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

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 
For the quarterly period ended SeptemberJune 30, 20162017
OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 For the transition period from ______ to ______
Commission File No. 1-6571
Merck & Co., Inc.
2000 Galloping Hill Road
Kenilworth, N.J. 07033
(908) 740-4000
Incorporated in New Jersey I.R.S. Employer
  Identification No. 22-1918501
The number of shares of common stock outstanding as of the close of business on OctoberJuly 31, 20162017: 2,757,137,5172,727,354,340
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 such filing requirements for the past 90 days.  Yes     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     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, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and “smaller reporting“emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer
Accelerated filer
Non-accelerated filer 
Smaller reporting company 
  
Non-accelerated filer
(Do not check if a smaller reporting company)
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 
 


Part I - Financial Information
Item 1. Financial Statements
MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF INCOME
(Unaudited, $ in millions except per share amounts)
 
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
2016 2015 2016 20152017 2016 2017 2016
Sales$10,536
 $10,073
 $29,692
 $29,283
$9,930
 $9,844
 $19,365
 $19,156
Costs, Expenses and Other              
Materials and production3,409
 3,761
 10,559
 11,084
3,080
 3,578
 6,095
 7,150
Marketing and administrative2,393
 2,472
 7,169
 7,698
2,438
 2,458
 4,849
 4,776
Research and development1,664
 1,500
 5,475
 4,906
1,749
 2,151
 3,545
 3,810
Restructuring costs161
 113
 386
 386
166
 134
 317
 225
Other (income) expense, net22
 (170) 88
 624
58
 19
 117
 67
7,649
 7,676
 23,677
 24,698
7,491
 8,340
 14,923
 16,028
Income Before Taxes2,887
 2,397
 6,015
 4,585
2,439
 1,504
 4,442
 3,128
Taxes on Income699
 566
 1,487
 1,108
488
 295
 935
 789
Net Income2,188
 1,831
 4,528
 3,477
1,951
 1,209
 3,507
 2,339
Less: Net Income Attributable to Noncontrolling Interests4
 5
 13
 12
5
 4
 11
 9
Net Income Attributable to Merck & Co., Inc.$2,184
 $1,826
 $4,515
 $3,465
$1,946
 $1,205
 $3,496
 $2,330
Basic Earnings per Common Share Attributable to Merck & Co., Inc. Common Shareholders$0.79
 $0.65
 $1.63
 $1.23
$0.71
 $0.44
 $1.28
 $0.84
Earnings per Common Share Assuming Dilution Attributable to Merck & Co., Inc. Common Shareholders$0.78
 $0.64
 $1.62
 $1.22
$0.71
 $0.43
 $1.27
 $0.83
Dividends Declared per Common Share$0.46
 $0.45
 $1.38
 $1.35
$0.47
 $0.46
 $0.94
 $0.92
 
MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME
(Unaudited, $ in millions)
 
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
2016 2015 2016 20152017 2016 2017 2016
Net Income Attributable to Merck & Co., Inc.$2,184
 $1,826
 $4,515
 $3,465
$1,946
 $1,205
 $3,496
 $2,330
Other Comprehensive Income (Loss) Net of Taxes:              
Net unrealized loss on derivatives, net of reclassifications(74) (118) (367) (42)(143) (91) (375) (293)
Net unrealized (loss) gain on investments, net of reclassifications(30) (67) 96
 (35)
Benefit plan net (loss) gain and prior service (cost) credit, net of amortization(144) 29
 (280) 106
Net unrealized gain on investments, net of reclassifications35
 63
 78
 126
Benefit plan net gain (loss) and prior service credit (cost), net of amortization47
 (108) 73
 (136)
Cumulative translation adjustment82
 (85) 447
 (279)47
 244
 356
 365
(166) (241) (104) (250)(14) 108
 132
 62
Comprehensive Income Attributable to Merck & Co., Inc.$2,018
 $1,585
 $4,411
 $3,215
$1,932
 $1,313
 $3,628
 $2,392
 The accompanying notes are an integral part of these condensed consolidated financial statements.


MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEET
(Unaudited, $ in millions except per share amounts)
 
September 30, 2016 December 31, 2015June 30, 2017 December 31, 2016
Assets      
Current Assets      
Cash and cash equivalents$7,907
 $8,524
$7,786
 $6,515
Short-term investments5,160
 4,903
4,181
 7,826
Accounts receivable (net of allowance for doubtful accounts of $173 in 2016
and $165 in 2015) (excludes accounts receivable of $10 in 2016 and 2015
classified in Other assets)
7,364
 6,484
Inventories (excludes inventories of $1,104 in 2016 and $1,569 in 2015
classified in Other assets - see Note 5)
5,244
 4,700
Accounts receivable (net of allowance for doubtful accounts of $200 in 2017
and $195 in 2016)
7,439
 7,018
Inventories (excludes inventories of $1,076 in 2017 and $1,117 in 2016
classified in Other assets - see Note 5)
5,407
 4,866
Other current assets3,765
 5,140
3,354
 4,389
Total current assets29,440
 29,751
28,167
 30,614
Investments11,657
 13,039
12,138
 11,416
Property, Plant and Equipment, at cost, net of accumulated depreciation of $16,022
in 2016 and $15,923 in 2015
12,029
 12,507
Property, Plant and Equipment, at cost, net of accumulated depreciation of $16,375
in 2017 and $15,749 in 2016
12,094
 12,026
Goodwill18,260
 17,723
18,358
 18,162
Other Intangibles, Net20,506
 22,602
16,119
 17,305
Other Assets6,443
 6,055
5,928
 5,854
$98,335
 $101,677
$92,804
 $95,377
Liabilities and Equity      
Current Liabilities      
Loans payable and current portion of long-term debt$1,487
 $2,583
$3,181
 $568
Trade accounts payable2,481
 2,533
2,934
 2,807
Accrued and other current liabilities9,087
 11,216
9,363
 10,274
Income taxes payable1,208
 1,560
1,979
 2,239
Dividends payable1,292
 1,309
1,301
 1,316
Total current liabilities15,555
 19,201
18,758
 17,204
Long-Term Debt23,656
 23,829
21,706
 24,274
Deferred Income Taxes6,374
 6,535
4,560
 5,077
Other Noncurrent Liabilities8,793
 7,345
8,068
 8,514
Merck & Co., Inc. Stockholders’ Equity      
Common stock, $0.50 par value
Authorized - 6,500,000,000 shares
Issued - 3,577,103,522 shares in 2016 and 2015
1,788
 1,788
Common stock, $0.50 par value
Authorized - 6,500,000,000 shares
Issued - 3,577,103,522 shares in 2017 and 2016
1,788
 1,788
Other paid-in capital39,897
 40,222
39,776
 39,939
Retained earnings46,028
 45,348
45,046
 44,133
Accumulated other comprehensive loss(4,252) (4,148)(5,094) (5,226)
83,461
 83,210
81,516
 80,634
Less treasury stock, at cost:
815,442,334 shares in 2016 and 795,975,449 shares in 2015
39,717
 38,534
Less treasury stock, at cost:
849,974,743 shares in 2017 and 828,372,200 shares in 2016
42,053
 40,546
Total Merck & Co., Inc. stockholders’ equity43,744
 44,676
39,463
 40,088
Noncontrolling Interests213
 91
249
 220
Total equity43,957
 44,767
39,712
 40,308
$98,335
 $101,677
$92,804
 $95,377
The accompanying notes are an integral part of this condensed consolidated financial statement.


MERCK & CO., INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited, $ in millions)
 
Nine Months Ended 
 September 30,
Six Months Ended 
 June 30,
2016 20152017 2016
Cash Flows from Operating Activities      
Net income$4,528
 $3,477
$3,507
 $2,339
Adjustments to reconcile net income to net cash provided by operating activities:      
Depreciation and amortization4,286
 4,815
2,355
 3,111
Intangible asset impairment charges572
 80
131
 567
Foreign currency devaluation related to Venezuela
 715
Equity income from affiliates(59) (210)
Dividends and distributions from equity affiliates12
 12
Deferred income taxes(65) (846)(272) (120)
Share-based compensation225
 221
156
 148
Other247
 815
63
 166
Net changes in assets and liabilities(3,002) (787)(2,337) (2,438)
Net Cash Provided by Operating Activities6,744
 8,292
3,603
 3,773
Cash Flows from Investing Activities      
Capital expenditures(1,063) (790)(732) (654)
Purchases of securities and other investments(10,084) (12,425)(6,280) (6,355)
Proceeds from sales of securities and other investments11,300
 16,531
9,363
 7,388
Acquisition of Cubist Pharmaceuticals, Inc., net of cash acquired
 (7,598)
Acquisitions of other businesses, net of cash acquired(778) (110)
Dispositions of businesses, net of cash divested
 151
Acquisitions of businesses, net of cash acquired(347) (157)
Other(22) 100
62
 21
Net Cash Used in Investing Activities(647) (4,141)
Net Cash Provided by Investing Activities2,066
 243
Cash Flows from Financing Activities      
Net change in short-term borrowings909
 (1,526)(24) (9)
Proceeds from issuance of debt8
 7,938
Payments on debt(2,386) (2,905)(301) (2,351)
Purchases of treasury stock(2,418) (3,005)(2,153) (1,573)
Dividends paid to stockholders(3,853) (3,854)(2,601) (2,579)
Proceeds from exercise of stock options790
 434
408
 381
Other(117) (63)(86) (101)
Net Cash Used in Financing Activities(7,067) (2,981)(4,757) (6,232)
Effect of Exchange Rate Changes on Cash and Cash Equivalents353
 (1,063)359
 300
Net (Decrease) Increase in Cash and Cash Equivalents(617) 107
Net Increase (Decrease) in Cash and Cash Equivalents1,271
 (1,916)
Cash and Cash Equivalents at Beginning of Year8,524
 7,441
6,515
 8,524
Cash and Cash Equivalents at End of Period$7,907
 $7,548
$7,786
 $6,608
The accompanying notes are an integral part of this condensed consolidated financial statement.
Notes to Condensed Consolidated Financial Statements (unaudited)

1.Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of Merck & Co., Inc. (Merck or the Company) have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the United States for complete consolidated financial statements are not included herein. These interim statements should be read in conjunction with the audited financial statements and notes thereto included in Merck’s Form 10-K filed on February 26, 2016.28, 2017.
The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. In the Company’s opinion, all adjustments necessary for a fair statement of these interim statements have been included and are of a normal and recurring nature. Certain reclassifications have been made to prior year amounts to conform to the current presentation.
Recently Adopted Accounting Standards
In the first quarter ofOn December 31, 2016, the Company adopted accounting guidance issued by the Financial Accounting Standards Board (FASB)Merck and Sanofi Pasteur S.A. (Sanofi) terminated their equally-owned joint venture, Sanofi Pasteur MSD (SPMSD), which developed and marketed vaccines in April 2015, which requires debt issuanceEurope. Beginning in 2017, Merck is recording vaccine sales and incurring costs to be presented as a direct deduction from the carrying amount of that debt on the balance sheet as opposed to being presented as a deferred charge. Approximately $100 million of debt issuance costs were reclassified in the first quarter of 2016 as a result of operating its vaccines business in the adoptionEuropean markets that were previously part of the new standard. Prior period amounts have been recast to conform to the new presentation.
In the second quarter of 2016, the Company elected to early adopt an accounting standards update issued by the FASB in March of 2016 intended to simplify the accounting and reporting for employee share-based payment transactions. Among other provisions, the new standard requires that excess tax benefits and deficiencies that arise upon vesting or exercise of share-based payments be recognized in the income statement (as opposed to previous guidance under which tax effects were recorded to Other paid-in-capital in certain instances). This aspect of the new guidance,SPSMD joint venture, which was required to be adopted prospectively, resulted in the recognition of $35 million and $64 million of excess tax benefits in Taxes on incomeaccounted for the third quarter and first nine months of 2016, respectively, arising from share-based payments. The new guidance also amended the presentation of certain share-based payment items in the statement of cash flows. Cash flows related to excess income tax benefits are now classified as an operating activity (formerly included as a financing activity). The Company elected to adopt this aspect of the new guidance prospectively. The standard also clarified that cash payments made to taxing authorities on the employees’ behalf for shares withheld should be presented as a financing activity. This aspect of the guidance was adopted retrospectively; accordingly, the Company reclassified $118 million of such payments from operating activities to financing activities in the Condensed Consolidated Statement of Cash Flows for the nine months ended September 30, 2015 to conform to the current presentation. The Company has elected to continue to estimate the impact of forfeitures when determining the amount of compensation cost to be recognized each period rather than account for them as they occur.equity method affiliate.
Recently Issued Accounting Standards
In May 2014, the FASBFinancial Accounting Standards Board (FASB) issued amended accounting guidance on revenue recognition that will be applied to all contracts with customers. The objective of the new guidance is to improve comparability of revenue recognition practices across entities and to provide more useful information to users of financial statements through improved disclosure requirements. In August 2015,The new standard permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the FASB approved a one-year deferralcumulative effect of adopting the guidance being recognized at the date of initial application (modified retrospective method). The Company will adopt the new standard on January 1, 2018 and currently plans to use the modified retrospective method. The majority of the effective date making this guidance effectiveCompany’s business is ship and bill and, on that primary revenue stream, Merck does not expect significant differences. Additionally, the Company has not identified significant changes related to the recognition of revenue for interimits multiple element arrangements or discount and annual periods beginning in 2018. Reporting entities may choosetrade promotion programs when applying the new guidance. However, the Company’s analysis is preliminary and subject to adopt the standard as of the original effective date. The Company is currently assessing the impact of adoption on its consolidated financial statements.change.
In January 2016, the FASB issued revised guidance for the accounting and reporting of financial instruments. The new guidance requires that equity investments with readily determinable fair values currently classified as available-for-sale be measured at fair value with changes in fair value recognized in net income. The new guidance also simplifies the impairment testing of equity investments without readily determinable fair values and changes certain disclosure requirements. This guidance is effective for interim and annual periods beginning in 2018. Early adoption is not permitted. The Company is currently assessing the impact of adoption on its consolidated financial statements.
In February 2016, the FASB issued new accounting guidance for the accounting and reporting of leases. The new guidance requires that lessees recognize a right-of-use asset and a lease liability recorded on the balance sheet for each of its leases (other than leases that meet the definition of a short-term lease).  Leases will be classified as either operating or finance. Operating leases will result in straight-line expense in the income statement (similar to current operating leases) while finance leases will result in more expense being recognized in the earlier years of the lease term (similar to current capital leases). The new guidance will be effective for interim and annual periods beginning in 2019. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In June 2016, the FASB issued amended guidance on the accounting for credit losses on financial instruments within its scope. The guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for interim and annual periods beginning in
Notes to Condensed Consolidated Financial Statements (unaudited)

2020, with earlier application permitted in 2019. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In August 2016, the FASB issued guidance on the classification of certain cash receipts and payments in the statement of cash flows intended to reduce diversity in practice. The guidance is effective for interim and annual periods beginning in 2018. Early adoption is permitted. The guidance is to be applied retrospectively to all periods presented but may be applied prospectively if retrospective application would be impracticable. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows.
In October 2016, the FASB issued guidance on the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Under existing guidance, the recognition of current and deferred income taxes for an intra-entity asset transfer is prohibited until the asset has been sold to a third party. The new guidance will require the recognition of the income tax consequences of an intra-entity transfer of an asset (with the exception of inventory) when the intra-entity transfer occurs. The guidance is effective for interim and annual periods beginning in 2018. Early adoption is permitted. The new guidance is to be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings in the beginning of the period of adoption. The Company does not anticipate the adoption of the new guidance will have a material effect on its consolidated financial statements.
In November 2016, the FASB issued guidance requiring that amounts generally described as restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance is effective for interim and annual periods beginning in 2018 and should be applied using a retrospective transition method to each period presented. Early adoption is permitted. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows.
In March 2017, the FASB amended the guidance related to net periodic benefit cost for defined benefit plans that requires entities to (1) disaggregate the current service cost component from the other components of net benefit cost and present it with other employee compensation costs in the income statement within operations if such a subtotal is presented; (2) present the other components of net benefit cost separately in the income statement and outside of income from operations; and (3) only capitalize the service cost component when applicable. The new guidance is effective for interim and annual periods in 2018. Entities must use a retrospective transition method to adopt the requirement for separate presentation in the income statement of
Notes to Condensed Consolidated Financial Statements (unaudited)

service costs and other components and a prospective transition method to adopt the requirement to limit the capitalization of benefit costs to the service cost component. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In May 2017, the FASB issued guidance clarifying when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The new guidance is effective prospectively for interim and annual periods beginning in 2018. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In February 2016, the FASB issued new accounting guidance for the accounting and reporting of leases. The new guidance requires that lessees recognize a right-of-use asset and a lease liability recorded on the balance sheet for each of its leases (other than leases that meet the definition of a short-term lease).  Leases will be classified as either operating or finance. Operating leases will result in straight-line expense in the income statement (similar to current operating leases) while finance leases will result in more expense being recognized in the earlier years of the lease term (similar to current capital leases). The new guidance will be effective for interim and annual periods beginning in 2019. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In June 2016, the FASB issued amended guidance on the accounting for credit losses on financial instruments. The guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for interim and annual periods beginning in 2020, with earlier application permitted in 2019. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In January 2017, the FASB issued guidance that provides for the elimination of Step 2 from the goodwill impairment test. Under the new guidance, impairment charges are recognized to the extent the carrying amount of a reporting unit exceeds its fair value with certain limitations. The new guidance is effective for interim and annual periods in 2020. Early adoption is permitted. The Company does not anticipate the adoption of the new guidance will have a material effect on its consolidated financial statements.
2.Acquisitions, Divestitures, Research Collaborations and License Agreements
The Company continues its strategyto pursue the acquisition of establishingbusinesses and establishment of external alliances such as research collaborations and licensing agreements to complement its internal research capabilities, including research collaborations, licensing preclinical and clinical compounds to drive both near- and long-term growth. The Company supplements its internal research with a licensing and external alliance strategy focused on the entire spectrum of collaborations from early research to late-stage compounds, as well as access to new technologies.capabilities. These arrangements often include upfront payments, as well as expense reimbursements or payments to the third party, and milestone, royalty or profit share payments,arrangements, contingent upon the occurrence of certain future events linked to the success of the asset in development. The Company also reviews its marketed products and pipeline to examine candidates which may provide more value through out-licensing and, as part of its portfolio assessment process, may also divest certain products.
In July 2016, Merck acquired Afferent Pharmaceuticals (Afferent), a privately held pharmaceutical company focused on the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions. Afferent’s lead investigational candidate, MK-7264 (formerly AF-219), is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis with cough. Total consideration transferred of $510 million included cash paid for outstanding Afferent shares of $487 million, as well as share-based compensation payments to settle equity awards attributable to precombination service and cash paid for transaction costs on behalf of Afferent. In addition, former Afferent shareholders are eligible to receive a total of up to an additional $750 million contingent upon the attainment of certain clinical development and commercial milestones for multiple indications and candidates, including MK-7264. This transaction was accounted for as an acquisition of a business; accordingly, the assets acquired and liabilities assumed were recorded at their respective fair values as of the acquisition date. The Company determined the fair value of the contingent consideration was $223 million at the acquisition date utilizing a probability-weighted estimated cash flow stream adjusted for the expected timing of each payment using an appropriate discount rate dependent on the nature and timing of the milestone payment. Merck recognized an intangible asset for in-process research and development (IPR&D) of $779 million, net deferred tax liabilities of $258 million, and other net assets of $29 million (primarily consisting of cash acquired). The excess of the consideration transferred over the fair value of net assets acquired of $183 million was recorded as goodwill that was allocated to the Pharmaceutical segment and is not deductible for tax purposes. The fair value of the identifiable intangible asset related to IPR&D was determined using an income approach, through which fair value is estimated based upon the asset’s probability-adjusted future net cash flows, which reflects the stage of development of the project and the associated probability of successful completion. The net cash flows were then discounted to present value using a discount rate of 12.0%. Actual cash flows are likely to be different than those assumed.assets. Pro forma financial information hasfor acquired businesses is not been included because Afferent’spresented if the historical financial results of the acquired entity are not significant when compared with the Company’s financial results.
In July 2016,2017, Merck through its wholly owned subsidiary Healthcare Services & Solutions, LLC, acquiredand AstraZeneca entered a majority ownership interestglobal strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Lynparza is an oral, poly (ADP-ribose) polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment. The StayWell Company LLC (StayWell), a portfolio companycompanies will develop and commercialize Lynparza, both as monotherapy and in combination trials with other potential medicines. Independently, Merck and AstraZeneca will develop and commercialize Lynparza in combinations with their respective PD-1 and PD-L1 medicines, Keytruda (pembrolizumab) and Imfinzi (durvalumab). The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of Vestar Capital Partners (Vestar). StayWell is a health engagement company that helps its clients engage and educate people to improve health and business results.MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer. Under the terms of the transaction,agreement, AstraZeneca and Merck paid $150will share the development and commercialization costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Gross profits from Lynparza and selumetinib product sales generated through monotherapies or combination therapies will be shared equally. Merck will fund all development and commercialization costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialization costs of Imfinzi in combination with Lynparza or selumetinib. As part of the agreement, Merck will make an upfront payment to AstraZeneca of $1.6 billion and will make payments of $750 million over a multi-year period for a majority ownership interest.certain license options. The Company will record an aggregate charge of $2.35 billion in Research and development expenses in the third quarter of 2017 related to these payments. In addition, Merck will pay AstraZeneca up to an additional $6.15 billion contingent upon successful achievement of future regulatory and sales milestones for total aggregate consideration of up to $8.5 billion. Future milestone payments will be capitalized and amortized over the estimated useful life of the corresponding intangible asset. Additionally, Merck provided StayWellwill record its share of product sales of Lynparza and selumetinib, net of commercialization costs, as alliance revenue within the Pharmaceutical segment and its share of development costs associated with a $150 million intercompany loan to pay down preexisting third-party debt.the collaboration as part of Research and development expenses. Merck has an option to buy, and Vestar has an option to require Merck to buy, some or all of Vestar’s remaining ownership interest beginning three years from the acquisition date at fair value. This transaction was accounted for as an acquisition of a business. Merck recognized intangible assets of $238 million, deferred tax liabilities of $84 million, other net liabilities of $5 million and noncontrolling interest of $124 million. The excess of the consideration transferred over the fair value of net assets acquired of $275 million was recorded as goodwill and is
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

largely attributablemay terminate the agreement in its entirety or with respect to anticipated synergies expecteda given compound (and all products comprising such compound) upon prior written notice to arise afterAstraZeneca of at least 180 days.  If the acquisition. The goodwill was allocatedagreement is terminated with respect to a given compound, the agreement shall remain in full force and effect with respect to the Healthcare Services segmentother compounds.  The parties also have the right to terminate the agreement in its entirety or on a product-by-product or country-by-country basis upon mutual written agreement.  The agreement may also be terminated at any time with respect to a given product, upon written notice by a party if the other party is in material breach of the agreement with respect to such product and is not deductible for tax purposes. The intangible assets recognized primarily relate to customer relationships, which are being amortized over a 10-year useful life, and medical information and solutions content, which are being amortized over a five-year useful life. Pro forma financial information has not been included because StayWell’s historical financial results are not significant when compared withcured such breach within the Company’s financial results.time periods provided for under the agreement. 
Also in July 2016,In March 2017, Merck announced it had executed an agreement to acquireacquired a controlling interest in Vallée S.A. (Vallée), a leading privately held producer of animal health products in Brazil. Vallée has an extensive portfolio of products spanning parasiticides, anti-infectives and vaccines that include products for livestock, horses, and companion animals. Under the terms of the agreement, Merck will acquire approximately 93%acquired 93.5% of the shares of Vallée for approximately $400$358 million. Of the total purchase price, $176 million was placed into escrow pending resolution of certain contingent items. The transaction was accounted for as an acquisition of a business. Merck recognized intangible assets of $297 million related to currently marketed products, net deferred tax liabilities of $95 million, other net assets of $1 million and noncontrolling interest of $25 million. In addition, the Company recorded liabilities of $37 million for contingencies identified at the acquisition date and corresponding indemnification assets of $37 million, representing the amounts to be reimbursed to Merck if and when the contingent liabilities are paid. The excess of the consideration transferred over the fair value of net assets acquired of $180 million was recorded as goodwill. The goodwill was allocated to the Animal Health segment and is not deductible for tax purposes. The estimated fair values of identifiable intangible assets related to currently marketed products were determined using an income approach through which fair value is estimated based on exchange rates at the timemarket participant expectations of the announcement. This agreement is subjecteach asset’s discounted projected net cash flows. The probability-adjusted future net cash flows of each product were then discounted to regulatory review and certain closing conditions.present value utilizing a discount rate of 15.5%. Actual cash flows are likely to be different than those assumed. The intangible assets related to currently marketed products are being amortized over their estimated useful lives of 15 years.
In June 2016, Merck and Moderna Therapeutics (Moderna) entered into a strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The development program will entail multiple studies in several types of cancer and include the evaluation of mRNA-based personalized cancer vaccines in combination with Merck’s Keytruda. Pursuant to the terms of the agreement, Merck made an upfront cash payment to Moderna of $200 million in July of 2016, which was accrued for and recorded in Research and development expenses in the second quarter of 2016. Following human proof of concept studies, Merck has the right to elect to make an additional payment to Moderna. If Merck exercises this right, the two companies will then equally share cost and profits under a worldwide collaboration for the development of personalized cancer vaccines. Moderna will have the right to elect to co-promote the personalized cancer vaccines in the United States. The agreement entails exclusivity around combinations with Keytruda. Moderna and Merck will each have the ability to combine mRNA-based personalized cancer vaccines with other (non-PD-1) agents.
As previously disclosed, in 2014, the Company entered into a worldwide clinical development collaboration with Bayer AG (Bayer) to market and develop soluble guanylate cyclase (sGC) modulators, including Bayer’s Adempas. The arrangement provided for potential future milestone payments of up to $1.1 billion based upon the achievement of agreed-upon sales goals. During the second quarter of 2016, the Company determined it was probable that, in 2017, sales of Adempas would exceed the threshold triggering a $350 million milestone payment from Merck to Bayer. Accordingly, in the second quarter of 2016, the Company recorded a $350 million liability and a corresponding intangible asset and also recognized $50 million of cumulative amortization expense within Materials and production costs. The remaining intangible asset at June 30, 2016 of $300 million is being amortized over the then-remaining estimated useful life of the asset of 10.5 years as supported by projected future cash flows, subject to impairment testing. Additional potential future milestone payments of $775 million have not yet been accrued as they are not deemed by the Company to be probable at this time.
In January 2016, Merck acquired IOmet Pharma Ltd (IOmet), a privately held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. The acquisition provides Merck with IOmet’s preclinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. The transaction was accounted for as an acquisition of a business. Total purchase consideration in the transaction of $227 million included a cash payment of $150 million and future additional milestone payments of up to $250 million that are contingent upon certain clinical and regulatory milestones being achieved. The transaction was accounted for as an acquisition of a business. The Company determined the fair value of the contingent consideration was $77$94 million at the acquisition date utilizing a probability-weighted estimated cash flow stream adjusted for the expected timing of each payment utilizing a discount rate of 10.5%. Merck recognized intangible assets for IPR&Din-process research and development (IPR&D) of $155 million and net deferred tax assets of $26$32 million. The excess of the consideration transferred over the fair value of net assets acquired of $46$57 million was recorded as goodwill that was allocated to the Pharmaceutical segment and is not deductible for tax purposes. The fair values of the identifiable intangible assets related to IPR&D were determined using an income approach. The assets’ probability-adjusted future net cash flows were then discounted to present value also using a discount rate of 10.5%. Actual cash flows are likely to be different than those assumed. Pro forma financial information has not been included because IOmet’s historical financial results are not significant when compared withIn July 2017, Merck made a $100 million payment as a result of the Company’s financial results.achievement of a clinical milestone, which was accrued for at estimated fair value at the time of acquisition as noted above.
AlsoAdditionally, in January 2016, Merck sold the U.S. marketing rights to Cortrophin and Corticotropin Zinc Hydroxide to ANI Pharmaceuticals, Inc. (ANI). Under the terms of the agreement, ANI made a payment of $75 million, which was recorded in Sales in the first ninesix months of 2016, and may make additional payments to the Company based on future sales. Merck does not have any ongoing supply or other performance obligations after the closing date.
In July 2015, Merck acquired cCAM, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Total purchase consideration in the transaction of $201 million included an upfront payment of $96 million in cash and future additional payments of up to $510 million associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction was accounted for as an acquisition of a business. The Company determined the fair value of the contingent consideration was $105 million at the acquisition date utilizing a probability-weighted estimated cash flow stream adjusted for the expected timing of each payment utilizing a discount rate of 10.5%. Merck recognized an intangible asset for IPR&D of $180 million and other net assets of $7 million. The excess of the

