Hi, everyone. My name is Trung Huynh. I'm the U.S. Pharma Analyst here at UBS. It's my pleasure today to present Merck, and we have Jannie Oosthuizen. Hopefully, I've not destroyed that pronunciation. President of Human Health in the U.S. at Merck. Thanks for your time. For everyone, if anyone wants to ask a question, just stick your hand up, and I'll try and get to you. Also, if you have the app downloaded, you can send me your questions through the app, and I can attempt to ask those questions. But yeah, let's begin. So before we start, Jannie, how about can you give us a bit of background about yourself, an introduction to yourself, and perhaps, give us a recap of your highlights from 3Q results?
Perfect. Well, thank you, Trung. Thanks for having us. So Jannie Oosthuizen, I've been with Merck for the last 9 years. P rior to Merck, I spent about 21 years with Eli Lilly. It was mostly the international markets. I worked previously in headquarters for Lilly in the US. The rest of my time I spent pretty much traveling the world with my family, working in places like Russia, South Korea, Asia Pacific, in total for 12 years. Before returning to the US, I led the MSD business in Japan, the Merck business in Japan, for 5 years. Came back in 2021 to lead the global oncology business at Merck, and then moved into the head of US Human Health at the beginning of 2022.
So it's just about two years that I've been leading the Merck US human health business. So that's me. In terms of Merck, I think, you know, we've had a really strong year. We just came off our quarter three with growth of about 8% if you exclude LAGEVRIO and exchange rate. Total $16 billion across human health and animal health in the third quarter. If you pull that apart a little bit, about $14.3 billion. Well, $14.3 billion was the human health component of the $16 billion, and we grew the business 10% in quarter three. The key drivers were oncology, as you can expect, with KEYTRUDA continuing to do extremely well.
We grew KEYTRUDA 17% in the quarter to $6.3 billion. The rest of the growth was coming from GARDASIL at 16%, $2.6 billion in total sales. You know, and that's pretty much the highlights for quarter three, I think.
Excellent. Well, I guess let's start off with the growth drivers, obviously, KEYTRUDA. In 2022, we saw supernormal growth for KEYTRUDA, driven in part by new indications that you added on in 2021.
Yeah.
Things like triple negative breast and so on and so forth. In 2023, that sales growth has come down, obviously, because of the law of large numbers, but also in 2022 you didn't have as many approvals and indications in 2021 to grow your 2022 base. This year, we have seen some really interesting developments. We've seen KEYNOTE-671 get approved quite recently. We've seen some data recently at ESMO with the EV-302 study.
Mm-hmm.
We're gonna see additional approvals in Europe. So as we head into 2024, do you think these things can, you know, see a little boost for 2024 on, on sales, or should we continue to think, you know, law of large numbers, this is a big drug, it should just keep-
Yeah
... coming out?
Just one that I omitted, the other growth driver for this year is VAXNEUVANCE, which we feel really good about.
Yeah.
So that was the additional component for our growth coming from, from the pediatric business, where we took about a third of the, the pediatric market. You're right. So, you know, we kind of lapping a lot of those launches from two years ago now, driven by triple negative breast, adjuvant, RCC, adjuvant melanoma, that has been just phenomenal growth drivers, and we still saw some of that, through this year. As we move forward, these early-stage indications will continue to be a significant growth driver for the KEYTRUDA business. You know, we are—when we look at it, we are growing our business across almost every tumor. So there's a big metastatic base that continues to deliver well, but increasingly, the growth is driven by the early stage.
We see in 2023, early stage is about 20% of our revenue, and it's gonna go up to 25% by 2025, in the US, probably closer to 30%. So, as we continue with the early-stage expansion, and lung will definitely be a part of it, we've already launched KEYNOTE-091, where we took leadership, and we're in the process now of launching, you know, KEYNOTE-671, that will continue to expand our presence in that front setting in lung. And hopefully be a catalyst for, you know, treatment rates and diagnosis to continue to go up in lung as well. And if we can do that, I think it will continue to be a strong contributor to our growth moving forward.
