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Morgan Stanley 22nd Annual Global Healthcare Conference

Sep 5, 2024

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, great. Thanks for joining us, everybody. I'm Terence Flynn, the U.S. Biopharm Analyst here at Morgan Stanley. Before we get started, for important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. Very pleased to be hosting Bristol Myers this afternoon. Today from the company, we have Chris Boerner, the company's CEO, and Dave Elkins, the company's CFO. But thank you both so much for joining us this close to the right after summer, back to school season. Appreciate you taking time out of your day to join us. Chris, I think we'll turn it over to you for some opening remarks, and then we'll launch into questions.

Christopher Boerner
CEO, Bristol Myers Squibb

Thank you, and it's great to be here with everyone. Maybe I'll just say a couple of things. First, we're obviously coming off of a pretty good second quarter. We actually saw nice growth really across the entire portfolio. Importantly, we saw good performance with our growth portfolio. That business now is just over 45% of the total revenue for the company, and it's well on its way, given the momentum we have in that portfolio, to be over 50% of the business as we get into next year. So really happy with the performance of the growth business. We also saw good performance on our legacy product. Obviously, since the second quarter, we've been able to clarify the impact that IRA has on ELIQUIS.

It's pretty clear that that's gonna be an important medicine, not only for patients, but an important product for the company in the near to medium term. And of course, collectively, that legacy business is important because while the business might be declining in certain areas, that continues to spit off cash that can then be reinvested in the business. So if you add it all up, we've got good momentum coming out of Q2. We'll see some inventory dynamics play out in Q3, but we feel good about where we're gonna end the year, and that led us to raise our EPS guidance and clarify that we think we'll come in on the upper end of the top line range that we had previously given.

And as I think about it, maybe a second thing I'd highlight is that how we performed in the second quarter, I think really starts to bridge to how we're thinking about the company as a whole. So we, since I became CEO in November, have really been on a mission to transform BMS to be able to deliver sustained top-line growth as a company, particularly as we get to the end of this decade, and then importantly continue to drive long-term shareholder value. And the way we do that is really threefold, and it starts with going back to Q2 performance, really driving and delivering on the opportunity that we have with the current portfolio, and that's commercial execution on the products that are on the market. We've got a number of important launches that are coming up.

It starts with the KarXT launch. We have a PDUFA for that in September, and then at the end of the year, we have nivolumab subQ coming in, and that's gonna be important for the IO business long term. And then, of course, behind that, we've got a really exciting late-stage set of assets, and we're entering this catalyst-rich period, where you're gonna start to see line extensions for key products like CAMZYOS and REBLOZYL, as well as important pivotal data that you'll see across a number of products, LPA1, iberdomide, mezigdomide, and of course, milvexian, just to name a few. So that's gonna be super important for us. In addition, we continue to look for ways to streamline and make more agile the organization.

We talked about earlier this year, freeing up about $1.5 billion in resources that we could then reinvest into the company, so we're making good progress there, and we're gonna continue to be focused on the efficiency and productivity of our operations, and then finally, and David, of course, can speak more to this, is we're gonna continue to be very focused on how we allocate capital. We've got a very good balance sheet that gives us the ability to invest in the business. We're gonna continue to prioritize business development. We have said previously that we're gonna focus in the short term on paying down the debt and delivering the P&L, but we certainly have the capacity to do business development, and of course, we'll continue to look for ways to return capital to shareholders, notably through a very attractive dividend.

But if you add it up, we feel good about where we are. We're making good progress across all three of those dimensions and happy to answer any questions.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Great. No, thanks, thanks so much, Chris. Really, really appreciate it. I guess maybe the first place to start, just given, you know, topical here coming out of IRA, is just, you know, the first big picture question is just remind us at a strategic level, how you're thinking about the portfolio in a post-IRA world, and then any learnings from the first round of negotiation that, you know, you can apply to that kind of strategy.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah, well, I mean, I think as we look at how IRA played out, and we alluded to this in the second quarter and then clarified it with the guidance we provided with ELIQUIS, we feel good about our ability to manage ELIQUIS and the impact that IRA is gonna have on it. And what you see in the guidance that we provided for 2026 and 2027 in the lead-up to the LOE is that there's really no material impact on EPS from that product. That's gonna, as I said earlier, continue to be a meaningful and important driver of growth for us in the short to medium term. So we feel, we feel really good about that.

