Title

Presentation

Neurocrine Biosciences, Inc. beats earnings expectations. Reported EPS is $1.91, expectations were $1.68.

Operator: Please standby, your meeting is about to begin. Hello and welcome everyone joining today’s Neurocrine Biosciences, Inc. 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 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.

Todd Tushla: Thank you, and happy Cinco de Mayo to everyone. Welcome to Neurocrine Biosciences, Inc. first quarter 2026 earnings call. Joining me today are Kyle Gano, Chief Executive Officer; Matthew C. Abernethy, Chief Financial Officer; Eric S. Benevich, Chief Commercial Officer; Sanjay Keswani, Chief Medical Officer; and Sameer Sadanti, 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 Solano 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 in the tables at the end of our earnings release issued earlier today, which has been posted on the Investor Relations page of Neurocrine Biosciences, Inc.’s website. Following prepared remarks, we will address your questions. With that, I will hand the call off to Kyle.

Kyle Gano: Thanks, Todd. Good afternoon, everyone. Over the past several years, we have 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 Neurocrine Biosciences, Inc.’s history, quarterly net product sales exceeded $800 million, representing 44% year-over-year growth. These outstanding results were primarily driven by INGREZZA, now in its ninth year since launch and continuing to grow at a double-digit rate. With INGREZZA guidance reaffirmed at $2.7 to $2.8 billion, Cranesini 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 VICAT XR and the pending acquisition of Soleno Therapeutics, 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 have been impressed by the Solano 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 iCAD XR. We look forward to formally welcoming them to the Neurocrine Biosciences, Inc. 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 1 and four new phase 2 programs this year alone. In 2027, we will report key data readouts for rosuvampodoro in major depressive disorder, dereclidine in schizophrenia, and MBIP 2118 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, Neurocrine Biosciences, Inc. is uniquely positioned to deliver sustained value for both patients and shareholders. Enterprise-wide momentum has never been stronger, and we are just getting started. With that, I will turn the call over to Matt.

Matthew C. Abernethy: 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 INGREZZA and Carnicity, this performance reflects strong underlying demand and the meaningful impact we are having on patients’ lives. Starting with INGREZZA, first quarter 2026 sales were $657 million, up 20% year-over-year, driven by double-digit volume growth in 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 INGREZZA 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 Cranesity, 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 and favorable reimbursement dynamics. As anticipated, we saw some slight gross-to-net pressure in Q1 due to commercial copay resets. As we look ahead, we remain very encouraged by what we are seeing and continue to believe Princeton 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 GAAP and non-GAAP basis, respectively, reflecting strong operating execution.

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, INGREZZA and crenicity 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 Solenno and Bicat XR, 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 osavampitur, dereclidine, and our CRF2 obesity program. With that, I will hand the call over to Eric S. Benevich, our Chief Commercial Officer.

Eric S. Benevich: Thanks, Matt. May 1 marked the nine-year anniversary of the INGREZZA launch. It is 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 are 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 INGREZZA. With continued rapid growth in 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 health care providers to call on for our recently expanded sales force, we anticipate these tailwinds to support strong demand and sales through the back half of the year. Before I wrap up my comments on INGREZZA, I would 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 TDAW.

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 Crinesity, the strong momentum from 2025, the first year of our commercial launch, carried over into our Q1 2026 performance. The Crinesity 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 2025. Importantly, we are seeing growing trial and adoption across all prescriber segments including CAH centers of excellence, pediatric endocrinologists, and community adult endocrinologists.

Through Q1, we have seen over 1,200 health care providers prescribe Cranesiti. Adoption remains balanced across both pediatric and adult populations, as well as between female and male patients, with a modest ongoing skew toward 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 reinforce 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, Cranesity is well on its way to achieving blockbuster status. With that, I will turn the call over to Sanjay Keswani, our Chief Medical Officer, to discuss progress with our exciting clinical pipeline.

