|
Delaware
|
|
22-0790350
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S Employer
Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.10 Par Value
|
BMY
|
New York Stock Exchange
|
1.000% Notes due 2025
|
BMY25
|
New York Stock Exchange
|
1.750% Notes due 2035
|
BMY35
|
New York Stock Exchange
|
Bristol-Myers Squibb Contingent Value Rights
|
BMY RT
|
New York Stock Exchange
|
Celgene Contingent Value Rights
|
CELG RT
|
New York Stock Exchange
|
Large accelerated filer ☒
|
|
Accelerated filer ☐
|
|
Non-accelerated filer ☐
|
|
Smaller reporting company ☐
|
|
Emerging growth company ☐
|
|
|
|
PART I—FINANCIAL INFORMATION
|
|
|
|
Item 1.
|
|
|
|
|
|
Item 2.
|
|
|
|
Item 3.
|
|
|
|
Item 4.
|
|
|
|
PART II—OTHER INFORMATION
|
|
|
|
Item 1.
|
|
|
|
Item 1A.
|
|
|
|
Item 2.
|
|
|
|
Item 5.
|
|
|
|
Item 6.
|
|
|
|
*
|
Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index at the end of this Quarterly Report on Form 10-Q.
|
|
Three Months Ended March 31,
|
||||||
EARNINGS
|
2020
|
|
2019
|
||||
Net product sales
|
$
|
10,541
|
|
|
$
|
5,713
|
|
Alliance and other revenues
|
240
|
|
|
207
|
|
||
Total Revenues
|
10,781
|
|
|
5,920
|
|
||
|
|
|
|
||||
Cost of products sold(a)
|
3,662
|
|
|
1,824
|
|
||
Marketing, selling and administrative
|
1,606
|
|
|
1,006
|
|
||
Research and development
|
2,372
|
|
|
1,348
|
|
||
Amortization of acquired intangible assets
|
2,282
|
|
|
24
|
|
||
Other expense/(income), net
|
1,163
|
|
|
(261
|
)
|
||
Total Expenses
|
11,085
|
|
|
3,941
|
|
||
|
|
|
|
||||
(Loss)/Earnings Before Income Taxes
|
(304
|
)
|
|
1,979
|
|
||
Provision for Income Taxes
|
462
|
|
|
264
|
|
||
Net (Loss)/Earnings
|
(766
|
)
|
|
1,715
|
|
||
Noncontrolling Interest
|
9
|
|
|
5
|
|
||
Net (Loss)/Earnings Attributable to BMS
|
$
|
(775
|
)
|
|
$
|
1,710
|
|
|
|
|
|
||||
(Loss)/Earnings per Common Share
|
|
|
|
||||
Basic
|
$
|
(0.34
|
)
|
|
$
|
1.05
|
|
Diluted
|
(0.34
|
)
|
|
1.04
|
|
(a)
|
Excludes amortization of acquired intangible assets.
|
|
Three Months Ended March 31,
|
||||||
COMPREHENSIVE (LOSS)/INCOME
|
2020
|
|
2019
|
||||
Net (Loss)/Earnings
|
$
|
(766
|
)
|
|
$
|
1,715
|
|
Other Comprehensive (Loss)/Income, net of taxes and reclassifications to earnings:
|
|
|
|
||||
Derivatives qualifying as cash flow hedges
|
70
|
|
|
14
|
|
||
Pension and postretirement benefits
|
16
|
|
|
49
|
|
||
Available-for-sale debt securities
|
1
|
|
|
26
|
|
||
Foreign currency translation
|
(116
|
)
|
|
29
|
|
||
Other Comprehensive (Loss)/Income
|
(29
|
)
|
|
118
|
|
||
|
|
|
|
||||
Comprehensive (Loss)/Income
|
(795
|
)
|
|
1,833
|
|
||
Comprehensive Income Attributable to Noncontrolling Interest
|
9
|
|
|
5
|
|
||
Comprehensive (Loss)/Income Attributable to BMS
|
$
|
(804
|
)
|
|
$
|
1,828
|
|
ASSETS
|
March 31,
2020 |
|
December 31,
2019 |
||||
Current Assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
15,817
|
|
|
$
|
12,346
|
|
Marketable debt securities
|
2,505
|
|
|
3,047
|
|
||
Receivables
|
8,290
|
|
|
7,685
|
|
||
Inventories
|
2,836
|
|
|
4,293
|
|
||
Other current assets
|
2,405
|
|
|
1,983
|
|
||
Total Current Assets
|
31,853
|
|
|
29,354
|
|
||
Property, plant and equipment
|
6,112
|
|
|
6,252
|
|
||
Goodwill
|
22,452
|
|
|
22,488
|
|
||
Other intangible assets
|
61,666
|
|
|
63,969
|
|
||
Deferred income taxes
|
605
|
|
|
510
|
|
||
Marketable debt securities
|
651
|
|
|
767
|
|
||
Other non-current assets
|
5,946
|
|
|
6,604
|
|
||
Total Assets
|
$
|
129,285
|
|
|
$
|
129,944
|
|
|
|
|
|
||||
LIABILITIES
|
|
|
|
||||
Current Liabilities:
|
|
|
|
||||
Short-term debt obligations
|
$
|
3,862
|
|
|
$
|
3,346
|
|
Accounts payable
|
3,069
|
|
|
2,445
|
|
||
Other current liabilities
|
12,301
|
|
|
12,513
|
|
||
Total Current Liabilities
|
19,232
|
|
|
18,304
|
|
||
Deferred income taxes
|
6,531
|
|
|
6,454
|
|
||
Long-term debt
|
42,844
|
|
|
43,387
|
|
||
Other non-current liabilities
|
10,701
|
|
|
10,101
|
|
||
Total Liabilities
|
79,308
|
|
|
78,246
|
|
||
|
|
|
|
||||
Commitments and contingencies
|
|
|
|
||||
|
|
|
|
||||
EQUITY
|
|
|
|
||||
Bristol-Myers Squibb Company Shareholders’ Equity:
|
|
|
|
||||
Preferred stock
|
—
|
|
|
—
|
|
||
Common stock
|
292
|
|
|
292
|
|
||
Capital in excess of par value of stock
|
43,254
|
|
|
43,709
|
|
||
Accumulated other comprehensive loss
|
(1,549
|
)
|
|
(1,520
|
)
|
||
Retained earnings
|
32,671
|
|
|
34,474
|
|
||
Less cost of treasury stock
|
(24,757
|
)
|
|
(25,357
|
)
|
||
Total Bristol-Myers Squibb Company Shareholders’ Equity
|
49,911
|
|
|
51,598
|
|
||
Noncontrolling interest
|
66
|
|
|
100
|
|
||
Total Equity
|
49,977
|
|
|
51,698
|
|
||
Total Liabilities and Equity
|
$
|
129,285
|
|
|
$
|
129,944
|
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net (loss)/earnings
|
$
|
(766
|
)
|
|
$
|
1,715
|
|
Adjustments to reconcile net (loss)/earnings to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization, net
|
2,477
|
|
|
170
|
|
||
Deferred income taxes
|
(53
|
)
|
|
78
|
|
||
Stock-based compensation
|
210
|
|
|
53
|
|
||
Impairment charges
|
53
|
|
|
45
|
|
||
Pension settlements and amortization
|
11
|
|
|
66
|
|
||
Divestiture gains and royalties
|
(173
|
)
|
|
(166
|
)
|
||
Equity investment losses/(gains)
|
339
|
|
|
(175
|
)
|
||
Contingent consideration fair value adjustments
|
556
|
|
|
—
|
|
||
Other adjustments
|
(42
|
)
|
|
(6
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Receivables
|
(743
|
)
|
|
236
|
|
||
Inventories
|
1,448
|
|
|
35
|
|
||
Accounts payable
|
703
|
|
|
136
|
|
||
Income taxes payable
|
229
|
|
|
120
|
|
||
Other
|
(355
|
)
|
|
(917
|
)
|
||
Net Cash Provided by Operating Activities
|
3,894
|
|
|
1,390
|
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Sale and maturities of marketable debt securities
|
1,394
|
|
|
1,211
|
|
||
Purchase of marketable debt securities
|
(735
|
)
|
|
(242
|
)
|
||
Capital expenditures
|
(186
|
)
|
|
(204
|
)
|
||
Divestiture and other proceeds
|
205
|
|
|
310
|
|
||
Acquisition and other payments, net of cash acquired
|
(25
|
)
|
|
(15
|
)
|
||
Net Cash Provided by Investing Activities
|
653
|
|
|
1,060
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Short-term debt obligations, net
|
26
|
|
|
(73
|
)
|
||
Repayment of long-term debt
|
—
|
|
|
(1,250
|
)
|
||
Repurchase of common stock
|
(81
|
)
|
|
—
|
|
||
Dividends
|
(1,017
|
)
|
|
(669
|
)
|
||
Other
|
18
|
|
|
(37
|
)
|
||
Net Cash Used in Financing Activities
|
(1,054
|
)
|
|
(2,029
|
)
|
||
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash
|
(67
|
)
|
|
3
|
|
||
Increase in Cash, Cash Equivalents and Restricted Cash
|
3,426
|
|
|
424
|
|
||
Cash, Cash Equivalents and Restricted Cash at Beginning of Period
|
12,820
|
|
|
6,911
|
|
||
Cash, Cash Equivalents and Restricted Cash at End of Period
|
$
|
16,246
|
|
|
$
|
7,335
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Net product sales
|
$
|
10,541
|
|
|
$
|
5,713
|
|
Alliance revenues
|
105
|
|
|
129
|
|
||
Other revenues
|
135
|
|
|
78
|
|
||
Total Revenues
|
$
|
10,781
|
|
|
$
|
5,920
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Gross product sales
|
$
|
14,686
|
|
|
$
|
7,994
|
|
GTN adjustments(a)
|
|
|
|
||||
Charge-backs and cash discounts
|
(1,340
|
)
|
|
(774
|
)
|
||
Medicaid and Medicare rebates
|
(1,498
|
)
|
|
(800
|
)
|
||
Other rebates, returns, discounts and adjustments
|
(1,307
|
)
|
|
(707
|
)
|
||
Total GTN adjustments
|
(4,145
|
)
|
|
(2,281
|
)
|
||
Net product sales
|
$
|
10,541
|
|
|
$
|
5,713
|
|
(a)
|
Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $72 million and $78 million for the three months ended March 31, 2020 and 2019, respectively.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Prioritized Brands
|
|
|
|
||||
Revlimid
|
$
|
2,915
|
|
|
$
|
—
|
|
Eliquis
|
2,641
|
|
|
1,925
|
|
||
Opdivo
|
1,766
|
|
|
1,801
|
|
||
Orencia
|
714
|
|
|
640
|
|
||
Pomalyst/Imnovid
|
713
|
|
|
—
|
|
||
Sprycel
|
521
|
|
|
459
|
|
||
Yervoy
|
396
|
|
|
384
|
|
||
Abraxane
|
300
|
|
|
—
|
|
||
Empliciti
|
97
|
|
|
83
|
|
||
Reblozyl
|
8
|
|
|
—
|
|
||
Inrebic
|
12
|
|
|
—
|
|
||
|
|
|
|
||||
Established Brands
|
|
|
|
||||
Baraclude
|
122
|
|
|
141
|
|
||
Vidaza
|
158
|
|
|
—
|
|
||
Other Brands(a)
|
418
|
|
|
487
|
|
||
Total Revenues
|
$
|
10,781
|
|
|
$
|
5,920
|
|
|
|
|
|
||||
United States
|
$
|
6,766
|
|
|
$
|
3,449
|
|
Europe
|
2,567
|
|
|
1,480
|
|
||
Rest of the World
|
1,335
|
|
|
874
|
|
||
Other(b)
|
113
|
|
|
117
|
|
||
Total Revenues
|
$
|
10,781
|
|
|
$
|
5,920
|
|
(a)
|
Includes BMS and Celgene products in 2020.
