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Bristol-Myers Squibb (BMY)

Filed: 25 Oct 17, 8:00pm


 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
 
 
x

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2017
 
 ¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM             TO             
Commission file number:              1-1136
 
 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.)
 
 
345 Park Avenue, New York, N.Y. 10154
(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)
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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 “accelerated filer”, “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
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 September 30, 2017, there were 1,636,699,696 shares outstanding of the Registrant’s $0.10 par value common stock.
 




BRISTOL-MYERS SQUIBB COMPANY
INDEX TO FORM 10-Q
SEPTEMBER 30, 2017
 

*    Indicates brand names of products which are trademarks not owned by BMS. Specific trademark ownership information is included in the Exhibit Index.





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 September 30, Nine Months Ended September 30,
EARNINGS2017 2016 2017 2016
Net product sales$4,862
 $4,492
 $14,212
 $12,888
Alliance and other revenues392
 430
 1,115
 1,296
Total Revenues5,254
 4,922
 15,327
 14,184
        
Cost of products sold1,572
 1,305
 4,393
 3,563
Marketing, selling and administrative1,147
 1,144
 3,388
 3,450
Research and development1,543
 1,138
 4,490
 3,540
Other (income)/expense(191) (224) (1,377) (1,198)
Total Expenses4,071
 3,363
 10,894
 9,355
        
Earnings Before Income Taxes1,183
 1,559
 4,433
 4,829
Provision for Income Taxes327
 344
 1,129
 1,220
Net Earnings856
 1,215
 3,304
 3,609
Net Earnings/(Loss) Attributable to Noncontrolling Interest11
 13
 (31) 46
Net Earnings Attributable to BMS$845
 $1,202
 $3,335
 $3,563
        
Earnings per Common Share       
Basic$0.52
 $0.72
 $2.02
 $2.13
Diluted$0.51
 $0.72
 $2.02
 $2.12
        
Cash dividends declared per common share$0.39
 $0.38
 $1.17
 $1.14


CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
Dollars in Millions
(UNAUDITED)

 Three Months Ended September 30, Nine Months Ended September 30,
COMPREHENSIVE INCOME2017 2016 2017 2016
Net Earnings$856
 $1,215
 $3,304
 $3,609
Other Comprehensive Income/(Loss), net of taxes and reclassifications to earnings:       
Derivatives qualifying as cash flow hedges(1) 4
 (61) (126)
Pension and postretirement benefits18
 72
 74
 (213)
Available-for-sale securities22
 (8) 41
 46
Foreign currency translation7
 1
 28
 26
Other Comprehensive Income/(Loss)46
 69
 82
 (267)
        
Comprehensive Income902
 1,284
 3,386
 3,342
Comprehensive Income/(Loss) Attributable to Noncontrolling Interest11
 13
 (31) 46
Comprehensive Income Attributable to BMS$891
 $1,271
 $3,417
 $3,296
The accompanying notes are an integral part of these consolidated financial statements.


3




BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED BALANCE SHEETS
Dollars in Millions, Except Share and Per Share Data
(UNAUDITED) 
ASSETSSeptember 30,
2017
 December 31,
2016
Current Assets:   
Cash and cash equivalents$4,644
 $4,237
Marketable securities2,478
 2,113
Receivables5,922
 5,543
Inventories1,250
 1,241
Prepaid expenses and other754
 570
Total Current Assets15,048
 13,704
Property, plant and equipment5,014
 4,980
Goodwill6,865
 6,875
Other intangible assets1,213
 1,385
Deferred income taxes2,346
 2,996
Marketable securities2,526

2,719
Other assets965
 1,048
Total Assets$33,977
 $33,707
    
LIABILITIES   
Current Liabilities:   
Short-term debt obligations$1,461
 $992
Accounts payable1,699
 1,664
Accrued liabilities5,418
 5,271
Deferred income647
 762
Income taxes payable213
 152
Total Current Liabilities9,438
 8,841
Deferred income492
 547
Income taxes payable996
 973
Pension and other liabilities1,155
 1,283
Long-term debt6,982
 5,716
Total Liabilities19,063
 17,360
    
Commitments and contingencies (Note 17)
 
    
EQUITY   
Bristol-Myers Squibb Company Shareholders’ Equity:   
Preferred stock
 
Common stock221
 221
Capital in excess of par value of stock1,845
 1,725
Accumulated other comprehensive loss(2,421) (2,503)
Retained earnings34,141
 33,513
Less cost of treasury stock(19,003) (16,779)
Total Bristol-Myers Squibb Company Shareholders’ Equity14,783
 16,177
Noncontrolling interest131
 170
Total Equity14,914
 16,347
Total Liabilities and Equity$33,977
 $33,707
The accompanying notes are an integral part of these consolidated financial statements.

4




BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF CASH FLOWS
Dollars in Millions
(UNAUDITED)

 Nine Months Ended September 30,
 2017 2016
Cash Flows From Operating Activities:   
Net earnings$3,304
 $3,609
Adjustments to reconcile net earnings to net cash provided by operating activities:   
Depreciation and amortization, net592
 260
Deferred income taxes283
 (500)
Stock-based compensation149
 149
Impairment charges223
 75
Pension settlements and amortization148
 122
Divestiture gains and royalties(546) (1,082)
Asset acquisition charges510
 274
Other adjustments108
 (56)
Changes in operating assets and liabilities:   
Receivables(539) (896)
Inventories7
 (107)
Accounts payable63
 (142)
Deferred income(91) 445
Income taxes payable400
 (183)
Other(453) (353)
Net Cash Provided by Operating Activities4,158
 1,615
Cash Flows From Investing Activities:   
Sale and maturities of marketable securities4,296
 3,674
Purchase of marketable securities(4,434) (2,248)
Capital expenditures(801) (844)
Divestiture and other proceeds526
 1,193
Acquisition and other payments(672) (311)
Net Cash Provided by/(Used in) Investing Activities(1,085) 1,464
Cash Flows From Financing Activities:   
Short-term debt obligations, net1,198
 102
Issuance of long-term debt1,488
 
Repayment of long-term debt(1,224) 
Repurchase of common stock(2,220) (231)
Dividends(1,938) (1,912)
Other(29) (7)
Net Cash Used in Financing Activities(2,725) (2,048)
Effect of Exchange Rates on Cash and Cash Equivalents59
 16
Increase in Cash and Cash Equivalents407
 1,047
Cash and Cash Equivalents at Beginning of Period4,237
 2,385
Cash and Cash Equivalents at End of Period$4,644
 $3,432
The accompanying notes are an integral part of these consolidated financial statements.

5






Note 1. BASIS OF PRESENTATION AND RECENTLY ISSUED ACCOUNTING STANDARDS

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 September 30, 2017 and December 31, 2016, the results of operations for the three and nine months ended September 30, 2017 and 2016, and cash flows for the nine months ended September 30, 2017 and 2016. All intercompany balances and transactions have been eliminated. These financial statements and the related notes should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2016 included in the 2016 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.

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 sales rebate and return accruals; legal contingencies; income taxes; determining if an acquisition or divestiture is a business or an asset; and pension and postretirement benefits. Actual results may differ from estimates.

Certain prior period amounts were reclassified to conform to the current period presentation. The consolidated statements of cash flows previously presented interest rate swap contract terminations and issuance of common stock as separate line items within cash flows from financing activities which are now presented as components of other financing activities. The reclassifications provide a more concise financial statement presentation and additional information is disclosed in the notes if material.

Recently Adopted Accounting Standards
Share-based Payment Transactions
Amended guidance for share-based payment transactions was adopted in the first quarter of 2017. Net excess tax benefits of $30 million for the nine months ended September 30, 2017 were recognized prospectively as a reduction of tax expense rather than capital in excess of par value of stock. Net excess tax benefits are also presented as an operating cash flow rather than a financing cash flow, and cash payments to tax authorities in connection with shares withheld for statutory tax withholding requirements are presented as a financing cash flow rather than an operating cash flow. The changes in cash flow presentation were applied retrospectively and increased operating cash flows and decreased financing cash flows by $113 million for the nine months ended September 30, 2017 and $193 million for the nine months ended September 30, 2016.

Income Tax Accounting for Intra-entity Transfers of Assets Other Than Inventory
Amended guidance on income tax accounting for intra-entity transfers of assets other than inventory was early adopted in the first quarter of 2017 on a modified retrospective approach. The amended guidance requires tax consequences of these transfers be recognized in the period the transfer takes place. Net reductions to prepaid and deferred tax assets pertaining to pre-2017 internal transfers of intellectual property of $787 million were adjusted through retained earnings as a cumulative effect of an accounting change which will reduce the annual tax expense by $86 million beginning in 2017. In addition, the tax consequences of additional internal transfers of intellectual property that may occur in the future will be included in income tax expense upon transfer and not amortized in subsequent periods.

Recently Issued Accounting Standards
Accounting for Hedging Activities
In August 2017, the FASB issued amended guidance on derivatives and hedging. The amended guidance revises and expands items eligible for hedge accounting, simplifies hedge effectiveness testing and changes the timing of recognition and presentation for certain hedged items. Certain disclosure requirements are also modified for hedging activities on a prospective basis. The guidance is effective in 2019 with early adoption permitted on a modified retrospective approach. The Company is assessing the potential impact of the new standard.

6




Presentation of Net Periodic Pension and Postretirement Benefits
In March 2017, the FASB issued amended guidance requiring all net periodic benefit components for defined benefit pension and other postretirement plans other than service costs to be recorded outside of income from operations (other income). The guidance is effective in 2018 on a retrospective basis. The Company expects that annual cost of products sold; marketing, selling and administrative; and research and development expenses will increase by approximately $130 million in the aggregate with a corresponding offset in other income.

Revenue from Contracts with Customers
Amended guidance for revenue recognition will be adopted in the first quarter of 2018 using the modified retrospective method with the cumulative effect of the change recognized in retained earnings. The new guidance referred to as ASC 606 requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers and replaces most of the existing revenue recognition standards in U.S. GAAP. A five step model will be utilized to achieve the core principle; (1) identify the customer contract, (2) identify the contract’s performance obligations, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations and (5) recognize revenue when or as a performance obligation is satisfied.

The Company’s assessment of the new standard’s impact is substantially complete. The timing of recognizing revenue is not expected to change for typical net product sales to customers, most existing alliance arrangements as well as royalties and sale-based milestones from out-licensing arrangements. In addition, the timing of recognizing royalties, sales-based milestones and other forms of contingent consideration resulting from the divestiture of businesses is not expected to change.

However, transaction prices are no longer required to be fixed or determinable and certain variable consideration might be recognized prior to the occurrence or resolution of the contingent event to the extent it is probable that a significant reversal in the amount of estimated cumulative revenue will not occur. Certain estimated future royalties and termination fees for licensing rights previously reacquired by alliance partners are expected to be recognized as contract assets upon adoption of the new standard. Refer to the Sanofi and Erbitux* Japan arrangements in "Note 3. Alliances" of the 2016 Form 10-K. As a result of the new guidance and cumulative effect adjustment, revenue and other income is expected to be lower in 2018 by approximately $225 million and $125 million, respectively, compared to what would have been reported under the previous standard.

