The following is excerpted from the question-and-answer section of the transcript.
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: <_ALACRA_META_ABSTRACT>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.
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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
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?
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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.
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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?
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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?
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Question: Geoffrey Meacham - Citigroup Inc. - Analyst
: Fantastic. Thank you very much, guys. It's been our pleasure. Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thank you.
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