Bristol-Myers Squibb Company (BMY) Earnings Call Transcript & Summary
May 28, 2025
Earnings Call Speaker Segments
Courtney Breen
analystFantastic. Hi, everyone. It's great to have you here for this fireside, the first of our pharmaceutical fireside during the SDC. My name is Courtney Breen. I am the U.S. biopharma analyst here at Bernstein. And I am thrilled to have Chris Boerner here with me today from Bristol. I will hand over to him to give you a little bit of his background, but also share some opening remarks on what's going on at Bristol and the industry. And then we'll dive into a series of questions. Just a reminder, you'll see some QR codes around, there are the ability to ask questions through the Pigeonhole app. So please put those in there, so we can integrate them through the conversation today. So I'll hand over to you, Chris.
Christopher Boerner
executiveThanks, Courtney. It's great to be here with everyone. I guess, the timing of this couldn't be better. There's obviously a lot going on in and around the industry, and I'm sure we'll have a chance to dive into some of that. But a little bit of background on where we are at Bristol. So I've been in the role as CEO now since the end of 2023, November of '23. And I think since then, we've been pretty consistently executing against a clear focus that we have, which is recognizing we've got a number of LOEs that are hitting the company over a relatively short period of time. We set a very clear direction in November of '23, which was that we were going to focus on emerging from this decade as one of the fastest-growing companies in the sector. And that's the North Star. And so how we deliver on that is really threefold. First, we focus a lot on the business that we have today. So we have a nice growth portfolio that's actually growing steadily. We had about 16% growth in Q1. Continuing to deliver on that consistently, recognizing that you have another side of the business, which is our legacy portfolio, that's going to continue to decline as a result of the LOE exposure that we have. But we've got to keep that growth business growing on a nice trajectory. And you can see that performance coming through every quarter where we've had -- consistently meeting expectations and then, in many instances, beating and raising. And so feel good about the growth of that business through the rest of this year and beyond. Second thing we had to do is deliver on our late-stage pipeline. We are in the very early days of a number of data readouts that are going to play out over the next 18 to 24 months. In fact, between now and the end of next year, we will have 15 registrational data readouts, 6 of those are for new molecular entities. Then we have a number of data readouts coming beyond that. And that's just from the late-stage pipeline; we obviously have a robust earlier and mid-stage pipeline that we can talk about as well. And then the third focus area has been continue to drive financial discipline across the organization. We announced in 2024 that we were going to get about $1.5 billion in cost savings. Those cost savings at that time would be reinvested. We had just done the Karuna deal and we knew we needed to make investments in continuing the development program for COBENFY. So we delivered on that, and we're well on our way now to delivering on an additional $2 billion in cost savings that we announced this year. And the focus there is to drop that to the bottom line, recognizing that we have real opportunities to make this company more efficient, rewire how we're operating as a company and really set the company up for what I think will be an important next few years where I think you're likely to see in this industry a higher premium be placed on companies that are operating efficiently and are very financially disciplined. And we wanted to get ahead of that. And so that's what we've been focused on there as well. And if you add those 3 things up, that gives us a lot of confidence that we've got the substrate in order to exit this decade among the fastest-growing companies in the sector. Now still early days, we've got to execute. And I think what you're seeing at the company right now is heads down and very focused on delivering and delivering consistently. If we continue to do that, I have a lot of confidence on the future of the company and that we're setting ourselves up to exit this decade well and be a thriving company into the next decade. So look forward to answering questions, and thanks for being here.
Courtney Breen
analystFantastic. Thanks, Chris. You mentioned about the timeliness of this conversation, and it certainly is kind of a particularly dynamic time. We try in these conversations to be long-term oriented and think about big strategic decisions that you're facing, but there's also a lot of imminent pressure on the industry that may change some of those strategic decisions. And so we've got tariffs, MFN, Medicaid kind of cuts, PBM reform, we've got HHS changes, NIH, FDA kind of organizational and cuts going on. How do you rank kind of order some of those pressures? And what are the ones that you're focusing on? And how do you approach that in the context of this very noisy environment?
