of recurrent or metastatic HNC, received by our alliance partner, Ono.
|
|
February 2017
|
FDA approval for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
|
|
Orencia
|
July 2017
|
EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
|
July 2017
|
FDA approval for the treatment of active PsA in adults.
|
|
March 2017
|
FDA approval of a new subcutaneous administration option for use in patients two years of age and older with moderately to severely active polyarticular JIA.
|
|
Yervoy
|
July 2017
|
FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients.
|
Hepatitis C Franchise
|
April 2017
|
China FDA approval of the
Daklinza
and
Sunvepra
regimen for treatment-naive or experienced patients infected with genotype 1b chronic HCV. In addition,
Daklinza
was approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||
|
Total Revenues
|
|
2017 vs. 2016
|
|
Total Revenues
|
|
2017 vs. 2016
|
||||||||||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
Total Change
|
|
Foreign Exchange
(b)
|
|
2017
|
|
2016
|
|
Total Change
|
|
Foreign Exchange
(b)
|
||||||||||||
United States
|
$
|
2,864
|
|
|
$
|
2,790
|
|
|
3
|
%
|
|
—
|
|
|
$
|
8,467
|
|
|
$
|
8,015
|
|
|
6
|
%
|
|
—
|
|
Europe
|
1,262
|
|
|
946
|
|
|
33
|
%
|
|
5
|
%
|
|
3,596
|
|
|
2,855
|
|
|
26
|
%
|
|
(1
|
)%
|
||||
Rest of the World
|
970
|
|
|
1,069
|
|
|
(9
|
)%
|
|
(2
|
)%
|
|
2,858
|
|
|
2,922
|
|
|
(2
|
)%
|
|
(1
|
)%
|
||||
Other
(a)
|
158
|
|
|
117
|
|
|
35
|
%
|
|
N/A
|
|
|
406
|
|
|
392
|
|
|
4
|
%
|
|
N/A
|
|
||||
Total
|
$
|
5,254
|
|
|
$
|
4,922
|
|
|
7
|
%
|
|
1
|
%
|
|
$
|
15,327
|
|
|
$
|
14,184
|
|
|
8
|
%
|
|
(1
|
)%
|
(a)
|
Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
|
(b)
|
Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
% Change
|
|
2017
|
|
2016
|
|
% Change
|
||||||||||
Gross product sales
|
$
|
6,555
|
|
|
$
|
5,698
|
|
|
15
|
%
|
|
$
|
18,723
|
|
|
$
|
16,252
|
|
|
15
|
%
|
GTN adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Charge-backs and cash discounts
|
(583
|
)
|
|
(427
|
)
|
|
37
|
%
|
|
(1,521
|
)
|
|
(1,174
|
)
|
|
30
|
%
|
||||
Medicaid and Medicare rebates
|
(573
|
)
|
|
(397
|
)
|
|
44
|
%
|
|
(1,474
|
)
|
|
(1,018
|
)
|
|
45
|
%
|
||||
Other rebates, returns, discounts and adjustments
|
(537
|
)
|
|
(382
|
)
|
|
41
|
%
|
|
(1,516
|
)
|
|
(1,172
|
)
|
|
29
|
%
|
||||
Total GTN adjustments
|
(1,693
|
)
|
|
(1,206
|
)
|
|
40
|
%
|
|
(4,511
|
)
|
|
(3,364
|
)
|
|
34
|
%
|
||||
Net product sales
|
$
|
4,862
|
|
|
$
|
4,492
|
|
|
8
|
%
|
|
$
|
14,212
|
|
|
$
|
12,888
|
|
|
10
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
GTN adjustments percentage
|
26
|
%
|
|
21
|
%
|
|
5
|
%
|
|
24
|
%
|
|
21
|
%
|
|
3
|
%
|
||||
U.S.
|
32
|
%
|
|
26
|
%
|
|
6
|
%
|
|
30
|
%
|
|
26
|
%
|
|
4
|
%
|
||||
Non-U.S.