Now, stepping back and looking at IRA generally, we still have very serious concerns about IRA, primarily because of the impact that that legislation can have on innovation. So we're gonna continue to factor in IRA into how we think about investment decisions that we're making. It was clear that we had to consider it when we did the deals that we did at the end of last year, so that's gonna continue to play a role there. But as we look at IRA and the business that we have today, the impact on ELIQUIS is manageable.

When you look at the impact, for example, of the Part D redesign, we think that's really sort of is neutral to our portfolio, helps some products like ELIQUIS, has a negative impact on other products like REVLIMID and POMALYST, but I think it nets out to be a neutral impact on us.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, great. One follow-up on just the ELIQUIS guidance that you guys gave is, does that assume that PBMs are gonna seek additional rebates on top of that new price? Or I know that there was a range there, but maybe you could just talk through that aspect of the ELIQUIS price.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah. We, we've been clear that it... in all likelihood, PBMs will attempt to use the MFP and the public MFP in their negotiations. What I would say on that is a few things. First, we have a long history of being able to manage multiple books of business in our negotiations with PBMs, commercial business versus the government channel. And we're gonna continue to leverage a very good team in doing that on a forward-looking basis to manage any potential spillover that you would see there. As it reflects the guidance that we gave, we considered multiple scenarios in the guidance that we gave, both with respect to commercial scenarios that could play out over the next few years, as well as the impact of various policy initiatives like IRA.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. And maybe a two-part question. So I think on the first quarter call, you talked about potentially providing earnings guidance with the ELIQUIS guidance that was not in the release. And again, the second part is the latest perspective on trough earnings guidance, because I know that was something that you guys had kind of floated earlier this year as a possibility. So it's a kind of related question. What's the strategy now on kind of how to think about those two aspects? And again, maybe it's interrelated here.

Christopher Boerner
CEO, Bristol Myers Squibb

Is that a tap?

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Sorry about that.

Christopher Boerner
CEO, Bristol Myers Squibb

No, that's totally fine.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

I was making sure it wasn't a fire.

Christopher Boerner
CEO, Bristol Myers Squibb

No, no, no, we're good.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Yeah.

Christopher Boerner
CEO, Bristol Myers Squibb

So look, I think that as it relates to earnings related to ELIQUIS, as I said just a minute ago, I think the way we see it is, where we netted out and the guidance reflects this, is that there's really no material impact on-

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay.

Christopher Boerner
CEO, Bristol Myers Squibb

... EPS. So that, that explains that. As we think about just guidance more generally, I think what we've said consistently, and certainly is still true post Q2, is that we're going to move more towards short-term guidance, move away from providing longer term guidance to focus on those things where we have clear line of sight and where we can not only hold ourselves accountable, but investors can hold us accountable for delivering. So that's going to be our focus going forward. And in terms of how we think about providing guidance, we have historically provided guidance at the beginning of the year, and so that's the process that we're going to provide going forward.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. Okay, great. Maybe Dave, one for you is just, you know, obviously you have a lot going on in the pipeline side. You have a lot of new product launches now. How do you kind of, you know, manage that spend in the context of operating margins? Again, what are some of the puts and takes that you're considering here as you think about, you know, making the necessary investments but also, you know, maintaining an efficient operating margin structure?

David Elkins
CFO, Bristol Myers Squibb

Yeah, that's a really important question and something we're very much focused on. As you know, we've got it at 37% operating margin this year and next year, and we feel really good about that. There's a couple components. First, if you think about gross margins, our, our gross margins have been coming down and we've been guiding that down, and that's primarily related to REVLIMID and POMALYST. But as you know, REVLIMID is pretty much through its generic cycle next year, and POMALYST in 2026. But then if you think about the growth portfolio, and now that's 46% of our total portfolio, grew 21%, excluding currency. That's a high margin business as well. As that business continues to grow and a bigger part of our business, that'll be accretive to our margins.

And then the third thing to really think about is, you know, with the guidance that we provided with ELIQUIS, remember ELIQUIS, the gross margins, we share 50% of that with Pfizer. So as ELIQUIS goes down and goes LOE in 2028, you know, that actually is accreted to margins as well. So that's one component of it. The second component of it is, Chris was talking about from a operating expense base, our ability to move resources around, we've gotten really good at. One, if you think about the acquisitions that we've done, really good examples, whether it's launch products, freeing up REVLIMID and POMALYST resources to support REBLOZYL and BREYANZI. If you think about launching CAMZYOS, we're able to use the ELIQUIS resources. So we've been really good at reallocating resources in that.

