Neurocrine Biosciences, Inc.

At any time, please press star zero, and a member of our team will be happy to help you. ¶¶ ¶¶ ? ? ? ? Thank you for your continued patience.

Your meeting will begin shortly.

¶¶ Thank you. ¶¶ © transcript Emily Beynon Thank you.

Please stand by, your meeting is about to begin. Hello and welcome everyone joining today's Neurocrine Biosciences Q1 2026 earnings call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. To register to ask a question at any time, please press star 1 on your telephone keypad. Please note, this call is being recorded. We are standing by if you should need any assistance. It is now my pleasure to turn the meeting over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

Thank you, and happy Cinco de Mayo to everyone. Welcome to Neurocurrent Biosciences' first quarter 2026 earnings call. Joining me today are Kyle Gano, Chief Executive Officer, Matt Abernathy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, Sanjay Kaswani, Chief Medical Officer, and Samir Sedanti, Vice President of Strategy and Corporate Development. During today's call, we will be making forward-looking statements, including statements containing projections regarding future events, such as the anticipated closing of our acquisition of Celeno Therapeutics. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. In addition, some of the information discussed today includes non-GAAP financial measures that have not been calculated in accordance with U.S. GAAP. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented at the table at the end of our earnings release issued earlier today, which has been posted on the investor relations page of the company's website. Following prepared remarks, we will address your questions. With that, I'll hand the call off to Kyle.

Thanks, Todd. Good afternoon, everyone. Over the past several years, we've articulated a clear vision to become a leading biopharmaceutical company driven by growing and diversifying our revenue base while advancing and expanding our pipeline. Our first quarter performance reflects meaningful progress along that path. For the first time in Neurocrime's history, quarterly net product sales exceeded $800 million, representing 44% year-over-year growth. These outstanding results were primarily driven by Ingresa, now in its ninth year since launch and continue to grow at a double-digit rate. With ingressive guidance reaffirmed at $2.7 to $2.8 billion, chronicity now annualizing at over $600 million per year, and the pending addition of ICAT-XR to our commercial portfolio, we are well positioned to deliver record net product sales in 2026. Regarding ICAT-XR and the pending acquisition of Selenotherapeutics, we will be limited in our ability to address questions today given the ongoing tender offer. The acquisition remains on track to close in the second quarter. That said, we've been impressed by the Celino team's accomplishments in delivering strong clinical results in a complex disease, enabling broad utilization with a simple label, and overseeing a strong launch of ICAT-XR. We look forward to formally welcoming them to the Neurocrine team shortly. Together, we will remain focused on ensuring a seamless integration with a singular goal of serving patients with Prader-Willi syndrome in the United States. Beyond strengthening our commercial portfolio, we continue to invest in our R&D engine across neurology, psychiatry, endocrinology, and immunology. Our pipeline progress is evident by our plan for six new Phase I and four new Phase II programs this year alone. In 2027, we will report key data readouts for Osteo-Vapidora Major Depressive Disorder, Direct Lidine and Schizophrenia, and MBI-P2118 in obesity, just to name a few. When you combine the durability and remaining growth opportunity for our commercial assets, our innovative R&D engine, and our strengthening financial profile, Neurocrin is uniquely positioned to deliver sustained value for both patients and shareholders. Enterprise-wide momentum has never been stronger, and we're just getting started. With that, I'll turn the call over to Matt.

Thank you, Kyle, and good afternoon, everyone. First, congratulations to our commercial and medical teams on an outstanding quarter. we delivered more than $800 million in total revenue with over 40% year-over-year growth. Importantly, for both Ingresa and Kernesity, this performance reflects strong underlying demand and the meaningful impact we are having on patients' lives. Starting with Ingresa, first quarter 2026 sales were $657 million, up 20% year-over-year. driven by double-digit volume growth and record new patient additions. When adjusting for one less order week in Q1 2025, growth was approximately 11%. We are encouraged by the strength of the business exiting Q1 and are reaffirming our 2026 ingressive guidance of $2.7 to $2.8 billion. Consistent with our historical approach, we will revisit guidance following the first half of the year, Turning to chronicity, first quarter 2026 sales were $153 million, driven by strong persistency and consistent new patient enrollment forms compared to Q4. We continue to see broad prescriber adoption in favorable reimbursement dynamics. As anticipated, we saw some slight growth in net pressure in Q1 due to commercial copay resets. As we look ahead, We remain very encouraged by what we're seeing and continue to believe Pernicity is well-positioned to become a blockbuster medicine. Our revenue performance continues to support R&D investment while expanding profitability. During the first quarter, we generated around $200 million of net income on a gap and non-gap basis, respectively, reflecting strong operating executions. On a GAAP basis, these results included gains related to equity investments and the sale of the diurnal business. On a non-GAAP basis, these results include $44 million in milestone expense and IPR&D. As you model operating expenses for the rest of the year, the full impact of the commercial expansion will be seen starting in the second quarter. So stepping back, Ingress and Chronicity together provide a growing commercial foundation generating durable cash flows that enable continued investment in innovation and strategic business development opportunities. This aligns directly with our capital allocation priorities to, number one, drive revenue growth, number two, advance our pipeline, and three, invest in business development. Regarding the announced acquisition of Celeno and VicatXR, We are excited to add this asset to our portfolio and strengthen our long-term growth profile. We are not providing financial guidance related to the transaction at this time and will limit commentary during Q&A. Assuming a second quarter close, we expect to provide additional financial details on our Q2 earnings call. Overall, the first quarter reflects strong momentum across both our commercial portfolio and pipeline. with multiple key data readouts expected over the next 18 months, including Osevanpator, DirectLadeen, and our CRF2 obesity program. With that, I will hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