Sanjay Keswani: Thanks, Eric, and good afternoon, everyone. I would like to begin with highlights from two recent scientific conferences. Firstly, the American Association for Clinical Endocrinology 2026 annual meeting in Las Vegas. At this meeting, we presented new two-year KRONASTI data from the phase 3 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 Cranespi 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 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 INGREZZA to deuterated tetrabenazine. These data demonstrated greater treatment persistence with INGREZZA 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 INGREZZA 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 INGREZZA’s differentiated profile. Turning to our clinical portfolio, our focus this year is on building and advancing the pipeline. We have initiated three phase 2 studies, all of which are currently enrolling. These include NBI 890, our next-generation VMAT2 follow-on in tardive dyskinesia; dereclidine, our selective M4 muscarinic agonist in bipolar mania; and NBI 570, our selective dual M1 and M4 muscarinic agonist in schizophrenia. Our fourth phase 2 study will be for crinecerfont 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 1 programs underway, including NBIP 2118, 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 NBIP 1968, our proprietary triple G agonist in combination with NBIP 218 for obesity; NBIB 223, our gene therapy program for Friedreich’s ataxia; and NBI 188, our CRF1 antagonist for an indication in women’s health. This strong pipeline momentum in 2026 positions Neurocrine Biosciences, Inc. for multiple significant data catalysts in 2027, including top-line phase 3 readouts for osavapitor in major depressive disorder and the first phase 3 study of direct renal schizophrenia, with a second phase 3 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.

Kyle Gano: Thanks, Sanjay. Nikki, I think we are ready for questions now.

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

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Tazeen Ahmad: Hi, guys. Thanks for taking my question. Congratulations on a strong quarter. I wanted to ask about KRONESTEDY 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.

Kyle Gano: Thanks, Tazeen. I will let Eric take that question.

Eric S. Benevich: Tazeen, hi. I would say overall that we are ahead of where we expected to be at this point, approximately five quarters into the launch. Certainly, we are 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 in Q4, along with continued strong persistency, compliance, and favorable reimbursement. As a result, the prescriptions and the sales are really accumulating nicely. I will point out, though, that most physicians that have prescribed Cranesiti have only treated one patient thus far. And even though we have made great progress in the first year of the launch, the majority of patients have yet to be treated. So we see substantial opportunity ahead.

Operator: Thank you. We will move next to Paul Andrew Matteis with Stifel. Please go ahead. Your line is open.

Paul Andrew Matteis: Great. Thanks very much, and let me add my congrats on a great quarter. For INGREZZA and KRONESITI, can you confirm that there were not any material changes in inventory build or other one-offs that would have temporarily boosted the results for this 1Q? And then as a second part, for INGREZZA, in prior years there has been some nuanced seasonality considerations and headwinds in 1Q that 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 have contracted, and what could the cadence look like sequentially this year versus prior years? Thank you.

Matthew C. Abernethy: Yes, 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. We would expect it to be somewhat similar to what you have seen historically, so well done to the team, and we are set up for a nice growth year the rest of 2026.

Operator: Thank you. Our next question comes from Brian Corey Abrahams with RBC Capital Markets. Please go ahead. Your line is open.

Brian Corey Abrahams: Hey. Good afternoon. Thanks for taking my question, and my congrats on the strong quarter as well. On KRONESTENESITI, 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 is the right way we should be thinking about the expected cadence going forward just based on the trends that you have been observing of late? Thanks.

Kyle Gano: Thanks, Brian. I think Eric did a nice job articulating what we have 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 that sell orphan medicines. But leaning into that and providing color where we think it is relevant, in terms of Q1 we did see good steady new patient starts going from Q4 to Q1, and that extended to persistency and compliance as well, and then continued good reimbursement rate of dispensed scripts. With that, there has been broad accumulation of patients over time since launch, and that is what has given rise to our strong performance in Q1. We look forward to building on that with our expanded sales team for the remainder of the year.

Operator: We will move next to Cory William Kasimov with Evercore ISI. Please go ahead. Your line is open.

