Notes to Condensed Consolidated Financial Statements (unaudited)
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 (GAAP) 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, 2020.
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.
Planned Spin-Off of Women’s Health, Legacy Brands and Biosimilars into New Company
In February 2020, Merck announced its intention to spin-off products from its women’s health, legacy brands and biosimilars businesses into a new, independent, publicly traded company named Organon & Co. (Organon) through a distribution of Organon’s publicly traded stock to Company shareholders. The distribution is expected to qualify as tax-free to the Company and its shareholders for U.S. federal income tax purposes. The legacy brands included in the transaction consist of dermatology, non-opioid pain, respiratory, and select cardiovascular products including Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), as well as the rest of Merck’s diversified brands franchise. Merck’s existing research pipeline programs will continue to be owned and developed within Merck as planned. Organon will have development capabilities initially focused on late-stage development and life-cycle management and is expected over time to develop research capabilities in selected therapeutic areas. The spin-off is expected to be completed in the first half of 2021, subject to market and certain other conditions. Subsequent to the spin-off, the historical results of the women’s health, legacy brands and biosimilars businesses will be reflected as discontinued operations in the Company’s consolidated financial statements.
Recently Adopted Accounting Standards
In June 2016, the Financial Accounting Standards Board (FASB) issued new guidance on the accounting for credit losses on financial instruments. The new 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 Company adopted the new guidance effective January 1, 2020. There was no impact to the Company’s consolidated financial statements upon adoption.
In November 2018, the FASB issued new guidance for collaborative arrangements intended to reduce diversity in practice by clarifying whether certain transactions between collaborative arrangement participants should be accounted for under revenue recognition guidance (ASC 606). The Company adopted the new guidance effective January 1, 2020, which resulted in minor changes to the presentation of information related to the Company’s collaborative arrangements.
Recently Issued Accounting Standards Not Yet Adopted
In December 2019, the FASB issued amended guidance on the accounting and reporting of income taxes. The guidance is intended to simplify the accounting for income taxes by removing exceptions related to certain intraperiod tax allocations and deferred tax liabilities; clarifying guidance primarily related to evaluating the step-up tax basis for goodwill in a business combination; and reflecting enacted changes in tax laws or rates in the annual effective tax rate. The amended guidance is effective for interim and annual periods in 2021. Early adoption is permitted. The amendments in the new guidance are to be applied on a retrospective basis, on a modified retrospective basis through a cumulative-effect adjustment to retained earnings or prospectively, depending on the amendment. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In January 2020, the FASB issued new guidance intended to clarify certain interactions between accounting standards related to equity securities, equity method investments and certain derivatives. The guidance addresses accounting for the transition into and out of the equity method of accounting and measuring certain purchased options and forward contracts to acquire investments. The new guidance is effective for interim and annual periods in 2021 and is to be applied prospectively. Early adoption is permitted. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
In March 2020, the FASB issued optional guidance to ease the potential burden in accounting for (or recognizing the effects of) reference rate reform on financial reporting. The guidance provides optional expedients and exceptions for applying GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform. The optional guidance is effective upon issuance and can be applied on a prospective basis at any time between January 1, 2020 through December 31, 2022. The Company is currently evaluating the impact of adoption on its consolidated financial statements.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
|
|
2.
|
Acquisitions, Research Collaborations and License Agreements
|
The Company continues to pursue acquisitions and the establishment of external alliances such as research collaborations and licensing agreements to complement its internal research capabilities. These arrangements often include upfront payments, as well as expense reimbursements or payments to the third party, and milestone, royalty or profit share 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 assets. Pro forma financial information for acquired businesses is not presented if the historical financial results of the acquired entity are not significant when compared with the Company’s financial results.
In July 2020, Merck acquired the U.S. rights to Sentinel Flavor Tabs and Sentinel Spectrum Chews from Virbac Corporation for approximately $400 million. Sentinel products provide protection against common parasites in dogs. The transaction will be accounted for as an acquisition of an asset. There are no future contingent payments associated with the acquisition.
Also, in July 2020, Merck and Ridgeback Biotherapeutics LP (Ridgeback Bio), a closely held biotechnology company, closed a collaboration agreement to develop MK-4482 (formerly known as EIDD-2801), an orally available antiviral candidate currently in clinical development for the treatment of patients with COVID-19. Merck gained exclusive worldwide rights to develop and commercialize MK-4482 and related molecules. Under the terms of the agreement, Ridgeback Bio received an upfront payment and also is eligible to receive future contingent payments dependent upon the achievement of certain developmental and regulatory approval milestones, as well as a share of the net profits of MK-4482 and related molecules, if approved. Merck and Ridgeback are committed to ensure that any medicines developed for SARS-CoV-2 (the causative agent of COVID-19) will be accessible and affordable globally.
In June 2020, Merck acquired privately held Themis Bioscience GmbH (Themis), a company focused on vaccines and immune-modulation therapies for infectious diseases and cancer for $366 million in cash. Merck may make additional contingent payments of up to $740 million, including up to $80 million for development milestones, up to $260 million for regulatory approval milestones, and up to $400 million for commercial milestones. Themis has a broad pipeline of vaccine candidates and immune-modulatory therapies developed using its innovative measles virus vector platform based on a vector originally developed by scientists at the Institut Pasteur and licensed exclusively to Themis for select viral indications. The acquisition builds upon an ongoing collaboration between the two companies to develop vaccine candidates using the measles virus vector platform and is expected to accelerate the development of Themis’ COVID-19 vaccine candidate (V591). V591 is in preclinical development and clinical studies are planned to start in the third quarter of 2020. The transaction was accounted for as an acquisition of a business. The Company determined the fair value of the contingent consideration was $97 million at the acquisition date utilizing a probability-weighted estimated cash flow stream using an appropriate discount rate dependent on the nature and timing of the milestone payment. Merck recognized intangible assets for in-process research and development (IPR&D) of $136 million, cash of $62 million, deferred tax assets of $72 million and other net liabilities of $22 million. The excess of the consideration transferred over the fair value of net assets acquired of $215 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. Actual cash flows are likely to be different than those assumed. In connection with the transaction, Merck has entered into a memorandum of understanding that reflects the parties’ commitments to address the COVID-19 pandemic by developing, manufacturing and distributing the vaccine on a global basis and with pricing that makes the vaccine both available around the world and accessible to those who need it.
In May 2020, Merck and the International AIDS Vaccine Initiative, Inc. (IAVI), a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, announced a new collaboration to develop V590, an investigational vaccine against SARS-CoV-2 being studied for the prevention of COVID-19. This vaccine candidate will use the recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s approved Ebola Zaire virus vaccine, Ervebo (Ebola Zaire Vaccine, Live), which was the first rVSV vaccine approved for use in humans. Under the terms of the agreement, Merck made an upfront payment of $6.5 million and may make additional contingent payments of up to $100 million for sales-based milestones, as well as royalty payments. Merck has also signed an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within an agency of the United States Department of Health and Human Services, to provide initial funding support for this effort. Under the agreement, IAVI and Merck will work together to advance the development and global clinical evaluation of a SARS-CoV-2 vaccine candidate designed and engineered by IAVI scientists. The vaccine candidate is in preclinical development, and clinical studies are planned to start later in 2020. Merck will lead regulatory filings globally. Both organizations will work together to develop the vaccine and make it accessible and affordable globally, if approved.
In January 2020, Merck acquired ArQule, Inc. (ArQule), a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. Total consideration paid of $2.7 billion included $138 million of share-based compensation payments to settle equity awards attributable to precombination
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
service and cash paid for transaction costs on behalf of ArQule. The Company incurred $95 million of transaction costs directly related to the acquisition of ArQule, consisting almost entirely of share-based compensation payments to settle non-vested equity awards attributable to postcombination service. These costs were included in Selling, general and administrative expenses in the first six months of 2020. ArQule’s lead investigational candidate, MK-1026 (formerly ARQ 531), is a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently being evaluated for the treatment of B-cell malignancies.
The estimated fair value of assets acquired and liabilities assumed from ArQule is as follows:
|
|
|
|
|
|
|
($ in millions)
|
January 16, 2020
|
Cash and cash equivalents
|
$
|
145
|
|
IPR&D MK-1026 (formerly ARQ 531) (1)
|
2,280
|
|
IPR&D MK-7075 (formerly ARQ 092) (1)
|
170
|
|
Licensing arrangement for ARQ 087
|
80
|
|
Deferred income tax liabilities
|
(434
|
)
|
Other assets and liabilities, net
|
35
|
|
Total identifiable net assets
|
2,276
|
|
Goodwill (2)
|
414
|
|
Consideration transferred
|
$
|
2,690
|
|
|
|
(1)
|
The estimated fair values of the identifiable intangible assets related to in-process research and development (IPR&D) were determined using an income approach. The future net cash flows were discounted to present value utilizing a discount rate of 12.5%. Actual cash flows are likely to be different than those assumed.
|
|
|
(2)
|
The goodwill was allocated to the Pharmaceutical segment and is not deductible for tax purposes.
|
On April 1, 2019, Merck acquired Antelliq Corporation (Antelliq), a leader in digital animal identification, traceability and monitoring solutions. These solutions help veterinarians, farmers and pet owners gather critical data to improve management, health and well-being of livestock and pets. Merck paid $2.3 billion to acquire all outstanding shares of Antelliq and spent $1.3 billion to repay Antelliq’s debt. The transaction was accounted for as an acquisition of a business.
The estimated fair value of assets acquired and liabilities assumed from Antelliq is as follows:
|
|
|
|
|
|
|
($ in millions)
|
April 1, 2019
|
Cash and cash equivalents
|
$
|
31
|
|
Accounts receivable
|
73
|
|
Inventories
|
93
|
|
Property, plant and equipment
|
60
|
|
Identifiable intangible assets (useful lives ranging from 18-24 years) (1)
|
2,689
|
|
Deferred income tax liabilities
|
(589
|
)
|
Other assets and liabilities, net
|
(82
|
)
|
Total identifiable net assets
|
2,275
|
|
Goodwill (2)
|
1,376
|
|
Consideration transferred
|
$
|
3,651
|
|
|
|
(1)
|
The estimated fair values of identifiable intangible assets relate primarily to trade names and were determined using an income approach. The future net cash flows were discounted to present value utilizing a discount rate of 11.5%. Actual cash flows are likely to be different than those assumed.
|
|
|
(2)
|
The goodwill recognized is largely attributable to anticipated synergies expected to arise after the acquisition and was allocated to the Animal Health segment. The goodwill is not deductible for tax purposes.
|
The Company’s results for the second quarter of 2019 include two months of activity for Antelliq. The Company incurred $47 million of transaction costs directly related to the acquisition of Antelliq, consisting largely of advisory fees, which are reflected in Selling, general and administrative expenses in the first six months of 2019.
Also in April 2019, Merck acquired Immune Design, a late-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease, for $301 million in cash. The transaction was accounted for as an acquisition of a business. Merck recognized intangible assets of $156 million, cash of $83 million and other net assets of $42 million. The excess of the consideration transferred over the fair value of net assets acquired of $20 million was recorded as goodwill that was allocated to the Pharmaceutical segment and is not deductible for tax purposes. The fair values of
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
the identifiable intangible assets related to IPR&D were determined using an income approach. Actual cash flows are likely to be different than those assumed.
3. Collaborative Arrangements
Merck has entered into collaborative arrangements that provide the Company with varying rights to develop, produce and market products together with its collaborative partners. Both parties in these arrangements are active participants and exposed to significant risks and rewards dependent on the commercial success of the activities of the collaboration. Merck’s more significant collaborative arrangements are discussed below.
AstraZeneca
In July 2017, Merck and AstraZeneca PLC (AstraZeneca) entered into a global 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 certain types of advanced ovarian, breast, pancreatic and prostate cancers. The companies are jointly developing and commercializing 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. The companies will also jointly develop and commercialize AstraZeneca’s Koselugo (selumetinib), an oral, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications. In April 2020, Koselugo was approved by the U.S. Food and Drug Administration (FDA) for the treatment of pediatric patients two years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialization costs for Lynparza and Koselugo monotherapy and non-PD-L1/PD-1 combination therapy opportunities.
Profits from Lynparza and Koselugo product sales generated through monotherapies or combination therapies are shared equally. Merck will fund all development and commercialization costs of Keytruda in combination with Lynparza or Koselugo. AstraZeneca will fund all development and commercialization costs of Imfinzi in combination with Lynparza or Koselugo. AstraZeneca is the principal on Lynparza and Koselugo sales transactions. Merck records its share of Lynparza and Koselugo product sales, net of cost of sales and commercialization costs, as alliance revenue and its share of development costs associated with the collaboration as part of Research and development expenses. Reimbursements received from AstraZeneca for research and development expenses are recognized as reductions to Research and development costs.
