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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 MARCH 31, 2016
|
|
¨
|
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 March 31,
|
||||||
EARNINGS
|
2016
|
|
2015
|
||||
Net product sales
|
$
|
3,964
|
|
|
$
|
3,059
|
|
Alliance and other revenues
|
427
|
|
|
982
|
|
||
Total Revenues
|
4,391
|
|
|
4,041
|
|
||
|
|
|
|
||||
Cost of products sold
|
1,052
|
|
|
847
|
|
||
Marketing, selling and administrative
|
1,068
|
|
|
1,029
|
|
||
Research and development
|
1,136
|
|
|
1,016
|
|
||
Other (income)/expense
|
(520
|
)
|
|
(299
|
)
|
||
Total Expenses
|
2,736
|
|
|
2,593
|
|
||
|
|
|
|
||||
Earnings Before Income Taxes
|
1,655
|
|
|
1,448
|
|
||
Provision for Income Taxes
|
449
|
|
|
249
|
|
||
Net Earnings
|
1,206
|
|
|
1,199
|
|
||
Net Earnings Attributable to Noncontrolling Interest
|
11
|
|
|
13
|
|
||
Net Earnings Attributable to BMS
|
$
|
1,195
|
|
|
$
|
1,186
|
|
|
|
|
|
||||
Earnings per Common Share
|
|
|
|
||||
Basic
|
$
|
0.72
|
|
|
$
|
0.71
|
|
Diluted
|
$
|
0.71
|
|
|
$
|
0.71
|
|
|
|
|
|
||||
Cash dividends declared per common share
|
$
|
0.38
|
|
|
$
|
0.37
|
|
|
Three Months Ended March 31,
|
||||||
COMPREHENSIVE INCOME
|
2016
|
|
2015
|
||||
Net Earnings
|
$
|
1,206
|
|
|
$
|
1,199
|
|
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:
|
|
|
|
||||
Derivatives qualifying as cash flow hedges
|
(86
|
)
|
|
6
|
|
||
Pension and postretirement benefits
|
(161
|
)
|
|
(44
|
)
|
||
Available-for-sale securities
|
13
|
|
|
16
|
|
||
Foreign currency translation
|
9
|
|
|
31
|
|
||
Other Comprehensive Income/(Loss)
|
(225
|
)
|
|
9
|
|
||
|
|
|
|
||||
Comprehensive Income
|
981
|
|
|
1,208
|
|
||
Comprehensive Income Attributable to Noncontrolling Interest
|
11
|
|
|
13
|
|
||
Comprehensive Income Attributable to BMS
|
$
|
970
|
|
|
$
|
1,195
|
|
ASSETS
|
March 31,
2016 |
|
December 31,
2015 |
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
2,644
|
|
|
$
|
2,385
|
|
Marketable securities
|
1,663
|
|
|
1,885
|
|
||
Receivables
|
4,957
|
|
|
4,299
|
|
||
Inventories
|
1,336
|
|
|
1,221
|
|
||
Prepaid expenses and other
|
615
|
|
|
625
|
|
||
Total Current Assets
|
11,215
|
|
|
10,415
|
|
||
Property, plant and equipment
|
4,455
|
|
|
4,412
|
|
||
Goodwill
|
6,875
|
|
|
6,881
|
|
||
Other intangible assets
|
1,380
|
|
|
1,419
|
|
||
Deferred income taxes
|
3,230
|
|
|
2,844
|
|
||
Marketable securities
|
3,689
|
|
|
4,660
|
|
||
Other assets
|
1,048
|
|
|
1,117
|
|
||
Total Assets
|
$
|
31,892
|
|
|
$
|
31,748
|
|
|
|
|
|
||||
LIABILITIES
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Short-term borrowings
|
$
|
106
|
|
|
$
|
139
|
|
Accounts payable
|
1,543
|
|
|
1,565
|
|
||
Accrued liabilities
|
4,311
|
|
|
4,738
|
|
||
Deferred income
|
1,165
|
|
|
1,003
|
|
||
Income taxes payable
|
472
|
|
|
572
|
|
||
Total Current Liabilities
|
7,597
|
|
|
8,017
|
|
||
Deferred income
|
606
|
|
|
586
|
|
||
Income taxes payable
|
852
|
|
|
742
|
|
||
Pension and other liabilities
|
1,693
|
|
|
1,429
|
|
||
Long-term debt
|
6,593
|
|
|
6,550
|
|
||
Total Liabilities
|
17,341
|
|
|
17,324
|
|
||
|
|
|
|
||||
Commitments and contingencies (Note 18)
|
|
|
|
||||
|
|
|
|
||||
EQUITY
|
|
|
|
||||
Bristol-Myers Squibb Company Shareholders’ Equity:
|
|
|
|
||||
Preferred stock, $2 convertible series, par value $1 per share: Authorized 10 million shares; 4,161 issued
|
|
|
|
||||
and outstanding in both 2016 and 2015, liquidation value of $50 per share
|
—
|
|
|
—
|
|
||
Common stock, par value of $0.10 per share: Authorized 4.5 billion shares; 2.2 billion issued in both 2016
|
|
|
|
||||
and 2015
|
221
|
|
|
221
|
|
||
Capital in excess of par value of stock
|
1,503
|
|
|
1,459
|
|
||
Accumulated other comprehensive loss
|
(2,693
|
)
|
|
(2,468
|
)
|
||
Retained earnings
|
32,176
|
|
|
31,613
|
|
||
Less cost of treasury stock – 539 million common shares in both 2016 and 2015
|
(16,821
|
)
|
|
(16,559
|
)
|
||
Total Bristol-Myers Squibb Company Shareholders’ Equity
|
14,386
|
|
|
14,266
|
|
||
Noncontrolling interest
|
165
|
|
|
158
|
|
||
Total Equity
|
14,551
|
|
|
14,424
|
|
||
Total Liabilities and Equity
|
$
|
31,892
|
|
|
$
|
31,748
|
|
|
Three Months Ended March 31,
|
||||||
|
2016
|
|
2015
|
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net earnings
|
$
|
1,206
|
|
|
$
|
1,199
|
|
Adjustments to reconcile net earnings to net cash (used in)/provided by operating activities:
|
|
|
|
||||
Depreciation and amortization, net
|
65
|
|
|
104
|
|
||
Deferred income taxes
|
(246
|
)
|
|
(7
|
)
|
||
Stock-based compensation
|
47
|
|
|
54
|
|
||
Impairment charges
|
19
|
|
|
13
|
|
||
Pension settlements and amortization
|
39
|
|
|
50
|
|
||
Divestiture gains and royalties
|
(507
|
)
|
|
(234
|
)
|
||
Asset acquisition charges
|
100
|
|
|
—
|
|
||
Other adjustments
|
(10
|
)
|
|
(21
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Receivables
