Neurocrine Biosciences Inc Q3 2024 Earnings Call Transcript

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

Question: Chris Shibutani - Goldman Sachs - Analyst : Thank you very much. Good morning. Congratulations on a clearly strong quarter commercially. I wanted to ask about going forward thinking about the pipeline, people as well as strategy. Eiry, we appreciate your comments. I think you have announced previously that you're looking to step away. Kyle, have you given thought to the point people who will be running the role that Eiry has been involved with as well as your previous role, which was really managing the business development leadership there, since I noticed quite a bit of focus on capital allocation. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 30, 2024 / 12:00PM, NBIX.OQ - Q3 2024 Neurocrine Biosciences Inc Earnings Call And secondly, can you just give us an update on the NextGen VMAT2 inhibitor? I know we started Phase I at the start of this year. But some visibility into when we could learn more would be great. Thank you.

Question: Chris Shibutani - Goldman Sachs - Analyst : Yeah. Thank you.

Question: Paul Matteis - Stifel - Analyst : Thanks so much for taking my question. Kyle, congrats on moving to the CEO seat. I want to ask you a question just about BD and philosophically where you stand. You guys in your public commentary over the years have kind of ebbed and flowed to the degree to which you've talked about prioritizing smaller deals versus something larger in the $3 billion to $4 billion range. How do you think about capacity now, and strategically, do you feel like this is the right time for Neurocrine over the next year, year and a half to do something that's more meaningful and bolder for a later stage asset? Or do you still like this kind of smaller BD, spread the best strategy that you've employed so far? Thanks so much.

Question: Chris Shibutani - Goldman Sachs - Analyst : Okay. Thanks, guys.

Question: David Ansellem - Piper Sandler - Analyst : Hey, thanks. So looking into '25 and beyond, how are you thinking about the potential that you might need to compete more on price to hold INGREZZA share versus Austedo? And then as you think about IRA negotiations, do you anticipate any impact on INGREZZA pricing once Austedo is included in IRA negotiations? In other words, some sort of spillover effect, if you will. And then secondly, just on '568, just remind us how you're thinking about indications beyond schizophrenia, say, the psychosis, for instance and/or are you looking at the other muscarinics for indications beyond schizophrenia? Just help us understand your thought process there. Thank you.

Question: David Ansellem - Piper Sandler - Analyst : Understood. Thank you.

Question: Phoebe Tan - Jefferies - Analyst : Hi. Thank you for taking your question. This is Phoebe on for Akash. On your M1/M4 asset, can you talk about why you feel confident that you don't have to dose with Tropium like [CAH] datas? And then additionally, what should we expect to learn from initial Phase I human data next year for the muscarinic? Thank you.

Question: Phoebe Tan - Jefferies - Analyst : Okay.

Question: Tazeen Ahmad - Bank of America Securities - Analyst : Hi, guys. Good morning. Thanks for taking my question. On INGREZZA, you had another really strong quarter. How should we be thinking about sequentially the flow in 4Q? Because based on your guidance, it does seem like it could be a little bit flattish. I know traditionally, 4Q tends to be a stronger quarter, so can you give us a little bit of color on that? Thanks.

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : Oh, hey. Thanks for taking the question. Congrats on all the progress. We're curious about your level of interest in epilepsy since it's still an area of super high unmet need and it's also proven to be a difficult area to conduct clinical trials, so we're just curious how committed is Neurocrine to epilepsy and do you plan to replace the Idorsia molecule with another asset? Thank you.

Question: Jay Olson - Oppenheimer & Co. Inc. - Analyst : That's great. Thank you.

Question: Ash Verma - UBS - Analyst : Hi. Thanks for taking my question. Just on 568, now that we've had some time to digest the results in Phase II, just what are you learning? Do you think this orthosteric agonism was the issue in this case, and how should we think about the rest of the muscarinic pipeline based on what you've learned? Thanks.

Question: Ash Verma - UBS - Analyst : Yeah. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. OCTOBER 30, 2024 / 12:00PM, NBIX.OQ - Q3 2024 Neurocrine Biosciences Inc Earnings Call

Question: Anupam Rama - J.P. Morgan - Analyst : Hey, guys. Thanks so much for taking the question. I'm going to ask the same question I've asked for the last 10 years on third-quarter earnings. So any chance of an INGRESA pre-announce and guidance at a Smart Healthcare Conference in January? Or is this more of a fourth-quarter earnings report scenario in February?

Question: Evan Seigerman - BMO Capital Markets - Analyst : Hi, guys. Great. Thank you so much for taking my question. So, you know, as we think about your salesforce expansion and the opportunities for treatment of Chorea associated with Huntington's disease, how should we really frame that opportunity? I know Eric's been there. But, you know, with the investment, where do you see, I guess, INGREZZA going in the next couple of years? I mean, how does this really compare with the TD market? I think secondarily, why focus on epidemiology for TD now? Does that imply that, you know, you're not satisfied with where TD is going? You know, you're trying to emphasize that there's still more room to grow. I'm just trying to get a better understanding of what that commercial story looks like.

