Q1 2023 Neurocrine Biosciences Inc Earnings Call

Speaker 1: That.

Speaker 2: Good day, everyone, and welcome to the Neurocreen Biosciences Report's first quarter results. At this time, all participants are in a listen-only mode. Here you will have the opportunity to ask questions during the question-and-answer session.

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Speaker 2: Please note this call may be recorded and I will be standing by should you need any assistance.

Speaker 2: It is now my pleasure to turn the call over to Todd Tushla, Vice President of Investor Relations. Please go ahead. Todd Tushla, Vice President of Investor Relations

Speaker 3: Thank you, operator, and good morning, everyone. Welcome to Neurocran's first quarter 2023 earnings call. This morning I'm joined by Kevin Gorman, our chief executive officer, Matt Abernathy, our chief financial officer, Irie Roberts, our chief medical officer, Eric Benevitch, our chief commercial officer, and Kyle Gano, our chief business development and strategy officer.

Speaker 3: I'll remind everyone that during today's call we will be making forward-looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to review the risk factor discussed in our latest SEC filings. After our prepared remarks we will once again do our best to address all of your questions.

Speaker 3: And now I'll hand the caller with Kevin Gorman.

Speaker 3: Thank you, Todd, and good morning. Well, Ingreza has had yet another very good quarter of sales. And I say this from a dollar perspective, but more importantly, the fundamentals of bringing Ingreza to patients is even stronger, with more new prescriptions than ever. And remarkably to me, this occurred in Q1, typically our toughest quarter because of insurance we offer.

Speaker 3: is that persistence and adherence remain as strong as ever. Patients and prescribers recognize the impact that Ingreza has on their patients' tardive dyskinesia and on their lives.

Speaker 3: So we're entering Q2 with momentum and with fundamentals like this in Q1. It bodes very well for a very strong year. Now Matt will make some cautionary statements for Q2 that are very valid. But take those in the context that 2023 is setting up to be quite strong.

Speaker 3: One of the aspects in the hurricane that I am most proud of is our ability to make difficult decisions.

Speaker 3: With the ultimate goal, to utilize our resources wisely to be able to bring as many life-changing medicines to patients as we are capable. That requires making tough fiscal decisions to deploy our cash and our talent to grow our business.

Speaker 3: To that end, we announce this morning that we will be returning the commercialization rights of on-genesis to be out.

Speaker 3: Make no mistake on Genesis is a very good drug as evidenced by the positive feedback we received over the past two plus years.

Speaker 3: Unfortunately, from the time we licensed the SMAVSIM to the launch in 2020, the Parkinson's adjunctive therapeutic category went through fundamental changes, which posed significant commercial challenges. Despite our best efforts, we have been unable to mount those challenges.

Speaker 3: We are not the only company experiencing these challenges in this therapeutic category.

Speaker 3: Going forward, both our and BL's primary focus is to ensure new and existing patients do not experience any interruption in receiving on-genres as we transfer commercial activities.

Speaker 3: Now, finally, as I will discuss on this call, we continue to make very good progress on our clinical portfolio and are in track for a number of phase 2 and phase 3 readouts later this year and the August Padufa of Valdena scene for the treatment of Korea in Huntington's disease.

Speaker 3: As you know, enrollment was impacted in a number of our programs by several macro factors, but the teams have worked diligently and have kept all these programs on time, on budget, while retaining the highest level of quality.

Speaker 3: So with that, I will turn the call over to Matt.

Speaker 3: Thank you, Devon. Good morning. Ingressive performance in Q1 was strong with record NRAC team sales coming in at $410 million. The team did an excellent job navigating seasonal payer dynamics and driving new patients, setting us up for a great year. We did see a small benefit from timing and customer orders at the end of Q1, driving a several-day increase in days on G&D channel inventory.

Speaker 3: Given we're only one quarter into 2023, we are reiterating sales guidance and will reevaluate after the second quarter. Needless to say, Inresa set up for a great year. On the financials, we are maintaining our S-GNA and R&D expense guidance with exception of IPR&D for the Voyager collaboration. Similar to prior years, S-GNA had an increase in spending for Q1 and expected to step down the remainder of the year.

Speaker 3: With that, I look forward to your questions and now hand the call over to Eric.

Speaker 3: your questions and now hand the call over to Eric. Eric? Thanks Matt.