|
(424
|
)
|
|
(91
|
)
|
||
Inventories
|
(44
|
)
|
|
51
|
|
||
Accounts payable
|
(77
|
)
|
|
(83
|
)
|
||
Deferred income
|
235
|
|
|
334
|
|
||
Income taxes payable
|
5
|
|
|
81
|
|
||
Other
|
(794
|
)
|
|
(824
|
)
|
||
Net Cash (Used in)/Provided by Operating Activities
|
(386
|
)
|
|
626
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Sale and maturities of marketable securities
|
1,760
|
|
|
1,508
|
|
||
Purchase of marketable securities
|
(523
|
)
|
|
(821
|
)
|
||
Capital expenditures
|
(242
|
)
|
|
(136
|
)
|
||
Divestiture and other proceeds
|
439
|
|
|
203
|
|
||
Acquisition and other payments
|
(8
|
)
|
|
—
|
|
||
Net Cash Provided by Investing Activities
|
1,426
|
|
|
754
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Short-term borrowings, net
|
(33
|
)
|
|
(260
|
)
|
||
Interest rate swap contract terminations
|
42
|
|
|
27
|
|
||
Issuance of common stock
|
71
|
|
|
174
|
|
||
Repurchase of common stock
|
(231
|
)
|
|
—
|
|
||
Dividends
|
(641
|
)
|
|
(623
|
)
|
||
Net Cash Used in Financing Activities
|
(792
|
)
|
|
(682
|
)
|
||
Effect of Exchange Rates on Cash and Cash Equivalents
|
11
|
|
|
25
|
|
||
Increase in Cash and Cash Equivalents
|
259
|
|
|
723
|
|
||
Cash and Cash Equivalents at Beginning of Period
|
2,385
|
|
|
5,571
|
|
||
Cash and Cash Equivalents at End of Period
|
$
|
2,644
|
|
|
$
|
6,294
|
|
|
Prior Presentation
|
Current Presentation
|
Consolidated Statements of Earnings
|
Advertising and product promotion
|
Included in Marketing, selling and administrative expenses
|
Consolidated Balance Sheets
|
Assets held-for-sale
|
Included in Prepaid expenses and other
|
Accrued expenses
|
Combined as Accrued liabilities
|
|
Accrued rebates and returns
|
||
Dividends payable
|
||
Pension, postretirement and postemployment liabilities
|
Combined as Pension and other liabilities
|
|
Other liabilities
|
||
Consolidated Statement of Cash Flows
|
Net earnings attributable to noncontrolling interest
|
Included in Other adjustments
|
Divestiture gains and royalties included in Other adjustments
|
Divestiture gains and royalties
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Oncology
|
|
|
|
||||
Empliciti (elotuzumab)
|
$
|
28
|
|
|
$
|
—
|
|
Erbitux* (cetuximab)
|
—
|
|
|
165
|
|
||
Opdivo (nivolumab)
|
704
|
|
|
40
|
|
||
Sprycel (dasatinib)
|
407
|
|
|
375
|
|
||
Yervoy (ipilimumab)
|
263
|
|
|
325
|
|
||
Cardiovascular
|
|
|
|
||||
Eliquis (apixaban)
|
734
|
|
|
355
|
|
||
Immunoscience
|
|
|
|
||||
Orencia (abatacept)
|
475
|
|
|
400
|
|
||
Virology
|
|
|
|
||||
Baraclude (entecavir)
|
291
|
|
|
340
|
|
||
Hepatitis C Franchise
(a)
|
427
|
|
|
264
|
|
||
Reyataz (atazanavir sulfate) Franchise
|
221
|
|
|
294
|
|
||
Sustiva (efavirenz) Franchise
(b)
|
273
|
|
|
290
|
|
||
Neuroscience
|
|
|
|
||||
Abilify* (aripiprazole)
(c)
|
33
|
|
|
554
|
|
||
Mature Products and All Other
|
535
|
|
|
639
|
|
||
Total Revenues
|
$
|
4,391
|
|
|
$
|
4,041
|
|
*
|
Indicates brand names of products which are trademarks not owned or wholly owned by BMS. Specific trademark ownership information is included at the end of this quarterly report on Form 10-Q.
|
(a)
|
Includes
Daklinza
(daclatasvir) revenues of $420 million and $180 million for the three months ended March 31, 2016 and 2015, respectively, and
Sunvepra
(asunaprevir) revenues of $7 million and $84 million for the three months ended March 31, 2016 and 2015, respectively.
|
(b)
|
Includes alliance revenue of $241 million and $251 million for the three months ended March 31, 2016 and 2015, respectively.
|
(c)
|
Includes alliance revenue of $508 million for the three months ended March 31, 2015. BMS's U.S. commercialization rights to
Abilify*
expired in April 2015.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Net product sales
|
$
|
3,964
|
|
|
$
|
3,059
|
|
Alliance revenues
|
409
|
|
|
955
|
|
||
Other revenues
|
18
|
|
|
27
|
|
||
Total Revenues
|
$
|
4,391
|
|
|
$
|
4,041
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Revenues from alliances:
|
|
|
|
||||
Net product sales
|
$
|
1,231
|
|
|
$
|
994
|
|
Alliance revenues
|
409
|
|
|
955
|
|
||
Total Revenues
|
$
|
1,640
|
|
|
$
|
1,949
|
|
|
|
|
|
||||
Payments to/(from) alliance partners:
|
|
|
|
||||
Cost of products sold
|
$
|
476
|
|
|
$
|
389
|
|
Marketing, selling and administrative
|
1
|
|
|
25
|
|
||
Research and development
|
33
|
|
|
122
|
|
||
Other (income)/expense
|
(253
|
)
|
|
(301
|
)
|
||
|
|
|
|
||||
Noncontrolling interest, pre-tax
|
2
|
|
|
5
|
|
Selected Alliance Balance Sheet information:
|
|
|
|
||||
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Receivables - from alliance partners
|
$
|
1,113
|
|
|
$
|
958
|
|
Accounts payable - to alliance partners
|
535
|
|
|
542
|
|
||
Deferred income from alliances
|
1,506
|
|
|
1,459
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Interest expense
|
$
|
43
|
|
|
