Q1 2025 Neurocrine Biosciences Inc Earnings Call

Speaker Change: [music].

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Todd Tushla: Good day, everyone, and welcome to Neurocrine Biosciences Report's first quarter 2025 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.

Good day, everyone and welcome to Neurocrine Biosciences reports first quarter 2025 result.

Speaker Change: 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.

Speaker Change: 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 to slow Vice President of Investor Relations. Please go ahead.

Todd Tushla: It is now my pleasure to turn the conference over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

Speaker Change: Yeah.

Todd Tushla: Thank you and happy Cinco de Mayo to everyone.

Speaker Change: Thank you and happy 5 de Mayo to everyone. Welcome to Neurocrine Biosciences first quarter 2025 earnings call with me today are Kyle Gano, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, Eric benefits, Chief Commercial officer and for one last time as Chief Medical Officer IV Roberts.

Todd Tushla: Welcome to Neurocrine Biosciences first quarter 2025 earnings call.

Kyle Gano: With me today are Kyle Gano, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, Eric Benevich, Chief Commercial Officer, and for one last time as Chief Medical Officer, Eiry Roberts. 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.

Speaker Change: 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. Following prepared remarks, we will strive to get to everyone's questions now I will turn the call over to Kyle. Thanks.

Kyle Gano: I encourage you to review the risks factors discussed in our latest SEC filings. Following prepared remarks, we will strive to get to everyone's questions.

Kyle Gano: Now I will turn the call over to Kyle. 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 Ingresa and encouraging early adoption of Chronicity. With reaffirmed guidance for Ingresa and solid momentum heading into Q2, combined with an early but promising launch trajectory for Chronicity, 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.

Kyle Gano: 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.

Kyle Gano: The first quarter reflected strong execution across both of our brands with record new patient starts for in Gaza and encouraging early adoption of Chronicity.

Kyle Gano: With reaffirmed guidance for <unk> and solid momentum heading into Q2 combined with an early but promising launch trajectory for Chronicity, we are well positioned to drive both near and long term revenue growth as we evolved 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.

Kyle Gano: Amazing to see the efforts from our commercial and medical teams this quarter. Well done.

Kyle Gano: <unk>.

Kyle Gano: On the R&D front, our portfolio continues to advance meaningfully. We are encouraged by the progression of OSA-Vampator and MBI-568 into Phase III Registrational Studies. The strong magnitude of effect demonstrated in both programs' Phase II Proof-of-Concept studies gives us confidence in continued investment. We are on track for expanding our muscarinic portfolio into new Phase II studies later this year. This includes MBI-568 into bipolar mania and MBI-570, our dual M1-M4 agonist, into schizophrenia.

Kyle Gano: On the R&D front, our portfolio continues to advance meaningfully we are encouraged by the progression of <unk> and MBIA 568 in two phase III Registrational studies, the strong magnitude of effect demonstrated in both programs phase two proof of concept studies gives us confidence and continued investment we are on track for expanding our mud.

Kyle Gano: The granite portfolio into new Phase II studies later this year. This includes <unk> 568 into bipolar mania, and MBIA $5 70, our dual <unk> agonist into schizophrenia.

Kyle Gano: From a leadership perspective, we are thrilled to welcome Dr. Sanjay Keswani as our incoming chief medical officer in June. Dr. 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.

Kyle Gano: From a leadership perspective, we are thrilled to welcome Dr. Sanjay kept suwannee as our incoming chief Medical Officer in June.

Speaker Change: <unk> IV Roberts, our current CMO will transition into a strategic advisory role where her expertise will continue to shape key programs.

Matt Abernethy: In closing and reflecting on the quarter I am extremely proud of our team in progress are 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: With that, I'll turn the call over to Matt. Thank you, Kyle, and good afternoon. We made tremendous progress throughout the first quarter, both with the re-acceleration of new patient growth for Ingresa and with their successful Chronicity launch. We're 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 Ingresa, we posted $545 million in first quarter product sales. As anticipated, first quarter sales were impacted by one less order week, patient reauthorization processes, and gross net dynamics.

