UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

___________________________

FORM 10-Q

___________________________

x☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~June 30, 2019~~March 31, 2020

¨☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to _______

Commission File Number ~~1-1136~~001-01136

___________________________

BRISTOL-MYERS SQUIBB COMPANY

(Exact name of registrant as specified in its charter)

___________________________



Delaware		22-0790350
(State or other jurisdiction of incorporation or organization)		(I.R.S Employer Identification No.)

430 E. 29th Street, 14FL, New York, NY 10016

(Address of principal executive offices) (zip code)

(212) 546-4000

(Registrant’s telephone number, including area code)

___________________________

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:



Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.10 Par Value	BMY	New York Stock Exchange
1.000% Notes due 2025	BMY25	New York Stock Exchange
1.750% Notes due 2035	BMY35	New York Stock Exchange
Bristol-Myers Squibb Contingent Value Rights	BMY RT	New York Stock Exchange
Celgene Contingent Value Rights	CELG RT	New York Stock Exchange

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to the filing requirements for the past 90 days. Yes x☒ No ¨☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x☒ No ¨☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of ~~“large~~“large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.



Large accelerated filer x☒	Accelerated filer ¨☐	Non-accelerated filer ¨☐	Smaller reporting company ¨☐	Emerging growth company ¨☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨☐ No x☒

APPLICABLE ONLY TO CORPORATE ISSUERS:

At ~~June 30, 2019,~~March 31, 2020, there were ~~1,635,766,530~~2,262,689,755 shares outstanding of the Registrant’s $0.10 par value common stock.

BRISTOL-MYERS SQUIBB COMPANY

INDEX TO FORM 10-Q

~~June 30, 2019~~March 31, 2020




PART I—FINANCIAL INFORMATION

Item 1.
Financial Statements:
Consolidated Statements of Earnings and Comprehensive (Loss)/Income	3
Consolidated Balance Sheets	4
Consolidated Statements of Cash Flows	5
Notes to Consolidated Financial Statements	6

Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations	27

Item 3.
Quantitative and Qualitative Disclosure About Market Risk	4344

Item 4.
Controls and Procedures	4344

PART II—OTHER INFORMATION

Item 1.
Legal Proceedings	4345

Item 1A.
Risk Factors	4345

Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds	4446

Item 5.
Submission of Matters to a Vote of Security Holders	47

Item 6.
Exhibits	4448

Summary of Abbreviated Terms	4549
Signatures	4650


*	Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index at the end of this Quarterly Report on Form 10-Q.

PART I—FINANCIAL INFORMATION

Item 1. FINANCIAL STATEMENTS

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF EARNINGS

Dollars in Millions, Except Per Share Data

(UNAUDITED)


	Three Months Ended June 30,					Six Months Ended June 30,						Three Months Ended March 31,
EARNINGS	2019		2018			2019			2018			2020			2019
Net product sales	$	6,031	$	5,461		$	11,744		$	10,433		$	10,541		$	5,713
Alliance and other revenues	242		243			449			464			240			207
Total Revenues	6,273		5,704			12,193			10,897			10,781			5,920

Cost of products sold(a)	1,992		1,625			3,836			3,209			3,662			1,824
Marketing, selling and administrative	1,076		1,131			2,082			2,111			1,606			1,006
Research and development	1,328		2,435			2,679			3,685			2,372			1,348
Other income (net)	101		(4		)	(159		)	(404		)
Amortization of acquired intangible assets												2,282			24
Other expense/(income), net												1,163			(261		)
Total Expenses	4,497		5,187			8,438			8,601			11,085			3,941

Earnings Before Income Taxes	1,776		517			3,755			2,296
(Loss)/Earnings Before Income Taxes												(304		)	1,979
Provision for Income Taxes	337		135			601			419			462			264
Net Earnings	1,439		382			3,154			1,877
Net (Loss)/Earnings												(766		)	1,715
Noncontrolling Interest	7		9			12			18			9			5
Net Earnings Attributable to BMS	$	1,432	$	373		$	3,142		$	1,859
Net (Loss)/Earnings Attributable to BMS												$	(775	)	$	1,710
						��
Earnings per Common Share
(Loss)/Earnings per Common Share
Basic	$	0.88	$	0.23		$	1.92		$	1.14		$	(0.34	)	$	1.05
Diluted	0.87		0.23			1.92			1.13			(0.34		)	1.04


(a)	Excludes amortization of acquired intangible assets.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)/INCOME

Dollars in Millions

(UNAUDITED)

Three Months Ended June 30, Six Months Ended June 30,
COMPREHENSIVE INCOME 2019 2018 2019 2018
Net Earnings $ 1,439
$ 382
$ 3,154
$ 1,877
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:
Derivatives qualifying as cash flow hedges (28 ) 85
(14 ) 66
Pension and postretirement benefits 39
43
88
172
Available-for-sale securities 13
(7 ) 39
(33 )
Foreign currency translation (1 ) (221 ) 28
(216 )
Other Comprehensive Income/(Loss) 23
(100 ) 141
(11 )

Comprehensive Income 1,462
282
3,295
1,866
Comprehensive Income Attributable to Noncontrolling Interest 7
9
12
18
Comprehensive Income Attributable to BMS $ 1,455
$ 273
$ 3,283
$ 1,848



	Three Months Ended March 31,
COMPREHENSIVE (LOSS)/INCOME	2020			2019
Net (Loss)/Earnings	$	(766	)	$	1,715
Other Comprehensive (Loss)/Income, net of taxes and reclassifications to earnings:
Derivatives qualifying as cash flow hedges	70			14
Pension and postretirement benefits	16			49
Available-for-sale debt securities	1			26
Foreign currency translation	(116		)	29
Other Comprehensive (Loss)/Income	(29		)	118

Comprehensive (Loss)/Income	(795		)	1,833
Comprehensive Income Attributable to Noncontrolling Interest	9			5
Comprehensive (Loss)/Income Attributable to BMS	$	(804	)	$	1,828

The accompanying notes are an integral part of these consolidated financial statements.

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED BALANCE SHEETS

Dollars in Millions

(UNAUDITED)


ASSETS	June 30, 2019			December 31, 2018			March 31, 2020			December 31, 2019
Current Assets:
Cash and cash equivalents	$	28,404		$	6,911		$	15,817		$	12,346
Marketable securities	953			1,973
Marketable debt securities							2,505			3,047
Receivables	5,667			5,965			8,290			7,685
Inventories	1,308			1,195			2,836			4,293
Prepaid expenses and other	1,384			1,116
Other current assets							2,405			1,983
Total Current Assets	37,716			17,160			31,853			29,354
Property, plant and equipment	4,849			5,027			6,112			6,252
Goodwill	6,533			6,538			22,452			22,488
Other intangible assets	995			1,091			61,666			63,969
Deferred income taxes	1,442			1,371			605			510
Marketable securities	994			1,775
Other assets	2,634			2,024
Marketable debt securities							651			767
Other non-current assets							5,946			6,604
Total Assets	$	55,163		$	34,986		$	129,285		$	129,944

LIABILITIES
Current Liabilities:
Short-term debt obligations	$	545		$	1,703		$	3,862		$	3,346
Accounts payable	2,005			1,892			3,069			2,445
Accrued and other current liabilities	7,161			7,059
Other current liabilities							12,301			12,513
Total Current Liabilities	9,711			10,654			19,232			18,304
Income taxes payable	2,971			3,043
Deferred income taxes							6,531			6,454
Long-term debt							42,844			43,387
Other non-current liabilities	1,897			1,516			10,701			10,101
Long-term debt	24,433			5,646
Total Liabilities	39,012			20,859			79,308			78,246

Commitments and contingencies

EQUITY
Bristol-Myers Squibb Company Shareholders’ Equity:
Preferred stock	—			—			—			—
Common stock	221			221			292			292
Capital in excess of par value of stock	2,150			2,081			43,254			43,709
Accumulated other comprehensive loss	(2,621		)	(2,762		)	(1,549		)	(1,520		)
Retained earnings	35,870			34,065			32,671			34,474
Less cost of treasury stock	(19,571		)	(19,574		)	(24,757		)	(25,357		)
Total Bristol-Myers Squibb Company Shareholders’ Equity	16,049			14,031			49,911			51,598
Noncontrolling interest	102			96			66			100
Total Equity	16,151			14,127			49,977			51,698
Total Liabilities and Equity	$	55,163		$	34,986		$	129,285		$	129,944

The accompanying notes are an integral part of these consolidated financial statements.

BRISTOL-MYERS SQUIBB COMPANY

CONSOLIDATED STATEMENTS OF CASH FLOWS

Dollars in Millions

(UNAUDITED)


	Six Months Ended June 30,						Three Months Ended March 31,
	2019			2018			2020			2019
Cash Flows From Operating Activities:
Net earnings	$	3,154		$	1,877
Adjustments to reconcile net earnings to net cash provided by operating activities:
Net (loss)/earnings							$	(766	)	$	1,715
Adjustments to reconcile net (loss)/earnings to net cash provided by operating activities:
Depreciation and amortization, net	339			300			2,477			170
Deferred income taxes	(87		)	(37		)	(53		)	78
Stock-based compensation	101			106			210			53
Impairment charges	174			104			53			45
Pension settlements and amortization	126			104			11			66
Divestiture gains and royalties	(320		)	(497		)	(173		)	(166		)
Asset acquisition charges	25			85
Equity investment (gains)/losses	(246		)	341
Equity investment losses/(gains)							339			(175		)
Contingent consideration fair value adjustments							556			—
Other adjustments	(14		)	(27		)	(42		)	(6		)
Changes in operating assets and liabilities:
Receivables	307			112			(743		)	236
Inventories	28			(122		)	1,448			35
Accounts payable	156			(101		)	703			136
Deferred income	9			92
Income taxes payable	(65		)	216			229			120
Other	(214		)	(321		)	(355		)	(917		)
Net Cash Provided by Operating Activities	3,473			2,232			3,894			1,390
Cash Flows From Investing Activities:
Sale and maturities of marketable securities	2,288			1,080
Purchase of marketable securities	(437		)	(447		)
Sale and maturities of marketable debt securities							1,394			1,211
Purchase of marketable debt securities							(735		)	(242		)
Capital expenditures	(395		)	(437		)	(186		)	(204		)
Divestiture and other proceeds	368			583			205			310
Acquisition and other payments	(49		)	(1,170		)
Net Cash Provided by/(Used in) Investing Activities	1,775			(391		)
Acquisition and other payments, net of cash acquired							(25		)	(15		)
Net Cash Provided by Investing Activities							653			1,060
Cash Flows From Financing Activities:
Short-term debt obligations, net	84			(546		)	26			(73		)
Issuance of long-term debt	18,790			—
Repayment of long-term debt	(1,256		)	(5		)	—			(1,250		)
Repurchase of common stock	—			(320		)	(81		)	—
Dividends	(1,340		)	(1,307		)	(1,017		)	(669		)
Other	(39		)	(59		)	18			(37		)
Net Cash Provided by/(Used in) Financing Activities	16,239			(2,237		)
Effect of Exchange Rates on Cash and Cash Equivalents	6			(26		)
Net Increase/(Decrease) in Cash and Cash Equivalents	21,493			(422		)
Cash and Cash Equivalents at Beginning of Period	6,911			5,421
Cash and Cash Equivalents at End of Period	$	28,404		$	4,999
Net Cash Used in Financing Activities							(1,054		)	(2,029		)
Effect of Exchange Rates on Cash, Cash Equivalents and Restricted Cash							(67		)	3
Increase in Cash, Cash Equivalents and Restricted Cash							3,426			424
Cash, Cash Equivalents and Restricted Cash at Beginning of Period							12,820			6,911
Cash, Cash Equivalents and Restricted Cash at End of Period							$	16,246		$	7,335

The accompanying notes are an integral part of these consolidated financial statements.

Note 1. BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING STANDARDS

Basis of Consolidation

Bristol-Myers Squibb Company 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, 2019~~March 31, 2020 and December 31, ~~2018,~~2019 and the results of operations ~~for the three and six months ended June 30, 2019 and 2018,~~ and cash flows for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 and ~~2018.~~2019. All intercompany balances and transactions have been eliminated. BMS's consolidated financial statements include the assets, liabilities, operating results and cash flows of Celgene from the date of acquisition on November 20, 2019. These financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, ~~2018~~2019 included in the ~~2018~~2019 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

~~The Company~~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 ~~chief executive officer~~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; and pension and postretirement benefits.~~taxes. Actual results may differ from estimates.

~~Reclassification~~Reclassifications

Certain reclassifications were made to conform the prior period ~~amounts were reclassified to conform~~interim consolidated financial statements to the current period presentation. Accrued liabilities, Deferred income and Income taxes payable previously presented separately in Total Current Liabilities in the consolidated balance sheets are now presented as Accrued and other current liabilities. Deferred income and Pension and other liabilities previously presented separately in Total Liabilities in the consolidated balance sheets are now presented as Other non-current liabilities.

Recently Adopted Accounting Standards

~~Leases~~

Amended guidance for lease accounting was adopted on January 1, 2019 using the modified retrospective method with the cumulative effect of the change recognized in retained earnings in the period of adoption. The new guidance requires an entity to recognize a right-of-use asset and a lease liability initially measured at the present value of future lease payments. The cumulative effect of the accounting change was not material. The Company elected the package of practical expedients upon adoption and will apply the practical expedient not to separate lease and non-lease components for new and modified leases commencing after adoption. In addition, the Company applied the short-term lease recognition exemption for leases with terms at inception not greater than 12 months. The amended guidance does not materially impact the Company’s results of operations other than recognition of the operating lease right-of-use asset and lease liability.

~~Goodwill Impairment Testing~~

Amended guidance that simplifies the recognition and measurement of a goodwill impairment loss by eliminating Step 2 of the quantitative goodwill impairment test was adopted prospectively in the first quarter of 2019. Under the amended guidance, a goodwill impairment loss is recognized for the amount by which the reporting units carrying amount, including goodwill, exceeds its fair value up to the amount of its allocated goodwill. The adoption of the amended guidance did not have an impact on the Company’s results of operations.

~~Recently Issued Accounting Standards Not Yet Adopted~~

Financial Instruments - Measurement of Credit Losses

In June 2016, the FASB issued amended guidance for the measurement of credit losses on financial instruments. Entities will be required to use a forward-looking estimated loss model. Available-for-sale debt security credit losses will be recognized as allowances rather than a reduction in amortized cost. ~~The~~BMS adopted the amended guidance ~~is effective January 1, 2020 with early adoption permitted in 2019~~ on a modified retrospective ~~approach.~~approach on January 1, 2020. The amended guidance isdid not ~~expected to materially~~ impact ~~the Company’s~~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,				Three Months Ended March 31,
Dollars in Millions	2019		2018		2019		2018		2020		2019
Net product sales	$	6,031	$	5,461	$	11,744	$	10,433	$	10,541	$	5,713
Alliance revenues	146		154		275		306		105		129
Other revenues	96		89		174		158		135		78
Total Revenues	$	6,273	$	5,704	$	12,193	$	10,897	$	10,781	$	5,920

The following table summarizes GTN adjustments:


	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Gross product sales	$	8,819		$	7,509		$	16,813		$	14,210		$	14,686		$	7,994
GTN adjustments^(a)
Charge-backs and cash discounts	(890		)	(663		)	(1,664		)	(1,246		)	(1,340		)	(774		)
Medicaid and Medicare rebates	(1,090		)	(765		)	(1,890		)	(1,322		)	(1,498		)	(800		)
Other rebates, returns, discounts and adjustments	(808		)	(620		)	(1,515		)	(1,209		)	(1,307		)	(707		)
Total GTN adjustments	(2,788		)	(2,048		)	(5,069		)	(3,777		)	(4,145		)	(2,281		)
Net product sales	$	6,031		$	5,461		$	11,744		$	10,433		$	10,541		$	5,713


(a)	Includes adjustments tofor provisions for product sales made in prior periods resulting from changes in estimates of ~~$49~~$72 million and ~~$127~~$78 million for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and $60 million and $110 million for the three and six months ended June 30, 2018,~~ respectively.

The following table summarizes the disaggregation of revenue by product and region:


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
Dollars in Millions	2019		2018		2019		2018		2020		2019
Prioritized Brands
Revlimid									$	2,915	$	—
Eliquis									2,641		1,925
Opdivo	$	1,823	$	1,627	$	3,624	$	3,138	1,766		1,801
Eliquis	2,042		1,650		3,967		3,156
Orencia	778		711		1,418		1,304		714		640
Pomalyst/Imnovid									713		—
Sprycel	544		535		1,003		973		521		459
Yervoy	367		315		751		564		396		384
Abraxane									300		—
Empliciti	91		64		174		119		97		83
Reblozyl									8		—
Inrebic									12		—

Established Brands
Baraclude	147		179		288		404		122		141
Other Brands	481		623		968		1,239
Vidaza									158		—
Other Brands^(a)									418		487
Total Revenues	$	6,273	$	5,704	$	12,193	$	10,897	$	10,781	$	5,920

United States	$	3,667	$	3,230	$	7,116	$	6,008	$	6,766	$	3,449
Europe	1,491		1,408		2,971		2,814		2,567		1,480
Rest of the World	988		923		1,862		1,796		1,335		874
Other^(a)	127		143		244		279
Other^(b)									113		117
Total Revenues	$	6,273	$	5,704	$	12,193	$	10,897	$	10,781	$	5,920


(a)	Includes BMS and Celgene products in 2020.


(b)	Other revenues include royalties and alliance-related revenues for products not sold by ~~the Company's~~BMS's regional commercial organizations.

Revenue recognized from performance obligations satisfied in prior periods was ~~$117~~$130 million and ~~$264~~$147 million for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and $150 million and $300 million for the three and six months ended June 30, 2018,~~ respectively, consisting primarily of royalties for out-licensing arrangements and revised estimates for ~~gross-to-net~~GTN adjustments related to prior period sales. Contract assets were not material at ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018.~~2019.

Note 3. ALLIANCES

~~The Company~~BMS enters into collaboration arrangements with third parties for the ~~research,~~ development ~~manufacturing and/or~~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. ~~The Company~~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. ~~The Company~~BMS refers to these collaborations as alliances and its partners as alliance partners.

Selected financial information pertaining to ~~the Company's~~ alliances was as follows, including net product sales when ~~the Company~~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,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Revenues from alliances:
Net product sales	$	2,570		$	2,178		$	4,948		$	4,098		$	2,723		$	2,378
Alliance revenues	146			154			275			306			105			129
Total Revenues	$	2,716		$	2,332		$	5,223		$	4,404		$	2,828		$	2,507

Payments to/(from) alliance partners:
Cost of products sold	$	1,080		$	891		$	2,099		$	1,690		$	1,306		$	1,019
Marketing, selling and administrative	(32		)	(28		)	(60		)	(50		)	(40		)	(28		)
Research and development	7			1,057			21			1,062			46			14
Other income (net)	(16		)	(16		)	(30		)	(30		)
Other expense/(income), net													(15		)	(14		)


Dollars in Millions					March 31, 2020		December 31, 2019
Selected Alliance Balance Sheet information:
Dollars in Millions	June 30, 2019		December 31, 2018
Receivables - from alliance partners	$	351	$	395
Accounts payable - to alliance partners	1,068		904
Receivables – from alliance partners					$	309	$	347
Accounts payable – to alliance partners					1,284		1,026
Deferred income from alliances^(a)	469		491		432		431


(a)	Includes unamortized upfront and milestone payments.

The nature, ~~and~~ purpose, significant rights and obligations of the parties and specific accounting policy elections for each of the Company's significant alliances are discussed in the ~~Company's 2018~~2019 Form 10-K. ~~There were no significant~~Significant developments and updates related to alliances during ~~2019.~~the three months ended March 31, 2020 are set forth below.

Otsuka

Otsuka is no longer co-promoting Sprycel in the U.S. and the EU in 2020 and as a result, this arrangement is no longer considered a collaboration under ASC 808. Revenues earned and fees paid to Otsuka in the Oncology Territory in 2020 are not included in the table above.

Note 4. ACQUISITIONS, DIVESTITURES, LICENSING AND OTHER ARRANGEMENTS

Acquisitions

Business Combination

Celgene

On November 20, 2019, BMS completed the Celgene acquisition. The acquisition is expected to further position BMS as a leading biopharmaceutical company for sustained innovation and long-term growth and to address the needs of patients with cancer, inflammatory, immunologic or cardiovascular diseases through high-value innovative medicines and leading scientific capabilities. The transaction was accounted for as a business combination, which requires that assets acquired and liabilities assumed be recognized at their fair value as of the acquisition date. The purchase price allocation is preliminary and subject to change, including the valuation of inventory, property, plant and equipment, intangible assets, income taxes and legal contingencies among other items. The amounts recognized will be finalized as the information necessary to complete the analysis is obtained, but no later than one year after the acquisition date. Measurement period adjustments increased goodwill by $22 million in the first quarter of 2020 due to purchase price allocation increases of $58 million to equity investments and $30 million to legal contingency liabilities, net of deferred income taxes.

~~Note 4. ACQUISITIONS, DIVESTITURES AND OTHER ARRANGEMENTS~~

~~Acquisitions~~

~~IFM~~

In the second quarter of 2019, a $25 million milestone was achieved and paid as additional contingent consideration following the commencement of a Phase I clinical study under the STING agonist program. The additional consideration was included in Research and development expense as the IFM acquisition in 2017 was accounted for as an asset acquisition.

Divestitures

The following table summarizes ~~proceeds, gains or losses and royalty income resulting from divestitures.~~the financial impact of divestitures including royalties, which are included in Other expense/(income), net. Revenue and pretax earnings related to all divestitures and assets held-for-sale were not material in all periods presented (excluding divestiture gains or losses).

Three Months Ended June 30,

Proceeds^(a)
Divestiture Losses/(Gains) Royalty Income
Dollars in Millions 2019 2018 2019 2018 2019 2018
Diabetes Business $ 164
$ 155
$ —
$ —
$ (161 ) $ (165 )
Erbitux* Business
3
50
—
—
—
(50 )
Manufacturing Operations 1
1
—
—
—
—
Mature Brands and Other 2
2
8
(25 ) (1 ) (2 )
Total $ 170
$ 208
$ 8
$ (25 ) $ (162 ) $ (217 )


	Six Months Ended June 30,															Three Months Ended March 31,
	Proceeds^(a)				Divestiture Losses/(Gains)					Royalty Income						Net Proceeds^(a)				Divestiture Gains					Royalty Income
Dollars in Millions	2019		2018		2019		2018			2019			2018			2020		2019		2020			2019		2020			2019
Diabetes Business	$	328	$	243	$	—	$	—		$	(326	)	$	(327	)	$	153	$	164	$	—		$	—	$	(127	)	$	(165	)
Erbitux* Business	8		109		—		—			—			(97		)
Erbitux*																4		5		—			—		—			—
Manufacturing Operations	3		159		—		—			—			—			—		2		(1		)	—		—			—
Plavix* and Avapro/Avalide																7		—		(12		)	—		—			—
Mature Brands and Other	2		72		8		(70		)	(2		)	(3		)	31		—		(3		)	—		(31		)	(1		)
Total	$	341	$	583	$	8	$	(70	)	$	(328	)	$	(427	)	$	195	$	171	$	(16	)	$	—	$	(158	)	$	(166	)


(a)	Includes royalties received subsequent to the related sale of the asset or business.

~~Assets Held-For-Sale~~

Note 5. OTHER EXPENSE/(INCOME), NET



	Three Months Ended March 31,
Dollars in Millions	2020			2019
Interest expense	$	362		$	45
Pension and postretirement	(4		)	44
Royalties and licensing income	(410		)	(308		)
Divestiture gains	(16		)	—
Acquisition expenses	—			165
Contingent consideration	556			—
Investment income	(61		)	(56		)
Integration expenses	174			22
Provision for restructuring	160			12
Equity investment losses/(gains)	339			(175		)
Litigation and other settlements	32			1
Transition and other service fees	(61		)	(2		)
Reversion excise tax	76			—
Other	16			(9		)
Other expense/(income), net	$	1,163		$	(261	)

~~UPSA Business~~

Note 6. RESTRUCTURING

~~In 2018,~~A restructuring and integration plan is being implemented as an initiative to realize $2.5 billion of sustainable run-rate synergies resulting from cost savings and avoidance from the ~~Company agreed to sell its UPSA consumer health business for approximately $1.6 billion.~~Celgene acquisition. The transaction closed in July 2019 and will result in a gain of approximately $1.2 billion in the third quarter of 2019. Assets were reclassified to assets held-for-sale as of June 30, 2019 and December 31, 2018 and included within Prepaid expenses and other. Liabilities were reclassified to liabilities related to assets held-for-sale and included within Accrued and other current liabilities.

~~Manufacturing Operations~~

~~In the second quarter of 2019, the Company agreed to sell its manufacturing and packaging facility in Anagni, Italy to Catalent for approximately $50 million. The transaction is~~synergies are expected to ~~close by the end of 2019 subject to regulatory approvals and the satisfaction of certain other customary closing conditions and will~~ be accounted for as a sale of a business. Catalent will provide certain manufacturing and packaging services for the Company for a period of time subsequent to closing. The business was accounted for as held-for-sale and its assets were reduced to the estimated relative fair value resulting in a $109 million impairment charge that was includedrealized in Cost of products ~~sold. Assets were reclassified~~sold (10%), Marketing, selling and administrative expenses (55%) and Research and development expenses (35%). The majority of charges are expected to ~~assets held-for-sale as~~be incurred through 2022, and range between $2.8 billion to $3.0 billion. Cumulative charges of ~~June 30, 2019~~approximately $1.0 billion have been recognized including integration planning and ~~included within Prepaid~~execution expenses, employee termination benefit costs and ~~other. Liabilities were reclassified to liabilities related to assets held-for-sale and included within Accrued~~accelerated stock-based compensation, contract termination costs and other ~~current liabilities.~~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 600 for the three months ended March 31, 2020.