Christopher Boerner
executiveWell, I mean, I think, first of all, just if you step back, as a leadership team of the company, we've said we've got to maintain sort of an even keel here. It's very easy to get distracted by the news of the day. And so I think what's most important is recognizing we've got to engage in the external environment, we've got to prioritize those things that are most important to the company and to the industry. We'll have passion around those. But we've also got to control what we can control. And so continuing to stay focused first and foremost on delivering what we can control within the company is priority #1. And within the context of the external environment, there's a lot hitting us, but I think you can bucket it into sort of 3 -- roughly 3 categories. You've got changes that are taking place across government agencies: NIH, FDA, et cetera. And clearly, we're paying attention to those. Given the fact that we have so many near-term registrational opportunities, having a high-functioning FDA, for example, is going to be really important. I can say on that dimension, really hasn't been much of an impact to the company thus far. We're able to get time with the agency, their reviewers. And we're able to get in-person meetings for the first time in a number of years there. So it's clearly something we're paying attention to though because, obviously, at FDA, it's a near-term impact. But quite frankly, if you go back and look at the public-private partnership that's been part of the ecosystem of this industry, we're paying attention to that as well. But so far, no real impact on the business there. The second category is tariffs. I think at this point, it's sort of anybody's guess as to how exactly this is going to play out. But in our view, what we said is, okay, let's derisk as much as we can. So product outside of the U.S., let's bring it in. Let's do whatever we can to make sure we're setting ourselves up for, however this plays out, that we're in a strong position. Remember, with our business, we're largely a U.S. company today. The majority of our business is here, the majority of the resources that we invest. We just announced recently a commitment for $40 billion in additional investment over the next 5 years. So that I think puts us in a good position. But obviously, we're going to have to wait and see what ultimately transpires around tariffs, and we'll adjust accordingly. But I think we've done everything we need to do in the lead-up to that. And then finally is the executive order, which is probably the topic that's getting the most attention now. If you step back, we actually think there are some things in that executive order we are in strong agreement with the administration on. They highlighted, for example, that this is a -- there are third parties in this industry that make things more complex, that drive inefficiencies, whether those are PBMs or 340B. And seeing some reform there is going to be very important. We agree with the administration on that. We think ex-U.S. countries need to pay more for healthcare. We're aligned there. Clearly, where it gets more potentially impactful is as you think about most-favored-nation and foreign reference pricing. But again, it's still early days. The next steps in this process are that we're going to be engaging directly with the administration on a voluntary basis to see if there's something constructive that we can do to really, ultimately, at the end of the day, continue to bring the price of medicines down in the U.S. for patients, while at the same time recognizing that, whatever we do, we don't want to distort this ecosystem that has made biopharma really the crown jewel in the United States and something that's an envy of other countries. So that's how we're approaching it. There's a lot of uncertainty out there still, a lot to be played out. But our view is let's engage with this administration constructively, and we'll see how it plays out.
Courtney Breen
analystYou touched on something there in terms of kind of derisking in the current environment and you talked about bringing in inventory. And certainly, when you look at the sector as a whole, we've seen kind of 300% increases in products that have been brought into the U.S. on a monthly basis relative to at other points. Can you talk about kind of how aggressive you've had to be there? And if you put -- that puts the industry in a good place from an EPS perspective for the next year, or is it really just a drop in the bucket trying to manage the potential tariffs?
Christopher Boerner
executiveWell, I think every company is going to have a different starting point for this. In our case, remember, we were in a pretty good position from the get-go with respect to where we had manufacturing and where product was coming into the United States from. And I think we've been able to do as much as we can do to mitigate at this point. And obviously, we're going to have to wait and see what the specifics look like. But if I just step back from tariffs, I think the impact of tariffs is going to be, from our standpoint, based on what we know today, relatively manageable. The bigger question is: what do you see in terms of overall pricing dynamics and what does the commercial market look like in the United States? And there, I think we're going to have to continue to engage quite aggressively to make sure that we continue to see the right opportunities to reward innovation, that we're, of course, doing what we can to bring prices down for Americans. There are a lot of things that we've engaged on over time already on that front. There are opportunities, I think, we can work constructively with the administration on. But that's going to be a real focus area for us.
Courtney Breen
analystAbsolutely. And I think MFN is certainly the focus for so many investors today, kind of asking what could this future world potentially look like? How real is it? What probability of implementation? And what can the industry do? Because the industry is talking a lot about finding common ground or constructive places to collaborate. Perhaps just the first question on that, do you have more information than we have when it comes to MFN and what it potentially could look like? Or are you going on the same kind of information that has been made publicly available so far?
Christopher Boerner
executiveWell, I mean, I think we're all modeling what the potential impact could be, not only for our companies, but for the sector overall. And in many respects, we're working on publicly available information. Now obviously, we're engaging directly with the administration, and it's too early to provide a lot of commentary on that. But I would say it's an active discussion right now. The good news is that when you talk to the administration, when you talk to members of Congress, there's a recognition that this is a critically important industry. Also resonating is the fact that this is not an industry that is -- this is an industry that's subject to competitive dynamics globally. So remember, this is an industry where you have China is investing heavily. And so how we think about the next set of policy moves is important because policy moves can make this ecosystem that we have here more robust and it can also work in the other direction. And I think that discussion is setting a good context for what happens next. I think people in the administration recognize this is an industry that's important and we need to make sure that, at the end of the day, it continues to thrive. At the same time, I think there is a focus on what do we do to bridge the gap between what's paid for medicines in the U.S. and what's paid outside of the U.S. And I think there are ways we're going to have to engage with the administration on what can we do to bring prices up outside of the U.S. and what are reasonable steps that we can take in the U.S. that don't distort the overall dynamics of the industry. And that's going to be the needle that has to be threaded.