Matt Abernethy: Thank you Kyle and good afternoon, we've made tremendous progress throughout the first quarter, both with the Reacceleration of new patient growth for <unk> and with their successful Chronicity launch.

Matt Abernethy: Executing from a position of strength with these two growing commercial products, our robust clinical pipeline in CNS disorders in a strong financial foundation that provides flexibility for continued investment to drive shareholder value.

Matt Abernethy: Turning within Grubhub, we posted $545 million in first quarter product sales as anticipated first quarter sales were impacted by one less order week patient reauthorization processes.

Matt Abernethy: And gross to net dynamics, although noisy I do want to make a few very specific comments about the quarter and impressive.

Matt Abernethy: Although noisy, I do want to make a few very specific comments about the quarter and Ingresa. 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 needs. Second, effective April 1st, 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're reaffirming our 2025 sales guidance range of $2.5 billion to $2.6 billion, which factors in the expected acceleration of new patient additions, offset by growth to net impact from contracting activity.

Matt Abernethy: 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.

Matt Abernethy: Second effective April one 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.

Matt Abernethy: Finally, as Kyle mentioned, we are reaffirming our 2025 sales guidance range of $2 5 billion to $2 $6 billion, which factors in the expected acceleration of new patient additions offset by gross to net impact from contracting activities.

Matt Abernethy: Turning to Chronicity, where we just completed our first full quarter of launch. We achieved net revenue of $15 million, which includes 413 enrollment forms, with 70% of dispenses receiving reimbursement. Although we are still early in our launch efforts, we're encouraged by this initial success.

Matt Abernethy: Turning to Chronicity, where we just completed our first full quarter of launch we achieved net revenue of $15 million, which includes 413 enrollment forms with 70% of dispenses receiving reimbursement.

Matt Abernethy: Though we are still early in our launch efforts. We are encouraged by this initial success.

Matt Abernethy: 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&D pipeline. and three investments to enable business development. And lastly, consider returning capital to our shareholders. During the first quarter, we continued to reflect these priorities to drive revenue growth with investments in our expanded Ingressive Sales Force and Chronicity Launch. In addition, we continued to make investments advancing our pipeline in R&D with the initiation of two major Phase III programs. Just a reminder, R&D expense for the first quarter of 2025 includes $45 million in milestone expense, primarily for the initiation of our OSA-Vampitore Phase III program in MDD, and we'll recognize $15 million in milestone expense in the second quarter for the initiation of MBI-568 Phase III program in Schizophrenia.

Matt Abernethy: A few financial comments, our capital allocation priorities remain intact with our number one priority being investments to drive revenue growth.

Matt Abernethy: Number two priority is investments to advance our R&D pipeline.

Matt Abernethy: 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, but the investments in our expanded and grosses salesforce in Chronicity launch. In addition, we continue to make investments in advancing our pipeline in <unk>.

Matt Abernethy: R&D with the initiation of two major phase III programs.

Matt Abernethy: As a reminder, R&D expense for the first quarter of 2025 includes $45 million of milestone expense, primarily for the initiation of our <unk> phase III program, and MDT and well recognized $15 million of milestone expense in the second quarter for the initiation of MDI 506.

Matt Abernethy: <unk> phase III program in schizophrenia.

Matt Abernethy: In addition, we've been able to retire 3.6 million shares over the past two quarters, and have retained a strong balance sheet with approximately $1.8 billion in cash to support our commercial and clinical development strategies for continued growth.

Eric Benefits: In addition, we've been able to retire three 6 million shares over the past two quarters and have retained a strong balance sheet with approximately $1 $8 billion in cash to support our commercial and clinical development strategies for continued growth with that I will now hand, the call over to Eric <unk> our chief.

Eric Benevich: With that, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric. Thanks, Matt.

Eric Benefits: Commercial officer Eric.

Eric Benefits: Thanks, Matt we're celebrating two significant milestones for <unk> first a couple of 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.

Eric Benevich: We're celebrating two significant milestones for Ingresa. First, a couple of 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.

Eric Benevich: I want to take a moment and thank our teams for their exceptional dedication and performance.

Eric Benefits: I want to take a moment and thank our teams for their exceptional dedication and performance.