Thanks, Matt. May 1st marked the nine-year anniversary of the InGresa launch. It's remarkable that now, nine years post-FDA approval and launch, we continue to deliver record new patient starts. This is a testament to both our commercial execution and the high unmet need of the tardive dyskinesia community. Our ongoing investments in the sales force, marketing initiatives including DTC, and improved formulary access are clearly driving strong results. I want to acknowledge our commercial and medical teams who continue to make a meaningful difference for patients to relieve the burden of tardive dyskinesia or chorea associated with Huntington's disease. While proud of these achievements, we're even more encouraged by the significant opportunity that remains. Approximately 90% of the estimated 800,000 TD patients in the U.S. are currently not receiving standard-of-care first-line treatment with a VMAT2 inhibitor like Ingreza. With continued rapid growth and antipsychotic utilization, the prevalence of tardive dyskinesia is expected to rise over time at a rate exceeding U.S. population growth. With an increased base of psychiatric healthcare providers to call on for our recently expanded sales force, we anticipate these tailwinds to support strong demand in sales through the back half of the year. Before I wrap up my comments on Ingresa, I'd like to remind everyone that May is Mental Health Awareness Month, and this week in particular is TD Awareness Week, what we affectionately refer to as TDOT around here. This is an important week we circle on our calendar each year where we partner with key patient advocacy organizations in mental health, along with state and local governments across the country, to raise awareness and to deliver hope to the many thousands of people needlessly suffering from TD. Now, returning to chronicity, the strong momentum from 2025, the first year of our commercial launch, carried over into our Q1 2026 performance. The chronicity launch continues to progress extremely well, with steady new patient starts, high persistency and compliance rates, and favorable reimbursement, consistent with the trends we observed in the fourth quarter of 2025. Importantly, we're seeing growing trial and adoption across all prescriber segments, including CAH Centers of Excellence, pediatric endocrinologists, and community adult endocrinologists. Through Q1, we've seen over 1,200 healthcare providers prescribe chronicity. Adoption remains balanced across both pediatric and adult populations, as well as between female and male patients, with a modest ongoing skew towards pediatrics and females consistent with prior trends. As Sanjay will discuss in more detail, we continue to generate compelling long-term efficacy, safety, and tolerability data that further reinforces the value proposition and chronicity's emerging position as a standard of care treatment together with low-dose GCs for patients with classic CAH. With sales now annualizing at greater than 600 million, chronicity is well on its way to achieving blockbuster status. So with that, I'll turn the call over to Dr. Sanjay Keswani, our chief medical officer, to discuss progress with our exciting clinical pipeline.

Thanks, Eric, and good afternoon, everyone. I'd like to begin with highlights from two recent scientific conferences. Firstly, the American Association of Clinical Endocrinology 2026 Annual Meeting in Las Vegas. At this meeting, we presented new two-year chronicity data from the Phase III Catalyst Adult Study, demonstrating sustained and substantial reductions in glucocorticoid doses in adults with classic congenital adrenal hyperplasia. Approximately 70% of patients achieved glucocorticoid doses within the physiological range without compromising androgen control. Indeed, a similar proportion of patients, i.e. 70%, sustainably achieved normal levels of androgens. These two-year findings demonstrated that chronicity provided durable androgen control while enabling meaningful reductions in glucocorticoid exposure, resulting in positive impacts on bone health bone aging, hirsutism, acne, weight, and insulin resistance. Importantly, these benefits were sustained over time with greater than 80% study retention and no new safety or tolerability signals were observed. Collectively, these findings support chronicity as a long-term treatment option that meaningfully advances the standard of care for people living with classic CAH. We look forward to providing additional two-year data across a broader set of clinical endpoints and outcomes at upcoming medical meetings, including ENDO 2026 in June. Also in April, at the Academy of Managed Care Pharmacy 2026 annual meeting, we presented the first real-world head-to-head claims data comparing Ingresa to deuterated tetrabenazine. These data demonstrated greater treatment persistence with Ingresa capsules, including higher rates of long-term treatment continuation and lower rates of switching between medications among adults with tardive dyskinesia. Importantly, this higher persistence with Ingresa was observed early in treatment and sustained over a six-month follow-up period. As a first real-world comparison of its kind, These findings provide meaningful evidence to inform decisions in clinical practice and further reinforce Ingresa's differentiated profile. Turning to our clinical portfolio, our focus this year is on building and advancing the pipeline. We've initiated three phase two studies, all of which are currently enrolling. These include NBI 890, our next generation VMAT2 follow-on in tardibus gynesia, Durecladine, our selective M4 muscarinic agonist in bipolar mania. And NBI570, our selective dual M1 and M4 muscarinic agonist in schizophrenia. Our fourth phase two study will be for cronisophant in patients under four years of age with classic CAH. This study is on track for initiation in the coming months. In addition, we currently have a total of nine phase one programs underway. including NBIP2118, a corticotropin-releasing factor type 2 receptor peptide agonist for obesity, with top-line data expected in 2027. We plan to initiate four additional phase 1 studies in 2026, including NBIP1968, our proprietary GGG agonist in combination with NBIP2118 for obesity, NBI-B223, our gene therapy program for Friedrich's ataxia, and NBI-188, our CRF1 antagonist for an indication in women's health. This strong pipeline momentum in 2026 positions Neurocrine for multiple significant data catalysts in 2027, including top-line Phase III readouts for Ossipapitor in major depressive disorder and the first phase three study of direct adenine schizophrenia, with a second phase three study readout anticipated the following year. In summary, our execution in 2026 is focused on advancing a broad and diversified pipeline, setting the foundation for significant clinical and commercial value creation beginning in 2027. And as we highlighted at our 2025 R&D day last December, this is just the beginning. With that, I will hand the call back to Kyle.

