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
: 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?
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?
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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?
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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?
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
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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