Merck & Co., Inc. (MRK) Earnings Call Transcript & Summary
December 5, 2024
Earnings Call Speaker Segments
Geoffrey Meacham
analystWelcome to the morning session of the first Annual Citi Global Healthcare Conference. My name is Geoff Meacham. I'm the senior biopharma analyst here at Citi. Mary Kate Davis from my team with me on stage as well. And we're thrilled today to open up with Merck. And speaking on behalf of Merck, we have Chairman and CEO, Rob Davis. Welcome.
Robert Davis
executiveThank you.
Geoffrey Meacham
analystAnd we have Eliav Barr, Senior VP, Head of Global Clinical Development and CMO. Welcome.
Eliav Barr
executiveThank you.
Geoffrey Meacham
analystSo Rob, let's just kick it off. Maybe bigger picture, we had Scott Gottleib here yesterday. We're talking about potential policy changes, IRA, et cetera. Give us your perspective on kind of what we may or may not expect looking into the next year. I realize that it's obviously pretty early in the process.
Robert Davis
executiveYes. Sure. Sure. So as we look forward with the new administration with the Trump administration coming in, I would say, first and foremost, we're very much focused on how can we work with the administration to improve overall focus on the ecosystem inhibition we bring, the value of the industry, the jobs we create, and to drive for improved health for patients. So I think there's a lot we have in common with the administration around that. . Clearly, the ability to focus on chronic diseases is something, as an industry, we've long been talking about, understanding both from prevention all the way through to treatment, as well as understanding the value of healthy lifestyles. So as you think about the continuum of care there, we're very much aligned with what we need to do there. Obviously, we continue to be concerned from an IRA perspective that -- particularly the kill penalty, the difference between small molecules at 9 years versus large molecules at 13, will lead to long-term bad outcomes as you think about innovation in the space. And are hopeful, given the makeup of Congress now, that maybe we can drive for some improvements in that area, and feel like there's a chance that we can get that done. And then obviously, we continue to want to make sure that patients get access to their medicines at affordable prices. And we continue to be very focused on PBM reform and the fact that we're the only system in the world where half of the profit goes to people that don't make, discover or in any way really are involved in the fundamentals of what bring these important medicines to market. So as I sit here today, I'm cautiously optimistic that we can get some good things done.
Geoffrey Meacham
analystAnd just a follow-up on that. I know Bobby Kennedy is -- assuming he's confirmed. He's been public about comments about vaccine safety and -- particularly in pediatric settings. Like what's your perspective on whether this adds extra risk to the vaccine franchise? You guys are one of the leaders in this field.
Robert Davis
executiveYes. Well, first and foremost, I would say we continue to strongly believe in the value of vaccines. If you think about it, they're probably from a prevention, they are the most effective and cost-effective means to prevent disease. Tens of millions of hospitalizations have been avoided. A million deaths have been avoided if you look over the last couple of decades. And you could argue, next to clean water, probably nothing else has had the impact -- positive impact on public health versus vaccine. So we continue to be very much in favor and supportive of the value that vaccines bring. And given the long track record we have, both from an efficacy perspective, but also from a safety perspective, we are very much confident in both the science behind our vaccines and the safety and effectiveness they bring. As you think about the administration and the focus. If you separate the pediatrics from the adults, on the pediatric vaccines basis, largely, that is a state- and local-driven exercise. States determine whether or not they're going to have mandates for vaccines. I think we all recognize that child vaccine -- childhood vaccines are critical. You think about something like measles. We've seen when measles rises up again, that's a devastating disease, and it will come quickly if we don't continue to see strong vaccinations in that area. So we're going to continue to support that. And I think if you look at the American Academy of Pediatricians, the president recently put out a statement on affording the value of pediatric vaccination. So while, obviously, the federal government plays an important role, as we look with -- given the strong fundamentals in the health care system among physicians and just with the established systems at a state level, I don't think you're going to see a lot of disruption there. On the adult basis, most of these are voluntary vaccines. They're not mandated vaccine. If you think about our vaccines, GARDASIL, hopefully soon. We're going to have clesrovimab, which is going to be a pediatric we can speak to, a monoclonal antibody. But then also we've got CAPVAXIVE and VAXNEUVANCE. So we believe, while you might hear noise, the fundamentals of what have driven that business, we still feel very confident in.
