Neurocrine Biosciences Q1 2026 Earnings Call - Commercial Momentum Accelerates as Pipeline Catalysts Loom in 2027

Basma, Analyst, Leerink4: Hello 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 one 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.

Brian Abrahams, Analyst, RBC Capital Markets3: Thank you and happy Cinco de Mayo to everyone. Welcome to Neurocrine Biosciences 1st quarter 2026 earnings call. Joining me today are Kyle Gano, Chief Executive Officer, Matthew Abernethy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, Sanjay Keswani, Chief Medical Officer, and Samir Siddhanti, 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 Soleno 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 US 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 the company’s website. Following prepared remarks, we will address your questions. With that, I’ll hand the call off to Kyle.

Basma, Analyst, Leerink0: 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 Neurocrine’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 billion-$2.8 billion, CRENESSITY now annualizing at over $600 million per year, and the pending addition of VYKAT XR to our commercial portfolio, we are well-positioned to deliver record net product sales in 2026.

Regarding VYKAT 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’ve been impressed by the Soleno 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 VYKAT XR. We look forward to formally welcoming them to the Neurocrine team shortly. Together, we will remain focused on ensuring a seamless integration with the 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 6 new Phase I and 4 new Phase II programs this year alone.

In 2027, we will report key data readouts for osavampator in Major Depressive Disorder, direclidine in schizophrenia, and NBIP-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 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.

Basma, Analyst, Leerink2: 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 CRENESSITY, 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 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 INGREZZA guidance of $2.7 billion-$2.8 billion. Consistent with our historical approach, we will revisit guidance following the first half of the year.

Turning to CRENESSITY, 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 co-pay resets. As we look ahead, we remain very encouraged by what we’re seeing and continue to believe CRENESSITY 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 into 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. Stepping back, INGREZZA and CRENESSITY 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 1, drive revenue growth, number 2, advance our pipeline, and 3, invest in business development. Regarding the announced acquisition of Soleno and VYKAT 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 osavampator, direclidine, and our CRF2 obesity program. With that, I will hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Thanks, Matt. May 1st marked the nine-year anniversary of the INGREZZA launch. It’s remarkable that now 9 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 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 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 INGREZZA, I’d like to remind everyone that May is Mental Health Awareness Month, and this week in particular is Tardive Dyskinesia Awareness Week, what we affectionately refer to as TDAW 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.

Returning to CRENESSITY, the strong momentum from 2025, the first year of our commercial launch, carried over into our Q1 2026 performance. The CRENESSITY 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 CRENESSITY. 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 CRENESSITY’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, CRENESSITY is well on its way to achieving blockbuster status. With that, I’ll turn the call over to Dr. Sanjay Keswani, our Chief Medical Officer, to discuss progress with our exciting clinical pipeline.

Brian Abrahams, Analyst, RBC Capital Markets0: Thanks, Eric. 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 2-year CRENESSITY data from the phase III CAHtalyst 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 2-year findings demonstrated that CRENESSITY 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 CRENESSITY 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 2-year data across a broader set of clinical endpoints and outcomes at upcoming medical meetings, including ENDO 2026 in June. 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 6-month follow-up period. As the 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’ve initiated three phase II studies, all of which are currently enrolling. These include NBI-890, our next-generation VMAT2 follow-on in tardive dyskinesia. direclidine, our selective M4 muscarinic agonist in bipolar mania. NBI-’570, our selective dual M1 and M4 muscarinic agonist in schizophrenia. Our fourth phase II study will be for crinecerfont in patients under 4 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 I 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 I studies in 2026, including NBIP-1968, our proprietary triple G agonist in combination with NBIP-2118 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 for multiple significant data catalysts in 2027, including top-line phase III readouts for osavampator in Major Depressive Disorder and the first phase III study of direclidine in schizophrenia, with a second phase III 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.

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.

Basma, Analyst, Leerink0: Thanks, Sanjay. Nikki, I think we’re ready for questions now.

Basma, Analyst, Leerink4: Thank you. If you would like to ask a question, please press star one on your keypad. To leave the queue at any time, press star two. Once again, that is star and one to ask a question. We will take our first question from Tahseen Akmaz with Bank of America. Please go ahead. Your line is open.