$
|
51
|
|
Investment income
|
(24
|
)
|
|
(30
|
)
|
||
Provision for restructuring
|
4
|
|
|
12
|
|
||
Litigation and other settlements
|
43
|
|
|
12
|
|
||
Equity in net income of affiliates
|
(26
|
)
|
|
(26
|
)
|
||
Out-licensed intangible asset impairment
|
15
|
|
|
13
|
|
||
Divestiture gains
|
(270
|
)
|
|
(154
|
)
|
||
Royalties and licensing income
|
(254
|
)
|
|
(98
|
)
|
||
Transition and other service fees
|
(53
|
)
|
|
(27
|
)
|
||
Pension charges
|
22
|
|
|
27
|
|
||
Written option adjustment
|
—
|
|
|
(36
|
)
|
||
Other
|
(20
|
)
|
|
(43
|
)
|
||
Other (income)/expense
|
$
|
(520
|
)
|
|
$
|
(299
|
)
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Earnings Before Income Taxes
|
$
|
1,655
|
|
|
$
|
1,448
|
|
Provision for Income Taxes
|
449
|
|
|
249
|
|
||
Effective tax rate
|
27.1
|
%
|
|
17.2
|
%
|
|
Three Months Ended March 31,
|
||||||
Amounts in Millions, Except Per Share Data
|
2016
|
|
2015
|
||||
Net Earnings Attributable to BMS used for Basic and Diluted EPS Calculation
|
$
|
1,195
|
|
|
$
|
1,186
|
|
|
|
|
|
||||
Weighted-average common shares outstanding – basic
|
1,669
|
|
|
1,663
|
|
||
Incremental shares attributable to share-based compensation plans
|
11
|
|
|
13
|
|
||
Weighted-average common shares outstanding – diluted
|
1,680
|
|
|
1,676
|
|
||
|
|
|
|
||||
Earnings per Common Share:
|
|
|
|
||||
Basic
|
$
|
0.72
|
|
|
$
|
0.71
|
|
Diluted
|
$
|
0.71
|
|
|
$
|
0.71
|
|
|
March 31, 2016
|
|
December 31, 2015
|
||||||||||||||||||||
Dollars in Millions
|
Level 1
|
|
Level 2
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Total
|
||||||||||||
Cash and cash equivalents - Money market and other securities
|
$
|
—
|
|
|
$
|
2,139
|
|
|
$
|
2,139
|
|
|
$
|
—
|
|
|
$
|
1,825
|
|
|
$
|
1,825
|
|
Marketable securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Certificates of deposit
|
—
|
|
|
661
|
|
|
661
|
|
|
—
|
|
|
804
|
|
|
804
|
|
||||||
Corporate debt securities
|
—
|
|
|
4,590
|
|
|
4,590
|
|
|
—
|
|
|
5,638
|
|
|
5,638
|
|
||||||
Equity funds
|
—
|
|
|
94
|
|
|
94
|
|
|
—
|
|
|
92
|
|
|
92
|
|
||||||
Fixed income funds
|
—
|
|
|
7
|
|
|
7
|
|
|
—
|
|
|
11
|
|
|
11
|
|
||||||
Derivative assets:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Interest rate swap contracts
|
—
|
|
|
11
|
|
|
11
|
|
|
—
|
|
|
31
|
|
|
31
|
|
||||||
Forward starting interest rate swap contracts
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
15
|
|
|
15
|
|
||||||
Foreign currency forward contracts
|
—
|
|
|
31
|
|
|
31
|
|
|
—
|
|
|
50
|
|
|
50
|
|
||||||
Equity investments
|
42
|
|
|
—
|
|
|
42
|
|
|
60
|
|
|
—
|
|
|
60
|
|
||||||
Derivative liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Interest rate swap contracts
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
||||||
Forward starting interest rate swap contracts
|
—
|
|
|
(56
|
)
|
|
(56
|
)
|
|
—
|
|
|
(7
|
)
|
|
(7
|
)
|
||||||
Foreign currency forward contracts
|
—
|
|
|
(55
|
)
|
|
(55
|
)
|
|
—
|
|
|
(10
|
)
|
|
(10
|
)
|
|
2015
|
||||||||||
Dollars in Millions
|
ARS
|
|
Written option liabilities
|
|
Contingent consideration liability
|
||||||
Fair value at January 1
|
$
|
12
|
|
|
$
|
(198
|
)
|
|
$
|
(8
|
)
|
Settlements and other
|
—
|
|
|
69
|
|
|
—
|
|
|||
Changes in fair value
|
—
|
|
|
36
|
|
|
—
|
|
|||
Fair value at March 31
|
$
|
12
|
|
|
$
|
(93
|
)
|
|
$
|
(8
|
)
|
Dollars in Millions
|
Amortized
Cost |
|
Gross
Unrealized Gain in Accumulated OCI |
|
Gross
Unrealized Loss in Accumulated OCI |
|
Fair Value
|
|||||||||
March 31, 2016
|
|
|
|
|
|
|
|
|||||||||
Certificates of deposit
|
$
|
661
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
661
|
|
|
Corporate debt securities
|
4,552
|
|
|
41
|
|
|
(3
|
)
|
|
4,590
|
|
|||||
Equity investments
|
74
|
|
|
2
|
|
|
(34
|
)
|
|
42
|
|
|||||
Total
|
$
|
5,287
|
|
|
$
|
43
|
|
|
$
|
(37
|
)
|
|
$
|
5,293
|
|
|
|
|
|
|
|
|
|
|
|||||||||
December 31, 2015
|
|
|
|
|
|
|
|
|||||||||
Certificates of deposit
|
$
|
804
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
804
|
|
|
Corporate debt securities
|
5,646
|
|
|
15
|
|
|
(23
|
)
|
|
5,638
|
|
|||||
Equity investments
|
74
|
|
|
10
|
|
|
(24
|
)
|
|
60
|
|
|||||
Total
|
$
|
6,524
|
|
|
$
|
25
|
|
|
$
|
(47
|
)
|
|
$
|
6,502
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Current marketable securities
(a)
|
$
|
1,663
|
|
|
$
|
1,885
|
|
Non-current marketable securities
(b)
|
3,689
|
|
|
4,660
|
|
||
Other assets
|
42
|
|
|
60
|
|
||
Available-for-sale securities
|
$
|
5,394
|
|
|
$
|
6,605
|
|
(a)
|
The fair value option for financial assets was elected for investments in equity and fixed income funds. The fair value of these investments were
$101 million
at
March 31, 2016
and
$103 million
at
December 31, 2015
and were included in current marketable securities.
|
(b)
|
All non-current marketable securities mature within five years as of
March 31, 2016
and
December 31, 2015
.
