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

Dr. Dean Li: Thank you very much. So, first, I don’t want to get ahead too much of our March 6 Investor meeting where we are least showing the data that we have in relationship to the oral PCSK9 and sotatercept. I will just sort of emphasize what we are trying to accomplish and what we are trying to accomplish is we are trying to accomplish the most potent LDL lowering oral pill for lowering cholesterol. There should be no co-chain, there should be very little need to interact with the healthcare system, which makes it reach very easy and very accessible, not just in the U.S. but globally. And we need to do it at a price point of what I would call a branded oral medicine would be not in order to maximize the access. In relationship with Phase 3, there’s a general set sort of view of how that is.

One is you would drive it, because LDL lowering is such a clean biomarker. So that’s something. But one would also have that, at the same time, drive towards outcomes, which is also going to be important. So our Phase 3 trial design is informed by the history of the field has been and what the FDA’s regulatory sort of outline have been for others.

Rob Davis: Great. Thank you, Louise. Next question, please, Kelly.

Operator: Our next question comes from Tim Anderson from Wolfe Research. Tim, your line is open.

Tim Anderson: Thank you. If I could ask you a question on V940 cancer vaccine, what tumor types outside of melanoma, do you already have any positive human data and even if those are earlier stage? And if you don’t have any human data in nonmelanoma tumor types, can you talk about animal data? I am trying to obviously think about what Phase 3 trials you may be starting in 2023 with that product? Thank you.

Dr. Dean Li: Thank you very much. So you are speaking about the wonderful partnership that we have with Moderna in the personalized cancer vaccine. I just want to preface everything. What we have released is topline data in melanoma. That data will be presented sometime in the near-term where we present the data that we have for melanoma and we have work to do to move that into Phase 3. So I — we have a lot of work to do just in melanoma. I am not going to speak ahead of a human data we have outside of that. But I would say two things that are really important. One is one can watch which of the tumors have sensitivity to an immune approach and one can watch about the clinical development with KEYTRUDA to sort of map out where you would think about doing that.

The second issue that I would emphasize is that, when we are talking about an IO-IO strategy, which often people speak about, I view this personalized neoantigen therapy as an IO-IO strategy with KEYTRUDA. And the reason I want to emphasize that is, there is a view that we are beginning to develop that IO-IO strategies may be especially useful in early cancer stages and you see that in our interest in our combination projects related to checkpoint inhibitors, but also in relationship to personalized neoantigen therapy. And so we think that, that’s around that we are going to advance and the critical component for us to be able to advance that is to advance KEYTRUDA as a monotherapy in indications, because it creates us to actually do these clinical trials.

Rob Davis: Great. Thank you, Tim. Next question please, Kelly.

Operator: Our next question comes — Geoff from Bank of America. Geoff, your line is open.

Geoff Meacham: Great. Good morning, guys. Thanks for the question. Dean, on subcu feature, can you talk about the cadence of data this year and what you are ultimately looking for from a risk/benefit perspective, as you evaluate different technologies? And Rob, I wasn’t sure where this program ranks on kind of your strategic priorities across IO? Thank you.