And then, you know, in the metastatic settings, the combination KEYTRUDA plus PADCEV is really gonna be a game changer for first-line metastatic urothelial cancer, where there's really been no new treatment delivered in the last 10 years. And, you know, we still see five-year survival at less than 10%. So this is gonna be a significant change for patients in that first-line setting. And the data we saw on ESMO is basically more than doubling the patient opportunity in that first-line setting.
Mm.
So it's gonna be a big contributor to our growth moving forward. You know, KEYTRUDA is a big base business. You know, if you look at it, we have grown year-to-date 21%, sitting at $18.3 billion. So it's a big base to move. We feel really good about that growth. You know, will we accelerate that growth? I think that's a big ask, so but we will definitely continue to see significant growth coming through on KEYTRUDA.
Excellent. So one of that, the KEYNOTE-671 recently got approved. I know very, very early days. How have physicians taken that data? And also payers, how have those discussions gone?
Yeah. So, you know, on the US side, from a payer perspective, there's no real additional discussion needed. You know, the indication is approved, it will be, it will be reimbursed after the label. But it is early days, as you say, we literally just started to launch about a week, two weeks ago. But you have to believe, you know, with us delivering both EFS and OS, two primary endpoints in this early stage, setting, has to be very significant for prescribers in terms of, you know, confidence to use the product in the neoadjuvant, adjuvant setting. But also, I think for systems to put forward a more concerted effort to make sure that patients are screened, and when screened, and when a nodule is detected, that there's real follow-up.
And to get patients now on a treatment that is proven to be, you know, extending life. So, it's early days, and, you know, we but we're very excited about what the data is handing us in terms of the entry into early stage lung.
How important is that OS data? Because when we speak to KOLs, they talk about how, Opdivo is well used in the neoadjuvant study, that they had that 816 study. But that doesn't have OS data. So do you think, you know, getting that OS data is the additional bump needed for physicians to use?
Yeah.
You know, KEYTRUDA in the neoadjuvant setting?
Yeah, I believe it will make a difference. You know, we've seen the field getting more used to other endpoints, but I think there's still an expectation for OS. And when they see OS, I think it's still a very significant endpoint that is meaningful in terms of increasing the confidence to use the product in that setting. So, I think Keytruda should get really good traction based on the OS data. Obviously, you know, Opdivo was used early on when no other product had OS in that setting.
Mm.
So I think now that we have OS, we'll need to see. And I'm not sure if the others will come with OS, it will not be a primary endpoint, it will be secondary endpoints anyway. So I think this is really meaningful for KEYTRUDA in this setting.
You noted 25% of your 2025 sales potentially from adjuvant or, or 50% of the growth is going to come from adjuvant. How much of that is lung? Lung is clearly the, the biggest adjuvant area, along with breast, so.
Yeah. So we don't, you know, we don't really put out what the different tumors are driving, but what I would say is that lung will increasingly become meaningful, especially if we can increase, you know, screening, diagnosis, and treatment rates in that setting. You know, it's gonna be a... I think lung, we always said it's gonna be a bit of a slower build, just because there's such a low screening happening at the moment.
Mm.
So a lot of room for improvement and growing that patient population. And then, you know, even... You know, we look at it, there's basically three types of patients that we focusing on to advance this field. The one is those patients that are diagnosed, and they either plan to be resected or they have already been resected, right? So we can take care of both those patient types with either 671 or 091. And hopefully, increasingly, we'll be able to get the multidisciplinary team to consider the neoadjuvant adjuvant, the perioperative approach. The second one is, you know, patients that they've detected a nodule through a CT scan or an X-ray, but for some reason, there's no follow-up.
You know, I think there should be a real urgency now for the systems to make sure that these patients are not lost, given that there's a highly effective treatment that could be administered alongside surgery. And then, you know, thirdly, it's these patients that are at high risk and not screened at all. So how do we expand screening? So I think if we can hit on all three, those, we're really gonna see a good expansion in the front line lung setting. That will become a meaningful contribution. But I think this is positioning us for lung to be a good growth driver for our KEYTRUDA business moving forward.
Excellent. We had a surprise last week with KEYTRUDA. We got approval in first-line biliary tract. That was the KEYNOTE-966. That was a few months ahead of schedule there. I guess no one's asking me a question on this, but what are your thoughts about this as a potential opportunity? And then we did look at the data and you hit OS, but you also missed, I think, ORR and PFS.
