Merck : SASB Report

OUR 2020

SASB DISCLOSURE

2020 SASB Disclosure

of Merck KGaA, Darmstadt, Germany

This is our first Sustainability Accounting Standards Board (SASB) disclosure report that aligns with the SASB Biotechnology & Pharmaceuticals industry standard. Our reporting against the SASB standard is a voluntary disclosure to meet the increasing demands of our investors and other stakeholders. The disclosed metrics provide transparent, financially material, and meaningful information on sustainability. In order to fulfill the interests and requirements of our stakeholders in the future, we will continuously develop and expand our SASB reporting.

Sustainability Accounting Standards Board (SASB) Index

Biotechnology & Pharmaceuticals Standard

Our disclosure against the following SASB metrics essentially include our Group-wide approach. In case we refer to one particular business (e.g. our Healthcare business), we indicate this explicitly in our response.

Activity Metrics

HC-BP-000.A	Number of patients treated	In 2020, we treated around 92 million patients with our Healthcare
		medicines. Additionally, we donated enough praziquantel tablets to
		treat around 90.5 million school-aged children in 2020.
HC-BP-000.B	Number of drugs (1) in portfolio and (2) in research	For our Healthcare portfolio please see:
	and development (Phases 1-3)	-2020 Annual Report(p. 15-19)
		For our Healthcare pipeline please see:
		- ourwebsite
		-2020 Annual Report(p. 57-58)

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Safety of Clinical Trial Participants

HC-BP-210a.1	Discussion, by world region, of management process	See 2020 Sustainability Report:
	for ensuring quality and patient safety during	-	Clinical trials
	clinical trials	See our website:
		-	R&D Policies

HC-BP-210a.2 Number of FDA Sponsor Inspections related to clinical trial management and pharmacovigilance that resulted in: (1) Voluntary Action Indicated (VAI) and (2) Official Action Indicated (OAI)

In 2020 we had three FDA Good Clinical Practice (GCP) inspections related to clinical trials, none of which resulted in an VAI or OAI.

HC-BP-210a.3	Total amount of monetary losses as a result of legal	Not reported
	proceedings with clinical trials in developing countries
	[€]

	Access to Medicines
HC-BP-240a.1	Description of actions and initiatives to promote access	See 2020 Sustainability Report:
	to health care products for priority diseases and in	-Health for all
	priority countries as defined by the Access to
	Medicine Index

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HC-BP-240a.2 List of products on the WHO List of Prequalified Medicinal Products as part of its Prequalification of Medicines Programme (PQP)

Currently there is no product on the list.

Affordability & Pricing

HC-BP-240b.1	Number of settlements of Abbreviated New Drug	Not reported
	Application (ANDA) litigation that involved payments
	and/or provisions to delay bringing an authorized
	generic product to market for a defined time period.
HC-BP-240b.2	Percentage change in: (1) average list price and	Please see table on the average list price of our Healthcare US product
	(2) average net price across U.S. product portfolio	portfolio in the appendix.
	compared to previous year

HC-BP-240b.3 Percentage change in: (1) list price and (2) net price of product with largest increase compared to previous year

We only report the percentage change in average list price across our US product portfolio. The largest increase compared to the previous year amounted to 9.7% (Mavenclad®). Please see table in the appendix.

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Drug Safety

HC-BP-250a.1 List of products listed in the Food and Drug Administration's (FDA) MedWatch Safety Alerts for Human Medical Products database

See FDA website:

• Safety information and adverse event reporting program
• Adverse event reporting system (FAERS) public dashboard

HC-BP-250a.2	Number of fatalities associated with products as	See FDA website:
	reported in the FDA Adverse Event Reporting System	-Adverse event reporting system (FAERS) public dashboard
	[total number]
HC-BP-250a.3	Number of recalls issued, total units recalled	In 2020 we had six drug product recalls in total. None of those recalls
		was a global one, they affected individual countries only. One recall was
		related to the USA and only impacted a single batch of one product.
		None of the recalls was related to serious injury or fatality, all were
		either Class II or III. According to our internal policies, any recall type
		is reported and discussed with the relevant national regulatory
		authority, including the US FDA. All recall processes are managed under
		a Global Standard Procedure "Product Recall and Withdrawal
		Management" which is applied worldwide for medicinal products
		(pharmaceutical prescription, biological) and devices.

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