... otherwise I would do this. But, yeah, thank you very much for joining us today for the lunch session. My name is Mohit Bansal. I'm one of the biotech and pharma analysts here at Wells Fargo, and I'm very happy to have the Merck management team with us. We have Caroline Litchfield, the EVP and CFO of the company. We also have Eliav Barr to talk about all the pipeline here, exciting pipeline. So Eliav is the Senior Vice President and Chief Medical Officer of all the pipelines here, managing all the pipeline development here at Merck. So thank you very much for joining us today.
Thank you for having us.
Thank you.
So, Caroline, why don't we start with, you know, just give a high-level overview of what-
Sure
...you, what the progress Merck has been making and what is the investment case in the company right now?
Sure
- given the investor setup here?
Okay. So thank you all for being here, and thank you for your interest in and support of Merck. Merck is at a time of transformation. We're moving forward with a diversified set of growth drivers for our future. Indeed, we're in the midst of launching 20 products, all of which have the potential to advance patient care, almost all of which have blockbuster potential. We have stated that we have the potential for more than $50 billion of revenues by the mid-2030s from this expansive pipeline, and as a team, we're focused on bringing forward these innovations and excelling in the marketplace. We're pleased with our recent launches of WINREVAIR, of CAPVAXIVE. We're at the early stages of our ENFLONSIA launch. You've seen some data readouts. Just this week, we highlighted our phase III data for enlicitide, our oral PCSK9.
We'll have readouts in ophthalmology, in HIV, in the coming months, next year. So we're excited about our future, and our confidence in our ability at navigating the KEYTRUDA LOE is increasing. But we acknowledge we're not yet done. We continue to look to bring forward our pipeline, to excel in our launches, and augment our pipeline and portfolio with business development, as we did with the planned announcement of the acquisition of Verona. So we're excited for our future, and we look forward to all of your questions.
Awesome. Great, so why don't we start with a small product named KEYTRUDA you have? So the product has been growing. So again, people are concerned about the cliffs and all that, but we'll come to that. But before that, we have seen tremendous growth in earlier lines of setting. So what are the next avenues of growth there, and can this product sustain the growth in next few years here as well?
So if I start, Eliav-
Yeah
We can add what we have coming through. We're really proud of the impact that KEYTRUDA is having for patients as they're being treated with cancer. And as you all know, we are offering treatment for a wide range of different cancers, 42 indications now approved in the United States across 18 different tumor types and two tumor-agnostic indications also. So we've seen profound impacts for patients and extremely strong growth and impact for our company. As we go forward, we do expect continued growth for KEYTRUDA, and the opportunities for growth will come from new indications. We are still launching the early-stage lung cancer indication in our ex-U.S. markets. We have women's cancers, such as endometrial cancer, cervical cancer, which are important opportunities for patient impact and growth. And we have bladder cancer indications, some launching right now, some that we're hopeful for, readouts next year.
So we do see continued growth in KEYTRUDA, albeit it will slow-
Right
As we continue to penetrate in some of those indications we've been in for some time. Another opportunity for us with KEYTRUDA is also the new formulation, our subcutaneous-
Right
version, and that will enable us to benefit many patients by having an administration that will just take a minute or two.
Right
for the patient. It's going to be extremely helpful for patients, we believe, who are taking KEYTRUDA in monotherapy or in combination with another oral agent or in the earliest stage cancer setting. Today, about 25% of the revenue of KEYTRUDA is for patients being treated in the earliest stage setting, and that's growing, and this will be an opportunity for those patients. So as we look at the subcutaneous opportunity, we're very excited about that and would expect adoption to be around 30%-40% of the overall KEYTRUDA business in about an 18-24-month window post-launch. So there's some of the elements.
Right
We remain excited about as we continue to help patients with cancer.
Can you talk a little bit about, I mean, what could make this adoption faster or slower? I mean, there is another PD-1 with subcu option out there, so what can you learn from that experience?
Yeah. So I think what's unique for KEYTRUDA is the breadth of indications it has and its utilization in the earlier stage setting, and that will, we hope, enable more patients to benefit from a subcutaneous formulation in their treatment journey. What we've learned from others is the importance of pricing, access and the J-code, so as we look at entering the marketplace, we are pricing to enable broad access for the product, and we are also mindful, though, that within that first six-month window, where we will not have a permanent J-code, we will expect that to be somewhat of a headwind.