Brian Abrahams, Analyst, RBC Capital Markets2: Hi, guys. Thanks for taking my question. Congratulations on a strong quarter. I wanted to ask about CRENESSITY growth. Relative to where you thought it would be at this stage, how is that launch progressing? 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.

Basma, Analyst, Leerink0: Thanks, Tahseen. I’ll let Eric take that question.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah. Tahseen, 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. As a result, the prescriptions and the sales are really accumulating nicely. I will point out, though, that most physicians that have prescribed CRENESSITY have only treated one patient thus far. Even though we’ve made great progress in the first year of the launch, the majority of patients have yet to be treated. We see a, you know, substantial opportunity ahead.

Brian Abrahams, Analyst, RBC Capital Markets2: Thanks.

Basma, Analyst, Leerink4: Thank you. We will move next with Paul Matteis with Stifel. Please go ahead.

Basma, Analyst, Leerink5: Great. Thanks very much. Let me add my congrats on a great quarter. For INGREZZA and CRENESSITY, 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. Just as a second part to this for INGREZZA, 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 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? Just as a result, like, what could the cadence look like sequentially this year versus prior years? Thank you.

Basma, Analyst, Leerink0: Yeah. In the inventory there was nothing material, nothing to note. A really clean quarter reflecting very strong underlying demand. 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. Well done to the team and we’re set up for a nice growth year, the rest of 2026.

Basma, Analyst, Leerink4: Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Please go ahead. Your line is open.

Brian Abrahams, Analyst, RBC Capital Markets: Hey, good afternoon. Thanks for taking my question and my congrats on the strong quarter as well. On CRENESSITY, it sounds like the new patient start forms have been steady and consistent. 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.

Basma, Analyst, Leerink0: 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 that wear orphan medicines. Leaning into that and providing color where we think it’s relevant. In terms of Q1, we did see good steady new patient starts going from Q4 to Q1, and that extended to persistency and consistency or compliance as well, and then continued good reimbursement rate of dispense scripts.

With that, there’s been broad accumulation of patients over time since launch, and that’s what’s given rise to our strong performance in Q1, and we look forward to building on that with our expanded sales team here the remainder of the year.

Basma, Analyst, Leerink4: Thank you. We will move next with Cory Kasimov with Evercore ISI. Please go ahead. Your line is open.

Cory Kasimov, Analyst, Evercore ISI: Great. Thanks. Appreciate you taking the question. Yeah, it was a great quarter, but I do wanna 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 III neuropsych assets. So 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.

Basma, Analyst, Leerink0: Thanks. I appreciate the question. I think I’ll let Sanjay take this.

Brian Abrahams, Analyst, RBC Capital Markets0: With respect to our current phase III programs, specifically in osavampator for MDD and direclidine in schizophrenia, they’re all enrolling really well. We’re very happy with the current enrollment rate. Indeed, they should be reading out next year for osavampator all 3 phase III studies. As for direclidine, we’re expecting the first phase III next year, but the second phase III the following year. Everything on track as originally envisaged.

Cory Kasimov, Analyst, Evercore ISI: Okay. Thank you.

Basma, Analyst, Leerink4: Thank you. Our next question comes from Corinne Johnson with Goldman Sachs. Please go ahead.

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

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Hi. As a reminder, the patient population with classic CAH that are starting CRENESSITY are quite different than from a payer perspective than what we see with tardive dyskinesia. CAH population is primarily commercially insured and secondarily Medicaid is the second biggest segment. We don’t see a surge in reauthorizations at the beginning of the calendar year like we do with INGREZZA 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 gonna be either 6 or 12 months. Then those reauthorizations happen as that initial set of prescriptions, you know, runs out of authorized fills.

Overall, you know, we’ve seen really high rate of reauthorization approvals just like we saw with initial approvals for CRENESSITY, and it’s going very well.

Basma, Analyst, Leerink4: Thank you. Our next question comes from Phil Nadeau with TD Cowen. Please go ahead. Your line is open.

