Neurocrine Biosciences Inc Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Philip Nadeau - TD Cowen - Analyst : Good afternoon. Thanks for taking our question. You've been very clear that you expect a measured launch for CRENESSITY in terms of revenue during the first half of this year. We've also guided to giving new start forms as you did today. There's a very vigorous debate among investors as to what is a good trajectory of new start forms and what isn't. I was curious if you people willing to provide any of Neurocrine's perspective on what pace of new start forms we should anticipate through the first half of this year and into the second half of 2025?

Question: Philip Nadeau - TD Cowen - Analyst : Thanks for taking our question.

Question: Paul Matteis - Stifel - Analyst : Hey, thanks so much. I appreciate the question. Can you expound upon some driver guidance. I feel like looking at our model, I'm really confused because you grew 26%. The guide is less than 10% sequentially. And I know historically, you guys have given conservative guidance. You've done a great job of VMAT, but I'm just concerned, are you trying to send us a greater message here that this market is actually sort of changing going into 2025? Like what are you seeing during the quarter? And I'm wondering if the Street is just making something here, given that I think opens is above the high end. Thank you.

Question: Tazeen Ahmad - Bank of America - Analyst : Great. Thank you so much for taking my question. Mine is also on INGREZZA. Can you talk about general expectations for 1Q '25 maybe comparing that to prior 1Q, which was part of seasonality? I guess I'm more curious about it this year, just given expectations potentially for lowered revenue per script this year relative to 2024. Should we be thinking that you could have a decline on the quarter-on-quarter revenue this year? Thanks. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 06, 2025 / 9:30PM, NBIX.OQ - Q4 2024 Neurocrine Biosciences Inc Earnings Call

Question: Akash Tewari - Jefferies - Analyst : Hi, thanks so much. A quick one on INGREZZA and then on CRENESSITY. Should we expect that 60-40 market share split holding up given the evolving payer dynamic between INGREZZA and OITO, your guide currently implies a 4% to 5% market share loss versus Teva's guide. And then your team's talked about physicians will likely need to see patients in person before prescribing them CRENESSITY. Some of our KOL work has suggested otherwise. How many of your new patient starts are done actually with telehealth? And how do you see that dynamic evolving over time?

Question: Cory Kasimov - Evercore - Analyst : Hey, guys. Thanks for taking my question. Wonder if you can provide additional detail on payer traction with CRENESSITY kind of feedback thus far? And how long you expect the free drug program might last? Thank you.

Question: David Amsellem - Piper Sandler - Analyst : Thanks. So you cited utilization management related to INGREZZA. Can you elaborate on what that's looking like? And how does that tie in to your competitors' behavior vis-a-vis payers. In other words, is your competitor getting more aggressive with payers in terms of positioning on plans?

Question: Malcolm Kono - JPMorgan Chase & Co - Analyst : This is actually Malcolm Kono for Anupam. So with regard to the INGREZZA guidance, can you talk a little bit about the levers of growth amongst the segments? Are you expecting outsized growth from any one of the three segments?

Question: Malcolm Kono - JPMorgan Chase & Co - Analyst : Great, thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 06, 2025 / 9:30PM, NBIX.OQ - Q4 2024 Neurocrine Biosciences Inc Earnings Call

Question: Chris Shibutani - Goldman Sachs - Analyst : Thank you. Maybe if I could move to the operating expense side of the equation, particularly with the guidance. Now thinking about how with INGREZZA, over the course of the several years, you did have periods where you reassessed, reinvested at a more extensive levels. How confident are you in terms of the current thinking about INGREZZA? And then reflecting upon what the potential will be in a market that obviously has some differences, how should we think about your confidence and potential need to adjust either up or down or in some other way with CRENESSITY's launch?

Question: Marc Goodman - Leerink Partners - Analyst : Yeah. Matt, with your comments on ordering patterns, are you suggesting that fourth quarter may have been helped by inventory? Did inventories change and you're expecting maybe first quarter for that to reverse? And then I guess my question really is for Eiry to talk about the M1/M4, the 570 molecule that you're pushing forward. Can you just describe the characteristics of that product and how you expect it to be differentiated from the one that's on the market today?

Question: Marc Goodman - Leerink Partners - Analyst : Are there obvious differences versus Karuna's drug?

Question: Jeff Hung - Morgan Stanley - Analyst : Can you talk about the feedback that you heard from the end of Phase 2 meetings for Osavampator and 568? And for FCC, was there any concern by the agency on lack of dose response or the benefit was seen with the mainly with 20-milligram dose?

Question: Charlie Moore - Baird - Analyst : This is Charlie Moore on for Brian. So we were just wondering, looking earlier in the pipeline about your Friedreich's ataxia gene therapy collaboration with Voyager. And it would just be great to get some color on how you think it could differentiate from current clinical stage gene therapies, one dual and one targeting cardiac tissue, as well as if that's still on track to initiate first in human trials this year.