Cory William Kasimov: Great. Thanks. I 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 am curious if there is anything you can say as to the accrual of your ongoing phase 3 neuropsych assets in both MDD and schizophrenia, and when do 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 attract a little bit more attention there? Thank you.

Sanjay Keswani: Thanks. I appreciate the question. With respect to our current phase 3 programs, specifically osafampitur for MDD and dereclidine in schizophrenia, they are all enrolling really well. We are very happy with the current enrollment rate, and indeed they should be reading out next year for losobambital, all three phase 3 studies. As for dereclidine, we are expecting the first phase 3 next year, with the second phase 3 the following year. So everything is on track as originally envisaged.

Operator: Thank you. Our next question comes from Corinne Johnson with Goldman Sachs. Please go ahead. Your line is open.

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

Eric S. Benevich: Hi. As a reminder, the patient population with classic CAH that are starting chronicity are quite different from a payer perspective than what we see with tardive dyskinesia. The CAH population is primarily commercially insured, and secondarily Medicaid is the second biggest segment. So we do not see a surge in reauthorizations at the beginning of the calendar year like we do with INGREZZA because of the low Medicare exposure. Typically, when a patient gets authorization for their first prescription, it is normally either six or 12 months, and then those reauthorizations happen as that initial set of prescriptions runs out of authorized fills. Overall, we have seen a really high rate of reauthorization approvals, just like we saw with initial approvals for crinesidine. It is going very well.

Operator: Our next question comes from Philip M. Nadeau with TD Cowen. Please go ahead. Your line is open.

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

Eric S. Benevich: In a nutshell, we have not saturated any part of this market yet. It is still early days with the commercial ramp for Crinesity. As a reminder, thinking about the three segments of prescribers out there—the centers of excellence, the pediatric endocrinologists, and the adult and community endocrinologists—what we estimated was about roughly 15% of the patients are currently under the care of one of those centers of excellence. In general, the distribution of the business so far has been proportional in terms of sources of business. 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 are an adult patient, and if it is a pediatric patient, it could be two or three times a year.

I think that contributes to this very steady rate of new patient adds. Being early in the launch, some of these physicians are getting their initial experience and they have additional patients; they are just waiting for them to come through. I think the sales force expansion is really going to allow us to increase not only the depth of prescribing, but also the breadth of the prescriber base.

Operator: Thank you. We will move next to Brian Peter Skorney with Baird. Please go ahead. Your line is open.

Brian Peter Skorney: Hey, good afternoon, everyone. Thanks for taking the question. Great quarter. It seems like we have become pretty adept at modeling the first quarter headwind that INGREZZA faces. You have spoken about much of an impairment for Carnassity, but I am just wondering if you could give any color or even quantification of any sort of seasonality you are seeing there. Should we look at this as a step-up here on out that would be somewhere in the $20 million per quarter range?

Matthew C. Abernethy: On the gross-to-net front, maybe a couple points of improvement coming off of Q1. But overall, we are still pretty early in this launch cycle, so to be able to tag a normal seasonality would be hard for us to say.

Eric S. Benevich: We do know, as I was mentioning earlier, the flow of patients is pretty consistent quarter in, quarter out, just because of how constrained the prescriber universe is. I would not necessarily point to massive levels of seasonality like you see with INGREZZA. We do not have the bolus of reauthorization in Q1 like we do for INGREZZA, and it is still early in the commercial ramp for crinicity. We are learning a lot about the patient dynamics and the ebbs and flows, but the overarching theme has been really consistent adoption across the community. With the sales force expansion, we will be able to get deeper with the existing base and also expand that base over time.

Operator: Our next question comes from Anupam Rama with JPMorgan. Please go ahead. Your line is open.

Anupam Rama: Hey, guys. Thanks so much for taking the question. Just a quick question about the upcoming ENDO meeting. What are some of the key market or physician outreach initiatives that you are going to have at the conference, as well as any reminders of any data updates we could be expecting for Kinesseti at the meeting? Thanks so much.