|
(b)
|
Other revenues include royalties and alliance-related revenues for products not sold by BMS's regional commercial organizations.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Revenues from alliances:
|
|
|
|
||||
Net product sales
|
$
|
2,723
|
|
|
$
|
2,378
|
|
Alliance revenues
|
105
|
|
|
129
|
|
||
Total Revenues
|
$
|
2,828
|
|
|
$
|
2,507
|
|
|
|
|
|
||||
Payments to/(from) alliance partners:
|
|
|
|
||||
Cost of products sold
|
$
|
1,306
|
|
|
$
|
1,019
|
|
Marketing, selling and administrative
|
(40
|
)
|
|
(28
|
)
|
||
Research and development
|
46
|
|
|
14
|
|
||
Other expense/(income), net
|
(15
|
)
|
|
(14
|
)
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Selected Alliance Balance Sheet information:
|
|
|
|
||||
Receivables – from alliance partners
|
$
|
309
|
|
|
$
|
347
|
|
Accounts payable – to alliance partners
|
1,284
|
|
|
1,026
|
|
||
Deferred income from alliances(a)
|
432
|
|
|
431
|
|
(a)
|
Includes unamortized upfront and milestone payments.
|
|
Three Months Ended March 31,
|
||||||||||||||||||||||
|
Net Proceeds(a)
|
|
Divestiture Gains
|
|
Royalty Income
|
||||||||||||||||||
Dollars in Millions
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
||||||||||||
Diabetes Business
|
$
|
153
|
|
|
$
|
164
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(127
|
)
|
|
$
|
(165
|
)
|
Erbitux*
|
4
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Manufacturing Operations
|
—
|
|
|
2
|
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Plavix* and Avapro*/Avalide*
|
7
|
|
|
—
|
|
|
(12
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Mature Brands and Other
|
31
|
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
|
(31
|
)
|
|
(1
|
)
|
||||||
Total
|
$
|
195
|
|
|
$
|
171
|
|
|
$
|
(16
|
)
|
|
$
|
—
|
|
|
$
|
(158
|
)
|
|
$
|
(166
|
)
|
(a)
|
Includes royalties received subsequent to the related sale of the asset or business.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Interest expense
|
$
|
362
|
|
|
$
|
45
|
|
Pension and postretirement
|
(4
|
)
|
|
44
|
|
||
Royalties and licensing income
|
(410
|
)
|
|
(308
|
)
|
||
Divestiture gains
|
(16
|
)
|
|
—
|
|
||
Acquisition expenses
|
—
|
|
|
165
|
|
||
Contingent consideration
|
556
|
|
|
—
|
|
||
Investment income
|
(61
|
)
|
|
(56
|
)
|
||
Integration expenses
|
174
|
|
|
22
|
|
||
Provision for restructuring
|
160
|
|
|
12
|
|
||
Equity investment losses/(gains)
|
339
|
|
|
(175
|
)
|
||
Litigation and other settlements
|
32
|
|
|
1
|
|
||
Transition and other service fees
|
(61
|
)
|
|
(2
|
)
|
||
Reversion excise tax
|
76
|
|
|
—
|
|
||
Other
|
16
|
|
|
(9
|
)
|
||
Other expense/(income), net
|
$
|
1,163
|
|
|
$
|
(261
|
)
|
Dollars in Millions
|
Three Months Ended
March 31, 2020
|
||
Employee termination costs
|
$
|
146
|
|
Other termination costs
|
4
|
|
|
Provision for restructuring
|
150
|
|
|
Integration expenses
|
174
|
|
|
Total charges(a)
|
$
|
324
|
|
(a)
|
Included in Other expense/(income), net.
|
Dollars in Millions
|
Three Months Ended
March 31, 2020
|
||
Liability at January 1
|
$
|
77
|
|
Charges
|
131
|
|
|
Change in estimates
|
1
|
|
|
Provision for restructuring(a)
|
132
|
|
|
Foreign currency translation and other
|
6
|
|
|
Payments
|
(91
|
)
|
|
Liability at March 31
|
$
|
124
|
|
(a)
|
Excludes $18 million of accelerated stock-based compensation.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Employee termination costs
|
$
|
3
|
|
|
$
|
4
|
|
Other termination costs
|
7
|
|
|
8
|
|
||
Provision for restructuring
|
10
|
|
|
12
|
|
||
Accelerated depreciation
|
30
|
|
|
31
|
|
||
Asset impairments
|
42
|
|
|
1
|
|
||
Total charges
|
$
|
82
|
|
|
$
|
44
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Cost of products sold
|
$
|
16
|
|
|
$
|
12
|
|
Marketing, selling and administrative
|
—
|
|
|
1
|
|
||
Research and development
|
56
|
|
|
19
|
|
||
Other expense/(income), net
|
10
|
|
|
12
|
|
||
Total charges
|
$
|
82
|
|
|
$
|
44
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Liability at December 31
|
$
|
23
|
|
|
$
|
99
|
|
Cease-use liability reclassification
|
—
|
|
|
(3
|
)
|
||
Liability at January 1
|
23
|
|
|
96
|
|
||
Charges
|
7
|
|
|
15
|
|
||
Change in estimates
|
3
|
|
|
(3
|
)
|
||
Provision for restructuring
|
10
|
|
|
12
|
|
||
Payments
|
(16
|
)
|
|
(45
|
)
|
||
Liability at March 31
|
$
|
17
|
|
|
$
|
63
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
(Loss)/Earnings Before Income Taxes
|
$
|
(304
|
)
|
|
$
|
1,979
|
|
Provision for Income Taxes
|
462
|
|
|
264
|
|
||
Effective Tax Rate
|
(152.0
|
)%
|
|
13.3
|
%
|
|
Three Months Ended March 31,
|
||||||
Amounts in Millions, Except Per Share Data
|
2020
|
|
2019
|
||||
Net (Loss)/Earnings Attributable to BMS Used for Basic and Diluted EPS Calculation
|
$
|
(775
|
)
|
|
$
|
1,710
|
|
|
|
|
|
||||
Weighted-Average Common Shares Outstanding – Basic
|
2,258
|
|
|
1,634
|
|
||
Incremental Shares Attributable to Share-Based Compensation Plans
|
—
|
|
|
3
|
|
||
Weighted-Average Common Shares Outstanding – Diluted
|
2,258
|
|
|
1,637
|
|
||
|
|
|
|
||||
(Loss)/Earnings per Common Share
|
|
|
|
||||
Basic
|
$
|
(0.34
|
)
|
|
$
|
1.05
|
|
Diluted
|
(0.34
|
)
|
|
1.04
|
|
|
March 31, 2020
|
|
December 31, 2019
|
||||||||||||||||||||
Dollars in Millions
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||
Cash and cash equivalents - money market and other securities
|
$
|
—
|
|
|
$
|
13,528
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,448
|
|
|
$
|
—
|
|
Marketable debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Certificates of deposit
|
—
|
|
|
1,062
|
|
|
—
|
|
|
—
|
|
|
1,227
|
|
|
—
|
|
||||||
Commercial paper
|
—
|
|
|
869
|
|
|
—
|
|
|
—
|
|
|
1,093
|
|
|
—
|
|
||||||
Corporate debt securities
|
—
|
|
|
1,225
|
|
|
—
|
|
|
—
|
|
|
1,494
|
|
|
—
|
|
||||||
Derivative assets
|
|
|
202
|
|
|
|
|
—
|
|
|
140
|
|
|
—
|
|
||||||||
Equity investments
|
1,822
|
|
|
145
|
|
|
—
|
|
|
2,020
|
|
|
175
|
|
|
—
|
|
||||||
Derivative liabilities
|
—
|
|
|
(29
|
)
|
|
—
|
|
|
—
|
|
|
(40
|
)
|
|
—
|
|
||||||
Contingent consideration liability:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Contingent value rights
|
2,862
|
|
|
—
|
|
|
—
|
|
|
2,275
|
|
|
—
|
|
|
—
|
|
||||||
Other acquisition related contingent consideration
|
—
|
|
|
—
|
|
|
69
|
|
|
—
|
|
|
—
|
|
|
106
|
|
|
Ranges (weighted average) utilized as of:
|
Inputs
|
March 31, 2020
|
Discount rate
|
2.2% to 2.7% (2.4%)
|
Probability of payment
|
0% to 80% (2.6%)
|
Projected year of payment for development and regulatory milestones
