Note 1. BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING STANDARDS
Basis of Consolidation
Bristol-Myers Squibb Company (“BMS”) prepared these unaudited consolidated financial statements following the requirements of the SEC and U.S. GAAP for interim reporting. Under those rules, certain footnotes and other financial information that are normally required for annual financial statements can be condensed or omitted. The Company is responsible for the consolidated financial statements included in this Quarterly Report on Form 10-Q, which include all adjustments necessary for a fair presentation of the financial position at June 30, 2021 and December 31, 2020, the results of operations for the three and six months ended June 30, 2021 and 2020, and cash flows for the six months ended June 30, 2021 and 2020. All intercompany balances and transactions have been eliminated. These financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 included in the 2020 Form 10-K. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.
Business Segment Information
BMS operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. A global research and development organization and supply chain organization are responsible for the discovery, development, manufacturing and supply of products. Regional commercial organizations market, distribute and sell the products. The business is also supported by global corporate staff functions. Consistent with BMS’s operational structure, the Chief Executive Officer (“CEO”), as the chief operating decision maker, manages and allocates resources at the global corporate level. Managing and allocating resources at the global corporate level enables the CEO to assess both the overall level of resources available and how to best deploy these resources across functions, therapeutic areas, regional commercial organizations and research and development projects in line with our overarching long-term corporate-wide strategic goals, rather than on a product or franchise basis. The determination of a single segment is consistent with the financial information regularly reviewed by the CEO for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting future periods. For further information on product and regional revenue, see “—Note 2. Revenue.”
Use of Estimates and Judgments
Revenues, expenses, assets and liabilities can vary during each quarter of the year. Accordingly, the results and trends in these unaudited consolidated financial statements may not be indicative of full year operating results. The preparation of financial statements requires the use of management estimates, judgments and assumptions. The most significant assumptions are estimates used in determining accounting for business combinations; impairments of intangible assets; sales rebate and return accruals; legal contingencies; and income taxes. Actual results may differ from estimates.
Reclassifications
Certain reclassifications were made to conform the prior period consolidated financial statements to the current period presentation. Cash payments resulting from licensing arrangements, including upfront and contingent milestones previously included in operating activities in the consolidated statements of cash flows are now presented in investing activities. The adjustment resulted in an increase to net cash provided by operating activities and net cash used in investing activities of $267 million in the six months ended June 30, 2020. Proceeds received from the sale of equity investment securities previously presented in Divestiture and other proceeds in the consolidated statements of cash flows is now presented separately in Proceeds from sales of equity investment securities. These reclassifications did not have an impact on net assets or net earnings.
Recently Adopted Accounting Standards
In December 2019, the FASB issued amended guidance on the accounting and reporting of income taxes. The guidance is intended to simplify the accounting for income taxes by removing exceptions related to certain intraperiod tax allocations and deferred tax liabilities; clarifying guidance primarily related to evaluating the step-up tax basis for goodwill in a business combination; and reflecting enacted changes in tax laws or rates in the annual effective tax rate. BMS adopted the new guidance effective January 1, 2021. The amended guidance did not have a material impact on BMS’s results of operations.
Note 2. REVENUE
The following table summarizes the disaggregation of revenue by nature:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Net product sales
|
$
|
11,405
|
|
|
$
|
9,817
|
|
|
$
|
22,203
|
|
|
$
|
20,358
|
|
|
Alliance revenues
|
159
|
|
|
163
|
|
|
301
|
|
|
268
|
|
|
Other revenues
|
139
|
|
|
149
|
|
|
272
|
|
|
284
|
|
|
Total Revenues
|
$
|
11,703
|
|
|
$
|
10,129
|
|
|
$
|
22,776
|
|
|
$
|
20,910
|
|
Products are sold principally to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics and government agencies. Customer orders are generally fulfilled within a few days of receipt resulting in minimal order backlog. Contractual performance obligations are usually limited to transfer of control of the product to the customer. The transfer occurs either upon shipment, upon receipt of the product after considering when the customer obtains legal title to the product, or upon infusion for cell therapies and when BMS obtains a right of payment. At these points, customers are able to direct the use of and obtain substantially all of the remaining benefits of the product.
The following table summarizes GTN adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Gross product sales
|
$
|
16,782
|
|
|
$
|
13,788
|
|
|
$
|
32,341
|
|
|
$
|
28,474
|
|
|
GTN adjustments(a)
|
|
|
|
|
|
|
|
|
Charge-backs and cash discounts
|
(1,720)
|
|
|
(1,292)
|
|
|
(3,306)
|
|
|
(2,632)
|
|
|
Medicaid and Medicare rebates
|
(2,139)
|
|
|
(1,482)
|
|
|
(3,857)
|
|
|
(2,980)
|
|
|
Other rebates, returns, discounts and adjustments
|
(1,518)
|
|
|
(1,197)
|
|
|
(2,975)
|
|
|
(2,504)
|
|
|
Total GTN adjustments
|
(5,377)
|
|
|
(3,971)
|
|
|
(10,138)
|
|
|
(8,116)
|
|
|
Net product sales
|
$
|
11,405
|
|
|
$
|
9,817
|
|
|
$
|
22,203
|
|
|
$
|
20,358
|
|
(a) Includes adjustments for provisions for product sales made in prior periods resulting from changes in estimates of $85 million and $302 million for the three and six months ended June 30, 2021, and $44 million and $116 million for the three and six months ended June 30, 2020, respectively.
The following table summarizes the disaggregation of revenue by product and region:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Prioritized Brands
|
|
|
|
|
|
|
|
|
Revlimid
|
$
|
3,202
|
|
|
$
|
2,884
|
|
|
$
|
6,146
|
|
|
$
|
5,799
|
|
|
Eliquis
|
2,792
|
|
|
2,163
|
|
|
5,678
|
|
|
4,804
|
|
|
Opdivo
|
1,910
|
|
|
1,653
|
|
|
3,630
|
|
|
3,419
|
|
|
Orencia
|
814
|
|
|
750
|
|
|
1,572
|
|
|
1,464
|
|
|
Pomalyst/Imnovid
|
854
|
|
|
745
|
|
|
1,627
|
|
|
1,458
|
|
|
Sprycel
|
541
|
|
|
511
|
|
|
1,011
|
|
|
1,032
|
|
|
Yervoy
|
510
|
|
|
369
|
|
|
966
|
|
|
765
|
|
|
Abraxane
|
296
|
|
|
308
|
|
|
610
|
|
|
608
|
|
|
Empliciti
|
86
|
|
|
97
|
|
|
171
|
|
|
194
|
|
|
Reblozyl
|
128
|
|
|
55
|
|
|
240
|
|
|
63
|
|
|
Inrebic
|
16
|
|
|
15
|
|
|
32
|
|
|
27
|
|
|
Onureg
|
12
|
|
|
—
|
|
|
27
|
|
|
—
|
|
|
Zeposia
|
28
|
|
|
1
|
|
|
46
|
|
|
1
|
|
|
Breyanzi
|
17
|
|
|
—
|
|
|
17
|
|
|
—
|
|
|
Abecma
|
24
|
|
|
—
|
|
|
24
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
Established Brands
|
|
|
|
|
|
|
|
|
Vidaza
|
45
|
|
|
126
|
|
|
99
|
|
|
284
|
|
|
Baraclude
|
109
|
|
|
121
|
|
|
222
|
|
|
243
|
|
|
Other Brands
|
319
|
|
|
331
|
|
|
658
|
|
|
749
|
|
|
Total Revenues
|
$
|
11,703
|
|
|
$
|
10,129
|
|
|
$
|
22,776
|
|
|
$
|
20,910
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
$
|
7,388
|
|
|
$
|
6,487
|
|
|
$
|
14,398
|
|
|
$
|
13,253
|
|
|
Europe
|
2,689
|
|
|
2,136
|
|
|
5,242
|
|
|
4,703
|
|
|
Rest of the World
|
1,435
|
|
|
1,334
|
|
|
2,781
|
|
|
2,669
|
|
|
Other(a)
|
191
|
|
|
172
|
|
|
355
|
|
|
285
|
|
|
Total Revenues
|
$
|
11,703
|
|
|
$
|
10,129
|
|
|
$
|
22,776
|
|
|
$
|
20,910
|
|
(a) Other revenues include royalties and alliance-related revenues for products not sold by BMS’s regional commercial organizations.
Revenue recognized from performance obligations satisfied in prior periods was $146 million and $430 million for the three and six months ended June 30, 2021 and $98 million and $228 million for the three and six months ended June 30, 2020, respectively, consisting primarily of revised estimates for GTN adjustments related to prior period sales and royalties for out-licensing arrangements. Contract assets were not material at June 30, 2021 and December 31, 2020.
Note 3. ALLIANCES
BMS enters into collaboration arrangements with third parties for the development and commercialization of certain products. Although each of these arrangements is unique in nature, both parties are active participants in the operating activities of the collaboration and exposed to significant risks and rewards depending on the commercial success of the activities. BMS may either in-license intellectual property owned by the other party or out-license its intellectual property to the other party. These arrangements also typically include research, development, manufacturing, and/or commercial activities and can cover a single investigational compound or commercial product or multiple compounds and/or products in various life cycle stages. The rights and obligations of the parties can be global or limited to geographic regions. BMS refers to these collaborations as alliances and its partners as alliance partners.
Selected financial information pertaining to alliances was as follows, including net product sales when BMS is the principal in the third-party customer sale for products subject to the alliance. Expenses summarized below do not include all amounts attributed to the activities for the products in the alliance, but only the payments between the alliance partners or the related amortization if the payments were deferred or capitalized.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Revenues from alliances:
|
|
|
|
|
|
|
|
|
Net product sales
|
$
|
2,805
|
|
|
$
|
2,201
|
|
|
$
|
5,687
|
|
|
$
|
4,924
|
|
|
Alliance revenues
|
159
|
|
|
163
|
|
|
301
|
|
|
268
|
|
|
Total Revenues
|
$
|
2,964
|
|
|
$
|
2,364
|
|
|
$
|
5,988
|
|
|
$
|
5,192
|
|
|
|
|
|
|
|
|
|
|
|
Payments to/(from) alliance partners:
|
|
|
|
|
|
|
|
|
Cost of products sold
|
$
|
1,346
|
|
|
$
|
1,050
|
|
|
$
|
2,743
|
|
|
$
|
2,356
|
|
|
Marketing, selling and administrative
|
(48)
|
|
|
(38)
|
|
|
(97)
|
|
|
(78)
|
|
|
Research and development
|
736
|
|
|
233
|
|
|
743
|
|
|
279
|
|
|
Other (income)/expense, net
|
(14)
|
|
|
(16)
|
|
|
(19)
|
|
|
(31)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Selected Alliance Balance Sheet information:
|
|
|
|
|
Receivables – from alliance partners
|
$
|
349
|
|
|
$
|
343
|
|
|
Accounts payable – to alliance partners
|
2,032
|
|
|
1,093
|
|
|
Deferred income from alliances(a)
|
349
|
|
|
366
|
|
(a) Includes unamortized upfront and milestone payments.
Specific information pertaining to significant alliances including their nature and purpose; the significant rights and obligations of the parties; and specific accounting policy elections are discussed in the 2020 Form 10-K.
Eisai
In the second quarter of 2021, BMS and Eisai commenced an exclusive global strategic collaboration for the co-development and co-commercialization of MORAb-202, a selective folate receptor alpha antibody-drug conjugate being investigated in endometrial, ovarian, lung and breast cancers. MORAb-202 is currently in Phase I/II clinical trials for solid tumors.
