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.
Some of those programs feel really good about that actually some of the enrollments are accelerating. So we'll see how that plays
out here.
But to your point on any kind of trough guidance, it's us performing with the growth portfolio, and that continues to deliver quarter
on quarter. We had two really strong quarters, but we've got to continue to deliver throughout 2025, I think all of you are going to
be looking to us, what do we deliver with COBENFY and how that, that does in its first year.
We're very much focused on that launch as well, which will go into the growth portfolio. And then I think the data readouts are all
going to be de-risking events and you guys model our portfolio and the pipeline is saying, we do you risk adjust that until you get
the data readouts. But we got a lot of data readouts.
Like just this year, you saw we had ACR this weekend. We had -- even though it's very early, but CD19 in immunosuppressive diseases,
this is an opportunity to really reset these like lupus diseases where your patients are having organ failure. And we talk a bit about
that, but we have cirrhotic arthritis for Sutyktu coming out this year. We got the approval of Opdivo subcutaneous happening in
December. And as we think about next year, we've got important indications that we'll get nonobstructive HCM for CAMZYOS.
We also have the approval of first-line myelofibrosis for Reblozyl, which was an important continued growth driver for Reblozyl. And
then I've even talked about iber and mezigdomide, which are the projected degradations that are in multiple myeloma that could
be the next follow-on REVLIMID and POMALYST products, that with those Phase 3 readouts coming in '26 as 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.
So we stay very much focused in those therapeutic areas that we know. And then obviously, Karuna is a new area that we're reentering,
but there's a high unmet need. We had conviction in the science on this asset. We looked at many assets before making the decision
to go into Karuna.
And what we said at the beginning of this year is we need to fully fund these programs, and that's why we put our savings initiatives
in place to build out the clinical programs and invest the needs because we're focused on the long-term health of this company, the
long-term growth trajectory of this company.
What we also said this year is about execution. Let's execute on these deals, let's get them integrated. They are now integrated into
the organization. And then let's also focus on to COBENFY's launch because we know everybody's watching whether or not we do
well and make the most of COBENFY and we don't want the organization to be distracted. So we're paying down the debt.
We made that commitment about $10 billion of debt to strengthen the balance sheet over this period, focus on the integration. You
should expect us to do more smaller bolt-on acquisitions and collaborations. But then as we get through integrating these, that will
give us the opportunity to pivot to other acquisitions.
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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 diseases where people are dying. Safety profile is really important. We believe not only do we
have one of the safest constructs, but efficacy, as we were talking about, is very strong.
And what we saw with these 15 patients is complete malignant B-cell depletion in both blood and tissue. And that's truly remarkable
to see that. So look 15 patients. We don't want to get ahead of ourselves. We got to see, but it looks very promising.
I think we're at the forefront. We're really excited to bring this as quickly as we can to registrational studies in multiple indications
right away. So going after and being really efficient and freeing up resources, we want to do everything we can to bring this in as
many indications as we can as quickly as possible. So you'll hear more about that next year.
But also thinking about it, and thank you for raising the point about where we are. I mean we spent years figuring out the
manufacturing. You may recall there is vector constraints. We fixed those vector constraints. We've bought a vector manufacturing.
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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.
So we see a significant opportunity there from that perspective to really focus on the efficiency of the health care system. And I also
just think about it from a patient perspective, patient guides so much of what we do. Anybody that knows anyone has to go in for
their treatments.
This is when you're being reminded of your disease and you're sitting there in a chair for over an hour sometimes waiting to get
views and then getting infused and then leaving, being able to just go in, get your injection, come out. For the patients themselves,
this is a huge benefit for patients.
So we're really focused on those areas. And when we talk to physicians and we talk to patient groups, we hear the similar type of
feedback. So I think this is really -- we're really excited about it, as you can tell. We're really excited about treating this as a major
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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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