Neurocrine at Stifel 2025 CNS Forum: Strategic Insights and Challenges

On Tuesday, 18 March 2025, Neurocrine Biosciences Inc. (NASDAQ: NBIX) participated in the Stifel 2025 Virtual CNS Forum, highlighting both strategic advances and challenges. The company addressed slower-than-expected growth for its flagship drug INGREZZA, while maintaining optimism for future revenue. The launch of Krenesity and updates on pipeline programs were also focal points.

Key Takeaways

• Neurocrine maintains its full-year revenue guidance of 2.5 to 2.6 billion dollars despite a challenging start to Q1 for INGREZZA.
• The company is adapting to payer dynamics influenced by the Inflation Reduction Act.
• Krenesity’s launch is focused on education, with expectations for increased market share as momentum builds.
• Updates on the AMPA potentiator and Muscarinic programs show promise, with upcoming Phase II and III data releases.

Financial Results

Ingrezza:

• Full-year revenue guidance: 2.5 billion to 2.6 billion dollars, representing 10% growth
• Q1 challenges: Slower new patient starts, fewer ordering weeks, and a 3% to 4% gross-to-net change
• Payer dynamics: Delays in prescription fulfillment due to tightening strategies

Krenesity:

• Launch in progress, with enrollment and net sales updates to be provided quarterly

Operational Updates

Ingrezza:

• Enhancing new patient starts through reimbursement efforts and disease awareness
• Monitoring IRA impact on payer strategies

Krenesity:

• Initial launch well-received among patients and endocrinologists
• Focus on educating physicians and patients about drug benefits

AMPA Potentiator:

• Phase III trials designed to control placebo effects
• Phase II data to be shared at an R&D day

Future Outlook

Ingrezza:

• Recovery expected in Q2, with growth acceleration in the second half of 2025

Krenesity:

• Continued education efforts to drive market share growth

AMPA Potentiator:

• Phase III studies moving forward with a simplified design

Muscarinic Program:

• Phase III trials progressing with a focus on the 20mg dose

Q&A Highlights

Ingrezza:

• Payer dynamics and IRA impact discussed, with potential for increased insurer contracting

Krenesity:

• Emphasis on a measured launch approach and education to overcome community apathy

AMPA Potentiator:

• Explanation of limited data disclosure and placebo effect management in trials

Muscarinic Program:

• Confidence in the 20mg dose, addressing dose response debates

Neurocrine’s strategic focus on education, payer engagement, and pipeline advancement positions it for growth despite current challenges. For more details, please refer to the full transcript.

Full transcript - Stifel 2025 Virtual CNS Forum:

Paul, Moderator: Great. Thanks very much for joining everybody. It’s my pleasure to be moderating this panel with Kyle and Sameer from Neurocrine. I think in this discussion, we’re gonna try to hit a few INGREZZA questions first, a few CH questions, and then in the spirit of this CNS focused conference, take a little bit deeper into the pipeline of the Muscarenic program and the AMPA program. But maybe to start, Kyle, you guys have obviously talked a lot with investors about what’s going on with Ingrezza, what’s been changing within Ingrezza.

And I think given the surprise of the fourth quarter and the guide, you know, I talked to a lot of investors who really don’t even know how to sort of model this going forward. And what would you sort of say to someone who says, you know what? We saw this steep drop off in 4Q, the guide is a big change. How can we be confident that you guys are forecasting this franchise correctly and that everything is still sort of generally speaking on track?

Kyle, Neurocrine: Well, I guess I’ll start with, first of all, Paul, thanks for having us here. Sameer Sadanti will be taking on all the Muscarinic and BD questions. But on the INGREZZA side of things, it’s amazing to think here we are eight years into launch, we’re talking about still growing blockbuster $2,500,000,000 in revenue is our guide for this year. That’s 10% year to year growth at the midpoint. Still a lot of growth to be excited about there.