|
15
|
%
|
|
14
|
%
|
|
1
|
%
|
|
14
|
%
|
|
12
|
%
|
|
2
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
% Change
|
|
2017
|
|
2016
|
|
% Change
|
||||||||||
Prioritized Brands
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Opdivo
|
$
|
1,265
|
|
|
$
|
920
|
|
|
38
|
%
|
|
$
|
3,587
|
|
|
$
|
2,464
|
|
|
46
|
%
|
U.S.
|
778
|
|
|
712
|
|
|
9
|
%
|
|
2,307
|
|
|
1,949
|
|
|
18
|
%
|
||||
Non-U.S.
|
487
|
|
|
208
|
|
|
**
|
|
|
1,280
|
|
|
515
|
|
|
**
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Eliquis
|
1,232
|
|
|
884
|
|
|
39
|
%
|
|
3,509
|
|
|
2,395
|
|
|
47
|
%
|
||||
U.S.
|
717
|
|
|
512
|
|
|
40
|
%
|
|
2,119
|
|
|
1,424
|
|
|
49
|
%
|
||||
Non-U.S.
|
515
|
|
|
372
|
|
|
38
|
%
|
|
1,390
|
|
|
971
|
|
|
43
|
%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Orencia
|
632
|
|
|
572
|
|
|
10
|
%
|
|
1,817
|
|
|
1,640
|
|
|
11
|
%
|
||||
U.S.
|
432
|
|
|
387
|
|
|
12
|
%
|
|
1,243
|
|
|
1,109
|
|
|
12
|
%
|
||||
Non-U.S.
|
200
|
|
|
185
|
|
|
8
|
%
|
|
574
|
|
|
531
|
|
|
8
|
%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Sprycel
|
509
|
|
|
472
|
|
|
8
|
%
|
|
1,478
|
|
|
1,330
|
|
|
11
|
%
|
||||
U.S.
|
278
|
|
|
259
|
|
|
7
|
%
|
|
806
|
|
|
702
|
|
|
15
|
%
|
||||
Non-U.S.
|
231
|
|
|
213
|
|
|
8
|
%
|
|
672
|
|
|
628
|
|
|
7
|
%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Yervoy
|
323
|
|
|
285
|
|
|
13
|
%
|
|
975
|
|
|
789
|
|
|
24
|
%
|
||||
U.S.
|
239
|
|
|
222
|
|
|
8
|
%
|
|
727
|
|
|
600
|
|
|
21
|
%
|
||||
Non-U.S.
|
84
|
|
|
63
|
|
|
33
|
%
|
|
248
|
|
|
189
|
|
|
31
|
%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Empliciti
|
60
|
|
|
41
|
|
|
46
|
%
|
|
168
|
|
|
103
|
|
|
63
|
%
|
||||
U.S.
|
39
|
|
|
36
|
|
|
8
|
%
|
|
112
|
|
|
97
|
|
|
15
|
%
|
||||
Non-U.S.
|
21
|
|
|
5
|
|
|
**
|
|
|
56
|
|
|
6
|
|
|
**
|
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Established Brands
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Hepatitis C Franchise
|
73
|
|
|
379
|
|
|
(81
|
)%
|
|
347
|
|
|
1,352
|
|
|
(74
|
)%
|
||||
U.S.
|
24
|
|
|
192
|
|
|
(88
|
)%
|
|
96
|
|
|
745
|
|
|
(87
|
)%
|
||||
Non-U.S.
|
49
|
|
|
187
|
|
|
(74
|
)%
|
|
251
|
|
|
607
|
|
|
(59
|
)%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Baraclude
|
264
|
|
|
306
|
|
|
(14
|
)%
|
|
819
|
|
|
896
|
|
|
(9
|
)%
|
||||
U.S.
|
14
|
|
|
17
|
|
|
(18
|
)%
|
|
40
|
|
|
49
|
|
|
(18
|
)%
|
||||
Non-U.S.