Speaker 4: K-1 2023 was another good quarter for us, and as Kevin said, the fundamentals were strong.

Speaker 4: As usual, we spend a good portion of the quarter managing through seasonal pair dynamics.

Speaker 4: And despite these challenges, we achieved 36% year-over-year sales growth with a record number of new patient starts and continued strong compliance to treatment.

Speaker 4: We estimate around a third of patients have now been diagnosed with tardive dyskinesia. However, the fact remains only about half the time are diagnosed patients even offered treatment with a VMAT-2 inhibitor. The American Psychiatric Association recommended first-line standard of care.

Speaker 4: Therefore, our ongoing educational efforts continue to be focused on recognition and diagnosis of TD.

Speaker 4: an encouraging treatment of appropriate patients with ingreza.

Speaker 4: For several years now, our Q1 earnings call coincidentally occurs the first week of May, which is designated as Tardive Diskinesia Awareness Week. Furthermore, May is also designated as Mental Health Awareness Month. Looking back, while we are proud of the progress we've made with Ingrasa over the last six years since launch, we still strive to improve the diagnosis and treatment rates for TD and we'll do so over the next decade and more to come. With that, I'll turn the call over to my colleague, Dr. Ivey Roberts, our Chief Medical Officer. Thank you, Eric, and good morning to everyone on the call.

Speaker 5: 846 for the treatment of Anadonia associated with major depressive disorder.

Speaker 5: All four of these data readouts will occur in Q4 2023.

Speaker 5: In addition, we are looking forward to the August 20th for due for date for valve anazine as a potential treatment option for patients with career associated with Huntington disease.

Speaker 5: We are ready and eager to engage further with the HD community in service to patients living with HD Korea in the event of successful approval.

Speaker 5: I'm pleased to say that our first module, NBI 568, currently under evaluation in a phase two dose finding study in schizophrenia, continues to make excellent progress with enrollment. In addition to NBI 568, we plan to take NBI 570, a dual M1M4 agonist, into phase one clinical development this year, potentially followed by other differentially selective M1M4 agonists over time. Overall, I'm very pleased with the performance of our teams in executing to our portfolio goals this past.

Speaker 2: Go in and company, please go ahead. Your line is open.

Speaker 6: Good morning, congratulations on the progress and thanks for taking our questions. Two related commercial questions from us in terms of being a resident number. It does seem like you've solved the seasonality problem with growth, whatever for a Q1. Can you talk a bit more about what you've done to ensure that Q1 isn't the downquarter that had been in the past?

Speaker 6: And second, Matt, on your stocking issue, I think you said a few days of inventory increased, a biormat that perhaps translates into about $20 million of...

Speaker 6: Is that a reasonable estimate? Yes, thanks.

Speaker 3: No, it's much less than $20 million. I'd just say it's around $10 million or so is what the inventory build was. You know, as it relates to the quarters of really strong quarter over $100 million of Europe or your growth.

Speaker 3: And we did, of course, benefit from a touch of inventory, but record numbers of new patients, and sharing patients stayed on medication, and had a really, really good persistency. We felt good with how the quarters shook out.

Speaker 3: Eric can talk a bit about what we've done to ensure that we kept patients on medicine through Q1 and through the reauthorization process, but I'd say last year was the first year that you saw sequential growth for the brand Q4-Q1 and we've seen something very similar this year, Q4-Q1.

Speaker 4: Yeah, Phil, I would just say that, you know, as we have gone through the first few years of the launch with Ingrés, we've attempted to learn every Q1, what works, how we can improve, and ultimately it's involved a lot of teamwork.

Speaker 4: Where are there more patients that are likely to require annual reauthorization for the refills? And each year, even though the base of patients gets bigger in the number of people that could potentially experience treatment at interruptions grows, we get a little bit better from an execution standpoint. And that's really what's driving our success this year and frankly last year. Perfect. Thank you.

Speaker 7: Hi, good morning, guys. Thanks for taking my question. I just wanted to follow up on what the current status of neurologists, I guess, coming back to in person. I know that during the height of COVID, that was a big challenge. And you guys sound way to navigate around that. But is it still the case that a lot of patients are being seen virtually, or is that something that's used as a pandemic?

Speaker 4: has come up with a prize and then I have a follow-up. Thanks. Hi, Tazeem. So neurology and psychiatry, quite different in that regard. Obviously during the pandemic, the really all physician specialties went to a high degree of virtual patient care.

