Merck & Co., Inc. (NYSE:MRK) Morgan Stanley 22nd Annual Global Healthcare Conference September 5, 2024 2:35 PM ET
Company Participants
Rob Davis – Chairman and CEO
Dean Li – President of Merck Research Laboratories
Conference Call Participants
Terence Flynn – Morgan Stanley
Terence Flynn
Good afternoon, everybody. Thanks for joining us. Terence Flynn, US Biopharma Analyst at Morgan Stanley. Before we get started, for important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. Very pleased to be hosting Merck this afternoon. Joining us from the company, we have Rob Davis, who’s the company’s Chairman and CEO; and Dean Li, who is Head — President of Merck Research Laboratories. But, thank you both so much for carving time out to join us today.
Maybe, Rob, I’ll turn it over to you to kind of frame things out for us before we dive into my questions. But thanks again.
Rob Davis
Great. Well, no, thank you. Thanks for hosting us, and thank you for joining us all here in the room. Maybe just a few comments to set context and we can jump into the discussion.
Dean and I often reflect on — we’re about a little over three years in our respective roles since we started running the show, if you will, at Merck. And we reflect on how are we making progress, how good do we feel. And I just wanted to share some statistics because I think it’s helpful. As we think about why you hear from us, the confidence as we look long term, and to be very clear, we continue to focus long term in the business. I’ll speak about the short term, and I know we’ll talk a little bit about GARDASIL in a moment, but maybe to keep the context.
As we look at where we were a little over three years ago, we have nearly tripled the number of Phase 3 assets we have, unique assets in Phase 3. We have about 21 now unique assets in Phase 3. That’s nearly triple where we were just three years ago. Over eight of those come from business development. We feel very good about both our ability to augment the pipeline, and many of those come from our internal pipeline, which really reflects what Dean has been able to accomplish in accelerating the program. The other important thing to note, as we look forward, we will be launching in the next five years nearly as many new drugs as we launched in the last 10. And importantly, as I talk about those 21 programs moving into Phase 3, the vast majority, we think, have blockbuster plus potential.
So as we sit here today and continue to reflect on where we are in our journey to really putting Merck in a position to be a sustainable growth driver well into the next decade, my confidence continues to be high as does my confidence in the short-term performance of the company as well. We’re having a good year. The company is continuing to perform. If you look back at in our last quarter, we raised guidance. We’re now expecting 8% to 10% growth from revenue on an ex-exchange basis for the full year. So we’re continuing to deliver good short-term growth while we’re continuing to make important investments in our R&D pipeline for the long term. So I just want to set that context. We can dive into the details and give you an update on what we’re seeing in the market. But I just thought that would help to set context and maybe drive some of the questions as we think about the pipeline looking forward.
Question-and-Answer Session
Q – Terence Flynn
Absolutely. I appreciate that, Rob. And I guess the one follow-up there is just as you look at the opportunity set and what you’ve already done, how much more do you feel you have to go here? Do you have enough substrate? That’s kind of the first part of the question. The second is, when I look at your approach versus maybe some of your peers and other companies, it seems like you guys have leaned in maybe somewhat more aggressively on kind of pre-Phase 3 or Phase 3 ready assets, more willing to take on some clinical risk as opposed to some other companies who may be adopted an approach where they’re looking for more derisked revenue-generating assets. So first, how much more do you have to do? And then number two, should we expect kind of a similar approach when you think of Prometheus, Acceleron, those type of deals. Is that still the kind of color of things that you’re thinking about?
Rob Davis
No, I appreciate the question. And to the first part of the question, obviously, I think I just spoke to the progress. I don’t think we’re done. You’re never done. There’s always an opportunity to continue to add, and we continue to be very committed to both adding to the depth and the breadth of our pipeline, obviously, a number of programs, but also across modalities and therapeutic areas. We’re very different in our therapeutic area reach in our modality today than just where we were four years ago. We will continue to build on that. But our strategy from a business development perspective remains unchanged. While we continue to be focused, our view has always been, science drives us to where we should go. We always first ask, is there an unmet need? And is there interesting science aimed at that need? Does it bring something to Merck and add to something we’re doing scientifically? Or importantly, can we bring something to it so that some of the parts is greater than the whole, if you will? And then if we see an alignment of that with value, we will act, and I think that’s been consistent. We continue to look in the range of anywhere between $1 billion and $15 billion. I did earlier say we would go from 0 to $15 billion. Dean was kind enough to ask if anyone had any $0 opportunities. Unfortunately, none were offered. So we’ve now raised it to $1…
Terence Flynn
We have some negative EV companies out there.