Basma, Analyst, Leerink6: 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 the answer to her question, you said that the vast majority of physicians have only written for CRENESSITY once. We’re curious to have a little bit more detail on where the patients starting are 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. 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.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah, in a nutshell, we haven’t saturated any part of this market yet. Still early days with the commercial ramp for CRENESSITY. As a reminder, you know, thinking about the three segments of prescribers out there, the CAH Centers of Excellence, the pediatric endocrinologists and the adult community endocrinologists. You know, what we estimated was about 15-ish% of the patients are currently under the care of one of those CAH Centers of Excellence. 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. 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. If it’s a pediatric patient, it could be two or three times a year. You know, I think that’s a contributor to this very steady rate of new patient adds. 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 sales force 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.

Basma, Analyst, Leerink6: That’s very helpful. Thank you.

Basma, Analyst, Leerink4: Thank you. We will move next with Brian Skorney with Baird. Please go ahead. Your line is open.

Brian Skorney, Analyst, Baird: 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 headlines that INGREZZA faces. You’ve spoken about, you know, much different payer mix for CRENESSITY, but I’m just wondering if you could 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?

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Hey, Brian, a clarifier. Are you making the comment relative to INGREZZA or what to expect seasonality for CRENESSITY?

Brian Skorney, Analyst, Baird: No, What, if anything, you’re seeing in terms of seasonality for CRENESSITY? I think we, you know, the street pretty much understands the seasonality dynamic for INGREZZA now.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah.

Brian Skorney, Analyst, Baird: I’m just asking, you know, help us try to understand what, if any, there is for CRENESSITY that you’re seeing?

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah, on the gross-to-net front, maybe a couple points of improvement coming off of Q1. Overall, we’re still pretty early in this launch cycle to be able to tag a normal seasonality, it would be hard for us to say. 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. I wouldn’t necessarily point to massive levels of seasonality like you Maybe not massive, but seasonality like you see with INGREZZA.

Brian Skorney, Analyst, Baird: Yeah. No. I’ll just tag on.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: 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 INGREZZA. It’s still early in the commercial ramp for CRENESSITY, and we’re learning a lot about the patient dynamics and, sort of the ebbs and flows. I think the overlying theme has been just really consistent adoption across the community. Obviously, with the sales force expansion, we’ll be able to, you know, get deeper with the existing prescriber base and also expand that base over time.

Brian Skorney, Analyst, Baird: Okay, great. That’s helpful. Thank you.

Basma, Analyst, Leerink4: Thank you. Our next question comes from Anupam Rama with JPMorgan.

Anupam Rama, Analyst, JPMorgan: Hey, guys. Thanks so much for taking the question, and congrats on the quarter. Just a quick question about the upcoming ENDO meeting. What are some of the key market, sort of physician outreach initiatives you’re gonna have at the conference? Remind us of any data updates we could be expecting for CRENESSITY at the meeting. Thanks so much.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Anupam, I’ll sort of handle the first part of your question. 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 pediatric endos that had experience with CRENESSITY. There were 2 different seminars on CAH 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, certainly came away with a lot of momentum. We expect to have similar momentum coming out of the ENDO meeting in June.

Brian Abrahams, Analyst, RBC Capital Markets0: Yeah, I’ll just answer the second part of the question, Anupam. I think the community continued to be enthused by our 2-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 obviously incredibly important in terms of attainment of adult heights for children. This is all in the context of really good safety and tolerability. We’ve now had 35,000 patient week exposures. All in all, I’m really excited about the reception we’re getting from the community, both at recent Endo conferences and at future ones this year.

Basma, Analyst, Leerink4: Thank you. Our next question comes from Jay Olson with Oppenheimer. Please go ahead. Your line is open.

Jay Olson, Analyst, Oppenheimer: 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 I study design and what sort of initial data we should expect in 2027? 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.

Basma, Analyst, Leerink0: Yeah. Jay, this is Kyle. Thanks for the question. I think I’ll just focus on the Friedreich’s ataxia program, we can catch up offline on the other programs in the portfolio. We’re looking at starting the FA 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. We are planning on sharing patient-level data towards the end of next year. Kind of consider this as a phase I-B trial. We’ll be starting initially in the patient population. We’re excited to potentially offer curative therapy for patients, 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.