Yeah.
you know, have you spoken to doctors about that, and how has that been translated?
I mean, it's also early, early days. You know, I think this is hopefully pretty meaningful for patients. It is a small tumor, so it's not a significant driver in the business, but, but critically important if it, if it does address an unmet need. But it's early days. I don't have any, any, firsthand or aneCVOTal feedback from prescribers.
One of the important lifecycle management studies with KEYTRUDA is getting it in a subcutaneous dose. Can you give us an update, perhaps, on the timing of that? When should we see that phase three data in lung? And you also previously had a non-hyaluronidase dose. What happened with that one there?
Yeah. So on your second question, so the formulation we're taking forward is the co-formulation of pembrolizumab and hyaluronidase, right? Two active, two active ingredients, from a co-formulation perspective, that we also believe would be treated separate from a IRA perspective to, to, Keytruda, you know, in, in the vial. So, so that's the one thing. The second one is in terms of the, the subcu study. So we will have a readout in our- in late 2024, second half of 2024, so that's when we will see that. So looking forward to that, and then, you know, we believe that subcu will be particularly, you know ...
The application will particularly be relevant in the early stage setting, where treatment is going on for a bit longer, in combination with orals, where, you know, you don't need an infusion, or for some of the indications where KEYTRUDA is still used as monotherapy. So those will be, I think, the most significant areas where the subcu will be used eventually.
Okay. Do you have any updated thoughts on IRA and how it relates to the subcutaneous formulation, given the fact that CMS really wants to see innovation here? Like, what's your sort of, you know, base case thoughts on if that's going to be included or not?
Yeah. So they are asking some clarification in terms of how they look at the, you know, the rule around fixed-dose combinations. And the way that we interpret it now is that if it's two active ingredients in a fixed-dose combination, that it will be viewed as a separate product. So our expectation in terms of current interpretation is that subcu will not be negotiated with KEYTRUDA ultimately.
Okay, excellent. Okay, if we can move past KEYTRUDA and the second big growth driver, GARDASIL, continues to surprise investors.
Yeah.
The sheer growth is incredible. For 2024, where are you with supply, given the fact that, you know, there is increasingly, you know, a lot of demand for this product now?
Yeah, that's right. Yeah, no, Gardasil has done exceptionally well, and, you know, there's, there's still a huge opportunity if you just look at global vaccination rates and, and the evidence we have that Gardasil is a meaningful, vaccine in terms of preventing HPV-related cancers. You know, we, we are still not completely, unconstrained from a supply perspective, but we have made significant progress. So, you know, and that's really what's been helpful in driving the growth in China, in particular, where there's huge underlying demand, and we've been increasingly able to supply, for that demand. But as we head into 2024, you know, we, we will still be constrained. We should be unconstrained by 2025.
So that's the timeline that we want to be in a position where we can really supply in an unconstrained way across the world.
Okay. You, you noted, I think, earlier this year, right at the start, you want to double Gardasil sales in the future. Geographically, where is that going to come from? I think from our sort of analysis, we think that China's probably 70% of the ex-U.S. market.
Yeah.
I guess, is that right? And then where else? What's the geographies that you can grow?
Yeah. So we spoke that we will get to $11 billion-plus of sales for, you know, and we will continue to see growth in China. I mean, China has done exceptionally well, but there's still opportunity in China. And then when we look beyond that, I think there's really broadly three areas. You know, in low and middle-income countries, you know, once we can pursue that volume, and that's really where the unconstrained supply will come in. We know it's going to be at lower price points, so we also need to look at manufacturing costs that can accommodate a lower price point. So that's the one thing that needs to be true to really expand into that low, middle-income country opportunity.
Within the established markets, you know, we need to increasingly move beyond the cohorts, basically the adolescent cohorts, that were vaccinated within, you know, publicly funded programs. And really what we're looking at is the mid-adult segment, right? So it's basically that 27-45-year-old population, where I think there's a, you know, we believe there's a strong scientific rationale. More than 30% of infections, HPV infections, happen after the age of 27, so there's a really strong rationale to vaccinate that population. But a lot of education is also needed to bring about that understanding and, you know, to really get the activation going. So that's a bit more resource intensive to get that done, but certainly an opportunity that will continue to add to this growth.
