The Quarterly
BMY Q2 2017 10-Q

Bristol Myers Squibb Co (BMY) SEC Quarterly Report (10-Q) for Q3 2017

BMY 2017 10-K
BMY Q2 2017 10-Q BMY 2017 10-K



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

PART I-FINANCIAL INFORMATION

Item 1.

Financial Statements:

Consolidated Statements of Earnings and Comprehensive Income

3

Consolidated Balance Sheets

4

Consolidated Statements of Cash Flows

5

Notes to Consolidated Financial Statements

6

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

21

Item 3.

Quantitative and Qualitative Disclosure About Market Risk

34

Item 4.

Controls and Procedures

34

PART II-OTHER INFORMATION

Item 1.

Legal Proceedings

34

Item 1A.

Risk Factors

34

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

34

Item 6.

Exhibits

35

Summary of Abbreviated Terms

36

Signatures

37


*    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,

EARNINGS

2017

2016

2017

2016

Net product sales

$

4,862


$

4,492


$

14,212


$

12,888


Alliance and other revenues

392


430


1,115


1,296


Total Revenues

5,254


4,922


15,327


14,184


Cost of products sold

1,572


1,305


4,393


3,563


Marketing, selling and administrative

1,147


1,144


3,388


3,450


Research and development

1,543


1,138


4,490


3,540


Other (income)/expense

(191

)

(224

)

(1,377

)

(1,198

)

Total Expenses

4,071


3,363


10,894


9,355


Earnings Before Income Taxes

1,183


1,559


4,433


4,829


Provision for Income Taxes

327


344


1,129


1,220


Net Earnings

856


1,215


3,304


3,609


Net Earnings/(Loss) Attributable to Noncontrolling Interest

11


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 INCOME

2017

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 benefits

18


72


74


(213

)

Available-for-sale securities

22


(8

)

41


46


Foreign currency translation

7


1


28


26


Other Comprehensive Income/(Loss)

46


69


82


(267

)

Comprehensive Income

902


1,284


3,386


3,342


Comprehensive Income/(Loss) Attributable to Noncontrolling Interest

11


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)

ASSETS

September 30,
2017

December 31,
2016

Current Assets:

Cash and cash equivalents

$

4,644


$

4,237


Marketable securities

2,478


2,113


Receivables

5,922


5,543


Inventories

1,250


1,241


Prepaid expenses and other

754


570


Total Current Assets

15,048


13,704


Property, plant and equipment

5,014


4,980


Goodwill

6,865


6,875


Other intangible assets

1,213


1,385


Deferred income taxes

2,346


2,996


Marketable securities

2,526



2,719


Other assets

965


1,048


Total Assets

$

33,977


$

33,707


LIABILITIES

Current Liabilities:

Short-term debt obligations

$

1,461


$

992


Accounts payable

1,699


1,664


Accrued liabilities

5,418


5,271


Deferred income

647


762


Income taxes payable

213


152


Total Current Liabilities

9,438


8,841


Deferred income

492


547


Income taxes payable

996


973


Pension and other liabilities

1,155


1,283


Long-term debt

6,982


5,716


Total Liabilities

19,063


17,360


Commitments and contingencies (Note 17)



EQUITY

Bristol-Myers Squibb Company Shareholders' Equity:

Preferred stock

-


-


Common stock

221


221


Capital in excess of par value of stock

1,845


1,725


Accumulated other comprehensive loss

(2,421

)

(2,503

)

Retained earnings

34,141


33,513


Less cost of treasury stock

(19,003

)

(16,779

)

Total Bristol-Myers Squibb Company Shareholders' Equity

14,783


16,177


Noncontrolling interest

131


170


Total Equity

14,914


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, net

592


260


Deferred income taxes

283


(500

)

Stock-based compensation

149


149


Impairment charges

223


75


Pension settlements and amortization

148


122


Divestiture gains and royalties

(546

)

(1,082

)

Asset acquisition charges

510


274


Other adjustments

108


(56

)

Changes in operating assets and liabilities:

Receivables

(539

)