|
2020 to 2029 (2022)
|
Projected year of payment for sales-based milestones and other amounts calculated as a percentage of annual sales
|
N/A
|
Dollars in Millions
|
Three Months Ended March 31, 2020
|
||
Fair value as of January 1
|
$
|
106
|
|
Changes in estimated fair value
|
(36
|
)
|
|
Foreign exchange
|
(1
|
)
|
|
Fair value as of March 31
|
$
|
69
|
|
|
March 31, 2020
|
|
December 31, 2019
|
||||||||||||||||||||||||||||
Dollars in Millions
|
Amortized Cost
|
|
Gross Unrealized
|
|
|
|
Amortized Cost
|
|
Gross Unrealized
|
|
|
||||||||||||||||||||
|
Gains
|
|
Losses
|
|
Fair Value
|
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|||||||||||||||||||
Certificates of deposit
|
$
|
1,062
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,062
|
|
|
$
|
1,227
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,227
|
|
Commercial paper
|
869
|
|
|
—
|
|
|
—
|
|
|
869
|
|
|
1,093
|
|
|
—
|
|
|
—
|
|
|
1,093
|
|
||||||||
Corporate debt securities
|
1,216
|
|
|
11
|
|
|
(2
|
)
|
|
1,225
|
|
|
1,487
|
|
|
8
|
|
|
(1
|
)
|
|
1,494
|
|
||||||||
|
$
|
3,147
|
|
|
$
|
11
|
|
|
$
|
(2
|
)
|
|
3,156
|
|
|
$
|
3,807
|
|
|
$
|
8
|
|
|
$
|
(1
|
)
|
|
3,814
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Equity investments
|
|
|
|
|
|
|
1,967
|
|
|
|
|
|
|
|
|
2,195
|
|
||||||||||||||
Total
|
|
|
|
|
|
|
$
|
5,123
|
|
|
|
|
|
|
|
|
$
|
6,009
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Marketable debt securities - current
|
$
|
2,505
|
|
|
$
|
3,047
|
|
Marketable debt securities - non-current(a)
|
651
|
|
|
767
|
|
||
Other non-current assets
|
1,967
|
|
|
2,195
|
|
||
Total
|
$
|
5,123
|
|
|
$
|
6,009
|
|
(a)
|
All non-current marketable debt securities mature within five years as of March 31, 2020 and December 31, 2019.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Net (loss)/gain recognized
|
$
|
(228
|
)
|
|
$
|
95
|
|
Less: Net gain recognized for equity investments sold
|
—
|
|
|
14
|
|
||
Net unrealized (loss)/gain on equity investments held
|
$
|
(228
|
)
|
|
$
|
81
|
|
(a)
|
Included in Other current assets and Other non-current assets.
|
(b)
|
Included in Other current liabilities and Other non-current liabilities.
|
|
Three Months Ended March 31, 2020
|
||||||
Dollars in Millions
|
Cost of products sold
|
|
Other expense/(income), net
|
||||
Interest rate swap contracts
|
$
|
—
|
|
|
$
|
(7
|
)
|
Cross-currency interest rate swap contracts
|
—
|
|
|
(2
|
)
|
||
Foreign currency forward contracts
|
(23
|
)
|
|
(76
|
)
|
||
Foreign currency zero-cost collar contracts
|
—
|
|
|
(9
|
)
|
|
Three Months Ended March 31, 2019
|
||||||
Dollars in Millions
|
Cost of products sold
|
|
Other expense/(income), net
|
||||
Interest rate swap contracts
|
$
|
—
|
|
|
$
|
(5
|
)
|
Cross-currency interest rate swap contracts
|
—
|
|
|
(2
|
)
|
||
Foreign currency forward contracts
|
(30
|
)
|
|
9
|
|
||
Forward starting interest rate swap options
|
—
|
|
|
35
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Derivatives qualifying as cash flow hedges
|
|
|
|
||||
Foreign currency forward contracts gain/(loss):
|
|
|
|
||||
Recognized in Other Comprehensive (Loss)/Income(a)
|
$
|
97
|
|
|
$
|
45
|
|
Reclassified to Cost of products sold
|
(20
|
)
|
|
(30
|
)
|
||
|
|
|
|
||||
Derivatives qualifying as net investment hedges
|
|
|
|
||||
Cross-currency interest rate swap contracts gain:
|
|
|
|
||||
Recognized in Other Comprehensive (Loss)/Income
|
6
|
|
|
6
|
|
||
|
|
|
|
||||
Non-derivatives qualifying as net investment hedges
|
|
|
|
||||
Non-U.S. dollar borrowings gain:
|
|
|
|
||||
Recognized in Other Comprehensive (Loss)/Income
|
20
|
|
|
8
|
|
(a)
|
The amount is expected to be reclassified into earnings in the next 12 months.
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Non-U.S. short-term borrowings
|
$
|
345
|
|
|
$
|
351
|
|
Current portion of long-term debt
|
3,261
|
|
|
2,763
|
|
||
Other
|
256
|
|
|
232
|
|
||
Total
|
$
|
3,862
|
|
|
$
|
3,346
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Principal Value
|
$
|
44,310
|
|
|
$
|
44,335
|
|
|
|
|
|
||||
Adjustments to Principal Value:
|
|
|
|
||||
Fair value of interest rate swap contracts
|
25
|
|
|
6
|
|
||
Unamortized basis adjustment from swap terminations
|
168
|
|
|
175
|
|
||
Unamortized bond discounts and issuance costs
|
(271
|
)
|
|
(280
|
)
|
||
Unamortized purchase price adjustments of Celgene debt
|
1,873
|
|
|
1,914
|
|
||
Total
|
$
|
46,105
|
|
|
$
|
46,150
|
|
|
|
|
|
||||
Current portion of long-term debt
|
$
|
3,261
|
|
|
$
|
2,763
|
|
Long-term debt
|
42,844
|
|
|
43,387
|
|
||
Total
|
$
|
46,105
|
|
|
$
|
46,150
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Trade receivables
|
$
|
7,660
|
|
|
$
|
6,888
|
|
Less charge-backs and cash discounts
|
(437
|
)
|
|
(391
|
)
|
||
Less bad debt allowances
|
(23
|
)
|
|
(21
|
)
|
||
Net trade receivables
|
7,200
|
|
|
6,476
|
|
||
Alliance, royalties, VAT and other
|
1,090
|
|
|
1,209
|
|
||
Receivables
|
$
|
8,290
|
|
|
$
|
7,685
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Finished goods
|
$
|
1,283
|
|
|
$
|
2,227
|
|
Work in process
|
2,651
|
|
|
3,267
|
|
||
Raw and packaging materials
|
164
|
|
|
172
|
|
||
Total inventories
|
$
|
4,098
|
|
|
$
|
5,666
|
|
|
|
|
|
||||
Inventories
|
$
|
2,836
|
|
|
$
|
4,293
|
|
Other non-current assets
|
1,262
|
|
|
1,373
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Land
|
$
|
194
|
|
|
$
|
187
|
|
Buildings
|
5,848
|
|
|
6,336
|
|
||
Machinery, equipment and fixtures
|
3,055
|
|
|
3,157
|
|
||
Construction in progress
|
456
|
|
|
527
|
|
||
Gross property, plant and equipment
|
9,553
|
|
|
10,207
|
|
||
Less accumulated depreciation
|
(3,441
|
)
|
|
(3,955
|
)
|
||
Property, plant and equipment
|
$
|
6,112
|
|
|
$
|
6,252
|
|
Dollars in Millions
|
Estimated Useful Lives
|
|
March 31,
2020 |
|
December 31,
2019 |
||||
Goodwill(a)
|
|
|
$
|
22,452
|
|
|
$
|
22,488
|
|
|
|
|
|
|
|
||||
Other intangible assets:
|
|
|
|
|
|
||||
Licenses
|
5 – 15 years
|
|
482
|
|
|
482
|
|
||
Acquired developed product rights
|
3 – 15 years
|
|
50,427
|
|
|
46,827
|
|
||
Capitalized software
|
3 – 10 years
|
|
1,263
|
|
|
1,297
|
|
||
IPRD
|
|
|
15,900
|
|
|
19,500
|
|
||
Gross other intangible assets
|
|
|
68,072
|
|
|
68,106
|
|
||
Less accumulated amortization
|
|
|
(6,406
|
)
|
|
(4,137
|
)
|
||
Other intangible assets
|
|
|
$
|
61,666
|
|
|
$
|
63,969
|
|
(a)
|
Includes measurement period adjustments. Refer to “—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for more information.