As part of the agreement, Merck made an upfront payment to AstraZeneca of $1.6 billion in 2017 and made payments of $750 million over a multi-year period for certain license options. In addition, the agreement provides for additional contingent payments from Merck to AstraZeneca related to the successful achievement of sales-based and regulatory milestones.
In the second quarter of 2020, Merck determined it was probable that sales of Lynparza in the future would trigger $400 million of sales-based milestone payments from Merck to AstraZeneca. Accordingly, Merck recorded a $400 million liability and a corresponding increase to the intangible asset related to Lynparza. Prior to 2020, Merck accrued sales-based milestone payments aggregating $1.0 billion related to Lynparza, of which $200 million and $250 million was paid to AstraZeneca in 2019 and 2018, respectively, and $250 million was paid in the first six months of 2020. Potential future sales-based milestone payments of $2.7 billion have not yet been accrued as they are not deemed by the Company to be probable at this time.
In the second quarter of 2020, Lynparza received regulatory approvals triggering capitalized milestone payments of $135 million from Merck to AstraZeneca. In 2019 and 2018, Lynparza received regulatory approvals triggering capitalized milestone payments of $60 million and $140 million, respectively, in the aggregate from Merck to AstraZeneca. Potential future regulatory milestone payments of $1.4 billion remain under the agreement.
The intangible asset balance related to Lynparza (which includes capitalized sales-based and regulatory milestone payments) was $1.3 billion at June 30, 2020 and is included in Other Intangibles, Net on the Consolidated Balance Sheet. The amount is being amortized over its estimated useful life through 2028 as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Alliance revenue - Lynparza
|
$
|
178
|
|
|
$
|
111
|
|
|
$
|
323
|
|
|
$
|
190
|
|
|
|
|
|
|
|
|
|
Cost of sales (1)
|
137
|
|
|
73
|
|
|
164
|
|
|
92
|
|
Selling, general and administrative
|
39
|
|
|
33
|
|
|
72
|
|
|
59
|
|
Research and development
|
37
|
|
|
33
|
|
|
73
|
|
|
78
|
|
|
|
|
|
|
|
|
|
($ in millions)
|
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
Receivables from AstraZeneca included in Other current assets
|
|
|
|
|
$
|
168
|
|
|
$
|
128
|
|
Payables to AstraZeneca included in Accrued and other current liabilities (2)
|
|
|
|
|
324
|
|
|
577
|
|
Payables to AstraZeneca included in Other Noncurrent Liabilities (2)
|
|
|
|
|
400
|
|
|
—
|
|
(1) Represents amortization of capitalized milestone payments.
(2) Includes accrued milestone payments.
Eisai
In March 2018, Merck and Eisai Co., Ltd. (Eisai) announced a strategic collaboration for the worldwide co-development and co-commercialization of Lenvima (lenvatinib), an orally available tyrosine kinase inhibitor discovered by Eisai. Lenvima is currently approved for the treatment of certain types of thyroid cancer, hepatocellular carcinoma, in combination with everolimus for certain patients with renal cell carcinoma, and in combination with Keytruda for the treatment of certain patients with endometrial carcinoma. Under the agreement, Merck and Eisai will develop and commercialize Lenvima jointly, both as monotherapy and in combination with Keytruda. Eisai records Lenvima product sales globally (Eisai is the principal on Lenvima sales transactions), and Merck and Eisai share profits equally. Merck records its share of Lenvima product sales, net of cost of sales and commercialization costs, as alliance revenue. Expenses incurred during co-development, including for studies evaluating Lenvima as monotherapy, are shared equally by the two companies and reflected in Research and development expenses.
Under the agreement, Merck made an upfront payment to Eisai of $750 million and agreed to make payments of up to $650 million for certain option rights through 2021 (of which $325 million was paid in March 2019, $200 million was paid in March 2020 and $125 million is expected to be paid in March 2021). In addition, the agreement provides for additional contingent payments from Merck to Eisai related to the successful achievement of sales-based and regulatory milestones.
In the second quarter of 2020, Merck determined it was probable that sales of Lenvima in the future would trigger sales-based milestone payments aggregating $370 million from Merck to Eisai. Accordingly, Merck recorded a $370 million liability and a corresponding increase to the intangible asset related to Lenvima. Prior to 2020, Merck accrued sales-based milestone payments aggregating $950 million. Of these amounts, $50 million was paid to Eisai in 2019 and an additional $500 million was paid in the first six months of 2020. Potential future sales-based milestone payments of $2.7 billion have not yet been accrued as they are not deemed by the Company to be probable at this time.
In 2018, Lenvima received regulatory approvals triggering capitalized milestone payments of $250 million in the aggregate from Merck to Eisai. Potential future regulatory milestone payments of $135 million remain under the agreement.
The intangible asset balance related to Lenvima (which includes capitalized sales-based and regulatory milestone payments) was $1.2 billion at June 30, 2020 and is included in Other Intangibles, Net on the Consolidated Balance Sheet. The amount is being amortized over its estimated useful life through 2026 as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Alliance revenue - Lenvima
|
$
|
151
|
|
|
$
|
97
|
|
|
$
|
279
|
|
|
$
|
171
|
|
|
|
|
|
|
|
|
|
Cost of sales (1)
|
135
|
|
|
23
|
|
|
170
|
|
|
74
|
|
Selling, general and administrative
|
19
|
|
|
19
|
|
|
31
|
|
|
38
|
|
Research and development
|
56
|
|
|
62
|
|
|
120
|
|
|
109
|
|
|
|
|
|
|
|
|
|
($ in millions)
|
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
Receivables from Eisai included in Other current assets
|
|
|
|
|
$
|
173
|
|
|
$
|
150
|
|
Payables to Eisai included in Accrued and other current liabilities (2)
|
|
|
|
|
325
|
|
|
700
|
|
Payables to Eisai included in Other Noncurrent Liabilities (3)
|
|
|
|
|
570
|
|
|
525
|
|
(1) Represents amortization of capitalized milestone payments.
(2) Includes accrued milestone and future option payments.
(3) Includes accrued milestone payments.
Bayer AG
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 (riociguat), which is approved to treat pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. The two companies have implemented a joint development and commercialization strategy. The collaboration also includes clinical development of Bayer’s vericiguat, which is in development for the potential treatment of worsening heart failure. Vericiguat is currently under review by the FDA. Under the agreement, Bayer leads commercialization of Adempas in the Americas, while Merck leads commercialization in the rest of the world. For vericiguat, if approved, Bayer will lead commercialization in the rest of world and Merck will lead in the Americas. Both companies share in development costs and profits on sales and have the right to co-promote in territories where they are not the lead. Merck records sales of Adempas in its marketing territories, as well as alliance revenue, which is Merck’s share of profits from the sale of Adempas in Bayer’s marketing territories. In addition, the agreement provides for additional contingent payments from Merck to Bayer related to the successful achievement of sales-based milestones.
Prior to 2020, Merck accrued $725 million of sales-based milestone payments for this collaboration, of which $350 million was paid to Bayer in 2018. There is an additional $400 million potential future sales-based milestone payment that has not yet been accrued as it is not deemed by the Company to be probable at this time.
The intangible asset balance related to this collaboration (which includes the acquired intangible asset balance, as well as capitalized sales-based milestone payments) was $832 million at June 30, 2020 and is included in Other Intangibles, Net on the Consolidated Balance Sheet. The amount is being amortized over its estimated useful life through 2027 as supported by projected future cash flows, subject to impairment testing.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Summarized financial information related to this collaboration is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Alliance revenue - Adempas
|
$
|
79
|
|
|
$
|
51
|
|
|
$
|
133
|
|
|
$
|
94
|
|
Net sales of Adempas recorded by Merck
|
57
|
|
|
53
|
|
|
113
|
|
|
100
|
|
Total sales
|
$
|
136
|
|
|
$
|
104
|
|
|
$
|
246
|
|
|
$
|
194
|
|
|
|
|
|
|
|
|
|
Cost of sales (1)
|
28
|
|
|
29
|
|
|
57
|
|
|
58
|
|
Selling, general and administrative
|
17
|
|
|
11
|
|
|
28
|
|
|
20
|
|
Research and development
|
16
|
|
|
32
|
|
|
41
|
|
|
62
|
|
|
|
|
|
|
|
|
|
($ in millions)
|
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
Receivables from Bayer included in Other current assets
|
|
|
|
|
$
|
62
|
|
|
$
|
49
|
|
Payables to Bayer included in Other Noncurrent Liabilities (2)
|
|
|
|
|
375
|
|
|
375
|
|
(1) Includes amortization of intangible assets.
(2) Represents accrued milestone payment.
In early 2019, Merck approved a new global restructuring program (Restructuring Program) as part of a worldwide initiative focused on further optimizing the Company’s manufacturing and supply network, as well as reducing its global real estate footprint. This program is a continuation of the Company’s plant rationalization, builds on prior restructuring programs and does not include any actions associated with the planned spin-off of Organon. As the Company continues to evaluate its global footprint and overall operating model, it subsequently identified additional actions under the Restructuring Program, and could identify further actions over time. The actions currently contemplated under the Restructuring Program are expected to be substantially completed by the end of 2023, with the cumulative pretax costs to be incurred by the Company to implement the program estimated to be approximately $2.5 billion. The Company estimates that approximately 60% of the cumulative pretax costs will result in cash outlays, primarily related to employee separation expense and facility shut-down costs. Approximately 40% of the cumulative pretax costs will be non-cash, relating primarily to the accelerated depreciation of facilities to be closed or divested. The Company expects to record charges of approximately $800 million in 2020 related to the Restructuring Program. Actions under previous global restructuring programs have been substantially completed.
The Company recorded total pretax costs of $150 million and $159 million in the second quarter of 2020 and 2019, respectively, and $318 million and $346 million for the first six months of 2020 and 2019, respectively, related to restructuring program activities. Since inception of the Restructuring Program through June 30, 2020, Merck has recorded total pretax accumulated costs of approximately $1.2 billion. For segment reporting, restructuring charges are unallocated expenses.
The following tables summarize the charges related to restructuring program activities by type of cost:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2020
|
|
Six Months Ended June 30, 2020
|
($ in millions)
|
Separation
Costs
|
|
Accelerated
Depreciation
|
|
Other
|
|
Total
|
|
Separation
Costs
|
|
Accelerated
Depreciation
|
|
Other
|
|
Total
|
Cost of sales
|
$
|
—
|
|
|
$
|
31
|
|
|
$
|
(6
|
)
|
|
$
|
25
|
|
|
$
|
—
|
|
|
$
|
56
|
|
|
$
|
37
|
|
|
$
|
93
|
|
Selling, general and administrative
|
—
|
|
|
11
|
|
|
—
|
|
|
11
|
|
|
—
|
|
|
22
|
|
|
—
|
|
|
22
|
|
Research and development
|
—
|
|
|
31
|
|
|
—
|
|
|
31
|
|
|
—
|
|
|
48
|
|
|
—
|
|
|
48
|
|
Restructuring costs
|
35
|
|
|
—
|
|
|
48
|
|
|
83
|
|
|
82
|
|
|
—
|
|
|
73
|
|
|
155
|
|
|
$
|
35
|
|
|
$
|
73
|
|
|
$
|
42
|
|
|
$
|
150
|
|
|
$
|
82
|
|
|
$
|
126
|
|
|
$
|
110
|
|
|
$
|
318
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2019
|
|
Six Months Ended June 30, 2019
|
($ in millions)
|
Separation
Costs
|
|
Accelerated
Depreciation
|
|
Other
|
|
Total
|
|
Separation
Costs
|
|
Accelerated
Depreciation
|
|
Other
|
|
Total
|
Cost of sales
|
$
|
—
|
|
|
$
|
64
|
|
|
$
|
1
|
|
|
$
|
65
|
|
|
$
|
—
|
|
|
$
|
98
|
|
|
$
|
1
|
|
|
$
|
99
|
|
Selling, general and administrative
|
—
|
|
|
32
|
|
|
—
|
|
|
32
|
|
|
—
|
|
|
32
|
|
|
—
|
|
|
32
|
|
Research and development
|
—
|
|
|
2
|
|
|
1
|
|
|
3
|
|
|
—
|
|
|
2
|
|
|
1
|
|
|
3
|
|
Restructuring costs
|
25
|
|
|
—
|
|
|
34
|
|
|
59
|
|
|
153
|
|
|
—
|
|
|
59
|
|
|
212
|
|
|
$
|
25
|
|
|
$
|
98
|
|
|
$
|
36
|
|
|
$
|
159
|
|
|
$
|
153
|
|
|
$
|
132
|
|
|
$
|
61
|
|
|
$
|
346
|
|
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Separation costs are associated with actual headcount reductions, as well as those headcount reductions which were probable and could be reasonably estimated.