But with the line of sight that you have with the $1.5 billion strategic value capture that we have, that was really to fund the deals that we closed in the fourth quarter. But we got really good at identifying savings, so we believe we got a lot of substrate there. One, we were able to, you know, prioritize the portfolio, increase the ROIC of that portfolio, but also that helped strengthen the growth trajectory in the second half of the decade. The other thing that we were able to do was our third-party spend. There's a lot of things that we were able to insource, like in clinical operations, but as well as in some of the back office. And over a year ago, we really had very few employees in India. We now have over 2,000 employees there.

So we were able to save money by insourcing some of the activities that we did with third-party service providers, and we're not done there. We have a supplier summit that's coming up, where we're going to be working with some of our most important suppliers. Not only to help us get more efficient, but also help us from a technology perspective, to leverage technology more, to improve productivity, both in R&D, but as well as within our supply chain. And the third thing that we are doing is, you know, we continue to take layers of management, out of the organization to streamline decision-making, making us more agile. And this has been a push that Chris has been really since coming into the CEO, really getting us to focus on those things that are most important, but also being more agile.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Yeah. Do you feel pretty good about maintaining competitive margin levels?

David Elkins
CFO, Bristol Myers Squibb

We do.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

We should take that away. Okay. Okay, great. Want to move to KarXT, just given, you know, the-

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

... PDUFA dates coming up next month. Obviously, you know, important product launch for you guys. Maybe just talk high level about some of the commercial preparation that you guys are undertaking here ahead of that PDUFA date. And then kind of the related question on, you know, just pricing, reimbursement dynamics. What are some of the puts and takes that we need to think about, recognizing you're not going to guide on price yet-

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

... but just what are some of the inputs there?

Christopher Boerner
CEO, Bristol Myers Squibb

This has been a significant push for us since we announced the deal. We actually started a lot of the commercial prep work at risk, even before the deal closed, as appropriate, because we wanted to get ahead of this. I would say the focus that we've had is three or fourfold. First, we knew coming into this launch that this is the first new innovation in thirty years, the first new mechanism to launch in neuropsych in schizophrenia, specifically in 70 years. We had a lot of market preparation to do. We hired a very seasoned medical organization to begin prepping the market as appropriate for this launch.

We also initiated, as part of that, a number of medical studies that will inform the use of the product, both in terms of how to use it and how to use it potentially in combination with other assets. So all of that work was done in the lead-up to this month, and so that team's been in place for some time. The second thing is, remember, about 80% of this patient population is going to be either Medicare or Medicaid. And a lot of the reimbursement-focused activities are going to be in the States with individual state Medicaid agencies. So we've obviously had a Medicaid team prior to the acquisition of Karuna, but we bulked that team up, and as appropriate, begun to engage with these payers in the lead-up to this approval.

And of course, the third area is Karuna had begun to build a commercial infrastructure. We've taken virtually all of that into the company and expanded it, in particular, on the sales side, so that we could have a much broader base of use early in this launch. So those have been really the big areas of focus for us. In terms of how the dynamics are going to play out, I would think about this as a 2025 launch, and the reason for that is effectively, we're going to be approved in October. And as I mentioned, a lot of the activity that has to take place early on is going to be getting these state Medicaid agencies not to cover the product because it's a covered and protected class, so they have to cover the product.

It's where does it sit on formulary? And so a lot of that work needs to take place towards the end of this year. There will obviously be sampling as appropriate to give physicians experience, but this is really going to be a 2025 launch, and I would expect this to ramp over the course of this year, that year, as access and reimbursement comes online, both with Medicare and Medicaid. But if you step back, this is a product that has considerable commercial potential. There are 1.6 million schizophrenic patients just in the U.S. who are treated. 75% of those patients are not adequately controlled on atypicals, and what we have is a very differentiated drug. It's a drug that's delivering efficacy in line with the best of the atypicals, with a better safety profile.

And we've been able to demonstrate with multiple studies, including large phase 3 studies, that you're seeing improvements in positive and negative symptoms as well as cognition. And so there's a lot of excitement in this community, and we're incredibly excited to bring this innovation to market.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Great. Just a few follow-ups is, at this point, no FDA ad com because we're so close. That should be our expectation.

