Neurocrine Biosciences, Inc (NBIX) Q2 2025 Earnings Call Transcript

Neurocrine Biosciences, Inc (NASDAQ: NBIX) Q2 2025 Earnings Call dated Jul. 30, 2025

Corporate Participants:

Todd Tushla — Investor Relations

Kyle W. Gano — Chief Executive Officer

Matt Abernethy — Chief Financial Officer

Eric Benevich — Chief Commercial Officer

Sanjay Keswani — Chief Medical Officer

Eiry Roberts — Chief Medical Officer

Unidentified Speaker

Analysts:

Tazeen Ahmad — Analyst

Phil Nadeau — Analyst

Paul Matteis — Analyst

Cory Kasimov — Analyst

Jay Olson — Analyst

Brian Abrahams — Analyst

Anupam Rama — Analyst

Brian Scorney — Analyst

Yatin Suneja — Analyst

Unidentified Participant

Corinne Johnson — Analyst

Danielle Breaux — Analyst

Ash Verma — Analyst

David Ansellem — Analyst

Marc Goodman — Analyst

Myles Minter — Analyst

David Hoang — Analyst

Sumant Kulkarni — Analyst

Michael Riad — Analyst

Laura Chico — Analyst

Evan Seigerman — Analyst

Presentation:

Operator

Good day everyone, and welcome to today’s Neurocrine Biosciences Second Quarter 2025 Results Conference. 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. [Operator Instructions] Please note this call may be recorded and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead sir.

Todd Tushla — Investor Relations

Thank you, and Happy Wednesday everyone. Welcome to Neurocrine Biosciences second quarter 2025 earnings call. With me today are Kyle Gano, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, Eiry Roberts and for one first time, as Chief Medical Officer Sanjay Keswani. During today’s call we will be making forward-looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially.

I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks, we will jump into Q&A. I now turn the call over to Kyle.

Kyle W. Gano — Chief Executive Officer

Thank you, Todd. Good afternoon, everyone. We were especially pleased with our standout second quarter that delivered high double-digit growth which showcased our diversified revenue profile and highlighted the organization’s ongoing evolution. From a commercial perspective, our INGREZZA base business continues to post solid growth, and we are excited by the strong early performance of CRENESSITY. For INGREZZA, our strategic investments to enhance payor [Phonetic] access led to another record of new patient starts and TRx for the quarter, further strengthening our leadership in the VMAT2 class. We remain confident these market access initiatives will continue to drive long-term growth for the INGREZZA franchise.

For CRENESSITY, we once again outperform internal expectations. To-date, CRENESSITY has been well received by both patients and prescribers, underscoring the significant unmet needs within the Classic Congenital Adrenal Hyperplasia Community. With a strong product profile across efficacy, safety and tolerability, we believe CRENESSITY is well positioned to become the standard of care for patients with Classic CAH and has all the attributes to be Neurocrine’s second commercial blockbuster. Coming off a successful ENDO conference this month, I’m reminded how far we’ve come. In fact, it was back in March of 2015 at ENDO that we first presented proof-of-concept data in CAH with a CRF receptor antagonist.

This year, over a decade later, I had the opportunity to meet directly with clinicians in the field, which gave me an even deeper appreciation for the impact we are making for CAH patients and for the importance of the work we do every day at Neurocrine. Putting patients at the center isn’t just the guiding principle, it’s what drives meaningful progress. It goes without saying we’re deeply grateful to the patients, their caregivers and families, and investigators who made this progress possible in partnership with the Neurocrine team. We look forward to our continued collaboration.

Turning to the clinical pipeline, we believe we have one of the industry’s deepest diversified neuroscience focused pipelines. I would like to welcome Sanjay Keswani, who officially joined us in June as our Chief Medical Officer. He joins Neurocrine at an exciting time as we have initiated multiple Phase 3 programs within a single calendar year, with both osavampator and NBI-‘568 enrolling patients in registrational studies. At our upcoming R&D Day on December 16th, we look forward to sharing additional data from both programs as well as our perspective on the psychiatry portfolio and progress in our R&D transformation. On the preclinical front, our R&D engine, led by Chief Scientific Officer, Jude Onyia, is advancing internally discovered biologics candidates towards the clinic, which further diversifies our mechanistic approach to address a broad range of diseases aligned with our expertise and strategic focus.

Overall, I’m pleased with our performance in the first half of the year. Looking ahead, sustained revenue contribution from both INGREZZA and now CRENESSITY will enable us to further invest in advancing and expanding our pipeline, and importantly helping more patients than ever before in solidifying Neurocrine’s position as a leading neurology-focused enterprise.

With that, I will turn the call over to Matt.

Matt Abernethy — Chief Financial Officer

Thank you, Kyle, and good afternoon, everyone. Neurocrine’s evolution into a multi-product growth company was underscored by $682 million in net product sales during the second quarter representing 17% year-over-year growth. We expect the profile of both CRENESSITY and INGREZZA to drive meaningful revenue growth, and generate significant cash flow over the coming years positioning Neurocrine to become a leading CNS company.

CRENESSITY grew sequentially from $15 million in Q1 2025 to $53 million in Q2 2025, reflecting strong early adoption by CAH patients and clinicians eager for better treatment options. Although only six months into launch, we are quite encouraged by what we’re seeing in terms of steady new patient starts, greater than 75% of all dispense prescriptions being reimbursed, and overall positive anecdotal feedback on product performance. As Eric says, so far so great, and kudos to everyone involved in this launch.

Shifting to INGREZZA. We delivered $624 million in second quarter sales, including another record number of new patient starts, reflecting the fruits of the sales force expansion, our DTC campaign and early positive signs from our investment in expanded access. Importantly, on both NRx and TRx front, we are seeing prescription market share gains in the first half of 2025. While we expect to gain volume share for the remainder of 2025, dollar share will be impacted in the near-term due to contracting. These are intentional investments that position INGREZZA for continued volume and sales growth, as well as market share gains over the coming years.