I know that that comes on the heels of a very large growth year in 2024. In fact, that was the largest growth year that we’ve seen really since launch on a percentage basis. So appreciate the feedback, the questions that we’ve gotten externally. I guess I would just start by reiterating some of the things that we’ve been pointing to that we’ve seen over the course of 2024, in particular in the area of payer dynamics, certainly been tightening up and making it more difficult hurdles being put at patients, physicians wanting to get INGREZZA with the net effect of delaying prescriptions ultimately getting filled here and paid for patients. And what that meant for us coming from Q4 to Q1 is really a reduced new patient start momentum relative to prior years.

And that’s not something that you’d like to have starting a new year. On top of that, for this year, when we think about Q1, is always a reauthorization quarter, which is tough and challenging. But at the tail end of this quarter, we also have one less ordering week. So those two pieces at the beginning of the quarter and how you end the quarter are really quite impactful for how we view the start of the year. And we all know that this concept of the earlier you can get patients on INGREZZA on a medicine like INGREZZA in terms of a specialty medicine in the year, there’s a compounding effect that you see as each quarter goes by.

So when we think about guidance for the year, we certainly kept in mind and looked at the variables that we see presenting themselves coming them in coming into Q1 of this year, the low patient start momentum, the knowledge of the fact of one less ordering week, we do also have a 3% to 4% gross to net change going from Q4 to Q1. These are all variables that played into our guidance. But ultimately, what we see here, Paul, is Q1 is going to be more challenging than we’ve seen in years past. There’ll be a recovery in Q2. And then with a lot of investments we’ve made over the past, you’d say, three to six months, we would have seen acceleration of growth in the second half of twenty twenty five.

And that’s all of these things played into that guide that we have that 2.5 to 2.6 guide for the year.

Paul, Moderator: Thanks, Kyle. All makes sense. The only piece I’m still trying to wrap my head around here is, you know, you and I’ve talked to Matt about this too, have talked about, you know, reimbursement challenges, maybe a lower conversion rate between, you know, an NRX that’s written and then a patient actually going on therapy. And I guess as we sit here today in March, like, how much of this is actually on your control in your control and modifiable in this calendar year? Because in my simplistic understanding, I think, okay, well, access challenges, that means more contracting and giving back more on price.

And usually, that kind of resets and is done on an annual basis. So as we think about the next nine point five months, to what degree can you actually improve some of these underlying challenges?

Kyle, Neurocrine: Yes. No, that’s a fair question. I guess one of the things that I’ll start with is that what we’re really talking about here for the most part that is are getting new patients on INGREZZA. The patients that are already on INGREZZA and getting a repeat prescription throughout the course of the year, there’s a stickiness to this medicine and it’s easy to get those patients a refill of their prescription. But the new patient starts, that’s where they see the payer hurdles the most prevalent.

And there are things that we can do as an organization to help make that better. Certainly, we have an experienced field reimbursement team that’s out there in the field. It’s something that we continuously work on, scale and educate to navigate quarters like Q1, but then throughout the year on the evolving payer landscape. I do believe the payer landscape evolution that we’ve seen in terms of tightening this whole process of getting a prescription in the hand of patients is the result of IRA uncertainty by the payers and plans that we’re currently engaging with. But aside from that, working with the field and reimbursement team, it still goes back to making the disease aware in the minds of the physicians, the nurse practitioners and putting the disease state front and center because ultimately these are the individuals that are going to be fighting for the INGREZZA script once it’s written for the patient and helping those physicians understand the importance of treating the disease.

And then part and parcel to that will be just increased marketing messaging around the attributes of INGREZZA of why they’re aligned with meeting the unmet needs of patient’s heart of dyskinesia. So I think I’d start with talking about new patient starts here, not patients already on medicine. There are things that we can and will continue to do in terms of improving challenging the plans and payers to make sure that we get the prescriptions in the hands of patients most efficiently. And then when it comes to the plans specifically, I think probably more so than others and it’s not just another times and it’s not just Neurocrine. I think we’re all taking a very close look at how we want to perhaps change our relationships with plans here in the near to midterm because they are trying to figure out what their new strategy is going to be for their own business as they’re having to deal with medicines that go through the Inflation Reduction Act and their iPAY moment.