In addition to the items discussed above, the following recently issued accounting standards have not been adopted. Refer to the 2016 Form 10-K for additional information and their potential impacts.
Accounting Standard UpdateEffective Date
Recognition and Measurement of Financial Assets and LiabilitiesJanuary 1, 2018
Definition of a BusinessJanuary 1, 2018
LeasesJanuary 1, 2019
Financial Instruments - Measurement of Credit LossesJanuary 1, 2020
Goodwill Impairment TestingJanuary 1, 2020

Note 2. BUSINESS SEGMENT INFORMATION

BMS operates in a single segment engaged in the discovery, development, licensing, manufacturing, marketing, distribution and sale of innovative medicines that help patients prevail over serious diseases. A global research and development organization and supply chain organization are responsible for the discovery, development, manufacturing and supply of products. Regional commercial organizations market, distribute and sell the products. The business is also supported by global corporate staff functions. The determination of a single segment is consistent with the financial information regularly reviewed by the chief executive officer for purposes of evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting future periods.
Product revenues and the composition of total revenues were as follows:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Prioritized Brands       
Opdivo$1,265
 $920
 $3,587
 $2,464
Eliquis1,232
 884
 3,509
 2,395
Orencia632
 572
 1,817
 1,640
Sprycel509
 472
 1,478
 1,330
Yervoy323
 285
 975
 789
Empliciti60
 41
 168
 103
Established Brands       
Hepatitis C Franchise73
 379
 347
 1,352
Baraclude264
 306
 819
 896
Sustiva Franchise183
 275
 555
 819
Reyataz Franchise174
 238
 555
 706
Other Brands539
 550
 1,517
 1,690
Total Revenues$5,254
 $4,922
 $15,327
 $14,184
        
Net product sales$4,862
 $4,492
 $14,212
 $12,888
Alliance revenues334
 402
 957
 1,229
Other revenues58
 28
 158
 67
Total Revenues$5,254
 $4,922
 $15,327
 $14,184

Note 3. ALLIANCES

BMS enters into collaboration arrangements with third parties for the development and commercialization of certain products. Although each of these arrangements is unique in nature, both parties are active participants in the operating activities of the collaboration and are exposed to significant risks and rewards depending on the commercial success of the activities. BMS may either in-license intellectual property owned by the other party or out-license its intellectual property to the other party. These arrangements also typically include research, development, manufacturing and/or commercial activities and can cover a single investigational compound or commercial product or multiple compounds and/or products in various life cycle stages. The rights and obligations of the parties can be global or limited to geographic regions. We refer to these collaborations as alliances and our partners as alliance partners. Products sold through alliance arrangements in certain markets include Opdivo, Eliquis, Orencia, Sprycel, Yervoy, Empliciti, Sustiva (Atripla*) and certain other brands.

Selected financial information pertaining to our alliances was as follows, including net product sales when BMS is the principal in the third-party customer sale for products subject to the alliance. Expenses summarized below do not include all amounts attributed to the activities for the products in the alliance, but only the payments between the alliance partners or the related amortization if the payments were deferred or capitalized.
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Revenues from alliances:       
Net product sales$1,764
 $1,465
 $5,045
 $4,031
Alliance revenues334
 402
 957
 1,229
Total Revenues$2,098
 $1,867
 $6,002
 $5,260
        
Payments to/(from) alliance partners:       
Cost of products sold$678
 $572
 $1,969
 $1,543
Marketing, selling and administrative(16) (3) (39) (10)
Research and development(12) (7) (6) 23
Other (income)/expense(151) (160) (545) (864)
        
Noncontrolling interest, pretax4
 3
 9
 13
 

7




Selected Alliance Balance Sheet information:   
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Receivables - from alliance partners$878
 $903
Accounts payable - to alliance partners634
 555
Deferred income from alliances(a)
1,060
 1,194
(a)
Includes unamortized upfront, milestone and other licensing proceeds, revenue deferrals attributed to Atripla* and undelivered elements of diabetes business divestiture proceeds. Amortization of deferred income (primarily related to alliances) was $59 million and $193 million for the nine months ended September 30, 2017 and 2016, respectively.
    
Specific information pertaining to each of our significant alliances is discussed in our 2016 Form 10-K, including their nature and purpose, the significant rights and obligations of the parties and specific accounting policy elections. Significant developments and updates related to alliances during the nine months ended September 30, 2017 are set forth below.

AstraZeneca
BMS received $100 million from AstraZeneca as additional contingent consideration for the diabetes business divestiture upon achievement of a regulatory approval milestone in the first quarter of 2017 (included in other income).

F-Star Alpha
In the first quarter of 2017, BMS discontinued development of FS102 (an anti-HER2 antibody fragment) which was in Phase I development for the treatment of breast and gastric cancer. BMS will not exercise its option to purchase F-Star Alpha which was previously consolidated by BMS as a variable interest entity. As a result, an IPRD charge of $75 million was included in R&D expense and attributed to noncontrolling interest in the first quarter of 2017.

Note 4. ACQUISITIONS, DIVESTITURES AND LICENSING ARRANGEMENTS

Acquisitions
IFM
In the third quarter of 2017, BMS acquired all of the outstanding shares of IFM, a private biotechnology company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory diseases. The acquisition provides BMS with full rights to IFM's preclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer. The consideration includes an upfront payment of $300 million and contingent development, regulatory and sales-based milestone payments of up to $1.0 billion for the first product from each of the two programs and additional contingent milestone payments of up to $555 million for any subsequent products from these programs. No significant IFM processes were acquired, therefore the transaction was accounted for as an asset acquisition because IFM was determined not to be a business as that term is defined in ASC 805 - Business Combinations. BMS also paid $25 million for certain negotiation rights to collaborate, license or acquire an NLRP3 antagonist program from a newly formed entity established by the former shareholders of IFM. The transactions resulted in $310 million of R&D expense and $15 million of deferred tax assets for net operating losses and tax credit carryforwards.
Flexus
In the second quarter of 2017, a $100 million milestone was achieved and paid to former stockholders of Flexus as additional contingent consideration following the commencement of a Phase II clinical study of an anti-cancer IDO inhibitor. The additional consideration was included in R&D expense as the Flexus acquisition in 2015 was accounted for as an asset acquisition.
Cardioxyl
In the second quarter of 2017, a $100 million milestone was achieved and paid to former stockholders of Cardioxyl as additional contingent consideration following the commencement of a Phase II clinical study of a cardiovascular Nitroxyl Donor. The additional consideration was included in R&D expense as the Cardioxyl acquisition in 2015 was accounted for as an asset acquisition.

8




Divestitures
SK Biotek
In the second quarter of 2017, BMS agreed to sell its small molecule active pharmaceutical ingredient manufacturing operations in Swords, Ireland to SK Biotek. The divestiture includes the transfer of the facility, the majority of employees at the site, inventories and certain third-party contract manufacturing obligations. The purchase price is expected to be approximately $140 million subject to inventory levels on the date of closing. The transaction is expected to close in the fourth quarter of 2017 subject to SK Biotek's receipt of certain environmental permits and other customary closing conditions and will be accounted for as a sale of a business. Net assets of approximately $140 million were accounted for as held-for-sale as of September 30, 2017, consisting primarily of inventories and property, plant and equipment, and were included in prepaid expenses and other. The assets were reduced to their estimated relative fair value after considering the purchase price resulting in an impairment charge of $128 million that was included in cost of products sold in the nine months ended September 30, 2017. SK Biotek will provide certain manufacturing services for BMS through 2022. Revenues and pretax earnings related to this operation were not material in 2017 and 2016 (excluding the impairment charge).

Licensing Arrangements
Halozyme
In the third quarter of 2017, BMS and Halozyme announced a global collaboration and license agreement to develop subcutaneously administered BMS IO medicines using Halozyme's ENHANZE* drug-delivery technology. This technology may allow for more rapid delivery of large volume injectable medications, such as medications that are currently delivered intravenously, through subcutaneous delivery. BMS agreed to pay $105 million to Halozyme for access to the technology which will be included in R&D expense in the fourth quarter of 2017. BMS has designated multiple IO targets, including PD-1, to develop using the ENHANZE* technology and has an option to select additional targets within five years from the effective date up to a maximum of 11 targets. BMS may pay up to $160 million upon achievement of contingent development, regulatory and sales-based milestone events for each of the nominated collaboration targets, additional milestone payments for combination products and future royalties on sales of products using the ENHANZE* technology. The agreement is subject to obtaining customary regulatory and antitrust approvals.
CytomX
In the second quarter of 2017, BMS expanded its strategic collaboration with CytomX to discover novel therapies using CytomX’s proprietary Probody platform. As part of the original May 2014 collaboration to discover, develop and commercialize Probody therapeutics, BMS selected four oncology targets, including CTLA-4. Pursuant to the expanded agreement, CytomX will grant BMS exclusive worldwide rights to develop and commercialize Probody therapeutics for up to eight additional targets. BMS paid CytomX $75 million for the rights to the initial four targets which was expensed as R&D prior to 2017. BMS paid $200 million to CytomX for access to the additional targets which was included in R&D expense in the second quarter of 2017. BMS will also reimburse CytomX for certain research costs over the collaboration period, pay up to $448 million upon achievement of contingent development, regulatory and sales milestone events for each collaboration target and future royalties if a product is approved and commercialized.
Biogen
In the second quarter of 2017, BMS out-licensed to Biogen exclusive rights to develop and commercialize BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy. Biogen paid $300 million to BMS which was included in other income in the second quarter of 2017 as BMS has no further performance obligations as part of the agreement. BMS is also entitled to contingent development, regulatory and sales based milestone payments of up to $410 million if achieved as well as future royalties if the product is ultimately approved and commercialized. BMS originally acquired the rights to this compound in 2014 through its acquisition of iPierian. Biogen assumed all of BMS’s remaining obligations to the former stockholders of iPierian.
Roche
In the second quarter of 2017, BMS out-licensed to Roche exclusive rights to develop and commercialize BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy. Roche paid $170 million to BMS which was included in other income in the second quarter of 2017 as BMS has no further performance obligations as part of the agreement. BMS will also be entitled to contingent development and regulatory milestone payments of up to $205 million if achieved and future royalties if the product is ultimately approved and commercialized.

9




Note 5. OTHER (INCOME)/EXPENSE
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Interest expense$48
 $42
 $145
 $127
Investment income(37) (32) (104) (81)
Provision for restructuring28
 19
 207
 41
Litigation and other settlements(a)

 (1) (489) 48
Equity in net income of affiliates(21) (19) (59) (65)
Divestiture (gains)/losses1
 (21) (126) (574)
Royalties and licensing income(b)
(209) (158) (1,093) (579)
Transition and other service fees(12) (57) (32) (184)
Pension charges22
 19
 91
 66
Intangible asset impairments
 
 
 15
Equity investment impairment
 
 
 45
Loss on debt redemption
 
 109
 
Other(11) (16) (26) (57)
Other (income)/expense$(191) $(224) $(1,377) $(1,198)
(a)
Includes BMS's share of a patent-infringement litigation settlement of $481 million related to Merck's PD-1 antibody Keytruda* in the nine months ended September 30, 2017.
(b)Includes upfront licensing fees of $470 million from Biogen and Roche in the nine months ended September 30, 2017.

