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 Schott - JPMorgan - Analyst
: Great, thanks so much. Just two quick ones for me. First on Cobenfy. It seems like feedback and coverage dynamics are progressing
well. Can you just elaborate on how you're thinking about the ramp of the drug from here as we balance as you highlight kind of
entrenched physician prescribing habits against what seems like a relatively poor standard of care and pretty large unmet need in
the space. I just trying to get so like the ramp, how you're thinking about it for '25?
And the second one is just on the cost program. Once you're done with this incremental $2 billion, should we think about additional
cost opportunities as you go through that 2028 LOE cycle, or is this going to really put the company in the, I guess, the right place
as we think about the longer-term model and longer-term business. So basically kind of thinking about is, is the 27% run rate kind
of a good way to think about this? Or is there another step down as we head into Eliquis and OPDIVO? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks for the questions, Chris. I'll have Adam take the first question, and then I'll take the second. Adam?
Adam Lenkowsky - Bristol-Myers Squibb Co - Executive Vice President, Chief Commercialization Officer, Member of the Leadership
Team
Great. Thanks, Chris. So regards to the Cobenfy, we're very pleased with what we're seeing with Cobenfy with three months post
launch, and the launch is really off to a strong start. We're now at approximately 1,000 TRxs per week. And we made very good
progress achieving our access goals. So for Medicaid and Medicare, we're tracking ahead of our expectations.
We've achieved over 90% Medicaid access and over 80% Medicare access, recall those two payers represent over 80% of the covered
lives in this category. And as expected, the majority have one step edit post generic. We're also making very good progress with
commercial payers. The feedback over the last several months has been very positive.
There's been a lot of enthusiasm around the efficacy and safety profile. I'm also pleased with the number of trialists that we're seeing
since launch, and we have an opportunity to further expand and increase adoption with roughly 30,000 psychiatrists.
So as you said, this is the first new mechanism of action in decades in the treatment of schizophrenia. And so we're out with our
teams educating customers on Cobenfy's differentiated profile and we're breaking reflexive prescribing habits, and that's going to
take some time.
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Question: Chris Schott - JPMorgan - Analyst
: Thanks, Chris. Alison, can we go to our next question.
Question: Luisa Hector - Berenberg - Analyst
: Hello. thank you for taking my questions. I just wanted to take your assumption for Part D redesign, if you can quantify it in 2025.
And then just an update on (inaudible), I don't see it on the slides, but any updates on the filing plans there. Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks for the question, Luisa. I'll have Adam take both of those questions.
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Question: Geoff Meacham - Citi - Analyst
: Great, good morning, guys. Thanks so much for the question. I had another one on Cobenfy. I know, Chris, you highlighted the
expansion opportunities on slide 6. I guess, are there others that you could add or accelerate beyond what you have? I guess the
main question is, since the [emracladine] failure are there changes to the investment plan that you're contemplating?
And then on the policy front, I want to get your perspective as RFKJ's nomination or a confirmation looks I think fairly imminent,
what are the potential puts and takes on IRA revisions? Obviously, been a lot of chatter on what discounting could look like in the
outer years. Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Sure. I'll take the first part of that question and then turn it over to Samit and Adam, and then I'll come back and talk about the policy
bit. Just let me give you a top line on Cobenfy. Obviously, the competitive dynamics and changes on the competitive front haven't
impacted the short term on that product. We have always been focused on delivering that product as quickly as possible. patients.
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Question: Chris Shibutani - Goldman Sachs - Analyst
: Thank you. Good morning. I'm struck by the ability to do several things at the same time while trying to realign your costs and
integrate these businesses. There have been several advancements of time lines in terms of data readouts.
And there's also been an absence of slippage across integrating aspects of the pipeline that are very important. What are the keys
in your opinion, to being able to deliver on this progress and in particular, the advancement of time lines?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Maybe I'll start and then turn it over to Samit. I think, Chris, you've correctly pointed out there a lot of moving parts. But I would say
one of the reasons that we've been fixated on operational excellence, becoming a more nimble and focused organization is making
sure that we're staying absolutely focused on those things that are going to drive value to the company and value to shareholders.