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 the sites have and will continue to operate up through the respective closure dates and, since future undiscounted cash flows are sufficient to recover the respective book values, Merck is 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 2020 and 2019 includes asset abandonment, facility shut-down and other related costs, as well as pretax gains and losses resulting from the sales of facilities and related assets. Additionally, other activity includes certain employee-related costs associated with pension and other postretirement benefit plans (see Note 11) and share-based compensation.
The following table summarizes the charges and spending relating to restructuring program activities for the six months ended June 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions)
|
Separation
Costs
|
|
Accelerated
Depreciation
|
|
Other
|
|
Total
|
Restructuring reserves January 1, 2020
|
$
|
690
|
|
|
$
|
—
|
|
|
$
|
69
|
|
|
$
|
759
|
|
Expense
|
82
|
|
|
126
|
|
|
110
|
|
|
318
|
|
(Payments) receipts, net
|
(328
|
)
|
|
—
|
|
|
(163
|
)
|
|
(491
|
)
|
Non-cash activity
|
—
|
|
|
(126
|
)
|
|
34
|
|
|
(92
|
)
|
Restructuring reserves June 30, 2020 (1)
|
$
|
444
|
|
|
$
|
—
|
|
|
$
|
50
|
|
|
$
|
494
|
|
|
|
(1)
|
The remaining cash outlays are expected to be substantially completed by the end of 2023.
|
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 changes 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, Japanese yen and Chinese renminbi. 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 forecasted sales hedged as it gets closer to the expected date of the forecasted 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 Company manages its anticipated transaction exposure principally with purchased local currency put options, forward contracts and purchased collar options.
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 unrealized gains or losses on these contracts are recorded in Accumulated other comprehensive income (AOCI) and reclassified into Sales when the hedged anticipated revenue is recognized. 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
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
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 Company manages operating activities and net asset positions at each local subsidiary in order to mitigate the effects of exchange on monetary assets and liabilities. The Company also uses a balance sheet risk management program 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 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 cash flows from these contracts are reported as operating activities in the Condensed Consolidated Statement of Cash Flows.
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 also uses forward exchange contracts to hedge a portion of 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 unrealized gains or losses on these contracts are recorded in foreign currency translation adjustment within OCI and remain in AOCI until either the sale or complete or substantially complete liquidation of the subsidiary. The Company excludes certain portions of the change in fair value of its derivative instruments from the assessment of hedge effectiveness (excluded components). Changes in fair value of the excluded components are recognized in OCI. The Company recognizes in earnings the initial value of the excluded components on a straight-line basis over the life of the derivative instrument, rather than using the mark-to-market approach. 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.
The effects of the Company’s net investment hedges on OCI and the Consolidated Statement of Income are shown below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of Pretax (Gain) Loss Recognized in Other Comprehensive Income (1)
|
|
Amount of Pretax (Gain) Loss Recognized in Other (income) expense, net for Amounts Excluded from Effectiveness Testing
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Net Investment Hedging Relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
$
|
8
|
|
|
$
|
17
|
|
|
$
|
5
|
|
|
$
|
7
|
|
|
$
|
(4
|
)
|
|
$
|
(8
|
)
|
|
$
|
(11
|
)
|
|
$
|
(15
|
)
|
Euro-denominated notes
|
72
|
|
|
28
|
|
|
21
|
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
(1) No amounts were reclassified from AOCI into income related to the sale of a subsidiary.
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 February 2020, five interest rate swaps with notional amounts of $250 million each matured. These swaps effectively converted the Company’s $1.25 billion, 1.85% fixed-rate notes due 2020 to variable rate debt. At June 30, 2020, the Company was a party to 14 pay-floating, receive-fixed interest rate swap contracts designated as fair value hedges of fixed-rate notes in which the notional amounts match the amount of the hedged fixed-rate notes as detailed in the table below.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020
|
($ in millions)
|
Par Value of Debt
|
|
Number of Interest Rate Swaps Held
|
|
Total Swap Notional Amount
|
3.875% notes due 2021
|
$
|
1,150
|
|
|
5
|
|
|
$
|
1,150
|
|
2.40% notes due 2022
|
1,000
|
|
|
4
|
|
|
1,000
|
|
2.35% notes due 2022
|
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 along with the offsetting 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.
The table below presents the location of amounts recorded on the Consolidated Balance Sheet related to cumulative basis adjustments for fair value hedges:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carrying Amount of Hedged Liabilities
|
|
Cumulative Amount of Fair Value Hedging Adjustment Increase (Decrease) Included in the Carrying Amount
|
($ in millions)
|
June 30, 2020
|
|
December 31, 2019
|
|
June 30, 2020
|
|
December 31, 2019
|
Balance Sheet Line Item in which Hedged Item is Included
|
|
|
|
|
|
|
|
Loans payable and current portion of long-term debt
|
$
|
1,160
|
|
|
$
|
1,249
|
|
|
$
|
10
|
|
|
$
|
(1
|
)
|
Long-Term Debt
|
2,318
|
|
|
3,409
|
|
|
71
|
|
|
14
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
|
|
Fair Value of Derivative
|
|
U.S. Dollar
Notional
|
|
Fair Value of Derivative
|
|
U.S. Dollar
Notional
|
($ in millions)
|
Balance Sheet Caption
|
Asset
|
|
Liability
|
|
Asset
|
|
Liability
|
|
Derivatives Designated as Hedging Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contracts
|
Other current assets
|
$
|
10
|
|
|
$
|
—
|
|
|
$
|
1,150
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Interest rate swap contracts
|
Other Assets
|
72
|
|
|
—
|
|
|
2,250
|
|
|
15
|
|
|
—
|
|
|
3,400
|
|
Interest rate swap contracts
|
Accrued and other current liabilities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|
1,250
|
|
Foreign exchange contracts
|
Other current assets
|
83
|
|
|
—
|
|
|
4,959
|
|
|
152
|
|
|
—
|
|
|
6,117
|
|
Foreign exchange contracts
|
Other Assets
|
70
|
|
|
—
|
|
|
1,993
|
|
|
55
|
|
|
—
|
|
|
2,160
|
|
Foreign exchange contracts
|
Accrued and other current liabilities
|
—
|
|
|
27
|
|
|
1,884
|
|
|
—
|
|
|
22
|
|
|
1,748
|
|
Foreign exchange contracts
|
Other Noncurrent Liabilities
|
—
|
|
|
1
|
|
|
11
|
|
|
—
|
|
|
1
|
|
|
53
|
|
|
|
$
|
235
|
|
|
$
|
28
|
|
|
$
|
12,247
|
|
|
$
|
222
|
|
|
$
|
24
|
|
|
$
|
14,728
|
|
Derivatives Not Designated as Hedging Instruments
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
Other current assets
|
$
|
93
|
|
|
$
|
—
|
|
|
$
|
5,324
|
|
|
$
|
66
|
|
|
$
|
—
|
|
|
$
|
7,245
|
|
Foreign exchange contracts
|
Accrued and other current liabilities
|
—
|
|
|
103
|
|
|
5,865
|
|
|
—
|
|
|
73
|
|
|
8,693
|
|
|
|
$
|
93
|
|
|
$
|
103
|
|
|
$
|
11,189
|
|
|
$
|
66
|
|
|
$
|
73
|
|
|
$
|
15,938
|
|
|
|
$
|
328
|
|
|
$
|
131
|
|
|
$
|
23,436
|
|
|
$
|
288
|
|
|
$
|
97
|
|
|
$
|
30,666
|
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
($ in millions)
|
Asset
|
|
Liability
|
|
Asset
|
|
Liability
|
Gross amounts recognized in the condensed consolidated balance sheet
|
$
|
328
|
|
|
$
|
131
|
|
|
$
|
288
|
|
|
$
|
97
|
|
Gross amounts subject to offset in master netting arrangements not offset in the condensed consolidated balance sheet
|
(115
|
)
|
|
(115
|
)
|
|
(84
|
)
|
|
(84
|
)
|
Cash collateral received
|
(38
|
)
|
|
—
|
|
|
(34
|
)
|
|
—
|
|
Net amounts
|
$
|
175
|
|
|
$
|
16
|
|
|
$
|
170
|
|
|
$
|
13
|
|
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The table below provides information regarding the location and amount of pretax (gains) losses of derivatives designated in fair value or cash flow hedging relationships:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
|
|
Other (income) expense, net (1)
|
|
Other comprehensive income (loss)
|
|
Sales
|
|
Other (income) expense, net (1)
|
|
Other comprehensive income (loss)
|
|
Three Months Ended June 30,
|
|
Three Months Ended June 30,
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
Six Months Ended June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Financial Statement Line Items in which Effects of Fair Value or Cash Flow Hedges are Recorded
|
$
|
10,872
|
|
|
$
|
11,760
|
|
|
$
|
(390
|
)
|
|
$
|
140
|
|
|
$
|
(2
|
)
|
|
$
|
(16
|
)
|
|
$
|
22,929
|
|
|
$
|
22,575
|
|
|
$
|
(318
|
)
|
|
$
|
327
|
|
|
$
|
(200
|
)
|
|
$
|
183
|
|
(Gain) loss on fair value hedging relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap contracts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hedged items
|
—
|
|
|
—
|
|
|
1
|
|
|
55
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
68
|
|
|
88
|
|
|
—
|
|
|
—
|
|
Derivatives designated as hedging instruments
|
—
|
|
|
—
|
|
|
(8
|
)
|
|
(45
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(76
|
)
|
|
(68
|
)
|
|
—
|
|
|
—
|
|
Impact of cash flow hedging relationships
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of (loss) gain recognized in OCI on derivatives
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(109
|
)
|
|
10
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
69
|
|
|
(2
|
)
|
Increase (decrease) in Sales as a result of AOCI reclassifications
|
42
|
|
|
75
|
|
|
—
|
|
|
—
|
|
|
(42
|
)
|
|
(75
|
)
|
|
88
|
|
|
119
|
|
|
—
|
|
|
—
|
|
|
(88
|
)
|
|
(119
|
)
|
Interest rate contracts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of gain recognized in Other (income) expense, net on derivatives
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
Amount of loss recognized in OCI on derivatives
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|
(5
|
)
|
(1) Interest expense is a component of Other (income) expense, net.
The table below provides information regarding the income statement effects of derivatives not designated as hedging instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amount of Derivative Pretax (Gain) Loss Recognized in Income
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
($ in millions)
|
Income Statement Caption
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Derivatives Not Designated as Hedging Instruments
|
|
|
|
|
|
|
|
|
|
Foreign exchange contracts (1)
|
Other (income) expense, net
|
|
$
|
49
|
|
|
$
|
2
|
|
|
$
|
(131
|
)
|
|
$
|
120
|
|
Foreign exchange contracts (2)
|
Sales
|
|
4
|
|
|
(6
|
)
|
|
(3
|
)
|
|
4
|
|
Interest rate contracts (3)
|
Other (income) expense, net
|
|
9
|
|
|
—
|
|
|
9
|
|
|
—
|
|
(1) 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.
(2) These derivative contracts serve as economic hedges of forecasted transactions.
(3) These derivatives serve as economic hedges against rising treasury rates.
