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Citi Annual Global Healthcare Conference 2025

Dec 3, 2025

Geoff Meacham
Analyst, Citi

The second day of the Citi Global Healthcare Conference. My name is Geoff Meacham. I'm the Senior Biopharma Analyst and Kate Davis. With me as well from my team here on stage. We're thrilled to have Merck in this session. We have Eliav Barr, who is the SVP, Head of Global Clinical Development and CMO, and then Chirfi Guindo, Chief Marketing Officer. Eliav, Chirfi, good to see you guys.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

See you as well. Thank you for having us.

Chirfi Guindo
CMO, Merck Research

Thank you.

Geoff Meacham
Analyst, Citi

Thanks for the time. So maybe we'll start with the first, with the Cidara deal, right? So maybe just give us some kind of context for the thought process that went into this. I mean, I'm assuming it's more than just, you know, kind of economics and to try to manage the LOE. This is a real growth opportunity. It's a real unmet need. It's very different in terms of the platform technology. But I want to get kind of your insights into that.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Maybe I can start with the medical side, and then I'll ask Chirfi to speak about the commercial opportunity. You know, influenza is a pretty bad disease. It's estimated around 110 million people in a season will have a medically attended illness. And so I think it's a pretty bad disease. The current flu vaccines are reasonable, but oftentimes they're off, and they're not particularly as effective. Moreover, they tend not to be effective in those individuals who are most likely to get sick from flu, the immunocompromised, those with comorbidities, and so on, where immune response may not be quite as robust. And then, of course, year to year, there's strain variability. What's great about CD388 is that it's a drug that's strain agnostic, is able to be efficacious across populations. 76% efficacy in the dose chosen for phase three.

That's better than, you know, even the best of the flu vaccines. And as I mentioned, being able to use it in all variety of different kinds of patients. So I think there's a high unmet medical need. It fits perfectly into our concepts around prophylaxis. We have both chemoprophylaxis and, of course, vaccines in our pipeline. We have got a lot of other drugs in respiratory that are important. And so, you know, there's a lot of overlap there. And so I think the commercial opportunity is great. And I'll ask Chirfi to speak to it.

Chirfi Guindo
CMO, Merck Research

No, no, absolutely. I mean, the fact that you are going to be able to protect, especially those high-risk individuals and immunocompromised individuals who often do not respond well to the traditional flu vaccine, it really is a big deal. And so as you think about it commercially, by the time we come to market towards the end of the decade, we anticipate that there will be about 110 million people in the United States who would be candidates for this treatment. Once again, it's not a vaccine. It's an antiviral that you take once at the beginning of the season, and then you give full protection to the population for the whole duration of the season, right? You know, irrespective of the strain of influenza that you're talking about. And so that is really the attractiveness from a public health standpoint of CD388.

So from 110 million that we anticipate, about 85 million fit the category of high risk or immunocompromised. You know, these are people, you know, cancer survivors, people who live with, you know, COPD, you know, atherosclerotic cardiovascular disease, you know, PAH, and so on, and people who just have a weak immune response. And then you have about 25 million or so who are older adults who are not immunocompromised or who do not have those comorbid conditions that we talked about. So that is the pool of individuals that we anticipate coming into, you know, being candidates for protection with CD388. So very, very attractive. You know, just to a couple more numbers that I could give you for context. In the United States last year, there were 1.6 million hospitalizations due to influenza, right, in the last season.

And this season is, you know, planning out to be a tough one as well. So if you can provide protection to those individuals at high risk, I think the value proposition would be really, really compelling. So we look forward to really commercializing this. And we've announced greater than $5 billion commercial opportunity starting at the end of the decade and escalating into the early 2030s. So really meaningful opportunity.

Geoff Meacham
Analyst, Citi

I guess let me follow up to that, Chirfi. I think when you can see the differentiation, the fact that it's not a vaccine, it's an antiviral. I guess the biggest uncertainty I would imagine would be the payer context, right? So you'll have to have obviously phase three data. You'll have to have maybe pharmacoeconomic data that shows the but is maybe the commercial approach to go after the highest risk patients that may have not gotten a vaccine anyway to try to make payers sort of understand the differential value proposition?