Given current performance and considering market access investments for the remainder of the year, we’ve refined the INGREZZA net sales guidance range to $2.5 billion to $2.55 billion which accounts for anticipated double-digit volume gains, partially offset by higher near-term growth to net impact. Overall, INGREZZA is well positioned for continued growth heading into 2026.

A few financial comments. Our capital allocation priorities remained intact, drive revenue growth, advance our R&D programs, enable business development, and return capital to shareholders. Our progress in the first half of 2025 reflect these priorities with the strong launch of CRENESSITY. Continued INGREZZA growth and the initiation of our two Phase 3 programs for Osavampator and MDD, and Muscarinic Schizophrenia trials.

We have increased SG&A GAAP and non-GAAP operating expense guidance by $25 million to support continued CRENESSITY and INGREZZA sales growth, and we expect SG&A leverage throughout the second half of 2025. With $1.8 billion in cash and a strong balance sheet, we are well positioned to support our commercial and clinical development strategies for continued growth. With that, I’ll now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

Eric Benevich — Chief Commercial Officer

Thanks Matt. Q2 was a quarter of continued strong execution of our INGREZZA growth strategy. Our strategic investments in the INGREZZA franchise over the past year are yielding tangible results. These investments, such as last year’s Salesforce expansion, enhanced marketing initiatives and increased contracting for Medicare formulary coverage, combined with strong efforts from our commercial and medical teams, led to a record number of new patient starts and total prescriptions for the quarter. In fact, this was the second quarter in a row of all time high new patient starts.

Q2 sales of $624 million represented 15% sequential growth and year-over-year sales growth of 8%. In addition, we saw continued prescription VMAT2 market share gains in Q2. In Q2 and again in early Q3 as Matt noted, we contracted to further expand Medicare formulary coverage for INGREZZA. We now have formulary coverage for approximately 70% of Medicare beneficiary lives in the TD market. These incremental rebate agreements were mid-year adds to key formularies outside of the regular bid cycle. They substantially improve our coverage and will make it easier for patients and providers to start or reinitiate INGREZZA therapy going forward. The formulary adds in Q2 and Q3 represent approximately a 25 point increase in coverage in just two quarters, and embody the stellar work done by our Market Access team.

We acknowledge that these rebate agreements encompass prescriptions for all current INGREZZA patients insured under those plans, not just the new incremental patients. So we saw an impact on our gross to net which somewhat offset our strong volume growth. However, we believe that over time these Medicare formulary investments will allow us to grow our volume and share faster than we otherwise would. With less than half of the estimated 800,000 TD patients as yet diagnosed, and approximately 13 more years of exclusivity, we believe these sales, marketing, and access investments position the INGREZZA franchise well for growth in the years to come.

Now, turning to CRENESSITY. The launch is off to a strong start with early results surpassing our internal expectations. In Q2 we received 664 new treatment forms and over a 1000 have come in since we launched in late December. This was an important milestone for our franchise. Q2 net sales were $53 million, more than triple our Q1 sales, and over 75% of all dispensed prescriptions in the quarter were reimbursed. Clearly, we’re building strong momentum with this launch. To date, we’ve seen widespread adoption across both pediatric and adult patients, with a slight trend towards pediatrics after two full quarters on the market.

Furthermore, we’ve seen prescriptions written by a range of CAH healthcare providers, including those practicing at multidisciplinary centers of excellence, pediatric endocrinologists, and community-based adult endocrinologists. Given the early stage of the launch, most individual prescribers have only initiated treatment for one or two patients so far, which is to be expected. Now, let me share a little color on the launch. Earlier in July, our commercial and medical teams had a strong showing at the Endocrine Society Annual Meeting in San Francisco, where we presented 16 posters including long-term CRENESSITY, efficacy, and tolerability data and weight related outcomes.

Attendance at our commercial and medical booths, as well as our sponsored symposia was very good. Feedback from endocrinologists who have already treated patients with CRENESSITY was quite positive and the interest level was high amongst those who haven’t yet had a chance to prescribe. With two full quarters, complete CRENESSITY’s performance continues to trend very positively. We have all the right ingredients here for a future blockbuster. High unmet need, strong efficacy and safety data, a broad and favorable label, and highly dedicated teams who put CAH patients’ needs first. Once again, I’d like to thank our commercial and medical teams for driving strong results for both INGREZZA and CRENESSITY in Q2. And with that, for the first time ever, I’ll hand the call over to my new colleague, Dr. Sanjay Keswani, our Chief Medical Officer.

Sanjay Keswani — Chief Medical Officer

Thanks Eric, and good afternoon, everyone. Before I begin, I want to express how enthusiastic I am to join call [Phonetic] the Neurocrine team as Chief Medical Officer. I’d also like to acknowledge my predecessor, Dr. Eiry Roberts, for her remarkable leadership and the significant clinical advancements accomplished during her tenure. I’m grateful that Eiry will continue to support us as a strategic advisor through the end of next year. Now onto the clinical update. The registrational studies for both osavampator in major depressive disorder and NBI-‘568 in Schizophrenia are progressing well.

Indeed, we have just screened the first patient in our second Phase 3 study in Schizophrenia 4,5,6,8. Hence, all the Phase 3 studies as well as the open label studies for 5, 6, 8 and osavampator are up and running, and we anticipate top-line data readouts for osavampator in 2027 and a bit later for 568 in the 2027-2028 timeframe. Regarding data readouts this year, we disclosed in May that for the adjunctive treatment of Schizophrenia, valbenazine did not meet the primary endpoint of improvement in the positive and negative syndrome scale or PANSS.

Recall, this study was designed as a learning opportunity for our next generation VMAT2 follow on programs, and has indeed provided valuable insights. Notably, we observed numerical separation and improvements in the valbenazine ARM compared to placebo as well as statistically significant improvement in positive symptoms. We look forward to sharing the full study results at an upcoming scientific meeting.

