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

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Kevin Gorman: Our upside did not take into account any changes in the number of physicians back into the office or any changes that have to do with the emergency health order in telemedicine.

Tazeen Ahmad: Okay. Thanks, Kevin.

Operator: And we’ll take our next question from Brian Skorney with Baird. Please go ahead.

Brian Skorney: Hi. Good morning, everyone. Thank you for taking my question. I was hoping maybe you could walk through some of your internal assumptions around the market opportunity in CAH, given the Phase 3 data reading out the latter half of this year. I know a number of years ago, you did a Commercial Day discussing this market when you had an earlier iteration of programs. It does seem like investor expectations around commercial here are somewhat muted compared to your neuro program. So just hoping to kind of get a light out of how you currently think about what the commercial can look like here?

Eric Benevich: Good morning. So let me preface this by saying that, of course, we still have crinecerfont in the clinic. It’s an investigational medicine not approved yet for the treatment of CAH. But certainly, we’re excited about the opportunity that it presents. Just taking a step back, in the U.S. there is somewhere between 20,000 and 30,000 people living with congenital adrenal hyperplasia, a similar number in Europe as well. Standard of care today is essentially glucocorticoids that are required to essentially replace the missing cortisol for these patients. What crinecerfont is intended to do and what we hope to see in the clinical trial is not only improvement of day-to-day control of the patient’s androgens but also the opportunity to potentially reduce the dose of the steroids that they’re taking for their entire lives.

And so we certainly see this as a significant game changer in terms of the standard of care. And there are no new treatments for CAH for decades. So really what it bodes down to is let’s see what the data look like. We’re excited about the opportunity, and there’s a significant unmet need in terms of being able to help these patients, improve their day-to-day disease management and overall reduce the potential for long-term issues from treatment with steroids. Eiry, do you have anything to add?

Eiry Roberts: No, I think the only thing I’d add is, obviously, if you think about the unmet need in — for patients in CAH, as Eric mentioned, there’s been no new treatments that were non-steroidal in nature ever actually in this disease area. And given that our program includes both a pediatric study and adult study, it gives us an opportunity to really understand how to serve this patient population right through from early years of childhood through adulthood. And I think we’re really excited about that opportunity and look forward to reading out the data later this year.

Brian Skorney: Great. Thank you.

Operator: And we’ll take our next question from Phil Nadeau with Cowen & Company. Please go ahead.

Phil Nadeau: Good morning and thanks for taking our question. It’s a follow-on to Brian’s about the CAH trials. The primary endpoint in the adult trial is change in glucocorticoid dose while the primary in the pediatrics is change in serum A4. Can you remind us why you chose two different endpoints for the two different studies? And then also what the powering of the two trials are and what would be considered clinically meaningful changes in those endpoints? Thank you.

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