Neurocrine Biosciences Q1 2025 Earnings Call Transcript

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Provided by Quartr
May 5, 2025
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Operator

Good day, everyone, and welcome to Neurocrine Biosciences Reports First Quarter twenty twenty five Results. 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. Please note, today's call will be recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Todd Tuchla, Vice President of Investor Relations.

Operator

Please go ahead.

Todd Tushla
Todd Tushla
VP, IR at Neurocrine Biosciences

Thank you, and happy Cinco de Mayo to everyone. Welcome to Neurocrine Biosciences first quarter twenty twenty five earnings call. With me today are Kyle Gano, Chief Executive Officer Matt Abernathy, Chief Financial Officer Eric Benovich, Chief Commercial Officer and for one last time as Chief Medical Officer, Ivy Roberts. During today's call, we will

Todd Tushla
Todd Tushla
VP, IR at Neurocrine Biosciences

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. Following prepared remarks, we will strive to get to everyone's questions. Now I will turn the call over to Kyle.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Thanks, Todd. Good afternoon, everyone. Neurocrine has never been in a stronger position as we maintain an enterprise wide focus on execution and evolution. Even with external factors continuing to create market volatility, we remain focused on controlling what we can, executing with discipline to meaningfully deliver for both patients and shareholders. The first quarter reflected strong execution across both of our brands with record new patient starts for INGREZZA and encouraging early adoption of KRONESITY.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

With reaffirmed guidance for INGREZZA and solid momentum heading into Q2, combined with an early but promising launch trajectory for Crenesity, we are well positioned to drive both near and long term revenue growth as we evolve from a single blockbuster to a multiple blockbuster neuroscience company. Amazing to see the efforts from our commercial and medical teams this quarter. Well done. On the R and D front, our portfolio continues to advance meaningfully. We are encouraged by the progression of osevampatore and MBI-five sixty eight into phase three registrational studies.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

The strong magnitude of effect demonstrated in both programs' phase two proof of concept studies gives us confidence in continued investment. We are on track for expanding our muscarinic portfolio into new phase two studies later this year. This includes MBI-five sixty eight into bipolar mania and MBI-five seventy, our dual M1M4 agonist into schizophrenia. From a leadership perspective, we are thrilled to welcome Doctor. Sanjay Keswani as our incoming chief medical officer in June.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Doctor. Eiry Roberts, our current CMO, will transition into a strategic advisory role where her expertise will continue to shape key programs. In closing and reflecting on the quarter, I'm extremely proud of our team and progress. Our growing diversified revenue base, expanding pipeline, and strong balance sheet position us well to continue building on our momentum as a leading global neuroscience company. With that, I'll turn the call over to Matt.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Thank you, Kyle, and good afternoon. We made tremendous progress throughout the first quarter, both with the reacceleration of new patient growth for INGREZZA and with our successful KRONESITY launch. We are executing from a position of strength with these two growing commercial products, a robust clinical pipeline in CNS disorders, and a strong financial foundation that provides flexibility for continued investment to drive shareholder value. Starting with INGREZZA, we posted $545,000,000 in first quarter product sales. As anticipated, first quarter sales were impacted by one less order week, patient reauthorization processes, and gross to net dynamics.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Although noisy, I do want to make a few very specific comments about the quarter and INGREZZA. First, we had record new patient additions in the first quarter, which is a testament to the quality of our product, the dedication of our team, and the continued unmet medical need. Second, effective 04/01/2025, we expanded our formulary coverage in Medicare Part D, which significantly increases patient access, providing a foundation to expand our customer base in the years to come. Finally, as Kyle mentioned, we are reaffirming our 2025 sales guidance range of $2,500,000,000 to $2,600,000,000 which factors in the expected acceleration of new patient additions, offset by gross to net impact from contracting activities. Turning to Cranesiti, where we just completed our first full quarter of launch.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

We achieved net revenue of $15,000,000 which includes four thirteen enrollment forms, with 70% of Dispenses receiving reimbursement. Although we are still early in our launch efforts, we're encouraged by this initial success. A few financial comments. Our capital allocation priorities remain intact, with our number one priority being investments to drive revenue growth number two priority is investments to advance our R and D pipeline and three, investments to enable business development and lastly, consider return of capital to our shareholders. During the first quarter, we continued to reflect these priorities to drive revenue growth with investments in our expanded INGREZZA sales force and KRONESIT launch.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

In addition, we continued to make investments advancing our pipeline in R and D with the initiation of two major Phase III programs. Just a reminder, R and D expense for the first quarter of twenty twenty five includes $45,000,000 of milestone expense, primarily for the initiation of our osavampitur Phase III program in MDD, and will recognize $15,000,000 in milestone expense in the second quarter for the initiation of MBI-five 68 Phase III program in schizophrenia. In addition, we've been able to retire 3,600,000.0 shares over the past two quarters and have retained a strong balance sheet with approximately $1,800,000,000 in cash to support our commercial and clinical development strategies for continued growth. With that, I will now hand the call over to Eric Benovich, our Chief Commercial Officer. Eric?

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Thanks, Matt. We're celebrating two significant milestones for INGREZZA. First, a couple weeks ago was the eighth anniversary of FDA approval. Remarkably, eight years into the launch, our commercial and medical teams achieved record new patient starts in the first quarter despite a challenging payer environment. I want to take a moment and thank our teams for their exceptional dedication and performance.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

This May also marks tardive dyskinesia awareness week. Currently, we estimate that just over forty percent of patients with TD have been given a diagnosis to explain their abnormal movements, and less than ten percent are currently receiving standard of care treatment with a VMAT2 inhibitor, such as INGREZZA. So there remains a significant opportunity for growth of the VMAT2 class and INGREZZA as the VMAT2 class leader. As part of our support for TD Awareness Week, Neurocrine continues to collaborate with the Movement Disorders Policy Coalition, mental health advocacy organizations, healthcare providers, and policymakers nationwide to increase awareness, reduce stigma, and drive diagnosis so that TD sufferers can access available treatment options. Matt provided a nice summary of INGREZZA and KRONESITY performance in his opening remarks, and I'd like to provide additional color.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

