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Collaborative Arrangements | 9 Months Ended
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Sep. 30, 2021
Collaborative Arrangements [Abstract] |
Collaborative Arrangements | 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. For further details refer to Note 4 to the consolidated financial statements included in Merck’s 2020 Form 10‑K. AstraZeneca In 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. Independently, Merck and AstraZeneca will develop and commercialize Lynparza in combinations with their respective PD-1 and PD-L1 medicines, Keytruda and Imfinzi. The companies are also jointly developing and commercializing AstraZeneca’s Koselugo (selumetinib) for multiple indications. 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. 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 and also made payments 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. As of September 30, 2021, sales-based milestone payments accrued but not yet paid totaled $400 million. 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. Additionally, 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 $1.1 billion at September 30, 2021 and is included in Other Intangibles, Net. The amount is being amortized over its estimated useful life through 2028 as supported by projected future cash flows, subject to impairment testing. Summarized financial information related to this collaboration is as follows:
| Three Months Ended September 30, |  | Nine Months Ended September 30,
($ in millions) | 2021 |  | 2020 |  | 2021 |  | 2020
Alliance revenue - Lynparza | $ | 246 |  |  | $ | 196 |  |  | $ | 721 |  |  | $ | 519 |
Alliance revenue - Koselugo | 6 |  |  | 3 |  |  | 20 |  |  | 3 |
Total alliance revenue | $ | 252 |  |  | $ | 199 |  |  | $ | 741 |  |  | $ | 522 |
Cost of sales (1) | 42 |  |  | 41 |  |  | 125 |  |  | 205 |
Selling, general and administrative | 44 |  |  | 40 |  |  | 127 |  |  | 112 |
Research and development | 27 |  |  | 20 |  |  | 87 |  |  | 93 |
($ in millions) |  |  |  |  | September 30, 2021 |  | December 31, 2020
Receivables from AstraZeneca included in Other current assets |  |  |  |  | $ | 248 |  |  | $ | 215 |
Payables to AstraZeneca included in Accrued and other current liabilities (2) |  |  |  |  | 415 |  |  | 423 |
(1) Represents amortization of capitalized milestone payments. (2) Includes accrued milestone payments. Eisai In 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. 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 applicable 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 are shared by the two companies in accordance with the collaboration agreement and reflected in Research and development expenses. Certain expenses incurred solely by Merck or Eisai are not shareable under the collaboration agreement, including costs incurred in excess of agreed upon caps and costs related to certain combination studies of Keytruda and Lenvima. Under the agreement, Merck made an upfront payment to Eisai and also made payments over a multi-year period for certain options rights (of which the final $125 million option payment was made 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. Merck made sales-based milestone payments of $200 million to Eisai in the first nine months of 2021. As of September 30, 2021, sales-based milestone payments accrued but not yet paid totaled $600 million. Potential future sales-based milestone payments of $2.6 billion have not yet been accrued as they are not deemed by the Company to be probable at this time. In the third quarter of 2021, Lenvima received a regulatory approval triggering a capitalized milestone payment of $75 million from Merck to Eisai. Potential future regulatory milestone payments of $50 million remain under the agreement. The intangible asset balance related to Lenvima (which includes capitalized sales-based and regulatory milestone payments) was $1.0 billion at September 30, 2021 and is included in Other Intangibles, Net. The amount is being amortized over its estimated useful life through 2026 as supported by projected future cash flows, subject to impairment testing. Summarized financial information related to this collaboration is as follows:
| Three Months Ended September 30, |  | Nine Months Ended September 30,
($ in millions) | 2021 |  | 2020 |  | 2021 |  | 2020
Alliance revenue - Lenvima | $ | 188 |  |  | $ | 142 |  |  | $ | 498 |  |  | $ | 421 |
Cost of sales (1) | 49 |  |  | 46 |  |  | 143 |  |  | 215 |