(896

)

Inventories

7


(107

)

Accounts payable

63


(142

)

Deferred income

(91

)

445


Income taxes payable

400


(183

)

Other

(453

)

(353

)

Net Cash Provided by Operating Activities

4,158


1,615


Cash Flows From Investing Activities:

Sale and maturities of marketable securities

4,296


3,674


Purchase of marketable securities

(4,434

)

(2,248

)

Capital expenditures

(801

)

(844

)

Divestiture and other proceeds

526


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, net

1,198


102


Issuance of long-term debt

1,488


-


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 Equivalents

59


16


Increase in Cash and Cash Equivalents

407


1,047


Cash and Cash Equivalents at Beginning of Period

4,237


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 Update

Effective Date

Recognition and Measurement of Financial Assets and Liabilities

January 1, 2018

Definition of a Business

January 1, 2018

Leases

January 1, 2019

Financial Instruments - Measurement of Credit Losses

January 1, 2020

Goodwill Impairment Testing

January 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 Millions

2017

2016

2017

2016

Prioritized Brands

Opdivo

$

1,265


$

920


$

3,587


$

2,464


Eliquis

1,232


884


3,509


2,395


Orencia

632


572


1,817


1,640


Sprycel

509


472


1,478


1,330


Yervoy

323


285


975


789


Empliciti

60


41


168


103


Established Brands

Hepatitis C Franchise

73


379


347


1,352


Baraclude

264


306


819


896


Sustiva Franchise

183


275


555


819


Reyataz Franchise

174


238


555


706


Other Brands

539


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 revenues

334


402


957


1,229


Other revenues

58


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 Millions

2017

2016

2017

2016

Revenues from alliances:

Net product sales

$

1,764


$

1,465


$

5,045


$

4,031


Alliance revenues

334


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, pretax

4


3


9


13



7




Selected Alliance Balance Sheet information:

Dollars in Millions

September 30,
2017

December 31,
2016

Receivables - from alliance partners

$

878


$

903


Accounts payable - to alliance partners

634


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 Millions

2017

2016

2017

2016

Interest expense

$

48


$

42


$

145


$

127


Investment income

(37

)

(32

)

(104

)

(81

)

Provision for restructuring

28


19


207


41


Litigation and other settlements (a)

-


(1

)

(489

)

48


Equity in net income of affiliates

(21

)

(19

)

(59

)

(65

)

Divestiture (gains)/losses

1


(21

)

(126

)

(574

)

Royalties and licensing income (b)

(209

)

(158

)

(1,093

)

(579

)

Transition and other service fees

(12

)

(57

)

(32

)

(184

)

Pension charges

22


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 Millions

2017

2016

2017

2016

Employee termination costs

$

18


$

17


$

190


$

32


Other termination costs

10


2


17


9


Provision for restructuring

28


19


207


41


Accelerated depreciation

64


15


216


42


Asset impairments

1


-


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 Millions

2017

2016

2017

2016

Cost of products sold

$

1


$

7


$

131


$

15


Research and development

64


14


232


40


Other (income)/expense

28


19


207


41


Total charges

$

93


$

40


$

570


$

96


Nine Months Ended September 30,

Dollars in Millions

2017

2016

Liability at January 1

$

114


$

125


Charges

233


48


Change in estimates

(26

)

(7

)

Provision for restructuring

207


41


Foreign currency translation

17


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 Millions

2017

2016

2017

2016

Earnings Before Income Taxes

$

1,183


$

1,559


$

4,433


$

4,829


Provision for Income Taxes

327


344


1,129


1,220


Effective Tax Rate

27.6

%

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 Data

2017

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 – basic

1,639


1,671


1,648


1,670


Incremental shares attributable to share-based compensation plans

6


8


7


9


Weighted-average common shares outstanding – diluted

1,645


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 Millions

Level 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 investments

90


-


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 Millions

Amortized Cost

Gross Unrealized

Amortized Cost

Gross Unrealized

Gains

Losses

Fair Value

Gains

Losses

Fair Value

Certificates of deposit

$

176


$

-


$

-


$

176


$

27


$

-


$

-


$

27


Commercial paper

977


-


-


977


750


-


-


750


Corporate debt securities

3,713


15


(3

)