|
Dollars in Millions
|
March 31,
2020 |
|
December 31, 2019
|
||||
Prepaid and refundable income taxes
|
$
|
999
|
|
|
$
|
754
|
|
Research and development
|
445
|
|
|
410
|
|
||
Other
|
961
|
|
|
819
|
|
||
Other current assets
|
$
|
2,405
|
|
|
$
|
1,983
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31, 2019
|
||||
Equity investments
|
$
|
3,144
|
|
|
$
|
3,405
|
|
Inventories
|
1,262
|
|
|
1,373
|
|
||
Operating leases
|
724
|
|
|
704
|
|
||
Pension and postretirement
|
189
|
|
|
456
|
|
||
Restricted cash(a)
|
342
|
|
|
390
|
|
||
Other
|
285
|
|
|
276
|
|
||
Other non-current assets
|
$
|
5,946
|
|
|
$
|
6,604
|
|
(a)
|
Restricted cash consists of escrow for litigation settlements and funds restricted for annual Company contributions to the defined contribution plan in the U.S. Restricted cash of $429 million was included in cash, cash equivalents and restricted cash at March 31, 2020 in the consolidated statements of cash flows.
|
Dollars in Millions
|
March 31,
2020 |
|
December 31, 2019
|
||||
Rebates and returns
|
$
|
4,407
|
|
|
$
|
4,275
|
|
Income taxes payable
|
1,996
|
|
|
1,517
|
|
||
Employee compensation and benefits
|
678
|
|
|
1,457
|
|
||
Research and development
|
1,308
|
|
|
1,324
|
|
||
Dividends
|
1,037
|
|
|
1,025
|
|
||
Interest
|
393
|
|
|
493
|
|
||
Royalties
|
328
|
|
|
418
|
|
||
Operating leases
|
136
|
|
|
133
|
|
||
Other
|
2,018
|
|
|
1,871
|
|
||
Other current liabilities
|
$
|
12,301
|
|
|
$
|
12,513
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31, 2019
|
||||
Income taxes payable
|
$
|
5,364
|
|
|
$
|
5,368
|
|
Contingent value rights
|
2,862
|
|
|
2,275
|
|
||
Pension and postretirement
|
841
|
|
|
725
|
|
||
Operating leases
|
688
|
|
|
672
|
|
||
Deferred income
|
394
|
|
|
424
|
|
||
Deferred compensation
|
254
|
|
|
287
|
|
||
Other
|
298
|
|
|
350
|
|
||
Other non-current liabilities
|
$
|
10,701
|
|
|
$
|
10,101
|
|
|
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 December 31, 2019
|
2,923
|
|
|
$
|
292
|
|
|
$
|
43,709
|
|
|
$
|
(1,520
|
)
|
|
$
|
34,474
|
|
|
672
|
|
|
$
|
(25,357
|
)
|
|
$
|
100
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(775
|
)
|
|
—
|
|
|
—
|
|
|
9
|
|
||||||
Other Comprehensive Loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(29
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Cash dividends declared(a)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,028
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Share repurchase program
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|
(81
|
)
|
|
—
|
|
||||||
Stock compensation
|
—
|
|
|
—
|
|
|
(455
|
)
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
681
|
|
|
—
|
|
||||||
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(43
|
)
|
||||||
Balance at March 31, 2020
|
2,923
|
|
|
$
|
292
|
|
|
$
|
43,254
|
|
|
$
|
(1,549
|
)
|
|
$
|
32,671
|
|
|
660
|
|
|
$
|
(24,757
|
)
|
|
$
|
66
|
|
(a)
|
Cash dividends declared per common share were $0.45 for the three months ended March 31, 2020.
|
|
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 December 31, 2018
|
2,208
|
|
|
$
|
221
|
|
|
$
|
2,081
|
|
|
$
|
(2,762
|
)
|
|
$
|
34,065
|
|
|
576
|
|
|
$
|
(19,574
|
)
|
|
$
|
96
|
|
Accounting change - cumulative effect(a)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Adjusted balance at January 1, 2019
|
2,208
|
|
|
221
|
|
|
2,081
|
|
|
(2,762
|
)
|
|
34,070
|
|
|
576
|
|
|
(19,574
|
)
|
|
96
|
|
||||||
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,710
|
|
|
—
|
|
|
—
|
|
|
5
|
|
||||||
Other Comprehensive Income
|
—
|
|
|
—
|
|
|
—
|
|
|
118
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Cash dividends declared(b)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(671
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock compensation
|
—
|
|
|
—
|
|
|
22
|
|
|
—
|
|
|
—
|
|
|
(4
|
)
|
|
3
|
|
|
—
|
|
||||||
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
||||||
Balance at March 31, 2019
|
2,208
|
|
|
$
|
221
|
|
|
$
|
2,103
|
|
|
$
|
(2,644
|
)
|
|
$
|
35,109
|
|
|
572
|
|
|
$
|
(19,571
|
)
|
|
$
|
99
|
|
(a)
|
Refer to “—Note 1. Accounting Policies and Recently Issued Accounting Standards” in the Company's 2019 Form 10-K for additional information.
|
(b)
|
Cash dividends declared per common share were $0.41 for the three months ended March 31, 2019.
|
|
2020
|
|
2019
|
||||||||||||||||||||
Dollars in Millions
|
Pretax
|
|
Tax
|
|
After Tax
|
|
Pretax
|
|
Tax
|
|
After Tax
|
||||||||||||
Three Months Ended March 31,
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Derivatives qualifying as cash flow hedges:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gains/(losses)
|
$
|
97
|
|
|
$
|
(10
|
)
|
|
$
|
87
|
|
|
$
|
45
|
|
|
$
|
(5
|
)
|
|
$
|
40
|
|
Reclassified to net earnings(a)
|
(20
|
)
|
|
3
|
|
|
(17
|
)
|
|
(30
|
)
|
|
4
|
|
|
(26
|
)
|
||||||
Derivatives qualifying as cash flow hedges
|
77
|
|
|
(7
|
)
|
|
70
|
|
|
15
|
|
|
(1
|
)
|
|
14
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Pension and postretirement benefits:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Actuarial gains/(losses)
|
8
|
|
|
(2
|
)
|
|
6
|
|
|
(2
|
)
|
|
—
|
|
|
(2
|
)
|
||||||
Amortization(b)
|
9
|
|
|
(1
|
)
|
|
8
|
|
|
17
|
|
|
(4
|
)
|
|
13
|
|
||||||
Settlements(b)
|
2
|
|
|
—
|
|
|
2
|
|
|
49
|
|
|
(11
|
)
|
|
38
|
|
||||||
Pension and postretirement benefits
|
19
|
|
|
(3
|
)
|
|
16
|
|
|
64
|
|
|
(15
|
)
|
|
49
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Available-for-sale debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unrealized gains
|
2
|
|
|
(1
|
)
|
|
1
|
|
|
23
|
|
|
—
|
|
|
23
|
|
||||||
Realized losses
|
—
|
|
|
—
|
|
|
—
|
|
|
3
|
|
|
—
|
|
|
3
|
|
||||||
Available-for-sale debt securities
|
2
|
|
|
(1
|
)
|
|
1
|
|
|
26
|
|
|
—
|
|
|
26
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Foreign currency translation
|
(110
|
)
|
|
(6
|
)
|
|
(116
|
)
|
|
32
|
|
|
(3
|
)
|
|
29
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Other Comprehensive (Loss)/Income
|
$
|
(12
|
)
|
|
$
|
(17
|
)
|
|
$
|
(29
|
)
|
|
$
|
137
|
|
|
$
|
(19
|
)
|
|
$
|
118
|
|
(a)
|
Included in Cost of products sold.
|
(b)
|
Included in Other expense/(income), net.
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Derivatives qualifying as cash flow hedges
|
$
|
89
|
|
|
$
|
19
|
|
Pension and postretirement benefits
|
(883
|
)
|
|
(899
|
)
|
||
Available-for-sale debt securities
|
7
|
|
|
6
|
|
||
Foreign currency translation
|
(762
|
)
|
|
(646
|
)
|
||
Accumulated other comprehensive loss
|
$
|
(1,549
|
)
|
|
$
|
(1,520
|
)
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Service cost – benefits earned during the year
|
$
|
12
|
|
|
$
|
7
|
|
Interest cost on projected benefit obligation
|
8
|
|
|
44
|
|
||
Expected return on plan assets
|
(23
|
)
|
|
(64
|
)
|
||
Amortization of prior service credits
|
(1
|
)
|
|
(1
|
)
|
||
Amortization of net actuarial loss
|
11
|
|
|
18
|
|
||
Curtailments and settlements
|
2
|
|
|
49
|
|
||
Net periodic pension benefit cost
|
$
|
9
|
|
|
$
|
53
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Cost of products sold
|
$
|
10
|
|
|
$
|
4
|
|
Marketing, selling and administrative
|
88
|
|
|
30
|
|
||
Research and development
|
94
|
|
|
19
|
|
||
Other expense/(income), net
|
18
|
|
|
—
|
|
||
Total stock-based compensation expense
|
$
|
210
|
|
|
$
|
53
|
|
|
|
|
|
||||
Income tax benefit(a)
|
$
|
46
|
|
|
$
|
10
|
|
(a)
|
Income tax benefit excludes excess tax benefits of $23 million and $2 million from share-based compensation awards that were vested or exercised during the three months ended March 31, 2020 and 2019, respectively.