And then the third one is really gender-neutral vaccination, where we know that the evidence for, you know, preventing other HPV-related cancers like head and neck, or oropharyngeal, you know, means that there's a real need to also vaccinate males.
Right.
and similarly, there, we need to look at education and bringing about understanding for, you know, the meaningful protection that can be done. There, there's still a number of markets that have not approved the indication for gender-neutral. You know, including China. The study is ongoing, and we are hopeful to get the indication in China, but it's really expanding that indication, you know, across the market as well, so that we can really go after that gender-neutral vaccination.
Yeah.
Yeah.
Okay. And perhaps an unfair question, because you're, you know, President of Human Health in the U.S., but China, Merck is one of the bigger players in China. We've seen a significant slowdown in the Chinese economy there. Have you seen any kind of impact to Merck? But there's also, you know, crackdown on regulation-
Yeah.
Yeah.
Yeah. I mean, on the anti-corruption drive, you know, we think that's a good thing for business. I think, that's, you know, and my counterpart, Joe Romanelli, who actually managed China and now is leading international, do believe that, you know, that will help to create an even playing field, which we think is good for business, but it's also good for patients, right? That decisions are made in the interest of what is best for patients and not for any other reason.
Yeah.
So, in terms of the economic slowdown, I mean, that's been ongoing for a while. We haven't seen it in our business for the most part, because our business is pretty much in the private segment. So it's less affected by public funding, government spend. And I think it's also indicative of the value that KEYTRUDA, as well as GARDASIL in particular, bring to the Chinese population, as well as, you know, JANUVIA in terms of diabetes. But our business is mostly in the private segment, so less affected, I guess, by government constraints at this point.
Is there any manufacturing risk? Do you have much exposure to China there?
From a supply chain point of view?
Correct.
Yeah, I mean, we, you know, we constantly look at expanding our, you know, supply chain to multiple sources and not be overly dependent on China. Obviously, China, you know, is a big supplier to the world, but that is something that we're actively addressing to make sure that, you know, supply chains can continue to run from other sources around the world.
Okay, excellent. So I'll switch it up to ADCs, an area where you've recently invested in.
Mm.
It's certainly an area that appears to be getting hotter by the day. Bristol did another deal in that area a couple of days ago, I think. What appeals to Merck about the ADC opportunity?
Yeah. So I think, you know, we've advanced the field of oncology significantly over the last 10, 12 years with immuno-oncology. Despite all the advancements, we know there's still significant unmet need, right? Many patients are benefiting from what is possible today, but still a lot of patients are not responding or not, you know, really getting the help needed to treat their cancer. So we believe that ADCs is a meaningful expansion to continue to drive benefit for patients and improve the outcomes. You know, it's a targeted way to deliver chemotherapy. And, you know, we're really excited to be part of this push into the next chapter of how oncology is gonna continue to evolve.
And with the partnerships that you have and the experience that you're gaining, are you... I guess, can you develop your own platform here? Where, where is Merck in that sort of period?
Yeah, I don't want to speak on behalf of Dean, but I think there are capabilities starting to feature that will, you know... And obviously, when you look at ADCs, there's, you know, at least three components, right? In terms of the antibody-
Yep.
the linker technology, and then the payload. So I think increasingly it's evident that, you know, the tissue targeting is gonna be a clear choice of what man we use, but there's gonna be a lot of technology and innovation around the linkers and the payloads. So that's definitely an area that we will be interested in to continue to evolve.
Okay, excellent. And, you do have a Trop2, ADC.
Yeah.
We've seen a lot of competitor data surrounding Trop2 very recently. How's that evolved your thinking about Trop2 in Merck?