BMS and Eisai will jointly develop and commercialize MORAb-202 in the U.S., Canada, Europe, Russia, Japan, China and certain other countries in the Asia-Pacific region (the “collaboration territory”). Eisai will be responsible for the global manufacturing and supply. Profits, research and development and commercialization costs are shared in the collaboration territories. BMS will be responsible for development and commercialization outside of the collaboration territory and will pay a royalty on those sales.
A $650 million upfront collaboration fee was included in Research and development expense in the second quarter of 2021 and paid in the third quarter of 2021. BMS is also obligated to pay up to $2.5 billion upon the achievement of contingent development, regulatory and sales-based milestones.
Note 4. DIVESTITURES, LICENSING AND OTHER ARRANGEMENTS
Divestitures
The following table summarizes the financial impact of divestitures including royalties, which are included in Other (income)/expense, net. Revenue and pretax earnings related to all divestitures were not material in all periods presented (excluding divestiture gains or losses).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Net Proceeds(a)
|
|
Divestiture (Gains)/Losses
|
|
Royalty Income
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Diabetes Business
|
$
|
132
|
|
|
$
|
127
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(152)
|
|
|
$
|
(129)
|
|
|
Erbitux* Business
|
6
|
|
|
3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Manufacturing Operations
|
23
|
|
|
10
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mature Brands and Other
|
41
|
|
|
1
|
|
|
(11)
|
|
|
9
|
|
|
—
|
|
|
(1)
|
|
|
Total
|
$
|
202
|
|
|
$
|
141
|
|
|
$
|
(11)
|
|
|
$
|
9
|
|
|
$
|
(152)
|
|
|
$
|
(130)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
Net Proceeds(a)
|
|
Divestiture (Gains)/Losses
|
|
Royalty Income
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Diabetes Business
|
$
|
296
|
|
|
$
|
280
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(286)
|
|
|
$
|
(256)
|
|
|
Erbitux* Business
|
6
|
|
|
7
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Manufacturing Operations
|
23
|
|
|
10
|
|
|
—
|
|
|
(1)
|
|
|
—
|
|
|
—
|
|
|
Plavix* and Avapro*/Avalide*
|
5
|
|
|
7
|
|
|
—
|
|
|
(12)
|
|
|
—
|
|
|
—
|
|
|
Mature Brands and Other
|
52
|
|
|
32
|
|
|
(11)
|
|
|
6
|
|
|
(1)
|
|
|
(32)
|
|
|
Total
|
$
|
382
|
|
|
$
|
336
|
|
|
$
|
(11)
|
|
|
$
|
(7)
|
|
|
$
|
(287)
|
|
|
$
|
(288)
|
|
(a) Includes royalties received subsequent to the related sale of the asset or business.
Licensing and Other Arrangements
The following table summarizes the financial impact of Keytruda* royalties, Tecentriq* royalties, up-front licensing fees and milestones for products that have not obtained commercial approval, which are included in Other (income)/expense, net.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Keytruda* royalties
|
$
|
(204)
|
|
|
$
|
(155)
|
|
|
$
|
(396)
|
|
|
$
|
(316)
|
|
|
Tecentriq* royalties
|
(23)
|
|
|
—
|
|
|
(45)
|
|
|
—
|
|
|
Up-front licensing fees
|
—
|
|
|
—
|
|
|
—
|
|
|
(30)
|
|
|
Contingent milestone income
|
(2)
|
|
|
(5)
|
|
|
(2)
|
|
|
(46)
|
|
|
Amortization of deferred income
|
(15)
|
|
|
(15)
|
|
|
(30)
|
|
|
(30)
|
|
|
Other royalties
|
(9)
|
|
|
(6)
|
|
|
(12)
|
|
|
(11)
|
|
|
Total
|
$
|
(253)
|
|
|
$
|
(181)
|
|
|
$
|
(485)
|
|
|
$
|
(433)
|
|
Agenus
In July 2021, BMS obtained a global exclusive license to Agenus’ proprietary AGEN1777 bispecific antibody program that blocks TIGIT and an additional target. AGEN1777 is being studied in oncology and is in preclinical development. BMS will be responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide, including strategic decisions, regulatory responsibilities, funding and manufacturing. BMS paid a $200 million upfront licensing fee to Agenus and is obligated to pay up to $1.4 billion upon achievement of contingent development, regulatory and sales-based milestones as well as royalties on global net sales.
Note 5. OTHER (INCOME)/EXPENSE, NET
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Interest expense
|
$
|
330
|
|
|
$
|
357
|
|
|
$
|
683
|
|
|
$
|
719
|
|
|
Contingent consideration
|
—
|
|
|
(165)
|
|
|
(510)
|
|
|
391
|
|
|
Royalties and licensing income
|
(405)
|
|
|
(311)
|
|
|
(772)
|
|
|
(721)
|
|
|
Equity investment gains
|
(148)
|
|
|
(818)
|
|
|
(749)
|
|
|
(480)
|
|
|
Integration expenses
|
152
|
|
|
166
|
|
|
293
|
|
|
340
|
|
|
Provision for restructuring
|
78
|
|
|
115
|
|
|
123
|
|
|
275
|
|
|
Litigation and other settlements
|
44
|
|
|
(1)
|
|
|
36
|
|
|
31
|
|
|
Transition and other service fees
|
(22)
|
|
|
(50)
|
|
|
(37)
|
|
|
(111)
|
|
|
Investment income
|
(12)
|
|
|
(25)
|
|
|
(21)
|
|
|
(86)
|
|
|
Reversion excise tax
|
—
|
|
|
—
|
|
|
—
|
|
|
76
|
|
|
Divestiture (gains)/losses
|
(11)
|
|
|
9
|
|
|
(11)
|
|
|
(7)
|
|
|
Intangible asset impairment
|
—
|
|
|
21
|
|
|
—
|
|
|
21
|
|
|
|
|
|
|
|
|
|
|
|
Loss on debt redemption
|
—
|
|
|
—
|
|
|
281
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
(8)
|
|
|
(34)
|
|
|
(20)
|
|
|
(21)
|
|
|
Other (income)/expense, net
|
$
|
(2)
|
|
|
$
|
(736)
|
|
|
$
|
(704)
|
|
|
$
|
427
|
|
Note 6. RESTRUCTURING
Celgene Acquisition Plan
In 2019, a restructuring and integration plan was implemented as an initiative to realize sustainable run rate synergies resulting from cost savings and avoidance from the Celgene acquisition which is currently expected to be approximately $3.0 billion. The synergies are expected to be realized in Cost of products sold (10%), Marketing, selling and administrative expenses (55%) and Research and development expenses (35%). Charges of approximately $3.0 billion are expected to be incurred through 2022. Cumulative charges of approximately $2.3 billion have been recognized including integration planning and execution expenses, employee termination benefit costs and accelerated stock-based compensation, contract termination costs and other shutdown costs associated with site exits. Cash outlays in connection with these actions are expected to be approximately $2.5 billion. Employee workforce reductions were approximately 240 and 900 for the six months ended June 30, 2021 and 2020, respectively.
MyoKardia Acquisition Plan
In 2020, a restructuring and integration plan was initiated to realize expected cost synergies resulting from cost savings and avoidance from the MyoKardia acquisition. Charges of approximately $150 million are expected to be incurred through 2022, and consist of integration planning and execution expenses, employee termination benefit costs and other costs. Cumulative charges of approximately $95 million have been recognized for these actions.
Company Transformation
In 2016, a restructuring plan was announced to evolve and streamline BMS’s operating model. Cumulative charges of approximately $1.5 billion were recognized for these actions since the announcement. Actions under the plan were completed as of December 31, 2020.
The following provides the charges related to restructuring initiatives by type of cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Celgene Acquisition Plan
|
$
|
200
|
|
|
$
|
317
|
|
|
$
|
373
|
|
|
$
|
641
|
|
|
MyoKardia Acquisition Plan
|
19
|
|
|
—
|
|
|
56
|
|
|
—
|
|
|
Company Transformation
|
—
|
|
|
23
|
|
|
—
|
|
|
105
|
|
|
Total charges
|
$
|
219
|
|
|
$
|
340
|
|
|
$
|
429
|
|
|
$
|
746
|
|
|
|
|
|
|
|
|
|
|
|
Employee termination costs
|
$
|
75
|
|
|
$
|
107
|
|
|
$
|
119
|
|
|
$
|
256
|
|
|
Other termination costs
|
3
|
|
|
8
|
|
|
4
|
|
|
19
|
|
|
Provision for restructuring
|
78
|
|
|
115
|
|
|
123
|
|
|
275
|
|
|
Integration expenses
|
152
|
|
|
166
|
|
|
293
|
|
|
340
|
|
|
Accelerated depreciation
|
—
|
|
|
11
|
|
|
—
|
|
|
41
|
|
|
Asset impairments
|
—
|
|
|
39
|
|
|
24
|
|
|
81
|
|
|
Other shutdown costs, net
|
(11)
|
|
|
9
|
|
|
(11)
|
|
|
9
|
|
|
Total charges
|
$
|
219
|
|
|
$
|
340
|
|
|
$
|
429
|
|
|
$
|
746
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
$
|
—
|
|
|
$
|
11
|
|
|
$
|
24
|
|
|
$
|
27
|
|
|
Marketing, selling and administrative
|
—
|
|
|
1
|
|
|
—
|
|
|
1
|
|
|
Research and development
|
—
|
|
|
39
|
|
|
—
|
|
|
95
|
|
|
Other (income)/expense, net
|
219
|
|
|
289
|
|
|
405
|
|
|
623
|
|
|
Total charges
|
$
|
219
|
|
|
$
|
340
|
|
|
$
|
429
|
|
|
$
|
746
|
|
The following summarizes the charges and spending related to restructuring plan activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
Liability at December 31
|
$
|
148
|
|
|
$
|
100
|
|
|
Provision for restructuring(a)
|
114
|
|
|
228
|
|
|
Foreign currency translation and other
|
(2)
|
|
|
1
|
|
|
Payments
|
(134)
|
|
|
(188)
|
|
|
Liability at June 30
|
$
|
126
|
|
|
$
|
141
|
|
(a) Includes a reduction of the liability resulting from changes in estimates of $8 million and $6 million for the six months ended June 30, 2021 and 2020, respectively. Excludes $9 million and $47 million for the six months ended June 30, 2021 and 2020, respectively, of accelerated stock-based compensation relating to the Celgene Acquisition Plan.
Note 7. INCOME TAXES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Earnings Before Income Taxes
|
$
|
1,553
|
|
|
$
|
1,627
|
|
|
$
|
4,083
|
|
|
$
|
1,323
|
|
|
Provision for Income Taxes
|
492
|
|
|
1,707
|
|
|
993
|
|
|
2,169
|
|
|
Effective Tax Rate
|
31.7
|
%
|
|
104.9
|
%
|
|
24.3
|
%
|
|
163.9
|
%
|
Income taxes in interim periods are determined based on the estimated annual effective tax rates and the tax impact of discrete items that are reflected immediately. The effective tax rates in 2021 and 2020 were impacted by low jurisdictional tax rates attributed to the unwinding of inventory fair value adjustments and intangible asset amortization and contingent value rights fair value adjustments that are not taxable or deductible. The three and six months ended June 30, 2020 includes an $853 million deferred tax charge resulting from an internal transfer of certain intangible assets to the U.S. and an additional $255 million GILTI tax charge upon finalization of the Otezla* divestiture tax consequences with tax authorities. Additional changes to the effective tax rate may occur in future periods due to various reasons, including changes to the estimated pretax earnings mix and tax reserves and revised interpretations or changes to the relevant tax code.
