Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q2 2023 Earnings Call Transcript

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And so as we look at the data, we’ll be able to look across the populations at the consistency of the information we have. And as I mentioned initially, I think both endpoints become important in the conversation around how this medicine could be used in patients out in the field.

Operator: We will take our next question from Mohit Bansal with Wells Fargo. Your line is open. Mohit, your line is open.

Unidentified Analyst: Sorry. This is Serena on for Mohit. Thanks for taking our question. So I wanted to ask more about the expected launch in Huntington’s Chorea. And if you can talk about any differences versus tardive dyskinesia that expectations for compliance rates or duration and if you expect to bolus the patients waiting for an autistic [ph] alternative or new patients to be switched from [indiscernible]? Thank you.

Kevin Gorman: Yes, let me kind of start with the last part of your question and work forward. So obviously, we’re excited about the opportunity. And we think that with the data that we’ve generated, we have potentially a differentiated product. We’re eagerly anticipating the PDUFA date and a favorable outcome with the FDA and what those labeling look like. But it’s important to note that we haven’t been out there talking about valbenazine in TD – or excuse me, in HD with the HD community. So we’ll really be introducing valbenazine as a new treatment option to the movement disorder neurologists and then general neurologists that treat the majority of these patients and obviously introducing valbenazine to the HD patient community and the families as well.

So initially, I think that uptake will occur in those patients that are either newly diagnosed with their Chorea or they’ve had Chorea for some time, and they’ve been reluctant to be treated with existing treatment options. We don’t expect that there’ll be a lot of switching in this market. And certainly, we haven’t seen that in the TD market either. But ultimately, the product attributes that make INGREZZA so attractive in TD, the simplicity of true once-daily dosing without complicated titration, the efficacy, the side of the low rate of side effects. These are things that we think would translate well over to the HD Chorea opportunity, and we look forward to making a new treatment option available because certainly, one is needed.

Operator: We will take our next question from David Amsellem with Piper Sandler. Your line is open.

David Amsellem: Thanks. So regarding crinecerfont, this is more of a commercial question to the extent that the product works, do you think that ultimately, new starts are going to be driven in the pediatric setting, given sort of the obvious pitfalls of a high steroid burden in peds as it relates to growth. Is that the right way to think about this market and uptake of the drug? Or do you see a real opportunity in adults as well? Thank you.

Kevin Gorman: Yes. I’ll start off by just caveating my comments by saying, first, we need to see the data. And secondly, obviously, we need to get approved by the FDA. But with that, I see a significant opportunity really across all patient segments. There’s been no significant medical advances for the CAH opportunity for decades. Literally, the standard of care is and has been and remains glucocorticoids. And as Eiry was discussing, there are significant issues associated with high-dose GC treatment. And so if you look at the different patient segments and think about who might benefit from treatment with cronesterfont, the ability both to improve day-to-day control over the androgens, the excess androgens as well as being able to lower the steroid burden for these patients.

Certainly, younger patients would benefit as they’re going through their growth years. And we’ve seen that there’s great interest in treating these younger patients. But adults also at various stages of their lives will benefit from a new treatment approach. And so we think that there’s going to be significant opportunity across all of those patient segments. We’re just looking forward to generating the data and being able to bring a new totally different approach to treatment of CAH to that population, which definitely deserves one.

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