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

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Matt Abernethy: So real quick on the spending front. The only item that I would call out from a timing or seasonality perspective is we’ve historically seen a big step up in spending in the first quarter, and that’s just associated with specific items that we incur during the first quarter of each year. So I’d encourage you to look back and see what the step ups have been. Historically, a much larger concentration of spending will occur during the first quarter. From a tax perspective this year, I’m expecting an effective tax rate of between 24% and 25%. On the cash tax side, we burned through all of our NOLs in 2022 as a result of the tax legislation associated with capitalized R&D. And so as a result of that, we will be a federal cash tax payer here in 2023.

Still holding out some level of hope that that might be put on hold in terms of the capitalized R&D tax legislation. But for now, what I would guide you to is that we would be expecting to be a full federal cash taxpayer this year.

Marc Goodman: Thanks.

Operator: We will take our next question from Ash Verma with UBS. Please go ahead.

Ashwani Verma: Hi. Thanks for taking my question. Congrats on the quarter. So for the 568 muscarinic Phase 2 trial that you have, you previously said that it’s a dose finding study. Can you share if it’s a once-daily or twice-daily molecule? And from your perspective, how much would dosing frequency matter for competitive differentiation?

Eiry Roberts: Yes, I think — thanks for the question, Ash. We haven’t shared very much information in detail about our program. You’re correct. It is a dose finding study. It’s an adaptive study of up to 200 patients which started towards the end of last year in patients with acute schizophrenia — acute psychosis. The enrollment in that program is going extremely well right now, and we’re looking forward very much to seeing both the impact of this M4 selective agonist on the symptoms of psychosis and also obviously importantly this safety and tolerability profile.

Ashwani Verma: Thanks.

Operator: And we’ll take our next question from David Amsellem with Piper Sandler. Please go ahead.

David Amsellem: Thanks. So on the muscarinic portfolio, you’re building the selective M4. 568 is offering the potential for an improved safety profile. So I guess with that in mind, I’m wondering if you could better articulate how you’re thinking of the value proposition of the dual M1/M4 and what kind of role that would play as you think about pipeline and from a competitive perspective? And then secondly, as you think of the portfolio here, what’s your view on the potential beyond schizophrenia, particularly for the muscarinic and mood disorders, say, bipolar mania and how are you thinking about development there? Thank you.

Eiry Roberts: There’s a lot of questions in there. Thank you. So we are very excited about the portfolio of assets that came to us from the collaboration with Sosei Heptares. And I think that’s one of the real strengths of this collaboration in our mind. Clearly, the M4 agonism is a validated mechanism in the treatment of acute psychosis. I think that’s been confirmed both in Phase 3 and Phase 2 clinical trials now. But through mechanisms different from direct agonism, you have obviously the pan agonist as a normal combination and then you also have the positive allosteric modulator, which requires the presence of acetal cooling to be effective. And so in the context of the M4 selective agonist, it’s really early to be able to make a statement around differentiation around safety.

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