Merck & Co., Inc. (NYSE:MRK) Q4 2023 Earnings Call Transcript

It’s the way of thinking that we’ve discussed previously. And I would just add that it’s really important, there is also data out there where people are doing retrospective biomarker data in this. For us to demonstrate true efficacy in any patient population, we need a biomarker strategy that is prospective and one that can be easily actionable throughout the world. Thanks.

Peter Dannenbaum: Thank you, Terence. Next question please, Ivy?

Operator: Next, we will go to the line of Tim Anderson from Wolfe Research. Please go ahead.

Adam Jolly: Hi, thank you for taking our question. This is Adam on for Tim. On GARDASIL, a 2-dose regimen was recently approved in China. We’re wondering if that poses a revenue problem. Potentially, it doesn’t, if it just means that more supply gets spread out across more people, and Merck ends up selling just as many doses in total. Can Merck share its perspective here?

Rob Davis: Sure. Adam, thanks for the question. So there has actually been Chinese competitors with an offering for some time actually in the Chinese market. And that market is large. We continue to believe in the eligible cohorts in just the urban females, which was the Tier 1 to Tier 3 cities, is about 200 million – a little over 200 million women. And so of that, we think probably about 30% have actually received vaccination. So, you are still looking at 120 million, 130 million eligible population. As we look at this and as we have seen over time, we continue to be very competitive. We are maintaining a vast majority of share in the private market. And really, you are seeing most of the local competitors go to the lower-tier cities and to a different population than we have been targeting.

So, that does not change our view of the growth potential in China. Long-term, obviously we will continue to face competition there, and we are positioning ourselves to continue to succeed there. But the approval you are talking about is not changing our view.

Caroline Litchfield: The only add, if I may is we had significant opportunity to protect further females in China. At the end of 2023, we also submitted to the regulatory authorities our data on GARDASIL for males. So, we are hopeful to introduce that in the Chinese market in the future.

Peter Dannenbaum: Great. Thanks Adam. Next question please.

Operator: Next, we will go to the line of Mohit Bansal from Wells Fargo. Please go ahead.

Mohit Bansal: Great. Thank you very much for taking my question and congrats on the progress. Maybe one question on V116 as well. So, Pfizer has recently made comments around adult market shrinking at this point. So, could you comment on how do you see the peak opportunity for V116 in the context of adult market shrinking and then you are taking share from a shrinking market? Thank you.

Rob Davis: Yes. I will start and then Caroline can jump in as well. But I think as you look at the market size and the comments, I don’t want to speak to comments that others have made. I think it’s also important to understand that as we bring a vaccine which brings significant incremental coverage, at 83% versus, if you look at PCV20, just as an example, it’s closer to, I think about 30%. So, you are looking at significant incremental coverage, which I think it can have an impact on how you think both about catch-up to cover the disease. As Dean noted in his prepared comments, we have eight serotypes covering 30% of what is causing disease, which is unique to us. So, we think that, that will have implications both in terms of the catch-ups as well as potentially to be able to go for patients 50 and plus versus 65 and plus.

So, if you take all of those things into account, we still see this as a very large opportunity for us. Our view is it’s about an $8 billion market in ‘23. We anticipate it actually growing to be over $10 billion later in the decade. And with that being the pediatric segment of that is about 70%, so we are looking at 30% of that is what is the adult piece. So, as we see it, this is still a growing market, a good market. And we remain very confident that V116 will both have a majority share and be a meaningful contributor.

Peter Dannenbaum: Great. Thanks Mohit. Next question please.

Operator: Next, we will go to the line of Chris Schott from JPMorgan. Please go ahead.

Chris Schott: Great. Thanks for the question. Just a bigger-picture question on business development. The company has obviously been very active the past few years. And I am just trying to get a sense of just kind of size and stage of assets that you consider just given the current R&D investments you are making and the asset – the kind of the amount of capital you are allocating there. So, I guess specifically, are deals along the lines of an Acceleron or a Prometheus still deals that Merck would look at and prioritize, or at this point, should we be thinking about maybe earlier-stage assets that, that would be more of the focus? Thanks so much.

Rob Davis: Chris, thanks for the question. Obviously, first, I just want to reinforce the pride I have in what Dean and the team have been able to do and the meaningful progress we are making both in our internal pipeline and what we have been able to do through the business development, which is I think in some ways, in a weird way, underlying your question. But as we sit here today, while I feel very good about the progress we have made in the growing portfolio, the diverse and deep portfolio we have in our pipeline, we do continue to believe we need more, and we will continue to prioritize business development. And I would say that our views of deals like Prometheus, like Acceleron are still the size of deals we are very interested in, if we can find great assets.

So, clearly that’s an area of focus. But also continuing to do smaller deals as well, like what you saw with Harpoon. So, it’s going to be a range of deals. But I think as you look in that zero to kind of $15 billion, $1 billion to $15 billion, it continues to be where we will look for. And then obviously, we have also, I think shown that not only are we very open to doing an acquisition, but we see collaboration as an important tool as well, very similar to what we did with Daiichi Sankyo. So, we are going to be looking at the full suite and including deals that fit those categories.

Peter Dannenbaum: Great. Thanks Chris. Next question please.

Operator: Next, we will go to the line of Andrew Baum from Citi. Please go ahead.

Andrew Baum: Thank you. I was going to ask you about your expectations for the AI – ACIP recommendation on revaccination of prevent [ph] or vaccinated patients, but I suspect you may not want to share that view. So instead, maybe I could ask you about the first-line TROP2 SKB non-small cell trial that you are running in combination with KEYTRUDA. Some of the recently published academic data suggests that TROP2 internalization is a biomarker in patients who are primary resistant to PD-1. So, it just seems like an old population to be exploring the drug in, assuming that is real and not a fake signal. And I take completely the caveats that it’s retrospective data analysis in other settings. But given that, it would seem to be more sensible to have a combination with chemo and layering on top. And can you do this given the profile of the drug in terms of bone marrow suppression?