And so one of those things has been a very laser-like focus on R&D productivity. The work that we've done in that regard has enabled
us to accelerate a number of programs that are going to add value for the company.
In fact, one of the reasons we have this wave of catalysts that are coming forward over the next 24 months is that we have been
focused on ensuring we hit the time lines that we set internally and where possible, accelerate and Samit and the team has done a
nice job of helping us do that.
So Samit, do you want to comment on specifics.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
Yes, absolutely. Thank you for the question, Chris. As Chris said, the laser focus is the start. But then again, following the principles
we laid out a few years back, in fact, between Robert and myself from the research and discovery perspective, the cause of biology
to discover the drugs matching the modality to the mechanisms and then picking the right diseases.
And then after that, accelerating that proof of concept generation. But then if you look at the late development, we broke down the
process into multiple pieces and dig deeper into where we were doing well, whereas, wherever the space is where we had the
opportunity to shorten the time lines. And there, we identified several opportunities, and then we started to dig deeper into it.
The other thing we did last year is also prioritize our portfolio and made certain decisions what we will pursue versus what we will
not pursue. Some assets, some trials were stopped and then we started focusing on where the most amount of scientific rigor was
there to be able to achieve the proof of concept. And once that was achieved, how do we then accelerate that into generation of
the data to bring the drug to the patients and to commercialization. All of that has helped.
And the examples that are right in front of you, last year, we were able to accelerate and deliver the psoriatic arthritis data early, this
year, we'll be able to give Camzyo's data early. This year, we'll be able to bring in ADAPT. And now we are working on the next trial
as well as we think about multiple myeloma, LPA1 and IPF as well as SLE trials, for SOTYKTU. And, of course, that mindset will go in
all of these seven trials that we've talked about for Cobenfy as well.
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Question: Tim Anderson - Bank of America - Analyst
: Thank you very much. I have a couple of questions. So the revenue guidance for '25 is about $1 billion less than consensus in as
much as you've looked at consensus, where are you seeing the biggest differences, could Cobenfy be one of those contributors of
the delta? And then a longer-term question on earnings.
In the past, Chris, you've suggested trough earnings would really be in the very late 2020s. And to me, it felt like, maybe 2028, 2029.
Is that still the right way to think about it? And could a product like Cobenfy or some of these other programs possibly pull that
forward?
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks for the questions, Tim. Maybe I'll start and then turn it over to David for the first part of your question, and then I'll come back
for the second part.
Look, with respect to how we thought about guidance and the outlook for this year, I think you as well as I think everybody knows
the LOE exposure that we have as a company as expected. This year, we're seeing the increased step down on Revlimid as well as
the stacking of full year impacts products like POMALYST, which lost exclusivity in Europe as well as in the US price and our guidance
reflects that.
But keep in mind, those are short-term impacts. And the long term, which is what we're focused on, we feel good about the progression
that we're making on the new product portfolio. And then as we discussed just in the last question, we have an exciting set of assets
that are going to be reading out that will frame out what the company looks like in the back part of the decade.
And maybe I'll ask David to fill in some of the specifics on the LOEs and the guidance.
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Question: Mohit Bansal - Wells Fargo - Analyst
: Great, thank you very much for taking my question. My question is regarding Eliquis. So I mean, so there was some thoughts about
Eliquis getting some tailwind because of RD design given that there's no donut hole now. And maybe the like given the price point
the impact of RD design may not be a lot. So in the context of that, how are you thinking about the growth for this brand for this
year? Thank you.
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Question: Chun Chung - UBS - Analyst
: Hi guys, thanks for taking my question. Just two, please. So firstly, can you just give us some color on the gross margin cadence for
2025? You touched upon 1Q dynamics, but should we just follow the REVLIMID step downs for the year? I there any other considerations
that we should think about here?
And then just wondering if you can give us any early insights into the access and coverage of Opdivo Quantic, and any thoughts on
the uptake for '25. Thanks
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks for the questions, Chun. David, do you want to take the first one and then Adam, you can comment on the second.