Rob Davis
Fair enough. Fair enough. But — so we’re going to continue that strategy. We have been, I think, thoughtful across the range of phases of development. Where we see interesting science, we’re willing to take a risk and move. We did that with Acceleron. That was based on the strength of the science. We did that a little bit with Prometheus as well. But we’re not foreclosed to commercial opportunities. It’s just that if we ever look at a commercial opportunity, it’s going to have to be one that also brings with it a compelling scientific story that we either bring something to or brings something to us. So we look across the entire spectrum. We continue to be interested in doing more deals. We will be disciplined. And we will continue as we look forward to look at how we can broaden our pipeline. And more to come, but I feel very good about the progress. It’s why you hear me talk about in other settings, we see us facing the KEYTRUDA situation now as more of a hill than a cliff because of all of what we’ve done in the last 3.5 years, thinking about we still have a few years yet to go.
Terence Flynn
Okay. Great. Maybe there’s two more follow-ups there before you dig into some of the products and pipeline. Just we’re kind of past the first round of IRA negotiated prices on the Part D side. As you think about the strategy that you’re pursuing, have you adapted at all now for a post-IRA world in terms of how you’re thinking about internal development, external opportunities? That’s kind of the first — maybe we’ll start there, and then I’ll go to the second one.
Rob Davis
Yes. So as we look at the IRA, I think, first and foremost, as you think about how we play in our business, important to understand, we assume the IRA is in place as it is written. We build those assumptions into both how we think about and prosecute our internal pipeline in the way we think about clinical development and how we think about value, both whether it’s an internal asset or an external asset. So every time we’re making a move either with an internal asset or externally, it’s assuming the IRA is in place and those economics inform our decision-making. I continue to believe that overall, the IRA will have a blunting effect. I continue to be concerned that it disproportionately disfavors small molecules to large molecules. So a lot of the concerns you’ve heard, I continue to have. But that said, it’s — the situation is the law of the land, if you will, and we are operating under those premises and feel like there’s still a great path to find opportunities for growth, albeit it does change the way we think about development, and it has changed the way we think about external opportunities as well.
Terence Flynn
And then last one on the environment, is it a buyer’s market or a seller’s market right now or is it too idiosyncratic?
Rob Davis
It continues to be idiosyncratic. I’ve said in the past, and it continues to be the case, it’s a little bit of the haves and the have-nots. For those companies that have compelling clinical data, once that comes into play, you see, obviously, there’s a lot of companies very focused on business development, and they continue to command very healthy premiums, but there clearly are others who are struggling. And I think that dynamic is — makes it very much more of an asset specific discussion than it does a macro discussion to the market.
Terence Flynn
Okay. Great. Well, obviously, as you alluded to, a lot of focus on GARDASIL coming out of the second quarter earnings call. Would love your latest perspective here just as you think about the dynamics in China. I mean, we talk to our team in China and put a note out in collaboration with them where it sounds like there’s an inventory dynamic at the CDC as kind of one piece of it, but there’s also some macro implications for, again, out-of-pocket drugs like GARDASIL. For example, that creates maybe some uncertainty on the demand side. So would just love your latest perspective as you think through kind of the puts and takes now that you’re a couple of months past earnings and how to think about the forward here as we go into 2025.