Chirfi Guindo
CMO, Merck Research

Yeah, you know, I'll provide a couple of insights on this, how we're looking at this. First of all, in the phase three program, we will have people who have been vaccinated and people who have not been vaccinated, right? So, you know, in terms of launch, in terms of commercial approach, we would consider the unvaccinated or the previously vaccinated as candidates equally, provided they're high risk, right? So that's really, really important. Cidara did some payer research. You know, we had opportunities to review some of that in diligence and so forth. And in that research, payers in the U.S., again, indicated that a price point between $500 and $600 per dose would actually present good value if you're talking about those high-risk individuals that I indicated. And so, you know, we will do our own research when we come to it, once we progress.

The value proposition we believe is going to be compelling.

Geoff Meacham
Analyst, Citi

Yep. And then, Eliav, just the final one on this program. When you look at the development path, you mean potential for an interim analysis. So is there anything that you can build into the pivotal program that could maybe help you with the market opportunity, the downstream, just to try to, you know, further separate out the differentiation?

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

The population of the ANCHOR study is greater than 65-year-old patients. So it's in the right target population. The questions, obviously, the way it works in clinical trials is that, you know, your power towards your primary endpoints, which, you know, obviously is medically attended flu with symptoms and so on. But there will be opportunities for things like hospitalizations. As Chirfi noted, there's a lot of these. And then measures of severity, even more than that. I think the influenza program is kind of similar to that. You know, we had medically attended lower respiratory infections, and then we had hospitalizations, we had ICU admissions, and ultimately, you know, those data were very important. So we want to make sure that the study is large enough to be able to have all those critical endpoints.

Once we have access to the drug and to the company, which we hope will be soon, we'll be able to take a look and make sure that the study is properly sized for longer-term outcomes, not longer-term, but more rare outcomes. It certainly is well designed for the outcomes that it's currently evaluating.

Geoff Meacham
Analyst, Citi

Okay, thank you.

Mary Kate Davis
Analyst, Citi

Great. I guess moving to another deal that you guys have closed this year, Verona. So that's recently closed, and you're bringing in Ohtuvayre into your commercial portfolio for the treatment of COPD. Could you maybe talk about that opportunity and how you're looking at that product?

Chirfi Guindo
CMO, Merck Research

Yeah. So first of all, we're really proud of the work. We're really pleased with the work that the Verona team has done. You know, really impressive work in launching this, developing the asset, first of all, Ohtuvayre, and launching it in the United States so far. The feedback has been excellent as far as we've been able to determine. And so the opportunity for Ohtuvayre is for us to really, you know, bring the commercial engine that we have as Merck to really scale the work, the good work that Verona has, you know, started. And so the feedback is excellent from customers. And we believe that there's a huge opportunity for us to apply this engine and to reach more patients and, you know, create the value.

You know, we've announced a significant opportunity in this space, you know, and that's where I think the excitement is coming from. The feedback so far from the market research that we have conducted is excellent. And we believe that this is going to be a transformative agent.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

So by the way, you know, just to remind ourselves, the placement of Ohtuvayre, the GOLD guidelines, is really quite favorable. And, you know, it's fairly broad across different kinds of COPD. It's the first kind of non-steroidal anti-inflammatory agent that I think, and I think that's very important, particularly because, as we all know, steroid inhalers predispose patients towards pneumonia and other local fungal infections. So I think it has great opportunities. We're looking at it also for non-cystic fibrosis bronchiectasis. And so I think that there's enormous potential within the sphere of chronic pulmonary diseases to improve outcomes for patients.

Geoff Meacham
Analyst, Citi

Yep. From a commercial perspective, you know, you guys will have a pretty substantial respiratory portfolio. Was Ohtuvayre, you know, the incremental investment in commercial and marketing, was it sort of nominal in addition to what you're doing already in PAH, or is it going to be a substantial sort of add-on to the commercial effort?

Chirfi Guindo
CMO, Merck Research

Yeah, yeah, we certainly have an engine, right, that we can apply to scale and augment the good work that the Verona team has started to do. And so that is really the opportunity that we see. You know, we have obviously digital capabilities. We are going to reinforce the, you know, the MSL capabilities, the commercial capabilities more broadly. And so this is really going to be a nice opportunity for us to create value.