Christopher Boerner
CEO, Bristol Myers Squibb

No, and in fact, the FDA discussions have gone well, and we're on track to deliver on the PDUFA.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, and how about the label? Anything, you know, that we should have on our radar screen from a labeling perspective?

Christopher Boerner
CEO, Bristol Myers Squibb

No. I mean, obviously in any label, there are things that you're working through, things that you'd like to see tweaked or moved. But in general, the discussions we've had with the FDA have gone quite well. We're happy where we sit and looking forward to the PDUFA date.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. You know, when I was looking back, I think there was another drug that was launched for schizophrenia several years ago, and the Medicaid process, I remember, took... Seemed to take, like, six to 12 months. Is that kind of a reasonable estimation? I know every state is different.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

But, like, how many months does it take to kind of go through that process? I understand the coverage. It's more, like you said, getting it on the formulary. So what does that kind of pace look like?

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah, I think that's a reasonable analog to use. I mean, obviously, in any launch, you're going to try to accelerate that as fast as you can. I'd mentioned that we already had a Medicaid team in the field to support the other parts of our business. We bulked that up, and as appropriate, we've begun engaging with these agencies already. So, you know, I think we feel good about where we are in the launch planning here. We've got teams in the field. They're a highly experienced team, so we feel good about it, but that's a reasonable analog.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. And then, as you mentioned the opportunity, the 1.6 million patients, is that just the monotherapy opportunity, or does that also include adjunctive? Because I know that's the other piece where you're running a trial there.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

So maybe just help us think about what are the adjunctive additional label or data bring to the table?

Christopher Boerner
CEO, Bristol Myers Squibb

Those are 1.6 million patients who are treated in any form.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay.

Christopher Boerner
CEO, Bristol Myers Squibb

But you're correct to point out the importance of adjunctive. We are running an adjunctive study. We expect that to read out next year. The dynamics of this market are really interesting because given the fact that about three-quarters of treated patients are not being well controlled, what you're going to see with this approval is you're going to see some patients who are going to be switched because they're not getting the right level of efficacy. You're going to see some patients who are switched because there's a novel mechanism here, and they're looking to see an improved safety profile. You're going to be seeing some patients who will be used in combination with the existing therapies that they're on, and of course, there will be some de novo monotherapy use. No other product in this space has an adjunctive indication.

So our view is when we get that data and are able to put it on label, it's a real competitive advantage. But one of the reasons we began running some of these medical studies at risk early on, was we knew we wanted to inform physician practice, however they choose to use the product. If they choose to use it as a monotherapy, if they choose to use it in combination, and we wanted to have data early in this launch, even in advance of our adjunctive label, in order to inform that. So we feel good that we've got the right studies in place in the lead into that, and obviously, we'll wait and see the phase three data and the adjunctive indication next year.

One thing that's absolutely for sure is that physicians are going to want to try to use this product, and then over time, they'll figure out how to best use it in terms of the frequency of dosing and how they're going to dose and how they're going to administer mono or combo.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, and one other, you know, question we get, obviously, is the, you know, competitive profile relative to AbbVie's emraclidine.

Christopher Boerner
CEO, Bristol Myers Squibb

Yep.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

You know, we have yet to see the pivotal data there. We're going to get that later this year, but as you look back at their prior data, what would you call out as some of the kind of, you know, differences between these two agents as we think about that market development?

Christopher Boerner
CEO, Bristol Myers Squibb

First, I think the way to think about this market, in general, is this is a very large market. If there's one thing we've learned from the atypicals, is this is a market that can sustain multiple large players. Let's sort of level set on that.... Having said that, we really like our competitive profile. What do we like about it? First, it's an M 1/ M 4, so that is a difference between what you see with the competitive product, which focuses only on M 4. The reason we like M 1/M4 is, as I said earlier, we've seen efficacy output showing clear improvement in positive symptoms, negative symptoms, and cognition.

And cognition is coming, we believe, from the M1 component of that, going back to early data that Lilly had presented on an asset in the Alzheimer's space, showing an improvement in cognition. And so we like the mechanism of action that we have vis-à-vis competitors. The other thing to point out is that we've got multiple studies, including multiple large phase three studies, that are going to inform this. We will see phase two data from AbbVie, I expect later this year. We'll have to see what that data looks like. But as I sit here and look at what we've got, we've got a drug with a really attractive mechanism of action. We have clear activity that shows efficacy equivalent with the best of the atypicals with a better safety profile.