3,725


3,945


10


(8

)

3,947


Equity investments

57


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 Millions

September 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 Millions

Notional

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 contracts

1,351


25


548


(28

)

967


66


198


(9

)

Derivatives not designated as hedging instruments:

Foreign currency forward contracts

322


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 Millions

September 30,
2017

December 31,
2016

Commercial paper

$

799


$

-


Bank drafts and short-term borrowings

662


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 Millions

September 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 terminations

234


287


Unamortized bond discounts and issuance costs

(83

)

(81

)

Total

$

6,982


$

6,465


Current portion of long-term debt

$

-


$

749


Long-term debt

6,982


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 Millions

2017

Principal Value:

1.600% Notes due 2019

$

750


3.250% Notes due 2027

750


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 Millions

2017

Principal amount

$

337


Carrying value

366


Debt redemption price

474


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 Millions

September 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 receivables

4,332


3,774


Alliance receivables

878


903


Prepaid and refundable income taxes

334


627


Other

378


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 Millions

September 30,
2017

December 31,
2016

Finished goods

$

380


$

310


Work in process

956


988


Raw and packaging materials

224


264


Total inventories

$

1,560


$

1,562


Inventories

$

1,250


$

1,241


Other assets

310


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 Millions

September 30,
2017

December 31,
2016

Land

$

105


$

107


Buildings

5,188


4,930


Machinery, equipment and fixtures

3,034


3,287


Construction in progress

938


849


Gross property, plant and equipment

9,265


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 Millions

September 30,
2017

December 31,
2016

Licenses

$

564


$

564


Developed technology rights

2,357


2,357


Capitalized software

1,339


1,441


IPRD

32


107


Gross other intangible assets

4,292


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 Millions

Shares

Par Value

Shares

Cost

Balance at January 1, 2016

2,208


$

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, 2016

2,208


$

221


$

1,650


$

(2,735

)

$

33,272


537


$

(16,795

)

$

168


Balance at December 31, 2016

2,208


$

221


$

1,725


$

(2,503

)

$

33,513


536


$

(16,779

)

$

170


Accounting change - cumulative effect (a)

-


-


-


-


(787

)

-


-


-


Adjusted balance at January 1, 2017

2,208


$

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, 2017

2,208


$

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 benefits

35


(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 securities

27


(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 benefits

113


(39

)

74


(331

)

118


(213

)

Available-for-sale securities:

Unrealized gains

49


(7

)

42


29


(13

)

16


Realized (gains)/losses (c)

(1

)

-


(1

)

30


-


30


Available-for-sale securities

48


(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 Millions

September 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 securities

34


(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 Millions

2017

2016

2017

2016

Service cost – benefits earned during the year

$

7


$

6


$

19


$

19


Interest cost on projected benefit obligation

48


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 loss

20


22


61


62


Curtailments and settlements

22


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 data

2017

2016

2017

2016

Total Revenues

$

5,254


$

4,922


$

15,327


$

14,184


Diluted Earnings Per Share

GAAP

0.51


0.72


2.02


2.12


Non-GAAP

0.75


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 :

Product

Date

Approval

Opdivo

September 2017

FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib.

September 2017

Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono.

August 2017

FDA 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 2017

EC 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 2017

EC approval for the treatment of SCCHN in adults progressing on or after platinum-based therapy.

March 2017

Approval in Japan for the treatment of recurrent or metastatic HNC, received by our alliance partner, Ono.

February 2017

FDA approval for the treatment of patients with previously treated locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Orencia

July 2017

EC 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 2017

FDA approval for the treatment of active PsA in adults.

March 2017

FDA approval of a new subcutaneous administration option for use in patients two years of age and older with moderately to severely active polyarticular JIA.

Yervoy

July 2017

FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients.