Geoff Meacham
Analyst, Citi

Yep, and let's move to WINREVAIR. So congrats on the CADENCE trial in left heart disease. So that's, we did a session at the Cleveland Clinic this past April, and there was significant enthusiasm for this in terms of unmet need. Where do we, you know, kind of go from here when you think about the next steps into a phase three? Is there a potential to, you know, is this a filable trial? I know that's not really usually the Merck way, but this clearly is, you know, a substantial trial in an unmet need.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Right. So first of all, we agree that the unmet need is substantial in this pre- and post-capillary pulmonary hypertension patients with HFpEF. It's a population that's enormously underserved. There's nothing there for them. And they have a pretty high mortality rate. The CADENCE trial was designed as a proof of concept study. It had a lot of measurements, both from the pressures and, you know, heart function point of view and other elements, which we'll share in due course. But we were very happy that the PVR data were very clear and associated with all the other data that we collected in the study. We think that there's a really good opportunity for patients. In the field now, there's really not much for patients. And I understand the enthusiasm that people might have for this to become some sort of filing study.

The truth is it's a proof of concept trial. The primary endpoint was not a filing endpoint. We'll talk to FDA about the design of phase three trials. More than, you know, I think that that's something that we'll be doing. We're going to start phase three next year. The field is, you know, it's an unknown area. It's an area that doesn't have regulatory guidance. We'll have to figure out the best way to design the trial and go forward. You know, I think that the other reason why we would anyway want to do a phase three trial is from the payer point of view. They probably want to make sure that they're, you know, seeing the right kind of value to be able to gain and give access to patients. My net net is we'll look at the data.

We'll have the presentation in 2026 at an important medical meeting. We'll allow people to, we'll have a really good consultation with all of our scientific leaders. We've already done that. We'll present FDA with the data and our plans, and we'll go from there.

Geoff Meacham
Analyst, Citi

Yep. It does seem like given, and we had Marty yesterday at a session that, you know, he's thinking about in terms of unmet need, there is maybe streamlined approaches. This seems like as good a candidate as any, but I guess you have to have the FDA discussion.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Yeah, you know, we present data and they present us with their ideas. See how enthusiastic they are. And, you know, again, I think that the study was pretty clear and gives us an opportunity to improve outcomes, not just in pulmonary, but also in cardiac function.

Mary Kate Davis
Analyst, Citi

Maybe looking at the opportunity in PAH, you've presented a lot of data kind of building. Have you seen this translate into higher usage from physicians?

Chirfi Guindo
CMO, Merck Research

Pulmonary arterial hypertension. Yes. Is a simple answer.

Geoff Meacham
Analyst, Citi

From a durability perspective, have there been, has that been better than you thought when you initially, you know, did the Acceleron deal?

Chirfi Guindo
CMO, Merck Research

Yeah, so the feedback has been tremendous, right? So WINREVAIR in PAH is meeting all of our high expectations, right? So what I would say is, you know, just give me a second here. Just bring my thoughts together for a second here. In PAH, what we're experiencing really is the feedback has been tremendous, right? And so the data is panning it out. And we're seeing continuous positive feedback from the overall community. So maybe Eliav, you can provide that.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Sure. Yeah. So I think if you look at overall from the STELLAR study, when we look at the durability of the response, and now we have people several years out, the safety profile is pretty much the same. Efficacy remains very good. And patients are sticking on trial. The things that I think are moving the needle in the marketplace is that we've had some terrific guidelines placement. And we're also really interested in, we're also seeing a lot of use both in people with three drugs. And now we're moving towards those on a background of two drugs. You know, right now with the three studies that we've shown, we've taken the spectrum from newly diagnosed patients all the way to those who are near, you know, advanced and close to lung transplant or having to have hospice care.

I think we have all the data out there. From an uptake point of view, things have been going very well.

Chirfi Guindo
CMO, Merck Research

Yeah. What I would add is really that, you know, you have the triple. What we're seeing is, you know, certainly in the U.S., where we are really, you know, we have most experience so far, we're seeing really uptake, you know, in the triple segment of the population. We continue to be very encouraged by the adoption in that category that represents about a third of the patients. Another third is in the dual, the so-called dual category. And so, you know, we're seeing now the opportunity, you know, with the new data we have is to begin to really have greater penetration in the dual category of patient population. But the feedback has been tremendous. And, you know, and so the data will pan out. But the real-world experience continues to be very encouraging as we continue to on the launch trajectory for WINREVAIR.

Mary Kate Davis
Analyst, Citi

That's excellent. I guess how are you looking at the OUS opportunity for WINREVAIR as well?