We've got a multi-year advantage in the best of circumstances over a competitor, and it's a market where you can sustain multiple large players, so you add it all up, we feel great about where we are.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

One area, AbbVie's pointed this food effect, I guess, of the trospium.

Christopher Boerner
CEO, Bristol Myers Squibb

Mm-hmm.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

-component. Anything, you know... I mean, what's your response to that, I guess, as you think about the, the profile? Because that's one area that they pointed out as, like, a differential, I guess-

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

First, emraclidine.

Christopher Boerner
CEO, Bristol Myers Squibb

Well, I just know from prior experience, first of all, you don't get to a discussion of how you dose or food effects if you don't work your way through a continuum that starts with efficacy. So again, efficacy, safety, and then you can get to dosing and administration. And the way I look at it is, yes, we're gonna be twice a day. We got a great profile. As I said earlier, we've got ongoing studies to show different ways that you could potentially dose this drug over time. And the way physicians have told us they're gonna think about this is, take it on an empty stomach in the morning and take it before you go to bed on an empty stomach.

So we think it's a manageable, dosing frequency, and, the food criteria is not gonna be a major impediment to how we launch this product. And again, multi-year head start and a lot of excitement in this space. We feel great about where we are.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, maybe the last one is just there's obviously, we've talked about schizophrenia a lot, but Alzheimer's disease psychosis is the other one.

Christopher Boerner
CEO, Bristol Myers Squibb

Yep.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

How do you think about that opportunity, and when do we start to, you know, have a better handle on how that might materialize?

Christopher Boerner
CEO, Bristol Myers Squibb

We anticipate the Alzheimer's disease, psychosis, and agitation data in twenty twenty-six. So that study is up and running. And one of the things that we did when we acquired Karuna is we sent our team to the heritage Karuna organization and said, "Look, what were the things on the development program you were most excited about, and what were the things that you wish you could have had the resources to do?" So in addition to schizophrenia, which is inclusive of mono and adjunctive, as we've discussed, Alzheimer's disease, agitation, psychosis, which will come in 2026 . We have a bipolar disorder. All of those were embedded in the deal that we did. We just announced in Q2 that we've added two new indications, one in Alzheimer's disease, cognition. That goes back to that M1 component of our mechanism of action.

And then we've also added autism disease illnesses, and that was, that's another new indication for this, where we're quite excited about, and those studies will be kicking off.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, great. So lots to watch for here on the forward. Maybe I thought just 'cause, you know, again, very topical, this data just came out and as a competitor data, but it relates to one of your pipeline assets, milvexian-

Christopher Boerner
CEO, Bristol Myers Squibb

Yep.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Which is a Factor XIa inhibitor here, which would be a follow-on product to ELIQUIS, which has been a huge commercial success, the standard of care in AFib. So Bayer, as people are probably aware, had a competitor drug, asundexian, phase III data in AFib, but DMC stopped the trial. I think this was November of last year, that we were finally able to see the data at ESC. You know, watched the conference over the weekend, read the New England Journal publication. We had a note out on this, but that was my take. So would love, you know, your guys'-

Christopher Boerner
CEO, Bristol Myers Squibb

Yep.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Take on the data and then the implications for milvexian, where a broad phase three program is going, ongoing, both AFib and some of the other indications.

Christopher Boerner
CEO, Bristol Myers Squibb

We have three ongoing studies, phase III in parallel: acute coronary syndrome, secondary stroke, and AFib. The data that were presented at ESC are the AFib data from asundexian, the study that was stopped. In the lead up to that, our perspective was that the Bayer study was underdosed, and I would say nothing has changed in our perspective. We remain incredibly excited about the opportunity for Factor XIa in AFib. There's a lot of continued excitement from the KOL community for Factor XIa in this space. By the way, that's evidenced by the fact that our study continues to enroll quite quickly. We obviously are continuing to have DMC reviews of our data, including relatively recently, so the way we look at it is, there's really no change in perspective coming out of ESC.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. So I guess they really don't want us to get through this presentation.

David Elkins
CFO, Bristol Myers Squibb

They really don't.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Is it my rating? All right. So I agree, underdose was one of the things that the discussant-

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Investigators' publication talked about. The other thing was the patient population.

