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.
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NOVEMBER 19, 2024 / 1:30PM, NBIX.OQ - Neurocrine Biosciences Inc at Jefferies London Healthcare Conference
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?
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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. 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.
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?
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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