Chirfi Guindo
CMO, Merck Research

Yeah. So we just started in Japan, you know, really, really encouraging start in the Japanese environment. And, you know, in Europe, we also have, you know, we're going through the reimbursement process from country to country. But the overall feedback is really consistent with what we have seen also in the U.S. in terms of physician and patient experience. And so we look forward to really, you know, realizing the value there as well. And so, yeah.

Geoff Meacham
Analyst, Citi

I guess the question in PAH is, you know, you want patients to be healthy enough that they're on drug, whether they're on a doublet or a triplet for an extended period. But they also are probably not going to take an injectable if they're class one, right? Maybe some class two.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

I mean, I think it's important to understand that sotatercept has, I think, been showing that across the different segments of patients, whether you're newly diagnosed, that's Hyperion, whether you've been on drug for quite some time and have worsening mostly on three drugs, that's STELLAR, or whether you're, you know, in pretty advanced state, that's ZENITH, that you have similar benefits in time to clinical worsening and in hard endpoints like hospitalization or death. The point is, I think, the way people get on drug or on therapy is they usually take the two generics together, right? So that's kind of the base point, and then the question is, what's your next drug?

What I think we've shown throughout the trial program and with incredible consistency, regardless of where you are in the disease journey, is that sotatercept improves heart outcomes along with all the good stuff that happens when you can walk around more and have a better exercise tolerance. So I think physicians now have gotten used to the three drug regimen, the drug, how to administer, all the things that have to happen in a practice. And I think we'll move to the second, to the two drug regimen. One thing that we will have next year that's going to be very important is the auto injector. And, you know, these are, that might say, oh, it's not, how sexy is that? It's very sexy if you're a patient that needs to fiddle around with the dosing regimen.

And now you can have at home kind of, you know, nice single shot. So I think that's going to make it easier for patients. And I think what we've done both with guidelines and with the work that we have both with the commercial and medical affairs team is to help people just reduce the kind of barriers. Some of them are artificial. Some of them are, I don't know how to use it in my practice or how is it all going to work, all of that so that we can have adoption. And I think that's translated into the really nice trajectory that we've seen so far with the use. Yeah.

Geoff Meacham
Analyst, Citi

Yeah. And convenience is a huge factor, especially with the prostacyclins. And those can be a little clunky if they're.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Yeah. Yeah. And so, you know, I think this is a good, and again, patients don't want to come into the hospital or into the office to get their injection. So once we have the auto-injector, I think we'll get a lot more ease of use.

Geoff Meacham
Analyst, Citi

Yep. So let's switch gears to the, you know, the oral PCSK9 program. And the injectable PCSK9s have had, you know, very, you know, good commercial success. I think it took a couple of years for them to get the price and, you know, and volume and align with payers. So you do have obviously the dosing convenience. But as you think about the overall profile, you know, how are you thinking about, you know, going into the market? Is it more switches? Are there new patients that you think are particularly suited for an oral modality?

Chirfi Guindo
CMO, Merck Research

Yeah. What I would say is, you know, just coming out of the AHA where the data was presented, I mean, really the, you know, the opportunity we have here really is to, you know, to provide the full benefit of PCSK9. Because, you know, so far it's a great modality, but it has really not had the impact that one would have hoped. And I think the scientific community was so ecstatic when they saw our data, right, within Enlicitide presented. And the reason why they saw that is, you know, this is something that could finally reach more patients, right? And really make a difference in the lives of patients and so forth. So the data is really compelling when you think about the efficacy data as compared to the injectables.

And so, you know, I like to simplify it as, you know, you're getting a robust, you're getting a robust effect, right? So, you know, 60%, you know, I would say 60%, 50%, 50%, 30%, you know, to simplify the math for a moment, right? So you're getting the, you know, you're getting the robust 60% LDL lowering, right? And so you're getting the 50%, you know, basically lowering of the other parameters, right? And then you get your, you know, finally you get 30%, right? So you put it all together, the profile of MK-0616 is going to be unmatched by any oral agent, right? And so this is what's giving the community confidence or excitement rather that this is really going to be a game changer in the practice of cardiovascular medicine.

And so we're talking about, you know, addressing the CV epidemic because now we are going to have a tool that is going to allow us to do just that going forward.