Christopher Boerner
CEO, Bristol Myers Squibb

Right.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

That maybe the system has gotten a lot more, a lot better at managing these patients now, just given ELIQUIS and other treatments. And so I think there was a commentary that the control arm, the rate of events in the control arm was lower than expected.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

And so how do you think about that relative to the population that you guys enrolled? And obviously, you have a rich history here with ELIQUIS.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

And data to draw on. So how do you think about that aspect, which was the other one that the discussants raised?

Christopher Boerner
CEO, Bristol Myers Squibb

Obviously, there are going to be some of those kinds of nuances that come out of the data that were presented, that we're going to take back and say: "Well, how does that affect our study?" What I will tell you on the surface of it, based on what we know about our blinded data, which remember, we see our blinded data post-DMC reviews, and what we've seen there is we don't think any of those sort of more nuanced points have any negative read-through for sure into our study, and could potentially have a positive effect. The way we look at it is there's no real change based on some of those nuances, but we'll of course be taking a look at them.

But if you level it up one step and say: "What did we really learn here?" A lot of the concern coming out of the November stopping of that study was, is there a read-through on Factor XIa in AFib? And what we said at the time, because it was our perspective even before they stopped their study, is that they had underdosed the study. And remember what we have, we have a study that clinically, pre-clinically, and in modeling that we have done internally and that has been done externally, we know we have a more potent anticoagulant in milvexian than asundexian. So that's starting point number one. The second step is to say, if you look at the dose we took into phase III, it's fourfold higher than the dose they took in.

You add those two points up. It's pretty clear to us, and in fact, it was even referenced in the New England presentation or the New England publication, that in all likelihood, Bayer underdosed the study. So we walk out of that conference saying, nuances aside in things that they saw in their study, we still have a lot of confidence that Factor XIa has a role to play here. We have to wait and see the data, but nothing's changed in our excitement around milvexian coming out of that program.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Remind us, the timeline is what, 2026, 2027?

Christopher Boerner
CEO, Bristol Myers Squibb

2026. It's event-driven, so you know, that's one, that's the other thing that we'll be looking at, is their event rate and how that relates to ours.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. Okay, great. Another presentation coming up is OPDUALAG-

Christopher Boerner
CEO, Bristol Myers Squibb

Yep.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

... for lung cancer. You were talking about this before. You guys are hosting an ESMO event. Again, maybe just level set. It's kind of the hypothesis here. Obviously, OPDUALAG is approved in melanoma. You guys have been studying IO combinations, you know, for the last 20 years or so. And again, I think this is the next, you know, focal point is LAG3 for lung cancer. And so, talk to us maybe about, you know, what we hope to learn from this study, and then I know you kicked off the phase III recently as well.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah. Well, the reason we did the phase II was to try to inform, not necessarily would the drug work in the overarching lung cancer population, but could we identify a subset of lung cancer where we saw really good activity? And what we said a few quarters ago, and what we'll show at ESMO, is data that gives us confidence that we've identified a subset of patients where not only do we like what we're seeing with OPDUALAG, but we like it in comparison to the data, both the clinical data and the real-world data that we've seen with pembro chemo. And so you will have seen in the clinicaltrials.gov that that's a non-squamous 1%-49%. Pay attention to the above 50% when we show the data at ESMO.

But we think we have a clear opportunity, and at a minimum, the non-squamous 1%-49% population, and potentially, as I just referenced, a broader population. So we're quite excited about it. And, you know, the reason OPDUALAG is important, just to level set, is that not only do we have an opportunity that we know of in advanced melanoma, but now we've got this opportunity in lung cancer. And when you layer onto that nivo subQ, that gives us confidence that we can extend a portion of our IO business through the end of this decade and into the next decade.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Yeah. I mean, I think looking back at some of these studies, I know here you've got a nivo control arm, and then you're going to have to go versus,

Christopher Boerner
CEO, Bristol Myers Squibb

Standard of care.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

... standard of care in phase III. But I feel like every time we see one of these phase II trials, and again, this is, you know, part of our job is just the cross-trial comparisons, the handwringing in terms of how does OPDIVO or how does KEYTRUDA perform versus some of the prior studies. And so anything in terms of that control arm performance that we need to think about? And obviously, there's, like, two different groups of patients here, so how do you think about control arm performance relative to historical studies?

Christopher Boerner
CEO, Bristol Myers Squibb

I mean, it's the classic pitfall of doing cross-trial comparisons. You know, having said that, you can look at the active arm and how it performed just in and of itself. Not just the delta between the active and the control arm, but rather just the performance of the active arm and compare that to what you saw in the active arm of these other studies. Not only do we like the delta, but we also like just the absolute activity that you'll see at ESMO in how OPDUALAG performed vis-à-vis what we've seen in, for example, 189 , as well as there's a plethora of real-world data that has been presented over the last number of years in first-line lung cancer, looking at the real-world performance of pembro chemo, and so we will...