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
As we said, the step down will be mainly driven by REVLIMID and POMALYST. Volumes coming through with those gross margins
being slightly higher than the average. And the only other consideration obviously is Eliquis.
And I think as Adam had covered typically Eliquis is larger in the first half of the year than the second half of the year. This year, that's
going to be inverted in that our lowest quarter for Eliquis the first quarter, but our sales will be higher in the second half of the year
than the first half of the year. So that would be the other consideration as you think through the gross margin of the company in
total.
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Question: Evan Sigerman - BMO Capital Markets - Analyst
: Hi guys, thank you so much for taking my question. One on BD, more specifically, now that we're on this side of the muscarinic debate
with Cobenfy approved and peer acuity not showing an efficacy, can you walk us through kind of your process in determining why
you went for Karuna when you wanted to get into schizophrenia. And on kind of a more mechanistic perspective, what's happening
with Camzyos? We saw a nice step up. What are you seeing in the field that's driving the uptake there? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks for the questions, Evan. I'll start and then turn it over to Adam. There's no magic bullet with respect to how you approach
business development from our standpoint. But I think there were a few things that we did well with the Karuna acquisition that
will frame how we continue to do business development.
First, I would note that the senior leadership team of the company owns the decision to move forward with that acquisition. Capital
allocation is critically important as we've discussed. Business development is a top priority for us as a company. It's important as we
navigate the back part of this decade, and when you're allocating investor capital at that scale, it's critical that senior leaders take
ownership and accountability for it. So we did that.
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Question: Akash Tewari - Jefferies - Analyst
: Hey, thanks so much. So what's the risk around the adjunct schizophrenia trial for Cobenfy? Because we haven't seen a lot of companies
run that specific trial. And if they have, they've often failed. So why wouldn't the probability of success for this trial be more like a
50-50 coin flip? And on the Camzyo's label update, are you aiming for six months echo monitoring requirements? And if so, how do
you think that will help expand access into the community setting? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks for the question, Samit and Adam.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
Sure. Thank you for the question. On the adjective schizophrenia, I remember where we started off and how patients are treated in
the real world. So we obviously have developed the drug as a monotherapy, but these patients were primarily before they got onto
the trial, we're receiving the D2 agonist and thereafter, there was a washout period, patients came on the drug and then, of course,
the trial evaluated the primary endpoint in emerging one, two and three at a shorter window.
But remember, merging four and five have now read out with a 52-week follow-up. Many of those patients obviously, are also taking
concomitant medications in the background.
So, and we've seen that efficacy continued to be maintained within, as we look towards the 52-week data point as well. So overall,
from that perspective, we are confident on the overall safety profile that is emerging on that. And then, of course, from a blinded
data perspective, the study has continued at this point.
So now we are only a few months away from the readout for that trial. And, of course, on top of that, we'll look at ADAPT trials also
reading out beginning at the back end of this year.
Coming to Camzyos, a point that I would like to make is it is very important that we continue to decrease the burden on the site on
the patients and the treating physicians. And from that perspective, it was important the data that we've collected from the real
world as well as in the clinical trials suggest that the overall safety profile of Camzyos is maintained.
Many of the patients are treated actually at the lowest holes of 2.5 and 5 milligrams and considering all of that data is where we
approach the health authorities, and you've already seen the action taken in Europe and now looking forward to the April action as
we think about the maintenance for these patients with a longer duration in between echos as we look to the US reviews as well.
Adam, if you want to add anything?
Adam Lenkowsky - Bristol-Myers Squibb Co - Executive Vice President, Chief Commercialization Officer, Member of the Leadership
Team
Just adding just one bit, and point you to the the European label. The label was updated late last year to reduce the frequency of
echo monitoring for patients taking Camzyo's from every 12 weeks to once every 6 months when patients are in the maintenance
phase. So that's after week 12.
And what we would expect is not so much in the community, but this will open up additional capacity at the centers of excellence.