Eric Benevich: This second week of May also marks Tardive Dyskinesia Awareness Month. Currently, we estimate that just over 40% of patients with TD have been given a diagnosis to explain their abnormal movements, and less than 10% are currently receiving standard of care treatment with a VMAT2 inhibitor, such as Ingress So there remains a significant opportunity for growth of the VMAT-2 class and INGRESA as the VMAT-2 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, health care providers and policymakers nationwide to increase awareness, reduce stigma and drive diagnosis so that TD sufferers can access available treatment options.

Eric Benefits: This second week of May also marks tardive dyskinesia awareness week.

Eric Benefits: Currently we estimate that just over 40% of patients with TD had been given a diagnosis to explain their abnormal movements and less than 10% are currently receiving standard of care treatment with a <unk> inhibitor such as aggressive.

Eric Benefits: So there remains a significant opportunity for growth of the <unk> two class and in <unk> as the <unk> two class leader.

Eric Benefits: As part of our support for TD awareness week Neurocrine continues to collaborate with the movement disorders policy coalition.

Eric Benefits: Mental health advocacy organizations health care providers, and policymakers nationwide to increase awareness reduced stigma and drive diagnosis. So that TD suffers can access available treatment options.

Eric Benevich: Matt provided a nice summary of Ingresa and Chronicity performance in his opening remarks, and I'd like to provide additional color. 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 growth 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.

Matt Abernethy: Matt provided a nice summary of <unk> performance in his opening remarks.

Speaker Change: And I'd like to provide additional color.

Speaker Change: First we're pleased to have expanded formulary coverage from less than half two approximately two thirds of Medicare PD and HD beneficiaries.

While this affects our gross to net access will be improved for HCP customers and the patients they care for.

Speaker Change: We view these as important investments to ensure patient access today and into the future.

Eric Benevich: Second, as noted in our last call, we believe the Inflation Reduction Act, or IRA, has notably influenced payer behavior and reimbursement . particularly for specialty medicines like Ingress. The second half of last year, we saw an impact on the prior authorization process for new In Q1, we saw the impact on the reauthorization process for continuing 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.

Speaker Change: Second as noted in our last call. We believe the inflation reduction act or IRA has notably influenced payer behavior and reimbursement dynamics.

Speaker Change: Particularly for specialty medicines like <unk>.

Speaker Change: In the second half of last year, we saw an impact on the prior authorization process for new patients in.

Speaker Change: 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.

Eric Benevich: Great job, team.

Speaker Change: Great job teams.

Eric Benevich: Third, we reaffirmed our 2025 Ingresa Guide Looking forward, our growth strategy encompasses our recently expanded Salesforce Investments in Improved Formula Reactions and Enhanced Marketing Initiatives that will strengthen Ingresa'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. with continued significant unmet need across the Tardive Dyskinesia and Huntington's Korea patient community. We anticipate sales to accelerate in Q2 and through the second half of 2025. And this momentum should position as well heading into 2026 and beyond.

Speaker Change: Third we reaffirmed our 2025 and <unk> guidance.

Speaker Change: Looking forward our growth strategy encompasses our recently expanded sales force investments and improved formulary access and enhanced marketing initiatives that will strengthening <unk> market, leading position as the only <unk> inhibitor that is highly effective uniquely selective with therapeutic dosing from day one.

Speaker Change: And proven across the widest range of patients.

Speaker Change: With continued significant unmet need across the tardive dyskinesia and Huntington's chorea patient communities, we anticipate sales to accelerate in Q2 and through the second half of 2025.

Speaker Change: And this momentum should position us well heading into 2026 and beyond.

Eric Benevich: For Chronicity, 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 413 treatment forms, which serve as a new prescription. and we reported $15 million in net sales. We're observing strong uptake across both pediatric and adult CEH patient populations. with slightly higher initial adoption rates in pediatric and adolescent segments. 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.

We're chronicity, while we're still in the very early stages I'm pleased to say that the launch is exceeding our expectations.

Speaker Change: Matt noted in Q1, we received 413 treatment forms which serve as a new prescription and.

Speaker Change: And we reported $15 million in net sales.