Jay Olson, Analyst, Oppenheimer: Thank you.

Basma, Analyst, Leerink4: Thank you. We will move next with Myles Minter with William Blair.

Basma, Analyst, Leerink3: Thanks everyone for taking the question. Congrats on the quarter. Just wanted to get your updated thoughts on your triple G 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. 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 I development here this year. Thanks.

Brian Abrahams, Analyst, RBC Capital Markets0: Thanks for your question, Myles Minter. It’s still early days for us. Clearly we’re gonna be very excited about the readout for, as you mentioned, our CRF2 agonist for obesity, which will be next year. We’re assuming that will be our core constituent to the number of different combinations, including one with the Triple G program. Our Triple G program, we are targeting for first-in-human this year. 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.

Basma, Analyst, Leerink4: Thank you. We will move next with Ashwani Verma with UBS. Please go ahead. Your line is open.

Brian Abrahams, Analyst, RBC Capital Markets7: This is Hoyle on for Ash. Thanks for taking our question. For INGREZZA payer coverage standpoint, we saw that VYKAT XR has lost preferred coverage with few key plans recently. We just wanted to understand the implications of that for INGREZZA for rest of this year and next year. Do you think it’s possible that PBMs are switching commercial coverage in front of the IRA year to defend their rebates? Thank you.

Basma, Analyst, Leerink0: 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 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 that are approved for INGREZZA, but we wouldn’t expect any wide changes out there in terms of reimbursement for INGREZZA.

Basma, Analyst, Leerink4: Thank you. We will move next with Marc Goodman with Leerink. Please go ahead. Your line is open.

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

Brian Abrahams, Analyst, RBC Capital Markets0: With respect to the first part of the question. Unfortunately, weight gain as well as issues with insulin resistance and other cardiometabolic issues are actually quite common in the pediatric CAH population, and this largely relates to the high doses of glucocorticoids that they receive. 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. The impacts we’ve seen with CRENESSITY with respect to 2-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.

Basma, Analyst, Leerink0: Yeah, actually, I just want to emphasize that we’ve seen really.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Very strong persistence and compliance with CRENESSITY in the real-world setting, consistent with what we saw in our phase III 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. In the 2-year open label data that we just have been presenting recently at the conferences, over 80% of patients completed 2 years. 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.

Brian Abrahams, Analyst, RBC Capital Markets0: I agree.

Basma, Analyst, Leerink: Thank you.

Basma, Analyst, Leerink4: Thank you. We will move next with Mohit Bansal with Wells Fargo Securities. Please go ahead. Your line is open.

Brian Abrahams, Analyst, RBC Capital Markets8: Hi, this is Susan on for Mohit. Congrats on the solid quarter. 2 questions from us. 1 on CRENESSITY. I apologize if I missed this, but did you quantify new patient starts versus persistent patients? If you can’t give specific answer, just high level, what does that look like? The follow-up on pipeline. For schizophrenia and MDD, how do you guys envision positioning the drugs? Thanks.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: I’ll handle the first part of your question. No, we didn’t 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.

Brian Abrahams, Analyst, RBC Capital Markets0: Right. The second part of the question. 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. 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.

Basma, Analyst, Leerink4: Thank you. We will move next with Ami Fadia with Needham. Please go ahead.

Basma, Analyst, Leerink7: Hi, this is Poorna Kannan on for Ami Fadia. Thank you for taking our question, and congrats on the great quarter. For CRENESSITY, you have previously noted that you’ve penetrated about 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 NBIP-2118, what would you need to see in the phase I data that would support further development? Thank you.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: We’re not at the point yet where we’re giving guidance on CRENESSITY. 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, you know, we saw a very steady and consistent, I should say, and consistent, rate of new patient adds in Q1. With the sales force expansion, you know, we expect that we’ll be able to 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. With our patient-finding efforts, you know, we expect to be able to reach and activate some of those patients this year as well. Feel very good about where we are with the launch of CRENESSITY, certainly there’s a lot of room for organic growth going forward.

Brian Abrahams, Analyst, RBC Capital Markets0: On NBIP-2118, we’re just getting that study up and running, and we’ll have data on that in the second half of 2027.