First, we're pleased to have expanded formulary coverage from less than half to approximately two thirds of Medicare, TD, and HD beneficiaries. While this affects our gross to net, access will be improved for our HCP customers and the patients they care for. We view these as important investments to ensure patient access today and into the future. Second, as noted in our last call, we believe the Inflation Reduction Act, or IRA, has notably influenced payer behavior and reimbursement dynamics, particularly for specialty medicines like INGREZZA. In the second half of last year, we saw an impact on the prior authorization process for new patients.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

In Q1, we saw the impact on the reauthorization process for continuing patients, which was a bit more challenging versus prior years. Regardless, our field sales and field reimbursement teams were persistent in their efforts to help health care providers and patients manage through evolving payer requirements. Great job, teams. Third, we reaffirmed our 2025 INGREZZA guidance. Looking forward, our growth strategy encompasses our recently expanded sales force, investments in improved formulary access, and enhanced marketing initiatives that will strengthen INGREZZA's market leading position as the only VMAT2 inhibitor that is highly effective, uniquely selective with therapeutic dosing from day one and proven across the widest range of patients.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

With continued significant unmet need across tardive dyskinesia and Huntington's chorea patient communities, we anticipate sales to accelerate in Q2 and through the second half of twenty twenty five. And this momentum should position us well heading into 2026 and beyond. For Crinesity, while we're still in the very early stages, I'm pleased to say that the launch is exceeding our expectations. As Matt noted, in Q1, we received four thirteen treatment forms, which serve as a new prescription, and we reported $15,000,000 in net sales. We're observing strong uptake across both pediatric and adult CAH patient populations, with slightly higher initial adoption rates in pediatric and adolescent segments.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

The prescriber response has been particularly encouraging with good initial trial across all endocrinologist segments, including centers of excellence, pediatric endocrinologists, and community adult endocrinologists. While it's too early to comment on longer term outcomes, we're pleased with the warm reception of Cranesity from the medical and patient communities. On the payer front, we noted that 70% of the dispensers in the quarter were reimbursed. Coverage requirements have generally aligned with our approved labeling, including diagnosis of classic CH, patient age of four years or older, and concurrent glucocorticoid therapy. As we move forward through the balance of the year, we expect more health plans to conduct formulary reviews and publish their coverage criteria.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

However, some plans may choose not to formally review Crinesity and continue to review prescription claims via their exceptions process. Overall, initial metrics are trending in the right direction across all key performance indicators, but I do want to remind everyone that one quarter is too soon to define a trend for either adoption or reimbursement. We're going to learn a lot over the coming quarters specific to persistency, compliance rates, and overall rate of adoption. If Crinesity ultimately delivers significant benefit in the real world as it did in clinical trials, we fully believe it can become the new standard of care together with cortisol replacement for CAH patients. Once more, I'd like to congratulate our commercial and medical teams for getting Cranesiti off to such a great start.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

So with that, I'll turn the call over to my colleague, Doctor. Eiry Roberts, our chief medical officer.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Thanks, Eric, and good afternoon to everyone. We continue to make substantial progress advancing Neurocrine's early to mid stage clinical pipeline, particularly across our muscarinic portfolio, next generation VMAT2 inhibitors and epilepsy programs. Today, I'll focus specifically on our late stage registrational assets and key twenty twenty five data milestones. I'll start with osavampetor, our AMPA positive allosteric modulator. I'm pleased to announce initiation of all three randomized, double blind, placebo controlled studies evaluating its efficacy and safety as an adjunctive treatment for major depressive disorder.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

These studies will measure the change in total MADRS from baseline to day fifty six as their primary endpoint, with top line data expected throughout 2027. Turning to our selective M4 agonist, NBI-five sixty eight. Just last week, we announced the initiation of the first of three Phase III registrational studies to evaluate the efficacy, safety and tolerability of NBI-five sixty eight as a potential treatment for schizophrenia. We anticipate initiating the two additional studies in the coming months. All three studies will be double blind, placebo controlled trials comparing the twenty mg dose of NBI-five sixty eight versus placebo, with reduction from baseline in the positive and negative syndrome scale at week five as the primary endpoint.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

We expect top line data from these studies in the twenty twenty seven-twenty twenty eight timeframe. This year, we will report top line data from two Phase III studies of valbenazine, the first in adjunctive treatment of schizophrenia, which serves as a proof of concept study for VMAT2 inhibition in this disease state. While these results will guide the development of our next generation VMAT2 inhibitors, including NBI-eight ninety and NBI-six seventy five, we do not plan to expand the valbenazine label for this indication. The second readout, expected later this year, will evaluate valbenazine's efficacy in treating dyskinetic cerebral palsy. With no currently approved treatments for the seventy five thousand to one hundred thousand patients in The US living with DCP, successful results could lead to a label expansion for this indication.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

For NBI-seven seventy, our NMDA NR2B subreceptor negative allosteric modulator, the Phase two dose finding study in major depressive disorder remains on track for top line data in the second half of twenty twenty five. This study's primary outcome measure focuses on the MADRS change from baseline to day five, potentially demonstrating more rapid onset compared to osavampatore's phase three, day 56 endpoint. As this marks my final earnings call as Neurocrine's Chief Medical Officer, I'd like to share some closing observations. Neurocrine stands stronger than ever, making this an optimal time for the transition. Our industry leading pipeline continues to grow, fueled by Jude Onye's excellent progress establishing a sustainable internal innovation engine.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

My seven plus years at Neurocrine have been marked by remarkable evolution and I'm confident in Sanjay Kiswani's capability to lead as the next Chief Medical Officer. I look forward to maintaining an active advisory role, supporting both Sanjay and our late stage programme teams. Finally, I extend my gratitude to the board, Kevin, Kyle, my Neurocrine colleagues and all our external partners, including the investment community. Neurocrine is well positioned to help countless future patients, and I'm proud to have contributed to this journey. With that, I'll hand the call back to Kyle.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Kyle?