At June 30, 2020, the Company estimates $9 million of pretax net unrealized gains on derivatives maturing within the next 12 months that hedge foreign currency denominated sales over that same period will be reclassified from AOCI to Sales. The amount ultimately reclassified to Sales may differ as foreign exchange rates change. Realized gains and losses are ultimately determined by actual exchange rates at maturity.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Investments in Debt and Equity Securities
Information on investments in debt and equity securities is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2020
|
|
December 31, 2019
|
|
Amortized
Cost
|
|
Gross Unrealized
|
|
Fair
Value
|
|
Amortized
Cost
|
|
Gross Unrealized
|
|
Fair
Value
|
($ in millions)
|
Gains
|
|
Losses
|
|
Gains
|
|
Losses
|
|
U.S. government and agency securities
|
$
|
74
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
74
|
|
|
$
|
266
|
|
|
$
|
3
|
|
|
$
|
—
|
|
|
$
|
269
|
|
Foreign government bonds
|
2
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Commercial paper
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
668
|
|
|
—
|
|
|
—
|
|
|
668
|
|
Corporate notes and bonds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
608
|
|
|
13
|
|
|
—
|
|
|
621
|
|
Asset-backed securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
226
|
|
|
1
|
|
|
—
|
|
|
227
|
|
Total debt securities
|
$
|
76
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
76
|
|
|
$
|
1,768
|
|
|
$
|
17
|
|
|
$
|
—
|
|
|
$
|
1,785
|
|
Publicly traded equity securities (1)
|
|
|
|
|
|
|
1,307
|
|
|
|
|
|
|
|
|
|
|
|
838
|
|
Total debt and publicly traded equity securities
|
|
|
|
|
|
|
|
|
|
$
|
1,383
|
|
|
|
|
|
|
|
|
|
|
|
$
|
2,623
|
|
(1) Unrealized net (gains) losses recognized in Other (income) expense, net on equity securities still held at June 30, 2020 were $(464) million and $(469) million in the second quarter and first six months of 2020, respectively. Unrealized net losses (gains) recognized in Other (income) expense, net on equity securities still held at June 30, 2019 were $39 million and $(75) million in the second quarter and first six months of 2019, respectively.
At June 30, 2020 and June 30, 2019, the Company also had $487 million and $465 million, respectively, of equity investments without readily determinable fair values included in Other Assets. The Company recognizes unrealized gains on these equity investments based on favorable observable price changes from transactions involving similar investments of the same investee and recognizes unrealized losses based on unfavorable observable price changes. During the first six months of 2020, the Company recognized unrealized gains of $18 million and unrealized losses of $3 million in Other (income) expense, net related to these equity investments held at June 30, 2020. During the first six months of 2019, the Company recognized unrealized gains of $4 million and unrealized losses of $10 million in Other (income) expense, net related to these investments held at June 30, 2019. Cumulative unrealized gains and cumulative unrealized losses based on observable prices changes for investments in equity investments without readily determinable fair values still held at June 30, 2020 were $127 million and $24 million, respectively.
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 Using
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
($ in millions)
|
June 30, 2020
|
|
December 31, 2019
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign government bonds
|
$
|
—
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Commercial paper
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
668
|
|
|
—
|
|
|
668
|
|
Corporate notes and bonds
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
621
|
|
|
—
|
|
|
621
|
|
Asset-backed securities (1)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
227
|
|
|
—
|
|
|
227
|
|
U.S. government and agency securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
209
|
|
|
—
|
|
|
209
|
|
Publicly traded equity securities
|
1,249
|
|
|
—
|
|
|
—
|
|
|
1,249
|
|
|
518
|
|
|
—
|
|
|
—
|
|
|
518
|
|
|
1,249
|
|
|
2
|
|
|
—
|
|
|
1,251
|
|
|
518
|
|
|
1,725
|
|
|
—
|
|
|
2,243
|
|
Other assets (2)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency securities
|
74
|
|
|
—
|
|
|
—
|
|
|
74
|
|
|
60
|
|
|
—
|
|
|
—
|
|
|
60
|
|
Publicly traded equity securities
|
58
|
|
|
—
|
|
|
—
|
|
|
58
|
|
|
320
|
|
|
—
|
|
|
—
|
|
|
320
|
|
|
132
|
|
|
—
|
|
|
—
|
|
|
132
|
|
|
380
|
|
|
—
|
|
|
—
|
|
|
380
|
|
Derivative assets (3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forward exchange contracts
|
—
|
|
|
142
|
|
|
—
|
|
|
142
|
|
|
—
|
|
|
169
|
|
|
—
|
|
|
169
|
|
Purchased currency options
|
—
|
|
|
104
|
|
|
—
|
|
|
104
|
|
|
—
|
|
|
104
|
|
|
—
|
|
|
104
|
|
Interest rate swaps
|
—
|
|
|
82
|
|
|
—
|
|
|
82
|
|
|
—
|
|
|
15
|
|
|
—
|
|
|
15
|
|
|
—
|
|
|
328
|
|
|
—
|
|
|
328
|
|
|
—
|
|
|
288
|
|
|
—
|
|
|
288
|
|
Total assets
|
$
|
1,381
|
|
|
$
|
330
|
|
|
$
|
—
|
|
|
$
|
1,711
|
|
|
$
|
898
|
|
|
$
|
2,013
|
|
|
$
|
—
|
|
|
$
|
2,911
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
798
|
|
|
$
|
798
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
767
|
|
|
$
|
767
|
|
Derivative liabilities (3)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forward exchange contracts
|
—
|
|
|
128
|
|
|
—
|
|
|
128
|
|
|
—
|
|
|
95
|
|
|
—
|
|
|
95
|
|
Written currency options
|
—
|
|
|
3
|
|
|
—
|
|
|
3
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
1
|
|
Interest rate swaps
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
1
|
|
|
—
|
|
|
131
|
|
|
—
|
|
|
131
|
|
|
—
|
|
|
97
|
|
|
—
|
|
|
97
|
|
Total liabilities
|
$
|
—
|
|
|
$
|
131
|
|
|
$
|
798
|
|
|
$
|
929
|
|
|
$
|
—
|
|
|
$
|
97
|
|
|
$
|
767
|
|
|
$
|
864
|
|
|
|
(1)
|
Primarily all of the asset-backed securities were highly rated (Standard & Poor’s rating of AAA and Moody’s Investors Service rating of Aaa), secured primarily by auto loan, credit card and student loan receivables, with weighted-average lives of primarily 5 years or less.
|
|
|
(2)
|
Investments included in other assets are restricted as to use, including for the payment of benefits under employee benefit plans.
|
|
|
(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.
|
As of June 30, 2020 and December 31, 2019, Cash and cash equivalents included $10.4 billion and $8.9 billion of cash equivalents, respectively (which would be considered Level 2 in the fair value hierarchy).
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Contingent Consideration
Summarized information about the changes in liabilities for contingent consideration associated with business acquisitions is as follows:
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
($ in millions)
|
2020
|
|
2019
|
Fair value January 1
|
$
|
767
|
|
|
$
|
788
|
|
Additions
|
97
|
|
|
—
|
|
Changes in estimated fair value (1)
|
40
|
|
|
50
|
|
Payments
|
(106
|
)
|
|
(85
|
)
|
Fair value June 30 (2)(3)
|
$
|
798
|
|
|
$
|
753
|
|
(1) Recorded in Cost of sales, Research and development expenses, and Other (income) expense, net. Includes cumulative translation adjustments.
(2) Balance at June 30, 2020 includes $138 million recorded as a current liability for amounts expected to be paid within the next 12 months.
(3) At June 30, 2020 and December 31, 2019, $608 million and $625 million, respectively, of the liabilities relate to the termination of the Sanofi-Pasteur MSD joint venture in 2016. As part of the termination, Merck recorded a liability for contingent future royalty payments of 11.5% on net sales of all Merck products that were previously sold by the joint venture through December 31, 2024. The fair value of this liability is determined utilizing the estimated amount and timing of projected cash flows using a risk-adjusted discount rate of 8% to present value the cash flows.
The additions to contingent consideration in 2020 relate to the acquisition of Themis (see Note 2). The payments of contingent consideration in both periods relate to liabilities recorded in connection with the termination of the Sanofi-Pasteur MSD joint venture in 2016.
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 June 30, 2020, was $34.5 billion compared with a carrying value of $30.9 billion and at December 31, 2019, was $28.8 billion compared with a carrying value of $26.3 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, Europe and China 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 global economic conditions, including the volatility associated with international sovereign economies, and associated impacts on the financial markets and its business.
The Company has accounts receivable factoring agreements with financial institutions in certain countries to sell accounts receivable. The Company factored $1.9 billion and $2.7 billion of accounts receivable in the second quarter of 2020 and the fourth quarter of 2019, respectively, under these factoring arrangements, which reduced outstanding accounts receivable. The cash received from the financial institutions is reported within operating activities in the Consolidated Statement of Cash Flows. In certain of these factoring arrangements, for ease of administration, the Company will collect customer payments related to the factored receivables, which it then remits to the financial institutions. The net cash flows relating to these collections are reported as financing activities in the Consolidated Statement of Cash Flows. The cost of factoring such accounts receivable was de minimis.
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. Cash collateral received by the Company from various counterparties was $38 million and $34 million at June 30, 2020 and December 31, 2019, respectively. The obligation to return such collateral is recorded in Accrued and other current liabilities. No cash collateral was advanced by the Company to counterparties as of June 30, 2020 or December 31, 2019.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Inventories consisted of:
|
|
|
|
|
|
|
|
|
($ in millions)
|
June 30, 2020
|
|
December 31, 2019
|
Finished goods
|
$
|
2,032
|
|
|
$
|
1,772
|
|
Raw materials and work in process
|
5,874
|
|
|
5,650
|
|
Supplies
|
190
|
|
|
207
|
|
Total (approximates current cost)
|
8,096
|
|
|
7,629
|
|
Decrease to LIFO cost
|
(119
|
)
|
|
(171
|
)
|
|
$
|
7,977
|
|
|
$
|
7,458
|
|
Recognized as:
|
|
|
|
Inventories
|
$
|
6,056
|
|
|
$
|
5,978
|
|
Other assets
|
1,921
|
|
|
1,480
|
|
Amounts recognized as Other Assets are comprised almost entirely of raw materials and work in process inventories. At June 30, 2020 and December 31, 2019, these amounts included $1.7 billion and $1.3 billion, respectively, of inventories not expected to be sold within one year. In addition, these amounts included $266 million and $168 million at June 30, 2020 and December 31, 2019, respectively, of inventories produced in preparation for product launches.
In June 2020, the Company issued $4.5 billion principal amount of senior unsecured notes consisting of $1.0 billion of 0.75% notes due 2026, $1.25 billion of 1.45% notes due 2030, $1.0 billion of 2.35% notes due 2040 and $1.25 billion of 2.45% notes due 2050. Merck intends to use the net proceeds from the offering for general corporate purposes, including without limitation the repayment of outstanding commercial paper borrowings and other indebtedness with upcoming maturities.
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 governmental and 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 condition, 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.
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 June 30, 2020, approximately 3,590 cases are pending against Merck in either federal or state court. Plaintiffs in the vast majority of these cases generally allege that they sustained femur fractures and/or other bone injuries (Femur Fractures) in association with the use of Fosamax.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
All federal cases involving allegations of Femur Fractures have been or will be transferred to a multidistrict litigation in the District of New Jersey (Femur Fracture MDL). 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.
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 appealed that decision to the U.S. Court of Appeals for the Third Circuit (Third Circuit). In March 2017, the Third Circuit issued a decision reversing the Femur Fracture MDL court’s preemption ruling and remanding the appealed cases back to the Femur Fracture MDL court. In May 2019, the U.S. Supreme Court decided that the Third Circuit had incorrectly concluded that the issue of preemption should be resolved by a jury, and accordingly vacated the judgment of the Third Circuit and remanded the proceedings back to the Third Circuit to address the issue in a manner consistent with the Supreme Court’s opinion. In November 2019, the Third Circuit remanded the cases back to the District Court in order to allow that court to determine in the first instance whether the plaintiffs’ state law claims are preempted by federal law under the standards described by the Supreme Court in its opinion. Briefing on the issue is closed, and the parties await the decision of the District Court.
Accordingly, as of June 30, 2020, approximately 970 cases were actively pending in the Femur Fracture MDL.
As of June 30, 2020, approximately 2,345 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge James Hyland in Middlesex County. The parties selected an initial group of cases to be reviewed through fact discovery, and Merck has continued to select additional cases to be reviewed.
As of June 30, 2020, approximately 275 cases alleging Femur Fractures have been filed and are pending in California state court. All of the Femur Fracture cases filed in California state court have been coordinated before a single judge in Orange County, California.
Additionally, there are four Femur Fracture cases pending in other state courts.
Discovery is presently stayed in the Femur Fracture MDL and in the state court in California. Merck 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 June 30, 2020, Merck is aware of approximately 1,440 product users alleging that Januvia and/or Janumet caused the development of pancreatic cancer and other injuries.
Most claims have been filed in multidistrict litigation before the U.S. District Court for the Southern District of California (MDL). Outside of the MDL, the majority of claims have been filed in coordinated proceedings before 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 federal preemption.
