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Citi's 2024 Global Healthcare Conference

Dec 5, 2024

Geoff Meacham
Senior Biopharma Analyst, Citi

Welcome 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.

Rob Davis
Chairman and CEO, Merck

Thank you.

Geoff Meacham
Senior Biopharma Analyst, Citi

We have Eliav Barr, Senior VP and Head of Global Clinical Development and CMO. Welcome.

Eliav Barr
SVP and CMO, Merck

Thank you.

Geoff Meacham
Senior Biopharma Analyst, Citi

So, Rob, let's just kick it off, you know, maybe bigger picture. We had, you know, Scott Gottlieb here yesterday. We're talking about, you know, potential policy changes, you know, IRA, et cetera. You know, give us your perspective on kind of what we may or may not expect looking into next year. I realize that it's obviously pretty early in the.

Rob Davis
Chairman and CEO, Merck

Yeah, sure, sure. No, you know, 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 innovation we bring, the value of the industry, the jobs we create, and to drive for, you know, 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 a healthy lifestyle. So as you think about the continuum of care there, we're very much aligned with what we need to do there.

You know, obviously, we continue to be concerned from an IRA perspective that particularly the pill penalty, the difference between small molecules at nine years versus large molecules at 13, will lead to long-term bad outcomes as you think about innovation in the space. And we're 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, you know, 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 brings these important medicines to market.

So, as I sit here today, I'm cautiously optimistic that we can get some good things done.

Geoff Meacham
Senior Biopharma Analyst, Citi

Just to follow up on that, I know Bobby Kennedy, assuming he's confirmed, you know, he's been, you know, public about, you know, comments about vaccine safety and particularly in pediatric settings. Like, what's your perspective on whether this adds, you know, extra risk to the vaccine franchise? You guys are one of the leaders in this.

Rob Davis
Chairman and CEO, Merck

Yeah. Well, you know, 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're the most effective and cost-effective means to prevent disease. You know, 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 vaccines. So we continue to be very much in favor and supportive of the value that vaccines bring. And, you know, 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.

You know, as you think about the administration and the focus, if you separate the pediatrics from the adults on the pediatric vaccines basis, you know, 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 childhood vaccines are critical. You think about something like measles. You know, 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 Pediatrics, the president recently put out a statement supporting the value of pediatric vaccinations.

While obviously the federal government plays an important role as we look with, given the strong fundamentals in the healthcare 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 vaccines. If you think about our vaccines, Gardasil, hopefully soon what we're going to have, you know, clesrovimab, which is going to be our pediatric, we can speak to monoclonal antibody. But then also we've got Capvaxive and Vaxneuvance. So we believe, you know, while you might hear noise, the fundamentals of what have driven that business, we still feel very confident in.

Geoff Meacham
Senior Biopharma Analyst, Citi

Let's turn to Gardasil. I think that that has been one of the, you know, biggest uncertainties over the past couple of quarters is the, you know, the Chinese situation. Maybe just give us a status update of where we are there.

Rob Davis
Chairman and CEO, Merck

You know, maybe I just start by saying overall, we continue to be very proud of what Gardasil has done to combat cervical cancer around the world. You know, we still are in a situation where a thousand women a day globally are dying from cervical cancer, which is a completely preventable disease. And so, you know, 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, you know, 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. We believe that the opportunity there is still significant. It's just going to take time for us to activate it. There's still 120 million women in the tier one to five cities to be vaccinated. Hopefully, we'll have the male indication coming soon. We filed that. It's moving through. We would expect hopefully to see approval of the male indication in China in the early part of next year. That obviously opens up a new market. We'll be the only company, we believe, with a male indication in China.

There's about 200 million men and boys in that same age kind of, or that same city cohort of the tier one to five cities. Large opportunity in China. 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.

Geoff Meacham
Senior Biopharma Analyst, Citi

Would you say the supply-demand situation in China, you know, could be more normalized in 2025, you know, first half, second half of the year? Or is it still early to tell at this point?

Rob Davis
Chairman and CEO, Merck

It'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 onselling 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 or roughly $2 billion-$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 a 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, you know, we have a strong portfolio overall. And with even that decline in China next year, you are going to see overall solid growth for Merck. So, you know, it is something we are managing.

I 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 and the opportunity. Less than 10% of the world's population are vaccinated. So the opportunity is there. We just need to go after it.

Geoff Meacham
Senior Biopharma Analyst, Citi

And of that decline, you have offsets that could be Capvaxive, which you mentioned, and clesrovimab. So talk us about those programs and what that could mean maybe in the intermediate to longer term to your business.

Rob Davis
Chairman and CEO, Merck

We're really excited about both of those products. Maybe just start with Capvaxive first. You know, if you look at this, and we have approval and we've started to launch, but the reality of it is through most of this year, including into the fourth quarter, we've been establishing our contracts with customers and getting reimbursement and 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, you know, 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. It was very, 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 covering 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 two-thirds 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, you know, 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, you know, I'm very excited about this. This is a monoclonal antibody for the 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 the single fixed dose, simple for the physicians. They only have to stock one vial of this, one profile of the drug.