Speaker 4: But today we estimate it's less than 10% of patient visits in neurology are virtual. So it's gone back pretty close to pre-pendemic levels. And I think the feedback that we hear for neurologists is to a great extent they rely on a physical exam. And you can't do that remotely. So there's a big delta between what we see in neurology and what we see in psychiatry where there's still high degrees.

Speaker 4: it changes a little bit from quarter to quarter.

Speaker 8: Okay, thank you.

Speaker 2: area. Select our episodes. Up till next with a. So

Speaker 4: Hey, thanks so much. I appreciate you taking the question. I wanted to ask a question around the Karnester font studies. I know you've been reluctant to set the bar on steroids sparing, but I wanted to talk more broadly just about secondary endpoints in the trial and side effects related to steroids sparing.

Speaker 4: What secondary endpoints or what steroid clinical consequences in these studies or in the open label extension, do you think you have the best shot is showing a benefit on so as to corroborate the primary endpoint, both from a regulatory and commercial reimbursement perspective. Thank you. Morning Paul. On that question, just to remind the

Speaker 3: I would send the inventory front. It really just came down to a timing of in order at the end of a quarter. It wasn't an intentional stocking by our channel. We don't operate the channel that way with the big bulls of buying and Q4, that would simply down and Q1. It really was just...

Speaker 3: in a reminder on the first part of the question. Oh, Kira. Correct. Yeah, so where to point now on Kira X that we've reached scale that we're not going to be providing Kira X publicly. And anymore, we're going to be providing commentary around net sales, how we're doing on, on interacts and commentary around what our net prices is doing. There is, of course, third party syndicated data that's available. It's directly correct, I'd say. But of course, it doesn't capture the full data set of what we see internally for in Greza. So at this time, given it's the beginning of the year, given we've made the Schiff Center distribution.

Speaker 3: touch of seasonal headwind as you would expect in our ghost tonight in Q1. It's around 2% or so. I'm not going to give the exact net revenue per script here for Q1, but going to talk about it more in terms of what we expect for the for the full year. So overall, expect really a net price increase for the year of around 2% to 3%.

Speaker 4: Hi, Nina. So this may not be a super satisfying answer, but we're seeing growth coming from everywhere. And what I mean by that is that, you know, I post the expansion and the reorganization of our field teams last year. We now have dedicated sales forces in psychiatry.

Speaker 4: neurology and LTC and all three of those.

Speaker 4: segments are growing nicely as evidenced by the, you know, two-on-results and especially the record number of new patients starts that we saw this past quarter. And you know, the second part of your question was really related to, is this being driven by the Salesforce expansion? And, you know, our belief is that the Salesforce

Speaker 6: very much with the announcement of the strategic decision on engentists. Obviously, I expect that you've also done some broader portfolio reviews to think out to the balance of the decade. Can you comment about sort of the international plans in particular for Krenestra funds? You did the deal over in the UK in 2022. Remind us what the regulatory status is there. And then this

Speaker 9: how the commercial opportunities could play out in that realm for you guys. Thanks.

Speaker 10: Thanks, Chris.

Speaker 10: with respect to being able to internationalize in Gaza, you're absolutely right. We made the Kronesser Fund, sorry, I have in Gaza on the mind this morning as you could understand. With Kronesser Fund is that the purchase of Dyerna was a way of setting us up for an entry into Europe . The newkward bit. We

Speaker 10: UK and Europe . So from a development standpoint, we're leveraging the diurnal folk and I should say the the neuroconfolk now that are over there in a big way already. They also have MSLs in addition to the clinical and the CRAs that they have over there. So that that is turning out well for us right now.

Speaker 10: good data and then it'll be followed by the EU. When it comes to a broader portfolio I really think what you see here is that Neurocrin and the portfolio we currently have and what we have been doing is being a neuroscience company we have had an exquisite focus on orally active small molecules of course because many of them whether you're talking about neuropsychiatric and neurological

Speaker 10: in preclinically and in research, antibodies, peptides, proteins, gene therapies. Now, in order to broaden our reach and get to actual disease modifying and curative therapies within the neuroendocrine and neurological diseases, I think that psychiatry will still be dominated by oral...

Speaker 9: Great, thanks for the perspectives.

Speaker 2: We will take our next question from Brian Abrams with RBC, Capitol Markets. Please go ahead.