The following ~~table summarizes~~tables summarize the ~~net assets held-for-sale as of June 30, 2019~~charges and ~~December 31, 2018.~~activity related to the Celgene acquisition:

Dollars in Millions June 30,
2019 December 31,
2018
Cash and cash equivalents $ 18
$ —
Receivables 40
79
Inventories 94
81
Property, plant and equipment 229
187
Goodwill 132
127
Other 23
5
Assets held-for-sale $ 536
$ 479

Accounts payable $ 31
$ 35
Accrued and other current liabilities 81
78
Deferred income taxes 26
25
Other liabilities 25
14
Liabilities related to assets held-for-sale $ 163
$ 152

Net assets held-for-sale $ 373
$ 327



Dollars in Millions	Three Months Ended March 31, 2020
Employee termination costs	$	146
Other termination costs	4
Provision for restructuring	150
Integration expenses	174
Total charges^(a)	$	324


(a)	Included in Other expense/(income), net.



Dollars in Millions	Three Months Ended March 31, 2020
Liability at January 1	$	77
Charges	131
Change in estimates	1
Provision for restructuring^(a)	132
Foreign currency translation and other	6
Payments	(91		)
Liability at March 31	$	124

~~Note 5. OTHER INCOME (NET)~~

Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions 2019 2018 2019 2018
Interest expense $ 123

$ 45
$ 168

$ 91
Investment income (119 )
(38 ) (175 )
(74 )
Equity investment (gains)/losses (71 )
356
(246 )
341
Provision for restructuring 10

37
22

57
Acquisition expenses 303

—
468

—
Integration expenses 106
—
128
—
Litigation and other settlements —

(1 ) 1

(1 )
Equity in net income of affiliates —

(27 ) —

(51 )
Divestiture losses/(gains) 8

(25 ) 8

(70 )
Royalties and licensing income (303 )
(353 ) (611 )
(720 )
Transition and other service fees (2 )
(1 ) (4 )
(5 )
Pension and postretirement 26

(19 ) 70

(30 )
Intangible asset impairment 15

—
15

64
Other 5

22
(3 )
(6 )
Other income (net) $ 101

$ (4 ) $ (159 )
$ (404 )

~~Note 6. RESTRUCTURING~~


(a)	Excludes $18 million of accelerated stock-based compensation.

In October 2016, ~~the Company announced~~ a restructuring plan was announced to evolve and streamline ~~its~~BMS's operating model. The majority of ~~the~~ charges are expected to be incurred through 2020, range between ~~$1.5~~$1.6 billion to $2.0 billion. Cumulative charges of approximately $1.5 billion ~~and consist of~~have been recognized including employee termination benefit costs, contract termination costs, ~~plant and equipment~~ accelerated depreciation and impairment charges and other ~~shutdown~~ costs associated with ~~early~~ manufacturing and R&D site exits. The remaining charges are expected to result from additional site exit costs. Cash outlays in connection with these actions are expected to be approximately 40% to 50% of the total charges. Charges of approximately $1.3 billion have been recognized for these actions since the announcement. Restructuring charges are recognized upon meeting certain criteria, including finalization of committed plans, reliable estimates and discussions with local works councils in certain markets.

~~Employee workforce reductions were approximately 100 and 300 for the six months ended June 30, 2019 and 2018, respectively.~~

The following tables summarize the charges and activity related to the ~~restructuring actions:~~Company transformation:


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
Dollars in Millions	2019		2018		2019		2018		2020		2019
Employee termination costs	$	3	$	26	$	7	$	35	$	3	$	4
Other termination costs	7		11		15		22		7		8
Provision for restructuring	10		37		22		57		10		12
Accelerated depreciation	32		31		63		52		30		31
Asset impairments	109		—		110		10		42		1
Other shutdown costs	—		2		—		5
Total charges	$	151	$	70	$	195	$	124	$	82	$	44


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
Dollars in Millions	2019		2018		2019		2018		2020		2019
Cost of products sold	$	122	$	14	$	134	$	27	$	16	$	12
Marketing, selling and administrative	—		—		1		1		—		1
Research and development	19		19		38		39		56		19
Other income (net)	10		37		22		57
Other expense/(income), net									10		12
Total charges	$	151	$	70	$	195	$	124	$	82	$	44

Six Months Ended June 30,
Dollars in Millions 2019 2018
Liability at December 31 $ 99
$ 186
Cease-use lease liability reclassification (3 ) —
Liability at January 1 96
186

Charges 27
61
Change in estimates (5 ) (4 )
Provision for restructuring 22
57
Foreign currency translation —
1
Payments (74 ) (129 )
Liability at June 30 $ 44
$ 115



	Three Months Ended March 31,
Dollars in Millions	2020			2019
Liability at December 31	$	23		$	99
Cease-use liability reclassification	—			(3		)
Liability at January 1	23			96
Charges	7			15
Change in estimates	3			(3		)
Provision for restructuring	10			12
Payments	(16		)	(45		)
Liability at March 31	$	17		$	63

Note 7. INCOME TAXES


	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Earnings Before Income Taxes	$	1,776		$	517		$	3,755		$	2,296
(Loss)/Earnings Before Income Taxes													$	(304	)	$	1,979
Provision for Income Taxes	337			135			601			419			462			264
Effective Tax Rate	19.0		%	26.1		%	16.0		%	18.2		%	(152.0		)%	13.3		%

The ~~reduction in the effective~~ tax ~~rate~~impact attributed to specified items was primarily due to a non-deductible ~~equity investment fair~~contingent value ~~loss adjustment relating to Nektar in the second quarter of 2018. Jurisdictional tax rates and other tax impacts attributed to non-deductible R&D~~rights charges, valuation allowance on equity investment fair value adjustments and ~~other specified items increased the effective~~low jurisdictional tax ~~rate by 0.5%~~rates attributed to inventory and intangible asset purchase price adjustments in the ~~second quarter of 2019 and decreased by 0.6% year-to-date. These items increased the effective tax rate by 8.6% in the second quarter of 2018 and by 0.9% year-to-date.~~three months ended March 31, 2020. The tax impact of these discrete items are reflected immediately and are not considered in estimating the annual effective tax rate. Additional changes to the effective tax rate may occur in future periods due to various reasons including pretax earnings mix, tax reserves, cash repatriations and revised interpretations of the relevant tax code.

~~The Company~~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. It is reasonably possible that new issues will be raised by tax authorities, which may require adjustments to the amount of unrecognized tax benefits; however, an estimate of such adjustments cannot reasonably be made at this time.

It is also reasonably possible that the total amount of unrecognized tax benefits at ~~June 30, 2019~~March 31, 2020 could decrease in the range of approximately ~~$365~~$290 million to ~~$405~~$330 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. 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. ~~The Company~~BMS believes that it has adequately provided for all open tax years by tax jurisdiction.

Note 8. (LOSS)/EARNINGS PER SHARE

Three Months Ended June 30, Six Months Ended June 30,
Amounts in Millions, Except Per Share Data 2019 2018 2019 2018
Net Earnings Attributable to BMS used for Basic and Diluted EPS Calculation $ 1,432
$ 373
$ 3,142
$ 1,859

Weighted-average common shares outstanding - basic 1,636
1,633
1,635
1,633
Incremental shares attributable to share-based compensation plans 1
3
2
5
Weighted-average common shares outstanding - diluted 1,637
1,636
1,637
1,638

Earnings per share - basic $ 0.88
$ 0.23
$ 1.92
$ 1.14
Earnings per share - diluted 0.87
0.23
1.92
1.13



	Three Months Ended March 31,
Amounts in Millions, Except Per Share Data	2020			2019
Net (Loss)/Earnings Attributable to BMS Used for Basic and Diluted EPS Calculation	$	(775	)	$	1,710

Weighted-Average Common Shares Outstanding – Basic	2,258			1,634
Incremental Shares Attributable to Share-Based Compensation Plans	—			3
Weighted-Average Common Shares Outstanding – Diluted	2,258			1,637

(Loss)/Earnings per Common Share
Basic	$	(0.34	)	$	1.05
Diluted	(0.34		)	1.04

The total number of potential shares of common stock excluded from the diluted EPS computation because of the antidilutive impact was 138 million for the three months ended March 31, 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, 2019					December 31, 2018					March 31, 2020							December 31, 2019
Dollars in Millions	Level 1		Level 2			Level 1		Level 2			Level 1		Level 2			Level 3		Level 1		Level 2			Level 3
Cash and cash equivalents - money market and other investments	$	—	$	27,797		$	—	$	6,173
Marketable securities
Cash and cash equivalents - money market and other securities											$	—	$	13,528		$	—	$	—	$	10,448		$	—
Marketable debt securities:
Certificates of deposit	—		166			—		971			—		1,062			—		—		1,227			—
Commercial paper	—		30			—		273			—		869			—		—		1,093			—
Corporate debt securities	—		1,751			—		2,379			—		1,225			—		—		1,494			—
Equity investments	—		—			—		125
Derivative assets	—		46			—		44					202					—		140			—
Equity investments	207		288			88		266			1,822		145			—		2,020		175			—
Derivative liabilities	—		(255		)	—		(31		)	—		(29		)	—		—		(40		)	—
Contingent consideration liability:
Contingent value rights											2,862		—			—		2,275		—			—
Other acquisition related contingent consideration											—		—			69		—		—			106

As further described in “Item 8. Financial Statements and Supplementary Data—Note 9. Financial Instruments and Fair Value Measurements” in the Company's ~~2018~~2019 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, estimated annual sales 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, shorten or lengthen the time required to achieve such events, or increase or decrease estimated annual sales would result in corresponding increases or decreases in the fair values of these obligations. The fair value of our contingent consideration as of March 31, 2020 was calculated using the following significant unobservable inputs:



	Ranges (weighted average) utilized as of:
Inputs	March 31, 2020
Discount rate	2.2% to 2.7% (2.4%)
Probability of payment	0% to 80% (2.6%)
Projected year of payment for development and regulatory milestones	2020 to 2029 (2022)
Projected year of payment for sales-based milestones and other amounts calculated as a percentage of annual sales	N/A

There were no ~~Level~~transfers between levels 1, 2 and 3 ~~financial assets or liabilities as~~during the three months ended March 31, 2020. The following table represents a roll-forward of ~~June 30, 2019 and December 31, 2018.~~the fair value of level 3 instruments:



Dollars in Millions	Three Months Ended March 31, 2020
Fair value as of January 1	$	106
Changes in estimated fair value	(36		)
Foreign exchange	(1		)
Fair value as of March 31	$	69

Available-for-sale Debt Securities and Equity Investments

Changes in fair value of equity investments are included in Other ~~income (net).~~expense/(income), net. The following table summarizes ~~the Company's~~ available-for-sale debt securities and equity investments:


	June 30, 2019									December 31, 2018															March 31, 2020															December 31, 2019
Dollars in Millions	Amortized Cost		Gross Unrealized							Amortized Cost				Gross Unrealized											Amortized Cost				Gross Unrealized											Amortized Cost				Gross Unrealized
Dollars in Millions	Amortized Cost		Gains		Losses			Fair Value					Gains				Losses				Fair Value				Amortized Cost			Gains				Losses				Fair Value				Amortized Cost			Gains				Losses				Fair Value
Certificates of deposit	$	166	$	—	$	—		$	166	Amortized Cost	$	971			$	—			$	—			$	971		$	1,062			$	—			$	—			$	1,062		$	1,227			$	—			$	—			$	1,227
Commercial paper	30		—		—			30		273				—				—				273			869				—				—				869			1,093				—				—				1,093
Corporate debt securities	1,749		4		(2		)	1,751		2,416				—				(37		)		2,379			1,216				11				(2		)		1,225			1,487				8				(1		)		1,494
	$	1,945	$	4	$	(2	)	$	1,947	$	3,660			$	—			$	(37	)		$	3,623		$	3,147			$	11			$	(2	)		3,156			$	3,807			$	8			$	(1	)		3,814

Equity investments								495														479															1,967															2,195
Total								$	2,442													$	4,102														$	5,123														$	6,009

Dollars in Millions June 30,
2019 December 31,
2018
Current marketable securities $ 953
$ 1,973
Non-current marketable securities^(a)
994
1,775
Other assets 495
354
Total $ 2,442
$ 4,102



Dollars in Millions	March 31, 2020		December 31, 2019
Marketable debt securities - current	$	2,505	$	3,047
Marketable debt securities - non-current^(a)	651		767
Other non-current assets	1,967		2,195
Total	$	5,123	$	6,009


(a)	All non-current marketable debt securities mature within five years as of ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018.~~2019.

Equity investments not measured at fair value and excluded from the above fair value table were limited partnerships and other equity method investments of ~~$142~~$424 million at ~~June 30, 2019~~March 31, 2020 and ~~$114~~$429 million at December 31, ~~2018~~2019 and other equity investments without readily determinable fair values of ~~$191~~$754 million at ~~June 30, 2019~~March 31, 2020 and ~~$206~~$781 million at December 31, ~~2018.~~2019. These amounts are included in Other non-current assets. Upward adjustments to equity investments without readily determinable fair values for the three months ended March 31, 2020 were $75 million resulting from observable price changes for similar securities for the same issuer and were recorded in Other expense/(income), net. Downward adjustments to equity investments without readily determinable fair values for the three months ended March 31, 2020 were $188 million due to the significant adverse change in the global economy during the period primarily caused by the COVID-19 pandemic.

The following table summarizes the net ~~gain/~~(loss)/gain recorded for equity investments with readily determinable fair values held as of ~~June 30, 2019~~March 31, 2020 and ~~2018:~~2019:

Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions 2019 2018 2019 2018
Net gain/(loss) recognized $ 59
$ (374 ) $ 154
$ (359 )
Less: Net gain/(loss) recognized for equity investments sold —
—
14
—
Net unrealized gain/(loss) on equity investments held $ 59
$ (374 ) $ 140
$ (359 )



	Three Months Ended March 31,
Dollars in Millions	2020			2019
Net (loss)/gain recognized	$	(228	)	$	95
Less: Net gain recognized for equity investments sold	—			14
Net unrealized (loss)/gain on equity investments held	$	(228	)	$	81

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 isare temporarily reported in Accumulated other comprehensive loss and included in earnings when the hedged item affects earnings. Upon adoption of the amended guidance for derivatives and hedging in the first quarter of 2018, the entire change in fair value of the hedging instrument included in the assessment of hedge effectiveness is recorded in the derivatives qualifying as cash flow hedges component of Other Comprehensive (Loss)/Income. 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)~~sold and Other expense/(income), net) within the next 12 months. The notional amount of outstanding foreign currency forward contracts was primarily attributed to the euro of ~~$996 million~~$1.7 billion and Japanese yen of ~~$476 million~~$1.2 billion at ~~June 30, 2019.~~March 31, 2020.

The earnings impact related to discontinued cash flow hedges and hedge ineffectiveness was not ~~significant~~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. The foreign currency zero-cost collar contracts outstanding as of March 31, 2020 had settlement dates within 12 months. If the U.S. Dollar weakens relative to the currency of the hedged anticipated sales, the purchased put option value reduces to zero and we benefit 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~~1.0 billion) at ~~June 30, 2019~~March 31, 2020 are designated as net investment hedges to hedge euro currency exposures of the net investment in certain foreign ~~affiliates. These borrowings~~affiliates and are ~~designated as net investment hedges and~~ recognized in long-term debt. The effective portion of foreign exchange gain on the remeasurement of euro debt was ~~$2 million and $16 million gain in 2019 and 2018, respectively, and were recorded~~included in the foreign currency translation component of ~~Other Comprehensive Income/(Loss)~~Accumulated other comprehensive loss with the related offset in ~~Long-term~~long-term debt.

In January 2018, the Company entered into $300 million of cross-currency interest rate swap contracts maturing in December 2022 designated to hedge Japanese yen currency exposures of the Company's net investment in its Japan subsidiary. Contract fair value changes are recorded in the foreign currency translation component of Other Comprehensive ~~Income/~~(Loss)/Income with a related offset in Other non-current assets or Other non-current liabilities.

Cross-currency interest rate swap contracts of $400 million at March 31, 2020 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 (Loss)/Income 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 ~~(2.4%~~(1.0% as of ~~June 30, 2019)~~March 31, 2020) 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 ~~match those of~~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. When the underlying swap is terminated prior to maturity, the fair value adjustment to the underlying debt is amortized as a reduction to interest expense over the remaining term of the debt.

Following the announcement of the Company's pending acquisition of Celgene, the Company entered into forward starting interest rate swap option contracts, with a total notional value of $7.6 billion, to hedge future interest rate risk associated with the anticipated issuance of long-term debt to fund the pending Celgene acquisition. In April 2019, the Company entered into deal contingent forward starting interest rate swap contracts, with an aggregate notional principal amount of $10.4 billion, to hedge interest rate risk associated with the anticipated issuance of long-term debt to fund the Celgene acquisition and terminated the forward starting interest rate swap option contracts. The deal contingent forward starting interest rate swap contracts were unwound upon the Company's May 2019 issuance of the new notes, refer to “—Debt Obligations.”

The following table summarizes the fair value of outstanding derivatives:


	June 30, 2019									December 31, 2018									March 31, 2020									December 31, 2019
	Asset^(a)				Liability^(b)					Asset^(a)				Liability^(b)					Asset^(a)				Liability^(b)					Asset^(a)				Liability^(b)
Dollars in Millions	Notional		Fair Value		Notional		Fair Value			Notional		Fair Value		Notional		Fair Value			Notional		Fair Value		Notional		Fair Value			Notional		Fair Value		Notional		Fair Value
Derivatives designated as hedging instruments:	Derivatives designated as hedging instruments:																		Derivatives designated as hedging instruments:
Interest rate swap contracts	$	255	$	6	$	—	$	—		$	—	$	—	$	755	$	(10	)	$	255	$	25	$	—	$	—		$	255	$	6	$	—	$	—
Cross-currency interest rate swap contracts	50		1		250		(3		)	50		—		250		(5		)	400		7		—		—			175		2		125		(1		)
Foreign currency forward contracts	1,150		38		666		(10		)	1,503		44		496		(10		)	2,383		75		301		(2		)	766		27		980		(20		)

Derivatives not designated as hedging instruments:	Derivatives not designated as hedging instruments:																		Derivatives not designated as hedging instruments:
Foreign currency forward contracts	176		1		453		(2		)	54		—		600		(6		)	1,177		73		772		(19		)	2,342		91		1,173		(10		)
Deal contingent forward starting interest rate swap contracts	—		—		10,350		(240		)	—		—		—		—
Foreign currency zero-cost collar contracts																			1,522		22		1,597		(8		)	2,482		14		2,235		(9		)


(a)	Included in ~~prepaid expenses~~Other current assets and ~~other and other~~Other non-current assets.


(b)	Included in ~~accrued and other~~Other current liabilities and ~~other~~Other non-current liabilities.

The ~~following~~following table summarizes the financial statement classification and amount of ~~gain/(loss)~~(gain)/loss recognized on hedging instruments:


	Three Months Ended June 30, 2019					Six Months Ended June 30, 2019					Three Months Ended March 31, 2020
Dollars in Millions	Cost of products sold		Other income (net)			Cost of products sold		Other income (net)			Cost of products sold			Other expense/(income), net
Interest rate swap contracts	$	—	$	7		$	—	$	12		$	—		$	(7	)
Cross-currency interest rate swap contracts	—		2			—		4			—			(2		)
Foreign currency forward contracts	26		11			56		2			(23		)	(76		)
Forward starting interest rate swap option contracts	—		—			—		(35		)
Deal contingent forward starting interest rate swap contracts	—		(240		)	—		(240		)
Foreign currency zero-cost collar contracts											—			(9		)

Three Months Ended June 30, 2018 Six Months Ended June 30, 2018
Dollars in Millions Cost of products sold Other income (net) Cost of products sold Other income (net)
Interest rate swap contracts $ —
$ 6
$ —
$ 13
Cross-currency interest rate swap contracts —
2
—
4
Foreign currency forward contracts (13 ) 16
(33 ) 7



	Three Months Ended March 31, 2019
Dollars in Millions	Cost of products sold			Other expense/(income), net
Interest rate swap contracts	$	—		$	(5	)
Cross-currency interest rate swap contracts	—			(2		)
Foreign currency forward contracts	(30		)	9
Forward starting interest rate swap options	—			35

The following table summarizes the effect of derivative and non-derivative instruments designated as hedging instruments in Other Comprehensive ~~Income/~~(Loss):/Income:


	Three Months Ended June 30,					Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018		2019			2018			2020			2019
Derivatives qualifying as cash flow hedges
Foreign currency forward contracts gain/(loss):
Recognized in Other Comprehensive Income/(Loss)^(a)	$	(6	)	$	83	$	39		$	45
Recognized in Other Comprehensive (Loss)/Income^(a)												$	97		$	45
Reclassified to Cost of products sold	(26		)	13		(56		)	33			(20		)	(30		)

Derivatives qualifying as net investment hedges
Cross-currency interest rate swap contracts gain/(loss):
Recognized in Other Comprehensive Income/(Loss)	(4		)	12		2			(4		)
Cross-currency interest rate swap contracts gain:
Recognized in Other Comprehensive (Loss)/Income												6			6

Non-derivatives qualifying as net investment hedges
Non U.S. dollar borrowings gain/(loss):
Recognized in Other Comprehensive Income/(Loss)	(6		)	62		2			16
Non-U.S. dollar borrowings gain:
Recognized in Other Comprehensive (Loss)/Income												20			8


(a)	The amount is expected to be reclassified into earnings in the next 12 months.

Debt Obligations

Short-term debt obligations include:


Dollars in Millions	June 30, 2019		December 31, 2018		March 31, 2020		December 31, 2019
Non-U.S. short-term borrowings	$	355	$	320	$	345	$	351
Current portion of long-term debt	—		1,249		3,261		2,763
Other	190		134		256		232
Total	$	545	$	1,703	$	3,862	$	3,346

Long-term debt and the current portion of long-term debt include:


Dollars in Millions	June 30, 2019			December 31, 2018			March 31, 2020			December 31, 2019
Principal Value	$	24,515		$	6,776		$	44,310		$	44,335
Adjustments to Principal Value

Adjustments to Principal Value:
Fair value of interest rate swap contracts	6			(10		)	25			6
Unamortized basis adjustment from swap terminations	188			201			168			175
Unamortized bond discounts and issuance costs	(276		)	(72		)	(271		)	(280		)
Unamortized purchase price adjustments of Celgene debt							1,873			1,914
Total	$	24,433		$	6,895		$	46,105		$	46,150

Current portion of long-term debt	$	—		$	1,249		$	3,261		$	2,763
Long-term debt	24,433			5,646			42,844			43,387
Total							$	46,105		$	46,150

The fair value of long-term debt was ~~$25.9~~$51.9 billion at ~~June 30, 2019~~March 31, 2020 and ~~$7.1~~$50.7 billion at December 31, ~~2018~~2019 valued using Level 2 ~~inputs.~~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. Interest payments were ~~$110~~$491 million and ~~$117~~$57 million for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ respectively, net of amounts related to interest rate swap contracts.

During the first quarter of 2019, the $750 million 1.600% Notes and the $500 million 1.750% Notes matured and were repaid.

In May 2019, the Company issued an aggregate principal amount of $19.0 billion of floating rate and fixed rate unsecured senior notes. The notes rank equally in right of payment with all of the Company's existing and future senior unsecured indebtedness and the fixed rate notes are redeemable at any time, in whole, or in part, at varying specified redemption prices plus accrued and unpaid interest. All of the notes are subject to special mandatory redemption at a redemption price equal to 101% of the aggregate principal amount of the notes plus accrued and unpaid interest if the pending acquisition of Celgene is not completed by July 30, 2020 or the Company notifies the trustee in respect of the notes that it will not pursue the consummation of the Celgene acquisition. The following table summarizes the note issuances:

Dollars in Millions 2019
Principal Value:
Floating Rate Notes due 2020 $ 750
Floating Rate Notes due 2022 500
2.550% Notes due 2021 1,000
2.600% Notes due 2022 1,500
2.900% Notes due 2024 3,250
3.200% Notes due 2026 2,250
3.400% Notes due 2029 4,000
4.125% Notes due 2039 2,000
4.250% Notes due 2049 3,750
Total $ 19,000

Proceeds net of discount and deferred loan issuance costs $ 18,790

As of ~~June 30, 2019, the Company~~March 31, 2020, BMS had four separate revolving credit facilities totaling $6.0 billion, which consisted of a 364-day $2.0 billion facility expiring in January ~~2020,~~2021, a $1.0 billion facility that was renewed to January 2022 and two five-year $1.5 billion facilities that were extended to September 2023 and July 2024, ~~respectively, and a $1.0 billion facility expiring in January 2022. All of these~~respectively. The facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for ~~the Company's~~BMS's commercial paper borrowings. ~~The Company's~~BMS's $1.0 billion facility and ~~the Company's~~its two $1.5 billion revolving facilities are extendable annually by one year on the anniversary date with the consent of the lenders. BMS's 364-day $2.0 billion facility can be renewed for one year on each anniversary date, subject to certain terms and conditions. No borrowings were outstanding under ~~any~~ revolving credit ~~facility~~facilities at ~~June 30, 2019~~March 31, 2020 or December 31, ~~2018.~~

In connection with the Company's pending acquisition of Celgene, the Company entered into a bridge commitment letter that provided for up to $33.5 billion in a 364-day senior unsecured bridge facility in January 2019. The Company also entered into an $8.0 billion term loan credit agreement consisting of a $1.0 billion 364-day tranche, a $4.0 billion three-year tranche and a $3.0 billion five-year tranche. The term loan reduced the commitments under the bridge facility by $8.0 billion and the net cash proceeds from the issuance of $19.0 billion of new notes in May 2019 further reduced the bridge facility commitments. As a result of these reductions and the amount of available cash, the Company terminated the bridge facility in its entirety immediately following the closing of the notes offering. The term loan is subject to customary terms and conditions and does not have any financial covenants. No amounts will be borrowed under the term loan prior to the closing of the pending acquisition of Celgene. If drawn upon, the proceeds under the term loan will be used solely to fund a portion of the cash to be paid in the pending acquisition of Celgene, the anticipated refinancing of debt of Celgene and the payment of related fees and expenses.

