Merck & Co., Inc. (NYSE:MRK) Q4 2022 Earnings Call Transcript

Andrew Baum: Hi. Thank you. A couple of questions, could you please address the demand on Merck’s business to 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 look at that, we expect those products, that portfolio of opportunity on an unrisk adjusted basis to be in excess of $10 billion as you approach the mid-2030s. We recently discussed the fact we see the business development deals we have done. We have brought in new assets apart from KEYTRUDA, apart from Lynparza, Lenvima and WELIREG, that themselves, these new mechanisms, I would point you to things like Orion and Imago, those products, along with what we see in the ADC space as a portfolio, we think themselves have the potential for $10 billion or more of revenue as you get into the early to mid-2030s.

So today we sit there with the expectation that we are starting to make meaningful progress and that excludes all the work we are doing to bring an incremental value to patients on KEYTRUDA. Obviously, as great as KEYTRUDA is, it still only has an overall response rate averaging around 30%. We need to deepen and drive better response. We are looking to do that through combinations and through other means to find ways to improve on KEYTRUDA. We are looking to continue to expand into new tumor types as well and clearly move into earlier lines of therapy where we believe we can start to move to a point that we can actually give people an extension of life, and hopefully, someday get to a point that we talk about cancer a chronic disease, not a fatal disease.