Yeah. So, you know, we bring that into... You know, if you think about non-small cell lung cancer, there's two pieces. There's the one which is, you know, in EGFR mutations, post-TKI, where I think there's an application. But if you think about moving into non-small cell in the first line setting, the, the way we think about it is today there's a pretty high hurdle in terms of KEYTRUDA plus chemo in the all-comer population and KEYTRUDA as monotherapy in the PD-L1 high expressers, for instance. So when you bring a Trop2 into that setting, how are you gonna create a differentiated effect, right? So we do believe that it's probably gonna require a, a biomarker approach for, for, for entering into these tumors and lines where there's-
Mm-hmm
... a very high standard of care already, and going after a smaller segment. And probably it could be that multiple ADCs will be needed to replace, you know, chemotherapy and even a KEYTRUDA plus chemo type of combination at the time. So it might not just be one push with one ADC into that space, but it might be multiple, to really target that segment that will produce a differentiated effect.
Okay, excellent. And I want to move on to the pipeline in the last 20 minutes, but if anyone has a question, then, you know, please raise your hand or send me a question on the iPad. On the pipeline, I get many questions on the next catalyst for Merck. People, compared to peers, they think you perhaps might have a more modest catalyst path. I'm curious, somewhat agree, but somewhat disagree. Perhaps can you outline the main catalyst that we should expect coming from that over the next sort of year?
Yeah. Yeah, so, you know, I think, one of the exciting launches that we will have early in 2024 is sotatercept as we move into PAH. So certainly we've seen the data. We know the, you know, the PAH community is ready to use the product. So, sotatercept will definitely be a great start to 2024. We will see data on V116 soon at the World Vaccine Congress West Coast in November. And then, hopefully, a filing that will take place before the end of the year for V116, which is our push into adult pneumococcal vaccination.
We feel very excited about what we're gonna continue to do with population-specific vaccines moving forward, V116 being the next one after VAXNEUVANCE. So those are two really exciting ones. I talked about the data that we're gonna see for sub-Q earlier. We also have Islatravir, Lenacap avir reading out early in 2024, so there's a lot happening, and I think we have increasingly better visibility across these areas in terms of what it means for the next decade for Merck.
Okay, excellent. So the big one, sotatercept launch. On the call at 3Q, you mentioned there were physicians warehousing patients for that. So perhaps can you expand on that? And yeah, what's the initial feedback you've had from physicians?
Yeah, and I think, you know, just first of all, we kind of maybe not calling it warehousing so much as, we know that there's a lot of physicians, especially, you know, the experts and COEs, that have very specific patients in mind that they believe is ready to be put on sotatercept as a next step. You know, these are patients that maybe had disease progression already. There really isn't anything else versus what they're on today. They're already on triple therapy. S o there's, you know, there's in physicians' minds already, a list of patients that they have in mind that should go on sotatercept, or maybe patients on dual therapy that couldn't tolerate, you know, the prostacyclin. So likewise, those are patients that physicians have in mind. So, so that's more ...
So it's maybe not technically a warehousing, but definitely, you know, some predefined patients that physicians would like to get on sotatercept as soon as possible.
Yeah.
Yeah.
and the data are excellent. The STELLAR data are excellent.
Mm-hmm.
We'll have more studies read out hopefully this year, or sorry, next year.
Next year, yeah.
Hyperion and CADENCE. Given ... Do you think you could potentially have interim readouts next year?
Yeah, I think there's, I mean, there's always a view to do interim if possible. So we will have to see. I don't know if there's a specific plan set for that, but, you know, we often have interim reads. So CADENCE will read out next year. HYPERION will be October 2025, and then, you know ... Oh, no, actually, HYPERION is 2028. ZENITH will be 2025.
Okay.
Yeah. That's right.
And how do you think about the opportunities in these settings? Like the PH setting hasn't gone-
Yeah.
I mean-
I mean, if you think- exactly. I mean, if you think about, if you think about CADENCE, you know, that left heart pulmonary hypertension patients, you know, it's a population that has nothing today, right? So this will really be an additional population to be added, and hopefully can benefit significantly from what sotatercept can do. Hyperion will inform us how early should treatment be started, you know, so how long should you wait? And that could potentially be even cost-saving to the system.
Yeah.
So, you know, I think it's very exciting to think about that. And then ZENITH, you know, enrollment is doing really well. These are end-stage patients, but can you get them off the transplant list, right? So, I think this is a product that's going to continue to bring more and more value to the system over time as these data sets read out.