Question: Mohit Bansal - Wells Fargo - Analyst : Thank you for taking my question. Sorry for keeping -- staying on INGREZZA here. So if I look at the fourth quarter number, if I just straight line it, it looks like your low end of the guidance assumes just flat line using fourth quarter. So is there something massively changing in your contracting or the pricing dynamic? It does seem like that from your comments. So can you help us understand that? And then also, are you expecting or modeling any benefit of sales force expansion here? Because that would mean second quarter -- second half bump, but that doesn't seem to be part of the guidance here. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 06, 2025 / 9:30PM, NBIX.OQ - Q4 2024 Neurocrine Biosciences Inc Earnings Call

Question: Ashwani Verma - UBS - Analyst : Thanks for taking my question. So just one more on INGREZZA. So do you expect to see more of the utilization management headwind in 2025 on the Medicare Part D plans? We've heard Part D plans are moving branded drugs lower, because they have the catastrophic coverage. And with that burden going up, they need to make up the dollars elsewhere. If you can comment on that, that would be great.

Question: Sumant Kulkarni - Canaccord - Analyst : Good afternoon. Thank you for taking my question. It's another one on INGREZZA. The product has been on the market for some time now. Your comments suggest there's still some way to go on penetration in the tardive dyskinesia market. But we seem to be at a point every few quarters when the debate around the growth trajectory around INGREZZA seems to intensify. And then you kind of grow out of that by beating your initial numbers. So to help settle this uncertainty or debate somewhat what's your latest philosophy on offering any detail on what you think eventual peak sales potential for INGREZZA might be in the US? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 06, 2025 / 9:30PM, NBIX.OQ - Q4 2024 Neurocrine Biosciences Inc Earnings Call

Question: Myles Minter - William Blair - Analyst : Maybe one for Eiry just back on 570. You haven't completed the Phase 1 yet, but just curious as to your decision to move in adults, experiencing schizophrenia, acute psychosis, and not Alzheimer's disease psychosis. Does that mean you're still contemplating that indication? Or is it maybe that you're seeing something on the tolerability side for that molecule that you want to go into adults first prior to the elderly population. Thanks very much.

Question: Myles Minter - William Blair - Analyst : Makes sense. Thanks.

Question: Laura Chico - Wedbush Securities - Analyst : I'm sorry, just one clarification for me. With respect to the field force expansion, and I guess I'm trying to relate back to the 25% guidance here, wondering whether you're going to see the biggest benefit from driving new patient starts? Is this the channel expansion or increasing adherence. I guess I'm just trying to understand where the field force impact is most likely to be felt. Any commentary there?

Question: Ami Fadia - Needham - Analyst : Hi, good evening. Thanks for keeping me in. I have two very quick questions. Firstly, just follow-up on all the questions around the INGREZZA guidance. It certainly seems quite conservative given all the other comments around the trends. But it sounds like you're taking a conservative view, keeping in mind kind of the increased hurdles with regards to prior auth if you can comment if that's kind of what's driving this conservatism or if you're missing something there? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 06, 2025 / 9:30PM, NBIX.OQ - Q4 2024 Neurocrine Biosciences Inc Earnings Call And then just with regards to the 11 patient forms for CRENESSITY, can you give us some color around where these patients are being treated and something about kind of what was the trigger for prescribing the drug to these patients? Were they sort of very high corticosteroids or were they sort of not well controlled on their current treatments? Any color would be helpful.

Question: Ami Fadia - Needham - Analyst : Thank you.

Question: Uy Ear - Mizuho - Analyst : Hey, guys. Thanks for taking in question. So on questions on INGREZZA, quick one on 4Q. Was there significant or any volume growth in the quarter from Q3 to Q4? And quickly on the guidance as well. Does the guidance assume benefits from the sales force expansion? Just wanted to make sure we're clear on that. And thirdly, if I can, could you maybe just help us think how to perhaps think about the INGREZZA sales post 2027, I guess, after the price negotiation for state?

Question: Leonid Timashev - RBC Capital Markets - Analyst : Hi. This is Joe on for Brian. So related to the earlier question on TD market share split, I believe the market share has been pretty stable over time even after competitor [XR] launch. I was just wondering if there's anything more that will drive the changes to the competitive dynamics this year and how are you thinking about the changes in payer dynamics beyond 2025? Do you believe the complexity and the dynamics will persist?

Question: Malcolm Hoffman - BMO Capital Markets - Analyst : Malcolm Hoffman for Adam Seigerman. I wanted to ask if you could talk about the decision to amend the agreement with Takeda in get worldwide development and commercial rights ex-Japan for Osavampator? Is this decision driven by increased confidence in pursuing additional indications beyond MDD? Or was this decision more based on just the profile in MDD alone?