And as a result, physicians will be able to treat more patients.
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Question: Terence Flynn - Morgan Stanley - Analyst
: Great, thanks for taking the questions. Maybe two for me. David, I just wanted to clarify on the new productivity initiative, should
we think about the run rate year-end for '27 as being $15 billion. So an incremental $1 billion off of the $16 million now. I just wanted
to make sure I understand it correctly.
And then on iberdomide, the addition to the MRD endpoint, did FDA sign off on that? And if so, are you able to get approval on just
an MRD endpoint? Or do you need follow-up data from the PFS? And anything you can say about what kind of efficacy delta you'd
need on MRD? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks, Terence, David and Samit.
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yes. thanks for the question. Yes, you have that right. So we said an incremental to $2 billion program, all that dropping to the bottom
line. We said $1 billion of that which dropped this year with operating expenses of $16 billion, this further $1 billion achieved by
2027 would get you to operating expenses of $15.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
In terms of thinking about iberdomide, of course, quite excited that based on the discussions that you probably followed from the
ODAC setting perspective at MRD as an endpoint is more and more becoming important because in multiple myeloma, there are
multiple lines of therapies that are available, but still no cure available for patients with multiple myeloma.
So it is important that we continue to figure out how to accelerate the process of drug development and that's why newer end points
are needed. So, of course, we've discussed with the FDA the ability to include MRD as one of the primary endpoints in the clinical
trial, and we'll certainly be reading that out most likely in this year.
Now everything in the regulatory world will be dependent on the risk benefit ratio and the overall magnitude that we'll observe at
the end of the day. So when the data is available, that's when we will engage with the regulators in terms of how they will see that
data and what else they would need. Remember, we have not taken out PFS as the second primary endpoint within the trial as well.
So, of course, the patients will be followed for PFS and as well as the secondary endpoint, which is overall survival as well. So we are
going to collect maximum data from the clinical trial and engage the authorities based on the magnitude and the timing of the
readout.
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Question: Courtney Breen - Bernstein - Analyst
: Thanks so much for taking my call today. Two parts, I think you spoke a little bit about business development in an answer before
and referenced it as a top priority from a capital allocation perspective. Can you just talk a little bit about TA alignment, kind of what
good looks like, particularly in the context of the organization you have right now, I think, last year was a little bit of digesting the
deals that you've done quickly. And so wanting to understand kind of how you're thinking about that appetite now and over the
course of the year?
And then the second was just around kind of Cobenfy, specifically kind of gross-to-net evolution as we're thinking about this access
evolving from kind of initial private pay to more of the government setting to then adding on a little bit of the commercial environment.
That would be really helpful to understand how you're expecting that to flow. Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Both good questions. I'll start and then turn it over to Adam. As we said earlier, and as you reiterated, business development is a top
priority for us. Think about that both in terms of partnerships and where it makes sense, acquisitions. And the way we think about
therapeutic areas is that we're really focused on strengthening our position in the core therapeutic areas that we have today, and
that we can do by bringing promising areas of science into the company as well as looking for assets that can improve the growth
profile of the company.
And I think you saw shortly after I became CEO in 2023, we did both of those things. What's important and the way we think about
it is that we need to like the science and feel that we're the rightful owners of it. The financials have to make sense. And again, we've
included in that thinking strengthening the growth profile as a key factor we're considering.
And we have to believe that we can drive value for the company and ultimately for shareholders. And as we look across the core
therapeutic areas that we have today, we see opportunities as we see opportunities to strengthen our position in those therapeutic
areas. The nice thing is that we're in a very strong financial position. And as I said earlier, that financial strength and flexibility gives
us strategic flexibility and that flexibility includes doing business development where it makes sense.
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Question: Seamus Fernandez - Guggenheim Securities - Analyst
: Oh, great. Thanks for the question. So just quickly on Cobenfy, I was hoping you could talk about the patient experience that you're
seeing so far in the field. We know that patients certainly feel better cognitively, but there are questions around the tolerability and
the BID dosing. So just interested to know if there's any early signs of sort of durability and how you're managing the GI profile that's
been talked about a bit by some thought leaders in that regard.