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

consideration transferred over the fair value of net assets acquired of $14 million was recorded as goodwill that was allocated to the Pharmaceutical segment and is not deductible for tax purposes. The fair value of the identifiable intangible asset related to IPR&D was determined using an income approach. The asset’s probability-adjusted future net cash flows were discounted to present value also using a discount rate of 10.5%. Actual cash flows are likely to be different than those assumed. Pro forma financial information has not been included because cCAM’s historical financial results are not significant when compared with the Company’s financial results.
Also in July 2015, Merck and Allergan plc (Allergan) entered into an agreement pursuant to which Allergan acquired the exclusive worldwide rights to MK-1602 and MK-8031, Merck’s investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the treatment and prevention of migraine. Under the terms of the agreement, Allergan acquired these rights for upfront payments of $250 million, of which $125 million was paid in August 2015 upon closing of the transaction and the remaining $125 million was paid in April of 2016. The Company recorded a gain of $250 million within Other (income) expense, net in the third quarter of 2015 related to the transaction. Allergan is fully responsible for development of the CGRP programs, as well as manufacturing and commercialization upon approval and launch of the products. Under the agreement, Merck is eligible for the receipt of potential development and commercial milestone payments and royalties at tiered double-digit rates based on commercialization of the programs. During the third quarter of 2016, Merck recognized a gain of $40 million within Other (income) expense, net for the achievement of a research and development milestone, which was paid by Allergan.
In February 2015, Merck and NGM Biopharmaceuticals, Inc. (NGM), a privately held biotechnology company, entered into a multi-year collaboration to research, discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. NGM will lead the research and development of the existing preclinical candidates and have the autonomy to identify and pursue other discovery stage programs at its discretion. Merck will have the option to license all resulting NGM programs following human proof-of-concept trials. If Merck exercises this option, Merck will lead global product development and commercialization for the resulting products, if approved. Under the terms of the agreement, Merck made an upfront payment to NGM of $94 million, which was included in Research and development expenses, and purchased a 15% equity stake in NGM for $106 million. Merck committed up to $250 million to fund all of NGM’s efforts under the initial five-year term of the collaboration, with the potential for additional funding if certain conditions are met. Prior to Merck initiating a Phase 3 study for a licensed program, NGM may elect to either receive milestone and royalty payments or, in certain cases, to co-fund development and participate in a global cost and revenue share arrangement of up to 50%. The agreement also provides NGM with the option to participate in the co-promotion of any co-funded program in the United States. Merck has the option to extend the research agreement for two additional two-year terms.
Acquisition of Cubist Pharmaceuticals, Inc.
In January 2015, Merck acquired Cubist Pharmaceuticals, Inc. (Cubist), a leader in the development of therapies to treat serious infections caused by a broad range of bacteria. This transaction, which was accounted for as an acquisition of a business, closed on January 21, 2015; accordingly, the results of operations of the acquired business have been included in the Company’s results of operations beginning after that date. Total consideration transferred of $8.3 billion included cash paid for outstanding Cubist shares of $7.8 billion, as well as share-based compensation payments to settle equity awards attributable to precombination service and cash paid for transaction costs on behalf of Cubist. In addition, the Company assumed all of the outstanding convertible debt of Cubist, which had a fair value of approximately $1.9 billion at the acquisition date. Merck redeemed this debt in February 2015.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The estimated fair value of assets acquired and liabilities assumed from Cubist is as follows:
($ in millions) 
Cash and cash equivalents$733
Accounts receivable123
Inventories216
Other current assets55
Property, plant and equipment151
Identifiable intangible assets: 
Products and product rights (11 year weighted-average useful life)6,923
IPR&D50
Other noncurrent assets184
Current liabilities (1)
(233)
Deferred income tax liabilities(2,519)
Long-term debt(1,900)
Other noncurrent liabilities (1)
(122)
Total identifiable net assets3,661
Goodwill (2)
4,670
Consideration transferred$8,331
(1)
Included in current liabilities and other noncurrent liabilities is contingent consideration of $73 million and $50 million, respectively.
(2)
The goodwill recognized is largely attributable to anticipated synergies expected to arise after the acquisition and was allocated to the Pharmaceutical segment. The goodwill is not deductible for tax purposes.
The estimated fair values of identifiable intangible assets related to currently marketed products were determined using an income approach through which fair value is estimated based on market participant expectations of each asset’s discounted projected net cash flows. The probability-adjusted future net cash flows of each product were then discounted to present value utilizing a discount rate of 8%. Actual cash flows are likely to be different than those assumed. In connection with the Cubist acquisition, liabilities were recorded for potential future consideration that is contingent upon the achievement of future sales-based milestones. The fair value of contingent consideration liabilities was determined at the acquisition date using unobservable inputs. These inputs include the estimated amount and timing of projected cash flows, the probability of success (achievement of the contingent event) and a risk-adjusted discount rate of 8% used to present value the probability-weighted cash flows. Changes in the inputs could result in a different fair value measurement.
The following unaudited supplemental pro forma data presents consolidated information as if the acquisition of Cubist had been completed on January 1, 2014:
 Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
($ in millions, except per share amounts)2015 2015
Sales$10,073
 $29,369
Net income attributable to Merck & Co., Inc.1,833
 3,645
Basic earnings per common share attributable to Merck & Co., Inc. common shareholders0.65
 1.29
Earnings per common share assuming dilution attributable to Merck & Co., Inc. common shareholders0.65
 1.28
The unaudited supplemental pro forma data reflects the historical information of Merck and Cubist adjusted to include additional amortization expense based on the fair value of assets acquired, additional interest expense that would have been incurred on borrowings used to fund the acquisition, transaction costs associated with the acquisition, and the related tax effects of these adjustments. The pro forma data should not be considered indicative of the results that would have occurred if the acquisition had been consummated on January 1, 2014, nor are they indicative of future results.
3.Restructuring
The Company incurs substantial costs for restructuring program activities related to Merck’s productivity and cost reduction initiatives, as well as in connection with the integration of certain acquired businesses. In 2010 and 2013, the Company commenced actions under global restructuring programs designed to streamline its cost structure. The actions under these programs include the elimination of positions in sales, administrative and headquarters organizations, as well as the sale or closure of certain manufacturing and research and development sites and the consolidation of office facilities. The Company also continues to reduce its global real estate footprint and improve the efficiency of its manufacturing and supply network. The non-facility related
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

restructuring actions under these programs are substantially complete; the remaining activities primarily relate to ongoing facility rationalizations.
The Company recorded total pretax costs of $212$210 million and $217$351 million in the thirdsecond quarter of 20162017 and 2015,2016, respectively, and $759$425 million and $770$547 million for the first ninesix months of 20162017 and 2015,2016, respectively, related to restructuring program activities. Since inception of the programs through SeptemberJune 30, 20162017, Merck has recorded total pretax accumulated costs of approximately $12.2$13.0 billion and eliminated approximately 39,63041,920 positions comprised of employee separations, as well as the elimination of contractors and vacant positions. The Company expects to substantially complete the remaining actions under these programs by the end of 2017 and incur approximately $800$300 million of additional pretax costs. The Company estimates that approximately two-thirds of the cumulative pretax costs will result in cash outlays, primarily related to employee separation expense. Approximately one-third of the cumulative pretax costs are non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested.
For segment reporting, restructuring charges are unallocated expenses.
The following tables summarize the charges related to restructuring program activities by type of cost:
Three Months Ended September 30, 2016 Nine Months Ended September 30, 2016Three Months Ended June 30, 2017 Six Months Ended June 30, 2017
($ in millions)
Separation
Costs
 
Accelerated
Depreciation
 Other Total 
Separation
Costs
 
Accelerated
Depreciation
 Other Total
Separation
Costs
 
Accelerated
Depreciation
 Other Total 
Separation
Costs
 
Accelerated
Depreciation
 Other Total
Materials and production$
 $18
 $18
 $36
 $
 $69
 $80
 $149
$
 $(4) $37
 $33
 $
 $47
 $49
 $96
Marketing and administrative
 1
 
 1
 
 8
 83
 91

 2
 
 2
 
 2
 1
 3
Research and development
 14
 
 14
 
 133
 
 133

 8
 1
 9
 
 6
 3
 9
Restructuring costs61
 
 100
 161
 172
 
 214
 386
118
 
 48
 166
 202
 
 115
 317
$61
 $33
 $118
 $212
 $172
 $210
 $377
 $759
$118
 $6
 $86
 $210
 $202
 $55
 $168
 $425
Three Months Ended September 30, 2015 Nine Months Ended September 30, 2015Three Months Ended June 30, 2016 Six Months Ended June 30, 2016
($ in millions)
Separation
Costs
 
Accelerated
Depreciation
 Other Total 
Separation
Costs
 
Accelerated
Depreciation
 Other Total
Separation
Costs
 
Accelerated
Depreciation
 Other Total 
Separation
Costs
 
Accelerated
Depreciation
 Other Total
Materials and production$
 $17
 $53
 $70
 $
 $47
 $233
 $280
$
 $29
 $37
 $66
 $
 $51
 $62
 $113
Marketing and administrative
 5
 12
 17
 
 53
 17
 70

 4
 83
 87
 
 7
 83
 90
Research and development
 9
 8
 17
 
 25
 9
 34

 64
 
 64
 
 119
 
 119
Restructuring costs12
 
 101
 113
 100
 
 286
 386
85
 
 49
 134
 111
 
 114
 225
$12
 $31
 $174
 $217
 $100
 $125
 $545
 $770
$85
 $97
 $169
 $351
 $111
 $177
 $259
 $547
Separation costs are associated with actual headcount reductions, as well as those headcount reductions which were probable and could be reasonably estimated. In the thirdsecond quarter of 2017 and 2016, and 2015, approximately 300475 positions and 685585 positions, respectively, and for the first ninesix months of 2017 and 2016, and 2015, approximately 1,3551,020 positions and 2,6351,055 positions, respectively, were eliminated under restructuring program activities. These position eliminations were comprised of actual headcount reductions and the elimination of contractors and vacant positions.
Accelerated depreciation costs primarily relate to manufacturing, research and administrative facilities and equipment to be sold or closed as part of the programs. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the asset, based upon the anticipated date the site will be closed or divested or the equipment disposed of, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. All of the sites have and will continue to operate up through the respective closure dates and, since future undiscounted cash flows were sufficient to recover the respective book values, Merck recordedis recording accelerated depreciation over the revised useful life of the site assets. Anticipated site closure dates, particularly related to manufacturing locations, have been and may continue to be adjusted to reflect changes resulting from regulatory or other factors.
Other activity in 20162017 and 20152016 includes asset abandonment, shut-down and other related costs, as well as pretax gains and losses resulting from sales of facilities and related assets. Additionally, other activity includes certain employee-related costs associated with pension and other postretirement benefit plans (see Note 12)10) and share-based compensation.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The following table summarizes the charges and spending relating to restructuring program activities for the ninesix months ended SeptemberJune 30, 2016:2017:
($ in millions)
Separation
Costs
 
Accelerated
Depreciation
 Other Total
Separation
Costs
 
Accelerated
Depreciation
 Other Total
Restructuring reserves January 1, 2016$592
 $
 $53
 $645
Restructuring reserves January 1, 2017$395
 $
 $146
 $541
Expense172
 210
 377
 759
202
 55
 168
 425
(Payments) receipts, net(251) 
 (200) (451)(167) 
 (234) (401)
Non-cash activity
 (210) (164) (374)
 (55) 50
 (5)
Restructuring reserves September 30, 2016 (1)
$513
 $
 $66
 $579
Restructuring reserves June 30, 2017 (1)
$430
 $
 $130
 $560
(1) 
The remaining cash outlays are expected to be substantially completed by the end of 2017.
4.Financial Instruments
Derivative Instruments and Hedging Activities
The Company manages the impact of foreign exchange rate movements and interest rate movements on its earnings, cash flows and fair values of assets and liabilities through operational means and through the use of various financial instruments, including derivative instruments.
A significant portion of the Company’s revenues and earnings in foreign affiliates is exposed to changes in foreign exchange rates. The objectives and accounting related to the Company’s foreign currency risk management program, as well as its interest rate risk management activities are discussed below.
Foreign Currency Risk Management
The Company has established revenue hedging, balance sheet risk management and net investment hedging programs to protect against volatility of future foreign currency cash flows and changes in fair value caused by volatility in foreign exchange rates.
The objective of the revenue hedging program is to reduce the variability caused by changes in foreign exchange rates that would affect the U.S. dollar value of future cash flows derived from foreign currency denominated sales, primarily the euro and Japanese yen. To achieve this objective, the Company will hedge a portion of its forecasted foreign currency denominated third-party and intercompany distributor entity sales (forecasted sales) that are expected to occur over its planning cycle, typically no more than two years into the future. The Company will layer in hedges over time, increasing the portion of third-party and intercompany distributor entityforecasted sales hedged as it gets closer to the expected date of the forecasted foreign currency denominated sales. The portion of forecasted sales hedged is based on assessments of cost-benefit profiles that consider natural offsetting exposures, revenue and exchange rate volatilities and correlations, and the cost of hedging instruments. The hedged anticipated sales are a specified component of a portfolio of similarly denominated foreign currency-based sales transactions, each of which responds to the hedged currency risk in the same manner. The Company manages its anticipated transaction exposure principally with purchased local currency put options, and forward contracts. In connection with the Company’s revenue hedging program, acontracts and purchased collar option strategy may also be utilized.options.
Purchased put options provide the Company with a right, but not an obligation, to sell foreign currencies in the future at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, total changes in the options’ cash flows offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the options’ value reduces to zero, but the Company benefits from the increase in the U.S. dollar equivalent value of the anticipated foreign currency cash flows.
Forward contracts obligate the Company to sell foreign currencies in the future at a predetermined price. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the increase in the fair value of the forward contracts offsets the decrease in the expected future U.S. dollar cash flows of the hedged foreign currency sales. Conversely, if the U.S. dollar weakens, the decrease in the fair value of the forward contracts offsets the increase in the value of the anticipated foreign currency cash flows.
With a purchased collar option strategy, the Company writes a local currency call option and purchases a local currency put option. As compared to a purchased put option strategy alone, a purchased collar strategy reduces the upfront costs associated with purchasing puts through the collection of premiums by writing call options. If the U.S. dollar weakens relative to the currency of the hedged anticipated sales, the purchased put option value of the collar strategy reduces to zero and the Company benefits from the increase in the U.S. dollar equivalent value of its anticipated foreign currency cash flows; however, this benefit would be capped at the strike level of the written call. If the U.S. dollar strengthens relative to the currency of the hedged anticipated sales, the written call option value of the collar strategy reduces to zero and the changes in the purchased put cash flows of the
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

collar strategy would offset the decline in the expected future U.S. dollar equivalent cash flows of the hedged foreign currency sales.
The fair values of these derivative contracts are recorded as either assets (gain positions) or liabilities (loss positions) in the Condensed Consolidated Balance Sheet. Changes in the fair value of derivative contracts are recorded each period in either current earnings or Other comprehensive income (OCI), depending on whether the derivative is designated as part of a hedge transaction and, if so, the type of hedge transaction. For derivatives that are designated as cash flow hedges, the effective portion of the unrealized gains or losses on these contracts is recorded in Accumulated other comprehensive income (AOCI) and reclassified into Sales when the hedged anticipated revenue is recognized. The hedge relationship is highly effective and hedge ineffectiveness has been de minimis. For those derivatives which are not designated as cash flow hedges, but serve as economic hedges of forecasted sales, unrealized gains or losses are recorded in Sales each period. The cash flows from both designated and non-designated contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows. The Company does not enter into derivatives for trading or speculative purposes.
The primary objectiveCompany manages operating activities and net asset positions at each local subsidiary in order to mitigate the effects of theexchange on monetary assets and liabilities. The Company also uses a balance sheet risk management program is to mitigate the exposure of net monetary assets that are denominated in a currency other than a subsidiary’s functional currency from the effects of volatility in foreign exchange. In these instances, Merck principally utilizes forward exchange contracts, which enable the Company to buy and sell foreign currencies in the future at fixed exchange rates and economically offset the consequences of changes in foreign exchange from the monetary assets. Merck routinely enters into contracts to offset the effects of exchange on exposures denominated in developed country currencies, primarily the euro and Japanese yen. For exposures in developing country currencies, the Company will enter into forward contracts to partially offset the effects of exchange on exposures when it is deemed economical to do so based on a cost-benefit analysis that considers the magnitude of the exposure, the volatility of the exchange rate and the cost of the hedging instrument. The Company will also minimize the effect of exchange on monetary assets and liabilities by managing operating activities and net asset positions at the local level. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Monetary assets and liabilities denominated in a currency other than the functional currency of a given subsidiary are remeasured at spot rates in effect on the balance sheet date with the effects of changes in spot rates reported in Other (income) expense, net. The forward contracts are not designated as hedges and are marked to market through Other (income) expense, net. Accordingly, fair value changes in the forward contracts help mitigate the changes in the value of the remeasured assets and liabilities attributable to changes in foreign currency exchange rates, except to the extent of the spot-forward differences. These differences are not significant due to the short-term nature of the contracts, which typically have average maturities at inception of less than one year.
The Company may also usesuse forward exchange contracts to hedge its net investment in foreign operations against movements in exchange rates. The forward contracts are designated as hedges of the net investment in a foreign operation. The Company hedges a portion of the net investment in certain of its foreign operations and measures ineffectiveness based upon changes in spot foreign exchange rates.rates that are recorded in Other (income) expense, net. The effective portion of the unrealized gains or losses on these contracts is recorded in foreign currency translation adjustment within OCI, and remains in AOCI until either the sale or complete or substantially complete liquidation of the subsidiary. The cash flows from these contracts are reported as investing activities in the Condensed Consolidated Statement of Cash Flows.
Foreign exchange risk is also managed through the use of foreign currency debt. The Company’s senior unsecured euro-denominated notes have been designated as, and are effective as, economic hedges of the net investment in a foreign operation. Accordingly, foreign currency transaction gains or losses due to spot rate fluctuations on the euro-denominated debt instruments are included in foreign currency translation adjustment within OCI. Included in the cumulative translation adjustment are pretax losses of $60339 million and pretax gains $25529 million for the first ninesix months of 20162017 and 2015,2016, respectively, from the euro-denominated notes.
Interest Rate Risk Management
The Company may use interest rate swap contracts on certain investing and borrowing transactions to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. The Company does not use leveraged swaps and, in general, does not leverage any of its investment activities that would put principal capital at risk.
In May 2016, four interest rate swaps with notional amounts of $250 million each matured. These swaps effectively converted the Company’s $1.0 billion, 0.70% fixed-rate notes due 2016 to variable rate debt. At SeptemberJune 30, 2016,2017, the Company was a party to 26 pay-floating, receive-fixed interest rate swap contracts designated as fair value hedges of fixed-rate notes in which the notional amounts match the amount of the hedged fixed-rate notes as detailed in the table below.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

($ in millions)September 30, 2016June 30, 2017
Debt InstrumentPar Value of Debt Number of Interest Rate Swaps Held Total Swap Notional AmountPar Value of Debt Number of Interest Rate Swaps Held Total Swap Notional Amount
1.30% notes due 2018$1,000
 4
 $1,000
$1,000
 4
 $1,000
5.00% notes due 20191,250
 3
 550
1,250
 3
 550
1.85% notes due 20201,250
 5
 1,250
1,250
 5
 1,250
3.875% notes due 20211,150
 5
 1,150
1,150
 5
 1,150
2.40% notes due 20221,000
 4
 1,000
1,000
 4
 1,000
2.35% notes due 20221,250
 5
 1,250
1,250
 5
 1,250
The interest rate swap contracts are designated hedges of the fair value changes in the notes attributable to changes in the benchmark London Interbank Offered Rate (LIBOR) swap rate. The fair value changes in the notes attributable to changes in the LIBOR swap rate are recorded in interest expense and offset by the fair value changes in the swap contracts. The cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Presented in the table below is the fair value of derivatives on a gross basis segregated between those derivatives that are designated as hedging instruments and those that are not designated as hedging instruments:
  September 30, 2016 December 31, 2015
  Fair Value of Derivative 
U.S. Dollar
Notional
 Fair Value of Derivative 
U.S. Dollar
Notional
($ in millions)Balance Sheet CaptionAsset Liability Asset Liability 
Derivatives Designated as Hedging Instruments            
Interest rate swap contracts (noncurrent)Other assets$158
 $
 $5,200
 $42
 $
 $2,700
Interest rate swap contracts (current)Accrued and other current liabilities
 
 
 
 1
 1,000
Interest rate swap contracts (noncurrent)Other noncurrent liabilities
 1
 1,000
 
 23
 3,500
Foreign exchange contracts (current)Other current assets274
 
 4,265
 579
 
 4,171
Foreign exchange contracts (noncurrent)Other assets96
 
 2,162
 386
 
 4,136
Foreign exchange contracts (current)Accrued and other current liabilities
 20
 845
 
 1
 77
  $528

$21

$13,472

$1,007

$25

$15,584
Derivatives Not Designated as Hedging Instruments            
Foreign exchange contracts (current)Other current assets$92
 $
 $6,157
 $212
 $
 $8,783
Foreign exchange contracts (noncurrent)Other assets
 
 
 18
 
 179
Foreign exchange contracts (current)Accrued and other current liabilities
 35
 4,062
 
 37
 2,508
Foreign exchange contracts (noncurrent)Other noncurrent liabilities
 1
 7
 
 1
 6
  $92
 $36
 $10,226
 $230
 $38
 $11,476
  $620

$57

$23,698

$1,237

$63

$27,060
  June 30, 2017 December 31, 2016
  Fair Value of Derivative 
U.S. Dollar
Notional
 Fair Value of Derivative 
U.S. Dollar
Notional
($ in millions)Balance Sheet CaptionAsset Liability Asset Liability 
Derivatives Designated as Hedging Instruments            
Interest rate swap contractsOther assets$21
 $
 $2,700
 $20
 $
 $2,700
Interest rate swap contractsAccrued and other current liabilities
 4
 1,000
 
 
 
Interest rate swap contractsOther noncurrent liabilities
 19
 2,500
 
 29
 3,500
Foreign exchange contractsOther current assets154
 
 4,223
 616
 
 6,063
Foreign exchange contractsOther assets31
 
 1,388
 129
 
 2,075
Foreign exchange contractsAccrued and other current liabilities
 58
 1,692
 
 1
 48
Foreign exchange contractsOther noncurrent liabilities
 
 
 
 1
 12
  $206

$81

$13,503

$765

$31

$14,398
Derivatives Not Designated as Hedging Instruments            
Foreign exchange contractsOther current assets$134
 $
 $5,586
 $230
 $
 $8,210
Foreign exchange contractsAccrued and other current liabilities
 120
 5,807
 
 103
 2,931
  $134
 $120
 $11,393
 $230
 $103
 $11,141
  $340

$201

$24,896

$995

$134

$25,539
As noted above, the Company records its derivatives on a gross basis in the Condensed Consolidated Balance Sheet. The Company has master netting agreements with several of its financial institution counterparties (see Concentrations of Credit Risk below). The following table provides information on the Company’s derivative positions subject to these master netting arrangements as if they were presented on a net basis, allowing for the right of offset by counterparty and cash collateral exchanged per the master agreements and related credit support annexes:
 September 30, 2016 December 31, 2015
($ in millions)Asset Liability Asset Liability
Gross amounts recognized in the consolidated balance sheet$620
 $57
 $1,237
 $63
Gross amount subject to offset in master netting arrangements not offset in the consolidated
balance sheet
(50) (50) (59) (59)
Cash collateral (received) posted(299) 
 (862) 
Net amounts$271
 $7
 $316
 $4
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

 June 30, 2017 December 31, 2016
($ in millions)Asset Liability Asset Liability
Gross amounts recognized in the consolidated balance sheet$340
 $201
 $995
 $134
Gross amount subject to offset in master netting arrangements not offset in the consolidated
balance sheet
(132) (132) (131) (131)
Cash collateral received(65) 
 (529) 
Net amounts$143
 $69
 $335
 $3
The table below provides information on the location and pretax gain or loss amounts for derivatives that are: (i) designated in a fair value hedging relationship, (ii) designated in a foreign currency cash flow hedging relationship (iii) designated in a foreign currency net investment hedging relationship and (iv)(iii) not designated in a hedging relationship:
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2016 2015 2016 20152017 2016 2017 2016
Derivatives designated in a fair value hedging relationship              
Interest rate swap contracts              
Amount of loss (gain) recognized in Other (income) expense, net on derivatives (1)
$59
 $(130) $(139) $(97)
Amount of (gain) loss recognized in Other (income) expense, net on hedged item (1)
(60) 125
 135
 91
Amount of gain recognized in Other (income) expense, net on derivatives (1)
$(22) $(48) $(7) $(198)
Amount of loss recognized in Other (income) expense, net on hedged item (1)
20
 47
 4
 194
Derivatives designated in foreign currency cash flow hedging relationships              
Foreign exchange contracts              
Amount of gain reclassified from AOCI to Sales
(44) (170) (251) (528)(49) (65) (144) (207)
Amount of loss (gain) recognized in OCI on derivatives
69
 17
 311
 (464)
Derivatives designated in foreign currency net investment hedging relationships       
Amount of loss recognized in OCI on derivatives
169
 75
 432
 242
Derivatives not designated in a hedging relationship       
Foreign exchange contracts              
Amount of gain recognized in Other (income) expense, net on derivatives (2)

 (1) 
 (4)(3) (140) (49) (116)
Amount of loss (gain) recognized in OCI on derivatives

 13
 
 (5)
Derivatives not designated in a hedging relationship       
Foreign exchange contracts       
Amount of loss (gain) recognized in Other (income) expense, net on derivatives (3)
29
 (155) (87) (360)
Amount of gain recognized in Sales

 
 
 (1)
(1) There was $1$2 million and $5$1 million of ineffectiveness on the hedge during the thirdsecond quarter of 2017 and 2016, respectively, and 2015, respectively,$3 million and $4 million, and $6 millionrespectively, of ineffectiveness on the hedge forduring the first ninesix months of 20162017 and 2015,2016, respectively.
(2)There was no ineffectiveness on the hedge. Represents the amount excluded from hedge effectiveness testing.
(3) These derivative contracts mitigate changes in the value of remeasured foreign currency denominated monetary assets and liabilities attributable to changes in foreign currency exchange rates.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

At SeptemberJune 30, 20162017, the Company estimates $5250 million of pretax net unrealized gainslosses on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCI to Sales. The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity.

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Investments in Debt and Equity Securities
Information on investments in debt and equity securities is as follows:
September 30, 2016 December 31, 2015June 30, 2017 December 31, 2016
Fair
Value
 
Amortized
Cost
 Gross Unrealized 
Fair
Value
 
Amortized
Cost
 Gross Unrealized
Fair
Value
 
Amortized
Cost
 Gross Unrealized 
Fair
Value
 
Amortized
Cost
 Gross Unrealized
($ in millions)Gains Losses Gains LossesGains Losses Gains Losses
Corporate notes and bonds$10,857
 $10,791
 $71
 $(5) $10,259
 $10,299
 $7
 $(47)$10,469
 $10,460
 $28
 $(19) $10,577
 $10,601
 $15
 $(39)
U.S. government and agency securities2,293
 2,288
 6
 (1) 1,761
 1,767
 
 (6)2,009
 2,018
 
 (9) 2,232
 2,244
 1
 (13)
Commercial paper1,516
 1,516
 
 
 2,977
 2,977
 
 
1,607
 1,607
 
 
 4,330
 4,330
 
 
Asset-backed securities1,397
 1,394
 4
 (1) 1,284
 1,290
 
 (6)1,399
 1,399
 2
 (2) 1,376
 1,380
 1
 (5)
Mortgage-backed securities895
 892
 4
 (1) 694
 697
 1
 (4)710
 714
 1
 (5) 796
 801
 1
 (6)
Foreign government bonds494
 493
 1
 
 607
 586
 22
 (1)569
 571
 
 (2) 519
 521
 
 (2)
Equity securities410
 316
 102
 (8) 534
 409
 125
 
376
 285
 92
 (1) 349
 281
 71
 (3)
$17,862
 $17,690
 $188
 $(16) $18,116
 $18,025
 $155
 $(64)$17,139
 $17,054
 $123
 $(38) $20,179
 $20,158
 $89
 $(68)
Available-for-sale debt securities included in Short-term investments totaled $5.24.2 billion at SeptemberJune 30, 20162017. Of the remaining debt securities, $10.410.8 billion mature within five years. At SeptemberJune 30, 20162017 and December 31, 2015,2016, there were no debt securities pledged as collateral.
Fair Value Measurements
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The Company uses a fair value hierarchy which maximizes the use of observable inputs and minimizes the use of unobservable inputs when measuring fair value. There are three levels of inputs used to measure fair value with Level 1 having the highest priority and Level 3 having the lowest:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity. Level 3 assets or liabilities are those whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques with significant unobservable inputs, as well as assets or liabilities for which the determination of fair value requires significant judgment or estimation.
If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis
Financial assets and liabilities measured at fair value on a recurring basis are summarized below:
Fair Value Measurements Using Fair Value Measurements UsingFair Value Measurements Using Fair Value Measurements Using
Quoted Prices
In Active
Markets for
Identical Assets
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
 Total 
Quoted Prices
In Active
Markets for
Identical Assets
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
 Total
Quoted Prices
In Active
Markets for
Identical Assets
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
 Total 
Quoted Prices
In Active
Markets for
Identical Assets
(Level 1)
 
Significant
Other
Observable
Inputs
(Level 2)
 
Significant
Unobservable
Inputs
(Level 3)
 Total
($ in millions)September 30, 2016 December 31, 2015June 30, 2017 December 31, 2016
Assets                              
Investments                              
Corporate notes and bonds$
 $10,651
 $
 $10,651
 $
 $10,259
 $
 $10,259
$
 $10,305
 $
 $10,305
 $
 $10,389
 $
 $10,389
U.S. government and agency securities30
 1,950
 
 1,980
 
 1,761
 
 1,761
67
 1,649
 
 1,716
 29
 1,890
 
 1,919
Commercial paper
 1,516
 
 1,516
 
 2,977
 
 2,977

 1,607
 
 1,607
 
 4,330
 
 4,330
Asset-backed securities (1)

 1,265
 
 1,265
 
 1,284
 
 1,284

 1,314
 
 1,314
 
 1,257
 
 1,257
Mortgage-backed securities (1)

 663
 
 663
 
 694
 
 694

 596
 
 596
 
 628
 
 628
Foreign government bonds
 493
 
 493
 
 607
 
 607

 568
 
 568
 
 518
 
 518
Equity securities249
 
 
 249
 360
 
 
 360
213
 
 
 213
 201
 
 
 201
279
 16,538
 
 16,817
 360
 17,582
 
 17,942
280
 16,039
 
 16,319
 230
 19,012
 
 19,242
Other assets (2)
                              
U.S. government and agency securities
 313
 
 313
 
 
 
 

 293
 
 293
 
 313
 
 313
Corporate notes and bonds
 164
 
 164
 
 188
 
 188
Mortgage-backed securities (1)

 232
 
 232
 
 
 
 

 114
 
 114
 
 168
 
 168
Corporate notes and bonds
 206
 
 206
 
 
 
 
Asset-backed securities (1)

 132
 
 132
 
 
 
 

 85
 
 85
 
 119
 
 119
Foreign government bonds
 1
 
 1
 
 
 
 

 1
 
 1
 
 1
 
 1
Equity securities161
 
 
 161
 155
 19
 
 174
163
 
 
 163
 148
 
 
 148
161

884



1,045

155

19



174
163

657



820

148

789



937
Derivative assets (3)(2)
                              
Purchased currency options
 399
 
 399
 
 1,041
 
 1,041

 180
 
 180
 
 644
 
 644
Forward exchange contracts
 139
 
 139
 
 331
 
 331
Interest rate swaps
 158
 
 158
 
 42
 
 42

 21
 
 21
 
 20
 
 20
Forward exchange contracts
 63
 
 63
 
 154
 
 154

 620
 
 620
 
 1,237
 
 1,237

 340
 
 340
 
 995
 
 995
Total assets$440

$18,042

$

$18,482

$515

$18,838

$

$19,353
$443

$17,036

$

$17,479

$378

$20,796

$

$21,174
Liabilities                              
Other liabilities                              
Contingent consideration$
 $
 $894
 $894
 $
 $
 $590
 $590
$
 $
 $1,002
 $1,002
 $
 $
 $891
 $891
Derivative liabilities (3)(2)
                              
Forward exchange contracts
 55
 
 55
 
 38
 
 38

 178
 
 178
 
 93
 
 93
Interest rate swaps
 23
 
 23
 
 29
 
 29
Written currency options
 1
 
 1
 
 1
 
 1

 
 
 
 
 12
 
 12
Interest rate swaps
 1
 
 1
 
 24
 
 24

 57
 
 57
 
 63
 
 63

 201
 
 201
 
 134
 
 134
Total liabilities$

$57

$894

$951

$

$63

$590

$653
$

$201

$1,002

$1,203

$

$134

$891

$1,025
(1) 
Primarily all of the asset-backed securities are highly-rated (Standard & Poor’s rating of AAA and Moody’s Investors Service rating of Aaa), secured primarily by auto loan, credit card autoand student loan and home equity receivables, with weighted-average lives of primarily 5 years or less. Mortgage-backed securities represent AAA-rated securities issued or unconditionally guaranteed as to payment of principal and interest by U.S. government agencies.
(2)
The increase in investments included in Other assets reflects certain assets previously restricted for retiree benefits that became available to fund certain other health and welfare benefits during the second quarter of 2016 (see Note 12).
(3) 
The fair value determination of derivatives includes the impact of the credit risk of counterparties to the derivatives and the Company’s own credit risk, the effects of which were not significant.
There were no transfers between Level 1 and Level 2 during the first ninesix months of 2016.2017. As of SeptemberJune 30, 20162017, Cash and cash equivalents of $7.97.8 billion included $7.26.7 billion of cash equivalents (considered(which would be considered Level 2 in the fair value hierarchy).
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Contingent Consideration
Summarized information about the changes in liabilities for contingent consideration is as follows:
Nine Months Ended September 30,Six Months Ended June 30,
($ in millions)2016 20152017 2016
Fair value January 1$590
 $428
$891
 $590
Changes in fair value (1)
29
 8
108
 19
Additions300
 228
3
 77
Payments(25) (50)
 (25)
Fair value September 30$894
 $614
Fair value June 30 (2)
$1,002
 $661
(1) Recorded in Research and development expenses, and Materials and production costs.costs and Other (income) expense, net. Includes cumulative translation adjustments.
(2) Amount at June 30, 2017, includes $308 million recorded as a current liability for amounts expected to be paid within the next 12 months, including $100 million related to the acquisition of IOmet (see Note 2).
The Company recognized liabilities foradditions to contingent consideration in the first six months of 2016 relatedrelate to the acquisitionsacquisition of IOmet and Afferent and in 2015 related to the acquisitions of Cubist and cCAM (see Note 2), reflected as “Additions” in the table above.. The payments of contingent consideration reflected in the table above forfirst six months of 2016 relate to the first commercial sale of Zerbaxa in the European Union and for 2015 relate to the first commercial sale of Zerbaxa in the United States.Union.
Other Fair Value Measurements
Some of the Company’s financial instruments, such as cash and cash equivalents, receivables and payables, are reflected in the balance sheet at carrying value, which approximates fair value due to their short-term nature.
The estimated fair value of loans payable and long-term debt (including current portion) at SeptemberJune 30, 20162017, was $27.026.0 billion compared with a carrying value of $25.124.9 billion and at December 31, 20152016, was $27.025.7 billion compared with a carrying value of $26.424.8 billion. Fair value was estimated using recent observable market prices and would be considered Level 2 in the fair value hierarchy.
Concentrations of Credit Risk
On an ongoing basis, the Company monitors concentrations of credit risk associated with corporate and government issuers of securities and financial institutions with which it conducts business. Credit exposure limits are established to limit a concentration with any single issuer or institution. Cash and investments are placed in instruments that meet high credit quality standards as specified in the Company’s investment policy guidelines.
The majority of the Company’s accounts receivable arise from product sales in the United States and Europe and are primarily due from drug wholesalers and retailers, hospitals, government agencies, managed health care providers and pharmacy benefit managers. The Company monitors the financial performance and creditworthiness of its customers so that it can properly assess and respond to changes in their credit profile. The Company also continues to monitor economic conditions, including the volatility associated with international sovereign economies, and associated impacts on the financial markets and its business, taking into consideration global economic conditions and the ongoing sovereign debt issues in certain European countries. At SeptemberJune 30, 20162017, the Company’s total net accounts receivable outstanding for more than one year were approximately $125160 million. The Company does not expect to have write-offs or adjustments to accounts receivable which would have a material adverse effect on its financial position, liquidity or results of operations.
Derivative financial instruments are executed under International Swaps and Derivatives Association master agreements. The master agreements with several of the Company’s financial institution counterparties also include credit support annexes. These annexes contain provisions that require collateral to be exchanged depending on the value of the derivative assets and liabilities, the Company’s credit rating, and the credit rating of the counterparty. As of SeptemberJune 30, 20162017 and December 31, 20152016, the Company had received cash collateral of $29965 million and $862529 million, respectively, from various counterparties and the obligation to return such collateral is recorded in Accrued and other current liabilities. The Company had not advanced any cash collateral to counterparties as of SeptemberJune 30, 20162017 or December 31, 20152016.