Continuing with valbenazine top-line results from our Phase 3 study for the treatment of Dyskinetic Cerebral Palsy will read out in Q4 of this year. In addition, the Phase 2 proof-of-concept and dose finding study for NBI-‘770 are NMDA NR2B Negative Allosteric Modulator will also read out top-line data in Q4. With a positive readout these data could pave the way for a confirmatory Phase 2 study or the initiation of a Phase 3 trial. Turning to our new programs. Last month, we announced the initiation of the Phase 1 study for NBIP-‘1435, a long acting Corticotropin Releasing Factor 1 receptor antagonist administered subcutaneously for the potential treatment of Congenital Adrenal Hyperplasia. This program masks the first investigational peptide from our internal pipeline to advance into the clinic. This is also the first of what we anticipate to be many biological compounds advancing from Chief Scientific Officer Jude Onyia’s, Research Division. Regarding our early-stage Muscarinic programs, we remain on track to initiate the Phase 2 study of NBI-‘570, our dual M1/M4 selective Agonist for the treatment of Schizophrenia.

We also expect to report Phase 1 results later this year for both NBI-‘567, our M1 preferring dual Agonist, and NBI-‘569 our M4 preferring dual Agonist. I look forward to engaging with many of you over the coming months ahead in advance of our R&D Day at Neurocrine’s campus in San Diego on December 16th. With that, I’ll hand the call back to Kyle.

Kyle W. Gano — Chief Executive Officer

Thanks Sanjay. I think we’re ready for questions now.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from Tazeen Ahmad with Bank of America.

Tazeen Ahmad

Hi guys, good afternoon. Thanks for taking my question. So, mine I think is going to be for Matt. Matt, we know that you’re super detail oriented, but taking that into account, you’re narrowing the top end of guidance by $50 million and we’ve still got half of the year left. And I fully appreciate the comments that you made about having mid-year ads and improving access on Medicare, but, I guess how are you triangulating that level of certainty and is that number potentially up for future adjustment as the year progresses? Thanks.

Matt Abernethy

Yeah, thanks Tazeen. It really comes down to the contracting and where net price was coming into the year. As you mentioned, I am detail oriented, and so never like to have anything change throughout the year. But that’s not the case of our business. It’s very dynamic, and on the pricing front we had assumed a flat pricing coming into the year based upon the contracting in place. But throughout this year we’ve been able to pull forward actually some major programs from in contracting from 2026 into 2025. So from a pricing perspective went from flattish pricing expectations to call it negative 5% price decline for the year. And so I think that that should help triangulate where the guidance range is at. From a volume perspective, kudos to the team. Record numbers of TRx, record numbers of new patients, double-digit volume growth. So on the volume side, everything is going well for us as well as in the marketplace. This adjustment down on the top end really comes back to a change in assumption around pricing.

Operator

We’ll move to our next question from Phil Nadeau with TD Cowen.

Phil Nadeau

Good morning, or good afternoon. Thanks for taking our question. Congrats on the CRENESSITY number. It does seem to be launching much more quickly than most of us had anticipated. Can you talk about the dynamics you’re encountering at the clinics? In particular, were there any boluses of patients added to CRENESSITY during the quarter? Any reason why we shouldn’t extrapolate the growth we saw in Q2 to future quarters, or any other dynamics that we should consider as we try to digest the big number you just put up and what that portends for future quarters? Thanks.

Kyle W. Gano

Yeah, hi Phil. So, I’ll comment and maybe Eiry has some additional commentary here. But before the launch and after Q1, we had sort of guided towards what we called a measured launch. And the reasons for that were primarily around patient flow through the practices. We know that adult patients usually only see their endocrinologists once, maybe twice a year, pediatric patients two or three times a year. And endocrinologists had indicated to us that they intended to offer CRENESSITY treatment as patients flow through.

Those dynamics haven’t really changed. We’re still seeing that patients are being initiated subsequent to an in person visit. That being said, we have seen strong adoption. Obviously, we feel really good about the pace of patient starts and is building over time. Certainly, I think it’s a function of our ability to reach the endocrinologist and to get the word out within the patient and family communities. So, kind of getting back to this concept of a bolus. No, it’s not really a bolus or patients that were necessarily waiting for CRENESSITY because for the most part people weren’t aware of it prior to its approval.

But we have seen what I would describe as very steady and consistent adoption. And certainly, we view the activity that we had at ENDO as sort of another booster for us in terms of being able to accelerate that awareness within the endocrinology community.

Eiry Roberts

Hi Phil. Thanks, the only thing I’d add there is, I mean, I do think we have a lot of interest and excitement out there in the community. And we certainly felt that during our participation in ENDO, and that comes from both the clinicians and also the patients. We heard from several of the clinicians that we work with on the medical side that they were receiving a lot of questions from patients and requests from patients to get in and get the opportunity to talk about CRENESSITY.

Certainly, the other place you’d think of a bolus is if there was one coming from the clinical trial environment. And as you know, we signaled that we were shutting down the adult open label trial, and those patients are steadily moving on to commercial CRENESSITY. So, it isn’t a bolus effect there either. And obviously we still have our pediatric open label extension trial going, which is going to provide us with longer term clinical data that we think will be very important.

Operator

We will move next to Paul Matteis with Stifel.

Paul Matteis

Hey, congrats on the great progress with CRENESSITY. Thanks for taking my question. I was wondering if you can share any data or metrics or at least qualitative color and how concentrated prescribing has been at this point. If we look at some other rare disease launches that have had a great start but, maybe tapered off after a bit, it feels like there can be this sort of COE academic dynamic and then the patient acquisition effort increases over time as you have to go to the community. So, how do you think CAH stacks up with these sort of treatment dynamics and what you’re seeing with CRENESSITY. Thank you.

Kyle W. Gano

Yeah, Paul. So, certainly we’re very excited about, the adoption that we’re seeing. And prior to the launch and subsequently, our estimate has been that, if you think about sort of three segments of endocrinology prescribers, we’ve got our centers of excellence that are accredited, and then there are others that are not accredited by the CARES Foundation. Overall, we estimate that around 15% or so of the total CAH patient population flows through a small number of those centers, let’s call it 20% or less.