Note 6. RESTRUCTURING

In October 2016, the Company announced a restructuring plan to evolve and streamline its operating model and expects to incur charges in connection with employee workforce reductions and early site exits. The majority of the charges are expected to be incurred through 2020, range between $1.5 billion to $2.0 billion and consist of employee termination benefit costs, contract termination costs, plant and equipment accelerated depreciation and impairment charges and other site shutdown costs. Cash outlays in connection with these actions are expected to be approximately 40% to 50% of the total charges. Charges of $631 million have been recognized for these actions since the announcement ($82 million and $534 million for the three and nine months ended September 30, 2017, respectively). These charges include an impairment charge for the manufacturing operations in Swords, Ireland discussed in "—Note 4. Acquisitions, Divestitures and Licensing Arrangements." Restructuring charges are recognized upon meeting certain criteria, including finalization of committed plans, reliable estimates and discussions with local works councils in certain markets.

Other restructuring charges recognized prior to the above actions were primarily related to specialty care transformation initiatives designed to create a more simplified organization across all functions and geographic markets. In addition, accelerated depreciation and other charges were incurred in connection with the expected early exits of a manufacturing site in Ireland and R&D site in the U.S.

Employee workforce reductions were approximately 1,200 and 500 for the nine months ended September 30, 2017 and 2016, respectively, across all geographic regions for manufacturing, marketing, selling, administrative and R&D personnel.

The following tables summarize the charges and activity related to the restructuring actions:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Employee termination costs$18
 $17
 $190
 $32
Other termination costs10
 2
 17
 9
Provision for restructuring28
 19
 207
 41
Accelerated depreciation64
 15
 216
 42
Asset impairments1
 
 144
 
Other shutdown costs
 6
 3
 13
Total charges$93
 $40
 $570
 $96

10




         Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Cost of products sold$1
 $7
 $131
 $15
Research and development64
 14
 232
 40
Other (income)/expense28
 19
 207
 41
Total charges$93
 $40
 $570
 $96
 Nine Months Ended September 30,
Dollars in Millions2017 2016
Liability at January 1$114
 $125
Charges233
 48
Change in estimates(26) (7)
Provision for restructuring207
 41
Foreign currency translation17
 2
Spending(179) (88)
Liability at September 30$159
 $80

Note 7. INCOME TAXES
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Earnings Before Income Taxes$1,183
 $1,559
 $4,433
 $4,829
Provision for Income Taxes327
 344
 1,129
 1,220
Effective Tax Rate27.6% 22.1% 25.5% 25.3%

The effective tax rate is lower than the U.S. statutory rate of 35% which is primarily attributable to undistributed earnings of certain foreign subsidiaries in low tax jurisdictions that have been considered or are expected to be indefinitely reinvested offshore. These undistributed earnings primarily relate to operations in Switzerland, Ireland and Puerto Rico. If these undistributed earnings are repatriated to the U.S. in the future, or if it were determined that such earnings are to be remitted in the foreseeable future, additional tax provisions would be required. Due to complexities in the tax laws and assumptions that would have to be made, it is not practicable to estimate the amounts of income taxes that would have to be provided. Reforms to U.S. tax laws related to foreign earnings have been proposed and if adopted, may increase taxes, which could reduce the results of operations and cash flows. BMS operates under a favorable tax grant in Puerto Rico not scheduled to expire prior to 2023.

Jurisdictional tax rates and other tax impacts attributed to R&D charges, divestiture transactions and other discrete pretax items increased the effective tax rate by 3.7% and 3.1% in the nine months ended September 30, 2017 and 2016, respectively, including non-deductible R&D asset acquisition charges and goodwill allocated to business divestitures. The tax impact for discrete items are reflected immediately and are not considered in estimating the annual effective tax rate.

The adoption of the amended guidance for intra-entity transfers of assets other than inventory and share-based payment transactions reduced the effective tax rate by 2.1% in the nine months ended September 30, 2017. Refer to "—Note 1. Basis of Presentation and Recently Issued Accounting Standards" for additional information.

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 September 30, 2017 could decrease in the range of approximately $255 million to $315 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.


11




Note 8. EARNINGS PER SHARE
 Three Months Ended September 30, Nine Months Ended September 30,
Amounts in Millions, Except Per Share Data2017 2016 2017 2016
Net Earnings Attributable to BMS used for Basic and Diluted EPS Calculation$845
 $1,202
 $3,335
 $3,563
        
Weighted-average common shares outstanding – basic1,639
 1,671
 1,648
 1,670
Incremental shares attributable to share-based compensation plans6
 8
 7
 9
Weighted-average common shares outstanding – diluted1,645
 1,679
 1,655
 1,679
        
Earnings per Common Share:       
Basic$0.52
 $0.72
 $2.02
 $2.13
Diluted$0.51
 $0.72
 $2.02
 $2.12

Note 9. FINANCIAL INSTRUMENTS AND FAIR VALUE MEASUREMENTS

Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
 September 30, 2017 December 31, 2016
Dollars in MillionsLevel 1 Level 2 Level 1 Level 2
Cash and cash equivalents - Money market and other securities$
 $3,915
 $
 $3,532
Marketable securities:       
Certificates of deposit
 176
 
 27
Commercial paper
 977
 
 750
Corporate debt securities
 3,725
 
 3,947
Equity funds
 119
 
 101
Fixed income funds
 7
 
 7
Derivative assets
 31
 
 75
Equity investments90
 
 24
 
Derivative liabilities
 (63) 
 (30)

As further described in "Note 9. Financial Instruments and Fair Value Measurements" in our 2016 Form 10-K, our 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). There were no Level 3 financial assets or liabilities as of September 30, 2017 and December 31, 2016.

Available-for-sale Securities

The following table summarizes available-for-sale securities:
 September 30, 2017 December 31, 2016
Dollars in MillionsAmortized Cost Gross Unrealized   Amortized Cost Gross Unrealized  
 Gains Losses Fair Value  Gains Losses Fair Value
Certificates of deposit$176
 $
 $
 $176
 $27
 $
 $
 $27
Commercial paper977
 
 
 977
 750
 
 
 750
Corporate debt securities3,713
 15
 (3) 3,725
 3,945
 10
 (8) 3,947
Equity investments57
 34
 (1) 90
 31
 
 (7) 24
 $4,923
 $49
 $(4) $4,968
 $4,753
 $10
 $(15) $4,748
                
Financial assets measured using the fair value option            
Equity and fixed income funds(a)
      126
       108
Total      $5,094
       $4,856

12




Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Current marketable securities$2,478
 $2,113
Non-current marketable securities(b)
2,526
 2,719
Other assets(c)
90
 24
Total$5,094
 $4,856
(a)The fair value option for financial assets was elected for investments in equity and fixed income funds and are included in current marketable securities.
(b)All non-current marketable securities mature within five years as of September 30, 2017 and December 31, 2016.
(c)Includes equity investments.

Qualifying Hedges and Non-Qualifying Derivatives
The following table summarizes the fair value of outstanding derivatives:
 September 30, 2017 December 31, 2016
 
Asset(a)
 
Liability(b)
 
Asset(a)
 
Liability(b)
Dollars in MillionsNotional Fair Value Notional Fair Value Notional Fair Value Notional Fair Value
Derivatives designated as hedging instruments:               
Interest rate swap contracts$
 $
 $755
 $(3) $750
 $1
 $755
 $(3)
Forward starting interest rate swap contracts
 
 
 
 500
 8
 250
 (11)
Foreign currency forward contracts1,351
 25
 548
 (28) 967
 66
 198
 (9)
                
Derivatives not designated as hedging instruments:               
Foreign currency forward contracts322
 6
 1,183
 (32) 106
 
 360
 (7)
(a)Included in prepaid expenses and other and other assets.
(b)Included in accrued liabilities and pension and other liabilities.

Cash Flow Hedges — The notional amount of outstanding foreign currency forward contracts was primarily attributed to the euro ($2.2 billion) and Japanese yen ($586 million) at September 30, 2017. BMS terminated forward starting interest rate swap contracts in the first quarter of 2017 with an aggregate notional value of $750 million. The proceeds and related gain were not material.

Net Investment Hedges — Non-U.S. dollar borrowings of €950 million ($1.1 billion) are designated to hedge euro currency exposures of the net investment in certain foreign affiliates.

Fair Value Hedges — The notional amount of fixed-to-floating interest rate swap contracts terminated was $500 million in 2016 generating proceeds of $43 million (including accrued interest).

Debt Obligations
Short-term debt obligations include:
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Commercial paper$799
 $
Bank drafts and short-term borrowings662
 243
Current portion of long-term debt
 749
Total$1,461
 $992

The average amount of commercial paper outstanding was $211 million at a weighted-average rate of 1.12% during 2017. The maximum amount of commercial paper outstanding was $1.0 billion with $799 million outstanding at September 30, 2017.

13




Long-term debt and the current portion of long-term debt include:
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Principal Value$6,834
 $6,261
Adjustments to Principal Value:   
Fair value of interest rate swap contracts(3) (2)
Unamortized basis adjustment from swap terminations234
 287
Unamortized bond discounts and issuance costs(83) (81)
Total$6,982
 $6,465
    
Current portion of long-term debt$
 $749
Long-term debt6,982
 5,716

The fair value of debt was $7.4 billion at September 30, 2017 and $6.9 billion at December 31, 2016 valued using Level 2 inputs. Interest payments were $172 million and $140 million for the nine months ended September 30, 2017 and 2016, respectively, net of amounts related to interest rate swap contracts.

On February 27, 2017, BMS issued senior unsecured notes in a registered public offering. The notes rank equally in right of payment with all of BMS's existing and future senior unsecured indebtedness. BMS may redeem the notes, in whole or in part, at any time prior to maturity at a predetermined redemption price. The following table summarizes the note issuances:
Dollars in Millions2017
Principal Value: 
1.600% Notes due 2019$750
3.250% Notes due 2027750
Total$1,500
  
Proceeds net of discount and deferred loan issuance costs$1,488

During the third quarter of 2017, $750 million of 0.875% Notes matured and were repaid.

During the second quarter of 2017, the Company repurchased certain long-term debt obligations with interest rates ranging from 5.875% to 6.875%. The following summarizes the debt repurchase activity:
Dollars in Millions2017
Principal amount$337
Carrying value366
Debt redemption price474
Loss on debt redemption(a)
109
(a)Including acceleration of debt issuance costs, gain on previously terminated interest rate swap contracts and other related fees.