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

5.Inventories
Inventories consisted of:
($ in millions)September 30, 2016 December 31, 2015June 30, 2017 December 31, 2016
Finished goods$1,421
 $1,343
$1,396
 $1,304
Raw materials and work in process4,432
 4,374
4,654
 4,222
Supplies175
 168
175
 155
Total (approximates current cost)6,028
 5,885
6,225
 5,681
Increase to LIFO costs320
 384
258
 302
$6,348
 $6,269
$6,483
 $5,983
Recognized as:      
Inventories$5,244
 $4,700
$5,407
 $4,866
Other assets1,104
 1,569
1,076
 1,117
Amounts recognized as Other assets are comprised almost entirely of raw materials and work in process inventories. At SeptemberJune 30, 20162017 and December 31, 20152016, these amounts included $1.0$1.0 billion and $1.5 billion, respectively, of inventories not expected to be sold within one year. In addition, these amounts included $56 million and $6380 million at SeptemberJune 30, 20162017 and December 31, 20152016, respectively, of inventories produced in preparation for product launches.
6.Other Intangibles
In connection with acquisitions, the Company measures the fair value of marketed products and research and development pipeline programs and capitalizes these amounts. See Note 2 for information on intangible assets acquired as a result of business acquisitions in the first six months of 2017 and 2016.
During the second quarter and first ninesix months of 2017, the Company recorded an intangible asset impairment charge of $47 million within Materials and production costs related to Intron A, a treatment for certain types of cancers. Sales of Intron A are being adversely affected by the availability of new therapeutic options. During the second quarter, sales of Intron A in the United States eroded more rapidly than previously anticipated by the Company, which led to changes in the cash flow assumptions for Intron A. These revisions to cash flows indicated that the Intron A intangible asset value was not fully recoverable on an undiscounted cash flows basis. The Company utilized market participant assumptions to determine its best estimate of the fair value of the intangible asset related to Intron A that, when compared with its related carrying value, resulted in the impairment charge noted above. The remaining intangible asset value for Intron A at June 30, 2017 was $25 million.
During the second quarter and first six months of 2016, the Company recorded $347 million of intangible asset impairment charges within Materialsof $95 million and production costs. Of this amount,$347 million, respectively. During the second quarter of 2016, the Company wrote off amounts that had been capitalized in connection with in-licensed products that, for business reasons, the Company returned to the licensor. The remaining impairment charges of $252 million relatesin the first six months of 2016 related to Zontivity, a product for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction or with peripheral arterial disease. In March 2016, following several business decisions that reduced sales expectations for Zontivity in the United States and Europe, the Company lowered its cash flow projections for Zontivity. The Company utilized market participant assumptions and considered several different scenarios to determine the fair value of the intangible asset related to Zontivity that, when compared with its related carrying value, resulted in the impairment charge noted above. In addition, the Company wrote-off $95 million that had been capitalized in connection with in-licensed products Grastek and Ragwitek, allergy immunotherapy tablets that, for business reasons, the Company has determined it will return to the licensor.
Also, during the second quarter and first ninesix months of 2016, the Company recorded $225$195 million and $220 million, respectively, of IPR&D impairment charges within Research and development expenses. Of this amount,these amounts, $112 million relatesrelated to a charge for an in-licensed program for house dust mite allergies that, for business reasons, will bewas returned to the licensor. The remaining IPR&D impairment charges primarily relaterelated to deprioritized pipeline programs that were deemed to have no alternative use during the period, including a $79 million impairment charge for MK-8342B, an investigational candidate for contraception. During the first nine months of 2015, the Company recorded $62 million of IPR&D impairment charges. Of this amount, $50 million relates to the surotomycin clinical development program. During the second quarter of 2015, the Company received unfavorable efficacy data from a clinical trial for surotomycin. The evaluation of this data, combined with an assessment of the commercial opportunity of surotomycin, resulted in the IPR&D impairment charge noted above.period.
The Company may recognize additional non-cash impairment charges in the future related to other marketed products or pipeline programs and such charges could be material.
7.Joint Ventures and Other Equity Method Affiliates
Equity income from affiliates reflects the performance of the Company’s joint ventures and other equity method affiliates including Sanofi Pasteur MSD (SPMSD) and certain investment funds. Equity income from affiliates was $21 million and $63 million for the third quarter of 2016 and 2015, respectively, and $59 million and $210 million for the first nine months of 2016 and 2015, respectively, and is included in Other (income) expense, net (see Note 13).
Sanofi Pasteur MSD
In March 2016, Merck and Sanofi Pasteur announced their intention to end their joint vaccines operations in Europe. The joint venture Sanofi Pasteur MSD (SPMSD), owned equally by Sanofi Pasteur and Merck, was created in 1994 to develop and commercialize vaccines originating from both companies’ pipelines to improve and promote public health in 19 European
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

countries. Sanofi Pasteur and Merck expect the project to be completed by the end of 2016, subject to local labor laws and regulations and regulatory approvals. Upon concluding the joint venture, Merck plans to integrate its European vaccine business into its operations, manage its product portfolio and pursue its growth strategy in Europe. SPMSD vaccine sales were $351 million and $318 million for the third quarter of 2016 and 2015, respectively, and were $725 million and $655 million for the first nine months of 2016 and 2015, respectively.
AstraZeneca LP
In 1998, Merck and Astra completed the restructuring of the ownership and operations of their existing joint venture whereby Merck acquired Astra’s interest in KBI Inc. (KBI) and contributed KBI’s operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P. (the Partnership). Astra contributed the net assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership. The Partnership, renamed AstraZeneca LP (AZLP) upon Astra’s 1999 merger with Zeneca Group Plc, became the exclusive distributor of the products for which KBI retained rights. In connection with AstraZeneca’s 2014 exercise of its option to purchase Merck’s interest in KBI, the Company deferred $327 million of the exercise price, which reflected an estimate of the fair value of Merck’s interest in Nexium and Prilosec. This amount, which is subject to a true-up in 2018 based on actual sales from closing in 2014 to June 2018, was deferred and recognized over time in Other (income) expense, net as the contingency was eliminated as sales occurred. The deferred income amount has been fully amortized based on the sales performance of Nexium and Prilosec subsequent to the 2014 option exercise. Beginning in the first quarter of 2016, the Company is recognizing income and a corresponding receivable for amounts that will be due to Merck from AstraZeneca based on the sales performance of Nexium and Prilosec subject to the true-up in June 2018. The Company recognized $76 million of such income in the first nine months of 2016.
8.Long-Term Debt
In November 2016, the Company issued €1.0 billion principal amount of senior unsecured notes consisting of €500 million principal amount of 0.50% notes due 2024 and €500 million principal amount of 1.375% notes due 2036. The Company intends to use the net proceeds of the offering of $1.1 billion for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities.
In June 2016, the Company terminated its existing credit facility and entered into a new $6.0 billion, five-year credit facility that matures in June 2021. The facility provides backup liquidity for the Company’s commercial paper borrowing facility and is to be used for general corporate purposes. The Company has not drawn funding from this facility.
9.7.Contingencies
The Company is involved in various claims and legal proceedings of a nature considered normal to its business, including product liability, intellectual property, and commercial litigation, as well as certain additional matters including environmental matters. In the opinion of the Company, it is unlikely that the resolution of these matters will be material to the Company’s financial position, results of operations or cash flows.
Given the nature of the litigation discussed below and the complexities involved in these matters, the Company is unable to reasonably estimate a possible loss or range of possible loss for such matters until the Company knows, among other factors, (i) what claims, if any, will survive dispositive motion practice, (ii) the extent of the claims, including the size of any potential class, particularly when damages are not specified or are indeterminate, (iii) how the discovery process will affect the litigation, (iv) the settlement posture of the other parties to the litigation and (v) any other factors that may have a material effect on the litigation.
The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. These accruals are adjusted periodically as assessments change or additional information becomes available. For product liability claims, a portion of the overall accrual is actuarially determined and considers such factors as past experience, number of claims reported and estimates of claims incurred but not yet reported. Individually significant contingent losses are accrued when probable and reasonably estimable. Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable.
The Company’s decision to obtain insurance coverage is dependent on market conditions, including cost and availability, existing at the time such decisions are made. The Company has evaluated its risks and has determined that the cost of obtaining product liability insurance outweighs the likely benefits of the coverage that is available and, as such, has no insurance for most product liabilities effective August 1, 2004.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

VioxxLitigation
Product Liability Lawsuits
As previously disclosed, Merck was a defendant in a number of putative class action lawsuits alleging economic injury as a result of the purchase of Vioxx, all but one of which have been settled. Under the settlement, Merck agreed to pay up to $23 million to resolve all properly documented claims submitted by class members, approved attorneys’ fees and expenses, and approved settlement notice costs and certain other administrative expenses. The claims review process has been completed with the Company paying approximately $700,000. The amount of attorneys’ fees to be paid is yet to be determined.
Merck is also a defendant in a lawsuit (together with the above-referenced lawsuits, the Vioxx Product Liability Lawsuits) brought by the Attorney General of Utah. The lawsuit is pending in Utah state court. Utah alleges that Merck misrepresented the safety of Vioxx and seeks damages and penalties under the Utah False Claims Act. No trial date has been set. Merck recently reached agreements with the Attorneys General in Alaska and Montana to settle their state consumer protection act cases against the Company for $15.25 million and $16.7 million, respectively. As a result, Alaska’s action was dismissed with prejudice on September 30, 2016, and Montana’s action was dismissed with prejudice on October 6, 2016.
Shareholder Lawsuits
As previously disclosed, in addition to the Vioxx Product Liability Lawsuits, various putative class actions and individual lawsuits were filed against Merck and certain former employees alleging that the defendants violated federal securities laws by making alleged material misstatements and omissions with respect to the cardiovascular safety of Vioxx (Vioxx Securities Lawsuits). The Vioxx Securities Lawsuits were coordinated in a multidistrict litigation in the U.S. District Court for the District of New Jersey before Judge Stanley R. Chesler. As previously disclosed, Merck has reached a resolution of the Vioxx securities class action for which a reserve was recorded in 2015 and under which Merck created a settlement fund in 2016 of $830 million (the Settlement Class Fund) and agreed to pay an additional amount for approved attorneys’ fees and expenses up to $232 million (the Fee/Expense Fund). On June 28, 2016, the court approved the settlement and awarded attorneys’ fees and expenses in the amount of $222 million; the remaining amount of the Fee/Expense Fund will be added to the Settlement Class Fund. The Company paid the total settlement amount into escrow in April 2016. After available funds under certain insurance policies, Merck’s net cash payment for the settlement and fees was approximately $680 million. The settlement covers all claims relating to Vioxx by settlement class members who purchased Merck securities between May 21, 1999, and October 29, 2004. The settlement is not an admission of wrongdoing and, as part of the settlement agreement, defendants continue to deny the allegations.
In addition, Merck has reached a resolution of the above referenced individual securities lawsuits filed by foreign and domestic institutional investors, which were also consolidated with the Vioxx Securities Lawsuits.
As a result of these settlements, Merck has resolved all of the Vioxx Securities Lawsuits.
Insurance
As a result of the previously disclosed insurance arbitration, the Company’s insurers paid insurance proceeds of approximately $380 million in connection with the settlement of the class action. The Company also has Directors and Officers insurance coverage applicable to the Vioxx Securities Lawsuits with remaining stated upper limits of approximately $145 million, which the Company has not received. There are disputes with the insurers about the availability of the Company’s Directors and Officers insurance coverage for these claims. The amounts actually recovered under the Directors and Officers policies discussed in this paragraph may be less than the stated upper limits.
International Lawsuits
As previously disclosed, in addition to the lawsuits discussed above, Merck has been named as a defendant in litigation relating to Vioxx in Brazil and Europe (collectively, the Vioxx International Lawsuits). The litigation in these jurisdictions is generally in procedural stages and Merck expects that the litigation may continue for a number of years.
Reserves
The Company has an immaterial reserve with respect to certain Vioxx Product Liability Lawsuits. The Company has established no other liability reserves for, and believes that it has meritorious defenses to, the remaining Vioxx Product Liability Lawsuits and Vioxx International Lawsuits and will vigorously defend against them.
Other Product Liability Litigation
Fosamax
As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (Fosamax Litigation). As of SeptemberJune 30, 20162017, approximately 4,3104,180 cases are filed and pending against Merck in either federal or state court. In approximately 2015 of these actions, plaintiffs allege, among other things, that they have suffered osteonecrosis of the jaw (ONJ), generally subsequent to invasive dental procedures, such as tooth extraction or dental implants and/or delayed
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

healing, in association with the use of Fosamax. In addition, plaintiffs in approximately 4,2904,165 of these actions generally allege that they sustained femur fractures and/or other bone injuries (Femur Fractures) in association with the use of Fosamax.
Cases Alleging ONJ and/or Other Jaw Related Injuries
In August 2006, the Judicial Panel on Multidistrict Litigation (JPML) ordered that certain Fosamax product liability cases pending in federal courts nationwide should be transferred and consolidated into one multidistrict litigation (Fosamax ONJ MDL) for coordinated pre-trial proceedings.
In December 2013, Merck reached an agreement in principle with the Plaintiffs’ Steering Committee (PSC) in the Fosamax ONJ MDL to resolve pending ONJ cases not on appeal in the Fosamax ONJ MDL and in the state courts for an aggregate amount of $27.7 million. Merck and the PSC subsequently formalized the terms of this agreement in a Master Settlement Agreement (ONJ Master Settlement Agreement) that was executed in April 2014 and included over 1,200 plaintiffs. In July 2014, Merck elected to proceed with the ONJ Master Settlement Agreement at a reduced funding level of $27.3 million since the participation level was approximately 95%. Merck has fully funded the ONJ Master Settlement Agreement and the escrow agent under the agreement has been making settlement payments to qualifying plaintiffs. The ONJ Master Settlement Agreement has no effect on the cases alleging Femur Fractures discussed below.
Discovery is currently ongoing in some of the approximately 15 remaining ONJ cases that are pending in various federal and state courts and the Company intends to defend against these lawsuits.
Cases Alleging Femur Fractures
In March 2011, Merck submitted a Motion to Transfer to the JPML seeking to have all federal cases alleging Femur Fractures consolidated into one multidistrict litigation for coordinated pre-trial proceedings. The Motion to Transfer was granted in May 2011, and all federal cases involving allegations of Femur Fracture have been or will be transferred to a multidistrict litigation in the District of New Jersey (the Femur(Femur Fracture MDL). Judge Pisano presided over the Femur Fracture MDL until March 2015, at which time the Femur Fracture MDL was reassigned from Judge Pisano to Judge Freda L. Wolfson following Judge Pisano’s retirement. In the only bellwether case tried to date in the Femur Fracture MDL, Glynn v. Merck, the jury returned a verdict in Merck’s favor. In addition, in June 2013, the Femur Fracture MDL court granted Merck’s motion for judgment as a matter of law in the Glynn case and held that the plaintiff’s failure to warn claim was preempted by federal law. The Glynn decision was not appealed by plaintiff.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

In August 2013, the Femur Fracture MDL court entered an order requiring plaintiffs in the Femur Fracture MDL to show cause why those cases asserting claims for a femur fracture injury that took place prior to September 14, 2010, should not be dismissed based on the court’s preemption decision in the Glynn case. Pursuant to the show cause order, in March 2014, the Femur Fracture MDL court dismissed with prejudice approximately 650 cases on preemption grounds. Plaintiffs in approximately 515 of those cases are appealingappealed that decision to the U.S. Court of Appeals for the Third Circuit.Circuit (Third Circuit). The Femur Fracture MDL court has sincealso dismissed without prejudice another approximately 540 cases pending plaintiffs’ appeal of the preemption ruling to the Third Circuit. On June 30, 2016,March 22, 2017, the Third Circuit heard oral argument on plaintiffs’ appeal ofissued a decision reversing the Femur Fracture MDL court’s preemption ruling and remanding the parties awaitappealed cases back to the decision.Femur Fracture MDL court. On April 5, 2017, Merck filed a petition seeking a rehearing on the Third Circuit’s March 22, 2017 decision, which was denied on April 24, 2017. The deadline for Merck to file a petition for a writ of certiorari to the U.S. Supreme Court is August 22, 2017.
In addition, in June 2014, Judge Pisanothe Femur Fracture MDL court granted Merck summary judgment in the Gaynor v. Merck case and found that Merck’s updates in January 2011 to the Fosamax label regarding atypical femur fractures were adequate as a matter of law and that Merck adequately communicated those changes. The plaintiffs in Gaynor have appealed Judge Pisano’s decisiondid not appeal the Femur Fracture MDL court’s findings with respect to the adequacy of the 2011 label change but did appeal the dismissal of their case based on preemption grounds, and the Third Circuit.Circuit subsequently reversed that dismissal in its March 22, 2017 decision. In August 2014, Merck filed a motion requesting that Judge Pisanothe Femur Fracture MDL court enter a further order requiring all plaintiffs in the Femur Fracture MDL who claim that the 2011 Fosamax label is inadequate and the proximate cause of their alleged injuries to show cause why their cases should not be dismissed based on the court’s preemption decision and its ruling in the Gaynor case. In November 2014, the court granted Merck’s motion and entered the requested show cause order. No plaintiffs responded to or appealed the November 2014 show cause order.
As of SeptemberJune 30, 2016, three2017, approximately 520 cases were pending in the Femur Fracture MDL excludingfollowing the 515reinstatement of the cases dismissed with prejudicethat had been on preemption grounds that are pending appeal andto the Third Circuit. The 540 cases dismissed without prejudice that arewere also pending the final resolution of the aforementioned appeal.appeal have not yet been reinstated.
As of SeptemberJune 30, 20162017, approximately 2,9402,820 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Jessica MayerJames Hyland in Middlesex County. The parties selected an initial group of 30 cases to be reviewed through fact discovery. Two additional groups of 50 cases each to be reviewed through fact discovery were selected in November 2013 and March 2014, respectively. A further group of 25 cases to be reviewed through fact discovery was selected by Merck in July 2015, and Merck has recently begun selecting the next group ofcontinued to select additional cases to be reviewed through fact discovery.discovery during 2016 and 2017.
As of SeptemberJune 30, 20162017, approximately 285280 cases alleging Femur Fractures have been filed and are pending in California state court. A petition was filed seeking to coordinate all Femur Fracture cases filed in California state court before a single judge in Orange County, California. The petition was granted and Judge Thierry Colaw is currently presiding over the coordinated proceedings. In March 2014, the court directed that a group of 10 discovery pool cases be reviewed through fact discovery and subsequently scheduled the Galper v. Merck case, which plaintiffs selected, as the first trial. The Galper trial began in February 2015 and the jury returned a verdict in Merck’s favor in April 2015, and plaintiff has appealed that verdict to the
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

California appellate court. Oral argument on plaintiff’s appeal in Galper was held in November 2016 and, on April 24, 2017, the California appellate court issued a decision affirming the lower court’s judgment in favor of Merck. The next Femur Fracture trial in California that was scheduled to begin in April 2016 was stayed at plaintiffs’ request and a new trial date has not been set.
Additionally, there are five Femur Fracture cases pending in other state courts.
Discovery is ongoing in the Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits.
Januvia/Janumet
As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Januvia and/or Janumet. As of SeptemberJune 30, 20162017, Merck is aware of approximately 1,1401,215 product user claims have been served on Merck alleging generally that use of Januvia and/or Janumet caused the development of pancreatic cancer and other injuries. These complaints were filed in several different state and federal courts.
Most of the claims were filed in a consolidated multidistrict litigation proceeding in the U.S. District Court for the Southern District of California called “In re Incretin-Based Therapies Products Liability Litigation” (MDL). The MDL includes federal lawsuits alleging pancreatic cancer due to use of the following medicines: Januvia, Janumet, Byetta and Victoza, the latter two of which are products manufactured by other pharmaceutical companies. The majority of claims not filed in the MDL were filed in the Superior Court of California, County of Los Angeles (California State Court).
In November 2015, the MDL and California State Court - in separate opinions - granted summary judgment to defendants on grounds of preemption. Of the approximately 1,215 product user claims, these rulings resulted in the dismissal of approximately 1,175 product user claims.
Plaintiffs are appealing the MDL and California State Court preemption rulings.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

As of SeptemberJune 30, 2016, nine2017, eight product users have claims pending against Merck in state courts other than the California State Court.
In November 2015,Court, including four active product user claims pending in Illinois state court. On June 30, 2017, the MDL and California State Court – in separate opinions – grantedIllinois court denied Merck’s motion for summary judgment to defendants on grounds of preemption. OfMerck is seeking permission to appeal that order on an interlocutory basis and to stay proceedings in the approximately 1,140 servedtrial court. Trial for three of the product users in Illinois is currently scheduled to begin in November 2017; trial for the fourth product user claims, these rulings resultedis scheduled to begin in the dismissal of approximately 1,100 product user claims.
Plaintiffs are appealing the MDL and California State Court preemption rulings.February 2018.
In addition to the claims noted above, the Company has agreed as of September 30, 2016, to toll the statute of limitations for approximately 50 additional claims. The Company intends to continue defending against these lawsuits.
Propecia/Proscar
As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Propecia and/or Proscar. As of SeptemberJune 30, 20162017, approximately 1,3701,190 lawsuits have been filed by plaintiffs who allege that they have experienced persistent sexual side effects following cessation of treatment with Propecia and/or Proscar. Approximately 5040 of the plaintiffs also allege that Propecia or Proscar has caused or can cause prostate cancer, testicular cancer or male breast cancer. The lawsuits have been filed in various federal courts and in state court in New Jersey. The federal lawsuits have been consolidated for pretrial purposes in a federal multidistrict litigation before Judge Brian Cogan of the Eastern District of New York. The matters pending in state court in New Jersey have been consolidated before Judge MayerJames Hyland in Middlesex County. In addition, there is one matter pending in state court in Massachusetts andCalifornia, one matter pending in state court in New York.Ohio, and one matter on appeal in the Massachusetts Supreme Judicial Court. The Company intends to defend against these lawsuits.
Governmental Proceedings
As previously disclosed,The Company recently received an investigative subpoena from the Company’s subsidiariesCalifornia Insurance Commissioner’s Fraud Liaison Bureau (the Bureau) seeking information from January 1, 2007 to the present related to the pricing and promotion of Cubicin. The Bureau is investigating whether Cubist Pharmaceuticals, Inc., which the Company acquired in China have received2015, unlawfully induced the presentation of false claims for Cubicin to private insurers under the California Insurance Code False Claims Act. The Company is cooperating with the investigation.
From time to time, the Company receives inquiries and is the subject of preliminary investigation activities from competition and other governmental authorities in markets outside the United States. These authorities may continue to receiveinclude regulators, administrative authorities, and law enforcement and other similar officials, and these preliminary investigation activities may include site visits, formal or informal requests or demands for documents or materials, inquiries regarding their operations from various Chinese governmental agencies. Someor interviews and similar matters. Certain of these preliminary inquiries or activities may lead to the commencement of formal proceedings. Should those proceedings be determined adversely to the Company, monetary fines and/or remedial undertakings may be relatedrequired.
The UK Competition and Markets Authority (the CMA) issued a Statement of Objections against the Company and MSD Sharp & Dohme Limited (MSD UK) on May 23, 2017. In the Statement of Objections, the CMA alleges that MSD UK abused a dominant position through a discount program for Remicade over the period from March 2015 to matters involving other multinational pharmaceutical companies, as well as Chinese entities doing business with such companies.February 2016. The Company’s policy is to cooperate with these authoritiesCompany and to provide responses as appropriate.MSD UK are contesting the CMA’s allegations.
Commercial and Other Litigation
K-DUR Antitrust Litigation
As previously disclosed, inIn June 1997 and January 1998, Schering-Plough Corporation (Schering-Plough) settled patent litigation with Upsher-Smith, Inc. (Upsher-Smith) and ESI Lederle, Inc. (Lederle), respectively, relating to generic versions of Schering-Plough’s long-acting potassium chloride product supplement used by cardiac patients, for which Lederle and Upsher-Smith had filed Abbreviated New Drug Applications (ANDAs). Following the commencement of an administrative proceeding by the U.S. Federal Trade Commission (FTC) in 2001 alleging anti-competitive effects from those settlements (which was resolved in Schering-Plough’s favor), putativePutative class and non-class action suits were then filed on behalf of direct and indirect purchasers of K-DURK‑DUR against Schering-Plough, Upsher-Smith and Lederle and were consolidated in a multidistrict litigation in the U.S. District Court for the District of New Jersey. These suits claimed violations of federal and state antitrust laws, as well as other state statutory and common law causes of action, and sought unspecified damages. In April 2008, the indirect purchasers voluntarily dismissed their case. In March 2010, the District Court granted summary judgment to the defendants on the remaining lawsuits and dismissed the matter in its entirety. In July 2012, the Third Circuit Court of Appeals reversed the District Court’s grant of summary judgment and remanded the case for further proceedings. At the same time, the Third Circuit upheld a December 2008 decision by the District Court certifying certain direct purchaser plaintiffs’ claims as a class action.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