Thanks, Sanjay. Nikki, I think we're ready for questions now.

Thank you. If you would like to ask a question, please press star 1 on your keypad. To leave the queue at any time, press star 2. And once again, that is star and 1 to ask a question. We will take our first question from Tasin Akhmas with Bank of America. Please go ahead. Your line is open.

Hi, guys. Thanks for taking my question. Congratulations on a strong quarter. I wanted to ask about chronicity growth. Relative to where you thought it would be at this stage, how is that launch progressing? And can you talk to us about what the physician activation efforts have been? Are they reactivating older patients? And where are most of their scripts currently coming from? Thanks.

Thanks, Suzanne. I'll let Eric take that question.

Yeah. Tizian, hi. I would say overall that we're ahead of where we expected to be at this point, you know, approximately five quarters into the launch. Certainly we're very pleased with the continued adoption that we saw in Q1. I would describe the new patient starts as very steady and consistent with the trend that we saw from Q4, along with continued strong persistency and compliance. and favorable reimbursement. So as a result, the prescriptions and the sales are really accumulating nicely. I will point out, though, that most physicians that have prescribed chronicity have only treated one patient thus far. And even though we've made great progress in the first year of the launch, the majority of patients have yet to be treated. So we see, you know, substantial opportunity ahead.

Thanks. Thank you.

We will move next with Paul Matisse with Stifel. Please go ahead. Your line is open.

Great. Thanks very much. And let me add my congrats on a great quarter. For Ingresa and Kernessity, can you confirm that there weren't any material changes in inventory build or other one-offs that would have temporarily boosted the results for this 1Q? And then just as a second part to this, for Ingresa, in prior years, there's been some nuanced seasonality considerations and headwinds in 1Q that you know, have been problematic for you temporarily in January and February, but then ultimately lead to some tailwinds into 2Q. I was wondering if you can speak to what that seasonality dynamic might have been this quarter. Has it gotten better now that you've contracted? And just as a result, like, what could the cadence look like sequentially this year versus prior years? Thank you.

Yeah, so on the inventory, there was nothing material, nothing to note, a really clean quarter, reflecting very strong underlying demand. The team did a really good job managing through seasonality this quarter and would expect it to be somewhat similar to what you've seen historically. So well done to the team, and we're set up for a nice growth year the rest of 2026.

Thank you.

Our next question comes from Brian Abrams with RBC Capital Markets. Please go ahead. Your line is open.

Hey, good afternoon. Thanks for taking my question and my congrats on the strong quarter as well. On chronicity, so it sounds like the new patient start forms have been steady and consistent. I was wondering if you could elaborate a little bit more on that and maybe what's the right way we should be thinking about the expected cadence going forward just based on the trends that you've been observing of late. Thanks.

Thanks, Brian. This is Kyle. I think Eric did a nice job articulating what we've seen in terms of new patient starts for Q1. As we mentioned previously, we are moving away from sharing specific numbers and focusing more on top line net sales moving forward, which would be consistent with other companies just where orphan medicines, but leaning into that and providing color where we think it's relevant. And in terms of Q1, we did see good steady new patients starts going from Q4 to Q1, and that extended to persistency and consistency or compliance as well, and then continued good reimbursement rate of dispensed scripts. So with that, there's been broad accumulation of patients over time since long, and that's what's given rise to a strong performance in Q1.

And we look forward to building on that with our expanded sales team here the remainder of the year.

Thank you.