Note 10. RECEIVABLES


Dollars in Millions	June 30, 2019			December 31, 2018			March 31, 2020			December 31, 2019
Trade receivables	$	4,822		$	4,914		$	7,660		$	6,888
Less charge-backs and cash discounts	(281		)	(245		)	(437		)	(391		)
Less bad debt allowances	(38		)	(33		)	(23		)	(21		)
Net trade receivables	4,503			4,636			7,200			6,476
Prepaid and refundable income taxes	166			218
Alliance, royalties, VAT and other	998			1,111			1,090			1,209
Receivables	$	5,667		$	5,965		$	8,290		$	7,685

Non-U.S. receivables sold on a nonrecourse basis were ~~$341~~$180 million and ~~$397~~$174 million for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ respectively. Receivables from the ~~Company's three~~3 largest ~~pharmaceutical wholesalers~~customers in the U.S. represented approximately ~~70%~~55% and 50% of total trade receivables at ~~June 30, 2019~~March 31, 2020 and December 31, ~~2018.~~2019, respectively.

Note 11. INVENTORIES


Dollars in Millions	June 30, 2019		December 31, 2018		March 31, 2020		December 31, 2019
Finished goods	$	460	$	396	$	1,283	$	2,227
Work in process	916		1,026		2,651		3,267
Raw and packaging materials	217		202		164		172
Total inventories	$	1,593	$	1,624	$	4,098	$	5,666

Inventories	$	1,308	$	1,195	$	2,836	$	4,293
Other assets^(a)	285		429
Other non-current assets					1,262		1,373


~~(a)~~	~~Other assets include inventory expected to remain on hand beyond one year in both periods.~~

Total inventories include fair value adjustments resulting from the Celgene acquisition of $2.1 billion at March 31, 2020 and $3.5 billion at December 31, 2019. 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, 2019			December 31, 2018			March 31, 2020			December 31, 2019
Land	$	105		$	104		$	194		$	187
Buildings	5,257			5,231			5,848			6,336
Machinery, equipment and fixtures	2,879			2,962			3,055			3,157
Construction in progress	453			548			456			527
Gross property, plant and equipment	8,694			8,845			9,553			10,207
Less accumulated depreciation	(3,845		)	(3,818		)	(3,441		)	(3,955		)
Property, plant and equipment	$	4,849		$	5,027		$	6,112		$	6,252

Depreciation expense was ~~$133~~$170 million and ~~$266~~$133 million for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and $126 million and $239 million for the three and six months ended June 30, 2018,~~ respectively.

~~Note 13. LEASES~~

The Company leases facilities for office, research and development, and for storage and distribution purposes, comprising approximately 90% of the total lease obligation. Lease terms vary based on the nature of operations and the market dynamics in each country; however, all leased facilities are classified as operating leases with remaining lease terms between one and 20 years. Most leases contain specific renewal options for periods ranging between one and 10 years where notice to renew must be provided in advance of lease expiration or automatic renewals where no advance notice is required. Periods covered by an option to extend the lease were included in the non-cancellable lease term when exercise of the option was determined to be reasonably certain. Certain leases also contain termination options that provide the flexibility to terminate the lease ahead of its expiration with sufficient advance notice. Periods covered by an option to terminate the lease were included in the non-cancellable lease term when exercise of the option was determined not to be reasonably certain. Judgment is required in assessing whether renewal and termination options are reasonably certain to be exercised. The Company considers factors such as contractual terms compared to current market rates, leasehold improvements expected to have significant value, costs to terminate a lease and the importance of the facility to the Company’s operations. Costs determined to be variable and not based on an index or rate were not included in the measurement of real estate lease liabilities. As most leases do not provide an implicit rate, the Company's incremental borrowing rate was applied on a portfolio approach to discount its real estate lease liabilities.

The remaining 10% of the Company’s total lease obligation is comprised of vehicles used primarily by the Company’s salesforce and an R&D facility operated by a third party under the Company's direction. Vehicle lease terms vary by country with terms generally between one and four years.

~~The following table summarizes the components of lease expense:~~

Dollars in Millions Three Months Ended June 30, 2019 Six Months Ended June 30, 2019
Operating lease cost $ 28
$ 55
Variable lease cost 4
10
Short-term lease cost 5
10
Sublease income (2 ) (2 )
Total operating lease expense $ 35
$ 73

1716

~~Operating lease right-of-use assets and liabilities were as follows as of June 30, 2019 and January 1, 2019:~~

Dollars in Millions June 30,
2019 January 1,
2019
Other assets $ 509
$ 543

Accrued and other current liabilities 67
40
Other non-current liabilities 516
548
Total liabilities $ 583
$ 588

~~Future lease payments for non-cancellable operating leases as of June 30, 2019 were as follows:~~

Dollars in Millions Operating Leases
2019 (excluding the six months ended June 30, 2019) $ 46
2020 85
2021 75
2022 70
2023 61
Thereafter 395
Total future lease payments 732

Less imputed interest 149
Total lease liability $ 583

Right-of-use assets obtained in exchange for new operating lease obligations were not material for the three and six months ended June 30, 2019. Cash paid for amounts included in the measurement of operating lease liabilities was $19 million for the six months ended June 30, 2019, net of a $33 million lease incentive received in the second quarter. The weighted-average remaining lease term was 11 years and the discount rate was 4% as of June 30, 2019.

Note ~~14.~~13. GOODWILL AND OTHER INTANGIBLE ASSETS


Dollars in Millions	Estimated Useful Lives	June 30, 2019			December 31, 2018			Estimated Useful Lives	March 31, 2020			December 31, 2019
Goodwill(a)		$	6,533		$	6,538			$	22,452		$	22,488

Other intangible assets:
Licenses	5 – 15 years	$	482		$	510		5 – 15 years	482			482
Developed technology rights	9 – 15 years	2,357			2,357
Acquired developed product rights								3 – 15 years	50,427			46,827
Capitalized software	3 – 10 years	1,201			1,156			3 – 10 years	1,263			1,297
IPRD		—			32				15,900			19,500
Gross other intangible assets		4,040			4,055				68,072			68,106
Less accumulated amortization		(3,045		)	(2,964		)		(6,406		)	(4,137		)
Other intangible assets		$	995		$	1,091			$	61,666		$	63,969


(a)	Includes measurement period adjustments. Refer to “—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for more information.

In March 2020, $3.6 billion of IPRD was reclassified to acquired developed product rights upon approval of Zeposia in the U.S. In April 2020, the FDA approved Reblozyl to treat Anemia in adults with lower-risk MDS. As a result, $7.5 billion of IPRD will be reclassed to acquired developed products rights in the second quarter of 2020. Amortization expense of other intangible assets was $2.3 billion and $53 million for the three months ended March 31, 2020 and 2019, respectively.

Note 14. SUPPLEMENTAL FINANCIAL INFORMATION



Dollars in Millions	March 31, 2020		December 31, 2019
Prepaid and refundable income taxes	$	999	$	754
Research and development	445		410
Other	961		819
Other current assets	$	2,405	$	1,983



Dollars in Millions	March 31, 2020		December 31, 2019
Equity investments	$	3,144	$	3,405
Inventories	1,262		1,373
Operating leases	724		704
Pension and postretirement	189		456
Restricted cash^(a)	342		390
Other	285		276
Other non-current assets	$	5,946	$	6,604


(a)	Restricted cash consists of escrow for litigation settlements and funds restricted for annual Company contributions to the defined contribution plan in the U.S. Restricted cash of $429 million was included in cash, cash equivalents and restricted cash at March 31, 2020 in the consolidated statements of cash flows.



Dollars in Millions	March 31, 2020		December 31, 2019
Rebates and returns	$	4,407	$	4,275
Income taxes payable	1,996		1,517
Employee compensation and benefits	678		1,457
Research and development	1,308		1,324
Dividends	1,037		1,025
Interest	393		493
Royalties	328		418
Operating leases	136		133
Other	2,018		1,871
Other current liabilities	$	12,301	$	12,513

~~Amortization expense was $51 million and $104 million for the three and six months ended June 30, 2019 and $47 million and $93 million for the three and six months ended June 30, 2018, respectively.~~

In the first quarter of 2019, a $32 million IPRD impairment charge was recorded in Research and development following our decision to discontinue development of an investigational compound obtained in the acquisition of Medarex. In the first quarter of 2018, a $64 million impairment charge was recorded in Other income (net) for an out-licensed asset obtained in the acquisition of ZymoGenetics, Inc., which did not meet its primary endpoint in a Phase II clinical study.

1817

~~Note 15. ACCRUED AND OTHER CURRENT LIABILITIES~~

Dollars in Millions June 30,
2019 December 31,
2018
Rebates and returns $ 2,633
$ 2,417
Employee compensation and benefits 443
848
Research and development 884
805
Dividends 671
669
Royalties 361
391
Deal contingent forward starting interest rate swap contracts 240
—
Branded Prescription Drug Fee 263
188
Liabilities related to assets held-for-sale 163
152
Litigation and other settlements 80
118
Operating leases 67
—
Restructuring 38
85
Pension and postretirement benefits 35
35
Deferred income 92
172
Income taxes payable 360
398
Other 831
781
Accrued and other current liabilities $ 7,161
$ 7,059



Dollars in Millions	March 31, 2020		December 31, 2019
Income taxes payable	$	5,364	$	5,368
Contingent value rights	2,862		2,275
Pension and postretirement	841		725
Operating leases	688		672
Deferred income	394		424
Deferred compensation	254		287
Other	298		350
Other non-current liabilities	$	10,701	$	10,101

Note ~~16.~~15. EQUITY

The following table summarizes changes in equity for the ~~six~~three months ended ~~June 30, 2019:~~March 31, 2020:

Common Stock
Capital in Excess
of Par Value
of Stock
Accumulated Other Comprehensive Loss
Retained
Earnings
Treasury Stock
Noncontrolling
Interest
Dollars and Shares in Millions Shares Par Value Shares Cost
Balance at December 31, 2018 2,208
$ 221
$ 2,081
$ (2,762 ) $ 34,065
576
$ (19,574 ) $ 96
Accounting change - cumulative effect^(a)
—
—
—
—
5
—
—
—
Adjusted balance at January 1, 2019 2,208
221
2,081
(2,762 ) 34,070
576
(19,574 ) 96
Net earnings —
—
—
—
1,710
—
—
5
Other Comprehensive Income/(Loss) —
—
—
118
—
—
—
—
Cash dividends declared^(b)
—
—
—
—
(671 ) —
—
—
Stock compensation —
—
22
—
—
(4 ) 3
—
Distributions —
—
—
—
—
—
—
(2 )
Balance at March 31, 2019 2,208
$ 221
$ 2,103
$ (2,644 ) $ 35,109
572
$ (19,571 ) $ 99
Net earnings —
—
—
—
1,432
—
—
7
Other Comprehensive Income/(Loss) —
—
—
23
—
—
—
—
Cash dividends declared^(b)
—
—
—
—
(671 ) —
—
—
Stock compensation —
—
47
—
—
—
—
—
Distributions —
—
—
—
—
—
—
(4 )
Balance at June 30, 2019 2,208
$ 221
$ 2,150
$ (2,621 ) $ 35,870
572
$ (19,571 ) $ 102



	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		Capital in Excess of Par Value of Stock			Accumulated Other Comprehensive Loss			Retained Earnings			Shares		Cost			Noncontrolling Interest
Balance at December 31, 2019	2,923	$	292	$	43,709		$	(1,520	)	$	34,474		672		$	(25,357	)	$	100
Net loss	—	—		—			—			(775		)	—		—			9
Other Comprehensive Loss	—	—		—			(29		)	—			—		—			—
Cash dividends declared^(a)	—	—		—			—			(1,028		)	—		—			—
Share repurchase program	—	—		—			—			—			1		(81		)	—
Stock compensation	—	—		(455		)	—			—			(13	)	681			—
Distributions	—	—		—			—			—			—		—			(43		)
Balance at March 31, 2020	2,923	$	292	$	43,254		$	(1,549	)	$	32,671		660		$	(24,757	)	$	66


(a)	Cash dividends declared per common share were $0.45 for the three months ended March 31, 2020.

The following table summarizes changes in equity for the three months ended March 31, 2019:



	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		Capital in Excess of Par Value of Stock		Accumulated Other Comprehensive Loss			Retained Earnings			Shares		Cost			Noncontrolling Interest
Balance at December 31, 2018	2,208	$	221	$	2,081	$	(2,762	)	$	34,065		576		$	(19,574	)	$	96
Accounting change - cumulative effect^(a)	—	—		—		—			5			—		—			—
Adjusted balance at January 1, 2019	2,208	221		2,081		(2,762		)	34,070			576		(19,574		)	96
Net earnings	—	—		—		—			1,710			—		—			5
Other Comprehensive Income	—	—		—		118			—			—		—			—
Cash dividends declared^(b)	—	—		—		—			(671		)	—		—			—
Stock compensation	—	—		22		—			—			(4	)	3			—
Distributions	—	—		—		—			—			—		—			(2		)
Balance at March 31, 2019	2,208	$	221	$	2,103	$	(2,644	)	$	35,109		572		$	(19,571	)	$	99


(a)	Refer to “—Note 1. ~~Basis of Presentation~~Accounting Policies and Recently Issued Accounting Standards” in the Company's 2019 Form 10-K for additional information.


(b)	Cash dividends declared per common share were $0.41 for the three months ended March 31, ~~2019 and June 30,~~ 2019.

~~The following table summarizes changes in equity for the six months ended June 30, 2018:~~

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, 2017 2,208
$ 221
$ 1,898
$ (2,289 ) $ 31,160
575
$ (19,249 ) $ 106
Accounting change - cumulative effect^(a)
—
—
—
(34 ) 332
—
—
—
Adjusted balance at January 1, 2018 2,208
$ 221
$ 1,898
$ (2,323 ) $ 31,492
575
$ (19,249 ) $ 106
Net earnings —
—
—
—
1,486
—
—
9
Other Comprehensive Income/(Loss) —
—
—
89
—
—
—
—
Cash dividends declared^(b)
—
—
—
—
(655 ) —
—
—
Stock repurchase program —
—
—
—
—
3
(166 ) —
Stock compensation —
—
18
—
—
(4 ) (18 ) —
Distributions —
—
—
—
—
—
—
(2 )
Balance at March 31, 2018 2,208
$ 221
$ 1,916
$ (2,234 ) $ 32,323
574
$ (19,433 ) $ 113
Net earnings —
—
—
—
373
—
—
9
Other Comprehensive Income/(Loss) —
—
—
(100 ) —
—
—
—
Cash dividends declared^(b)
—
—
—
—
(652 ) —
—
—
Stock repurchase program —
—
—
—
—
2
(147 ) —
Stock compensation —
—
50
—
—
—
—
—
Distributions —
—
—
—
—
—
—
(21 )
Balance at June 30, 2018 2,208
$ 221
$ 1,966
$ (2,334 ) $ 32,044
576
$ (19,580 ) $ 101


~~(a)~~	~~Refer to “—Note 1. Accounting Policies and Recently Issued Accounting Standards” in the Company's 2018 Form 10-K for additional information.~~


~~(b)~~	~~Cash dividends declared per common share were $0.40 for the three months ended March 31, 2018 and June 30, 2018.~~

~~The Company~~BMS has a ~~stock~~share repurchase program, authorized by its Board of Directors, allowing for repurchases ~~in the open market or through private transactions, including plans established in accordance with Rule 10b5-1 under the Securities Exchange Act~~ of ~~1934, as amended (the “Exchange Act”). The stock repurchase program does not have an expiration date and may be suspended or discontinued at any time.~~its shares. 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 $1.0 billion as of December 31, 2019. In February 2020, the Board of Directors approved an increase of $5.0 billion to the share repurchase authorization for BMS's common stock. BMS repurchased 1.4 million shares of its common stock for $81 million in the first quarter of 2020. The remaining share repurchase capacity under the share repurchase program was approximately $5.9 billion as of March 31, 2020.

2018

The components of Other Comprehensive ~~Income/~~(Loss)/Income were as follows:


	2019									2018									2020									2019
Dollars in Millions	Pretax			Tax			After tax			Pretax			Tax			After tax			Pretax			Tax			After Tax			Pretax			Tax			After Tax
Three Months Ended June 30,
Three Months Ended March 31,
Derivatives qualifying as cash flow hedges:
Unrealized gains/(losses)	$	(6	)	$	1		$	(5	)	$	83		$	(10	)	$	73		$	97		$	(10	)	$	87		$	45		$	(5	)	$	40
Reclassified to net earnings^(a)	(26		)	3			(23		)	13			(1		)	12			(20		)	3			(17		)	(30		)	4			(26		)
Derivatives qualifying as cash flow hedges	(32		)	4			(28		)	96			(11		)	85			77			(7		)	70			15			(1		)	14

Pension and postretirement benefits:
Actuarial (losses)/gains	(12		)	3			(9		)	—			—			—
Actuarial gains/(losses)																			8			(2		)	6			(2		)	—			(2		)
Amortization^(b)	16			(2		)	14			16			(3		)	13			9			(1		)	8			17			(4		)	13
Settlements^(b)	44			(10		)	34			38			(8		)	30			2			—			2			49			(11		)	38
Pension and postretirement benefits	48			(9		)	39			54			(11		)	43			19			(3		)	16			64			(15		)	49

Available-for-sale securities:
Unrealized gains/(losses)	13			—			13			(8		)	1			(7		)
Available-for-sale debt securities:
Unrealized gains																			2			(1		)	1			23			—			23
Realized losses																			—			—			—			3			—			3
Available-for-sale debt securities																			2			(1		)	1			26			—			26

Foreign currency translation	(3		)	2			(1		)	(204		)	(17		)	(221		)	(110		)	(6		)	(116		)	32			(3		)	29

Total Other Comprehensive Income/(Loss)	$	26		$	(3	)	$	23		$	(62	)	$	(38	)	$	(100	)

Six Months Ended June 30,
Derivatives qualifying as cash flow hedges:
Unrealized gains/(losses)	$	39		$	(4	)	$	35		$	45		$	(4	)	$	41
Reclassified to net earnings^(a)	(56		)	7			(49		)	33			(8		)	25
Derivatives qualifying as cash flow hedges	(17		)	3			(14		)	78			(12		)	66

Pension and postretirement benefits:
Actuarial (losses)/gains	(14		)	3			(11		)	112			(24		)	88
Amortization^(b)	33			(6		)	27			36			(6		)	30
Settlements^(b)	93			(21		)	72			69			(15		)	54
Pension and postretirement benefits	112			(24		)	88			217			(45		)	172

Available-for-sale securities:
Unrealized gains/(losses)	36			—			36			(40		)	7			(33		)
Realized losses	3			—			3			—			—			—
Available-for-sale securities	39			—			39			(40		)	7			(33		)

Foreign currency translation	29			(1		)	28			(211		)	(5		)	(216		)

Total Other Comprehensive Income/(Loss)	$	163		$	(22	)	$	141		$	44		$	(55	)	$	(11	)
Other Comprehensive (Loss)/Income																			$	(12	)	$	(17	)	$	(29	)	$	137		$	(19	)	$	118


(a)	Included in Cost of products sold.


(b)	Included in Other ~~income (net).~~expense/(income), net.

The accumulated balances related to each component of Other Comprehensive ~~Income/~~(Loss),/Income, net of taxes, were as follows:


Dollars in Millions	June 30, 2019			December 31, 2018			March 31, 2020			December 31, 2019
Derivatives qualifying as cash flow hedges	$	37		$	51		$	89		$	19
Pension and postretirement benefits	(2,014		)	(2,102		)	(883		)	(899		)
Available-for-sale securities	9			(30		)
Available-for-sale debt securities							7			6
Foreign currency translation	(653		)	(681		)	(762		)	(646		)
Accumulated other comprehensive loss	$	(2,621	)	$	(2,762	)	$	(1,549	)	$	(1,520	)

Note ~~17.~~16. RETIREMENT BENEFITS

The Company sponsors defined benefit pension plans, defined contribution plans and termination indemnity plans for regular full-time employees. The principal defined benefit pension plan is the Bristol-Myers Squibb Retirement Income Plan (the “Plan”), covering most U.S. employees and representing approximately 67% of the consolidated pension plan assets and 61% of the obligations. Future benefits related to service for this plan were eliminated in 2009. BMS contributes at least the minimum amount required by the ERISA. Plan benefits are based primarily on the participant’s years of credited service and final average compensation. As of June 30, 2019, Plan assets consist primarily of fixed-income securities.

In December 2018, BMS announced plans to fully terminate the Plan. Pension obligations related to the Plan of $3.8 billion will be distributed through a combination of lump sum payments to eligible Plan participants who elected such payments and through the purchase of group annuity contracts from wholly owned insurance subsidiaries of Athene Holding Ltd. (“Athene”). The benefit obligation for the Plan as of June 30, 2019 was therefore determined on a plan termination basis and included the obligation attributable to eligible active and deferred vested participants who elected lump sum payments during the election window which will be paid in July 2019. The remaining obligation expected to be transferred to Athene includes an annuity purchase price premium. The Plan has sufficient assets to satisfy all transaction obligations. The transaction is expected to close in the third quarter 2019 and will result in a non-cash pre-tax pension settlement charge of approximately $1.5 billion.

The net periodic benefit ~~cost/(credit)~~cost of defined benefit pension plans includes:


	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Service cost – benefits earned during the year	$	5		$	7		$	12		$	14		$	12		$	7
Interest cost on projected benefit obligation	37			50			81			96			8			44
Expected return on plan assets	(70		)	(109		)	(134		)	(218		)	(23		)	(64		)
Amortization of prior service credits	(1		)	(1		)	(2		)	(2		)	(1		)	(1		)
Amortization of net actuarial loss	17			19			35			40			11			18
Curtailments and settlements	44			38			93			69			2			49
Net periodic pension benefit cost/(credit)	$	32		$	4		$	85		$	(1	)
Net periodic pension benefit cost													$	9		$	53

Pension settlement charges were recognized after determining ~~that~~ the annual lump sum payments will ~~likely~~ exceed the annual interest and service costs for ~~the primary and~~ certain ~~other U.S. and international~~ pension plans. The charges included the acceleration of a portion of unrecognized actuarial losses. Non-current pension liabilities were ~~$423~~$560 million at ~~June 30, 2019~~March 31, 2020 and ~~$427~~$569 million at December 31, ~~2018.~~2019. Defined contribution plan expense in the U.S. was approximately ~~$50~~$85 million and ~~$90~~$40 million for the three ~~and six~~ months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ respectively. Comprehensive medical and group life benefits are provided for substantially all U.S. retirees electing to participate in comprehensive medical and group life plans and to a lesser extent certain benefits for non-U.S. employees. The net periodic benefit credits were not material in both periods.

2219

As a result of the Bristol-Myers Squibb Retirement Income Plan termination in 2019, $381 million of assets held in a separate account within the Pension Trust used to fund retiree medical plan payments was reverted back to the Company, resulting in an excise tax of $76 million in the first quarter of 2020.

Note 17. EMPLOYEE STOCK BENEFIT PLANS

Stock-based compensation expense was as follows:



	Three Months Ended March 31,
Dollars in Millions	2020		2019
Cost of products sold	$	10	$	4
Marketing, selling and administrative	88		30
Research and development	94		19
Other expense/(income), net	18		—
Total stock-based compensation expense	$	210	$	53

Income tax benefit^(a)	$	46	$	10


(a)	Income tax benefit excludes excess tax benefits of $23 million and $2 million from share-based compensation awards that were vested or exercised during the three months ended March 31, 2020 and 2019, respectively.

The total stock-based compensation expense for the three months ended March 31, 2020 includes $123 million related to the Celgene post-combination service period for the replacement awards and $18 million of accelerated vesting of the replacement awards related to the Celgene acquisition. It also includes $9 million related to CVR obligation on unvested stock awards.

The number of units granted and the weighted-average fair value on the grant date for the three months ended March 31, 2020 were as follows:



Units in Millions	Units	Weighted-Average Fair Value
Restricted stock units	12.5	$	53.63
Market share units	0.9	53.88
Performance share units	1.4	55.66



Dollars in Millions	Stock Options		Restricted Stock Units		Market Share Units		Performance Share Units
Unrecognized compensation cost	$	92	$	1,397	$	77	$	135
Expected weighted-average period in years of compensation cost to be recognized	1.9		2.9		3.4		2.1

Note 18. LEGAL PROCEEDINGS AND CONTINGENCIES

~~The Company~~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. The Company recognizes accruals for such contingencies when it is probable that a liability will be incurred and the amount of loss can be reasonably estimated. These matters 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. Legal proceedings that are ~~material~~significant or that ~~the Company~~BMS believes could become significant or material are described below.

~~Although the Company~~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 ~~these~~the matters, ~~there~~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 ~~that~~ any other or future lawsuits, claims, government investigations or other legal proceedings will not be ~~material. Unless otherwise noted, the Company is unable~~material to ~~assess the outcome~~BMS’s financial position, results of ~~the respective litigation nor is it able to provide an estimated range of potential loss.~~operations or cash flows for a particular period. Furthermore, failure to enforce ~~the Company's~~BMS’s patent rights would likely result in substantial decreases in the respective product revenues from generic competition.