In August 2012, the Company filed a petition for certiorari with the U.S. Supreme Court seeking review of the Third Circuit’s decision. In June 2013, the Supreme Court granted that petition, vacated the judgment of the Third Circuit, and remanded the case for further consideration in light of its decision in FTC v. Actavis, Inc. That decision held that whether a so-called “reverse payment” - i.e., a payment from the holder of a pharmaceutical patent to a party challenging the patent made in connection with a settlement of their dispute - violates the antitrust laws should be determined on the basis of a “rule of reason” analysis. In September 2013, the Third Circuit returned the case to the District Court for further proceedings in accordance with the Actavis standard. In April 2015, the Company filed motions for summary judgment. On February 25, 2016, the District Courtcourt denied the Company’s motion for summary judgment relating to all of the direct purchasers’ claims concerning the settlement with Upsher-Smith and granted the Company’s motion for summary judgment relating to all of the direct purchasers’ claims concerning the settlement with Lederle. In anticipation
As previously disclosed, in February 2017, Merck and Upsher-Smith reached a settlement in principle with the class of trial, which is expecteddirect purchasers and the opt-outs to occurthe class. Merck will contribute approximately $80 million in the spring ofaggregate towards the overall settlement. On April 5, 2017, the partiesclaims of the opt-outs were dismissed with prejudice pursuant to a written settlement agreement with those parties. On May 15, 2017, Merck and the class executed a settlement agreement, which received preliminary approval from the court on May 23, 2017. The final approval hearing is scheduled for October 31, 2016,5, 2017, following notice of the settlement to the class members.
Sales Force Litigation
As previously disclosed, in May 2013, Ms. Kelli Smith filed a complaint against the Company in the U.S. District Court for the District of New Jersey on behalf of herself and a putative class of female sales representatives and a putative sub-
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

class of female sales representatives with children, claiming (a) discriminatory policies and practices in selection, promotion and advancement, (b) disparate pay, (c) differential treatment, (d) hostile work environment and (e) retaliation under federal and state discrimination laws. Plaintiffs sought and were granted leave to file an amended complaint. In January 2014, plaintiffs filed an amended complaint adding four additional named plaintiffs. In October 2014, the court denied the Company’s motion to dismiss or strike the class claims as premature. In September 2015, plaintiffs filed additional motions, to exclude certain expert opinions and defendants filedincluding a motion for summary judgment.conditional certification under the Equal Pay Act; a motion to amend the pleadings seeking to add ERISA and constructive discharge claims and a Company subsidiary as a named defendant; and a motion for equitable relief. Merck filed papers in opposition to the motions. On April 27, 2016, the court granted plaintiff’s motion for conditional certification but denied plaintiffs’ motions to extend the liability period for their Equal Pay Act claims back to June 2009. As a result, the liability period will date back to April 2012, at the earliest. On April 29, 2016, the Magistrate Judge granted plaintiffs’ request to amend the complaint to add the following: (i) a Company subsidiary as a corporate defendant; (ii) an ERISA claim and (iii) an individual constructive discharge claim for one of the named plaintiffs. Approximately 700 individuals have opted-in to this action; the opt-in period has closed. On August 1, 2017, plaintiffs filed their motion for class certification. This motion seeks to certify a Title VII pay discrimination class and also seeks final collective action certification of plaintiffs’ Equal Pay Act claim.
Merck KGaA Litigation
In January 2016, to protect its long-established brand rights in the United States, the Company filed a lawsuit against Merck KGaA, Darmstadt, Germany (KGaA), operating as the EMD Group in the United States, alleging it improperly uses the name “Merck” in the United States. KGaA has filed suit against the Company in France, the United Kingdom (UK), Germany, Switzerland, Mexico, and India alleging breach of the parties’ co-existence agreement, unfair competition and/or trademark infringement. In December 2015, the Paris Court of First Instance issued a judgment finding that certain activities by the Company directed towards France did not constitute trademark infringement and unfair competition while other activities were found to infringe. The Company and KGaA appealed the decision, and the appeal was heard in May 2017. In June 2017, the French appeals court held that certain of the activities by the Company directed to France constituted unfair competition or trademark infringement. In January 2016, the UK High Court issued a judgment finding that the Company had breached the co-existence agreement and infringed KGaA’s trademark rights as a result of certain activities directed towards the UK based on use of the word MERCK on promotional and information activity. As noted in the UK decision, this finding was not based on the Company’s use of the sign MERCK in connection with the sale of products or any material pharmaceutical business transacted in the UK. The Company and KGaA have both appealed this decision, and the appeal was heard in June 2017. The Company is currently awaiting the decision.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file ANDAs with the U.S. Food and Drug Administration (FDA) seeking to market generic forms of the Company’s products prior to the expiration of relevant patents owned by the Company. To protect its patent rights, the Company may file patent infringement lawsuits against such generic companies. Certain products of the Company (or products marketed via agreements with other companies) currently involved in such patent infringement litigation in the United States include: Cancidas, Invanz, Nasonex, Noxafil, and NuvaRing. Similar lawsuits defending the Company’s patent rights may exist in other countries. The Company intends to vigorously defend its patents, which it believes are valid, against infringement by generic companies attempting to market products prior to the expiration of such patents. As with any litigation, there can be no assurance of the outcomes, which, if adverse, could result in significantly shortened periods of exclusivity for these products and, with respect to products acquired through acquisitions, potentially significant intangible asset impairment charges.
Cancidas — In February 2014, a patent infringement lawsuit was filed in the United States against Xellia Pharmaceuticals ApS (Xellia) with respect to Xellia’s application to the FDA seeking pre-patent expiry approval to market a generic version of Cancidas. In June 2015, the district court found that Xellia infringed the Company’s patent and ordered that Xellia’s application not be approved until the patent expires in September 2017 (including pediatric exclusivity). Xellia appealed this decision, and the appeal was heard in March 2016. In May 2016, the parties reached a settlement whereby Xellia can launch its generic version in August 2017, or earlier under certain conditions. In August 2014, a patent infringement lawsuit was filed in the United States against Fresenius Kabi USA, LLC (Fresenius) in respect of Fresenius’s application to the FDA seeking pre-patent expiry approval to market a generic version of Cancidas. The trial in this matter is currently scheduled to begin in November 2016. The lawsuit automatically stays FDA approval of Fresenius’s application until December 2016 or until an adverse court decision, if any, whichever may occur earlier.
Invanz — In July 2014, a patent infringement lawsuit was filed in the United States against Hospira, Inc. (Hospira) in respect of Hospira’s application to the FDA seeking pre-patent expiry approval to market a generic version of Invanz. The lawsuit automatically stays FDA approval of Hospira’s application until November 2016 or until an adverse court decision, if any, whichever may occur earlier. The trial in this matter was held in April 2016 and, in October 2016, the district court ruled that the patent is valid and infringed. In August 2015, a patent infringement lawsuit was filed in the United States against Savior Lifetec Corporation (Savior) in respect of Savior’s application to the FDA seeking pre-patent expiry approval to market a generic version of Invanz. The lawsuit automatically stays FDA approval of Savior’s application until November 2017 or until an adverse court decision, if any, whichever may occur earlier.
Nasonex — In July 2014, a patent infringement lawsuit was filed in the United States against Teva Pharmaceuticals USA, Inc. (Teva Pharma) in respect of Teva Pharma’s application to the FDA seeking pre-patent expiry approval to market a generic version of Nasonex. The lawsuit automatically stays FDA approval of Teva Pharma’s application until November 2016 or until an adverse court decision, if any, whichever may occur earlier. The trial in this matter was held in June 2016. In November 2016, and the Company is currently awaitingdistrict court ruled that the court’s decision. patent was valid but not infringed. In March 2017, the parties reached a settlement whereby Teva Pharma can launch its generic version in September 2017, or earlier under certain conditions.
In March 2015, a patent infringement lawsuit was filed in the United States against Amneal Pharmaceuticals LLC (Amneal) in respect of Amneal’s application to the FDA seeking pre-patent expiry approval to market a generic version of Nasonex. The lawsuit automatically stays FDA approval of Amneal’s application until August 2017 or until an adverse court decision, if any, whichever may occur earlier. The trial in this matter was held in June 2016 and2016. In January 2017, the district court ruled that the patent was valid but not infringed. The Company is currently awaiting the court’shas appealed this decision.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

A previous decision, issued in June 2013, held that the Merck patent in the Teva Pharma and Amneal lawsuits covering mometasone furoate monohydrate was valid, but that it was not infringed by Apotex Corp.’s proposed product. In April 2015, a patent infringement lawsuit was filed against Apotex Inc. and Apotex Corp. (Apotex) in respect of Apotex’s application to the FDA seeking pre-patent expiry approval to market a generic version of Nasonexnow-launched product that the Company believes differs from the generic version in the previous lawsuit.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Noxafil In August 2015, the Company filed a lawsuit against Actavis Laboratories Fl, Inc. (Actavis) in the United States in respect of that company’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Noxafil. The lawsuit automatically stays FDA approval of Actavis’s application until December 2017 or until an adverse court decision, if any, whichever may occur earlier. The trial was held in July 2017 and closing arguments will be held in August 2017. In March 2016, the Company filed a lawsuit against Roxane Laboratories, Inc. (Roxane) in the United States in respect of that company’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Noxafil. The lawsuit automatically stays FDA approval of Roxane’s application until August 2018 or until an adverse court decision, if any, whichever may occur earlier. In February 2016, the Company filed a lawsuit against Par Sterile Products LLC, Par Pharmaceutical, Inc., Par Pharmaceutical Companies, Inc. and Par Pharmaceutical Holdings, Inc. (collectively, Par) in the United States in respect of that company’s application to the FDA seeking pre-patent expiry approval to sell a generic version of Noxafil. In October 2016, the parties reached a settlement whereby Par can launch its generic version in January 2023, or earlier under certain conditions.
NuvaRing — In December 2013, the Company filed a lawsuit against a subsidiary of Allergan plc in the United States in respect of that company’s application to the FDA seeking pre-patent expiry approval to sell a generic version of NuvaRing. The trial in this matter was held in January 2016. In August 2016, the district court ruled that the patent was invalid and the Company has appealed this decision. In September 2015, the Company filed a lawsuit against Teva Pharma in the United States in respect of that company’s application to the FDA seeking pre-patent expiry approval to sell a generic version of NuvaRing.
Based on its ruling in the Allergan plc matter, the district court dismissed the Company’s lawsuit in December 2016. The Company had been involvedhas appealed this decision and the appeal will be heard in ongoing litigation in Canada with Apotex concerning the Company’s patents related to lovastatin, alendronate, and norfloxacin. All of the litigation has now been either settled or concluded. As a consequence of the conclusion of all of this litigation, in the first nine months of 2016, the Company recorded a net gain of $117 million included in Other (income) expense, net (see Note 13).September 2017.
Anti-PD-1 Antibody Patent Oppositions and Litigation
As previously disclosed, Ono Pharmaceutical Co. (Ono) has a European patent (EP 1 537 878) (’878) that broadly claims the use of an anti-PD-1 antibody, such as the Company’s immunotherapy, Keytruda, for the treatment of cancer. Ono has previously licensed its commercial rights to an anti-PD-1 antibody to Bristol-Myers Squibb (BMS) in certain markets. The Company believes that the ’878 patent is invalid and filed an opposition in the European Patent Office (EPO) seeking its revocation. In June 2014, the Opposition Division of the EPO found the claims in the ’878 patent are valid. The Company received the Opposition Division’s written opinion in September 2014 and the Company submitted its substantive appeal in February 2015. In April 2014, the Company, and three other companies, opposed another European patent (EP 2 161 336) (’336) owned by BMS and Ono also own European Patent EP 2 161 336 (’336) that, it believes is invalid. The ’336 patent, as granted, broadly claimed anti-PD-1 antibodies that could include Keytruda. In February 2015
As previously disclosed, the Company and May 2016, BMS and Ono submitted requests to amend the claims of the ’336 patent. During a hearingwere engaged in July 2016, the EPO allowed the May 2016 amendment and, as a result, the claims of the ’336 patent no longer broadly claim anti-PD-1 antibodies such as Keytruda.
In May 2014, the Company filed a lawsuitworldwide litigation, including in the UK seeking revocation of the UK national versions of both the ’878 and ’336 patents. In July 2014, Ono and BMS sued the Company seeking a declaration that the ’878 patent would be infringed in the UK by the marketing of Keytruda. The Company has sought a declaration from the UK court that Keytruda will not infringe the ’336 patent in the UK. BMS and Ono notified the Company of their request to amend the claims of the EPO ’336 patent and of their intention to seek permission from the court to similarly amend the UK national version so that the claims of the ’336 patent would no longer broadly claim anti-PD-1 antibodies such as Keytruda. A trial was held in the UK in July 2015. At that trial, the issues of validity and infringement of the ’878 patent were heard at the same time by the court. In October 2015, the court issued its judgment, finding the ’878 patent valid and infringed. Merck appealed this judgment. The appeal is scheduled to be heard in March 2017. BMS and Ono have concurrently started a proceeding to determine the amount of damages and royalties the Company would pay should the appeal be denied. A hearing in that proceeding is scheduled for November 2017.
In February 2015, the Company filed lawsuits in the Netherlands seeking revocation of the Dutch national versions of both the ’878 and ’336 patents. BMS and Ono amended the claims of the ’336 patent so that the claims of the ’336 patent no longer broadly claim anti-PD-1 antibodies such as Keytruda. Trial regardingUnited States, over the validity and infringement of the ’878 patent, was held inthe ’336 patent and their equivalents.
In January 2016. In June 2016,2017, the District Court in The Hague issued its judgment finding the Dutch ‘878 patent validCompany announced that it had entered into a settlement and infringed. The Company has appealed this judgment.
In December 2015,license agreement with BMS and Ono filed lawsuits againstresolving the worldwide patent infringement litigation related to the use of an anti-PD-1 antibody for the treatment of cancer, such as Keytruda. Under the settlement and license agreement, the Company made a one-time payment of $625 million (which was recorded as an expense in France, Ireland, Spain, Switzerland and Germany alleging infringement of the ’878 patent. In France,Company’s 2016 financial results) to BMS and Ono filed for preliminary relief seeking payment of damages while the case is pending. A hearing on this preliminary relief was held in February 2016 and BMS’s and Ono’s request for preliminary relief was denied. The trial regarding infringement and validity of the French version of the ’878 patent is scheduled for November 2017. A trial concerning the infringement of the German version of the ’878 patent is currently scheduled to begin in July 2017. In October 2016, the Company filed a lawsuit in Spain seeking the revocation of the Spanish version of the ’878 patent. Dates for trials regarding the validity and infringement of the Irish, Spanish and Swiss national versions of the ’878 patent have not yet been scheduled.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The Company continues to believe the ’878 patent is invalid.
The Company can file lawsuits seeking revocation of the ’878 patents in other national courts in Europe at any time, and Ono and BMS can file patent infringement actions against the Company in other national courts in Europe at or around the time the Company launches Keytruda. If a national court determines that the Company infringed a valid claim in the ’878 patent, Ono and BMS may be entitled to monetary damages, includingwill pay royalties on futurethe worldwide sales of Keytruda, and potentially could seek an injunction for a non-exclusive license to prevent the Company from marketingmarket Keytruda in that country.
The United States Patent and Trademark Office (USPTO) granted US Patent Nos. 8,728,474 to Ono and 8,779,105 to Ono and BMSany market in May 2014. These patents are equivalent to the ’878 and ’336 patents, respectively. In September 2014, BMS and Ono filed a lawsuit in the United States alleging that, by marketingwhich it is approved. For global net sales of Keytruda, the Company will infringe US Patent No. 8,728,474. BMSpay royalties as follows:
6.5% of net sales occurring from January 1, 2017 through and Ono are not seekingincluding December 31, 2023; and
2.5% of net sales occurring from January 1, 2024 through and including December 31, 2026.
The parties also agreed to prevent or stop the marketing of Keytrudadismiss all claims worldwide in the United States. The trial in this matter is currently scheduled to begin in April 2017. The Company believes that the 8,728,474 patent and the 8,779,105 patent are both invalid. In June 2015 and July 2015, Ono filed lawsuits in the United States alleging that, by marketing Keytruda, the Company will infringe US Patent Nos. 9,067,999 and 9,073,994, which are patents related to the 8,728,474 patent. The Company believes the 9,067,999 and 9,073,994 patents are also invalid. In June 2016, the Company filed petitions for Inter Partes Review (IPR) in the USPTO alleging that the 9,067,999 and 9,073,994 patents are invalid. The USPTO has until December 2016 to decide these petitions.
In April 2016, the Company filed a declaratory judgment action in the United States against BMS and Ono seeking a ruling that US Patent Nos. 8,779,105 and 9,084,776 are invalid and/or not infringed by the sale of Keytruda. These patents are equivalents of the ’336 patent, as originally granted. In June 2016, Ono and BMS filed a counterclaim that the Company’s marketing, making, using, selling, offering for sale, and/or importing Keytruda in the United States for the treatment of certain cancers, including melanoma and non-small-cell lung cancer, infringes these patents.
In September 2014, the Company filed a lawsuit in Australia seeking revocation of Australian Patent No. 2011203119, which is equivalent to the ’336 patent as originally granted. In March 2015, BMS and Ono counterclaimed in this matter alleging that the Company’s manufacture and supply of Keytruda to the Australian market will infringe Australian Patent No. 2011203119. A trial on this patent is scheduled for September 2017.
Ono and BMS have similar and other patents and applications, which the Company is closely monitoring, pending in the United States, Japan and other countries.
The Company is confident that it will be able to market Keytruda in any country in which it is approved and that it will not be prevented from doing so by the Ono or BMS patents or any pending applications.relevant legal proceedings.
In October 2015, PDL Biopharma (PDL) filed a lawsuit in the United States against the Company alleging that the manufacture of Keytruda infringed US Patent No. 5,693,761 (’761 patent), which expired in December 2014. This patent claims platform technology used in the creation and manufacture of recombinant antibodies and PDL is seeking damages for pre-expiry infringement of the ’761 patent. In April 2017, the parties reached a settlement pursuant to which, in exchange for a lump sum, PDL dismissed its lawsuit with prejudice and granted the Company a fully paid-up non-exclusive license to the ’761 patent.
In July 2016, the Company filed a declaratory judgment action in the United States against Genentech and City of Hope seeking a ruling that US Patent No. 7,923,221 (the Cabilly III patent), which claims platform technology used in the creation and manufacture of recombinant antibodies, is invalid and that Keytruda and bezlotoxumab do not infringe the Cabilly III patent. In July 2016, the Company also filed a petition in the USPTO for IPRInter Partes Review (IPR) of certain claims of US Patent No. 6,331,415 (the Cabilly II patent), which claims platform technology used in the creation and manufacture of recombinant antibodies and is also owned by Genentech and City of Hope, as being invalid. TheIn December 2016, the USPTO has six monthsdenied the petition but allowed the Company to decide this petition.join an IPR filed previously by another party. In May 2017, the parties reached a settlement pursuant to which the Company dismissed its lawsuit with prejudice and moved to terminate the IPR and Genentech and City of Hope granted the Company a fully paid-up non-exclusive license to the Cabilly II and Cabilly III patents.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Gilead Patent Litigation and Opposition
In August 2013, Gilead Sciences, Inc. (Gilead) filed a lawsuit in the United StatesU.S. District Court for the Northern District of California seeking a declaration that two Company patents were invalid and not infringed by the sale of their two sofosbuvir containing products, SolvadiSovaldi and Harvoni. The Company filed a counterclaim that the sale of these products did infringe these two patents and sought a reasonable royalty for the past, present and future sales of these products. In March 2016, at the conclusion of a jury trial, the patents were found to be not invalid and infringed. The jury awarded the Company $200 million as a royalty for sales of these products up to December 2015. After the conclusion of the jury trial, the court held a bench trial on the equitable defenses raised by Gilead. In June 2016, the court found for Gilead and determined that Merck could not collect the jury award and that the patents were unenforceable with respect to Gilead. The Company has appealed the court’s decision. Gilead has also asked the court to overturn the jury’s decision on validity. The court held a hearing on Gilead’s motion onin August 4, 2016, and the court subsequently rejected Gilead’s request. The Company will pay 20%, net of legal fees, of damages or royalties, if any, that it is awardedreceives to Ionis Pharmaceuticals, Inc.
The Company, through its Idenix Pharmaceuticals, Inc. subsidiary, has pending litigation against Gilead in the United States, the UK, Norway, Canada, Germany, France, and Australia based on different patent estates that would also be infringed by Gilead’s sales of these two products. Gilead has opposed the European patent at the EPO.European Patent Office (EPO). Trial in the United States was held in December 2016 and the jury returned a verdict for the Company, awarding damages of $2.54 billion. The Company submitted post-trial motions, including on the issues of enhanced damages and future royalties. Gilead submitted post-trial motions for judgment as a matter of law. A hearing on the motions is currently
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

scheduled for December 2016.September 2017. In Australia, the UK, Norway, AustraliaCompany was initially unsuccessful and that case is currently under appeal. In Canada, the Company was initially unsuccessful and those cases are currently under appeal.the Federal Court of Appeals has affirmed the lower court decision. The Company is considering its options in Canada, including seeking leave to the Supreme Court for further review. In the UK and Norway, the patent was held invalid and no further appeal was filed. The EPO opposition division revoked the European patent, and the Company has appealed this decision. The cases in France and Germany have been stayed pending the final decision of the EPO.
Other Litigation
There are various other pending legal proceedings involving the Company, principally product liability and intellectual property lawsuits. While it is not feasible to predict the outcome of such proceedings, in the opinion of the Company, either the likelihood of loss is remote or any reasonably possible loss associated with the resolution of such proceedings is not expected to be material to the Company’s financial position, results of operations or cash flows either individually or in the aggregate.
Legal Defense Reserves
Legal defense costs expected to be incurred in connection with a loss contingency are accrued when probable and reasonably estimable. Some of the significant factors considered in the review of these legal defense reserves are as follows: the actual costs incurred by the Company; the development of the Company’s legal defense strategy and structure in light of the scope of its litigation; the number of cases being brought against the Company; the costs and outcomes of completed trials and the most current information regarding anticipated timing, progression, and related costs of pre-trial activities and trials in the associated litigation. The amount of legal defense reserves as of SeptemberJune 30, 20162017 and December 31, 20152016 of approximately $200175 million and $245185 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.
10.Equity
 
  
Common Stock
Other
Paid-In
Capital
Retained
Earnings
Accumulated
Other
Comprehensive
Loss
 
Treasury Stock
Non-
Controlling
Interests
Total
($ and shares in millions)SharesPar ValueSharesCost
Balance at January 1, 20153,577
$1,788
$40,423
$46,021
$(4,323)739
$(35,262)$144
$48,791
Net income attributable to Merck & Co., Inc.


3,465




3,465
Other comprehensive loss, net of tax



(250)


(250)
Cash dividends declared on common stock


(3,826)



(3,826)
Treasury stock shares purchased




53
(3,005)
(3,005)
Share-based compensation plans and other

(263)

(17)840

577
Changes in noncontrolling ownership interests

(21)



(55)(76)
Net income attributable to noncontrolling interests






12
12
Distributions attributable to noncontrolling interests






(9)(9)
Balance at September 30, 20153,577
$1,788
$40,139
$45,660
$(4,573)775
$(37,427)$92
$45,679
Balance at January 1, 20163,577
$1,788
$40,222
$45,348
$(4,148)796
$(38,534)$91
$44,767
Net income attributable to Merck & Co., Inc.


4,515




4,515
Other comprehensive loss, net of tax



(104)


(104)
Cash dividends declared on common stock


(3,835)



(3,835)
Treasury stock shares purchased




44
(2,418)
(2,418)
Share-based compensation plans and other

(325)

(25)1,235

910
Changes in noncontrolling ownership interests






124
124
Net income attributable to noncontrolling interests






13
13
Distributions attributable to noncontrolling interests






(15)(15)
Balance at September 30, 20163,577
$1,788
$39,897
$46,028
$(4,252)815
$(39,717)$213
$43,957

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

11.8.Equity
 
  
Common Stock
Other
Paid-In
Capital
Retained
Earnings
Accumulated
Other
Comprehensive
Loss
 
Treasury Stock
Non-
Controlling
Interests
Total
($ and shares in millions)SharesPar ValueSharesCost
Balance at January 1, 20163,577
$1,788
$40,222
$45,348
$(4,148)796
$(38,534)$91
$44,767
Net income attributable to Merck & Co., Inc.


2,330




2,330
Other comprehensive income, net of taxes



62



62
Cash dividends declared on common stock


(2,557)



(2,557)
Treasury stock shares purchased




30
(1,573)
(1,573)
Share-based compensation plans and other

(311)

(15)730

419
Net income attributable to noncontrolling interests






9
9
Distributions attributable to noncontrolling interests






(11)(11)
Balance at June 30, 20163,577
$1,788
$39,911
$45,121
$(4,086)811
$(39,377)$89
$43,446
Balance at January 1, 20173,577
$1,788
$39,939
$44,133
$(5,226)828
$(40,546)$220
$40,308
Net income attributable to Merck & Co., Inc.


3,496




3,496
Other comprehensive income, net of taxes



132



132
Cash dividends declared on common stock


(2,583)



(2,583)
Treasury stock shares purchased




34
(2,153)
(2,153)
Share-based compensation plans and other

(163)

(12)646

483
Acquisition of Vallée






25
25
Net income attributable to noncontrolling interests






11
11
Distributions attributable to noncontrolling interests






(7)(7)
Balance at June 30, 20173,577
1,788
39,776
45,046
(5,094)850
(42,053)249
39,712
9.Share-Based Compensation Plans
The Company has share-based compensation plans under which the Company grants restricted stock units (RSUs) and performance share units (PSUs) to certain management level employees. The Company also issues RSUs to employees of certain of the Company’s equity method investees. In addition, employees and non-employee directors may be granted options to purchase shares of Company common stock at the fair market value at the time of grant.
The following table provides the amounts of share-based compensation cost recorded in the Condensed Consolidated Statement of Income:
 Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
($ in millions)2016 2015 2016 2015
Pretax share-based compensation expense$77
 $75
 $225
 $221
Income tax benefit(24) (23) (69) (69)
Total share-based compensation expense, net of taxes$53
 $52
 $156
 $152
Amounts in the table above do not reflect share-based compensation costs to settle non-vested Afferent and Cubist equity awards attributable to postcombination service that were recognized as transaction expense in 2016 and 2015, respectively (see Note 2).
 Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2017 2016 2017 2016
Pretax share-based compensation expense$82
 $80
 $156
 $148
Income tax benefit(25) (25) (47) (45)
Total share-based compensation expense, net of taxes$57
 $55
 $109
 $103
During the first ninesix months of 20162017 and 2015,2016, the Company granted 65 million RSUs with a weighted-average grant date fair value of $54.6163.97 per RSU and 45 million RSUs with a weighted-average grant date fair value of $59.7954.54 per RSU, respectively. During the first ninesix months of 20162017 and 2015,2016, the Company granted 64 million stock options with a weighted-average exercise price of $54.6263.98 per option and 56 million stock options with a weighted-average exercise price of $59.82$54.61 per option, respectively. The weighted-average fair value of options granted for the first ninesix months of 20162017 and 20152016 was $5.897.05 and $6.46$5.89 per option, respectively, and was determined using the following assumptions:
Nine Months Ended September 30,Six Months Ended 
 June 30,
2016 20152017 2016
Expected dividend yield3.8% 4.1%3.6% 3.8%
Risk-free interest rate1.4% 1.7%2.0% 1.4%
Expected volatility19.6% 19.9%17.9% 19.6%
Expected life (years)6.2
 6.2
6.1
 6.2
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

At SeptemberJune 30, 20162017, there was $524633 million of total pretax unrecognized compensation expense related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted-average period of 2.12.2 years. For segment reporting, share-based compensation costs are unallocated expenses.
12.10.Pension and Other Postretirement Benefit Plans
The Company has defined benefit pension plans covering eligible employees in the United States and in certain of its international subsidiaries. The net periodic benefit cost (credit) of such plans consisted of the following components: 
  Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
 2016 2015 2016 2015
($ in millions)U.S. International U.S. International U.S. International U.S. International
Service cost$66
 $59
 $65
 $61
 $212
 $179
 $230
 $190
Interest cost116
 51
 108
 52
 342
 155
 326
 156
Expected return on plan assets(203) (95) (203) (95) (623) (288) (614) (286)
Net amortization18
 18
 33
 26
 48
 55
 119
 79
Termination benefits6
 1
 2
 
 11
 2
 20
 1
Curtailments3
 (2) (1) (2) 3
 (1) (10) (3)
Settlements
 
 
 1
 
 
 
 4
 $6
 $32
 $4
 $43
 $(7) $102
 $71
 $141
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

  Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
 2017 2016 2017 2016
($ in millions)U.S. International U.S. International U.S. International U.S. International
Service cost$77
 $63
 $73
 $62
 $154
 $124
 $146
 $120
Interest cost113
 42
 113
 52
 226
 83
 226
 105
Expected return on plan assets(218) (97) (210) (97) (436) (191) (420) (193)
Amortization of unrecognized prior service credit(13) (3) (14) (3) (27) (5) (27) (6)
Net loss amortization44
 24
 29
 21
 89
 47
 57
 43
Termination benefits3
 1
 1
 
 8
 2
 5
 
Curtailments1
 (1) 
 
 4
 (1) 
 1
 $7
 $29
 $(8) $35
 $18
 $59
 $(13) $70
The Company provides medical benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net cost (credit) of such plans consisted of the following components: 
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2016 2015 2016 20152017 2016 2017 2016
Service cost$14
 $22
 $41
 $61
$14
 $13
 $28
 $27
Interest cost19
 28
 62
 83
20
 21
 40
 42
Expected return on plan assets(19) (36) (88) (107)(20) (34) (39) (69)
Net amortization(25) (13) (78) (44)
Amortization of unrecognized prior service credit(24) (26) (49) (53)
Termination benefits1
 1
 1
 6

 
 1
 1
Curtailments(5) (1) (7) (8)(2) (1) (5) (2)
$(15) $1
 $(69) $(9)$(12) $(27) $(24) $(54)
In connection with restructuring actions (see Note 3), termination charges were recorded on pension and other postretirement benefit plans related to expanded eligibility for certain employees exiting Merck. Also, in connection with these restructuring actions, curtailments and settlements were recorded on pension and other postretirement benefit plans as reflected in the tables above.
The Company now anticipates that contributions to its international pension plans will approximate $450 million during 2016.
As a result of certain allowable administrative actions that occurred in June 2016, approximately $990 million of other postretirement benefit plan assets are no longer restricted for retiree benefits and became available to fund certain other health and welfare benefits.
13.11.Other (Income) Expense, Net
Other (income) expense, net, consisted of: 
 Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
($ in millions)2016 2015 2016 2015
Interest income$(87) $(68) $(244) $(214)
Interest expense170
 165
 513
 503
Exchange losses3
 228
 79
 1,038
Equity income from affiliates(21) (63) (59) (210)
Other, net(43) (432) (201) (493)
 $22
 $(170) $88
 $624
The higher exchange losses in 2015 compared with 2016 are primarily related to the Venezuelan Bolívar. During the second quarter of 2015, upon evaluation of evolving economic conditions in Venezuela and volatility in the country, the Company determined it was unlikely that all outstanding net monetary assets would be settled at the then official (CENCOEX) rate of 6.30 VEF (Bolívar Fuertes) per U.S. dollar. Accordingly, during the second quarter of 2015, the Company recorded a charge of $715 million to devalue its net monetary assets in Venezuela to an amount that represented the Company’s estimate of the U.S. dollar amount that would ultimately be collected. Since January 2010, Venezuela has been designated hyperinflationary and, as a result, local foreign operations are remeasured in U.S. dollars with the impact recorded in results of operations. During the third quarter of 2015, the Company recorded additional exchange losses of $138 million in the aggregate reflecting the ongoing effect of translating transactions and net monetary assets consistent with the second quarter of 2015.
The declines in equity income from affiliates in the third quarter and first nine months of 2016 as compared with the corresponding periods of 2015 were driven primarily by lower equity income from certain research investment funds.
Other, net (as reflected in the table above) in the first nine months of 2016 includes a gain of $117 million related to the settlement of certain patent litigation (see Note 9). Other, net in the third quarter and first nine months of 2015 includes a $250 million gain on the sale of certain migraine clinical development programs (see Note 2). Other, net in the first nine months of 2015 also includes an expense of $78 million for a contribution of investments in equity securities to the Merck Foundation.
Interest paid for the nine months ended September 30, 2016 and 2015 was $470 million and $452 million, respectively.

 Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2017 2016 2017 2016
Interest income$(96) $(78) $(194) $(157)
Interest expense193
 171
 375
 343
Exchange losses19
 37
 11
 76
Equity (income) loss from affiliates(5) (4) 8
 (38)
Other, net(53) (107) (83) (157)
 $58
 $19
 $117
 $67
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

The change in equity (income) loss from affiliates in the first six months of 2017 as compared with the same period of 2016 was driven primarily by lower equity income from certain research investment funds, as well as by the termination of the SPMSD joint venture on December 31, 2016.
Other, net (as reflected in the table above) in the second quarter and first six months of 2016 includes a gain of $115 million related to the settlement of certain patent litigation.
Interest paid for the six months ended June 30, 2017 and 2016 was $343 million and $321 million, respectively.
14.12.Taxes on Income
The effective income tax rates of 24.2%20.0% and 23.6%19.6% for the thirdsecond quarter of 20162017 and 2015,2016, respectively, and 24.7%21.0% and 24.2%25.2% for the first ninesix months of 20162017 and 2015,2016, respectively, reflect the impacts of acquisition and divestiture-related costs and restructuring costs, partially offset by the beneficial impact of foreign earnings. The effective income tax raterates for the second quarter and first ninesix months of 2017 also include a benefit of $88 million related to the settlement of a state income tax issue. The effective income tax rates for the second quarter and first six months of 2016 also reflectsreflect the beneficial impact of orphan drug federal income tax credits, primarily for Keytruda.The effective income tax rate for the first nine months of 2015 reflects the favorable impact of a net benefit of $370 million related to the settlement of certain federal income tax issues. In addition, the effective income tax rate for the first nine months of 2015 reflects the unfavorable effects of non-tax deductible foreign exchange losses related to Venezuela (see Note 13) and a $75 million out-of-period discrete adjustment, recorded in the second quarter related to deferred taxes associated with prior year restructuring activities. Management considered the discrete adjustment to be immaterial to current and prior period financial statements as reported.quarter.
The Company is under examination by numerous tax authorities in various jurisdictions globally. The ultimate finalization of the Company’s examinations with relevant taxing authorities can include formal administrative and legal proceedings, which could have a significant impact on the timing of the reversal of unrecognized tax benefits. The Company believes that its reserves for uncertain tax positions are adequate to cover existing risks or exposures. However, there is one item that is currently under discussion with the Internal Revenue Service relating to the 2006 through 2008 examination. The Company has concluded that its position should be sustained upon audit. However, if this item were to result in an unfavorable outcome or settlement, it could have a material adverse impact on the Company’s financial position, liquidity and results of operations.
15.13.Earnings Per Share
The calculations of earnings per share are as follows:
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ and shares in millions except per share amounts)2016 2015 2016 20152017 2016 2017 2016
Net income attributable to Merck & Co., Inc.$2,184
 $1,826
 $4,515
 $3,465
$1,946
 $1,205
 $3,496
 $2,330
Average common shares outstanding2,765
 2,814
 2,769
 2,825
2,734
 2,768
 2,739
 2,771
Common shares issuable (1)
21
 22
 22
 25
18
 21
 20
 21
Average common shares outstanding assuming dilution2,786
 2,836
 2,791
 2,850
2,752
 2,789
 2,759
 2,792
Basic earnings per common share attributable to Merck & Co., Inc. common shareholders$0.79
 $0.65
 $1.63
 $1.23
$0.71
 $0.44
 $1.28
 $0.84
Earnings per common share assuming dilution attributable to Merck & Co., Inc. common shareholders$0.78
 $0.64
 $1.62
 $1.22
$0.71
 $0.43
 $1.27
 $0.83
(1) 
Issuable primarily under share-based compensation plans.
For the three months ended SeptemberJune 30, 20162017 and 20152016, 45 million and 1013 million, respectively, and for the first ninesix months of 2017 and 2016, and 2015, 134 million and 712 million, respectively, of common shares issuable under share-based compensation plans were excluded from the computation of earnings per common share assuming dilution because the effect would have been antidilutive.

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

16.14.Other Comprehensive Income (Loss)
Changes in AOCI by component are as follows:
Three Months Ended September 30,Three Months Ended June 30,
($ in millions)Derivatives Investments 
Employee
Benefit
Plans
 
Cumulative
Translation
Adjustment
 
Accumulated Other
Comprehensive
Income (Loss)
Derivatives Investments 
Employee
Benefit
Plans
 
Cumulative
Translation
Adjustment
 
Accumulated Other
Comprehensive
Income (Loss)
Balance July 1, 2015, net of taxes$606
 $143
 $(2,909) $(2,172) $(4,332)
Balance April 1, 2016, net of taxes$202
 $104
 $(2,435) $(2,065) $(4,194)
Other comprehensive income (loss) before reclassification adjustments, pretax(16) (81) 3
 (87) (181)(75) 76
 (183) 255
 73
Tax9
 24
 2
 2
 37
27
 (5) 68
 (11) 79
Other comprehensive income (loss) before reclassification adjustments, net of taxes(7) (57) 5
 (85) (144)(48) 71
 (115) 244
 152
Reclassification adjustments, pretax(171)
(1) 
(16)
(2) 
46
(3) 

 (141)(66)
(1) 
(10)
(2) 
7
(3) 

 (69)
Tax60
 6
 (22) 
 44
23
 2
 
 
 25
Reclassification adjustments, net of taxes(111)
(10)
24


 (97)(43)
(8)
7


 (44)
Other comprehensive income (loss), net of taxes(118) (67) 29
 (85) (241)(91) 63
 (108) 244
 108
Balance September 30, 2015, net of taxes$488
 $76
 $(2,880) $(2,257) $(4,573)
Balance June 30, 2016, net of taxes$111
 $167
 $(2,543) $(1,821) $(4,086)
                  
Balance July 1, 2016, net of taxes$111
 $167
 $(2,543) $(1,821) $(4,086)
Balance April 1, 2017, net of taxes$106
 $40
 $(3,180) $(2,046) $(5,080)
Other comprehensive income (loss) before reclassification adjustments, pretax(69) (22) (177) 70
 (198)(169) 26
 29
 (25) (139)
Tax24
 (3) 21
 12
 54
59
 3
 (3) 72
 131
Other comprehensive income (loss) before reclassification adjustments, net of taxes(45) (25) (156) 82
 (144)(110) 29
 26
 47
 (8)
Reclassification adjustments, pretax(45)
(1) 
(5)
(2) 
11
(3) 

 (39)(50)
(1) 
8
(2) 
27
(3) 

 (15)
Tax16
 
 1
 
 17
17
 (2) (6) 
 9
Reclassification adjustments, net of taxes(29)
(5)
12


 (22)(33)
6

21


 (6)
Other comprehensive income (loss), net of taxes(74) (30) (144) 82
 (166)(143) 35
 47
 47
 (14)
Balance September 30, 2016, net of taxes$37
 $137
 $(2,687) $(1,739) $(4,252)
Balance June 30, 2017, net of taxes$(37) $75
 $(3,133) $(1,999) $(5,094)

Nine Months Ended September 30,Six Months Ended June 30,
($ in millions)Derivatives Investments 
Employee
Benefit
Plans
 
Cumulative
Translation
Adjustment
 
Accumulated Other
Comprehensive
Income (Loss)
Derivatives Investments 
Employee
Benefit
Plans
 
Cumulative
Translation
Adjustment
 
Accumulated Other
Comprehensive
Income (Loss)
Balance January 1, 2015, net of taxes$530
 $111
 $(2,986) $(1,978) $(4,323)
Other comprehensive income (loss) before reclassification adjustments, pretax464
 18
 18
 (181) 319
Tax(159) (1) (2) (98) (260)
Other comprehensive income (loss) before reclassification adjustments, net of taxes305
 17
 16
 (279) 59
Reclassification adjustments, pretax(534)
(1) 
(78)
(2) 
154
(3) 

 (458)
Tax187
 26
 (64) 
 149
Reclassification adjustments, net of taxes(347) (52) 90
 
 (309)
Other comprehensive income (loss), net of taxes(42) (35) 106
 (279) (250)
Balance September 30, 2015, net of taxes$488
 $76
 $(2,880) $(2,257) $(4,573)
         
Balance January 1, 2016, net of taxes$404
 $41
 $(2,407) $(2,186) $(4,148)$404
 $41
 $(2,407) $(2,186) $(4,148)
Other comprehensive income (loss) before reclassification adjustments, pretax(311) 108
 (395) 424
 (174)(242) 130
 (218) 354
 24
Tax109
 8
 88
 23
 228
85
 11
 67
 11
 174
Other comprehensive income (loss) before reclassification adjustments, net of taxes(202) 116
 (307) 447
 54
(157) 141
 (151) 365
 198
Reclassification adjustments, pretax(254)
(1) 
(26)
(2) 
25
(3) 

 (255)(209)
(1) 
(21)
(2) 
14
(3) 

 (216)
Tax89
 6
 2
 
 97
73
 6
 1
 
 80
Reclassification adjustments, net of taxes(165) (20) 27
 
 (158)(136) (15) 15
 
 (136)
Other comprehensive income (loss), net of taxes(367) 96
 (280) 447
 (104)(293) 126
 (136) 365
 62
Balance September 30, 2016, net of taxes$37
 $137
 $(2,687) $(1,739) $(4,252)
Balance June 30, 2016, net of taxes$111
 $167
 $(2,543) $(1,821) $(4,086)
         
Balance January 1, 2017, net of taxes$338
 $(3) $(3,206) $(2,355) $(5,226)
Other comprehensive income (loss) before reclassification adjustments, pretax(432) 113
 25
 238
 (56)
Tax151
 (4) 6
 118
 271
Other comprehensive income (loss) before reclassification adjustments, net of taxes(281) 109
 31
 356
 215
Reclassification adjustments, pretax(145)
(1) 
(49)
(2) 
55
(3) 

 (139)
Tax51
 18
 (13) 
 56
Reclassification adjustments, net of taxes(94) (31) 42
 
 (83)
Other comprehensive income (loss), net of taxes(375) 78
 73
 356
 132
Balance June 30, 2017, net of taxes$(37) $75
 $(3,133) $(1,999) $(5,094)
(1) 
Relates to foreign currency cash flow hedges that were reclassified from AOCI to Sales.
(2) 
Represents net realized (gains) losses on the sales of available-for-sale investments that were reclassified from AOCI to Other (income) expense, net.
(3) 
Includes net amortization of prior service cost and actuarial gains and losses included in net periodic benefit cost (see Note 12)10).
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)


17.15.Segment Reporting
The Company’s operations are principally managed on a products basis and include the Pharmaceutical, Animal Health, AlliancesHealthcare Services and Healthcare ServicesAlliances operating segments. The Animal Health, Healthcare Services and Alliances segments are not material for separate reporting.
The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the Company or through joint ventures.products. Human health pharmaceutical products consist of therapeutic and preventive agents, generally sold by prescription, for the treatment of human disorders. The Company sells these human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers such as health maintenance organizations, pharmacy benefit managers and other institutions. Vaccine products consist of preventive pediatric, adolescent and adult vaccines, primarily administered at physician offices. The Company sells these human health vaccines primarily to physicians, wholesalers, physician distributors and government entities. A large component of pediatric and adolescent vaccines is soldvaccine sales are made to the U.S. Centers for Disease Control and Prevention Vaccines for Children program, which is funded by the U.S. government. Additionally, the Company sells vaccines to the Federal government for placement into vaccine stockpiles. Sales of vaccines in most major European markets were marketed through the Company’s SPMSD joint venture until its termination on December 31, 2016.
The Company also has animal health operationsan Animal Health segment that discover, develop, manufacturediscovers, develops, manufactures and marketmarkets animal health products, including vaccines, which the Company sells to veterinarians, distributors and animal producers. The Company’s Healthcare Services segment provides services and solutions that focus on engagement, health analytics and clinical services to improve the value of care delivered to patients. During the third quarter of 2016, the Company made changes to the composition of the Animal Health segment that resulted in the inclusion of certain revenues and costs that were previously included in non-segment revenues and profits. Prior periods have been recast to reflect these changes on a comparable basis.

Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

Sales of the Company’s products were as follows:
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2016 2015 2016 20152017 2016 2017 2016
Primary Care and Women’s Health              
Cardiovascular              
Zetia$671
 $633
 $1,985
 $1,836
$367
 $702
 $701
 $1,314
Vytorin273
 302
 843
 942
182
 293
 423
 570
Atozet63
 33
 112
 56
Adempas67
 40
 151
 72
Diabetes              
Januvia1,006
 1,014
 2,976
 2,942
948
 1,064
 1,787
 1,970
Janumet548
 562
 1,624
 1,625
563
 569
 1,059
 1,075
General Medicine and Women’s Health              
NuvaRing195
 190
 571
 538
199
 200
 359
 376
Implanon/Nexplanon148
 176
 446
 437
178
 164
 349
 298
Dulera97
 133
 331
 383
Follistim AQ101
 95
 268
 288
79
 73
 160
 167
Hospital and Specialty              
Hepatitis              
Zepatier164
 
 326
 
517
 112
 895
 161
HIV              
Isentress372
 377
 1,050
 1,137
Isentress/Isentress HD
282
 338
 587
 678
Hospital Acute Care              
Cubicin320
 325
 969
 805
Bridion163
 113
 310
 204
Noxafil147
 132
 434
 360
155
 143
 296
 288
Invanz152
 153
 409
 424
150
 143
 286
 257
Cancidas142
 139
 406
 436
112
 131
 233
 263
Bridion139
 89
 343
 262
Cubicin103
 357
 198
 649
Primaxin77
 75
 231
 228
71
 81
 133
 154
Immunology              
Remicade311
 442
 999
 1,398
208
 339
 437
 688
Simponi193
 178
 581
 505
199
 199
 383
 387
Oncology              
Keytruda356
 159
 919
 352
881
 314
 1,465
 563
Emend137
 141
 405
 396
143
 143
 276
 268
Temodar78
 83
 216
 238
65
 73
 130
 139
Diversified Brands              
Respiratory              
Singulair239
 201
 705
 658
203
 229
 389
 465
Nasonex94
 121
 425
 625
85
 101
 224
 331
Dulera69
 121
 151
 234
Other              
Cozaar/Hyzaar131
 150
 389
 524
119
 132
 231
 258
Arcoxia114
 123
 342
 361
89
 117
 192
 228
Fosamax68
 86
 217
 277
66
 73
 127
 148
Zocor54
 56
 150
 168
Vaccines (1)
              
Gardasil/Gardasil 9
860
 625
 1,631
 1,410
469
 393
 1,001
 770
ProQuad/M-M-R II/Varivax
496
 390
 1,236
 1,096
399
 383
 754
 739
RotaTeq171
 160
 489
 441
123
 130
 347
 318
Pneumovax 23
166
 120
 329
 228
Zostavax190
 179
 464
 503
160
 149
 313
 274
Pneumovax 23
175
 138
 403
 354
Other pharmaceutical (2)
1,224
 1,298
 3,464
 3,806
1,116
 1,128
 2,156
 2,214
Total Pharmaceutical segment sales9,443
 8,925
 26,247
 25,755
8,759
 8,700
 16,944
 16,804
Other segment sales (3)
977
 903
 2,862
 2,745
1,056
 980
 2,089
 1,885
Total segment sales10,420
 9,828
 29,109
 28,500
9,815
 9,680
 19,033
 18,689
Other (4)
116
 245
 583
 783
115
 164
 332
 467
$10,536
 $10,073
 $29,692
 $29,283
$9,930
 $9,844
 $19,365
 $19,156
(1) 
These amountsOn December 31, 2016, Merck and Sanofi terminated their equally-owned joint venture, SPMSD, which marketed vaccines in most major European markets. Accordingly, vaccine sales in 2017 include sales in the European markets that were previously part of SPMSD. Amounts for 2016 do not reflectinclude sales of vaccines sold in most major European markets through the Company’s joint venture, SPMSD, the results of which are reflected in equity income from affiliates which is included in Other (income) expense, net. These amountsAmounts for 2016 do, however, reflectinclude supply sales to SPMSD. In March 2016, Merck and Sanofi announced their intent to end the SPMSD joint venture (see Note 7).
(2) 
Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately.
(3) 
Represents the non-reportable segments of Animal Health, Healthcare Services and Alliances.
(4) 
Other is primarily comprised of miscellaneous corporate revenues, including revenue hedging activities, as well as third-party manufacturing sales. Other in the first ninesix months of 2017 and 2016 also includes $50 million and $75 million, respectively, related to the sale of the U.S. marketing rights to certain products (see Note 2).products.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)

A reconciliation of segment profits to Income before taxes is as follows:
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2016 2015 2016 20152017 2016 2017 2016
Segment profits:              
Pharmaceutical segment$6,162
 $5,641
 $16,698
 $16,088
$5,613
 $5,420
 $10,793
 $10,537
Other segments389
 394
 1,129
 1,208
508
 386
 961
 739
Total segment profits6,551
 6,035
 17,827
 17,296
6,121
 5,806
 11,754
 11,276
Other profits21
 204
 341
 582
43
 93
 186
 320
Unallocated:              
Interest income87
 68
 244
 214
96
 78
 194
 157
Interest expense(170) (165) (513) (503)(193) (171) (375) (343)
Equity income from affiliates(27) 25
 (13) 161
5
 (6) (7) 14
Depreciation and amortization(365) (381) (1,228) (1,169)(332) (438) (702) (864)
Research and development(1,444) (1,291) (4,651) (4,310)(1,527) (1,833) (3,126) (3,206)
Amortization of purchase accounting adjustments(772) (1,180) (2,932) (3,658)(779) (1,027) (1,557) (2,161)
Restructuring costs(161) (113) (386) (386)(166) (134) (317) (225)
Gain on sale of certain migraine clinical development programs40
 250
 40
 250
Foreign currency devaluation related to Venezuela
 
 
 (715)
Other unallocated, net(873) (1,055) (2,714) (3,177)(829) (864) (1,608) (1,840)
$2,887
 $2,397
 $6,015
 $4,585
$2,439
 $1,504
 $4,442
 $3,128
Segment profits are comprised of segment sales less standard costs and certain operating expenses directly incurred by the segments. For internal management reporting presented to the chief operating decision maker, Merck does not allocate materials and production costs, other than standard costs, the majority of research and development expenses or general and administrative expenses, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. In addition, costs related to restructuring activities, as well as the amortization of purchase accounting adjustments are not allocated to segments.
Other profits are primarily comprised of miscellaneous corporate profits, as well as operating profits related to third-party manufacturing sales.
Other unallocated, net includes expenses from corporate and manufacturing cost centers, goodwill and product intangible asset impairment charges, gains or losses on sales of businesses, expense or income related to changes in the estimated fair value of contingent consideration, and other miscellaneous income or expense items.



Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
BusinessRecent Developments
Global Oncology Collaboration
In January 2016, Merck acquired IOmet Pharma Ltd, a privately held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism.
In June 2016,July 2017, Merck and Moderna Therapeutics announcedAstraZeneca entered a global strategic oncology collaboration to co-develop and license agreement toco-commercialize AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Lynparza is an oral, poly (ADP-ribose) polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment. The companies will develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines.
Lynparza, both as monotherapy and in combination trials with other potential medicines. Independently, Merck and AstraZeneca will develop and commercialize Lynparza in combinations with their respective PD-1 and PD-L1 medicines, Keytruda (pembrolizumab) and Imfinzi (durvalumab). The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer. As part of the agreement, Merck will make an upfront payment to AstraZeneca of $1.6 billion and will make payments of $750 million over a multi-year period for certain license options. The Company will record an aggregate charge of $2.35 billion in Research and development expenses in the third quarter of 2017 related to these payments. In July 2016,addition, Merck acquired Afferent Pharmaceuticals (Afferent), a privately held pharmaceutical company focused on the developmentwill pay AstraZeneca up to an additional $6.15 billion contingent upon successful achievement of therapeutic candidates targeting the P2X3 receptorfuture regulatory and sales milestones for the treatmenttotal aggregate consideration of common, poorly-managed, neurogenic conditions.
Also in July 2016, Merck acquired a majority ownership interest in The StayWell Company LLC (StayWell), a health engagement company that helps its clients engage and educate peopleup to improve health and business results.
Additionally in July 2016, Merck announced it had executed an agreement to acquire a controlling interest in Vallée S.A. (Vallée), a leading privately held producer of animal health products in Brazil.
See$8.5 billion (see Note 2 to the condensed consolidated financial statementsstatements). 
Cyber-attack
On June 27, 2017, the Company experienced a network cyber-attack that led to a disruption of its worldwide operations, including manufacturing, research and sales operations. While the Company does not yet know the magnitude of the impact of the disruption, which remains ongoing in certain operations, it continues to work to minimize the effects.
The Company is in the process of restoring its manufacturing operations. To date, Merck has largely restored its packaging operations and has mostly restored its formulation operations. The Company is in the process of restoring its Active Pharmaceutical Ingredient operations but is not yet producing bulk product. The Company’s external manufacturing was not impacted. Throughout this time, Merck has continued to fulfill orders and ship product.
The Company is confident in the continuous supply of key products such as Keytruda, Januvia (sitagliptin) and Zepatier (elbasvir and grazoprevir). In addition, Merck does not currently expect a significant impact to sales of its other top products; however, the Company anticipates that it will have temporary delays in fulfilling orders for additional information oncertain other products in certain markets. Merck does not currently expect a significant impairment to the above transactions.value of intangible assets related to marketed products or inventories. Full resumption of affected operations will take time and the Company will incur expenditures related to remediation efforts.
The Company has insurance coverage insuring against costs resulting from cyber-attacks. However, there may be disputes with the insurers about the availability of the insurance coverage for claims related to this incident.
Operating Results
Sales
Worldwide sales were $10.59.9 billion for the thirdsecond quarter of 2016,2017, an increase of 5%1% compared with the thirdsecond quarter of 2015.2016. Worldwide sales were $19.4 billion for the first six months of 2017, an increase of 1% compared with the first six months of 2016. Foreign exchange unfavorably affected global sales performance by 1% in both the thirdsecond quarter and first six months of 2016, which includes a lower benefit from revenue hedging activities as compared with the third quarter of 2015.2017. Sales growth in both periods was driven primarily by higher sales in the oncology franchise largely from Keytruda, the ongoing launch of hepatitis C virus (HCV) treatment Gardasil Zepatier9 (Human Papillomavirus 9-valent Vaccine, Recombinant)/, and growth in vaccine products including Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant), /KeytrudaGardasil (pembrolizumab), Zepatier (elbasvir9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and grazoprevir), ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), Bridion (sugammadex) Injection, Adempas (riociguat), Singulair (montelukast), Pneumovax 23 (pneumococcal vaccine polyvalent). Sales in the second quarter and Zetia (ezetimibe)first six months of 2017 benefited from the December 31, 2016 termination of Sanofi Pasteur MSD (SPMSD), as well asa joint venture between Merck and Sanofi Pasteur S.A. (Sanofi), which marketed vaccines in most major European markets. In 2017, Merck began recording vaccine sales in the markets that were previously part of the SPMSD joint venture. Also contributing to sales growth in the second quarter and first six months of 2017 were higher sales of Bridion (sugammadex) Injection, Adempas (riociguat), and Animal Health products. Sales in the third quarter of 2016 benefited from approximately $150 million of additional sales in Japan resulting from the timing of shipments in anticipation of a resource planning system that was implemented by the Company in the fourth quarter of 2016. products, particularly Bravecto (fluralaner).


Partially offsetting revenue growth in the thirdsecond quarter and first six months of 2017 were declines attributable to the effects of generic and biosimilar competition for certain products including Zetia (ezetimibe), which lost U.S. market exclusivity in December 2016, Vytorin (ezetimibe and simvastatin), which lost U.S. market exclusivity in April 2017, Cubicin (daptomycin for injection) and Remicade (infliximab) and Dulera Inhalation Aerosol (mometasone furoate/formoterol fumarate dihydrate), as well as lower sales of products within Diversified Brands including Dulera Inhalation Aerosol (mometasone furoate/formoterol fumarate dihydrate), Singulair (montelukast) and Nasonex (mometasone furoate monohydrate),. Declines in the diabetes franchise of CozaarJanuvia (losartan potassium) and HyzaarJanumet (losartan potassium(sitagliptin/metformin HCl) and hydrochlorothiazide). Sales performance in the third quarter of 2016 reflects a decline of approximately $170 million due to reduced operations in Venezuela.
Worldwide sales were $29.7 billion for the first nine months of 2016, growth of 1% as compared with the first nine months of 2015. Foreign exchange unfavorably affected global sales performance by 3% in the first nine months of 2016, which includes a lower benefit from revenue hedging activities as compared with the first nine months of 2015. Sales growth was driven primarily by highercombined sales of Keytruda, Zepatier,Isentress/Isentress HD Gardasil 9/Gardasil, Zetia, Adempas, ProQuad, Bridion, Simponi (golimumab) and Noxafil (posaconazole), as well as higher sales of Animal Health products. Revenue in the first nine months of 2016 benefited from approximately one month of additional sales for products acquired in connection with the January 2015 acquisition of Cubist Pharmaceuticals, Inc. (Cubist). Sales in the first nine months of 2016(raltegravir) also benefited from approximately $150 million of additional sales in Japan resulting from the timing of shipments as noted above. In addition, the Company recognized revenue of $75 million in the first nine months of 2016 in connection with the sale of the U.S. marketing rights to certain products. Largely offsettingoffset revenue growth in the second quarter and first ninesix months of 2016 were declines in Remicade, Nasonex, Cozaar and Hyzaar, Isentress (raltegravir), Fosamax (alendronate sodium) and Dulera, as well as declines in other products within Diversified Brands. Sales performance in the first nine months of 2016 reflects a decline of approximately $620 million due to reduced operations in Venezuela.2017.
Global efforts toward health care cost containment continue to exert pressure on product pricing and market access worldwide. In the United States health care reform is contributing to an increasepricing pressures continue on many of the Company’s products and, in the number of patients in the Medicaid program under which sales of pharmaceutical products are subject to substantial rebates. In manyseveral international markets, government-mandated pricing actions have reduced prices of generic and patented drugs. In addition, other austerity measures negatively affected the Company’s revenue performance in the first ninesix months of 2016.2017. The Company anticipates these pricing actions including the biennial price reductions in Japan, and other austerity measures will continue to negatively affect revenue performance for the remainder of 2016.2017.


Sales of the Company’s products were as follows:
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2016 2015 2016 20152017 2016 2017 2016
Primary Care and Women’s Health              
Cardiovascular              
Zetia$671
 $633
 $1,985
 $1,836
$367
 $702
 $701
 $1,314
Vytorin273
 302
 843
 942
182
 293
 423
 570
Atozet63
 33
 112
 56
Adempas67
 40
 151
 72
Diabetes              
Januvia1,006
 1,014
 2,976
 2,942
948
 1,064
 1,787
 1,970
Janumet548
 562
 1,624
 1,625
563
 569
 1,059
 1,075
General Medicine and Women’s Health              
NuvaRing195
 190
 571
 538
199
 200
 359
 376
Implanon/Nexplanon148
 176
 446
 437
178
 164
 349
 298
Dulera97
 133
 331
 383
Follistim AQ101
 95
 268
 288
79
 73
 160
 167
Hospital and Specialty              
Hepatitis              
Zepatier164
 
 326
 
517
 112
 895
 161
HIV              
Isentress372
 377
 1,050
 1,137
Isentress/Isentress HD
282
 338
 587
 678
Hospital Acute Care              
Cubicin320
 325
 969
 805
Bridion163
 113
 310
 204
Noxafil147
 132
 434
 360
155
 143
 296
 288
Invanz152
 153
 409
 424
150
 143
 286
 257
Cancidas142
 139
 406
 436
112
 131
 233
 263
Bridion139
 89
 343
 262
Cubicin103
 357
 198
 649
Primaxin77
 75
 231
 228
71
 81
 133
 154
Immunology              
Remicade311
 442
 999
 1,398
208
 339
 437
 688
Simponi193
 178
 581
 505
199
 199
 383
 387
Oncology              
Keytruda356
 159
 919
 352
881
 314
 1,465
 563
Emend137
 141
 405
 396
143
 143
 276
 268
Temodar78
 83
 216
 238
65
 73
 130
 139
Diversified Brands              
Respiratory              
Singulair239
 201
 705
 658
203
 229
 389
 465
Nasonex94
 121
 425
 625
85
 101
 224
 331
Dulera69
 121
 151
 234
Other              
Cozaar/Hyzaar131
 150
 389
 524
119
 132
 231
 258
Arcoxia114
 123
 342
 361
89
 117
 192
 228
Fosamax68
 86
 217
 277
66
 73
 127
 148
Zocor54
 56
 150
 168
Vaccines (1)
              
Gardasil/Gardasil 9
860
 625
 1,631
 1,410
469
 393
 1,001
 770
ProQuad/M-M-R II/Varivax
496
 390
 1,236
 1,096
399
 383
 754
 739
RotaTeq171
 160
 489
 441
123
 130
 347
 318
Pneumovax 23
166
 120
 329
 228
Zostavax190
 179
 464
 503
160
 149
 313
 274
Pneumovax 23
175
 138
 403
 354
Other pharmaceutical (2)
1,224
 1,298
 3,464
 3,806
1,116
 1,128
 2,156
 2,214
Total Pharmaceutical segment sales9,443
 8,925
 26,247
 25,755
8,759
 8,700
 16,944
 16,804
Other segment sales (3)
977
 903
 2,862
 2,745
1,056
 980
 2,089
 1,885
Total segment sales10,420
 9,828
 29,109
 28,500
9,815
 9,680
 19,033
 18,689
Other (4)
116
 245
 583
 783
115
 164
 332
 467
$10,536
 $10,073
 $29,692
 $29,283
$9,930
 $9,844
 $19,365
 $19,156
(1) 
These amountsOn December 31, 2016, Merck and Sanofi terminated their equally-owned joint venture, SPMSD, which marketed vaccines in most major European markets. Accordingly, vaccine sales in 2017 include sales in the European markets that were previously part of SPMSD. Amounts for 2016 do not reflectinclude sales of vaccines sold in most major European markets through the Company’s joint venture, Sanofi Pasteur MSD (SPMSD),SPMSD, the results of which are reflected in equity income from affiliates which is included in Other (income) expense, net. These amountsAmounts for 2016 do, however, reflectinclude supply sales to SPMSD. In March 2016, Merck and Sanofi announced their intent to end the SPMSD joint venture (see “Selected Joint Venture and Affiliate Information” below).
(2) 
Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately.
(3) 
Represents the non-reportable segments of Animal Health, Healthcare Services and Alliances.
(4) 
Other is primarily comprised of miscellaneous corporate revenues, including revenue hedging activities, as well as third-party manufacturing sales. Other in the first ninesix months of 2017 and 2016 also includes $50 million and $75 million, respectively, related to the sale of the U.S. marketing rights to certain products (see Note 2 to the condensed consolidated financial statements).products.