Note 10. RECEIVABLES
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Trade receivables$4,564
 $3,948
Less charge-backs and cash discounts(184) (126)
Less bad debt allowances(48) (48)
Net trade receivables4,332
 3,774
Alliance receivables878
 903
Prepaid and refundable income taxes334
 627
Other378
 239
Receivables$5,922
 $5,543

Non-U.S. receivables sold on a nonrecourse basis were $460 million and $470 million for the nine months ended September 30, 2017 and 2016, respectively. Receivables from our three largest pharmaceutical wholesalers in the U.S. represented 64% and 66% of total trade receivables at September 30, 2017 and December 31, 2016, respectively.

14




Note 11. INVENTORIES
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Finished goods$380
 $310
Work in process956
 988
Raw and packaging materials224
 264
Total inventories$1,560
 $1,562
    
Inventories$1,250
 $1,241
Other assets310
 321

Inventories of $120 million are included in assets held-for-sale as of September 30, 2017 due to the expected transfer of manufacturing operations in Swords, Ireland to SK Biotek. Refer to "—Note 4. Acquisitions, Divestitures and Licensing Arrangements" for additional information. Other assets include inventory expected to remain on hand beyond one year in both periods and inventory pending regulatory approval of $54 million at December 31, 2016.

Note 12. PROPERTY, PLANT AND EQUIPMENT
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Land$105
 $107
Buildings5,188
 4,930
Machinery, equipment and fixtures3,034
 3,287
Construction in progress938
 849
Gross property, plant and equipment9,265
 9,173
Less accumulated depreciation(4,251) (4,193)
Property, plant and equipment$5,014
 $4,980

Depreciation expense was $509 million and $319 million for the nine months ended September 30, 2017 and 2016, respectively. Refer to "—Note 4. Acquisitions, Divestitures and Licensing Arrangements" for additional information relating to the expected transfer of manufacturing operations in Swords, Ireland to SK Biotek.

Note 13. OTHER INTANGIBLE ASSETS
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Licenses$564
 $564
Developed technology rights2,357
 2,357
Capitalized software1,339
 1,441
IPRD32
 107
Gross other intangible assets4,292
 4,469
Less accumulated amortization(3,079) (3,084)
Other intangible assets$1,213
 $1,385

Amortization expense was $142 million and $134 million for the nine months ended September 30, 2017 and 2016, respectively.

15




Note 14. ACCRUED LIABILITIES
Dollars in Millions September 30,
2017
 December 31,
2016
Rebates and returns $1,901
 $1,680
Employee compensation and benefits 702
 818
Research and development 689
 718
Dividends 639
 660
Branded Prescription Drug Fee 251
 234
Royalties 249
 246
Restructuring 121
 90
Pension and postretirement benefits 41
 44
Litigation and other settlements 35
 43
Other 790
 738
Accrued liabilities $5,418
 $5,271

Note 15. EQUITY
 Common Stock 
Capital in  Excess
of Par Value
of Stock
 Accumulated Other Comprehensive Loss 
Retained
Earnings
 Treasury Stock 
Noncontrolling
Interest
Dollars and Shares in MillionsShares Par Value Shares Cost 
Balance at January 1, 20162,208
 $221
 $1,459
 $(2,468) $31,613
 539
 $(16,559) $158
Net earnings
 
 
 
 3,563
 
 
 46
Other comprehensive loss
 
 
 (267) 
 
 
 
Cash dividends declared
 
 
 
 (1,904) 
 
 
Stock repurchase program
 
 
 
 
 4
 (231) 
Stock compensation
 
 191
 
 
 (6) (5) 
Distributions
 
 
 
 
 
 
 (36)
Balance at September 30, 20162,208
 $221
 $1,650
 $(2,735) $33,272
 537
 $(16,795) $168
                
Balance at December 31, 20162,208
 $221
 $1,725
 $(2,503) $33,513
 536
 $(16,779) $170
Accounting change - cumulative effect(a)

 
 
 
 (787) 
 
 
Adjusted balance at January 1, 20172,208
 $221
 $1,725
 $(2,503) $32,726
 536
 $(16,779) $170
Net earnings
 
 
 
 3,335
 
 
 28
Other comprehensive income
 
 
 82
 
 
 
 
Cash dividends declared
 
 
 
 (1,920) 
 
 
Stock repurchase program
 
 
 
 
 40
 (2,226) 
Stock compensation
 
 120
 
 
 (5) 2
 
Variable interest entity
 
 
 
 
 
 
 (59)
Distributions
 
 
 
 
 
 
 (8)
Balance at September 30, 20172,208
 $221
 $1,845
 $(2,421) $34,141
 571
 $(19,003) $131
(a)Refer to "—Note 1. Basis of Presentation and Recently Issued Accounting Standards" for additional information.
    
BMS has a stock 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. The stock repurchase program does not have an expiration date and may be suspended or discontinued at any time. Treasury stock is recognized at the cost to reacquire the shares. Shares issued from treasury are recognized utilizing the first-in first-out method. BMS repurchased approximately 3.8 million shares for $226 million during the three months ended September 30, 2017.

In February 2017, BMS executed accelerated share repurchase agreements to repurchase an aggregate $2 billion of common stock. The agreements were funded through a combination of debt and cash. In February 2017, an initial delivery of approximately 28.7 million shares of BMS common stock, representing approximately 80% of the notional amount of the agreements, was received by BMS and included in treasury stock. Upon settlement of the accelerated share repurchase agreements in May 2017, BMS received an additional 7.8 million shares determined using the volume-weighted average price of BMS common stock during the term of the transaction.

16




The components of other comprehensive income/(loss) were as follows:
 2017 2016
 Pretax Tax After tax Pretax Tax After tax
Three Months Ended September 30,           
Derivatives qualifying as cash flow hedges:           
Unrealized losses$(28) $12
 $(16) $(14) $4
 $(10)
Reclassified to net earnings(a)
21
 (6) 15
 21
 (7) 14
Derivatives qualifying as cash flow hedges(7) 6
 (1) 7
 (3) 4
Pension and postretirement benefits:           
Actuarial gains/(losses)(5) 2
 (3) 72
 (26) 46
Amortization(b)
19
 (11) 8
 20
 (7) 13
Curtailments and settlements(c)
21
 (8) 13
 19
 (6) 13
Pension and postretirement benefits35
 (17) 18
 111
 (39) 72
Available-for-sale securities:           
Unrealized gains/(losses)28
 (5) 23
 (8) 4
 (4)
Realized gains(c)
(1) 
 (1) (4) 
 (4)
Available-for-sale securities27
 (5) 22
 (12) 4
 (8)
Foreign currency translation(10) 17
 7
 (2) 3
 1
 $45
 $1
 $46
 $104
 $(35) $69
            
Nine Months Ended September 30,           
Derivatives qualifying as cash flow hedges:           
Unrealized losses$(81) $31
 $(50) $(199) $66
 $(133)
Reclassified to net earnings(a)
(11) 
 (11) 12
 (5) 7
Derivatives qualifying as cash flow hedges(92) 31
 (61) (187) 61
 (126)
Pension and postretirement benefits:           
Actuarial losses(40) 17
 (23) (453) 160
 (293)
Amortization(b)
57
 (22) 35
 56
 (19) 37
Curtailments and settlements(c)
96
 (34) 62
 66
 (23) 43
Pension and postretirement benefits113
 (39) 74
 (331) 118
 (213)
Available-for-sale securities:           
Unrealized gains49
 (7) 42
 29
 (13) 16
Realized (gains)/losses(c)
(1) 
 (1) 30
 
 30
Available-for-sale securities48
 (7) 41
 59
 (13) 46
Foreign currency translation(8) 36
 28
 20
 6
 26
 $61
 $21
 $82
 $(439) $172
 $(267)

(a)Included in cost of products sold
(b)Included in cost of products sold, research and development and marketing, selling and administrative expenses
(c)Included in other (income)/expense

The accumulated balances related to each component of other comprehensive loss, net of taxes, were as follows:
Dollars in MillionsSeptember 30,
2017
 December 31, 2016
Derivatives qualifying as cash flow hedges$(23) $38
Pension and other postretirement benefits(2,023) (2,097)
Available-for-sale securities34
 (7)
Foreign currency translation(409) (437)
Accumulated other comprehensive loss$(2,421) $(2,503)


17




Note 16. PENSION AND POSTRETIREMENT BENEFIT PLANS

The net periodic benefit cost/(credit) of defined benefit pension plans includes:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Service cost – benefits earned during the year$7
 $6
 $19
 $19
Interest cost on projected benefit obligation48
 45
 142
 145
Expected return on plan assets(104) (104) (308) (314)
Amortization of prior service credits(1) (1) (3) (3)
Amortization of net actuarial loss20
 22
 61
 62
Curtailments and settlements22
 19
 91
 66
Special termination benefits
 
 
 1
Net periodic benefit cost/(credit)$(8) $(13) $2
 $(24)

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. pension plans. The charges included the acceleration of a portion of unrecognized actuarial losses. Non-current pension liabilities were $477 million at September 30, 2017 and $600 million at December 31, 2016. Defined contribution plan expense in the U.S. was $46 million and $49 million for the three months ended September 30, 2017 and 2016, respectively, and $142 million and $141 million for the nine months ended September 30, 2017 and 2016, respectively.

Note 17. LEGAL PROCEEDINGS AND CONTINGENCIES
The Company 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. 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 or that the Company believes could become material are described below.
Although the Company believes it has substantial defenses in these matters, there can be no assurance that there will not be an increase in the scope of pending matters or that any future lawsuits, claims, government investigations or other legal proceedings will not be material. Unless otherwise noted, the Company is unable to assess the outcome of the respective litigation nor is it able to provide an estimated range of potential loss. Furthermore, failure to enforce our 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 has been remanded to the Federal Court for further proceedings related to damages sought by Apotex. The Australian government has intervened in this matter and is also seeking damages for alleged losses experienced during the period when the injunction was in place. The Company and Apotex have settled the Apotex case, and the case has been dismissed. The Australian government's claim is