|
Units in Millions
|
Units
|
|
Weighted-Average Fair Value
|
|||
Restricted stock units
|
12.5
|
|
|
$
|
53.63
|
|
Market share units
|
0.9
|
|
|
53.88
|
|
|
Performance share units
|
1.4
|
|
|
55.66
|
|
Dollars in Millions
|
Stock Options
|
|
Restricted Stock Units
|
|
Market Share Units
|
|
Performance Share Units
|
||||||||
Unrecognized compensation cost
|
$
|
92
|
|
|
$
|
1,397
|
|
|
$
|
77
|
|
|
$
|
135
|
|
Expected weighted-average period in years of compensation cost to be recognized
|
1.9
|
|
|
2.9
|
|
|
3.4
|
|
|
2.1
|
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions, except per share data
|
2020
|
|
2019
|
||||
Total Revenues
|
$
|
10,781
|
|
|
$
|
5,920
|
|
|
|
|
|
||||
Diluted (Loss)/Earnings Per Share
|
|
|
|
||||
GAAP
|
$
|
(0.34
|
)
|
|
$
|
1.04
|
|
Non-GAAP
|
1.72
|
|
|
1.10
|
|
•
|
Existing sites can continue to recruit new patients when appropriate
|
•
|
No new sites will be activated until further notice
|
•
|
No sites will be initiated nor activated until further notice
|
Product
|
Date
|
Approval
|
Reblozyl
|
April 2020
|
FDA approval of Reblozyl for the treatment of anemia failing an erythropoiesis stimulating agent in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions.
|
Zeposia
|
March 2020
|
FDA approval of Zeposia (ozanimod) 0.92 mg for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
|
Opdivo+Yervoy
|
March 2020
|
FDA approval of Opdivo+Yervoy combination for the treatment of HCC in patients who have been previously treated with sorafenib.
|
|
Three Months Ended March 31,
|
|
2020 vs. 2019
|
||||||||||
Dollars in Millions
|
2020
|
|
2019
|
|
% Change
|
|
Foreign Exchange(b)
|
||||||
United States
|
$
|
6,766
|
|
|
$
|
3,449
|
|
|
96
|
%
|
|
—
|
|
Europe
|
2,567
|
|
|
1,480
|
|
|
73
|
%
|
|
(3
|
)%
|
||
Rest of the World
|
1,335
|
|
|
874
|
|
|
53
|
%
|
|
(5
|
)%
|
||
Other(a)
|
113
|
|
|
117
|
|
|
(3
|
)%
|
|
N/A
|
|
||
Total
|
$
|
10,781
|
|
|
$
|
5,920
|
|
|
82
|
%
|
|
(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 March 31,
|
|||||||||
Dollars in Millions
|
2020
|
|
2019
|
|
% Change
|
|||||
Gross product sales
|
$
|
14,686
|
|
|
$
|
7,994
|
|
|
84
|
%
|
GTN adjustments
|
|
|
|
|
|
|||||
Charge-backs and cash discounts
|
(1,340
|
)
|
|
(774
|
)
|
|
73
|
%
|
||
Medicaid and Medicare rebates
|
(1,498
|
)
|
|
(800
|
)
|
|
87
|
%
|
||
Other rebates, returns, discounts and adjustments
|
(1,307
|
)
|
|
(707
|
)
|
|
85
|
%
|
||
Total GTN adjustments
|
(4,145
|
)
|
|
(2,281
|
)
|
|
82
|
%
|
||
Net product sales
|
$
|
10,541
|
|
|
$
|
5,713
|
|
|
85
|
%
|
|
|
|
|
|
|
|||||
GTN adjustments percentage
|
28
|
%
|
|
28
|
%
|
|
—
|
%
|
||
U.S.
|
34
|
%
|
|
36
|
%
|
|
(2
|
)%
|
||
Non-U.S.
|
14
|
%
|
|
13
|
%
|
|
1
|
%
|
|
Three Months Ended March 31,
|
|||||||||
Dollars in Millions
|
2020
|
|
2019
|
|
% Change
|
|||||
Prioritized Brands
|
|
|
|
|
|
|||||
Revlimid
|
$
|
2,915
|
|
|
$
|
—
|
|
|
N/A
|
|
U.S.
|
1,966
|
|
|
—
|
|
|
N/A
|
|
||
Non-U.S.
|
949
|
|
|
—
|
|
|
N/A
|
|
||
|
|
|
|
|
|
|||||
Eliquis
|
2,641
|
|
|
1,925
|
|
|
37
|
%
|
||
U.S.
|
1,777
|
|
|
1,206
|
|
|
47
|
%
|
||
Non-U.S.
|
864
|
|
|
719
|
|
|
20
|
%
|
||
|
|
|
|
|
|
|||||
Opdivo
|
1,766
|
|
|
1,801
|
|
|
(2
|
)%
|
||
U.S.
|
1,008
|
|
|
1,124
|
|
|
(10
|
)%
|
||
Non-U.S.
|
758
|
|
|
677
|
|
|
12
|
%
|
||
|
|
|
|
|
|
|||||
Orencia
|
714
|
|
|
640
|
|
|
12
|
%
|
||
U.S.
|
500
|
|
|
449
|
|
|
11
|
%
|
||
Non-U.S.
|
214
|
|
|
191
|
|
|
12
|
%
|
||
|
|
|
|
|
|
|||||
Pomalyst/Imnovid
|
713
|
|
|
—
|
|
|
N/A
|
|
||
U.S.
|
489
|
|
|
—
|
|
|
N/A
|
|
||
Non-U.S.
|
224
|
|
|
—
|
|
|
N/A
|
|
||
|
|
|
|
|
|
|||||
Sprycel
|
521
|
|
|
459
|
|
|
14
|
%
|
||
U.S.
|
300
|
|
|
240
|
|
|
25
|
%
|
||
Non-U.S.
|
221
|
|
|
219
|
|
|
1
|
%
|
||
|
|
|
|
|
|
|||||
Yervoy
|
396
|
|
|
384
|
|
|
3
|
%
|
||
U.S.
|
257
|
|
|
275
|
|
|
(7
|
)%
|
||
Non-U.S.
|
139
|
|
|
109
|
|
|
28
|
%
|
||
|
|
|
|
|
|
|||||
Abraxane
|
300
|
|
|
—
|
|
|
N/A
|
|
||
U.S.
|
205
|
|
|
—
|
|
|
N/A
|
|
||
Non-U.S.
|
95
|
|
|
—
|
|
|
N/A
|
|
||
|
|
|
|
|
|
|||||
Empliciti
|
97
|
|
|
83
|
|
|
17
|
%
|
||
U.S.
|
59
|
|
|
58
|
|
|
2
|
%
|
||
Non-U.S.
|
38
|
|
|
25
|
|
|
52
|
%
|
||
|
|
|
|
|
|
|||||
Reblozyl
|
8
|
|
|
—
|
|
|
N/A
|
|
||
U.S.
|
8
|
|
|
—
|
|
|
N/A
|
|
||
Non-U.S.
|
—
|
|
|
—
|
|
|
N/A
|
|
||
|
|
|
|
|
|
|||||
Inrebic
|
12
|
|
|
—
|
|
|
N/A
|
|
||
U.S.
|
12
|
|
|
—
|
|
|
N/A
|
|
||
Non-U.S.
|
—
|
|
|
—
|
|
|
N/A
|
|
|
Three Months Ended March 31,
|
|||||||
Dollars in Millions
|
2020
|
|
2019
|
|
% Change
|
|||
Established Brands
|
|
|
|
|
|
|||
Baraclude
|
122
|
|
|
141
|
|
|
(13
|
)%
|
U.S.
|
3
|
|
|
7
|
|
|
(57
|
)%
|
Non-U.S.
|
119
|
|
|
134
|
|
|
(11
|
)%
|
|
|
|
|
|
|
|||
Vidaza
|
158
|
|
|
—
|
|
|
N/A
|
|
U.S.
|
2
|
|
|
—
|
|
|
N/A
|
|
Non-U.S.
|
156
|
|
|
—
|
|
|
N/A
|
|
|
|
|
|
|
|
|||
Other Brands(a)
|
418
|
|
|
487
|
|
|
(14
|
)%
|
U.S.
|
180
|
|
|
90
|
|
|
100
|
%
|
Non-U.S.
|
238
|
|
|
397
|
|
|
(40
|
)%
|
|
|
|
|
|
|
|||
Total Revenues
|
10,781
|
|
|
5,920
|
|
|
82
|
%
|
U.S.
|
6,766
|
|
|
3,449
|
|
|
96
|
%
|
Non-U.S.
|
4,015
|
|
|
2,471
|
|
|
62
|
%
|
(a)
|
Includes BMS and Celgene products in 2020.
|
•
|
U.S. revenues increased due to higher demand and the change in buying patterns resulting from the COVID-19 pandemic, partially offset by higher rebates and discounts.
|
•
|
International revenues increased due to higher demand and the change in buying patterns resulting from the COVID-19 pandemic. Excluding foreign exchange impacts, revenues increased by 23% in the first quarter.
|
•
|
U.S. revenues decreased due to the smaller previously-treated advanced lung cancer market and increased competition for the Opdivo+Yervoy combination in kidney cancer.
|
•
|
International revenues increased due to higher demand as a result of approvals for additional indications and launches in new countries. Excluding foreign exchange impacts, revenues increased by 17% in the first quarter.
|
•
|
U.S. revenues increased due to higher demand and higher average net selling prices.
|
•
|
International revenues increased due to higher demand. Excluding foreign exchange impacts, international revenue increased by 16% in the first quarter.
|
•
|
U.S. revenues increased due to higher demand, the change in buying patterns resulting from the COVID-19 pandemic and higher average net selling prices.
|
•
|
International revenues increased due to the change in buying patterns resulting from the COVID-19 pandemic, offset by unfavorable foreign exchange impacts.
|
•
|
U.S. revenues decreased due to increased competition for the Opdivo+Yervoy combination for kidney cancer.
|
•
|
International revenues increased due to higher demand as a result of approvals for additional indications and launches primarily in Europe. Excluding foreign exchange impacts, revenues increased by 32% in the first quarter.
|
•
|
International revenues increased due to higher demand.
|
•
|
International revenues decreased due to lower average net selling prices resulting from generic competition.
|
•
|
U.S. revenues include $103 million from Celgene products in 2020.