Plaintiffs appealed in both forums. In November 2017, the U.S. Court of Appeals for the Ninth Circuit vacated the judgment and remanded for further discovery. In November 2018, the California state appellate court reversed and remanded on similar grounds. In March 2019, the parties in the MDL and the California coordinated proceedings agreed to coordinate and adopt a schedule for completing discovery on general causation and preemption issues and for renewing summary judgment and Daubert motions. Under the stipulated case management schedule, the hearings for Daubert and summary judgment motions are expected to take place in the second half of 2020.
As of June 30, 2020, six product users have claims pending against Merck in state courts other than California, including Illinois. In June 2017, the Illinois trial court denied Merck’s motion for summary judgment based on federal preemption. Merck appealed, and the Illinois appellate court affirmed in December 2018. Merck filed a petition for leave to appeal to the Illinois Supreme Court in February 2019. In April 2019, the Illinois Supreme Court stayed consideration of the pending petition to appeal until the U.S. Supreme Court issued its opinion in Merck Sharp & Dohme Corp. v. Albrecht (relating to the Fosamax matter discussed above). Merck filed the opinion in Albrecht with the Illinois Supreme Court in June 2019. The petition for leave to appeal was decided in September 2019, in which the Illinois Supreme Court directed the intermediate appellate court to reconsider its earlier ruling. The Illinois Appellate Court issued a favorable decision concluding, consistent with Albrecht, that preemption presents a legal question to be resolved by the court.
In addition to the claims noted above, the Company has agreed to toll the statute of limitations for approximately 50 additional claims. The Company intends to continue defending against these lawsuits.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Vioxx
As previously disclosed, Merck is a defendant in a lawsuit brought by the Attorney General of Utah alleging that Merck misrepresented the safety of Vioxx. The lawsuit is pending in Utah state court. Utah seeks damages and penalties under the Utah False Claims Act. A bench trial in this matter has been rescheduled for April 6, 2021.
Governmental Proceedings
On June 17, 2020, Merck received a Civil Investigative Demand (CID) from the U.S. Department of Justice. The CID requests answers to interrogatories, as well as various documents, regarding temperature excursions at a third-party storage facility containing certain Merck products. Merck is cooperating with the government’s investigation and intends to produce information and/or documents as necessary in response to the CID.
As previously disclosed, the Company’s subsidiaries in China have received and may continue to receive inquiries regarding their operations from various Chinese governmental agencies. Some of these inquiries may be related to matters involving other multinational pharmaceutical companies, as well as Chinese entities doing business with such companies. The Company’s policy is to cooperate with these authorities and to provide responses as appropriate.
As previously disclosed, 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 include 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 or 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 required.
Commercial and Other Litigation
Zetia Antitrust Litigation
As previously disclosed, Merck, MSD, Schering Corporation and MSP Singapore Company LLC (collectively, the Merck Defendants) are defendants in putative class action and opt-out lawsuits filed in 2018 on behalf of direct and indirect purchasers of Zetia alleging violations of federal and state antitrust laws, as well as other state statutory and common law causes of action. The cases have been consolidated for pretrial purposes in a federal multidistrict litigation before Judge Rebecca Beach Smith in the Eastern District of Virginia. In December 2018, the court denied the Merck Defendants’ motions to dismiss or stay the direct purchaser putative class actions pending bilateral arbitration. In August 2019, the district court adopted in full the report and recommendation of the magistrate judge with respect to the Merck Defendants’ motions to dismiss on non-arbitration issues, thereby granting in part and denying in part Merck Defendants’ motions to dismiss. In addition, in June 2019, the representatives of the putative direct purchaser class filed an amended complaint, and in August 2019, retailer opt-out plaintiffs filed an amended complaint. The Merck Defendants moved to dismiss the new allegations in both complaints. In October 2019, the magistrate judge issued a report and recommendation recommending that the district judge grant the motions in their entirety. In December 2019, the district court adopted this report and recommendation in part. The district court granted the Merck Defendants’ motion to dismiss to the extent the motion sought dismissal of claims for overcharges paid by entities that purchased generic ezetimibe from Par Pharmaceutical, Inc. (Par Pharmaceutical) and dismissed any claims for such overcharges. In November 2019, the direct purchaser plaintiffs and the indirect purchaser plaintiffs filed motions for class certification. On June 18, 2020, the magistrate judge issued a report and recommendation recommending that the district judge grant in part the direct purchasers’ motion for class certification and certify a class of 35 direct purchasers. On July 2, 2020, defendants objected to the report and recommendation. The indirect purchasers’ class certification motion is still pending before the magistrate judge. Trial in this matter has been rescheduled to begin on February 23, 2021.
Patent Litigation
From time to time, generic manufacturers of pharmaceutical products file abbreviated New Drug Applications (NDAs) with the 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. 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 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.
Bridion — Between January and March 2020, the Company received multiple Paragraph IV Certification Letters under the Hatch-Waxman Act notifying the Company that generic drug companies have filed applications to the FDA seeking pre-patent expiry approval to sell generic versions of Bridion (sugammadex) Injection. In March and April 2020, the Company filed patent
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
infringement lawsuits in the U.S. District Courts for the District of New Jersey and the Northern District of West Virginia against those generic companies. These lawsuits, which assert one or more patents covering sugammadex and methods of using sugammadex, automatically stay FDA approval of the generic applications until June 2023 or until adverse court decisions, if any, whichever may occur earlier. No schedule for the cases has been set by the courts.
Januvia, Janumet, Janumet XR — In February 2019, Par Pharmaceutical filed suit against the Company in the U.S. District Court for the District of New Jersey, seeking a declaratory judgment of invalidity of a patent owned by the Company covering certain salt and polymorphic forms of sitagliptin that expires in 2026. In response, the Company filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware against Par Pharmaceutical and additional companies that also indicated an intent to market generic versions of Januvia, Janumet, and Janumet XR following expiration of key patent protection in 2022, but prior to the expiration of the later-granted patent owned by the Company covering certain salt and polymorphic forms of sitagliptin that expires in 2026, and a later granted patent owned by the Company covering the Janumet formulation which expires in 2028. Par Pharmaceutical dismissed its case in the U.S. District Court for the District of New Jersey against the Company and will litigate the action in the U.S. District Court for the District of Delaware. The Company filed a patent infringement lawsuit against Mylan Pharmaceuticals Inc. and Mylan Inc. (Mylan) in the Northern District of West Virginia. The Judicial Panel of Multidistrict Litigation entered an order transferring the Company’s lawsuit against Mylan to the U.S. District Court for the District of Delaware for coordinated and consolidated pretrial proceedings with the other cases pending in that district. The U.S. District Court for the District of Delaware has scheduled the lawsuits for a single 3-day trial on invalidity issues in October 2021. The Court will schedule separate 1-day trials on infringement issues if necessary. In the Company’s case against Mylan, the U.S. District Court for the Northern District of West Virginia has conditionally scheduled a three-day trial in December 2021 on all issues. In February 2020, the Company amended its complaint against one defendant, Teva Pharmaceuticals USA, Inc., to add patent infringement claims related to a patent that expires in 2025 and covers certain processes for manufacturing sitagliptin.
The Company has settled with five generic companies such that these generic companies can bring their products to the market in November 2026 or earlier under certain circumstances.
In October 2019, Mylan filed a petition for Inter Partes Review (IPR) at the United States Patent and Trademark Office (USPTO) seeking invalidity of some, but not all, of the claims of the 2026 patent. The USPTO instituted IPR proceedings in May 2020, finding a reasonable likelihood that the challenged claims are not valid. A trial is scheduled for February 2021 and a final decision is expected in May 2021. After institution, three additional IPR petitions were filed by Teva Pharmaceuticals USA, Inc., Dr. Reddy’s Laboratories, Inc., and Sun Pharmaceutical Industries Ltd., as well as related entities, which requested joinder with Mylan’s IPR proceedings. If the challenges are successful, the unchallenged claims of the 2026 patent will remain valid, subject to the Court proceedings described above.
In Germany, a generic company has sought the revocation of the Supplementary Protection Certificate (SPC) for Janumet. If the generic company is successful, Janumet could lose market exclusivity in Germany as early as July 2022. It is possible that challenges to the Janumet SPC could occur in other European countries.
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 condition, 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 June 30, 2020 and December 31, 2019 of approximately $265 million and $240 million, respectively, represents the Company’s best estimate of the minimum amount of defense costs to be incurred in connection with its outstanding litigation; however, events such as additional trials and other events that could arise in the course of its litigation could affect the ultimate amount of legal defense costs to be incurred by the Company. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves and may determine to increase the reserves at any time in the future if, based upon the factors set forth, it believes it would be appropriate to do so.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Common Stock
|
Other
Paid-In
Capital
|
Retained
Earnings
|
Accumulated
Other
Comprehensive
Loss
|
Treasury Stock
|
Non-
controlling
Interests
|
Total
|
($ and shares in millions except per share amounts)
|
Shares
|
Par Value
|
Shares
|
Cost
|
Balance at April 1, 2019
|
3,577
|
|
$
|
1,788
|
|
$
|
38,768
|
|
$
|
44,065
|
|
$
|
(5,346
|
)
|
994
|
|
$
|
(51,736
|
)
|
$
|
131
|
|
$
|
27,670
|
|
Net income attributable to Merck & Co., Inc.
|
—
|
|
—
|
|
—
|
|
2,670
|
|
—
|
|
—
|
|
—
|
|
—
|
|
2,670
|
|
Other comprehensive loss, net of taxes
|
—
|
|
—
|
|
—
|
|
—
|
|
(16
|
)
|
—
|
|
—
|
|
—
|
|
(16
|
)
|
Cash dividends declared on common stock ($0.55 per share)
|
—
|
|
—
|
|
—
|
|
(1,440
|
)
|
—
|
|
—
|
|
—
|
|
—
|
|
(1,440
|
)
|
Treasury stock shares purchased
|
—
|
|
—
|
|
1,000
|
|
—
|
|
—
|
|
24
|
|
(2,235
|
)
|
—
|
|
(1,235
|
)
|
Share-based compensation plans and other
|
—
|
|
—
|
|
(284
|
)
|
—
|
|
—
|
|
(8
|
)
|
401
|
|
—
|
|
117
|
|
Net loss attributable to noncontrolling interests
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(26
|
)
|
(26
|
)
|
Other changes in noncontrolling interests
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(3
|
)
|
(3
|
)
|
Balance at June 30, 2019
|
3,577
|
|
$
|
1,788
|
|
$
|
39,484
|
|
$
|
45,295
|
|
$
|
(5,362
|
)
|
1,010
|
|
$
|
(53,570
|
)
|
$
|
102
|
|
$
|
27,737
|
|
Balance at April 1, 2020
|
3,577
|
|
$
|
1,788
|
|
$
|
39,697
|
|
$
|
48,272
|
|
$
|
(6,391
|
)
|
1,053
|
|
$
|
(57,161
|
)
|
$
|
95
|
|
$
|
26,300
|
|
Net income attributable to Merck & Co., Inc.
|
—
|
|
—
|
|
—
|
|
3,002
|
|
—
|
|
—
|
|
—
|
|
—
|
|
3,002
|
|
Other comprehensive loss, net of taxes
|
—
|
|
—
|
|
—
|
|
—
|
|
(2
|
)
|
—
|
|
—
|
|
—
|
|
(2
|
)
|
Cash dividends declared on common stock ($0.61 per share)
|
—
|
|
—
|
|
—
|
|
(1,550
|
)
|
—
|
|
—
|
|
—
|
|
—
|
|
(1,550
|
)
|
Share-based compensation plans and other
|
—
|
|
—
|
|
(324
|
)
|
—
|
|
—
|
|
(5
|
)
|
311
|
|
—
|
|
(13
|
)
|
Net income attributable to noncontrolling interests
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
8
|
|
8
|
|
Distributions attributable to noncontrolling interests
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(1
|
)
|
(1
|
)
|
Balance at June 30, 2020
|
3,577
|
|
$
|
1,788
|
|
$
|
39,373
|
|
$
|
49,724
|
|
$
|
(6,393
|
)
|
1,048
|
|
$
|
(56,850
|
)
|
$
|
102
|
|
$
|
27,744
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
Common Stock
|
Other
Paid-In
Capital
|
Retained
Earnings
|
Accumulated
Other
Comprehensive
Loss
|
Treasury Stock
|
Non-
controlling
Interests
|
Total
|
($ and shares in millions except per share amounts)
|
Shares
|
Par Value
|
Shares
|
Cost
|
Balance at January 1, 2019
|
3,577
|
|
$
|
1,788
|
|
$
|
38,808
|
|
$
|
42,579
|
|
$
|
(5,545
|
)
|
985
|
|
$
|
(50,929
|
)
|
$
|
181
|
|
$
|
26,882
|
|
Net income attributable to Merck & Co., Inc.