Speaker Change: We're observing strong uptake across both pediatric and adult CAH patient populations with slightly higher initial adoption rates in pediatric and adolescent segments.

Speaker Change: 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.

Eric Benevich: While it's too early to comment on longer-term outcomes, we're pleased with the warm reception of Chronicity from the medical and patient community. On the payer front, we noted that 70% of the dispenses in the quarter were reimbursed. Coverage requirements have generally aligned with our approved labeling, including diagnosis of classic CAH, Patient age of four years or older and concurrent glucocorticoid therapy.

Speaker Change: While it's too early to comment on longer term outcomes. We're pleased with the warm reception of Chronicity from the medical and patient communities.

Speaker Change: On the payer front, we noted that 70% of the dispensers in the quarter were reimbursed.

Speaker Change: Coverage requirements are generally aligned with our approved labeling including diagnosis diagnosis of classic CAH.

Speaker Change: Patient age of four years or older and concurrent glucocorticoid therapy.

Eric Benevich: As we move forward through the balance of the year, we expect more health plans to conduct formulary reviews and publish their coverage criteria. However, some plans may choose not to formally review chronicity and continue to review prescription claims via their exceptions. Overall, initial metrics are trending in the right direction across all key performance indicators.

Speaker Change: As we move forward through the balance of the year, we expect more health plans to conduct formulary reviews and published their coverage criteria. However.

Speaker Change: However, some plans may choose not to formally review Chronicity and continue to review prescription claims via their exceptions process.

Speaker Change: Overall initial metrics and trending in the right direction across all key performance indicators.

Eric Benevich: 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 chronicity 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 CEH patients.

Speaker Change: But I do want to remind everyone that one quarter is too soon to define a trend for either adoption or reimbursement.

Speaker Change: We're going to learn a lot over the coming quarters specific to persistency compliance rates and overall rate of adoption.

Speaker Change: If chronicity 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.

Eric Benevich: Once more, I'd like to congratulate our commercial and medical teams for getting Chronicity off to such a great start.

Speaker Change: Once more I would like to congratulate our commercial and medical teams for getting chronicity off to such a great start.

Eiry Roberts: So with that, I'll turn the call over to my colleague, Dr. Eiry Roberts, our Chief Medical Officer. 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 2025 data milestones.

Speaker Change: So with that I'll turn the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer.

Ivy Roberts: Thanks, Eric and good afternoon to everyone.

Speaker Change: We continue to make substantial progress advancing neurocrine early to mid stage clinical pipeline, particularly across our muscarinic portfolio next generation <unk>, two inhibitors and epilepsy programs.

Speaker Change: Today, I will focus specifically on our late stage Registrational assets and key 2025 data and milestones.

Eiry Roberts: I'll start with Osavamptor, our AMPA-positive allosteric modulator. I'm pleased to announce the initiation of all three randomized double-blind placebo-controlled studies, evaluating its efficacy and safety as an adjunctive treatment for major depressive disorder. These studies will measure the change in total Madras from baseline to day 56 as their primary endpoint, with top line data expected throughout 2027. Turning to our Selective M4 agonist, NBI 568, just last week we announced the initiation of the first of three Phase 3 Registrational Studies to evaluate the efficacy, safety and tolerability of NBI 568 as a potential treatment for schizophrenia. We anticipate initiating the two additional studies in the coming months.

Speaker Change: I'll start with <unk>, our <unk> positive allosteric modulator.

Speaker Change: I am pleased to announce the initiation of all three randomized double blind placebo controlled studies evaluating its efficacy and safety as an adjunctive treatment for major depressive disorder.

Speaker Change: These studies will measure the change in total mattress from baseline to day 56 us their primary endpoint with topline data expected throughout 2027.

Speaker Change: Turning to our selective and full agonist MDI 568, just last week, we announced the initiation of the first of three.

Speaker Change: <unk> phase III Registrational studies to evaluate the efficacy safety and Tolerability of MDI 568, as a potential treatment for schizophrenia.

Speaker Change: We anticipate initiating the two additional studies in the coming months.