Basma, Analyst, Leerink7: Got it. Thank you.

Basma, Analyst, Leerink4: Thank you. We will move next with David Amsellem with Piper Sandler. Please go ahead. Your line is open.

David Amsellem, Analyst, Piper Sandler: Thanks. Wondering if you could talk more about NBIP-01435, given that you’re gonna have phase II data in CAH next year. Can you talk about relative potency versus CRENESSITY at the CRF1 receptor? Then also, what do you need to see in terms of differentiation versus CRENESSITY in terms of clinical outcomes and biomarker outcomes in order to justify further advancement? Thanks.

Brian Abrahams, Analyst, RBC Capital Markets0: Yeah. We’re really excited about our NBIP-01435 program. Just for context, this is an injectable peptide. The nice thing here is we could administer this infrequently to individuals. 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 CAH. We can directly compare the biomarker readouts, including androgen reduction, for this phase II program compared to our prior results with CRENESSITY.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Maybe just to add a bit here more on this. You call it our R&D day. We outlined a tiered strategy for our endocrine franchise as it relates to diseases of HPA axis dysregulation. You know, CRENESSITY is gonna be the foundational therapy that’s part of this for many years into the future. You can consider that first line in an NBIP-01435 offers patients an alternative route of administration and potentially other types of differentiation as we’ll be able to identify in the clinical program. You can think of that as second line.

Basma, Analyst, Leerink0: Part of a whole series of programs that we think that can target different patient populations, for CAH patients moving forward.

Basma, Analyst, Leerink4: Thank you. We will take our next question from Yigal Nochomovitz with Citi. Please go ahead. Your line is open.

Brian Abrahams, Analyst, RBC Capital Markets5: Yeah. Hi. Thanks. 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?

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah. 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. 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.

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.

Brian Abrahams, Analyst, RBC Capital Markets5: Okay. Thanks. Just 1 quick 1 on CRENESSITY and the pediatric extension for those patients under-

Basma, Analyst, Leerink0: Hey, you can go Yigal, I’ll follow up with you after the call. Thanks.

Basma, Analyst, Leerink4: Thank you. We will move next with Sumant Kulkarni with Canaccord. Please go ahead.

Brian Abrahams, Analyst, RBC Capital Markets1: Thanks. It’s a two-parter. What are your thoughts on developing CRF antagonists in cognition and working memory re-related indications? 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 in the pipeline?

Basma, Analyst, Leerink0: Yeah. Matt, this is Kyle. I’ll take your second question here on the partnering piece. Our goal 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 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 of disease. 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, Neurocrine was built on partnerships both in and out licensing.

Brian Abrahams, Analyst, RBC Capital Markets0: With respect to the first question, it’s really, really interesting concept. Indeed, just anecdotally in our CAH patients, we have reported improvements in executive functioning, suggestive that there may be a link to CRF and cognition. Clearly, that’s an area of study for us, and I’m sure we’ll be producing some data on that down the road.

Brian Abrahams, Analyst, RBC Capital Markets1: Thanks.

Basma, Analyst, Leerink4: Thank you. We will move next with Yatin Suneja with Guggenheim. Please go ahead. Your line is open.

Brian Abrahams, Analyst, RBC Capital Markets4: 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 and maybe in the long term? Thanks.

Basma, Analyst, Leerink0: 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. I think that’s the appropriate way to model.

Brian Abrahams, Analyst, RBC Capital Markets4: Thank you.

Basma, Analyst, Leerink4: Thank you. We will move next with Danielle Brill with Truist Securities. Please go ahead.

Danielle Brill, Analyst, Truist Securities: Hi, guys. Good afternoon. Thanks so much for the question and congrats on the strong quarter. You mentioned with CRENESSITY that you have slightly more traction with females in pediatrics as expected, but curious what additional clinical or real-world evidence are needed or would help drive broader buy-in from the male and adult CAH patients. Sorry if I missed this before, but was there any rationale behind the Diurnal sale or anything to read into on that? Thank you.

Basma, Analyst, Leerink0: Yeah. This is Kyle Gano. 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 well 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 Benevich, would you like to take that one?