|
•
|
International revenues decreased primarily due to divestiture of the UPSA business and certain other brands and continued generic erosion.
|
|
Three Months Ended March 31,
|
|||||||||
Dollars in Millions
|
2020
|
|
2019
|
|
% Change
|
|||||
Cost of products sold(a)
|
$
|
3,662
|
|
|
$
|
1,824
|
|
|
**
|
|
Marketing, selling and administrative
|
1,606
|
|
|
1,006
|
|
|
60
|
%
|
||
Research and development
|
2,372
|
|
|
1,348
|
|
|
76
|
%
|
||
Amortization of acquired intangible assets
|
2,282
|
|
|
24
|
|
|
**
|
|
||
Other expense/(income), net
|
1,163
|
|
|
(261
|
)
|
|
**
|
|
||
Total Expenses
|
$
|
11,085
|
|
|
$
|
3,941
|
|
|
**
|
|
•
|
Cost of products sold increased by approximately $1.8 billion due to unwinding of inventory fair value adjustments of $1.4 billion, higher royalties and Eliquis profit sharing of $376 million and Celgene product costs.
|
•
|
Marketing, selling and administrative expenses increased by approximately $600 million primarily due to costs associated with the broader portfolio resulting from the Celgene acquisition.
|
•
|
Research and development increased by approximately $1.0 billion primarily due to costs associated with the broader portfolio resulting from the Celgene acquisition.
|
•
|
Amortization of acquired intangible assets increased by $2.3 billion in 2020 as a result of Revlimid, Pomalyst/Imnovid and other marketed product rights obtained in the Celgene acquisition.
|
•
|
Other expense/(income), net changed by $1.4 billion primarily due to higher interest, restructuring, integration expenses and fair value adjustments to equity investments and contingent value rights as summarized below.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Interest expense
|
$
|
362
|
|
|
$
|
45
|
|
Pension and postretirement
|
(4
|
)
|
|
44
|
|
||
Royalties and licensing income
|
(410
|
)
|
|
(308
|
)
|
||
Divestiture gains
|
(16
|
)
|
|
—
|
|
||
Acquisition expenses
|
—
|
|
|
165
|
|
||
Contingent consideration
|
556
|
|
|
—
|
|
||
Investment income
|
(61
|
)
|
|
(56
|
)
|
||
Integration expenses
|
174
|
|
|
22
|
|
||
Provision for restructuring
|
160
|
|
|
12
|
|
||
Equity investment losses/(gains)
|
339
|
|
|
(175
|
)
|
||
Litigation and other settlements
|
32
|
|
|
1
|
|
||
Transition and other service fees
|
(61
|
)
|
|
(2
|
)
|
||
Reversion excise tax
|
76
|
|
|
—
|
|
||
Other
|
16
|
|
|
(9
|
)
|
||
Other expense/(income), net
|
$
|
1,163
|
|
|
$
|
(261
|
)
|
•
|
Interest expense includes interest incurred primarily on the approximately $19.0 billion of notes issued in May 2019 and approximately $19.9 billion of Celgene debt assumed in the acquisition. Interest expense was partially offset by $41 million of amortization of the purchase price adjustment attributed to Celgene's debt.
|
•
|
Pension and postretirement includes the interest cost, expected return on plan assets and amortization components of the net periodic benefit cost (credit) as well as net charges for settlements, curtailments and special termination benefits of $49 million in 2019.
|
•
|
Royalties and licensing income primarily includes diabetes royalties of $127 million in 2020 and $165 million in 2019, Keytruda* royalties of $161 million in 2020 and $120 million in 2019, regulatory milestone of $40 million from Biohaven following the regulatory approval of Nurtec* ODT (rimegepant) and $30 million from ViiV following the acceptance of two regulatory filings in 2020 and out-licensing income of $30 million from Boehringer Ingelheim for the exclusive rights to develop and commercialize BMS's TREM-1 program.
|
•
|
Divestiture gains include a $12 million gain related to the termination of our U.S. and Puerto Rico partnership with Sanofi in the first quarter of 2020.
|
•
|
Acquisition expenses include the following items related to the Celgene transaction in 2019: (1) upfront bridge facility commitment fee of $67 million, (2) acquisition financing hedge losses of $35 million and (3) financial advisory, legal, proxy filing and other regulatory fees of $63 million.
|
•
|
Contingent consideration includes fair value adjustments of $585 million resulting from an increase in the traded price of contingent value rights issued with the Celgene acquisition, partially offset by $29 million of other fair value adjustments on contingent considerations assumed in the Celgene acquisition.
|
•
|
Integration expenses include consulting fees incurred in connection with Celgene integration activities.
|
•
|
Provision for restructuring includes exit costs primarily related to employee termination benefits and contract terminations. Restructuring charges related to the Celgene transaction were $150 million in 2020, including $18 million of accelerated vesting of Celgene equity awards. Restructuring charges related to the prior company transformation initiatives were $10 million in 2020 and $12 million in 2019. Refer to “Item 1. Financial Statements—Note 6. Restructuring” for further information.
|
•
|
Equity investment losses/(gains) includes fair value adjustments. The fair value of equity investments with or without readily determinable fair values in 2020 were significantly impacted by changes in market conditions primarily caused by the COVID-19 pandemic resulting in downward adjustments of $674 million, partially offset by observable upward adjustments of $335 million including $253 million attributed to our investment in Acceleron Pharma, Inc. In addition, $80 million of income was related to the termination of our Europe and Asia partnership with Sanofi in 2019.
|
•
|
Transition and other service fees include fees of $52 million in the first quarter of 2020 resulting from the divestiture of Otezla*.
|
•
|
Reversion excise tax resulted from the transfer of the retiree medical plan assets back to the Company. Refer to “Item 1. Financial Statements—Note 16. Retirement Benefits” for further information.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
(Loss)/Earnings Before Income Taxes
|
$
|
(304
|
)
|
|
$
|
1,979
|
|
Provision for Income Taxes
|
462
|
|
|
264
|
|
||
Effective Tax Rate
|
(152.0
|
)%
|
|
13.3
|
%
|
||
|
|
|
|
||||
Impact of Specified Items
|
(168.0
|
)%
|
|
(1.2
|
)%
|
||
Effective Tax Rate Excluding Specified Items
|
16.0
|
%
|
|
14.5
|
%
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Inventory purchase price accounting adjustments
|
$
|
1,420
|
|
|
$
|
—
|
|
Employee compensation charges
|
2
|
|
|
—
|
|
||
Site exit and other costs
|
16
|
|
|
12
|
|
||
Cost of products sold
|
1,438
|
|
|
12
|
|
||
|
|
|
|
||||
Employee compensation charges
|
15
|
|
|
—
|
|
||
Site exit and other costs
|
6
|
|
|
1
|
|
||
Marketing, selling and administrative
|
21
|
|
|
1
|
|
||
|
|
|
|
||||
License and asset acquisition charges
|
25
|
|
|
—
|
|
||
IPRD impairments
|
—
|
|
|
32
|
|
||
Inventory purchase price accounting adjustments
|
17
|
|
|
—
|
|
||
Employee compensation charges
|
18
|
|
|
—
|
|
||
Site exit and other costs
|
56
|
|
|
19
|
|
||
Research and development
|
116
|
|
|
51
|
|
||
|
|
|
|
||||
Amortization of acquired intangible assets
|
2,282
|
|
|
—
|
|
||
|
|
|
|
||||
Interest expense(a)
|
(41
|
)
|
|
—
|
|
||
Pension and postretirement
|
—
|
|
|
49
|
|
||
Royalties and licensing income
|
(83
|
)
|
|
—
|
|
||
Divestiture gains
|
(16
|
)
|
|
—
|
|
||
Acquisition expenses
|
—
|
|
|
165
|
|
||
Contingent consideration
|
556
|
|
|
—
|
|
||
Integration expenses
|
174
|
|
|
22
|
|
||
Provision for restructuring
|
160
|
|
|
12
|
|
||
Equity investment losses/(gains)
|
339
|
|
|
(175
|
)
|
||
Reversion excise tax
|
76
|
|
|
—
|
|
||
Other expense/(income), net
|
1,165
|
|
|
73
|
|
||
|
|
|
|
||||
Increase to pretax income
|
5,022
|
|
|
137
|
|
||
|
|
|
|
||||
Income taxes on items above
|
(291
|
)
|
|
(43
|
)
|
||
|
|
|
|
||||
Increase to net earnings
|
$
|
4,731
|
|
|
$
|
94
|
|
(a)
|
Includes amortization of purchase price adjustments to Celgene debt.