|
250
|
|
|
289
|
|
|
(13
|
)%
|
|
779
|
|
|
847
|
|
|
(8
|
)%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Sustiva Franchise
|
183
|
|
|
275
|
|
|
(33
|
)%
|
|
555
|
|
|
819
|
|
|
(32
|
)%
|
||||
U.S.
|
157
|
|
|
234
|
|
|
(33
|
)%
|
|
471
|
|
|
689
|
|
|
(32
|
)%
|
||||
Non-U.S.
|
26
|
|
|
41
|
|
|
(37
|
)%
|
|
84
|
|
|
130
|
|
|
(35
|
)%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Reyataz Franchise
|
174
|
|
|
238
|
|
|
(27
|
)%
|
|
555
|
|
|
706
|
|
|
(21
|
)%
|
||||
U.S.
|
85
|
|
|
125
|
|
|
(32
|
)%
|
|
260
|
|
|
367
|
|
|
(29
|
)%
|
||||
Non-U.S.
|
89
|
|
|
113
|
|
|
(21
|
)%
|
|
295
|
|
|
339
|
|
|
(13
|
)%
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Other Brands
|
539
|
|
|
550
|
|
|
(2
|
)%
|
|
1,517
|
|
|
1,690
|
|
|
(10
|
)%
|
||||
U.S.
|
101
|
|
|
94
|
|
|
7
|
%
|
|
286
|
|
|
284
|
|
|
1
|
%
|
||||
Non-U.S.
|
438
|
|
|
456
|
|
|
(4
|
)%
|
|
1,231
|
|
|
1,406
|
|
|
(12
|
)%
|
•
|
U.S. revenues increased in both periods due to higher demand. We expect increased competition for
Opdivo
to continue in the future.
|
•
|
International revenues increased in both periods due to higher demand as a result of launches of additional indications and approvals in new countries.
|
•
|
U.S. and international revenues increased in both periods due to higher demand resulting from increased commercial acceptance of novel oral anticoagulants and market share gains.
|
•
|
U.S. revenues increased in both periods due to higher average net selling prices and demand.
|
•
|
International revenues increased in both periods due to higher demand.
|
•
|
U.S. revenues increased in both periods primarily due to higher demand.
|
•
|
International revenues increased in both periods due to higher demand.
|
•
|
U.S. revenues increased in both periods primarily due to higher demand.
|
•
|
International revenues increased in both periods due to higher demand.
|
•
|
Empliciti
was launched in the U.S. in December 2015, in the EU in May 2016 and in Japan in September 2016.
|
•
|
U.S. and international revenues decreased in both periods due to lower demand resulting from increased competition.
|
•
|
International revenues continued to decrease in both periods due to lower demand resulting from increased competition.
|
•
|
U.S. revenues continued to decrease in both periods due to lower demand resulting from increased competition. The loss of exclusivity for
Sustiva
is expected in December 2017 which may result in the termination of the joint venture agreement with Gilead and further reduce revenues beyond 2017.
|
•
|
U.S. revenues continued to decrease due to lower demand resulting from increased competition. The loss of exclusivity is expected in December 2017 and will result in a higher decline in revenues in future periods due to generic competition.
|
•
|
International revenues continued to decrease in both periods due to lower demand.
