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 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 ovarian and breast cancer. 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 (durvalumab). The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer. Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialization costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities.

Gross profits from Lynparza and selumetinib product sales generated through monotherapies or combination therapies will be shared equally. Merck will fund all development and commercialization costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialization costs of Imfinzi in combination with Lynparza or selumetinib. AstraZenca is currently the principal on Lynparza sales transactions. Merck is recording its share of product sales of Lynparza, net of costs of sales and commercialization costs, as alliance revenue within the Pharmaceutical segment 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 and is making payments of $750 million over a multi-year period for certain license options ($250 million was paid in December 2017, $400 million will be paid in 2018 and $100 million will be paid in 2019). The Company recorded an aggregate charge of $2.35 billion in Research and development expenses in 2017 related to the upfront payment and future license options payments. In addition, Merck will pay AstraZeneca up to an additional $6.15 billion contingent upon successful achievement of future regulatory milestones of $2.05 billion and sales-based milestones of $4.1 billion for total aggregate consideration of up to $8.5 billion.

During the fourth quarter of 2017, based on the performance of Lynparza since the formation of the collaboration, Merck determined it was probable that annual sales of Lynparza in the future would exceed $250 million, which would trigger a $100 million sales-based milestone payment from Merck to AstraZeneca upon achievement of the sales milestone. Accordingly, in the fourth quarter of 2017, Merck recorded a $100 million liability and a corresponding intangible asset and also recognized $4 million of cumulative amortization expense within Materials and production costs. The remaining intangible asset will be amortized over its remaining estimated useful life of 11 years, subject to impairment testing. The remaining $4.0 billion of potential future sales-based milestone payments have not yet been accrued as they are not deemed by the Company to be probable at this time.

Also, in January 2018, Lynparza received approval in the United States for the treatment of certain patients with metastatic breast cancer, triggering a $70 million milestone payment from Merck to AstraZeneca. This milestone payment will be capitalized and amortized over the remaining useful life of Lynparza.

Summarized information related to this collaboration is as follows:



Year Ended December 31	2017
Alliance revenues (net of commercialization costs)	$	20

Materials and production costs	4
Marketing and administrative expenses	1
Research and development expenses	2,419

Receivables from AstraZeneca	12
Payables to AstraZeneca	643

Expenses do not include all amounts attributed to activities related to the collaboration, rather only the amounts relating to payments between partners. Amounts in materials and production costs include amortization of related intangible assets.

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 equally share costs and profits from the collaboration and implemented a joint development and commercialization strategy. The collaboration also includes clinical development of Bayer’s vericiguat, which is in Phase 3 trials for worsening heart failure, as well as opt-in rights for other early-stage sGC compounds in development by Bayer. Merck in turn made available its early-stage sGC compounds under similar terms. Under the agreement, Bayer leads commercialization of Adempas in the Americas, while Merck leads commercialization in the rest of the world. For vericiguat and other potential opt-in products, Bayer will lead commercialization in the rest of world and Merck will lead in the Americas. For all products and candidates included in the agreement, both companies will share in development costs and profits on sales and will have the right to co-promote in territories where they are not the lead. In 2016, Merck began promoting and distributing Adempas in Europe. Transition from Bayer in other Merck territories, including Japan, continued in 2017.

In 2016, the Company determined it was probable that annual sales of Adempas would exceed $500 million triggering a $350 million payment from Merck to Bayer. Accordingly, in 2016, the Company recorded a $350 million liability and a corresponding intangible asset and also recognized $50 million of cumulative amortization expense within Materials and production costs. The remaining intangible asset is being amortized over its then-remaining estimated useful life, subject to impairment testing. In 2017, annual sales of Adempas exceeded $500 million triggering the $350 million milestone payment from Merck to Bayer, which will be paid in the first quarter of 2018. There are $775 million of additional potential future sales-based milestone payments that have not yet been accrued as they are not deemed by the Company to be probable at this time.

Summarized information related to this collaboration is as follows:



Years Ended December 31	2017		2016		2015
Net product sales recorded by Merck	$	149	$	88	$	—
Merck’s profit share of sales in Bayer's marketing territories	151		81		30
Total sales	300		169		30

Materials and production costs	99		133		67
Marketing and administrative expenses	27		26		3
Research and development expenses	96		45		3

Receivables from Bayer	33		—
Payables to Bayer	352		353