Geoffrey Meacham
analystWell, let's turn to GARDASIL. I think that has been one of the biggest uncertainties over the past couple of quarters, is the Chinese situation. So maybe just give us a status update on where we are there.
Robert Davis
executiveWell, maybe I'll just start by saying, overall, we continue to be very proud of what GARDASIL has done to combat cervical cancer around the world. We're still in a situation where 1,000 women a day globally earning from cervical cancer, which is a completely preventable disease. And so that's something we need to keep at the front and center and keep driving for the importance of getting this vaccine. And if you look across the total of our business, we're seeing strong growth overall around the world, double-digit growth in really nearly every region other than China. And obviously China itself, we have seen the slowdown that's happening there. We understand the fundamentals of what's happening. We are very focused on that with our partner, Zhifei, making good progress and bringing incremental resources to bear to drive and activate demand. We have seen demand slow, but it is stabilizing. And we believe that the opportunity there is still significant and it's just going to take time for us to activate it. There's still 120 million women in the Tier 1 to 5 cities to be vaccinated. And hopefully, we'll have male indication coming soon. We filed. That is moving through. We would expect, hopefully, to see approval of the male indication in China in the early part of next year. And that obviously opens up a new market. We'll be the only company, we believe, with a male indication in China. And there's about 200 million men and boys in that same age kind of -- or that same city cohort of the Tier 1 to 5 cities. So large opportunity in China. And then we're going to continue to build on that, driving for continued growth outside of China, where now that we have capacity, we're really putting on a full court press around consumer activation.
Geoffrey Meacham
analystWould you say the supply/demand situation in China could be more normalized in '25, first half, second half of the year? Or is it still early to tell at this point?
Robert Davis
executiveIt's too early to tell. But I maybe just reflect back on the guidance we gave at the third quarter. So if you look in the third quarter, we had indicated we had sold about $500 million of vaccines into China. And remember, we book the sale when we ship into the country. And then our partner, Zhifei, is actually responsible for on-selling into the marketplace. We at that time communicated we'd expect roughly the same number of shipments in the fourth quarter, which are both reduced levels from where we were in the first half of 2024. So that's about another $500 million you'd expect in revenue in the fourth quarter. And then as you look into 2025 and over the next several years, we had guided 200 -- roughly $2 billion to $3 billion, in that range, really at the low end of that and closer to the $2 billion as you look at 2025. So you will see a decline in China in 2025, and then it growing off of that with the male indication as that fully comes on. But with that, I think the important point I just want to make, we have a strong portfolio overall. And with even that decline in China next year, you're going to see overall solid growth for Merck. So it's something we're managing. I'd still completely believe we're on track to deliver the $11 billion. Based on what we're seeing everywhere else outside of China, as I mentioned, and what we're doing to drive that demand in the opportunity. Less than 10% of the world's population are vaccinated. So the opportunities there, we just need to go after it.
Geoffrey Meacham
analystAnd of that decline, you have offsets that could be CAPVAXIVE, what you mentioned, and clesrovimab. So talk to us about those programs and what that could mean maybe in the intermediate to longer term to your business.