|
|
|
|
March 31, 2016
|
|
December 31, 2015
|
||||||||||||
Dollars in Millions
|
Balance Sheet Location
|
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
||||||||
Derivatives designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
||||||||
Interest rate swap contracts
|
Other assets
|
|
$
|
1,250
|
|
|
$
|
11
|
|
|
$
|
1,100
|
|
|
$
|
31
|
|
Interest rate swap contracts
|
Pension and other liabilities
|
|
—
|
|
|
—
|
|
|
650
|
|
|
(1
|
)
|
||||
Forward starting interest rate swap contracts
|
Other assets
|
|
—
|
|
|
—
|
|
|
500
|
|
|
15
|
|
||||
Forward starting interest rate swap contracts
|
Pension and other liabilities
|
|
750
|
|
|
(56
|
)
|
|
250
|
|
|
(7
|
)
|
||||
Foreign currency forward contracts
|
Prepaid expenses and other
|
|
506
|
|
|
31
|
|
|
1,016
|
|
|
50
|
|
||||
Foreign currency forward contracts
|
Accrued liabilities
|
|
1,354
|
|
|
(54
|
)
|
|
787
|
|
|
(10
|
)
|
||||
Foreign currency forward contracts
|
Pension and other liabilities
|
|
16
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Principal Value
|
$
|
6,362
|
|
|
$
|
6,339
|
|
Adjustments to Principal Value:
|
|
|
|
||||
Fair value of interest rate swap contracts
|
11
|
|
|
30
|
|
||
Unamortized basis adjustment from swap terminations
|
308
|
|
|
272
|
|
||
Unamortized bond discounts and issuance costs
|
(88
|
)
|
|
(91
|
)
|
||
Total
|
$
|
6,593
|
|
|
$
|
6,550
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Trade receivables
|
$
|
3,498
|
|
|
$
|
3,070
|
|
Less allowances
|
(135
|
)
|
|
(122
|
)
|
||
Net trade receivables
|
3,363
|
|
|
2,948
|
|
||
Alliance receivables
|
1,113
|
|
|
958
|
|
||
Prepaid and refundable income taxes
|
207
|
|
|
182
|
|
||
Other
|
274
|
|
|
211
|
|
||
Receivables
|
$
|
4,957
|
|
|
$
|
4,299
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Finished goods
|
$
|
402
|
|
|
$
|
381
|
|
Work in process
|
919
|
|
|
868
|
|
||
Raw and packaging materials
|
227
|
|
|
199
|
|
||
Total inventories
|
$
|
1,548
|
|
|
$
|
1,448
|
|
|
|
|
|
||||
Inventories
|
$
|
1,336
|
|
|
$
|
1,221
|
|
Other assets
|
212
|
|
|
227
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Land
|
$
|
107
|
|
|
$
|
107
|
|
Buildings
|
4,611
|
|
|
4,515
|
|
||
Machinery, equipment and fixtures
|
3,392
|
|
|
3,347
|
|
||
Construction in progress
|
647
|
|
|
662
|
|
||
Gross property, plant and equipment
|
8,757
|
|
|
8,631
|
|
||
Less accumulated depreciation
|
(4,302
|
)
|
|
(4,219
|
)
|
||
Property, plant and equipment
|
$
|
4,455
|
|
|
$
|
4,412
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Licenses
|
$
|
559
|
|
|
$
|
574
|
|
Developed technology rights
|
2,357
|
|
|
2,357
|
|
||
Capitalized software
|
1,318
|
|
|
1,302
|
|
||
In-process research and development
|
120
|
|
|
120
|
|
||
Gross other intangible assets
|
4,354
|
|
|
4,353
|
|
||
Less accumulated amortization
|
(2,974
|
)
|
|
(2,934
|
)
|
||
Other intangible assets
|
$
|
1,380
|
|
|
$
|
1,419
|
|
Dollars in Millions
|
|
March 31,
2016 |
|
December 31,
2015 |
||||
Accrued rebates and returns
|
|
$
|
1,519
|
|
|
$
|
1,324
|
|
Employee compensation and benefits
|
|
385
|
|
|
904
|
|
||
Dividends payable
|
|
642
|
|
|
655
|
|
||
Accrued research and development
|
|
527
|
|
|
553
|
|
||
Litigation and other settlements
|
|
169
|
|
|
189
|
|
||
Royalties
|
|
126
|
|
|
161
|
|
||
Restructuring
|
|
66
|
|
|
89
|
|
||
Pension and postretirement benefits
|
|
47
|
|
|
47
|
|
||
Other
|
|
830
|
|
|
816
|
|
||
Accrued liabilities
|
|
$
|
4,311
|
|
|
$
|
4,738
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Alliances
|
$
|
1,506
|
|
|
$
|
1,459
|
|
Other
|
265
|
|
|
130
|
|
||
Total deferred income
|
$
|
1,771
|
|
|
$
|
1,589
|
|
|
|
|
|
||||
Current portion
|
$
|
1,165
|
|
|
$
|
1,003
|
|
Non-current portion
|
606
|
|
|
586
|
|
|
Common Stock
|
|
Capital in Excess
of Par Value
of Stock
|
|
Retained
Earnings
|
|
Treasury Stock
|
|
Noncontrolling
Interest
|
||||||||||||||||
Dollars and Shares in Millions
|
Shares
|
|
Par Value
|
|
Shares
|
|
Cost
|
|
|||||||||||||||||
Balance at January 1, 2015
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,507
|
|
|
$
|
32,541
|
|
|
547
|
|
|
$
|
(16,992
|
)
|
|
$
|
131
|
|
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
1,186
|
|
|
—
|
|
|
—
|
|
|
15
|
|
|||||
Cash dividends declared
|
—
|
|
|
—
|
|
|
—
|
|
|
(617
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Employee stock compensation plans
|
—
|
|
|
—
|
|
|
(193
|
)
|
|
—
|
|
|
(6
|
)
|
|
309
|
|
|
—
|
|
|||||
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
|||||
Balance at March 31, 2015
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,314
|
|
|
$
|
33,110
|
|
|
541
|
|
|
$
|
(16,683
|
)
|
|
$
|
143
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Balance at January 1, 2016
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,459
|
|
|
$
|
31,613
|
|
|
539
|
|
|
$
|
(16,559
|
)
|
|
$
|
158
|
|
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
1,195
|
|
|
—
|
|
|
—
|
|
|
11
|
|
|||||
Cash dividends declared
|
—
|
|
|
—
|
|
|
—
|
|
|
(632
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock repurchase program
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4
|
|
|
(231
|
)
|
|
—
|
|
|||||
Employee stock compensation plans
|
—
|
|
|
—
|
|
|
44
|
|
|
—
|
|
|
(4
|
)
|
|
(31
|
)
|
|
—
|
|
|||||
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|||||
Balance at March 31, 2016
|
2,208
|
|
|
$
|
221
|
|
|
$
|
1,503
|
|
|
$
|
32,176
|
|
|
539
|
|
|
$
|
(16,821
|
)
|
|
$
|
165
|
|
|
2016
|
|
2015
|
||||||||||||||||||||
|
Pretax
|
|
Tax
|
|
After tax
|
|
Pretax
|
|
Tax
|
|
After tax
|
||||||||||||
Three Months Ended March 31,
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Derivatives qualifying as cash flow hedges:
(a)
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gains/(losses)
|
$
|
(126
|
)
|
|
$
|
42
|
|
|
$
|
(84
|
)
|
|
$
|
35
|
|
|
$
|
(11
|
)
|
|
$
|
24
|
|
Reclassified to net earnings
|
(4
|
)
|
|
2
|
|
|
(2
|
)
|
|
(27
|
)
|
|
9
|
|
|
(18
|
)
|
||||||
Derivatives qualifying as cash flow hedges
|
(130
|
)
|
|
44
|
|
|
(86
|
)
|
|
8
|
|
|
(2
|
)
|
|
6
|
|
||||||
