The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: So we're going to just do a fireside here for about half an hour. And then you guys, there's a QR code. If you have questions, I have the audience
response thing here. I already have a couple loaded. So you're welcome to add that. We can do that at the very end.
So I don't know, Chris, do you want to start off with anything kind of high level, how we should think about 2025 from a -- then or like a strategy
perspective?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, look, let's start with 2024. 2024, first year as CEO, and I would say, we're happy with where we are. Our focus as a company is on delivering in
the short term but really importantly, setting a foundation for long-term sustainable growth. And we believe we have the substrate to deliver
top-tier growth within the sector by the end of the decade.
And so it's all been about this year, focusing on execution, execution on the near-term drivers of our growth portfolio, but continuing to get that
pipeline, operating as efficiently and as productively as we would like to deliver long-term value, continuing to focus on financial discipline that
David can speak to. And I think you're going to continue to see those themes play out as we get into 2025.
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: Yes. Let's start with that. So with COBENFY, you guys have talked about the launch, taking a little bit of time to secure reimbursement and access
in a broad way. And I guess, same idea with Camzyos previously and [OnsiteIQ2] previously. So help us through that process, Chris, or David, if you
think about, is it possible to -- what steps can you accelerate with respect to the launch? And obviously, we can talk about competition too.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Sure. Well, we're incredibly excited about the launch of this product. COBENFY is, we believe, a transformational opportunity in schizophrenia. This
is an area, as you know, Geoff, where there's significant unmet need. Patients are typically getting some amount of efficacy on atypicals, but that
efficacy carries with it significant side effects, fatigue and weight gain, et cetera.
And what we love about the profile for COBENFY is you get efficacy on par with the best of the atypicals, but you don't have that side effect profile.
There was a lot of excitement around this product and the lead up to the a month ago.
And really, the feedback we've gotten since approval has been fantastic. Physicians are very happy with the profile that they're seeing. We've had
great feedback from patients. And so as we've thought about this launch, our focus is really twofold. First, drive awareness for this product. This is
a product that, in our view, given the label is clean. If you're a schizophrenic patient, you should have the opportunity to benefit this medicine, so
driving awareness of the efficacy and safety profile is priority one.
And then second, as you know, is driving access. This is a very different situation than what would be experienced with [OnsiteIQ2], for example.
This is a protected class, so this will have to be covered. The question is the quality of coverage, and about 80% of patients with schizophrenia have
government insurance, either Medicare or Medicaid.
And that's going to take some time to get that coverage lock down. We anticipate we'll have (technical difficulty) most of the Medicaid programs
locked down later this year and into the first part of next year. And then Medicare will take a bit longer, and we anticipate that by the second half
of 2025.
So the way to think about this launch is that we'll continue to build scripts and volume at the end of this year into next year. But this launch will
really take off as we get into the second half of 2025.
Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: That's fantastic. Okay. Let's turn to the upcoming ASH meeting. So that's in a few -- in about a week or so. Give us some perspective on what you
think that's going to be the headliners for Bristol, what could be impactful? And maybe at a high level, with all the launches that you have that are
hitting the kind of the sweet spot, I don't hear you guys talk as much about ABECMA, Breyanzi, the cell therapy business, maybe where does that
rank for you guys from a strategy perspective?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, cell therapy continues to be a very important platform for the company and maybe we can start there as we think about ASH. While it is not
a hematologic or oncology indication that we're pursuing, I'll start with CD19 next T because we'll have additional data at ASH.
You may remember at ACR, just a few weeks ago, we presented very exciting data for that cell therapy program in autoimmune disease. We had
a dozen or so patients, including SLE patients, where we saw profound efficacy with a manageable safety profile. And what's particularly exciting
with CD19 is we are seeing clear signs of immunio reset.
We're seeing B-cell depletion, naive, healthy B-cells returning, patients coming off of all of their immunosuppressive medicines, including steroids
and staying off of those therapies. So that's very exciting. And so you'll see additional follow-up data on SLE. And for the first time, you'll see MS
data at ASH. So that's very, very excited.
And then as you get into hematology and oncology, look, we've got a number of programs that we read out staying in cell therapy, GPRC5D, we'll
have data sets there in later lines as well as relapse and remitting patients. That data was the bell of the ball at ASH two years ago. So it's nice to
see additional data on that program.
You'll see data on our cell [martz], notably mezigdomide. This will be the first PFS data, I believe, that we'll be showing at ASH for mezigdomide.
So that's very exciting.
And a program that's also a CELMoD for us that is really not gotten a lot of attention. We've not talked a lot about it is golcadomide, and that is in
large B-cell lymphoma. We've previously shown data for that program, and you'll see an update not only on relapsed patients in large B-cell
lymphoma, but importantly, first-line data with R-CHOP. And so there again, you'll see efficacy and safety data so pay attention to that one as well.
Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: And you mentioned the Revlimid LOE, but when you look to '26, you have ELIQUIS. I wanted to ask you guys from maybe a policy perspective. I
know it's early, and we just have several nominations. But there is there anything that you guys are thinking about for next year on the policy front
that could provide a new sort of wrinkle? I don't think people expect the IRA to -- I mean it's here to stay, but maybe around that, the discounting
is there anything on that front that you guys want to call out?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, our base case is that IRA continues to be here. We were one of the first to go through IRA. So there were a lot of learnings that came out of
that for us. But what I would say, stepping back to your sort of more general policy question. Look, first of all, it's too soon to say anything about
how specific policies may change in the new administration.
But what I'm incredibly proud of is the work that we have done to build a resilient company, and that's a resilient company that can thrive under
a Democratic or Republican administration in the US, and that's something that we consider globally.
And so look, we are adept at working with either side of the aisle. Our focus is on building an ecosystem where we can do what we do so well,
which is bring first investment class medicines to patients and do that as quickly as possible. And so we'll obviously stay focused on working with
the administration.
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: Chris, can I follow up on that? So when you look at OPDUALAG, for example, you're combining of a novel therapy with OPDIVO, and that has, I
think, a long runway. Is it clear what -- how many years of protection you may get with nivo subcu? I know there's a lot of uncertainty what payers
may do and how CMS may look at it.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, our expectation is that we'll have protection for nivo subcu well into the 2030s, which is why we think that's an anchor for us to extend that
business into the next decade. But more generally, in addition to nivo subcu, as you point out with products like OPDUALAG, we're continuing to
look for innovative products that we can layer on top of that.
So OPDUALAG, we have a strong business today in melanoma. That's continued opportunity for us in the metastatic setting. And then there are a
number of additional line extensions for that product. We're very excited to have initiated this year with rela and OPDIVO in first-line lung cancer.
We think there's an opportunity there.
And then if I step back even further and look at the oncology business, look, we continue to build out a very exciting late-stage set of assets. We
have initiated or will initiate 8 registrational opportunities in solid tumor oncology across modalities. So CELMoD with AR LDD in prostate cancer,
great opportunity. You'll see additional data from that in the next 12 to 18 months.
We are excited about the opportunity with PRMT5, which was a product that we got through the Mirati acquisition, and we'll be initiating pivotal
studies with PRMT5 next year.
Rayze Bio was an acquisition we did in December of last year. RYZ101 continues to progress nicely. You'll see data on that program in 2025 and
Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: Makes sense. Thank you. Yes. So let's talk about the growth portfolio. You mentioned a couple of the assets on cell therapy. But when you look at
OPDUALAG or SOTYKTU or Camzyos, I mean, walk us through what the fundamental drivers could be for next year that may be over and above
kind of expectation?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, look, I can tell you from a growth profile standpoint, where we're really paying attention to is, first and foremost, the launch of COBENFY. This
is an area of significant opportunity. There are 1.6 million patients being treated with schizophrenia in the US. That translates to over 50 million
scripts for atypicals in a given year. So this is absolutely a clear opportunity for us, and our focus is on delivering on that launch as quickly as possible
through some of the things we've already talked about.
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: And just -- you mentioned from a looking external as well as in-house investments in oncology, but really across the business. Talk a little bit about
the kind of capital priorities? Like where would you put BD? I mean, probably I suspect you have more bolt-ons, but where would you put that in
terms of the priorities for '25? Is it more debt pay down versus -- how do you balance that?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yes. The first thing is we've been really focused on integrating the deals that we closed at the end of last year, and we're pretty much through those
integrations now. So that was -- two is COBENFY. We got to make that a completely successful launch and doing everything we can to accelerate
those Phase III programs.
But then as we think through it, paying down that debt is critically important to us to strengthen our financial position, and we're well on our way.
We've done over $6 billion of the $10 billion that we plan to do by the first half of 2026. And as I said, we have a very attractive dividend and
continuing to pay that dividend. We know it's really critical for our shareholders.
But at the end of the day, business development is core to what we do, bringing in innovation. We know not all the best innovation is going to be
coming from one company. You have to constantly be looking externally. And as Chris said, we're looking to do partnerships, bolt-on acquisitions,
to continue to bring in really innovative scientific medicines that will address unmet needs in the therapeutic areas where we have expertise. So
you should continue to expect that we'll do those types of deals.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
When you step back and think about what we've tried to do over the course of this year is layout how do we deliver in the short term but build the
company and establish the foundation to drive top-tier growth by the end of the decade. And the building blocks for that are the existing growth
business that we have with the growth profile, making sure we're delivering on that.
We talked about some of the products that I think are particularly important in that business. But given the growth we've seen with that business
over the course of this year, that's going to be -- that's going to provide one leg of the stool, if you will, for what that foundation looks like at the
end of the decade.
