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: Chris Shibutani - Goldman Sach Group Inc - Analyst
: <_ALACRA_META_ABSTRACT>Yes, no, you were -- a lot of incredible institutions, golden age with Genentech, sue Desmond-Hellmann, a lot of folks that also ties
over to Bristol from a -- corporate standpoint and relationships focused on oncology, the delivery of that, you had a front row seat
with Giovanni, particularly on the commercial side, tremendous success in 2022.
In terms of just developing first in class kind of, not simple, when you're trying to disrupt the landscape like Kamsios, which we'll talk
about a little bit later, was just a paradigm shift. And there was always going to be a lot of weeds to hack and path to navigate, et
cetera. And so you were very much a part of that.
You used the word focus, which is obviously very core, very difficult, particularly at a time when there's a lot of moving parts. And
by that, I mean, you kind of ruined everyone's holiday vacation last with the day before the day after Christmas, announcing some
deals.
Very exciting enough from the standpoint of thinking about all the stuff that has to happen literally at the time that you are sitting
in the seat and figuring out how to move parts around, it seems as if there's always the McKinsey whiteboard exercise, we're going
to do this this and this then there's actually having it actualize.
So talk about that process and where you are in that because a lot of us sit here with our spreadsheets and we're analyzing margins.
I'd never manage the P&L within a pharmaceutical organization, so what's that actually like and how satisfied are you with where
you're at?
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: So I want to use the word specifically prioritize because that tends to be where the investors are keenly watching for variations and
how the information is phrased. You just rattled off a litany of the capital allocation priorities.
I would say that there is an interest and appetite a desire amongst a lot of shareholders that I talk to for you to continue along the
path of the business development pursuit yields, the notion that it's like, okay, you have with subjects doing immunology Renaissance
with, with KarXT, you're back in the game, post-abilify, we remember there in terms of their.
Getting critical mass in those two verticals, immunology and neurosciences Neurosciences little bit less in terms of the payer backdrop.
But nonetheless, thinking about having a portfolio approach having a little bit more a sort shoulder breadth of that. Can you go
further, and if so, is that something that you're eager to do?
Or are we currently a little bit vascular digesting? And where are you with the capital allocation priorities? And then within BD, where
does that fit and what is your alacrity?
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: And it's interesting cell therapies. I think it's kicked off at JPMorgan with little bit of buzz and excitement in the air about translating
that platform into the immune-mediated diseases.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Yes,
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Sticking to immunology, let's talk about a product that has very attractive profile, keen interest from the clinician community. A little
bit more of a sort of rough sledding from the reimbursement coverage. Talk about where we're at there and where we might be
able to progress between now and the end of the year, for instance?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Yes, well, look, this is a space that is incredibly competitive. It's one where market access is the name of the game. And let's remember,
when we launched Sotyktu, we came out of the gate very, very fast. We were able to get to double digit market share in a number
of months.
And given the competitive dynamics, what that led to was an increase in the amount of spend and increasing the amount of rebating
and transparently. We had to step back and say, do we have the right resources and have we put the right muscle around this?
And so over the course of the end of Q4, certainly into Q1, we continued to up invest to make this product successful, and that's
going to be our focus. We've had good wins on the access side. We'll be announcing another big PBM win on in the Q2 call. And so
we feel good about where we are but undoubtedly to be successful in this space, it's going to be commercial muscle and it's going
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Right now and does have the poetic studies TYK at the end and psoriatic arthritis and I think there's also the recent data from Alopecia
areata as well.
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Okay. Terrific. Label expansion opportunities. So do stay tuned. Let's talk about the second member of the class of 2022 have novel
approvals and launches Camzyos.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Yes.
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Additional opportunities as well. I think MBARC is the name of the study.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
That's right.
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Right now is going to bring up that follow-up compound because there's this ecosystem where investors are very aware of Affi
Campaign, that's a competitive agent in there. And I often find that there's a little tug of war over people feel as if is this a zero-sum
game and who's going to eat his lunch versus the opportunity for the for the potential opportunity to expand because there's so
much in the way of physician education patient education, et cetera.