Okay. One of the more interesting pipeline drugs that we think is the oral PCSK9. The phase two data are, again, very good.
Yeah.
How are you going to stop it going the way of the injectable PCSK9s? Yeah-
Yeah.
You've mentioned pricing a lot whenever anyone discusses it, so just some of your thoughts there.
Yeah. So I think, you know, first of all, we obviously will be able to take 616 and oral into a very different setting where patients can access it, versus where you have to go for an injectable PCSK9 today. From a access and reimbursement perspective, you know, no doubt there's a lot of work we need to do from a guideline and policy point of view to make sure that access, you know, is as broad as possible, and that's work that we're embarking on. But our ambition is really to democratize the, you know, the availability of a proven pathway, you know?
Mm-hmm.
So how do we bring that to every patient that is struggling to basically get to goal in terms of managing their LDL cholesterol? Today, 70% of patients at risk of cardiovascular disease is not at goal, right? So, so we know there's a significant need. Only 5% of patients are accessing injectable PCSK9. So, you know, you can look at that as, you know, it's why are so few using it? Or you can say, well, there's a significant opportunity to change that, and I think we are determined to do that.
... How important is CVOT studies here? Like, is that when we'll actually start to see an inflection of the-
Yeah, I think, you know, I think there's gonna be certainly a big opportunity up front that we will take, and then CVOT will come in as part of lifecycle management. And in the U.S., you know, I think the big opportunity will be to unlock the primary prevention segment of the market, which is huge, right? So I think it's gonna be two phases, but we do believe, despite not having CVOT, that we need to establish an urgency to bring down LDL cholesterol in a population that need it today, and then over time, work with the CVOT to hopefully broaden access to an even larger population.
Yeah, it's interesting that you mentioned the primary population, primary prevention population. It's the opportunity there is huge.
Yeah.
But you're starting the secondary prevention trials now, and then you'll have the CVOT. Again, relating back to IRA, does it... 'cause when IRA kicks in, it starts from the point-
Yeah, yeah
-that you have your first approval. So is that changing the way your clinical study program is approached?
Well, you know, again, I think, I don't know if, you know, I don't think it's right to let patients wait because the IRA is looming, right?
Mm.
So I think we have an urgency to get this out to patients, not just in the U.S., but globally, as soon as possible. And by the way, we believe that, and all PCSK9 has huge opportunity, not just in the developed markets, but really, you know, in the entire world. So that's a big part of it. This really is gonna be a big volume push. And, as I say, it would have been handy to have CVOT earlier, but we're not gonna wait for that before we launch. And we just have to make this work in the context of the IRA. So, I think we're determined to make sure that, you know, we harvest the opportunity up front and continue to do it over the life cycle.
Excellent. I think one of your next catalysts on the horizon is PRA023.
Yeah.
Which you acquired from Prometheus there.
Right.
What's your expectations there as we get that maintenance data, and what do you need to be used in the first line, as a first-line therapy in IBD?
So the way we look at, you know, our re-entry into immunology, so to speak, is that we want to bring into immunology what we did in oncology, which is a biomarker approach. So we believe that, you know, the efficacy data we see in the all comers today is encouraging. We've seen that in the induction, so it gives a lot of hope for how the maintenance is gonna work out. So if you can have that, you know, great effect in an all comer population, similar to current treatments, and then, you know, think of a biomarker population where you can have an even greater effect size, it's gonna be a very strong entry into that first-line setting.
We know there's a lot of, a lot of cycling through therapies for these patients, so, you know, having a strong entry into a first-line setting on a biomarker population, but having, you know, efficacy data to cover in that second-line use, I think is gonna continue to expand the opportunity beyond the first line as well. We are very, very excited about what PRA023 or MK-7240 is gonna bring for us.
Yeah. Yeah.
Yeah.
And are you establishing any infrastructure there, at the moment? Because immunology-
Yeah
is not the biggest area within the today.
Yeah. You're right. In the U.S., we haven't been in immunology for a while. We still have infrastructure outside of the U.S., you know, where it's still being promoted in collaboration with J&J. But we have some time to build this, and this is what we will do, right? So we will definitely build this back. I think there's still a lot of institutional memory in terms of immunology.