Speaker 4: Thanks so much. Congrats on all the progress and thanks for taking my question. What's regards to Kinesa font? So our market research has suggested that patients are very excited about a new treatment option, but there's some equilibrium that some may have struck on their steroid use, which may make them reticent to disrupt things. And I guess I'm wondering.

Speaker 4: how you plan to address this. You obviously have a lot of expertise building markets. Do you think it's just a matter of having strong totality of data and not being convincing enough, or there are certain self-populations you may think about targeting initially who might be optimal candidates or educational campaigns you might envision. And how might this impact how we should be thinking about potential offtake curves for this drug? And then maybe just a real...

Speaker 5: living with CH and that that and met need if we're successful with our face-to-programme and for Kinesifant can be met by Kinesifant. The reason why I think you hear some kind of ambivalence about willingness to switch from steroid is that these patients have had nothing but steroid and in fact there's been no new approved medications for over 50 years in this space.

Speaker 5: And so I think people have had to settle for less than optimal care. And so to your point, I think our ability to demonstrate a broad range of robust data in support of the benefit risk of Kinesifant will allow us to address that and that will need to be supported by a significant amount of education.

Speaker 5: and other approaches in the similar fashion to what we have done within Gresa NTD.

Speaker 4: Yeah, and I'll just add that, you know, it's early days yet.

Speaker 4: We haven't completed our registration trials. And as a company, we haven't really started our formal efforts to reach and educate, you know, the various, a patient and care partner communities within CH.

Speaker 4: Prenaur-Surfon does represent, you know, I think a pretty meaningful paradigm shift. And you know, part of what we'll be doing on the other side of data and leading up to approval and, you know, knock on wood launch is to educate on the value of treatment with Prenaur-Surfon.

Speaker 4: and what that means to patients, what they can expect. You noted that we've demonstrated success in TD in building a new market from scratch, and I think we can apply some of our learnings towards the opportunity in CAH.

Speaker 3: So from a brand from a revenue recognition perspective, you recognize revenue once the bottles are shipped and delivered to the distribution, your distributor. So what I would say in terms of your question, yes, it was shipped delivered.

Speaker 3: And it really just had to do with the timing of when those specialty distributors, pharmacies place the order at the end of the quarter. It was just a bit out of cadence and higher than what would normally be held at that distributor.

Speaker 2: Thanks so much everyone. We'll take our next question from a new Paul Marama with JP Morgan. Please go ahead.

Hey guys, thanks so much for taking a question. Just wanted to maybe dig in a little bit more on the long-term care facilities. I know you've stressed this as an area of growth for ingreza and made some brief comments earlier in the call. But what are you seeing in terms of trends in this segment specifically?

Hi, Anupam. So I would say that, you know, we're a few quarters in, but it's still early days yet. This is a brand new segment for us, long-term care and some, a site of care that we had looked at at the very beginning of the launch and decided that we didn't have the capacity to take that on.

And so obviously last year we made the commitment, we build a dedicated team, and they've been out there and doing all the things necessary for long-term success in long-term care. But ultimately, it's still an area that's just getting off the ground.

relative to psychiatry and neurology that are more a little bit further along in terms of market development. But very pleased with the progress that we're seeing. And certainly look forward to providing more detail as we get a little bit further down the road.

relative to psychiatry and neurology that are more a little bit further along in terms of market development. But very pleased with the progress that we're seeing and certainly look forward to providing more detail as we get a little bit further down the road. Thanks so much for taking our question.

I'll take our next question from Carter Gold with Bartleece. Please go ahead. Great. Good morning. Thanks for taking the questions. Maybe I agree. I'm coming to 352. I don't believe you guys have disclosed the dose as you're looking at.

in the FOS study, but maybe just clarify that if you have. And I guess more broadly, how you're thinking about sort of target exposure, you know, sort of a city state, you see or, you know, a trough level, any color on that, and if the Phase 1 TMS data may be informative on that front. Thank you.

were used in order to define the doses that we took into that study. And so we are confident that we are covering the target with that dose range. And that this is a well controlled signal seeking study in terms of the efficacy and benefit risk for 352. And we will take our next question from miles mentor with William Blair. Please go ahead.

