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: Akash Tewari - Jefferies - Analyst
: Yeah. Sounds good. And it's great to hear your former intern. As was at ISI eight years ago.
Question: Akash Tewari - Jefferies - Analyst
: Not CEO of Neurocrine, but -- Okay. Let's start off with maybe just INGREZZA. And I think the Street was nervous because we're all
sitting here tracking IQVIA data and thinking -- and this was not only a dynamic in Q3 but even Q2, where it felt like you're looking
at OSTETO-XR, it's seemingly taking share. And I remember talking with Todd, and Todd is always so calm and relax, makes me feel
good. But I could sense you're trying to -- I could sense your team is very adamant about two things, like A, that kind of 60-40 market
share holding up? And then B, don't read into this IQVIA data too much.
Talk to me about what the dynamic that's going on here. I mean I'm sure you're getting this question a lot. Why has there been
maybe a divergence between what we're seeing with Scripps. And then more importantly, what you're actually reporting on revenues?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Exactly. And over the last two years, and particularly post the pandemic, you've talked about the investments you've
made in long-term care facilities. And I think you've said that it could be like maybe 10%, 15% of your share growth over time. It's
interesting on the Q3 call, you also up the prevalence estimates for tardive from $600,000 to $800,000. A, what drove on a Q3 call
for you to suddenly up your TD estimates? What are you seeing out in the market? And then number two, how much of that is driven
by increased visibility in those long-term care facilities? And generally speaking, how should we see that segment of the business
grow over the next few years?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Maybe just lastly, you have next-gen VMAT2 inhibitors in development. And I feel like there's multiple angles, right? A,
you've run a lot of studies with INGREZZA in other indications, (inaudible) and maybe we haven't seen the success there as we've
seen with tardive dyskinesia. So a, are the next-gen VMAT2 inhibitors going for indications where you've already tried INGREZZA
and you feel like maybe a more potent molecule would have success and maybe that's where INGREZZA may be altered.
And then number two is potential long-acting formulations. And the ability to convert over time, a significant portion of this market
into an LAI type dynamic. Talk to me about what are the options with your next-gen VMAT2 inhibitor programs, I think you're going
to have data next year, how should we be thinking about this?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Now I have a question that -- it was interesting when the multidiscipline review for KarXT came out and I think when
we were looking at those Phase II data sets and then even Korea's data set, there's a perception, okay, well, Neurocrine didn't have
a dose response but these other programs did. And it was really fascinating to me because they actually had an exposure response
relationship even with crinecerfont drug. And what you saw was that the idea that even KarXT had a clear dose response isn't
necessarily true.
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NOVEMBER 19, 2024 / 1:30PM, NBIX.OQ - Neurocrine Biosciences Inc at Jefferies London Healthcare Conference
And this is actually something (inaudible) for a while. Like if you have AEs, it's probably a sign that you have adequate TD effect. So
this will get theoretical, but when you look at emraclidine failure, how much of that do you think was maybe not titrating, right,
where maybe they thought there's a clear dose response with their drug. But in reality -- and obviously, their Phase III data didn't
show that. Do you feel like part of the reason why they had the effect size they did is because they didn't necessarily assure that
patients had adequate PD exposure?
And then number two, when you think about your Phase III trial design, right, you've talked about the ability maybe we'll titrate,
maybe we don't. What would your base case be right now for your Phase III design? Do you think titration is important for this class?
Question: Akash Tewari - Jefferies - Analyst
: one to one?
Question: Akash Tewari - Jefferies - Analyst
: Yeah. And actually, to that point, there is speculation patient expectancy. There were maybe pauses in the trial during COVID for
and emraclidine, when you think about the conduct of that study, maybe there's not a read across on the mechanism of action, but
let's think about placebo. What can you do to ensure that you're not going to have such a historically high placebo rate? And what
gives you confidence you can pull that?
Question: Akash Tewari - Jefferies - Analyst
: Understood. Maybe just lastly, and I wish you guys did this more. You didn't publish a lot of data on the M4. I was sitting here at
trolling patents, which can sometimes blow up on you. But are you going to release more data on the M4, I certainly think there's
an appetite for that. So in terms of releasing more data, the healthy volunteer study, the dose response going up to 20 megs on EEG
or other metrics, will there be more disclosures on the M4 next year and what?
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NOVEMBER 19, 2024 / 1:30PM, NBIX.OQ - Neurocrine Biosciences Inc at Jefferies London Healthcare Conference
Question: Akash Tewari - Jefferies - Analyst
: Understood. You mentioned you have a very broad muscarinic portfolio. I mean you have another pretty intriguing drug, which is
a selective M1/M4. So you could have a cognitive benefit. And then theoretically, you may not have to dose patients with troxium.
Can you talk about, a, what data we're going to be getting out of that program next year? And how derisking is that going to be for
investors in terms of are you getting into the brain? Are you going to be selective enough from a safety profile? And then number
two, why you feel confident that you're going to have a profile that doesn't need to be dosed with tropes.
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