Eric S. Benevich: Anupam, I will handle the first part of your question. We are 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 these past few weeks. This past weekend, the Pediatric Endocrine Society meeting was in San Francisco, and I was there and was really impressed with the energy and enthusiasm that we were seeing from the pediatric endocrinologists that had experience with Crinesity. There were two different seminars on CAH at that meeting, and both of them were packed rooms, which I think is indicative of the level of interest. We had a bunch of KOL engagements at that meeting, and we certainly came away with a lot of momentum. We expect to have similar momentum coming out of the ENDO meeting in June.

Sanjay Keswani: I will answer the second part of the question, Anupam. The community continues to be enthused by our two-year open-label data showing the impact of decreased doses of glucocorticoid and also decreased androgen levels. 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 incredibly important in terms of attainment of adult height for children. This is all in the context of really good safety and tolerability. We have now had 35,000 patient-week exposures. All in all, we are really excited about the reception we are getting from the community, both at recent ENDO conferences and at future ones this year.

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

Jay Olson: Hey. Congrats on all the progress, and thank you for providing this update. Since you are planning to move your Friedreich’s ataxia gene therapy program to the clinic this year, can you talk about the phase 1 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 model fits into your core therapeutic areas. Thank you.

Kyle Gano: Jay, thanks for the question. I will focus on the Friedreich’s ataxia program, and we can catch up offline on the other programs in the portfolio. We are looking at starting the FA program here shortly. Once we have all the details ironed out, you will see that up on clinicaltrials.gov. We will talk in more detail, but we are planning on sharing patient-level data toward the end of next year. Consider this a phase 1b trial. We will be starting initially in the patient population. We are excited to potentially offer curative therapy for patients and 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.

Operator: We will move next with Myles Robert Minter with William Blair. Please go ahead. Your line is open.

Myles Robert Minter: Thanks, everyone, for taking the question. Congrats on the quarter. Just wanted to get your updated thoughts on your GGG agonist here. We have Lilly’s type 2 diabetes data, which is pretty impressive but did show pretty high rates of vomiting, diarrhea, and nausea. Considering you are still proposing to put this in a combo with a CRF2 agonist, what are your updated thoughts on the therapeutic window here as you put that into phase 1 development this year? Thanks.

Sanjay Keswani: Thanks for your question, Myles. It is still early days for us. We are very excited about the readout for our CRF2 agonist for obesity next year, and we are assuming that will be a core constituent of a number of different combinations, including one with the triple G program. The GGG program we are targeting for first-in-human this year, and we will have the potential to look iteratively at clinical data for both programs to understand the ideal combination as it affects the risk-benefit profile.

Operator: We will move next with Ashwani Verma with UBS. Please go ahead. Your line is open.

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

Kyle Gano: I will take this question. 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 INGREZZA, 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 are approved for INGREZZA, but we would not expect any wide changes out there in terms of reimbursement for INGREZZA.

Operator: We will move next with Analyst from Leerink. Please go ahead. Your line is open.

Basma: Good afternoon. This is Basma on for Mark. Thank you for taking our question. To follow up on the 24-month data: can you remind us again of the prevalence of insulin resistance and obesity in pediatric CAH patients and also in adults? How was this data received by physicians and how clinically meaningful did they find it? Regarding persistency, it has also been very strong to date. Can you remind us what are the main reasons for patients discontinuing Chronicity? Thank you.

Sanjay Keswani: With respect to the first part of the question, unfortunately weight gain as well as issues with insulin resistance and other cardiometabolic issues are quite common in the pediatric CAH population, and this largely relates to the high doses of glucocorticoids that they receive. It is also thought that the elevated androgen levels can contribute to this cardiometabolic morbidity. The impacts we have seen with Cranesity in our two-year data have been really well received by the community as clinically meaningful.