Pension and postretirement benefits:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Actuarial losses
|
(292
|
)
|
|
103
|
|
|
(189
|
)
|
|
(120
|
)
|
|
42
|
|
|
(78
|
)
|
||||||
Amortization
(b)
|
17
|
|
|
(3
|
)
|
|
14
|
|
|
23
|
|
|
(6
|
)
|
|
17
|
|
||||||
Curtailments and settlements
(c)
|
22
|
|
|
(8
|
)
|
|
14
|
|
|
27
|
|
|
(10
|
)
|
|
17
|
|
||||||
Pension and postretirement benefits
|
(253
|
)
|
|
92
|
|
|
(161
|
)
|
|
(70
|
)
|
|
26
|
|
|
(44
|
)
|
||||||
Available-for-sale securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gains
|
27
|
|
|
(14
|
)
|
|
13
|
|
|
25
|
|
|
(8
|
)
|
|
17
|
|
||||||
Realized gains
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
—
|
|
|
(1
|
)
|
||||||
Available-for-sale securities
|
27
|
|
|
(14
|
)
|
|
13
|
|
|
24
|
|
|
(8
|
)
|
|
16
|
|
||||||
Foreign currency translation
|
2
|
|
|
7
|
|
|
9
|
|
|
46
|
|
|
(15
|
)
|
|
31
|
|
||||||
|
$
|
(354
|
)
|
|
$
|
129
|
|
|
$
|
(225
|
)
|
|
$
|
8
|
|
|
$
|
1
|
|
|
$
|
9
|
|
(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
|
March 31,
2016 |
|
December 31, 2015
|
||||
Derivatives qualifying as cash flow hedges
|
$
|
(52
|
)
|
|
$
|
34
|
|
Pension and other postretirement benefits
|
(2,241
|
)
|
|
(2,080
|
)
|
||
Available-for-sale securities
|
(10
|
)
|
|
(23
|
)
|
||
Foreign currency translation
|
(390
|
)
|
|
(399
|
)
|
||
Accumulated other comprehensive loss
|
$
|
(2,693
|
)
|
|
$
|
(2,468
|
)
|
|
Three Months Ended March 31,
|
||||||||||||||
|
Pension Benefits
|
|
Other Benefits
|
||||||||||||
Dollars in Millions
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Service cost – benefits earned during the year
|
$
|
6
|
|
|
$
|
6
|
|
|
$
|
1
|
|
|
$
|
1
|
|
Interest cost on projected benefit obligation
|
51
|
|
|
61
|
|
|
3
|
|
|
3
|
|
||||
Expected return on plan assets
|
(104
|
)
|
|
(102
|
)
|
|
(6
|
)
|
|
(7
|
)
|
||||
Amortization of prior service credits
|
(1
|
)
|
|
(1
|
)
|
|
(1
|
)
|
|
(1
|
)
|
||||
Amortization of net actuarial loss
|
19
|
|
|
24
|
|
|
—
|
|
|
1
|
|
||||
Curtailments and settlements
|
22
|
|
|
27
|
|
|
—
|
|
|
—
|
|
||||
Special termination benefits
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Net periodic benefit cost/(credit)
|
$
|
(6
|
)
|
|
$
|
15
|
|
|
$
|
(3
|
)
|
|
$
|
(3
|
)
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Restricted stock units
|
$
|
20
|
|
|
$
|
21
|
|
Market share units
|
9
|
|
|
9
|
|
||
Performance share units
|
18
|
|
|
24
|
|
||
Total stock-based compensation expense
|
$
|
47
|
|
|
$
|
54
|
|
|
|
|
|
||||
Income tax benefit
|
$
|
15
|
|
|
$
|
18
|
|
|
Three Months Ended March 31, 2016
|
|||||
Units in Millions
|
Units
|
|
Weighted-Average Fair Value
|
|||
Restricted stock units
|
2.1
|
|
|
$
|
61.23
|
|
Market share units
|
0.7
|
|
|
65.26
|
|
|
Performance share units
|
1.1
|
|
|
64.87
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions, except per share data
|
2016
|
|
2015
|
||||
Total Revenues
|
$
|
4,391
|
|
|
$
|
4,041
|
|
Total Expenses
|
2,736
|
|
|
2,593
|
|
||
Earnings Before Income Taxes
|
1,655
|
|
|
1,448
|
|
||
Provision for Income Taxes
|
449
|
|
|
249
|
|
||
Effective tax rate
|
27.1
|
%
|
|
17.2
|
%
|
||
|
|
|
|
||||
Net Earnings Attributable to BMS
|
|
|
|
||||
GAAP
|
1,195
|
|
|
1,186
|
|
||
Non-GAAP
|
1,235
|
|
|
1,193
|
|
||
|
|
|
|
||||
Diluted Earnings Per Share
|
|
|
|
||||
GAAP
|
0.71
|
|
|
0.71
|
|
||
Non-GAAP
|
0.74
|
|
|
0.71
|
|
||
|
|
|
|
||||
Cash, Cash Equivalents and Marketable Securities
|
7,996
|
|
|
11,886
|
|
Product
|
Date
|
Approval
|
Opdivo
|
April 2016
|
European Union (EU) approval for the treatment of previously treated renal cell carcinoma (RCC).
|
April 2016
|
EU approval for the treatment of previously treated patients with metastatic non-squamous (NSQ) non-small cell lung cancer (NSCLC).
|
|
January 2016
|
U.S. Food and Drug Administration (FDA) expanded the use of
Opdivo
as a single agent to include previously untreated BRAF mutation positive advanced melanoma patients.
|
|
Opdivo
+
Yervoy
|
January 2016
|
FDA approval for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation positive unresectable or metastatic melanoma.
|
Hepatitis C Portfolio -
Daklinza
|
February 2016
|
FDA approval for use with sofosbuvir for the treatment of chronic hepatitis C (HCV) in genotypes 1 and 3 in three additional patient populations.
|
January 2016
|
EU approval for use with sofosbuvir for the treatment of chronic HCV in three new patient populations.
|
|
Three Months Ended March 31,
|
||||||||||||
|
Total Revenues
|
|
2016 vs. 2015
|
||||||||||
Dollars in Millions
|
2016
|
|
2015
|
|
Total Change
|
|
Foreign
Exchange
(b)
|
||||||
United States
|
$
|
2,537
|
|
|
$
|
2,044
|
|
|
24
|
%
|
|
—
|
|
Europe
|
870
|
|
|
782
|
|
|
11
|
%
|
|
(4
|
)%
|
||
Rest of the World
|
840
|
|
|
1,019
|
|
|
(18
|
)%
|
|
(7
|
)%
|
||
Other
(a)
|
144
|
|
|
196
|
|
|
(27
|
)%
|
|
N/A
|
|
||
Total
|
$
|
4,391
|
|
|
$
|
4,041
|
|
|
9
|
%
|
|
(2
|
)%
|
(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 March 31,
|
|||||||||
Dollars in Millions
|
|
2016
|
|
2015
|
|
% Change
|
|||||
Gross product sales
|
|
$
|
4,966
|
|
|
$
|
3,635
|
|
|
37
|
%
|
Gross-to-Net Adjustments:
|
|
|
|
|
|
|
|||||
Charge-backs and cash discounts
|
|
(352
|
)
|
|
(200
|
)
|
|
76
|
%
|
||
Medicaid and Medicare rebates
|
|
(260
|
)
|
|
(146
|
)
|
|
78
|
%
|
||
Sales returns
|
|
(43
|
)
|
|
(18
|
)
|
|
139
|
%
|
||
Other rebates, discounts and adjustments
|
|
(347
|
)
|
|
(212
|
)
|
|
64
|
%
|
||
Total Gross-to-Net Adjustments
|
|
(1,002
|
)
|
|
(576
|
)
|
|
74
|
%
|
||
Net product sales
|
|
$
|
3,964
|
|
|
$
|
3,059
|
|
|
30
|
%
|
•
|
Charge-backs and cash discounts increased primarily due to higher product sales in the U.S. which also increased by 76%, particularly regarding
Opdivo
,
Eliquis
and
Daklinza
.
|
•
|
Medicaid and Medicare rebates increased primarily due to higher product sales in the U.S., particularly regarding Medicare for
Eliquis
and Medicaid and Medicare for
Daklinza
.
|
•
|
Other rebates, discounts and adjustments increased primarily due to additional rebates and discounts for
Daklinza
in Europe and
Eliquis
worldwide.