Rob Davis
Yeah, no, I’m happy to address that. I would start at the global level and say we continue to be very confident in the opportunity that GARDASIL presents, both in terms of the meaningful clinical effect it can have. Just as a statistic, we always — we’re at a financial conference, but we always should talk about the human impact here. You still have 1,000 women a day dying of cervical cancer globally, which is pretty amazing when you think this is a curable disease in the sense that you can prevent ever having it if you just have the GARDASIL vaccine. And so we remain very committed to bringing that vaccine to the market. Not to mention the fact that we still are only about a little less than 10% penetrated, and the market is 10% penetrated on a global basis. So the opportunity is still huge to make a positive impact in people’s lives and in turn, make a benefit for the business. As it relates to China specifically, we continue now to have confidence around where China is and where China is going to go. I would tell you that we have a good understanding of the dynamics of what’s happening in China. We are very focused on it, from me, from Caroline, our CFO, all the way down to our commercial organization, and we’re making progress. I think those are the important points to understand. As we sit here today, working with our partner, Zhifei, we’re very focused on how we can continue to address and drive demand in the marketplace. They are increasing their promotional resources across the market, both in terms of expanding presence in more points of vaccination as well as broadening the cities we touch, both within the Tier 1 to 3 and Tier 4 to 5. We are bringing incremental resources ourselves to help drive activation and education, all aimed at driving demand, and you’re going to continue to see that activity. As it relates to the inventory levels, as it relates specifically to GARDASIL, we believe you are seeing a normalizing of the inventory levels as it relates to GARDASIL in the marketplace. That is a good sign. They were never completely out of whack, but obviously, they had risen a little bit, and we’re seeing them come back to normal. That’s important. We are continuing to see a lower level of overall scientific engagement from the local provincial CDCs in the marketplace, and we think that’s probably going to continue for some period of time. We can speculate on what it is, but that is the fact that we’re seeing in the marketplace. That said, the opportunity is still significant. If you look at it from a Tier 1 to 3 city, we’re just over 40% penetrated. The market is 40% penetrated in the Tier 1 to 3s for the HPV vaccines. It’s about 30% penetrated for the Tier 4 and 5 cities, and that penetration is relative to a base of about 200 million, a little over 200 million females that are split roughly evenly between the Tier 1 and 3 and Tier 4 and 5 cities. So if you look at that, that means there’s still about 120 million or a little more than 120 million females who are within the eligible age range, who fit the economic and demographics of what we believe are people who would be interested in this vaccine and who we need to go activate demand. And we are investing in that, as I mentioned, but it’s going to take time. And we’re confident we’ll be able to do it. We’ve been doing it. We know how to do it, and that work is underway. We are very excited about the potential, assuming approval, to have the male indication, hopefully, early to mid next year. And that will be initially for G4, and over time, we think we will have both G4 and G9. Importantly, we will be the only company with a male indication for some period of time, and we’re going to take advantage of that opportunity to try to bring the same benefit for the males as the females. I think one thing that’s underappreciated about GARDASIL is there are a lot of HPV-related cancers beyond just cervical cancer. For instance, in the United States, head and neck cancer, we have approval for. Head and neck cancer is a prevalent cancer in Asia. It is a predominantly male cancer. So this is more than just protecting the female, this is protecting both genders. We’re going to stress that as we drive that market. We’re excited about that. As you think about the female population, obviously, we had always expected that as you work through the bolus when we expanded to the age range up to 45 that you would see that peak and then start to decline over time and then stabilize to a base. And that is effectively what is happening. And then the growth would then come from the male indication. So the male indication will be important as a driver of growth with a solid base of females continuing, and we’re confident we’ll be able to maintain a good share position in the face of a competitive landscape as we look forward. So that is the basis for why we continue to believe China will be a meaningful contributor. But I think we can’t lose sight of there’s so much more in the world to do than just China. It’s interesting. If you look at it, over the last few years, it’s really been a situation until very recently, we did not have the capacity to try to truly activate demand because we were limited in supply. As we recognized and made the investments in manufacturing to be able to free up capacity so we could actually be unconstrained, which we think we will be as we move into next year, we started the activities around the world to do more to drive gender-neutral vaccinations everywhere across the globe. Obviously, we see a highly penetrated market in the United States, but a lot of opportunity still in Europe, a lot of opportunity. We just talked about China. Japan is another meaningful opportunity. We’re going to drive that. We see a real opportunity to continue to penetrate in the mid-adults segment. And that is probably the single biggest growth opportunity in the near term. We’re investing behind that across the globe. And we’ve just started those efforts through Europe, through South Asia and continuing to drive in the United States. And then we have the low and middle income countries, which we’ve never really been able to fully satisfy because we didn’t have the product. So if you look at all of those levers and then layer on top of China, we have multiple levers that give us confidence that we can take this business from $9 billion, which is where it was at the end of 2023 to $11 billion by 2030. And that’s why we continue to talk about achieving that $11 billion target by 2030.