Product sales are recorded net of the provision for discounts, which includes indirect customer discounts that occur when a contracted customer purchases directly through an intermediary wholesale purchaser, known as chargebacks, as well as indirectly in the form of rebates owed based upon definitive contractual agreements or legal requirements with private sector and public sector (Medicaid and Medicare Part D) benefit providers, after the final dispensing of the product by a pharmacy to a benefit plan participant. These discounts, in the aggregate, reduced U.S. sales by $2.6$2.8 billion and $2.1$2.3 billion for the three months ended SeptemberJune 30, 20162017 and 20152016, respectively, and by $7.1$5.3 billion and $5.8$4.5 billion for the first ninesix months ofended June 30, 2017 and 2016, and 2015, respectively. Inventory levels at key U.S. wholesalers for each of the Company’s major pharmaceutical products are generally less than one month.
Pharmaceutical Segment
Primary Care and Women’s Health
Cardiovascular
Combined global sales of Zetia (marketed in most countries outside the United States as Ezetrol) and, Vytorin (ezetimibe and simvastatin) (marketed outside the United States as Inegy), and Atozet (ezetimibe and atorvastatin) (marketed in certain countries outside of the United States), medicines for lowering LDL cholesterol, were $944$612 million in the thirdsecond quarter of 2016,2017 and $2.8$1.2 billion infor the first ninesix months of 2016, increases2017, declines of 1%40% and 2%36%, respectively, compared with the same periods of 2015. In addition, in the third quarter and first nine months of 2016, the Company recorded $39 million and $96 million, respectively, of2016. The sales declines primarily reflect lower volumes of AtozetZetia (ezetimibe and atorvastatin), which the Company markets in certain countries outside of the United States. Sales of the ezetimibe family (including AtozetVytorin) were $984 million in the third quarter of 2016, growth of 4% compared with the third quarter of 2015, and were $2.9 billion for the first nine months of 2016, growth of 5% compared with the same period of 2015. Foreign exchange favorably affected global sales performance by 1% in the third quarter of 2016 and unfavorably affected global sales performance by 1% in first nine months of 2016. Sales growth in both periods reflects higher pricing in the United States as well as volume growth in Europe, and higher sales in Japan due to timing of shipments, partially offset by lower volumes in the United States and lower sales in Venezuela due to reduced operations in this country.
from generic competition. By agreement, a generic manufacturer may launchlaunched a generic version of Zetia in the United States in December 2016 and the Company anticipates a rapid and substantial decline in U.S. Zetia sales thereafter.2016. The U.S. patent and exclusivity periods for Zetia and Vytorin otherwise expireexpired in April 2017. Sales of2017 and the Company is experiencing rapid and substantial declines in U.S. Zetia and Vytorin in the United States were $1.3 billion and $341 million, respectively, for the first nine months of 2016.sales. The Company has market exclusivity in major European markets for Ezetrol until April 2018 and for Inegy until April 2019.
In October 2014, Merck andPursuant to a collaboration with Bayer AG (Bayer) announced a collaboration to market and develop novel therapies for cardiovascular disease. Under the terms of the agreement,, Merck hasacquired lead commercial rights for Adempas,, a novel cardiovascular drug for the treatment of pulmonary arterial hypertension, in countries outside the Americas while Bayer continues to havehas lead rights in the Americas, including the United States. Starting inIn 2016, Merck began promoting and distributing Adempas in Europe. Transition from Bayer in other Merck territories will continue in 2017. Merck recorded sales of $48$67 million and $120$40 million for Adempas in the thirdsecond quarter of 2017 and 2016, respectively, and $151 million and $72 million for the first ninesix months of 2017 and 2016, respectively, which includes sales in Merck’s marketing territories, as well as Merck’s share of profits from the sale of Adempas in Bayer’s marketing territories.
In September 2016, Merck sold the marketing rights for Zontivity (vorapaxar) in the United States and Canada to Aralez Pharmaceuticals Inc. for a $25 million upfront payment and royalties at graduated rates, plus potential future consideration dependent upon the achievement of certain aggregate annual sales-based milestones. Previously, in March 2016, following several business decisions that reduced sales expectations for Zontivity in the United States and Europe, the Company lowered its cash flow projections for Zontivity. The Company utilized market participant assumptions and considered several different scenarios to determine the fair value of the intangible asset related to Zontivity that, when compared with its related carrying value, resulted in an impairment charge of $252 million recorded in Materials and production costs in the first nine months of 2016.
Diabetes
Worldwide combined sales of Januvia (sitagliptin) and Janumet (sitagliptin/metformin HCl) , medicines that help lower blood sugar levels in adults with type 2 diabetes, were $1.6$1.5 billion in the thirdsecond quarter of 2017, a decline of 8% compared with the second quarter of 2016, and were $2.8 billion in the first six months of 2017, a decline of 1%7% compared with the thirdsame period of 2016. Foreign exchange unfavorably affected global sales performance by 1% in both the second quarter and first six months of 2015 including a 1% favorable effect from foreign exchange.2017. The decline reflectsdeclines primarily reflect lower sales in the United States driven by continued pricing pressures, as well as the timing ofpressure and lower customer purchases in the third quarter of 2015inventory levels that resulted in an unfavorable comparison to this quarter,were partially offset by higher demand. The declinecontinued volume growth. Lower demand and pricing in Europe also reflects no sales in Venezuela in the third quarter of 2016 duecontributed to the Company’s reduced operations in that country.sales declines. These declines were partially offset by higher sales in Japan reflecting the timing of shipments, as well as volume growth in EuropeAsia Pacific and certain emerging markets. Global salesLatin America.
In April 2017, Merck announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Merck’s supplemental New Drug Applications for Januvia, Janumet and Janumet XR (sitagliptin and metformin HCl extended-release). With these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. Merck has reviewed the letter and is discussing next steps with the FDA.
In July 2017, Merck announced that the FDA granted tentative approval for Lusduna Nexvue (insulin glargine injection), a follow-on biologic basal insulin for the treatment of people with type 1 and type 2 diabetes. Lusduna Nexvue is being developed by Merck with funding from Samsung Bioepis Co., Ltd (Samsung Bioepis). With the tentative approval, Lusduna Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement. Under the Hatch-Waxman Act, the initiation of Sanofi’s lawsuit in September 2016 automatically invoked a stay on final FDA approval of JanuviaLusduna and Janumet were $4.6 billionNexvue for the first nine months of 2016, an increase of 1% compared with the samea period of 2015. Sales growth was driven primarily by higher sales in Japan reflecting the timing of shipments, as well as higher volumes in Europe, Canada and certain emerging markets. These increases were partially offset by lower salesup to 30 months, or in the United States, reflecting pricing pressures and the timingevent a court finds in favor of customer purchasesMerck, whichever comes sooner. Lusduna was approved in the prior year as noted above, partially offset by higher demand, as well as lower salesEuropean Union (EU) in Venezuela due to the Company’s reduced operations in that country.January 2017.


General Medicine and Women’s Health 
Worldwide sales of NuvaRing (etonogestrel/ethinyl estradiol vaginal ring), a vaginal contraceptive product, increased 3%were $199 million in the thirdsecond quarter of 2016 to2017, essentially flat as compared with the second quarter of 2016. Global sales of $195 millionNuvaRing and grew 6%declined 4% in the first ninesix months of 20162017 to $571$359 million compared with the same periods of 2015. Sales growth in both periodsdriven primarily reflects higher pricingby lower sales in the United States reflecting the timing of customer purchases, partially offset by volume declines in Europe. Foreign exchange unfavorably affected global sales performance by 1% in the first nine months of 2016.higher pricing. In August 2016, the U.S. District Court ruled that the Company’s delivery system patent for NuvaRing is invalid. The Company is appealing this verdict to the U.S. Court of Appeals for the Federal Circuit. However, given the U.S. District Court’s decision, there may be generic entrants into the U.S. market in advance of the


April 2018 patent expiration. If this should occur, the Company anticipates a significant decline in U.S. NuvaRing sales thereafter. U.S. sales of NuvaRing were $421$265 million for the first ninesix months of 2016.2017. As a result of the unfavorable U.S. District Court decision, the Company evaluated the intangible asset related to NuvaRing, which had a carrying value of $365 million at September 30, 2016, for impairment and concluded that it was not impaired. The intangible asset value for NuvaRing was $228 million at June 30, 2017.
Worldwide sales of Implanon/Nexplanon (etonogestrel implant), single-rod subdermal contraceptive implants, declined 16%grew 9% to $148$178 million in the thirdsecond quarter of 2016 compared with the third quarter of 2015 reflecting declines in certain emerging markets, particularly in Venezuela due2017 and increased 17% to reduced operations in this country, as well as lower sales in the United States. Global sales of Implanon/Nexplanon increased 2% to $446$349 million in the first ninesix months of 20162017 compared with the same periodperiods of 2015 driven2016 primarily byreflecting higher demandpricing and volume growth in the United States, partially offset by declines in certain emerging markets, particularly in Venezuela.States. Foreign exchange unfavorably affected global sales performance by 3%1% for both the third quarter and first ninesix months of 2016.
Global sales of Dulera Inhalation Aerosol, a combination medicine for the treatment of asthma, decreased 27% to $97 million in the third quarter of 2016 and declined 14% to $331 million in the first nine months of 2016 compared with the same periods of 2015, driven by lower sales in the United States reflecting competitive pricing pressures that were partially offset by higher demand.
Global sales of Follistim AQ (follitropin beta injection) (marketed in most countries outside the United States as Puregon), a fertility treatment, were $101 million in the third quarter of 2016, an increase of 6% compared with the third quarter of 2015 including a 2% unfavorable effect from foreign exchange. Sales growth reflects volume increases in the United States resulting from the resolution of a supply issue, partially offset by volume declines in Europe. Worldwide sales of Follistim AQ were $268 million in the first nine months of 2016, a decrease of 7% compared with the same period of 2015 including a 2% unfavorable effect from foreign exchange. The sales decline primarily reflects lower demand in Europe and certain emerging markets.
In the second quarter of 2016, the Company determined that, for business reasons, it would terminate the North America partnership agreement with ALK-Abelló (ALK) that included both Grastek (Timothy Grass Pollen Allergen Extract) and Ragwitek (Short Ragweed Pollen Allergen Extract) allergy immunotherapy tablets for sublingual use. This decision was not due to efficacy or safety concerns for the tablets. Merck has provided ALK with six months’ notice that it is terminating the agreement and therefore these compounds will be returned to ALK. In connection with this decision, the Company wrote-off amounts capitalized in connection with the assets (see Note 6 to the condensed consolidated financial statements).2017.
Hospital and Specialty
Hepatitis
Global sales of Zepatier were $164 million and $326$517 million in the thirdsecond quarter of 2017 compared with $112 million in the second quarter of 2016 and were $895 million in the first ninesix months of 2016, respectively.2017 compared with $161 million in the first six months of 2016. Sales growth in both periods primarily reflects higher sales in the United States, Europe and Japan as the Company continues to launch Zepatier globally. In January 2016, the U.S. Food and Drug Administration (FDA)FDA approved Zepatier for the treatment of adult patients with chronic hepatitis C virus (HCV)HCV genotype (GT) 1 or GT4 infection with or without ribavirin.in adults. Zepatieris a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg).recommended for use with ribavirin in certain patient populations. Zepatier became available in the United States in February 2016. Zepatier is alsowas approved in certain other markets.
In July 2016,by the European Commission (EC) approved Zepatier forin July 2016 and became available in European markets in late November 2016. Launches are expected to continue across the treatment of chronic HCVEU in adult patients, allowing marketing of2017. The Company has also launched Zepatier in all 28 European Union (EU) member states.Japan and in other international markets. Sales in the United States in the first six months of 2017 reflect an approximately $40 million favorable adjustment to rebate accruals due to mix of business. The Company continueswill continue to work to supply the EU market, with product launches estimated to begin between the fourth quarter of 2016 and the first quarter of 2017. In the course of the European review forfocus on expanding Zepatier,’s utilization globally, but anticipates that uptake may be affected by the European Medicines Agency (EMA) cited Merck’s third-party manufacturer for issues largely related to inadequate record-keepingongoing decline in overall patient volumes in many markets and the need for improvement in their quality management systems. The Company does not believe that these problems will affect the supply to the U.S. market.by increased competition.
HIV
GlobalCombined global sales of Isentress/Isentress, anHD, HIV integrase inhibitorinhibitors for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, were $372282 million in the thirdsecond quarter of 2016,2017, a decline of 1%17% compared with the thirdsecond quarter of 2015 including2016, and were $587 million in the first six months of 2017, a decline of 13% compared with the first six months of 2016. Foreign exchange unfavorably affected global sales performance by 2% unfavorable effect from foreign exchange.in the second quarter of 2017. The decline reflectsdeclines reflect lower demand and pricing in Europe and lower volumes in the United States and Europe due to competitive pressures, partially offset byas well as lower volumes in Brazil. In May 2017, the FDA approved Isentress HD, a favorable adjustment1200 mg once-daily dose of Isentress, to discount reservesbe administered orally as two 600 mg tablets, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of


inIsentress 400 mg given twice daily. In July 2017, the EC granted marketing authorization of the once-daily dose of Isentress (Isentress 600 mg as it will be known outside the United States. States) in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg. Regulatory reviews are underway for once-daily versions of Isentress in other countries and regions around the world.
Hospital Acute Care
Worldwide sales of IsentressBridion, for the reversal of two types of neuromuscular blocking agents used during surgery, were $163 million in the second quarter of 2017, an increase of 44% compared with the second quarter of 2016. Global sales of Bridion were $1.1 billion for$310 million in the first ninesix months of 2016, a decline2017, an increase of 8%52% compared with the same period of 20152016 including a 3%1% unfavorable effect from foreign exchange. Sales growth in both periods primarily reflects volume growth in the United States.
Global sales of Invanz (ertapenem sodium), for the treatment of certain infections, were $150 million in the second quarter of 2017, growth of 5% compared with the second quarter of 2016, and were $286 million in the first six months of 2017, an increase of 11% compared with the same period of 2016. Sales growth in both periods primarily reflects higher pricing in the United States. The patent that provides U.S. market exclusivity for Invanz will expire in November 2017 and the Company anticipates a significant decline in U.S. Invanzsales decline wasthereafter. U.S. sales of Invanz were $175 million in the first six months of 2017.
Global sales of Cancidas (caspofungin acetate), an anti-fungal product, were $112 million in the second quarter of 2017 and $233 million for the first six months of 2017, declines of 14% and 12%, respectively, compared with the same periods of 2016. Foreign exchange unfavorably affected global sales performance by 1% and 3% for the second quarter and first six months of 2017, respectively. The declines were driven primarily by lower volumes in the United States, as well as lower demand and pricing in Europe due to competitive pressures, partially offset by a favorable adjustment to discount reserves in the United States and higher volumesgeneric competition in certain emergingEuropean markets. The EU compound patent for
Hospital Acute CareCancidas expired in April 2017 and the Company anticipates declines in Cancidas sales in those European markets will continue.
Sales of Cubicin, an I.V. antibiotic for complicated skin and skin structure infections or bacteremia when caused by designated susceptible organisms, were $320$103 million in the thirdsecond quarter of 2017, a decline of 71% compared with the second quarter of 2016, and were $198 million in the first six months of 2017, a decline of 2%69% compared with the third quarter of 2015. The decline was driven primarily by lower salessame period in the United States resulting from the June 2016 expiration of the2016.


The U.S. composition patent for Cubicin. This expired in June 2016. Accordingly, the Company is experiencing a rapid and substantial decline was partially offset byin U.S. Cubicin sales offrom generic competition and expects the decline to continue. The Company anticipates it will lose market exclusivity for Cubicin in certain international markets for whichEurope later in 2017.
In October 2016, Merck announced that the Company acquired marketing rights in the fourth quarter of 2015 (including Europe, Latin America, Australia, New Zealand, China, South Africa and certain other Asia Pacific countries). SalesFDA approved Zinplava Injection 25 mg/mL. Zinplava is indicated to reduce recurrence of CubicinClostridium difficile were $969 millioninfection (CDI) in the first nine monthspatients 18 years of 2016 compared with $805 million in the first nine monthsage or older who are receiving antibacterial drug treatment of 2015.CDI and are at high risk for CDI recurrence. CubicinZinplava was acquired in connection with the purchase of Cubist on January 21, 2015. Accordingly, the increase in sales in the first nine months of 2016 compared with the first nine months of 2015 is largely attributable to nearly one month of additional sales in 2016. Additionally, the sales increase reflects sales of Cubicin in certain international markets for which the Company acquired marketing rights as noted above. As a result of the June 2016 expiration of the U.S. composition patent for Cubicin, the Company anticipates a significant decline in U.S. Cubicin sales. U.S. sales of Cubicin were $824 million in the first nine months of 2016.
Worldwide sales of Noxafil, for the prevention of invasive fungal infections, grew 11% in the third quarter of 2016 to $147 million and increased 21% in the first nine months of 2016 to $434 million compared with the same periods of 2015. Sales growth in both periods was driven primarily by higher pricingbecame available in the United States as well as volume growth in Europe reflecting an ongoing positive impact from the approval of new formulations, and higher demand in emerging markets. Foreign exchange unfavorably affected global sales performance by 3% in both the third quarter and first nine months of 2016.
Global sales ofFebruary 2017. CancidasZinplava (caspofungin acetate), an anti-fungal product, were $142 million in the third quarter of 2016, an increase of 2% compared with the third quarter of 2015 including a 4% unfavorable effect from foreign exchange. Worldwide sales of Cancidas were $406 million for the first nine months of 2016, a decline of 7% compared with the same prior year period, including a 4% unfavorable effect from foreign exchange. The sales decline in the year-to-date period was driven primarily by lower volumes in certain emerging markets, as well as lower pricing in Europe.
Worldwide sales of Bridion, for the reversal of two types of neuromuscular blocking agents used during surgery, were $139 million in the third quarter of 2016, an increase of 56% compared with the third quarter of 2015 including a 7% favorable effect from foreign exchange. Global sales of Bridion were $343 million for the first nine months of 2016, an increase of 31% compared with the same period of 2015 including a 1% favorable effect from foreign exchange. Sales growth in both periods reflects volume growth in most markets, including in the United States where it was approved by the FDAEC in December 2015, partially offset by declinesJanuary 2017 and became available in Venezuela due to reduced operations by the CompanyEU in this country. Sales growth in both periods was benefited by the timing of shipments in Japan.March 2017.
Immunology
Sales of Remicade, a treatment for inflammatory diseases (marketed by the Company in Europe, Russia and Turkey), were $311208 million in the thirdsecond quarter of 20162017 and $999$437 million forin the first ninesix months of 2016,2017, declines of 30%39% and 29%37%, respectively, compared with the same periods of 2015.2016. Foreign exchange unfavorably affected sales performance by 2%3% in both the thirdsecond quarter and first ninesix months of 2016. In February 2015, the2017. The Company lost market exclusivity for Remicade in major European markets in 2015 and no longer has market exclusivity in any of its marketing territories. The Company is experiencing pricing and volume declines in these markets as a result of biosimilar competition and expects the declines to continue.
In July 2017, Merck launched Renflexis (infliximab-abda), a biosimilar of Remicade, in the United States. Renflexis was approved by the FDA in April 2017 for all eligible indications. Renflexis is the first medicine available in the United States under a global biosimilars development and commercialization agreement between Merck and Samsung Bioepis.
Sales of Simponi (golimumab), a once-monthly subcutaneous treatment for certain inflammatory diseases (marketed by the Company in Europe, Russia and Turkey), were $193199 million in the thirdsecond quarter of 2017, essentially flat as compared with the second quarter of 2016, and $581were $383 million forin the first ninesix months of 2016, growth2017, a decline of 8% and 15%, respectively,1% compared with the same periods in 2015.period of 2016. Foreign exchange unfavorably affected global sales performance by 3% and 4% for both the thirdsecond quarter and first ninesix months of 2016. Sales growth2017, respectively. Excluding the unfavorable effect of foreign exchange, sales performance in both periods was driven primarily by higher volumes in Europe reflecting in part an ongoing positive impact from the ulcerative colitis indication.volumes.
Oncology
Global sales of Keytruda, an anti-PD-1 (programmed death receptor-1) therapy, were $356$881 million in the thirdsecond quarter of 2017 compared with $314 million in the second quarter of 2016 and were $1.5 billion in the first six months of 2017 compared with $159$563 million in the third quarter of 2015 and were $919 million for the first ninesix months of 2016 compared with $352 million for the first nine months of 2015.2016. Sales growth in both periods primarily reflects higher saleswas driven by volume growth in Europe,all markets, particularly in the United States, and emerging markets as the Company continues to launch Keytruda with new indications. Sales in the United States continue to build across the multiple approved indications, in particular for the treatment of non-small-cell lung cancer (NSCLC). During the second quarter of 2017, Keytruda received four new indications in the United Sates and an additional indication in Europe.
In October 2016, Merck announced thatMay 2017, the FDA approved Keytruda in combination with pemetrexed and carboplatin, a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression. The National Cancer Care Network also recommended the combination for treatment of patients with non-small-cell lung cancer (NSCLC)metastatic nonsquamous NSCLC. Keytruda is the only anti-PD-1 approved in the first-line setting as both monotherapy and combination therapy for appropriate patients with metastatic NSCLC. In October 2016, Keytruda was approved by the FDA as monotherapy in the first-line setting for patients with metastatic NSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50% or more)≥50%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. With this new indication, Keytruda as monotherapy is


now the only anti-PD-1 therapy to be approved in the first-line treatment setting also indicated for these patients. In addition, the FDA approved a labeling update to include data from KEYNOTE-010 in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1 (TPS of 1% or more)≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. In December 2016, Keytruda was approved in Japan for the treatment of certain patients with PD-L1-positive unresectable advanced/recurrent NSCLC in the first- and second-line treatment settings. Additionally, in January 2017, the EC approved Keytruda for the first-line treatment of metastatic NSCLC in adults whose tumors have high PD-L1 expression (TPS of 50% or more) with no EGFR or ALK positive tumor mutations.
In August 2016, Merck announced that the FDA approved Keytruda for the treatment of patients with recurrent or metastatic head and neck cancersquamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. In July 2017, Merck announced that the pivotal Phase 3 KEYNOTE-040 trial investigating Keytruda in previously treated patients with recurrent or metastatic HNSCC did not meet its pre-specified primary endpoint of overall survival (OS) (HR, 0.82 [95% CI, 0.67-1.01]; p = 0.03 [one-sided]). The safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of Keytruda; no new safety signals were identified. The current indication remains unchanged and clinical trials continue, including KEYNOTE-048, a Phase 3 clinical trial of Keytruda in the first-line treatment of recurrent or metastatic HNSCC.


In March 2017, the FDA approved Keytruda for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) refractory to treatment, or who have relapsed after three or more prior lines of therapy. In May 2017, the EC approved Keytruda for the treatment of adult patients with relapsed or refractory cHL who have failed autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.
In May 2017, the FDA approved Keytruda for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, Keytruda is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. In the second-line setting, Keytruda is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. In July 2017, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of Keytruda for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma. The recommendation will now be reviewed by the EC for marketing authorization in the EU. A final decision is expected in the third quarter of 2017.
Also in May 2017, the FDA approved Keytruda for a first-of-its-kind indication: the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Keytruda is now approved in the United States and in the EU as monotherapy for the treatment of previously untreated metastaticcertain patients with NSCLC, in patients whose tumors express high levels of PD-L1 and previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma and previously treated recurrent or metastatic HNSCC.cHL. Keytruda is also approved in the EUUnited States as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults and for the treatment ofcertain patients with locally advancedHNSCC, urothelial carcinoma, and MSI-H or metastatic NSCLCmismatch repair deficient cancer, and in combination with pemetrexed and carboplatin in certain patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. The Company has launched Keytruda for the treatment of melanoma in more than 50 markets outside of the United States.
The Company plans additional regulatory filings in the United States and other countries.with NSCLC. The Keytruda clinical development program includes studies across a broad range of cancer types (see “Research and Development” below). SeePursuant to the settlement of worldwide patent infringement litigation related to Keytruda (see Note 97 to the condensed consolidated financial statements for a discussionstatements), the Company will pay royalties of patent litigation related to6.5% on net sales of Keytruda. in 2017 through 2023; and 2.5% on net sales of Keytruda in 2024 through 2026.
Global sales of Emend (aprepitant), for the prevention of chemotherapy-induced and post-operative nausea and vomiting, were $137$143 million in the thirdsecond quarter of 2016, a decline of 3%2017, essentially flat compared with the thirdsecond quarter of 20152016 including a 1% unfavorable effect from foreign exchange. Sales performance reflects higher volumes in Japan that were offset by volume declines in the United States. Worldwide sales of Emend were $405$276 million in the first ninesix months of 2016, growth2017, an increase of 2%3% compared with the first nine monthssame period of 2015 including a 3% unfavorable effect from foreign exchange. Sales2016, driven primarily by volume growth in the year-to-date period reflects higher pricing in the United States,Japan, partially offset by volume declines in Japan. In February 2016, Merck announced that the FDA approved a supplemental new drug application for single-dose Emend for injection for the prevention of delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy. With this approval, Emend for injection is the first intravenous single-dose NK1 receptor antagonist approved in the United States for both highly emetogenic chemotherapy as well as moderately emetogenic chemotherapy.and Europe.
Diversified Brands
Merck’s diversified brands include human health pharmaceutical products that are approaching the expiration of their marketing exclusivity or are no longer protected by patents in developed markets, but continue to be a core part of the Company’s offering in other markets around the world.
Respiratory
Worldwide sales of Singulair (montelukast), a once-a-day oral medicine for the chronic treatment of asthma and for the relief of symptoms of allergic rhinitis, were $239$203 million in the thirdsecond quarter of 2016, an increase of 19% compared with the third quarter of 20152017 and were $705$389 million for the first ninesix months of 2016, an increase2017, declines of 7%11% and 16%, respectively, compared with the first nine monthssame periods of 2015. The increase in both periods was driven primarily by higher sales in Japan reflecting the timing of shipments and the favorable effect of foreign exchange.2016. Foreign exchange favorablyunfavorably affected global sales performance by 9%1% in the thirdsecond quarter of 2016 and2017. The sales declines were largely driven by 2%lower volumes in the first nine months of 2016.Japan. The patents that provided market exclusivity for Singulair in Japan expired in February and October of 2016. As a result, the Company anticipatesis experiencing a significant decline in Singulair sales in Japan in future periods. Singulair sales in Japan were $367 million inand expects the first nine months of 2016.decline to continue. The Company no longer has market exclusivity for Singulair in any major market.
Global sales of Nasonex, an inhaled nasal corticosteroid for the treatment of nasal allergy symptoms, declined 23%16% to $94$85 million in the thirdsecond quarter of 20162017 and decreased 32% to $425$224 million in the first ninesix months of 20162017 compared with the same periods of 2015.2016. Foreign exchange favorably affected global sales performance by 2% in the third quarter of 2016 and unfavorably affected global sales performance by 1% in the first ninesix months of 2016.2017. The sales declines were driven primarily by lower volumes in the United States from generic competition. In March 2016, Apotex launched a generic version of Nasonex in the United States pursuant to a June 2012 U.S. District Court for the District of New Jersey ruling (upheld on appeal to the U.S. Court of Appeals for the Federal Circuit) holding that Apotex’s generic version of Nasonex does not infringe on the Company’s formulation patent. Accordingly, the Company is experiencing a substantial decline in U.S. Nasonex sales and expects the decline to continue. The declines in global Nasonex sales in the third quarter and first nine months of 2016 were also driven by lower volumes and pricing in Europe from ongoing generic erosion and lower sales in Venezuela due to reduced operations by the Company in this country.competition.
Other
Global sales of CozaarDulera and its companion agent Hyzaar (aInhalation Aerosol, a combination medicine for the treatment of Cozaar and hydrochlorothiazide), treatments for hypertension,asthma, were $131$69 million in the thirdsecond quarter of 2017, a decline of 43% compared with the second quarter of 2016, and $389were $151 million forin the first ninesix months of 2016, declines2017, a decline of 12% and 26%, respectively,35% compared with the same periodsfirst six months of 2015. Foreign exchange favorably affected global2016. The declines were driven by lower sales performancein the United States reflecting competitive pricing pressures.


Vaccines
by 1%On December 31, 2016, Merck and Sanofi terminated their equally-owned joint venture, SPMSD, which developed and marketed vaccines in the third quarter of 2016 and unfavorably affected global sales performance by 4% in the first nine months of 2016. The sales declines primarily reflect lowerEurope. Accordingly, vaccine sales in emerging markets, particularly in Venezuela due to reduced operations by the Company in this country. Lower volumes in Japan also contributed to the year-to-date decline. The patents that provided market exclusivity for Cozaar and Hyzaar in the United States and in most major international markets have expired. Accordingly, the Company is experiencing declines in Cozaar and Hyzaar sales and expects the declines to continue.
Vaccines
The following discussion of vaccines does not2017 include sales of Merck vaccines sold in most majorthe European markets through Sanofi Pasteur MSD (SPMSD),that were previously part of the Company’sSPMSD joint venture, with Sanofi Pasteur,whereas sales in periods prior to 2017 do not. Prior to 2017, vaccine sales in these European markets were sold through the SPMSD joint venture, the results of which are reflected in equity income from affiliates included in Other (income) expense, net (see “Selected Joint Venture and Affiliate Information” below)Note 11 to the condensed consolidated financial statements). Supply sales to SPMSD, however, are included. In March 2016, Merckincluded in vaccine sales in periods prior to 2017. Incremental vaccine sales resulting from the termination of the SPMSD joint venture in the second quarter and Sanofi Pasteur announced their intentionfirst six months of 2017 were approximately $70 million and $135 million, respectively, of which approximately $40 million and $90 million, respectively, relate to terminate SPMSD and end their joint vaccines operations in Europe (see Note 7 to the condensed consolidated financial statements) Gardasil/Gardasil 9.
Merck’s sales of Gardasil 9/Gardasil/Gardasil, 9, vaccines to help prevent certain cancers and diseases caused by certain types of human papillomavirus (HPV), grew 38%were $469 million in the thirdsecond quarter of 2017, an increase of 19% compared with the second quarter of 2016 to $860 million and increased 16% in the first nine months of 2016 to $1.6 billion compared with the corresponding prior year periods.including a 1% unfavorable effect from foreign exchange. Sales growth in both periods was driven primarily by higher sales in Europe resulting from the termination of the SPMSD joint venture noted above, higher demand in Asia Pacific, and timing in Brazil. U.S. sales of Gardasil/Gardasil 9 were relatively flat in the second quarter of 2017 compared to the second quarter of 2016 as lower volumes from the timing of public sector purchases were offset by higher pricing. Merck’s sales of Gardasil/Gardasil 9 were $1.0 billion in the first six months of 2017, growth of 30% compared with the first six months of 2016. Sales growth was driven primarily by higher sales in Europe resulting from the termination of the SPMSD joint venture, higher sales in the United States, fromlargely reflecting demand and pricing, as well as higher volumes reflecting in part the timing of public sector purchases. Sales growth in the third quarter of 2016 also reflects higher demand in emerging markets, partially driven by government tendersAsia Pacific and timing in Brazil. In October 2016, the FDA approved a 2-dose vaccination regimen for Gardasil 9, for use in girls and boys 9 through 14 years of age, and the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to recommend the 2-dose vaccination regimen for certain 9 through 14 year olds. The Company anticipatesis beginning to experience an impact from the transition from a 3-dose vaccine regimen to a 2-dose vaccination regimen will have an unfavorable effect on sales ofregimen. Gardasil 9 going forward.recently received marketing authorization from the China Food and Drug Administration for use in females aged 20 to 45 to prevent cervical cancers and cervical pre-cancers (cervical intraepithelial neoplasia, or CIN1/2/3, and adenocarcinoma in situ or AIS) caused by HPV types 16 and 18.
Merck’s sales of ProQuad(Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a pediatric combination vaccine to help protect against measles, mumps, rubella and varicella, were $150$130 million in the thirdsecond quarter of 2017 compared with $117 million in the second quarter of 2016 compared with $70 milliondriven by higher volumes and pricing in the third quarterUnited States. Merck’s sales of 2015 andProQuad were $389$233 million in the first ninesix months of 20162017 compared with $292$239 million in the first ninesix months of 20152016. The decline was driven primarily by the effects of public sector purchasing in the United States, as well as higher demand$29 million of sales in 2016 to the U.S. Center for Disease Control and pricing in the United States.Prevention Pediatric Vaccine Stockpile. Merck’s sales of M‑M‑R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help protect against measles, mumps and rubella, were $115$86 million for the thirdsecond quarter of 2017 compared with $78 million for the second quarter of 2016 and were $178 million in the first six months of 2017 compared with $103$154 million for the third quarter of 2015 and were $269 million forin the first ninesix months of 2016 compared with $285 million for the first nine months of 2015.2016. The sales decline in the year-to-date period largely reflects higher demand in the prior year period due to measles outbreaks in the United States, partially offsetincreases were driven primarily by higher pricing.sales in Europe resulting from the termination of the SPMSD joint venture. Merck’s sales of Varivax (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox (varicella), were $232$183 million for the thirdsecond quarter of 2017 compared with $188 million for the second quarter of 2016 compared with $218 million for the third quarter of 2015, primarily reflecting volume growth in certain emerging markets. Merck’s sales of Varivaxand were $578 million for the first nine months of 2016 compared with $519$343 million in the first ninesix months of 2015 primarily driven2017 compared with $346 million in the first six months of 2016. The declines reflect lower sales in Latin America and the United States, partially offset by higher sales in Europe resulting from the United States reflectingtermination of the effects of public sector purchasing and higher pricing that were partially offset by lower demand. Volume growth in certain emerging markets also contributed to the sales increase in the year-to-date period.SPMSD joint venture.
Merck’s sales of RotaTeq (Rotavirus Vaccine, Live Oral, Pentavalent), a vaccine to help protect against rotavirus gastroenteritis in infants and children, were $171123 million in the thirdsecond quarter of 2016, an increase2017, a decline of 7%5% compared with the thirdsecond quarter of 2015, primarily reflecting higher pricing and2016. The decline reflects lower volumes in the United States.States driven primarily by the effects of public sector purchasing, partially offset by higher sales in Europe resulting from the termination of the SPMSD joint venture. Merck’s sales of RotaTeq were $489$347 million in the first ninesix months of 2016, growth2017, an increase of 11%9% compared with the same periodfirst six months of 20152016. The increase was driven primarily by higher sales in Europe resulting from the termination of the SPMSD joint venture, as well as higher volumes and pricing in the United States.
Merck’s sales of Pneumovax 23, a vaccine to help prevent pneumococcal disease, were $166 million in the second quarter of 2017, an increase of 38% compared with the second quarter of 2016. Merck’s sales of Pneumovax 23 were $329 million in the first six months of 2017, an increase of 44% compared with the first six months of 2016 including a 1% unfavorable effect from foreign exchange. The increaseSales growth in both periods was driven primarily driven by the effects of public sector purchasingvolume growth in most regions, particularly in the United States, as well as volume growth in certain emerging markets.States.
Merck’s sales of Zostavax (Zoster Vaccine Live), a vaccine to help prevent shingles (herpes zoster) in adults 50 years of age and older, were $190160 million in the thirdsecond quarter of 2016,2017, an increase of 6%7% compared with the thirdsecond quarter of 2015.2016, and were $313 million in the first six months of 2017, an increase of 14% compared with the first six months of 2016. Sales growth in both periods was driven primarilylargely by volume growth in certain emerging markets and in Canada,the Asia Pacific region, partially offset by lower demand in the United States. Merck’s sales of Zostavax were $464 million for the first nine months of 2016, a decline of 8% compared with the first nine months of 2015 including a 1% unfavorable effect from foreign exchange. The sales decline in the year-to-date period was driven primarily by lower volumes in the United States, partially offset by higher pricing in the United States and higher demand in emerging markets. The Company is continuing to educate U.S. customers on the broad managed care coverage for Zostavax and the process for obtaining reimbursement. Merck is continuing to launch Zostavax outside of the United States.
Merck’s sales of Pneumovax 23, a vaccine to help prevent pneumococcal disease, grew 27% in the third quarter of 2016 to $175 million driven primarily by higher pricing and demand in the United States, as well as by higher sales in Japan due to the timing of shipments. Merck’s sales of Pneumovax 23 increased 14% in the first nine months of 2016 to $403 million compared with the same prior year period primarily reflecting higher pricing in the United States, higher demand in certain emerging markets, as well as higher sales in Japan due to the timing of shipments. Foreign exchange favorably affected global sales performance by 3% and 1% in the third quarter and first nine months of 2016, respectively.