Geoff Meacham
Analyst, Citi

Yeah.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

So if you look at the problem that the current cholesterol regimen, so to speak, has is that the actual goals that people need to get to are not very easily achievable with statins. So the current situation had, you know, with regard to things that people can access, which are pills, was that, you know, you just go ahead and start a statin. I think that with injectable PCSK9s, of course, the efficacy is terrific with regards to cholesterol lowering, but access has just been dismal when you think about the large number of patients who actually need these drugs. And because of that, I don't think there's been very much impetus for guidelines to be much more prescriptive and very specific about which LDL levels you need to get to to reach your goal.

Now with an oral medicine that's, you know, just very easy to use, very easy to prescribe, will be priced both for access and for value and have the same kind of mindset for the treating physicians who tends to be a general practitioner, nurse practitioner, et cetera, in a community center. Those guys can, the ease of access will be very good. And now there's going to be an impetus to be able to change guidelines to be more prescriptive. And I think that's where both ACC and AHA are looking to do, at least that's what scientific leaders have uniformly told us, so that we can actually reach a focus people on reaching a goal, break the current inertia, which is I got you on a statin, I'm done with your LDL cholesterol, not really thinking about it anymore.

But now focusing on what's the target, what's the goal. The, you know, statins will get you a certain part of the way there. Unfortunately, they can't get you all the way there. Now these days we really want to have very low LDL cholesterol levels. So we think that having an oral PCSK9 that can be easily used doesn't create any adverse experiences, no new drug-drug interactions, and can be available without a lot of paperwork will allow that movement. And hopefully that will impact the rates of disease and death from cardiovascular disease. So we'll see.

Geoff Meacham
Analyst, Citi

Is it reasonable to assume, let's say in the next couple of years, guidelines will evolve to everyone's on a statin and then you have sort of verticals of who needs a PCSK9, oral or injectable, who needs a CETP, who may need an Lp (a)?

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Yeah. I actually think.

Geoff Meacham
Analyst, Citi

I just don't know how it's going to all shake out.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

I'll tell you that the enemy, so at this point in time, the enemy of being able to move things so that patients actually benefit is complexity. I think that the first position, the easiest one will be who, what is the level of LDL cholesterol you need to get to? And my hope is that there's just going to be one number, but it's possible that they'll maybe have two, the two numbers being, you know, those people who don't have clear evidence of atherosclerotic cardiovascular disease, but have risk factors, and those people who already declared themselves. And that's like something like 70 and 55. So all in all, if we can get that done and, you know, that's simple, simple, and then we can do PCSK9. Now, you know, the L p(a) stuff is going to be very, very important as well.

However, there's a lot of education that's going to be needed around that, especially like what's the right test to use to measure L p(a) , what level you need to get to. So I see that as being a slower uptake. Eventually it's going to be very important. But I look at the LDL cholesterol as people understand what it is, but they really need to be forced to a goal. And if you can get that as a quality measure, then all of a sudden physicians are actually thinking, I need to get them to that goal, not I just need to put them on a statin.

Geoff Meacham
Analyst, Citi

Can you capture that in the label? I wasn't sure the regulatory, you know, kind of discussions or.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

We never, you know, we can't talk about, we don't know what the label is up to the FDA to ultimately agree to. What we can say is what patients we studied in the clinical trials program, which included primary prevention patients and secondary prevention patients. We anticipate that those kind of patients would be in the product circular. We don't know. That's something that FDA needs to opine on. Yeah.

Geoff Meacham
Analyst, Citi

Okay. All right. So let's switch gears to the, there's a lot to go over of the vaccine space. So on Gardasil, just sort of the one stock question on that. I mean, you guys have talked about recovery unlikely this year, maybe the end of next year, kind of give us a catch up maybe on a global basis. Like in one year's time, do you think you'll have a lot of the headwinds behind you or do you think this is more of a longer lasting?

Chirfi Guindo
CMO, Merck Research

Yeah. We think that, you know, we've really reached a point where we are going to continue to drive, you know, modest, you know, modest growth going forward at this point, and obviously the China situation is, you know, was a problem, but, you know, at this point in time, it represents less than 1%, right, of the revenue, so on a going forward basis, we are looking forward to continuing to, you know, drive, you know, modest single digit growth going forward for Gardasil. You know, we still have work to do. We're proud of the work we've done really in providing protection, you know, around the world. So this is something that our company is extremely proud of and that work must continue going forward.