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions, except per share data
|
2020
|
|
2019
|
||||
Net (Loss)/Earnings Attributable to BMS Used for Diluted EPS Calculation – GAAP
|
$
|
(775
|
)
|
|
$
|
1,710
|
|
Specified Items
|
4,731
|
|
|
94
|
|
||
Net Earnings Attributable to BMS Used for Diluted EPS Calculation – Non-GAAP
|
$
|
3,956
|
|
|
$
|
1,804
|
|
|
|
|
|
||||
Weighted-Average Common Shares Outstanding – Diluted – GAAP
|
2,258
|
|
|
1,637
|
|
||
Incremental Shares Attributable to Share-Based Compensation Plans
|
40
|
|
|
—
|
|
||
Weighted-Average Common Shares Outstanding – Diluted
|
2,298
|
|
|
1,637
|
|
||
|
|
|
|
||||
Diluted (Loss)/Earnings Per Share Attributable to BMS – GAAP
|
$
|
(0.34
|
)
|
|
$
|
1.04
|
|
Diluted EPS Attributable to Specified Items
|
2.06
|
|
|
0.06
|
|
||
Diluted EPS Attributable to BMS – Non-GAAP
|
$
|
1.72
|
|
|
$
|
1.10
|
|
Dollars in Millions
|
March 31,
2020 |
|
December 31,
2019 |
||||
Cash and cash equivalents
|
$
|
15,817
|
|
|
$
|
12,346
|
|
Marketable debt securities – current
|
2,505
|
|
|
3,047
|
|
||
Marketable debt securities – non-current
|
651
|
|
|
767
|
|
||
Total cash, cash equivalents and marketable debt securities
|
18,973
|
|
|
16,160
|
|
||
Short-term debt obligations
|
(3,862
|
)
|
|
(3,346
|
)
|
||
Long-term debt
|
(42,844
|
)
|
|
(43,387
|
)
|
||
Net debt position
|
$
|
(27,733
|
)
|
|
$
|
(30,573
|
)
|
|
Three Months Ended March 31,
|
||||||
Dollars in Millions
|
2020
|
|
2019
|
||||
Cash flow provided by/(used in):
|
|
|
|
||||
Operating activities
|
$
|
3,894
|
|
|
$
|
1,390
|
|
Investing activities
|
653
|
|
|
1,060
|
|
||
Financing activities
|
(1,054
|
)
|
|
(2,029
|
)
|
Product
|
Indication
|
Date
|
Developments
|
Revlimid
|
Lymphoma
|
February 2020
|
Received supplemental Japan NDA approval for Revlimid in relapsed or refractory follicular lymphoma and marginal zone lymphoma.
|
Opdivo
|
CRC
|
February 2020
|
Ono, our alliance partner for Opdivo in Japan, announced that Japan's MHLW approved Opdivo for the treatment of patients with MSI-H unresectable advanced or recurrent CRC that has progressed following chemotherapy. The approval was based on the the result from Opdivo monotherapy cohort of a multi-center, open-label Phase II CheckMate-142 study conducted by BMS, evaluating Opdivo in patients with HSI-H or mismatch repair deficient recurrent or metastatic CRC that has progressed on or after, or been intolerant of prior treatment with chemotherapy including fluoropyrimidine anticancer drugs.
|
ESCC
|
February 2020
|
Announced that Japan’s MHLW approved Opdivo for the treatment of patients with unresectable advanced or recurrent ESCC that has progressed following chemotherapy. The approval was based on the Phase III ATTRACTION-3 trial conducted by Ono in collaboration with BMS, which evaluated Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent ESCC refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.
|
|
Gastric
|
March 2020
|
Received NMPA approval for Opdivo in 3L gastric cancer in China. The approval was supported by the ONO-4538-12 Phase III study.
|
|
NSCLC
|
February 2020
|
Ono, our alliance partner for Opdivo in Japan, announced the submission of a supplemental application in Japan for Opdivo to expand the use for the treatment of unresectable advanced or recurrent NSCLC, in combination treatment with platinum-doublet chemotherapy, for a partial change in approved items of the manufacturing and marketing approval.
|
|
RCC
|
April 2020
|
Announced with Exelixis, that CheckMate-9ER, a pivotal Phase III trial evaluating Opdivo in combination with Cabometyx* compared to sunitinib in previously untreated advanced or metastatic RCC, met its primary endpoint of progression-free survival at final analysis, as well as the secondary endpoints of overall survival at a pre-specified interim analysis, and objective response rate.
|
|
February 2020
|
Announced five-year follow-up results from the Phase III CheckMate-025 study, which continue to demonstrate that treatment with Opdivo delivers superior overall survival and objective response rates in patients with previously treated advanced or metastatic RCC compared to those treated with everolimus.
|
||
Ovarian Cancer
|
January 2020
|
Ono, our alliance partner for Opdivo in Japan, announced that Opdivo did not demonstrate a significant improvement in overall survival, a primary endpoint, versus chemotherapy in patients with platinum-refractory advanced or recurrent ovarian cancer in the final analysis of a multi-center, randomized, open-label Phase III clinical study (ONO-4538-23) conducted in Japan.
|
Product
|
Indication
|
Date
|
Developments
|
Opdivo+Yervoy
|
HCC
|
March 2020
|
Announced that Opdivo 1mg/kg plus Yervoy 3 mg/kg (injections for intravenous use) was approved by the FDA to treat HCC in patients who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo+Yervoy cohort of the Phase I/II CheckMate-040 trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
|
MPM
|
April 2020
|
Announced that CheckMate-743, a pivotal Phase III trial evaluating Opdivo in combination with Yervoy in previously untreated MPM met its primary endpoint of overall survival. Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy (pemetrexed and cisplatin or carboplatin).
|
|
NSCLC
|
April 2020
|
Announced that the FDA accepted our sBLA for Opdivo+Yervoy, administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. This application is based on data from Phase III CheckMate-9LA trial evaluating Opdivo+Yervoy combined with chemotherapy compared to chemotherapy alone as a first-line treatment in patients with metastatic NSCLC regardless of PD-L1 expression and histology. The FDA granted the application Priority Review with a PDUFA goal date of August 6, 2020, in addition to granting Fast Track designation.
|
|
April 2020
|
Announced the EMA validated a type II variation application for Opdivo+Yervoy, combined with limited chemotherapy, for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations.
|
||
March 2020
|
Ono, our alliance partner for Opdivo in Japan, announced that the companies submitted a supplemental application in Japan for combination therapy of Opdivo+Yervoy, in combination treatment with a limited cycle of platinum-doublet chemotherapy, to expand the use for first-line treatment of unresectable, advanced or recurrent NSCLC, for a partial change in approved items of the manufacturing and marketing approval in Japan. This application is based on data from Phase III CheckMate-9LA trial evaluating Opdivo+Yervoy combined with chemotherapy compared to chemotherapy alone as a first-line treatment in patients with metastatic NSCLC regardless of PD-L1 expression and histology.
|
||
January 2020
|
Announced voluntary withdrawal of the Company's application in the EU for the combination of Opdivo and Yervoy for the treatment of advanced NSCLC based on data from CheckMate-227. The application was originally filed in 2018 for patients with first-line NSCLC who have tumor mutational burden ≥10 mutations/megabase, based on the final analysis of progression-free survival, a co-primary endpoint in the trial. The application was subsequently amended to include the statistically significant result of overall survival, a co-primary endpoint, from CheckMate-227 Part 1a evaluating Opdivo+Yervoy versus chemotherapy in patients whose tumors expressed PD-L1 ≥1%.
Though the CHMP acknowledged the integrity of the patient level data, the CHMP determined a full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data. The company has no plans to refile this application in the EU. |
||
January 2020
|
Announced that the FDA accepted our sBLA for Opdivo in combination with Yervoy for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. This application is based on data from Part 1 of the Phase 3 CheckMate -227 trial evaluating Opdivo plus Yervoy versus chemotherapy in patients with previously untreated NSCLC, in which the dual immunotherapy combination demonstrated significant improvement in overall survival versus chemotherapy alone. The FDA granted the application Priority Review with a PDUFA goal date of May 15, 2020.
|
||
RCC
|
February 2020
|
Announced updated results from the Phase III CheckMate-214 study evaluating the combination of Opdivo+Yervoy versus sunitinib in patients with previously untreated advanced or metastatic RCC. With a minimum follow-up of 42 months, the combination of Opdivo+Yervoy continues to show superior overall survival, objective response rates, duration of response and complete response rates. The safety profile for Opdivo+Yervoy was consistent with prior findings and no new safety signals or drug-related death occurred with extended follow-up. The data were presented at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in San Francisco.
|
Orencia
|
RA
|
February 2020
|
Ono, our alliance partner for Orencia in Japan, announced that the Companies have received an approval of “Orencia for Intravenous Infusion 250mg,” “Orencia for Subcutaneous Injection 125mg Syringe 1mL” and “Orencia for Subcutaneous Injection 125mg Auto-injector 1mL” (“Orencia”) to include the description of “prevention of the structural damage of the joints” in the currently approved indication of RA for a partial change in approved items of the manufacturing and marketing approval in Japan.
|
Empliciti+Revlimid
|
Multiple Myeloma
|
March 2020
|
Announced topline results from the Phase III ELOQUENT-1 trial evaluating the combination of Empliciti plus Revlimid and dexamethasone, versus Revlimid and dexamethasone alone, in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival, the study’s primary endpoint.
|
Product
|
Indication
|
Date
|
Developments
|
Reblozyl
|
MDS
|
April 2020
|
Received a positive CHMP opinion for the treatment of adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy and adult patients with transfusion-dependent anemia associated with beta thalassemia.
|
April 2020
|
Announced the FDA has approved Reblozyl for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk MDS with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis. Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
|
||
Beta Thalassemia
|
March 2020
|
Announced that the New England Journal of Medicine has published results from BELIEVE, the pivotal Phase III study evaluating the safety and efficacy of Reblozyl for the treatment of anemia in adults with beta thalassemia who require regular red blood cell transfusions.
|
Zeposia
|
RMS
|
March 2020
|
Announced that the CHMP of EMA has adopted a positive opinion for Zeposia for the treatment of adult patients with RMS with active disease as defined by clinical or imaging features. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicine for the EU.
|
March 2020
|
Announced that the FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia, an oral medication taken once daily, is the only approved sphingosine-1-phosphate receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients. An up-titration scheme should be used to reach the maintenance dosage of Zeposia, as a transient decrease in heart rate and atrioventricular conduction delays may occur.
|
liso-cel
|
Lymphoma
|
May 2020
|
Announced that the FDA has extended the PDUFA date by three months for the BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The new PDUFA date set by the FDA is November 16, 2020.