~~INTELLECTUAL PROPERTY~~

Plavix* ~~- Australia~~

As previously disclosed, 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. (Apotex), has since changed its name to Apotex. In August 2007, Apotex filed an application in the Federal Court of Australia (the Federal Court) 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 granted Sanofi’s injunction. A subsidiary of the Company 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 Apotex case, and a trial occurred in April 2008. 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. The Company 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 which have stayed the Federal Court’s ruling. Apotex filed a notice of appeal appealing the holding of validity of the clopidogrel bisulfate, hydrochloride, hydrobromide, and taurocholate claims. A hearing on the appeals occurred in February 2009. On September 29, 2009, the Full Court held all of the claims of Patent No. 597784 invalid. In November 2009, the Company and Sanofi applied to the High Court of Australia (High Court) for special leave to appeal the judgment of the Full Court. In March 2010, the High Court denied the Company and Sanofi’s request to hear the appeal of the Full Court decision. The case was remanded to the Federal Court for further proceedings related to damages sought by Apotex. The Company and Apotex have settled the Apotex case, and the case was dismissed. The Australian government has intervened in this matter and is seeking maximum damages up to 449 million AUD ($313 million), plus interest, which would be split between the Company and Sanofi, for alleged losses experienced for paying a higher price for branded Plavix* during the period when the injunction was in place. The Company and Sanofi have disputed that the Australian government is entitled to any damages and the Australian government's claim is still pending and a trial was concluded in September 2017. The Company is expecting a decision in 2019.

~~Sprycel~~ ~~- Europe~~

In May 2013, Apotex, Actavis Group PTC ehf, Generics [UK] Limited (Mylan) and an unnamed company filed oppositions in the EPO seeking revocation of European Patent No. 1169038 (the ‘038 patent) covering dasatinib, the active ingredient in ~~Sprycel~~. On January 20, 2016, the Opposition Division of the EPO revoked the ‘038 patent. In May 2016, the Company appealed the EPO’s decision to the EPO Board of Appeal. In February 2017, the EPO Board of Appeal upheld the Opposition Division’s decision, and revoked the ‘038 patent. Orphan drug exclusivity and data exclusivity for ~~Sprycel~~ ~~in the EU expired in November 2016. The EPO Board of Appeal’s decision does not affect the validity of the Company's other~~ ~~Sprycel~~ patents within and outside Europe, including different patents that cover the monohydrate form of dasatinib and the use of dasatinib to treat CML. Additionally, in February 2017, the EPO Board of Appeal reversed and remanded an invalidity decision on European Patent No. 1610780 and its claim to the use of dasatinib to treat CML, which the EPO’s Opposition Division had revoked in October 2012. In December 2018, the EPO’s Opposition Division upheld the validity of the patent directed to the use of dasatinib to treat CML, which expires in 2024. The Company intends to take appropriate legal actions to protect ~~Sprycel~~.

2320

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 ~~Patent Oppositions and~~ Litigation

In September 2015, Dana-Farber Cancer Institute ~~(Dana-Farber)~~(“Dana-Farber”) filed a complaint in the U.S. District Court for the District of Massachusetts ~~federal court~~ seeking to correct the inventorship on up to ~~six~~6 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, ~~the Company~~BMS settled the lawsuit with Pfizer. A bench trial in the lawsuit with Dana-Farber took place in February 2019. In May 2019, the ~~judge in the case~~Court issued an opinion ruling that the two scientists should be added as inventors to the patents. The decision ~~has been~~was appealed to the Federal Circuit. In June 2019, Dana Farber filed a new lawsuit in the District of Massachusetts against ~~the Company~~BMS seeking damages as a result of the ~~court's~~Court’s decision adding the scientists as inventors. This case has been stayed pending the outcome of BMS’s appeal to the Federal Circuit.

CAR T

On October 18, 2017, the day on which the FDA approved Kite Pharma, Inc.’s (“Kite”) Yescarta* product, Juno, along with Sloan Kettering Institute for Cancer Research (“SKI”), filed a complaint against Kite in the U.S. District Court for the Central District of California. The complaint alleged that Yescarta* 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. The Appeals Court has not yet entered a schedule for the appeal.

Eliquis ~~Patent Litigation~~ - U.S.

In 2017, ~~twenty-five~~BMS received Notice Letters from NaN generic companies ~~sent the Company Paragraph-IV certification letters informing the Company~~notifying BMS that they had filed aNDAs containing paragraph IV certifications seeking approval of generic versions of Eliquis. As a result, ~~two~~2 Eliquis patents listed in the FDA Orange Book are being challenged: the composition of matter patent claiming apixaban specifically and a formulation patent. In ~~April 2017, the Company,~~response, BMS, along with its partner Pfizer, initiated patent ~~lawsuits~~infringement actions under the Hatch-Waxman Act against all generic filers in ~~federal district courts~~the U.S. District Court for the District of Delaware in ~~Delaware and West Virginia.~~April 2017. In August 2017, the U.S. Patent and Trademark Office granted patent term restoration to the composition of matter patent, thereby restoring the term of the Eliquis composition of matter patent, which is ~~the Company’s~~BMS’s basis for projected LOE, from February 2023 to November 2026. ~~The Company has~~BMS settled ~~lawsuits~~ with a number of aNDA ~~filers through March 2019. The~~filers. These settlements do not affect ~~the Company’s~~BMS’s projected LOE for Eliquis. A trial with the remaining aNDA filers took place in late 2019. Post-trial briefing is ~~scheduled~~complete and BMS is expecting a decision in 2020.

Plavix* - Australia

Sanofi was notified that, in August 2007, GenRx Proprietary Limited (“GenRx”) obtained regulatory approval of an application for ~~October 2019~~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 ($276 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. The Australian government can appeal the Federal Court’s decision.

Pomalyst - U.S.

Beginning in 2017, Celgene received Notice letters on behalf of Teva Pharmaceuticals USA, Inc. (“Teva”); Apotex Inc. (“Apotex”) and Apotex Corp.; Hetero Labs Limited, Hetero Labs Limited Unit-V, Hetero Drugs Limited, Hetero USA, Inc. (together, “Hetero”); Aurobindo Pharma Ltd.; Mylan Pharmaceuticals Inc.; and Breckenridge Pharmaceutical, Inc. (“Breckenridge”) 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 ~~Delaware.~~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 first set of 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 the companies asserting a newly-issued patent that is listed in the FDA Orange Book and that covers formulations comprising pomalidomide. In April 2020, Breckenridge filed its answer and counterclaims alleging that the patent is invalid and not infringed. The other companies have not yet submitted any responsive pleading. The Court has consolidated these additional litigations with the first set of litigations. A trial is scheduled to begin in September 2020.

In February and March 2019, Celgene subsequently 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 answer and/or counterclaims alleging that each of these patents is invalid and/or not infringed. In these actions, the Court has ordered that the parties be ready for trial by April 15, 2021.

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. The Court has not set a trial date in this action.

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. DRL has not yet submitted a responsive pleading, and the Court has not set a trial date in this action.

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 and sought an injunction. Natco Canada alleges that the asserted patents are invalid and/or not infringed. The Court has set the trial to begin on November 15, 2021.

Celgene received a Notice of Allegation in March 2020 from Dr. Reddy’s Laboratories Ltd. (“DRL Canada”) notifying Celgene that it had filed an aNDS with Canada’s Minister of Health with respect to certain of Celgene’s Canadian patents. DRL 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 and sought an injunction. DRL Canada alleges that the asserted patents are invalid and/or not infringed. The Court has not set a trial date.

Revlimid - Canada

Celgene received two Notices of Allegation in July 2018 from Natco Canada notifying Celgene of the filing of Natco Canada’s two separate aNDSs 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 Revlimid in Canada. In response, Celgene initiated patent infringement actions in the Federal Court of Canada and sought an injunction. Natco alleges that the asserted patents are invalid and/or not infringed. The trial, which was scheduled to start on March 30, 2020, has been postponed due to COVID-19. The Court has not set a new trial date.

Revlimid - U.S.

Celgene has received Notice Letters on behalf of DRL; Zydus Pharmaceuticals (USA) Inc.; Cipla Ltd., India; Apotex; Sun Pharma Global FZE, Sun Pharma Global Inc., Sun Pharmaceutical Industries, Inc., and Sun Pharmaceutical Industries Limited (“Sun”); Hetero; Mylan Pharmaceuticals Inc., Mylan Inc., and Mylan N.V. (“Mylan”); and Aurobindo Pharma Limited, Eugia Pharma Specialities Limited, Aurobindo Pharma USA, Inc., and Aurolife Pharma LLC 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, some of which have filed answers and/or counterclaims alleging that the asserted patents are invalid and/or not infringed. In a second litigation involving Sun, Sun filed a motion to dismiss, which was denied. Sun has not yet filed a responsive pleading in that second litigation. Mylan has filed a motion to dismiss the District of New Jersey action, and that motion remains pending. 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. In April 2020, Mylan Pharmaceuticals Inc. filed its answer and counterclaims alleging that the patents are invalid, unenforceable and not infringed and Mylan Inc. and Mylan N.V. filed a motion to dismiss.

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 initiated a patent infringement lawsuit under the Hatch-Waxman Act in the U.S. District Court for the District of New Jersey. No trial date has been set. In 2013, BMS entered into a settlement agreement with Apotex regarding a patent infringement suit covering the monohydrate form of dasatinib whereby Apotex can launch its generic dasatinib monohydrate aNDA product in September 2024 or earlier in certain circumstances.

In March 2020, BMS received a Notice Letter from Teva 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 a FDA Orange Book-listed monohydrate form patent expiring in 2026. In response, BMS initiated a patent infringement lawsuit under the Hatch-Waxman Act in the U.S. District Court for the District of New Jersey. No trial date has been set.

PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION

Plavix* State Attorneys General Lawsuits

~~The Company~~BMS and certain ~~affiliates of~~ Sanofi entities are defendants in consumer protection and/or false advertising actions brought by the attorneys general of Hawaii and New Mexico relating to the sales and promotion of Plavix*. The Hawaii matter is currently scheduled for trial in ~~April~~October 2020.

PRODUCT LIABILITY LITIGATION

~~The Company~~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, ~~the Company~~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., approximately 212 cases remain pending on behalf of 218 plaintiffs, who either chose not to participate in the settlement program or filed their claims after the settlement cut-off date. There are nine cases pending in Canada (four class actions, five individual injury claims). Out of the nine cases, only three are active (the class actions in Quebec and Ontario and one individual injury claim). Both class actions have now been certified and will proceed separately.

Byetta*

Amylin, a former subsidiary of ~~the Company,~~BMS, and Lilly are co-defendants in product liability litigation related to Byetta*. To date, there are approximately ~~560~~584 separate lawsuits pending on behalf of approximately ~~2,200~~2,234 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 aan MDL or in a coordinated proceeding in California Superior Court in Los Angeles ~~(JCCP)~~(“JCCP”). In November 2015, the ~~defendants'~~defendants’ motion for summary judgment based on federal preemption was granted in both the MDL and the JCCP. In November 2017, the Ninth Circuit reversed the MDL summary judgment order and remanded the case to the MDL. In November 2018, the California Court of Appeal reversed the state court summary judgment order and remanded those cases to the JCCP for further proceedings. Amylin ~~has~~had product liability insurance covering a substantial number of claims involving Byetta*(which has been exhausted). As part of BMS’s global diabetes business divestiture, BMS sold Byetta* to AstraZeneca in February 2014 and any additional liability to Amylin with respect to Byetta* is expected to be shared ~~between the Company and~~with AstraZeneca.

Abilify*

~~The Company 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 2,000 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 United States District Court for the Northern District of Florida. On February 15, 2019, the Company 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 the various state courts, including California and New Jersey.~~

~~Eliquis~~

~~The Company and Pfizer are co-defendants in product liability litigation related to~~ ~~Eliquis. Plaintiffs assert claims, including claims for wrongful death, as a result of bleeding they allege was caused by their use of~~ ~~Eliquis~~. As of April 2019, no claims remain pending in the MDL in the U.S. District Court for the Southern District of New York or in state court. One case remains pending in Canada. Over 200 cases have been dismissed with prejudice in the MDL. The claims of 23 plaintiffs were appealed to the Second Circuit Court of Appeals, which, in March 2019, affirmed the MDL's dismissals. The plaintiffs did not file a petition for certiorari to the U.S. Supreme Court. This litigation is now concluded.

Onglyza*

~~The Company~~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 2019,~~April 2020, claims are pending in state and federal court on behalf of approximately ~~290~~285 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 ~~the Company’s~~BMS’s global diabetes business divestiture, ~~the Company~~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~~2 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 ~~the Company, the Company’s~~BMS, BMS’s Chief Executive Officer, Giovanni Caforio, ~~the Company’s~~BMS’s Chief Financial Officer at the time, Charles A. Bancroft and certain former and current executives of ~~the Company.~~BMS. The case in California has been voluntarily dismissed. The remaining complaint alleges violations of securities laws for ~~the Company’s~~BMS’s disclosures related to the CheckMate-026 clinical trial in lung cancer. ~~A fully briefed~~In September 2019, the Court granted BMS’s motion to dismiss, ~~is pending before~~but allowed the ~~court. The Company intends~~plaintiffs leave to ~~defend itself vigorously in this litigation.~~file an amended complaint. In October 2019, the plaintiffs filed an amended complaint. BMS has moved to dismiss the amended complaint.

~~OTHER LITIGATION~~Celgene Securities Class Action

~~Acquisition of Celgene Litigation~~

~~Following the announcement of the Company's pending acquisition of Celgene, thirteen complaints~~Beginning in March 2018, two putative class actions were filed by against Celgene ~~shareholders~~ and certain of its officers in the U.S. District Court for the District of ~~Delaware,~~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 (ozanimod). 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. No trial date has been set for the claims that survived the Court’s order.

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 ~~U.S. District Court for~~same allegations as the ~~Southern District of New York and~~Celgene Securities Class Action against the ~~Court of Chancery of the State of Delaware seeking~~same remaining defendants in that action. The Company intends to ~~enjoin the Company's pending acquisition of Celgene. The complaints in~~vigorously defend against these actions name as defendants Celgene and the members of Celgene's Board of Directors. Five of these complaints also name the Company and Burgundy Merger Sub, Inc., a wholly-owned subsidiary of the Company that was formed solely for the purpose of completing the pending acquisition of Celgene and will be merged with and into Celgene upon the completion of the acquisition, as defendants. Of the complaints naming the Company as a defendant, four are styled as putative class actions. The plaintiffs allege violations of various federal securities laws and breaches of fiduciary duties in connection with the acquisition of Celgene by the Company. After the Company and Celgene released supplemental disclosures relating to the proposed acquisition in early April 2019, the plaintiffs in these cases agreed to dismiss their actions. As of June 30, 2019, all of these complaints have been dismissed, including all five complaints that named the Company and Burgundy Merger Sub, Inc. as defendants.claims.

Separately, a fourteenth complaint styled as a putative class action was filed in the Court of Chancery of the State of Delaware on behalf of the Company's shareholders naming members of the Company's Board of Directors as defendants. This complaint alleges that each of the members of the Company's Board of Directors breached his or her fiduciary duties to the Company and its shareholders by failing to disclose material information about the pending acquisition. The lawsuit was voluntarily dismissed in April 2019.

~~Acquisition of Flexus Litigation~~

In February 2015, the Company acquired Flexus including rights to its IDO-1 inhibitor. In September 2015, Incyte Corporation (“Incyte”) sued Flexus and Flexus's founders (“Flexus Defendants”) in the Superior Court of the State of Delaware. In its initial and subsequent amended complaints, Incyte alleged claims against the Flexus Defendants, among others, for the misappropriation of various trade secrets relating to the research and development of Incyte's IDO-1 inhibitor. In November 2018, following a trial, a jury in the Superior Court of Delaware returned a defense verdict for the Flexus Defendants. Incyte did not appeal the decision. This litigation is now concluded.OTHER LITIGATION

Average Manufacturer Price Litigation

~~The Company~~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 ~~the Company~~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. ~~The case is currently scheduled for trial~~In January 2020, BMS reached an agreement in ~~January 2020.~~principle to resolve this matter subject to the negotiation of a definitive settlement agreement and other contingencies. BMS cannot provide assurances that its efforts to reach a final settlement will be successful.

HIV Medication Antitrust Lawsuits

~~The Company~~BMS and several other manufacturers of HIV medications are defendants in related lawsuits brought by indirect purchasers in 2019 and direct purchasers in 2020 in the U.S. District Court for the Northern District of California, and by indirect purchasers in 2020 in the U.S. District Court for the Southern District of Florida, in each case alleging 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 complaints allege additional theories of liability with respect to other defendants. The indirect purchaser complaint filed in Florida has been transferred and consolidated with the matters pending in the Northern District of California. In March 2020, in ruling on the defendants’ motions to dismiss the indirect purchasers’ complaint, the Court granted defendants’ motions to dismiss plaintiffs’ conspiracy claims but otherwise denied the motion to dismiss as to Gilead, BMS, and Janssen. Certain plaintiffs filed an amended complaint in April 2020. A trial is scheduled for February 2022.

Humana Litigations

On May 16, 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 set.

On March 1, 2019, Humana filed a separate lawsuit against Celgene in the U.S. District Court for the District of New Jersey. Humana’s complaint alleges that Celgene violated various antitrust, consumer protection, and unfair competition laws to delay or prevent generic competition for Thalomid and Revlimid brand drugs, including (a) allegedly refusing to sell samples of products to generic manufacturers for purposes of bioequivalence testing intended to be included in aNDAs for approval to market generic versions of these products; (b) allegedly bringing unjustified patent infringement lawsuits, procuring invalid patents, and/or entering into anticompetitive patent settlements; (c) allegedly securing an exclusive supply contract for supply of thalidomide active pharmaceutical ingredient. 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. 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 set.

Thalomid and Revlimid Antitrust Class Action Litigation

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, are seeking injunctive relief and damages. The various lawsuits were consolidated into a master action for all purposes. In October 2017, the plaintiffs filed a motion for certification of two damages classes under the laws of thirteen states and the District of Columbia and a nationwide injunction class. Celgene filed an opposition to the plaintiffs’ motion and a motion for judgment on the pleadings dismissing all state law claims where the plaintiffs no longer seek to represent a class. In October 2018, the Court denied the plaintiffs’ motion for class certification and Celgene’s motion for judgment on the pleadings. In December 2018, the plaintiffs filed a new motion for class certification, which Celgene opposed. In July 2019, the parties reached a settlement under which all the putative class plaintiff claims would be dismissed with prejudice. In December 2019, after certain third-party payors who were members of the settlement class refused to release their potential claims and participate in the settlement, Celgene exercised its right to terminate the settlement agreement. In March 2020, Celgene reached a revised settlement with the class plaintiffs subject to approval by the Court. That settlement does not resolve the claims of certain entities that opted out of the first settlement.

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 the class action litigation. 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. The Company intends to vigorously defend these claims.

GOVERNMENT INVESTIGATIONS

Like other pharmaceutical companies, ~~the Company~~BMS and certain of its subsidiaries are subject to extensive regulation by national, state and local ~~government agencies~~authorities in the U.S. and other countries in which BMS operates. As a result, ~~the Company,~~BMS, from time to time, is subject to various governmental and regulatory inquiries and ~~investigations.~~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, ~~the Company~~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 ~~the Company’s~~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 ~~the Company~~BMS is responsible under various state, federal and foreign laws, ~~the Company~~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 ~~the Company~~BMS accrues liabilities when they are probable and reasonably estimable. ~~The Company~~BMS estimated its share of future costs for these sites to be ~~$66~~$69.4 million at ~~June 30, 2019,~~March 31, 2020, 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.

~~NOTE 19. PENDING CELGENE ACQUISITION~~

On January 3, 2019, the Company announced that it entered into a definitive merger agreement under which it will acquire Celgene. Under the terms of the agreement, which has been approved by the respective Boards of Directors of the Company and Celgene, if the merger is completed, Celgene shareholders will receive one share of the Company's common stock and $50.00 in cash for each share of Celgene common stock held by them. Celgene shareholders will also receive one tradeable contingent value right for each share of Celgene representing the right to receive $9.00 in cash, which is subject to the achievement of future regulatory milestones. Based on the closing price of a share of the Company's common stock on January 2, 2019, the most recent trading day prior to the date of the announcement, the merger consideration represented approximately $74 billion. The amount of consideration to be received by Celgene shareholders will fluctuate with changes in the price of shares of BMS common stock.

The Company expects to fund the anticipated cash portion of the merger consideration through a combination of available cash, including $18.8 billion of net proceeds raised in the May 2019 issuance of new notes, borrowings under the term loan established earlier in the year and short-term borrowings. The Company also expects to enter into an accelerated share repurchase program of approximately $5.0 billion, subject to Board of Directors’ approval. The ultimate amount of shares to be repurchased may change based on company and market factors. See “Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations—Financial Position, Liquidity and Capital Resources” for a discussion of the Company's financing arrangements in connection with the pending acquisition.

The acquisition was approved by the Company’s and Celgene’s shareholders on April 12, 2019. Consummation of the pending acquisition remains subject to the satisfaction of customary closing conditions and regulatory approvals, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), and approvals under the antitrust laws of other jurisdictions. With respect to the review of the pending acquisition pursuant to the HSR Act, the Company and Celgene on March 25, 2019 each received a request for additional information and documentary materials (also known as a “second request”) from the FTC in connection with its review. To allow the pending acquisition to close on a timely basis in light of concerns expressed by the FTC, the Company is planning to divest Otezla*. The planned divestiture will be subject to further review by the FTC and will require the Company to enter into a consent decree with the FTC. Once the FTC accepts the consent order and the other customary closing conditions are satisfied, the Company intends to close the Celgene acquisition at the earliest possible date, which it currently expects to be at the end of 2019 or the beginning of 2020.

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Management’s discussion and analysis of results of operations and financial condition is provided as a supplement to and should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q to enhance the understanding of our results of operations, financial condition and cash flows.

EXECUTIVE SUMMARY

Bristol-Myers Squibb Company is a global ~~specialty~~ biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Our principal strategy is to combine the resources, scale and capability of a pharmaceutical company with the speed and focus on innovation of the biotech industry. Our ~~focus as a specialty~~vision is to be the world's leading biopharmaceutical company ~~is on discovering, developing~~that transforms patients' lives through science in areas where we believe that we have an opportunity to make a meaningful difference: oncology (both solid tumors and ~~delivering transformational medicines for patients facing serious diseases. Our four strategic priorities are to drive business performance,~~hematology), immunology, cardiovascular and fibrosis. We continue to advance the next wave of innovative medicines by investing significantly in our pipeline both internally and through business development activities. For further ~~build a leading franchise~~information on our strategy, see “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations-Executive Summary-Strategy” in ~~IO, maintain a diversified portfolio both within and outside of IO, and continue~~ our disciplined approach to capital allocation, including establishing partnerships, collaborations and in-licensing or acquiring investigational compounds as an essential component of successfully delivering transformational medicines to patients.2019 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.

~~On January 3, 2019, we announced that we entered into a definitive merger agreement to acquire Celgene. The acquisition was approved by our and Celgene’s respective shareholders~~We completed the Celgene transaction on ~~April 12,~~November 20, 2019. We expect that ~~the pending~~our acquisition of Celgene will ~~enable~~further position us ~~to create~~as a leading ~~focused specialty~~ biopharmaceutical company, ~~that is well positioned~~expanding our oncology, hematology and immunology portfolios with several near-term assets and additional external partnerships. Commencing from the acquisition date, BMS's consolidated financial statements include the assets, liabilities, operating results and cash flows of Celgene.

In December 2019, a novel strain of coronavirus (“COVID-19”) emerged and has subsequently expanded to ~~address the needs of patients with cancer, inflammatory, immunologic or cardiovascular diseases through high-value innovation medicines~~a pandemic resulting in significant risks and ~~leading scientific capabilities. The transaction remains subject~~disruptions to the ~~satisfaction~~health and welfare of ~~customary closing conditions~~the global population and ~~regulatory approvals, including review by~~economy. Due to the ~~FTC, but is expected to close~~evolving nature of the COVID-19 situation, we cannot reasonably assess or predict at this time the ~~end~~full extent of ~~2019 or~~ the ~~beginning of 2020. Refer to “Item 1. Financial Statements—Note 19. Pending Celgene Acquisition” for further discussion~~negative impact that the COVID-19 pandemic may have on our ~~pending acquisition~~business, financial condition, results of ~~Celgene.~~operations and cash flows. The impact will depend on future developments such as the ultimate duration and the severity of the spread of the COVID-19 pandemic in the U.S. and globally, the effectiveness of federal, state, local and foreign government actions on mitigation and spread of COVID-19, the pandemic's impact on the U.S. and global economies, changes in our customers' behavior emanating from the pandemic and how quickly we can resume our normal operations, among others. Refer to “—~~Financial Position, Liquidity~~COVID-19 and ~~Capital Resources”~~Market Factors” for ~~a discussion of our financing arrangements in connection with the pending acquisition.~~further information.

Our revenues increased by ~~12%~~82% for the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 as a result of the Celgene acquisition, which contributed $4.2 billion of revenues or 71% of the growth, change in buying patterns resulting from the COVID-19 pandemic and higher demand for Eliquis ~~and~~ ~~Opdivo~~. Changes in buying patterns resulting from the COVID-19 pandemic contributed approximately $500 million of revenues. The ~~$0.79 increase~~$1.38 decrease in GAAP EPS primarily resulted from ~~higher revenues, lower license and asset acquisition charges~~amortization of acquired intangible assets, the unwinding of inventory fair value adjustments, contingent value rights and equity investment ~~losses primarily related to the Nektar collaboration in 2018.~~fair value adjustments, partially offset by higher revenues. After adjusting for specified items, non-GAAP EPS increased ~~$0.34 due to higher revenues.~~$0.62 as a result of the Celgene acquisition.