And then, an important segment is also the pediatric endocrinologists. There’s a little over 1,000 of them out there. They care for all these pediatric patients and even some of the young adults. And then there’s the community endocrinologists. And that’s where, as we say, that the tail gets long. Ultimately, though, this isn’t a super a concentrated patient population. Somewhere north of 20,000, we estimate in the US and most of the adult community, endocrinologists, if they have CAH in their practice, they have one or two patients.

And so in my prepared remarks I commented that most of the prescribers so far have written for one or two patients, and in some instances that’s all they have. But certainly, we see a lot of HCPs that have yet to prescribe. And in those centers of excellence, there’s still a lot of room for growth in terms of adoption. So, it’s still early days yet. We’re two quarters in. We’re pleased with the trajectory of the launch, but for the most part, this isn’t a super concentrated patient population.

Eiry Roberts

Hi, Paul. The only thing I’d add there is that I think we are hearing that given the breadths of the label and the efficacy and tolerability data that was generated for CRENESSITY, that the ease of starting the therapy is helping ensure that it isn’t something that is requiring that center of excellence presence in order to be able to get patients onto the medication.

Unidentified Speaker

Sorry. This is an exciting launch. So the last add here from the team, when you look at how steady the new patient additions were throughout the quarter, I mean, it was very consistent within a pretty tight range week by week. So, I think if we would have had some inflection or some bolus effect, I don’t think you’d see the steadiness in terms of overall adoption and new scripts written each week. So, kudos to the team for finding these patients and getting them help and then also for the reimbursement team to be able to have above 75% of scripts reimbursed at this point, just quite a accomplishment.

Operator

Welcome. Next to Cory Kasimov with Evercore.

Cory Kasimov

Hey, good afternoon, guys. Thanks for taking the question. Wanted to follow up on Eiry’s earlier comment on the adult OLE program and patients rolling from that over to commercial product. Are you able to provide any more granularity there in terms of percentage of patients that have moved over and whether you would expect arrest to follow suit? Are there any nuances in this process that would perhaps prevent them from doing so? Thank you.

Kyle W. Gano

Hi, Cory. So, we’re talking about less than 40 patients here, and you’re going to see some of those. We saw some fall into Q2 and some fall into Q3. So, in the context of over 600 patients starts in the quarter, pretty de minimis in terms of the overall landscape of what we’re seeing with CRENESSITY.

Operator

We’ll go next to Jay Olson with Oppenheimer.

Jay Olson

Oh, hey, congrats on the CRENESSITY launch success and thank you for providing this update. I wanted to thank Eiry for her substantial contributions and wish her all the best. And I also wanted to welcome Sanjay. So, congratulations on joining the team. And could you please share with us some of the key findings that you learned from your due diligence that attracted you to Neurocrine. Thank you.

Sanjay Keswani

Nice to meet you, Jay. Yeah, I’m super excited to join Kyle and the Neurocrine team. And yeah, I’d also like to acknowledge Eiry, who’s sitting just beside me for her terrific leadership. Yeah. In terms of some of the reasons I joined, I thought the company was really at a transformational stage, evolving from primarily a small molecule 2 product company to potentially a multiple modality company targeting multiple therapeutic areas with multiple products. So, the potential here to positively impact the lives of many patients and their families who are suffering with unmet need is a major source of motivation for me.

With respect to the portfolio, my perspective is that the late phase psychiatry portfolio has a high probability of success, because they’re essentially validated targets. And I’m also really excited by our large early phase portfolio which largely comprises large molecules such as bispecifics, antibody drug conjugates and peptides, with many of these programs having transformational potential. And as Kyle mentioned, we’ll discuss some of this at our R&D Day later this year.

So, I think that Neurocrine has walked the talk with respect to substantial R&D investment. So thank you for the question.

Operator

We’ll go next to Brian Abrahams with RBC Capital Markets.

Brian Abrahams

Hey, good afternoon. Thanks for taking my question. I’m curious if you could talk about what steered your decision to contract INGREZZA mid-year, how long these contracts we should think about these contracts generally being in place for, and should we not expect now additional contracting shortly after the new IRA price is established for your competitor. Thanks.

Kyle W. Gano

Hi Brian, this is Kyle. You probably heard from me when I stepped into the role, a lot more conversation about looking at maximizing access for patients. I think it’s something that is important to me and the company and it’s always been a north star for us to do that for patients. We think that’s in their best interest in terms of offering options for their care. I also think it provides a great deal of flexibility for us moving into the new era of IRA that starts next year with the first round of 10 that go through their price negotiation.

So, as you know with the contracting process, this starts well in advance of the year that you’re looking to actually observe your new price, if you will. And our contracting efforts that we outlined here were actually started, initiated with the mindset that we begin in 2026. And obviously when you start the year in these discussions, you don’t know where they’re going to go. But we got them to a good place for ’26 and the opportunity to accelerate or pull them forward into 2025. So, you saw some of the efforts there result into an advantage for us starting in Q2, and then another one that has played out for the start here in Q3. So that’s where we are today on this. I think that’s part and parcel of where we landed on narrowing the band of our guidance to $2.5 billion to $2.55 billion. But I do want to go back to a point that Matt started earlier in the call. What we saw here in Q2 was a second quarter of new record, new prescriptions, as well as total prescriptions and that led to a market share increase in new to brand prescriptions as well as total prescriptions. That doesn’t happen by chance eight years into commercialization.

It really is a function of sound business fundamentals, and this is across our salesforce expansion that started later or late last year through the marketing initiatives that we outlined for this year, and the market access advantages that we now have. So, you pair those together with a very strong demand in the patient segment within TD, and we’re seeing the uptick in the volume that we think is very important for our business this year in terms of new patient starts. But even more important in 2026.