Mm.
We will leverage that. And, I think we've shown... I mean, similar to where we were 10 years ago, we had almost nothing in oncology, and we were able to pivot and, you know, build a phenomenal oncology business. You know, we're doing the same in rare disease now with PAH. We'll be creating a clear focus on that area to make sure that we bring the best experience to patients in PAH. And similarly, we will pivot for immunology when the time is right to do that.
You have a bunch of fixed-dose combinations with IO. Perhaps can you give us an update on the timelines of when these things are expected to start reading out for you guys?
Yeah. So, so we have the combination with TIGIT, KEYTRUDA plus TIGIT, or pembrolizumab plus LAG-3 and CTLA-4. So we should see the pembrolizumab LAG-3 data reading out in 2024. So we will see, we will see that come through in CRC specifically. Then in 2025, we will see the TIGIT combination, and 2026 is CTLA-4.
Okay, excellent. You also have a KRAS. You've shown some promising phase 1 data.
Yeah.
I think you've made comments that you want to accelerate this quickly through the clinical trial process. Yeah. Any comments on the phase 1 data or your excitement over-
Yeah, not so much on the data itself. I mean, it is still early stage. I think, you know, what we obviously when you look at targeted therapies, KRAS is a significant portion of populations. Lung is about 15%, so it's a pretty significant size that is addressed with KRAS specifically. I think the most exciting component about this, or aspect for this compound, is the combinability-
Mm.
with KEYTRUDA potentially moving forward, or maybe even other products, right? So I think it's as we look at, you know, deepening responses with combinations, the KRAS we have seems to be combinable, which is what is, I think, very exciting about it.
Yeah, it's interesting you mention that, because Mirati, who have a KRAS, has a combination study with KEYTRUDA-
Yeah, yeah
... in the frontline setting.
That's right.
I guess with Bristol now acquiring, does that change in any way?
For them or for us?
For you.
For us, no, I think we will continue, right, our work and see where we take it. I don't think that necessarily changes it. I think it kind of goes back to the early days of immuno-oncology, when we were all running, you know, at breakneck speed to figure out where do we go next. I think we'll do the same, continue to do the same with the combinations.
Yeah. We're heading into the last five minutes. Does anyone have a question? Okay, and then three things you think that investors are overlooking today at Merck.
Yeah, I think, the first one is, I think we've made significant progress over the last two years in really setting our company up for great success in the next decade. And I think we have good visibility now across cardiometabolic, oncology, and vaccines, immunology, of, of what this means from a revenue perspective moving forward. So, really, you know... And it's not to say that more is not needed. We definitely will continue to do more, but I think that's the first one is, you know, just the amount of work we've done to position Merck well for the next decade. The second one is, V116, which we spoke about it.
Mm.
I think this is really gonna be, you know. We’re gonna continue to bring, as I said, to the right populations, the right vaccine for the right type of coverage to protect them from disease. And if you just look at, you know, with one serotype more than PCV20, we’re gonna keep around 30% more protection from an IPD perspective. And if you compare that even to the 24 variants that’s coming with Vaxcyte and Affinivax, we’re still gonna beat that by 25%, right? So, that will give them about 60% coverage of disease versus 85 with V116. So I think just shifting this paradigm to more is not better, it’s really about the right serotype composition for the population and the disease that you’re trying to cover.
I think that will continue to benefit how VAXNEUVANCE is perceived as well.
Mm.
The other one is the data set. You know, really, I think it's one to watch. We know the data are strong, patients are waiting, and there's more to come beyond the first indication. And then the other one is WELIREG. You know, WELIREG has been in the market, has been doing well in VHL-related tumors. And with KEYNOTE-564, we are now expanding into advanced renal cell in later lines, so that will be early in 2024 as well, if we get that approval. So, yeah, those are probably... Maybe I mentioned four instead of three, but those are the four areas I would highlight.
Okay, excellent. Well, if there's no more questions, I thank you for your time. Thanks very much. There's a lot of exciting things-
Yeah
Going on at Merck at the moment, so, you know, it's keeping your hands busy.
Thank you, John.
We've got the next session in the next 20 minutes.
All right, perfect. Thank you.
Thank you.