18




still pending and a trial was concluded in September 2017. The Company is expecting a decision in 2018. It is not possible at this time to predict the outcome of the Australian government’s claim or its impact on the Company.
Sprycel - European Union
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. The ‘038 patent is scheduled to expire in April 2020 (excluding potential term extensions). 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 our 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. The Company intends to take appropriate legal actions to protect Sprycel. We may experience a decline in European revenues in the event that generic dasatinib product enters the market.
Anti-PD-1 Antibody Patent Oppositions and Litigation
In September 2015, Dana-Farber Cancer Institute (Dana-Farber) filed a complaint in Massachusetts federal court seeking to correct the inventorship of five 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 September 2017, Pfizer filed a motion seeking to intervene in this case alleging that one of the scientists identified by Dana-Farber was employed by a company eventually acquired by Pfizer. This motion has not been acted upon by the court.
Eliquis Patent Litigation
In February, March and April 2017, twenty-five generic companies sent the Company Paragraph-IV certification letters informing the Company that they had filed abbreviated new drug applications (ANDAs) seeking approval of generic versions of Eliquis. As a result, two Eliquis patents listed in the FDA Orange Book have now been challenged: the composition of matter patent claiming apixaban specifically and a formulation patent. In April 2017, the Company, along with its partner Pfizer, initiated patent lawsuits under the Hatch-Waxman Act against all generic filers in federal district courts in Delaware and West Virginia. In August 2017, the United States 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 basis for projected loss of exclusivity, from February 2023 to November 2026. In September 2017, the Company settled its lawsuit with Teva Pharmaceuticals USA, Inc. and the parties agreed to dismiss the case. The settlement does not impact the Company’s projected loss of exclusivity for Eliquis.
PRICING, SALES AND PROMOTIONAL PRACTICES LITIGATION
Plavix* State Attorneys General Lawsuits
The Company and certain affiliates of Sanofi are defendants in consumer protection and/or false advertising actions brought by several states relating to the sales and promotion of Plavix*. It is not possible at this time to reasonably assess the outcome of these lawsuits or their potential impact on the Company.
PRODUCT LIABILITY LITIGATION
The Company 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 also faces unfiled claims involving its products.
Plavix*
As previously disclosed, the Company and certain affiliates of Sanofi are defendants in a number of individual lawsuits in various state and federal courts claiming personal injury damage allegedly sustained after using Plavix*. Over 5,000 claims involving injury plaintiffs as well as claims by spouses and/or other beneficiaries, have been filed in state and federal courts in various states including California, New Jersey, Delaware and New York. In February 2013, the Judicial Panel on Multidistrict Litigation granted the Company and Sanofi’s motion to establish a multi-district litigation (MDL) to coordinate Federal pretrial proceedings in Plavix* product liability and related cases in New Jersey Federal Court. Following the United States Supreme Court’s June 2017 reversal of a California Supreme Court decision that had held that the California state courts can exercise personal jurisdiction over the claims of non-California residents, over 2,000 out-of-state resident plaintiffs' claims (including spouses and beneficiaries) previously pending in the California state court have been, or are in the process of being dismissed. Some number of these California non-resident plaintiffs’ claims may be re-filed in federal court. It is not possible at this time to reasonably assess the outcome of these lawsuits or the potential impact on the Company.

19




Byetta*
Amylin, a former subsidiary of the Company, and Lilly are co-defendants in product liability litigation related to Byetta*. To date, there are over 500 separate lawsuits pending on behalf of approximately 2,000 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 Company has agreed in principle to resolve over 15 of these claims. The majority of these cases have been brought by individuals who allege personal injury sustained after using Byetta*, primarily pancreatic cancer and pancreatitis, and, in some cases, claiming alleged wrongful death. The majority of cases were pending in Federal Court in San Diego in an MDL or in a coordinated proceeding in California Superior Court in Los Angeles (JCCP). In November 2015, the defendants' motion for summary judgment based on federal preemption was granted in both the MDL and the JCCP. The plaintiffs in the MDL have appealed to the U.S. Court of Appeals for the Ninth Circuit and the JCCP plaintiffs have appealed to the California Court of Appeal. Amylin has product liability insurance covering a substantial number of claims involving Byetta* and any additional liability to Amylin with respect to Byetta* is expected to be shared between the Company and AstraZeneca. It is not possible to reasonably predict the outcome of any lawsuit, claim or proceeding or the potential impact on the Company.
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 400 cases filed in state and federal courts and several additional cases are pending in Canada. The Judicial Panel on Multidistrict Litigation has consolidated the federal court cases for pretrial purposes in the United States District Court for the Northern District of Florida.
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. The majority of these claims are pending in an MDL in the United States District Court for the Southern District of New York and in state court in Delaware. As of October 2017, there are over 150 cases pending in the MDL and state courts in the United States and one pending in Canada. Over 80 cases have been dismissed with prejudice by the MDL. Plaintiffs have appealed some of the dismissed cases to the Second Circuit Court of Appeals.
SHAREHOLDER DERIVATIVE LITIGATION
Since December 2015, three shareholder derivative lawsuits were filed in New York state court against certain officers and directors of the Company. The plaintiffs allege, among other things, breaches of fiduciary duty surrounding the Company’s previously disclosed October 2015 civil settlement with the Securities and Exchange Commission of alleged Foreign Corrupt Practices Act violations in China in which the Company agreed to a payment of approximately $14.7 million in disgorgement, penalties and interest. As of October 2017, all three of the lawsuits have been dismissed. The Company received a notice of appeal for one of the lawsuits in September 2017.
GOVERNMENT INVESTIGATIONS
Like other pharmaceutical companies, the Company and certain of its subsidiaries are subject to extensive regulation by national, state and local government agencies in the U.S. and other countries in which BMS operates. As a result, the Company, from time to time, is subject to various governmental inquiries and investigations. It is possible that criminal charges, substantial fines and/or civil penalties, could result from government investigations.
ENVIRONMENTAL PROCEEDINGS
As previously reported, the Company 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 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 is responsible under various state, federal and foreign laws, the Company 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 accrues liabilities when they are probable and reasonably estimable. The Company estimated its share of future costs for these sites to be $63 million at September 30, 2017, 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.

20




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

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 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 four strategic priorities are to drive business performance, continue to build a strong franchise in IO, maintain a diversified portfolio both within and outside of IO, and continue our disciplined approach to capital allocation, including establishing partnerships and collaborations as an essential component of successfully delivering transformational medicines to patients. Refer to the Summary of Abbreviated Terms at the end of this Quarterly Report on Form 10-Q for terms used throughout the document.

Our revenues increased by 8% for the nine months ended September 30, 2017 as a result of higher demand for our prioritized brands including Opdivo and Eliquis partially offset by increased competition for established brands, primarily Daklinza. The $0.10 decrease in GAAP EPS was due to higher license, asset acquisition and restructuring related charges and lower divestiture related income. These items were partially offset by higher revenues, royalties and licensing income and the patent-infringement litigation settlement related to Merck's PD-1 antibody Keytruda* (pembrolizumab). After adjusting for licensing income, litigation settlements, license and asset acquisition charges and other specified items, non-GAAP EPS increased $0.12.
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions, except per share data2017 2016 2017 2016
Total Revenues$5,254
 $4,922
 $15,327
 $14,184
        
Diluted Earnings Per Share       
GAAP0.51
 0.72
 2.02
 2.12
Non-GAAP0.75
 0.77
 2.32
 2.20

Our non-GAAP financial measures, including non-GAAP earnings and related EPS information, are adjusted to exclude specified items which 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.”

Puerto Rico Update
Like many others in the pharmaceutical industry, we have manufacturing and commercial operations in Puerto Rico which were impacted by the recent hurricanes. Our two manufacturing sites sustained some damage but are currently operating at limited capacity. We continue to work to restore to normal operations. Our first priority was to ensure the safety and well-being of our employees. We have accounted for 100% of our employees and continue to provide humanitarian aid as needed. Our business continuity plans have been successful to date despite very challenging conditions with no supply disruption to date. In addition, we do not foresee any product supply issues. Although our financial results for the quarter were not significantly impacted, we will continue to monitor and assess the ongoing effects.

21




Significant Product and Pipeline Approvals

The following is a summary of significant approvals received in 2017:
ProductDateApproval
OpdivoSeptember 2017FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib.
September 2017Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono.
August 2017FDA approval for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
June 2017EC approval for the treatment of patients with previously treated locally advanced unresectable or metastatic urothelial carcinoma, a type of bladder cancer, in adults after failure of platinum-containing therapy.
April 2017EC approval for the treatment of SCCHN in adults progressing on or after platinum-based therapy.
March 2017Approval in Japan for the treatment of recurrent or metastatic HNC, received by our alliance partner, Ono.
February 2017FDA approval for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
OrenciaJuly 2017EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
July 2017FDA approval for the treatment of active PsA in adults.
March 2017FDA approval of a new subcutaneous administration option for use in patients two years of age and older with moderately to severely active polyarticular JIA.
YervoyJuly 2017FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients.
Hepatitis C FranchiseApril 2017
China FDA approval of the Daklinza and Sunvepra regimen for treatment-naive or experienced patients infected with genotype 1b chronic HCV. In addition, Daklinza was approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection.
Refer to "—Product and Pipeline Developments" for all of the developments in our marketed products and late-stage pipeline in 2017.

Acquisitions and Licensing Arrangements
Acquisition and licensing transactions 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 and fibrosis. Significant transactions entered into in 2017 are summarized below. Refer to "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures and Licensing Arrangements" for further information.
Halozyme
In the third quarter of 2017, BMS and Halozyme announced a global collaboration and license agreement to develop subcutaneously administered BMS IO medicines using Halozyme's ENHANZE* drug-delivery technology. This transaction is expected to close in the fourth quarter of 2017 subject to obtaining customary regulatory and antitrust approvals.
IFM
In the third quarter of 2017, BMS acquired all of the outstanding shares of IFM, a private biotechnology company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory diseases. The acquisition provides BMS with full rights to IFM's preclinical STING and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer.
Biogen
In the second quarter of 2017, BMS out-licensed to Biogen exclusive rights to develop and commercialize BMS-986168, an anti-eTau compound in development for Progressive Supranuclear Palsy.
Roche
In the second quarter of 2017, BMS out-licensed to Roche exclusive rights to develop and commercialize BMS-986089, an anti-myostatin adnectin in development for Duchenne Muscular Dystrophy.

22




CytomX
In the second quarter of 2017, BMS and CytomX, a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, expanded their strategic collaboration to discover novel therapies that will include up to eight additional targets using CytomX’s proprietary Probody platform.

RESULTS OF OPERATIONS

Regional Revenues
 Three Months Ended September 30, Nine Months Ended September 30,
 Total Revenues 2017 vs. 2016 Total Revenues 2017 vs. 2016
Dollars in Millions2017 2016 Total Change 
Foreign Exchange(b)
 2017 2016 Total Change 
Foreign Exchange(b)
United States$2,864
 $2,790
 3 % 
 $8,467
 $8,015
 6 % 
Europe1,262
 946
 33 % 5 % 3,596
 2,855
 26 % (1)%
Rest of the World970
 1,069
 (9)% (2)% 2,858
 2,922
 (2)% (1)%
Other(a)
158
 117
 35 % N/A
 406
 392
 4 % N/A
Total$5,254
 $4,922
 7 % 1 % $15,327
 $14,184
 8 % (1)%

(a)Other revenues include royalties and alliance-related revenues for products not sold by our regional commercial organizations.
(b)Foreign exchange impacts were derived by applying the prior period average currency rates to the current period sales.
U.S. revenues increased in both periods due to higher demand for Eliquis and Opdivo partially offset by lower demand for established brands due to increased competition, primarily Daklinza. Average U.S. net selling prices were approximately 2% higher after charge-backs, rebates and discounts in the nine months ended September 30, 2017 compared to the prior year period. Refer to “—Product Revenues” below for additional information.
Europe revenues increased in both periods due to higher demand for Opdivo and Eliquis partially offset by lower demand for Daklinza due to increased competition.
Rest of the World revenues decreased in both periods due to lower demand for established brands, including Daklinza, due to increased competition and the divestiture of certain other brands partially offset by higher demand for Opdivo and Eliquis.
No single country outside the U.S. contributed more than 10% of total revenues during the nine months ended September 30, 2017 or 2016. 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 (excluding alliance and other revenues such as Atripla*):

Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 % Change 2017 2016 % Change
Gross product sales$6,555
 $5,698
 15% $18,723
 $16,252
 15%
GTN adjustments:           
Charge-backs and cash discounts(583) (427) 37% (1,521) (1,174) 30%
Medicaid and Medicare rebates(573) (397) 44% (1,474) (1,018) 45%
Other rebates, returns, discounts and adjustments(537) (382) 41% (1,516) (1,172) 29%
Total GTN adjustments(1,693) (1,206) 40% (4,511) (3,364) 34%
Net product sales$4,862
 $4,492
 8% $14,212
 $12,888
 10%
            
GTN adjustments percentage26% 21% 5% 24% 21% 3%
U.S.32% 26% 6% 30% 26% 4%
Non-U.S.15% 14% 1% 14% 12% 2%
Reductions to provisions for product sales made in prior periods resulting from changes in estimates were $65 million and $143 million in the nine months ended September 30, 2017 and 2016, respectively. GTN adjustments are primarily a function of product sales volume, regional and payer channel mix, contractual and legislative discounts and rebates. GTN adjustments are increasing at a higher rate than gross product sales due to higher U.S. Eliquis gross product sales, which has a relatively high GTN adjustment percentage.