We will move next with Corey Cosimoff with Evercore ISI. Please go ahead. Your line is open.

Great. Thanks. Appreciate you taking the question. And, yeah, it was a great quarter, but I do want to switch gears a little bit and ask about the pipeline. I'm curious if there's anything you can say as to the accrual of your ongoing Phase 3 neuropsych assets to both MDD and schizophrenia, and when you think you might be in a better position to provide more granular or narrow guidance on timing of these top-line readouts that might kind of attract a little bit more attention there. Thank you.

Thanks. I appreciate the question. I think I'll let Sanjay take this.

Hi. Yeah. So with respect to our current phase three program, specifically in Ossiphampertor for MDD and direct adenine schizophrenia, they're all enrolling really well. So we're very happy with the current enrollment rate. And indeed, they should be reading out next year for Ossiphampertor, all three phase three studies, And as the Director-Dean, we're expecting the first phase three next year, but the second phase three the following year. So everything on track as originally envisaged.

Okay, thank you.

Thank you. Our next question comes from Corinne Johnson with Goldman Sachs. Please go ahead, your line is open.

Thanks, and good afternoon, guys. I was just curious if you could talk a little bit about the reauthorization processes you saw for chronicity in 1Q, and if you could provide any kind of commentary on reimbursement trends you're seeing in that population. Thanks.

Yeah, hi. So, as a reminder, the patient population with classic CAH that are starting chronicity are quite different than from a payer perspective than what we see with tardive dyskinesia. So CH population is primarily commercially insured and secondarily Medicaid, the second biggest segment. So we don't see a surge in reauthorizations at the beginning of the calendar year like we do with Ingresa because of the low Medicare exposure. Really what we see is that typically when a patient gets authorization for their first prescription, it's normally going to be either six or 12 months. And then those reauthorizations happen as that initial set of prescriptions, you know, runs out of authorized fills. So overall, you know, we've seen really high rate of reauthorization approvals, just like we saw with initial approvals for chronicity, and it's going very well.

Thank you.

Our next question comes from Phil Nadeau with TD Cowen. Please go ahead. Your line is open.

Good afternoon. Let me add my congratulations on a good quarter. I want to follow up on the answer that you gave to Zine's question. I think in the answer to her question, you said that the vast majority of physicians have only written for chronicity once. We're curious to have a little bit more detail on where the patients starting or coming from, whether it's community or expert centers. Our own checks suggest that there have been a decent proportion of patients coming from expert centers. So is that likely to continue? Do you feel like you've begun to saturate that part of the market and are moving more into community, or is there still a lot more room to go at the expert centers? Thanks a

Yeah, in a nutshell, we haven't saturated any part of this market yet. Still early days with the commercial ramp for chronicity. As a reminder, you know, thinking about the three segments of prescribers out there, the centers of excellence, the pediatric endocrinologists, and the adult community endocrinologists. You know, what we estimated was about 15-ish percent of the patients are currently under the care of one of those centers of excellence. And I would say in general, in terms of the distribution of the business so far, it's been proportional in terms of, you know, sources of business. And ultimately, we recognize that probably the biggest rate limiter for getting patients started is the flow of patients through these practices. Most of these patients only see their physician once a year if they're an adult patient. And if it's a pediatric patient, it could be two or three times a year. So, you know, I think that's a contributor to this very steady rate of new patient ads. And certainly being early in the launch, some of these physicians are getting their initial experience and if they have additional patients, they're just waiting for them to come through. I think the Salesforce expansion is really going to allow us to increase not only the depth of prescribing, but also to increase the breadth of the prescriber base.

That's very helpful. Thank you.

Thank you. We will move next with Brian Scorny with Baird. Please go ahead. Your line is open.

Hey, good afternoon, everyone. Thanks for taking the question. Great quarter. It seems like, you know, we've become pretty accustomed and the street seems good at modeling sort of the first quarter headwinds that Ingresa faces. You've spoken about a much different payer mix for chronicity, but I'm just wondering if you can kind of give any color or even quantification of any sort of seasonality you're seeing there. I mean, or should we kind of look at this as sort of a step up from here on out would be somewhere in the $20 million per quarter range?

Hey, Brian, a clarifier. Are you making the comment relative to Impreza or what to expect seasonality for chronicity?

No, what's expected, what, if anything, you're seeing in terms of seasonality for cornacity, I think, I think we're, we, you know, the street pretty much understands the seasonality dynamic from gross analysis. You know, can we try to help us try to understand what, if any, there is for cornacity that you're seeing?

Yeah, on the gross to net front, maybe a couple points of improvement coming off of Q1. But overall, we're still pretty early in this launch cycle. So to be able to tag a normal seasonality it would be hard for us to say. But we do know, as Eric was mentioning earlier, the flow of patients is pretty consistent quarter in, quarter out, just because of how constrained the prescriber universe is. So I wouldn't necessarily point to massive levels of seasonality like you, maybe not massive, but seasonality like you see with Ingresa.