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Thanks, Eiry. And just to pause here a moment before we move into questions, I do want to take a moment to recognize Eiry for her many contributions over the years. Eiry's played a vital role in shaping Neurocrine into what it is today and really helped many thousands of patients along the way. If I think about the future here with Eiry, she continue will continually be a player and help us along the way. As she mentioned just a moment ago, this will be her final earnings call as an executive of the company.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

So, Eiry, once again, thank you for your dedication, your leadership, and your support over the years. With that, let's open it up to questions.

Operator

We'll move first to Paul Matias with Stifel. Your line is open.

Paul Matteis
Paul Matteis
Managing Director, Head of Therapeutics Research at Stifel Financial Corp

Hey, thanks for taking my questions. And Eiry, congrats. Always good to work with you. Two quick ones. As it relates to INGREZZA, sounds like the quarter was not as challenging as some feared.

Paul Matteis
Paul Matteis
Managing Director, Head of Therapeutics Research at Stifel Financial Corp

I was wondering if you could comment on what you're seeing into 2Q and if you feel like getting back to the prior growth rate at some point is attainable. And then just on Frenicity, congrats on the progress. Should we be looking at this 400 number as a bolus and then it could attenuate from here? Or do you feel like it's just the beginning? Thank you.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Paul, this is Kyle. Maybe I'll start here and then I'll ask Eric or Matt to chime in. On INGREZZA, I think when we look at Q1, you've probably heard us talking about the challenges of the quarter over the past couple of months. I think it played out exactly as we expected it. We had that low momentum coming into the year, the difficulties of reauthorization, the one less selling week, the hits on gross to net, all those were factors that came into play.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

But just to round out the quarter, we saw that one element that gives us great confidence going into the remainder of the year, and that is the momentum that you get from having that growth in new patient starts. And I think it goes without saying that the growth in new patient starts was the record that we've seen of all time in terms of a quarter, and it came in the most challenging quarter. So I think there's a lot to be said there for momentum going into q two, the remainder of the year, and really just an amazing job by the team out there in the field. So I think that we have that momentum going into the remainder of the year. We have a number of elements that we put in place late last year that will play a factor for us positively this year.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

We mentioned the sales force expansion, the expanded access that we have now, and other marketing initiatives that will be kicking off here very shortly. All these things will help us to continue the recovery of growth in Q2 and an acceleration the second half of the year. In terms of Kranesky, maybe I'll let Eric speak to that and we can go from there.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, no, Paul, I think your question is in terms of, you know, should we expect this number of treatment forms or new patient NRx referrals going forward? As I mentioned in my prepared remarks, we only have one quarter of experience with this launch. Obviously, we're really pleased with the adoption that we're seeing. But ultimately, we need a little bit more time to understand what that pattern is gonna look like. And so, you know, as we go forward, we'll continue to share, you know, what the treatment form or referral rate is and obviously, you know, provide additional metrics like we did in this particular quarter.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

But I think it's too soon to tell, but I will reiterate, it's we're off to a great start and certainly this exceeded our expectations at this phase.

Paul Matteis
Paul Matteis
Managing Director, Head of Therapeutics Research at Stifel Financial Corp

Thanks, guys.

Operator

We'll take our next question from Akash Tewari with Jefferies. Your line is open.

Phoebe Tan
Phoebe Tan
Senior Biotechnology Equity Research Associate at Jefferies

Hi. This is Phoebe on for Akash. Thank you for taking our questions.

Phoebe Tan
Phoebe Tan
Senior Biotechnology Equity Research Associate at Jefferies

Similarly to what was just asked, could you provide any color on TRINESITY's sort of pair dynamics moving forward? 70% is higher than we had anticipated, so just wondering how you expect it to move forward from here. Thank you.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah. Just like with the adoption, the reimbursement, I think, exceeded our expectations as well. As I mentioned earlier, 70% of the fills in the quarter were reimbursed. And, you know, certainly that's very, you know, favorable for one quarter in, but I would like to caution everyone and remind them that this is still a product that for the most part hasn't gone through formulary reviews. And so for the most part, we're talking about reimbursement via the exceptions process.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

And so as we move through the year, you know, we do expect that some of the plans, maybe most of the plans, will be doing formal reviews of Chronicity and determining what their coverage criteria look like. But at this stage, it's still formulary exceptions, and we're off to a great start in terms of securing reimbursement.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Yeah, this is Matt. Just a big shout out to the Market Access team. Kudos to them for educating all the payers in terms of the disease burden and also the benefits that Chronicity could potentially provide. This is a high value medicine helping a lot of patients, and it's been fairly seamless between prescription written and ultimately getting filled. And so I do want to give that kudos to the team that has been working hard on that.

Operator

We'll move next to Tazeen Ahmad with Bank of America. Your line is open.

Tazeen Ahmad
Tazeen Ahmad
MD - US Equity Research at Bank of America

Hi, good afternoon. Thanks for taking my questions. First, Diary, great job on everything, and good luck in your next chapter. I did want to ask about the share split between what you're seeing now on INGREZZA versus Teva for new to treatment TD patients. I don't know if you could share any color on that.

Tazeen Ahmad
Tazeen Ahmad
MD - US Equity Research at Bank of America

And then on Cranesiti, can you give us a split of what percent of patients and I'm sorry if I missed it are peds versus adults in the early innings of usage? Thanks.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, so we haven't provided historically share split exactly because if you look at the syndicated prescription data, it under reports INGREZZA, so we've always cautioned to not look at the numbers as exact measures. But overall, you know, what we have said is that we have had the majority in TD, and we continue to have the majority of prescriptions. That's for both TRx and for NRx. And so we'll leave it at that. The other thing that you were asking about in terms of the split or the demographics of the patient population, very early on, you know, what we were seeing was sort of equal distribution of pediatric and adult patients and pretty equal distribution of females versus males.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

But as we've gotten more treatment forms in and the launch continues to mature, we have seen that it's starting to trend in the direction that we expected prior to the approval, which is more pediatric and adolescent patients than adults and more female versus male. Once again, we've got a long way to go in terms of understanding the launch dynamics and, you know, one quarter does not make a trend. But ultimately, you know, it is essentially trending in the direction that we expected it to prior to the launch.