Robert Davis
executiveYes. Well, we're really excited about both of those products. Maybe just start with CAPVAXIVE first. If you look at this, and we have approval and we've started to launch, but the reality of it is though most of the coding into the fourth quarter, we've been establishing our contracts with customers and getting reimbursement coverage in place. So the growth really in that product is going to come in 2025 in the United States. And then you're going to start to see it roll out next year around the world, and then really see the rest of the world take off in 2026 as reimbursement starts to kick in. But if you look at it, the thing that we like to point out is we cover roughly 85% of the serotypes that cause disease in adults. This is an adult-specific vaccine. So it was tailored to the adult-causing -- serotypes that cause pneumococcal disease in adults. So it was very specific in that regard. That's over 30% or roughly 30% better coverage than the competition. So as we sit here today, looking at that market and the fact that we just -- you probably saw with the ACIP, they extended to -- the recommendation to go from 65 to now be coming 50 to 65, as well as 65 and plus. And that population is about 120 million people in the United States. So with about half of that in that under 65. So there's about 60 million people, 50 to 65, we can go activate. And really what drove that broader recommendation from the ACIP was the strength of the health economic data we showed given the efficacy of this vaccine. And then obviously, with the 60 million people in the 65-plus, about 2/3 of that group have been vaccinated. But there still is an opportunity to capture the remainder and then, in some cases, look at revaccination. So as we sit here today, we believe we're going to have a majority of the share given the strength of our clinical data, and we continue to believe this will be a blockbuster. And feel even stronger about that now that we have the 50-plus indication. On clesrovimab, I'm very excited about this. This is a monoclonal antibody treatment of RSV in infants. Importantly, and where we think we will have a real commercial differentiation, single-fixed dose, not weight-related, so it's a single fixed dose. Simple for the physicians. They only have to stock one picture of this, one profile of the drug. And importantly, it gives coverage for the full 6 months of the RSV season and it doesn't matter when the infant is born. So it doesn't matter when in the season, it gives the 6-month coverage. So we think from a commercial perspective, we have a very competitive vaccine. We think this is still a very -- is a big market and a growing market. And we're confident that we will be able to have everything ready to go at the time we move into the '25, '26 season. So I think those both are important opportunities, both are blockbuster opportunities. But maybe I'd ask Eliav if he can comment on some of the clinical data around clesrovimab, because we actually think it has a great clinical profile.
Eliav Barr
executiveRight. So one of the things that's impressive about clesrovimab is that you see reductions in severe outcomes from RSV hospitalizations, severe lower respiratory tract infection, rates reductions in the 85% to 91% range. And that's an extraordinary benefit given the -- how common this disease is, as well as benefits across the spectrum of even milder disease, which is a little bit less a problem for physicians. So I think this is going to be a really great opportunity. Again, no diminution of efficacy through the full 6 months of therapy and -- of 6 months of coverage, I should say. And I think that this is going to be a major addition for patients and for physicians.
Geoffrey Meacham
analystLet's move on to other launches. WINREVAIR is the big topic here. M.K., you want to...
Mary Kate Davis
analystYes, absolutely. So launch is ongoing here. Could you just add some additional color on where you see it going in terms of strategy for access, market penetration and maybe movement into other centers and geographies here?
Robert Davis
executiveYes. So maybe just -- you didn't quite ask it, but I'm going to answer it. I would say the launch continues to go quite well. So first and foremost, that's the important point. Whether we look at it from a patient perspective, what we're hearing in the real-world setting, patient experience. Adherence continues to be, frankly, better than expected. Discontinuations are lower than expected. We're seeing very strong physician support given the risk/benefit of this drug. And growing both the breadth and depth, so you're seeing more physicians coming on. But importantly, you're seeing increasingly physicians doing repeat prescribing. And while we continue to see about 80% of the use in the sickest patients, and this gets a little bit to your question, we are seeing about 40% of physicians have started to move and have done at least one patient in, what would either we could call either dual therapy or without prostacyclin, depending on how you want to characterize it. And so we feel very good that, that opportunity to expand from the sickest patients where, not surprisingly, that's where doctors focus most into the less sick patients is going quite effectively. And the reimbursement is also quite strong. We're seeing very good access. We had now 60% of the plans have formal coverage in place. That's up from 30% as of the second quarter, and we expect to have largely coverage in place across almost all plans by the end of the year. And in total, patients are getting good access. About 80% of the patients who are being a script ultimately end up on commercial products. So across every measure, including the safety profile, we feel very good about where we are. But I think the real question you're getting at is that what's next? And we do think there is a next. We do think there's an opportunity to continue to expand. Obviously, we're very excited about the -- really the phenomenal data we just saw coming out of ZENITH and the early stoppage of that study. But maybe I'll turn it over to Eliav, who can kind of walk through how we see that supporting a broader use over time, along with HYPERION and CADENCE.