Yeah, I'd rather tag on. Oh, I'm sorry. I'll just tag on and say that, you know, we don't have the bolus of reauthorizations in Q1 like we do for Ingresa. And it's still early in the commercial ramp for chronicity. And we're learning a lot about the patient dynamics and sort of the ebbs and flows. But I think the overlying theme has been just really consistent adoption across the community. And obviously with the Salesforce expansion, we'll be able to, you know, get deeper with the existing prescriber base and also expand that base over time.

Okay, great. That's helpful. Thank you.

Thank you. Our next question comes from Anupam Rama with J.B. Morgan. Please go ahead. Your line is open.

Hey, guys. Thanks so much for taking the question, and congrats on the quarter. So just a quick question about the upcoming ENDO meeting. What are some of the key market – sort of physician outreach initiatives you're going to have at the conference, as well as remind us of any data updates we could be expecting for Kinesity at the meeting. Thanks so much.

So, Anupam, I'll sort of handle the first part of your question. So, you know, obviously we're looking forward to ENDO coming up in June as an opportunity to engage with the broader endocrinology community. In fact, we were just at a couple of important endocrinology meetings just these past few weeks. This past weekend, the Pediatric Endocrine Society meeting was up in your neck of the woods in San Francisco. And I was there and was really impressed with the, let's call it the energy and the enthusiasm that we were seeing from the pediatric endos that had experience with chronicity. There were two different seminars on CH at that meeting, and both of them were packed rooms, which I think is indicative of the level of interest. Had a bunch of KOL engagements at that meeting, and so it certainly came away with a lot of momentum, and we expect to have similar momentum coming out of the ENDO meeting in June.

And I'll just answer the second part of the question, Annapam. The community continued to be enthused by our two-year open label data showing the impact of decreased doses of glucocorticoid and also decreased androgen levels. And so that relates to better weight control, decreased insulin resistance, as well as decreased issues of virilization, like decreased acne, and also decreased advancement of bone age, which is obviously incredibly important in terms of attainment of adult heights for children. And this is all in the context of really good safety and tolerability. So we've now had 35,000 patient-week exposures. So all in all, I'm really excited about the reception we're getting from the community, both at recent endoconferences and at future ones this year.

Thank you.

Our next question comes from Jay Olson with Oppenheimer. Please go ahead. Your line is open.

Oh, hey, congrats on all the progress, and thank you for providing this update. Since you're planning to move your Friedreich's ataxia gene therapy program to the clinic this year, can you just talk about the phase one study design and what sort of initial data we should expect in 2027? And then separately for your NLRP3 program that you recently licensed, if you could maybe talk about the timeline for moving that into the clinic and where that molecule fits into your core therapeutic areas. Thank you.

Yeah, Jay, this is Kyle. Thanks for the question. I think I'll just focus on the Friedreich's Ataxia program and we can catch up offline on the other programs in the portfolio. But we're looking at starting the FAA program here shortly. Once we have all the details of that ironed out, you'll see that up on clinicaltrials.gov. We'll be able to talk in more details on that. But we are planning on sharing patient-level data towards the end of next year. So we'll kind of consider this as a Phase 1B trial. We'll be starting initially in the patient population. So we're excited to potentially offer curative therapy for patients, and I look forward to talking more about this later this year, in particular at R&D Day, when we can go over the program in more detail.

Thank you.

Thank you. We will move next with Myles Minter with William Blair. Please go ahead. Your line is open.

Thanks, everyone, for taking the question. Congrats on the quarter. I just wanted to get your updated thoughts on your GGG agonist here. Obviously, we've got Lilly's Transcend type 2 diabetes data, which is pretty impressive, but did show pretty high rates of vomiting and diarrhea and nausea. So, Just considering you're still proposing to put this in a combo with a CRF2 agonist, I'm just wondering your updated thoughts on the therapeutic window here and as you put that into the Phase 1 development here this year. Thanks.

Thanks for your question, Myles. Yeah, it's still early days for us. So, clearly, we're going to be very excited about the readout for, as you mentioned, our CRFR2 agonist for obesity, which will be next year. And we're assuming that will be our core constituents of a number of different combinations, including one with the GGG program. The GGG program, we are targeting for first in human this year. And so we'll have the potential to actually look iteratively at clinical data for both programs to understand the ideal combination as it affects the risk-benefit profile.

Thank you.

We will move next with Ash Verma with UBS. Please go ahead. Your line is open.

This is for Ash. Thanks for taking our question. For ingress of payer coverage standpoint, we saw that a state of XR has lost preferred coverage with few key plans recently. We just wanted to understand the implications of that for Ingresa for the rest of this year and next year. Do you think it's possible that PBMs are switching commercial coverage in front of the IRAE or to defend their rebates? Thank you.

Maybe I'll take this question here. Our coverage as it relates to 2026 is very similar to where we exited 2025. We have about 70% of all TD and HD Medicare beneficiary lives covered for INGREZA, and that puts us in a good spot in terms of the loss of deuterated tetrabenazine on certain plans. I think on a relative basis, things that are approved for INGREZA, but we wouldn't expect any wide changes out there in terms of reimbursement for INGREZA.