Hepatitis C Franchise

April 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 Millions

2017

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

 %

-


Europe

1,262


946


33

 %

5

 %

3,596


2,855


26

 %

(1

)%

Rest of the World

970


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 Millions

2017

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 percentage

26

%

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 Millions

2017

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


**


Eliquis

1,232


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

 %

Orencia

632


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

 %

Sprycel

509


472


8

 %

1,478


1,330


11

 %

U.S.

278


259


7

 %

806


702


15

 %

Non-U.S.

231


213


8

 %

672


628


7

 %

Yervoy

323


285


13

 %

975


789


24

 %

U.S.

239


222


8

 %

727


600


21

 %

Non-U.S.

84


63


33

 %

248


189


31

 %

Empliciti

60


41


46

 %

168


103


63

 %

U.S.

39


36


8

 %

112


97


15

 %

Non-U.S.

21


5


**


56


6


**


Established Brands

Hepatitis C Franchise

73


379


(81

)%

347


1,352


(74

)%

U.S.

24


192


(88

)%

96


745


(87

)%

Non-U.S.

49


187


(74

)%

251


607


(59

)%

Baraclude

264


306


(14

)%

819


896


(9

)%

U.S.

14


17


(18

)%

40


49


(18

)%

Non-U.S.

250


289


(13

)%

779


847


(8

)%

Sustiva Franchise

183


275


(33

)%

555


819


(32

)%

U.S.

157


234


(33

)%

471


689


(32

)%

Non-U.S.

26


41


(37

)%

84


130


(35

)%

Reyataz Franchise

174


238


(27

)%

555


706


(21

)%

U.S.

85


125


(32

)%

260


367


(29

)%

Non-U.S.

89


113


(21

)%

295


339


(13

)%

Other Brands

539


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 Millions

2017

2016

% Change

2017

2016

% Change

Cost of products sold

$

1,572


$

1,305


20

 %

$

4,393


$

3,563


23

 %

Marketing, selling and administrative

1,147


1,144


-


3,388


3,450


(2

)%

Research and development

1,543


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 Millions

2017

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 charges

310


45


753


309


IPRD impairments

-


-


75


-


Accelerated depreciation and other

64


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 Millions

2017

2016

2017

2016

Provision for restructuring

$

28


$

19


$

207


$

41


Litigation and other settlements

-


(1

)

(489

)

48


Divestiture (gains)/losses

1


(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 Millions

2017

2016

2017

2016

Earnings Before Income Taxes

$

1,183


$

1,559


$

4,433


$

4,829


Provision for Income Taxes

327


344


1,129


1,220


Effective Tax Rate

27.6

%

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 Millions

2017

2016

2017

2016

Impairment charges

$

1


$

-


$

128


$

-


Accelerated depreciation and other shutdown costs

-


7


3


15


Cost of products sold

1


7


131


15


License and asset acquisition charges

310


45


753


309


IPRD impairments

-


-


75


-


Accelerated depreciation and other

64


14


232


40


Research and development

374


59


1,060


349


Provision for restructuring

28


19


207


41


Litigation and other settlements

-


(3

)

(481

)

40


Divestiture gains

-


(13

)

(100

)

(559

)

Royalties and licensing income

-


-


(497

)

-


Pension charges

22


19


91


66


Intangible asset impairments

-


-


-


15


Loss on debt redemption

-


-


109


-


Other (income)/expense

50


22


(671

)

(397

)

Increase/(decrease) to pretax income

425


88


520


(33

)

Income taxes on specified items

(41

)

(3

)

51


156


Increase to net earnings

384


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 data

2017

2016

2017

2016

Net Earnings Attributable to BMS used for Diluted EPS Calculation – GAAP

$

845


$

1,202


$

3,335


$

3,563


Specified Items

384


85


512


123


Net Earnings used for Diluted EPS Calculation – Non-GAAP

$

1,229


$

1,287


$

3,847


$

3,686


Average Common Shares Outstanding – Diluted

1,645


1,679


1,655


1,679


Diluted Earnings Per Share – GAAP

$

0.51


$

0.72


$

2.02


$

2.12


Diluted EPS Attributable to Specified Items

0.24


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 Millions

September 30,
2017

December 31,
2016

Cash and cash equivalents

$

4,644


$

4,237


Marketable securities – current

2,478


2,113


Marketable securities – non-current

2,526


2,719


Cash, cash equivalents and marketable securities

9,648


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.