|
ide-cel; bb2121
|
Multiple Myeloma
|
March 2020
|
Announced the submission of BLA to the FDA for idecabtagene vicleucel (ide-cel; bb2121), the company's lead investigational BCMA-directed CAR T-cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
|
CC-486
|
AML
|
May 2020
|
Announced that the FDA has accepted our NDA for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with AML, who achieved complete remission or complete remission with incomplete blood count recovery, following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation. The new drug application submission was based on the efficacy and safety results of the pivotal Phase III QUAZAR AML-001 study, which met the primary endpoint of improved overall survival for patients receiving AML maintenance treatment with CC-486 versus placebo. The FDA granted the application Priority Review and set a PDUFA goal date of September 3, 2020.
|
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
|
|
|
|
|
|
|
|
||||||
January 1 to 31, 2020
|
1,462,609
|
|
|
$
|
66.64
|
|
|
—
|
|
|
$
|
1,000
|
|
February 1 to 29, 2020
|
559,236
|
|
|
62.39
|
|
|
—
|
|
|
6,000
|
|
||
March 1 to 31, 2020
|
2,891,728
|
|
|
57.56
|
|
|
1,413,647
|
|
|
5,919
|
|
||
Three months ended March 31, 2020
|
4,913,573
|
|
|
|
|
1,413,647
|
|
|
|
(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 our common stock and in June 2012 increased its authorization for the repurchase of our 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 our common stock and in November 2019 further increased its authorization for the repurchase of our common stock by approximately $7.0 billion. In February 2020, the Board of Directors approved an increase of $5.0 billion to the total outstanding share repurchase authorization. The remaining share repurchase capacity under the program was approximately $5.9 billion as of March 31, 2020. The share repurchase program does not have an expiration date. Refer to “Item 1. Financial Statements—Note 15. Equity” for information on the share repurchase program.
|
|
For
|
|
Against
|
|
Abstain
|
|
Broker Non-Vote
|
Peter J. Arduini
|
1,559,396,505
|
|
41,068,251
|
|
3,966,972
|
|
342,470,123
|
Robert Bertolini
|
1,560,064,008
|
|
40,300,186
|
|
4,067,534
|
|
342,470,123
|
Michael W. Bonney
|
1,299,847,889
|
|
299,506,217
|
|
5,077,622
|
|
342,470,123
|
Giovanni Caforio, M.D.
|
1,461,368,177
|
|
128,873,665
|
|
14,189,886
|
|
342,470,123
|
Matthew W. Emmens
|
1,564,285,144
|
|
35,860,117
|
|
4,286,467
|
|
342,470,123
|
Julia A. Haller, M.D.
|
1,597,389,902
|
|
3,359,319
|
|
3,682,507
|
|
342,470,123
|
Dinesh C. Paliwal
|
1,563,335,629
|
|
37,173,415
|
|
3,922,684
|
|
342,470,123
|
Theodore R. Samuels
|
1,562,148,047
|
|
38,058,137
|
|
4,225,544
|
|
342,470,123
|
Vicki L. Sato, Ph.D.
|
1,390,886,310
|
|
186,211,919
|
|
27,333,499
|
|
342,470,123
|
Gerald L. Storch
|
1,551,920,470
|
|
48,467,993
|
|
4,043,265
|
|
342,470,123
|
Karen H. Vousden, Ph.D.
|
1,563,238,539
|
|
37,545,762
|
|
3,647,427
|
|
342,470,123
|
Phyllis R. Yale
|
1,590,093,666
|
|
9,899,337
|
|
4,438,725
|
|
342,470,123
|
For
|
|
Against
|
|
Abstain
|
|
Broker Non-Vote
|
1,488,216,779
|
|
108,570,439
|
|
7,644,510
|
|
342,470,123
|
For
|
|
Against
|
|
Abstain
|
|
|
1,884,281,232
|
|
52,808,475
|
|
9,812,144
|
|
|
For
|
|
Against
|
|
Abstain
|
|
Broker Non-Vote
|
710,926,387
|
|
883,136,445
|
|
10,368,896
|
|
342,470,123
|
For
|
|
Against
|
|
Abstain
|
|
Broker Non-Vote
|
693,125,224
|
|
900,453,724
|
|
10,852,780
|
|
342,470,123
|
Exhibit No.
|
|
Description
|
31a.
|
|
|
31b.
|
|
|
32a.
|
|
|
32b.
|
|
|
101.INS
|
|
XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document.
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document.
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
104
|
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
|
*
|
Indicates, in this Quarterly Report on Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Atripla is a trademark of Gilead Sciences, Inc.; Avapro/Avalide (known in the EU as Aprovel/Karvea) and Plavix are trademarks of Sanofi; Byetta is a trademark of Amylin Pharmaceuticals, LLC; Cabometyx is a trademark of Exelixis, Inc.; Erbitux is a trademark of ImClone LLC; Onglyza is a trademark of AstraZeneca AB; Gleevec is a trademark of Novartis International AG; Keytruda is a trademark of Merck Sharp & Dohme Corp; Nurtec is a trademark of Biohaven Pharmaceutical Holding Company Ltd.; Otezla is a trademark of Amgen Inc.; and Yescarta is a trademark of Kite Pharma, Inc. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.
|
2019 Form 10-K
|
Annual Report on Form 10-K for the fiscal year ended December 31, 2019
|
LIBOR
|
London Interbank Offered Rate
|
ALK
|
anaplastic lymphoma kinase
|
Lilly
|
Eli Lilly and Company
|
Amgen
|
Amgen Inc.
|
LOE
|
loss of exclusivity
|
AML
|
acute myeloid leukemia
|
MDL
|
multi-district litigation
|
Amylin
|
Amylin Pharmaceuticals, Inc.
|
MDS
|
myelodysplastic syndromes
|
aNDA
|
abbreviated new drug applications
|
MHLW
|
Ministry of Health, Labour and Welfare
|
AstraZeneca
|
AstraZeneca PLC
|
MPM
|
malignant pleural mesothelioma
|
BCMA
|
B-cell maturation antigen
|
MSI-H
|
high microsatellite instability
|
Biohaven
|
Biohaven Pharmaceutical Holding Company Ltd.
|
Nektar
|
Nektar Therapeutics
|
BLA
|
biologics license application
|
NKT
|
natural killer T cells
|
CAR
|
chimeric antigen receptor
|
NMPA
|
National Medical Products Administration
|
Catalent
|
Catalent, Inc.
|
NSCLC
|
non-small cell lung cancer
|
Celgene
|
Celgene Corporation
|
NVAF
|
non-valvular atrial fibrillation
|
CERCLA
|
U.S. Comprehensive Environmental Response, Compensation and Liability Act
|
Ono
|
Ono Pharmaceutical Co., Ltd.
|
CHMP
|
Committee for Medicinal Products for Human Use
|
OTC
|
over-the-counter
|
CML
|
chronic myeloid leukemia
|
Otsuka
|
Otsuka Pharmaceutical Co., Ltd.
|
CRC
|
colorectal cancer
|
PD-1
|
programmed cell death protein 1
|
CVR
|
contingent value rights
|
PD-L1
|
programmed death-ligand 1
|
EGFR
|
estimated glomerular filtration rate
|
PDUFA
|
The Prescription Drug User Fee Act
|
EMA
|
European Medicines Agency
|
Pfizer
|
Pfizer, Inc.
|
EPO
|
European Patent Office
|
PsA
|
psoriatic arthritis
|
EPS
|
earnings per share
|
Quarterly Report on Form 10-Q
|
Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2019
|
ERISA
|
Employee Retirement Income Security Act of 1974
|
R&D
|
research and development
|
ESCC
|
esophageal squamous cell carcinoma
|
RA
|
rheumatoid arthritis
|
EU
|
European Union
|
RCC
|
renal cell carcinoma
|
FASB
|
Financial Accounting Standards Board
|
RMS
|
relapsing forms of multiple sclerosis
|
FDA
|
U.S. Food and Drug Administration
|
Sanofi
|
Sanofi S.A.
|
Flexus
|
Flexus Biosciences, Inc.
|
sBLA
|
supplemental Biologics License Application
|
GAAP
|
U.S. generally accepted accounting principles
|
SEC
|
Securities and Exchange Commission
|
GTN
|
gross-to-net
|
U.S.
|
United States
|
HCC
|
hepatocellular carcinoma
|
UK
|
United Kingdom
|
HIV
|
human immunodeficiency viruses
|
VAT
|
value added tax
|
IO
|
immuno-oncology
|
ViiV
|
ViiV Healthcare Limited
|
IPRD
|
in-process research and development
|
VTE
|
venous thromboembolic
|
JIA
|
juvenile idiopathic arthritis
|
|
|
|
|
|
BRISTOL-MYERS SQUIBB COMPANY
(REGISTRANT)
|
|
|
|
|
|
|
Date:
|
May 7, 2020
|
|
By:
|
/s/ Giovanni Caforio, M.D.
|
|
|
|
|
Giovanni Caforio, M.D.
Chairman of the Board and Chief Executive Officer
|
|
|
|
|
|
Date:
|
May 7, 2020
|
|
By:
|
/s/ David V. Elkins
|
|
|
|
|
David V. Elkins
Chief Financial Officer
|
1.
|
I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020;
|
2.
|
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.
|
/s/ Giovanni Caforio, M.D.
|
Giovanni Caforio, M.D.
Chairman of the Board and Chief Executive Officer
|
1.
|
I have reviewed Bristol-Myers Squibb Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020;
|
2.
|
Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared;
|
b.
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function):
|
a.
|
all significant deficiencies and material weaknesses in the design or operation of internal controls over financial reporting, which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls over financial reporting.
|
/s/ David V. Elkins
|
David V. Elkins
Chief Financial Officer
|
/s/ Giovanni Caforio, M.D.
|
Giovanni Caforio, M.D.
Chairman of the Board and Chief Executive Officer
|
/s/ David V. Elkins
|
David V. Elkins
Chief Financial Officer
|