23




Product Revenues
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 % Change 2017 2016 % Change
Prioritized Brands           
Opdivo$1,265
 $920
 38 % $3,587
 $2,464
 46 %
U.S.778
 712
 9 % 2,307
 1,949
 18 %
Non-U.S.487
 208
 **
 1,280
 515
 **
            
Eliquis1,232
 884
 39 % 3,509
 2,395
 47 %
U.S.717
 512
 40 % 2,119
 1,424
 49 %
Non-U.S.515
 372
 38 % 1,390
 971
 43 %
            
Orencia632
 572
 10 % 1,817
 1,640
 11 %
U.S.432
 387
 12 % 1,243
 1,109
 12 %
Non-U.S.200
 185
 8 % 574
 531
 8 %
            
Sprycel509
 472
 8 % 1,478
 1,330
 11 %
U.S.278
 259
 7 % 806
 702
 15 %
Non-U.S.231
 213
 8 % 672
 628
 7 %
            
Yervoy323
 285
 13 % 975
 789
 24 %
U.S.239
 222
 8 % 727
 600
 21 %
Non-U.S.84
 63
 33 % 248
 189
 31 %
            
Empliciti60
 41
 46 % 168
 103
 63 %
U.S.39
 36
 8 % 112
 97
 15 %
Non-U.S.21
 5
 **
 56
 6
 **
            
Established Brands           
Hepatitis C Franchise73
 379
 (81)% 347
 1,352
 (74)%
U.S.24
 192
 (88)% 96
 745
 (87)%
Non-U.S.49
 187
 (74)% 251
 607
 (59)%
            
Baraclude264
 306
 (14)% 819
 896
 (9)%
U.S.14
 17
 (18)% 40
 49
 (18)%
Non-U.S.250
 289
 (13)% 779
 847
 (8)%
            
Sustiva Franchise183
 275
 (33)% 555
 819
 (32)%
U.S.157
 234
 (33)% 471
 689
 (32)%
Non-U.S.26
 41
 (37)% 84
 130
 (35)%
            
Reyataz Franchise174
 238
 (27)% 555
 706
 (21)%
U.S.85
 125
 (32)% 260
 367
 (29)%
Non-U.S.89
 113
 (21)% 295
 339
 (13)%
            
Other Brands539
 550
 (2)% 1,517
 1,690
 (10)%
U.S.101
 94
 7 % 286
 284
 1 %
Non-U.S.438
 456
 (4)% 1,231
 1,406
 (12)%
**    Change in excess of 100%

24



Opdivo (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 in both periods due to higher demand. We expect increased competition for Opdivo to continue in the future.
International revenues increased in both periods due to higher demand as a result of launches of additional indications and approvals in new countries.
Eliquis (apixaban) — an oral Factor Xa inhibitor, targeted at stroke prevention in adult patients with non-valvular atrial fibrillation and the prevention and treatment of venous thromboembolic disorders.
U.S. and international revenues increased in both periods due to higher demand resulting from increased commercial acceptance of novel oral anticoagulants and market share gains.
Orencia (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 juvenile idiopathic arthritis.
U.S. revenues increased in both periods due to higher average net selling prices and demand.
International revenues increased in both periods due to higher demand.
Sprycel (dasatinib) — an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia 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).
U.S. revenues increased in both periods primarily due to higher demand.
International revenues increased in both periods due to higher demand.
Yervoy (ipilimumab) — a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma.
U.S. revenues increased in both periods primarily due to higher demand.
International revenues increased in both periods due to higher demand.
Empliciti (elotuzumab) — a humanized monoclonal antibody for the treatment of multiple myeloma.
Empliciti was launched in the U.S. in December 2015, in the EU in May 2016 and in Japan in September 2016.
Hepatitis C Franchise — Daklinza (daclatasvir) - an NS5A replication complex inhibitor; Sunvepra (asunaprevir) - an NS3 protease inhibitor; and beclabuvir - an NS5B inhibitor. Includes Ximency, a single pill combination of daclatasvir, asunaprevir and beclabuvir in Japan.
U.S. and international revenues decreased in both periods due to lower demand resulting from increased competition.
Baraclude (entecavir) — an oral antiviral agent for the treatment of chronic hepatitis B.
International revenues continued to decrease in both periods due to lower demand resulting from increased competition.
Sustiva (efavirenz) Franchise — a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV, which includes Sustiva, an antiretroviral drug, and bulk efavirenz, which is also included in the combination therapy, Atripla*.
U.S. revenues continued to decrease in both periods due to lower demand resulting from increased competition. The loss of exclusivity for Sustiva is expected in December 2017 which may result in the termination of the joint venture agreement with Gilead and further reduce revenues beyond 2017.
Reyataz (atazanavir sulfate) Franchise — Includes Reyataz - a protease inhibitor for the treatment of HIV and Evotaz (atazanavir 300 mg and cobicistat 150 mg) - a combination therapy containing Reyataz and Tybost* (cobicistat).
U.S. revenues continued to decrease due to lower demand resulting from increased competition. The loss of exclusivity is expected in December 2017 and will result in a higher decline in revenues in future periods due to generic competition.
International revenues continued to decrease in both periods due to lower demand.
Other Brands — includes all other products, including those which have lost exclusivity in major markets, OTC brands and royalty revenue.
International revenues decreased in both periods due to out-licensing and divestiture of certain other brands and continued generic erosion.

25




Estimated End-User Demand
Pursuant to the SEC Consent Order described in our 2016 Annual Report on 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. No U.S. products had estimated levels of inventory in the distribution channel in excess of one month on hand at September 30, 2017. Below are international products that had estimated levels of inventory in the distribution channel in excess of one month at June 30, 2017.
Dafalgan, an analgesic product sold principally in Europe, had 1.2 months of inventory on hand internationally at direct customers compared to 1.3 months of inventory on hand at March 31, 2017. The level of inventory on hand was primarily due to the ordering patterns of pharmacists in France.
Fervex, a cold and flu product, had 4.0 months of inventory on hand at direct customers compared to 2.7 months of inventory on hand at March 31, 2017. The level of inventory on hand was attributable to France to support product seasonality.
Perfalgan, an analgesic product, had 1.5 months of inventory on hand internationally at direct customers compared to 1.6 months of inventory on hand at March 31, 2017. The level of inventory on hand was due to extended delivery lead time primarily in the Gulf Countries.
Sunvepra, a Hepatitis C product, had 1.1 months of inventory on hand at direct customers compared to 1.1 months of inventory on hand at March 31, 2017. The level of inventory on hand was attributable to decreasing in-market sales primarily in Japan.
Ximency, a Hepatitis C product, had 1.1 months of inventory on hand at direct customers compared to 2.4 months of inventory on hand at March 31, 2017. The product was launched in February 2017 in Japan.
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 and our distributors. Our three largest wholesalers account for approximately 95% of total gross sales of U.S. products. Factors that may influence our estimates include generic competition, 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.

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 a result, all of the information required to estimate months on hand in the direct customer distribution channel for non-U.S. businesses for the quarter ended September 30, 2017 is not available prior to the filing of this quarterly report on Form 10-Q. We will disclose any product with 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 annual report on Form 10-K.

Expenses
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 % Change 2017 2016 % Change
Cost of products sold$1,572
 $1,305
 20 % $4,393
 $3,563
 23 %
Marketing, selling and administrative1,147
 1,144
 
 3,388
 3,450
 (2)%
Research and development1,543
 1,138
 36 % 4,490
 3,540
 27 %
Other (income)/expense(191) (224) (15)% (1,377) (1,198) 15 %
Total Expenses$4,071
 $3,363
 21 % $10,894
 $9,355
 16 %

Cost of products sold increased in both periods due to higher Eliquis profit sharing (approximately $150 million and $520 million for the three and nine months ended September 30, 2017, respectively) and higher inventory charges, including a $70 million charge resulting from lower expected HCV demand requirements. The nine months ended September 30, 2017 also included a $128 million impairment charge to reduce the carrying value of assets held-for-sale to their estimated fair value. Refer to "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures and Licensing Arrangements" for further information.

26





Research and development expense increased in both periods due to higher license and asset acquisition charges, accelerated depreciation and the expansion of Opdivo development programs. The nine months ended September 30, 2017 also included higher IPRD impairment charges.

The significant license and asset acquisition transactions and other charges included in R&D expense were as follows:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
IFM$310
 $
 $310
 $
CytomX
 
 200
 10
Flexus
 
 93
 100
Cardioxyl
 
 100
 
Padlock
 
 
 139
Cormorant
 35
 
 35
Other
 10
 50
 25
License and asset acquisition charges310
 45
 753
 309
IPRD impairments
 
 75
 
Accelerated depreciation and other64
 14
 232
 40

License and asset acquisition charges include upfront payments for the IFM, CytomX, Padlock and Cormorant arrangements and milestone payments for the CytomX, Flexus and Cardioxyl arrangements. These arrangements were related to certain investigational oncology, cardiovascular and immunoscience compounds.
IPRD impairment charges in the nine months ended September 30, 2017 related to the discontinued development of an investigational compound which was part of our alliance with F-Star Alpha.
Accelerated depreciation and other charges resulted from the expected exit of R&D sites in the U.S. through 2020 primarily due to the reduction in the estimated useful lives of the related assets for each site.

Refer to "Item 1. Financial Statements—Note 3. Alliances, Note 4. Acquisitions, Divestitures and Licensing Arrangements and Note 6. Restructuring" for further information.