Mm-hmm.
-to growth in those initial months. That said, and as I mentioned, we still expect to see us get to a 30%-40% adoption and to get to that level in an 18- to 24-month window.
Got it. Very, very helpful. I think the question is for you, Eliav. Like, again, like, if you think about, you know, now, like, you last few years, you have been trying to build up pieces of the puzzle to actually fill that perceived hole, when KEYTRUDA goes off patent. So you have TROP2, you have PD-1 VEGF now, early stage, and you have a bunch of other assets. So if you look at that portfolio, I mean, if you had to, like. Like, how would you Which kid you like the most kind of question, right?
Yeah. Well, you know, it, you have to be careful not to discriminate against all of your children. But in reality, we've got 24 oncology assets in clinical trials right now. Among those, we can divide them into three categories. Those to continue the immune stimulation against cancer, and V940, our collaboration with Moderna on personalized individual neoantigen therapy is one. The second category is to improve on chemotherapies and other tissue-targeting approaches, and here, I would highlight our TROP2 sac-TMT, as well as our collaboration with Daiichi Sankyo. Among those, both I-DXd and R-DXd, these are two compounds for small cell, prostate, ovarian cancer, and others, and so you can see they're relatively broad.
With respect to the last category, the last category is specific targeting agents that address those drivers of tumor growth. MK-1084, our KRAS G12C mutant inhibitor, is really an outstanding exemplar of that. Belzutifan is already marketed and is continuing to be in large-scale clinical trials. We've had some positive results there. And then there'll be others like KRAS and other agents that are novel hormonal agents that I think will be very important in the treatment of different kinds of cancer. So we have a very large portfolio in oncology. I really feel confident that we'll be able to leverage pembrolizumab to create very important new medicines that will help outcomes and improve lives.
Got it. So, like, let's start with TROP2 ADC here because you have a massive program going on. We have not seen a ton of data, but you obviously have seen the data. So can you talk a little bit about your confidence level in terms of what you have seen with the data Kelun has been generating and what gives you confidence to start this massive program?
Absolutely. So the TROP2 ADC from that we have sacituzumab tirumotecan, or sTMT, is a unique molecule that was developed in Kelun in China. And you know, one of the things that very much helps us with this is that we have a lot of advance notice from them in the clinical trials that they've seen there. But it's unique to the extent that it's very potent, it does not have interstitial lung disease issues, and that the dose we've chosen is actually fairly well-tolerated and can be used in the more maintenance settings. So if you compare the strategies that we've employed compared to some of the other TROP2 ADCs, they're quite different.
We have seen a very exciting early signals that have led us to 14 clinical trials that are available, 9 of which are publicly available on ct.gov. Nine of which are for new indications where others have not gone, and 5 of which are where we have a differentiated approach. We think that those that sac-TMT will be a great workhorse agent for to combine with pembrolizumab or any other immune checkpoint inhibitor. We're also going back to the beginning with Kelun; we've already seen they have some pretty amazing results in China. Of course, we have to replicate that in the global setting, but that provides us with a lot of confidence.
Got it. So what's the confidence level that this TROP2 ADC or Kelun TROP2 ADC would be able to differentiate against, especially Trodelvy, right? Because obviously, the other one has ILD issue, but Trodelvy is there.
Sure. And you know, Trodelvy has got pretty significant GI tox, but you know, those drugs have been focused on specific lung and breast indications, whereas and have not done very well elsewhere. We have actually a program that's much more, that's much broader in maintenance settings, and the first indications will be in things like GYN cancers. Caroline mentioned the importance of pembrolizumab in that patient population, and we think that that'll be an important leverage point for us. I'd also point out that there's a lot of excitement, at least for us, in maintenance settings, where we've seen, for example, in lung cancer, maintenance chemotherapy has been difficult to take and maintenance VEGF has been difficult-
Right.
-to take. But with TROP2 ADCs, we think we'll be able to achieve that. So, it's a differentiated program. We think we're going to have, we've hit the sweet spot in terms of the dose, and with that, I think it's gonna be a very important addition.