Okay, thanks for taking the questions. Just some of the decisions to not provide updates on the prescription growth rate for ingress and moving forward. Maybe you can comment on the accuracy of the scripts that we can see through our Q3 and IMS. I know previously you've cautioned against that, but maybe you can comment whether that is getting better as a way to track ingress or. And then secondly, I just wanted to just thoughts on how much you need to build the Huntington and the Korea market. You know, is it similar to Todd of Disknazers or is it more about just taking shape?

had been historically.

historically. So with that I'm going to end.

So the second part of the question over to Eric specifically to HD. Yeah, hi. So, you know, with regards to the H.C. Korea market opportunity, you know, obviously we're excited about.

the plans that we have for introducing Valbenazine to that patient population. And as we've said before, we see that there's still significant unmet need in this group of patients that are...

living with Huntington's disease and experiencing Korea. Only about 20% of people with HC Korea are actually treated with the MET2 inhibitors, which are the only agents that are actually indicated for Korea and HD. Obviously, we're excited about the clinical profile that emerged from our development program.

And we believe that some of the reasons that Tengrez is the most prescribed agent in TD would apply equally here in HD Korea. But we need to get approval. We're looking forward to that. And obviously we're doing all the things that you need to do in advance to prepare.

for that eventual expansion of the label. Will Dicker next question from Jeff Rihong? Who is Morgan Stanley ? Please go ahead. Hi, this is Mike Rihod on for Jeff Hung. Thanks for taking our question. We also had a question on the 352 Phase II study in FOS. So the patient's...

are interested in serving here, one that have incomplete or inadequate response to previously used anti-seasure medication. That is why we allow up to four other medications in the context of the patient population coming into the trial. Obviously, we understand the pharmacokinetics and disposition of 352 well from the...

from Mark Goodman with SVB Securities. Please go ahead. The matter seems like there's a lot going on in R&D behind the scenes and I guess we should expect R&D spending to kind of continue to increase over the next few years. Can you just give us a sense of how the company will be managing that process and how we should be thinking of modeling R&D? I mean.

As a percent of sales as we go up will be getting leverage. I mean, we're just just, we're going to continue to increase and it just gives us a sense of how you're thinking about that because obviously the numbers could get big. Yeah, I think Mark, so I'm just going to start out just from the high level and just saying that we're taking advantage right now of...

I think I'm very impressed in over the last couple of years or so, just the progress that we've made in being able to move ourselves from just a small molecule company to a real biologics company from the research standpoint. Matt can talk a little bit more about how that's going to stack up against sales and the financials. Yeah, how we think about it from a capital allocation perspective is that somewhere around 30% of sales would be some level that we'd want to invest in R&D and we feel like that would allow us to build a pipeline in a portfolio that would cause us to be a sustaining.

company. When you look at where we're at from a piano perspective today, if you think about the CH trials that we have ongoing, the Muscarinic programs, FOS, you know, a dozen other programs now in the clinic. We have a lot of momentum right now.

And I think all of us around the table are really looking forward to start seeing the cards turn over from all the efforts that we've undertook the last several years. And I think that is really teed up for the second half of this year and as we flag, I expect the CAH data to be available early in Q4.

So from a capital allocation perspective, I think it's fair to assume 30% or so, but it's obviously dependent upon value-creating programs, and we're not just going for quantity. We really want to find the quality that will drive value for patients and for shareholders. Thanks. If I could just ask a quick...

question on the Anadonia work. Irie, can you just talk about the work that you've done to support the dosing and how you're thinking about dosing and what's been done oral once a week?

Adonia, work, Irie. Can you talk about the work that you've done to support the dosing and how you're thinking about dosing and what's been done? I mean, oral once a week. How we've gotten there.

Yeah, so for our Anadonia program, the dosing schedule that we're using in that Phase 2 study was defined based on our pre-clinical and Phase 1 clinical data and an understanding of the biology associated with this.

target. And so from that perspective, in a similar fashion to some of the other medications such as ketamine, esketamine, used in the major depressive disorders, that's what enabled us to come up with the dosing schedule that we're testing there. Obviously, this is a proof of concept study.

Also, there is very little work that has been done historically in anhedonia, as you know. There are no medications approved for the treatment of anhedonia, which is a really difficult symptom within the major depressive disorder spectrum. And at the end of this year and in Q4, we look forward to understanding whether we're able to demonstrate a signal in anhedonia in this study.