Other income increased in the nine months ended September 30, 2017 due to higher royalties and licensing income and litigation and other settlement income partially offset by lower divestiture gains and transition and other service fees and higher restructuring charges. The significant changes included in other income were as follows:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Provision for restructuring$28
 $19
 $207
 $41
Litigation and other settlements
 (1) (489) 48
Divestiture (gains)/losses1
 (21) (126) (574)
Royalties and licensing income(209) (158) (1,093) (579)
Transition and other service fees(12) (57) (32) (184)

Restructuring charges relate to changes to the Company's operating model to drive continued success in the near- and long-term through a more focused investment in commercial opportunities for key brands and markets, a competitive and more agile R&D organization that can accelerate the pipeline, streamline operations and realign manufacturing capabilities that broaden biologics capabilities to reflect the current and future portfolio as well as streamline and simplify our small-molecule supply network. The new operating model is expected to enable the Company to deliver the strategic, financial and operational flexibility necessary to invest in the highest priorities across the Company. Aggregate restructuring charges of approximately $250 million are expected to be incurred in 2017 for all actions in addition to accelerated depreciation impacts resulting from early site exits.
Litigation and other settlements include BMS's share of a patent-infringement litigation settlement related to Merck's PD-1 antibody Keytruda* in the first quarter of 2017 as BMS and Ono signed a global patent license agreement with Merck. Merck made an initial payment of $625 million to BMS and Ono, of which BMS received $481 million. Merck is also obligated to pay ongoing royalties on global sales of Keytruda* of 6.5% from January 1, 2017 through December 31, 2023, and 2.5% from January 1, 2024 through December 31, 2026. The companies also granted certain rights to each other under their respective

27




patent portfolios pertaining to PD-1. Payments and royalties are shared between BMS and Ono on a 75/25 percent allocation, respectively after adjusting for each parties' legal fees.
Divestiture gains include additional contingent consideration for the diabetes business ($100 million) in the first quarter of 2017, an OTC product business in the second quarter of 2016 ($277 million) and the investigational HIV medicines business in the first quarter of 2016 ($272 million).
Royalties and licensing income include upfront licensing fees from Biogen ($300 million) and Roche ($170 million) in the second quarter of 2017 in connection with the out-licensing of certain investigational genetically defined disease compounds.
Transition and other service fees in 2016 included fees resulting from the divestiture of the diabetes business in 2014 and the investigational HIV medicines business in 2016.

Refer to "Item 1. Financial Statements—Note 4. Acquisitions, Divestitures and Licensing Arrangements, Note 5. Other (Income)/Expense, Note 6. Restructuring and Note 9. Financial Instruments and Fair Value Measurements" for further information.

Income Taxes
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Earnings Before Income Taxes$1,183
 $1,559
 $4,433
 $4,829
Provision for Income Taxes327
 344
 1,129
 1,220
Effective Tax Rate27.6% 22.1% 25.5% 25.3%

The jurisdictional tax rates and other tax impacts attributed to R&D charges, divestiture transactions and other specified items increased the effective tax rate by 3.7% and 3.1% in the nine months ended September 30, 2017 and 2016, respectively. In addition, the adoption of amended income tax accounting guidance reduced the effective tax rate by 2.1% in the nine months ended September 30, 2017 which was offset by earnings mix between high and low tax jurisdictions. Refer to "Item 1. Financial Statements—Note 1. Basis of Presentation and Recently Issued Accounting Standards and Note 7. Income Taxes" for further information.

Comprehensive U.S. tax reform continues to be discussed and proposed, including among other items, changes to the corporate tax rate, a border adjustment tax and changes to how the U.S. taxes foreign earnings. It is currently uncertain whether any of these changes will be enacted, and if so, the effective dates. If comprehensive tax reform occurs, our financial condition, results of operations and cash flows could be significantly impacted, however, we are unable to determine the potential impact at this time.


Non-GAAP Financial Measures

Our non-GAAP financial measures, including 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 restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with the acquisition or licensing of third-party intellectual property rights, divestiture and debt redemption gains or losses, pension charges and legal and other contractual settlements, 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.

Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and 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 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.


28




Specified items were as follows:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions2017 2016 2017 2016
Impairment charges$1
 $
 $128
 $
Accelerated depreciation and other shutdown costs
 7
 3
 15
Cost of products sold1
 7
 131
 15
        
License and asset acquisition charges310
 45
 753
 309
IPRD impairments
 
 75
 
Accelerated depreciation and other64
 14
 232
 40
Research and development374
 59
 1,060
 349
        
Provision for restructuring28
 19
 207
 41
Litigation and other settlements
 (3) (481) 40
Divestiture gains
 (13) (100) (559)
Royalties and licensing income
 
 (497) 
Pension charges22
 19
 91
 66
Intangible asset impairments
 
 
 15
Loss on debt redemption
 
 109
 
Other (income)/expense50
 22
 (671) (397)
        
Increase/(decrease) to pretax income425
 88
 520
 (33)
Income taxes on specified items(41) (3) 51
 156
Increase to net earnings384
 85
 571
 123
Noncontrolling interest
 
 (59) 
Increase to net earnings used for Diluted Non-GAAP EPS calculation$384
 $85
 $512
 $123

The reconciliations from GAAP to Non-GAAP were as follows:
 Three Months Ended September 30, Nine Months Ended September 30,
Dollars in Millions, except per share data2017 2016 2017 2016
Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP$845
 $1,202
 $3,335
 $3,563
Specified Items384
 85
 512
 123
Net Earnings used for Diluted EPS Calculation – Non-GAAP$1,229
 $1,287
 $3,847
 $3,686
        
Average Common Shares Outstanding – Diluted1,645
 1,679
 1,655
 1,679
        
Diluted Earnings Per Share – GAAP$0.51
 $0.72
 $2.02
 $2.12
Diluted EPS Attributable to Specified Items0.24
 0.05
 0.30
 0.08
Diluted Earnings Per Share – Non-GAAP$0.75
 $0.77
 $2.32
 $2.20

29




FINANCIAL POSITION, LIQUIDITY, AND CAPITAL RESOURCES

Our net cash position was as follows:
Dollars in MillionsSeptember 30,
2017
 December 31,
2016
Cash and cash equivalents$4,644
 $4,237
Marketable securities – current2,478
 2,113
Marketable securities – non-current2,526
 2,719
Cash, cash equivalents and marketable securities9,648
 9,069
Short-term debt obligations(1,461) (992)
Long-term debt(6,982) (5,716)
Net cash position$1,205
 $2,361

Cash, cash equivalents and marketable securities held in the U.S. were approximately $200 million at September 30, 2017. Most of the remaining $9.4 billion is held primarily in low-tax jurisdictions attributable to earnings expected to be indefinitely reinvested offshore. Cash repatriations are subject to restrictions in certain jurisdictions and may be subject to withholding and additional U.S. income taxes. We believe that our existing cash, cash equivalents and marketable securities together with cash generated from operations and issuance of commercial paper in the U.S. will be sufficient to satisfy our normal cash requirements for at least the next few years, including dividends, capital expenditures, milestone payments, working capital and maturities of long-term debt.

Management continuously evaluates the Company’s capital structure to ensure the Company is 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.

The Company repurchased $2.2 billion of common stock in 2017 through accelerated share repurchase agreements, Rule 10b5-1 plans and open market purchases. The stock repurchases were funded by $1.5 billion of new long-term debt and cash. The Company repaid $750 million of long-term debt at maturity in the third quarter of 2017 and repurchased $337 million of long-term debt in the second quarter of 2017. Refer to “Item 1. Financial Statements—Note 9. Financial Instruments and Fair Value Measurements and Note 15. Equity" for further information.

We issued commercial paper to fund near-term domestic liquidity requirements during 2017. The average amount of commercial paper outstanding was $211 million at a weighted-average rate of 1.12% during 2017. The maximum amount of commercial paper outstanding was $1.0 billion with $799 million outstanding at September 30, 2017.

Dividend payments were $1.9 billion in each of the nine months ended September 30, 2017 and 2016. Dividends declared per common share were $1.17 and $1.14 in the nine months ended September 30, 2017 and 2016, respectively. Dividend decisions are made on a quarterly basis by our Board of Directors. Annual capital expenditures were $1.2 billion in 2016 and are expected to be approximately $1.0 billion in 2017 and $900 million in 2018. We continue 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 therapies for our growing biologics portfolio when completed in 2019.

Our investment portfolio includes non-current marketable 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 duration 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.

We currently have three separate revolving credit facilities totaling $5 billion from a syndicate of lenders. The facilities provide for customary terms and conditions with no financial covenants. Our 364 day $2.0 billion facility expires in March 2018 and our two $1.5 billion facilities were extended to October 2021 and July 2022. Our two $1.5 billion, five-year 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 September 30, 2017 or December 31, 2016.

Additional regulations in the U.S. could be passed in the future including additional healthcare reform initiatives, comprehensive tax reform, 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.

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Credit Ratings

BMS's 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. BMS's long-term and short-term credit ratings assigned by Standard & Poor's are A+ and A-1+, respectively, with a stable long-term credit outlook. BMS's long-term and short-term credit ratings assigned by Fitch are A- and F2, respectively, with a stable long-term credit outlook. Our 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. Our short-term ratings reflect the agencies' opinion that we have good to extremely strong capacity for timely repayment. 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:
 Nine Months Ended September 30,
Dollars in Millions2017 2016
Cash flow provided by/(used in):   
Operating activities$4,158
 $1,615
Investing activities(1,085) 1,464
Financing activities(2,725) (2,048)
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 (120 days to 150 days). 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 $2.5 billion change in cash flow from operating activities compared to 2016 was primarily attributable to the following items in addition to increased sales and the timing of cash collections and payments in the ordinary course of business:
Lower income tax payments of approximately $1.4 billion;
Higher out-license proceeds of approximately $500 million primarily related to the Biogen and Roche transactions; and
BMS's share of litigation settlement proceeds of $481 million related to Merck's PD-1 antibody Keytruda*.
Partially offset by:
Higher R&D licensing payments of approximately $300 million primarily due to the CytomX transaction.
Investing Activities

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

The $2.5 billion change in cash flow from investing activities compared to 2016 was primarily attributable to:
Lower net sales of marketable securities with maturities greater than 90 days of $1.6 billion due to higher available cash balances;
Lower business divestiture proceeds of approximately $700 million primarily due to certain OTC products and investigational HIV business divestitures in 2016; and
Higher asset acquisition payments of approximately $400 million primarily due to the acquisition of IFM in 2017.
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 $677 million change in cash flow from financing activities compared to 2016 was primarily attributable to:
Higher repurchase of common stock of $2.0 billion primarily due to the accelerated share repurchase agreements.
Partially offset by:
Higher net borrowings of $1.4 billion primarily to fund the repurchase of common stock.