Got it. Very helpful. Thank you for that. Now let's just talk a little bit about, you know, the immune checkpoints, right? I mean, so before we get to VEGF PD-1, I mean, the question I want to ask is that we have seen multiple iterations, like there was IDO there was LAG-3, there was TIGIT. Like, again, every trial kind of proves that KEYTRUDA is a very good drug, so, like, if you're trying to compare against it. What is different with VEGF PD-1 versus the prior failures, which made you look into it?
Sure. So just to step back, VEGF inhibitors have been tested pretty extensively-
Mm-hmm.
In the setting of various cancers. One of the things that's clear is that in some cancers, they have both PFS and OS benefits, so the most important is overall survival benefit, right? Progression-free survival is important, but nothing like overall survival. So, you know, that mechanism of action has been important. One of the things that's notable about VEGF inhibitors in general is that they have really good progression-free survival and not so good overall survival. And so that's been sort of a cloud and a limitation to that field, where there's only been a few indications where VEGF inhibitors have been incorporated. We've done an extensive program looking at the combination of VEGF inhibition and PD-1 separately.
In those cases, the benefits are really quite limited to renal cell cancer and endometrial cancer, which are really quite vascular tumors. Now come the PD-1 VEGF bispecific, and there's all sorts of theories around why these drugs might have a specific and special benefit. The results so far that we've seen with ivonescimab, and to some extent with BNT327, has been interesting with respect to progression-free survival. Akeso has noted that they have hit, in the final analysis, an overall survival benefit in one of their studies in EGFR mutant non-small cell lung cancer. But you know, that was only in the final analysis, so the big question with all of these drugs: Will you be able to have an OS advantage?
The reason for that is that VEGF inhibition, chronically administered, is not well tolerated. There's always been a question about second, the second agent, that is, after you've progressed, whether you've created a change in the biology that leads to high resistance. That's why everyone's been so focused, both from an investor point of view and certainly for us, where is the OS benefit? Is there OS benefit? Is that OS benefit convincing? Does it justify some of the tox that's seen? In what specific settings will that be good? We'll have to see about that.
You have quite a lot of experience with your own LENVIMA experience there.
Mm-hmm.
So how can you use those learnings into the development of this program?
Oh, a lot. A lot. There's a lot of. So, you know, one of the things that is so wonderful about our oncology group is that we have all of the data from hundreds of pembro trials now forming the basis of standard of care in and around the world, as well as the so-called LEAP program, which is the program that was with Lenvatinib. From all the data, we can model out what are the potential additional benefits that you have, and what might be the places where you start to see problems with VEGF inhibition.
And so we've looked at that carefully, and our development strategy for MK-210, which is our PD-1 VEGF, will be very much focused on settings where we might, where we think the sweet spot will be. Again, it still remains to be determined whether these agents are going to be just PFS agents but have issues with OS, and that uncertainty, even with that one result, still remains. And remember, in China, for a regulatory approval, you need progression-free survival. That's it.
Right.
In the United States, OS is king, and FDA has insisted on it, especially in settings like frontline metastatic lung cancer. So that's gonna be the challenge for the field.
So this brings me to the next question because, you know, if you look at the front runners, Summit/BioNTech, they're all going after KEYTRUDA in its strongest indication, that is lung cancer, right? First-line lung cancer. Logically makes sense, but at the same time, you're going after KEYTRUDA in an indication where KEYTRUDA is very good. So, I mean, when you think about it, I mean, you will have an advantage of, like, slightly behind, but at the same time, you can learn from them. Is there a room, is there a way to think about going after indications where KEYTRUDA is, works, but it could work better with a VEGF, a PD-1? How, like... You know, you get my question here, right?
I get the question.
Yeah.
So the question is, is there places where there's room to go with your PD-1 inhibition? And the answer is, it's... That's one of the reasons why we are so excited that we have the ability to look across-
Mm
... therapeutic indications, with pembro, not only with Lenvatinib, but also recall we've done some clinical trials with a whole variety of other TKIs based on collaborations that we've done, with ADCs, with all sorts of other things. So we can take a good look at where that special advantage might be. You know, the way I consider PD-1 VEGF, there won't be. It's not gonna be another KEYTRUDA.
Right.
They're just not. They're going to be specific places with specific potential benefits and specific strata of patients. That's the—that last bit is the important bit.
Right.
Because all comers, it's gonna be a very hard, high bar to win in a drug like pembrolizumab that is pretty active. That's extremely active. So, you know, you'll have to look at even in places where KEYTRUDA is somewhat less active, where the hazard ratio is a little bit less-
Right.