We spent a lot of time this year on R&D productivity and efficiency. You don't get long-term growth unless you have a highly functioning R&D
engine. And so that R&D engine is going to begin to deliver key catalysts, really starting with the launch of nivo subcu later this year. We'll have
PSA data for SOTYKTU. But the catalysts just start coming in 2025 and then particularly late in '25 and 2026. And as those catalysts read out, the
second leg of the stool for the growth at the end of this decade becomes clear.
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: When you look to the ELIQUIS LOE, I know there's been some investor dialogue about potentially setting sort of trough EPS guidance and what
maximum impact. Is there -- what informs you guys thinking about that?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
So I'd say, first, there was a lot of focus on what the IRA buds and really the worst-case scenario for IRA came off the table. So that's why we provided
guidance for ELIQUIS in '26 and '27. And then generic entry comes in 2028, with full generic entry in April of '28.
But still, that's 2 or 3 years out there. And in this industry, providing long-term guidance when you got changes in the administration, you just have
natural risks with the business that we do with clinical studies. We're just focused on providing guidance in the near term, like we typically do on
our fourth quarter call, we'll provide guidance for the following year.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Our focus is on making sure that we can provide investors guidance on things that we have clear line of sight into where you can hold us accountable
for delivering against that in much the same way, we're holding ourselves accountable for delivering against that. And in this industry, I think that
lends itself much more to shorter-term guidance, and that's going to continue to be our focus.
Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: Just to add on to that, so an investor question, when you look at the Bristol's presence and neuroscience, COBENFY is obviously a foundational
piece. But is there a desire to add more assets to neuroscience to make that a much bigger part of Bristol? Or is it let's take COBENFY, let's see where
it goes with that, and then we'll sort of earn the right to do more neuro type of deal?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, if you go back to when we did the Karuna deal. Initially, our thinking was that, that would be a bridge from neuropsych back into our
neurodegeneration portfolio, which is a bit earlier in development. And so when you had an indication like Alzheimer's disease psychosis, that was
the bridge.
What I think has been very clear is that there's a real opportunity for us, not only in neurodegeneration with that earlier pipeline, but also in
neuropsych. The level of excitement for COBENFY in the neurocytespace has just been profound. And what's clear is there's a meaningful opportunity
given the significant unmet need.
And frankly, the leadership position, we have the opportunity now to carve out for ourselves in neuropsych to continue to see that as an opportunity
as well. So very much so, we're interested in building out the portfolio in both neuropsych and neurodegeneration.
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: And just to follow up on that, Chris. When you look at the therapeutic areas at Bristol, there are some that you're in that you're not in, for example,
like metabolic, et cetera. Is there -- are we at a point where let's get the integration done and let's focus on the current TAs? What's the capacity or
the bar, I would say, to add a new TA?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, let me first say that our primary focus is going to continue to be on those areas where we have a very clear right to win today. So think about
solid tumor oncology, clearly an area the company has a long history and we've talked about. We've got a nice foundation of existing assets today
or soon to launch assets and then a very nice and growing pipeline of new assets. That includes, I would say, if you think more broadly in oncology,
hematology as well. So oncology is one area.
Clearly, we have a focus on cardiovascular disease as a company. That's again, an area the company has been in for many, many years. We know
the space well. We've got ELIQUIS and Camzyos today, but exciting, again, a follow-up opportunities with Camzyos as well as [Novexy]. And that's
an area that we, of course, know well. And then neuroscience, we've talked about.
Immunology, our focus is going to continue to be on assets that have transformational potential, which is why we like CD19 and the opportunity
to fundamentally reset the immune system. So within that area, we're going to be very targeted on where can we play to win in areas that has --
where we have transformational potential.
Beyond that, with respect to metabolics, what I would say is, look, the company has been in areas very much related to metabolics. We're not in
that space today, but it's an area we're going to continue to watch. And obviously, we'll see how the science continues to evolve. And our focus
though is going to be for looking for transformational opportunities where we have a right to win.
Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: And last question from an investor, just on Milvexian. We mentioned that sort of in passing, but help us with kind of the bar, how you view the bar
for success? Maybe your assessment too of the competitive landscape? And perhaps what are line extensions even beyond what you guys have
talked about through ACS, et cetera?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, what we're focused on right now is we've got 3 parallel studies running. We've got AFib, ACS and secondary stroke. And those studies continue
to enroll very nicely. Our focus again is on accelerating where we can. And what we like about all three is, first of all, we've got compelling data
from Phase II for ACS and secondary stroke, which gives us a lot of confidence in that.
And coming out of ESC this year, we have a lot of conviction on the opportunity that we have in AFib. There had been some question given a
competitor that had failed in that area. We had always felt that the competitor study had been underdosed.
One of the advantages of being in areas you know very well, as you know how to do really good drug development in that area. We felt that was
being applied to the case of [Novexy] and AFib. The opportunity there is now that we will be the only oral product with a Factor 11a in that space
is quite significant. And so we look forward to seeing that data play out as we get into late 2026 and 2027. But that's a really significant opportunity
for us. It's an area we know own. We're excited to see the data play out.
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