Well, Brian , obviously, hitting statistical significance is important as a first step in the context of understanding the benefit-risk of cranesophon. The way we've designed these programs, we believe that the primary endpoints that we've chosen, namely androgen levels at week 4 in the pediatric study and the ability to reduce steroid dose in the adult study, those are important endpoints for patients in and of themselves. Having said that, obviously, the study looks at a lot of very different parameters beyond that. The parameters across the two studies are very similar. So you're correct that the totality of the data will be...

Great, thank you.

And then quickly on Ingerez, I'm curious if you've encountered any headwinds or you expect any disruption from Teva's new once-daily-off set-up. Thank you. I think, as Kevin alluded to earlier, the quality of our clinical trial data is paramount to us in terms of the trial design and our ability to protect the blinding of subjects and obviously the safety and integrity of subjects throughout the trial. And we have many measures in place in order to address that, including central discussion of endpoints, central discussion of overview of the actual data itself. And so, I think in the context of that and in terms of the variability for these patients of the hormone.

have been trained, we're very confident that Ingressive will remain the most preferred, most prescribed, a TD treatment. And it's the only one with one pill, once a day, dosing and no mandatory titration. So we feel good about our momentum in the market. We're going to continue to do the things that we've been doing to do.

Well, congrats on the quarter and thanks for the update. Recognizing that you've got a large deal on the books already this year. Just curious about your appetite for additional business development, what your thoughts are on potential areas of interest and priorities for capital allocation for the remainder of the year. Thank you. Thanks, Jay. This is Kyle. Appreciate the question.

Obviously, we remain quite active on the BD side of things. That's part of what we do here at NERC. And I think that we work with the spirit of urgency, but we don't feel like we need to do anything without looking at a program and seeing our technology if it's the right type of program to bring into the company.

As our interests that we've outlined previously, we're currently looking at things in neurology, psychiatry, endocrinology, and immunology with a lens on neurology across those broad categories. Our priorities are pillars, of course, in Grezza and valbenazine and in the pipeline of business development. We've talked a lot about the areas that are of interest to us and where we find ourselves like.

but we're open to later later stage and commercial opportunities. We've also mentioned that in previous meetings as well.

And given the diversity of deals that we've done, over time you can see that we're also agnostic in terms of deal structures. So, remain active. We'll continue to look at bringing in new programs to the company and having more news on that over time. So, maybe I'll stop there.

Great. Thank you, Kyle.

Thank you, Kyle.

Next question from Laura Chico with Wedbush Securities. Please go ahead. Good morning. Thank you very much for taking the question. I wanted to pivot back towards Cateaprania and wondering if you could remind us on the strategy with respect to the musklerinic agents that you mentioned your advancing.

a dual M1M4 later this year. I guess bigger picture though, would you consider ultimately advancing multiple agents such as an M4 selective and an M1M4? I guess maybe any commentary there on how you see the evolution proceeding. Thank you.

Thanks. That was one of the attractions of the deal that we were able to do with Soce Heptaurus was the ability to again access to not just one molecule in the Mescarina Gaginous space but to a range of a portfolio of molecules with differential selectivity.

There's a huge opportunity we believe for this set of targets to serve patients broadly with both neuropsychiatric disorders and neurological disorders. We're starting, obviously, with the M4 selective agonist in the treatment of acute psychosis. And as Matt mentioned earlier as well, I think we're doing extremely well with the enrollment.

And then when we think about M1 selective molecules, which we also have within the portfolio of assets that we gain access to, there obviously are broad range of different opportunities there ranging from cognition to other neurological disorders. So we're very excited about that portfolio and we believe that this set of mechanisms can be.

potentially very beneficial for patients across a broad range of indications.

Students with GP is expecting compensation winners asidentified candidates for cerebral Pilots intervene for several cases. Whatever cleared and the return date is theAR may. We present your request. We present your request.

Now, thanks for taking my question. Assuming Krenasapond is approved, could you give us your latest thoughts on potential pricing? Clearly, in a target of mischievousness and CCAH are very different disease states, but if you could give us a frame of reference for Krenasapond, it is relative to annual in-reza pricing that would be very helpful. Another reason I am asking this is because if I remember right, in-reza price at launch, far exceeded investor expectations at the time.

So, Samont, I do think it's very premature to talk about pricing at this point for a number of reasons, not the least of which we do not have any of the phase three data in. Pricing is one that is...

is very much hinges on what is the ultimate benefit that you bring to this patient population. We see that crinocerfon can be highly beneficial to this patient population, but one needs to develop the data set, go and have discussions with the FDA, ultimately come out with the label.