	Three Months Ended June 30,				Six Months Ended June 30,				Three Months Ended March 31,
Dollars in Millions, except per share data	2019		2018		2019		2018		2020			2019
Total Revenues	$	6,273	$	5,704	$	12,193	$	10,897	$	10,781		$	5,920

Diluted Earnings Per Share
Diluted (Loss)/Earnings Per Share
GAAP	$	0.87	$	0.23	$	1.92	$	1.13	$	(0.34	)	$	1.04
Non-GAAP	1.18		1.01		2.29		1.95		1.72			1.10

Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items ~~which~~that represent certain costs, expenses, gains and losses and other items impacting the comparability of financial results. For a detailed listing of all specified items and further information and reconciliations of non-GAAP financial measures refer to “—Non-GAAP Financial Measures.”

COVID-19 and Market Factors

The COVID-19 pandemic is affecting global healthcare systems as well as major economic and financial markets. Virtually all industries are facing challenges associated with the economic conditions resulting from efforts to address this pandemic. For example, many entities in certain industries have seen sharp declines in revenues due to regulatory and organizational mandates (e.g., “shelter in place” mandates, non-essential business and school closures) and voluntary changes in consumer behavior (e.g., “physical distancing”). As the spread of the pandemic increases, entities are experiencing conditions often associated with a sudden and severe economic downturn, including, but not limited to, financial market volatility and erosion of market value, deteriorating credit, liquidity concerns, further increases in government intervention, increasing unemployment, broad declines in consumer discretionary spending, increasing inventory levels, reductions in production because of decreased demand and supply constraints, layoffs and furloughs, and other restructuring activities.

We currently do not anticipate disruptions to the supply of our medicines for patients due to the COVID-19 pandemic. All of our internal manufacturing facilities and key contract manufacturers are operating with proper measures taken to help ensure employee safety. An appropriate amount of safety stock is maintained based on anticipated needs. We have implemented a number of measures to protect the health and safety of our workforce including a mandatory work-from-home policy for our global workforce who can perform their jobs from home as well as restrictions on business travel, workplace and in-person meetings. Field-based personnel in the U.S. and certain other markets suspended in-person customer interactions in healthcare settings and moved to a remote engagement model to ensure continued support for healthcare professionals, patient care and access to our medicines.

The situation remains dynamic and it is still early to assess the potential impact on our operations such as the ability and willingness of patients to access treatment centers or obtain a prescription and changes in prescribing patterns that may potentially affect our operations in the long-term. We have observed certain changes in buying patterns including payers implementing new policies to encourage larger prescription sizes and earlier refills to help patients avoid trips to the pharmacy and decreased patient office visits. It is uncertain whether these trends will continue in the future. We believe our revenues were higher than previously expected by approximately $500 million in the first quarter of 2020 as a result with Eliquis being the most impacted product. As the U.S. healthcare system is dealing with the unprecedented COVID-19 pandemic, we made the decision to delay commercialization of Zeposia based on what is in the best health interest of our patients, customers and workforce. In contrast, we are making Reblozyl available for MDS patients following its recent approval for this additional indication. The timing of specific product launches will be decided after considering the relevant facts and circumstances for each situation. Our U.S. patient assistance programs were also expanded to provide our branded products for free to eligible patients that have lost employment and health insurance due to COVID-19. It is uncertain what the aggregate impact of the above factors will have on our revenues and expenses during 2020.

The following decisions were taken regarding the conduct of clinical trials to protect the safety of study participants, our employees and staff at clinical trial sites and ensure regulatory compliance and scientific integrity of trial data.

For ongoing studies (i.e. those that have passed First Patient First Visit):

Existing sites can continue to recruit new patients when appropriate

No new sites will be activated until further notice

For new studies (i.e. those that have not yet passed First Patient First Visit):

No sites will be initiated nor activated until further notice

We also temporarily suspended screening, enrollment and apheresis in our cellular therapy clinical trials. The temporary suspension does not impact the ongoing BLA activities with the FDA for idecabtagene vicleucel (ide-cel, bb2121) or lisocabtagene maraleucel (liso-cel, JCAR017). Although the clinical trials that form the basis for these applications have completed enrollment, certain site inspections have not yet occurred and may be delayed. The full impact of the COVID-19 pandemic on our clinical trials is still being assessed. Studies that have not yet completed enrollment may likely be delayed. In addition, research and early development activities performed in laboratories have been temporarily suspended.

The COVID-19 pandemic significantly impacted the financial markets. We incurred downward adjustments to our equity investment fair values of $674 million in the first quarter of 2020 primarily due to the decline in equity prices resulting from the pandemic. Additional charges related to equity investments may occur in the future due to the extreme volatility. There is also a potential adverse impact to our financial results due to the significant strengthening of the U.S. dollar which resulted in lower recorded revenues and foreign currency losses. In addition, lower interest rates may lead to reduction in our previously expected interest income. We also assigned a preliminary value of approximately $64 billion to intangible assets obtained in the Celgene acquisition that closed in November 2019. To the extent that estimated future cash flows are lower than previously expected as a direct or indirect result of the pandemic, including delays in the enrollment or timely completion of clinical programs, FDA site inspections and other interactions with regulatory bodies in general, regulatory approvals, launches of newly approved products or lower demand in general, significant charges might be incurred.

Refer to “Part II—Item 1A. Risk Factors” for an update to the Company's risk factors resulting from the COVID-19 pandemic.

Additional regulations in the U.S. could be passed in the future including additional healthcare reform initiatives, further changes to tax laws, additional pricing laws and potential importation restrictions which may reduce our results of operations, operating cash flow, liquidity and financial flexibility. We continue to monitor the potential impact of the economic conditions in certain European and other countries and the related impact on prescription trends, pricing discounts and creditworthiness of our customers. We believe these economic conditions will not have a material impact on our liquidity, cash flow or financial flexibility.

The UK departed from the EU on January 31, 2020. The departure began a transition period that is set to end on December 31, 2020, during which the UK and the EU will negotiate their future relationship. Similar to other companies in our industry, certain regulatory, trade, labor and other aspects of our business will likely be affected during the transition period and over time. However, we currently do not believe that these matters and other related financial effects will have a material impact on our consolidated results of operations, financial position or liquidity. Our sales in the UK represent less than 3% of our total revenues.

Significant Product and Pipeline Approvals

The following is a summary of the significant approvals received in 2020:



Product	Date	Approval



~~Opdivo+Yervoy~~Reblozyl	~~March 2019~~April 2020	~~Announced conversion of accelerated~~ FDA ~~approval to full FDA approval for~~ ~~Opdivo+Yervoy~~ ~~for first line metatstatic melanoma treatment based on longer follow-up data from CheckMate-067.~~
~~January 2019~~	~~Announced the EC~~ approval of ~~Opdivo~~ ~~plus low-dose~~ ~~Yervoy~~Reblozyl for ~~previously untreated~~the treatment of anemia failing an erythropoiesis stimulating agent in adult patients with ~~intermediate~~very low- to intermediate-risk MDS who have ring sideroblasts and ~~poor-risk advanced RCC.~~require RBC transfusions.



~~Orencia~~Zeposia	~~April 2019~~March 2020	~~Announced the EC~~FDA approval of an extension application to add 2 new strengths of 50 mg and 87.5 mg for solution for injection in a pre-filled syringe (PFS) - in addition to the existing 125 mg strength - for subcutaneous administration, as well as a new indication for ~~Orencia~~Zeposia ~~solution for injection in a PFS~~(ozanimod) 0.92 mg for the treatment of ~~moderate to severe~~adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active ~~polyarticular juvenile idiopathic arthritis in paediatric patients 2 years of age and older.~~secondary progressive disease.



~~Sprycel~~Opdivo+Yervoy	~~February 2019~~March 2020	~~Announced the EC~~FDA approval of ~~Sprycel~~Opdivo~~, in both tablet and powder for oral suspension formulations, in~~+Yervoy combination ~~with chemotherapy~~ for the treatment of ~~pediatric~~HCC in patients who have been previously treated with ~~newly diagnosed Philadelphia chromosome-positive ALL.~~sorafenib.

Refer to “—Product and Pipeline Developments” for all of the developments in our marketed products and late-stage pipeline in ~~2019.~~2020.

Acquisitions, Divestitures, Licensing and Collaboration Arrangements

Acquisitions, divestitures, licensing and collaboration arrangements allow us to focus our resources behind our growth opportunities that drive the greatest long-term value. We are focused on the following core therapeutic areas: oncology, including IO, immunoscience, cardiovascular diseases and fibrosis. In the second quarter of 2019, we provided notice of termination to PsiOxus Therapeutics, Ltd. pertaining to the License and Collaboration agreement for the development of NG-348, an “armed” oncolytic virus in solid tumors. Refer to “Item 1. Financial Statements—Note 3. Alliances” and “—Note 4. Acquisitions, Divestitures, Licensing and Other Arrangements” for further information. Refer to “Item 1. Financial Statements—Note 19. Pending Celgene Acquisition” for further discussion on our pending acquisition of Celgene. Refer to “—Financial Position, Liquidity and Capital Resources” for a discussion of our financing arrangements in connection with the pending acquisition.

RESULTS OF OPERATIONS

Regional Revenues

The composition of the changes in revenues was as follows:


	Three Months Ended June 30,								Six Months Ended June 30,
	Total Revenues				2019 vs. 2018				Total Revenues				2019 vs. 2018				Three Months Ended March 31,				2020 vs. 2019
Dollars in Millions	2019		2018		% Change		Foreign Exchange^(b)		2019		2018		% Change		Foreign Exchange^(b)		2020		2019		% Change		Foreign Exchange^(b)
United States	$	3,667	$	3,230	14	%	—		$	7,116	$	6,008	18	%	—		$	6,766	$	3,449	96	%	—
Europe	1,491		1,408		6	%	(7	)%	2,971		2,814		6	%	(7	)%	2,567		1,480		73	%	(3	)%
Rest of the World	988		923		7	%	(7	)%	1,862		1,796		4	%	(7	)%	1,335		874		53	%	(5	)%
Other^(a)	127		143		(11	)%	N/A		244		279		(13	)%	N/A		113		117		(3	)%	N/A
Total	$	6,273	$	5,704	10	%	(3	)%	$	12,193	$	10,897	12	%	(3	)%	$	10,781	$	5,920	82	%	(1	)%


(a)	Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.


(b)	Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.

U.S. revenues for the three months ended March 31, 2020 were impacted by $2.8 billion from Revlimid and other Celgene products, which contributed 81% of the growth and higher demand for Eliquis. Changes in buying patterns resulting from COVID-19 pandemic contributed approximately $300 million of revenues. Average net selling prices, including Celgene products, increased ~~due to~~3% for the three months ended March 31, 2020.

Europe revenues for the three months ended March 31, 2020 were impacted by $965 million from Celgene products, which contributed 65% of the growth, the change in buying patterns resulting from the COVID-19 pandemic and higher demand for Eliquis and ~~Opdivo. Average U.S. net selling prices were 1% higher after discounts, charge-backs and rebates and are expected to be roughly flat on a full year basis.~~

~~Europe revenues increased due to higher demand for~~ Opdivo ~~and~~ ~~Eliquis~~, partially offset by foreign exchange and lower demand for established ~~brands and lower average~~brands. Average net selling ~~prices.~~prices, including Celgene products, were lower for the three months ended March 31, 2020.

Rest of the World revenues ~~increased due to~~for the three months ended March 31, 2020 were impacted by $477 million from Celgene products, which contributed 55% of the growth, the change in buying patterns resulting from the COVID-19 pandemic and higher demand for Opdivo, and Eliquis~~and~~ ~~Yervoy~~, partially offset by foreign ~~exchange.~~exchange and lower demand for established brands. Average net selling prices, including Celgene products, were lower for the three months ended March 31, 2020.

No single country outside the U.S. contributed more than 10% of total revenues during the ~~six~~three months ended ~~June 30, 2019~~March 31, 2020 or ~~2018.~~2019. Our business is typically not seasonal.

GTN Adjustments

The reconciliation of gross product sales to net product sales by each significant category of GTN adjustments was as follows:


	Three Months Ended June 30,								Six Months Ended June 30,								Three Months Ended March 31,
Dollars in Millions	2019			2018			% Change		2019			2018			% Change		2020			2019			% Change
Gross product sales	$	8,819		$	7,509		17	%	$	16,813		$	14,210		18	%	$	14,686		$	7,994		84	%
GTN adjustments
Charge-backs and cash discounts	(890		)	(663		)	34	%	(1,664		)	(1,246		)	34	%	(1,340		)	(774		)	73	%
Medicaid and Medicare rebates	(1,090		)	(765		)	42	%	(1,890		)	(1,322		)	43	%	(1,498		)	(800		)	87	%
Other rebates, returns, discounts and adjustments	(808		)	(620		)	30	%	(1,515		)	(1,209		)	25	%	(1,307		)	(707		)	85	%
Total GTN adjustments	(2,788		)	(2,048		)	36	%	(5,069		)	(3,777		)	34	%	(4,145		)	(2,281		)	82	%
Net product sales	$	6,031		$	5,461		10	%	$	11,744		$	10,433		13	%	$	10,541		$	5,713		85	%

GTN adjustments percentage	32		%	27		%	5	%	30		%	27		%	3	%	28		%	28		%	—	%
U.S.	39		%	35		%	4	%	38		%	34		%	4	%	34		%	36		%	(2	)%
Non-U.S.	15		%	13		%	2	%	14		%	12		%	2	%	14		%	13		%	1	%

Reductions to provisions for product sales made in prior periods resulting from changes in estimates were ~~$127~~$72 million and ~~$110~~$78 million for the ~~six~~three months ended ~~June 30,~~March 31, 2020 and 2019, ~~and 2018,~~ respectively. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual or legislative discounts and rebates. GTN adjustments ~~are increasing at a higher rate than gross product sales~~percentage remained unchanged primarily due to the addition of Celgene hematology brands which have lower U.S. GTN adjustment percentages, and were partially offset by higher U.S. Eliquis gross product sales, which has a relatively high GTN adjustment percentage as a result of competitive pressures to maintain its position on healthcare payer formularies allowing patients continued access through their medical plans.

2930

Product Revenues

Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions 2019 2018 % Change 2019 2018 % Change
Prioritized Brands
Opdivo $ 1,823
$ 1,627
12 % $ 3,624
$ 3,138
15 %
U.S. 1,112
1,024
9 % 2,236
1,962
14 %
Non-U.S. 711
603
18 % 1,388
1,176
18 %

Eliquis 2,042
1,650
24 % 3,967
3,156
26 %
U.S. 1,269
979
30 % 2,475
1,864
33 %
Non-U.S. 773
671
15 % 1,492
1,292
15 %

Orencia 778
711
9 % 1,418
1,304
9 %
U.S. 566
501
13 % 1,015
886
15 %
Non-U.S. 212
210
1 % 403
418
(4 )%

Sprycel 544
535
2 % 1,003
973
3 %
U.S. 307
310
(1 )% 547
524
4 %
Non-U.S. 237
225
5 % 456
449
2 %

Yervoy 367
315
17 % 751
564
33 %
U.S. 253
228
11 % 528
390
35 %
Non-U.S. 114
87
31 % 223
174
28 %

Empliciti 91
64
42 % 174
119
46 %
U.S. 63
41
54 % 121
78
55 %
Non-U.S. 28
23
22 % 53
41
29 %

Established Brands
Baraclude 147
179
(18 )% 288
404
(29 )%
U.S. 7
9
(22 )% 14
19
(26 )%
Non-U.S. 140
170
(18 )% 274
385
(29 )%

Other Brands 481
623
(23 )% 968
1,239
(22 )%
U.S. 90
138
(35 )% 180
285
(37 )%
Non-U.S. 391
485
(19 )% 788
954
(17 )%

Total Revenues 6,273
5,704
10 % 12,193
10,897
12 %
U.S. 3,667
3,230
14 % 7,116
6,008
18 %
Non-U.S. 2,606
2,474
5 % 5,077
4,889
4 %



	Three Months Ended March 31,
Dollars in Millions	2020		2019		% Change
Prioritized Brands
Revlimid	$	2,915	$	—	N/A
U.S.	1,966		—		N/A
Non-U.S.	949		—		N/A

Eliquis	2,641		1,925		37	%
U.S.	1,777		1,206		47	%
Non-U.S.	864		719		20	%

Opdivo	1,766		1,801		(2	)%
U.S.	1,008		1,124		(10	)%
Non-U.S.	758		677		12	%

Orencia	714		640		12	%
U.S.	500		449		11	%
Non-U.S.	214		191		12	%

Pomalyst/Imnovid	713		—		N/A
U.S.	489		—		N/A
Non-U.S.	224		—		N/A

Sprycel	521		459		14	%
U.S.	300		240		25	%
Non-U.S.	221		219		1	%

Yervoy	396		384		3	%
U.S.	257		275		(7	)%
Non-U.S.	139		109		28	%

Abraxane	300		—		N/A
U.S.	205		—		N/A
Non-U.S.	95		—		N/A

Empliciti	97		83		17	%
U.S.	59		58		2	%
Non-U.S.	38		25		52	%

Reblozyl	8		—		N/A
U.S.	8		—		N/A
Non-U.S.	—		—		N/A

Inrebic	12		—		N/A
U.S.	12		—		N/A
Non-U.S.	—		—		N/A

3031



	Three Months Ended March 31,
Dollars in Millions	2020	2019	% Change
Established Brands
Baraclude	122	141	(13	)%
U.S.	3	7	(57	)%
Non-U.S.	119	134	(11	)%

Vidaza	158	—	N/A
U.S.	2	—	N/A
Non-U.S.	156	—	N/A

Other Brands^(a)	418	487	(14	)%
U.S.	180	90	100	%
Non-U.S.	238	397	(40	)%

Total Revenues	10,781	5,920	82	%
U.S.	6,766	3,449	96	%
Non-U.S.	4,015	2,471	62	%


(a)	Includes BMS and Celgene products in 2020.

Revlimid (lenalidomide)—an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant.

Eliquis (apixaban)— an oral Factor Xa inhibitor targeted at stroke prevention in adult patients with NVAF and the prevention and treatment of VTE disorders.

U.S. revenues increased due to higher demand and the change in buying patterns resulting from the COVID-19 pandemic, partially offset by higher rebates and discounts.

International revenues increased due to higher demand and the change in buying patterns resulting from the COVID-19 pandemic. Excluding foreign exchange impacts, revenues increased by 23% in the first quarter.

Opdivo ~~(nivolumab)~~(nivolumab) — a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells that has been approved for several anti-cancer indications including bladder, blood, colon, head and neck, kidney, liver, lung, melanoma and stomach and continues to be investigated across other tumor types and disease areas.

•

U.S. revenues ~~increased due to higher demand resulting from the second quarter 2018 approval of the~~ ~~Opdivo+Yervoy~~ ~~combination for kidney cancer and increased use in adjuvant melanoma which was approved in December 2017. The lower growth rate in the second quarter 2019 as compared to 2018 was primarily~~decreased due to the timing of the kidney and adjuvant melanoma launches in prior periods in combination with a decline in previously-treated advanced lung cancer. Sequential reduction of revenue in recent quarters is due to lower demand in thesmaller previously-treated advanced lung cancer market and ~~we expect these trends to continue until~~increased competition for the ~~market stabilizes or new indications are approved and launched.~~Opdivo+Yervoy combination in kidney cancer.

International revenues increased due to higher demand as a result of approvals for additional indications and launches in new countries. Excluding foreign exchange impacts, revenues increased by ~~26%~~17% in the ~~second quarter and 28% year-to-date.~~

~~Eliquis(apixaban)~~ ~~— an oral Factor Xa inhibitor targeted at stroke prevention in adult patients with NVAF and the prevention and treatment of VTE disorders.~~

~~U.S. revenues increased due to market share gains within the oral anticoagulants market.~~

International revenues increased due to higher demand attributed to both oral anticoagulant market growth and market share gains. Excluding foreign exchange impacts, revenues increased by 21% in the second quarter and 22% year-to-date.first quarter.

Orencia ~~(abatacept)~~(abatacept) — a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA.

U.S. revenues increased due to higher demand and higher average net selling prices.

International revenues ~~excluding~~increased due to higher demand. Excluding foreign exchange impacts, international revenue increased by 7%16% in the ~~second quarter~~first quarter.

Pomalyst/Imnovid (pomalidomide) — a proprietary, distinct, small molecule that is administered orally and ~~3% year-to-date.~~modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Sprycel ~~(dasatinib)~~(dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib ~~meslylate)~~mesylate).

U.S. revenues ~~decreased in the second quarter~~increased due to ~~retail inventory workdown, partially offset by~~ higher ~~average net selling prices~~demand, the change in buying patterns resulting from the COVID-19 pandemic and ~~increased year-to-date due to~~ higher average net selling prices.

International revenues ~~excluding~~increased due to the change in buying patterns resulting from the COVID-19 pandemic, offset by unfavorable foreign exchange ~~impacts increased by 10% in the second quarter and 7% year-to-date. We may experience a decline in European revenues due to generic competition.~~impacts.

Yervoy ~~(ipilimumab)~~(ipilimumab) — a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma.


•	U.S. revenues ~~increased~~decreased due to ~~higher demand resulting from the second quarter 2018 approval of the~~ ~~Opdivo~~+~~Yervoy~~ ~~combination~~increased competition for ~~kidney cancer.~~


•	~~International revenues increased due to higher demand and from the approval of~~ the Opdivo+Yervoy combination for ~~melanoma and~~ kidney ~~cancer in Japan. Excluding foreign exchange impacts, revenues increased by 39% in the second quarter and 37% year-to-date.~~cancer.

International revenues increased due to higher demand as a result of approvals for additional indications and launches primarily in Europe. Excluding foreign exchange impacts, revenues increased by 32% in the first quarter.

Abraxane (paclitaxel albumin-bound particles for injectable suspension)—a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary nab^® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.

Empliciti ~~(elotuzumab)~~(elotuzumab) — a humanized monoclonal antibody for the treatment of multiple myeloma.

•

~~U.S. revenues increased due to the fourth quarter 2018 approval of~~ ~~Empliciti~~ ~~in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma.~~

International revenues increased due to higher demand.

Inrebic (fedratinib) — an oral kinase inhibitor with activity against wild type and mutationally activated JAK2 and FLT3. In August 2019, the FDA approved Inrebic for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

Reblozyl (luspatercept-aamt) — an erythroid maturation agent indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions and anemia failing an erythropoiesis stimulating agent in adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require RBC transfusions. In November 2019, the FDA approved Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require red blood cell transfusions. In April 2020, the FDA approved Reblozyl to treat Anemia in adults with lower-risk MDS.

Baraclude ~~(entecavir)~~(entecavir) — an oral antiviral agent for the treatment of chronic hepatitis B.

International revenues ~~continued to decrease~~decreased due to lower ~~demand~~average net selling prices resulting from ~~increased~~ generic competition.

Vidaza (azacitidine for injection)—is a pyrimidine nucleoside analog that has been shown to reverse the effects of deoxyribonucleic acid hypermethylation and promote subsequent gene re-expression and is indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and CML.

Other Brands — includes Sustiva, Reyataz, Daklinza and all other products that lost exclusivity in major markets, OTC brands and royalty revenue.

U.S. revenues include $103 million from Celgene products in 2020.

International revenues decreased primarily due to divestiture of the UPSA business and certain other brands and continued generic erosion.

Estimated End-User Demand

Pursuant to the SEC Consent Order described in our ~~2018~~2019 Form 10-K, we monitor inventory levels on hand in the U.S. wholesaler distribution channel and outside of the U.S. in the direct customer distribution channel. We are obligated to disclose products with levels of inventory in excess of one month on hand or expected demand, subject to a de minimis exception. Estimated levels of inventory in the distribution channel in excess of one month on hand for the following products were not material to our results of operations as of the dates indicated. Below are international products that had estimated levels of inventory in the distribution channel in excess of one month on hand at ~~March~~December 31, 2019.

~~Dafalgan~~Perfalgan, an analgesic product, ~~sold principally in Europe,~~ had ~~1.2~~3.2 months of inventory on hand internationally at direct customers compared to ~~1.1~~2.6 months of inventory on hand at ~~December 31, 2018. The level of inventory on hand was primarily due to the ordering patterns of pharmacists in France.~~

~~Efferalgan~~, an analgesic product sold principally in Europe, had 1.7 months of inventory on hand internationally at direct customers compared to 1.4 months of inventory on hand at December 31, 2018. The level of inventory on hand was primarily due to the ordering patterns of pharmacists in France.

~~Fervex~~, a cold and flu product, had 3.1 months of inventory on hand at direct customers compared to 2.5 months of inventory on hand at December 31, 2018. The level of inventory on hand was primarily due to the ordering patterns of pharmacists in France.

~~Perfalgan, an analgesic product, had 2.2 months of inventory on hand internationally at direct customers compared to 1.6 months of inventory on hand at December 31, 2018.~~September 30, 2019. The level of inventory on hand was primarily in the Gulf Countries due to extended delivery lead time.

~~Sustiva~~, an HIV product, had 1.8 months of inventory on hand internationally at direct customers compared to 2.1 months of inventory on hand at December 31, 2018. The level of inventory on hand was attributable to low volume in-market sales in Canada

In the U.S., we generally determine our months on hand estimates using inventory levels of product on hand and the amount of out-movement provided by our three largest wholesalers, which account for approximately ~~97%~~75% of total gross sales of U.S. products. Factors that may influence our estimates include generic competition, seasonality of products, wholesaler purchases in light of increases in wholesaler list prices, new product launches, new warehouse openings by wholesalers and new customer stockings by wholesalers. In addition, these estimates are calculated using third-party data, which may be impacted by their recordkeeping processes.