So we want to be flexible. We don’t want to necessarily take us down one particular path that blocks us into something. We need to make sure that we’re on top of what the plans are dealing with and making sure that we always have that North Star maximizing the access for patients, both in the near term and long term here.

Paul, Moderator: Yes. Okay. I guess in a but from a practical consequence, does this ultimately mean to give insurers more certainty in a world of uncertainty that you’re going to have to contract more on price going forward?

Kyle, Neurocrine: Well, I will say that since the launch of both INGREZZA and AUSTEDO, Teva has been pretty much on all the plans from day one and we have not been and we’ve been able to successfully navigate the exemptions process for new patients. I think as time has long, we’re going to have to see if that’s the best relationship and mechanism that we see moving forward for patients getting INGREZZA. And I do keep an eye on what this first round of 10 medicines are going to go through for the IRA this next year and what other brands in those same therapeutic categories feel or sense with the plans that they’re currently negotiating or may negotiate moving forward. Fortunately, we’re in the position where we can sit back and learn and how these dynamics are playing out over the next couple of years and see what changes to our own business that we might make to ultimately maximize the value and strength of what we have within the organization, specifically within INGREZZA.

Paul, Moderator: Yes. Okay. All right, great, Kyle. Let’s cover TAH briefly before we talk about the pipeline. I guess open ended question, how are the first three months tracking relative to

Sameer Sadanti, Neurocrine: what you expected?

Kyle, Neurocrine: So far, things are going great, Paul. Appreciate the question on this. It’s always exciting when you’re launching a new medicine. It’s basically a first in class our first medicine ever approved for disease data. I know we talk a lot about Kornacity being the first medicine approved for CH in over seventy years, but most patients don’t know any better during the course of their life with CH.

So it’s a very exciting time. It can feel the energy in the organization and certainly in the patient and physician community to have something that’s been specifically discovered and developed for their needs is quite satisfying here. I’ll tell you that the initial receptivity across the patients, the endocrinologists that we’re calling on and even payers has been quite high. And we think that given the data set that we have and the clean and broad label that Creonacity has all the hallmarks of being a potential blockbuster.

Paul, Moderator: Yes. I mean, you guys have hammered people on the idea that this is going to be a gradual, large, slow, have to build Is it is it the classic Neurocrine playbook or sandbag the early days? And I guess, look, I’m I’m half joking, but, you know, why wouldn’t this launch just as good, if not better than SKYCLAR as your debut, right? I mean, you’ve got a drug that has a pretty good efficacy profile. The safety is clean.

It’s an oral drug. These patients are already on medication, and this is on newborn screening, right, which which some of those other diseases are. And it feels like there’s a coalescent of factors here coalescence, excuse me, that, lend themselves to a great launch. What am I missing or not appreciating about the first three to six months?

Kyle, Neurocrine: Well, everything you said there is not a bad place to be in. But I will say that whenever you’re changing a standard of care for disease states, you normally start from the perspective that that’s going to take some time and we’ve certainly seen that with INGREZZA. I would say INGREZZA’s uptake over time has been pretty steady relative to other disease states that we’ve seen. It’s probably because one of the things that you touched on, most of the patients in tardive dyskinesia are in that disease state aren’t diagnosed. That’s different than in CH.

But still when it comes to changing the standard of care, we do expect a certain level of education that’s going to be required. And we know that depending on the patient type, they are limited to the number of interactions that they have with physicians on an annual basis. So that’s one of the barriers that we see is that limitation between the patient and physician interaction whether your child who is in the office more frequently, but still not a lot with their parent or if you’re an older male who may be in the office one time per year at most. Those are the things that we need to work through. And I think part and parcel of that would be is that there’s a general apathy amongst the community that they feel that a lot of the symptoms, a lot of their disease state that it just doesn’t it can’t get any better.

Paul, Moderator: So isn’t that more of an adult phenomenon than a pediatric phenomenon?