It is reasonably possible that the amount of unrecognized tax benefits at June 30, 2021 could decrease in the range of approximately $430 million to $480 million in the next twelve months as a result of the settlement of certain tax audits and other events. The expected change in unrecognized tax benefits may result in the payment of additional taxes, adjustment of certain deferred taxes and/or recognition of tax benefits.
BMS is currently under examination by a number of tax authorities, which have proposed or are considering proposing material adjustments to tax positions for issues such as transfer pricing, certain tax credits and the deductibility of certain expenses. As previously disclosed, BMS received several notices of proposed adjustments from the IRS related to transfer pricing and other tax positions for the 2008 to 2012 tax years. BMS disagrees with the IRS’s positions and continues to work cooperatively with the IRS to resolve these open tax audits. It is reasonably possible that new issues will be raised by tax authorities that may increase unrecognized tax benefits; however, an estimate of such increases cannot reasonably be made at this time. BMS believes that it has adequately provided for all open tax years by tax jurisdiction.
Note 8. EARNINGS/(LOSS) PER SHARE
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Amounts in Millions, Except Per Share Data
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Net Earnings/(Loss) Attributable to BMS Used for Basic and Diluted EPS Calculation
|
$
|
1,055
|
|
|
$
|
(85)
|
|
|
$
|
3,076
|
|
|
$
|
(860)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average Common Shares Outstanding – Basic
|
2,227
|
|
|
2,263
|
|
|
2,232
|
|
|
2,261
|
|
|
Incremental Shares Attributable to Share-Based Compensation Plans
|
25
|
|
|
—
|
|
|
26
|
|
|
—
|
|
|
Weighted-Average Common Shares Outstanding – Diluted
|
2,252
|
|
|
2,263
|
|
|
2,258
|
|
|
2,261
|
|
|
|
|
|
|
|
|
|
|
|
Earnings/(Loss) per Common Share
|
|
|
|
|
|
|
|
|
Basic
|
$
|
0.47
|
|
|
$
|
(0.04)
|
|
|
$
|
1.38
|
|
|
$
|
(0.38)
|
|
|
Diluted
|
0.47
|
|
|
(0.04)
|
|
|
1.36
|
|
|
(0.38)
|
|
The total number of potential shares of common stock excluded from the diluted earnings/(loss) per common share computation because of the antidilutive impact was 9 million for both the three and six months ended June 30, 2021 and 127 million for both the three and six months ended June 30, 2020.
Note 9. FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
|
Dollars in Millions
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Cash and cash equivalents - money market and other securities
|
$
|
—
|
|
|
$
|
9,246
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
12,361
|
|
|
$
|
—
|
|
|
Marketable debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit
|
—
|
|
|
1,591
|
|
|
—
|
|
|
—
|
|
|
1,020
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
—
|
|
|
498
|
|
|
—
|
|
|
—
|
|
|
698
|
|
|
—
|
|
|
Derivative assets
|
—
|
|
|
131
|
|
|
19
|
|
|
—
|
|
|
42
|
|
|
27
|
|
|
Equity investments
|
3,275
|
|
|
139
|
|
|
—
|
|
|
3,314
|
|
|
138
|
|
|
—
|
|
|
Derivative liabilities
|
—
|
|
|
42
|
|
|
—
|
|
|
—
|
|
|
270
|
|
|
—
|
|
|
Contingent consideration liability:
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent value rights
|
10
|
|
|
—
|
|
|
—
|
|
|
530
|
|
|
—
|
|
|
—
|
|
|
Other acquisition related contingent consideration
|
—
|
|
|
—
|
|
|
67
|
|
|
—
|
|
|
—
|
|
|
78
|
|
As further described in “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements” in the Company’s 2020 Form 10-K, the Company’s fair value estimates use inputs that are either (1) quoted prices for identical assets or liabilities in active markets (Level 1 inputs); (2) observable prices for similar assets or liabilities in active markets or for identical or similar assets or liabilities in markets that are not active (Level 2 inputs); or (3) unobservable inputs (Level 3 inputs).
Contingent consideration obligations are recorded at their estimated fair values and these obligations are revalued each reporting period until the related contingencies are resolved. The contingent value rights are adjusted to fair value using the traded price of the securities at the end of each reporting period. The fair value measurements for other contingent consideration liabilities are estimated using probability-weighted discounted cash flow approaches that are based on significant unobservable inputs related to product candidates acquired in business combinations and are reviewed quarterly. These inputs include, as applicable, estimated probabilities and timing of achieving specified development and regulatory milestones and the discount rate used to calculate the present value of estimated future payments. Significant changes which increase or decrease the probabilities of achieving the related development and regulatory events or shorten or lengthen the time required to achieve such events would result in corresponding increases or decreases in the fair values of these obligations. The fair value of other acquisition related contingent consideration as of June 30, 2021 was calculated using the following significant unobservable inputs:
|
|
|
|
|
|
|
|
|
|
|
Ranges (weighted average) utilized as of:
|
|
Inputs
|
June 30, 2021
|
|
|
|
Discount rate
|
0.3% to 1.3% (0.6%)
|
|
|
|
Probability of payment
|
0% to 80% (2.4%)
|
|
|
|
Projected year of payment for development and regulatory milestones
|
2022 to 2028
|
|
|
There were no transfers between levels 1, 2 and 3 during the six months ended June 30, 2021. The following table represents a roll-forward of the fair value of level 3 instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, 2021
|
|
Six Months Ended June 30, 2020
|
|
Dollars in Millions
|
Asset
|
|
Liability
|
|
Asset
|
|
Liability
|
|
Fair value as of January 1
|
$
|
27
|
|
|
$
|
78
|
|
|
$
|
—
|
|
|
$
|
106
|
|
|
|
|
|
|
|
|
|
|
|
Changes in estimated fair value
|
(8)
|
|
|
2
|
|
|
—
|
|
|
(36)
|
|
|
Payments
|
—
|
|
|
(12)
|
|
|
—
|
|
|
—
|
|
|
Foreign exchange
|
—
|
|
|
(1)
|
|
|
—
|
|
|
1
|
|
|
Fair value as of June 30
|
$
|
19
|
|
|
$
|
67
|
|
|
$
|
—
|
|
|
$
|
71
|
|
Available-for-sale Debt Securities and Equity Investments
The following table summarizes available-for-sale debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
|
Dollars in Millions
|
Amortized Cost
|
|
Gross Unrealized
|
|
|
|
Amortized Cost
|
|
Gross Unrealized
|
|
|
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|
|
Gains
|
|
Losses
|
|
Fair Value
|
|
Certificates of deposit
|
$
|
1,591
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,591
|
|
|
$
|
1,020
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate debt securities
|
490
|
|
|
8
|
|
|
—
|
|
|
498
|
|
|
684
|
|
|
14
|
|
|
—
|
|
|
698
|
|
|
Total available-for-sale debt securities(a)
|
$
|
2,081
|
|
|
$
|
8
|
|
|
$
|
—
|
|
|
$
|
2,089
|
|
|
$
|
1,704
|
|
|
$
|
14
|
|
|
$
|
—
|
|
|
$
|
1,718
|
|
(a) All marketable debt securities mature within two years as of June 30, 2021 and December 31, 2020.
The following summarizes the carrying amount of equity investments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Equity investments with readily determinable fair values
|
$
|
3,414
|
|
|
$
|
3,452
|
|
|
Equity investments without readily determinable fair values
|
616
|
|
|
694
|
|
|
Equity method investments
|
638
|
|
|
549
|
|
|
Total equity investments
|
$
|
4,668
|
|
|
$
|
4,695
|
|
The following summarizes the activity related to equity investments. Changes in fair value of equity investments are included in Other (income)/expense, net.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Net gain/(loss) recognized on equity investments with readily determinable fair values(a)
|
$
|
11
|
|
|
$
|
778
|
|
|
$
|
448
|
|
|
$
|
550
|
|
|
Realized gain/(loss) recognized on equity investments with readily determinable fair value sold
|
1
|
|
|
—
|
|
|
(2)
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
Upward adjustments on equity investments without readily determinable fair value
|
99
|
|
|
55
|
|
|
130
|
|
|
130
|
|
|
Impairments and downward adjustments on equity investments without readily determinable fair value
|
—
|
|
|
(14)
|
|
|
(1)
|
|
|
(202)
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative upward adjustments on equity investments without readily determinable fair value
|
|
|
|
|
243
|
|
|
|
|
Cumulative impairments and downward adjustments on equity investments without readily determinable fair value
|
|
|
|
|
(142)
|
|
|
|
(a) Net unrealized net gains on equity investments still held were $11 million and $353 million for the three and six months ended June 30, 2021 and $778 million and $550 million for the three and six months ended June 30, 2020, respectively.
Qualifying Hedges and Non-Qualifying Derivatives
Cash Flow Hedges — Foreign currency forward contracts are used to hedge certain forecasted intercompany inventory purchases and sales transactions and certain foreign currency transactions. The fair value for contracts designated as cash flow hedges are temporarily reported in Accumulated other comprehensive loss and included in earnings when the hedged item affects earnings. The net gain or loss on foreign currency forward contracts is expected to be reclassified to net earnings (primarily included in Cost of products sold and Other (income)/expense, net) within the next 12 months. The notional amount of outstanding foreign currency forward contracts was primarily attributed to the euro of $3.1 billion and Japanese yen of $1.1 billion at June 30, 2021.
The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not material during all periods presented. Cash flow hedge accounting is discontinued when the forecasted transaction is no longer probable of occurring within 60 days after the originally forecasted date or when the hedge is no longer effective. Assessments to determine whether derivatives designated as qualifying hedges are highly effective in offsetting changes in the cash flows of hedged items are performed at inception and on a quarterly basis. Foreign currency forward contracts not designated as hedging instruments are used to offset exposures in certain foreign currency denominated assets, liabilities and earnings. Changes in the fair value of these derivatives are recognized in earnings as they occur.
BMS may hedge a portion of its future foreign currency exposure by utilizing a strategy that involves both a purchased local currency put option and a written local currency call option that are accounted for as hedges of future sales denominated in that local currency. Specifically, BMS sells (or writes) a local currency call option and purchases a local currency put option with the same expiration dates and local currency notional amounts but with different strike prices. The premium collected from the sale of the call option is equal to the premium paid for the purchased put option, resulting in no net premium being paid. This combination of transactions is generally referred to as a “zero-cost collar.” The expiration dates and notional amounts correspond to the amount and timing of forecasted foreign currency sales. If the U.S. Dollar weakens relative to the currency of the hedged anticipated sales, the purchased put option value reduces to zero and BMS benefits from the increase in the U.S. Dollar equivalent value of our anticipated foreign currency cash flows; however, this benefit would be capped at the strike level of the written call, which forms the upper end of the collar.
Net Investment Hedges — Non-U.S. Dollar borrowings of €950 million ($1.1 billion) at June 30, 2021 are designated as net investment hedges to hedge euro currency exposures of the net investment in certain foreign affiliates and are recognized in long-term debt. The effective portion of foreign exchange gain on the remeasurement of euro debt was included in the foreign currency translation component of Accumulated other comprehensive loss with the related offset in long-term debt.
Cross-currency interest rate swap contracts of $400 million at June 30, 2021 are designated to hedge Japanese yen currency exposure of BMS’s net investment in its Japan subsidiaries. Contract fair value changes are recorded in the foreign currency translation component of Other Comprehensive Income/(Loss) with a related offset in Other non-current assets or Other non-current liabilities.