Courtney Breen
analystI think that's a great point and kind of this notion of finding common ground or that constructive space. Are there particular examples that you can give of how you might think about what that could look like? There's lots of different dynamics in the industry: list prices, net prices, various different segments, direct-to-consumers being raised. How do you think about common ground and the role that the industry can play in kind of creating wins for this administration?
Christopher Boerner
executiveLook, I do think there are opportunities here for us to find common ground. For example, on this concept that there are complexities created in the ecosystem in the U.S. by the role of third parties and intermediaries. The reality is that over $0.60 of every dollar that is paid on a branded product goes to somebody who did not discover, develop, never mind commercialize, that product. And that dynamic creates an opportunity for us to say, can we work with the administration to pull back some of those complexities, deal with some of the distortions created, for example, by 340B and use the resulting revenues associated with that to meaningfully start to look at co-pays that patients pay, and how can we bring overall price of medicines down? But in many respects, and I've said this in the congressional testimony that I had last year, that's a starting point. You've got to deal with the distortions created by PBMs if you want to deal with list prices in the U.S. So that's one thing. The other thing I would say is that, remember, ultimately, at the end of the day, what we should be focused on is what patients are paying. And the reality is we give -- we have robust patient assistance programs that we can provide on the commercial side of our business today. In fact, when you look at the co-pays that we have for our oral oncologics, for most of those co-pays on the commercial side of the business, it's at or roughly 0. Unfortunately, we're prohibited by statute from providing co-pay support in Medicare. That's something that we can work with the administration on, to either run a demo or try to address that legislatively. That's a second example. So I think there are those kinds of things that we can begin to work with the administration on to find common ground, and we're certainly going to try to do that.
Courtney Breen
analystFantastic. Perhaps diving into Bristol a little bit more. We've spoken a bit about the industry and kind of the pressures that you're facing. You obviously took the helm back in late 2023. And you've made a series of strategic in the company already with the rapid-fire on M&A very quickly after you took the helm, and we were all very busy over Christmas that year.
Christopher Boerner
executiveSo were we.
Courtney Breen
analystI bet. What do you point to as some of the most important changes that you're making in terms of how the organization functions to continue winning today and in the future?
Christopher Boerner
executiveWell, I think one of the things that we had to do, upfront I've already alluded to, which is we need to be crystal clear on what problems we were solving. And I think that started with talking to the organization about what are the next few years going to look like. Remember, when you have multiple LOEs that are hitting at roughly the same period of time, how you manage that, you've got to have an organization, in Bristol's case, of 30,000 people, all rowing in the same direction. So really being clear on what strategically were the most important priorities, delivering every single day on our business, making sure that we were delivering on the late-stage pipeline -- because, remember, no one was really focused on our pipeline in late 2023. And so we had to make sure that timelines were hit, that we were doing everything we can to ensure the success of those trials when they read out. And then third, the importance of financial discipline. It is my view that financial discipline and financial flexibility drive strategic flexibility. And that strategic flexibility is important because when the world changes, as we're seeing now, that gives you degrees of freedom. And also, if you find meaningful opportunities to source innovation externally, you have the capacity to do that. And so those 3 things, getting everyone aligned on, was priority #1. And then we spent a lot of time on the how we operate. We had, I felt, a real opportunity to drive execution and consistent execution across the company. We have a saying in the company, which is our say-to-do ratio, we needed to dial that up. And we needed everybody understanding that when we said we were going to do something, investors needed to have confidence that, 9x out of 10, we're going to deliver it. And so we put a lot of focus on that on the commercial side, but quite frankly, also on the research and development, manufacturing and enabling function sides as well. And then finally, I would say, this concept of financial discipline is not purely just to hit a financial metric. Obviously, that's important. But at the end of the day, our focus is to make sure we have an organization that's agile, that can move with speed, that's highly efficient and that's fully leveraging technology in order to deliver what we need to, to run our business. And clearly, there's ample opportunity when you look across an organization of this size, to say, are we fully leveraging AI, for example? Are we doing the things necessary to move from Point A to Point B with speed and minimize any disruption or distraction? And so there was a big push on that, and that's going to continue to be the focus as we deliver on the $2 billion commitment that we made earlier this year. But I would say that sort of focus on execution is something that's been a big driver for all of us over the last 18 months, and it's going to continue to be the case.
Courtney Breen
analystAbsolutely. And you mentioned 2 parts of that execution, one on the cost-cutting, financial flexibility, strategic flexibility, but also kind of that commercial execution as I think another area that people have been focused on. On the $2 billion that we've referenced a couple of times and you mentioned in the opening, can you give us some context as to why now is the right time to announce that and begin enacting on it, and where those opportunities really lie for you?