Other Segments
The Company’s other segments are the Animal Health, Healthcare Services and Alliances segments, which are not material for separate reporting.
Animal Health
Animal Health includes pharmaceutical and vaccine products for the prevention, treatment and control of disease in all major farm and companion animal species. Animal Health sales are affected by competition and the frequent introduction of generic products. Global sales of Animal Health products totaled $865$955 million for the thirdsecond quarter of 2016,2017, an increase of 5%6% compared with sales of $900 million in the thirdsecond quarter of 2015 including a 2% unfavorable effect from foreign exchange. Sales2016. Foreign exchange unfavorably affected global sales performance by 1% in the second quarter of 2017. Worldwide sales of Animal Health products were $2.6$1.9 billion in the first ninesix months of 2016,2017, an increase of 4%10%, compared with sales of $1.7 billion for the same periodfirst six months of 2015 including a 5% unfavorable effect from foreign exchange.2016. Sales growth in both periods reflects volume growth across most species areas, particularly in products for companion animals, driven primarily byreflects higher sales of companion animal products, driven by the Bravecto (fluralaner) chewable tablets for dogs to treatline of products that kill fleas and ticks.
In May 2016, the Company received marketing approval from the EMA for Bravecto Spot-On Solution for cats andticks in dogs and in July 2016,cats for up to 12 weeks, and higher sales of ruminant products reflecting the Company received approvalimpact of the Vallée S.A. acquisition. Sales growth in the United States to market the product under the tradename Bravecto Topical (fluralaner topical solution).
In July 2016, Merck announced it had executed an agreement to acquire a controlling interest in Vallée, a leading privately held produceryear-to-date period also reflects higher sales of animal health products in Brazil (see Note 2 to the condensed consolidated financial statements).swine and poultry products.
Costs, Expenses and Other
Materials and Production
Materials and production costs were $3.43.1 billion for the thirdsecond quarter of 2016 and $10.6 billion for the first nine months2017, a decline of 2016, declines of 9% and 5%, respectively,14% compared with the same periodssecond quarter of 2015.2016. Costs in the thirdsecond quarter of 2017 and 2016 and 2015 include $772$779 million and $1.2$1.0 billion, respectively, and for the first ninesix months of 2017 and 2016 and 2015 include $2.9$1.6 billion and $3.6$2.1 billion, respectively, of expenses for the amortization of intangible assets recognizedrecorded in connection with business acquisitions. CostsAdditionally, costs for the second quarter and first ninesix months of 2017 include $47 million and for the second quarter and first six months of 2016 also include $95 million and $347 million, respectively, of intangible asset impairment charges of $347 million related to marketed products (see Note 6 to the condensed consolidated financial statements). The Company may recognize additional non-cash impairment charges in the future onrelated to intangible assets related to marketed products that were measured at fair value and capitalized in connection with business acquisitions and such charges could be material. In addition, expenses forCosts in the first ninesix months of 20152017 also include a $76 million of amortization of purchase accounting adjustmentsintangible asset impairment charge related to Cubist’s inventories.a licensing agreement. Included in materials and production costs are costsexpenses associated with restructuring activities which amounted to $3633 million and $70$66 million in the thirdsecond quarter of 20162017 and 2015,2016, respectively, and $149$96 million and $280$113 million for the first ninesix months of 20162017 and 2015,2016, respectively, including accelerated depreciation and asset write-offs related to the planned sale or closure of manufacturing facilities. Separation costs associated with manufacturing-related headcount reductions have been incurred and are reflected in Restructuring costs as discussed below.
Gross margin was 67.6%69.0% in the thirdsecond quarter of 2017 compared with 63.7% in the second quarter of 2016 and was 68.5% in the first six months of 2017 compared with 62.7% in the third quarter of 2015 and was 64.4% in the first ninesix months of 2016 compared with 62.1% in the first nine months of 2015.2016. The improvementimprovements in gross margin in the third quarter and first nine months of 2016 as compared with the corresponding prior year periods waswere driven primarily by lower amortization of intangible assets, and purchase accounting adjustments to inventories, as well as lower restructuring and intangible asset impairment and restructuring charges as noted in the above, which reduced gross margin by 7.7 and 11.68.6 percentage points in the thirdsecond quarter of 2017 as compared with 12.0 percentage points in the second quarter of 2016 and 9.2 percentage points in the first ninesix months of 2016, respectively,2017 as compared with 12.4 and 13.6 percentage points forin the third quarter and first ninesix months of 2015, respectively.2016. The increase in gross margin improvement in both periods was also attributable toreflects the favorable effects of product mix. In the year-to-date period, foreign exchangemix and lower inventory write-offs also contributed to the gross margin improvement.write-offs.
Marketing and Administrative
Marketing and administrative (M&A) expenses decreased 3%declined 1% to $2.4 billion in the thirdsecond quarter of 20162017 compared with the thirdsecond quarter of 2015. The decline was2016 driven primarily by lower sellingrestructuring costs and promotional spending as a result of the Company’s prioritization of investments in key brands, the favorable effects of foreign exchange, as well as lower restructuring costs, partially offset by higher acquisition and divestiture-related costs. Marketing and administrative costs, including costs associated with the Company operating its vaccines business in the European markets that were previously part of the SPMSD joint venture, as well as higher promotional expenses declined 7%related to $7.2product launches. M&A expenses increased 2% to $4.8 billion in the first ninesix months of 20162017 compared with the same period of 2015.2016. The decline largely reflectsincrease was driven primarily by higher administrative costs and promotional expenses, partially offset by lower acquisitionrestructuring costs and divestiture-related costs, the favorable effects of foreign exchange, lower administrative expenses, such as legal defense costs, as well as lower selling costs. The decline in the year-to-date period was partially offset by higher promotional spending largely related to product launches and higher restructuring costs. Marketing and administrative expenses include acquisition and divestiture-related costs of $36 million and $26 million in the third quarter of 2016 and 2015, respectively, and $56 million and $389 million in the first nine months of 2016 and 2015, respectively, consisting of integration, transaction, and certain other costs related to business acquisitions, including severance costs which are not part of the Company’s formal restructuring programs, as well as transaction


and certain other costs related to divestitures of businesses. Acquisition and divestiture-related costs in the first nine months of 2015 include costs related to the acquisition of Cubist (see Note 2 to the condensed consolidated financial statements.) Marketing and administrativeexchange. M&A expenses for the thirdsecond quarter of 2017 and 2016 and 2015 also include $1$2 million and $17$87 million, respectively, and for the first ninesix months of 2017 and 2016 and 2015 include $91$3 million and $70$90 million, respectively, of restructuring costs, related primarily to accelerated depreciation for facilities to be closed or divested. Separation costs associated with sales force reductions have been incurred and are reflected in Restructuring costs as discussed below.
Research and Development
Research and development (R&D) expenses were $1.7 billion for the thirdsecond quarter of 2016, an increase2017, a decline of 11%19% compared with the thirdsecond quarter of 2015. The increase primarily reflects higher clinical development spending in 2016 combined with a reduction of expenses in the third quarter of 2015 related to changes in the estimated fair value of liabilities for contingent consideration. Research and development expenses were $5.5$3.5 billion for the first ninesix months of 2016, an increase2017, a decrease of 12%7% compared with the same period of 2015, reflecting increased clinical development spending, higher2016. The declines were driven primarily by lower in-process research and development (IPR&D) impairment charges, higherlower licensing and restructuring costs and increased licensing costs, partially offset by the favorable effects of foreign exchange.higher clinical development spending.


Research and developmentR&D expenses are comprised of the costs directly incurred by Merck Research Laboratories (MRL), the Company’s research and development division that focuses on human health-related activities, which were approximately $1.1 billion and $950 million in both the thirdsecond quarter of 2017 and 2016, and 2015, respectively, and $3.2were $2.2 billion and $2.9$2.1 billion for the first ninesix months of 20162017 and 2015,2016, respectively. Also included in research and developmentR&D expenses are costs incurred by other divisions in support of research and developmentR&D activities, including depreciation, production and general and administrative, as well as licensing activity, and certain costs from operating segments, including the Pharmaceutical and Animal Health segments, which in the aggregate were approximately $525$610 million and $600$770 million for the thirdsecond quarter of 20162017 and 2015,2016, respectively, and $1.9were approximately $1.3 billion and $2.0$1.4 billion for the first ninesix months of 2017 and 2016, and 2015, respectively. The decrease was driven in part by higher licensing costs in the prior year periods primarily related to a collaboration with Moderna (see Note 2 to the condensed consolidated financial statements). In addition, research and developmentR&D expenses include IPR&D impairment charges of $225$195 million and $62$220 million for the second quarter and first ninesix months of 2016, and 2015, respectively (see Note 6 to the condensed consolidated financial statements). The Company may recognize additional non-cash impairment charges in the future related to the cancellation or delay of other pipeline programs that were measured at fair value and capitalized in connection with business acquisitions and such charges could be material. Research and development expenses also include expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration recorded in connection with acquisitions. During the first nine months of 2016, the Company recognized charges of $30 million compared with a reduction in expenses of $71 million in the first nine months of 2015 resulting from changes in the estimated fair value of liabilities for contingent consideration. Research and developmentR&D expenses also reflect accelerated depreciation and asset abandonment costs associated with restructuring activities of $14$9 million and $17$64 million in the thirdsecond quarter of 20162017 and 2015,2016, respectively, and $133$9 million and $34$119 million for the first ninesix months of 20162017 and 2015,2016, respectively (see Note 3 to the condensed consolidated financial statements).
Restructuring Costs
The Company incurs substantial costs for restructuring program activities related to Merck’s productivity and cost reduction initiatives, as well as in connection with the integration of certain acquired businesses. In 2010 and 2013, the Company commenced actions under global restructuring programs designed to streamline its cost structure. The actions under these programs include the elimination of positions in sales, administrative and headquarters organizations, as well as the sale or closure of certain manufacturing and research and development sites and the consolidation of office facilities. The Company also continues to reduce its global real estate footprint and improve the efficiency of its manufacturing and supply network. The non-facility related restructuring actions under these programs are substantially complete; the remaining activities primarily relate to ongoing facility rationalizations.
Restructuring costs, primarily representing separation and other related costs associated with these restructuring activities, were $161166 million and $113134 million for the thirdsecond quarter of 20162017 and 2015,2016, respectively, and were $386$317 million and $225 million for both the first ninesix months of 2017 and 2016, and the first nine months of 2015.respectively. Separation costs were incurred associated with actual headcount reductions, as well as estimated expenses under existing severance programs for headcount reductions that were probable and could be reasonably estimated. Merck eliminated approximately 300475 positions and 685585 positions in the thirdsecond quarter of 20162017 and 2015,2016, respectively, and approximately 1,3551,020 and 1,055 positions and 2,635 positions infor the first ninesix months of 20162017 and 2015,2016, respectively, related to these restructuring activities. These position eliminations are comprised of actual headcount reductions, and the elimination of contractors and vacant positions. Also included in restructuring costs are asset abandonment, shut-down and other related costs, as well as employee-related costs such as curtailment, settlement and termination charges associated with pension and other postretirement benefit plans and share-based compensation plan costs. For segment reporting, restructuring costs are unallocated expenses.
Additional costs associated with the Company’s restructuring activities are included in Materials and production, Marketing and administrative and Research and development as discussed aboveabove. The Company recorded aggregate pretax costs of $210 million and $351 million in the second quarter of 2017 and 2016, respectively, and $425 million and $547 million for the first six months of 2017 and 2016, respectively, related to restructuring program activities (see Note 3 to the condensed consolidated


financial statements). The Company recorded aggregate pretax costs of $212 million and $217 million in the third quarter of 2016 and 2015, respectively, and $759 million and $770 million for the first nine months of 2016 and 2015, respectively, related to restructuring program activities. The Company expects to substantially complete the remaining actions under the programs by the end of 2017 and incur approximately $800$300 million of additional pretax costs. The Company anticipates that total costs associated with restructuring program activities in 2016 will be approximately $900 million.
Other (Income) Expense, Net
Other (income) expense, net was $2258 million of expense in the thirdsecond quarter of 2017 compared with $19 million of expense in the second quarter of 2016 compared with $170 million of income in the third quarter of 2015 driven primarily by a $250 million gain recognized in 2015 on the sale of certain migraine clinical development programs (see Note 2 to the condensed consolidated financial statements) and lower equity income in 2016 from certain research investment funds, partially offset by lower foreign exchange losses in 2016 related to Venezuela as discussed below. Other (income) expense, net was $88$117 million of expense in the first ninesix months of 20162017 compared with $624$67 million of expense in the first ninesix months of 2015 driven primarily by lower foreign exchange losses related to Venezuela, as well as a gain2016. For details on the components of $117 million in 2016 related to the settlement of certain patent litigation (seeOther (income) expense, net, see Note 911 to the condensed consolidated financial statements), partially offset by the gain recognized in 2015 related to the sale of certain migraine clinical development programs and lower equity income in 2016 from certain research investment funds.
Since January 2010, Venezuela has been designated hyperinflationary and, as a result, local foreign operations are remeasured in U.S. dollars with the impact recorded in results of operations. In the second quarter of 2015, the Venezuelan government identified multiple exchange rates, which included the CENCOEX rate (6.3 VEF per U.S. dollar at June 30, 2015) and the SIMADI rate (197.30 VEF per U.S. dollar at June 30, 2015). While the Venezuelan government had indicated that essential goods, including food and medicine, would remain at the CENCOEX rate, during the second quarter of 2015, upon evaluation of evolving economic conditions in Venezuela and volatility in the country, combined with a decline in transactions that were being settled at the CENCOEX rate, the Company determined it was unlikely that all outstanding net monetary assets would be settled at the CENCOEX rate. Accordingly, during the second quarter of 2015, the Company recorded a charge of $715 million within Other (income) expense, net to devalue its net monetary assets in Venezuela to an amount that represented the Company’s estimate of the U.S. dollar amount that would ultimately be collected. During the third quarter of 2015, the Company recorded additional exchange losses of $138 million in the aggregate reflecting the ongoing effect of translating transactions and net monetary assets consistent with the second quarter. As a result of the further deterioration of economic conditions in Venezuela and continued declines in transactions which were settled at the CENCOEX rate (subsequently replaced by the DIPRO rate), in the fourth quarter of 2015, the Company began using the SIMADI rate (subsequently replaced with the DICOM rate) to report its Venezuelan operations. At September 30, 2016, the DICOM rate was 658.89 VEF per U.S. dollar.statements.
Segment Profits              
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions)2016 2015 2016 20152017 2016 2017 2016
Pharmaceutical segment profits$6,162
 $5,641
 $16,698
 $16,088
$5,613
 $5,420
 $10,793
 $10,537
Other non-reportable segment profits389
 394
 1,129
 1,208
508
 386
 961
 739
Other(3,664) (3,638) (11,812) (12,711)(3,682) (4,302) (7,312) (8,148)
Income before income taxes$2,887
 $2,397
 $6,015
 $4,585
$2,439
 $1,504
 $4,442
 $3,128


Segment profits are comprised of segment sales less standard costs, certain operating expenses directly incurred by the segment, components of equity income or loss from affiliates and certain depreciation and amortization expenses. For internal management reporting presented to the chief operating decision maker, Merck does not allocate materials and production costs, other than standard costs, the majority of research and development expenses or general and administrative expenses, nor the cost of financing these activities. Separate divisions maintain responsibility for monitoring and managing these costs, including depreciation related to fixed assets utilized by these divisions and, therefore, they are not included in segment profits. Also excluded from the determination of segment profits are acquisition and divestiture-related costs, including the amortization of purchase accounting adjustments, and intangible asset impairment charges and changes in the estimated fair value of liabilities related to contingent consideration, restructuring costs, taxes paid at the joint venture level and a portion of equity income. Additionally, segment profits do not reflect other expenses from corporate and manufacturing cost centers and other miscellaneous income or expense. These unallocated items are reflected in “Other” in the above table. Also included in “Other” are miscellaneous corporate profits (losses), as well as operating profits (losses) related to third-party manufacturing sales.
Pharmaceutical segment profits grew 9%4% in the thirdsecond quarter of 20162017 and increased 4%grew 2% in the first ninesix months of 20162017 compared with the corresponding prior yearsame periods of 2016 primarily reflecting higher sales.sales and the favorable effects of product mix.


Taxes on Income
The effective income tax rates of 24.2%20.0% and 23.6%19.6% for the thirdsecond quarter of 20162017 and 2015,2016, respectively, and 24.7%21.0% and 24.2%25.2% for the first ninesix months of 20162017 and 2015,2016, respectively, reflect the impacts of acquisition and divestiture-related costs and restructuring costs, partially offset by the beneficial impact of foreign earnings. The effective income tax raterates for the second quarter and first ninesix months of 2017 also include a benefit of $88 million related to the settlement of a state income tax issue. The effective income tax rates for the second quarter and first six months of 2016 also reflectsreflect the beneficial impact of orphan drug federal income tax credits, primarily for Keytruda. The effective income tax rate for the first nine months of 2015 reflects the favorable impact of a net benefit of $370 million related to the settlement of certain federal income tax issues. In addition, the effective income tax rate for the first nine months of 2015 reflects the unfavorable effects of non-tax deductible foreign exchange losses related to Venezuela (see Note 13 to the condensed consolidated financial statements) and a $75 million out-of-period discrete adjustment, recorded in the second quarter related to deferred taxes associated with prior year restructuring activities. Management considered the discrete adjustment to be immaterial to current and prior period financial statements as reported.quarter.
The Company is under examination by numerous tax authorities in various jurisdictions globally. The ultimate finalization of the Company’s examinations with relevant taxing authorities can include formal administrative and legal proceedings, which could have a significant impact on the timing of the reversal of unrecognized tax benefits. The Company believes that its reserves for uncertain tax positions are adequate to cover existing risks or exposures. However, there is one item that is currently under discussion with the Internal Revenue Service relating to the 2006 through 2008 examination. The Company has concluded that its position should be sustained upon audit. However, if this item were to result in an unfavorable outcome or settlement, it could have a material adverse impact on the Company’s financial position, liquidity and results of operations.
Net Income and Earnings per Common Share
Net income attributable to Merck & Co., Inc. was $2.21.9 billion for the thirdsecond quarter of 20162017 compared with $1.81.2 billion for the thirdsecond quarter of 20152016 and was $4.5 billion for the first nine months of 2016 compared with $3.5 billion for the first ninesix months of 2015.2017 compared with $2.3 billion for the first six months of 2016. Earnings per common share assuming dilution attributable to Merck & Co., Inc. common shareholders (EPS) for the thirdsecond quarter of 20162017 were $0.780.71 compared with $0.640.43 in the thirdsecond quarter of 20152016 and were $1.62$1.27 in the first six months of 2017 compared with $0.83 for the first ninesix months of 2016 compared with $1.22 for the first nine months of 2015.2016.
Non-GAAP Income and Non-GAAP EPS
Non-GAAP income and non-GAAP EPS are alternative views of the Company’s performance that Merck is providing because management believes this information enhances investors’ understanding of the Company’s results andas it permits investors to understand how management assesses performance. Non-GAAP income and non-GAAP EPS exclude certain items because of the nature of these items and the impact that they have on the analysis of underlying business performance and trends. The excluded items (which should not be considered non-recurring) consist of acquisition and divestiture-related costs, restructuring costs and certain other items. These excluded items are significant components in understanding and assessing financial performance. Non-GAAP income and non-GAAP EPS are important internal measures for the Company. Senior management receives a monthly analysis of operating results that includes non-GAAP EPS. Management uses these measures internally for planning and forecasting purposes and to measure the performance of the Company along with other metrics. Senior management’s annual compensation is derived in part using non-GAAP income and non-GAAP EPS. Since non-GAAP income and non-GAAP EPS are not measures determined in accordance with GAAP, they have no standardized meaning prescribed by GAAP and, therefore, may not be comparable to the calculation of similar measures of other companies. The information on non-GAAP income and non-GAAP EPS should be considered in addition to, but not as a substitute for or superior to, net income and EPS prepared in accordance with generally accepted accounting principles in the United States (GAAP).



A reconciliation between GAAP financial measures and non-GAAP financial measures is as follows:
Three Months Ended 
 September 30,
 Nine Months Ended 
 September 30,
Three Months Ended 
 June 30,
 Six Months Ended 
 June 30,
($ in millions except per share amounts)2016 2015 2016 20152017 2016 2017 2016
Pretax income as reported under GAAP$2,887
 $2,397
 $6,015
 $4,585
$2,439
 $1,504
 $4,442
 $3,128
Increase (decrease) for excluded items:              
Acquisition and divestiture-related costs834
 1,146
 3,602
 4,134
882
 1,345
 1,765
 2,768
Restructuring costs212
 217
 759
 770
210
 351
 425
 547
Other items:       
Gain on the sale of certain migraine clinical development programs
 (250) 
 (250)
Foreign currency devaluation related to Venezuela
 
 
 715
Other(6) (33) (6) (47)
 
 (9) 
3,927
 3,477
 10,370
 9,907
3,531
 3,200
 6,623
 6,443
Taxes on income as reported under GAAP699
 566
 1,487
 1,108
488
 295
 935
 789
Estimated tax benefit on excluded items (1)
235
 186
 801
 831
172
 314
 375
 566
Net tax benefit from settlement of certain federal income tax issues
 
 
 370
Benefit related to settlement of state income tax issue88
 
 88
 
934
 752
 2,288
 2,309
748

609

1,398

1,355
Non-GAAP net income2,993
 2,725
 8,082
 7,598
2,783
 2,591
 5,225
 5,088
Less: Net income attributable to noncontrolling interests4
 5
 13
 12
5
 4
 11
 9
Non-GAAP net income attributable to Merck & Co., Inc.$2,989
 $2,720
 $8,069
 $7,586
$2,778
 $2,587
 $5,214
 $5,079
EPS assuming dilution as reported under GAAP$0.78
 $0.64
 $1.62
 $1.22
$0.71
 $0.43
 $1.27
 $0.83
EPS difference (2)
0.29
 0.32
 1.27
 1.44
0.30
 0.50
 0.62
 0.99
Non-GAAP EPS assuming dilution$1.07
 $0.96
 $2.89
 $2.66
$1.01
 $0.93
 $1.89
 $1.82
(1) 
The estimated tax impact on the excluded items is determined by applying the statutory rate of the originating territory of the non-GAAP adjustments.
(2) 
Represents the difference between calculated GAAP EPS and calculated non-GAAP EPS, which may be different than the amount calculated by dividing the impact of the excluded items by the weighted-average shares for the applicable period.
Acquisition and Divestiture-Related Costs
Non-GAAP income and non-GAAP EPS exclude the impact of certain amounts recorded in connection with business acquisitions and divestitures. These amounts include the amortization of intangible assets and amortization of purchase accounting adjustments to inventories, as well as intangible asset impairment charges and expense or income related to changes in the estimated fair value measurement of contingent consideration. Also excluded are integration, transaction, and certain other costs associated with business acquisitions including severance costs which are not part of the Company’s formal restructuring programs, as well as transaction and certain other costs associated with divestitures of businesses.divestitures.
Restructuring Costs
Non-GAAP income and non-GAAP EPS exclude costs related to restructuring actions (see Note 3 to the condensed consolidated financial statements). These amounts include employee separation costs and accelerated depreciation associated with facilities to be closed or divested. Accelerated depreciation costs represent the difference between the depreciation expense to be recognized over the revised useful life of the asset, based upon the anticipated date the site will be closed or divested or the equipment disposed of, and depreciation expense as determined utilizing the useful life prior to the restructuring actions. Restructuring costs also include asset abandonment, shut-down and other related costs, as well as employee-related costs such as curtailment, settlement and termination charges associated with pension and other postretirement benefit plans and share-based compensation costs.
Certain Other Items
Non-GAAP income and non-GAAP EPS exclude certain other items. These items are adjusted for after evaluating them on an individual basis, considering their quantitative and qualitative aspects, and typically consist of items that are difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Excluded from non-GAAP income and non-GAAP EPS in 20152017 is a gain on the sale of certain migraine clinical development programs (see Note 2 to the condensed consolidated financial statements), foreign exchange losses related to the devaluation of the Company’s net monetary assets in Venezuela (see Note 13 to the condensed consolidated financial statements), as well as a net tax benefit related to the settlement of certain federala state income tax issuesissue (see Note 1412 to the condensed consolidated financial statements).



Research and Development Update
Keytruda is an FDA-approved anti-PD-1 therapy in clinical development for expanded indications in different cancer types. Keytruda is currently approved as monotherapy for the treatment of certain patients with NSCLC, melanoma, cHL, HNSCC, urothelial carcinoma, and MSI-H or mismatch repair deficient cancer, and in combination with pemetrexed and carboplatin in certain patients with NSCLC (see “Pharmaceutical Segment” above).
In October 2016, Merck announced thatMay 2017, the FDA approvedaccepted for review a supplemental Biologics License Application (sBLA) for Keytruda seeking approval for the treatment of patients with recurrent or locally advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. The FDA granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of September 22, 2017.