|
|
Three Months Ended March 31,
|
||||||||||||
Dollars in Millions
|
2016
|
|
2015
|
|
% Change
|
|
% Change Attributable to Foreign Exchange
|
||||||
Oncology
|
|
|
|
|
|
|
|
||||||
Empliciti (elotuzumab)
|
$
|
28
|
|
|
$
|
—
|
|
|
N/A
|
|
|
N/A
|
|
U.S.
|
28
|
|
|
—
|
|
|
N/A
|
|
|
—
|
|
||
|
|
|
|
|
|
|
|
||||||
Erbitux* (cetuximab)
|
—
|
|
|
165
|
|
|
(100
|
)%
|
|
—
|
|
||
U.S.
|
—
|
|
|
157
|
|
|
(100
|
)%
|
|
—
|
|
||
Non-U.S.
|
—
|
|
|
8
|
|
|
(100
|
)%
|
|
—
|
|
||
|
|
|
|
|
|
|
|
||||||
Opdivo (nivolumab)
|
704
|
|
|
40
|
|
|
**
|
|
|
N/A
|
|
||
U.S.
|
594
|
|
|
38
|
|
|
**
|
|
|
—
|
|
||
Non-U.S.
|
110
|
|
|
2
|
|
|
**
|
|
|
N/A
|
|
||
|
|
|
|
|
|
|
|
||||||
Sprycel (dasatinib)
|
407
|
|
|
375
|
|
|
9
|
%
|
|
(3
|
)%
|
||
U.S.
|
210
|
|
|
181
|
|
|
16
|
%
|
|
—
|
|
||
Non-U.S.
|
197
|
|
|
194
|
|
|
2
|
%
|
|
(6
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Yervoy (ipilimumab)
|
263
|
|
|
325
|
|
|
(19
|
)%
|
|
(1
|
)%
|
||
U.S.
|
199
|
|
|
181
|
|
|
10
|
%
|
|
—
|
|
||
Non-U.S.
|
64
|
|
|
144
|
|
|
(56
|
)%
|
|
(5
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Cardiovascular
|
|
|
|
|
|
|
|
||||||
Eliquis (apixaban)
|
734
|
|
|
355
|
|
|
**
|
|
|
(2
|
)%
|
||
U.S.
|
468
|
|
|
200
|
|
|
**
|
|
|
—
|
|
||
Non-U.S.
|
266
|
|
|
155
|
|
|
72
|
%
|
|
(4
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Immunoscience
|
|
|
|
|
|
|
|
||||||
Orencia (abatacept)
|
475
|
|
|
400
|
|
|
19
|
%
|
|
(2
|
)%
|
||
U.S.
|
321
|
|
|
259
|
|
|
24
|
%
|
|
—
|
|
||
Non-U.S.
|
154
|
|
|
141
|
|
|
9
|
%
|
|
(6
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Virology
|
|
|
|
|
|
|
|
||||||
Baraclude (entecavir)
|
291
|
|
|
340
|
|
|
(14
|
)%
|
|
(3
|
)%
|
||
U.S.
|
17
|
|
|
46
|
|
|
(63
|
)%
|
|
—
|
|
||
Non-U.S.
|
274
|
|
|
294
|
|
|
(7
|
)%
|
|
(4
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Hepatitis C Franchise
(daclatasvir and
asunaprevir)
|
427
|
|
|
264
|
|
|
62
|
%
|
|
(3
|
)%
|
||
U.S.
|
259
|
|
|
—
|
|
|
N/A
|
|
|
—
|
|
||
Non-U.S.
|
168
|
|
|
264
|
|
|
(36
|
)%
|
|
(3
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Reyataz (atazanavir sulfate) Franchise
|
221
|
|
|
294
|
|
|
(25
|
)%
|
|
(4
|
)%
|
||
U.S.
|
120
|
|
|
143
|
|
|
(16
|
)%
|
|
—
|
|
||
Non-U.S.
|
101
|
|
|
151
|
|
|
(33
|
)%
|
|
(8
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Sustiva (efavirenz) Franchise
|
273
|
|
|
290
|
|
|
(6
|
)%
|
|
—
|
|
||
U.S.
|
228
|
|
|
234
|
|
|
(3
|
)%
|
|
—
|
|
||
Non-U.S.
|
45
|
|
|
56
|
|
|
(20
|
)%
|
|
—
|
|
||
|
|
|
|
|
|
|
|
||||||
Neuroscience
|
|
|
|
|
|
|
|
||||||
Abilify* (aripiprazole)
|
33
|
|
|
554
|
|
|
(94
|
)%
|
|
—
|
|
||
U.S.
|
—
|
|
|
508
|
|
|
(100
|
)%
|
|
—
|
|
||
Non-U.S.
|
33
|
|
|
46
|
|
|
(28
|
)%
|
|
(6
|
)%
|
||
|
|
|
|
|
|
|
|
||||||
Mature Products and All Other
|
535
|
|
|
639
|
|
|
(16
|
)%
|
|
(3
|
)%
|
||
U.S.
|
93
|
|
|
97
|
|
|
(4
|
)%
|
|
—
|
|
||
Non-U.S.
|
442
|
|
|
542
|
|
|
(18
|
)%
|
|
(4
|
)%
|
•
|
Empliciti
was launched in the U.S. in December 2015.
|
•
|
BMS transferred its rights to
Erbitux*
in North America to Eli Lilly and Company in October 2015.
|
•
|
U.S. revenues increased due to higher demand and the rapid commercial acceptance of
Opdivo
for the treatment of NSQ and squamous (SQ) NSCLC, RCC and unresectable melanoma.
|
•
|
International revenues increased due to higher demand and the rapid commercial acceptance of
Opdivo
.
Opdivo
was approved in Japan for unresectable melanoma (September 2014) and recurrent NSCLC (December 2015) and in the EU for unresectable melanoma (June 2015) and advanced SQ NSCLC (July 2015).
Opdivo
was also approved in other international markets in 2015.
|
•
|
U.S. revenues increased due to higher average net selling prices and demand.
|
•
|
International revenues remained relatively flat as higher demand was offset by unfavorable foreign exchange.
|
•
|
U.S. revenues increased due to higher demand.
|
•
|
International revenues decreased due to lower demand resulting from the introduction of other immuno-oncology products being used to treat patients with melanoma, including
Opdivo
.
|
•
|
U.S. and international revenues increased due to higher demand resulting from increased commercial acceptance of novel oral anticoagulants and market share gains.
|
•
|
U.S. revenues increased due to higher average net selling prices and demand.
|
•
|
International revenues increased due to higher demand partially offset by unfavorable foreign exchange.
|
•
|
U.S. revenues continue to decrease due to the loss of exclusivity in September 2014.
|
•
|
International revenues decreased following the loss of exclusivity in South Korea in October 2015 and unfavorable foreign exchange.
|
•
|
Daklinza
was launched in the U.S. in July 2015. U.S. revenues are expected to significantly decline in the second half of 2016 due to lower demand resulting from increased competition.
|
•
|
International revenues decreased and are expected to continue to significantly decline in 2016 from the prior year comparable periods due to lower demand resulting from increased competition, primarily in Japan.