Christopher Boerner
executiveWell, I think part of it is a financial exercise. Whenever you have a period like this where revenue is going to be under pressure, you have to say, "I've got to reconcile my cost base to that revenue." And so part of that is just driven by the dynamics that are going to play out over the course of this decade. Having said that, I think a big piece of this was really to drive how the company operated. And the way you do that can't be a blunt instrument. If you're talking about rewiring how a company operates, whether it's the processes that exist or how an organization functions, fully leveraging technology, that's not something you can deliver in 6 months. That's something that takes time. And so from our standpoint, why now was we wanted to get ahead of it. We wanted to be able to start those projects so that we could deliver them in a reasonable amount of time. Clearly, we're in the midst of the LOE exposure that we have. So that put impetus on doing it sooner rather than later. And I do have a belief when you look at the, where we started this conversation, some of the dynamics taking place outside of the industry that will affect us, I think there will be a higher premium placed in this industry over time on companies that operate efficiently and are fixated on being financially disciplined. And if I'm right, we want to get ahead of that. And so moving quicker to do this work was something that we felt was important. And we're in the midst of it now. We're well on the way to delivering $1 billion this year. We feel great about being able to deliver the $2 billion commitment overall. And we're going to continue to be focused on this topic.
Courtney Breen
analystAnd perhaps to just put a worst-case scenario kind of out there, many investors have begun asking me questions like, let's imagine drug pricing in the U.S. does drop dramatically. And obviously, Trump has given some references to 30% or 80% as some of these kind of headline ranges. The question that comes is kind of, how much can they cut to mitigate this earnings pressure? How much can they save through other options in the industry -- other options in their business? And certainly, we've heard politically from many of the companies saying, well, R&D would come under pressure. And obviously, that makes a lot of sense to say. But is SG&A also a place where there continues to be opportunity and perhaps it's a burning platform to disrupt how these companies have worked in the past?
Christopher Boerner
executiveWell, first of all, I think there are a lot of us who are fixated on making sure that the sky doesn't fall on the industry. So I think that's sort of -- put that to one side. But second, I think that how industry responds, I don't know that there's one answer to that because every company is going to have a different starting point. So the portfolios will be different, the businesses will be different. The starting point operating expense base is going to be different. I think that what will be true, as I said earlier though, is that I think, in general, there will be pressure for companies to be more operationally efficient. I think there will be more pressure on financials and that financial discipline is going to be much more important in this industry than it's ever been. And I think that many, if not most, companies are going to be either already or will be pressured to do something. What that looks like, again, is going to be different for every company. From our standpoint, I've already spoken to why we wanted to move quickly, I think it makes sense for us. I think from our standpoint, not everything is going to be cut, let's remember that. It's not sort of uniform and across the board. There will be some areas where we're going to be up-investing. We've up invested on the commercial side, for example. We've just launched COBENFY, we're putting significant resources behind that. We're up-investing on the R&D side. Again, I'll stick with COBENFY. We're launching 7 new Phase III studies on that program this year and additional Phase III studies next year. So there's absolutely going to be areas where we're going to be up-investing across the board. But by the same token, when you have products that have launched and are reaching a point where there's diminishing returns and the amount of impactable sales is lower, you're going to see a much faster move from us to pull resources on that and redirect those elsewhere. The cost cutting that we did in 2024 was fixated on taking a look at the portfolio and saying, what are those programs where we have strong scientific conviction, where we have real and meaningful opportunity that we can capture, we're going to up invest in those. But the flip side of that is if the science has evolved in a way that's less impressive or we don't think the commercial opportunity reaches the right threshold, we're going to pull those resources out and redirect them. And I think that sort of dynamic is something every company is going to have to build a stronger muscle in order to be able to do. And we wanted to get started early on that. We feel good about where we are. But I think the story of Bristol, I don't know, can be extrapolated to other companies because everyone's starting point is going to be different.
Courtney Breen
analystAbsolutely. And I think one of the comments that you made throughout that, and it's a bit of a theme that I've seen in some of the meetings that you had today as well, is this notion of being highly innovative, bringing highly innovative products that come first is really essential in a more pressured environment. And it seems like that's something that's been critical to the perhaps change in -- or evolution of your R&D portfolio.
Christopher Boerner
executiveLook, I mean, I think when you look at the level of competition in therapeutic areas generally, and certainly therapeutic areas like oncology, being first or second is absolutely critical. And if you're not first or second, you better have a really compelling differentiation story. And I think that mindset has driven how we've looked at the portfolio and tried to scrutinize. Can we be first or second? Do we have a really compelling value proposition that we can bring to the table? And if we can't answer that with a straight face, that, yes, on both dimensions, then I think we ought to take a hard look at it and say, is this where we want to be invested or are those resources better used elsewhere? Can we deliver better return to the company and a better return to shareholders by reserving those resources for another use?