We’re going to start off on day one on a good foot, and really have a strong year. So, I think that gives you a nice feel for our contracting process and thoughts here for this year in ’26.

Operator

We’ll move next. [Speech Overlap] I’m sorry, please go ahead.

Matt Abernethy

Yeah, I think Brian, you were also wanting some clarification around any additional contracting that we would expect to take place. And just do want to build on what Kyle said in that, we believe this sets us up really well for 2026. So, sitting here right now, do not expect or believe there’s going to be any major contract sign that would degrade pricing further from how we’re exiting 2025. So, sitting here right now, we would expect very similar pricing into 2026 based upon the amount of coverage that we have. But we’ll of course update everybody if that were to change.

Operator

We’ll go next to Anupam Rama with J P Morgan.

Anupam Rama

Hey guys, thanks so much for taking the question, and congrats on the CRENESSITY launch. Quickly on the valbenazine Schizophrenia update. What are you learning from that study on VMAT2 mechanism and Schizophrenia, target population considerations or trial design considerations as you look to the next gen VMAT2. Thanks so much.

Kyle W. Gano

Yeah, I think it’s as you mentioned, important to understand that that study in ATS was a learning opportunity for us specifically for our VMAT2 follow on programs. So what we saw was essentially some positive efficacy signal in the positive scale within the PANSS score. And so, I think that will be very helpful in terms of understanding the target patient population for the other programs that are following valbenazine. But I don’t know, Eiry, if you want to mention some more things.

Eiry Roberts

Yeah, no, happy to. Nice to talk to you, Anupam. I think the first thing to say was it was a well-designed, well controlled, large study. So actually, I think we were very pleased with the level of the data and information we were able to get out of the study. So that was a good thing. Secondly, I think it’s really helpful that it confirmed in a larger population of 400 patients the safety and tolerability profile that we knew was there for valbenazine. But it’s good to see it in these more acutely unwell individuals.

We obviously, beyond the PANSS positive score and the PANSS total score, were able to look at a whole series of the sub scores, and additional quality of life functional measures and other things of that sort. And what I’ll say is that there were some interesting signals in there across the sub scores that we will intend to publish on in due course over the next few months. And will obviously use that knowledge as well to inform the next generation of VMAT2 inhibitors in terms of choice of patient population indications and other elements.

Operator

We’ll move next to Brian Scorney with Baird.

Brian Scorney

Hey, good afternoon, everyone, and thank you for taking the question. Also, on CRENESSITY, congrats on a really strong quarter. Something you could maybe give us a little more detail on the derivation of that figure. Is there any inventory dynamic in this quarter? And can you disclose the number of build prescriptions represented here? Just seem hard to calculate. More than like 2000 TRx in the quarter, given the patient start forms and reimbursement numbers you gave us, which puts the net TRx somewhere in the high 20,000 range.

I guess are we in the right ballpark with those numbers? And how do you think about pricing going forward both on sort of gross to net and mix of adult and pediatrics. Thanks.

Matt Abernethy

Yeah, Brian, on the inventory front, because I’ve seen some notes on this, but on the inventory front, what we had in the quarter was a build of around $5 million. So that’s just reflective of growth in the channel as the scripts continue to grow. As we’ve said before, very consistent demand throughout the quarter. Very good job from our pharmacy getting patients ultimately on therapy. And gross to net so far has largely been on the heels of CO pay assistance as well as some distribution fees and costs and like we’ve said, haven’t been at a place of contracting yet. So good job to the team so far.

Operator

Will go next to Yatin Suneja with Guggenheim partners.

Yatin Suneja

Hey, guys, thank you for taking my question. I have a question regarding the IRA implication. If you can just maybe talk about, how do you envision the access to shake out? What would be the end goal? Will you seek access at parity once we know the negotiated price? I’m just curious if you can outline that dynamic for us the best you can. And also, your expectations on how, whether one drug will be mandated versus the other. Thank you so much.

Kyle W. Gano

Hi, yes, this is Kyle. I’ll start a response here and I’ll ask Eric to fill in any holes in my answer here. I think for IRA. I mean, there’s a couple pieces here that I would point you to. There’s our own IRA moment in 2029. That’s when our negotiated price is enacted. And then there’s our competitor in this space with utirated tetrabenazine in 2027. And if you wanted to speak to the near-term event with our competitor, I think we start with, we acknowledge we don’t have all the answers what’s going to happen due during an IRA. I don’t think anyone does. So, I think if we all acknowledge that piece, it’s a good place to land on.

In 2025 we’re going to see what happens with other brands in the same categories where medicines are negotiated. So, I think we’ll have some learnings there. And then the third piece I’d point out is our goal here is to maximize the number of patients on INGREZZA. That’s part of our maximizing our access strategy here. And I think that’s important to point out because INGREZZA is incredibly sticky. Patients, when they start INGREZZA, they tend to stay on it. So, when it comes to 2027, in the years between that and our own IP moment in 2029, we are talking about the new patients primarily.

And we think that we’re on a good footing here with the differentiation that we offer for INGREZZA relative to our competitor in this space when they go through their IP moments. Maybe I’ll stop there. Eric, anything to add?

Eric Benevich

Yeah, I just want to reinforce that I think we’re all going to learn together in 2026 in terms of how health plans are managing various classes where there’s one or more negotiated products. And certainly, our overall strategy from an access perspective is to have broad access and parity. And over time, we’ve been very successful with that. Obviously, we commented that in 2024 we started to see some tightening of access in terms of health plans, starting to reject more claims and so on. This wasn’t specific to INGREZZA.

This was more of a broader industry trend, and that’s carried forward into 2025. Frankly, that’s one of the reasons that we’ve invested in access, because we believe it’s very important to make it as easy as possible for

Operator

Providers and patients to get on product. And certainly, these increased investments that have led to a higher proportion of covered lives in Medicare, sets us up well for 2026 and beyond. So, we’re going to very carefully monitor the environment, but ultimately the goals don’t change. We want to help patients who want to make it available. And how we go about doing that is probably going to evolve over time. [Technical Issues] Hey, Jess, are you there?