And then the second question is just as we think about the overall kind of multiple myeloma opportunity, just hoping to get a sense
of where you think novel oral drugs like iberdomide or resignomide could appropriately fit within the context of the overall multiple
myeloma market. given the availability of generic Revlimid and POMALYST? Thanks.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks, Seamus. Adam, and then maybe, Samit, you can chime in as well.
Adam Lenkowsky - Bristol-Myers Squibb Co - Executive Vice President, Chief Commercialization Officer, Member of the Leadership
Team
Yes, Seamus, thanks for the questions. We've been really pleased with what we're hearing from both physicians and patients. The
feedback has been very positive with a lot of enthusiasm on the efficacy and the safety profile. So what we're hearing is patients are
seeing improvement in positive symptoms as early as the first week of treatment and on really the lowest dose of 50 milligrams.
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Question: David Risinger - Leerink Partners - Analyst
: Yes, thanks very much and congrats on all the updates. Sorry, I have another call coming in here. So my apologies. They want me
on the box to speak. So I have two questions.
First, with respect to the performance in '25. So obviously, the worse that the LOEs perform in '25, the better the setup for the
trajectory of growth for the company in '26. But if the loss of exclusivity products performed better than expected, then it makes it
a little bit tougher to grow in '26. Could you just discuss that a little bit and provide some initial context for '26? I know that you're
not providing guidance at this time.
And then second, just with respect to YERVOY, it's been performing very strongly, growing 20% roughly in the fourth quarter and
roughly 20% for full year 2025, sorry, 2024, can you comment on growth prospects for YERVOY going forward as well? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks, David. David Elkins and then Adam.
David Elkins - Bristol-Myers Squibb Co - Executive Vice President, Chief Financial Officer, Member of the Leadership Team
Yes. So just on your question around '25 and what to think about heading into '26. First, REVLIMID, as we said, we have additional
generic entry coming. So about 70% of the market will be supplied by generics. Remember, for REVLIMID, full generic entry in January
of '26. So we'll be through that by the end of the year.
And we have a generic entry [APOMALIS] next year as well. And the only other headwind that I would mention is we provided that
guidance on IRA, which really took out the worst-case scenario for Eliquis as we head into the IRA in '26 and '27. But really, our focus
remains on investing in the growth drivers.
You saw the strong execution in that growth portfolio that's now greater than 50% of our business. We exited double-digit growth
last year. We feel really good about the position that we're in this year. And then as you think about going into '26 with that growth
portfolio, you heard Adam talk about the additional indications in Camzyo and SOTYKTU as well as (inaudible) and we got some
really important data readouts that we're going to be able to add up to six new NMEs here over the next two years.
So that growth portfolio is really coming together. We're adding to that. And then you've heard all the commentary around Cobenfy
further adding to that growth portfolio. So there's pushes and pulls there. But what's becoming clear is the strength of the growth
profile as we go into the second half of the decade here.
Adam Lenkowsky - Bristol-Myers Squibb Co - Executive Vice President, Chief Commercialization Officer, Member of the Leadership
Team
As it relates to YERVOY, we're seeing solid demand growth across our core indications, first-line lung, first-line RCC as well as first-line
melanoma, where YERVOY is using combination. And that growth is coming both from the US and from our international markets.
In the US, we continue to see good adoption in the community.
And as you know, last year, we presented, I think is a remarkable 10-year long-term data in first-line melanoma. I think the last thing
means we're also preparing for launches this year in first-line HCC and first-line MSPCRC, both in combination with Yervoy, which
will help drive your voice performance. And we also have Opdivo YERVOY lung approval that's pending in China. So taken together,
we would expect continued growth from YERVOY in '25.
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Question: Matt Phipps - William Blair - Analyst
: Following up on the MRD primary endpoint for the (inaudible) trial, is there a time course that the FDA wants as far as how much
durability on that MRD? And why not add MRD endpoints to the teziimide trials? It does look like you already have MRD on the
II]. And then similarly, in multi myeloma, is there a point at which Abecma what is kind of the profitability
breakpoint for Abecma and the success of Arlo cell really kind of gate the need for a Abema .