|
•
|
International revenues decreased in both periods due to out-licensing and divestiture of certain other brands and continued generic erosion.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
% Change
|
|
2017
|
|
2016
|
|
% Change
|
||||||||||
Cost of products sold
|
$
|
1,572
|
|
|
$
|
1,305
|
|
|
20
|
%
|
|
$
|
4,393
|
|
|
$
|
3,563
|
|
|
23
|
%
|
Marketing, selling and administrative
|
1,147
|
|
|
1,144
|
|
|
—
|
|
|
3,388
|
|
|
3,450
|
|
|
(2
|
)%
|
||||
Research and development
|
1,543
|
|
|
1,138
|
|
|
36
|
%
|
|
4,490
|
|
|
3,540
|
|
|
27
|
%
|
||||
Other (income)/expense
|
(191
|
)
|
|
(224
|
)
|
|
(15
|
)%
|
|
(1,377
|
)
|
|
(1,198
|
)
|
|
15
|
%
|
||||
Total Expenses
|
$
|
4,071
|
|
|
$
|
3,363
|
|
|
21
|
%
|
|
$
|
10,894
|
|
|
$
|
9,355
|
|
|
16
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
IFM
|
$
|
310
|
|
|
$
|
—
|
|
|
$
|
310
|
|
|
$
|
—
|
|
CytomX
|
—
|
|
|
—
|
|
|
200
|
|
|
10
|
|
||||
Flexus
|
—
|
|
|
—
|
|
|
93
|
|
|
100
|
|
||||
Cardioxyl
|
—
|
|
|
—
|
|
|
100
|
|
|
—
|
|
||||
Padlock
|
—
|
|
|
—
|
|
|
—
|
|
|
139
|
|
||||
Cormorant
|
—
|
|
|
35
|
|
|
—
|
|
|
35
|
|
||||
Other
|
—
|
|
|
10
|
|
|
50
|
|
|
25
|
|
||||
License and asset acquisition charges
|
310
|
|
|
45
|
|
|
753
|
|
|
309
|
|
||||
IPRD impairments
|
—
|
|
|
—
|
|
|
75
|
|
|
—
|
|
||||
Accelerated depreciation and other
|
64
|
|
|
14
|
|
|
232
|
|
|
40
|
|
•
|
License and asset acquisition charges include upfront payments for the IFM, CytomX, Padlock and Cormorant arrangements and milestone payments for the CytomX, Flexus and Cardioxyl arrangements. These arrangements were related to certain investigational oncology, cardiovascular and immunoscience compounds.
|
•
|
IPRD impairment charges in the
nine months ended September 30, 2017
related to the discontinued development of an investigational compound which was part of our alliance with F-Star Alpha.
|
•
|
Accelerated depreciation and other charges resulted from the expected exit of R&D sites in the U.S. through 2020 primarily due to the reduction in the estimated useful lives of the related assets for each site.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Provision for restructuring
|
$
|
28
|
|
|
$
|
19
|
|
|
$
|
207
|
|
|
$
|
41
|
|
Litigation and other settlements
|
—
|
|
|
(1
|
)
|
|
(489
|
)
|
|
48
|
|
||||
Divestiture (gains)/losses
|
1
|
|
|
(21
|
)
|
|
(126
|
)
|
|
(574
|
)
|
||||
Royalties and licensing income
|
(209
|
)
|
|
(158
|
)
|
|
(1,093
|
)
|
|
(579
|
)
|
||||
Transition and other service fees
|
(12
|
)
|
|
(57
|
)
|
|
(32
|
)
|
|
(184
|
)
|
•
|
Restructuring charges relate to changes to the Company's operating model to drive continued success in the near- and long-term through a more focused investment in commercial opportunities for key brands and markets, a competitive and more agile R&D organization that can accelerate the pipeline, streamline operations and realign manufacturing capabilities that broaden biologics capabilities to reflect the current and future portfolio as well as streamline and simplify our small-molecule supply network. The new operating model is expected to enable the Company to deliver the strategic, financial and operational flexibility necessary to invest in the highest priorities across the Company. Aggregate restructuring charges of approximately $250 million are expected to be incurred in 2017 for all actions in addition to accelerated depreciation impacts resulting from early site exits.
|
•
|
Litigation and other settlements include BMS's share of a patent-infringement litigation settlement related to Merck's PD-1 antibody
Keytruda*
in the first quarter of 2017 as BMS and Ono signed a global patent license agreement with Merck. Merck made an initial payment of $625 million to BMS and Ono, of which BMS received $481 million. Merck is also obligated to pay ongoing royalties on global sales of
Keytruda*
of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other under their respective
|
•
|
Divestiture gains include additional contingent consideration for the diabetes business ($100 million) in the first quarter of 2017, an OTC product business in the second quarter of 2016 ($277 million) and the investigational HIV medicines business in the first quarter of 2016 ($272 million).