Terence Flynn
Okay. That’s great. I’ve got a few follow-ups. So the first one, maybe just to level set, you mentioned the 30% to 40% penetration in China amongst women in kind of Tier 1 through five cities. How does that compare to US and how does it compare to Europe, just to give us kind of like the level which it maybe could get to at some point?
Rob Davis
Yeah. So if you look in the US, and it depends on where you do the age cutoffs, obviously. But if you look in the US, at Page 15, we’re probably in the 80s, high 80s for females in the US. If you get into the mid adults, it starts to fall down to probably the — I’d look at Caroline, it’s 60% to 70% range. So we still have a meaningful opportunity to drive from where we are today in that market. And then Europe sits just a little bit behind. So if we were in the 80s in the US, Europe is in that 60% to 70% range. So there’s still a meaningful opportunity both for females and males. Males are going to be harder to activate, but we still think there’s a meaningful opportunity and we’ve shown around the world that you can do that. And I think highlighting the fact that it is related to HPV-related cancers and increasingly making that message understood really drives an important message because head and neck cancer is a growing cancer. The reality is cervical cancer rates are declining in part because of the success of our vaccination programs. Head and neck cancers are on the rise. So there’s more to do with HPV-related cancers out there.
Terence Flynn
Okay. And I’m sure that’s part of the message on the male side, too. So when we look at the comparable numbers in China, so 220 million women was the eligible population, what is the male segment roughly?
Rob Davis
We think it’s about — it’s probably — it’s a little bit larger, but for ease of math, say it’s roughly another 200 million. We actually think it’s maybe a little bit larger than that.
Terence Flynn
And any proxies to think about like what that penetration could look like? Because, again, I would assume it would be higher in women than men, but is it…
Rob Davis
Yeah. So maybe this one would be a good one to really focus, because we’re going to be focusing first on going after the younger cohort. So I’ll just look to the age — cohort. So if you look in the US, again, I mentioned for females, you’re in that mid to high 80s and up to age 15 with a single vaccination. So this — and the reason we relay it that way is the WHO’s guideline, what they strive for is 90% vaccination with a single vaccine to achieve elimination. That’s the target that’s been set. So that’s kind of what everyone is looking at, including China as part of the Healthy 2030. In the United States, mid-80s for female, it’s actually mid-80s for male and up to age 15 for their first dose as well. If you look in Europe, it’s that 60 to 70 for females, that’s 40 to 60 for male. So there’s more opportunity to bring up the neutral vaccinations, the male vaccinations in Europe. But both of those obviously set bars that are significantly higher than, I think, what people would expect and say there’s a real opportunity in China. Even if you assume culturally, it’s going to be harder to drive this in China than maybe other markets, combining the fact that we’re looking at it as truly affecting all HPV-related cancers and the importance of family in China and making that the message to go after the boys, we think you’re going to be able to get a meaningful percentage, although it will probably be less and take longer to get to where we are in the Western countries.
Terence Flynn
Okay. As we think about back half of ’24, obviously, you guys, you mentioned you raised guidance in conjunction with 2Q results, but there was this uncertainty on GARDASIL. So now that you have more visibility, should we expect to see a rebound of inventory levels? Does that give you more confidence in back half picture of the year here? Or again, are there still other moving pieces? I mean, how do you think about kind of back half cadence here for that business in the context of what you knew when you upgraded the guidance on 2Q?
Rob Davis
I would say that our confidence in the guidance we gave is every bit where it was. And so we feel very good about the guidance as we’ve continued to learn more. And as I said, we feel like we have a good handle. So we’re very confident in the guidance we’ve given, and that includes the assumptions around the inventory levels for GARDASIL.
Terence Flynn
Yeah. And then as you look out to that $11 billion, you expressed confidence here in multiple levers. Is there any way you could kind of rank order for us those drivers as you think about the attainment of that level? I mean, again, I know it’s already a $9 billion business. But how do you think about like the biggest drivers of getting to that $11 billion?