In fact, I think Samit's going to show this at, in the ESMO presentation, sort of how it compares against that panoply of data.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Yeah. So bottom line is you feel good about the absolute performance versus KEYNOTE-189, though, not just the real-world data?

Christopher Boerner
CEO, Bristol Myers Squibb

We feel that this is going to be a competitive profile-

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay.

Christopher Boerner
CEO, Bristol Myers Squibb

And you'll see that at ESMO.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. And remind us, we're going to get PFS data. It's not just ORR?

Christopher Boerner
CEO, Bristol Myers Squibb

You'll get PFS data.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. No OS, 'cause it's too early?

Christopher Boerner
CEO, Bristol Myers Squibb

No OS.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. Okay, got it. Anything else in terms of the phase III trial? I know you mentioned the 1-49, but any other-

Christopher Boerner
CEO, Bristol Myers Squibb

The only other-

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Points of that trial?

Christopher Boerner
CEO, Bristol Myers Squibb

No, the only other thing, Samit will talk more about it at ESMO, but the only other thing I would say is that, you know, we also liked the greater than 1-50 data, and he'll talk more about that at ESMO. The other thing-

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

The above 50, you mean?

Christopher Boerner
CEO, Bristol Myers Squibb

The above 50 .

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Above 50 . Okay.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Got it. Yep.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah, sorry, the above 50.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Yep.

Christopher Boerner
CEO, Bristol Myers Squibb

The other thing that we'll highlight, there are data that we have coming up in oncology. So by the end of this year, we hope to be able to present some very early data with RYZ101, which again, comes out of the acquisition we made of RayzeBio in December. We have a partnership with SystImmune. We expect to see some data there. So it's pretty interesting, the evolution of the oncology business, and we'll have a chance to talk about that at ESMO.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay, so it'll be broader beyond just OPDUALAG.

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Okay. Okay, great. Maybe just in the last few minutes, you know, some of the new product cycles, newer product cycles, CAMZYOS, REBLOZYL, SOTYKTU, maybe just high level again, you know, looking through your prior role as Chief Commercial Officer, what are some of the steps that you guys are taking to accelerate those launches, and maybe just pick two out in the interest of time?

Christopher Boerner
CEO, Bristol Myers Squibb

Yeah. Well, I would say just generally, the things that we are looking at are, first, we look at the level of investment. In fact, one of the first conversations that David and I had after I became CEO was, do we have the right level of investment across each of these products? And so we have ramped up our investment, for example, with SOTYKTU, making sure that we've got the right level of promotional resources to compete in this very competitive space. We've looked at the level of rebating in order to get market access, and again, that's something we'll continue to give updates on, including in the next quarter. So that was an area that we've made up investments.

We've also up invested on CAMZYOS, and something we've been consistently doing is making sure that we've got the right investment to consistently deliver supply for products like BREYANZI. So we feel good about the level of investment, but I would say that's one area. The second thing we've done is we've looked at level of resourcing. Obviously, that's true across a product like SOTYKTU and CAMZYOS. But it's particularly important, for example, as we think about the next launch with KarXT, where I think I referenced earlier that one of the things we've done is we've scaled up the original plans that Karuna had to ensure we've got adequate resourcing in the field to get broad utilization of that product. So that would be the second thing that we're focused on. But rest assured, this isn't a one and done exercise.

We review the commercial performance of our growth portfolio every Monday morning, and it's something that we're gonna continue to stay focused on to ensure we've got the right resourcing, the right people, the right level of field resources, to make these products successful.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Great! Well, thank you so much, Chris, Dave.

Christopher Boerner
CEO, Bristol Myers Squibb

It's been a pleasure.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

I appreciate it. Sorry about the fire alarm, but-

Christopher Boerner
CEO, Bristol Myers Squibb

All right.

Terence Flynn
U.S. Biopharm Analyst, Morgan Stanley

Appreciate the patience, and best of luck with the rest of the meetings.

Christopher Boerner
CEO, Bristol Myers Squibb

Thanks. Appreciate it.

David Elkins
CFO, Bristol Myers Squibb

Thanks, Terence.

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