Eliav Barr
executiveSure. So as we top line, there was an early stoppage of the ZENITH trial for overwhelming efficacy of the data. Really quite spectacular. Recall, these are patients who are really at the brink of a very severe event. In other words, they were close to the end game here. And what we're able to show is real disease modification. I think it's going to very much strengthen the understanding of how in WINREVAIR modifies the disease progress. Because it really pulled people back, not only from the brink of death, but into a more palatable ability to exercise and to actually do activities of daily living. I think that's going to be very important because physicians will start to understand that disease modification is something that's real here for this drug, and that the thought process will be, well, maybe if I start this a bit earlier, we can actually avoid patients getting into that status that led them to be a ZENITH-like patient. Moreover, we're also going to have the HYPERION trial. The HYPERION trial is a trial in patients much earlier in the disease arc, within a year of first diagnosis. That study is moving along expeditiously. And I would say that I'm very confident that it's going to be reading out quite well. One of the things that's been very interesting, just thinking about all of these studies, is that as we look at the cadence of HYPERION's enrollment, when WINREVAIR starts to become available, it's very difficult for patients to find themselves to enroll -- for us to find patients to enroll on the studies. And I think it points to the fact that the results of both STELLAR, ZENITH and what we believe will happen with HYPERION as well, is that's going to be very hard for placebo-controlled trials to be done anymore in this setting. Because I think the overwhelming efficacy, the disease modification, the reversal of severe morbidity and mortality benefit that you will see with WINREVAIR, will make it very difficult for there to be justification for placebo control. So it's a really exciting time with WINREVAIR.
Geoffrey Meacham
analystJust a follow up on that. When you look at the mechanism, what are -- I'm not sure if you guys are looking outside of PAH, but just there are lots of related pulmonology indications that you could take this down to. What's the consideration for that?
Eliav Barr
executiveSo we're -- we also have another trial called the CADENCE trial, and that's in type 2 pulmonary hypertension. It's a large patient population of individuals who've got pulmonary hypertension caused by -- primarily by cardiac disease, by hypertrophic disease. That study is a Phase IIa trial, and it will be reading out the next year. And I think it will be a very important milestone for WINREVAIR as well because it, again, takes us out of the PAH space into other parts of the pulmonary hypertension spectrum. And if it's positive, I think it's going to be a really important public health benefit and a very large patient population who otherwise has no therapy right now.
Geoffrey Meacham
analystRight. Just from a sort of -- last question from a commercial perspective. I mean, if you look at historically, going back to the days of Actelion and others in the space, it's mostly a U.S. and European kind of marketplace. To what degree is Merck investing in making this a full-on global indication? I wasn't sure the incidence rates around the world, if that opportunity exists.
Robert Davis
executiveWell, I mean, if you look -- I mean, primarily, if you look where this disease is most focused,as far as where patients are being identified, it is U.S., Europe and if you look in Japan. And we've in the past commented think that's about 90,000 patients across those, 40,000-ish in the U.S. and then the rest are sitting in Europe and Japan. We actually think China is not included in that number, and increasingly as we continue to look, is a real opportunity. So we're starting to really explore China as a market to go. But we are driving this globally. I was actually just with our Latin American team, for instance, yesterday. And it's -- WINREVAIR has already launched in some of the markets in Latin America. So this is a global launch. We're going to all places where PAH patients are identified. And I think over time, now that there's a new therapy available, you're going to see the drive to do diagnosis. So I think you're going to see the rates rise as more patients are identified, and we're investing to help drive that. So this will be a global launch. But clearly, our focus in the short term is U.S. and Europe for now, and then we'll move to Japan, and then continue to push into the smaller markets as we go.
Geoffrey Meacham
analystAnd let me ask you on that. So I know you guys view WINREVAIR as more of a cardiovascular drug. Historically, people looked at PAH as a rare disease drug. But essentially, though, you're talking about adding infrastructure in -- around the world and more of an orphan-ish model. Is that something that Merck strategically is engaged in? Do you think that, that could be a future? I'm just thinking about potential BD down the road, right?
Robert Davis
executiveYes. So to be clear, we have several places where we operate as an orphan drug company. Across -- a lot of our indications in oncology actually are orphan indications. So the only reason I raised that is I think people don't think of us as an orphan company. And in many ways, we have a lot of pockets where we do operate that way. . Clearly, what we're doing with WINREVAIR is a little different, and we are open to that. We tend to look at orphan indications that have the potential then to have follow-on or be a foundation for broader reaches. We've talked here about obviously, starting in PAH and potentially broadening into broader PH, that's what we're doing here with WINREVAIR. But we are open to orphan as opportunities to build on the presence we already have.