Kyle, Neurocrine: I think that whether you’re talking about different levels of motivated patients or physician, in this case, I’m thinking about physicians, a lot of them think that just like in TD that their patients are being adequately cared for with their hydrocortisone treatment. So you have to work through these different dynamics. I think that the message is that you have to worry about this education piece. There’s no open label extension pool of patients that’s going to immediately roll over and be an initial set of patients on Kranesti, that’s another one. And the other one is that you’ll have to work through the reimbursement process out of the gate as all the plans come up to speed on the medicine and how it’s ultimately going to be approved for patients.

And all that’s going to take some time, we think ultimately and that’s where we get to that measured launch view. What I would say is that while it’s going to be measured, I think once we get some momentum here, I think you will see an acceleration to peak market share or peak penetration of the market much more quickly than we’ve seen with INGREZZA that has been that more steady launch over time.

Paul, Moderator: Are you seeing so far greater receptivity in the pediatric population?

Kyle, Neurocrine: I think we’ve seen great receptivity across the board. But I think it’s still early enough days to know to not be able to say we’re seeing a trend in one particular area or another. I think there’s been good overall excitement in the category working with the CARES Foundation, the advocacy group that’s out there to make the medicine aware for those patients that are dialed in. And what we’re seeing is that exuberance being attached to that particular patient population. But I’d love to be able to answer that question and say a year’s time and we could speak more confidently about who’s using the medicine and what patient population, etcetera.

Paul, Moderator: Okay. All right. Last question. Let’s pretend it’s December 15. What do you want to be sitting on with this drug to say, okay, this was a successful

Kyle, Neurocrine: year? Well, you’re asking for some detailed information there.

Paul, Moderator: Yes, I’m asking for a specific revenue. Yes,

Kyle, Neurocrine: but we will be giving enrollment numbers on a quarterly basis. We’ll be giving you the net sales number. I think that we’re comfortable with that for the next couple of quarters until we can see where the market’s moving. And at some point, we’ll be able to give additional color on what we’re seeing right now. But But where we stand today, we’re barely three months in of a new launch.

Everything that we’re seeing thus far is going very well.

Paul, Moderator: Okay. Great. To everybody listening, you can all see I tried my absolute best. Awesome. Well, we look forward to the next quarter.

So, Sameer, maybe I can hammer you on some pipeline questions because I’m super interested in the AMPA program and muscular earnings are always really fun to talk about. And so maybe starting with the AMPA potentiator, I guess, why has Neurocrine been so secretive about the phase two data? And what’s the upside for you guys? Because I feel like, you know, you you don’t run the company for the investment community, but a phase two new mechanism in depression is tremendously exciting, right? And we see companies with positive Phase two data in depression trade at billions in market cap, and it doesn’t feel like there’s anything close to that Neurocrine stock.

So what’s been the thought process with the disclosure?

Kyle, Neurocrine: Maybe I’ll chime in on this one. If you think about the program and the collaboration that we have with Takeda when we announced the Phase II results, we were in a profit share type of arrangement. And all of this, when we moved into the number of programs we had into Phase II, we agreed we weren’t going to spend on anything else until we saw the Phase II results. When it came to most of Amphitore in Phase II, we got the spectacular Phase two results. The next piece was to preserve the intellectual property that came out of those study results and we didn’t have all that plan worked out, who was doing what, what group was going to file the patents, who was going to pay for them, etcetera.

So it did take some time to get through that dynamic. It’s a good problem to have, but when you’re working in a collaboration, it’s important that you work with your partner to get to a good outcome there. Other than that, which was the major driver here for not disclosing as much information at the time of the Phase II results was the appreciation that we’re going through a very high level exuberance attached to the Muscarinic. And we do believe that the bias expectation bias that we were seeing across the Muscarinic programs was something that was real and that we had a significant concern about for our own program as we were still in Phase II at the time. So the idea here was that no one had the expectation that an AMPAPAM will work in MDD.

Most of the other programs had fallen by the wayside mainly for safety, toxicology reasons. And we wanted to preserve that expectation bias or lack thereof for subsequent studies. And then the last point to point out that was a factor in what we disclosed or what we didn’t was, we appreciate there’s a number of AMPA programs on the shelves of many pharmaceutical companies. And certainly, we’re mindful of not wanting to educate others at this particular time about the pathway and how to take these molecules forward. So all those factors played a role here.