Unidentified Participant

Hi, Ami. Okay, great. Thanks for taking my question. A question on CRENESSITY. Can you give us a sense of the penetration across the different segments of the market from a physician perspective that you’ve talked about? And you mentioned that at present mostly physicians have one or two patients on treatment and that is likely to evolve over time. How long do you anticipate physicians sort of limit to maybe a handful of patients before they feel like they have enough experience with the treatment to start to expand that. Thank you.

Eric Benevich

Yeah. So, I’ll kind of go back to some of my prepared remarks. We recently crossed an important threshold of having over 1000 NRx is submitted, a treatment form submitted into our patient hub. And most endocrinologists have only that have treated, have only treated one or two patients so far. And the reality is, as I mentioned earlier, this is sort of a thinly spread population. Most of the adult endocrinologists, if they have any classic CAH patients in their practice, they might have one or two. So, in some instances, they’ve treated all the patients that they have. However, especially within pediatric endocrinology and in the centers of excellence, there’s still a lot of untreated patients.

And so, we have a long way to go, frankly, in terms of adoption. It’s still two quarters into a launch and there’s certainly endocrinologists that we have yet to meet with and to walk through the clinical data and the labeling. So, I would say if you want to try and back calculate how many prescribers there are, certainly looking at the number of treatment forms coming in and sort of that ratio where most have only one or two, you can get a sense that it’s less than that total number. But also ultimately, I think that we’ll see how things evolve as we move further into the launch and we continue to raise the awareness of not only the availability but of the benefits of CRENESSITY.

Operator

We’ll go next to Corinne Johnson with Goldman Sachs.

Corinne Johnson

Good afternoon, everyone. I wanted to ask on the reimbursement process from here, when do you anticipate transitioning to more of a formulary driven process and how do you anticipate that could impact net pricing on CRENESSITY?

Eric Benevich

Yeah, let me tackle that. So at launch, CRENESSITY was a non-formulary drug everywhere. And our expectation is that in some instances health plans will decide to do a formulary review. And often they’ll add it to formulary, but given that it’s a class of one, it’s more likely that in many instances they won’t bother to do a formulary review and it will remain as a non-formulary product. That doesn’t mean that it’s not covered. And certainly, we’re very pleased with the rate of reimbursement that we’re seeing.

Our expectation coming out of the gate with the approval was that in most instances, patients would need to go on to our free goods program for a month or possibly longer before getting their prescription claim approved and then transitioning over to commercially reimbursed product. The reality is that we’ve been pleasantly surprised at the fast rate of approvals for these claims. Most patients don’t need to go on free goods. And thus, the statistic that over three quarters of all the dispenses, both in Q1 and in Q2 have been reimbursed product.

So just to set expectations, I don’t know that we’re ever going to be in a place where, we’ll provide a formulary coverage statistics because in many instances health plans will continue to reimburse as a non formulary product, given the size and scope of this category.

Operator

We’ll go next to Danielle Breaux with Truist.

Danielle Breaux

Hi guys. Good afternoon. Thanks for the question. You mentioned some of the data that you presented at ENDO, and I was just curious about some of the feedback that you received there from the prescribing community. Specifically, as it relates to the change in glucocorticoid dose at 1 year remaining relatively flat versus 24 weeks and how we should think about that.

And then same thing on the insulin resistance data that you presented. It seems like we don’t see further benefits beyond 12 months. Is there anything to read into there? Why might that be? And then at any point in time will we see any additional clinical data, such as bone age data or other benefits from lowering steroid doses. Thank you.

Eiry Roberts

Hi. it’s Eiry here. I’ll address the last bit first. Yes, we do have ongoing open label trials for CRENESSITY, both in adults and pediatric. The adult patients being outside the United States, pediatrics being worldwide. And our intent is to continue to publish over the long haul from those studies because we do believe that those longer-term clinical data are absolutely critical. Just as a reminder, this was the first time that we had presented one year data from our registration or program and the first time we’d really been able to concentrate on those clinical outcomes that are so important to patients and to clinicians.

And just again, by means of kind of reminding everyone, the impact of crinecerfont[Phonetic] directly, CRENESSITY is to have a direct impact in lowering Androgens. And so we’re interested in understanding the long-term impact of controlling those Androgens over a 12 month period and even beyond. And then secondly, as a result of that reduction in 17 OHP, ACTH and Androgens levels that we’re able to achieve directly with CRENESSITY, we are able to reduce the steroid dosing in these patients from the supraphysiologic doses that are required to control the disease in the absence of CRENESSITY.

Going into the release of data from this program, we had said, and this was supported broadly, that any reduction in steroid dose was beneficial to patients over a lifetime. And I think that is in fact what is playing out. What we saw in the one year data was a consistent, small, modest effect, but a consistent effect across many metabolic parameters, including weight, homur[Indecipherable], the insulin resistance that you referred to. And that is a clinically beneficial change that we saw there that results in a potential for improved outcomes over a lifetime for those patients.

So it’s extremely important. We also saw changes in scores such as hirsutism scores in females, which are important in terms of looking at the direct Androgen effect. So with the release of all of those data, I will say that the response from the community was actually very positive. Clinicians were very interested and excited in the data. Looking forward to obviously continuing to follow those data over time. But it’s a really good start from our point of view in terms of how we’re able to serve patients.

Operator

We’ll go next to Mohit Bansal with Wells Fargo. Your line is open. Please go ahead or check your mute button.

Unidentified Speaker

I guess we’ll catch Mohit on the flip side. Can we go to the next one? Jess?

Operator

We will go next to Ash Verma with UBS.

Ash Verma

Hi, thanks for taking my question. Just a quick one on CRENESSITY formulary commentary that you made. So, are a lot of these reimbursement for a six month or six month or one year basis and then when CRENESSITY is up for reauthorization for these patients, would that require steroid dose reduction based on what you can tell right now? Thanks.