So how are you seeing the impact of that? I think that the go to is the notion that the hassle factor associated with the REMs could
be a source of differentiation. Just any commentary about anticipated competitive dynamics and the card you have in your back
pocket with 224?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, I would say on the competitive front, I've been somewhat consistent in this view that based on all of what we've seen and what
we know about a competitor in this case that we didn't think it was going to be a differentiated asset. Now that we've seen the data
card turnover, I maintain that this is not a differentiated product.
And so in some regards, you can say that the competitive landscape is clear air for us. Having said that, we know this market is one,
do you have a lot of patients who are undiagnosed? And so my view is that if you have an even undifferentiated competitor enter
the market, you have the opportunity to potentially expand diagnosis rates. We have a multiyear head start.
And the team that we've got in place. I feel great about our ability to get disproportionate share. And so in some ways, I'm not terribly
concerned about it and it could be a source of market expansion.
Beyond that, I would say, look, we're looking forward to the IMbark data. We'll see how that data looks. We have a lot of reason to
believe in the opportunity and have paths and we'll see what the data looks like and apply those learnings to MYK-224.
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Milvexian as a pipeline asset. Phase 2 data was kind of in the distant past at least a year ago. We're working with working busily on
Phase 3. I think confidence is something that often gets debated amongst investors in terms of the indications and the scale of the
program and the commitment. Now you're hedging some risk because you have a partnership here.
But how would you encourage someone to feel confident about the Milvexian opportunity here?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, I mentioned earlier, that BMS has a right to win in cardiovascular disease. Why do I think that's the case? We have a long history
in this space. We know this space very well. Going back to the Plavix days, we have a lot of people, whether it's in research and
development to know how to do clinical trial development in this space. And so one of the things you may recall from for the year,
obviously, there was a big question, Mark with the Bayer data. I think what I've been consistent in saying is we have to wait and see
the science play out. But there's one thing that I know is true.
We designed a Phase 3 study in AFib for this asset, milvexian that have the science is favorable. That study is going to show it. So we
feel very good that we designed the right study. We used a dose that was a therapeutically relevant dose. And so at this point, we
need to wait and see how the study plays out.
We won't have to wait terribly long because we anticipate that Phase 3 data in 2026. But again, it's one of three indications that are
roughly coterminous with one another. You have AFib, ACS and secondary stroke prevention, and we're excited to see how the
Phase 3 data pan out and our confidence in this program hasn't waned at all based on competitor data.
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Correct.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
And in the case of Part D redesign, that's unequivocally a good thing for Eliquis. And in fact, as we look at Part D redesign, generally,
that's something that's going to be very portfolio dependent. So it depends on what drugs you have. And so whereas it might be a
negative for a drug like Revlimid, which is a declining business for us. It's unequivocally a positive for aliquot. So that's sort of a wash
as you think about our portfolio.
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: This discussion on Eliquis and IRA is a logical segue to a topic that has been very much part of investor conversation with the stock
since the start of the year. And so that notion of this journey that the company will go from a profitability and earnings standpoint
for earnings guidance, short term, long-term optionality is endless.
I think investors are seeking some sort of consistency in messaging. I think you have gone away from the notion of providing trust
guidance. And I think it was actually a wonderful thing that you went on this listening tour is very much a signature of, I think what
I'm detecting of your management style so far is that you're going on this listening tour and doing things. And the team has spent
a lot of time in that regard.
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Yes. No, I think there's plenty of that you mentioned there. Let's touch upon a couple of them actually start by giving a little bit of
love to Reblozyl. Seems to be like quietly one of the better-performing athletes here. And what are we missing is what is the opportunity
that we might be underappreciating here because it doesn't get as much sunshine.