|
•
|
Royalties and licensing income include upfront licensing fees from Biogen ($300 million) and Roche ($170 million) in the second quarter of 2017 in connection with the out-licensing of certain investigational genetically defined disease compounds.
|
•
|
Transition and other service fees in 2016 included fees resulting from the divestiture of the diabetes business in 2014 and the investigational HIV medicines business in 2016.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Earnings Before Income Taxes
|
$
|
1,183
|
|
|
$
|
1,559
|
|
|
$
|
4,433
|
|
|
$
|
4,829
|
|
Provision for Income Taxes
|
327
|
|
|
344
|
|
|
1,129
|
|
|
1,220
|
|
||||
Effective Tax Rate
|
27.6
|
%
|
|
22.1
|
%
|
|
25.5
|
%
|
|
25.3
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Impairment charges
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
128
|
|
|
$
|
—
|
|
Accelerated depreciation and other shutdown costs
|
—
|
|
|
7
|
|
|
3
|
|
|
15
|
|
||||
Cost of products sold
|
1
|
|
|
7
|
|
|
131
|
|
|
15
|
|
||||
|
|
|
|
|
|
|
|
||||||||
License and asset acquisition charges
|
310
|
|
|
45
|
|
|
753
|
|
|
309
|
|
||||
IPRD impairments
|
—
|
|
|
—
|
|
|
75
|
|
|
—
|
|
||||
Accelerated depreciation and other
|
64
|
|
|
14
|
|
|
232
|
|
|
40
|
|
||||
Research and development
|
374
|
|
|
59
|
|
|
1,060
|
|
|
349
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Provision for restructuring
|
28
|
|
|
19
|
|
|
207
|
|
|
41
|
|
||||
Litigation and other settlements
|
—
|
|
|
(3
|
)
|
|
(481
|
)
|
|
40
|
|
||||
Divestiture gains
|
—
|
|
|
(13
|
)
|
|
(100
|
)
|
|
(559
|
)
|
||||
Royalties and licensing income
|
—
|
|
|
—
|
|
|
(497
|
)
|
|
—
|
|
||||
Pension charges
|
22
|
|
|
19
|
|
|
91
|
|
|
66
|
|
||||
Intangible asset impairments
|
—
|
|
|
—
|
|
|
—
|
|
|
15
|
|
||||
Loss on debt redemption
|
—
|
|
|
—
|
|
|
109
|
|
|
—
|
|
||||
Other (income)/expense
|
50
|
|
|
22
|
|
|
(671
|
)
|
|
(397
|
)
|
||||
|
|
|
|
|
|
|
|
||||||||
Increase/(decrease) to pretax income
|
425
|
|
|
88
|
|
|
520
|
|
|
(33
|
)
|
||||
Income taxes on specified items
|
(41
|
)
|
|
(3
|
)
|
|
51
|
|
|
156
|
|
||||
Increase to net earnings
|
384
|
|
|
85
|
|
|
571
|
|
|
123
|
|
||||
Noncontrolling interest
|
—
|
|
|
—
|
|
|
(59
|
)
|
|
—
|
|
||||
Increase to net earnings used for Diluted Non-GAAP EPS calculation
|
$
|
384
|
|
|
$
|
85
|
|
|
$
|
512
|
|
|
$
|
123
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Dollars in Millions, except per share data
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP
|
$
|
845
|
|
|
$
|
1,202
|
|
|
$
|
3,335
|
|
|
$
|
3,563
|
|
Specified Items
|
384
|
|
|
85
|
|
|
512
|
|
|
123
|
|
||||
Net Earnings used for Diluted EPS Calculation – Non-GAAP
|
$
|
1,229
|
|
|
$
|
1,287
|
|
|
$
|
3,847
|
|
|
$
|
3,686
|
|
|
|
|
|
|
|
|
|
||||||||
Average Common Shares Outstanding – Diluted
|
1,645
|
|
|
1,679
|
|
|
1,655
|
|
|
1,679
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Diluted Earnings Per Share – GAAP
|
$
|
0.51
|
|
|
$
|
0.72
|
|
|
$
|
2.02
|
|
|
$
|
2.12
|
|
Diluted EPS Attributable to Specified Items
|
0.24
|
|
|
0.05
|
|
|
0.30
|
|
|
0.08
|
|
||||
Diluted Earnings Per Share – Non-GAAP
|
$
|
0.75
|
|
|
$
|
0.77
|
|
|
$
|
2.32
|
|
|
$
|
2.20
|
|
Dollars in Millions
|
September 30,
2017 |
|