Eric Benevich

Yeah. So, if I understand your question correctly, it’s related to reauthorization. What are we seeing in terms of the authorized number of fills and timing for reauthorization and what kind of criteria are required? For the most part, what we’re seeing is patients either getting six prescriptions fills authorized initially or a 12. That seems to be the pattern generally. And for the most part, plans have, if they have published their approval criteria, they haven’t necessarily published reauthorization criteria.

But typically, what we’re seeing now is that first early cohort of patients that might have gotten onto commercial product early in the launch. that are getting reauthorized. Generally, it’s the provider affirming that they’re benefiting from treatment. So, we’re not seeing any hard and fast thresholds of GC dose or GC dose change or needing to provide labs related to the ACTH or the Androgens. So, for the most part, the reauthorization process has been going about as smoothly as the initial authorization process.

Operator

We’ll go next to David Ansellem with Piper Sandler.

David Ansellem

Thanks. So, had a question on the Muscarinics in the pipeline, particularly the M1/M4 Agonist 570. I’m sure you’re watching Bristol’s work with COBENFY [Phonetic] with significant interest. And what I wanted to ask is to the extent that the Adept 2 study in Alzheimer’s psychosis reads out favorably later this year, how does that play into your development plans potentially to get more aggressive with the advancement of 570, say in AD psychosis or potentially other indications? I know you have the Schizophrenia study enrolling, but how are you thinking about that more expansively just given its mechanism and that it’s precedented by another M1/M4 that’s on the market?

Sanjay Keswani

Thank you. Great. Yeah. So, we are watching COBENFY [Phonetic] data with INGREZZA. Of note, we have quite a robust Muscarinic portfolio. So, we have a number of M1 preferring as well as M4 preferring Agonist and as you mentioned, a dual M1/M4 570. So, we have a number of choices in terms of which ones we take to various indications. Indeed, AD psychosis is a really important indication for the field and we are interested in that. It may be with 570, but we have other Muscarinic Agonist which actually may be better suited for that rather elderly population because potentially there is a superior safety profile associated with it.

Are, any more questions? Any more?

Eiry Roberts

No, I think that was well said. And just to pick up on what Sanjay said at the end, I think one of the things that obviously we’re watching the COBENFY data very closely but you know, we do believe that the direct Agonist approach here without the need for an add back, particularly in that older population, could provide an opportunity for differentiation if we were to go forward.

Operator

We’ll go next to Marc Goodman with Leerink Partners.

Marc Goodman

Yeah Matt, just to confirm this negative 5% INGREZZA ASP comment for the year, is this a full year impact? Because I’m kind of assuming that the second half’s lower than the first half for ASP. So, when you say there’s no change for ASP in 2026, are you referring to the full year ASP, are you falling to where you actually are kind of ending the year which is lower than kind of the average for the year, if you understand my question. Thanks.

Matt Abernethy

Yeah. Regarding the 2026 trajectory — it’s a trajectory comment. How we’re exiting the year in 2025 would be what you would expect to continue into 2026. So, appreciate that clarification. In addition to that on the net price comment for the year, for 2025, the negative 5% price, as you mentioned, it’s more concentrated in the second half of the year. So, that was a full year commentary. So it is safe to assume that the price headwind is a bit more in the second half as compared to the first half.

But with that said, I think you take a step back and you look at the volume gains that we expect to have, and it’s just an incredible market and feel like we’re really well positioned with these formularies to continue to grow and build the market.

Operator

We’ll go next to Myles Minter with William Blair.

Myles Minter

Hey, thanks for taking the question. Can you just remind us of the discontinuation rates for CRENESSITY and the one-year open label extensions to the paediatric and the adult studies. And is that still probably the best proxy you have for the annualised retention rates on CRENESSITY in the real world or are there other key factors we have to consider for retention basis? Thanks very much.

Eiry Roberts

Yeah. Hi, Myles. I think the first thing to say is that we were very favorably surprised, I guess at how well tolerated and how safe CRENESSITY was across the adult and pediatric population. That’s the first thing to say. We had just a very small number of patients discontinued during the course of the program, and more than 95% of the patient’s rollover from both the pediatric and the adult program into the open label extension. Many of those patients have now been on study for greater than three years and we still continue to see very low discontinuation rates and the continued improvement in the outcome for those patients.

Sanjay Keswani

So, it’s still early in the launch cycle for CRENESSITY and we’re watching that, of course, over these first six months. But that’s a key variable as we think about what’s the long-term potential of CRENESSITY. And that’s something I think we’re going to know a lot more here in the second half of this year as well as then into the first half of next year as you see patients getting the blood draws and understanding glucocorticoid titration. But from a safety and tolerability perspective, as Eiry said, three years of patients on therapy, we have a lot to believe in, in terms of high levels of adherence.

Eric Benevich

Yeah. One last point to make in terms of the difference between real world and clinical trial experience typically in the real world with the medicine, affordability and coverage can impact persistency. We’re seeing really, really good coverage and we believe that CRENESSITY is very affordable for patients between the co-pay, buy-down and the other programs that we have. So, we don’t expect insurance to be a barrier to persistency.

Operator

We’ll go next to David Hoang with Deutsche Bank.

David Hoang

Hi there. Congrats on the quarter and thanks for taking my questions. So, first I just wanted to ask in terms of INGREZZA. So a competitor, so Teva reported this morning, I believe they raised their guidance for their product AUSTEDO for the year. Is there anything to maybe read into that as pertains to the relative growth of INGREZZA versus your competitor this past quarter and market share in terms of dollars? And then just quickly on CAH, I think you talked about 20-K prevalent patients in the US, do we have a sense of what percentage is regularly followed in clinics, maybe from things like medical claims data? Thanks a lot.