And at the end of the day, we are planning to share this data. And what we’re looking at is an R and D day later this year. I think this would give us a good venue to share a lot more information that we have across the psychiatry portfolio overall. So stay tuned on that. That’d be something nice to have some people out to our headquarters in San Diego and go through the portfolio together.

Paul, Moderator: Okay. That sounds great.

Sameer Sadanti, Neurocrine: Only thing I’d add there is that earlier this year, we amended our collaboration with Takeda on the AMPA program. And so now we own worldwide rights except for Japan. I think that does speak to our excitement around the compound. To Kyle’s point, we do need to be concerned about the expectation bias here. There’s been a raft, unfortunately, of recent late stage failures within MDD in particular also in schizophrenia.

So we’ll be measured with the disclosure, but certainly we know that the street wants more and you’ll see that throughout the rest of this year.

Paul, Moderator: Yeah. Okay. That makes sense. So I guess, you know, without showing the efficacy curves, which I was not realistic on this Zoom, I think when I look at Phase two data in psychiatry, there’s a couple of variables that I feel like are flags on the replicability of the data set. One is how does placebo do, right?

Did placebo grossly underperform in a way that kind of questions the integrity of the results? And then the second is dose response to some degree and understanding that a lot of psych drugs don’t have a linear dose response. You want to see a dose response that at least like passes the smell test. So what can you at least touch upon on these variables as it relates to the Phase two data set and as it relates to your confidence that it’s reputable in your Phase three program?

Kyle, Neurocrine: I’d say the overall conduct of the Phase two study was very high. We didn’t see anything unusual in terms of the placebo response here. We’re right in the normal range. And you saw the effect sizes there across the both doses. I would say whether you’re looking at the dose that didn’t underperform versus the other, in my mind, both doses were active here and that corresponds with a lot of the prior studies that we’ve done with this molecule.

There were multiple doses that look good in various animal models of disease to the extent that you want to put any validity on that. I think the challenge here in a lot of psychiatric trials is a lot of us haven’t been used to seeing these types of Phase II and Phase III trials in depression relatively recently. Twenty years ago, there’s a lot more companies in this space and producing

Paul, Moderator: We can still hear you.

Kyle, Neurocrine: That was odd. In any case, I think that where I was trying to go with that is that there’s a lot of trials that have been published in this space where there’s a flat dose response, there’s an inverted U and irregular dose response. In our world, that’s very familiar and we’re not too worried about having one study dose outperform another if they’re in particular talking about doses that are very similar. Ultimately, but we like it was a high quality performed study, very well controlled placebo effect and we got a spectacular result. So the question for us then is how do we manage a larger Phase III trial and try to preserve all those elements that we saw in a smaller Phase II trial?

Well, first and foremost, the Phase II trial that we conducted was a pretty good size, the 180 subjects, two doses of active versus placebo and it was across the number of clinical sites. So we’ll be scaling the subject number up a bit, but not much in Phase three. You can see out there where our sample size is about 200 and we’ll be simplifying the number of doses of active from two to one. So it’s a one to one active to placebo pivotal trial design in 200 subjects. And we think that we’ll be able to control things like the variability in the outcomes at the clinical sites in much the same way that we did in this Phase two because of the similarities in the scope and size of these studies.

So we are doing a Phase three program that includes three Phase three studies. They’re all similarly designed and it is with the mindset that this is a risky area and we’re trying to get at least two positive Phase III trials that would be required for an EA approval submission. So that’s kind of the mindset here on this. We’re trying to preserve the simplicity that we solve in Phase III by moving into Phase or Phase two moving into Phase three. And you’ll see that across the board is in the muscarinic programs as well, trying to preserve the simplicity element moving from an earlier stage trial to a later stage perhaps larger trial.