Revlimidand Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Revlimid REMS and Pomalyst REMS programs, respectively. These are proprietary risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimidand Pomalyst.Internationally, Revlimidand Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the products’ safe and appropriate distribution and use. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies. Abraxane, Inrebic and Vidaza are distributed through wholesaler channel in the U.S. and direct customer distribution channel outside of the U.S.

Our non-U.S. businesses have significantly more direct customers. Information on available direct customer product level inventory and corresponding out-movement information and the reliability of third-party demand information varies widely. We limit our direct customer sales channel inventory reporting to where we can influence demand. When this information does not exist or is otherwise not available, we have developed a variety of methodologies to estimate such data, including using historical sales made to direct customers and third-party market research data related to prescription trends and end-user demand. Given the difficulties inherent in estimating third-party demand information, we evaluate our methodologies to estimate direct customer product level inventory and to calculate months on hand on an ongoing basis and make changes as necessary. Factors that may affect our estimates include generic competition, seasonality of products, price increases, new product launches, new warehouse openings by direct customers, new customer stockings by direct customers and expected direct customer purchases for governmental bidding situations. As such, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. business for the quarter ended ~~June 30, 2019~~March 31, 2020 is not available prior to the filing of this Quarterly Report on Form 10-Q. We will disclose any product with levels of inventory ~~levels~~ in excess of one month on hand or expected demand for the current quarter, subject to a de minimis exception, in the next quarterly report on Form 10-Q.

3234

Expenses


	Three Months Ended June 30,							Six Months Ended June 30,								Three Months Ended March 31,
Dollars in Millions	2019		2018			% Change		2019			2018			% Change		2020		2019			% Change
Cost of products sold(a)	$	1,992	$	1,625		23	%	$	3,836		$	3,209		20	%	$	3,662	$	1,824		**
Marketing, selling and administrative	1,076		1,131			(5	)%	2,082			2,111			(1	)%	1,606		1,006			60	%
Research and development	1,328		2,435			(45	)%	2,679			3,685			(27	)%	2,372		1,348			76	%
Other income (net)	101		(4		)	**		(159		)	(404		)	(61	)%
Amortization of acquired intangible assets																2,282		24			**
Other expense/(income), net																1,163		(261		)	**
Total Expenses	$	4,497	$	5,187		(13	)%	$	8,438		$	8,601		(2	)%	$	11,085	$	3,941		**

** In excess of +/- 100%.

(a) Excludes amortization of acquired intangible assets.

~~Cost of products sold increased due to higher royalties and profit sharing ($196 million in the second quarter and $427 million year-to-date) resulting primarily from~~

•

Cost of products sold increased by approximately $1.8 billion due to unwinding of inventory fair value adjustments of $1.4 billion, higher royalties and Eliquis profit sharing of $376 million and Celgene product costs.~~Eliquis~~ sales, a $109 million impairment charge to reduce the carrying value of assets held-for-sale to the estimated fair value in the second quarter of 2019 and higher product costs, partially offset by foreign exchange.

Marketing, selling and administrative expenses ~~decreased~~increased by approximately $600 million primarily due to ~~foreign exchange impact of 3%.~~

costs associated with the broader portfolio resulting from the Celgene acquisition.

Research and development ~~decreased~~increased by approximately $1.0 billion primarily due to costs associated with the ~~impact of~~broader portfolio resulting from the ~~Nektar upfront payment and other significant charges in 2018.~~

~~Significant charges included in Research and development were as follows:~~

Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions 2019 2018 2019 2018
Nektar $ —
$ 1,050
^(a)
$ —
$ 1,050
^(a)
IFM 25
^(b)
25
^(b)
25
^(b)
25
^(b)
Cormorant —
—
—
60
^(b)
License and asset acquisition charges 25
1,075
25
1,135

IPRD impairments —
—
32
—

Site exit costs 19
19
38
39

Research and development significant charges $ 44
$ 1,094
$ 95
$ 1,174

Celgene acquisition.


~~(a)~~•	~~Upfront payment~~ Amortization of acquired intangible assets increased by $2.3 billion in 2020 as a result of Revlimid, Pomalyst/Imnovid and other marketed product rights obtained in the Celgene acquisition.


~~(b)~~	~~Milestone payment~~

Other expense/(income), net changed by $1.4 billion primarily due to higher interest, restructuring, integration expenses and fair value adjustments to equity investments and contingent value rights as summarized below.

3335

Other income (net) decreased due to Celgene acquisition and integration expenses, lower pension income, lower royalties and licensing income and higher interest expense, partially offset by higher equity investment gains and investment income.

~~Items included in Other income (net) were as follows:~~


	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Interest expense	$	123		$	45		$	168		$	91		$	362		$	45
Pension and postretirement													(4		)	44
Royalties and licensing income													(410		)	(308		)
Divestiture gains													(16		)	—
Acquisition expenses													—			165
Contingent consideration													556			—
Investment income	(119		)	(38		)	(175		)	(74		)	(61		)	(56		)
Equity investment (gains)/losses	(71		)	356			(246		)	341
Integration expenses													174			22
Provision for restructuring	10			37			22			57			160			12
Acquisition expenses	303			—			468			—
Integration expenses	106			—			128			—
Equity investment losses/(gains)													339			(175		)
Litigation and other settlements	—			(1		)	1			(1		)	32			1
Equity in net income of affiliates	—			(27		)	—			(51		)
Divestiture losses/(gains)	8			(25		)	8			(70		)
Royalties and licensing income	(303		)	(353		)	(611		)	(720		)
Transition and other service fees	(2		)	(1		)	(4		)	(5		)	(61		)	(2		)
Pension and postretirement	26			(19		)	70			(30		)
Intangible asset impairment	15			—			15			64
Reversion excise tax													76			—
Other	5			22			(3		)	(6		)	16			(9		)
Other income (net)	$	101		$	(4	)	$	(159	)	$	(404	)
Other expense/(income), net													$	1,163		$	(261	)

Interest expense includes ~~$83 million of~~ interest incurred primarily on the approximately $19.0 billion of ~~new~~ notes issued in May ~~2019.~~

~~Investment income includes $54~~2019 and approximately $19.9 billion of Celgene debt assumed in the acquisition. Interest expense was partially offset by $41 million of ~~interest income earned on the net proceeds~~amortization of the ~~new notes.~~

~~Equity investment (gains)/losses includes a fair value gain~~purchase price adjustment ~~of $118 million related~~attributed to our equity investment in uniQure N.V., $80 million related to the termination of our Europe and Asia partnership with Sanofi in 2019 and a fair value loss adjustment of $407 million related to our equity investment in Nektar in 2018.Celgene's debt.

Acquisition expenses include the following items related to the pending Celgene acquisition: (1) upfront bridge facility commitment fee amortization of $103 million, (2) fair value adjustment of $276 million related to the forward starting interest rate swap option contracts and deal contingent forward starting interest rate swap contracts and (3) financial advisory, legal, proxy filing and other regulatory fees of $89 million.

~~Integration expenses include consulting fees of $128 million incurred in connection with pre-integration planning activities.~~

~~Equity in net income of affiliates was related to our Europe and Asia partnership with Sanofi, which was terminated in 2019.~~

~~Divestiture losses/(gains) includes the divestiture of multiple mature global product lines in 2018.~~


•	~~Royalties and licensing income includes~~ Erbitux* ~~royalties, a $50 million fee for amending a royalty rate, a $25 million sales-based milestone in 2018 and higher~~ ~~Keytruda~~* royalties in 2019.

Pension and postretirement includes the interest cost, expected return on plan assets and amortization components of the net periodic benefit cost (credit) as well as net charges for settlements, curtailments and special termination benefits of ~~$93~~$49 million in 2019.

•

Royalties and licensing income primarily includes diabetes royalties of $127 million in 2020 and $165 million in 2019,Keytruda* royalties of $161 million in 2020 and $120 million in 2019, regulatory milestone of $40 million from Biohaven following the regulatory approval of Nurtec* ODT (rimegepant) and $30 million from ViiV following the acceptance of two regulatory filings in 2020 and out-licensing income of $30 million from Boehringer Ingelheim for the exclusive rights to develop and commercialize BMS's TREM-1 program.

Divestiture gains include a $12 million gain related to the termination of our U.S. and ~~$68~~Puerto Rico partnership with Sanofi in the first quarter of 2020.

Acquisition expenses include the following items related to the Celgene transaction in 2019: (1) upfront bridge facility commitment fee of $67 million, (2) acquisition financing hedge losses of $35 million and (3) financial advisory, legal, proxy filing and other regulatory fees of $63 million.

Contingent consideration includes fair value adjustments of $585 million resulting from an increase in the traded price of contingent value rights issued with the Celgene acquisition, partially offset by $29 million of other fair value adjustments on contingent considerations assumed in the Celgene acquisition.

Integration expenses include consulting fees incurred in connection with Celgene integration activities.

Provision for restructuring includes exit costs primarily related to employee termination benefits and contract terminations. Restructuring charges related to the Celgene transaction were $150 million in ~~2018.~~

~~Intangible asset impairment includes $64~~2020, including $18 million of accelerated vesting of Celgene equity awards. Restructuring charges related to the prior company transformation initiatives were $10 million in ~~2018~~2020 and $12 million in 2019. Refer to “Item 1. Financial Statements—Note 6. Restructuring” for ~~an out-licensed asset obtained~~further information.

Equity investment losses/(gains) includes fair value adjustments. The fair value of equity investments with or without readily determinable fair values in 2020 were significantly impacted by changes in market conditions primarily caused by the ~~acquisition~~COVID-19 pandemic resulting in downward adjustments of ~~ZymoGenetics,~~$674 million, partially offset by observable upward adjustments of $335 million including $253 million attributed to our investment in Acceleron Pharma, Inc.~~, which did not meet its primary endpoint~~ In addition, $80 million of income was related to the termination of our Europe and Asia partnership with Sanofi in ~~a Phase II clinical study.~~2019.


•	Transition and other service fees include fees of $52 million in the first quarter of 2020 resulting from the divestiture of Otezla*.

Reversion excise tax resulted from the transfer of the retiree medical plan assets back to the Company. Refer to “Item 1. Financial Statements—Note 16. Retirement Benefits” for further information.

Income Taxes


	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Earnings Before Income Taxes	$	1,776		$	517		$	3,755		$	2,296
(Loss)/Earnings Before Income Taxes													$	(304	)	$	1,979
Provision for Income Taxes	337			135			601			419			462			264
Effective Tax Rate	19.0		%	26.1		%	16.0		%	18.2		%	(152.0		)%	13.3		%

Impact of Specified Items	0.5		%	8.6		%	(0.6		)%	0.9		%	(168.0		)%	(1.2		)%
Effective Tax Rate Excluding Specified Items													16.0		%	14.5		%

The ~~reduction in the effective~~ tax ~~rate~~impact attributed to specified items was primarily due to a non-deductible contingent value rights charges, valuation allowance on equity investment fair value ~~loss adjustment relating~~adjustments and low jurisdictional tax rates attributed to ~~Nektar~~inventory and intangible asset purchase price adjustments in the ~~second quarter~~three months ended March 31, 2020. The effective tax rate excluding specified items increased by 1.4% primarily due to the recognition of ~~2018.~~prior period tax credits in 2019. Refer to “Item 1. Financial Statements—Note 7. Income Taxes” for additional information on the tax impact of specified items.

Non-GAAP Financial Measures

Our non-GAAP financial measures, such as non-GAAP earnings and related EPS information, are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods including (1) amortization of acquired intangible assets beginning in the fourth quarter of 2019, including product rights that generate a significant portion of our ongoing revenue and will recur until the intangible assets are fully amortized, (2) unwind of inventory fair value adjustments, (3) acquisition and integration expenses, ~~(2)~~(4) restructuring costs, ~~(3)~~(5) accelerated depreciation and impairment of property, plant and equipment and intangible assets, ~~(4)~~(6) R&D charges or other income resulting from ~~up-front~~upfront or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, ~~(5)~~(7) costs of acquiring a priority review voucher, (8) divestiture gains or losses, ~~(6)~~(9) stock compensation resulting from accelerated vesting of Celgene awards and certain retention-related compensation charges related to the Celgene transaction, (10) pension, legal and other contractual settlement charges, ~~(7)~~(11) interest expense on the ~~new~~ notes issued in May 2019 ~~in connection with~~prior to our ~~pending acquisition of~~ Celgene transaction and interest income earned on the net proceeds of those notes, (12) equity investment and ~~(8)~~contingent value rights fair value adjustments and (13) amortization of fair value adjustments of debt ~~redemption gains or losses,~~acquired from Celgene in our 2019 exchange offer, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Certain other significant tax items are also excluded such as the impact of the U.S. tax reform. We also provide international revenues for our priority products excluding the impact of foreign exchange. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in Exhibit 99.2 to our Form 8-K filed on ~~July 25, 2019~~May 7, 2020 and are incorporated herein by reference.

Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and ~~investors~~investors' overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with ~~GAAP.~~GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Amortization of acquired intangible assets were previously included in non-GAAP earnings and EPS information. These amounts have become significant to the financial results subsequent to the Celgene acquisition and as a result, have been excluded in the non-GAAP results to better reflect our core operating performance. Comparable prior period non-GAAP results have not been revised to include this adjustment as the related amounts were insignificant ($24 million for the three months ended March 31, 2019).

3537

Specified items were as follows:


	Three Months Ended June 30,						Six Months Ended June 30,						Three Months Ended March 31,
Dollars in Millions	2019			2018			2019			2018			2020			2019
Impairment charges	$	109		$	—		$	109		$	10
Accelerated depreciation and other shutdown costs	30			14			42			17
Inventory purchase price accounting adjustments													$	1,420		$	—
Employee compensation charges													2			—
Site exit and other costs													16			12
Cost of products sold	139			14			151			27			1,438			12

Employee compensation charges													15			—
Site exit and other costs													6			1
Marketing, selling and administrative	—			—			1			1			21			1

License and asset acquisition charges	25			1,075			25			1,135			25			—
IPRD impairments	—			—			32			—			—			32
Site exit costs and other	19			19			38			39
Inventory purchase price accounting adjustments													17			—
Employee compensation charges													18			—
Site exit and other costs													56			19
Research and development	44			1,094			95			1,174			116			51

Interest expense	83			—			83			—
Investment income	(54		)	—			(54		)	—
Equity investment (gains)/losses	(71		)	356			(246		)	341
Amortization of acquired intangible assets													2,282			—

Interest expense^(a)													(41		)	—
Pension and postretirement													—			49
Royalties and licensing income													(83		)	—
Divestiture gains													(16		)	—
Acquisition expenses													—			165
Contingent consideration													556			—
Integration expenses													174			22
Provision for restructuring	10			37			22			57			160			12
Acquisition expenses	303			—			468			—
Integration expenses	106			—			128			—
Divestiture losses/(gains)	8			(25		)	8			(68		)
Royalties and licensing income	—			(25		)	—			(75		)
Pension and postretirement	44			37			93			68
Intangible asset impairment	—			—			—			64
Other income (net)	429			380			502			387
Equity investment losses/(gains)													339			(175		)
Reversion excise tax													76			—
Other expense/(income), net													1,165			73

Increase to pretax income	612			1,488			749			1,589			5,022			137

Income taxes on items above	(105		)	(218		)	(148		)	(226		)	(291		)	(43		)
Income taxes attributed to U.S. tax reform	—			3			—			(29		)
Income taxes	(105		)	(215		)	(148		)	(255		)

Increase to net earnings	$	507		$	1,273		$	601		$	1,334		$	4,731		$	94


(a)	Includes amortization of purchase price adjustments to Celgene debt.

The reconciliations from GAAP to Non-GAAP were as follows:

Three Months Ended June 30, Six Months Ended June 30,
Dollars in Millions, except per share data 2019 2018 2019 2018
Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP $ 1,432
$ 373
$ 3,142
$ 1,859
Specified Items 507
1,273
601
1,334
Net Earnings Attributable to BMS used for Diluted EPS Calculation – Non-GAAP $ 1,939
$ 1,646
$ 3,743
$ 3,193

Average Common Shares Outstanding – Diluted 1,637
1,636
1,637
1,638

Diluted EPS Attributable to BMS – GAAP $ 0.87
$ 0.23
$ 1.92
$ 1.13
Diluted EPS Attributable to Specified Items 0.31
0.78
0.37
0.82
Diluted EPS Attributable to BMS – Non-GAAP $ 1.18
$ 1.01
$ 2.29
$ 1.95



	Three Months Ended March 31,
Dollars in Millions, except per share data	2020			2019
Net (Loss)/Earnings Attributable to BMS Used for Diluted EPS Calculation – GAAP	$	(775	)	$	1,710
Specified Items	4,731			94
Net Earnings Attributable to BMS Used for Diluted EPS Calculation – Non-GAAP	$	3,956		$	1,804

Weighted-Average Common Shares Outstanding – Diluted – GAAP	2,258			1,637
Incremental Shares Attributable to Share-Based Compensation Plans	40			—
Weighted-Average Common Shares Outstanding – Diluted	2,298			1,637

Diluted (Loss)/Earnings Per Share Attributable to BMS – GAAP	$	(0.34	)	$	1.04
Diluted EPS Attributable to Specified Items	2.06			0.06
Diluted EPS Attributable to BMS – Non-GAAP	$	1.72		$	1.10

3638

FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES

Our net ~~cash~~debt position was as follows:


Dollars in Millions	June 30, 2019			December 31, 2018			March 31, 2020			December 31, 2019
Cash and cash equivalents	$	28,404		$	6,911		$	15,817		$	12,346
Marketable securities – current	953			1,973
Marketable securities – non-current	994			1,775
Total cash, cash equivalents and marketable securities	30,351			10,659
Marketable debt securities – current							2,505			3,047
Marketable debt securities – non-current							651			767
Total cash, cash equivalents and marketable debt securities							18,973			16,160
Short-term debt obligations	(545		)	(1,703		)	(3,862		)	(3,346		)
Long-term debt	(24,433		)	(5,646		)	(42,844		)	(43,387		)
Net cash position	$	5,373		$	3,310
Net debt position							$	(27,733	)	$	(30,573	)

~~Cash, cash equivalents~~We assess our anticipated working capital needs, debt and ~~marketable securities held~~leverage levels, debt maturities, capital expenditure requirements, dividend payouts, potential share repurchases and future investments or acquisitions in ~~the U.S. increased~~order to ~~approximately $28.5 billion at June 30, 2019 due~~maximize shareholder return, efficiently finance our ongoing operations and maintain flexibility for future strategic transactions. We also evaluate our capital structure to ensure financial risks are efficiently managed, adequate liquidity access and lower cost of capital, which may lead to the ~~$18.8 billion~~repurchase of ~~net proceeds from the notes~~common stock, debt securities and contingent value rights issued in ~~May 2019. The net proceeds were invested in money market funds and will be used to fund a portion of the cash consideration for~~connection with the Celgene ~~acquisition.~~transaction prior to maturity or the issuance of additional debt securities. We believe that our existing cash, cash equivalents and marketable debt securities together with cash generated from operations and, if required, from the issuance of commercial paper ~~in the U.S., as well as borrowing available under our credit facilities,~~ will be sufficient to satisfy our anticipated ~~operating~~ cash needs for at least the next few years, including dividends, capital expenditures, milestone payments, working capital, ~~and~~restructuring initiations, business development, deemed repatriation transition ~~tax. In addition, we expect~~tax and approximately $9.5 billion of debt maturing through 2022 and contingent value right payments of approximately $6.8 billion in 2021.

During the first quarter 2020, cash, cash equivalents and marketable debt securities held in the U.S. increased by approximately $700 million to approximately $14.3 billion. Our long-term debt obligations due over the next five years of approximately $17.1 billion are expected to be funded by cash generated from operating activities and our ability to refinance debt. We continue to make capital expenditures in connection with our expansion of our manufacturing capabilities and other facility-related activities.

We have ~~sufficient cash available~~a share repurchase program authorized by our Board of Directors allowing for repurchases of our shares. The specific timing and ~~borrowing capacity~~number of shares repurchased will be determined by our management at its discretion and will vary based on market conditions, securities law limitations and other factors. The share repurchase program does not obligate us to ~~fund the aggregate cash portion~~repurchase any specific number of ~~the merger consideration to Celgene shareholders. We anticipate funding the cash consideration for the Celgene acquisition~~shares, does not have a specific expiration date and may be suspended or discontinued at any time. The repurchases may be effected through a combination of ~~available cash, borrowings~~one or more open market repurchases, privately negotiated transactions, transactions structured through investment banking institutions and other derivative transactions, including through transactions in compliance with Rule 10b-18 under the ~~term loan established earlier in~~Exchange Act and Rule 10b5-1 trading plans. The remaining share repurchase authority authorization under the ~~year and short-term borrowings.~~

~~Management continuously evaluates~~program was $1.0 billion as of December 31, 2019. Our Board of Directors approved an increase of $5.0 billion to the share repurchase authorization for our ~~capital structure to ensure that we are financed efficiently, which may result in the repurchase of~~ common stock ~~and debt securities, termination of interest rate swap contracts prior to maturity and issuance of debt securities. We announced that~~ in ~~connection with~~February 2020, increasing the ~~pending acquisition of Celgene we expect to enter into an accelerated~~total outstanding share repurchase ~~program~~authorization to approximately $6.0 billion. We repurchased 1.4 million shares of our common stock for $81 million during the three months ended March 31, 2020 reducing the remaining share repurchase capacity to approximately ~~$5.0~~$5.9 billion ~~which is subject to Board~~as of ~~Directors’ approval. The ultimate amount of shares to be repurchased may change based on company and market factors.~~March 31, 2020.

Dividend payments were ~~$1.3~~$1.0 billion in the ~~six~~three months ended ~~June 30, 2019 and 2018.~~March 31, 2020. Dividends declared per common share were ~~$0.82 and $0.80~~$0.45 in the ~~six~~three months ended ~~June 30,~~March 31, 2020. Annual capital expenditures were approximately $800 million in 2019 and ~~2018, respectively.~~are expected to be approximately $900 million in 2020 and $1.3 billion in 2021. Dividend decisions are made on a quarterly basis by our Board of Directors. ~~The merger agreement prohibits us~~

Under our commercial paper program, we may issue a maximum of $5 billion unsecured notes that have maturities of not more than 366 days from ~~declaring, setting aside or paying any dividend or other distribution other than our regular cash dividend~~the date of issuance. There were no commercial paper borrowings outstanding as of March 31, 2020.

As of March 31, 2020, we had four revolving credit facilities totaling $6.0 billion, which consisted of a 364-day $2.0 billion facility expiring in ~~the ordinary course of business consistent with past practice in an amount not to exceed $0.41 per share per quarter. Annual capital expenditures were approximately~~January 2021, a $1.0 billion facility expiring in ~~2018~~January 2022 and ~~are expected~~two five-year $1.5 billion facilities that were extended to September 2023 and July 2024, respectively. The facilities provide for customary terms and conditions with no financial covenants and may be ~~approximately $800 million in 2019 and $600 million in 2020. We continue~~used to expand our biologics manufacturing capabilities and other facility-related activities. For example, we are constructing a new large-scale biologics manufacturing facility in Ireland that will produce multiple therapiesprovide backup liquidity for our ~~growing biologics portfolio when approved~~commercial paper borrowings. Our $1.0 billion facility and our two $1.5 billion revolving facilities are extendable annually by one year on the anniversary date with the consent of the lenders. Our 364-day $2.0 billion facility can be renewed for ~~commercial use in early 2020.~~one year on each anniversary date, subject to certain terms and conditions. No borrowings were outstanding under revolving credit facilities at March 31, 2020 and December 31, 2019.

Our investment portfolio includes non-current marketable debt securities, which are subject to changes in fair value as a result of interest rate fluctuations and other market factors. Our investment policy establishes limits on the amount and time to maturity of investments with any institution. The policy also requires that investments are only entered into with corporate and financial institutions that meet high credit quality standards. Refer to “Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements” for further information.

Under our commercial paper program, we may issue a maximum of $5 billion unsecured notes that have maturities of not more than 366 days from the date of issuance. There were no commercial paper borrowings outstanding as of June 30, 2019.

As of June 30, 2019, we had four revolving credit facilities totaling $6.0 billion, which consisted of a 364-day $2.0 billion facility expiring in January 2020, two five-year $1.5 billion facilities that were extended to September 2023 and July 2024, respectively, and a $1.0 billion facility expiring in January 2022. All of these facilities provide for customary terms and conditions with no financial covenants and may be used to provide backup liquidity for our commercial paper borrowings. Our $1.0 billion facility and our two $1.5 billion revolving facilities 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, 2019 and December 31, 2018.

In connection with our pending acquisition of Celgene, we entered into a bridge commitment letter that provided for up to $33.5 billion in a 364-day senior unsecured bridge facility in January 2019. We also entered into an $8.0 billion term loan credit agreement consisting of a $1.0 billion 364-day tranche, a $4.0 billion three-year tranche and a $3.0 billion five-year tranche. The term loan reduced the commitments under the bridge facility by $8.0 billion and the net cash proceeds from the issuance of $19.0 billion of new notes in May 2019 further reduced the bridge facility commitments. As a result of these reductions and the amount of available cash, we terminated the bridge facility in its entirety. The term loan is subject to customary terms and conditions and does not have any financial covenants. No amounts will be borrowed under the term loan prior to the closing of the pending acquisition of Celgene. If drawn upon, the proceeds under the term loan will be used solely to fund a portion of the cash to be paid in the pending acquisition of Celgene, the anticipated refinancing of debt of Celgene and the payment of related fees and expenses.

