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: Akash Tewari - Jefferies LLC - Analyst
: Yeah, absolutely. And I want to touch on the pipeline in Milvexian and COBENFY, but you are the CFO, so I want to hit you on -- I feel like it's almost
an overdone question about where is the trough EPS and blah, blah, blah.
But I feel like when I talk to your team, I feel like Chris, as he's become CEO, the priority for the team is first the signal to noise ratio needs to improve.
Credibility needs is paramount of importance. And when I look at the pipeline readouts you're going to have in 2026 and beyond, I feel like time
is going to answer that question anyway, right?
It's not -- like what's the urgency for you guys three, four, five years out to say when the trough EPS is. It's going to be evident because you're going
to have pipeline success and you're going to have visibility on your launches.
So I'm sure you get this question all the time. Is there urgency on your end to call your shot on trough EPS? Or is the point look at what we're actually
doing from a business development perspective, look at what we're doing from a pipeline perspective, that's going to answer the question for you
automatically.
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yeah. It really comes down to what we're going to be judged upon is not what we say we're going to do, but what have we actually done? And
that's what we're focused on. That's say-to-do ratio of, if we say we're going to do it, let's do it. And I think the last two quarters, you guys have
probably hopefully have seen that, that's what we're really focused on.
It's really executing in the near term both on the growth portfolio, but as well as executing on the pipeline. And I think we've had a tremendous
track record of success of getting Phase 3 products approved, based upon that. And we had a lot of Phase 3 programs, as I said, they're going to
be reading out, which I can go through both this year as well as next year and into '26. So there's a lot of de-risking events that are really coming
for the company in the next 18 to 24 months. So we're focused on making sure that they go well.
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Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. Quickly just on BD, you've done almost $30 billion of business development over the last few years. So it's not like Bristol hasn't been
active on that front. But it's -- now I think -- I feel like you're almost in a period where you need to consolidate the acquisitions you've had. Where
is the BD strategy in the near term? And is there a leverage target is that maybe paying down that $10 billion in debt by '26, where you can start
becoming a bit more aggressive from the BD front on a go-forward basis?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Great question. So look, on BD, we did do a significant number of programs. But if you look at where we do business development, we're focused.
We do business development in the therapeutic areas where we have sales and marketing capabilities, where we have drug development capabilities
and scientific expertise. So going all the way back to MyoKardia, that was CAMZYOS.
That was in cardiovascular. We had high level of conviction on that product. We were able to move very quickly to bring that product in we are
able to drop that rate into the ELIQUIS salesforce and just reallocate the resources over to CAMZYOS.
We got that product approved quickly, and we moved quickly to continue to nonobstructive HCM, which is going to add another 20% to 30% of
the patient population to that, which gives you more long term. But then also think about the other programs that we did like RayzeBio.
We're really excited about the opportunity of radio ligand. We haven't spent a lot of time talking about that, but we'll probably be one of three
companies that are in there. We think about this as a massive opportunity. Chemotherapy is a $50 billion market in the US and being able to be
one of the leading players in this, which is a very complex manufacturing environment, but you're able to go after very difficult tumor types.
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Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. And just maybe lastly on BD. I remember when your team was at our New York conference, you explicitly said we could really use a
neuro product to kind of amplify our commercial, we have this sales force. We have the scale. We don't have the product and then lo and behold
the Karuna acquisition happened. When you think about your business units and where you think, hey, I could really use a new pipeline asset. Is it
solid tumors? Like where do you feel like you can really reload with a new asset?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yeah. I mean again, we stay focused on the therapeutic areas that we're in. So I think we all believe in this room that there's still a lot of opportunity
in unmet medical need in solid tumor oncology. And that's an area that we're going to continue. System immune was a great example of that,
where we did that, radiopharmaceuticals was with RayzeBio was another example of that.
Look, we believe in cardiovascular with Milvexian, continue to progress that one and follow on with Milvexian after CAMZYOS. So I feel really good
about where we are with the cardiovascular franchise.
Neuro, look, there's so much opportunity with COBENFY. If you think through not just from adjunctive going into Alzheimer's disease psychosis
and going into agitation, but also cognition. There's really nothing out there in cognition. And we've already announced that we're going to go
into bipolar as well as autism. We're going to start studies there as well.
So that's a lot of substrate. And COBENFY, we see each one of those indications could be multibillion-dollar, indications in of themselves. So we
had a lot to build out and deliver. We have plenty -- what I want to leave you with is we've got plenty of substrate with both our growth portfolio,
but as well as with the pipeline that's coming over the next 18 to 24 months, we're just going to complement that with business development on
top of that. But you should look to us to do what we've historically done, which is a focus in the therapeutic areas that we're currently in.