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Subcu, I think the PDUFA is December 29, or something, which is like a Sunday to more trading days, even allergic to the holidays
or something serious when we ship them. What are you saying in terms of reassuring us that there isn't risk associated with that
being a event here.
I think we have some insight into sort of what the subcu can deliver, but reassure me I'm worried just because I do that for a living
then talk about where you think the opportunity is and what the ultimate penetration of subcu could be?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
We've seen the Phase 3 data. So that should mitigate some concerns on. And we like the data we've seen. We've had no indication
that there's any potential hiccup with that PDUFA. And the other thing to note is that this PDUFA gives us an opportunity to potentially
convert the IV business across multiple indications to subcu.
We have a multiyear head start relative to the LOE for Opdivo. So we have plenty of runway there. And what we've said consistently
is that we believe we can convert about 30% to 40% of this business of IV over to subcu, and that's mainly going to come from a few
areas. First, obviously, PD-1 monotherapy, Opdivo monotherapy is a big opportunity.
If you look at combination use where you then subsequently have a maintenance phase with Opdivo monotherapy, that's an
opportunity. And so those would be the two big areas, but we see opportunities in early disease and later disease. And again, we
think it's about 20% to 30% of the over 30% to 40% of the overall business.
Now in addition to subcu, though, as we think about the I-O franchise into the 2030s. Opulan becomes very important. And there
we obviously have proof of concept in first-line metastatic melanoma. We know this mechanism works because of the component.
We'll see the actual adjutant data in 2026, but we have high reason to believe there. We said on the Q1 call that we've seen proof of
concept in lung.
You'll see that data later in the year. And then we expect HCC proof of concept later this year. And so if you add all of that up between
Opdualag and subcu, we see a significant piece of the IO business that extends into the 2030s. And the important thing there is no
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: I'm going to tack on a couple of more staying with oncology raised bio biopharmaceuticals, clearly dynamic from a strategic standpoint.
You have this asset tell us why this will make sense with you and how you're going to make sure that you're integration of it is
appropriate. And given the uniqueness of kind of supply chain and all those dynamics?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, we like the platform because it's one of the fastest growing platforms in solid tumor oncology. And when we looked at getting
into the space, we looked for three things. We looked for an opportunity that had a bond market or near market opportunity. So a
late-stage asset that we could bring to market relatively quickly.
We wanted a platform, meaning you could have a clinical set of assets coming behind that. And then most important in this space
in many respects is supply chain and manufacturing. And what we liked about Rayze is they clearly thought that through. They had
multiple suppliers for titanium that they were leveraging for the clinical program and they were building their own facility that was
well underway in Indianapolis.
And so you brought all three components of that together, and that was the reason we decided to move with this asset. Now your
point about integration is really important because we made the decision when we acquired this asset to run as a separate unit. So
in fact, that's my next trip. I'm leading here for San Diego this afternoon. And so it's run by somebody who used to be at Bristol,
knows the company very well on actually was at Mirati, and he's moved over to run Rayze for us.
And we've been able to keep that team intact because when we bought this company, we bought technology and we bought human
capital, we want to make sure that team stays intact and we didn't want to be overly forceful about trying to integrate that into the
rest of the company.
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Right?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
And that's an important when we'll see data on that one later this year. Look, the big challenge with PRMT5 people have been excited
about the efficacy for some amount of time. The challenge has been can you get the safety dialed in and there have been some
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Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: And anybody who claims to have an ad sort of agnostic tool kit and diversity, you do have an ADC play as well?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
We do and what we look when you think about oncology, there are platforms that are going to be relevant and we believe ADC is
one of those platforms we did the SystImmune deal a partnership at the end of the year last year. Look, we were really impressed
with the data that we saw we sent a team to China to interrogate that patient level data.
And we think there's real potential opportunity in lung potentially in breast cancer. So we're excited to see that data play out as well.
Question: Chris Shibutani - Goldman Sach Group Inc - Analyst
: Excellent. Okay. We're into overtime here, a lot to cover today and look forward to continued discussions.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Look forward to it.
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