In April 2019 we commenced an exchange offer for any and all outstanding notes issued by Celgene for up to $19.85 billion aggregate principal amount of new notes to be issued by us and cash. In conjunction with the offer to exchange the Celgene notes, we concurrently solicited consents to adopt certain proposed amendments to each of the indentures governing the Celgene notes to eliminate substantially all of the restrictive covenants in such indentures. In May 2019, we announced that the requisite number of consents had been received to adopt the proposed amendments with respect to all Celgene notes and that Celgene executed supplemental indentures to the Celgene indentures implementing the amendments, which were effective upon execution but will only become operative upon the settlement of the exchange offer and consent solicitations. As of July 18, 2019, approximately 89% of the total aggregate principal amount of Celgene notes have been validly tendered for notes to be issued by us since the exchange offer was commenced. The exchange offer and consent solicitations are conditioned upon the closing of the pending Celgene acquisition and we expect to extend the expiration of the offer and consent solicitations until the acquisition closes.

In May 2019 we issued an aggregate principal amount of $19.0 billion of floating rate and fixed rate unsecured senior notes at maturities ranging from 18 months to 30 years. The net proceeds will be used to fund a portion of the aggregate cash portion of the merger consideration to be paid to Celgene shareholders and to pay related fees and expenses. Any remaining proceeds may be used by us for general corporate purposes. Interest is payable semi-annually in the case of the fixed rate notes and quarterly in the case of the floating rate notes. The notes rank equally in right of payment with all of our existing and future senior unsecured indebtedness and the fixed rate notes are redeemable at any time, in whole, or in part, at varying specified redemption prices plus accrued and unpaid interest. All of the notes are subject to special mandatory redemption at a redemption price equal to 101% of the aggregate principal amount of the notes plus accrued and unpaid interest if the pending acquisition of Celgene is not completed by July 30, 2020 or we inform the trustee of the notes that we will not pursue the consummation of the Celgene acquisition.

Following the announcement of our pending acquisition of Celgene, we entered into forward starting interest rate swap option contracts, with a total notional value of $7.6 billion, to hedge future interest rate risk associated with the anticipated issuance of long-term debt to fund the acquisition. The forward starting interest rate swap option contracts were terminated in April 2019. Subsequently, we entered into deal contingent forward starting interest rate swap contracts, with an aggregate notional principal amount of $10.4 billion, to hedge future interest rate risk associated with the anticipated issuance of long-term debt to fund the pending Celgene acquisition. The deal contingent forward starting interest rate swap contracts were unwound upon our May 2019 issuance of the new notes.

The UK voted to depart from the EU during June 2016. Similar to other companies in our industry, certain regulatory, trade, labor and other aspects of our business will likely be affected over time. However, we currently do not believe that these matters and other related financial effects will have a material impact on our consolidated results of operations, financial position or liquidity. Our sales in the UK represent less than 3% of our consolidated revenues.

Credit Ratings

BMS's current long-term and short-term credit ratings assigned by Moody's Investors Service are A2 and Prime-1, respectively, with a negative long-term credit outlook, and BMS's current long-term and short-term credit ratings assigned by Standard & Poor's are A+ and A-1+, respectively. The long-term ratings reflect the agencies' opinion that we have a low default risk but are somewhat susceptible to adverse effects of changes in circumstances and economic conditions. The short-term ratings reflect the agencies' opinion that we have good to extremely strong capacity for timely repayment. The current long-term ratings do not reflect any impact from the pending acquisition of Celgene. In January 2019, Moody's placed BMS under review for downgrade and Standard & Poor's placed BMS on CreditWatch with negative implications, each following the announcement to acquire Celgene. We expect our credit ratings to remain at an investment grade level and we do not expect the changes to impact our ability to access short-term or long-term financing. However, we cannot guarantee the future actions of Moody's and/or Standard & Poor's. Any credit rating downgrade may affect the interest rate of any debt we may incur, the fair market value of existing debt and our ability to access the capital markets generally.

Cash Flows

The following is a discussion of cash flow activities:


	Six Months Ended June 30,					Three Months Ended March 31,
Dollars in Millions	2019		2018			2020			2019
Cash flow provided by/(used in):
Operating activities	$	3,473	$	2,232		$	3,894		$	1,390
Investing activities	1,775		(391		)	653			1,060
Financing activities	16,239		(2,237		)	(1,054		)	(2,029		)

Operating Activities

Cash flow from operating activities represents the cash receipts and disbursements from all of our activities other than investing and financing activities. Operating cash flow is derived by adjusting net earnings for noncontrolling interest, non-cash operating items, gains and losses attributed to investing and financing activities and changes in operating assets and liabilities resulting from timing differences between the receipts and payments of cash and when the transactions are recognized in our results of operations. As a result, changes in cash from operating activities reflect the timing of cash collections from customers and alliance partners; payments to suppliers, alliance partners and employees; customer discounts and rebates; and tax payments in the ordinary course of business. For example, annual employee bonuses are typically paid in the first quarter of the subsequent year. In addition, cash collections continue to be impacted by longer payment terms for certain biologic products in the U.S., primarily our newer oncology products including Opdivo, Yervoy and Empliciti ~~(90 days)~~(75 days in 2020 and 90 days in 2019). The longer payment terms are used to more closely align with the insurance reimbursement timing for physicians and cancer centers following administration to the patients.

The ~~$1.2~~$2.5 billion change in cash flow from operating activities compared to ~~2018~~2019 was primarily attributable ~~to:~~

~~Lower R&D licensing and collaboration payments of approximately $1.1 billion primarily due~~ to ~~the Nektar transaction in 2018; and~~

~~Higher~~higher cash collections and timing of payments in the ordinary course of business of approximately ~~$900 million.~~

~~Partially~~$2.9 billion, including $2.5 billion relating to Celgene, offset ~~by:~~

~~Higher income tax~~by higher interest payments of approximately ~~$500 million;~~$400 million in connection with the issuance of notes in May 2019 and

~~Approximately $300 million of~~ debt assumed in connection with the Celgene ~~acquisition and integration related payments in 2019.~~acquisition.

Investing Activities

Cash requirements from investing activities include cash used for acquisitions, manufacturing and facility-related capital expenditures and purchases of marketable debt securities with original maturities greater than 90 days at the time of purchase reduced by proceeds from business divestitures (including royalties) and the sale and maturity of marketable debt securities.

The ~~$2.2 billion~~$407 million change in cash flow from investing activities compared to ~~2018~~2019 was primarily attributable to ~~higher net sales and maturities~~a change in the amount of marketable debt securities with maturities greater than 90 days of approximately $1.2 billion and lower net acquisition and other payments of approximately $1.1 billion primarily due to the purchase of Nektar common stock and Flexus contingent consideration payment in 2018.held.

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Financing Activities

Cash requirements from financing activities include cash used to pay dividends, repurchase common stock and repay long-term debt and other borrowings reduced by proceeds from the exercise of stock options and issuance of long-term debt and other borrowings.

The ~~$18.5~~$1.0 billion change in cash flow from financing activities compared to ~~2018~~2019 was primarily due to debt maturities of $1.3 billion in the first quarter of 2019, partially offset by higher net borrowing activity of approximately $18.2 billion resulting from the issuance of new notes in connection with the pending acquisition of Celgene and lower repurchase of common stock of approximately $300 million in 2018.dividend payments.

Product and Pipeline Developments

Our R&D programs are managed on a portfolio basis from early discovery through late-stage development and include a balance of early-stage and late-stage programs to support future growth. Our late stage R&D programs in Phase III development include both investigational compounds for initial indications and additional indications or formulations for marketed products. ~~Spending on these programs represent approximately 35-45% of our annual R&D expenses in the last three years.~~ ~~Opdivo~~ was the only investigational compound or marketed product that represented greater than 10% of our R&D expenses in the last three years. Our late-stage development programs could potentially have an impact on our revenue and earnings within the next few years if regulatory approvals are obtained and products are successfully commercialized. The following are the developments in our marketed products and our late-stage pipeline:



Product	Indication	Date	Developments



Revlimid	Lymphoma	February 2020	Received supplemental Japan NDA approval for Revlimid in relapsed or refractory follicular lymphoma and marginal zone lymphoma.



Opdivo	CRC	February 2020	Ono, our alliance partner for Opdivo in Japan, announced that Japan's MHLW approved Opdivo for the treatment of patients with MSI-H unresectable advanced or recurrent CRC that has progressed following chemotherapy. The approval was based on the the result from Opdivo monotherapy cohort of a multi-center, open-label Phase II CheckMate-142 study conducted by BMS, evaluating Opdivo in patients with HSI-H or mismatch repair deficient recurrent or metastatic CRC that has progressed on or after, or been intolerant of prior treatment with chemotherapy including fluoropyrimidine anticancer drugs.
	ESCC	February 2020	Announced that Japan’s MHLW approved Opdivo for the treatment of patients with unresectable advanced or recurrent ESCC that has progressed following chemotherapy. The approval was based on the Phase III ATTRACTION-3 trial conducted by Ono in collaboration with BMS, which evaluated Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent ESCC refractory or intolerant to combination therapy with fluoropyrimidine and platinum-based drugs.
	Gastric	March ~~2019~~2020	Received NMPA approval for Opdivo in 3L gastric cancer in China. The approval was supported by the ONO-4538-12 Phase III study.
	NSCLC	February 2020	Ono, our alliance partner for Opdivo in Japan, announced the submission of a supplemental application ofin Japan for Opdivo ~~in Japan~~to expand the use for ~~additional indication~~the treatment of ~~MSI-H~~ unresectable advanced or recurrent ~~CRC that has progressed following~~NSCLC, in combination treatment with platinum-doublet chemotherapy, for a partial change in ~~the~~ approved items of the manufacturing and marketing approval. ~~This is mainly based on the result from~~
	RCC	April 2020	Announced with Exelixis, that CheckMate-9ER, a pivotal Phase ~~II CheckMate-142 study~~III trial evaluating Opdivo in ~~patients~~combination with ~~MSI-H or dMMR recurrent~~Cabometyx* compared to sunitinib in previously untreated advanced or metastatic ~~CRC that has progressed on or after, or been intolerant~~RCC, met its primary endpoint of progression-free survival at ~~least one previous line~~final analysis, as well as the secondary endpoints of ~~treatment with chemotherapy including fluoropyrimidine anticancer drugs.~~overall survival at a pre-specified interim analysis, and objective response rate.
	RCC	~~Esophageal~~February 2020	Announced five-year follow-up results from the Phase III CheckMate-025 study, which continue to demonstrate that treatment with Opdivo delivers superior overall survival and objective response rates in patients with previously treated advanced or metastatic RCC compared to those treated with everolimus.
	Ovarian Cancer	~~May 2019~~January 2020	Ono, our alliance partner for Opdivo in Japan, announced ~~the submission of a supplemental application of~~that Opdivo ~~for indication of unresectable~~did not demonstrate a significant improvement in overall survival, a primary endpoint, versus chemotherapy in patients with platinum-refractory advanced or recurrent ~~esophageal~~ovarian cancer in ~~Japan for~~the final analysis of a ~~partial change~~multi-center, randomized, open-label Phase III clinical study (ONO-4538-23) conducted in ~~approved items of manufacturing and marketing approval.~~Japan.
~~GBM~~	~~May 2019~~	~~Announced Phase III CheckMate-498 trial evaluating~~ ~~Opdivo~~ ~~plus radiation versus temozolomide plus radiation in patients with newly diagnosed MGMT-unmethylated GBM did not meet its primary endpoint of overall survival at final analysis.~~
~~HCC~~	~~June 2019~~	~~Announced topline results from CheckMate-459, a randomized Phase III study evaluating~~ ~~Opdivo~~ versus sorafenib as a first-line treatment in patients with unresectable HCC. The trial did not achieve statistical significance for its primary endpoint of overall survival per the pre-specified analysis.
~~NSCLC~~	~~April 2019~~	~~Announced results from pooled analyses of survival data from four studies (CheckMate-017, -057, -063 and -003) in patients with previously-treated advanced NSCLC who were treated with~~ ~~Opdivo. In the pooled analysis of the four studies, 14% of all~~ ~~Opdivo-treated patients were alive at four years. Notably, in patients with PD-L1 greater than or equal to 1% and less than 1%, four-year overall survival rate were 19% and 11%, respectively.~~
~~SCCHN~~	~~January 2019~~	~~Acceptance in China of sBLA filing for patients who had previously been treated for metastatic or recurrent SCCHN.~~

4041



Product	Indication	Date	Developments



Opdivo+Yervoy	HCC	~~June 2019~~March 2020	Announced ~~first results from~~that ~~Opdivo+~~Opdivo 1mg/kg plus Yervoy 3 mg/kg (injections for intravenous use) was approved by the FDA to treat HCC in patients who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on overall response rate and duration of response seen in the Opdivo+Yervoy cohort of the Phase I/II CheckMate-040 ~~study, evaluating the IO combination~~trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in patients with advanced HCC previously treated with sorafenib. With a minimum follow-up of 28 months, the blinded independent central review objective response rate was 31% per Response Evaluation Criteria in Solid Tumors version 1.1. At the time of data cutoff the median duration of response was 17.5 months.confirmatory trials.
	~~mCRPC~~MPM	~~February 2019~~April 2020	Announced ~~results from an~~that CheckMate-743, a pivotal Phase III trial evaluating Opdivo in combination with Yervoy in previously untreated MPM met its primary endpoint of overall survival. Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, Opdivo in combination with Yervoy resulted in a statistically significant and clinically meaningful improvement in overall survival compared to chemotherapy (pemetrexed and cisplatin or carboplatin).
	NSCLC	April 2020	Announced that the FDA accepted our sBLA for Opdivo+Yervoy, administered concomitantly with a limited course of chemotherapy, for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. This application is based on data from Phase ~~II CheckMate-650~~III CheckMate-9LA trial evaluating Opdivo+Yervoy combined with chemotherapy compared to chemotherapy alone as a first-line treatment in patients with ~~mCRPC showed that among 32 asymptomatic or minimally symptomatic patients whose disease had progressed after second-generation hormone therapy~~metastatic NSCLC regardless of PD-L1 expression and ~~who had not received chemotherapy (cohort 1),~~histology. The FDA granted the application Priority Review with a ~~median follow-up~~PDUFA goal date of 11.9 months, the objective response rate was 25%. Additionally, among 30 patients whose disease progressed after taxane-based chemotherapy (cohort 2), with a median follow-up of 13.5 months, the objective response rate was 10%.August 6, 2020, in addition to granting Fast Track designation.
		~~Melanoma~~	~~June 2019~~April 2020	Announced ~~five-year analysis~~the EMA validated a type II variation application for Opdivo+Yervoy, combined with limited chemotherapy, for the first-line treatment of patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations.
		March 2020	Ono, our alliance partner for Opdivo in Japan, announced that the companies submitted a supplemental application in Japan for combination therapy of Opdivo+Yervoy, in combination treatment with a limited cycle of platinum-doublet chemotherapy, to expand the use for first-line treatment of unresectable, advanced or recurrent NSCLC, for a partial change in approved items of the manufacturing and marketing approval in Japan. This application is based on data from Phase ~~I CA209-004 study, the longest follow-up for the~~III CheckMate-9LA trial evaluating Opdivo+Yervoy ~~combination~~combined with chemotherapy compared to chemotherapy alone as a first-line treatment in patients with ~~previously treated or untreated advanced melanoma to date. The analysis showed that with a median follow-up~~metastatic NSCLC regardless of ~~43.1 months (range: 0.9-76.7) in all patients, at four years or longer, overall survival rates were stable at 57%.~~PD-L1 expression and histology.
		~~June 2019~~January 2020	Announced voluntary withdrawal of the Company's application in the EU for the combination of Opdivo and Yervoy for the treatment of advanced NSCLC based on data from CheckMate-227. The application was originally filed in 2018 for patients with first-line NSCLC who have tumor mutational burden ≥10 mutations/megabase, based on the final analysis of progression-free survival, a co-primary endpoint in the trial. The application was subsequently amended to include the statistically significant result of overall survival, a co-primary endpoint, from CheckMate-227 Part 1a evaluating Opdivo+Yervoy versus chemotherapy in patients whose tumors expressed PD-L1 ≥1%. Though the CHMP acknowledged the integrity of the patient level data, the CHMP determined a full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data. The company has no plans to refile this application in the EU.
		January 2020	Announced that ~~an analysis exploring long-term quality of life (QoL) and symptom burden in~~ the Phase III CheckMate-067 study found that QoL was maintained during the treatment-free interval, the period where a patient is off study treatment and free of subsequent therapy, in patients with previously untreated unresectable or metastatic melanoma following discontinuation of therapy with ~~Opdivo~~ or ~~Opdivo+Yervoy.~~
	~~March 2019~~	~~Received~~ FDA ~~full approval~~accepted our sBLA for Opdivo in combination with Yervoy for the first-line treatment of patients with ~~unresectable~~metastatic or ~~metastatic melanoma~~recurrent NSCLC with no EGFR or ALK genomic tumor aberrations. This application is based on ~~additional longer term efficacy~~ data from CheckMate-067 (4-year overall survival) without restrictions in patient population. This approval fulfills two Post Marketing Requirements to verify and describe clinical benefit, thereby converting prior accelerated approval to full approval for nivolumab in combination with ipilimumab for patients with unresectable or metastatic melanoma and nivolumab monotherapy for BRAF Mutant subjects with unresectable or metastatic melanoma. Importantly, based on FDA review of the CheckMate-067 4-year overall survival data, the results of exploratory analyses by PD-L1 tumor expression have been removed entirely from the label.
~~NSCLC~~	~~July 2019~~	~~Announced~~ Part 1a1 of the Phase ~~III CheckMate-227 study~~3 CheckMate -227 trial evaluating~~Opdivo~~ ~~plus low dose~~ ~~Yervoy~~ versus chemotherapy met the co-primary endpoint of overall survival in first-line NSCLC patients whose tumors express PD-L1 ≥1%. In addition, the Company announced Part 2 of the Phase III CheckMate-227 study evaluating ~~Opdivo~~ ~~plus chemotherapy versus chemotherapy did not meet its primary endpoint of overall survival in first-line non-squamous NSCLC patients regardless of PD-L1 status.~~
~~NSCLC~~	~~January 2019~~	~~Announced voluntary withdrawal of the Company's sBLA for the~~ ~~Opdivo~~ ~~plus low-dose~~ ~~Yervoy~~ for treatment of first-line advanced NSCLC in patients with TMB greater than or equal to 10 mutations per megabase as data from CheckMate-227, Part 1a. After discussions with FDA, the Company believes further evidence on the relationship between TMB and PD-L1 is required to fully evaluate the impact of Opdivo plus Yervoy onversus chemotherapy in patients with previously untreated NSCLC, in which the dual immunotherapy combination demonstrated significant improvement in overall survival ~~in first-line NSCLC patients. This analysis will require availability~~versus chemotherapy alone. The FDA granted the application Priority Review with a PDUFA goal date of the final data from CheckMate-227, Part 1a, which the Company anticipates will be available in summer 2019. The data from Part 1a could not be provided on time within the review cycle of the current application.May 15, 2020.
RCC	February ~~2019~~2020	Announced ~~new~~updated results from the Phase III CheckMate-214 study ~~showing that therapy with~~evaluating the combination of ~~Opdivo~~ ~~plus low-dose~~ Opdivo+Yervoy ~~continued to demonstrate long-term survival benefits~~versus sunitinib in patients with previously untreated advanced or metastatic RCC.
~~January 2019~~	~~Announced~~ With a minimum follow-up of 42 months, the ~~EC approval~~combination of ~~Opdivo~~ ~~plus low-dose~~ Opdivo+Yervoy ~~for previously untreated patients with intermediate~~continues to show superior overall survival, objective response rates, duration of response and ~~poor-risk advanced RCC.~~
~~SCCHN~~	~~April 2019~~	~~Announced topline results from the Phase II CheckMate-714 trial evaluating~~ ~~Opdivo~~ ~~versus~~complete response rates. The safety profile for Opdivo+Yervoy~~in patients with recurrent or metastatic SCCHN. The study did not meet its primary endpoints.~~



~~Eliquis~~	~~NVAF/ACS~~	~~March 2019~~	~~Announced results from the Phase IV AUGUSTUS trial evaluating~~ ~~Eliquis~~ ~~versus vitamin K antagonists (VKAs)~~was consistent with prior findings and no new safety signals or drug-related death occurred with extended follow-up. The data were presented at the American Society of Clinical Oncology 2020 Genitourinary Cancers Symposium in patients with NVAF and ACS and/or undergoing PCI. Results show that in patients receiving a P2Y12 inhibitor with or without aspirin (antiplatelet therapies), the proportion of patients with major or clinically relevant non-major (CRNM) bleeding at six months was significantly lower for those treated with ~~Eliquis~~ ~~compared to those treated with a VKA.~~San Francisco.



~~Product~~	~~Indication~~	~~Date~~	~~Developments~~



Orencia	~~JIA~~RA	~~April 2019~~February 2020	~~Received the EC notification on the adoption of the approval on~~Ono, our alliance partner for Orencia ~~solution for subcutaneous injection~~ in ~~pre-filled syringe extension application (50 mg & 87.5 mg strength) and extension of indication for~~Japan, announced that the ~~treatment of polyarticular JIA in pediatric patients two years of age and older.~~
RA	~~June 2019~~	~~Announced data from a Phase IV mechanistic study exploring differences in the cellular and molecular mechanisms by which~~ ~~Orencia~~ and another treatment, adalimumab, interfere with disease progression in moderate-to-severe early RA patients seropositive for certain autoantibodies. Among 80 adult patients with early moderate-to-severe RA who had never been treated with a biologic medication and tested positive for autoantibodies called anti-citrullinated protein antibody and rheumatoid factor, numerically higher efficacy responses were seen with ~~Orencia~~ at week 24. These results, which are from a prospective analysis of the Early AMPLE head-to-head trial, are featured in a late-breaking oral presentation at the Annual European Congress of Rheumatology.
RA	~~March 2019~~	~~Announced the submission of supplemental applications~~Companies have received an approval of “Orencia for Intravenous Infusion 250mg,” “Orencia ~~125mg Syringe~~ for Subcutaneous Injection 125mg Syringe 1mL” and “Orencia ~~125mg Autoinjector~~ for Subcutaneous Injection 125mg Auto-injector 1mL” (“Orencia”) to include the description of ~~“inhibition~~“prevention of the structural damage of the joints” in the currently approved indication of RA for a partial change in approved items of the manufacturing and marketing approval in Japan.



~~Sprycel~~Empliciti+Revlimid	~~ALL~~Multiple Myeloma	~~February 2019~~March 2020	Announced topline results from the Phase III ELOQUENT-1 trial evaluating the combination of Empliciti plus Revlimid and dexamethasone, versus Revlimid and dexamethasone alone, in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible. At final analysis, the addition of Empliciti did not show a statistically significant improvement in progression-free survival, the study’s primary endpoint.



Product	Indication	Date	Developments



Reblozyl	MDS	April 2020	Received a positive CHMP opinion for the treatment of adult patients with transfusion-dependent anemia due to very low-, low- and intermediate-risk MDS with ring sideroblasts, who had an unsatisfactory response or are ineligible for erythropoietin-based therapy and adult patients with transfusion-dependent anemia associated with beta thalassemia.
	MDS	April 2020	Announced the ~~EC approval of~~FDA has approved ~~Sprycel~~Reblozyl~~, in both tablet and powder for oral suspension formulations, in combination with chemotherapy~~ for the treatment of ~~pediatric~~anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with ~~newly diagnosed Philadelphia chromosome-positive ALL.~~very low- to intermediate-risk MDS with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis. Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
	Beta Thalassemia	March 2020	Announced that the New England Journal of Medicine has published results from BELIEVE, the pivotal Phase III study evaluating the safety and efficacy of Reblozyl for the treatment of anemia in adults with beta thalassemia who require regular red blood cell transfusions.



~~Empliciti~~Zeposia	RMS	March 2020	Announced that the CHMP of EMA has adopted a positive opinion for Zeposia for the treatment of adult patients with RMS with active disease as defined by clinical or imaging features. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicine for the EU.
~~Empliciti~~Zeposia	RMS	March 2020	Announced that the FDA approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Zeposia, an oral medication taken once daily, is the only approved sphingosine-1-phosphate receptor modulator that offers RMS patients an initiation with no genetic test and no label-based first-dose observation required for patients. An up-titration scheme should be used to reach the maintenance dosage of Zeposia, as a transient decrease in heart rate and atrioventricular conduction delays may occur.



liso-cel	Lymphoma	May 2020	Announced that the FDA has extended the PDUFA date by three months for the BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T cell therapy for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The new PDUFA date set by the FDA is November 16, 2020.



ide-cel; bb2121	Multiple Myeloma	~~June 2019~~March 2020	Announced ~~updated data from ELOQUENT-3,~~ the ~~international randomized Phase II study evaluating~~ ~~Empliciti~~ ~~plus pomalidomide and dexamethasone (EPd) versus pomalidomide and dexamethasone (Pd) alone in patients with RRMM. In a non-prespecified analysis conducted~~submission of BLA to provide a descriptive assessment of overall survival after extended follow-up of at least 18.3 months, patients treated with EPd continued to experience sustained and clinically relevant overall survival and progression-free survival benefits compared with patients treated with Pd. These data were presented at the ~~24th Congress of~~FDA for idecabtagene vicleucel (ide-cel; bb2121), the ~~European Hematology Association in a poster display.~~
~~February 2019~~	~~Completed filing of a supplemental Japanese New Drug Application (sJNDA) for~~ ~~Empliciti~~ ~~in combination with pomalidomide and dexamethasone~~company's lead investigational BCMA-directed CAR T-cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least ~~two~~three prior therapies, including Revlimid*an immunomodulatory agent, a proteasome inhibitor and ~~proteasome inhibitor.~~an anti-CD38 antibody.