Courtney Breen
analystAbsolutely. And so kind of I want to pivot towards some of your products, that perhaps on the path, on the way there, M&A is a critical part of building the right kind of pipeline. And I mentioned upfront, you were kind of very active as soon as you came in as CEO in the late part of 2023 with 3 acquisitions in quick succession. You've now kind of integrated those and digested them and some have launched. So kind of there's some real progress that we've seen on that front. As you think about perhaps investing today in new opportunities to bring into the pipeline, have the parameters changed at all in terms of what does good look like for Bristol and what's appealing for Bristol to bring into its pipeline?
Christopher Boerner
executiveWell, I think over the years you'll hear a very similar story in terms of how we thought about business development. At a macro level, we have always sourced innovation both internally and externally. So there's nothing new there. Business development is a top priority. We've been clear about that consistently. And we've always said that deals need to make sense financially. We've got to be able to tell ourselves that we can drive value for Bristol, but also for our shareholders. It's got to make scientific sense. And then it's got to make strategic sense. And I think within that bucket, I think we've seen an evolution certainly over the last couple of years. We are investing on business development opportunities that we believe can, in a compelling way, drive additional growth in the back part of this decade, again, speaking to that North Star that we have strategically. So that's important. To the conversation we just had, we're placing a higher premium on: is this an opportunity that, when you look at it, you say Bristol is the rightful owner of that product, that you can make more of that than somebody else could? And importantly, these need to be medicines that are first or second in a disease category or best-in-class. And if we can convince ourselves that this is a product or a technology that we can make the most of and that we can drive real commercial value, then I think that's going to be something we're going to be interested in. And the nice thing is because the company has been so financially disciplined over the years, we've put ourselves in a financial position that, if we see something that meets that criteria, we can move and move quickly. That's what we did in November of '23. We saw 3 opportunities in a relatively short period of time, Karuna in neuroscience, RayzeBio in radiopharmaceuticals and a partnership with SystImmune. We felt they hit all of those criteria, and so we moved and got them done.
Courtney Breen
analystAbsolutely. Fantastic. That's really helpful to understand some of those strategic decisions that look a little different today relative to the rest. So perhaps jumping into some of your products. So I think COBENFY is a real area of focus, not only from a pipeline perspective, but also commercially. There's real excitement, although recently, there was a bit of a hit with the ARISE study. Perhaps you could take some time to talk the group through kind of what this means for COBENFY going forward. And is there going to be any impact commercially or to the pipeline on the back of that study?
Christopher Boerner
executiveYes. Well, look, COBENFY is an incredibly exciting product. The feedback that we've gotten on the launch has been absolutely stellar. This is a product that's the first new mechanism in 3 decades. The feedback we've gotten from both patients and physicians is that we're seeing really good efficacy in terms of both positive and negative symptoms. And of course, one of the big selling propositions for this product is that it doesn't carry with it the same really debilitating side effects that you see with existing therapies. And that's absolutely playing back to us in the feedback that we're getting. So we feel great about where we are with the launch. It's a nice, steady growth, and we're going to continue to see that. The ARISE study is interesting because, while the outcome was not what we had anticipated, remember, this is the use of COBENFY in combination with existing therapies, it, first of all, was not a dead negative study. The study, about 60% or more of patients had real clinical meaningful clinical benefit. And most importantly, the safety looks really good. So the study has absolutely no impact on the long-term potential of COBENFY in schizophrenia. And the reason for that is that the reason Karuna started this study was to show that you could combine COBENFY with standard-of-care atypicals and that you could do so safely. And in that regard, the study delivered what it needed to deliver, which was the safety profile. The other thing to remember is that no other product has an adjunctive indication, and that this study and its outcome has no impact on the ability of physicians to use the product, as many are today in an adjunctive setting. Again, it wasn't the outcome we anticipated, but our focus on COBENFY is as a monotherapy. The vast majority of the use in early-line schizophrenia is monotherapy. And so in many respects, this was always something that was going to be just practice-informing for those physicians who are using it in combination, mainly in later lines. But schizophrenia is just part of the story. And while it was a big piece of why we decided to do the Karuna transaction, we've also made significant investment in other areas that we think are also tremendously important. Alzheimer's disease is one of those. We have the first of 3 studies that we have ongoing in Alzheimer's disease psychosis that will read out later this year. We've also -- we'll be initiating 7 Phase IIIs, as I mentioned earlier, for COBENFY in other areas of Alzheimer's, cognition and agitation. And then we'll have bipolar as well this year that we'll be initiating. And then we'll start a study in irritability for autism, that to be next year. So there's a lot within this portfolio of opportunities with COBENFY to be excited about. But clearly, first and foremost, is delivering in schizophrenia.