-it's still a pretty high bar because oftentimes it's good with chemo.
Got it. Very helpful. And then, so now that you are generating data with your partner in China, so could we expect a drop two-like situation where you start to see the data, and then you invest in this program?
We are always. We give all of our assets stage-appropriate investment.
Okay.
It deserves no more and no less.
Right.
So we're very, very data-driven. We've had a pretty rapid development program in China, and based on that, we'll come forward with some interesting trial designs. You know, it's also helpful that our partner, Kelun, is there as well.
Mm-hmm.
So we can do a lot of work in that environment and prepare for phase III, should the data support it.
Like, what is your internal understanding about... You know, there are differences in molecules, but is it going to be a PD-1-like situation where, you know, ultimately clinical profiles were different than the molecules as such?
I do think in this particular instance, it's gonna be important to look at the ratios, and this isn't because of some magic. It's just too much VEGF inhibition. If you get bevacizumab-like VEGF inhibition, that's not so good.
Right.
They're just not tolerable.
Right.
And the same is true with, you know, some of the other TKIs that are valuable, but only in a specific segment of patients.
Right.
And so you have to get to that sweet spot. We've always been a believer in PD-1 inhibitors-
Right.
Not PD-L1, but, you know, that all will depend on the clinical profile.
Yeah, this is what I've heard. Like, I mean, bevacizumab has a 21 days half-life, and bispecific, at least the one which has reported, is only 4 days, so that may be one of the reasons why safety is probably better.
Yeah. It's... You know, but the other piece is if you have to really thread that needle, you wonder. I mean, that's gonna be an issue we have to address. Again, I'm excited about this class, but it has to be in a very data-driven way, and OS is king.
Got it.
Yeah.
Where are you with the cancer vaccine program at this point? I mean, like, we had some interesting phase II data, so how do you think about development there?
You know, one of the things that's been exciting about this program is how enthusiastic investigators are. I've always believed that enrollment speed is a not bad indicator-
Right
-of excitement and interest in the mechanism of action and in subsequent commercial success. You know, the area where we've... We've chosen a different development strategy than other cancer vaccines simply because we're interested in early cancers. We're interested in those cancers where patients have a potential curative opportunity, where they still have a fairly intact immune system, and where we can define the tumor mutations that are going to be most immunogenic. That said, we are spreading out. We've now looked at some cancers that are very immune responsive but don't have quite as many tumor mutations, and we will be doing some evaluations in first-line metastatic settings. But more than anything, I think that this the phase III trials that we've put together and the phase II programs are really focused on early-stage cancers.
The readouts will occur in the next couple of years, and with melanoma being first, and we're really excited to see what those results are. In the meantime, Moderna is gearing up to prepare for the good news, should it occur, and we'll be ready.
Awesome. So before we go into non-oncology side, so I have some questions for you. So, obviously, we have to talk about MFN and tariffs here. So, so the macro environment. Like, how do you see all these macro environment at this point coming out from administration, and how can a company like Merck can prepare for something like MFN, tariffs, and all those situations?
From a tariff regard, you've heard Rob talk to the fact that our company is well-positioned for what we currently know. We have worked very hard over many years to ensure that we have a diverse footprint for our supply chain, that we have manufacturing here in the United States and outside of the United States, and we've been investing here in the U.S. As we look at tariffs and we look at the placement of our products for our current portfolio, we feel that the impact of tariffs are manageable for our business. As we look at the many launches that we have coming, we're ensuring we have a footprint that enables manufacture here in the U.S., for the U.S., in Europe, for Europe, in Asia, for Asia.
Mm-hmm.
Now, clearly, we need to see the final details.
Right.
But as we sit here today, we feel that we are well positioned. With regards to MFN, we and the industry is supportive of the agenda to try and lower out-of-pocket costs here in the United States and ensure that countries around the world are paying their fair share for innovation. The recent letters we all received from the President has MFN focused in the Medicaid segment.
Right.
That's a relatively small segment, less than 10% of the revenues for our company here in the U.S. It looks at MFN as you launch products, and we would make sure we're launching products cognizant-
Right
MFN. And there's some other elements to it. So for us, as a company, we remain focused on innovation, focused on our pipeline, because if we have products that truly make a difference in the world, we price them commensurate with the benefit that we're bringing to society, that will drive growth into the future. And we'll see what the details of MFN may or may not be as the next months and years unfold.