|
•
|
U.S. revenues decreased due to lower demand resulting from increased competition partially offset by higher average net selling prices.
|
•
|
International revenues decreased due to the timing of government purchases in certain countries, lower demand resulting from increased competition and unfavorable foreign exchange.
|
•
|
U.S. revenues decreased due to lower demand resulting from increased competition partially offset by higher average net selling prices.
|
•
|
International revenues continue to decrease due to
Sustiva's
loss of exclusivity in Europe in November 2013.
|
•
|
BMS's U.S. commercialization rights to
Abilify*
expired in April 2015.
|
•
|
International revenues decreased due to the expiration of certain supply arrangements, increased competition for over-the-counter products and unfavorable foreign exchange.
|
|
Three Months Ended March 31,
|
|||||||||
Dollars in Millions
|
2016
|
|
2015
|
|
% Change
|
|||||
Cost of products sold
|
$
|
1,052
|
|
|
$
|
847
|
|
|
24
|
%
|
Marketing, selling and administrative
|
1,068
|
|
|
1,029
|
|
|
4
|
%
|
||
Research and development
|
1,136
|
|
|
1,016
|
|
|
12
|
%
|
||
Other (income)/expense
|
(520
|
)
|
|
(299
|
)
|
|
74
|
%
|
||
Total Expenses
|
$
|
2,736
|
|
|
$
|
2,593
|
|
|
6
|
%
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Earnings Before Income Taxes
|
$
|
1,655
|
|
|
$
|
1,448
|
|
Provision for Income Taxes
|
449
|
|
|
249
|
|
||
Effective tax rate
|
27.1
|
%
|
|
17.2
|
%
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Cost of products sold
(a)
|
$
|
4
|
|
|
$
|
34
|
|
|
|
|
|
||||
Marketing, selling and administrative
|
—
|
|
|
1
|
|
||
|
|
|
|
||||
License and asset acquisition charges
|
125
|
|
|
162
|
|
||
Other
|
13
|
|
|
—
|
|
||
Research and development
|
138
|
|
|
162
|
|
||
|
|
|
|
||||
Provision for restructuring
|
4
|
|
|
12
|
|
||
Divestiture gains
|
(269
|
)
|
|
(152
|
)
|
||
Pension charges
|
22
|
|
|
27
|
|
||
Written option adjustment
|
—
|
|
|
(36
|
)
|
||
Litigation and other settlements
|
43
|
|
|
14
|
|
||
Out-licensed intangible asset impairment
|
15
|
|
|
13
|
|
||
Other (income)/expense
|
(185
|
)
|
|
(122
|
)
|
||
|
|
|
|
||||
Increase/(decrease) to pretax income
|
(43
|
)
|
|
75
|
|
||
Income taxes on items above
|
83
|
|
|
(68
|
)
|
||
Increase to net earnings
|
$
|
40
|
|
|
$
|
7
|
|
(a)
|
Specified items in cost of products sold are accelerated depreciation, asset impairment and other shutdown costs.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions, except per share data
|
2016
|
|
2015
|
||||
Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP
|
$
|
1,195
|
|
|
$
|
1,186
|
|
Specified Items
|
40
|
|
|
7
|
|
||
Net Earnings used for Diluted EPS Calculation – Non-GAAP
|
$
|
1,235
|
|
|
$
|
1,193
|
|
|
|
|
|
||||
Average Common Shares Outstanding – Diluted
|
1,680
|
|
|
1,676
|
|
||
|
|
|
|
||||
Diluted Earnings Per Share – GAAP
|
$
|
0.71
|
|
|
$
|
0.71
|
|
Diluted EPS Attributable to Specified Items
|
0.03
|
|
|
—
|
|
||
Diluted Earnings Per Share – Non-GAAP
|
$
|
0.74
|
|
|
$
|
0.71
|
|
Dollars in Millions
|
March 31,
2016 |
|
December 31,
2015 |
||||
Cash and cash equivalents
|
$
|
2,644
|
|
|
$
|
2,385
|
|
Marketable securities – current
|
1,663
|
|
|
1,885
|
|
||
Marketable securities – non-current
|
3,689
|
|
|
4,660
|
|
||
Cash, cash equivalents and marketable securities
|
7,996
|
|
|
8,930
|
|
||
Short-term borrowings
|
(106
|
)
|
|
(139
|
)
|
||
Long-term debt
|
(6,593
|
)
|
|
(6,550
|
)
|
||
Net cash position
|
$
|
1,297
|
|
|
$
|
2,241
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2016
|
|
2015
|
||||
Cash flow provided by/(used in):
|
|
|
|
||||
Operating activities
|
$
|
(386
|
)
|
|
$
|
626
|
|
Investing activities
|
1,426
|
|
|
754
|
|
||
Financing activities
|
(792
|
)
|
|
(682
|
)
|
•
|
Higher income tax payments (approximately $600 million); and
|
•
|
Timing of customer collections resulting primarily from higher net product sales and longer payment terms for immuno-oncology products and the timing of payments with alliance partners in the ordinary course of business (approximately $400 million).
|
•
|
Higher net sales of marketable securities of approximately $500 million in 2016 to meet short-term liquidity requirements; and
|
•
|
Higher business divestiture proceeds of approximately $200 million (approximately $400 million in 2016 and $200 million in 2015). Divestitures included the sale of the investigational HIV business in 2016 and
Recothrom*
and other mature brand businesses in 2015.
|
•
|
In April 2016, the Company announced results from multiple clinical trials
|
◦
|
CheckMate-069 - In this Phase II trial, which is the first randomized study to evaluate the
Opdivo
+
Yervoy
combination regimen in patients with previously untreated advanced melanoma, the combination regimen demonstrated a two-year overall survival rate of 69% compared to 53% for
Yervoy
alone in patients with BRAF wild-type advanced melanoma. A change in tumor burden was also seen with the combination regimen, with a median change of 70% compared to 5% for
Yervoy
alone. Overall survival was an exploratory endpoint in this trial. The safety profile of the
Opdivo
+
Yervoy
combination regimen in this study was consistent with previously reported studies.
|
◦
|
CA209-003 - In this Phase I study, evaluating
Opdivo
monotherapy in heavily pretreated advanced melanoma patients, the Company reported extended follow-up, including five-year overall survival rates. These data represent the longest survival follow-up of patients who received an anti-PD-1 therapy in a clinical trial. At five years, patients who received
Opdivo
showed an overall survival rate of 34%, with an evident plateau in survival at approximately four years. The safety profile of
Opdivo
in study -003 was similar to previously reported studies, with no new safety signals identified.
|
•
|
In April 2016, the Company announced the Committee for Medicinal Products for Human Use (CHMP) recommended the approval of
Opdivo
in combination with
Yervoy
for the treatment of advanced (unresectable or metastatic) melanoma in adults. The CHMP also added an informative statement to the broad indication that relative to
Opdivo
monotherapy, an increase in progression-free survival for the combination of
Opdivo
with
Yervoy
is established only in patients with low tumor PD-L1 expression. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the EU.
|
•
|
In January 2016, the Company announced the FDA approved
Opdivo
in combination with
Yervoy
for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation positive unresectable or metastatic melanoma. This approval expands the original indication for the
Opdivo+Yervoy
regimen for the treatment of patients with BRAF
V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase III CheckMate-067 trial which evaluated progression-free survival and overall survival as co-primary endpoints. This indication is approved under accelerated approval based on progression-free survival.
|
•
|
In January 2016, the Company announced the FDA expanded the use of
Opdivo
as a single agent to include previously untreated BRAF
mutation positive advanced melanoma patients. The use of
Opdivo
as a single agent in patients with BRAF
V600 mutation positive
unresectable or metastatic melanoma is approved under accelerated approval based on progression-free survival.
|
•
|
In April 2016, the Company announced the EC approved
Opdivo
monotherapy for locally advanced or metastatic NSQ NSCLC after prior chemotherapy in adults.