Eric S. Benevich: I would emphasize that we have seen very strong persistency and compliance with Crinesiti in the real-world setting, consistent with what we saw in our phase 3 trials. As a reminder, in the adult and pediatric studies, around 95% of patients completed and rolled over. In the two-year open-label data we have been presenting recently, over 80% of patients completed two years. It has been very favorable in terms of patients continuing to stay on treatment, and that is a big contributor to the accumulation of prescriptions and sales we are seeing this early in the launch.

Operator: We will move next with Analyst from Wells Fargo Securities. Please go ahead. Your line is open.

Susan: Hi. This is Susan on for Mohit. Congrats on the solid quarter. Two questions. One on Carnestine: did you quantify new patient starts versus persistent patients? If you cannot give a specific answer, just high level, what does that look like? And then on pipeline, for schizophrenia and MDD, how do you envision positioning the drugs?

Eric S. Benevich: I will handle the first part of your question. No, we did not give a specific number of new patient starts. What we did say is that the rate of new patient adds in Q1 was very steady, and the trend was very consistent with what we saw in Q4 of last year.

Sanjay Keswani: For the second part, our current phase 3 MDD patient population includes patients who have not done well on an antidepressant. Typically, they are on an antidepressant that has not achieved a good response, and we are essentially adding on to that antidepressant to achieve a superior response. This is potentially the niche we could occupy in the marketplace as well. Clearly, we are also looking at other life-cycle opportunities with respect to this molecule.

Operator: We will move next with Analyst from Needham. Please go ahead. Your line is open.

Puna: Hi. This is Puna on for Ami. Thank you for taking our question, and congrats on a great quarter. For Chronicity, you have previously noted that you have penetrated approximately 10% of the addressable market, with higher demand in pediatric, followed by other females and other males. How do you see those trends evolving this year? And for NBIP 2118, what would you need to see in the phase 1 data that would support further development? Thank you.

Eric S. Benevich: We are not at the point yet where we are giving guidance on KRONESITY. We are still early in the commercial ramp and are learning a lot about this patient population and this prescriber base. We saw a very steady and consistent rate of new patient adds in Q1. With the sales force expansion, we expect we will be able to build depth in the prescriber base and continue to add new prescribers. There are also many patients not under the care of an endocrinologist. With our patient-finding efforts, we expect to reach and activate some of those patients this year as well. We feel very good about where we are with the launch of Crinesity, and there is a lot of room for organic growth going forward.

Kyle Gano: On NBIP 2118, we are just getting that study up and running, and we will have data on that in 2027.

Operator: We will move next with David A. Amsellem with Piper Sandler. Please go ahead. Your line is open.

David A. Amsellem: Thanks. Wondering if you could talk more about 1435 given that you are going to have phase 2 data in CAH next year. Can you talk about relative potency versus crinesity at the CRF1 receptor, and what do you need to see in terms of differentiation versus crinessity in terms of clinical outcomes and biomarker outcomes in order to justify further advancement?

Sanjay Keswani: We are really excited about our 1435 program. For context, this is an injectable peptide. The nice thing is we could administer this infrequently to individuals. We have some nice preclinical data with respect to durable efficacy that relates to both the length and the depth of efficacy as well. One of the nice things from a drug development point of view is that we have good biomarkers in CAH. We can directly compare the biomarker readouts, including androgen reduction, for this phase 2 program compared to our prior results with Crinesity.

Kyle Gano: To add more here, recall at our R&D Day, we outlined a tiered strategy for our endocrine franchise as it relates to diseases of HPA axis dysregulation. Quineste is going to be the foundational therapy that is part of this for many years into the future, so you can consider that first line. NBIP 1435 offers patients an alternative route of administration and potential other types of differentiation as we identify them in the clinical program. You can think of that as second line, and it is part of a whole series of programs that can target different patient populations for CAH moving forward.

Operator: We will take our next question from Yigal Nochomovitz with Citi. Please go ahead. Your line is open.