Got it. So the question we get a lot is that, I mean, would the companies consider pricing their ex-US drugs differently for the new year launches, going forward, considering the MFN and all those issues?
Yes, so we always look to price our products around the world commensurate with the value that we're bringing. Often in certain countries around the world, the processes that they have around the pricing is formulaic-
Mm-hmm.
in nature. What is helpful with the MFN news flow at the moment is governments understand that if they don't step up, they will be at risk of not having-
Okay
... innovation come to those markets. So for our company, we will continue to stand firm in launching our products at a price point that we think is appropriate and commensurate with the value that we're bringing.
That completely makes sense. Thank you for that. And then the other question is, like, I mean, IRA, and the question we get a lot, like, now, I think, with IRA, with the big, beautiful bill, you probably will have one-year extension for KEYTRUDA, but the question always is, would sub-Q be part of? Like, because the first guideline kind of suggested it won't be, but now it does look like it would be. But how are you thinking about sub-Q being part of or not part of?
Yeah.
Yeah.
So as we talked about earlier, we're really excited about the opportunity to launch a subcutaneous formulation of pembrolizumab. As we look at the IRA, the original IRA was in line with the FDA, in that subcutaneous is a new product, two active moieties combined, and therefore would not be subject to IRA at the same time as for KEYTRUDA, the IV portion. The CMS requested responses to a proposal that suggested maybe it would be subject to the IRA at the same time as KEYTRUDA IV is. We obviously gave our responses, and we think that's just bad policy, bad practice. That said, should KEYTRUDA IV and the subcutaneous formulation of pembrolizumab be under the IRA price setting at the same time, it doesn't fundamentally change the economics for the subcutaneous formulation. And the reason is, we are pricing the product to ensure broad access.
We'll do that at launch, but we'll also need to ensure we understand the market dynamics as biosimilars enter the market, as there's IRA price setting on KEYTRUDA IV, so that we do maintain access and maximize really the volume-
Right
... that we will have from KEYTRUDA, subcutaneous formulation.
Got it. Very helpful. One more question before we move back to the pipeline side. So, like, you mentioned, like, you announced the plans to reinvest the savings from $3 billion restructuring program here. So it is quite interesting, right? I mean, like, so there's restructuring, but again, at the same time, Merck, at this stage, has to invest in pipeline as well, right? Given the exciting opportunities out there. So how should we think about operating expenses growth, specifically R&D, in next few years here?
So as Mohit mentioned, our company announced last quarter a multi-year optimization program, and this multi-year optimization program will drive productivity across every element of our business, from our manufacturing, supply chain, the way we conduct our business, sales and marketing, research. And we're doing that to drive $3 billion of annual cost savings that we will fully reinvest in our future. Our company has one of the strongest pipelines we maybe ever had, and we must fuel that pipeline. So we will be increasing R&D investments because of the breadth of the pipeline. We have 80 phase III clinical programs today. We've got these 20-plus products launching. We've got an invisible pipeline, the early stage, that will be turning visible. So we will, as Eliav mentioned, appropriately fund R&D, grow R&D.
We will appropriately fund SG&A as we're bringing these new products to the market, ensuring that we're funding our launches to compete effectively and excel in those launches so that we drive growth for our business into the future.
Got it. Very, very helpful. Thank you for that. So maybe moving back to the non-oncology pipeline here, so WINREVAIR, I mean, the launch has been exciting. You have a new set of data and new indication coming with Cadence. So can you help us set the stage here, vis-à-vis the PAH, how big the opportunity could be? Because you'll probably go after a subset there, so can you help us understand all that?
So you're talking about the Cadence study?
Yes, yes.
Yeah. Sorry.
Yeah.
I didn't quite hear, so you're right. We have a phase II program in type two pulmonary hypertension. Type two pulmonary hypertension is a diverse set of diseases that are associated where pulmonary hypertension or high blood pressure in the pulmonary arteries is caused by different problems in the heart in the left heart, and so there are different kinds of diseases that cause that. We have a specific type of disease that you know roughly is in size the size of pulmonary arterial hypertension although not as well diagnosed where there's pressure both before in the precapillary and postcapillary. So it's called CPC-HFpEF. Very, very long name, but in short, people who've got high pressure both in the arterial system and in the venous system.