Geoff Meacham
Analyst, Citi

Yep.

Mary Kate Davis
Analyst, Citi

For beyond Gardasil, looking at the rest of your vaccine portfolio and some of the newer launches, can you maybe talk about how those are going and your expectations there?

Chirfi Guindo
CMO, Merck Research

The respiratory?

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

The launches of CAPVAXIVE.

Chirfi Guindo
CMO, Merck Research

Oh, yeah. CAPVAXIVE. Yeah. So, you know, CAPVAXIVE is going really well. So it's, you know, it's meeting our high expectations. So really, you know, we look forward to bringing it globally, right? So that's still early days from that perspective. Influenza is also early days. We are just in the starting phase in the United States. And, you know, both we believe are well differentiated assets. And we look forward to really, you know, scaling and executing the launch as we go forward.

Geoff Meacham
Analyst, Citi

Let's switch gears again to immunology. Again, there's quick hits on everything.

Chirfi Guindo
CMO, Merck Research

Yeah.

Geoff Meacham
Analyst, Citi

That's a good thing though, because it means you guys have quite a diverse portfolio.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Yes, we do.

Geoff Meacham
Analyst, Citi

TL1A, TL1A. So on the back of the Prometheus deal. So your first major readout, you know, could be next year.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Next year. Yes, it is.

Geoff Meacham
Analyst, Citi

That's highly anticipated. That, I think, consensus numbers for WINREVAIR were $1 billion at peak and maybe now it's like more than $5 billion. For this one, I guess it has not really moved because we haven't seen a lot of new information. Help us maybe frame kind of how you're looking at this opportunity in terms of your investments. Like, just it does seem like you could go after a number of different immune indications pretty quickly.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

First of all, the TL1A mechanism was attractive to us because it was both anti-inflammatory and antifibrotic, so it provides a dual point of action for diseases that have a lot of these problems. Of course, the whole field was discovered on the basis of inflammatory bowel disease, and that was where we went first. The UC data are going to be available. The induction study will be available next year, and then induction maintenance thereafter, and Crohn's disease will also be first in that. Aside from that, we've got about four other indications that I think are going to be very important, some of which will have phase two readouts, which will tell the tale in the 2026 timeframe. The first of these is systemic sclerosis-associated ILD, so this is interstitial lung disease caused by scleroderma. This is a mixed inflammatory fibrotic disease.

It's a sweet spot for a drug like Tulisokibart. The phase two study is pretty large, large enough that I think we'll be able to see a good signal. That's going to come in the April timeframe. And then later on in the year, we'll have a study in the hidradenitis suppurativa HS, which is again a dermatologic disease, inflammatory and fibrotic that I think we will be able to see. We also have a trial in axial SpA and spondyloarthropathy, as well as rheumatoid arthritis and other indications that we're looking to start soon, so you know, we're taking a page from the success stories in the immunology space. You know, Humira had multiple, multiple indications and a lot of the other drugs the same. Our focus is on, you know, inflammatory plus fibrosis.

And I think we have the right readouts coming through that will be able to validate why the Prometheus acquisition was such a good thing. And then we've got, of course, other Prometheus drugs in phase one that I think will also have an important role to play. Yeah.

Geoff Meacham
Analyst, Citi

Is a basket approach though for Tellus, is the best approach sort of to go linearly and have a, you know, phase three and figure out the next trials or do you?

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Oh, no, we're going to see. So this is why we're doing a bunch of phase twos in parallel now. I mean, I think that the key was to get ulcerative colitis and to get the base understanding of what the drug does by itself in ulcerative colitis and Crohn's. That's necessary and it's necessary both from a biologic point of view, but also most importantly to tell physicians, patients, payers, and regulators what this drug's capability is. We now have started with multiple phase two studies. There'll be more coming next year, and that's in the mono space. We're very interested in combination therapies. You know, I'm not an oncologist, but most of my time at Merck has been in oncology for a good reason, but so that's a world of combinations and we need to be able to do that here as well.

But it has to be rational combinations. And I think once we read the induction data, then we'll start a whole bunch of other studies. So this is. We're at the point of an inflection in the clinical trial field of broadening this drug up quite a bit. We see a lot of potential here.