Operator

We'll take our next question from Phil Nadeau with TD Cowen. Your line is open.

Philip Nadeau
MD, Health Care – Biotechnology at TD Cowen

Good afternoon. Thanks for taking our questions and let us add our congratulations to Eiry on a great career at Neurocrine. Two from us as well. First on INGREZZA trends, INGREZZA grew 15% from Q1 to Q2 in 2024. Can you give us some sense of what's likely to happen in Q2 of twenty twenty five?

Philip Nadeau
MD, Health Care – Biotechnology at TD Cowen

It seems like with one additional Tuesday, at least 8% growth is reasonable. But how are some of the factors that impacted Q1 transitioning into Q2? What should that do to sales? And then second, just a follow-up, brief follow-up question on Chronicity. You mentioned that Chronicity was relatively seamless from script to fill.

Philip Nadeau
MD, Health Care – Biotechnology at TD Cowen

Can you give us some sense of the time, the average time it takes from prescription being written or an enrollment start being received to when the patient actually gets drug in hand? Thanks.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Thanks, Phil, for the questions, as always. Yeah, from a Q1 to Q2 dynamic, you would expect a nice step up. You do gain back one order week in the quarter. That does provide a sequential benefit. You also have the record numbers of new patients that we mentioned earlier, and then the natural recovery of refill rate per patient.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

The one aspect that you will want to contemplate that's different than previous years. As mentioned, we did enter into some contracting during the quarter. And from and as a result of that, we do we will have a sequential hit in gross to net, I'd call it slightly down from Q1 to Q2, that will push down the growth profile just a little bit. But overall, you would expect a nice step up for Q2, and it positions us well for the second half of the year. As it relates to time, I would just say that it's time to ultimately get a fill or get the reimbursement for Chronesity.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

It's still too early in the cycle to give any specific number. As you have heard us say before, patients, once they have an enrollment form written, it's typically a five to seven day process where the pharmacy is trying to get reimbursement. And whether the patient has had reimbursement granted or not, a patient will ultimately get a fill. And as we alluded to in the percentages we provided, 30% did get free goods during the quarter. But overall, team performed very well, and I think the feedback on our pharmacy channel has gone great so far.

Philip Nadeau
MD, Health Care – Biotechnology at TD Cowen

That's very helpful. Thank you.

Operator

We'll move next to Brian Abrahams with RBC Capital Markets. Your line is open.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Hey, guys. Thanks very much for taking my questions. Congrats to Eiry on a great career at Neurocrine, and congrats on the strong KRONESITY start. Maybe just two quick ones for me. On Cranesiti.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Can you provide any more specifics on the proportions of patients being treated at centers of excellence versus community centers? And how these doctors are managing the glucocorticoid down titration, whether that differs at all? And then on INGREZZA, as you continue to invest in formulary access, can you give us any more specifics on how to think about contracting cadence going forward and what the pricing trends might look like beyond second quarter of this year? Thanks.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, so let me take a crack at the second question first, and then tackle the Crinesity question. Eiry might want to chime in as well. Contracting cadence. So we've always said that our priority is to maximize access for patients. And historically, we have contracted, but we've been fairly prudent in terms of selecting where we want to contract and where we think it can make a difference in terms of improving access.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

In the prepared remarks, we talked about increasing coverage in the Medicare segment for the TD market and the HD market from less than half to approximately two thirds with the most recent rebate agreement. And we're gonna continue to monitor the environment. I don't think there's anything immediate that could happen. Certainly nothing that we're anticipating in terms of additional rebate agreements. But certainly, if anything does happen, if we enter into any additional rebate agreements, we would flag that going forward.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

But ultimately, you know, the benefit of improving access certainly accrues starting this year, but carries into 2026 as well. So I think it sets us up well for the future. With regards to your question about, I'll call it sources of business, volume of treatment forms coming in from centers of excellence versus the community. You know, right now what we're seeing is that it's really across the board. We have seen adoption and referrals coming in from those centers of excellence, but keep in mind, there's not very many of them.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

There's only nine accredited centers of excellence accredited by the CARES Foundation, a similar number that have most of those services, but they're accredited. So we are seeing adoption and referrals also from community pediatric endocrinologists as well as pediatric adult endocrinologists. And it kind of ties back to the comments that we made earlier about really seeing that that Crinesity is being embraced by the broader endocrinology community. Anything to add, Eiry?

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

No, just about the steroid reduction piece of the question as well. The first thing, just to build on what Eric was saying, we've been incredibly impressed by the engagement of the endocrine community around Chronicity and the level of interest in gaining additional education on how to use the medicine effectively and safely. I think in general, as our medical team has engaged, there's a few things that we're learning. First of all, I think there is a real enthusiasm about the safety and tolerability profile that we saw with Cranesity and the registration studies, and so that creates a foundation for a good opportunity to start the medicine in a patient. The second thing is the label that we achieved for the medicine, which is broad in its description and doesn't require very specific or guided information on steroid reduction.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

And what that allows us to do is engage with clinicians as they ask questions of the medical team, to provide guidance where appropriate, while still ensuring that on an individualized basis, the clinician and the patient can decide what's the right regimen for the patient and how to reduce the steroids effectively.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah. All in all, many of these patients are just getting started on crinesity and just getting started on that journey. So I think we'll learn more in the coming quarters.

Brian Abrahams
Brian Abrahams
MD & Global Sector Head - Health Care Research at RBC Capital Markets

Thanks very much.

Operator

We'll take our next question from David Amsellem with Piper Sandler. Your line is open.

