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: Morgan Stanley - Morgan Stanley - Analyst
: Great. No, thanks. Thanks so much because really appreciate it. I guess maybe the first place to start, just given a topical here coming out of IRA,
just first big picture question is just remind us at a strategic level, how you're thinking about the portfolio in a post IRA world and then any learnings
from the first round of negotiation that you can apply to that kind of strategy?
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay, Chris. One and one follow-up on just the Eliquis guidance that you guys gave is, does that assume that PBMs are going to seek additional
rebates on top of that new price? Or I know that there was some there's a range there, but maybe just talk through that aspect of that Eliquis
spreads?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. And maybe a two-part question. So I think on the first quarter call, you talked about potentially providing earnings guidance with the Eliquis
guidance that was not in the release.
And again, the second part is the latest perspective on trough earnings guidance because I know that was something you guys had kind of floated
earlier this year as a possibility so it's a kind of related question. What's the strategy now on kind of how (inaudible) how to think about those two
aspects? And again, I'm maybe it's interrelated here that. I'm sorry about that.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay, great. Maybe Dave, one for you is just obviously you have a lot going on in the pipeline side, you have a lot of new product launches now.
How do you kind of manage that spend in the context of operating margins. Again, what are some of the puts and takes that you're considering
here as you think about making the necessary investments, but also maintaining efficient operating margin structure?
Question: Morgan Stanley - Morgan Stanley - Analyst
: You feel pretty good about maintaining kind of competitive margin levels (multiple speakers)
Question: Morgan Stanley - Morgan Stanley - Analyst
: We should take that away from. Okay, great. Want to move to KarXT to you just given that you have to do for dates coming up next month, obviously
important product launch for you guys. Maybe just talk high level about some of the commercial preparation that you guys are undertaking here
ahead of that PDUFA date.
And then kind of related question on just pricing reimbursement dynamics, what are some of the puts and takes that we need to think about
recognizing you're not going to guide on price yet, but what are some of the inputs there?
Question: Morgan Stanley - Morgan Stanley - Analyst
: Great. Maybe just a few follow-ups is at this point, no FDA AdCom because we're so close, that should be our expectation?
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. And how about the label, anything that we should have on our radar screen from a labeling perspective?
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. I was looking back, I think there was another drug was launched for schizophrenia several years ago. And the Medicaid process I remember
took it will take like 6 to 12 months. Is that kind of a reasonable estimation. I know every state has different billing.
How many months does it take to kind of go through that process? I understand the coverage or it's more like you said getting on the formulary.
So what does that kind of pace look like?
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. And then as you mentioned, opportunity to $1.6 million patients, is that just as the monotherapy opportunities also include an adjunctive
because I know that's the other piece where you're running a trial there. So maybe just help us think about what does the adjunctive additional
label data bring to the table?
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. And one other question we get obviously is that the competitive profile relative to AbbVie's and our equity and debt. So we have yet to see
the pivotal data there. We're going to get that later this year. But as you look back at their prior data, what would you call out is some of that kind,
you know, differences between these these two agents as we think about that market development?
Question: Morgan Stanley - Morgan Stanley - Analyst
: One area at every point of the food effect, I guess, of the trospium component. Anything, you know, I mean, what's your response to that? I guess
as you think about the profile because that's one area that they pointed out as like a differential, I guess. Yeah, first and rack.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. Maybe the last one is just there's obviously talk about schizophrenia a lot, but Alzheimer's disease psychosis, we otherwise. And so how do
you think about that opportunity? And when do we start to you know, have a better handle on how that might materialize.
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay, great. So lots to watch for here on the forward. Maybe I thought just because again, very topical is this data just came out and as a competitor
data, but it relates to one of your pipeline assets, no vaccine yet how much the Factor 11 inhibitor here, which would be a follow-on product to
Eliquis, which has been a huge commercial success, the standard of care in A-fib, so buyer, as people are probably aware, had a competitor drug
s indexing Phase 3 data and A-fib, the DMC stopped the trial.
I think it was November of last year that we were finally able to see the data at ESC, watch the conference over the weekend read The New England
Journal publication. We had a note out on this, but that was my take. So would love your guys take on the data and then the implications for no
vaccine where a Phase 3 for a broad Phase three program is going on ongoing, both A-fib and some of the other indications.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. So I guess I really don't want to get to the (multiple speakers) data aggregator.
All right. So I agree under dose was one of the things that discussed in his publication talked about. The other thing was the patient population
that might be the system has gotten a lot more a lot better at managing these patients now just given Eliquis and other treatments. And so I think
there was a commentary that the control arm, the rate of events in the control arm was lower than expected.
And so how do you think about that relative to the population that you guys enrolled? And obviously, you have a rich history here with Eliquis and
data drawn. So how do you think about that aspect, which was the other one that the discussions raise?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Morgan Stanley - Morgan Stanley - Analyst
: And remind us the time line is at '26, '27.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay, great. On another presentation coming up is up LAG-3 for lung cancer you were talking about before you guys are hosting a national event
on again, maybe just level set us kind of the hypothesis here. Obviously, LAG-3 approved in melanoma, and you guys have been studying I-O, I-O
combinations, you know, for the last 20 years or so.
And again, I think this is the next focal point is LAG-3 for lung cancer. And so talk to us maybe about, you know what we hope to learn from this
study and then I know you kicked off the Phase 3 recently as well.
Question: Morgan Stanley - Morgan Stanley - Analyst
: What I mean, I think looking back at some of these studies, I know here you've got a nivo control arm and then you're going to have to go versus
standard of care standard of care in Phase 3. But I feel like every time we see one of these Phase 2 trials and again, this is part of our job is just the
cross-trial comparisons, the handwringing in terms, how does Opdivo or how does Keytruda perform versus some of the prior studies?
And so anything in terms of that control arm performance that we need to think about? And obviously, there's like two different groups of patients
here. So how do you think about control arm performance relative to historical studies?
Question: Morgan Stanley - Morgan Stanley - Analyst
: So bottom line is you feel good about the absolute performance versus Keynote 189. No, not just the real-world data.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. And remind us, we're going to get PFS data. That's not just.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. Got it. Anything else in terms of the on the Phase 3 trial and I missed the one to 49 but any other the only thing is that the trial?
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay. So it would be a broader beyond just up to, I guess.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Okay, great. Maybe just in the last few minutes, some of the newer products like goes CAMS, I-O (inaudible). Maybe just high level again, you know,
looking through your prior role as Chief Commercial Officer, what are some of the steps that you guys are taking to accelerate those those launches
and maybe just pick two out in interest of time.
Question: Morgan Stanley - Morgan Stanley - Analyst
: Great. Well, thank you so much, Chris, Dave and I really appreciate it sorry, but the fire alarm, (inaudible) limitations and best of luck with the rest
of the things.
|