Fair Value Hedges — Fixed to floating interest rate swap contracts are designated as fair value hedges and used as an interest rate risk management strategy to create an appropriate balance of fixed and floating rate debt. The contracts and underlying debt for the hedged benchmark risk are recorded at fair value. The effective interest rate for the contracts is one-month LIBOR (0.10% as of June 30, 2021) plus an interest rate spread of 4.6%. Gains or losses resulting from changes in fair value of the underlying debt attributable to the hedged benchmark interest rate risk are recorded in interest expense with an associated offset to the carrying value of debt. Since the specific terms and notional amount of the swap are intended to align with the debt being hedged, all changes in fair value of the swap are recorded in interest expense with an associated offset to the derivative asset or liability on the consolidated balance sheet. As a result, there was no net impact in earnings. If the underlying swap is terminated prior to maturity, then the fair value adjustment to the underlying debt is amortized as a reduction to interest expense over the remaining term of the debt.
The following table summarizes the fair value of outstanding derivatives:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
|
December 31, 2020
|
|
|
Asset(a)
|
|
Liability(b)
|
|
Asset(a)
|
|
Liability(b)
|
|
Dollars in Millions
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
|
Notional
|
|
Fair Value
|
|
Derivatives designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contracts
|
$
|
255
|
|
|
$
|
16
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
255
|
|
|
$
|
24
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Cross-currency interest rate swap contracts
|
400
|
|
|
16
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
400
|
|
|
(10)
|
|
|
Foreign currency forward contracts
|
3,776
|
|
|
90
|
|
|
1,445
|
|
|
(36)
|
|
|
231
|
|
|
1
|
|
|
5,813
|
|
|
(259)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts
|
932
|
|
|
9
|
|
|
531
|
|
|
(6)
|
|
|
1,104
|
|
|
17
|
|
|
336
|
|
|
(1)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
|
—
|
|
|
19
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
27
|
|
|
—
|
|
|
—
|
|
(a) Included in Other current assets and Other non-current assets.
(b) Included in Other current liabilities and Other non-current liabilities.
The following table summarizes the financial statement classification and amount of (gain)/loss recognized on hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2021
|
|
Six Months Ended June 30, 2021
|
|
Dollars in Millions
|
Cost of products sold
|
|
Other (income)/expense, net
|
|
Cost of products sold
|
|
Other (income)/expense, net
|
|
Interest rate swap contracts
|
$
|
—
|
|
|
$
|
(7)
|
|
|
$
|
—
|
|
|
$
|
(15)
|
|
|
Cross-currency interest rate swap contracts
|
—
|
|
|
(3)
|
|
|
—
|
|
|
(6)
|
|
|
Foreign currency forward contracts
|
59
|
|
|
16
|
|
|
126
|
|
|
(16)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2020
|
|
Six Months Ended June 30, 2020
|
|
Dollars in Millions
|
Cost of products sold
|
|
Other (income)/expense, net
|
|
Cost of products sold
|
|
Other (income)/expense, net
|
|
Interest rate swap contracts
|
$
|
—
|
|
|
$
|
(7)
|
|
|
$
|
—
|
|
|
$
|
(14)
|
|
|
Cross-currency interest rate swap contracts
|
—
|
|
|
(3)
|
|
|
—
|
|
|
(5)
|
|
|
Foreign currency forward contracts
|
(35)
|
|
|
21
|
|
|
(58)
|
|
|
(55)
|
|
|
Foreign currency zero-cost collar contracts
|
—
|
|
|
10
|
|
|
—
|
|
|
1
|
|
The following table summarizes the effect of derivative and non-derivative instruments designated as hedging instruments in Other Comprehensive Income/(Loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Derivatives qualifying as cash flow hedges
|
|
|
|
|
|
|
|
|
Foreign currency forward contracts gain/(loss):
|
|
|
|
|
|
|
|
|
Recognized in Other Comprehensive Income/(Loss)(a)
|
$
|
(38)
|
|
|
$
|
(34)
|
|
|
$
|
221
|
|
|
$
|
63
|
|
|
Reclassified to Cost of products sold
|
53
|
|
|
(32)
|
|
|
89
|
|
|
(52)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives qualifying as net investment hedges
|
|
|
|
|
|
|
|
|
Cross-currency interest rate swap contracts gain:
|
|
|
|
|
|
|
|
|
Recognized in Other Comprehensive Income/(Loss)
|
—
|
|
|
4
|
|
|
26
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
|
Non-derivatives qualifying as net investment hedges
|
|
|
|
|
|
|
|
|
Non-U.S. dollar borrowings gain:
|
|
|
|
|
|
|
|
|
Recognized in Other Comprehensive Income/(Loss)
|
(16)
|
|
|
(32)
|
|
|
25
|
|
|
(12)
|
|
(a) The majority is expected to be reclassified into earnings in the next 12 months.
Debt Obligations
Short-term debt obligations include:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Non-U.S. short-term borrowings
|
$
|
63
|
|
|
$
|
176
|
|
|
Current portion of long-term debt
|
2,497
|
|
|
2,000
|
|
|
Other
|
95
|
|
|
164
|
|
|
Total
|
$
|
2,655
|
|
|
$
|
2,340
|
|
Long-term debt and the current portion of long-term debt include:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Principal Value
|
$
|
43,666
|
|
|
$
|
48,711
|
|
|
|
|
|
|
|
Adjustments to Principal Value:
|
|
|
|
|
Fair value of interest rate swap contracts
|
16
|
|
|
24
|
|
|
Unamortized basis adjustment from swap terminations
|
131
|
|
|
149
|
|
|
Unamortized bond discounts and issuance costs
|
(279)
|
|
|
(303)
|
|
|
Unamortized purchase price adjustments of Celgene debt
|
1,466
|
|
|
1,755
|
|
|
Total
|
$
|
45,000
|
|
|
$
|
50,336
|
|
|
|
|
|
|
|
Current portion of long-term debt
|
$
|
2,497
|
|
|
$
|
2,000
|
|
|
Long-term debt
|
42,503
|
|
|
48,336
|
|
|
Total
|
$
|
45,000
|
|
|
$
|
50,336
|
|
The fair value of long-term debt was $50.6 billion at June 30, 2021 and $58.5 billion at December 31, 2020 valued using Level 2 inputs, which are based upon the quoted market prices for the same or similar debt instruments. The fair value of short-term borrowings approximates the carrying value due to the short maturities of the debt instruments.
In the first quarter of 2021, BMS purchased aggregate principal amount of $3.5 billion of certain of its debt securities for approximately $4.0 billion of cash in a series of tender offers and “make whole” redemptions. In connection with these transactions, a $281 million loss on debt redemption was recognized based on the carrying value of the debt and included in Other (income)/expense, net. In addition, the $500 million 2.875% Notes matured and were repaid.
In the second quarter of 2021, the $1.0 billion 2.550% Notes matured and were repaid.
Interest payments were $807 million and $845 million for the six months ended June 30, 2021 and 2020, respectively, net of amounts related to interest rate swap contracts.
As of June 30, 2021, BMS had four separate revolving credit facilities totaling $6.0 billion, which consisted of a 364-day $2.0 billion facility expiring in January 2022, a three-year $1.0 billion facility expiring in January 2022 and two five-year $1.5 billion facilities that were extended to September 2025 and July 2026, respectively. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for BMS’s commercial paper borrowings and are extendable annually by one year on the anniversary date with the consent of the lenders. No borrowings were outstanding under any revolving credit facility at June 30, 2021 or December 31, 2020.
Note 10. RECEIVABLES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Trade receivables
|
$
|
8,309
|
|
|
$
|
7,882
|
|
|
Less charge-backs and cash discounts
|
(569)
|
|
|
(645)
|
|
|
Less allowance for expected credit loss
|
(27)
|
|
|
(18)
|
|
|
Net trade receivables
|
7,713
|
|
|
7,219
|
|
|
Alliance, royalties, VAT and other
|
1,304
|
|
|
1,282
|
|
|
Receivables
|
$
|
9,017
|
|
|
$
|
8,501
|
|
Non-U.S. receivables sold on a nonrecourse basis were $638 million and $464 million for the six months ended June 30, 2021 and 2020, respectively. Receivables from the three largest customers in the U.S. represented approximately 58% and 56% of total trade receivables at June 30, 2021 and December 31, 2020, respectively.
Note 11. INVENTORIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Finished goods
|
$
|
891
|
|
|
$
|
932
|
|
|
Work in process
|
1,852
|
|
|
2,015
|
|
|
Raw and packaging materials
|
270
|
|
|
207
|
|
|
Total inventories
|
$
|
3,013
|
|
|
$
|
3,154
|
|
|
|
|
|
|
|
Inventories
|
$
|
2,137
|
|
|
$
|
2,074
|
|
|
Other non-current assets
|
876
|
|
|
1,080
|
|
Total inventories include fair value adjustments resulting from the Celgene acquisition of $606 million at June 30, 2021 and $774 million at December 31, 2020. Other non-current assets include inventory expected to remain on hand beyond one year in both periods.
Note 12. PROPERTY, PLANT AND EQUIPMENT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Land
|
$
|
169
|
|
|
$
|
189
|
|
|
Buildings
|
5,705
|
|
|
5,732
|
|
|
Machinery, equipment and fixtures
|
3,194
|
|
|
3,063
|
|
|
Construction in progress
|
565
|
|
|
487
|
|
|
Gross property, plant and equipment
|
9,633
|
|
|
9,471
|
|
|
Less accumulated depreciation
|
(3,838)
|
|
|
(3,585)
|
|
|
Property, plant and equipment
|
$
|
5,795
|
|
|
$
|
5,886
|
|
Depreciation expense was $143 million and $278 million for the three and six months ended June 30, 2021 and $145 million and $315 million for the three and six months ended June 30, 2020, respectively.
Note 13. GOODWILL AND OTHER INTANGIBLE ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
Estimated Useful Lives
|
|
June 30,
2021
|
|
December 31,
2020
|
|
Goodwill
|
|
|
$
|
20,529
|
|
|
$
|
20,547
|
|
|
|
|
|
|
|
|
|
Other intangible assets:
|
|
|
|
|
|
|
Licenses
|
5 – 15 years
|
|
327
|
|
|
328
|
|
|
Acquired marketed product rights
|
3 – 15 years
|
|
60,712
|
|
|
59,076
|
|
|
Capitalized software
|
3 – 10 years
|
|
1,405
|
|
|
1,325
|
|
|
IPRD
|
|
|
4,360
|
|
|
6,130
|
|
|
Gross other intangible assets
|
|
|
66,804
|
|
|
66,859
|
|
|
Less accumulated amortization
|
|
|
(18,739)
|
|
|
(13,616)
|
|
|
Other intangible assets
|
|
|
$
|
48,065
|
|
|
$
|
53,243
|
|
In the six months ended June 30, 2021, $1.5 billion of IPRD was reclassified to acquired marketed product rights upon approval of Breyanzi and Abecma in the U.S. Amortization expense of other intangible assets was $2.5 billion and $5.1 billion for the three and six months ended June 30, 2021 and $2.5 billion and $4.8 billion for the three and six months ended June 30, 2020, respectively.
In the second quarter of 2021, a $230 million IPRD impairment charge was recorded in Research and development expense following a decision to discontinue development of an investigational compound in connection with the prioritization of current pipeline opportunities. The compound was being studied as a potential treatment for fibrotic diseases and was acquired in the acquisition of Celgene. The charge represented a full write-down based on the estimated fair value determined using discounted cash flow projections.
In the first quarter of 2021, Inrebic EU regulatory approval milestones of $300 million were achieved resulting in a $385 million increase to the acquired marketed product rights intangible asset, after establishing the applicable deferred tax liability. An impairment charge of $315 million was recognized in Cost of products sold as the carrying value of this asset exceeded the projected undiscounted cash flows of the asset. The charge was equal to the excess of the asset's carrying value over its estimated fair value using discounted cash flow projections.