Geoffrey Meacham
analystJust on BD, I know you guys are asked a lot on sort of categories that you may not be in. So you -- I mean, Merck has historically been in metabolics with respect to diabetes. What's the sort of appetite now just given a lot of the action in obesity? Is that still of interest to you guys, adding a category like that from a BD context?
Robert Davis
executiveYes. I mean, as we look at it though, I think what's important is understanding how do we want to play? Clearly, if you think of what you have today with the injectable peptides, largely Novo and Lilly today, that's not an area where we believe the primary opportunity resides. We are more focused in second and third-generation oral, small molecule opportunities, where you can do combinations of the GLP-1 with other agents, focusing on outcomes as well as just obesity and the comorbidities that exist. But the other thing -- and I know a lot of the people watching and in the room cover us, so know this, but those who maybe don't know this. We have a GLP-1 today. It's a GLP-1 in combination with glucagon in MK-6024, which is in NASH. And so we're very excited about that opportunity. We think we have best-in-class liver fat reductions. And with weight gains, frankly, equal to probably about what would be Ozempic-like types of weight reductions. So we continue to believe that is a significant opportunity because of the amount of liver fat reduction we see, which we think is best in class. So we will pursue that opportunity as an important opportunity. And then we are already internally doing discovery and development work in those next-generation opportunities, and we continue to look externally if we can find something that fits. But I think what you've seen from a business development perspective, we're only going to do it if we see the unmet scientific need that matches both our strategy and where we think we can drive value. So we're not going to do something just to do it, it has to meet our criteria. We're going to be disciplined. But if something is there, we will move. We have not found that opportunity yet, but we continue to look.
Geoffrey Meacham
analystFrom an internal perspective, I mean, you guys have had metabolic core R&D for decades, right? So this is not like a new category.
Robert Davis
executiveCorrect.
Geoffrey Meacham
analystYes. Well, let's go to KEYTRUDA. Do you want to ask some questions, M.K.?
Mary Kate Davis
analystYes, absolutely. Pivoting over, I guess, how are you looking at opportunities for KEYTRUDA growth over the next few years?
Robert Davis
executiveWell, KEYTRUDA is really an amazing drug. If you think about it, third quarter grew 21%, $7.4 billion, which is just mind boggling in some ways. But I think it speaks to the underlying fundamental value that KEYTRUDA is bringing in the oncology space as really foundational therapy. And as you look forward, we continue to see opportunities. So we have many additional indications coming. We're not done. We're moving into early lines of therapy. We have now 9 approvals in earlier stages of cancer, 4 of which have overall survival. More coming, and you're going to see that. But if you think of maybe the main areas of growth, women's cancer is an area where we see a real opportunity. Obviously, we've had a good position with metastatic cervical cancer, endometrial cancer, breast cancer as well in triple-negative breast cancer. We're now moving into the early stages of those areas, and you're going to see that. We have some important data in both some unapproved indications and then some coming. That's going to be driving globally because really right now, that's just starting to roll out outside the United States. So that will be very important. Bladder cancer or GU cancer in general is a big opportunity. Obviously, KEYNOTE, the A39 study, was an important study in combination with PADCEV. But we have more studies coming. And we have an early stage, and I'll let Eliav comment on it, muscle-invasive bladder cancer, which has had read positive data. So you're going to see us moving into bladder. And then obviously, I would just point to the fact that the foundation of what KEYTRUDA has allowed us to do is to broaden well beyond that. So our growth into antibody drug conjugates is going quite well. And then the whole host of small molecules we have that are important in targeted therapies that we're bringing to the marketplace. So I am quite confident that we are positioned to not only continue to lead in the I-O space in the short term with growth -- continued growth in KEYTRUDA, but be positioned for long-term leadership in oncology more broadly. But I don't know if you want to comment on some of the things in the pipeline.