Thank you.

We will move next with Mark Goodman with Learing. Please go ahead. Your line is open.

Good afternoon. This is Basma on for Mark. Thank you for taking our question. Just to follow up on a previous question on the 24-month data for chronicity, can you remind us again of the prevalence of the insulin resistance and obesity in pediatric CEH patients and also in adults? And how would this data received by the physicians and how clinically meaningful did they find it? Regarding the persistency, it's also been very strong to date. Can you remind us again what are the main reasons for patients discontinuing chronicity? That's it for us. Thank you.

So with respect to the first part of the question, so unfortunately, weight gain as well as issues with insulin resistance and other cardiometabolic issues are actually quite common in the pediatric CH population and this largely relates to the high doses of glucocorticoids that they receive and it's also thought that the androgen levels that they are typically on with respect to their elevation can also contribute to this cardiometabolic morbidity So the impacts we've seen with chronicity with respect to two-year data have been really well received by the community with respect to them being clinically meaningful. I'll hand it over to Eric for the second part.

Actually, I just want to emphasize that we've seen really very strong persistence and compliance with chronicity in the real-world setting. consistent with what we saw in our phase three trials. As a reminder, in the adult and the pediatric studies, it was around 95% of patients that completed in those trials and rolled over. And then in the two-year open label data that we just have been presenting recently at the conferences, over 80% of patients completed two years. So it's been very favorable in terms of patients continuing to stay on treatment And I think that that's a big contributor to the accumulation of prescriptions and sales that we're seeing this early in the launch.

Thank you. Thank you.

We will move next with Mohit Bansal with Wells Fargo Securities. Please go ahead. Your line is open.

Hi, this is Susan on for Mohit. Congrats on the solid quarter. Two questions from us. One on chronicity. I apologize if I missed this, but did you quantify new patient starts versus persistent patients? And if you can't give a specific answer, just high level, what does that look like? And then the follow-up on pipeline. For schizophrenia and MDD, how do you guys envision positioning the drugs? Thanks.

So I'll handle the first part of your question. No, we didn't give a specific number of new patient starts, but what we did say is that the rate of new patient ads in Q1 was very steady, and the trend was very consistent with what we saw in Q4 of last year.

Right. For the second part of the question, so of note, our current patient population for our Phase III studies are patients who have not done well on an antidepressant. Typically, they're an antidepressant that has not achieved a good response, and we're essentially adding on to that antidepressant to achieve a superior response. So this is potentially the niche that we could occupy in the marketplace as well. Clearly, we're also looking at other lifecycle opportunities with respect to this molecule.

Thank you.

We will move next with Ami Fadia with Needham. Please go ahead. Your line is open.

Hi, this is Poonam for Ami. Thank you for taking our question, and congrats on the great quarter. For chronicity, you have previously noted that you've penetrated approximately 10% of the addressable market with higher demand in pediatric, followed by adult females and adult males. How do you see those trends evolving this year? And for NBIP2118, what would you need to see in the phase one data that would support further development? Thank you.

Yeah, so we're not at the point yet where we're giving guidance on chronicity, but what I can say is that, you know, we're still early in the commercial ramp, and we're learning a lot about this patient population and this prescriber base. We saw a very steady and consistent rate of new patient ads in Q1. With the Salesforce expansion, we expect that we'll be able to build the depth in that prescriber base but also continue to add new prescribers. There's a lot of these patients also that are not under the care of an endocrinologist, and so with our patient-finding efforts, you know, we expect to be able to reach and activate some of those patients this year as well. So feel very good about where we are with the launch of chronicity, and certainly there's a lot of room for organic growth going forward.

On MBI-P2118, we're just getting that study up and running, and we'll have data on that in the second half of 2027.

Thank you. Thank you.

We will move next with David Amsalem with Piper Sandler. Please go ahead. Your line is open.

Thanks. Wondering if you could talk more about 1435, given that you're going to have Phase II data in CAH next year. Can you talk about relative potency versus chronicity at the CRF1 receptor? And then also, what do you need to see in terms of differentiation versus chronicity in terms of clinical outcomes? and biomarker outcomes in order to justify further advancement. Thanks.

Yeah, so we're really excited about our 1435 program. So just for context, this is an injectable peptide. So the nice thing here is we could administer this infrequently to individuals. The secondly, we have some nice data, at least preclinically, with respect to better durable efficacy And that relates to both the length of the efficacy, but also the depth of the efficacy as well. One of the nice things from a drug development point of view is that we have good biomarkers in the area of CEH. So we can directly compare the biomarker readouts, including androgen reduction for this phase two program compared to our prior results with chronicity.