Note 14. SUPPLEMENTAL FINANCIAL INFORMATION
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31, 2020
|
|
Income taxes
|
$
|
2,258
|
|
|
$
|
1,799
|
|
|
Research and development
|
576
|
|
|
492
|
|
|
Equity investments
|
1,046
|
|
|
619
|
|
|
Restricted cash
|
174
|
|
|
89
|
|
|
Other
|
983
|
|
|
787
|
|
|
Other current assets
|
$
|
5,037
|
|
|
$
|
3,786
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31, 2020
|
|
Equity investments
|
$
|
3,622
|
|
|
$
|
4,076
|
|
|
Inventories
|
876
|
|
|
1,080
|
|
|
Operating leases
|
1,006
|
|
|
859
|
|
|
Pension and postretirement
|
234
|
|
|
208
|
|
|
Restricted cash(a)
|
199
|
|
|
338
|
|
|
Other
|
517
|
|
|
458
|
|
|
Other non-current assets
|
$
|
6,454
|
|
|
$
|
7,019
|
|
(a) Restricted cash consists of funds restricted for annual Company contributions to the defined contribution plan in the U.S. and escrow for litigation settlements. Restricted cash of $373 million at June 30, 2021 and $428 million at June 30, 2020 was included in cash, cash equivalents and restricted cash in the consolidated statements of cash flows.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31, 2020
|
|
Rebates and returns
|
$
|
5,665
|
|
|
$
|
5,688
|
|
|
Income taxes
|
638
|
|
|
647
|
|
|
Employee compensation and benefits
|
896
|
|
|
1,412
|
|
|
Research and development
|
1,469
|
|
|
1,423
|
|
|
Dividends
|
1,107
|
|
|
1,129
|
|
|
Interest
|
373
|
|
|
434
|
|
|
Royalties
|
386
|
|
|
461
|
|
|
Operating leases
|
173
|
|
|
164
|
|
|
Contingent value rights
|
—
|
|
|
515
|
|
|
Other
|
2,020
|
|
|
2,154
|
|
|
Other current liabilities
|
$
|
12,727
|
|
|
$
|
14,027
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31, 2020
|
|
Income taxes payable
|
$
|
4,690
|
|
|
$
|
5,017
|
|
|
Pension and postretirement
|
838
|
|
|
899
|
|
|
Operating leases
|
962
|
|
|
833
|
|
|
Deferred income
|
324
|
|
|
357
|
|
|
Deferred compensation
|
416
|
|
|
344
|
|
|
Other
|
268
|
|
|
326
|
|
|
Other non-current liabilities
|
$
|
7,498
|
|
|
$
|
7,776
|
|
Note 15. EQUITY
The following table summarizes changes in equity for the six months ended June 30, 2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2020
|
2,923
|
|
|
$
|
292
|
|
|
$
|
44,325
|
|
|
$
|
(1,839)
|
|
|
$
|
21,281
|
|
|
679
|
|
|
$
|
(26,237)
|
|
|
$
|
60
|
|
|
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,021
|
|
|
—
|
|
|
—
|
|
|
8
|
|
|
Other Comprehensive Income
|
—
|
|
|
—
|
|
|
—
|
|
|
295
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Cash dividends declared(a)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,098)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Share repurchase program
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28
|
|
|
(1,768)
|
|
|
—
|
|
|
Stock compensation
|
—
|
|
|
—
|
|
|
(473)
|
|
|
—
|
|
|
—
|
|
|
(15)
|
|
|
806
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2021
|
2,923
|
|
|
$
|
292
|
|
|
$
|
43,852
|
|
|
$
|
(1,544)
|
|
|
$
|
22,204
|
|
|
692
|
|
|
$
|
(27,199)
|
|
|
$
|
68
|
|
|
Net earnings
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,055
|
|
|
—
|
|
|
—
|
|
|
6
|
|
|
Other Comprehensive Income
|
—
|
|
|
—
|
|
|
—
|
|
|
26
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Cash dividends declared(a)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,091)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Stock repurchase program
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
19
|
|
|
(1,235)
|
|
|
—
|
|
|
Stock compensation
|
—
|
|
|
—
|
|
|
212
|
|
|
—
|
|
|
—
|
|
|
(10)
|
|
|
236
|
|
|
—
|
|
|
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(8)
|
|
|
Balance at June 30, 2021
|
2,923
|
|
|
292
|
|
|
44,064
|
|
|
(1,518)
|
|
|
22,168
|
|
|
701
|
|
|
(28,198)
|
|
|
66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Cash dividends declared per common share were $0.49 for the three months ended March 31, 2021 and June 30, 2021.
The following table summarizes changes in equity for the six months ended June 30, 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, 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
|
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(85)
|
|
|
—
|
|
|
—
|
|
|
5
|
|
|
Other Comprehensive Loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(7)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Cash dividends declared(b)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,021)
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
Stock repurchase program
|
—
|
|
|
—
|
|
|
1,400
|
|
|
—
|
|
|
—
|
|
|
16
|
|
|
(1,400)
|
|
|
—
|
|
|
Stock compensation
|
—
|
|
|
—
|
|
|
(210)
|
|
|
—
|
|
|
—
|
|
|
(7)
|
|
|
506
|
|
|
—
|
|
|
Distributions
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(5)
|
|
|
Balance at June 30, 2020
|
2,923
|
|
|
292
|
|
|
44,444
|
|
|
(1,556)
|
|
|
31,565
|
|
|
669
|
|
|
(25,651)
|
|
|
66
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) Cash dividends declared per common share were $0.45 for the three months ended March 31, 2020 and June 30, 2020.
BMS has a share repurchase program, authorized by its Board of Directors, allowing for repurchases of its shares. The share repurchase program does not obligate us to repurchase any specific number of shares, does not have a specific expiration date and may be suspended or discontinued at any time. Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizing the first-in first-out method.
The outstanding share repurchase authority authorization under the program was $4.4 billion as of December 31, 2020. In January 2021, the Board of Directors approved an increase of $2.0 billion to the share repurchase authorization for BMS’s common stock. BMS repurchased approximately 47 million shares of its common stock for $3.0 billion during the six months ended June 30, 2021. The remaining share repurchase capacity under the share repurchase program was approximately $3.4 billion as of June 30, 2021.
BMS repurchased 1.4 million shares of its common stock for $81 million in the six months ended June 30, 2020.
In the fourth quarter of 2019, BMS executed accelerated share repurchase (“ASR”) agreements to repurchase an aggregate $7 billion of common stock. The ASR was funded with cash on-hand. In the fourth quarter of 2019, approximately 99 million shares of common stock (80% of the $7 billion aggregate repurchase price) were received by BMS and included in treasury stock. In the second quarter of 2020, the agreement was settled and approximately 16 million shares of common stock were received by BMS and transferred to treasury stock.
The components of Other Comprehensive Income/(Loss) were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2021
|
|
2020
|
|
Dollars in Millions
|
Pretax
|
|
Tax
|
|
After Tax
|
|
Pretax
|
|
Tax
|
|
After Tax
|
|
Three Months Ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives qualifying as cash flow hedges:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain/(losses)
|
$
|
(38)
|
|
|
$
|
(3)
|
|
|
$
|
(41)
|
|
|
$
|
(34)
|
|
|
$
|
4
|
|
|
$
|
(30)
|
|
|
Reclassified to net earnings(a)
|
53
|
|
|
(6)
|
|
|
47
|
|
|
(32)
|
|
|
3
|
|
|
(29)
|
|
|
Derivatives qualifying as cash flow hedges
|
15
|
|
|
(9)
|
|
|
6
|
|
|
(66)
|
|
|
7
|
|
|
(59)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pension and postretirement benefits:
|
|
|
|
|
|
|
|
|
|
|
|
|
Actuarial losses
|
1
|
|
|
2
|
|
|
3
|
|
|
(20)
|
|
|
5
|
|
|
(15)
|
|
|
Amortization(b)
|
10
|
|
|
(2)
|
|
|
8
|
|
|
9
|
|
|
(2)
|
|
|
7
|
|
|
Settlements(b)
|
5
|
|
|
(1)
|
|
|
4
|
|
|
2
|
|
|
(1)
|
|
|
1
|
|
|
Pension and postretirement benefits
|
16
|
|
|
(1)
|
|
|
15
|
|
|
(9)
|
|
|
2
|
|
|
(7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains/(losses)
|
(3)
|
|
|
1
|
|
|
(2)
|
|
|
12
|
|
|
(3)
|
|
|
9
|
|
|
Realized Losses
|
—
|
|
|
—
|
|
|
—
|
|
|
(1)
|
|
|
—
|
|
|
(1)
|
|
|
Available-for-sale debt securities
|
(3)
|
|
|
1
|
|
|
(2)
|
|
|
11
|
|
|
(3)
|
|
|
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
|
3
|
|
|
4
|
|
|
7
|
|
|
45
|
|
|
6
|
|
|
51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive Income/(Loss)
|
$
|
31
|
|
|
$
|
(5)
|
|
|
$
|
26
|
|
|
$
|
(19)
|
|
|
$
|
12
|
|
|
$
|
(7)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
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|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2021
|
|
2020
|
|
Dollars in Millions
|
Pretax
|
|
Tax
|
|
After Tax
|
|
Pretax
|
|
Tax
|
|
After Tax
|
|
Six Months Ended June 30,
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives qualifying as cash flow hedges:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain/(losses)
|
$
|
221
|
|
|
$
|
(14)
|
|
|
$
|
207
|
|
|
$
|
63
|
|
|
$
|
(6)
|
|
|
$
|
57
|
|
|
Reclassified to net earnings(a)
|
89
|
|
|
(10)
|
|
|
79
|
|
|
(52)
|
|
|
6
|
|
|
(46)
|
|
|
Derivatives qualifying as cash flow hedges
|
310
|
|
|
(24)
|
|
|
286
|
|
|
11
|
|
|
—
|
|
|
11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pension and postretirement benefits:
|
|
|
|
|
|
|
|
|
|
|
|
|
Actuarial losses
|
22
|
|
|
(3)
|
|
|
19
|
|
|
(12)
|
|
|
3
|
|
|
(9)
|
|
|
Amortization(b)
|
19
|
|
|
(5)
|
|
|
14
|
|
|
18
|
|
|
(3)
|
|
|
15
|
|
|
Settlements(b)
|
6
|
|
|
(1)
|
|
|
5
|
|
|
4
|
|
|
(1)
|
|
|
3
|
|
|
Pension and postretirement benefits
|
47
|
|
|
(9)
|
|
|
38
|
|
|
10
|
|
|
(1)
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Available-for-sale debt securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains/(losses)
|
(6)
|
|
|
2
|
|
|
(4)
|
|
|
14
|
|
|
(4)
|
|
|
10
|
|
|
Realized losses
|
—
|
|
|
—
|
|
|
—
|
|
|
(1)
|
|
|
—
|
|
|
(1)
|
|
|
Available-for-sale debt securities:
|
(6)
|
|
|
2
|
|
|
(4)
|
|
|
13
|
|
|
(4)
|
|
|
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation
|
12
|
|
|
(11)
|
|
|
1
|
|
|
(65)
|
|
|
—
|
|
|
(65)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive Income/(Loss)
|
$
|
363
|
|
|
$
|
(42)
|
|
|
$
|
321
|
|
|
$
|
(31)
|
|
|
$
|
(5)
|
|
|
$
|
(36)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)Included in Cost of products sold.
(b)Included in Other (income)/expense, net.