David Amsellem
David Amsellem
Sr. Research Analyst at Piper Sandler Companies

Thanks. Just staying with Cranesity. Can you talk about the mix between starts in adults versus pediatric and adolescent patients? Bearing in mind that these are early days, but can you talk to which of these patient groups, if any, you're gaining more early traction in? Thank you.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, David. I think I mentioned earlier that at the very beginning of the launch, in other words, the beginning of Q1, we were seeing it was about even split between adults and the pediatric patient population. But as we went through the quarter, we saw that we're getting more treatment form referrals for those pediatric and adolescent pages patients, excuse me. So we're starting to see a trend towards greater uptake in the younger population, which is what we expected to see. We'll have to see how things shake out over the next several quarters.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

As I said before, when you you've got very little data to work with, things can swing in one direction or another. But as we get more utilization, more adoption from the community, I think we'll have a better sense of how how the launch is going.

Operator

We'll move next to Anupam Rama with JPMorgan. Your line is open.

Anupam Rama
Anupam Rama
Analyst at JP Morgan

Hey, guys. Thanks so much for taking the question, and best of luck, Eiry, and everything you pursue going forward. On the INGREZZA and the record number of patient starts, what should we attribute this to in terms of thinking about your share of voice gain relative to AUSTEDO XR? I know you pointed to that as a headwind coming into the year. How we think about have you stabilized your share of voice?

Anupam Rama
Anupam Rama
Analyst at JP Morgan

Or were there other factors like TD market expansion or other factors we should be considering? Thanks so much.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, I mean, obviously, you know, we made an investment last year to expand our sales force, and we targeted that investment towards the areas that we thought would yield the best results and specifically into psychiatry and into long term care. So we're starting to see the tangible benefit of that. You know, we had cautioned that when you expand a sales team in the near term, it can be disruptive and can negatively impact your your productivity. But as the the new the newer representatives, you know, become more productive and they start to level up to the to the level of their their colleagues that have been in the field for some period of time, you know, then you start to see the tangible benefits. And I think that's really what we're seeing as it manifests in terms of new patient starts.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

So we're certainly pleased to see a record number of new patient starts in Q1. But we've also mentioned, you know, that we've implemented some newer marketing initiatives. And really, the idea is to be better at helping our customers to appreciate the meaningful differences between INGREZZA and the tetrabenazine products that are out there. So, you know, between having more people in the field calling on the right accounts and doing a better job of differentiating INGREZZA, I think really those are the two elements that probably have the biggest impact in terms of driving those new patient starts.

Anupam Rama
Anupam Rama
Analyst at JP Morgan

Thanks so much for taking our question.

Operator

We'll move next to Josh Schimmer with Cantor. Your line is open.

Josh Schimmer
Managing Director at Cantor Fitzgerald

Great. Thanks so much for taking the questions. A couple of quick ones. Has your contracting for INGREZZA contemplated the AUSTEDO IRA price negotiation implementation? Or will you have to renegotiate as you get closer to that kicking in, in 2027?

Josh Schimmer
Managing Director at Cantor Fitzgerald

And then just in terms of this the record number of starts, just trying to align that with your comments, I guess, around last year and early into this year that you didn't really expect your redeployed Salesforce to start to contribute meaningfully until later this year. Have they has that contribution occurred earlier than you expected, or are you still waiting for a significant inflection from their contributions? Thank you.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

I'll Josh, this is Kyle. I'll take on the the first question on the contracting piece. I think if you look at our history on contracting in the past, it has been really, you know, the the north star here is to maximize patient access, and that's always been how we viewed contracting. We've done that in years in the past. We've also walked away from contracting at certain time points when that was not the case.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

I think when we look at, the strategy overarching is to have a parity, type of situation with other products in this space to make sure patients have as many options as possible. The thing that's different moving forward is IRA does bring a complication into the story about how we view about how we view contracting and maximizing patient access. So this is a variable. Now that's part of the equation that's growing in magnitude of its significance, and that is something that we have an eye on, in particular for our competitors' iPay moment in 2027. Now, obviously, contracting that we do now is really with, an eye on 2026.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

And in some cases, you can pull forward into, the same year. But, we do look at that as something that's important for us to to continue looking at. And as things change and evolve over the coming months and year, we will certainly keep the external community

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

up

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

to date in case any changes in our contracting approaches change. But right now, we're happy where we landed with the expanded access here starting this quarter and moving into the remainder of the year. Eric, you have anything to add to that?

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah. Just in general, especially in the Medicare space, you year to year with your contracts. Several of the agreements that we have in place, however, carry us through 2025 and the entirety of 2026. And so that does provide some stability from a planning perspective and right up to the doorstep of that IPA moment as as Kyle described. The second piece was really around the contribution of the expanded sales force.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Was it earlier than what we expected? I would say no. It was pretty much in line with our expectations. I recall that the expanded sales team hit the field in q four, and, you know, we had said that we need a few quarters for the team to kinda hit their stride. And we saw that really manifest with the record new patient starts, especially as we move through q one.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Keep in mind that q one is a quarter every year that we have to go through somewhat of a rite of passage because of the many, many patients that need reauthorization. So kind of working our way through that with our customers, with the HCPs and the pharmacies does consume a lot of our effort in Q1 every year. But we're able to do that in tandem with driving new patient starts, and I really do think it's the tangible benefit of the expanded team, not just more people, but also the new hires becoming more proficient in driving diagnosis and treatment with INGREZZA. So I'd say right on schedule, feeling really good about the expanded team. And, you know, as we said earlier, we do expect to see accelerated growth for the balance of the year as we've reiterated with our guidance.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

You know, maybe just to add to that real quickly. Eight years in the launch, and I think we just had our greatest quarter in terms of new patient starts is phenomenal, and

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

I do attribute that to the team and their ability to catch up quickly and work through a very challenging q one.

Josh Schimmer
Managing Director at Cantor Fitzgerald

Thank you.

Operator

We'll take our next question from Jay Olson with Oppenheimer. Your line is open.

Jay Olson
Research Analyst at Oppenheimer & Co. Inc.

Oh hey, congrats to Eiry for all the amazing achievements that she's accomplished on behalf of patients. We have a question about the journey study of valbenazine for adjunctive treatment of schizophrenia. Clinicaltrials dot gov shows a March 2025 completion date. So should we expect those results any day now? And then as a follow-up, can you talk about the learnings you expect to leverage from the JOURNEY study?