30




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 Millions

2017

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.


31




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:

Product

Indication

Date

Developments

Opdivo

Gastric

September 2017

Approval in Japan for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy, received by our alliance partner, Ono.

HCC

September 2017

FDA approval for the treatment of patients with HCC, a type of liver cancer, who have been previously treated with sorafenib.

mCRC

August 2017

FDA 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.

Melanoma

October 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 Myeloma

September 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.

NSCLC

September 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.

Various

July 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+Yervoy

RCC

September 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.

SCLC

October 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




Product

Indication

Date

Developments

Eliquis

NVAF

August 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.

Orencia

PsA

July 2017

EC 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.

Sprycel

CML

July 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.

Yervoy

Melanoma

October 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 2017

FDA approval of an expanded indication for the treatment of unresectable or metastatic melanoma in pediatric patients.

Prostvac*

Prostate Cancer

September 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, 2017

63,794


$

56.63


52,851


$

2,134


August 1 to 31, 2017

2,994,306


$

57.68


2,985,959


$

1,962


September 1 to 30, 2017

812,937


$

62.53


803,249


$

1,912


Three months ended September 30, 2017

3,871,037


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.


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Item 6. EXHIBITS


Exhibits (listed by number corresponding to the Exhibit Table of Item 601 in Regulation S-K).

Exhibit No.

Description

12.

Computation of Earnings to Fixed Charges.

31a.

Section 302 Certification Letter.

31b.

Section 302 Certification Letter.

32a.

Section 906 Certification Letter.

32b.

Section 906 Certification Letter.

101.

The following financial statements from the Bristol-Myers Squibb Company Quarterly Report on Form 10-Q for the quarter ended 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-K

Annual Report on Form 10-K for the fiscal year ended December 31, 2016

AstraZeneca

AstraZeneca PLC

Biogen

Biogen Inc.

Cardioxyl

Cardioxyl Pharmaceuticals, Inc.

CML

chronic myeloid leukemia

CytomX

CytomX Therapeutics, Inc.

dMMR

DNA mismatch repair deficient

EPO

European Patent Office

EPS

earnings per share

EU

European Union

FASB

Financial Accounting Standards Board

FDA

U.S. Food and Drug Administration

Flexus

Flexus Biosciences, Inc.

F-Star Alpha

F-Star Alpha Ltd.

GAAP

U.S. generally accepted accounting principles

Gilead

Gilead Sciences, Inc.

GTN

Gross-to-Net

Halozyme

Halozyme Therapeutics, Inc.

HCC

Hepatocellular carcinoma

HIV

human immunodeficiency virus

HNC

head and neck cancer

IFM

IFM Therapeutics, Inc.

iPierian

iPierian, Inc.

IO

immuno-oncology

IPRD

In-process research and development

JIA

Juvenile Idiopathic Arthritis

mCRC

metastatic colorectal cancer

Merck

Merck & Co., Inc.

MSI-H

microsatellite instability-high

NDA

New Drug Application

NKT

natural killer T cells

NSCLC

non-small cell lung cancer

NVAF

non-valvular atrial fibrillation

Ono

Ono Pharmaceutical Co., Ltd.

OTC

Over-the-counter

Padlock

Padlock Therapeutics, Inc.

PD-1

programmed death receptor-1

PsA

active psoriatic arthritis

Quarterly Report on Form 10-Q

Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2017

RA

rheumatoid arthritis

RCC

renal cell carcinoma

R&D

Research and Development

sBLA

supplemental Biologics License Application

SCCHN

squamous cell carcinoma of the head and neck

SCLC

small cell lung cancer

SEC

Securities and Exchange Commission

SK Biotek

SK Biotek Co., Ltd.

UK

United Kingdom

U.S.

United States


36




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


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