Selling, general and administrative | 34 |  |  | 18 |  |  | 88 |  |  | 48 |
Research and development | 43 |  |  | 48 |  |  | 165 |  |  | 168 |
($ in millions) |  |  |  |  | September 30, 2021 |  | December 31, 2020
Receivables from Eisai included in Other current assets |  |  |  |  | $ | 223 |  |  | $ | 157 |
Payables to Eisai included in Accrued and other current liabilities (2) |  |  |  |  | 600 |  |  | 335 |
Payables to Eisai included in Other Noncurrent Liabilities (3) |  |  |  |  | — |  |  | 600 |
(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). The two companies have implemented a joint development and commercialization strategy. The collaboration also includes development of Bayer’s Verquvo (vericiguat), which was approved in the U.S. in January 2021, in Japan in June 2021 and in the EU in July 2021. Under the agreement, Bayer commercializes Adempas in the Americas, while Merck commercializes in the rest of the world. For Verquvo, Merck commercializes in the U.S. and Bayer commercializes in the rest of the world. Both companies share in development costs and profits on sales. Merck records sales of Adempas and Verquvo in its marketing territories, as well as alliance revenue. 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. Cost of sales includes Bayer’s share of profits from sales in Merck’s marketing territories. In addition, the agreement provides for contingent payments from Merck to Bayer related to the successful achievement of sales-based milestones. In the first quarter of 2021, following the approval of Verquvo noted above, Merck determined it was probable that sales of Adempas and Verquvo in the future would trigger the remaining $400 million sales-based milestone payment that was outstanding under this agreement. Accordingly, Merck recorded a liability of $400 million and a corresponding increase to the intangible assets related to this collaboration. Merck also recognized $153 million of cumulative amortization expense related to the recognition of this milestone in the first nine months of 2021. The intangible asset balance related to Adempas (which includes the acquired intangible asset balance, as well as capitalized sales-based milestone payments attributed to Adempas) was $869 million at September 30, 2021 and is being amortized over its estimated useful life through 2027 as supported by projected future cash flows, subject to impairment testing. The intangible asset balance related to Verquvo (which reflects the portion of the final sales-based milestone payment that was attributed to Verquvo) was $72 million at September 30, 2021 and is being amortized over its estimated useful life through 2031 as supported by projected future cash flows, subject to impairment testing. Summarized financial information related to this collaboration is as follows:
| Three Months Ended September 30, |  | Nine Months Ended September 30,
($ in millions) | 2021 |  | 2020 |  | 2021 |  | 2020
Alliance revenue - Adempas/Verquvo | $ | 100 |  |  | $ | 83 |  |  | $ | 248 |  |  | $ | 216 |
Net sales of Adempas recorded by Merck | 59 |  |  | 55 |  |  | 188 |  |  | 167 |
Net sales of Verquvo recorded by Merck | 2 |  |  | — |  |  | 3 |  |  | — |
Total sales | $ | 161 |  |  | $ | 138 |  |  | $ | 439 |  |  | $ | 383 |
Cost of sales (1) | 53 |  |  | 81 |  |  | 328 |  |  | 229 |
Selling, general and administrative | 31 |  |  | 12 |  |  | 84 |  |  | 32 |
Research and development | 16 |  |  | 12 |  |  | 36 |  |  | 53 |
($ in millions) |  |  |  |  | September 30, 2021 |  | December 31, 2020
Receivables from Bayer included in Other current assets |  |  |  |  | $ | 139 |  |  | $ | 65 |
Payables to Bayer included in Accrued and other current liabilities (2) |  |  |  |  | 467 |  |  | — |
(1) Includes amortization of intangible assets. Amount in the first nine months of 2021 includes $153 million of cumulative amortization as noted above. In addition, cost of sales in all periods now includes Bayer’s share of profits from sales in Merck’s marketing territories. (2) Includes accrued milestone payment.

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- Definition Collaborative Arrangements [Abstract] + References No definition available. + Details
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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (a) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (b) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -URI http://asc.fasb.org/topic&trid=5833765 + Details
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