Courtney Breen
analystAbsolutely. And so you mentioned kind of Alzheimer's as being that next big opportunity. And in many ways, when we think about this Alzheimer's population that you could potentially interact with, they're perhaps a bit more heterogeneous. It's not so well defined, because there is no treatment for this group today. There is some off-label use of your atypicals, but there isn't necessarily a really defined patient population here. But on the other hand, kind of as you think about something that perhaps raises the chances of success, you have very clear unmet needs. These patients aren't being treated well and so your ability to improve their outcomes perhaps is higher. How do you think about kind of the variability or the potential for this indication and where risk lies and kind of what makes you feel confident?
Christopher Boerner
executiveWell, look, I think that you've already highlighted some of the risk, which is that you have a heterogeneous population. And you always want to make sure that you're designing a study around a mechanism that you think has real strong scientific rationale for why it should work. The reason we have confidence in this particular opportunity is, I would say, threefold. First, mechanistically, it makes sense to take this mechanism, xanomeline and trospium, into this patient population. Second, we've got clinical data going back actually to early data that Lilly had from the late '90s where they looked at the xanomeline portion of COBENFY, it was a xanomeline alone and they were studying it in Alzheimer's disease. And what they found is that the drug worked on cognition also worked on psychosis, but it had toxicity, mainly some gut toxicity, that was limiting its potential use. So the brilliance of what Karuna did was to take xanomeline and find the right titration with trospium to deal with the side effects, but also deliver on the efficacy. So we have strong clinical rationale going back to those Lilly data to suggest that this may work in this setting. And the third reason is actually what we're seeing in the schizophrenia launch thus far. While the product is delivering on the positive and negative symptoms as well as some of those side effects that I referenced before, what we're also seeing is an impact on cognition. Physicians have actually defined something called COBENFY clarity, which is that patients are coming back to them with their personality back. They're able to get more cognitive benefit from the product than anybody had anticipated. And so we now have scientific rationale, we have clinical rationale going back a number of decades and we have real-world rationale based on the schizophrenia indication, all of which point in the same direction, which is that this product is going to have an impact in Alzheimer's. And where we're going to study it is first in Alzheimer's disease psychosis. When we acquired Karuna, we added a third study, there were 2 already ongoing in Alzheimer's disease psychosis, we backed it up with a third. We've got Alzheimer's disease agitation, which is a Phase III we're initiating this year. And then recognizing the potential cognitive benefit, we're also starting a cognition study this year.
Courtney Breen
analystFantastic. And certainly, that makes a lot of sense, and it's challenging with these trials because we know placebo controlled can be variable. So we'll have to kind of wait and see exactly how this plays out. But certainly, those readouts are going to be very, very exciting. You talked about kind of the end-market reaction to COBENFY and the launch that's ongoing. What does it take to continue to ensure that this launch performs really well? I think there's a lot of eyes on execution and kind of that point you made earlier. So what is it that you're aiming for? And what are you doing to ensure that execution?
Christopher Boerner
executiveWell, the great news is TRx data is published every Friday, and so it's a public scorecard and so everybody can watch the performance of this. I think what we're going to be focused on is continuing to see steady, week-over-week, continued improvement in TRxs. At the end of the day, at this stage of the launch, remember, we're still relatively early days here, we've got to continue to drive breadth and depth of use. We are focused on new riders every single week. And then for those who are riding the product today, moving beyond 1 or 2 patients and diving into really their broader schizophrenia population. And that's what we're fixated on. We're working both in the community as well as in the hospital setting. We've got a fantastic team in the field. And so right now, it's just nuts-and-bolts execution. The biggest challenges are going to be: first, most of these patients who would be eligible for COBENFY today are already on an existing therapy. The dynamic of how these patients get treated is, once they get diagnosed with schizophrenia, there's typically a process where you try to find something that works. And once you find it, you're somewhat reluctant to take patients off because you're worried about those positive symptoms coming back. So getting physicians comfortable to switch from their existing therapy to COBENFY is challenge number one. And that's just going to take -- that's going to take execution. It's going to take peer-to-peer education. It's going to take time talking to physicians about their experience. But we feel great about the profile that we have to do that. And again, the thing we're looking for is: what are we hearing back in terms of how patients are doing on the product? And on that dimension, it's been absolutely stellar. But it's going to take time to take out 30 years of history of how patients in this setting have been treated. But so far, so good. Early days, but it's all about execution at this point.
Courtney Breen
analystFantastic. That's super helpful. I think there's another pipeline asset that a lot of people are focused on, which is milvexian. It is the next generation as we think about the antithrombotics and the opportunity there. You've obviously played in the space before. As we think about kind of where this TAM resides, you've obviously got the atrial fibrillation, but many other indications, what -- how good does milvexian need to look to be able to displace what will be a much cheaper substitute in the atrial fibrillation? And kind of what does good look like for you in terms of where milvexian gets used in the future, assuming you've got positive trial data?
