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

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And so any reduction in steroids is meaningful for individuals. In the context of the clinical trial, we obviously are trying to reduce the steroids in a protocolized way, and we will get the opportunity very soon when we read out the data to understand what degree of steroid reduction is possible in the face of crinecerfont treatment.

Phil Nadeau: Can you remind me, have you disclosed the powering of the study?

Eiry Roberts: We have not disclosed the powering of the study against that primary endpoint. We do believe that the number of patients within the trial is predominantly driven by the safety database that’s needed to support the registration, and that was in conversations with the agency and regulators and that the trial is very adequately powered to address the endpoint.

Phil Nadeau: Perfect. Thank you.

Operator: We will take our next question from Jay Olson with Oppenheimer. Your line is open.

Jay Olson: Hey. Congrats on the quarter. And thanks for taking the question. Can you talk about the geographic scope of Neurocrine and how crinecerfont could potentially globalize your business, especially if you can leverage the Diurnal infrastructure to other assets in your pipeline beyond crinecerfont? Thank you.

Kevin Gorman: Thanks, Jay. Yes, crinecerfont could globalize, Neurocrine. So we ran this as a worldwide study mainly based in the United States, Europe. And so with Diurnal as part of Neurocrine now. And with this indication being one that is basically driven by centers of excellence throughout the United States, which obviously we would commercialize here. It’s also driven by centers of excellence throughout Europe. So we would see this as a good entree to our commercial operations in Europe. So we’ll be – we look to do a worldwide filing on this and commercialize both in U.S. and Europe.

Jay Olson: Great. Thank you very much.

Operator: We will take our next question from Carter Gould with Barclays. Your line is open.

Leon Wang: Hi. Congrats on the quarter. This is Leon Wang on for Carter. A question on BD. So given Dr. Robert is going to retire in 2025 and the successor hasn’t been announced yet, would you look to fill that position or have better color on that position before doing any additional BD? And given kind of the extended time line, can you give any additional details on where you are in that process? Thanks.

Kevin Gorman: Thanks, Leon. What I’d like to say is that when I rejoined Neurocrine approximately 6 years ago, we had 2 clinical programs going on at Neurocrine. We now have well over a dozen programs going on at Neurocrine. Several of them are late-stage Phase III programs, nearly a dozen or mid-stage programs. Eiry has built an excellent organization here, and she’s built an organization that allows for scale as these programs move forward and others are added over time. You rarely get what Eiry has given us, which is 2 full years of notice here. So she is highly involved in our efforts to look for her replacement if such a thing exists, and we’ll be here for a really good period of time in order to make the transition as efficient as possible. So again, the entire organization. Thanks, Eiry, for that.

Operator: We will take our next question from Marc Goodman with Leerink. Your line is open.

Marc Goodman: Yes. Good morning. Eiry, in the past, you’ve talked about how you’ve got the M1, you’ve got the M4, you’ve got an M1 M4 and you’re going to be moving all 3 of them forward. I was just curious kind of the strategy there, obviously, in the press release that talks about initiating Phase I for the M1 and 4. But I was curious about kind of the package and the whole franchise that you’re looking at. And if you’re going to run a blood pressure study with each one of these or have you yet? Thank you.

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