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks, Matt. Samit and Adam.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
Sure. Thank you, Matt, for the question. So for multiple myeloma, look, MRD endpoint is something that is new from the perspective
of using as a registration trial endpoint. And that's why we have to continue to follow the patients and provide the durability in terms
of not only an MRD, but also overall response rates, CR rate that we will see and these will be the points of discussion with the FDA
as we get into those time points once the magnitude is known for this endpoint as well as the events occur in the Iberdomide trial.
In terms of how we are thinking about use of this particular endpoint for other trials. We are continuing to evaluate the potential to
leverage an earlier MRD endpoint readout to accelerate the development of our multiple myeloma assets across the board, but it
will all depend on the timing, the population as well as how the event accrual is occurring.
Successor studies target a little bit more of a difficult-to-treat patient population. So we'll see how the event occurrence happens
and that may become as 1 of the studies that we may consider an endpoint as well in the future, but not at this time.
Adam Lenkowsky - Bristol-Myers Squibb Co - Executive Vice President, Chief Commercialization Officer, Member of the Leadership
Team
As it relates to Abecma, we know multiple myeloma is going to remain a very crowded and competitive space, and there are multiple
treatment options available. We remain committed to Abecma, but we're going to see continued depending intensity and competitive
pressures. So our focus is making sure that we're optimizing the value of bema and we're going to remain competitive in the space.
As you heard earlier from Chris and David, we're very excited also about GPRC5D which we believe is going to play a critically
important role in the treatment of post-BCMA CAR T with a single infusion and an improved safety profile.
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Question: Steven Scala - TD Cowen - Analyst
: Oh, thank you so much. I have two questions. First, Bristol's second-generation TYK2 completed Phase II in Psoriasis in August of
2024, but hasn't progressed. So curious what the profile of this agent is, what are plans and is IBD within those plans?
And secondly, Milvexian Phase III readouts in stroke and ACS are expected in 2026, but later in the year. Curious if events are tracking
for that 2026 readout and is there any possibility at all for a 2025 readout for either trial? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks, Steve. Samit
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
Thanks, Steve, for both the questions. So first of all, for the backup SOTYKTU, we completed those studies. We have the data, but as
you know, we are continuing to progress our overall plans for SOTYKTU this time. And as we spoke earlier, we have to decide within
our pipeline where we are going to really focus and prioritize, and at the current time, our focus is truly squarely on SOTYKTU and
maximizing that opportunity from a development and commercial perspective. So at this time, SOTYKTU is not in the development
as you already have stated.
From the SSP and ACS readout, events are tracking as well as the enrollment is going really well. We do not expect that readout in
2025. We expect that readout as we have stated at the back end of 2026.
Question: Kripa Devarakonda - Truist Securities - Analyst
: Hey guys, thank you so much for taking my question. I have a canvas question. Congrats on getting the label update in EU. I was
wondering with the label change in EU and potentially a change in the US as well. How do you see the peak opportunity now? And
with ODYSSEY data upcoming this year, can you help set expectations for the readout?
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Question: Olivia Brayer - Cantor Fitzgerald - Analyst
: Hey, good morning. Thank you for the question. What data did you submit to the FDA for the less restrictive Camzyos? Did that
include anything additional versus what was submitted to EMA. And are you asking the agency for the same two updates that were
proposed in the December agenda? I think those are around monitoring frequency and the use of LVOT gradient.
And then, Adam, I just wanted to clarify 1 point you made earlier. You said the European label was updated to reduce frequency. I
think you said from every 12 weeks to once every six months. I just wanted to clarify that I heard that correctly.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Thanks. Samit and Adam.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
Maybe I can start off. Thanks for the question, Olivia. We will not be able to give you the specifics at this time in terms of the asks of
the FDA. Certainly, there are several of them, and then we'll see which ones we are able to have a conversation and get from a relief
for the patient perspective.