Jay Olson
Research Analyst at Oppenheimer & Co. Inc.

How will you apply those learnings to your next gen VMAT2 inhibitors? And what, if any, are the implications from the recent failure of cobenefi in ATS? Thank you.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Yeah. Thanks very much, Josh. Thanks for the kind words as well. I really appreciate that. And I think in terms of the JOURNEY study, yeah, it's a very important study for us in terms of learning for the VMAT platform, and obviously this is a must win area for us, this biology, and so we're really interested in understanding what we'll learn from that trial.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

We will be reading out the study in the near future. I mean, said somewhere around the middle of the year and I think we're still on track from that, as you saw from clinicaltrials.gov as well. And, you know, I think we're going to be interested in understanding the potential efficacy as it's measured by, you know, reduction in the PANSS total score, but we also have a lot of other functional endpoints and other subgroup analyses within that study, which are going to allow us to understand more about what type of patient within that population might respond best to the biology that's represented within VMAT2 inhibition. I also think just one brief comment on the recent COBEMFY study. As you know, there are no medications approved for the adjunctive treatment of schizophrenia currently, and I think that study showed us again the difficulty in performing clinical research in this area.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

I mean, take on that was it was a well run study for a medication that has already been proven to be effective in the treatment of acute psychosis in cobenefi, and so the inability to show an additional improvement in that setting, I think, reflects more on the nature of the clinical trials that are performed in this area and also some of the challenges there in this patient population. Just one thing to add in that regard, because we have been asked, I know you didn't ask this, but we are asked does that have any implication for us with respect to our five sixty eight program? And it doesn't in any way dampen our interest and belief in the Phase three program that we have for five sixty eight in acute psychosis. I think we're very confident in the Phase two data that we generated for the twenty milligram dose and very pleased to have just started the Phase III program in that setting. And I think I said your name wrong, Jay.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

I'm terribly sorry about that. But yeah, and thanks again for the question.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

No worries. Thank you, Eiry.

Operator

We'll move next to Cory Kasimov with Evercore. Your line is open.

Cory Kasimov
Senior Managing Director at Evercore

Great. Good afternoon, guys. Let me add my congrats to Eiry on a great run at Neurocrine. So two questions on KRONESITY for me. One really quick one.

Cory Kasimov
Senior Managing Director at Evercore

Was there any amount of was there material amount of inventory stocking in the first quarter? And then a second question, when could we expect to see longer term KRONESITY data from your ongoing Phase III open label extension? What endpoints do you believe could be positively impacted by longer term androgen control? Thank you.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Hey, Corey. I love inventory questions. There was very little stocking in the quarter from an inventory perspective. I'll let Eiry comment on planned upcoming data.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Yeah, and just to remind everybody, more than ninety percent of the patients in the randomized trials of Cranesiti rolled over into the open label extensions, both on the pediatric and the adult side, and the vast majority patients have remained in the study ever since then, over ninety percent. And so we are in the process of actually shutting down The US portion of the adult open label extension study, and those individuals will be rolling on to commercial product over the next few months. The pediatric study we are keeping going, because it's generating additional very important data for us, and obviously we are continuing the studies outside The United States. With respect to the data from those studies, we will be releasing one year data on both androgen control, glucocorticoid levels, and clinical endpoints such as metabolic endpoints and other reproductive hormone related endpoints over the coming months at the ENDO meeting in July and most in the most the nearest future is this month at PES.

Cory Kasimov
Senior Managing Director at Evercore

That's very helpful. Thank you.

Operator

We'll take our next question from Brian Skorney with Baird. Your line is open.

Brian Skorney
Senior Research Analyst at Baird

Good afternoon, everyone. Thank you for taking my question. Eiry, congratulations on your, pending retirement. So maybe I'd also love to ask you a question, just from your comments on the $5.68 Phase III plans. It sounds like you wouldn't necessarily write off opportunity for five sixty eight in an adjunctive therapy setting.

Brian Skorney
Senior Research Analyst at Baird

So I'm just wondering, you know, and obviously you do a commercial leg up if you had a successful phase III study in that setting with cabenci failing. Is there a study design that you see that would be worth pursuing for May? Not sure if you think the risperidone subgroup analysis is a real effect or if there's some some other unique, design you you would think about pursuing.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Brian, this is Cobb. Maybe I'll start this question, and Irene and I can tag team a bit on this. I think what we've seen from the early CoBEMPHI launch is that seventy eight percent of patients are taking the therapy from a monotherapy perspective. Maybe there's some overlap there as patients transition from one medicine to the next, and there's some overlap of two medicines. But for the most part, it seems like it's used in a in a monotherapy type of setting.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

So that'd be kind of point number one. Number two is I think what we've seen proclombenefi, from BMS and others that have worked in this space, you know, we have our own data that we'll be having, be available around the first half of this year. ATS trials are extremely difficult to run. I think there's still a lot of learnings there that can be applied and thought about for the future. That's why we're excited about running the study and seeing the results for valbenazine in this space so we can get a feel for that, and the learnings from that will be plowed back into our next generation compounds.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

But when it comes to the muscarinic themselves, we think that there is a significantly large opportunity stand alone with the acute studies that we have planned for the registrational program and then moving into other indications, in particular, later this year with five six eight into bipolar mania. And that's our current strategy.

Operator

We'll move next to Mark Goodman with Leerink Partners. Your line is open.

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

Yeah. Matt, with INGREZZA, you've talked about five thousand eight hundred as the ASP that we should be thinking about for this year. Obviously, that number has changed if you could give us a sense of what the new number is. And then, Eiry, definitely we'll all miss you. Maybe just a question for you.