And maybe just to add a bit here more on this, recall at our R&D day we outlined a tiered strategy for our endocrine franchise as it relates to diseases of HP access dysregulation. You know, chronicity is going to be the foundational therapy that's part of this for many years into the future, so you can consider that first line. And then NBIP 1435 offers patients an alternative route of administration and potentially other types of differentiation as we'll be able to identify in the clinical program. And you can think of that as second line, and it's part of a whole series of programs that we think that can target different patient populations for CH patients moving forward.

Thank you.

We will take our next question from Igor Nochenovits with Citi. Please go ahead. Your line is open.

Hi, thanks, and congrats on the strong quarter as well. I was curious with regard to the 90% of TD patients that are not currently on a VMAT2 inhibitor. I'm wondering with regard to the recent consensus recommendations on TD screening in the long-term care setting, to what extent that may help advance the gains in market share in that 90% of the segment of TD patients.

Yes, certainly it's going to help. You know, what we've seen over time is that, you know, in part due to our educational efforts, we've raised awareness of tardive dyskinesia and certainly more commonly and more frequently we see routine screening for tardive dyskinesia across different care settings, including long-term care more recently. And so having some criteria and consensus around the need for screening and how to screen, especially for residents in long-term care facilities, you know, I think raises that index of suspicion in nursing homes, and we can get more people helped. The other thing that I'll reinforce here is that month of May is Mental Health Awareness Month, and this week in particular is TD Awareness Week, and certainly our teams in the field, our sales teams, our medical teams, are leveraging TD Awareness Week to really raise the energy and the excitement around TD screening across all care settings, including long-term care.

Okay, thanks. And just one quick one on craniosupport and the pediatric extension. Hey, you go.

I'll follow up with you after the call. Thanks.

Thank you.

We will move next with Sumant Kulkarni with Canaccord. Please go ahead.

Thanks. It's a two-parter. What are your thoughts on developing CRF antagonists in cognition and working memory-related indications? And you have a lot of pipeline programs now that target several therapeutic areas. So are there some that are already earmarked for external partnering depending on how they progress in the pipeline?

I'll take your second question here on the partnering piece. I'll go right now is to be able to move forward programs across our key therapeutic areas, neurology, psychiatry, endocrinology, and immunology. Right now, I would say our pipeline is more weighted to psychiatry, but as our R&D engine moves more programs in the clinic, you will see that evolve into other modalities, small molecules, proteins, peptides, as well as therapies across disease modification and symptomatic treatment of disease. And we'll follow the science into these different therapeutic areas as we have expertise now across these. Right now, we don't have anything slated for partnering, but as time moves along and we see how these programs progress, we'd certainly be in a spot to consider those types of relationships moving forward. It's not something that's foreign to us. As you know, Nurocrin was built on partnerships both in and out licensing.

Respect to the first question, it's a really, really interesting concept. Indeed, just anecdotally in our CH patients, we have reported improvements in executive functioning suggested that there may be a link between CRF and cognition. So clearly that's an area of study for us, and I'm sure we'll be producing some data on that down the road.

Thanks. Thank you.

We will move next with Jatin Suneja with Guggenheim, please go ahead. Your line is open.

A really quick one for Matt. Can you maybe help me understand the tax? I think last year was about 30% for the year. How should we model this year, maybe in the long term? Thanks.

Yeah, I always love tax questions. No, I would expect our non-GAAP effective tax rate to be between 22% and 24% this year and within the low 20s going forward. So I think that's the appropriate way to model.

Thank you.

Thank you.

We will move next with Danielle Brill with Tourist Securities.

Please go ahead. Hi, guys. Good afternoon. Thanks so much for the question and congrats on the strong quarter. So you mentioned with chronicity that you have slightly more traction with females and pediatrics as expected. Curious what additional clinical or real-world evidence are needed or would help drive broader buy-in from the male and adult CAH patients? And then, sorry if I missed this before, but was there any rationale behind the diurnal sale or anything to read into on that? Thank you.

Yeah, this is Kyle. I'll start with the diurnal piece. I think for our perspective, looking at the opportunity in Europe, which is primarily where the medicine is currently available, we felt it was better suited in an organization that had other products in the commercial landscape at the current time. We'll consider looking at our own medicines as they evolve through the pipeline in the commercial landscape, but we felt that was the right move earlier this year. On the other question, Eric, would you like to take that one?

Yeah. So, you know, thinking about these different patient segments, you know, it's very clear that, you know, there's high motivation to treat these pediatric patients. And we saw that at the Pediatric Endocrine Society meeting this past week. You know, the theme is that with these younger patients, you need to protect the bone age, you need to protect the growth trajectory, and you need to prevent early onset puberty. For older patients, for adult patients, you know, depending on gender, the rationale for treatment, I think, is a little bit different. Certainly, you know, for these adult patients, there's concern about bone mineral density, the potential for increased cardiovascular risk, mood disorders, et cetera. So depending on one's gender and one's stage of life, you know, I think that there's benefit from treatment with chronicity. For males in particular, I can say as an adult male myself, we're not the best at seeing our doctors frequently. We're not very compliant. So our expectation from pre-approval work that we did was that it would probably take a little bit longer to really to onboard adult male patients relative to the female patients and to the pediatric patients.