Sameer Sadanti, Neurocrine: Just to underscore two points there real quickly, Paul. This absolutely was not a case where we had an abnormally low placebo effect in Phase two. This was a placebo effect that’s consistent with what you’ve seen with other Phase two and Phase three programs. We expect it to be right around that range in Phase three as well. So the results were not driven by a low placebo effect.

Second, in terms of replicability, it’s a fair point that you bring up. You look at our Phase II results, 7.5 placebo adjusted difference in one dose, 3.5 another dose. I mean, you’re talking about big numbers here. We think that we have an active drug and that’s what’s driving the confidence. You take a straight simple straight average and maybe that’s the most intellectually honest way to look at it.

But if we were to get something around that result in Phase three, this is going to be a big winner commercially.

Paul, Moderator: Is this the kind of thing where you might take both doses forward, understanding that it’s hard from a small study like this to really make conclusions dose to dose?

Kyle, Neurocrine: Right now, we’re just taking a dose that we think is efficacious, the same dose across all Phase three studies. I will say that other than all the things that Sameer just mentioned, just to pile on here, we think we’re working in a validated pathway here. This is in the same pathway as ketamine. We work downstream at the AMPA receptor, which is what ketamine activates through the induction of glutamate. So we think there are multiple reasons here to be excited about the approach here.

What Takeda was able to fix was they developed a true AMPAPAM, not an agonist. And from the

Paul, Moderator: A seizure risk, is that

Kyle, Neurocrine: That’s right. Mitigates the seizure risk on this and it gives you that light touch of activating the system. It doesn’t necessarily work the same way as ketamine in terms of a fast onset of action, but it takes you to that large effect size that we saw in the Phase II.

Paul, Moderator: Yes. Okay. Great. So Phase III program starting and we’ll get data potentially later this year in R and D or I guess for detailed Phase II data.

Kyle, Neurocrine: That’s right.

Paul, Moderator: Awesome. So, Muscarinic, same tune, right? I mean, I think there’s been a lot like, it’s been a complicated eight to nine months for the M4 hypothesis, right, with your guys’ data, which certainly looks promising, but the dose response is a little bit confusing. And then you have this whole omicronidine setback, which there’s probably five variables that contributed to that. But I guess going into Phase three, you know, same deal, right?

Like, how much conviction can we have? And, you know, on a small study where you don’t have a linear dose response, what does the debate look like inside Neurocrine when you guys are talking about, like, is this a real biological finding? Is it randomness? Should we take forward one dose? Should we take forward multiple doses?

Like, you know, where are you guys kind of leaning out on these things?

Sameer Sadanti, Neurocrine: Yeah, absolutely. Maybe I’ll start and then Kyle, will look for you for additional detail here. We thought long and hard about this as we go into Phase three. This isn’t an insignificant bet for the company. These inpatient studies are timely expensive to run and resource intensive.

But when we looked at our data, we do have confidence in our twenty milligram dose. That’s the dose that lined up from preclinical models all the way through Phase one with the mismatch negativity in ASR data that looked good there into Phase two. The inverted dose response, as Kyle said, doesn’t scare us. You’ve seen this before with antipsychotics. You look at CAPLITA as an example.

The forty two milligram dose outperformed the eighty four milligram in the Phase two. They took the forty two into Phase three. That obviously hit. That’s been a nice drug for them. Even within the muscarinic class, if you look at the integrated summary comments by the FDA for the Kobenfea approval, I mean, these are small ends that we’re talking about.

But in that situation, their low dose actually numerically outperformed their high dose. The FDA themselves concluded that there was no dose response there seen between their pooled Phase II and Phase III data. So for us, as we think about it, the Phase III program, as Kyle has mentioned, similar to osevampitor is going to be very simple. One dose, twenty milligram versus placebo, one to one randomization, a tight number of sites, around 20 sites per study. We’re going to have very high oversight and high engagement.

You referenced one of our competitors that had a setback, obviously, in their Phase 2b program. Some of this comes down to execution, some of this comes down to trial design and patient selection. Ultimately, those are three things that we’re going to look to optimize in our Phase three results here. Kyle, anything you want to add?