Christopher Boerner
executiveWell, remember, the bar in atrial fibrillation is that we need to show efficacy at least as good as what you see with the Factor Xas with a better bleed profile. And the reason that they set it up that way is that we know today about 40% of patients in atrial fibrillation are either not getting a Factor Xa or they're being underdosed with that Factor Xa because of a concern of bleed. And so the bar is not to beat Eliquis in the 60% of the population that's getting full-dose Eliquis. The bar is to beat the opportunity to show you can get Factor Xa like efficacy with a much better bleed profile. And that's that 40% of the population. And so that's the bar in atrial fibrillation. And look, the study is performing well. We've had multiple opportunities to discuss differences between what we see with our program and some of -- one of the competitors' programs. And we've got 3 parallel Phase IIIs running for milvexian: acute coronary syndrome, secondary stroke and atrial fibrillation. And those studies will begin to read out over the next 18 months.
Courtney Breen
analystAbsolutely. Perhaps jumping back into the end-markets. You've got OPDIVO, we've got subcutaneous that's launching at the moment and you just got the EU approval this morning. Can you talk a little bit about kind of -- you've talked about the expectations, 30% to 40% generally. How might the EU look different or similar compared to the U.S. markets? And what are your expectations with that launch?
Christopher Boerner
executiveWell, look, what we're excited about with subcu nivolumab is that you take an infusion that is 30 minutes or longer and you get that down to 3 to 5 minutes. That has a real patient benefit. It has a real practice benefit. And that's what we're seeing play out in the launch in the United States. And so our focus both in the U.S. and ex-U.S. is to convert that business where we see opportunities to provide that benefit to patients and physicians as quickly as we can. And so what we've suggested in the U.S. is about 30% to 40% of that business can be converted. But clearly, we're going to do the best we can to move that as quickly as possible. I think that's going to be the same focus outside of the U.S. Depending upon which European country you're in, there will be different sets of dynamics. But I think the profile that we see with this product is as advantageous in Europe as it is in the United States. And our focus is to move that business as quickly as possible. We've got a fantastic team in oncology. We know this space incredibly well. You see that with continued very strong performance of OPDIVO in market. Obviously, YERVOY, we were the first company in the IO space. So this is an area we know well, we know how to execute and do so effectively.
Courtney Breen
analystAbsolutely. No, that's really helpful. And perhaps as you think about the ability to stem the tide of the impact of biosimilars, like what role can the subcutaneous play long term in terms of the shape of the OPDIVO curve?
Christopher Boerner
executiveWell, look, I mean, obviously, folks are aware of when OPDIVO goes off patent as we get closer to the end of the decade. We've got a very long patent life associated with OPDIVO Qvantig. And so that's going to be an opportunity to extend this IO franchise well into the next decade. What hinges -- success hinges upon with this product is being able to move quickly to convert the existing business that we have to subcu. The way you do that is continue to focus on the advantages that patients get. This is going to be particularly important for those patients who don't need to see a physician when they come into the office, in the adjuvant setting, for example, when you're in a maintenance setting, in the metastatic setting, and you can identify what those particular patient types are. In fact, the way we came up with 30% to 40% of the business is eligible for conversion is essentially a matrix. What patient population would this be the most advantageous in? It's the patient population I just described. And where do you see potential care constraints, within mainly the community and in some academic settings, where physicians are going to want to have an opportunity to do an injection when they don't need to spend a lot of time with that patient? You do the matrix of that, you get about 30% to 40% of our business. And that's what we think is most easily converted, and that's our focus.
Courtney Breen
analystFantastic Very, very helpful. You mentioned 15 registrational studies next year, 6 new products or NMAs, and I think 25 that you have kind of on the horizon. What would you want to highlight that you think perhaps investors are underappreciating or do you think is critical to raise attention to?