Thank you.

We'll move next with Laura Chico with Wedbush Securities. Please go ahead.

Hey, thanks very much for taking the question. I've got one on chronicity. I won't ask about the pace of new patient ads for the remainder of 26 versus 25, but I might ask about what your expectations are in terms of maintaining compliance and persistence this year versus last year. You mentioned the expanded field force. You've also seen gains on the reimbursement side. So just trying to think about how we should think about the persistency and compliance rates in 26 on chronicity. Thank you.

Thanks, Laura. So, you know, we've been looking at compliance and persistency throughout the course of the first year of the launch, and we've seen that it's very consistent regardless of when patients started on treatment, whether it was early last year, mid last year, or even the latter part of last year, it's been very consistent. I think it's really a function of two things. One is the really great tolerability of a profile of chronicity that emerged in the clinical trials and the open label extension, but also the fact that we have a single pharmacy distributor, which is Panther, And they do a great job of reaching out to the patients and following up with them. And they've had a lot of success in terms of when it's time to get that refill, being able to reach that patient and to get it authorized.

Thank you.

We will move next with David Huang with Deutsche Bank. Please go ahead. Your line is open.

Hi, this is Sam for David. Thanks for taking my question. Just a quick one on Cronosophon and CAA patients under the age of four, the impending phase two study. How should we be thinking about the opportunity for this patient subset, perhaps in terms of patient numbers or unmet need or potential contribution to the existing CAH franchise down the line? And then if there's anything else you can share in terms of the regulatory or commercial timeline for this development. Thanks.

So I'll tackle the, I guess, the unmet need part. So, you know, obviously, that's an important, like I said, for these younger patients, the earlier you can intervene, the better in terms of protecting that growth trajectory and the bone age and so on. Right now, the labeling is limited to patients that are age four and above, and we have gotten a fair number of inquiries from parents with children that are under four asking about the availability of, or whether they can get treatment, and certainly from their pediatric endocrinologist. So we recognize that there's an unmet need there, and we'd like to be able to address it.

Yeah, with respect to the regulatory path, so clearly we need data in patients less than four years of age. That's the main rationale for starting this U.S.-based study. And with respect to timelines, we're assuming in the next couple of years we'll have the data to potentially expand the label.

Thanks.

Thank you.

We will move next with Rudy Lee with Wolf Research. Please go ahead. Your line is open.

Thanks for taking my question, and congrats again on the strong quarter. I just have a follow-up question on Ingresa. I think we touched on seasonality already, can you provide more color on the pattern for the remaining three quarters, especially given the relatively stronger one Q versus prior years? And did you notice any changes in the market dynamics following the IRA negotiation for us, Tito? Thanks.

So, in general, you know, we expect 2026 to be similar to prior years where, you know, we experience seasonal payer disruption in Q1 primarily related to Medicare patients needing to get reauthorized and commercial patients having a reset of their out-of-pocket copay. Thankfully, we've moved through that phase of the year already. This year, we were also in the midst of an expansion, and I would point out that our team did an incredibly great job of continuing to keep the momentum going with our business and to expand our field sales organization further. and that became effective in early Q2. Generally, what we see after that Q1 payer seasonality is just a really strong focus on execution, being able to drive new patient starts through screening initiatives over the course of the balance of the year. And this year, in particular, with an expanded field sales team, as I mentioned in my prepared remarks, we expect to see tangible lift and benefit from the expanded team as we get into the latter part of the year.

Got it. Very helpful. Thanks.

Thank you. We will move next with Evan Sigerman with BMO Capital Markets. Please go ahead.

Hello. Malcolm Hoffman on for Evan. Thanks for taking our question, and congrats on the recorder. Just doubling back on the persistence and compliance rates for Pernesti, I know you noted that these have been really strong and consistent since the launch, but for the few discontinuations that do occur, are those mostly due to insurance-related issues or a product profile? And have those changed over the course of the first year at all? Thanks.

Yeah, it's hard to really comment on what's turned out to be a very low rate of patients discontinuing. You know, in general, I would say that we haven't seen people discontinuing due to insurance reasons. In fact, out-of-pocket costs are really low. They're less than $10 per patient per month, and many patients pay nothing at all. And so affordability hasn't really been an issue or a reason to discontinue. There have been instances where patients have moved or they've been lost to follow-up, but those are very few and far between, and certainly we've been very pleased with the persistency that we've seen about five quarters now into this launch.

Appreciate it. Thank you.

Thank you. And at this time, there are no further questions in queue. I will now turn the call back over to Kyle Gano for closing comments.

Thanks, Nikki, and thanks, everyone, for joining the call today. Your continuing interest and support in Neurocrine We are very encouraged by the strong start of the year that gives us a lot of momentum when we think about the remaining quarters and likewise our continued momentum across our commercial portfolio, the progress to advance our clinical pipeline, and we're very looking forward to connecting with you all upcoming investor conferences and events. Thanks again and talk to you soon.

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.