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

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Operator: We will take our next question from Chris Shibutani with Goldman Sachs. Your line is open.

Unidentified Analyst: Hi. Good morning, team. Thanks for taking our question. This is Steven on for Chris. I think historically, your team has been helpful in framing what the guidance range means in terms of some macroeconomic factors and just overall trends you see with your business. So I was wondering if you could frame this $1.77 billion to $1.82 billion range in that context? Thank you.

Kevin Gorman: Yes, I’d say the guidance range is primarily going to be driven by new patient demand. We had strong new patient demand in the first half of the year. And depending on the outcomes for the second half of the year, that’s really going to be what the driver of that range is. It’s $50 million. It’s going to show a nice sequential step-up in growth for the rest of the year. And I would just say the team is doing an excellent job. So from a macro perspective, you always have a bit of room for some disruption. But I’d say based upon how our business is operating, it really comes down to get the continuance of new patient additions, and we feel confident with the market and how it’s operating to provide the guidance we provided today.

Unidentified Analyst: Awesome. Thank you.

Operator: And we will take our next question from Anupam Rama with JPMorgan. Your line is open.

Anupam Rama: Hey, guys. Thanks so much for taking the question. With the Huntington’s PDUFA later this month, how are you thinking about the launch curve for INGREZZA in that indication? How do the properties of INGREZZA might shift the market dynamics there? Thanks so much.

Kevin Gorman: Good morning, Anupam. So yes, we’re – obviously, we’re excited about the opportunity and look forward to the FDA decision coming up in August. The way that we’re looking at it, the HD Chorea opportunity, there’s still significant unmet need for that patient population. We estimate around 25,000 or so patients in the U.S. with Chorea associated with Huntington’s disease. And only 2 out of 10 are currently treated with the only approved medicines, which are VMAT2 inhibitors, the tetrabenazine’s. And so there’s still significant unmet need and opportunity there. We’re looking forward to getting the labeling and certainly being able to get off the ground this year. From a financial perspective, it’s not tucked into our guidance, and 2023 numbers would be modest. But there’s still significant opportunity in that patient category, and we’re looking forward to being able to help more patients with valbenazine in the not-too-distant future. So stay tuned.

Operator: We will take our next question from Phil Nadeau with TD Cowen. Your line is open.

Phil Nadeau: Morning. Thanks for taking our question. As we look forward to the CAH pivotal data in early Q4, we’re curious to get your thoughts on the adult trial in particular. What is the protocol for reducing steroids in that trial? And what would you consider a clinically meaningful reduction that’s likely to support approval and drive use? Thanks.

Eiry Roberts: Morning, Phil. We’ve not actually talked about the specifics of the protocol for steroid reduction in that trial. What I will say is that in the adult Phase III trial, there is a protocol though, that guides clinicians on how to reduce the steroids in the face of the degree of androgen control that each individual patient is experiencing. And that was important because of the steroid reduction being the primary endpoint of the study and the need to control that rather than have it be more real-world setting, which is what we believe will be used once the drug is successful and if approved. With respect to the clinically meaningful reduction in steroid dosing level, I would say that for – as we’ve said consistently from the start of this Phase III program in our interactions and discussions with many stakeholders, including payers and clinicians and patients, the fact that these patients take a higher than physiologically needed doses of steroids for the duration of their life results in significant problems of comorbidities, metabolic disorder, bone issues, growth issues, et cetera.

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