And in terms of the data that were submitted, they come from both clinical trials as well as from the real-world evidence. So overall
data package was very strong, and we continue to have the dialogue with the regulatory agencies.
Adam Lenkowsky - Bristol-Myers Squibb Co - Executive Vice President, Chief Commercialization Officer, Member of the Leadership
Team
Yes. And Olivia, just to clarify, again, the label in Europe was updated to reduce the frequency of echo monitoring for patients taking
Camzyos post week 12. So after week 12, as pace move into the maintenance phase instead of once a quarter, they're able to now
have echos once every six months.
Question: James Shin - Deutsche Bank - Analyst
: Thank you for the question, guys. I just wanted to follow up on the Rise question. What are BMY's expectations for the PAN score
benefit? And then, any color on how ADAPT 2 will be disclosed? Will the MPIC be top line in the PR? And will this be followed by a
full data set at a Medical Congress Tom? Thank you.
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Question: Sean McCutcheon - Raymond James - Analyst
: All right guys, thanks for the question. Can you speak to the expectations for the cadence of data for the targeted radiotherapeutic
portfolio and prioritization of further investment in BD and internal development. following that investment in the infrastructure in
that segment. Thanks.
Samit Hirawat - Bristol-Myers Squibb Co - Executive Vice President, Chief Medical Officer, Global Drug Development, Member of
the Leadership Team
Yeah, from the, raised by portfolio perspective, of course, the phase III is already ongoing in (inaudible) net, and this is in the patient
population that has already received prior due to era. So it's and certainly the phase I data was very strong and we'll continue to look
for not only the responsor. But, of course, progression free survival is going to be important to continue to observe in this one, as
we look to the readout in 2026.
As you know that we are also exploring the activity of this drug in patients with small cell lung cancer in a Phase I study, and we
recently started a breast cancer program as well. And from the portfolio perspective, we have, we're looking forward to initiation of
our Phase I program for GPC3 as a new target. And then of course there's a pipeline behind it in the research space as well.
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Question: Alexandria Hammond - Wolfe Research - Analyst
: Thanks for squeezing me in. Just one on Bristol's long-term growth potential. So the team has mentioned an unappreciation to the
pipeline. Can you imply the key assets you expect to drive revenue looking at the back end of the decade, maybe your favorite child
or two? Thank you.
Christopher Boerner - Bristol-Myers Squibb Co - Chairman of the Board, Chief Executive Officer, Chief Operating Officer
Well, listen, I'll take that one. We feel great about the pipeline. We have a number of really exciting assets that are coming, we've
spoken at length, obviously, about Cobenfy. Clearly, we also are very excited about our CELMoD programs. We have multiple CELMoDs
that we've spoken about today, Ibara and (inaudible), but we haven't spoken about (inaudible), that's a potentially very meaningful
product in in lymphoma. (inaudible) important.
So it's very difficult to pick a favorite child here whenever there's such a wealth of opportunity in the late-stage pipeline. And we
haven't even talked about the next wave of assets, which include some really exciting opportunities, including products like CD19,
XT, ARLDD in prostate cancer as well as others. And by the way, I forgot to mention in the first wave of assets, LPA1, which is also a
very fighting opportunity.
So a plethora of potential catalysts that will be playing out over the next 24 months, and we look forward to seeing them then play
out and going from there.
So I think with that, we'll close today's call. I appreciate everyone staying on. I know we went a bit long, but hopefully, we're able to
get to virtually all of the questions. Let's take a step back and maybe summarize where we are.
Our priorities as a company, hopefully, you've seen on this call are clear. We're focused on continuing to deliver very strong commercial
execution and to deliver on the upcoming pipeline catalysts, some of which we just discussed.
We're going to continue to have the ability to enhance value creation through business development and all the while maintaining
strong financial flexibility. As I look at 2024, we made very good progress and I want to recognize our colleagues for all the hard work
that they had last year. We continue to take decisive action to further rightsize our cost structure and invest in future growth.
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