Eiry Roberts: All three studies will be double-blind placebo-controlled trials comparing the 20 milligram dose of NBI-568 versus placebo with reduction from baseline in the positive and negative syndrome scale, or PAMS, at week five as the primary endpoint. We expect top-line data from these studies in the 2027-2028 timeframe. This year, we will report top-line data from two Phase 3 studies of valbenazine, the first in adjunctive treatment of schizophrenia, which serves as a proof-of-concept study for VMAT2 inhibition in this disease stage. While these results will guide the development of our next generation VMAT2 inhibitors, including NBI 890 and 675, we do not plan to expand the valbenazine label for this indication.

Speaker Change: All three studies will be double blind placebo controlled trials, comparing the 20 milligram dose of <unk> $5 $6 eight versus placebo with reduction from baseline in the positive and negative syndrome scale or pans at week five as the primary endpoint.

Speaker Change: We expect top line data from these studies in the 2027 2028 timeframe.

Speaker Change: This year, we will report topline data from two phase III studies of <unk>.

Speaker Change: First in adjunctive treatment of schizophrenia, which serves as a proof of concept study <unk> two inhibition in this disease state.

Speaker Change: While these results will guide the development of our next generation <unk>, two inhibitors, including NPI $8 90, and 675, we do not plan to expand about benzene label for this indication.

Eiry Roberts: The second readout, expected later this year, will evaluate valbenazine's efficacy in treating dyskinetic cerebral palsy. With no currently approved treatments for the 75,000 to 100,000 patients in the U.S. living with DCP, successful results could lead to a label expansion for this indication. For NBI 770, our NMDA NR2B subreceptor negative allosteric modulator, the phase 2 dose finding study in major depressive disorder remains on track for top line data in the second half of 2025. This study's primary outcome measure focuses on the Madras change from baseline to day 5, potentially demonstrating more rapid onset compared to Ossa Vampator's phase 3, day 56 endpoint.

Speaker Change: The second readout expected later this year, we'll evaluate <unk> efficacy in treating disconnected cerebral palsy.

Speaker Change: With no currently approved treatments for the 75 to 100000 patients in the U S living with DCP successful results could lead to a label expansion for this indication.

Speaker Change: So <unk> 770, <unk>, our NMDA and ought to be sub receptor 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 2025.

Speaker Change: This study's primary outcome measure focuses on the mattress change from baseline to day, five potentially demonstrating more rapid onset compared to <unk> phase III data 56 endpoint.

Eiry Roberts: 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 Giudonia's excellent progress establishing a sustainable internal innovation engine. 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 program team. Finally, I extend my gratitude to the board, Kevin, Kyle, my neurocrine colleagues, and all our external partners, including the investment community.

Speaker Change: As this marks my final earnings call as <unk>, Chief Medical Officer, I'd like to share some closing observations.

Speaker Change: Sure couldn't stand stronger than ever making this an optimal time for the transition.

Speaker Change: Our industry, leading pipeline continues to grow fueled by Jude on us excellent progress, establishing a sustainable internal innovation engine.

Speaker Change: My seven plus years at Neurocrine have been not by remarkable evolution and I'm confident in <unk> capability to lead as the next Chief Medical Officer.

Speaker Change: I look forward to maintaining an active advisory role supporting both Sanjay and our late stage program teams.

Speaker Change: Finally, I extend my gratitude to the board, Kevin Kyle My Neurocrine colleagues and all our external partners, including the investment community.

Eiry Roberts: Neurocrine is well positioned to help countless future patients, and I'm proud to have contributed to this journey.

Speaker Change: <unk> is well positioned to help countless future patients and I'm proud to have contributed to this journey.

Kyle Gano: With that, I'll hand the call back to Kyle. Kyle? Thanks, Eiry.

Speaker Change: With that I'll hand, the call back to Kyle Kyle.

Kyle Gano: Thanks, Harry and just to pause here a moment before we move into questions I do want to take a moment to recognize IRA for her many contributions over the years <unk> has played a vital role in shaping neurocrine into what it is today and really helped many thousands of patients along the way.

Kyle Gano: And just to pause here a moment before we move into questions, I do want to take a moment to recognize Eiry for 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 will continually be a player and help us along the way.