Eliav Barr
executiveRight. So I think in addition to the opportunities that Rob pointed out, we just had a perioperative head and neck cancer readout that was pretty spectacular. It's a disease area that's a pretty large number of cancers, but not very much advancement recently, unfortunately, for patients. And so I think this is going to be a very important growth driver going forward. As Rob mentioned, there's multiple areas within the bladder cancer space, and I think they're going to be very important for KEYTRUDA going forward. As well as other parts of breast cancer spectrum, that I think will be very important. Aside from that, as I noted, our new agents are moving along expeditiously. We've got 10 Phase III trials or sac-TMT, our TROP2, ADC, and many more to come after that. Our interactions with Daiichi Sankyo, our collaboration is moving along expeditiously. And that also will give us an opportunity to go into cancers where KEYTRUDA has not been active in, including prostate cancer and also small cell lung cancer, where I think we have a very exciting opportunity with not just 1 highly active medicine, but 2, that we believe will work in combination to really fundamentally transform care for what is 15% of all lung cancers. The small molecule drugs are really important. Near-term, WELIREG, I think, is a great opportunity. And this drug in renal cell cancer, von Hippel-Lindau disease, is going to be very important, and it's growing. And I think will ultimately become a blockbuster given its high activity. So lots of exciting opportunities.
Mary Kate Davis
analystI guess as a follow-up, I'd love to talk a little bit more about your subcutaneous KEYTRUDA program as well. I guess, how is that going? What feedback are you receiving?
Eliav Barr
executiveJust from -- maybe I'll start with the R&D side and then Rob can talk about the commercial. We just read out top line results of a very nice study that will allow us to file. We anticipate that the drug will be available in -- towards the end of next year. And I would point out that this is a really important innovation for patients, particularly if you think about how pembrolizumab as a drug is becoming standard of care for curable early stage cancer, where patients are still working, have no -- not much comorbidities, and are really aren't interested to spend a lot of time in a infusion center, also being present with patients with metastatic disease who are quite ill. So I think this is going to be a really important innovation for them. We have many new regimens that are not infusions that won't -- that will require just pills. And I think, again, the more we can pull cancer patients away from the difficulties of having to spend the entire time in the cancer center and do things more in the doctor's office, I think it will be a major advantage for them, especially as they -- in that younger set that have curable cancer. But maybe...
Robert Davis
executiveYes. No. I mean, we're very excited about this. As Eliav said, really by early '26, we expect to have this on the marketplace. That's 2 years in front of the LOE of KEYTRUDA. And we are very focused on driving as many patients to the subcutaneous form. We think there's real value there. As we've talked about, if you look today, 25% -- or by the end of this year, 25% of our total KEYTRUDA sales will be coming from early stage cancers. That's going to continue to grow. We think that is a prime population to bring the subcutaneous form, too, for value, for the reasons that Eliav articulated. Plus those where you have combination with oral therapies or KEYTRUDA as monotherapy. So we're focusing there first. That's about 50%. We think by the time we get out to -- in the '26, '28 time frame, it's about 50% of our addressable population that we're going after with the subcutaneous form. But we're not foreclosing the metastatic space. I think it's -- people think that when we're focusing first on the early stage as I mentioned, but we also are thinking in the metastatic patient, potentially even in combination with chemotherapy. So it's -- we see this as a significant opportunity and we're going to focus on that 50% addressable population first, but we'll see where we go. And I would just point out, because people have asked this, and so it's maybe worth clarifying. If you think about it today, we're going to have both a 3-week and a 6-week subcutaneous form. And as we think forward with a lot of the drugs you could be in combination with, many of those won't be on 4-week regimens. You might be on a 2-week regimen, you might be on different regimens. And so if you think of a patient who has to show up and get their one -- drug A, and then 2 weeks later, show up and get the drug in an infusion center or to the doctor. If you can help to alleviate that burden for that patient by giving one of those in a subcutaneous form, it's both faster, 1 to 3 minutes is what it takes to be -- to get a subcutaneous infusion, is, we think, going to be meaningful. So our belief of this as an important opportunity continues to be quite strong, and our confidence in it and what it will bring as value is also quite strong.
Geoffrey Meacham
analystRob, let me follow up on that. Just when -- in an environment -- I know you said it's a hill, not a cliff, with respect to the LOE, an environment where biosimilars may be available for KEYTRUDA from an IV perspective. How do you view the Merck portfolio in that situation? Is it exclusively subcu, is what you're investing in? I know you also have IO-IO combinations which do give you longer-term value and that obviously adds to the tail.