December 31,
2016 |
||||
Cash and cash equivalents
|
$
|
4,644
|
|
|
$
|
4,237
|
|
Marketable securities – current
|
2,478
|
|
|
2,113
|
|
||
Marketable securities – non-current
|
2,526
|
|
|
2,719
|
|
||
Cash, cash equivalents and marketable securities
|
9,648
|
|
|
9,069
|
|
||
Short-term debt obligations
|
(1,461
|
)
|
|
(992
|
)
|
||
Long-term debt
|
(6,982
|
)
|
|
(5,716
|
)
|
||
Net cash position
|
$
|
1,205
|
|
|
$
|
2,361
|
|
|
Nine Months Ended September 30,
|
||||||
Dollars in Millions
|
2017
|
|
2016
|
||||
Cash flow provided by/(used in):
|
|
|
|
||||
Operating activities
|
$
|
4,158
|
|
|
$
|
1,615
|
|
Investing activities
|
(1,085
|
)
|
|
1,464
|
|
||
Financing activities
|
(2,725
|
)
|
|
(2,048
|
)
|
•
|
Lower income tax payments of approximately $1.4 billion;
|
•
|
Higher out-license proceeds of approximately $500 million primarily related to the Biogen and Roche transactions; and
|
•
|
BMS's share of litigation settlement proceeds of $481 million related to Merck's PD-1 antibody
Keytruda*.
|
•
|
Higher R&D licensing payments of approximately $300 million primarily due to the CytomX transaction.
|
•
|
Lower net sales of marketable securities with maturities greater than 90 days of $1.6 billion due to higher available cash balances;
|
•
|
Lower business divestiture proceeds of approximately $700 million primarily due to certain OTC products and investigational HIV business divestitures in 2016; and
|
•
|
Higher asset acquisition payments of approximately $400 million primarily due to the acquisition of IFM in 2017.
|
•
|
Higher repurchase of common stock of $2.0 billion primarily due to the accelerated share repurchase agreements.
|
•
|
Higher net borrowings of $1.4 billion primarily to fund the repurchase of common stock.
|
Product
|
Indication
|
Date
|
Developments
|
Opdivo
|
Gastric
|
September 2017
|
Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono.
|
HCC
|
September 2017
|
FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib.
|
|
mCRC
|
August 2017
|
FDA approval for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
|
|
Melanoma
|
October 2017
|
Announced FDA accepted for priority review the Company's sBLA for
Opdivo
to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA action date is February 14, 2018.
|
|
September 2017
|
Announced treatment with
Opdivo
resulted in significant improvement in recurrence-free survival compared to
Yervoy
in patients with stage IIIb/c or stage IV melanoma following complete surgical resection.
|
||
July 2017
|
Announced a Phase III trial evaluating
Opdivo
versus
Yervoy
in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint of recurrence-free survival at a planned interim analysis.
|
||
Multiple Myeloma
|
September 2017
|
Announced the FDA placed a partial clinical hold on CheckMate-602, CheckMate-039 and CA204142, three clinical trials investigating
Opdivo
based combinations in patients with relapsed or refractory multiple myeloma. This partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma.
|
|
NSCLC
|
September 2017
|
Announced three-year overall survival data from CheckMate-017 and CheckMate-057, two pivotal Phase III randomized studies evaluating
Opdivo
vs. docetaxel in patients with previously treated metastatic NSCLC.
