Neurocrine Biosciences, Inc. (NASDAQ:NBIX) Q4 2022 Earnings Call Transcript

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Jay Olson: Thank you for the update and congrats on all the progress. Can you talk about the leadership role that Neurocrine played in the small biotech exception that was built into the IRA provision for Medicare price negotiations and the implications for INGREZZA as we think about a long-term life cycle management? Thank you.

Kevin Gorman: Yes, Jay, thank you. I think Neurocrine work really effectively with a number of partners, including bio and other organizations. And so while we think there’s a lot more work that needs to be done with the legislation that passes, the fact that the small manufacturer and small biotech exemptions in there are extremely helpful to companies like Neurocrine, and we’re going to continue our work along with others in order to work with CMS and to work with legislatures over the years as this is rolled out.

Jay Olson: Thank you.

Operator: And we will take our next question from Charles Duncan with Cantor Fitzgerald. Please go ahead.

Charles Duncan: Yes. Good morning. Kevin and team, congrats on a great quarter and thanks for taking our questions. I had two brief ones. One is valbenazine in Huntington’s chorea. I guess I’m wondering if you could remind us as to not really pricing but the pharmacoeconomic value of valbenazine versus Austedo. And what is, call it, target product profile that differentiates it, perhaps even relative in schizophrenia? And my second question is development. That is regarding 846, I’m wondering if you see that as an adjunctive treatment in depression or a monotherapy.

Eric Benevich: Good morning, Charles. It’s Erik. I’ll maybe just take the first part of your question. With regards to the value prop for valbenazine in Huntington’s chorea, obviously we’re excited about the opportunity there and we’re excited about the data that were generated in the HD study. We’re under review at the FDA, so it’s not approved for that use. As we mentioned earlier, we are preparing for the opportunity once we get the approval to promote this into the HD chorea population. And we’re well positioned for that given the fact that we already have extensive footprint in neurology, especially with movement disorder specialists. And so if you think about the HD chorea population, only about 20% of patients living with chorea formed movements are currently getting treated with the VMAT2 inhibitor.

And there are reasons for this. Obviously, some folks are turned off or not willing to accept complicated titration regimens or concerned about tolerability issues. And so we think that we’ve got a differentiated profile. We’re excited and looking forward to bringing valbenazine forward once we do get the green light from the FDA. Eiry?

Eiry Roberts: Yes. Thanks, Eric. So the only thing I’d add to what Eric said is that some of same differentiating characteristics that we see for valbenazine versus deutetrabenazine in tardive dyskinesia also hold true for Huntington’s disease and maybe even more importance there in terms of the simple lack of complex titration, the lack of food effect and the ability to not have some of the challenges of splitting capsules in patients with dysphagia. So I think there’s several differentiators there from an importance point of view for patients we’re very encouraged by. With respect to 846, we have a Phase 2 proof-of-concept study in anhedonia and depression going on right now, which we anticipate will read out at the end of this year.

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