Rob Davis
Yeah. I mean, it will be different over time. In the near term, I think being able to go after the private market across the globe, which is the mid-adult segment, is a near-term very big opportunity. It’s going to take us longer to be able to go into the low and middle income. So earlier on, we’re very focused on driving the private market. We’re very focused early — there’s still real opportunity to drive for completion rates. If you noticed, I was very careful to talk about to first vaccination. Remember, in every market, this is really — it’s a two-dose vaccination depending on your age. It’s either two doses or three doses to completion. So we want to drive to get to vaccination completion in the United States. There’s a real opportunity if we can get to younger cohorts, so we’re starting to look at the age nine cohort to drive for vaccine completion. So that is a strategy where anywhere where we have a public program, we’re going to drive that. That’s going to be a major add. And then the gender neutral, those are the three big near term. Longer term is the low and middle income opportunity.
Terence Flynn
Yeah. Okay. And then again, the lower middle income, the price point would be somewhat lower.
Rob Davis
The price point will be lower, and part of our strategy is to drive down. We have a plan in place to bring down our manufacturing costs, which we’re advancing on track. And we believe that will open up our ability to go after a big part of that segment.
Terence Flynn
And remind us, manufacturing, I know you guys have made a ton of progress here. What size capacity you brought on, again, assuming that at a minimum, that contemplates the $11 billion, but assuming you have capacity to go above that if demand…
Rob Davis
We have — as we get into — we’re not yet there, because it’s kind of stepping itself up. But as we get into ’25 and beyond, we have capacity to meet full levels. We’re not — we will not be constrained.
Terence Flynn
Okay. Great. All right. Well, just in the interest of time, I know there’s a lot of other things going on at Merck, but that’s obviously top of mind for folks. So, thank you. WINREVAIR launch, obviously, coming out of the Acceleron acquisition, had a very strong first quarter. Maybe just talk to us about the ramp into second half, any of the puts and takes that we need to consider here. And then I think another area that you’re starting to talk some more about is the European opportunity where I know historically, that geography was smaller than the US, but maybe you guys have a different view of how that could play out here on the forward.
Rob Davis
Yeah. So if you look — maybe just this will be a much easier answer than GARDASIL. So if you look at where we are, the short answer, I’ll give the takeaway first, which is everything is on track to our high expectations for the launch of WINREVAIR. If you look at the pieces, prescriptions, we were at 2,000 total prescriptions as of the second quarter. I’m not going to give specifics, but we’re seeing good growth, consistent growth with what we would want to see. We’re seeing that being translated to patients getting therapy actually provided. We read 1,000 as of the second quarter. That also was ramping ratably right as long as you would expect. So prescriptions being written, translating to patients getting drugs are moving exactly as we would hope. In many ways, in fact, the reimbursement we’re seeing is doing better. So we’re getting more patients get through the reimbursement system than we had initially anticipated. That is a positive, I think, speaks to the access strategy we put in place. As we look at the prescribers, both the breadth, so the number of prescribers is growing nicely as is the depth. And by that, I mean the number of scripts they’re writing. So we are now starting to see more doctors write multiple scripts. So you’re seeing that grow as you would hope it would. And then overall, as we think about it from the position or the patient perspective, good experiences, good — no issues, no safety concerns cropping up. So if each of the pieces, whether you’re talking about payer, you’re talking about the prescribers, the prescriptions or the patients, everything is pretty much moving consistent with the high expectations we came into the year with. So I feel good about where we are. And then as it relates to Europe, we did get approval for Europe. And if you look, it’s actually a strong label. It allows for in-home administration, which is important. And we believe the opportunity is significant in Europe. When we originally came into this, we thought if you look at kind of the makeup, the US was roughly 40,000 patients. We would say the US or Europe and Japan kind of about double that. So you’re looking at 80,000, 90,000 patients. China, by the way, is a big opportunity as well, and we do expect to bring it to China. So that’s a future growth driver for China. But — so you look at it, so while Europe is not quite as big as the US because I included Japan in that, it’s close. And it’s — and the excitement we’re hearing from key opinion leaders is there. So with the label we have, we’re excited. You’re going to see us launch first in Germany and Austria because those markets, you can launch at the time of approval. Beyond that, we have to wait for the reimbursements system to work through. So really, that will all happen next year. So really, Europe is going to be a ’25 message more than the ’24 message, but all facts are moving in line with what we’d hope, and we feel good, as I said, about the label we have.