|
|
Various
|
July 2017
|
BMS and Clovis Oncology, Inc. announced a clinical collaboration to evaluate the combination of
Opdivo
and
Rubraca*
(rucaparib) in pivotal Phase III trials in advanced ovarian cancer and triple-negative breast cancer as well as a Phase II trial in metastatic castration-resistant prostate cancer.
|
|
Announced FDA accepted the Company's sBLAs to update
Opdivo
dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The FDA action date is March 5, 2018.
|
|||
|
|
|
|
Opdivo+Yervoy
|
RCC
|
September 2017
|
Announced CheckMate-214, a Phase III study evaluating
Opdivo+Yervoy
versus sunitinib in patients with previously untreated advanced or metastatic RCC, met its co-primary endpoint, demonstrating superior overall survival in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee has recommended that the trial be stopped early.
|
August 2017
|
Announced topline results from CheckMate-214. The combination of
Opdivo
+
Yervoy
met the co-primary endpoint of objective response rate and was favored in the co-primary endpoint of progression-free survival, however, it did not reach statistical significance.
|
||
July 2017
|
BMS and Exelixis, Inc. announced the initiation of the Phase III CheckMate 9ER trial to evaluate
Opdivo
in combination with
Cabometyx*
(cabozantinib) or
Opdivo
and
Yervoy
in combination with
Cabometyx*
versus sunitinib in patients with previously untreated, advanced or metastatic RCC.
|
||
SCLC
|
October 2017
|
Announced data evaluating
Opdivo
and
Opdivo+Yervoy
in previously treated SCLC patients whose tumors were evaluable for tumor mutation burden from the Phase I/II CheckMate-032 trial.
|
Product
|
Indication
|
Date
|
Developments
|
Eliquis
|
NVAF
|
August 2017
|
Announced results from a real-world data analysis of the U.S. Humana database, in which treatment with
Eliquis
was associated with a significantly lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin in patients aged 65 years and older with NVAF.
|
Announced data from EMANATE, a Phase IV trial, exploring the safety and efficacy of
Eliquis
in patients with NVAF undergoing cardioversion.
|
|||
Announced results from a real-world data analysis pooled from four large U.S. insurance claims databases, in which treatment with
Eliquis
was associated with a lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin for the overall population and for each of the selected high-risk patient sub-populations.
|
|||
|
|
|
|
Orencia
|
PsA
|
July 2017
|
EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
|
FDA approval for active PsA in adults, a chronic, inflammatory disease that can affect both the skin and musculoskeletal system.
|
|||
|
|
|
|
Sprycel
|
CML
|
July 2017
|
Announced the FDA accepted for priority review a supplemental NDA to treat children with Philadelphia chromosome-positive chronic phase CML, as well as a powder for oral suspension formulation of
Sprycel
. The FDA action date is November 9, 2017.
|
|
|
|
|
Yervoy
|
Melanoma
|
October 2017
|
Announced the FDA added five-year overall survival data from the Phase III CA184-029 trial to the prescribing information for
Yervoy
for the adjuvant treatment of fully resected cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm.
|
July 2017
|
FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients.
|
||
|
|
|
|
Prostvac*
|
Prostate Cancer
|
September 2017
|
Bavarian Nordic A/S announced an independent Data Monitoring Committee determined that the continuation of the Phase III PROSPECT study of
Prostvac*
in patients with metastatic castration-resistant prostate cancer is futile.
|
Period
|
Total Number of
Shares Purchased
(a)
|
|
Average
Price Paid
per Share
(a)
|
|
Total Number of
Shares Purchased as
Part of Publicly
Announced
Programs
(b)
|
|
Approximate Dollar
Value of Shares that
May Yet Be
Purchased Under the
Programs
(b)
|
||||||
Dollars in Millions, Except Per Share Data
|
|
|
|
|
|
|
|
||||||
July 1 to 31, 2017
|
63,794
|
|
|
$
|
56.63
|
|
|
52,851
|
|
|
$
|
2,134
|
|
August 1 to 31, 2017
|
2,994,306
|
|
|
$
|
57.68
|
|
|
2,985,959
|
|
|
$
|
1,962
|
|
September 1 to 30, 2017
|
812,937
|
|
|
$
|
62.53
|
|
|
803,249
|
|
|
$
|
1,912
|
|
Three months ended September 30, 2017
|
3,871,037
|
|
|
|
|
3,842,059
|
|
|
|
(a)
|
Includes shares repurchased as part of publicly announced programs and shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive program.