Kyle W. Gano

Yeah. This is Kyle. I’ll take your first question. When it comes to our competitor in this space, we don’t really speak to the dynamics of their marketplace and what they’re looking at. I think from the perspective of INGREZZA, I’m extremely encouraged by the volume growth that we saw this quarter. And I do want to reiterate, we increased our market share on both new to brand as well as total prescriptions. And so, I think that we’re really happy with the performance in the first half of this year. You combine that with our initiatives that we put in place starting the year with our additional market access, and we are looking forward to a strong second half as well.

So, I think I’ll leave that there for the time being. And then on the CRENESSITY side of things, Eric, do you want to comment on that?

Eric Benevich

Yeah. I just want to reiterate that our estimate is greater than 20,000 patients in the US and the reason that it’s an estimate and not a firm number is that some of these patients, first of all, there is no specific ICD-10 diagnosis code for classic CAH. There is a CAH diagnosis code, but that encompasses both classic and non-classic patients. And if you look at the medical literature, for every classic CAH patients, there’s three or possibly four non-classic patients. So, we have had to triangulate, doing a thorough medical literature review, looking at claims data and so on to get at that number. Some of these patients don’t have the CAH diagnosis code at all for various reasons.

And so, we feel like that 20,000 number in the US is a good estimate for the overall prevalent populations, subset of them that are more easily findable, I guess is the way I would put it. And certainly, there are, that are under the care of an endocrinologist, for example, but there are certainly a cohort of classic CAH patients that are not under the care of an endocrinologist and they’re probably being seen by internal medicine, family medicine or even OB-GYN.

So we will learn more about this market as we get deeper into the launch.

Operator

We’ll go next to Sumant Kulkarni with Canaccord.

Sumant Kulkarni

Good afternoon. Thanks for taking my question, which is science-based but could have significant strategic and stock implications. You have several years of internal experience in CRF-1 receptor antagonists, corticotropin is involved in stress response and there’s some intriguing external preclinical data on binge eating and this approach. Now that you’ve presented one year data on weight-related effects of CRENESSITY at ENDO. What are your thoughts on using this approach specifically for weight loss, especially as you have a longer acting version in the works which could help in compliance in that setting?

Eric Benevich

Yeah. We’re clearly very encouraged by the data that we saw from the one-year readout recently at ENDO for CRENESSITY. And as you can probably imagine, we have a wealth of knowledge about CRF-1 antagonism and CRF biology here at Neurocrine. So as we go forward, we’ve been considering a broad range of potential indications. And also obviously, we have a breadth of other research projects in our pipeline that may well seek to address some of those challenging disease areas moving forward.

Operator

We’ll go next to Sean Laaman with Morgan Stanley.

Michael Riad

Hi, this is Michael Riad on for Sean Laaman. Thank you for taking our question. For INGREZZA, could you comment on the current volume split between the neurology, psychiatry and long-term care channel? And regarding the double-digit volume growth you expect this year, could you provide any more color on respective contributions to that volume growth from the respective channels? Thank you.

Matt Abernethy

Yeah, I mean, what we saw was strong growth really across all three of the business segments. Overall psychiatry accounts for about 60% or so of our volume and 65%, maybe. And then the balance is split, between the other two segments pretty evenly, but all of them are growing at approximately the same rate. So, we’re really pleased with the overall growth trajectory for the franchise.

Operator

We’ll go next to Laura Chico with Wedbush Securities.

Laura Chico

Thanks very much for taking the question. On CRENESSITY I wanted to dive into a little bit more about the cadence of prescribing and kind of just clarifying, one, have the majority of patients transitioned from studies to paid script status at this point? And two, as we’re thinking about increasing breadth of prescribing, I guess, is there kind of an upper limit as to how many patients physicians are going to be able to manage on CRENESSITY? I guess, is there any capacity constraints that you can share? Thank you.

Eric Benevich

Yeah. We don’t see any capacity constraints in terms of managing patients on CRENESSITY. It fits right into how they’re already being cared for and we have a really good pharmacy partner to help with that. And so, I’ll leave it there.

Operator

And we’ll take our final —

Eric Benevich

Sorry. Laura, I forgot to mention. In regards to clinical trial patients, as I said earlier on the call, it’s less than 40 patients and you could assume half of them came on board in Q2 and the other half are going to come on board in Q3. So, it’s pretty de minimis in terms of overall new patients that are being added to therapy.

Operator

And we’ll move to our final question from Evan Seigerman with BMO Capital Markets.

Evan Seigerman

Hi guys. Thank you so much for taking my question. I wanted to touch on some of the thinking behind moving 568, excuse me, into Phase 3. I know that the Phase 2 trial didn’t [Phonetic] see a dose response. Walk me through what you were able to look — you get in the data to give you confidence in moving through this larger Phase 3 program. Thank you so much.

Eric Benevich

Well. I think we’ve discussed the merits of moving 568 into Phase 3. I will mention here we do have an INN name, so I wanted to do a shout out to the team for putting that together for us for this meeting. That’s directly [Indecipherable]. So, stay tuned on that. We’ll be able to put that in future correspondence and releases out there. I think, again, I’ll refer back to our Phase 2 commentary around the totality of the data that we have. All doses worked under Phase 2 and for the dose that we selected for Phase 3, we hit the primary endpoint with all the secondary endpoints as well, a very attractive profile overall from an efficacy, safety and tolerability profile. We think that will differentiate quite nicely if we’re able to reproduce those results in Phase 3 relative to COBENFY [Phonetic] out there today.

Operator

And that will conclude the Q&A session for today. I’ll turn the program back to Kyle Gano for any additional or closing remarks.

Kyle W. Gano

Thanks, Jess. Thank you all for your thoughtful questions and engaging discussion this afternoon. We cover a lot of ground, in particular across our commercial portfolio and our pipeline, and I hope you’re seeing a transition of the company to one defined by both revenue growth and diversity. I should say revenue diversity moving forward with both INGREZZA and CRENESSITY. Look forward to connecting at upcoming healthcare conferences and certainly in our R&D Day on December 16th. So, thanks again for joining. Talk to you soon.

Operator

[Operator Closing Remarks]