A lot of work goes on, actually has already started, but in the very beginnings of developing the entire wealth of data that we go through before we settle on a range of prices. So thank you for the question, but too premature. Thanks.

I know it's early, but any thoughts on how you would think about differentiation, whether it's efficacy, safety in schizophrenia versus the late-stage product, RXT, that's in development? That's number one. I just want to ask a second question on...

in psychiatry, pipeline in general. Over time, I wanted to make sure I didn't misinterpret your remarks, Kevin, but is it fair to say that you may take your foot off the gas in terms of small molecule development in psychiatry and just philosophically, how do you think about that? Thank you.

So I'll take the first part very quickly. No, there is no taking the foot off the gas. We're dedicated to psychiatry. What I was saying is that for the foreseeable future, we do not see a role for biologics in psychiatry. So therefore, our small molecule efforts in psychiatry will stay.

it to neurological diseases, neuroendocrine diseases, what that will allow neurocran to do, what it allows us to do right now is let's choose the right target for the right disease and then be able to hit it with the right therapeutic modality. We are not constrained any longer by just small molecules.

We have all of the therapeutic modalities at our fingertips. Irie? Yeah, on the question of differentiation, it really is too early to be able to talk about that. I think the power and the value that we have with this portfolio of highly differentiated Muscoorine agonist is the ability to conduct the pre-tunnelical and clinical experiments that will allow us to understand that differentiation.

And as I mentioned, I don't believe that for a dual M1M4 that we are constrained to schizophrenia as a single indication in that setting either. And so I do believe there's a lot of opportunity both in the neurological and psychiatry space for this portfolio. Yeah, this is Kyle. I'll just add and close on that. I think the where my starting point is on.

and taking that forward as Irie mentioned, we don't have clinical data to differentiate, but certainly being the position that we have right now as a starting position, we have a lot of excitement around this program across the dual and other molecules that we have.

Next question from Akash Tewari with Jeffries, please go ahead.

due to neutropenia. So what are your expectations for neutropenia going into your CH data and what level of dropouts have you baked in in your powering for the trial? Thank you. Thanks for that. So as you rightly said, the study in which a sporadic

laboratory measures of low white count were seen was in major depressive disorder. And conesophone was studied in a phase two study of major depressive disorder prior to us actually having our hands on the molecule. In that setting, there were no adverse events associated with the...

nor is there a signal in the pre-clinical setting. We now have over a thousand patients treated with Kronessa font and so obviously as you can imagine, patient safety is paramount for us in the context of this program and we don't worry about neutropenia in the context of this molecule.

in the pre-conocal setting. We now have over a thousand patients treated with Kinesa font and so obviously as you can imagine patient safety is paramount for us in the context of this program and we don't worry about neutropenia in the context of this molecule. That's really helpful. Thank you.

We will take our next question from Evan Segerman. Please go ahead with BMO Capital. Hey, guys. This is Keith on for Evan. Thanks for taking our questions. I guess on the anhedonia readout, I know we're a ways out, but could you give us a sense of what good data would look like?

Maybe more specifically what improvements on the DAR scale could translate to in the clinic or on a functional level. And then could you draw a line from anhedonia to broader set of negative symptomology across mental illness? How do you think of this as a distinct symptom? Thanks.

As you know, there are no drugs approved for the treatment of anhedonia and major depressive disease and in fact, there have been very few clinical trials done. This is a proof of concept phase 2 study. We have measures embedded within the study looking at both the anhedonic scales and also the major depressive scales themselves. It's impossible at this point in time prior to the readout that data to be able to draw any conclusions or

Our next question comes from Mohade Spensel with Wells Fargo. Please go ahead. Hi, this is Serena on firm Mohade Bonsal. Thanks so much for taking your question. So I want to ask two questions. First, on the cadence of SG&A Spend, just given that significant growth in Q1, what comes off in the rest of the year. Here.

or would they only be treated during time support control? Thank you.

I'll answer both of those questions. On the SG&A spending, there was a bull suspending in Q1. You should expect that to step down in Q2. The way I look at it is we expect to hit our expense guidance range. So I'd take the remainder.

of the FGNA spending and divided by three, it's gonna be pretty consistent, I believe Q2 through Q4. On the CH front, yeah, there is some centers of excellence that help treat many patients with CH. And I think that the KOLs there will be the thought leaders to help inform what the local endocrinologist do to help support patients with CH. And would you believe this would be?

