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CLAIM #43240 · Merck & Company Inc (MRK) · 2022Q4 earnings call · Feb 2, 2023 · due Dec 31, 2028

KEYTRUDA and our expectation will lose exclusivity in the United States in 2028 and in China in 2028. It leaves it in Europe in 2030 and in Japan in 2032.

Rob Davis · CEO

PENDING
graded after results covering Dec 31, 2028 are reported

How to check this claim

Look at: Patent/exclusivity expiration dates for KEYTRUDA by major market (US, China, EU, Japan)

It came true if: US and China loss of exclusivity occurs in 2028; EU in 2030; Japan in 2032, as confirmed by regulatory/patent filings or company disclosure

Where: Company 10-K/10-Q patent expiration disclosures or management commentary on earnings calls

In context

the hole associated with the KEYTRUDA LOE post-2028 or alternatively instead just build the exit growth rate and focus less on finding revenues to plug the hole as you think about your strategy? And perhaps quickly for, Dean, could you just give us some guidance on the timing for the PFS analysis and the PD-L1 high, greater than 50 cohort from KEYVIBE-003. Should we expect it in the next 12 months? I know the total PFS reset for the whole trial is somewhere in 2024, but it strikes me you may have a mere separate analysis for that greater than 50 subgroup? Thank you. Rob Davis: Great. Well, maybe, Andrew, I will start off and if Caroline or Dean want to jump in. But to give you a sense, obviously, we haven’t given specific guidance to the LOE period. But just to ground everyone into facts, KEYTRUDA and our expectation will lose exclusivity in the United States in 2028 and in China in 2028. It leaves it in Europe in 2030 and in Japan in 2032. So, obviously, by shorthand, we refer to 2028, but the reality of it is over most of the markets and KEYTRUDA increasingly is becoming, as you know, a global product, it’s spread out. But as we look at where we sit today, I would say, we feel good about the progress we have made. We are confident that we are on a path to sustainable growth into the next decade. Obviously, we have more work to do, but I would just point to you to a few proof points that I think support that. First of all, as we talked about in the last 18 months, we have made meaningful progress in our cardiovascular pipeline. We have eight potential approvals between 2025 and 2030. Obviously, the centerpiece of that is sotatercept and what we are seeing from the STELLAR data, which really was just quite phenomenal. If you

Verify independently

SEC filings for MRK · Claim quote is verbatim from the 2022Q4 earnings call.