Kyle Gano: About the future here at <unk> should continue will continually be a player and help us along the way, but as he mentioned just a moment ago. This will be her final earnings call as an executive of the company sorry once again.

Kyle Gano: But as she mentioned just a moment ago, this will be her final earnings call as executive of the company. So Eiry, once again, thank you for your dedication, your leadership and your support over the years.

Kyle Gano: Thank you for your dedication your leadership and your support over the years without let's open it up to questions.

Unknown Executive: With that, let's open it up to questions. At this time, if you would like to ask a question, please press the star and 1 on your telephone keypad. You may withdraw yourself from the queue at any time by pressing star 2. Again, that is star and 1.

Kyle Gano: At this time, if you would like to ask a question. Please press star and one on your telephone keypad.

Kyle Gano: You may withdraw yourself from the queue at any time by pressing star you again that is star one.

Paul Matteis: We'll move first to Paul Matteis with Stiefel. Your line is open. Hey, thanks for taking my questions, and Eiry, congrats, always good to work with you. Two quick ones, as it relates to Ingresa, sounds like the quarter was not as challenging as some feared. 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.

Paul Matteis: Well move first to Paul Matteis with Stifel. Your line is open.

Kyle Gano: Yeah.

Paul Matteis: Hey, Thanks for taking my question.

Congrats always good to work with you.

Speaker Change: Two quick ones as it relates to <unk>.

Speaker Change: It sounds like the quarter was not as as.

Speaker Change: As challenging as some here I was wondering if you could comment on what Youre seeing into Q2, and if you feel like getting back to the prior growth rate at some point is attainable and then just on <unk>. Congrats on the progress should we be looking at this 400 number as a bolus and then it can attenuate from here or do you feel like it is just the beginning.

Paul Matteis: And then just on Chronicity, congrats on the progress.

Paul Matteis: Should we be looking at this 400 number as a bolus, and then it can attenuate from here, or do you feel like it's just the beginning? Thank you.

Speaker Change: Thank you.

Kyle Gano: Paul, this is Kyle. Maybe I'll start here and then I'll ask Eric or Matt to chime in.

Kyle Gano: Paul This is Kyle maybe I'll start here, and then I'll ask Eric or Matt to chime in on <unk> I think when we look at Q1 <unk>.

Kyle Gano: On Ingresa, I think when we look at Q1, you've probably heard us talking about the challenges of the quarter over the past couple months. I think it played out exactly as we expected it. We had that low momentum coming in to the year, the difficulties of reauthorization, the one less selling week, the hits on gross net, all those were factors that came into play. 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.

Kyle Gano: 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 in to the year. The difficulties of re authorization. The one less selling week the hits on gross to net all of those were factors that came into play but just too.

Kyle Gano: 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.

Kyle Gano: 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 from momentum going into Q2, the remainder of the year, and really just an amazing job by the team out there in the field. So I think that we had 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: 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 theres a lot to be said there for momentum going into Q2, 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.

Kyle Gano: 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, we mentioned the sales force expansion the expanded access that we have now.

Kyle Gano: We mentioned the Salesforce 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.

Eric Benefits: Other marketing marketing initiatives that will be kicking off here very shortly all of 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 <unk>, maybe I'll, let Eric speak to that.

Eric Benevich: In terms of chronicity, maybe I'll let Eric speak to that, and we can go from there. Yeah, no, Paul, I think your question is in terms of, you know, should we expect this number of treatment forms or a new patient?

Kyle Gano: We can go from there.

Paul Matteis: Yeah, Paul I think your question is in terms of should we expect this.

Kyle Gano: Number of treatment forms or a new patient.

Kyle Gano: <unk> referrals going forward.

Speaker Change: As I mentioned in my prepared remarks, we only have one quarter of experience with this launch obviously, we were really pleased with the adoption that we're seeing.

Unknown Executive: Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc Thanks, guys.

Speaker Change: But ultimately we need a little bit more time to understand what that pattern is going to look like and so as we go forward, we'll continue to share what the treatment form a referral rate is and obviously provide additional metrics like we did in this particular quarter, but I think it's too soon to tell but.