Said, we start the conversation, where is the unmet medical need? What's the most interesting science to address that on medical need? And then
where do we have the capabilities, both from a sales and marketing, but as well as from a research and development perspective as well as
manufacturing to bring those to market because that's where we add value over and above the biotech company.
Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. I want to -- ACR was there, you had your CD19 data. The way that we kind of look at it, how different any of these CD19 programs are
really going to be is not necessarily the clinical profile, right? All of them show tertiary lymphoid cells getting depleted, the spleen gets depleted.
I feel like what's maybe underappreciated with Bristol is you've made a lot of advancements on your manufacturing profitability, scale, and that's
probably what doesn't get discussed enough.
So when do you think about, A, with your next CD19 program, clinical profile, what would you call out with your lupus data that stands out as
differentiated, but then B, from a manufacturing and scale perspective, to actually supply this and deliver it to payers in a way that makes sense
financially, what are the inherent advantages that Bristol really has?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yeah. That's a good question. Look, there's a couple of things. We cannot be more excited about CD19 next year and the opportunity that we have
to really reset the immune system for people suffering with lupus disease. And look, these patients are -- as you learn more about the disease, these
are patients that are going into organ failure.
This is the most serious disease that you can possibly have. The excitement around CD19, we know the construct well, we have Breyanzi that's out
there. The safety profile of this because that's one of the other big things, particularly going in to dealing with these markets versus hematological
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Question: Akash Tewari - Jefferies LLC - Analyst
: Now David, you made a comment at the start that I think stands out, obviously, we cover Merck. On subcu Opdivo and then just the value proposition
of a subcutaneous product, I think a lot of people listen to what Merck says.
And they said, look, it's going to make sense if you're taking a drug oral and then a subcu PD-1 product, it's going to make sense if you're using this
in an adjuvant setting. That's going to be 50%. I think even your team has given like a number of patients who would be in that kind of early stage
setting.
But that's not necessarily what you're talking about. You're talking about infusion capacity getting reduced on a hospital level. That doesn't seem
to be stratifying patients in an adjuvant and early stage or oral setting. That seems like I'm going to use subcu KEYTRUDA across all of the treatment
paradigms in which Opdivo is currently approved. Talk to me about that. Is that the right way we should be thinking about it a hard switch type
of strategy?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Look, we're treating like this as a launch as a major launch. And I just went through about two weeks ago, I went through with the brand team, the
launch preparations. Our team is ready to go once we get that PDUFA date and the product gets approved. At the end of this year, really a 2025
launch. But look, this is something where you're talking about changing medical practices, you're talking about making practices more efficient.
You're talking about freeing up practice time. So there's a constraint on the number of infusion chairs. And also think about it patient by the time
they commute, go in, do the infusion, you're talking about hours of time.
And then you're also thinking about everything that you have to do and taking care of those patients when they're there in the office versus
subcutaneous or for the patient, they just come in, they get their injection, they walk out. Number of man hours that is going to come out of the
healthcare system is going to help bring down the cost of the healthcare system.
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Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. Now just on Milvexian, it's interesting. The Q3 commentary, there's different ways that you can interpret, hey, we're increasing our
enrollment. And I don't think a lot of people -- the Librexia AF design paper actually got published earlier this year, I think one of the things that
stood out to our team is, if you look at the event rate assumption and the efficacy that you assume for ELIQUIS, just like what we saw with Asundexian
at ESC, ELIQUIS doing better now than it was when the original clinical data came out, you guys are assuming a more modern event rate assumption
for ELIQUIS.
So talk to me about why you've been going out of your way to call out your excitement about increasing the enrollment. What do you think the
street is missing here?
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yeah. I mean, look, think about it this way. we assumed a 1.3% event rate. It's coming in lower than that. You got to be excited for patients. I mean
it's blinded, so we don't know which arm it's in. But regardless, for the study overall, it's lower. So for these patients, that is a really great sign. And
the reason why the BEAR study was stopped, it was significantly -- the event rate was significantly higher than that. We have a DMC that reviews
the events, and they review it at a lower level.
And so we're really confident. So every day that goes by on Milvexian, we continue the studies and enrollment rates are increasing on the AFib
study. So that's why we're excited about this, and it gives us increasing confidence that we're heading right track on this. And we couldn't be more
excited to bring the product to market.
Question: Akash Tewari - Jefferies LLC - Analyst
: Understood. I'm going to let you guys go. Thank you so much. Really appreciate it.
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Thank you very much.
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