We have hopes that sotatercept or WINREVAIR will be active there simply because the biology is not too dissimilar, and when we look at what the arteries look like, they also have the same kind of proliferation of the vessel wall, the thickness of the vessel wall that happens with PAH, but it's a separate indication. Those data will be available later on this year and we'll be you know discussing them hopefully at the beginning of next year. You know, we'll see. Based on those data, it'd be a very important new addition to the WINREVAIR indications.
Got it. Very helpful. Another cardiovascular drug, I mean, PCSK9, oral PCSK9. Again, there have been ebbs and flows on this one. Like, obviously, like, you've had good data in phase II. The question is now with the AstraZeneca having no food effect versus food effect. I mean, how do you think about this, this carefully evolving there? Because the drug should work, yeah, so, but did work.
So look, the most important thing that physicians are looking for is a drug that's really active.
Okay.
First of all, you know, statins have been terrific, but guidelines are pushing people to have ever lower LDL cholesterol levels, and it's really important because, obviously, the benefit of LDL lowering has no basement. There's no bottom where it is no longer important. So you need to have medicines that are available that can be given and really improve on what statins have. Enlicitide or MK-0616 or PCSK9 oral inhibitor will democratize access to this particular mechanism of action as opposed to the injectables. It'll give the ability to take one pill once a day, no problem, in terms of, you know, access barriers and so on, and we think that's going to be a very important addition. And the data from phase II showed, you know, sixtyish% reduction in LDL cholesterol.
That's essentially consistent with the injectables. What we've seen in our phase III program is exciting results that are consistent with what we think we need to create a really important innovation for patients, akin to the injectables. In the phase III studies, the proof of the pudding, including the largest one, this business around taking it after when you get up in the morning, has not been an issue at all.
Yeah.
Compliance was really terrific. We had no adverse experiences, no difficulties where patients had a problem, and when we talked to our scientific leaders and practitioners, this really isn't an issue. What they're interested in is, what's the best reduction that you're going to get? And if you look at our phase II data, a little over 60% reduction in LDL cholesterol, reductions in Lp(a), and you know, time to market, it's very important. We have two years-
Right.
During which we'll be the sole oral PCSK9 inhibitor, we think, and at the same time, we'll also have the best profile, I think, overall.
Got it. Very helpful. Maybe, like, finishing up the cardiometabolic. So where are you with your GLP-1 at this point?
So, you know, we're very excited about cardiovascular and metabolic space because there's still such a high unmet medical need. And, you know, as we look at enlicitide, we're looking at also next generations where we would combine it with different agents that might further improve prevention of atherosclerosis. On the GLP-1 front, you've seen that there's been a lot of expectation setting around what kind of reductions are needed to excite investors. But from my point of view, I think, and from our point of view, the fact that you can have an oral medicine really is a big deal.
Right.
We have a MK-4082 that will enter phase I later on this year, and we think that the differentiation will be in what combinations you're going to put in together. What combinations are going to be tolerable? How many different titration steps you're going to need? Because remember, it's not easy for physicians to keep track of all of this, especially if they have to rush, rush, rush every patient through to meet their numbers. We'll have to see. I think oral, in general, in my mind, oral is always better than injectable.
Got it. Very helpful. Moving to the BD a little bit here, and I'll talk about GARDASIL as well. I wanted to know. 35 minutes, we did not talk about GARDASIL. So BD, I mean, like we saw, I think, Verona is one deal which is more commercial than the development. Merck has been historically, Merck has done more development deals than the commercial deals. So should we think of this as a change in direction a little bit? And, I mean, how should we think about deals going forward, given your balance sheet?
Business development remains a key priority for our company. There's so much good science that happens outside of Merck, and our goal is to bring that science into Merck, where the science and value aligns, so that we can bring benefit to patients as we have with WINREVAIR, as we hope to with our TL1A asset, as we will do, we hope, with the Verona asset. As we look at business development, our starting point is around the science, and is this innovation that will address an unmet medical need? We are not bound by what phase of development it is, and we're not actually bound by value, by price. What we're bound by is innovation that will make a difference, that in our hands, we can drive growth, and we can drive value for the shareholders.
So we will continue to progress on a whole suite of opportunities that span multiple phases of development and also will span multiple TAs as we look first and foremost to drive patient benefit, but growth for our business as we look out to the end of this decade and beyond.