Robert Davis
executiveYes. So if you look at the strategy for KEYTRUDA, if you will, and I really -- when you say KEYTRUDA, I think we should say for oncology. As we look into the next decade, it really is on the foundation of the strength of KEYTRUDA. The subcutaneous we just talked about is going to be important. But we are not necessarily believing that we all -- we continue to believe we will have IV usage as well. And as we look at the total pricing, our strategy is to be very competitive so that -- to make sure that pricing is not a driver of -- because we really see the volume opportunity for KEYTRUDA, if you will, the area under the curve, given the strength of the data. This is going to be a unique situation when KEYTRUDA goes off patent because you're going to have a drug with, today, 41 indications across 18 tumor types, plus MSI high and tumor mutational burden high, that's going to continue to grow. And so you're going to have this very broad usage of a drug with very strong clinical data behind it. We have, what now, about 25 studies with overall survival. No one else comes close to that. So the comfort with KEYTRUDA, the data we have in KEYTRUDA in combination with other drugs, as we move forward, we're going to be studying with -- in combination with all of our ADCs and many of the targeted small molecules we have. So we think that creates stickiness around our franchise which will drive value. We're going to lose share. I'm not in any way going to say we're not going to lose share. But I think we can maintain a meaningful part of the business through the strength of the portfolio we're going to have. Not just KEYTRUDA, but then with all of the combination agents that are going to sit around it.
Geoffrey Meacham
analystYes. And sort of a final question here. As you look to '25 and maybe '26 from the pipeline, I know you have the oral piece. Kind of there's a number of major new assets that, again, could contribute to the diversity of the portfolio. Just talk about maybe a couple of those that you're most excited about a bit more.
Robert Davis
executiveI will, and I appreciate the question because I think this is an underappreciated part of our story. If you look today, we have more than -- almost triple the number of Phase III assets today we had 3 years ago. Over 20 moving through the pipeline. We're going to launch in the next 5 years the same number of agents roughly we've launched in the last 10. But importantly, as we look forward, the majority -- vast majority of that we believe each have blockbuster-plus potential. And the diversity with which we now have opportunities across cardiometabolic, across immunology, vaccines and broad oncology, and now we've added ophthalmology as well. So that breadth, both in terms of therapeutic area and modality, small molecules, large molecules, cyclic peptides, vaccines, antibody drug conjugates, I think is underappreciated and it's why I have such confidence in the future. That's why we talk about KEYTRUDA being more of a hill than a cliff because we are going to have such a strong portfolio coming. And then beyond what we have in Phase III, you're going to see, in '25 and '26, a significant number of agents moving out of Phase I. As a company, we don't talk about Phase I programs, we only really talk about them as they start to move to Phase II. We call that the invisible pipeline, the Phase I. You're going to see a lot of things moving from the invisible to the visible as we start to move into Phase II in '25 and '26, which I think will drive further confidence. That's why I'm confident I'm going to be even more confident a year from now than I am today. But if you say where am I excited about? The oral PCSK9, our TL1A are 2 things. Maybe I'll ask Eliav to comment, I know he's got some things that he's seriously focused on.
Eliav Barr
executiveAs I mentioned, we talked about some of the near-term launches, I think that's going to be really great. HIV is actually an area that people haven't spent much time thinking about, But next year is going to be a very pillar for us because we'll have data on our once daily islatravir-doravirine combination, and also our once-monthly PrEP program MK-8527, a small pill once a month that I think will be really quite transformational in the treatment and the prevention of HIV, along with the progression of our pipeline there. Rob talked about enlicitide, we'll have the cholesterol efficacy results and fully enrolled CVOT. At that time point, we talked about WINREVAIR future indications. Ophthalmology, we're really excited about how quickly EyeBio has been integrated, and they were moving very quickly in the pipeline there. And then, of course, in oncology, you'll see a lot of readouts starting for it, not only our ADCs or antibody drug conjugates, but unique combinations that will have both with KEYTRUDA in specific populations. And 2 drugs together within the pipeline that I think in aggregate will create very transformative benefits for patients. So this is a great time for us in the R&D group, and we're really excited about all the studies that we're going to change public health.
Geoffrey Meacham
analystWith that, we're out of time. So Rob, Eliav, thank you so much. I appreciate the conversation.
Robert Davis
executiveThank you for having us.
Geoffrey Meacham
analystThank you.
Eliav Barr
executiveThank you for having us.
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