Speaker Change: I will reiterate.

Speaker Change: We're off to a great start and certainly this exceeded our expectations at this phase.

Speaker Change: Thanks, guys.

We'll take our next question from Apache Tiwari with Jefferies. Your line is open.

Phoebe: from Akash Tewari with Jeffreys. The line is open. Hi, this is Phoebe on for Akash. Thank you for taking our question. Similarly to what was just asked, could you provide any color on Trinicity'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.

Speaker Change: Hi, This is <unk> on for a cash thank you for taking our question.

Speaker Change: Similarly to what was just asked.

Speaker Change: Provide any color on connectivity is sort of paradigm that mix moving forward, 70% is higher than we had anticipated. So just wondering how you expect it to move product from here. Thank you.

Eric Benevich: Thank you. 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.

Speaker Change: Yes, just like with the adoption.

Speaker Change: The reimbursement I think exceeded our expectations as well as I mentioned earlier, 70% of the fills in the quarter were reimbursed.

Speaker Change: And.

Eric Benevich: You know, certainly that's 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 acceptance rate.

Speaker Change: Certainly.

Speaker Change: Favorable for one quarter in but I would like to caution everyone and remind them that.

Speaker Change: This is still a product that for the most part hasnt gone through formulary reviews and so.

Speaker Change: For the most part we're talking about reimbursement via the exceptions process and so as we move through the year. We do expect that some of the plans maybe most of the plans we will be doing formal reviews of chronicity and determining what their coverage criteria look like.

Matt Abernethy: 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 Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Malcolm Hoffman, Neurocrine Biosciences Inc Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Malcolm Hoffman, Neurocrine 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.

Speaker Change: But at this stage it's still.

Speaker Change: Formulary exceptions, and we're off to a great start in terms of securing reimbursement.

Matt Abernethy: Yes. 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 as a high value medicines, helping a lot of patients and it's been fair.

Matt Abernethy: Fairly seamless between prescription written and ultimately getting filled and so do you want to give that kudos to the team that has been working hard on that.

Matt Abernethy: And so do want to give that kudos to the team that has been working hard on that.

Tazeen Ahmad: For more information visit www.FEMA.gov We'll move next to Tazeen Ahmad with Bank of America. Your line is open. Hi, good afternoon. Thanks for taking my questions.

Matt Abernethy: Yes.

Speaker Change: We'll move next to <unk> Ahmad with Bank of America. Your line is open.

Speaker Change: Hi, Good afternoon. Thanks for taking my question first diary, great job on everything and good luck in your next chapter.

Tazeen Ahmad: First, Eiry, 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 Ingresa versus Teva for new to Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc Yeah, so we haven't provided historically share split. Exactly. Because if you look at the syndicated prescription data, it under reports in BRESA. And so we've always cautioned We have not looked at the numbers as exact measures, but overall, what we have said is that we have had the majority of prescriptions in TD and we continue to have the majority of That's for both TRX and for NRX.

Speaker Change: I did want to ask about the share split between what Youre seeing now.

Speaker Change: On <unk> versus <unk> for new treatments TD patients that are that you could share any color on that and then on <unk> can you give us a split of what percent of patients and I'm, sorry, if I missed that rfps versus adults in the early innings of usage.

Speaker Change: Yes, so we havent.

Speaker Change: Provided historically share split exactly because if you look at the syndicated prescription data it under reports in browser and so we've always cautioned.

Speaker Change: <unk>.

Speaker Change: Look at the at the numbers as exact measures, but overall.

Speaker Change: What we have said is that we have had the majority of prescriptions in TD and we continue to have the majority of prescriptions.

Speaker Change: That's for both <unk> and for interacts and so we'll leave it at that.

Unknown Executive: And so we'll leave it at that.

Unknown Executive: 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 a equal distribution of pediatrics.

Speaker Change: The other thing you were asking about in terms of the split or the demographics of the patient population very early on.

Speaker Change: What we were seeing was sort of equal distribution of pediatric and adult patients and pretty equal distribution of <unk>.