Kyle, Neurocrine: No, I think you captured everything there, Samira. It’s a a very similar story to those of AMPITOR. I think we’re going to have very good oversight. We’re going to have very simple studies. What we’re asking in terms of scale going from Phase II to Phase III is very small incremental changes.

We’re not talking about an imraclidin Phase 1b to Phase three trial difference of multiple five times the number of sites, five times the number of subjects, U. S. And Europe. Those are not things that we are dealing with moving from our Phase two to Phase three trial. Obviously, science happens.

The best of science can still lead to setbacks, but we’re really happy with the profile that we have at the twenty milligram dose and believe that the data that we’ve seen comes with a large magnitude of effect. It’s really up to us to do our best to manage the Phase 3s.

Paul, Moderator: Yes. Makes sense. Where are things with the M1M4? And do you feel like you can develop an M1M4 without a peripheral antagonist to cancel out the side effects?

Sameer Sadanti, Neurocrine: Yes. So there will be no peripheral antagonist with this program. The M1M4 Phase one data are expected to read out by middle of the year. We’ll be moving that program forward into a Phase two study in schizophrenia by the end of the year. Right now, that compound is looking good.

In vitro, it’s very strongly potent on both M1 and M4. We’ll see how that translates to in the clinic. But the hope here is that this could be a more potent and, you know, slightly different pharmacology version of five sixty eight would be a nice sister compound to follow-up with as a lifecycle management opportunity for the class. You’ll get more details on Phase two study designs, as we excuse me, as we move into the clinical study beginning at the end of the year. Kyle has referenced this R and D day and perhaps that could be a good forum for us to share more detail there of the Phase one data and how the Phase two study design is looking.

Paul, Moderator: Okay. Okay.

Kyle, Neurocrine: All right. We got

Paul, Moderator: two minutes and I’m going to try to squeeze in two more questions. Kyle, you have a BD background. Sameer, you are now in Kyle’s prior seat. Could we see Neurocrine do a meaningful BD transaction in the next year or is your plate full?

Kyle, Neurocrine: Sameer, you’re the head of BD.

Sameer Sadanti, Neurocrine: Absolutely. From my perspective right now, we have to put our heads down and focus on our Phase III trials. You know, we’re launching obviously with osevampitorin five sixty eight, that’s a lot of bandwidth internally. We’ve got the Korneseti launch ongoing as well. Never say never, but it would have to be the right opportunity.

But, you know, certainly right now our focus is on our ongoing clinical programs and the commercial launch for Krenesity.

Paul, Moderator: Yes. Okay. And then one last pipeline question. I feel like you guys go out of your way to say to people, hey, don’t forget about our NR2 B NAM. What is the quick pitch there and when are we going to get proof of concept data?

Kyle, Neurocrine: So this works a little bit downstream of ketamine at the NR2B subunit of the NDA receptor. And the hypothesis here again validated target, validated pathway that you can induce a hyperglutaminergic state, but not to the same extent of ketamine. So hopefully get that fast onset of action minus the dissociative effects of ketamine. That’s the goal. That’s why people have been attracted to this target.

And that’s what we’re looking at testing in this Phase two trial that’s ongoing now. Three doses of active versus placebo. And we’ll have data later this year on that. That will help us out the direction of where we go in terms of dose, dosing regimen for pivotal trials, learning a lot about this particular target right now and having a really nice molecule to actually look at a number of different parameters of using this approach in this biological pathway. So I’m quite excited about this to see where this lands.

As you know from NEREC when we’re working in difficult areas like depression, we like to pick a biological pathway that has some level of validation and we like to play along multiple parts of that pathway and see what ultimately will lead to the best outcome there for patients. So we’ve got one upstream with seven seventy and we’ve got one downstream with those of Amphitore.

Paul, Moderator: Awesome. Great. I think we’re up against time. Anything else either you guys would like to add before we finish?

Kyle, Neurocrine: Nope. Appreciate your support, Paul. Always happy to catch up with you.

Paul, Moderator: Alright. Thank you, Daniel. Good conversation.

Kyle, Neurocrine: Thank you.

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