|
(b)
|
In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock and in June 2012 increased its authorization for the repurchase of common stock by an additional $3.0 billion. In October 2016, the Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of common stock. The stock repurchase program does not have an expiration date. Refer to “Item 1. Financial Statements—Note
15
. Equity" for information on the accelerated share repurchase agreements.
|
Exhibit No.
|
|
Description
|
|
||
|
||
|
||
|
||
|
||
101.
|
|
The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, formatted in Extensible Business Reporting Language (XBRL):
(i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.
|
|
|
2016 Form 10-K
|
Annual Report on Form 10-K for the fiscal year ended December 31, 2016
|
AstraZeneca
|
AstraZeneca PLC
|
Biogen
|
Biogen Inc.
|
Cardioxyl
|
Cardioxyl Pharmaceuticals, Inc.
|
CML
|
chronic myeloid leukemia
|
CytomX
|
CytomX Therapeutics, Inc.
|
dMMR
|
DNA mismatch repair deficient
|
EPO
|
European Patent Office
|
EPS
|
earnings per share
|
EU
|
European Union
|
FASB
|
Financial Accounting Standards Board
|
FDA
|
U.S. Food and Drug Administration
|
Flexus
|
Flexus Biosciences, Inc.
|
F-Star Alpha
|
F-Star Alpha Ltd.
|
GAAP
|
U.S. generally accepted accounting principles
|
Gilead
|
Gilead Sciences, Inc.
|
GTN
|
Gross-to-Net
|
Halozyme
|
Halozyme Therapeutics, Inc.
|
HCC
|
Hepatocellular carcinoma
|
HIV
|
human immunodeficiency virus
|
HNC
|
head and neck cancer
|
IFM
|
IFM Therapeutics, Inc.
|
iPierian
|
iPierian, Inc.
|
IO
|
immuno-oncology
|
IPRD
|
In-process research and development
|
JIA
|
Juvenile Idiopathic Arthritis
|
mCRC
|
metastatic colorectal cancer
|
Merck
|
Merck & Co., Inc.
|
MSI-H
|
microsatellite instability-high
|
NDA
|
New Drug Application
|
NKT
|
natural killer T cells
|
NSCLC
|
non-small cell lung cancer
|
NVAF
|
non-valvular atrial fibrillation
|
Ono
|
Ono Pharmaceutical Co., Ltd.
|
OTC
|
Over-the-counter
|
Padlock
|
Padlock Therapeutics, Inc.
|
PD-1
|
programmed death receptor-1
|
PsA
|
active psoriatic arthritis
|
Quarterly Report on Form 10-Q
|
Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017
|
RA
|
rheumatoid arthritis
|
RCC
|
renal cell carcinoma
|
R&D
|
Research and Development
|
sBLA
|
supplemental Biologics License Application
|
SCCHN
|
squamous cell carcinoma of the head and neck
|
SCLC
|
small cell lung cancer
|
SEC
|
Securities and Exchange Commission
|
SK Biotek
|
SK Biotek Co., Ltd.
|
UK
|
United Kingdom
|
U.S.
|
United States
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
(REGISTRANT)
|
|
|
|
|
|
|
Date:
|
October 26, 2017
|
|
By:
|
/s/ Giovanni Caforio
|
|
|
|
|
Giovanni Caforio
Chief Executive Officer
|
|
|
|
|
|
Date:
|
October 26, 2017
|
|
By:
|
/s/ Charles Bancroft
|
|
|
|
|
Charles Bancroft
Chief Financial Officer
|
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
Suppliers
Price
Yield
Owner | Position | Direct Shares | Indirect Shares |
---|