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
: 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?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, let me maybe take that question and just say where we are in this journey. So when when I took over as CEO last November, I sat down with
the leadership team. And so we have one objective. And that objective is to reshape BMS to deliver long-term sustainable growth. And when we
look at the opportunity set that we have as a company. I'm convinced we not only will grow this company, but we have the ability to exit this
decade with top-tier growth.
And so we were then focused on how do we deliver that. Now when you look at obviously how investors are seeing the Company right now, I think
I generally see the opportunity, but there's also a recognition. We got near-term uncertainty with illiquids. We've got the LOE exposure we have
over the course of the decade, and in that context, we said as a team, we do three things. We do them exceptionally well.
First, we're going to focus the organization. There are so many opportunities. We've launched 12 drugs over the last three years. We have the
potential to launch seven NMEs over the next three years. We did the deals that you just described, which we think added additional opportunity.
We've got a number of data readouts over the next two years and delivering on those catalysts has to be priority number one, whether you're
sitting in commercial or R&D or any supporting functions. So that was step one.
Step two, and this gets to how do you effectively manage your P&L, is we have to look across the organization and say, how do we make this place
simpler to operate and drive and have a culture of having a sense of urgency and accountability for the delivery of all of the opportunity that we
have.
And so we've taken $1.5 billion in resources out of programs so that we can redirect them to higher ROI opportunities. We've delayered the
organization, simplified how we operate and that enables us to operate more with a sense of speed.
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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?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Yes. Well, we've been clear on is we did a number of deals at the end of last year, we need to make sure we execute against those deals. Now the
good news is we closed both RayzeBio and Karuna relatively quickly. And so in terms of digesting those deals. I think we're well down the path. A
keen focus we have right now is the launch of KarXT.
That is a critically important growth driver for us. We acquired that as part of Karuna, and we've got to deliver on that. Having said that, we've got
a fantastic balance sheet. We have the ability to continue to engage on business development. We're going to be disciplined, as I said, and pay
down the debt that we accrued in doing the deals last year.
But with that in mind, as we look at opportunities there, focus on the therapeutic areas we're in. We have a right to win in on (technical difficulty)
the focused areas, so that's an area we're going to continue, though. To look at.
Obviously, cardiovascular is an area. The company has a long (technical difficulty) Our radar on neuro is an area, as you point out wind in
neurodegeneration. Karuna gives us an immediate entry into NeuroPsych. But I think it's fair to say that the company is a bit subscale in that space.
And so that's going to be an area of focus for us.
And then immunology, what I would say about immunology on a forward looking basis is, look, we're incredibly excited about the opportunity we
have with CD19 NEX-T. That's an opportunity to fundamentally transform autoimmune disease, potentially deliver long-term durable responses,
maybe potentially a cure.
We'll see early proof-of-concept data in SLE later this year for CD19 NEX-T. We'll see additional proof of concept data next year. That's a potentially
substantive opportunity for us. And as we think about business development priorities in that space, I would think about us looking, it's more
transformational opportunities as areas where we would be in.
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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.
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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.
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
: It's almost like, I don't know, artificial intelligence, just like the Chris prescription trends, just look like in and calling up the walls up into the right,
as it's oddly linear. I remember we were all obsessing over the fact that the REMS was just like, oh, my God, it's such a complicated degree of
difficulty.
And I remember these folks have had Celgene and Revlimid, et cetera, so it's not as if the newbies to this can Joe's. The opportunity here is
transformational as a former clinician. I think about the options that were there what's going to get sort of maybe some sort of acceleration or
launch trajectory? Are we thinking about this the right way? Should we be patient?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, I think the way we should think about this is at a macro level to remember what cardiovascular launches look like and the progression of
cardiovascular commercialization. It's generally a straight line as you described up into the right, if you have a good drug. We've actually run the
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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?
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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.
So but here we sit June 2024. What is your thinking about the earnings journey and your communication about levels because you've intentionally
brought up during the first quarter call about we need to see IRA negotiations play out, and that was part of the calculus to almost be a gating
factor, if you can tell us more.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
We'll look. I mean, one of the things that we did very early in my tenure as CEO was to say, philosophically, it's my point of view that long-term
guidance in this industry is challenging and some arguably should be avoided.
In part because there's so much risk just in this industry generally that I tend to think let's stay focused on providing guidance to the things that
are that we have clear line of sight into and frankly, that investors can hold us accountable for because we can all see where we should be delivering
and you can step back and say, did you deliver it or not?
What was your say-do ratio on that and so on. And do that's philosophically how we approach this the reason we decided to not give long-term
guidance on this dimension is I think, multifactorial first. I think the main or one of the main questions behind this question is what's the shape of
the illiquid business.
We're going to be able to say that once we know the final output of the negotiation process with CMS, and we'll know that in a few months. So
the uncertainty around that will be taken off of the table. So that step one.
The second thing to recognize is that remember what you want to be able to describe is this the growth profile for the company in the back part
of the decade? We're going to give great color to that over the next 18 to 24 months because what you're going to see is a series of catalysts play
out.
Obviously, every quarter you're going to be able to watch and see what the growth profile does a growth portfolio does. And I would pay attention
to that portfolio in totality, but also the most important products in that portfolio, Camzyos, Breyanzi, Reblozyl, Opdualag, the momentum we build
with SOTYKTU. You'll get to see that on a quarterly basis.
Towards the end of this year going to the KarXT launch tremendous opportunity for the back part of the decade Subcu launches at the end of the
year, the PDUFA is in late December. That's an important component of us extending the IO franchise into the 2030s. That's going to be important.
And then as I mentioned, you've got a series of catalyst events playing out line extensions for Camzyos and Reblozyl next year, more CD19 proof
of concept data. And then you've got the big Phase 3 hitting as you get into the end of next year and '26, milvexian, LPA1, iber, mezi and then
additional proof-of-concept data across some of the earlier programs like anti-Tau that could be big needle movers for us at the very end of the
decade and into the next.
All of that's going to play out over the next, call it, 18 to 24 months. That's going to give you a much better picture of the growth profile of the
Company in the back part of the decade, and I think mitigates the need to give any sort of long-term guidance here.
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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.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Yes. Look, one of the things that we said, you'll remember there were a lot of sort of questions about how the second line launch going and the
like. And we said, look stay focused here. Let's make sure that we get the launch of the second line, right. People know how to dose titrate.
They know how to think about this. With respect to ESA and ESA switching. And that was the right thing to do because we knew the bigger
opportunity was in first line. What we're seeing with the commands launches, some very good uptake across both academia. And in the community
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.
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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?
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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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