CC-486	AML	May 2020	Announced that the FDA has accepted our NDA for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with AML, who achieved complete remission or complete remission with incomplete blood count recovery, following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation. The ~~sJNDA filing~~new drug application submission was ~~submitted~~ based on the efficacy and safety results of the pivotal Phase III QUAZAR AML-001 study, which met the primary endpoint of improved overall survival for patients receiving AML maintenance treatment with CC-486 versus placebo. The FDA granted the application Priority Review and set a ~~global phase II study. The orphan designation was already granted for the indication~~PDUFA goal date of ~~RRMM at the initial JNDA. This sJNDA will also be reviewed under “priority review.”~~September 3, 2020.

Critical Accounting Policies

The preparation of financial statements requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. Our critical accounting policies are those that significantly impact our financial condition and results of operations and require the most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Because of this uncertainty, actual results may vary from these estimates. For a discussion of our critical accounting policies, refer to ~~“—Item~~“Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our ~~2018~~2019 Form 10-K. There have been no material changes to our critical accounting policies during the ~~six~~three months ended ~~June 30, 2019.~~March 31, 2020. For information regarding the impact of recently adopted accounting standards, refer to “Item 1. Financial Statements—Note.1 Basis of Presentation and Recently Issued Accounting Standards.”

4243

~~Cautionary Statement~~Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q (including documents incorporated by reference) and other written and oral statements we make from time to time contain certain “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. You can identify these forward-looking statements by the fact they use words such as “should,” “could,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe,” “will” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. ~~All~~One can also identify forward-looking statements by the fact that ~~are~~they do not ~~statements of~~relate strictly to historical ~~facts are,~~ or ~~may be deemed to be, forward-looking statements.~~current facts. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, ~~that are difficult to predict, may be beyond our control~~ and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These statements are likely to relate to, among other things, our goals, plans and objectives regarding our financial position, results of operations, cash flows, market position, product development, product approvals, sales efforts, expenses, performance or results of current and anticipated products, our ~~pending~~business development strategy generally and in relation to our ability to realize the projected benefits of our acquisition of Celgene and to successfully integrate ours and Celgene's businesses and operations, the full extent of the negative impact of the COVID-19 pandemic on our operations and the development and commercialization of our products, the expiration of patents or data protection on certain products, including assumptions about our ability to retain patent exclusivity of certain products and the impact, and the outcome of contingencies such as legal proceedings and financial results. No forward-looking statement can be guaranteed. We included in this Quarterly Report on Form 10-Q, in the ~~2018~~2019 Form 10-K, particularly under the caption “Item 1A. Risk Factors,” and in our other filings with the SEC additional information on the factors that we believe could cause actual results to differ materially from any forward-looking statement.

Although we believe that we have been prudent in our plans and assumptions, no assurance can be given that any goal or plan set forth in forward-looking statements can be achieved and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made. Additional risks that we may currently deem immaterial or that are not presently known to us could also cause the forward-looking events discussed in this Quarterly Report on Form 10-Q not to occur. Except as otherwise required by applicable law, we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise after the date of this Quarterly Report on Form 10-Q.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

For a discussion of our market risk, refer to “Item 7A. Quantitative and Qualitative Disclosures ~~About~~about Market Risk” in our ~~2018~~2019 Form 10-K.

Item 4. CONTROLS AND PROCEDURES

Management carried out an evaluation, under the supervision and with the participation of its chief executive officer and chief financial officer, of the effectiveness of the design and operation of its disclosure controls and procedures, as defined in Exchange Act Rules 13a-15(e) and 15d-15(e), as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that as of ~~June 30, 2019,~~March 31, 2020, such disclosure controls and procedures are effective.

There were no changes in the Company’s internal control over financial reporting during the quarter ended ~~June 30, 2019~~March 31, 2020 that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

Information pertaining to legal proceedings can be found in “Item 1. Financial Statements—Note 18. Legal Proceedings and Contingencies,” to the interim consolidated financial statements, and is incorporated by reference herein.

Item 1A. RISK FACTORS

There have been no material changes from the risk factors disclosed in the Company’s ~~2018~~2019 Form ~~10-K.~~10-K except for the addition of the following risk factors related to the COVID-19 pandemic:

The COVID-19 pandemic is affecting our business and could have a material adverse effect on us.

The COVID-19 pandemic is affecting how we operate our business. We currently assume that the peak impact of the COVID-19 crisis on our business occurs in the second quarter of 2020, with a return to a more stable business environment in the third quarter of 2020 and minimal impact in the fourth quarter of 2020 and beyond. If the negative impact from the COVID-19 pandemic extends beyond our assumed timelines, our results may be worse than expected. The full extent of the impact will depend on future developments, such as the ultimate duration and the severity of the spread of COVID-19 in the U.S. and globally, the effectiveness of federal, state, local and foreign governments’ mitigation actions, the pandemic’s impact on the U.S. and global economies, as well as factors affecting healthcare and the delivery of medicines to patients, including but not limited to those discussed above under "Part I—Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations—COVID-19 and Market Factors", and how quickly we can return to more normal operations, among other things.

Although we currently do not anticipate any disruption to the supply of our medicines to patients, it is possible that we could experience manufacturing or supply issues due to COVID-19 in the future, which would increase the negative impact on our business and results of operations. In addition, if a natural disaster or other potentially disruptive event occurs on top of the current pandemic, it could deplete our safety stock levels and we could experience a manufacturing or supply issue.

We have suspended in-person interactions by our customer-facing (field) personnel in health care settings and moved to a remote engagement model in the U.S. and a number of other markets. We have also delayed the launch of certain newly approved products and may delay future expected launches as well. It is possible that these actions could have a greater negative impact on our business than currently expected. It is also possible that there could be a longer-lasting shift in interactions between field personnel and health care professionals that we have not anticipated, which could have a negative impact on our business and results of operations.

We are experiencing delays in the initiation and enrollment of patients in our clinical trials. We may experience additional delays or difficulties enrolling patients in clinical trials and/or delays or difficulties with our ongoing, fully enrolled clinical trials, which could further negatively impact the timing of our pipeline development programs and expected future revenues and/or cash flows. A prolonged clinical trial delay could potentially have a significant negative effect on our business, particularly if new competitive products enter the market or clinical trial results for our competitors’ products affect the value proposition for our product. Any such delays or difficulties in clinical development could also potentially lead to a material impairment of our intangible assets, including the approximately $64 billion of intangible assets we obtained through the Celgene transaction. In addition, research and early development activities performed in laboratories have been temporarily suspended, which is having a negative impact on the advancement of early pipeline assets. We have plans to mitigate this impact, but if we are not be able to fully mitigate it, the breadth of our future pipeline opportunities could be adversely affected.

We cannot predict or estimate the impact of any potential long-term changes to the healthcare industry from COVID-19. For example, there is potential for a shift in the U.S. payer channel mix due to changes in patient coverage from the current economic crisis, but we are not able to quantify what the impact would be on our results of operations. It is also possible that changes in the healthcare system could impose additional burdens on clinical trials, which could increase the costs of sponsoring clinical trials or lead to additional delays or difficulties with completing clinical trials. We may also experience additional pricing pressures and/or increased governmental regulation.

We could face additional risk from the impact of COVID-19 on our suppliers, vendors, outsourcing partners, alliance partners and other third parties that we rely on to research, develop, manufacture, commercialize, co-promote and sell our products, manage certain marketing, selling, human resource, finance, IT and other business unit and functional services. For example, if any of our third-party providers suffer from limited solvency because of the pandemic, it could negatively impact our operating model and our business. It is not possible to estimate the potential impact at this time.

4345

The strengthening U.S. dollar is having a negative impact on our International revenues as translated to U.S. dollars, and lower interest rates are reducing our interest income. Stock market declines are also negatively impacting the value of our equity investments. If the U.S. dollar continues to strengthen, interest rates continue to decline, and/or stock markets continue to decline, we could see a further reduction in revenues or other income or additional charges to our equity investments, which could have a negative impact on our earnings and cash flows.

We could also face potential other negative consequences stemming from the COVID-19 pandemic, including but not limited to increased cyber incidents such as phishing, social engineering and malware attacks, delays in planned integration milestones and ability to collect our receivables. It is possible that COVID-19 could exacerbate any of the other risks described in our Annual Report on Form 10-K for the year ended December 31, 2019 as well.

At this time, we cannot predict the full extent of the negative impact that the COVID-19 pandemic will have on our business, financial condition, results of operations and/or cash flows.

It is possible that the COVID-19 pandemic could delay the timing of the FDA’s approval decisions for liso-cel and ide-cel, which could have a material adverse effect on our contingent value rights (CVRs).

We have submitted BLAs for liso-cel and ide-cel, the two remaining assets underlying our CVRs (the third CVR asset, Zeposia (ozanimod), was approved earlier this year). These applications are under review by the FDA. Liso-cel has a PDUFA date of November 16, 2020. We do not yet have a PDUFA date for ide-cel, but we expect an approval decision by March 31, 2021, which is the time period specified within the CVR Agreement. It is possible that COVID-19 could impact FDA operations such that the review of either or both of these CVR assets could be delayed. Any delay in the timing of approval could reduce the resale price of the CVRs. If there is a significant delay that extends the FDA’s review period beyond December 31, 2020 for liso-cel or March 31, 2021 for ide-cel, then no payment will be made under the CVRs and the CVRs will expire without value.

Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

The following table summarizes the surrenders of our equity securities during the three months ended ~~June 30, 2019:~~March 31, 2020:

Period
Total Number of
Shares Purchased^(a)

Average
Price Paid
per Share^(a)

Total Number of
Shares Purchased as
Part of Publicly
Announced
Programs^(b)

Approximate Dollar
Value of Shares that
May Yet Be
Purchased Under the
Programs^(b)
Dollars in Millions, Except Per Share Data
April 1 to 30, 2019 12,884
$ 46.93
—
$ 1,348
May 1 to 31, 2019 9,945
47.33
—
1,348
June 1 to 30, 2019 12,201
45.47
—
1,348
Three months ended June 30, 2019 35,030
—



Period	Total Number of Shares Purchased^(a)	Average Price Paid per Share^(a)		Total Number of Shares Purchased as Part of Publicly Announced Programs^(b)	Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs^(b)
Dollars in Millions, Except Per Share Data
January 1 to 31, 2020	1,462,609	$	66.64	—	$	1,000
February 1 to 29, 2020	559,236	62.39		—	6,000
March 1 to 31, 2020	2,891,728	57.56		1,413,647	5,919
Three months ended March 31, 2020	4,913,573			1,413,647


(a)	Includes shares repurchased as part of publicly announced programs and shares of common stock surrendered to the Company to satisfy tax-withholding obligations in connection with the vesting of awards under our long-term incentive program.

(b)

In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of our common stock and in June 2012 increased its authorization for the repurchase of our common stock by an additional $3.0 billion. In October 2016, the Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of our common ~~stock.~~stock and in November 2019 further increased its authorization for the repurchase of our common stock by approximately $7.0 billion. In February 2020, the Board of Directors approved an increase of $5.0 billion to the total outstanding share repurchase authorization. The ~~stock~~remaining share repurchase capacity under the program was approximately $5.9 billion as of March 31, 2020. The share repurchase program does not have an expiration date. Refer to “Item 1. Financial Statements—Note ~~16.~~15. Equity” for information on the ~~accelerated~~ share repurchase ~~agreements.~~program.

Item 5. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.

The Annual Meeting of the Company was held on May 5, 2020.

Shareholders voted on the matters set forth below.

Item 1. The shareholders elected each of the Company’s 12 nominees to serve as directors of the Company until the 2021 Annual Meeting based upon the following votes:



	For	Against	Abstain	Broker Non-Vote
Peter J. Arduini	1,559,396,505	41,068,251	3,966,972	342,470,123
Robert Bertolini	1,560,064,008	40,300,186	4,067,534	342,470,123
Michael W. Bonney	1,299,847,889	299,506,217	5,077,622	342,470,123
Giovanni Caforio, M.D.	1,461,368,177	128,873,665	14,189,886	342,470,123
Matthew W. Emmens	1,564,285,144	35,860,117	4,286,467	342,470,123
Julia A. Haller, M.D.	1,597,389,902	3,359,319	3,682,507	342,470,123
Dinesh C. Paliwal	1,563,335,629	37,173,415	3,922,684	342,470,123
Theodore R. Samuels	1,562,148,047	38,058,137	4,225,544	342,470,123
Vicki L. Sato, Ph.D.	1,390,886,310	186,211,919	27,333,499	342,470,123
Gerald L. Storch	1,551,920,470	48,467,993	4,043,265	342,470,123
Karen H. Vousden, Ph.D.	1,563,238,539	37,545,762	3,647,427	342,470,123
Phyllis R. Yale	1,590,093,666	9,899,337	4,438,725	342,470,123

Item 2. The management proposal on the advisory vote to approve the compensation of our named executive officers was approved based upon the following votes:

Item 3. The appointment of Deloitte & Touche LLP as independent registered public accounting firm for the Company for 2020 was ratified based upon the following votes:

Item 4. The shareholder proposal on separate Chair & CEO was not approved based upon the following votes:

Item 5. The shareholder proposal on shareholder right to act by written consent was not approved based upon the following votes:

Item 6. EXHIBITS

Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).~~The Exhibits designated by the symbol ‡‡ are management contracts or compensatory plans or arrangements required to be filed pursuant to Item 15.~~



Exhibit No.		Description
~~10a.~~		~~Extension Notice, dated May 31, 2019, for the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of September 29, 2011.~~
~~10b.~~		Amendment and Waiver, dated as of June 20, 2019, to the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of September 29, 2011 among Bristol-Myers Squibb Company, the several financial institutions from time to time party to the agreement, and JPMorgan Chase Bank, N.A. and Citibank N.A. as administrative agents.
~~10c.~~		~~Extension Notice, dated May 31, 2019, for the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of July 30, 2012.~~
~~10d.~~		Amendment, dated as of June 20, 2019, to the Five Year Competitive Advance and Revolving Credit Facility Agreement dated as of July 30, 2012 among Bristol-Myers Squibb Company, the several financial institutions from time to time party to the agreement, and JPMorgan Chase Bank, N.A. and Citibank N.A. as administrative agents.
~~10e.~~		~~Letter Agreement between Bristol-Myers Squibb Company and Dr. Thomas J. Lynch, Jr., dated as of June 4, 2019. ‡‡~~
31a.		Section 302 Certification Letter.
31b.		Section 302 Certification Letter.
32a.		Section 906 Certification Letter.
32b.		Section 906 Certification Letter.
101.INS		XBRL Instance Document - the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.
101.SCH		XBRL Taxonomy Extension Schema Document.
101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF		XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB		XBRL Taxonomy Extension ~~Lable~~Label Linkbase Document.
101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document.
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Indicates, in this Quarterly Report on Form 10-Q, brand names of products, which are registered trademarks not solely owned by the Company or its subsidiaries. Abilify is a trademark of Otsuka Pharmaceutical Co., Ltd.; Atripla is a trademark of Gilead Sciences, Inc.; Avapro/Avalide (known in the EU as Aprovel/Karvea) and Plavix are trademarks of Sanofi; Byetta is a trademark of Amylin Pharmaceuticals, LLC; Cabometyx is a trademark of Exelixis, Inc.; Erbitux is a trademark of ImClone LLC;Onglyza is a trademark of AstraZeneca AB; Gleevec is a trademark of Novartis International AG; Keytruda is a trademark of Merck Sharp & Dohme Corp; ~~Onglyza~~ ~~is a trademark of AstraZeneca AB;~~ ~~Otezla~~ ~~and~~ ~~Revlimid~~ ~~are trademarks of Celgene Corporation; and~~ ~~Plavix~~Nurtec is a trademark of ~~Sanofi S.A.~~Biohaven Pharmaceutical Holding Company Ltd.; Otezla is a trademark of Amgen Inc.; and Yescarta is a trademark of Kite Pharma, Inc. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.

4448

SUMMARY OF ABBREVIATED TERMS

Bristol-Myers Squibb Company and its consolidated subsidiaries may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q, unless the context otherwise indicates. Throughout this Quarterly Report on Form 10-Q we have used terms which are defined below:



~~2018~~2019 Form 10-K	Annual Report on Form 10-K for the fiscal year ended December 31, ~~2018~~2019	LIBOR	London Interbank Offered Rate
ALK	anaplastic lymphoma kinase	Lilly	Eli Lilly and Company
~~ACS~~Amgen	~~acute coronary syndrome~~Amgen Inc.	LOE	loss of exclusivity
~~ALL~~AML	acute ~~lymphoblastic~~myeloid leukemia	~~mCRPC~~MDL	~~metastatic castration-resistant prostate cancer~~multi-district litigation
Amylin	Amylin Pharmaceuticals, Inc.	~~MDL~~MDS	~~multi-district litigation~~myelodysplastic syndromes
aNDA	abbreviated new drug applications	~~MGMT~~MHLW	~~O6-methylguanine-DNA methyltransferase~~Ministry of Health, Labour and Welfare
AstraZeneca	AstraZeneca PLC	MPM	malignant pleural mesothelioma
BCMA	B-cell maturation antigen	MSI-H	high microsatellite instability
~~Catalent~~Biohaven	~~Catalent, Inc.~~Biohaven Pharmaceutical Holding Company Ltd.	Nektar	Nektar Therapeutics
~~Celgene~~BLA	~~Celgene Corporation~~biologics license application	NKT	natural killer T cells
CAR	chimeric antigen receptor	NMPA	National Medical Products Administration
Catalent	Catalent, Inc.	NSCLC	non-small cell lung cancer
Celgene	Celgene Corporation	NVAF	non-valvular atrial fibrillation
CERCLA	U.S. Comprehensive Environmental Response, Compensation and Liability Act	~~NSCLC~~Ono	~~non-small cell lung cancer~~Ono Pharmaceutical Co., Ltd.
CHMP	Committee for Medicinal Products for Human Use	OTC	over-the-counter
CML	chronic myeloid leukemia	~~NVAF~~Otsuka	~~non-valvular atrial fibrillation~~
~~Cormorant~~	~~Cormorant Pharmaceuticals~~	~~Ono~~	~~Ono~~Otsuka Pharmaceutical Co., Ltd.
CRC	colorectal cancer	~~OTC~~	~~over-the-counter~~
~~dMMR~~	~~DNA mismatch repair deficient~~	~~Otsuka~~	~~Otsuka Pharmaceutical Co., Ltd.~~
EC	~~European Commission~~	~~PCI~~	~~percutaneous coronary intervention~~
~~EPO~~	~~European Patent Office~~	PD-1	programmed cell death protein 1
~~EPS~~CVR	~~earnings per share~~contingent value rights	PD-L1	programmed death-ligand 1
~~ERISA~~EGFR	~~Employee Retirement Income Security~~estimated glomerular filtration rate	PDUFA	The Prescription Drug User Fee Act ~~of 1974~~
EMA	European Medicines Agency	Pfizer	Pfizer, Inc.
EUEPO	European ~~Union~~Patent Office	PsA	psoriatic arthritis
~~FASB~~EPS	~~Financial Accounting Standards Board~~earnings per share	Quarterly Report on Form 10-Q	Quarterly Report on Form 10-Q for the quarterly period ended ~~June~~September 30, 2019
ERISA	Employee Retirement Income Security Act of 1974	R&D	research and development
ESCC	esophageal squamous cell carcinoma	RA	rheumatoid arthritis
EU	European Union	RCC	renal cell carcinoma
FASB	Financial Accounting Standards Board	RMS	relapsing forms of multiple sclerosis
FDA	U.S. Food and Drug Administration	~~R&D~~Sanofi	~~research and development~~Sanofi S.A.
Flexus	Flexus Biosciences, Inc.	RAsBLA	~~rheumatoid arthritis~~
~~FTC~~	~~U.S. Federal Trade Commission~~	~~RCC~~	~~renal cell carcinoma~~supplemental Biologics License Application
GAAP	U.S. generally accepted accounting principles	~~RRMM~~SEC	~~relapsed/refractory multiple myeloma~~
~~GBM~~	~~glioblastoma multiforme~~	~~Sanofi~~	~~Sanofi S.A.~~Securities and Exchange Commission
GTN	gross-to-net	~~sBLA~~U.S.	~~supplemental Biologics License Application~~United States
HCC	hepatocellular carcinoma	~~SCCHN~~UK	~~squamous cell carcinoma of the head and neck~~United Kingdom
HIV	human immunodeficiency viruses	~~SEC~~VAT	~~Securities and Exchange Commission~~
~~IFM~~	~~IFM Therapeutics, Inc.~~	~~STING~~	~~stimulator of interferon genes~~
~~IDO-1~~	~~indoleamine-pyrrole 2, 3-dioxygenase 1~~	~~TMB~~	~~tumor mutational burden~~value added tax
IO	immuno-oncology	~~U.S.~~ViiV	~~United States~~ViiV Healthcare Limited
IPRD	in-process research and development	UKVTE	~~United Kingdom~~venous thromboembolic
JIA	juvenile idiopathic arthritis	~~VAT~~	~~value added tax~~
~~LIBOR~~	~~London Interbank Offered Rate~~	~~VTE~~	~~venous thromboembolic~~

4549

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.



		BRISTOL-MYERS SQUIBB COMPANY (REGISTRANT)

Date:	~~July 25, 2019~~May 7, 2020	By:	/s/ Giovanni Caforio, M.D.
			Giovanni Caforio, M.D. Chairman of the Board and Chief Executive Officer

Date:	~~July 25, 2019~~May 7, 2020	By:	/s/ ~~Charles Bancroft~~David V. Elkins
			~~Charles Bancroft~~David V. Elkins Chief Financial Officer

4650



	Three Months Ended June 30,						Six Months Ended June 30,
COMPREHENSIVE INCOME	2019			2018			2019			2018
Net Earnings	$	1,439		$	382		$	3,154		$	1,877
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:
Derivatives qualifying as cash flow hedges	(28		)	85			(14		)	66
Pension and postretirement benefits	39			43			88			172
Available-for-sale securities	13			(7		)	39			(33		)
Foreign currency translation	(1		)	(221		)	28			(216		)
Other Comprehensive Income/(Loss)	23			(100		)	141			(11		)

Comprehensive Income	1,462			282			3,295			1,866
Comprehensive Income Attributable to Noncontrolling Interest	7			9			12			18
Comprehensive Income Attributable to BMS	$	1,455		$	273		$	3,283		$	1,848



	Three Months Ended June 30, 2018					Six Months Ended June 30, 2018
Dollars in Millions	Cost of products sold			Other income (net)		Cost of products sold			Other income (net)
Interest rate swap contracts	$	—		$	6	$	—		$	13
Cross-currency interest rate swap contracts	—			2		—			4
Foreign currency forward contracts	(13		)	16		(33		)	7



Dollars in Millions	2019
Principal Value:
Floating Rate Notes due 2020	$	750
Floating Rate Notes due 2022	500
2.550% Notes due 2021	1,000
2.600% Notes due 2022	1,500
2.900% Notes due 2024	3,250
3.200% Notes due 2026	2,250
3.400% Notes due 2029	4,000
4.125% Notes due 2039	2,000
4.250% Notes due 2049	3,750
Total	$	19,000

Proceeds net of discount and deferred loan issuance costs	$	18,790



Dollars in Millions	June 30, 2019		January 1, 2019
Other assets	$	509	$	543

Accrued and other current liabilities	67		40
Other non-current liabilities	516		548
Total liabilities	$	583	$	588



Dollars in Millions	Operating Leases
2019 (excluding the six months ended June 30, 2019)	$	46
2020	85
2021	75
2022	70
2023	61
Thereafter	395
Total future lease payments	732

Less imputed interest	149
Total lease liability	$	583



	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		Capital in Excess of Par Value of Stock		Accumulated Other Comprehensive Loss			Retained Earnings			Shares		Cost			Noncontrolling Interest
Balance at December 31, 2018	2,208	$	221	$	2,081	$	(2,762	)	$	34,065		576		$	(19,574	)	$	96
Accounting change - cumulative effect^(a)	—	—		—		—			5			—		—			—
Adjusted balance at January 1, 2019	2,208	221		2,081		(2,762		)	34,070			576		(19,574		)	96
Net earnings	—	—		—		—			1,710			—		—			5
Other Comprehensive Income/(Loss)	—	—		—		118			—			—		—			—
Cash dividends declared^(b)	—	—		—		—			(671		)	—		—			—
Stock compensation	—	—		22		—			—			(4	)	3			—
Distributions	—	—		—		—			—			—		—			(2		)
Balance at March 31, 2019	2,208	$	221	$	2,103	$	(2,644	)	$	35,109		572		$	(19,571	)	$	99
Net earnings	—	—		—		—			1,432			—		—			7
Other Comprehensive Income/(Loss)	—	—		—		23			—			—		—			—
Cash dividends declared^(b)	—	—		—		—			(671		)	—		—			—
Stock compensation	—	—		47		—			—			—		—			—
Distributions	—	—		—		—			—			—		—			(4		)
Balance at June 30, 2019	2,208	$	221	$	2,150	$	(2,621	)	$	35,870		572		$	(19,571	)	$	102



Period	Total Number of Shares Purchased^(a)	Average Price Paid per Share^(a)		Total Number of Shares Purchased as Part of Publicly Announced Programs^(b)	Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs^(b)
Dollars in Millions, Except Per Share Data
April 1 to 30, 2019	12,884	$	46.93	—	$	1,348
May 1 to 31, 2019	9,945	47.33		—	1,348
June 1 to 30, 2019	12,201	45.47		—	1,348
Three months ended June 30, 2019	35,030			—

Broker Non-Vote

1,488,216,779