Importantly, it gives coverage for the full six months of the RSV season. It doesn't matter when the infant is born. It doesn't matter when in the season, it gives the six-month coverage. We think from a commercial perspective, we have a very competitive vaccine. We think this is still a very, as a big market and a growing market. We're confident that we will be able to have everything ready to go at the time we move into the 2025, 2026 season. I think those both are important opportunities, both are blockbuster opportunities. 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
SVP and CMO, Merck

Right. So, you know, one of the things that's impressive about clesrovimab is that you see reductions in severe outcomes from RSV, hospitalizations, severe low respiratory tract infection rates, reductions in the 85%-91% range, and that's an extraordinary benefit given how common this disease is, as well as benefits across the spectrum of even milder disease, which is a little bit less of a problem for physicians, so I think this is going to be a really great opportunity again, no diminution of efficacy through the full six months of therapy and of six months of coverage, I should say, and I think that this is going to be a major addition for patients and for physicians.

Geoff Meacham
Senior Biopharma Analyst, Citi

Let's move on to other launches. So Winrevair is the big topic here. MK, you want to get a couple of.

Mary Kate Davis
Analyst, Citi

Yeah, 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?

Rob Davis
Chairman and CEO, Merck

Yeah. 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 of 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 be, you 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, you know, now 60% of the plans have formal coverage in place. That's up 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 getting 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 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 and supporting a broader use over time along with Hyperion and Cadence.

Eliav Barr
SVP and CMO, Merck

Sure. So as we toplined, there was an early stoppage of the ZENITH trial for overwhelming efficacy. And the data are 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 were able to show is real disease modification. I think it's going to very much strengthen the understanding of how 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, you know, 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, you know, 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.

Geoff Meacham
Senior Biopharma Analyst, Citi

Just follow up on that. When you look at the mechanism, you know, 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 know, you could take this down to. What's the consideration for that?

Eliav Barr
SVP and CMO, Merck

So 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 primarily by cardiac disease, by hypertrophic disease. That study is a phase II trial. And it will be reading out the next year. And I think it'll 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, you know, 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.

Geoff Meacham
Senior Biopharma Analyst, Citi

Right. Just from a sort of a last question from a commercial perspective, I mean, if you look historically going back to the days of Actelion and others in the space, it's mostly a U.S. and European, you know, kind of marketplace. To what degree is Merck investing in making this a full-on global indication? I wasn't sure of the incidence rates around the world if that opportunity exists.

Rob Davis
Chairman and CEO, Merck

I mean, if you look, I mean, primarily if you look at 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, we think that's about 90,000 patients across those 40,000-ish in the U.S. and then the rest 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 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.

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., Europe for now, and then we'll move to Japan and then continue to push into the smaller markets as we go.

Geoff Meacham
Senior Biopharma Analyst, Citi

And let me ask you on that. So I know you guys view Winrevair as more of a cardiovascular drug. Historically, people have looked at PAH as a rare disease drug. But essentially, though, you're talking about adding infrastructure in, you know, around the world and more of an orphan-ish model. Is that something that, you know, 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?

Rob Davis
Chairman and CEO, Merck

Yeah. So to be clear, we have several places where we operate as an orphan drug company across, you know, a lot of our indications in oncology actually are orphan indications. So the only reason I raise 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. You know, 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, you know, obviously starting in PAH and potentially broadening into broader PAH is what we're doing here with Winrevair. But we are open to orphan as opportunities to build on the presence we already have.

Geoff Meacham
Senior Biopharma Analyst, Citi

Just on BD, you know, I know you guys are asked a lot on sort of categories that, you know, you may not be in. So 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 and obesity? Is that still of interest to you guys, adding a category like that from a BD context?

Rob Davis
Chairman and CEO, Merck

Yes. 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, you know, 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 a 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, you know, which is in MASH. And so we're very excited about that opportunity.

We think we have best in class liver fat reductions 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. 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. 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. 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's there, we will move. We have not found that opportunity yet, but we continue to look.

Geoff Meacham
Senior Biopharma Analyst, Citi

From an internal perspective, I mean, you guys have had metabolic, you know, core R&D for decades, right? So this is not like a new category.

Rob Davis
Chairman and CEO, Merck

Correct.

Geoff Meacham
Senior Biopharma Analyst, Citi

Yep. Well, let's go to Keytruda. I mean, do you want to ask some questions in K?

Mary Kate Davis
Analyst, Citi

Yeah, absolutely. Pivoting over, I guess, how are you looking at opportunities for Keytruda growth over the next few years?

Rob Davis
Chairman and CEO, Merck

You know, Keytruda is really an amazing drug. If you think about it, third quarter grew 21%, $7.4 billion, which is just, you know, 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. You know, we have now nine approvals in earlier stages of cancer, four 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, and 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, both some on approved 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'll 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. We have an early stage, and I'll let Eliav comment on it, muscle-invasive bladder cancer, which has had really 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.