The accumulated balances related to each component of Other Comprehensive Income/(Loss), net of taxes, were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
June 30,
2021
|
|
December 31,
2020
|
|
Derivatives qualifying as cash flow hedges
|
$
|
49
|
|
|
$
|
(237)
|
|
|
Pension and postretirement benefits
|
(936)
|
|
|
(974)
|
|
|
Available-for-sale debt securities
|
7
|
|
|
11
|
|
|
Foreign currency translation
|
(638)
|
|
|
(639)
|
|
|
Accumulated other comprehensive loss
|
$
|
(1,518)
|
|
|
$
|
(1,839)
|
|
Note 16. EMPLOYEE STOCK BENEFIT PLANS
Stock-based compensation expense was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Dollars in Millions
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
Cost of products sold
|
$
|
15
|
|
|
$
|
9
|
|
|
$
|
30
|
|
|
$
|
19
|
|
|
Marketing, selling and administrative
|
65
|
|
|
86
|
|
|
125
|
|
|
174
|
|
|
Research and development
|
74
|
|
|
89
|
|
|
144
|
|
|
183
|
|
|
Other (income)/expense, net
|
3
|
|
|
29
|
|
|
9
|
|
|
47
|
|
|
Total stock-based compensation expense
|
$
|
157
|
|
|
$
|
213
|
|
|
$
|
308
|
|
|
$
|
423
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit(a)
|
$
|
33
|
|
|
$
|
40
|
|
|
$
|
64
|
|
|
$
|
86
|
|
(a) Income tax benefit excludes excess tax benefits from share-based compensation awards that were vested or exercised of $12 million and $29 million for the three and six months ended June 30, 2021 and $5 million and $28 million for the three and six months ended June 30, 2020, respectively.
The number of units granted and the weighted-average fair value on the grant date for the six months ended June 30, 2021 were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Units in Millions
|
Units
|
|
Weighted-Average Fair Value
|
|
|
|
|
|
|
Restricted stock units
|
8.2
|
|
|
$
|
56.62
|
|
|
Market share units
|
1.0
|
|
|
58.04
|
|
|
Performance share units
|
1.5
|
|
|
59.04
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dollars in Millions
|
Stock Options
|
|
Restricted Stock Units
|
|
Market Share Units
|
|
Performance Share Units
|
|
Unrecognized compensation cost
|
$
|
20
|
|
|
$
|
953
|
|
|
$
|
73
|
|
|
$
|
124
|
|
|
Expected weighted-average period in years of compensation cost to be recognized
|
0.9
|
|
2.8
|
|
3.2
|
|
2.0
|
Note 17. LEGAL PROCEEDINGS AND CONTINGENCIES
BMS and certain of its subsidiaries are involved in various lawsuits, claims, government investigations and other legal proceedings that arise in the ordinary course of business. These claims or proceedings can involve various types of parties, including governments, competitors, customers, suppliers, service providers, licensees, employees, or shareholders, among others. These matters may involve patent infringement, antitrust, securities, pricing, sales and marketing practices, environmental, commercial, contractual rights, licensing obligations, health and safety matters, consumer fraud, employment matters, product liability and insurance coverage, among others. The resolution of these matters often develops over a long period of time and expectations can change as a result of new findings, rulings, appeals or settlement arrangements. Legal proceedings that are significant or that BMS believes could become significant or material are described below.
While BMS does not believe that any of these matters, except as otherwise specifically noted below, will have a material adverse effect on its financial position or liquidity as BMS believes it has substantial defenses in the matters, the outcomes of BMS’s legal proceedings and other contingencies are inherently unpredictable and subject to significant uncertainties. There can be no assurance that there will not be an increase in the scope of one or more of these pending matters or any other or future lawsuits, claims, government investigations or other legal proceedings will not be material to BMS’s financial position, results of operations or cash flows for a particular period. Furthermore, failure to enforce BMS’s patent rights would likely result in substantial decreases in the respective product revenues from generic competition.
Unless otherwise noted, BMS is unable to assess the outcome of the respective matters nor is it able to estimate the possible loss or range of losses that could potentially result for such matters. Contingency accruals are recognized when it is probable that a liability will be incurred and the amount of the related loss can be reasonably estimated. Developments in legal proceedings and other matters that could cause changes in the amounts previously accrued are evaluated each reporting period. For a discussion of BMS’s tax contingencies, see “—Note 7. Income Taxes”.
INTELLECTUAL PROPERTY
Anti-PD-1 Antibody Litigation
In September 2015, Dana-Farber Cancer Institute (“Dana-Farber”) filed a complaint in the U.S. District Court for the District of Massachusetts seeking to correct the inventorship on up to six related U.S. patents directed to methods of treating cancer using PD-1 and PD-L1 antibodies. Specifically, Dana-Farber is seeking to add two scientists as inventors to these patents. In October 2017, Pfizer was allowed to intervene in this case alleging that one of the scientists identified by Dana-Farber was employed by a company eventually acquired by Pfizer during the relevant period. In February 2019, BMS settled the lawsuit with Pfizer. A bench trial in the lawsuit with Dana-Farber took place in February 2019. In May 2019, the District Court issued an opinion ruling that the two scientists should be added as inventors to the patents, which was affirmed on appeal. In May 2021, the U.S. Supreme Court declined to consider the case. In June 2019, Dana-Farber filed a new lawsuit in the District of Massachusetts against BMS seeking damages as a result of the Court’s decision adding the scientists as inventors. In February 2021, BMS filed a motion to dismiss the complaint.
CAR T
In October 2017, Juno and Sloan Kettering Institute for Cancer Research (“SKI”) filed a complaint for patent infringement against Kite Pharma, Inc. (“Kite”) in the U.S. District Court for the Central District of California. The complaint alleged that Kite’s Yescarta* product infringes certain claims of U.S. Patent No. 7,446,190 (the “’190 Patent”) concerning CAR T cell technologies. Kite filed an answer and counterclaims asserting non-infringement and invalidity of the ’190 Patent. In December 2019, following an eight-day trial, the jury rejected Kite’s defenses, finding that Kite willfully infringed the ’190 Patent and awarding to Juno and SKI a reasonable royalty consisting of a $585 million upfront payment and a 27.6% running royalty on Kite’s sales of Yescarta* through the expiration of the ’190 Patent in August 2024. In January 2020, Kite renewed its previous motion for judgment as a matter of law and also moved for a new trial, and Juno filed a motion seeking enhanced damages, supplemental damages, ongoing royalties, and prejudgment interest. In March 2020, the Court denied both of Kite’s motions in their entirety. In April 2020, the Court granted in part Juno’s motion and entered a final judgment awarding to Juno and SKI approximately $1.2 billion in royalties, interest and enhanced damages and a 27.6% running royalty on Kite’s sales of Yescarta* from December 13, 2019 through the expiration of the ’190 Patent in August 2024. In April 2020, Kite appealed the final judgment to the U.S. Court of Appeals for the Federal Circuit and the Court held an oral hearing on July 6, 2021.
Eliquis – Europe
In November 2020 and January 2021, Sandoz Limited (“Sandoz”) and Teva Pharmaceutical Industries Ltd. (“Teva Limited”), respectively, filed lawsuits in the United Kingdom seeking revocation of the UK apixaban composition of matter patent and related Supplementary Protection Certificate. BMS subsequently filed counterclaims for infringement in both actions. A trial is scheduled to begin in early 2022.
There are similar lawsuits filed in the Republic of Ireland, the Netherlands and Sweden seeking revocation of a composition of matter patent relating to Eliquis.
Additional infringement and invalidity actions involving Eliquis patents may be filed in various countries in Europe in the coming months.
Eliquis - U.S.
In 2017, BMS received Notice Letters from twenty-five generic companies notifying BMS that they had filed aNDAs containing paragraph IV certifications seeking approval of generic versions of Eliquis. As a result, two Eliquis patents listed in the FDA Orange Book are being challenged: the composition of matter patent claiming apixaban specifically and a formulation patent. In response, BMS, along with its partner Pfizer, initiated patent infringement actions under the Hatch-Waxman Act against all generic filers in the U.S. District Court for the District of Delaware in April 2017. In August 2017, the U.S. Patent and Trademark Office granted patent term restoration to the composition of matter patent to November 2026, thereby restoring the term of the Eliquis composition of matter patent, which is BMS’s basis for projected LOE. BMS settled with a number of aNDA filers. These settlements do not affect BMS’s projected LOE for Eliquis. A trial with the remaining aNDA filers took place in late 2019. In August 2020, the U.S. District Court issued a decision finding that the remaining aNDA filers’ products infringed the Eliquis composition of matter and formulation patents and that both Eliquis patents are not invalid. The remaining aNDA filers have appealed to the U.S. Court of Appeals for the Federal Circuit. The oral argument for the appeal is scheduled to occur in September 2021.
Plavix* - Australia
Sanofi was notified that, in August 2007, GenRx Proprietary Limited (“GenRx”) obtained regulatory approval of an application for clopidogrel bisulfate 75mg tablets in Australia. GenRx, formerly a subsidiary of Apotex Inc., subsequently changed its name to Apotex (“GenRx-Apotex”). In August 2007, GenRx-Apotex filed an application in the Federal Court of Australia seeking revocation of Sanofi’s Australian Patent No. 597784 (Case No. NSD 1639 of 2007). Sanofi filed counterclaims of infringement and sought an injunction. On September 21, 2007, the Federal Court of Australia granted Sanofi’s injunction. A subsidiary of BMS was subsequently added as a party to the proceedings. In February 2008, a second company, Spirit Pharmaceuticals Pty. Ltd., also filed a revocation suit against the same patent. This case was consolidated with the GenRx-Apotex case. On August 12, 2008, the Federal Court of Australia held that claims of Patent No. 597784 covering clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate salts were valid. The Federal Court also held that the process claims, pharmaceutical composition claims, and claim directed to clopidogrel and its pharmaceutically acceptable salts were invalid. BMS and Sanofi filed notices of appeal in the Full Court of the Federal Court of Australia (“Full Court”) appealing the holding of invalidity of the claim covering clopidogrel and its pharmaceutically acceptable salts, process claims, and pharmaceutical composition claims. GenRx-Apotex appealed the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims. On September 29, 2009, the Full Court held all of the claims of Patent No. 597784 invalid. In March 2010, the High Court of Australia denied a request by BMS and Sanofi to hear an appeal of the Full Court decision. The case was remanded to the Federal Court for further proceedings related to damages sought by GenRx-Apotex. BMS and GenRx-Apotex settled, and the GenRx-Apotex case was dismissed. The Australian government intervened in this matter seeking maximum damages up to 449 million AUD ($341 million), plus interest, which would be split between BMS and Sanofi, for alleged losses experienced for paying a higher price for branded Plavix* during the period when the injunction was in place. BMS and Sanofi dispute that the Australian government is entitled to any damages. A trial was concluded in September 2017. In April 2020, the Federal Court issued a decision dismissing the Australian government’s claim for damages. In May 2020, the Australian government appealed the Federal Court’s decision and an appeal hearing concluded in February 2021.
Pomalyst - Canada
Celgene received a Notice of Allegation in January 2020 from Natco Pharma (Canada) Inc. (“Natco Canada”) notifying Celgene that it had filed an Abbreviated New Drug Submission (“aNDS”) with Canada’s Minister of Health with respect to certain of Celgene’s Canadian patents. Natco Canada is seeking to market a generic version of Pomalyst in Canada. In response, Celgene initiated a patent infringement action in the Federal Court of Canada. Natco Canada alleges that the asserted patents are invalid and/or not infringed. A trial is scheduled to begin in November 2021.