|
—
|
|
—
|
|
—
|
|
5,585
|
|
—
|
|
—
|
|
—
|
|
—
|
|
5,585
|
|
Other comprehensive income, net of taxes
|
—
|
|
—
|
|
—
|
|
—
|
|
183
|
|
—
|
|
—
|
|
—
|
|
183
|
|
Cash dividends declared on common stock ($1.10 per share)
|
—
|
|
—
|
|
—
|
|
(2,869
|
)
|
—
|
|
—
|
|
—
|
|
—
|
|
(2,869
|
)
|
Treasury stock shares purchased
|
—
|
|
—
|
|
1,000
|
|
—
|
|
—
|
|
38
|
|
(3,325
|
)
|
—
|
|
(2,325
|
)
|
Share-based compensation plans and other
|
—
|
|
—
|
|
(324
|
)
|
—
|
|
—
|
|
(13
|
)
|
684
|
|
—
|
|
360
|
|
Net loss attributable to noncontrolling interests
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
(79
|
)
|
(79
|
)
|
Balance at June 30, 2019
|
3,577
|
|
$
|
1,788
|
|
$
|
39,484
|
|
$
|
45,295
|
|
$
|
(5,362
|
)
|
1,010
|
|
$
|
(53,570
|
)
|
$
|
102
|
|
$
|
27,737
|
|
Balance at January 1, 2020
|
3,577
|
|
$
|
1,788
|
|
$
|
39,660
|
|
$
|
46,602
|
|
$
|
(6,193
|
)
|
1,038
|
|
$
|
(55,950
|
)
|
$
|
94
|
|
$
|
26,001
|
|
Net income attributable to Merck & Co., Inc.
|
—
|
|
—
|
|
—
|
|
6,221
|
|
—
|
|
—
|
|
—
|
|
—
|
|
6,221
|
|
Other comprehensive loss, net of taxes
|
—
|
|
—
|
|
—
|
|
—
|
|
(200
|
)
|
—
|
|
—
|
|
—
|
|
(200
|
)
|
Cash dividends declared on common stock ($1.22 per share)
|
—
|
|
—
|
|
—
|
|
(3,099
|
)
|
—
|
|
—
|
|
—
|
|
—
|
|
(3,099
|
)
|
Treasury stock shares purchased
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
16
|
|
(1,281
|
)
|
—
|
|
(1,281
|
)
|
Share-based compensation plans and other
|
—
|
|
—
|
|
(287
|
)
|
—
|
|
—
|
|
(6
|
)
|
381
|
|
—
|
|
94
|
|
Net income attributable to noncontrolling interests
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
8
|
|
8
|
|
Balance at June 30, 2020
|
3,577
|
|
$
|
1,788
|
|
$
|
39,373
|
|
$
|
49,724
|
|
$
|
(6,393
|
)
|
1,048
|
|
$
|
(56,850
|
)
|
$
|
102
|
|
$
|
27,744
|
|
|
|
10.
|
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. 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.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The following table provides the amounts of share-based compensation cost recorded in the Condensed Consolidated Statement of Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Pretax share-based compensation expense
|
$
|
121
|
|
|
$
|
111
|
|
|
$
|
229
|
|
|
$
|
204
|
|
Income tax benefit
|
(16
|
)
|
|
(15
|
)
|
|
(31
|
)
|
|
(28
|
)
|
Total share-based compensation expense, net of taxes
|
$
|
105
|
|
|
$
|
96
|
|
|
$
|
198
|
|
|
$
|
176
|
|
During the first six months of 2020, the Company granted 6 million RSUs with a weighted-average grant date fair value of $77.74 per RSU and during the first six months of 2019 granted 6 million RSUs with a weighted-average grant date fair value of $76.31 per RSU. During the first six months of 2020, the Company granted 773 thousand PSUs with a weighted-average grant date fair value of $75.22 per PSU and during the first six months of 2019 granted 609 thousand PSUs with a weighted-average grant date fair value of $90.50 per PSU.
During the first six months of 2020, the Company granted 4 million stock options with a weighted-average exercise price of $77.67 per option and during the first six months of 2019 granted 3 million stock options with a weighted-average exercise price of $80.00 per option. The weighted-average fair value of options granted during the first six months of 2020 and 2019 was $9.93 and $10.63 per option, respectively, and was determined using the following assumptions:
|
|
|
|
|
|
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
Expected dividend yield
|
3.1
|
%
|
|
3.2
|
%
|
Risk-free interest rate
|
0.4
|
%
|
|
2.4
|
%
|
Expected volatility
|
22.1
|
%
|
|
18.7
|
%
|
Expected life (years)
|
5.8
|
|
|
5.9
|
|
At June 30, 2020, there was $908 million of total pretax unrecognized compensation expense related to nonvested stock options, RSU and PSU awards which will be recognized over a weighted-average period of 2.2 years. For segment reporting, share-based compensation costs are unallocated expenses.
|
|
11.
|
Pension and Other Postretirement Benefit Plans
|
The Company has defined benefit pension plans covering eligible employees in the United States and in certain of its international subsidiaries. The net periodic benefit cost of such plans consisted of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
($ in millions)
|
U.S.
|
|
International
|
|
U.S.
|
|
International
|
|
U.S.
|
|
International
|
|
U.S.
|
|
International
|
Service cost
|
$
|
88
|
|
|
$
|
74
|
|
|
$
|
74
|
|
|
$
|
60
|
|
|
$
|
175
|
|
|
$
|
148
|
|
|
$
|
144
|
|
|
$
|
120
|
|
Interest cost
|
109
|
|
|
33
|
|
|
113
|
|
|
44
|
|
|
217
|
|
|
68
|
|
|
228
|
|
|
89
|
|
Expected return on plan assets
|
(195
|
)
|
|
(101
|
)
|
|
(205
|
)
|
|
(107
|
)
|
|
(388
|
)
|
|
(205
|
)
|
|
(411
|
)
|
|
(214
|
)
|
Amortization of unrecognized prior service credit
|
(12
|
)
|
|
(3
|
)
|
|
(12
|
)
|
|
(3
|
)
|
|
(25
|
)
|
|
(6
|
)
|
|
(25
|
)
|
|
(6
|
)
|
Net loss amortization
|
76
|
|
|
31
|
|
|
35
|
|
|
16
|
|
|
152
|
|
|
62
|
|
|
70
|
|
|
31
|
|
Termination benefits
|
1
|
|
|
—
|
|
|
3
|
|
|
1
|
|
|
4
|
|
|
1
|
|
|
5
|
|
|
1
|
|
Curtailments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
(1
|
)
|
|
1
|
|
|
—
|
|
Settlements
|
9
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
9
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
$
|
76
|
|
|
$
|
36
|
|
|
$
|
8
|
|
|
$
|
11
|
|
|
$
|
146
|
|
|
$
|
69
|
|
|
$
|
12
|
|
|
$
|
21
|
|
The Company now anticipates contributing approximately $220 million to its U.S. pension plans in 2020, of which $170 million was contributed in the first half of the year.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
The Company provides medical benefits, principally to its eligible U.S. retirees and similar benefits to their dependents, through its other postretirement benefit plans. The net credit of such plans consisted of the following components:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Service cost
|
$
|
13
|
|
|
$
|
12
|
|
|
$
|
26
|
|
|
$
|
24
|
|
Interest cost
|
14
|
|
|
18
|
|
|
29
|
|
|
35
|
|
Expected return on plan assets
|
(19
|
)
|
|
(18
|
)
|
|
(37
|
)
|
|
(36
|
)
|
Amortization of unrecognized prior service credit
|
(22
|
)
|
|
(21
|
)
|
|
(45
|
)
|
|
(43
|
)
|
Curtailments
|
—
|
|
|
(1
|
)
|
|
(1
|
)
|
|
(1
|
)
|
|
$
|
(14
|
)
|
|
$
|
(10
|
)
|
|
$
|
(28
|
)
|
|
$
|
(21
|
)
|
In connection with restructuring actions (see Note 4), termination charges were recorded on pension plans related to expanded eligibility for certain employees exiting Merck. Also, in connection with these restructuring actions, curtailments were recorded on pension and other postretirement benefit plans and settlements were recorded on certain U.S. and international pension plans as reflected in the tables above.
The components of net periodic benefit cost (credit) other than the service cost component are included in Other (income) expense, net (see Note 12), with the exception of certain amounts for termination benefits, curtailments and settlements, which are recorded in Restructuring costs if the event giving rise to the termination benefits, curtailment or settlement is related to restructuring actions as noted above.
|
|
12.
|
Other (Income) Expense, Net
|
Other (income) expense, net, consisted of:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Interest income
|
$
|
(14
|
)
|
|
$
|
(75
|
)
|
|
$
|
(39
|
)
|
|
$
|
(164
|
)
|
Interest expense
|
209
|
|
|
233
|
|
|
421
|
|
|
442
|
|
Exchange losses
|
24
|
|
|
27
|
|
|
78
|
|
|
128
|
|
Income from investments in equity securities, net (1)
|
(551
|
)
|
|
(58
|
)
|
|
(603
|
)
|
|
(32
|
)
|
Net periodic defined benefit plan (credit) cost other than service cost
|
(80
|
)
|
|
(140
|
)
|
|
(170
|
)
|
|
(281
|
)
|
Other, net
|
22
|
|
|
153
|
|
|
(5
|
)
|
|
234
|
|
|
$
|
(390
|
)
|
|
$
|
140
|
|
|
$
|
(318
|
)
|
|
$
|
327
|
|
|
|
(1)
|
Includes net realized and unrealized gains and losses from investments in equity securities either owned directly or through ownership interests in investment funds. Unrealized gains and losses from investments that are directly owned are determined at the end of the reporting period, while ownership interests in investment funds are accounted for on a one quarter lag. The Company estimates that gains of approximately $300 million will be recognized in the third quarter of 2020 from ownership interests in investment funds.
|
The decline in interest income in the second quarter and first six months of 2020 reflects lower investments and lower interest rates. The lower exchange losses in the first six months of 2020 reflect losses on forward exchange contracts in 2019 related to the acquisition of Antelliq. The increase in income from investments in equity securities, net, in both the second quarter and first six months of 2020 was driven primarily by the recognition of unrealized gains on certain investments, most of which relate to Moderna, Inc., as well as NGM Biopharmaceuticals, Inc.
Other, net (as reflected in the table above) in the second quarter and first six months of 2019 includes $78 million and $162 million, respectively, of goodwill impairment charges related to certain businesses in the Healthcare Services segment.
Interest paid for the six months ended June 30, 2020 and 2019 was $387 million and $356 million, respectively.
The effective income tax rates of 14.5% and 18.9% for the second quarter of 2020 and 2019, respectively, and 15.3% and 13.0% for the first six months of 2020 and 2019, respectively, reflect the impacts of acquisition and divestiture-related costs and restructuring costs, partially offset by the beneficial impact of foreign earnings. In addition, the effective income tax rate for the first six months of 2019 reflects the favorable impact of a $360 million net tax benefit related to the settlement of certain federal income tax matters.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
In the first quarter of 2019, the Internal Revenue Service (IRS) concluded its examinations of Merck’s 2012-2014 U.S. federal income tax returns. As a result, the Company was required to make a payment of $107 million. The Company’s reserves for unrecognized tax benefits for the years under examination exceeded the adjustments relating to this examination period and therefore the Company recorded a $360 million net tax benefit in the first six months of 2019. This net benefit reflects reductions in reserves for unrecognized tax benefits for tax positions relating to the years that were under examination, partially offset by additional reserves for tax positions not previously reserved for.