We'll take our next question from Ash Verma with UBS. Please go ahead.

Thanks for taking my question. So for the TranSafon pediatric study, do you have four-week primary endpoint data on baseline info reduction in-house already? If you can comment on that please and are you waiting for the 28-week data on the secondaries to top-line this?

Thanks. Although the primary endpoint is the four-week data, the study is blinded out to the 24-week steroid reduction part of that maintenance treatment. And so as we signaled, the data will be in-house in Q4 of this year.

Our next question comes from Jatin with Guggenheim Partners. Please go ahead.

Hey guys, thank you for squeezing me in. Just a quick question on 3, 5, 3, the FOAS study. Can you really just give me a little bit up there on how the environment is and your confidence in 4, Q guidance. I mean, we're seeing, you know, a little bit of a delay in the environment from other competing studies, especially looking at FOAS. And then the other question I have is, is this just a outside U.S. focus study?

Thank you.

Next question from, comes from Ouiyear with Misuho. Please go ahead.

Hey guys, thanks for squeezing me in. Just a quick question. I think you guys mentioned, you know, growth when Grazer was coming from everywhere. Just wondering, you know, what the added sales force, are you seeing largely growth more from breath or are you also seeing depth?

in terms of physicians for striving more of drugs to be a patient. Thanks.

Yeah, to build on my earlier comments, you know, we're seeing nice growth across all three of the segments, psychiatry, neurology, and the newest segment, which is long-term care. You know, obviously, with the expansion of our sales team, we were able to reach more ACPs, ACPs that we hadn't been able to reach previously. So we are seeing...

are different segments in terms of how developed they are, but ultimately we're very pleased with the results that we're seeing across all segments of our business. If I can, can I squeeze in a question on Kvinessa Fond? Hey, we'll follow up with you. We gotta get one more question then, thanks. Thanks.

in terms of how developed they are. But ultimately, we're very pleased with the results that we're seeing across all segments of our business. If I can, can I squeeze in a question on Clonesafont? Hey, Uy we will follow up with you. We've got to get one more question in. Thanks. Ok.

And we will take our last question from Ami Fariha with NITAM. Please go ahead. Great, thanks for speaking. With regards to the performance of NRESA in the quarter, it was pretty strong and sort of leads me to think about the growth you see in the upcoming quarters and…

the growth that's baked into guidance. Can you comment on how you see that progressing? At what point would you consider reevaluating your guidance there? And then secondly, with regards to Huntington's disease, your

How quickly do you, given the awareness level amongst physicians that they do treat TD patients? Thank you.

around inventory, but our expectation is will we evaluate guidance here in the middle of the year and we'll see what underlying demand looks like, but as we sit here today as Kevin mentioned, as Eric mentioned, as I've mentioned, record numbers and new patients things look good from an underlying demand perspective. On HD, you know, I think post-approval, it is going to take a bit of time to educate

Thank you. I want to thank everyone today. Just a couple of closing comments. I know you probably think I sound like a broken record, but our performance today, and Gres's performance today really supports this. We are still at the very beginnings of this market. Eric has said many times he's never seen such an undeveloped market.

a huge runway with this drug in order to continue to invest in it as we have done and to then see how the growth of this drug is just going to continue in the future. Specific to this year, as I said as I started, you start a year like we've started it, it traditionally is just a really…

said always judge Ingress on its full year performance and that has always been outstanding. And as I, to reiterate, I think it's going to be outstanding again. The other things that we are really focused on is that we've made commitments to ourselves, to our patients, to you, that we're going to have several data readouts in the second half of this year and we're going to perform on those data readouts. We will have.

all of those in and we are very much looking forward to the Pedupa Dayton in August of this year with Huntington's. So once again, I'd like to thank you all this morning for your questions. I'm sorry that we couldn't get to absolutely everyone. There were times you're going to have to help us with not having multiple questions please in the future.

so that we can give everyone a chance. We try to keep our opening remarks short and our closing remarks shorter. So with that, I'll say have a wonderful day and look forward to talking to you soon in the meetings throughout the year.

Please also conclude today's program. Thank you for your participation. You may disconnect at any time.

Please also include today's program. Thank you for your participation. You may disconnect at any time. Goodbye.