Question: Cory Kasimov - Evercore ISI - Analyst : Hey, good morning, guys. Thanks for taking the question. I wanted to ask about Crinecerfont, and if you can talk about how many prescribers are located at the CAH Centers of Excellence and the portion of the overall patient population they serve, and are there certain segments of the CAH population they are most eager to treat upon approval? Thank you.

Question: Cory Kasimov - Evercore ISI - Analyst : That's helpful. Thank you.

Question: Carter Gould - Barclays - Analyst : Good morning. Thanks for taking the question. Maybe to follow up on one of the earlier questions some time ago in the queue. I guess for a long time we looked at Neurocrine's pipeline, you guys were sort of mid-stage heavy. That's clearly evolved. And now it's a little bit more of, I guess, a barbell approach where you've clearly made those Phase III investments or about to make those Phase III investments. And the earlier stage pipeline now, at least from kind of where we sit, seems very focused on VMATs and muscarinics. So can you maybe talk about how you're looking at that early stage portfolio? I guess the breadth and diversity of those assets and should we expect sort of another replenishment either through in-licensing or homegrown assets to sort of bubble up over the course of '25?

Question: Carter Gould - Barclays - Analyst : Understood. Thank you.

Question: Joe Passaro - RBC Capital Markets - Analyst : Hi, this is Joe in for Brian. Thank you for taking our question. Can you elaborate more on the growth drivers you're seeing on INGREZZA, the degree of demand versus gross to net versus any other contributions you could note for us and how are you thinking about -- what are you seeing on the ground in terms of the competitive landscape in the TD market? Thank you.

Question: Joe Passaro - RBC Capital Markets - Analyst : Got it. Thank you.

Question: Mohit Bansal - Wells Fargo - Analyst : Great. Thank you very much for taking my question and Kyle, congrats on your first call as a CEO. Maybe, would love to understand how internally you are thinking about, the upcoming competition in CAH space. I mean, kind of we are probably putting cards before the horse here, but there is an ACTH antagonist out there as well. How do you see that as a competitor to Crinecerfont? Do you see this as a direct competitor or more like in lines of therapy where something could be first line versus second line? How do you -- how should you think about that?

Question: Mohit Bansal - Wells Fargo - Analyst : Excellent. Thank you.

Question: Marc Goodman - Leerink Partners - Analyst : Yeah, I just want to come back to that question about aggressive competition in the competitive environment. There seems to be a lot of agita going into the quarter. A lot of investors kind of felt that Teva's been the one growing faster. They're making more noise. Can you give us a sense of what's really going on out there? You know, do you feel like you're outgunned with respect to the share of voice and the noise on the media? Maybe you could just give us a sense there. I think the prescription trends have really confused people. So anything you could do to help us just think about this. Thank you.

Question: Myles Minter - William Blair - Analyst : Hey, thanks for taking the question. I think just over a week ago there was some correspondence in the New England Journal about Crinecerfont from a couple of Spanish docs and they were kind of calling in a question the definition you use for normal thresholds of daily glucocorticoid "dosing". Just curious as to your response to that and if payers in particular in your early conversations are asking for surrogate metrics like insulin resistance and percent of total fat masses, sort of confirmatory endpoints that you are getting efficacy in this population? Thanks.

Question: Michael Riad - Morgan Stanley - Analyst : Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our questions and Kyle, congrats on the strong start. For the NMDA-NR2B program, is it safe to assume that 770 is being developed as an adjunct to background antidepressants? And if so, how are you thinking about evaluating the top line? What would you want to see to gauge the competitive potential like maybe versus SPRAVATO? 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. OCTOBER 30, 2024 / 12:00PM, NBIX.OQ - Q3 2024 Neurocrine Biosciences Inc Earnings Call

Question: Michael Riad - Morgan Stanley - Analyst : Thank you. That's very helpful.

Question: Uy Ear - Mizuho - Analyst : Hey guys. Thanks for taking my question. Just going back to the Crinecerfont launch. You guys indicated there you'll be giving our free drugs, what not? Before the insurance comes on, just maybe just help us understand a bit about the number of patients that are currently on free drugs at the moment with your extension safety extension studies, and how do you sort of maybe focus on in terms of uptakes? Would you be giving free drugs essentially to everyone that comes on or yeah, just want to get maybe a better sense of the demand at the outset? Like are you seeing a lot of excitement demand with respect to this drug? Thanks.

Question: Uy Ear - Mizuho - Analyst : Okay, Thank you.