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 IO 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
SVP and CMO, Merck

Right. So I think, 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 that I think are going to be very important for Keytruda going forward, as well as other parts of the breast cancer spectrum that I think will be very important. Aside from that, as he noted, our new agents are moving along expeditiously. We've got 10 phase III trials for 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 one highly active medicine, but two 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 is growing. And I think it will ultimately become a blockbuster given its high activity. So lots of exciting opportunities.

Mary Kate Davis
Analyst, Citi

Yeah, I 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
SVP and CMO, Merck

Just from, I'll maybe 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 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 not much comorbidities, and really aren't interested to spend a lot of time in an infusion center, you know, 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 will require just pills.

I think, again, you know, 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'll be a major advantage for them, especially as they in that younger set that have curable cancer with maybe.

Rob Davis
Chairman and CEO, Merck

Yeah, no, I mean, we're very excited about this. As Ellie has said, you know, really by early 2026, we expect to have this on the marketplace. That's two 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, you know, 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 to for value for the reasons that Ellie have articulated, plus those where you have combination with oral therapies or Keytruda as monotherapy. So, you know, we're focusing there first. That's about 50%.

We think by the time we get out to, you know, in the 2026, 2028 timeframe, that'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, you know, people think that when we were focusing first on the early stage, as I mentioned, but we also are thinking in the metastatic space and potentially even in combination with chemotherapy. So we see this as a significant opportunity. And we're going to focus in that 50% addressable population first, but we'll see where we go. And I would just point out because people have asked this, and it's maybe worth clarifying, if you think about it today, you know, we're going to have both a three-week and a six-week subcutaneous form.

As we think forward with a lot of the drugs you could be in combination with, many of those won't be on four-week regimens. You might be on a two-week regimen. You might be on, you know, on different regimens. And so if you think of a patient who has to show up and get the one, you know, drug A, and then two weeks later show up and get another 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. One to three minutes is what it takes to get a subcutaneous infusion, you know, we think going to be meaningful. So our belief of this as an important opportunity continues to be quite strong.

Our confidence in it and what it'll bring as value is also quite strong.

Geoff Meacham
Senior Biopharma Analyst, Citi

Rob, let me follow up on that. Just when in an environment, I know you said, you know, it's a hill, not a cliff with respect to the LOE. In an environment where, you know, biosimilars may be available for Keytruda from an IV perspective, you know, how do you view the Merck portfolio, you know, 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.

Rob Davis
Chairman and CEO, Merck

Yeah. So if you look at the strategy for Keytruda, if you will, and I really wouldn't 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 continue to believe we will have IV usage as well.

As we look at the total, you know, 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, you know, this is going to be a unique situation when Keytruda goes off patent because you're going to have a drug with, you know, today 41 indications across 18 tumor types plus MSI high and tumor mutational burden high. That's going to continue to grow. So you're going to have just a very broad usage of a drug with very strong clinical data behind it. We have what now 25 studies with overall survival. No one else comes close to that.

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 it in combination with all of our ADCs and many of the targeted small molecules we have. We think that creates a 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. 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.

Geoff Meacham
Senior Biopharma Analyst, Citi

Sort of final question here, as you look to 2025 and maybe 2026 from the pipeline, I know you have the oral piece that's kind of, there's a number of major, you know, new assets that, you know, again, could contribute to the diversity of the, you know, the portfolio. Just talk about maybe a couple of those that you're most excited about that are more actionable.

Rob Davis
Chairman and CEO, Merck

I will. And I appreciate the question because I think this is an underappreciated part of our story. You know, if you look today, we have more than almost triple the number of phase III assets today we had three years ago, over 20 moving through the pipeline. And we're going to launch in the next five 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, you know, 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 2025 and 2026, a significant number of agents moving out of phase I. You know, 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 to 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 2025 and 2026, which I think will drive further confidence. It'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, what am I excited about?

The oral PCSK9, our TL1A, our two things. Maybe I ask Eliav to comment. I know he's got some things that he's really focused on.

Eliav Barr
SVP and CMO, Merck

You know, as I mentioned, we talked about some of the near-term launches. I think it'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 pivotal year for us because we'll have data on our once daily slate, 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, in the prevention of HIV, along with progression of our pipeline there. Rob talked about islatravir. 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're moving very quickly in the pipeline there.

And then, of course, in oncology, you'll see a lot of readouts starting for not only our ADCs, our antibody drug conjugates, but unique combinations that we'll have both with Keytruda and specific populations and two 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 are going to change public health.

Geoff Meacham
Senior Biopharma Analyst, Citi

With that, we're out of time. So, Rob, Eliav, thank you so much. I appreciate the conversation.

Rob Davis
Chairman and CEO, Merck

Thank you for having us.

Eliav Barr
SVP and CMO, Merck

Thank you. Thanks for having us.

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