Opdivo
is the only approved PD-1 inhibitor to demonstrate superior overall survival in two separate Phase III trials in previously treated metastatic NSCLC; one trial in SQ NSCLC (CheckMate-017) and the other in NSQ NSCLC (CheckMate-057), the basis of this approval. Together, these trials confirm the benefit of
Opdivo
for patients with previously treated metastatic NSCLC, regardless of PD-L1 expression. The approval allows for the expanded marketing of
Opdivo
in previously treated metastatic NSCLC in all 28 Member States of the EU.
|
•
|
In April 2016, the Company announced the FDA granted Breakthrough Therapy Designation to
Opdivo
for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy.
|
•
|
In April 2016, the Company announced data from CheckMate-141, a Phase III open-label, randomized trial, evaluating
Opdivo
in patients with recurrent or metastatic SCCHN after platinum therapy compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab). In the trial patients treated with
Opdivo
experienced a 30% reduction in the risk of death, with a median overall survival of 7.5 months compared to 5.1 months for investigator’s choice. The one-year survival rate for
Opdivo
was 36% compared to 16.6% for investigator’s choice. The safety profile of
Opdivo
in CheckMate-141 was consistent with prior studies, with no new safety signals identified. In January 2016, the Company announced CheckMate-141 was stopped early because an assessment
|
•
|
In April 2016, the Company announced the FDA accepted a supplemental Biologics License Application (sBLA), which seeks to expand the use of
Opdivo
to patients with classical Hodgkin lymphoma (cHL) after prior therapies. The application included CheckMate-205 data, which evaluated
Opdivo
in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. The FDA granted the application a priority review and previously granted
Opdivo
Breakthrough Therapy Designation for cHL on May 14, 2014.
|
•
|
In April 2016, the Company announced the EC approved
Opdivo
monotherapy for an additional indication in advanced RCC after prior therapy in adults.
Opdivo
is the first and only PD-1 immune checkpoint inhibitor approved in Europe to demonstrate an overall survival benefit versus a standard of care in this patient population. This approval allows for the expanded marketing of
Opdivo
in previously treated advanced RCC in all 28 Member States of the EU.
|
•
|
In March 2016, the Company announced the European Medicines Agency (EMA) validated a type II variation application, which seeks to extend the current indications for
Opdivo
to include the treatment of patients with cHL after prior therapies. The application included CheckMate-205 data, which evaluated
Opdivo
in cHL patients who have received autologous stem cell transplant and brentuximab vedotin. Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.
|
•
|
In January 2016, the Company and AbbVie announced the CHMP of the EMA adopted a positive opinion recommending that
Empliciti
be granted approval for the treatment of multiple myeloma as combination therapy with
Revlimid*
and dexamethasone in patients who have received at least one prior therapy. The application now will be reviewed by the EC.
|
•
|
In February 2016, the Company announced the FDA approved
Daklinza
in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic HCV patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The
Daklinza
plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response (SVR) rates are reduced in genotype 3 patients with cirrhosis receiving
Daklinza
and sofosbuvir for 12 weeks without ribavirin. Sofosbuvir is a product of Gilead Sciences, Inc. (Gilead).
|
•
|
In February 2016, the Company announced results from the first completed all-oral chronic HCV regimen Phase III trial that includes a Chinese patient population. In the study, which evaluated
Daklinza
in combination with asunaprevir for 24 weeks in Asian (non-Japanese) patients with genotype 1b HCV, 91% of patients from China achieved sustained virologic response at post-treatment week 24 (SVR24), which rose to 98% of patients without NS5A resistance-associated variants (RAVs) at baseline. SVR24 results were similarly high across all subgroups with genotype 1b HCV, including those with cirrhosis, and patients from Korea and Taiwan. SVR24 rates were also higher in all patients without baseline NS5A RAVs, regardless of the presence or absence of cirrhosis, and lower in patients with baseline NS5A RAVs.
|
•
|
In January 2016, the Company announced the EC approved
Daklinza
for the treatment of chronic HCV in three new patient populations. The expanded label allows for the use of
Daklinza
in combination with sofosbuvir (with or without ribavirin, depending on the indication and HCV genotype) in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the EU.
|
Period
|
Total Number of
Shares Purchased
(a)
|
|
Average
Price Paid
per Share
(a)
|
|
Total Number of
Shares Purchased as
Part of Publicly
Announced Plans or
Programs
(b)
|
|
Approximate Dollar
Value of Shares that
May Yet Be
Purchased Under the
Plans or Programs
(b)
|
||||||
Dollars in Millions, Except Per Share Data
|
|
|
|
|
|
|
|
||||||
January 1 to 31, 2016
|
29,768
|
|
|
$
|
68.96
|
|
|
—
|
|
|
$
|
1,368
|
|
February 1 to 29, 2016
|
1,334,226
|
|
|
$
|
62.45
|
|
|
1,193,017
|
|
|
$
|
1,294
|
|
March 1 to 31, 2016
|
4,008,710
|
|
|
$
|
64.12
|
|
|
2,464,576
|
|
|
$
|
1,137
|
|
Three months ended March 31, 2016
|
5,372,704
|
|
|
|
|
3,657,593
|
|
|
|
(a)
|
The total number of shares purchased and the total number of shares purchased as part of publicly announced programs are different because shares of common stock are 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. In June 2012, the Board of Directors increased its authorization for the repurchase of stock by an additional $3.0 billion. The stock repurchase program does not have an expiration date and we may consider future repurchases.
|
Exhibit No.
|
|
Description
|
12.
|
|
Computation of Earnings to Fixed Charges.
|
31a.
|
|
Section 302 Certification Letter.
|
31b.
|
|
Section 302 Certification Letter.
|
32a.
|
|
Section 906 Certification Letter.
|
32b.
|
|
Section 906 Certification Letter.
|
101.
|
|
The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, formatted in Extensible Business Reporting Language (XBRL):
(i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income and retained earnings, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
(REGISTRANT)
|
|
|
|
|
|
|
Date:
|
April 28, 2016
|
|
By:
|
/s/ Giovanni Caforio
|
|
|
|
|
Giovanni Caforio
Chief Executive Officer
|
|
|
|
|
|
Date:
|
April 28, 2016
|
|
By:
|
/s/ Charles Bancroft
|
|
|
|
|
Charles Bancroft
Chief Financial Officer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
---|
DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
---|
No information found
Customers
Suppliers
Price
Yield
Owner | Position | Direct Shares | Indirect Shares |
---|