Terence Flynn
Okay. Great. What — I know you’re conducting some other studies and one of those potentially could move this into the first-line study. Maybe, Dean, you could just remind us of kind of progress with enrollment there and timelines. And then is it possible you see usage earlier in the paradigm before we get that data as doctors gain comfort or is that something because of reimbursement, we just shouldn’t consider?
Dean Li
Well, in terms of the label in the US, the label in the US is extremely broad, so that these — you’re talking about ZENITH and HYPERION, that covers that patient population in the label. But I think as physicians get more used to using this in their most sick patients and as there is more data flow, that there will be increased use in earlier stages. And I think for us, it’s looking at ZENITH. One thing that’s not in our label right now is a clear mortality benefit in the label. And if we can achieve that, that could be very important. Clearly HYPERION working in earlier stages will also help as well. But also from a real-world data standpoint, people will begin to do that and get experience there. And then the last thing is, this is focused on PAH, pulmonary hypertension in relationship to pulmonary arterial hypertension. We also have a trial in sort of left heart failure in relationship to pulmonary hypertension, and we should be seeing some of that data in the ’25 range.
Terence Flynn
That’s the group two CADENCE study?
Dean Li
Yeah.
Terence Flynn
Okay. So that’s a ’25 readout. Okay. And what gives you — again, I mean, maybe you could just level set, what’s the level of confidence in that population? What’s the biologic rationale for why we should be optimistic?
Dean Li
Yeah. I mean the biologic rationale for PAH is really clear because of the genetics. But actually, if you look at it, there is substantial remodeling of the heart and this is in that PAH population. The question is whether it will move to a situation where there isn’t genetics, but where the preclinical evidence in terms of remodeling of the heart, whether you can translate from the preclinical models as well as the clinical experience with PAH. And I would say that that’s probably — that’s one more biologic hypothesis that has to be crossed. And so we’re really eager to see whether the effects that we see on the heart and the cardiovascular system plays out in the broader patient population.
Terence Flynn
And what is the size, like, roughly when you compare that to the group?
Dean Li
It’s a substantially bigger size. I mean it’s — PAH is 40,000. I mean it’s substantial. When you talk about individuals who have pulmonary hypertension who — due to heart failure, it’s a larger size.
Terence Flynn
Okay. Great. And I guess as we think about — is that kind of a first half or second half ’25 readout? Can be more specific?
Dean Li
Second half.
Terence Flynn
Okay. Great.
Rob Davis
We phoned a friend.
Terence Flynn
No problem. I have to do that with my team a lot, so I totally understand. Great. The other thing, just again, a lot going on, so not too much time left here. But the TL1A from Prometheus, I think this is an asset where you’re going to have some updated Phase 2 data potentially next month at UEGW. And so just as you think about what we can learn — what further can we learn from this next set of data? And then remind us on kind of Phase 3 plans and where that stands, because, again, another important pipeline asset for you guys.
Dean Li
Yeah. I mean our excitement about this is it will be induction and maintenance data. The excitement for us is that when you look at the data and you look at all the different mechanisms in those patients who are refractory from first-line treatment, you see TL1A as effective as the most effective medicines. The other effective medicines sometimes have a black label on it, a black box warning on it. We have — the data looks like it’s highly effective, as effective as the most but also as safe as the safest ones. And so we’re really interested to examine that in ulcerative colitis. There is evidence that TL1A may do something to fibrosis. So that will be very interesting to see whether that plays out in Crohn’s. And clearly, we want to test that hypothesis of fibrosis in lung disease as well. And so all of that will move forward. And as we think about it, we wonder whether TL1A will become a base sort of anti-cytokine therapy for this patient population and maybe a base for future combinations in the future.