Christopher Boerner
executiveWell, I think we've talked about a number of them already. Obviously, COBENFY is an incredibly important product. It's one that, given the investments that we have been making, you should see a potential new indication every year for the rest of this decade. So that's going to be an important one. We've discussed milvexian. The size of that opportunity is substantive, particularly as you look at atrial fibrillation. And remember, you don't see Factor Xas being used today in either ACS or secondary stroke prevention. So that's a different bar there. Beyond those 2 products though, I'm incredibly excited about the opportunity that we have with iber and mezi. Those are 2 CELMoD programs in multiple myeloma. Remember, the vast majority of the business in multiple myeloma is still in the community setting. And while that business has moved to cell therapy and to biologics, physicians in the community setting are still looking for an oral set of options. And what we see with iber and mezi, depending upon how the data play out, will be an opportunity to potentially replace Rev and pom in earlier or later lines of therapy in multiple myeloma. You'll start seeing data on those programs later this year and into next year. So I'd focus on those. LPA1 is another one in both IPF and PPF. And what I like about that is the profile that we're seeing, and that that's a product that's relatively derisked. We have 2 -- we've seen 2 Phase IIs on our LPA1 program. The first was a number of years ago where you saw really good efficacy, but it had some toxicity. We went back, we reengineered the asset. And what you saw is the same level of efficacy but without those side effects. And so you've got good, strong reason to believe, and in both IPF and PPF, there's clear unmet need and existing therapies are suboptimal. So that's the second one. The third one I would highlight is golcadomide. We haven't been talking much about this CELMoD. This is in non-Hodgkin's lymphoma. But if you look at the level of activity that we've shown, it's fantastic. And so that product continues to perform well. We're in a Phase III with that asset. So that would be a third. And then the final one I would highlight, it's a little bit further back but it has transformative potential, was CD19 NEX-T. Remember, this is a cell therapy that's built on the backbone of BREYANZI, so we have a good sense of how this is going to perform from a safety standpoint, which is critically important as you move into autoimmune disease. This is going to be a competitive space, but the physicians who have really been at the front end of exploring the science are working with us, and we're now in a pole position. And based on the data that we're seeing in lupus, albeit early data, you're seeing very long durability of responses. And if those continue in patients who are very late line, most of them have organ involvement, and you think about the opportunity to potentially move this up, that could be a transformative product for patients who don't have a lot of options today. And remember, this is a patient population that is -- affects women, young women, disproportionately. People who are underserved generally are disproportionately impacted. So we have a real opportunity to transform that disease if these data continue to play out as we've seen thus far.
Courtney Breen
analystFantastic. Definitely some things for us to watch on the horizon. Just integrating a couple of additional questions that we've got in through from the Q&A. We were speaking earlier about kind of the agility that you're looking to integrate into the business and the cost savings that you're looking to deliver. How do you think about the net debt levels at Bristol? And is there a need to pull those down to ensure that you've got agility to perhaps make that strategic -- the strategically flexible decisions that are going to be critical for navigating the environment?
Christopher Boerner
executiveSure. We've been very focused on maintaining investor-grade level performance. And you've seen that. Look, we've made a -- the debt that we took on to take on the Celgene transaction, we paid that down, aligned with what we said we would do. When we did the Karuna transaction, we said that we would focus on paying that debt down. We're well on our way to delivering against that. And because we've been so financially focused and maintaining our overall expense base aligned to revenue, we feel good about where we are in terms of our ability to, if there's an opportunity that presents itself, to be able to leverage debt to do that. But we maintain our focus on paying down the debt that we have today in order to ensure that we have that financial flexibility going forward.
Courtney Breen
analystAbsolutely. And perhaps, I know on an earlier conversation, you've talked about kind of the kind of options that you have to spend inside Bristol and how you're thinking about M&A relative others. Well, what are your priorities now? And how have they changed as you think about debt versus dividends versus M&A versus investing internally?
Christopher Boerner
executiveWell, look, I mean, our capital allocation priorities remain unchanged. First, we're focused on business development. And second, we're focused on continuing to support the dividend. We paid a dividend for over 90 years. We've increased that dividend consistently over the last 15 years or so. And so we're committed to the dividend. We have the ability to do buybacks, but I would say that's a lower priority at the moment.
Courtney Breen
analystMakes a lot of sense in this environment. Another question that has come through that I do want to hit on because I think comes back full circle and connect the dots to M&A as well, as you think about kind of perhaps the industry being forced or being requested to cut prices and perhaps there being some contraction here in the U.S., does that translate to more M&A? Or is there going to be kind of perhaps a request to ensure that there is a free support from the government towards kind of M&A and consolidation in the industry where needed?
Christopher Boerner
executiveLook, I think there's a lot to play out in that question. Whether you start to see fundamental changes in the environment that lead to more of a push towards consolidation, I think that's just going to be something that will have to play out. This has been an industry that really hasn't seen a lot of large-scale consolidation over time. But that one, I think, is one that we just need to see how things change. With respect to broader M&A though, look, I think that while it's easy to think about the things that are not going well in the industry, or negative pressures, we should also remind ourselves that there's a lot to be really genuinely excited about in this industry. The level of innovation taking place globally is fantastic, not just in the United States. You go visit places like China, the amount of biotech activity there, the ability for us to begin to see line of sight to getting actual traction in previously intractable diseases like Alzheimer's disease, like schizophrenia, I mean that wasn't on anyone's radar screen 5 or 6 years ago. And so I think we're really seeing an opportunity for us to find innovative medicines to invest in. And we're going to do what we've always done, which is we're going to continue to source internally and externally, and we're going to go wherever those external opportunities are, whether they're in the U.S., in China or elsewhere.
Courtney Breen
analystFantastic. I think we're right at time. So thank you, Chris, so much for your time today. I think this has been really instructive both for the sector, but also for Bristol. So thank you again.
Christopher Boerner
executiveIt's my pleasure. Thanks.
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