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

Excluding $5.68, can you talk about the rest of the muscarinic portfolio and where we are? Thanks.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Yeah, Mark. I think I've gotten away from getting into the nuances of the exact net revenue per script for a handful of quarters now. But guess the guidance that I would give you is you typically see an improvement in gross to net going from Q1 to Q2. I would expect that to be sequentially down just slightly. And so I think that's the color that I would provide on net revenue per script, Mark.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Go ahead, Eiry.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Thanks, and thanks, Mark. On the remainder of the muscarinic portfolio, just to remind you, we have five seventy, which is a dual M1M4 agonist, five sixty nine, which is an M4 preferring agonist, and five sixty seven, which is an M1 preferring agonist, and then our own internally discovered nine eighty six, which is an M4 antagonist as a potential treatment for dystonia and Parkinson's tremor. With respect to the agonist, and actually including the M4 antagonist as well, all of those medicines are progressing currently through Phase one studies. For five seventy, we will be completing Phase one in the very near future and starting a Phase two study by the end of this year in acute psychosis, and that will be the next Phase two start for us from that platform. And then as five sixty nine and five sixty seven complete their Phase I studies, we'll be talking more about that and the potential next steps there, including any potential Phase II starts in the foreseeable future.

Marc Goodman
Senior MD - Neuroscience at Leerink Partners

Thanks.

Operator

We'll take our next question from Sean Lammen with Morgan Stanley. Your line is open.

Michael Riad
Michael Riad
Analyst at Morgan Stanley

Hey, this is Mike Riyadh on for Sean Lammen. Thank you for taking our questions and a big congrats to Eiry for all the impact you made. Thinking about INGREZZA, Teva's AUSTEDO guidance suggests a good amount of patients can come to AUSTEDO this year, but the data that was presented at AMCP show half of patients don't reach that therapeutic dose on AUSTEDO or XR. So thinking about that, how do you see the AUSTEDO drop off market evolving? And do you think that some proportion of those drop offs can switch to INGREZZA and help the new patient starts?

Michael Riad
Michael Riad
Analyst at Morgan Stanley

Thanks.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

We were very encouraged by the information that we recently released and published regarding the therapeutic dosing. And, you know, I just remind you that, obviously with the forty and eighty milligrams of INGREZZA, we start dosing at a therapeutic dose level and continue throughout the patient's period of time on the medicine. And so from that point of view, I think as Eric alluded to in his prepared remarks as well, I think we have a very high confidence level in the value that INGREZZA can bring to patients. You know, it's as we said highly effective, including in the data that we recently published on long term data in more elderly population as well, uniquely selective in terms of its VMAT2 inhibition, and we have the broader set of data that we believe in patient populations that can experience value. And so we're focused on that and continuing to educate around that.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, only other thing that I would add, just to piggyback here, is that the majority of patients, you know, that we see starting on INGREZZA have been and continue to be newly diagnosed and newly treated. There isn't a lot of switching that happens in the VMAT2 market, and, you know, we haven't seen that dynamic really change that much So, you know, we continue to make progress with, diagnosis and motivating treatment. But for the most part, the patients that are starting INGREZZA are, getting started on the VMAT2 for the first time.

Michael Riad
Michael Riad
Analyst at Morgan Stanley

I appreciate that. Thanks.

Operator

We'll move next to Ash Varma with UBS. Your line is open.

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Hi. Congrats from my side as well. Just on INGREZZA, maybe can you talk about any pull through on these new contracting or the Medicare Part D formulary access that you mentioned? When does that happen? Like, did that benefit 1Q or is that more of a 2Q or later in the year?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

And just secondly, what was the percentage increase in the sales force footprint? If you can remind us, and when do you expect that benefit to start to accrue? Thanks.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, I got the first part of your question in terms of the pull through effort. Can you repeat the second part?

Ashwani Verma
Ashwani Verma
Executive Director - SMID Biotech & Biopharma at UBS Group

Yeah, like, what was the percentage increase in the Salesforce footprint? And when do you expect that benefit to start to accrue?

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Okay. Well, I'll I'll I'll take on the second part first. We didn't give exact headcount numbers when we did the expansion in q four of last year. But, you know, it was a substantial increase of our psychiatry footprint. And as I mentioned before, we do think that it is starting to see tangible benefits here in the market, primarily manifest as the record number of new patient starts we saw in Q1.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

With regards to pull through, yes, you know, certainly our plan of action has always been when we have a formulary win, we attempt to pull it through. And the way that that, you know, translates is certainly through personal and nonpersonal promotion. Our sales teams are aware of where there's been an add of INGREZZA on to a formulary. They're aware of the HCPs that are having more patients underneath that plan, and they're sure to communicate those changes. And with regards to this most recent formulary win, that process has already started as of the April.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

So, you know, we're gonna continue to leverage when we do have increases in formulary coverage. But the way to think about it is it really benefits new patient starts. Existing patients who are already on treatment under that plan, they're already covered. They have a certain number of authorized refills. It's the new patient starts where there's a little less headwinds because it's now on formulary.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Thanks.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

But just to be clear on how the the financials flow on this, we will take a more immediate hit to gross to net starting in Q2. And the benefit from the new patient additions, as Eric mentioned, too, will accrete over time. So it typically takes two, three, four quarters to get to a place where you're ROI positive. But it's something that, as we mentioned and as Kyle mentioned, strategically important for us to continue to be a major player in this market. Thanks.

Operator

We'll take our next question from Mohit Bansal with Wells Fargo. Your line is open.

Analyst

Hi, this is Serena on for Mohit. Congrats on the great quarter. First, I wanted to ask a clarification question on INGREZZA gross to net.

Analyst

I think previously you guys have said that you would expect some tailwind from the lower phase in of rebate under Part D redesign. So I was wondering if that was any bit of a factor this year. And then wanted to ask on the Phase III program for May, how are you thinking about the number of sites, any ex U. S. Sites, and then any other changes in how the studies will be run versus the phase two beyond the selection of just one dose?

Analyst

Thanks.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Yeah. From the MedD design change on the mandatory rebates, that was a slight benefit. I'd call it like 1%. And that was a tailwind entering into this year. But that will, of course, be more than absorbed by the incremental contracting, which really is what's going to drive continued growth and value for INGREZZA and for the company going forward.

