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: David Risinger - Leerink Partners - Analyst
: <_ALACRA_META_ABSTRACT>So with respect to the Phase 3 trials that you're most excited about and before you go into the specific therapeutic categories, could
you talk about the big cards that are turning over, over the next couple of years?
Roland Chen - Bristol-Myers Squibb Co - Head of Immunology, Cardiovascular & Neuroscience Development
Yeah. Thanks, Dave. It's a really exciting time here at BMS for us. We have an extremely rich and innovative pipeline of assets with a
number of key pivotal late-stage readouts coming over the next two years across the therapeutic areas. I mean just to touch on a
few highlights in cardiovascular, we're looking forward to the readout of our ODYSSEY study.
And the second quarter of this year of Camzyos in patients with a nonobstructive form of HCM. As you know, Camzyos is our
first-in-class approved treatment for patients with symptomatic obstructive HCM. This is in the nonobstructive form an area where
there is a high degree of unmet need without good treatments.
And so we're excited about that. Staying with cardiovascular, we're looking forward to readouts in 2026 for milvexian in ACS and
SSP. Milvexian being our novel oral factor XIa inhibitor that we think has the potential to offer efficacy on a par with Eliquis, but with
an improved bleeding profile, and we're looking forward to readouts there, followed by a readout in 2027 from our Librexia-AF study.
This is a head-to-head study against Eliquis. And we're very excited about this opportunity to be potentially the only indicated oral
factor XIa inhibitor for patients with AF.
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Question: David Risinger - Leerink Partners - Analyst
: Excellent. That's great. So maybe before I go into some of the more specific questions on individual drugs. I did want to ask a high-level
question. So clearly -- and you're not in charge of commercial, but clearly, the plan was for Sotyktu to be an extraordinary success
with exceptional head-to-head data versus Otezla yielding dramatic uptake and market share shift away from Otezla to Sotyktu but
that hasn't happened.
So I don't know, how does that inform your development thinking, right? I'm not trying to suggest that running head-to-head trials
that succeed won't pay off. But just how does that inform your thinking in R&D as you work with your commercial colleagues on
development Phase 3 projects.
Question: David Risinger - Leerink Partners - Analyst
: Very helpful. Excellent. And so turning to Cobenfy. Could you talk about the efficacy bar in adjunctive schizophrenia? And what is
the Phase 3 trial powered to demonstrate.
Question: David Risinger - Leerink Partners - Analyst
: Very helpful. Thank you. So turning to AD psychosis. Why is Cobenfy being studied three times a day in AD psychosis when it's been
studied BID and other indications? And then I know that you're in the process of bridging to BID dosing. Will that change the side
of profile at all?
Question: David Risinger - Leerink Partners - Analyst
: And so when will you have clarity on the BID dosing? Or is that -- meaning -- I mean, obviously, you already have the IV dosing, but
is there any sort of transition that you plan for commercialization from TID to BID?
Question: David Risinger - Leerink Partners - Analyst
: Yeah. I was -- it was just sort of more so my curiosity. I mean, clearly, with Alzheimer's patients, they're going to be administered the
drugs by a caregiver anyway. They're not left to remember to take their drugs either twice a day or three times a day, anyway.
Question: David Risinger - Leerink Partners - Analyst
: Got it. And just remind us what are those side effects that you're hoping to minimize or see acceptable results in?
Question: David Risinger - Leerink Partners - Analyst
: Excellent. That's great. So just looking forward, so there are four planned Phase 3 programs for Cobenfy if I have that right, that's
bipolar disorder, Alzheimer's cognition, Alzheimer's agitation, and autism. It seems that two, in particular, a very high risk, specifically
Alzheimer's cognition and autism, right? Because there's really virtually nothing approved.
I mean obviously, there's some recently approved Alzheimer's drugs for cognition, but the benefits are quite marginal. So could you
just comment on what I stated and just why you are pursuing those two high-risk indications?
Question: David Risinger - Leerink Partners - Analyst
: Excellent. Thank you. So then pivoting to cardiovascular. Milvexian offers tremendous potential in three potential blockbuster
indications. And I'd like to ask about all three. So just at a high level, drug efficacy is typically correlated with side effects. And so
there is the expectation or the target product profile of delivering similar efficacy to Eliquis with far less bleeding risk.
And so just on the efficacy front in AF, how is that possible? And I guess, I believe that you're not quantifying the magnitude of factor
XIa inhibition. So how would you even know how -- to what degree you need to inhibit factor XIa, whether it's 98% or 92% to match
Eliquis?
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Question: David Risinger - Leerink Partners - Analyst
: Excellent. And then turning to secondary stroke. So Bristol chose a quarter of the dose that is studying an AF for SSP. Can you just
discuss the confidence that you have in that trial succeeding given that dose selection, meaning why 50 in a patient population that
probably has different comorbidities, maybe it should be 30% and some, maybe it should be 65 and some, you chose 50 for a very
large trial. And then what magnitude of benefit would be clinically relevant in secondary stroke?
Question: David Risinger - Leerink Partners - Analyst
: Excellent. And then obviously, if asundexian succeeds late this year in secondary stroke, that would be a positive, right, in terms of
validation. But I guess in the event that it disappoints what should we be focused on? Or how should we think about that? If that
asundexian trial fails, I know it's smaller, but -- than Bristol's, but just curious.
Question: David Risinger - Leerink Partners - Analyst
: Very good. And then in ACS, so I guess just at a high level, what gave Bristol confidence to advance Milvexian into Phase 3. So I asked
the question because Bayer had conducted a study in -- I think it was hard fit -- no, I forget, what was the study that -- they didn't
specifically study ACS in Phase 2.
Question: David Risinger - Leerink Partners - Analyst
: Yeah. So I think they titled it [AMI] or something, but effectively ACS. So after studying that drug in that trial. They decided not to
proceed into Phase 3. On the flip side, Bristol never conducted a trial in Phase 2 in ACS, but decided to go into Phase 3. So could you
just comment on that, please?
Question: David Risinger - Leerink Partners - Analyst
: Excellent. Well, we are over time. I have 12 more questions, but we are not getting to them today. So I'm glad we covered some big
drug opportunities. Really appreciate you being here.
Question: David Risinger - Leerink Partners - Analyst
: Thank you again.
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