Geoff Meacham
Analyst, Citi

We can move to oncology. I can't believe with five minutes to go, it's the first question on Keytruda. So let's talk about QLEX, so the sub Q. I know early days for the launch, but give us some context for how you're thinking about the wave of patients that are more likely to go on this versus Keytruda with the consideration obviously that biosimilars down the road are going to be eroding. Is it mostly pre-adjuvant, like pre-metastatic kind of patients?

Chirfi Guindo
CMO, Merck Research

You know, obviously, you know, QLEX is off to a really good start. We are really enthusiastic about the early feedback that we're getting here in the U.S. We just got the good news also from a European perspective on that formulation, Keytruda sub Q. We believe that this will be really a good option for patients in the earliest stages of disease. You know, we are, you know, gearing up for that. We have resourced the launch appropriately. For us, this is a launch, right? There is an opportunity here to impact earlier stages of cancer. That's kind of how we are thinking about the opportunity.

Geoff Meacham
Analyst, Citi

Can you force that through, you know, with payers, through discounting or rebates or whatever to try to, you know, to try to maybe narrow the initial adoption or is that just how it's going to work out in the?

Chirfi Guindo
CMO, Merck Research

At this stage, you know, you have mono use, where you have combination use within the earlier stages, you know, this is where the adoption is anticipated initially. And so, so far, you know, it's early days, we believe that, you know, subcutaneous Keytruda is going to be adopted in that segment. What we've indicated is, you know, an adoption rate in the initial 18-24 months or about 30%-40% of subcutaneous Keytruda in the United States. And so obviously the first six months, you know, might be slower because obviously we have to get the whole reimbursement system going and adoption will then kick in with that sort of magnitude.

Geoff Meacham
Analyst, Citi

Yep. For oncology for the ADC, so I think you have a couple of ADCs that are going to turn the corner in 12-18 months from now. Talk a little bit about the funding of the TROP2. I wanted to get maybe your perspective on that.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

You know, we have, so first of all, we think the TROP2 ADC is going to be a Sac-TMT, is a really differentiated molecule with a program that's really quite different from what has been used and done for the other ADCs. You know, I think that's, we have a lot, a lot of confidence in it. We're very pleased that Blackstone was able to see the data and were willing to plunk down quite a bit of money to help us. The reason, you know, what we need to be able to do is to, you see, we're just now talking about oncology. We've got this breadth of opportunity. It's gargantuan. A lot of things are moving in the right direction. Knock on wood. No wood here, but anyway, we're hoping that things are going to be, are going to expand even further.

We've got these acquisitions that now need to be fully funded. We've got launches that need to be fully funded. And so, you know, I think as a company, we wanted to make sure that the short-term P&L profile was appropriate for the expectations of shareholders. And so we thought this was going to be a really good deal. They put $700 million against our R&D spend in 2026 in exchange for low- to mid-single-digit royalties after the approval of, after the readout and approval of Sac-TMT for a particular study that's in triple-negative breast cancer. So overall, we thought that the deal was really good and it helps in ensuring that we're able to apply all of our resources to the extraordinary opportunities that we have.

This is also in the context, of course, our multi-year optimization where the company has chosen that they're going to work to streamline and to focus attention on the things that really will move the needle on behalf of patients and therefore the company. So I see this as a great opportunity from the R&D point of view for my shop. It gives me a lot of breathing room.

Geoff Meacham
Analyst, Citi

Is that approach to use Blackstone or others to help, you know, fund the development a good model for other ADCs in the pipeline?

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

You know, the other ADCs are partnered and so they're a little, it's a little bit more complex. There are other, and then there are some ADCs that are still within our group. I don't see this as a model that I'm going to use, that we're going to use every time, but this particular opportunity, because Sac-TMT is such a large part of our spend and our future and what we believe in, we thought that this would be, we're very, very, very confident in this program. And so that's why we allowed them to look in and see what we thought. And I'm psyched that they actually really, that they agreed with us that this is a tremendous opportunity. I don't know that it's going to be something we do every time, but it's, you know, when the opportunity arose, it was a good one.

Geoff Meacham
Analyst, Citi

Awesome. Eliav, Chirfi, thank you very much.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Thank you.

Chirfi Guindo
CMO, Merck Research

Thank you so much.

Eliav Barr
SVP, Head of Global Clinical Development and Chief Medical Officer, Merck Research

Thank you for your time.

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