The calculations of earnings per share are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ and shares in millions except per share amounts)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Net income attributable to Merck & Co., Inc.
|
$
|
3,002
|
|
|
$
|
2,670
|
|
|
$
|
6,221
|
|
|
$
|
5,585
|
|
Average common shares outstanding
|
2,527
|
|
|
2,574
|
|
|
2,531
|
|
|
2,579
|
|
Common shares issuable (1)
|
9
|
|
|
14
|
|
|
11
|
|
|
17
|
|
Average common shares outstanding assuming dilution
|
2,536
|
|
|
2,588
|
|
|
2,542
|
|
|
2,596
|
|
Basic earnings per common share attributable to Merck & Co., Inc. common shareholders
|
$
|
1.19
|
|
|
$
|
1.04
|
|
|
$
|
2.46
|
|
|
$
|
2.17
|
|
Earnings per common share assuming dilution attributable to Merck & Co., Inc. common shareholders
|
$
|
1.18
|
|
|
$
|
1.03
|
|
|
$
|
2.45
|
|
|
$
|
2.15
|
|
|
|
(1)
|
Issuable primarily under share-based compensation plans.
|
For the second quarter of 2020 and 2019, 8 million and 3 million, respectively, and for both the first six months of 2020 and 2019, 4 million 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.
|
|
15.
|
Other Comprehensive Income (Loss)
|
Changes in AOCI by component are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
($ in millions)
|
Derivatives
|
|
Investments
|
|
Employee
Benefit
Plans
|
|
Cumulative
Translation
Adjustment
|
|
Accumulated Other
Comprehensive
Income (Loss)
|
Balance April 1, 2019, net of taxes
|
$
|
118
|
|
|
$
|
4
|
|
|
$
|
(3,541
|
)
|
|
$
|
(1,927
|
)
|
|
$
|
(5,346
|
)
|
Other comprehensive income (loss) before reclassification adjustments, pretax
|
10
|
|
|
55
|
|
|
—
|
|
|
(25
|
)
|
|
40
|
|
Tax
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
6
|
|
|
4
|
|
Other comprehensive income (loss) before reclassification adjustments, net of taxes
|
8
|
|
|
55
|
|
|
—
|
|
|
(19
|
)
|
|
44
|
|
Reclassification adjustments, pretax
|
(76
|
)
|
(1)
|
(11
|
)
|
(2)
|
14
|
|
(3)
|
—
|
|
|
(73
|
)
|
Tax
|
16
|
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
|
13
|
|
Reclassification adjustments, net of taxes
|
(60
|
)
|
|
(11
|
)
|
|
11
|
|
|
—
|
|
|
(60
|
)
|
Other comprehensive income (loss), net of taxes
|
(52
|
)
|
|
44
|
|
|
11
|
|
|
(19
|
)
|
|
(16
|
)
|
Balance June 30, 2019, net of taxes
|
$
|
66
|
|
|
$
|
48
|
|
|
$
|
(3,530
|
)
|
|
$
|
(1,946
|
)
|
|
$
|
(5,362
|
)
|
Balance April 1, 2020, net of taxes
|
$
|
135
|
|
|
$
|
—
|
|
|
$
|
(4,201
|
)
|
|
$
|
(2,325
|
)
|
|
$
|
(6,391
|
)
|
Other comprehensive income (loss) before reclassification adjustments, pretax
|
(110
|
)
|
|
—
|
|
|
(21
|
)
|
|
63
|
|
|
(68
|
)
|
Tax
|
23
|
|
|
—
|
|
|
6
|
|
|
16
|
|
|
45
|
|
Other comprehensive income (loss) before reclassification adjustments, net of taxes
|
(87
|
)
|
|
—
|
|
|
(15
|
)
|
|
79
|
|
|
(23
|
)
|
Reclassification adjustments, pretax
|
(42
|
)
|
(1)
|
—
|
|
|
69
|
|
(3)
|
—
|
|
|
27
|
|
Tax
|
9
|
|
|
—
|
|
|
(15
|
)
|
|
—
|
|
|
(6
|
)
|
Reclassification adjustments, net of taxes
|
(33
|
)
|
|
—
|
|
|
54
|
|
|
—
|
|
|
21
|
|
Other comprehensive income (loss), net of taxes
|
(120
|
)
|
|
—
|
|
|
39
|
|
|
79
|
|
|
(2
|
)
|
Balance June 30, 2020, net of taxes
|
$
|
15
|
|
|
$
|
—
|
|
|
$
|
(4,162
|
)
|
|
$
|
(2,246
|
)
|
|
$
|
(6,393
|
)
|
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
($ in millions)
|
Derivatives
|
|
Investments
|
|
Employee
Benefit
Plans
|
|
Cumulative
Translation
Adjustment
|
|
Accumulated Other
Comprehensive
Income (Loss)
|
Balance January 1, 2019, net of taxes
|
$
|
166
|
|
|
$
|
(78
|
)
|
|
$
|
(3,556
|
)
|
|
$
|
(2,077
|
)
|
|
$
|
(5,545
|
)
|
Other comprehensive income (loss) before reclassification adjustments, pretax
|
(3
|
)
|
|
131
|
|
|
(1
|
)
|
|
131
|
|
|
258
|
|
Tax
|
1
|
|
|
—
|
|
|
6
|
|
|
—
|
|
|
7
|
|
Other comprehensive income (loss) before reclassification adjustments, net of taxes
|
(2
|
)
|
|
131
|
|
|
5
|
|
|
131
|
|
|
265
|
|
Reclassification adjustments, pretax
|
(124
|
)
|
(1)
|
(5
|
)
|
(2)
|
28
|
|
(3)
|
—
|
|
|
(101
|
)
|
Tax
|
26
|
|
|
—
|
|
|
(7
|
)
|
|
—
|
|
|
19
|
|
Reclassification adjustments, net of taxes
|
(98
|
)
|
|
(5
|
)
|
|
21
|
|
|
—
|
|
|
(82
|
)
|
Other comprehensive income (loss), net of taxes
|
(100
|
)
|
|
126
|
|
|
26
|
|
|
131
|
|
|
183
|
|
Balance June 30, 2019, net of taxes
|
$
|
66
|
|
|
$
|
48
|
|
|
$
|
(3,530
|
)
|
|
$
|
(1,946
|
)
|
|
$
|
(5,362
|
)
|
Balance January 1, 2020, net of taxes
|
$
|
31
|
|
|
$
|
18
|
|
|
$
|
(4,261
|
)
|
|
$
|
(1,981
|
)
|
|
$
|
(6,193
|
)
|
Other comprehensive income (loss) before reclassification adjustments, pretax
|
68
|
|
|
3
|
|
|
(21
|
)
|
|
(270
|
)
|
|
(220
|
)
|
Tax
|
(14
|
)
|
|
—
|
|
|
11
|
|
|
5
|
|
|
2
|
|
Other comprehensive income (loss) before reclassification adjustments, net of taxes
|
54
|
|
|
3
|
|
|
(10
|
)
|
|
(265
|
)
|
|
(218
|
)
|
Reclassification adjustments, pretax
|
(89
|
)
|
(1)
|
(21
|
)
|
(2)
|
138
|
|
(3)
|
—
|
|
|
28
|
|
Tax
|
19
|
|
|
—
|
|
|
(29
|
)
|
|
—
|
|
|
(10
|
)
|
Reclassification adjustments, net of taxes
|
(70
|
)
|
|
(21
|
)
|
|
109
|
|
|
—
|
|
|
18
|
|
Other comprehensive income (loss), net of taxes
|
(16
|
)
|
|
(18
|
)
|
|
99
|
|
|
(265
|
)
|
|
(200
|
)
|
Balance June 30, 2020, net of taxes
|
$
|
15
|
|
|
$
|
—
|
|
|
$
|
(4,162
|
)
|
|
$
|
(2,246
|
)
|
|
$
|
(6,393
|
)
|
|
|
(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 debt securities 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 11).
The Company’s operations are principally managed on a products basis and include three operating segments, which are the Pharmaceutical, Animal Health and Healthcare Services segments. The Pharmaceutical and Animal Health segments are the only reportable segments.
The Pharmaceutical segment includes human health pharmaceutical and vaccine 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. Human health 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 vaccine 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.
The Animal Health segment discovers, develops, manufactures and markets a wide range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all major livestock and companion animal species. The Company also offers an extensive suite of digitally connected identification, traceability and monitoring products. The Company sells its products to veterinarians, distributors and animal producers.
The Healthcare Services segment provided services and solutions that focus on engagement, health analytics and clinical services to improve the value of care delivered to patients. The Company has been in the process of divesting the businesses in the Healthcare Services segment. The remaining businesses were divested during the first quarter of 2020.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Sales of the Company’s products were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
($ in millions)
|
U.S.
|
|
Int’l
|
|
Total
|
|
U.S.
|
|
Int’l
|
|
Total
|
|
U.S.
|
|
Int’l
|
|
Total
|
|
U.S.
|
|
Int’l
|
|
Total
|
Pharmaceutical:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Keytruda
|
$
|
2,043
|
|
|
$
|
1,345
|
|
|
$
|
3,388
|
|
|
$
|
1,498
|
|
|
$
|
1,136
|
|
|
$
|
2,634
|
|
|
$
|
3,949
|
|
|
$
|
2,722
|
|
|
$
|
6,672
|
|
|
$
|
2,782
|
|
|
$
|
2,121
|
|
|
$
|
4,903
|
|
Alliance revenue - Lynparza (1)
|
105
|
|
|
73
|
|
|
178
|
|
|
66
|
|
|
45
|
|
|
111
|
|
|
190
|
|
|
133
|
|
|
323
|
|
|
116
|
|
|
74
|
|
|
190
|
|
Alliance revenue - Lenvima (1)
|
98
|
|
|
53
|
|
|
151
|
|
|
54
|
|
|
43
|
|
|
97
|
|
|
188
|
|
|
91
|
|
|
279
|
|
|
104
|
|
|
67
|
|
|
171
|
|
Emend
|
6
|
|
|
27
|
|
|
33
|
|
|
67
|
|
|
54
|
|
|
121
|
|
|
11
|
|
|
65
|
|
|
76
|
|
|
130
|
|
|
107
|
|
|
237
|
|
Vaccines
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gardasil/Gardasil 9
|
168
|
|
|
488
|
|
|
656
|
|
|
456
|
|
|
430
|
|
|
886
|
|
|
629
|
|
|
1,124
|
|
|
1,753
|
|
|
818
|
|
|
906
|
|
|
1,724
|
|
ProQuad/M-M-R II/Varivax
|
263
|
|
|
115
|
|
|
378
|
|
|
500
|
|
|
174
|
|
|
675
|
|
|
596
|
|
|
217
|
|
|
813
|
|
|
843
|
|
|
328
|
|
|
1,171
|
|
RotaTeq
|
100
|
|
|
68
|
|
|
168
|
|
|
104
|
|
|
68
|
|
|
172
|
|
|
241
|
|
|
150
|
|
|
391
|
|
|
258
|
|
|
125
|
|
|
383
|
|
Pneumovax 23
|
21
|
|
|
96
|
|
|
117
|
|
|
123
|
|
|
47
|
|
|
170
|
|
|
203
|
|
|
170
|
|
|
373
|
|
|
248
|
|
|
107
|
|
|
355
|
|
Vaqta
|
17
|
|
|
11
|
|
|
28
|
|
|
38
|
|
|
20
|
|
|
58
|
|
|
47
|
|
|
41
|
|
|
88
|
|
|
67
|
|
|
39
|
|
|
105
|
|
Hospital Acute Care
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bridion
|
107
|
|
|
117
|
|
|
224
|
|
|
129
|
|
|
149
|
|
|
278
|
|
|
250
|
|
|
274
|
|
|
524
|
|
|
248
|
|
|
285
|
|
|
533
|
|
Noxafil
|
6
|
|
|
67
|
|
|
73
|
|
|
100
|
|
|
93
|
|
|
193
|
|
|
14
|
|
|
154
|
|
|
168
|
|
|
191
|
|
|
192
|
|
|
383
|
|
Prevymis
|
28
|
|
|
35
|
|
|
63
|
|
|
19
|
|
|
18
|
|
|
38
|
|
|
55
|
|
|
68
|
|
|
123
|
|
|
37
|
|
|
33
|
|
|
70
|
|
Primaxin
|
1
|
|
|
63
|
|
|
64
|
|
|
—
|
|
|
70
|
|
|
71
|
|
|
1
|
|
|
114
|
|
|
115
|
|
|
1
|
|
|
129
|
|
|
130
|
|
Invanz
|
—
|
|
|
43
|
|
|
43
|
|
|
18
|
|
|
60
|
|
|
78
|
|
|
6
|
|
|
102
|
|
|
108
|
|
|
31
|
|
|
118
|
|
|
150
|
|
Cancidas
|
(2
|
)
|
|
45
|
|
|
43
|
|
|
3