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Product and Pipeline Developments
We manage our R&D programs on a portfolio basis, investing resources in each stage from early discovery through late-stage development. We continually evaluate our portfolio of R&D assets to ensure that there is an appropriate balance of early- and late-stage programs to support future growth. We consider our R&D programs that have entered into Phase III development to be significant, as these programs constitute our late-stage development pipeline. These programs include both investigational compounds in Phase III development for initial indications and marketed products in Phase III development for additional indications or formulations. The following are the recent developments in our marketed products and our late-stage pipeline:
ProductIndicationDateDevelopments
OpdivoGastricSeptember 2017Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono.
HCCSeptember 2017FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib.
mCRCAugust 2017FDA approval for the treatment of adult and pediatric patients with MSI-H or dMMR mCRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
MelanomaOctober 2017
Announced FDA accepted for priority review the Company's sBLA for Opdivo to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA action date is February 14, 2018.
September 2017
Announced treatment with Opdivo resulted in significant improvement in recurrence-free survival compared to Yervoy in patients with stage IIIb/c or stage IV melanoma following complete surgical resection.
July 2017
Announced a Phase III trial evaluating Opdivo versus Yervoy in patients with stage IIIb/c or stage IV melanoma who are at high risk of recurrence following complete surgical resection met its primary endpoint of recurrence-free survival at a planned interim analysis.
Multiple MyelomaSeptember 2017
Announced the FDA placed a partial clinical hold on CheckMate-602, CheckMate-039 and CA204142, three clinical trials investigating Opdivo based combinations in patients with relapsed or refractory multiple myeloma. This partial clinical hold is related to risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma.
NSCLCSeptember 2017
Announced three-year overall survival data from CheckMate-017 and CheckMate-057, two pivotal Phase III randomized studies evaluating Opdivo vs. docetaxel in patients with previously treated metastatic NSCLC.
VariousJuly 2017
BMS and Clovis Oncology, Inc. announced a clinical collaboration to evaluate the combination of Opdivo and Rubraca* (rucaparib) in pivotal Phase III trials in advanced ovarian cancer and triple-negative breast cancer as well as a Phase II trial in metastatic castration-resistant prostate cancer.
Announced FDA accepted the Company's sBLAs to update Opdivo dosing to include 480 mg infused over 30 minutes every four weeks for all currently approved monotherapy indications. The FDA action date is March 5, 2018.
    
Opdivo+YervoyRCCSeptember 2017
Announced CheckMate-214, a Phase III study evaluating Opdivo+Yervoy versus sunitinib in patients with previously untreated advanced or metastatic RCC, met its co-primary endpoint, demonstrating superior overall survival in intermediate- and poor-risk patients. The combination also met a secondary endpoint of improved OS in all randomized patients. Based on a planned interim analysis, an independent Data Monitoring Committee has recommended that the trial be stopped early.
August 2017
Announced topline results from CheckMate-214. The combination of Opdivo+Yervoy met the co-primary endpoint of objective response rate and was favored in the co-primary endpoint of progression-free survival, however, it did not reach statistical significance.
July 2017
BMS and Exelixis, Inc. announced the initiation of the Phase III CheckMate 9ER trial to evaluate Opdivo in combination with Cabometyx* (cabozantinib) or Opdivo and Yervoy in combination with Cabometyx* versus sunitinib in patients with previously untreated, advanced or metastatic RCC.
SCLCOctober 2017
Announced data evaluating Opdivo and Opdivo+Yervoy in previously treated SCLC patients whose tumors were evaluable for tumor mutation burden from the Phase I/II CheckMate-032 trial.

32




ProductIndicationDateDevelopments
EliquisNVAFAugust 2017
Announced results from a real-world data analysis of the U.S. Humana database, in which treatment with Eliquis was associated with a significantly lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin in patients aged 65 years and older with NVAF.
Announced data from EMANATE, a Phase IV trial, exploring the safety and efficacy of Eliquis in patients with NVAF undergoing cardioversion.
Announced results from a real-world data analysis pooled from four large U.S. insurance claims databases, in which treatment with Eliquis was associated with a lower risk of stroke/systemic embolism and lower rates of major bleeding compared to warfarin for the overall population and for each of the selected high-risk patient sub-populations.
    
OrenciaPsAJuly 2017EC approval for the treatment of active PsA in adults for whom the response to previous disease-modifying antirheumatic drug therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required.
FDA approval for active PsA in adults, a chronic, inflammatory disease that can affect both the skin and musculoskeletal system.
    
SprycelCMLJuly 2017
Announced the FDA accepted for priority review a supplemental NDA to treat children with Philadelphia chromosome-positive chronic phase CML, as well as a powder for oral suspension formulation of Sprycel. The FDA action date is November 9, 2017.
    
YervoyMelanomaOctober 2017
Announced the FDA added five-year overall survival data from the Phase III CA184-029 trial to the prescribing information for Yervoy for the adjuvant treatment of fully resected cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm.
July 2017FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients.
    
Prostvac*Prostate CancerSeptember 2017
Bavarian Nordic A/S announced an independent Data Monitoring Committee determined that the continuation of the Phase III PROSPECT study of Prostvac* in patients with metastatic castration-resistant prostate cancer is futile.

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 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2016 Annual Report on Form 10-K. There have been no material changes to our critical accounting policies during the nine months ended September 30, 2017.

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 and Section 21E of the Securities Exchange Act of 1934. You can identify these forward-looking statements by the fact they use words such as “should”, “expect”, “anticipate”, “estimate”, “target”, “may”, “project”, “guidance”, “intend”, “plan”, “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. One can also identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, our goals, plans and projections 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 and the outcome of contingencies such as legal proceedings and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years. We have included important factors in the cautionary statements included in this report and in the 2016 Annual Report on Form 10-K, particularly under “Item 1A. Risk Factors,” that we believe could cause actual results to differ materially from any forward-looking statement.

Although we believe 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. We undertake no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

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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 Market Risk” in our 2016 Annual Report on Form 10-K.

Item 4. CONTROLS AND PROCEDURES

Management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures. Based on their evaluation, as of the end of the period covered by this Form 10-Q, the Chief Executive Officer and Chief Financial Officer have concluded that such disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) are effective.

There were no changes in the Company’s internal control over financial reporting during the quarter ended September 30, 2017 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 17. 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 2016 Annual Report on Form 10-K.

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 September 30, 2017:
 
Period
Total Number of
Shares Purchased(a)
 
Average 
Price Paid
per Share(a)
 
Total Number of
    Shares Purchased as    
Part of Publicly
Announced
Programs(b)
 
Approximate Dollar
    Value of Shares that    
May Yet Be
Purchased Under the
Programs(b)
Dollars in Millions, Except Per Share Data       
July 1 to 31, 201763,794
 $56.63
 52,851
 $2,134
August 1 to 31, 20172,994,306
 $57.68
 2,985,959
 $1,962
September 1 to 30, 2017812,937
 $62.53
 803,249
 $1,912
Three months ended September 30, 20173,871,037
   3,842,059
  
 
(a)Includes shares repurchased as part of publicly announced programs and shares of common stock surrendered to the Company to satisfy tax withholding obligations in connection with the vesting of awards under our long-term incentive program.
(b)In May 2010, the Board of Directors authorized the repurchase of up to $3.0 billion of common stock and in June 2012 increased its authorization for the repurchase of common stock by an additional $3.0 billion. In October 2016, the Board of Directors approved a new share repurchase program authorizing the repurchase of an additional $3.0 billion of common stock. The stock repurchase program does not have an expiration date. Refer to “Item 1. Financial Statements—Note 15. Equity" for information on the accelerated share repurchase agreements.

34




Item 6. EXHIBITS

Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).
 
Exhibit No. Description
 
 
 
 
 
101. 
The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, formatted in Extensible Business Reporting Language (XBRL):
(i) consolidated statements of earnings, (ii) consolidated statements of comprehensive income, (iii) consolidated balance sheets, (iv) consolidated statements of cash flows, and (v) the notes to the consolidated financial statements.
  
*        Indicates, in this 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 Bristol-Myers Squibb and Gilead Sciences, LLC; Byetta is a trademark of Amylin Pharmaceuticals, LLC; Cabometyx is a trademark of Exelixis, Inc.; ENHANZE is a trademark of Halozyme, Inc.; Erbitux is a trademark of ImClone LLC; Gleevec is a trademark of Novartis AG; Keytruda is a trademark of Merck Sharp & Dohme Corp.; Plavix is a trademark of Sanofi; Prostvac is a trademark of BN ImmunoTherapeutics Inc.; Rubraca is a trademark of Clovis Oncology, Inc. and Tybost is a trademark of Gilead Sciences Ireland UC. Brand names of products that are in all italicized letters, without an asterisk, are registered trademarks of BMS and/or one of its subsidiaries.



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SUMMARY OF ABBREVIATED TERMS
Bristol-Myers Squibb Company may be referred to as Bristol-Myers Squibb, BMS, the Company, we, our or us in this Quarterly Report on Form 10-Q. Throughout this Quarterly Report on Form 10-Q we have used terms which are defined below:
2016 Form 10-KAnnual Report on Form 10-K for the fiscal year ended December 31, 2016
AstraZenecaAstraZeneca PLC
BiogenBiogen Inc.
CardioxylCardioxyl Pharmaceuticals, Inc.
CMLchronic myeloid leukemia
CytomXCytomX Therapeutics, Inc.
dMMRDNA mismatch repair deficient
EPOEuropean Patent Office
EPSearnings per share
EUEuropean Union
FASBFinancial Accounting Standards Board
FDAU.S. Food and Drug Administration
FlexusFlexus Biosciences, Inc.
F-Star AlphaF-Star Alpha Ltd.
GAAPU.S. generally accepted accounting principles
GileadGilead Sciences, Inc.
GTNGross-to-Net
HalozymeHalozyme Therapeutics, Inc.
HCCHepatocellular carcinoma
HIVhuman immunodeficiency virus
HNChead and neck cancer
IFMIFM Therapeutics, Inc.
iPierianiPierian, Inc.
IOimmuno-oncology
IPRDIn-process research and development
JIAJuvenile Idiopathic Arthritis
mCRCmetastatic colorectal cancer
MerckMerck & Co., Inc.
MSI-Hmicrosatellite instability-high
NDANew Drug Application
NKTnatural killer T cells
NSCLCnon-small cell lung cancer
NVAFnon-valvular atrial fibrillation
OnoOno Pharmaceutical Co., Ltd.
OTCOver-the-counter
PadlockPadlock Therapeutics, Inc.
PD-1programmed death receptor-1
PsAactive psoriatic arthritis
Quarterly Report on Form 10-QQuarterly Report on Form 10-Q for the quarterly period ended June 30, 2017
RArheumatoid arthritis
RCCrenal cell carcinoma
R&DResearch and Development
sBLAsupplemental Biologics License Application
SCCHNsquamous cell carcinoma of the head and neck
SCLCsmall cell lung cancer
SECSecurities and Exchange Commission
SK BiotekSK Biotek Co., Ltd.
UKUnited Kingdom
U.S.United States

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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:October 26, 2017 By:/s/ Giovanni Caforio
    
Giovanni Caforio
Chief Executive Officer
    
Date:October 26, 2017 By:/s/ Charles Bancroft
    
Charles Bancroft
Chief Financial Officer

37