In July 2017, the CHMP of the EMA adopted a positive opinion recommending the approval of Keytruda for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, Keytruda is recommended for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who are not eligible for cisplatin-containing chemotherapy. The recommendation will now be reviewed by the EC for marketing authorization in the EU. A final decision is expected in the third quarter of 2017. Keytruda is also under review in the EU in combination with pemetrexed and carboplatin for the first-line treatment of patients with NSCLC whose tumors have high PD-L1 expression (TPS of 50%metastatic or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. With this new indication, Keytruda is now the only anti-PD-1 therapy to be approved in the first-line treatment setting for these patients. In addition, the FDA approved a labeling update to include data from KEYNOTE-010 in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1 (TPS of 1% or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda. Also in October 2016, Merck announced results from KEYNOTE-021, Cohort G, which included patients with metastaticadvanced non-squamous NSCLC regardless of PD-L1 expression level, which showed thatexpression.
Additionally, Keytruda plus chemotherapy (carboplatin plus pemetrexed) achieved a 55% objective response rate compared to 29% for chemotherapy alone, the standard of care, and reduced the risk of disease progression or death by 47%. To date, Keytruda is the only anti-PD-1 therapy to demonstrate superior efficacy in combination with chemotherapy compared to chemotherapy alone in patients receiving first-line treatment.
Additionally, in October 2016, Merck announced that the Phase 3 KEYNOTE-045 trial investigating the use of Keytruda in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival. In this trial, Keytruda was superior compared to investigator choice chemotherapy. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) recommended that the trial be stopped early.
In April 2016, Merck announced that the FDA grantedhas received Breakthrough Therapy designation to Keytrudafrom the FDA for the treatment of patients with primary mediastinal B-cell lymphoma that is refractory to or has relapsed after two prior lines of therapy. Keytruda has also recently received Breakthrough Therapy designation in combination with axitnib as a first-line treatment for patients with advanced or refractory classical Hodgkin lymphoma (cHL).metastatic renal cell carcinoma; for the treatment of high-risk early-stage triple-negative breast cancer in combination with new adjuvant chemotherapy; and for the treatment of Merkel cell carcinoma. The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Breakthrough Therapy designation in cHL is based
In July 2017, Merck announced that the FDA has placed a full clinical hold on data from the ongoing Phase 1b KEYNOTE-013KEYNOTE-183 and Phase 2 KEYNOTE-087KEYNOTE-185 and a partial clinical hold on Cohort 1 of KEYNOTE-023, three combination studies evaluating single agentof Keytruda with lenalidomide or pomalidomide versus lenalidomide or pomalidomide alone in the blood cancer multiple myeloma. This decision follows a review of data by the Data Monitoring Committee in which more deaths were observed in the Keytruda arms of KEYNOTE-183 and KEYNOTE-185 and which led to the pause in new patient enrollment, as announced on June 12, 2017. The FDA has determined that the data available at the present time indicate that the risks of Keytruda plus pomalidomide or lenalidomide outweigh any potential benefit for patients with cHL.multiple myeloma. All patients enrolled in KEYNOTE-183 and KEYNOTE-185 and those in the Keytruda /lenalidomide/dexamethasone cohort in KEYNOTE-023 will discontinue investigational treatment with Keytruda. This clinical hold does not apply to other studies with Keytruda.
The Keytruda clinical development program includes patients withconsists of more than 30 tumor types in more than 360550 clinical trials, including more than 200300 trials that combine Keytruda with other cancer treatments. Registration-enabling trials of Keytruda are currently enrolling patients in melanoma, NSCLC,These studies encompass more than 30 cancer types including: bladder, colorectal, esophageal, gastric, head and neck, cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, ovarian cancer, hepatocellular, carcinoma, Hodgkin lymphoma, non-Hodgkin lymphoma, multiple myeloma,melanoma, nasopharyngeal, cancer,NSCLC, ovarian, prostate, cancer, renal, small-cell lung cancer and other tumors, with furthertriple-negative breast, many of which are currently in Phase 3 clinical development. Further trials in planningare being planned for other cancers.
In October 2016,June 2017, Merck in partnership with Pfizer Inc. (Pfizer) announced that two Phase 3 studies (VERTIS MET and VERTIS SITA) of ertugliflozin, an investigational oral SGLT-2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes, met their primary endpoints. In the studies, both doses of ertugliflozin tested (5 mg and 15 mg daily) achieved statistically significant reductions in A1C, a measure of average blood glucose over a two- to three-month timeframe, when added to metformin or in initial co-administration with sitagliptin. The results of these studies, along with 52-week extension data from three other studies in the VERTIS clinical development program of ertugliflozin, were presented at the 77th Scientific Sessions of the American Diabetes Association. Marketing applications for ertugliflozin and for two fixed-dose combination products (ertugliflozin and Januvia, ertugliflozin and metformin) are under review with the FDA approved Zinplava (bezlotoxumab) Injection 25 mg/mL. Zinplavaand the EMA. The PDUFA action date from the FDA is indicatedin December 2017 for the three New Drug Applications. Under the terms of the collaboration agreement with Pfizer, Merck made a $90 million milestone payment to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older who are receiving antibacterial drug treatment of CDI and are at high risk for CDI recurrence. Merck anticipates making Zinplava availablePfizer in the first quartersix months of 2017. Bezlotoxumab is also under review2017 recorded in Research and development expenses.
In 2017, Merck filed regulatory applications for the approval of MK-8228, letermovir, in the United States and EU.
Also Letermovir is an investigational oral or an intravenous infusion once-daily antiviral candidate for the prevention of clinically-significant cytomegalovirus (CMV) infection and disease. Letermovir has received Orphan Drug Status and Breakthrough Therapy designation in the United States and in the EU it has received accelerated assessment. In October 2016, Merck announced that the pivotal Phase 3 clinical study of letermovir an investigational antiviral medicine, met its primary endpoint. The global, multicenter, randomized, placebo-controlled study evaluated the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.
In July 2017, Merck will submitannounced the presentation of results from the DRIVE-AHEAD study, for presentation at a future scientific conference.
In September 2016, Merck in partnership with Pfizer Inc. (Pfizer) announced that athe second of two pivotal Phase 3 study (VERTIS SITA2)clinical trials evaluating the efficacy and safety of ertugliflozin, andoravirine, the Company’s investigational, oral SGLT2non-nucleoside reverse transcriptase inhibitor, for the treatment of patients with type 2 diabetes,HIV-1 infection. At 48 weeks, the study showed that a once-daily single tablet, fixed-dose combination of doravirine (DOR), lamivudine (3TC), and tenofovir disoproxil fumarate (TDF) met its primary endpoint. Both 5 mgefficacy endpoint of non-inferiority based on the proportion of participants achieving levels of HIV-1 RNA less than 50 copies/mL at 48 weeks of treatment, compared to a fixed-dose combination of efavirenz (EFV), emtricitabine (FTC), and 15 mg daily dosesTDF, in treatment-naïve adults infected with HIV-1. The study also met its primary safety endpoint, showing that treatment with DOR/3TC/TDF resulted in fewer patients reporting events of ertugliflozin showed significantly greater reductionsseveral pre-specified neuropsychiatric adverse events compared to EFV/FTC/TDF by week 48. Based on these findings, the Company plans to file regulatory applications in A1C (an average measurethe fourth quarter of blood glucose over the past two to three months) when added to patients on a background of sitagliptin and metformin. Merck and Pfizer plan to submit New Drug Applications to the FDA for ertugliflozin and two fixed-dose combinations (ertugliflozin plus Januvia [sitagliptin] and ertugliflozin plus metformin) by the end of 2016, with additional regulatory submissions outside of the United States to follow in 2017. Under the terms of the collaboration agreement with Pfizer, Merck will make a $90 million milestone payment to Pfizer once the filing is accepted by the FDA.
In August 2016, Merck announced that the FDA has accepted for review the New Drug Application for MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed in collaboration with and partially funded by Samsung Bioepis. Separately, the marketing authorization application for MK-1293, which Merck submitted to the EMA in December 2015, is also under review.
In July 2016, Merck announced two regulatory milestones for V920, an investigational rVSV-ZEBOV (Ebola) vaccine: the FDA has granted the vaccine candidate Breakthrough Therapy designation, and the EMA has granted PRIME (PRIority MEdicines) status. In November 2014, Merck and NewLink Genetics announced an exclusive licensing and collaboration agreement for the investigational Ebola vaccine.


Also in July 2016,In June 2017, Merck acquired Afferent, a privately held pharmaceutical company focused onannounced that the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions (see Note 2 to the condensed consolidated financial statements). Afferent’s lead investigational candidate, MK-7264 (formerly AF-219), is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF) with cough.
MK-0859, anacetrapib, is an investigational inhibitor of the cholesteryl ester transfer protein (CETP) in development for raising HDL-C and reducing LDL-C. Anacetrapib is being evaluated in a 30,000 patient, event-driven cardiovascular clinical outcomes trial sponsored by Oxford University, REVEAL (Randomized EValuation of the Effects of Anacetrapib Through Lipid-modification), involvingthrough Lipid modification) outcomes study of anacetrapib, Merck’s investigational cholesteryl ester transfer protein (CETP) inhibitor, met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with preexisting vascular disease. In November 2015,that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported. Merck announced thatplans to review the DMCresults of the trial with external experts, and will consider whether to file new drug applications with the FDA and other regulatory agencies. The results of the REVEAL outcomes study completed its planned reviewwill be presented at the European Society of unblinded study data and recommended the study continue with no changes. The DMC reviewed safety and efficacy data from the study, which included an assessment of futility. Merck remains blinded to the actual results of this analysis and to other REVEAL safety and efficacy data. Under the study, the last patient, last visit is expected to occurCardiology meeting in JanuaryAugust 2017. The Company anticipates receivingREVEAL study is a randomized, double-blind placebo-controlled clinical trial to assess the top-line results from the study mid-year 2017.
In September 2016, Merck announced that it is discontinuing the developmentefficacy and safety of odanacatib, an investigational cathepsin K inhibitoradding anacetrapib to effective LDL-lowering treatment with atorvastatin for osteoporosis, and will not seek regulatory approval for its use. Merck previously reported a numeric imbalance in adjudicated stroke events in the pivotal Phase 3 fracture outcomes study in postmenopausal women. The Company has decided to discontinue development after an independent adjudication and analysismedian duration of major adverse cardiovascular events confirmed an increasedat least 4 years among approximately 30,000 patients at high risk of stroke.
During the second quarter of 2016, the Company determined that, for business reasons, it would terminate the North America partnership agreement with ALK that included MK-8237, an investigational allergy immunotherapy tablet for house dust mite allergy. Merck has given ALK six months’ notice that it is terminating the agreement and therefore this compound will be returned to ALK. This decision was not due to efficacy or safety concerns. In connection with the decision, the Company recorded an IPR&D impairment charge (see Note 6 to the condensed consolidated financial statements).
During the second quarter of 2016, the Company decided, for business reasons, to discontinue the clinical development of MK-8342B, referred to as the Next Generation Ring, an investigational combination (etonogestrel and 17ß-estradiol) vaginal ring for contraception and the treatment of dysmenorrhea in women seeking contraception. This decision was not due to safety or efficacy concerns. As a result of this decision, the Company recorded an IPR&D impairment charge (see Note 6 to the condensed consolidated financial statements).
Also, in April 2016, Merck announced that, for business reasons, it will not proceed with submitting marketing applications for omarigliptin, an investigational, once-weekly DPP-4 inhibitor, in the United States or Europe. This decision did not result from concerns about the efficacy or safety of omarigliptin. Merck remains committed to omarigliptin in Japan, where it is approved and marketed as Marizev.cardiovascular events.
The chart below reflects the Company’s research pipeline as of NovemberAugust 1, 2016.2017. Candidates shown in Phase 3 include specific products and the date such candidate entered into Phase 3 development. Candidates shown in Phase 2 include the most advanced compound with a specific mechanism or, if listed compounds have the same mechanism, they are each currently intended for commercialization in a given therapeutic area. Small molecules and biologics are given MK-number designations and vaccine candidates are given V-number designations. Except as otherwise noted, candidates in Phase 1, additional indications in the same therapeutic area (other than with respect to Keytruda) and additional claims, line extensions or formulations for in-line products are not shown.



Phase 2Phase 3 (Phase 3 entry date)Under Review
Asthma
MK-1029
Cancer
MK-3475 Keytruda
Advanced Solid Tumors
Nasopharyngeal
Ovarian
PMBCL (Primary Mediastinal Large B-Cell Lymphoma)
Nasopharyngeal
Ovarian
Prostate
MK-2206
MK-8628
Cough, including cough with IPFIdiopathic Pulmonary Fibrosis
MK-7264
Diabetes Mellitus
MK-8521
Hepatitis C
MK-3682B (MK-3682/MK-5172(MK-5172 (grazoprevir)/MK-8408 (ruzasvir)/MK-3682 (uprifosbuvir))
MK-3682C (MK-8408 (ruzasvir)/MK-3682 (uprifosbuvir))
Pneumoconjugate Vaccine
V114
Schizophrenia
MK-8189
Alzheimer’s Disease
MK-8931 (verubecestat) (December 2013)
Atherosclerosis
MK-0859 (anacetrapib) (May 2008)
Bacterial Infection
MK-7655A (relebactam+imipenem/cilastatin)
 (October 2015)
Cancer
MK-3475 Keytruda 
Bladder (October 2014)
Breast (October 2015)
Colorectal (November 2015)
Esophageal (December 2015)
Gastric (May 2015) (EU)
Head and Neck (November 2014) (EU)
Hepatocellular (May 2016)
Hodgkin Lymphoma (July 2016)
Multiple Myeloma (December 2015)
Renal (October 2016)
CMV Prophylaxis in Transplant Patients
MK-8228 (letermovir) (June 2014)
Diabetes Mellitus
MK-8835 (ertugliflozin) (November 2013)(1)
MK-8835A (ertugliflozin+sitagliptin)
 (September 2015)(1)
MK-8835B (ertugliflozin+metformin)
  (August 2015)(1)
MK-0431J (sitagliptin+ipragliflozin) (October 2015) (Japan)(1)Small-Cell Lung (May 2017)
Ebola Vaccine
V920 (March 2015)
Heart Failure
MK-1242 (vericiguat) (September 2016)(1)
Herpes Zoster
V212 (inactivated VZV vaccine) (December 2010)
HIV
MK-1439 (doravirine) (December 2014)
MK-1439A (doravirine/lamivudine/tenofovir disoproxil fumarate) (June 2015)
New Molecular Entities/Vaccines
AllergyCMV Prophylaxis in Transplant Patients
MK-8237, House Dust MiteMK-8228 (letermovir) (U.S.)(2)
Clostridium difficileInfection
MK-6072 Zinplava (EU)/EU)
Diabetes Mellitus
MK-1293MK-0431J (sitagliptin+ipragliflozin) (Japan)(1)
MK-8835 (ertugliflozin) (U.S./EU)(1)
MK-8835A (ertugliflozin+sitagliptin) (U.S./EU)(1)
MK-8835B (ertugliflozin+metformin) (U.S./EU)(1)
Pediatric Hexavalent Combination Vaccine
V419 (U.S.)(3)(2)


Certain Supplemental Filings
Cancer
Keytruda
1st Line Non-Small-Cell Lung Cancer• Combination with carboplatin and pemetrexed in first line non-squamous non-small-cell lung (EU)
• First line cisplatin-ineligible bladder (EU)
• Second line metastatic bladder (EU)
• Third line gastric (U.S.)




Footnotes:
(1)  Being developed in a collaboration.
(2)  MK-8237 was being developed as part of a North America partnership with ALK. Merck has given ALK six months’ noticeV419 is an investigational pediatric hexavalent combination vaccine, DTaP5-IPV-Hib-HepB, that it is terminating the agreement and therefore this compound will be returned to ALK.
(3)  V419 is being developed and, if approved, will be commercialized through a partnership of Merck and Sanofi Pasteur. OnSanofi. In November 2, 2015, the FDA issued a Complete Response Letter (CRL)CRL with respect to V419. Both companies are reviewing the CRL and plan to have further communication with the FDA.

Selected Joint Venture and Affiliate Information
Sanofi Pasteur MSD
In 1994,On December 31, 2016, Merck and Pasteur Mérieux Connaught (now Sanofi Pasteur S.A.) established anterminated their equally-owned joint venture, to marketSPMSD, which developed and marketed vaccines in Europe and to collaborate in the development of combination vaccines for distribution in Europe. Total vaccine sales reported by SPMSD were $351$202 million and $318$383 million in the thirdsecond quarter of 2016 and 2015, respectively, and were $725 million and $655 million for the first ninesix months of 2016, respectively, which included $60 million and 2015, respectively. SPMSD$101 million, respectively, of sales of Gardasil/Gardasil 9were $61 million and $46 million for the third quarter of 2016 and 2015, respectively, and were $161 million and $126 million for the first nine months of 2016 and 2015, respectively.9. The Company recordsrecorded the results from its interest in SPMSD and other equity method affiliates in Other (income) expense, net.
In March 2016, Merck and Sanofi Pasteur announced their intention to terminate SPMSD and end their joint vaccines operations in Europe. Sanofi Pasteur and Merck expect the project to be completed by the end of 2016, subject to local labor laws and regulations and regulatory approvals. Upon concluding the joint venture, Merck plans to integrate its European vaccine business into its operations, manage its product portfolio and pursue its growth strategy in Europe.
AstraZeneca LP
In 1998, Merck and Astra completed the restructuring of the ownership and operations of their existing joint venture whereby Merck acquired Astra’s interest in KBI Inc. (KBI) and contributed KBI’s operating assets to a new U.S. limited partnership, Astra Pharmaceuticals L.P. (the Partnership). Astra contributed the net assets of its wholly owned subsidiary, Astra USA, Inc., to the Partnership. The Partnership, renamed AstraZeneca LP (AZLP) upon Astra’s 1999 merger with Zeneca Group Plc, became the exclusive distributor of the products for which KBI retained rights. In connection with AstraZeneca’s 2014 exercise of its option to purchase Merck’s interest in KBI, the Company deferred $327 million of the exercise price, which reflected an estimate of the fair value of Merck’s interest in Nexium and Prilosec. This amount, which is subject to a true-up in 2018 based on actual sales from closing in 2014 to June 2018, was deferred and recognized over time in Other (income) expense, net as the contingency was eliminated as sales occurred. The deferred income amount has been fully amortized based on the sales performance of Nexium and Prilosec subsequent(see Note 11 to the 2014 option exercise. Beginning in the first quarter of 2016, the Company is recognizing income and a corresponding receivable for amounts that will be due to Merck from AstraZeneca based on the sales performance of Nexium and Prilosec subject to the true-up in June 2018. The Company recognized $76 million of such income in the first nine months of 2016.condensed consolidated financial statements).


Liquidity and Capital Resources
($ in millions)September 30, 2016 December 31, 2015June 30, 2017 December 31, 2016
Cash and investments$24,724
 $26,466
$24,105
 $25,757
Working capital13,885
 10,550
9,409
 13,410
Total debt to total liabilities and equity25.6% 26.0%26.8% 26.0%
Cash provided by operating activities was $6.73.6 billion in the first ninesix months of 20162017 compared with $8.3$3.8 billion in the first ninesix months of 2015.2016. Cash provided by operating activities in the first six months of 2017 reflects a $625 million payment made by the Company related to the settlement of worldwide Keytruda patent litigation (see Note 7 to the condensed consolidated financial statements). Cash provided by operating activities in the first six months of 2016 includes a net payment of approximately $680 million to fund the Vioxx shareholder class action litigation settlement not covered by insurance proceeds. Cash provided by operating activities continues to be the Company’s primary source of funds to finance operating needs, capital expenditures, a portion of treasury stock purchases and dividends paid to shareholders. Cash provided by operating activities in the first nine months of 2016 reflects a net payment of approximately $680 million to fund the Vioxx shareholder class action litigation settlement not covered by insurance proceeds (see Note 9 to the condensed consolidated financial statements).
Cash used inprovided by investing activities was $6472.1 billion in the first six months of 2017 compared with $243 million in the first ninesix months of 2016 compared with $4.1 billion2016. The increase in the first nine months of 2015. The lower use of cash provided by investing activities in 20162017 was driven primarily by cash used in 2015 for the acquisition of Cubist, as well as lower purchases of securities and other investments in 2016, partially offset by lowerhigher proceeds from the sales of securities and other investments in 2016, theand lower purchases of securities and other investments, partially offset by a higher use of cash in 2016 for theto fund acquisitions Afferent and StayWell, as well as increasedhigher capital expenditures.
Cash used in financing activities was $7.14.8 billion in the first ninesix months of 20162017 compared with $3.06.2 billion in the first ninesix months of 20152016. The decrease in cash used in financing activities was driven primarily by lower proceeds from the issuance of debt, partially offset by an increase in short-term borrowings, lower payments on debt lower purchases of treasury stock and higher proceeds from the exercise of stock options.options, partially offset by higher purchases of treasury stock and dividends paid to shareholders.
At SeptemberJune 30, 20162017, the total of worldwide cash and investments was $24.724.1 billion, including $13.112.0 billion of cash, cash equivalents and short-term investments and $11.712.1 billion of long-term investments. Generally 80%-90% of cash and investments are held by foreign subsidiaries that would be subject to significant tax payments if such cash and investments were repatriated in the form of dividends. The Company records U.S. deferred tax liabilities for certain unremitted earnings, but when amounts earned overseas are expected to be indefinitely reinvested outside of the United States, no accrual for U.S. taxes is provided. The amount of cash and investments held by U.S. and foreign subsidiaries fluctuates due to a variety of factors including the timing and receipt of payments in the normal course of business. Cash provided by operating activities in the United States continues to be the Company’s primary source of funds to finance domestic operating needs, capital expenditures, a portion of treasury stock purchases and dividends paid to shareholders. The decline in working capital from December 31, 2016 to June 30, 2017 primarily reflects the reclassification of $3.0 billion of notes due in the first half of 2018 from long-term debt to short-term debt.
Capital expenditures totaled $1.1 billion732 million and $790654 million for the first ninesix months of 20162017 and 2015,2016, respectively.
Dividends paid to stockholders were $3.92.6 billion for both the first ninesix months of 20162017 and 2015.2016. In May 2016,2017, the Board of Directors declared a quarterly dividend on the Company’s common stock for the third quarter of $0.46$0.47 per share on the Company’s common stock that was paid in July 2016.2017. In July 2016,2017, the Board of Directors declared a quarterly dividend on the Company’s common stock for the fourth quarter of $0.46$0.47 per share on the Company’s common stock that was paidis payable in October 2016.2017.
In March 2015, Merck’s board of directors authorized additional purchases of up to $10 billion of Merck’s common stock for its treasury. The treasury stock purchase has no time limit and will be made over time in open-market transactions, block transactions on or off an exchange, or in privately negotiated transactions. During the first ninesix months of 2016,2017, the Company purchased $2.4$2.2 billion (44(34 million shares) for its treasury. As of SeptemberJune 30, 2016,2017, the Company’s remaining share repurchase authorization was $6.1$2.9 billion.
In November 2016, the Company issued €1.0 billion principal amountFebruary 2017, $300 million of senior unsecuredfloating rate notes consisting of €500 million principal amount of 0.50% notes due 2024matured in accordance with their terms and €500 million principal amount of 1.375% notes due 2036. The Company intends to use the net proceeds of the offering of $1.1 billion for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities.
were repaid. In January 2016, $850 million of 2.2% notes matured in accordance with their terms and were repaid. In May 2016, $1.0 billion of 0.70% notes and $500 million of floating rate notes matured in accordance with their terms and were repaid.
In February 2015, Merck issued $8.0 billion aggregate principal amount of senior unsecured notes. The Company usedhas a portion of the net proceeds of the offering of $7.9 billion to repay commercial paper issued to substantially finance the Company’s acquisition of Cubist. The remaining net proceeds were used for general corporate purposes, including for repurchases of the Company’s common stock, and the repayment of outstanding commercial paper borrowings and debt maturities.
Also in February 2015, the Company redeemed $1.9 billion of legacy Cubist debt acquired in the acquisition (see Note 2 to the condensed consolidated financial statements).


In June 2016, the Company terminated its existing credit facility and entered into a new $6.0 billion, five-year credit facility that matures in June 2021.2022. The facility provides backup liquidity for the Company’s commercial paper borrowing facility and is to be used for general corporate purposes. The Company has not drawn funding from this facility.



Critical Accounting Policies
The Company’s significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the consolidated financial statements for the year ended December 31, 20152016 included in Merck’s Form 10‑K filed on February 26, 2016.28, 2017. Certain of these accounting policies are considered critical as disclosed in the Critical Accounting Policies section of Management’s Discussion and Analysis of Financial Condition and Results of Operations included in Merck’s Form 10-K because of the potential for a significant impact on the financial statements due to the inherent uncertainty in such estimates. There have been no significant changes in the Company’s critical accounting policies since December 31, 2015.2016.
Recently Issued Accounting Standards
In May 2014, the Financial Accounting Standards Board (FASB) issued amended accounting guidance on revenue recognition that will be applied to all contracts with customers. The objective of the new guidance is to improve comparability of revenue recognition practices across entities and to provide more useful information to users of financial statements through improved disclosure requirements. In August 2015,The new standard permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the FASB approved a one-year deferralcumulative effect of adopting the guidance being recognized at the date of initial application (modified retrospective method). The Company will adopt the new standard on January 1, 2018 and currently plans to use the modified retrospective method. The majority of the effective date making this guidance effectiveCompany’s business is ship and bill and, on that primary revenue stream, Merck does not expect significant differences. Additionally, the Company has not identified significant changes related to the recognition of revenue for interimits multiple element arrangements or discount and annual periods beginning in 2018. Reporting entities may choosetrade promotion programs when applying the new guidance. However, the Company’s analysis is preliminary and subject to adopt the standard as of the original effective date. The Company is currently assessing the impact of adoption on its consolidated financial statements.change.
In January 2016, the FASB issued revised guidance for the accounting and reporting of financial instruments. The new guidance requires that equity investments with readily determinable fair values currently classified as available-for-sale be measured at fair value with changes in fair value recognized in net income. The new guidance also simplifies the impairment testing of equity investments without readily determinable fair values and changes certain disclosure requirements. This guidance is effective for interim and annual periods beginning in 2018. Early adoption is not permitted. The Company is currently assessing the impact of adoption on its consolidated financial statements.
In February 2016, the FASB issued new accounting guidance for the accounting and reporting of leases. The new guidance requires that lessees recognize a right-of-use asset and a lease liability recorded on the balance sheet for each of its leases (other than leases that meet the definition of a short-term lease).  Leases will be classified as either operating or finance. Operating leases will result in straight-line expense in the income statement (similar to current operating leases) while finance leases will result in more expense being recognized in the earlier years of the lease term (similar to current capital leases). The new guidance will be effective for interim and annual periods beginning in 2019. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In June 2016, the FASB issued amended guidance on the accounting for credit losses on financial instruments within its scope. The guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for interim and annual periods beginning in 2020, with earlier application permitted in 2019. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In August 2016, the FASB issued guidance on the classification of certain cash receipts and payments in the statement of cash flows intended to reduce diversity in practice. The guidance is effective for interim and annual periods beginning in 2018. Early adoption is permitted. The guidance is to be applied retrospectively to all periods presented but may be applied prospectively if retrospective application would be impracticable. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows.
In October 2016, the FASB issued guidance on the accounting for the income tax consequences of intra-entity transfers of assets other than inventory. Under existing guidance, the recognition of current and deferred income taxes for an intra-entity asset transfer is prohibited until the asset has been sold to a third party. The new guidance will require the recognition of the income tax consequences of an intra-entity transfer of an asset (with the exception of inventory) when the intra-entity transfer occurs. The guidance is effective for interim and annual periods beginning in 2018. Early adoption is permitted. The new guidance is to be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings in the beginning of the period of adoption. The Company does not anticipate the adoption of the new guidance will have a material effect on its consolidated financial statements.
In November 2016, the FASB issued guidance requiring that amounts generally described as restricted cash and restricted cash equivalents be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The guidance is effective for interim and annual periods beginning in 2018 and should be applied using a retrospective transition method to each period presented. Early adoption is permitted. The Company is currently evaluating the effect of the standard on its Consolidated Statement of Cash Flows.
In March 2017, the FASB amended the guidance related to net periodic benefit cost for defined benefit plans that requires entities to (1) disaggregate the current service cost component from the other components of net benefit cost and present it with other employee compensation costs in the income statement within operations if such a subtotal is presented; (2) present the other components of net benefit cost separately in the income statement and outside of income from operations; and (3) only capitalize the service cost component when applicable. The new guidance is effective for interim and annual periods in 2018. Entities must use a retrospective transition method to adopt the requirement for separate presentation in the income statement of service costs and other components and a prospective transition method to adopt the requirement to limit the capitalization of benefit costs to the service cost component. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In May 2017, the FASB issued guidance clarifying when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions.


The new guidance is effective prospectively for interim and annual periods beginning in 2018. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In February 2016, the FASB issued new accounting guidance for the accounting and reporting of leases. The new guidance requires that lessees recognize a right-of-use asset and a lease liability recorded on the balance sheet for each of its leases (other than leases that meet the definition of a short-term lease).  Leases will be classified as either operating or finance. Operating leases will result in straight-line expense in the income statement (similar to current operating leases) while finance leases will result in more expense being recognized in the earlier years of the lease term (similar to current capital leases). The new guidance will be effective for interim and annual periods beginning in 2019. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In June 2016, the FASB issued amended guidance on the accounting for credit losses on financial instruments. The guidance introduces an expected loss model for estimating credit losses, replacing the incurred loss model. The new guidance also changes the impairment model for available-for-sale debt securities, requiring the use of an allowance to record estimated credit losses (and subsequent recoveries). The new guidance is effective for interim and annual periods beginning in 2020, with earlier application permitted in 2019. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In January 2017, the FASB issued guidance that provides for the elimination of Step 2 from the goodwill impairment test. Under the new guidance, impairment charges are recognized to the extent the carrying amount of a reporting unit exceeds its fair value with certain limitations. The new guidance is effective for interim and annual periods in 2020. Early adoption is permitted. The Company does not anticipate the adoption of the new guidance will have a material effect on its consolidated financial statements.



Item 4. Controls and Procedures
Management of the Company, with the participation of its Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures over financial reporting for the period covered by this Form 10–Q. Based on this assessment, the Company’s Chief Executive Officer and Chief Financial Officer have concluded that as of SeptemberJune 30, 20162017, the Company’s disclosure controls and procedures are effective. For the period covered by this report, there have been no changes in internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

CAUTIONARY FACTORS THAT MAY AFFECT FUTURE RESULTS
This report and other written reports and oral statements made from time to time by the Company may contain so-called “forward-looking statements,” all of which are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially from those set forth in the statements. One can identify these forward-looking statements by their use of words such as “anticipates,” “expects,” “plans,” “will,” “estimates,” “forecasts,” “projects” and other words of similar meaning. One can also identify them by the fact that they do not relate strictly to historical or current facts. These statements are likely to address the Company’s growth strategy, financial results, product development, product approvals, product potential and development programs. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from the Company’s forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially.
The Company does not assume the obligation to update any forward-looking statement. One should carefully evaluate such statements in light of factors, including risk factors, described in the Company’s filings with the Securities and Exchange Commission, especially on Forms 10-K, 10-Q and 8-K. In Item 1A. “Risk Factors” of the Company’s Annual Report on Form 10‑K for the year ended December 31, 2015,2016, as filed on February 26, 2016,28, 2017, the Company discusses in more detail various important risk factors that could cause actual results to differ from expected or historic results. The Company notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. One should understand that it is not possible to predict or identify all such factors. Consequently, the reader should not consider any such list to be a complete statement of all potential risks or uncertainties.



PART II - Other Information
Item 1. Legal Proceedings
The information called for by this Item is incorporated herein by reference to Note 97 included in Part I, Item 1, Financial Statements (unaudited) — Notes to Condensed Consolidated Financial Statements.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Issuer purchases of equity securities for the three months ended SeptemberJune 30, 20162017 were as follows:
ISSUER PURCHASES OF EQUITY SECURITIES
     ($ in millions)
Period
Total Number
of Shares
Purchased(1)
 
Average Price
Paid Per
Share
 
Approximate Dollar Value of Shares
That May Yet Be Purchased
Under the Plans or Programs(1)
July 1 - July 313,391,145
 $58.56 $6,718
August 1 - August 315,007,108
 $61.94 $6,408
September 1 - September 305,387,193
 $62.55 $6,071
Total13,785,446
 $61.35 $6,071
     ($ in millions)
Period
Total Number
of Shares
Purchased(1)
 
Average Price
Paid Per
Share
 
Approximate Dollar Value of Shares
That May Yet Be Purchased
Under the Plans or Programs(1)
April 1 - April 305,448,401
 $62.97 $3,693
May 1 - May 316,218,475
 $63.59 $3,297
June 1 - June 306,123,210
 $64.60 $2,902
Total17,790,086
 $63.75 $2,902
(1) 
Shares purchased during the period were made as part of a plan approved by the Board of Directors in March 2015 to purchase up to $10 billion of Merck’s common stock for its treasury.



Item 6. Exhibits
Number  Description
  
3.1
  
3.2
  
31.1
  
31.2
  
32.1
  
32.2
  
101
The following materials from Merck & Co., Inc.’s Quarterly Report on Form 10-Q for the quarter ended SeptemberJune 30, 2016,2017, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statement of Income, (ii) the Condensed Consolidated Statement of Comprehensive Income, (iii) the Condensed Consolidated Balance Sheet, (iv) the Condensed Consolidated Statement of Cash Flows, and (v) Notes to the Condensed Consolidated Financial Statements.





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.
 
  MERCK & CO., INC.
   
Date: November 7, 2016August 8, 2017 /s/ Michael J. Holston
  MICHAEL J. HOLSTON
  Executive Vice President and General Counsel
   
Date: November 7, 2016August 8, 2017 /s/ Rita A. Karachun
  RITA A. KARACHUN
  Senior Vice President Finance - Global Controller


EXHIBIT INDEX
Number Description
  
3.1
  
3.2
   
31.1
  
31.2
  
32.1
  
32.2
  
101
The following materials from Merck & Co., Inc.’s Quarterly Report on Form 10-Q for the quarter ended SeptemberJune 30, 2016,2017, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Statement of Income, (ii) the Condensed Consolidated Statement of Comprehensive Income, (iii) the Condensed Consolidated Balance Sheet, (iv) the Condensed Consolidated Statement of Cash Flows, and (v) Notes to the Condensed Consolidated Financial Statements.

- 5348 -