Celgene received a second Notice of Allegation in November 2020 from Natco Canada notifying Celgene that it had filed a second aNDS with Canada’s Minister of Health with respect to certain of Celgene’s Canadian patents. In response, Celgene initiated a patent infringement action in the Federal Court of Canada. Natco Canada alleges that the asserted patents are invalid and/or not infringed. A trial is scheduled to begin in May 2022.
Celgene received four Notices of Allegation in February 2021 from Apotex Inc. notifying Celgene that it had filed two aNDSs with Canada’s Minister of Health with respect to certain of Celgene’s Canadian patents. Apotex Inc. is seeking to market a generic version of Pomalyst in Canada. In response, in April 2021, Celgene initiated patent infringement actions against Apotex Inc. in the Federal Court of Canada. In July 2021, Celgene and Apotex Inc. entered into a confidential settlement agreement and the cases were discontinued.
Pomalyst - U.S.
Beginning in 2017, Celgene received Notice letters on behalf of Apotex Inc. and Apotex Corp. (together, “Apotex”); Hetero Labs Limited, Hetero Labs Limited Unit-V, Hetero Drugs Limited, Hetero USA, Inc. (collectively, “Hetero”); Eugia Pharma Specialities Limited, Aurobindo Pharma Ltd., Aurobindo Pharma USA, Inc., and Aurolife Pharma LLC (collectively, “Aurobindo”); and Mylan Pharmaceuticals Inc. notifying Celgene that they had filed aNDAs containing paragraph IV certifications seeking approval to market generic versions of Pomalyst in the U.S. In response, Celgene filed patent infringement actions against the companies in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book-listed patents and the companies filed answers, counterclaims and declaratory judgment actions alleging that the asserted patents are invalid, unenforceable, and not infringed. These litigations were subsequently consolidated. In March 2020, Celgene subsequently filed additional patent infringement actions in the U.S. District Court for the District of New Jersey against each of the companies asserting a newly-issued patent that is listed in the FDA Orange Book and that covers formulations comprising pomalidomide. The companies each filed responsive pleadings alleging that the patent is invalid and not infringed. The Court has consolidated these additional litigations with the previously-consolidated litigations. In September 2020, the Court granted Mylan Pharmaceuticals Inc.’s motion to dismiss, which decision Celgene has appealed. In October 2020, Aurobindo received final approval from the FDA of its aNDA. In April and July 2021, Celgene entered into confidential settlement agreements with Apotex and Aurobindo, respectively, settling all outstanding claims in the litigation with Apotex and Aurobindo. Trial against the remaining defendant, Hetero, is set for November 2021.
In February and March 2019, Celgene filed additional patent infringement actions in the U.S. District Court for the District of New Jersey against the companies asserting certain patents that are not listed in the FDA Orange Book and that cover polymorphic forms of pomalidomide, and the companies filed answers and/or counterclaims alleging that each of these patents is invalid and/or not infringed. These actions have been consolidated with the earlier-filed actions against the companies.
In June 2019, Celgene received a Notice Letter from Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (together, “DRL”) notifying Celgene that they had filed an aNDA containing paragraph IV certifications seeking approval to market a generic version of Pomalyst in the U.S. In response, Celgene initiated a patent infringement action against DRL in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book-listed patents, and DRL filed an answer and counterclaims alleging that each of the patents is invalid and/or not infringed. In March 2020, Celgene filed an additional patent infringement action in the U.S. District Court for the District of New Jersey against DRL asserting a newly-issued patent that is listed in the FDA Orange Book and that covers formulations comprising pomalidomide, which has been consolidated with the above DRL case. In April 2021, DRL received tentative approval from the FDA of its aNDA. The Court has not set a trial date in this consolidated action.
In February 2021, Celgene filed an additional patent infringement action in the U.S. District Court for the District of New Jersey against DRL asserting certain patents that are not listed in the FDA Orange Book and that cover polymorphic forms of pomalidomide. No trial date has been set for this matter.
Revlimid - U.S.
Celgene has received Notice Letters on behalf of Sun Pharma Global FZE, Sun Pharma Global Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries Limited (collectively, “Sun”); Hetero; Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan N.V. (collectively, “Mylan”); Aurobindo; Lupin Limited (“Lupin”); Hikma Pharmaceuticals USA, Inc.; Biocon Pharma Limited, Biocon Limited, and Biocon Pharma, Inc.; and Torrent Pharmaceuticals Limited and Torrent Pharma Inc. notifying Celgene that they had filed aNDAs containing paragraph IV certifications seeking approval to market generic versions of Revlimid in the U.S. In response, Celgene filed patent infringement actions against the companies in the U.S. District Court for the District of New Jersey asserting certain FDA Orange Book-listed patents as well as other litigations asserting other non-FDA Orange Book-listed patents against certain defendants, who have filed answers and/or counterclaims alleging that the asserted patents are invalid and/or not infringed. No trial date has been scheduled in any of these New Jersey actions.
Celgene also filed a patent infringement action against Mylan in the U.S. District Court for the Northern District of West Virginia asserting certain FDA Orange Book-listed patents and other non-FDA Orange Book-listed patents. Mylan filed its answer and counterclaims alleging that the patents are invalid and/or not infringed.
In June and July 2021, Celgene entered into confidential settlement agreements with Sun, Aurobindo, and Mylan, respectively, settling all outstanding claims in the litigations with Sun, Aurobindo, and Mylan.
Sprycel - U.S.
In August 2019, BMS received a Notice Letter from Dr. Reddy’s Laboratories, Inc. notifying BMS that it had filed an aNDA containing paragraph IV certifications seeking approval of a generic version of Sprycel in the U.S. and challenging two FDA Orange Book-listed monohydrate form patents expiring in 2025 and 2026. In response, BMS filed a patent infringement action in the U.S. District Court for the District of New Jersey.
In 2020, BMS received a Notice Letter from Lupin notifying BMS that it had filed an aNDA containing paragraph IV certifications seeking approval of a generic version of Sprycel in the U.S. and challenging two FDA Orange Book-listed monohydrate form patents expiring in 2025 and 2026. In response, BMS filed patent infringement actions in the U.S. District Courts for the District of New Jersey and Delaware. The case in Delaware has been dismissed.
In July 2021, BMS entered into confidential settlement agreements with Dr. Reddy’s Laboratories, Inc. and Lupin, settling all outstanding claims in the litigations.
PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION
Plavix* State Attorneys General Lawsuits
BMS and certain Sanofi entities are defendants in consumer protection actions brought by the attorneys general of Hawaii and New Mexico relating to the labeling, sales and/or promotion of Plavix*. A trial in the Hawaii matter occurred in 2020. In February 2021, the Court issued a decision against Sanofi and BMS, imposing penalties in the total amount of $834 million, with $417 million attributed to BMS. Sanofi and BMS disagree with the decision and are appealing it. BMS remains confident in the merits of its case and its likelihood of success on appeal and BMS does not believe establishing a reserve is warranted for this matter. A trial in the New Mexico matter is scheduled to begin in April 2022.
PRODUCT LIABILITY LITIGATION
BMS is a party to various product liability lawsuits. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and economic loss. As previously disclosed, in addition to lawsuits, BMS also faces unfiled claims involving its products.
Abilify*
BMS and Otsuka are co-defendants in product liability litigation related to Abilify*. Plaintiffs allege Abilify* caused them to engage in compulsive gambling and other impulse control disorders. There have been over 2,500 cases filed in state and federal courts and additional cases are pending in Canada. The Judicial Panel on Multidistrict Litigation consolidated the federal court cases for pretrial purposes in the U.S. District Court for the Northern District of Florida. In February 2019, BMS and Otsuka entered into a master settlement agreement establishing a proposed settlement program to resolve all Abilify* compulsivity claims filed as of January 28, 2019 in the MDL as well as various state courts, including California and New Jersey. To date, approximately 2,700 cases, comprising approximately 3,900 plaintiffs, have been dismissed based on participation in the settlement program or failure to comply with settlement related court orders. In the U.S., less than 20 cases remain pending on behalf of plaintiffs, who either chose not to participate in the settlement program or filed their claims after the settlement cut-off date. There are eleven cases pending in Canada (four class actions, seven individual injury claims). Out of the eleven cases, only two are active (the class actions in Quebec and Ontario). Both class actions have now been certified and will proceed separately, subject to a pending appeal of the Ontario class certification decision.
Byetta*
Amylin, a former subsidiary of BMS, and Lilly are co-defendants in product liability litigation related to Byetta*. As of June 2021, there are approximately 590 separate lawsuits pending on behalf of approximately 2,250 active plaintiffs (including pending settlements), which include injury plaintiffs as well as claims by spouses and/or other beneficiaries, in various courts in the U.S. The majority of these cases have been brought by individuals who allege personal injury sustained after using Byetta*, primarily pancreatic cancer, and, in some cases, claiming alleged wrongful death. The majority of cases are pending in Federal Court in San Diego in an MDL or in a coordinated proceeding in California Superior Court in Los Angeles (“JCCP”). In April 2020 the defendants filed a motion for summary judgment based on federal preemption and a motion for summary judgment based on the absence of general causation evidence in the MDL and JCCP. Both motions were granted in March 2021 and April 2021, respectively. The orders will result in the dismissal of all claims alleging an injury of pancreatic cancer in the MDL and JCCP. Plaintiffs have appealed the MDL order and may seek appeals in the JCCP. BMS sold Byetta* to AstraZeneca in February 2014 as part of BMS’s global diabetes business divestiture and any additional liability to Amylin with respect to Byetta* is expected to be shared with AstraZeneca.
Onglyza*
BMS and AstraZeneca are co-defendants in product liability litigation related to Onglyza*. Plaintiffs assert claims, including claims for wrongful death, as a result of heart failure or other cardiovascular injuries they allege were caused by their use of Onglyza*. As of June 2021, claims are pending in state and federal court on behalf of approximately 270 individuals who allege they ingested the product and suffered an injury. In February 2018, the Judicial Panel on Multidistrict Litigation ordered all federal cases to be transferred to an MDL in the U.S. District Court for the Eastern District of Kentucky. A significant majority of the claims are pending in the MDL. As part of BMS’s global diabetes business divestiture, BMS sold Onglyza* to AstraZeneca in February 2014 and any potential liability with respect to Onglyza* is expected to be shared with AstraZeneca.
SECURITIES LITIGATION
BMS Securities Class Action
Since February 2018, two separate putative class action complaints were filed in the U.S. District for the Northern District of California and in the U.S. District Court for the Southern District of New York against BMS, BMS’s Chief Executive Officer, Giovanni Caforio, BMS’s Chief Financial Officer at the time, Charles A. Bancroft and certain former and current executives of BMS. The case in California has been voluntarily dismissed. The remaining complaint alleges violations of securities laws for BMS’s disclosures related to the CheckMate-026 clinical trial in lung cancer. In September 2019, the Court granted BMS’s motion to dismiss, but allowed the plaintiffs leave to file an amended complaint. In October 2019, the plaintiffs filed an amended complaint. In September 2020, the Court granted BMS’s motion to dismiss the amended complaint with prejudice. The plaintiffs appealed the Court’s decision in October 2020.
Celgene Securities Class Action
Beginning in March 2018, two putative class actions were filed against Celgene and certain of its officers in the U.S. District Court for the District of New Jersey (the “Celgene Securities Class Action”). The complaints allege that the defendants violated federal securities laws by making misstatements and/or omissions concerning (1) trials of GED-0301, (2) Celgene’s 2020 outlook and projected sales of Otezla*, and (3) the new drug application for Zeposia. The Court consolidated the two actions and appointed a lead plaintiff, lead counsel, and co-liaison counsel for the putative class. In February 2019, the defendants filed a motion to dismiss plaintiff’s amended complaint in full. In December 2019, the Court denied the motion to dismiss in part and granted the motion to dismiss in part (including all claims arising from alleged misstatements regarding GED-0301). Although the Court gave the plaintiff leave to re-plead the dismissed claims, it elected not to do so, and the dismissed claims are now dismissed with prejudice. In November 2020, the Court granted class certification with respect to the remaining claims. In December 2020, the defendants sought leave to appeal the Court’s class certification decision, which was denied without prejudice in March 2021. No trial date has been scheduled.