Yigal Nochomovitz: Hi. Thanks, and congrats on the strong quarter as well. I was curious with regards to the 90% of TD patients that are not currently on a VMAT2 inhibitor. With the recent consensus recommendations on TD screening in the long-term care setting, to what extent might that help advance gains in market share in that 90% segment?

Eric S. Benevich: Certainly, it is going to help. Over time, in part due to our educational efforts, we have raised awareness of tardive dyskinesia, and we more commonly see routine screening for tardive dyskinesia across different care settings, including long-term care more recently. Having consensus around the need for screening and how to screen, especially for residents in long-term care, raises that index of suspicion in nursing homes, and we can get more people helped. I will also reinforce that the month of May is Mental Health Awareness Month, and this week in particular is TD Awareness Week. Our sales and medical teams are leveraging TD Awareness Week to really raise the energy and excitement around TD screening across all care settings, including long-term care.

Matthew C. Abernethy: Yigal, I will follow up with you after the call. Thanks.

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

Sumant Satchidanand Kulkarni: Thanks. It is 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. Are there some that are already earmarked for external partnering depending on how they progress?

Kyle Gano: I will take the partnering piece. Our goal right now is to move forward programs across our key therapeutic areas—neurology, psychiatry, endocrinology, and immunology. Right now, our pipeline is more weighted to psychiatry, but as our R&D engine moves more programs into the clinic, you will see that evolve into other modalities—small molecules, proteins, peptides—as well as therapies across disease modification and symptomatic treatment. We will follow the science into these different therapeutic areas as we have expertise across them. Right now, we do not have anything slated for partnering, but as time moves along and we see how these programs progress, we would certainly consider those types of relationships. It is not foreign to us; Neurocrine Biosciences, Inc. was built on partnerships, both in- and out-licensing.

Sanjay Keswani: With respect to the first question, it is a really interesting concept. Anecdotally, in our CAH patients, we have reported improvements in executive functioning, suggesting there may be a link to CRF and cognition. That is an area of study for us, and we expect to produce data on that down the road.

Operator: We will move next with Yatin Suneja with Guggenheim. Please go ahead. Your line is open.

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

Matthew C. Abernethy: I always love tax questions. I would expect our non-GAAP effective tax rate to be between 22% and 24% this year and within the low 20s going forward. I think that is the appropriate way to model.

Operator: Thank you. We will move next with Danielle Brill Bongero with Truist Securities. Please go ahead.

Danielle Brill Bongero: Hi, guys. Good afternoon. Thanks so much for the question, and congrats on the strong quarter. You mentioned with KRONESITY that you have slightly more traction with females and pediatrics as expected, but what additional clinical or real-world evidence would help drive broader buy-in from male and adult CAH patients? And was there any rationale behind the Diurnal sale—anything to read into on that? Thank you.

Kyle Gano: I will start with the Diurnal piece. 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. We will consider looking at our own medicines as they evolve through the pipeline, but we felt that was the right move earlier this year. Eric, on the other question?

Eric S. Benevich: Thinking about different patient segments, it is clear there is high motivation to treat pediatric patients. At the Pediatric Endocrine Society meeting this past week, the theme was that with younger patients you need to protect bone age, protect the growth trajectory, and prevent early-onset puberty. For older patients, depending on gender, the rationale for treatment is a little different. For adult patients, there is concern about bone mineral density, potential for increased cardiovascular risk, mood disorders, etc. Depending on one’s gender and stage of life, there is benefit from treatment with chronicity. For males in particular, as an adult male myself, we are not the best at seeing our doctors frequently and we are not very compliant. Our expectation from pre-approval work was that it would probably take a little bit longer to onboard adult male patients relative to female and pediatric patients.

Operator: We will move next with Laura Kathryn Chico with Wedbush Securities. Please go ahead.