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah. You know, thinking about these different patient segments, you know, it’s very clear, 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.

Depending on one’s gender and one’s stage of life, you know, I think that there’s benefit from treatment with CRENESSITY. For males in particular, you know, I can say as an adult male myself, we’re not the best at seeing our doctors frequently. We’re not very compliant. Our expectation from pre-approval work that we did was that it would probably take a little bit longer to, you know, onboard adult male patients relative to the female patients and to the pediatric patients.

Basma, Analyst, Leerink4: Thank you. We will move next with Laura Chico with Wedbush Securities. Please go ahead.

Basma, Analyst, Leerink1: Hey, thanks very much for taking the question. I’ve got one on CRENESSITY. I won’t ask about the pace of new patient adds for the remainder of 2026 versus 2025, 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. Just trying to think about how we should think about the persistency and compliance rates in 2026 on CRENESSITY. Thank you.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: Yeah. Thanks, Laura. 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 CRENESSITY that emerged in the clinical trials and the open-label extension. Also, the fact that we have a single pharmacy distributor, which is PANTHERx Rare, and they do a great job of reaching out to the patients and following up with them.

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.

Basma, Analyst, Leerink4: Thank you. We will move next with David Huang with Deutsche Bank. Please go ahead. Your line is open.

Basma, Analyst, Leerink9: Hi, this is Sam Huang for David. Thanks for taking my question. Just a quick one on crinecerfont and CAH patients under the age of 4, the impending phase II 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? Then if there’s anything else you can share in terms of the regulatory or commercial timeline for this development. Thanks.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: I’ll tackle the unmet need part. You know, obviously, 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 4 and above. We have gotten a fair number of inquiries from parents with children that are under 4, asking about the availability of or whether they can get treatment, and certainly from their pediatric endocrinologist. We recognize that there’s an unmet need there, and we’d like to be able to address it.

Brian Abrahams, Analyst, RBC Capital Markets0: Yeah, in respect to the regulatory path, clearly we need data in patients less than 4 years of age. That’s the main rationale for starting this U.S.-based study. With respect to timelines, we’re assuming in the next 2 years we’ll have the data to potentially expand the label.

Basma, Analyst, Leerink9: Great. Thanks.

Basma, Analyst, Leerink4: Thank you. We will move next with Rudy Lee with Wolfe Research. Please go ahead. Your line is open.

Basma, Analyst, Leerink8: Thanks for taking my question, and congrats again on the strong quarter. Just have a follow-up question on INGREZZA. I think we touched on seasonality already, but can you provide more color on the pattern for the remaining three quarters, especially given the relatively stronger one Q versus prior years? Did you notice any changes in the market dynamics for the IRA negotiation for Raftio? Thanks.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: 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. You know, thankfully, we’ve moved through that phase of the year already. This year we were also in the midst of an expansion. 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. 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. You know, 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.

Basma, Analyst, Leerink8: Got it. Very helpful. Thanks.

Basma, Analyst, Leerink4: Thank you. We will move next with Evan Seigerman with BMO Capital Markets. Please go ahead.

Brian Abrahams, Analyst, RBC Capital Markets6: Hello, Malcolm often on for Evan. Thanks for taking our question. Congrats on your quarter. Just doubling back on the persistence and compliance rates for CRENESSITY. I know you noted that 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, and have those changed over the course of the first year at all? Thanks.

Eric Benevich, Chief Commercial Officer, Neurocrine Biosciences: 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. 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, those are very few and far between. Certainly we’ve been very pleased with the persistency that we’ve seen about 5 quarters now into this launch.

Brian Abrahams, Analyst, RBC Capital Markets6: Appreciate it. Thank you.

Basma, Analyst, Leerink4: Thank you. At this time, there are no further questions in queue. I will now turn the call back over to Kyle Gano for closing comments.

Basma, Analyst, Leerink0: 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 continuing momentum across our commercial portfolio, the progress to advance our clinical pipeline. We’re very looking forward to connecting with you all upcoming investor conferences and events. Thanks again and talk to you soon.

Basma, Analyst, Leerink4: Thank you. This brings us to the end of today’s meeting. We appreciate your time and participation. You may now disconnect.