Got it. So very active, very helpful. So, now moving to GARDASIL. So I think, I mean, at this point, I mean, how do you think about, I mean, like, is it fair to think that China is probably going to be where it is right now, and then growth will come from outside of the China markets at this point?
Yes, so Gardasil in China is an immaterial revenue-
Right
-driver now for the company, less than 1% of revenues. And as we look to 2026 and beyond, we're not counting-
Mm.
-on GARDASIL in China to drive our growth.
Right.
We have resources on the ground with our partner to ensure that we are educating people of the continued benefit of HPV protection, but we're not counting on it for our growth. Instead, for Gardasil, we expect growth will continue to come from further penetration of adolescent segments, especially the male-
Right
Cohort in countries internationally. Growth will come from the mid-adult segment, that's the age group 27 through 45. 50% of infections happen at that age, and so we are working on activating that group, although it takes time, and we will see growth from the low and middle-income markets. But most importantly, our company's growth is really going to be fueled by all of these new launches and new products that we've got coming through.
Got it. And then, I mean, there is a lot of, you know, headlines from the administration about the vaccines and then the necessity and... Like, I mean, so GARDASIL, there is this, I mean, there could be potential ACIP and the chances of, you know, less number of doses. So how do you think about that as a possibility? Also, I mean, similarly, like, we are hearing something about RSVs as well. So, like, again, I don't know, like, how do you think about-
Yeah
This narrative out there?
Maybe I'll have you comment first.
Right. So first of all, let's take Gardasil. The single-dose Gardasil story is unfolding. We don't know. We don't think that the ACIP is gonna consider it in September. In the future, we don't know. What we do know is that the Food and Drug Administration has been very, very clear about the evidentiary standards that they need to enable single-dose vaccination, and those standards are much higher than anything that's been generated to date. They're looking for clinical endpoints, that is, hard endpoints like precancerous lesions in both men and women, and in both for short-term but also long-term durability, and no loss of efficacy. So when you think about all of that, all of those requirements, it's gonna be very difficult to be able to get an FDA-approved single dose.
There are settings where ACIP may disagree with FDA and choose to make its own recommendations. We don't think that the evidentiary standard is there for this. There's no reason for this to be done. Now, more broadly, you know, we can't control and we don't know what ACIP will do. We're very confident that vaccines are a critical part of the healthcare infrastructure. They save lives. They've really made a difference over the past fifty, sixty years, and some of our vaccines have been out there for quite some time. Our RSV preventive, clesrovimab or ENFLONSIA , has been studied extensively. It went through a full FDA review. It was all very clear. It went through the ACIP review process.
A lot of all the data are fully public, and we got all the relevant recommendations. You know, how the ACIP will think things through in September, we don't know, but we're very confident that the efficacy and safety of ENFLONSIA, of Gardasil, of our all of our vaccines, and frankly, the vaccines of all the manufacturers that are part of the immunization schedule, these vaccines are incredibly well-tested. They are incredibly valuable. There's enormous post-marketing data, and I think that at the end of the day, professional societies and physicians who work with parents will understand that, and we hope that that will continue to reinforce vaccines.
Awesome, so I'm at my last question, and my last question is always the same. Fast-forward one year, two thousand twenty-six September, I hope you are here, I hope I'm here. So if I ask you the question one year down the line, that what would make you look back and say, "This was a great year for us?
So for me, it starts with our pipeline. You will have seen the progress in our pipeline as we really are moving, as I opened today, to a much more diverse set of growth drivers that will make a difference in the world. So seeing positive readouts on all of these assets that we have coming through and seeing excellence in our launches, that's what this looks like to me, with continued augmentation from business development.
Awesome.
Again, I look forward to the readouts of a lot of really exciting results. We haven't talked much about our HIV pipeline, but there's gonna be some really important readouts there. You know, same with some of our oncology products. And I look forward to, hopefully one year from today, where we see that there's stability in thinking around vaccination schedules and around how the enormous value that these vaccines have brought. And I'm really excited also to... We'll be excited to showcase our new oncology pipeline as well. So lots and lots of stuff going on. You know, we're gonna have a lot of readouts, and I'm really looking forward to a good year.
Okay.
Great. On that high note, thank you very much.
Thank you, Mohit.
Thank you.