|
|
|
64
|
|
|
67
|
|
|
1
|
|
|
98
|
|
|
98
|
|
|
4
|
|
|
125
|
|
|
129
|
|
Cubicin
|
10
|
|
|
21
|
|
|
32
|
|
|
22
|
|
|
45
|
|
|
67
|
|
|
25
|
|
|
53
|
|
|
78
|
|
|
64
|
|
|
91
|
|
|
155
|
|
Zerbaxa
|
17
|
|
|
15
|
|
|
32
|
|
|
13
|
|
|
14
|
|
|
27
|
|
|
37
|
|
|
32
|
|
|
69
|
|
|
25
|
|
|
28
|
|
|
53
|
|
Immunology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Simponi
|
—
|
|
|
191
|
|
|
191
|
|
|
—
|
|
|
214
|
|
|
214
|
|
|
—
|
|
|
406
|
|
|
406
|
|
|
—
|
|
|
422
|
|
|
422
|
|
Remicade
|
—
|
|
|
73
|
|
|
73
|
|
|
—
|
|
|
98
|
|
|
98
|
|
|
—
|
|
|
160
|
|
|
160
|
|
|
—
|
|
|
221
|
|
|
221
|
|
Neuroscience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Belsomra
|
22
|
|
|
61
|
|
|
84
|
|
|
21
|
|
|
55
|
|
|
76
|
|
|
49
|
|
|
114
|
|
|
163
|
|
|
45
|
|
|
98
|
|
|
143
|
|
Virology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Isentress/Isentress HD
|
76
|
|
|
120
|
|
|
196
|
|
|
94
|
|
|
153
|
|
|
247
|
|
|
151
|
|
|
290
|
|
|
441
|
|
|
202
|
|
|
300
|
|
|
502
|
|
Zepatier
|
15
|
|
|
24
|
|
|
39
|
|
|
39
|
|
|
68
|
|
|
108
|
|
|
33
|
|
|
62
|
|
|
94
|
|
|
72
|
|
|
149
|
|
|
221
|
|
Cardiovascular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Zetia
|
(1
|
)
|
|
138
|
|
|
137
|
|
|
6
|
|
|
150
|
|
|
156
|
|
|
(4
|
)
|
|
285
|
|
|
282
|
|
|
6
|
|
|
290
|
|
|
296
|
|
Vytorin
|
2
|
|
|
37
|
|
|
39
|
|
|
3
|
|
|
73
|
|
|
76
|
|
|
5
|
|
|
86
|
|
|
92
|
|
|
6
|
|
|
167
|
|
|
174
|
|
Atozet
|
—
|
|
|
115
|
|
|
115
|
|
|
—
|
|
|
92
|
|
|
92
|
|
|
—
|
|
|
238
|
|
|
238
|
|
|
—
|
|
|
186
|
|
|
186
|
|
Alliance revenue - Adempas (2)
|
73
|
|
|
6
|
|
|
79
|
|
|
49
|
|
|
2
|
|
|
51
|
|
|
122
|
|
|
11
|
|
|
133
|
|
|
89
|
|
|
5
|
|
|
94
|
|
Adempas
|
—
|
|
|
57
|
|
|
57
|
|
|
—
|
|
|
53
|
|
|
53
|
|
|
—
|
|
|
113
|
|
|
113
|
|
|
—
|
|
|
100
|
|
|
100
|
|
Diabetes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Januvia
|
413
|
|
|
441
|
|
|
854
|
|
|
471
|
|
|
437
|
|
|
908
|
|
|
768
|
|
|
860
|
|
|
1,628
|
|
|
855
|
|
|
877
|
|
|
1,732
|
|
Janumet
|
143
|
|
|
348
|
|
|
490
|
|
|
166
|
|
|
366
|
|
|
533
|
|
|
256
|
|
|
737
|
|
|
993
|
|
|
333
|
|
|
730
|
|
|
1,063
|
|
Women’s Health
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Implanon/Nexplanon
|
87
|
|
|
44
|
|
|
132
|
|
|
136
|
|
|
48
|
|
|
183
|
|
|
237
|
|
|
90
|
|
|
326
|
|
|
285
|
|
|
98
|
|
|
382
|
|
NuvaRing
|
35
|
|
|
28
|
|
|
63
|
|
|
206
|
|
|
34
|
|
|
240
|
|
|
61
|
|
|
65
|
|
|
126
|
|
|
391
|
|
|
68
|
|
|
459
|
|
Diversified Brands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Singulair
|
4
|
|
|
96
|
|
|
100
|
|
|
8
|
|
|
153
|
|
|
160
|
|
|
9
|
|
|
246
|
|
|
255
|
|
|
13
|
|
|
338
|
|
|
352
|
|
Cozaar/Hyzaar
|
4
|
|
|
94
|
|
|
98
|
|
|
6
|
|
|
103
|
|
|
109
|
|
|
12
|
|
|
189
|
|
|
200
|
|
|
10
|
|
|
202
|
|
|
213
|
|
Arcoxia
|
—
|
|
|
65
|
|
|
65
|
|
|
—
|
|
|
75
|
|
|
75
|
|
|
—
|
|
|
135
|
|
|
135
|
|
|
—
|
|
|
149
|
|
|
149
|
|
Nasonex
|
4
|
|
|
45
|
|
|
49
|
|
|
(1
|
)
|
|
73
|
|
|
72
|
|
|
10
|
|
|
110
|
|
|
120
|
|
|
(2
|
)
|
|
170
|
|
|
168
|
|
Follistim AQ
|
20
|
|
|
24
|
|
|
44
|
|
|
24
|
|
|
39
|
|
|
63
|
|
|
40
|
|
|
45
|
|
|
85
|
|
|
53
|
|
|
67
|
|
|
121
|
|
Other pharmaceutical (3)
|
385
|
|
|
720
|
|
|
1,103
|
|
|
369
|
|
|
837
|
|
|
1,203
|
|
|
792
|
|
|
1,500
|
|
|
2,293
|
|
|
697
|
|
|
1,589
|
|
|
2,283
|
|
Total Pharmaceutical segment sales
|
4,270
|
|
|
5,409
|
|
|
9,679
|
|
|
4,807
|
|
|
5,653
|
|
|
10,460
|
|
|
8,984
|
|
|
11,350
|
|
|
20,334
|
|
|
9,022
|
|
|
11,101
|
|
|
20,123
|
|
Animal Health:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Livestock
|
122
|
|
|
526
|
|
|
648
|
|
|
145
|
|
|
526
|
|
|
671
|
|
|
284
|
|
|
1,102
|
|
|
1,386
|
|
|
261
|
|
|
1,021
|
|
|
1,282
|
|
Companion Animals
|
220
|
|
|
233
|
|
|
453
|
|
|
190
|
|
|
263
|
|
|
453
|
|
|
442
|
|
|
486
|
|
|
928
|
|
|
367
|
|
|
500
|
|
|
867
|
|
Total Animal Health segment sales
|
342
|
|
|
759
|
|
|
1,101
|
|
|
335
|
|
|
789
|
|
|
1,124
|
|
|
726
|
|
|
1,588
|
|
|
2,314
|
|
|
628
|
|
|
1,521
|
|
|
2,149
|
|
Other segment sales (4)
|
—
|
|
|
—
|
|
|
—
|
|
|
47
|
|
|
—
|
|
|
48
|
|
|
23
|
|
|
—
|
|
|
23
|
|
|
86
|
|
|
—
|
|
|
87
|
|
Total segment sales
|
4,612
|
|
|
6,168
|
|
|
10,780
|
|
|
5,189
|
|
|
6,442
|
|
|
11,632
|
|
|
9,733
|
|
|
12,938
|
|
|
22,671
|
|
|
9,736
|
|
|
12,622
|
|
|
22,359
|
|
Other (5)
|
22
|
|
|
70
|
|
|
92
|
|
|
4
|
|
|
125
|
|
|
128
|
|
|
38
|
|
|
220
|
|
|
258
|
|
|
12
|
|
|
206
|
|
|
216
|
|
|
$
|
4,634
|
|
|
$
|
6,238
|
|
|
$
|
10,872
|
|
|
$
|
5,193
|
|
|
$
|
6,567
|
|
|
$
|
11,760
|
|
|
$
|
9,771
|
|
|
$
|
13,158
|
|
|
$
|
22,929
|
|
|
$
|
9,748
|
|
|
$
|
12,828
|
|
|
$
|
22,575
|
|
U.S. plus international may not equal total due to rounding.
|
|
(1)
|
Alliance revenue represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs (see Note 3).
|
|
|
(2)
|
Alliance revenue represents Merck’s share of profits from sales in Bayer’s marketing territories, which are product sales net of cost of sales and commercialization costs (see Note 3).
|
|
|
(3)
|
Other pharmaceutical primarily reflects sales of other human health pharmaceutical products, including products within the franchises not listed separately.
|
|
|
(4)
|
Represents sales for the Healthcare Services segment. All the businesses in the Healthcare Services segment were divested as of March 31, 2020.
|
|
|
(5)
|
Other is primarily comprised of miscellaneous corporate revenues, including revenue hedging activities, as well as third-party manufacturing sales. Other in the first six months of 2020 and 2019 also includes approximately $85 million and $15 million, respectively, related to the sale of the marketing rights for certain products.
|
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)
Product sales are recorded net of the provision for discounts, including chargebacks, which are customer discounts that occur when a contracted customer purchases through an intermediary wholesale purchaser, and rebates that are 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 $3.0 billion and $2.9 billion for the three months ended June 30, 2020 and 2019, respectively, and $6.2 billion and $5.5 billion for the six months ended June 30, 2020 and 2019, respectively.
Consolidated sales by geographic area where derived are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
United States
|
$
|
4,634
|
|
|
$
|
5,193
|
|
|
$
|
9,771
|
|
|
$
|
9,748
|
|
Europe, Middle East and Africa
|
3,071
|
|
|
3,163
|
|
|
6,605
|
|
|
6,265
|
|
China
|
834
|
|
|
763
|
|
|
1,699
|
|
|
1,509
|
|
Japan
|
867
|
|
|
921
|
|
|
1,678
|
|
|
1,720
|
|
Asia Pacific (other than China and Japan)
|
666
|
|
|
716
|
|
|
1,394
|
|
|
1,461
|
|
Latin America
|
510
|
|
|
658
|
|
|
1,066
|
|
|
1,219
|
|
Other
|
290
|
|
|
346
|
|
|
716
|
|
|
653
|
|
|
$
|
10,872
|
|
|
$
|
11,760
|
|
|
$
|
22,929
|
|
|
$
|
22,575
|
|
A reconciliation of segment profits to Income before taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
($ in millions)
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Segment profits:
|
|
|
|
|
|
|
|
Pharmaceutical segment
|
$
|
6,560
|
|
|
$
|
7,115
|
|
|
$
|
14,036
|
|
|
$
|
13,690
|
|
Animal Health segment
|
407
|
|
|
405
|
|
|
885
|
|
|
820
|
|
Other segment
|
—
|
|
|
(2
|
)
|
|
2
|
|
|
—
|
|
Total segment profits
|
6,967
|
|
|
7,518
|
|
|
14,923
|
|
|
14,510
|
|
Other profits
|
61
|
|
|
94
|
|
|
200
|
|
|
124
|
|
Unallocated:
|
|
|
|
|
|
|
|
Interest income
|
14
|
|
|
75
|
|
|
39
|
|
|
164
|
|
Interest expense
|
(209
|
)
|
|
(233
|
)
|
|
(421
|
)
|
|
(442
|
)
|
Depreciation and amortization
|
(390
|
)
|
|
(427
|
)
|
|
(772
|
)
|
|
(786
|
)
|
Research and development
|
(1,994
|
)
|
|
(2,093
|
)
|
|
(4,092
|
)
|
|
(3,935
|
)
|
Amortization of purchase accounting adjustments
|
(299
|
)
|
|
(378
|
)
|
|
(594
|
)
|
|
(775
|
)
|
Restructuring costs
|
(83
|
)
|
|
(59
|
)
|
|
(155
|
)
|
|
(212
|
)
|
Other unallocated, net
|
(548
|
)
|
|
(1,238
|
)
|
|
(1,771
|
)
|
|
(2,322
|
)
|
|
$
|
3,519
|
|
|
$
|
3,259
|
|
|
$
|
7,357
|
|
|
$
|
6,326
|
|
Pharmaceutical segment profits are comprised of segment sales less standard costs, as well as selling, general and administrative expenses directly incurred by the segment. Animal Health segment profits are comprised of segment sales, less all cost of sales, as well as selling, general and administrative expenses and research and development costs directly incurred by the segment. For internal management reporting presented to the chief operating decision maker, Merck does not allocate the remaining cost of sales not included in segment profits as described above, research and development expenses incurred in Merck Research Laboratories, the Company’s research and development division that focuses on human health-related activities, 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 other intangible asset impairment charges, gains or losses on sales of businesses, expense or income related to changes in the estimated fair value measurement of liabilities for contingent consideration, and other miscellaneous income or expense items.
Notes to Condensed Consolidated Financial Statements (unaudited) (continued)