Matt Abernethy
Matt Abernethy
Chief Financial Officer at Neurocrine Biosciences

Eiry, do want to comment on PISCES, please?

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Yes. We'll obviously provide more information as we get the remaining studies within the program up and running. But just a couple of comments. The first study is a US only study for the phase three, and as you mentioned, it is a single dose level of twenty milligrams, one to one randomization with placebo, so very simple in design. And we are taking all the learnings that we achieved from the Phase II, which we can talk more about once the full program is up and running.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

The number of sites doesn't increase substantially, which I think is really important, because if you remember, our Phase II was a study that was run over a number of sites and a relatively complex adaptive trial design. So we think the simplicity of the Phase III program that we've designed and are implementing will be beneficial for us moving forward.

Operator

We'll move next to Miles Minter with William Blair.

Myles Minter
Research Analyst - Healthcare at William Blair

To Diary as well for a great career there at Neurocrine. Just on osfabanpator, the two Phase three studies that are listed on ClinicalTrials.gov, just wondering about the powering assumptions for those trials given that 200 patients seems on the smaller end from what we're seeing from peer studies that have obviously had mixed results. And secondly, I think on slide six it says you've initiated four Phase three studies. What are the other two?

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

Yeah. So thanks, Myles. A couple of questions there. Let me get to the number of studies first of all. Within the registration package for osavampatore, there are three key studies: the two short term randomized placebo controlled studies and one longer term open label study, which is obviously essential to enable us to look at longer term safety.

Eiry Roberts
Eiry Roberts
Chief Medical Officer at Neurocrine Biosciences

With respect to the powering and the subject number, this could be quite a long conversation, but let me make it short. One of the things we worry most about in the context of major depressive disorder studies is placebo effect and obviously expectation bias. And there is also a large body of research that suggests that the larger the study gets beyond a number of around about 20, the increased likelihood of placebo response and therefore the increased likelihood of potentially failed studies. So whilst the each of the Phase three studies is adequately powered and appropriately powered to measure an effect size significantly smaller than that which we saw in Phase two, so we're highly confident in the size of the study, We have limited the size of the studies, because of our take on an understanding of the research in this area about the balancing act between increased subject numbers driving increased placebo response and increased risk of failed study.

Myles Minter
Research Analyst - Healthcare at William Blair

Thanks for the questions.

Operator

We'll move next to Laura Chico with Wedbush. Your line is open.

Laura Chico
Managing Director, Senior Biotechnology Analyst at Wedbush Securities

Good afternoon. I just wanted to revisit real quick on the INGREZZA patient numbers. Congrats on the record ads here. I'm not sure if you could also comment a little bit more about persistency and discontinuation rates. Think Eric, you mentioned the reauthorization was challenging, but are there differences in the duration of treatment depending on the channel from which patients are originating, say, long term care versus psych?

Laura Chico
Managing Director, Senior Biotechnology Analyst at Wedbush Securities

And then separately, I'm just curious with the R and D Day in the second half here, any highlights to share in terms of how we should be thinking about the potential focus of the event? Thank you.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

Yeah, with regards to the question around patient persistency, generally it's been very steady from the early days of the launch through the most recent cut that we looked at. And we haven't seen any real differences in persistency across the different channels, whether, you know, the patient's being treated by a psychiatrist, a neurologist, or more recently coming in through long term care. I did comment that this was a, you know, a challenging q one, a little bit more challenging perhaps than what we've seen in in years past. You know, anecdotally, feedback from the customers was that the reauthorization process was a bit more challenging from their perspective, and we saw slightly higher drop offs and delayed refills versus prior years. All of that was counterbalanced by the record number of new patient adds.

Eric Benevich
Eric Benevich
Chief Commercial Officer at Neurocrine Biosciences

And so that's really what gives us the, you know, the sort of the confidence and conviction acceleration of our growth, given the uptake that we saw with new patients in Q1. But overall, no, we're not seeing any real differences in patient persistency by segment.

Operator

And this does conclude the question and answer portion of our call. I would now like to turn it back to Kyle Gaino for any additional or closing remarks.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Thanks, everyone. I know we didn't get to all of your questions. For those of you that missed, we'll be following up with you individually. But thanks, everyone, for joining this afternoon. As you can see, we've made meaningful progress across several critical priorities of the business when we think about INGREZZA reaccelerating new patient starts, improving access for health care providers and the patients they serve, successfully launching KRONESTI and initiating multiple phase three studies.

Kyle Gano
Kyle Gano
CEO at Neurocrine Biosciences

Neurocrine has never been in a stronger position, and we'll continue to remain focused execution and evolution of the pipeline as we move through the remainder of the year. So looking forward to seeing all at the upcoming conferences or on your latest Zoom call. So looking forward to speaking with you soon. Thanks so much.

Operator

This does conclude today's program. Thank you for your participation. You may disconnect at any time, and have a wonderful rest of your day.

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Key Takeaways

  • Neurocrine delivered record new patient starts for INGREZZA in Q1 and reaffirmed its 2025 sales guidance of $2.5 billion–$2.6 billion, with momentum expected to accelerate in Q2 and beyond.
  • The launch of Crenesity achieved $15 million in net revenue with 413 treatment forms and a 70% reimbursement rate, driven by strong uptake across pediatric and adult endocrinologists.
  • The R&D pipeline advanced with Phase III initiations for osavampatore in major depressive disorder and NBI-568 in schizophrenia, and plans to start additional Phase II studies (MBI-568 for bipolar mania, MBI-570 for schizophrenia) later this year.
  • Neurocrine maintains a robust financial position with approximately $1.8 billion in cash, 3.6 million shares retired, and a disciplined capital allocation strategy prioritizing commercial growth, pipeline investment, business development, and potential shareholder returns.
  • Leadership evolution announced with Dr. Sanjay Keswani joining as Chief Medical Officer in June and Dr. Ivy Roberts transitioning to a strategic advisory role to continue guiding key development programs.
AI Generated. May Contain Errors.
Earnings Conference Call
Neurocrine Biosciences Q1 2025
00:00 / 00:00

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