Laura Kathryn Chico: Hey. Thanks very much for taking the question. I have one on Trinicity. I will not ask about the pace of new patient adds the remainder of 2026 versus 2025, but I might ask about your expectations for maintaining compliance and persistence this year versus last year. You mentioned the expanded field force and gains on the reimbursement side. How should we think about the persistency and compliance rates in 2026? Thank you.

Eric S. Benevich: Thanks, Laura. We have been looking at compliance and persistency throughout the first year of the launch, and it has been very consistent regardless of when patients started on treatment—early last year, mid last year, or the latter part of last year. I think it is really a function of two things: one is the really great tolerability profile of crinesity that emerged in the clinical trials and the open-label extension; and two, the fact that we have a single pharmacy distributor, Panther, that does a great job of reaching out to patients and following up with them. They have had a lot of success in terms of contacting patients when it is time to get a refill and getting it authorized.

Operator: We will move next with Analyst from Deutsche Bank. Please go ahead. Your line is open.

Sam: Hi. This is Sam on for David. Thanks for taking my question. Just a quick one on crinecerfont in CAH patients under the age of four: the impending phase 2 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 is there anything else you can share in terms of the regulatory or commercial timeline for this development? Thanks.

Eric S. Benevich: I will tackle the unmet-need part. For these younger patients, the earlier you can intervene, the better, in terms of protecting the growth trajectory and bone age, and so on. Right now, the labeling is limited to patients age four and above. We have gotten a fair number of inquiries from parents with children under four asking about the availability of treatment, and certainly from their pediatric endocrinologists. We recognize that there is an unmet need there, and we would like to be able to address it.

Sanjay Keswani: With respect to the regulatory path, we clearly need data in patients less than four years of age. That is the main rationale for starting this U.S.-based study. With respect to timelines, assuming things proceed as planned, in the next couple of years we will have the data to potentially expand the label.

Operator: We will move next with Analyst from Wolfe Research. Please go ahead. Your line is open.

Analyst: Thanks for taking my question. Congrats again on the strong quarter. I have a follow-up on INGREZZA. We touched on seasonality already. Can you provide more color on the pattern for the remaining three quarters, especially given the relatively stronger 1Q versus prior years? And did you notice any changes in the market dynamics following the IRA negotiation?

Eric S. Benevich: In general, we expect 2026 to be similar to prior years, where 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 have moved through that phase already. This year, we were also in the midst of a sales force expansion, and our team did an incredibly great job of continuing to keep the momentum going with our business. The expansion became effective in early Q2. Generally after Q1 payer seasonality, we see a strong focus on execution and driving new patient starts through screening initiatives over the balance of the year. With an expanded field sales team, as I mentioned in my prepared remarks, we expect to see tangible lift and benefit as we get into the latter part of the year.

Operator: We will move next with Evan David Seigerman with BMO Capital Markets. Please go ahead.

Malcolm Hoffman: Hello. Malcolm Hoffman on for Evan. Thanks for taking our question, and congrats on your quarter. Doubling back on the persistence and compliance rates for Pranesti: you noted these have been really strong and consistent since the launch. For the few discontinuations that do occur, are those mostly due to insurance-related issues or product profile? Have those changed over the course of the first year at all? Thanks.

Eric S. Benevich: It is hard to comment on what has turned out to be a very low rate of patients discontinuing. In general, we have not seen people discontinuing due to insurance reasons. In fact, out-of-pocket costs are really low—less than $10 per patient per month—and many patients pay nothing at all. Affordability has not been an issue or a reason to discontinue. There have been instances where patients have moved or have been lost to follow-up, but those are very few and far between. We have been very pleased with the persistency we have seen about five quarters into this launch.

Operator: At this time, there are no further questions in the queue. We will now turn the call back over to Kyle Gano for closing comments.

Kyle Gano: Thanks, Nikki, and thanks, everyone, for joining the call today and for your continued interest and support in Neurocrine Biosciences, Inc. We are very encouraged by the strong start to 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 are very much looking forward to connecting with you all at upcoming investor conferences and events. Thanks again, and talk to you soon.

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

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