In April 2020, certain Schwab management investment companies on behalf of certain Schwab funds filed an individual action in the U.S. District Court for the District of New Jersey asserting largely the same allegations as the Celgene Securities Class Action against the same remaining defendants in that action. In July 2020, the defendants filed a motion to dismiss the plaintiffs’ complaint in full. In March 2021, the Court granted in part and denied in part defendants’ motion to dismiss consistent with its decision in the Celgene Securities Class Action.
The California Public Employees’ Retirement System in April 2021 and DFA Investment Dimensions Group Inc., on behalf of certain of its funds, and American Century Mutual Funds, Inc., on behalf of certain of its funds, in July 2021 filed separate individual actions in the U.S. District Court for the District of New Jersey asserting largely the same allegations as the Celgene Securities Class Action and the Schwab individual action against the same remaining defendants in those actions.
Contingent Value Rights Litigation
In June 2021, an action was filed against BMS in the U.S. District Court for the Southern District of New York asserting claims of alleged breaches of a Contingent Value Rights Agreement (“CVR Agreement”) entered into in connection with the closing of BMS’s acquisition of Celgene Corporation in November 2019. The successor trustee under the CVR Agreement alleges that BMS breached the CVR Agreement by allegedly failing to use “diligent efforts” to obtain FDA approval of liso-cel (Breyanzi) before a contractual milestone date, thereby avoiding a $6.4 billion potential obligation to holders of the contingent value rights governed by the CVR Agreement and by allegedly failing to permit inspection of records in response to a request by the successor trustee. The successor trustee seeks damages in an amount to be determined at trial and other relief, including interest and attorneys’ fees. BMS disputes the successor trustee’s allegations.
OTHER LITIGATION
Average Manufacturer Price Litigation
BMS is a defendant in a qui tam (whistleblower) lawsuit in the U.S. District Court for the Eastern District of Pennsylvania, in which the U.S. Government declined to intervene. The complaint alleges that BMS inaccurately reported its average manufacturer prices to the Centers for Medicare and Medicaid Services to lower what it owed. Similar claims have been filed against other companies. In January 2020, BMS reached an agreement in principle to resolve this matter subject to the negotiation of a definitive settlement agreement and other contingencies. In March 2021, BMS finalized an agreement with the U.S. government and qui tam relator to resolve the claims asserted in the lawsuit. BMS has paid $75 million plus interest to the federal and state governments. Individual agreements will be negotiated with participating states based on the federal agreement. To the extent BMS does not finalize a settlement agreement with any state, that state’s share of the settlement will revert to BMS.
HIV Medication Antitrust Lawsuits
BMS and two other manufacturers of HIV medications are defendants in related lawsuits pending in the Northern District of California. The lawsuits allege that the defendants’ agreements to develop and sell fixed-dose combination products for the treatment of HIV, including Atripla* and Evotaz, violate antitrust laws. The currently pending actions, asserted on behalf of indirect purchasers, were initiated in 2019 in the Northern District of California and in 2020 in the Southern District of Florida. The Florida matter was transferred to the Northern District of California. In July 2020, the Court granted in part defendants’ motion to dismiss, including dismissing with prejudice plaintiffs’ claims as to an overarching conspiracy and plaintiffs’ theories based on the alleged payment of royalties after patent expiration. Other claims, however, remain. In September and October 2020, two purported class actions have also been filed asserting similar claims on behalf of direct purchasers. In March 2021, the Court dismissed one of the direct purchaser cases and limited the claims of the remaining direct purchaser case to those arising in 2016 or later. However, the Court gave plaintiffs leave to amend their complaints, and one plaintiff filed an amended complaint on March 16, 2021. A trial on both the direct and indirect purchaser claims is scheduled for November 2022.
In February 2021, BMS and two other manufacturers of HIV medications were sued in State Court in New Mexico by the Attorney General of the State of New Mexico in a case alleging that the defendants’ agreements to develop and sell various fixed-dose combination products for the treatment of HIV, including Atripla*, and agreements to settle certain patent litigation violate the antitrust laws of the State of New Mexico. No schedule has been set for the case.
Thalomid and Revlimid Litigations
Beginning in November 2014, certain putative class action lawsuits were filed against Celgene in the U.S. District Court for the District of New Jersey alleging that Celgene violated various antitrust, consumer protection, and unfair competition laws by (a) allegedly securing an exclusive supply contract for the alleged purpose of preventing a generic manufacturer from securing its own supply of thalidomide active pharmaceutical ingredient, (b) allegedly refusing to sell samples of Thalomid and Revlimid brand drugs to various generic manufacturers for the alleged purpose of bioequivalence testing necessary for aNDAs to be submitted to the FDA for approval to market generic versions of these products, (c) allegedly bringing unjustified patent infringement lawsuits in order to allegedly delay approval for proposed generic versions of Thalomid and Revlimid, and/or (d) allegedly entering into settlements of patent infringement lawsuits with certain generic manufacturers that allegedly have had anticompetitive effects. The plaintiffs, on behalf of themselves and putative classes of third-party payers, sought injunctive relief and damages. The various lawsuits were consolidated into a master action for all purposes. In March 2020, Celgene reached a settlement with the class plaintiffs. In October 2020, the Court entered a final order approving the settlement and dismissed the matter. That settlement does not resolve the claims of certain entities that opted out of the settlement.
In May 2018, Humana, Inc. (“Humana”) filed a lawsuit against Celgene in the Pike County Circuit Court of the Commonwealth of Kentucky. Humana’s complaint alleges Celgene engaged in unlawful off-label marketing in connection with sales of Thalomid and Revlimid and asserts claims against Celgene for fraud, breach of contract, negligent misrepresentation, unjust enrichment and violations of New Jersey’s Racketeer Influenced and Corrupt Organizations Act. The complaint seeks, among other things, treble and punitive damages, injunctive relief and attorneys’ fees and costs. In April 2019, Celgene filed a motion to dismiss Humana’s complaint, which the Court denied in January 2020. No trial date has been scheduled.
In March 2019, Humana filed a lawsuit against Celgene in the U.S. District Court for the District of New Jersey. Humana’s complaint makes largely the same claims and allegations as were made in the class action litigation. The complaint purports to assert claims on behalf of Humana and its subsidiaries in several capacities, including as a direct purchaser and as an indirect purchaser, and seeks, among other things, treble and punitive damages, injunctive relief and attorneys’ fees and costs. In May 2019, Celgene filed a motion to dismiss Humana’s complaint, and the Court has stayed discovery pending adjudication of that motion. No trial date has been scheduled.
In March 2020, United HealthCare Services, Inc. (“UHS”), affiliates of which opted out of the first settlement in the Thalomid and Revlimid Antitrust Class Action Litigation, filed a lawsuit against Celgene in the U.S. District Court for the District of Minnesota. UHS’s complaint makes largely the same claims and allegations as were made in the class action litigation in addition to certain claims regarding donations directed to copay assistance. The complaint purports to assert claims on behalf of UHS and its subsidiaries in several capacities, including as a direct purchaser and as an indirect purchaser, and seeks, among other things, treble and punitive damages, injunctive relief and attorneys’ fees and costs. In December 2020, Celgene’s motion to transfer the action to the District of New Jersey was granted and the case is now pending in that Court. In January 2021, Celgene filed a motion to dismiss UHS’s complaint, which the Court administratively terminated in June 2021 pending its decision on Celgene’s pending motion to dismiss Humana’s complaint. No trial date has been scheduled.
In May 2020, Celgene filed suit against Humana Pharmacy, Inc. (“HPI”), a Humana subsidiary, in Delaware Superior Court. Celgene’s complaint alleges that HPI breached its contractual obligations to Celgene by assigning claims to Humana that Humana is now asserting. The complaint seeks damages for HPI’s breach as well as a declaratory judgment. In September 2020, HPI filed a motion to dismiss Celgene’s complaint, which was denied in February 2021. A trial has been scheduled for March 2023.
In July 2020, Blue Cross Blue Shield Association (“BCBSA”) sued Celgene and BMS on behalf of the Federal Employee Program in the U.S. District Court for the District of Columbia. BCBSA’s complaint makes largely the same claims and allegations as were made in the class action litigation. In April 2021, the parties’ joint motion to transfer the action to the District of New Jersey was granted and the case is now pending in that Court. No trial date has been scheduled.
In August 2020, BCBSM Inc., Health Care Service Corporation (“HCSC”), Blue Cross and Blue Shield of Florida Inc., and Molina Healthcare, Inc. (“Molina”) sued Celgene and BMS in a Minnesota state court. The complaint makes largely the same claims and allegations as were made in the class action litigation but adds allegations on behalf of HCSC only as to alleged off-label marketing of Thalomid and Revlimid. In September 2020, Celgene and BMS removed the action to the U.S. District Court for the District of Minnesota. In March 2021, that Court denied plaintiffs’ motion to remand the action to state court, dismissed Molina for lack of personal jurisdiction and granted defendants’ motion to transfer the action to the District of New Jersey. The case is now pending in the District of New Jersey. No trial date has been scheduled.
In January 2021, Cigna Corporation (“Cigna”) sued Celgene and BMS in the U.S. District Court for the Eastern District of Pennsylvania. Cigna’s complaint makes largely the same claims and allegations as were made in the class action litigation. Cigna’s complaint purports to assert claims on behalf of Cigna and its subsidiaries in several capacities, including as a direct purchaser and as an indirect purchaser. In May 2021, the parties’ joint motion to transfer the action to the District of New Jersey was granted and the case is now pending in that Court. No trial date has been scheduled.
In May 2021, Molina sued Celgene and BMS in San Francisco Superior Court. Molina’s complaint makes largely the same claims and allegations as were made in the class action litigation. No trial date has been scheduled.
GOVERNMENT INVESTIGATIONS
Like other pharmaceutical companies, BMS and certain of its subsidiaries are subject to extensive regulation by national, state and local authorities in the U.S. and other countries in which BMS operates. As a result, BMS, from time to time, is subject to various governmental and regulatory inquiries and investigations as well as threatened legal actions and proceedings. It is possible that criminal charges, substantial fines and/or civil penalties, could result from government or regulatory investigations.
ENVIRONMENTAL PROCEEDINGS
As previously reported, BMS is a party to several environmental proceedings and other matters, and is responsible under various state, federal and foreign laws, including CERCLA, for certain costs of investigating and/or remediating contamination resulting from past industrial activity at BMS’s current or former sites or at waste disposal or reprocessing facilities operated by third parties.
CERCLA Matters
With respect to CERCLA matters for which BMS is responsible under various state, federal and foreign laws, BMS typically estimates potential costs based on information obtained from the U.S. Environmental Protection Agency, or counterpart state or foreign agency and/or studies prepared by independent consultants, including the total estimated costs for the site and the expected cost-sharing, if any, with other “potentially responsible parties,” and BMS accrues liabilities when they are probable and reasonably estimable. BMS estimated its share of future costs for these sites to be $75 million at June 30, 2021, which represents the sum of best estimates or, where no best estimate can reasonably be made, estimates of the minimal probable amount among a range of such costs (without taking into account any potential recoveries from other parties). The amount includes the estimated costs for any additional probable loss associated with the previously disclosed North Brunswick Township High School Remediation Site.