Terence Flynn
So we’ll get both — I don’t think we’ve seen much Crohn’s data, is that right? But we will get…
Dean Li
Yeah, you’re going to see — that will be moving forward. But the ulcerative colitis for — Phase 3 for ulcerative colitis and Crohn’s disease are off. I think the data that’s going to come out the second half is going to be maintenance and relationships also with colitis. There may be some other data in relationship to biomarkers as well that comes out.
Terence Flynn
On the Crohn’s side?
Dean Li
On the ulcerative colitis.
Terence Flynn
Ulcerative colitis. So Crohn’s, we won’t get data.
Dean Li
You’re not going to get that much data in this second half. It will be mainly ulcerative colitis.
Terence Flynn
Okay. Understood. And then the biomarker, again, I think your Phase 3 isn’t all comers, but is there going to be anything new on kind of the biomarker — I know that something else that was kind of there in the background…
Dean Li
Yes, the way that I explained, a different group — I was in the biomarker group for PD-L1, TMB, MSI high and this. The only issue that I have with biomarkers is when you see someone with PD-L1 positive, you give it; when it’s negative, you don’t. When I look at the data for the biomarkers that we have seen so far for IBD, it’s — you get super responders, but even the ones who are negative have a really impressive response. So we need to be really thoughtful as to how one thinks about the biomarker. So the bottom line is, in all comers, the efficacy is as best as the best drugs out there in relationship to the same line of treatment. That’s where we focus on.
Terence Flynn
Okay. Okay. Great. Another area that you guys have had a long history in is the pneumococcal market. And you have several options now on the market. Again, I know you have a pipeline here as well. There was some competitor data out recently, earlier stage. But how do you see this market evolving kind of near term, medium term? And how do you see yourself competing given there are now more than two players, it seems like maybe potentially coming?
Rob Davis
Yes. So in the short term, we are very confident in what you’re going to see with CAPVAXIVE. Obviously, we received approval. You saw the ACIP in June, and we hopefully will be in a situation, we’ll be launching later this year with data that’s very strong. We show a coverage of 85% of the serotypes that cause disease in adults. That’s 35% better than the next closest competitor. So we continue to believe we will have a majority share position. With that, we need to see in October what comes as it relates to the 50- to 64-year-old population. If you recall at the ACIP, they delayed that decision until this coming October. That will be an important readout. And I think that, that also helps to inform the broader strategic question, because it’s — as people look at having a third competitor with potentially in the 90% serotype coverage today, with one around 50 and us at around 85, we have parity recommendations in the marketplace, I think, in many ways because to ensure you have choice and competitiveness and supply in the marketplace. So we need to see how that evolves. The 50 to 64 will inform that because that will affect how should you think long term when you have multiple competitors in the marketplace. Our belief is there will be room for multiple players, and that’s how we’re proceeding. But I know we don’t have a lot of time or Dean could go into it. But we also are watching, because as Dean has pointed out to us internally and we’ve pointed out to others, it’s not too hard for us to add additional serotypes to get into the 95 — 90-plus range if we think that’s a strategic value to do that. We need to see how the market evolves before we make that decision relative to the trade-offs of what that would imply.
Terence Flynn
Yes. Okay. Great. Last minute. Any other pipeline asset, Dean, do you want to just highlight for people that we should have in our radar?
Dean Li
MK-0616, the PCSK9 oral will be having data at ’25, ’26 range. And then the other point is we have islatravir with doravirine reading out Phase 3. You have islatravir with lenacapavir starting Phase 3. I would imagine that you could see us with islatravir with another molecule that’s wholly owned by us trying to be advanced for the treatment of HIV. And probably very importantly is we think we have the possibility of advancing a molecule MK-8527 for an oral two month prep, which will be very important for the United States, the EU, but will be extremely important for Africa, Southeast Asia and those countries as well.
Rob Davis
I think what Dean just hit upon is probably one of the underappreciated — people were very focused on HIV for us a few years ago, kind of moved away, and we’ve — credit to Dean, they continued to work, and we’re seeing some really solid results. So I think that it will become a growing story as we move forward.
Terence Flynn
Great. Well, thank you so much. Rob, Dean. I appreciate the time.
Rob Davis
Appreciate it. Thank you very much. Thank you.
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