Phil Nadeau: and pretty equal distribution of Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc We'll take our next question from Phil Nadeau with T.D. Cowan, your line is open. Good afternoon.

Speaker Change: E mails versus males, but as we've gotten more treatment forms in and the launch continues to mature mature we have seen that it's starting to trend in the direction that we expected prior to the approval which is.

Speaker Change: More pediatric and adolescent patients than adults.

Speaker Change: And more female versus male once again, we've got a long way to go in terms of understanding the launch dynamics in one quarter does not make a trend but ultimately.

Speaker Change: It is essentially trending in the direction that we expected it to prior to the launch.

Speaker Change: We will take our next question from Phil Nadeau with Cowen.

Speaker Change: Cowen Your line is open.

Phil Nadeau: 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 Ingressa Trends. Ingressa grew 15 percent from Q1 to Q2 in 2024. Can you give us some sense of what's likely to happen in Q2 of 2025? It seems like with one additional Tuesday, at least 8 percent growth is reasonable. But how are some of the factors that impacted Q1 transitioning into Q2 and what should that do to sales?

Phil Nadeau: Good afternoon, Thanks for taking my questions and let us at our congratulations tyree.

Speaker Change: Americans.

Speaker Change: Two from us as well first on growth trends.

Speaker Change: Congrats it grew 15% from Q1 to Q2 in 2024 can you give us some sense of what's likely to happen in Q2 2025, it seems like with one additional Tuesday at least 8% growth is reasonable but.

Speaker Change: How are some of the factors that impacted Q1 transitioning into Q2.

Speaker Change: What should that due to sales and then second just a follow up follow up question on Chronicity.

Matt Abernethy: And then second, just a follow-up, brief follow-up question on chronicity. You mentioned that chronicity was relatively seamless from script to fill. Can you give us some sense of the time, the average time it takes from a prescription being written or an enrollment start being received to when the patient actually gets drug in hand? Thanks. 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.

Speaker Change: You mentioned that Chronicity was relatively seamless from script to Phil can you give us some sense of the time the average time it takes from prescription.

Speaker Change: Being written are in enrollment start being received to when the patient actually gets drug in hand.

Phil Nadeau: Thanks, Phil for the questions as always yes.

Phil Nadeau: Yes 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 of the one aspect that you will.

Matt Abernethy: 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 growth net. I 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.

Phil Nadeau: Want to contemplate that's different than previous years as mentioned, we did enter into some.

Phil Nadeau: Contracting during the quarter.

Phil Nadeau: And from and as a result of that we do we will have a sequential hit in gross to net I would call it slightly down.

Phil Nadeau: 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 <unk>.

Phil Nadeau: Second half.

Phil Nadeau: The year.

Matt Abernethy: As it relates to time, I would just say that it's time to ultimately get a fill or get the reimbursement for chronicity. 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.

Phil Nadeau: As it relates to time I would I would just say that it's time to ultimately get a fill or get the reimbursement for chronicity. It's still too early in the cycle to give any specific number.

Phil Nadeau: As you have heard us say before patients once they have an enrollment form written it's typically a 5% to seven day process, where the pharmacy is trying to get reimbursement and whether the patient has had reimbursement green.

Phil Nadeau: Granted or not a patient will ultimately go to Phil and as we alluded to in the percentages we provided.

Phil Nadeau: 30% did get free goods during the during the quarter, but overall team performed very well.

Matt Abernethy: But overall, team performed very well. And I think the feedback on our pharmacy channel has gone great.

Phil Nadeau: The feedback on our pharmacy channel has gone great so far.

Unknown Executive: That's very helpful. Thank you.

Phil Nadeau: That's very helpful. Thank you.

Brian Abrams: We'll move next to Brian Abrams with RBC Capital Markets. Your line is open. Hey guys, thanks very much for taking my questions.

Speaker Change: We'll move next to Brian Abrahams with RBC capital markets. Your line is open.

Brian Abrahams: Hey, guys. Thanks, very much for taking my questions Congrats Terry on a great career and.

Brian Abrams: Congrats to Eiry on a great career at Neurocrine and congrats on the strong chronicity start. Maybe just two quick ones for me on chronicity. Can you provide any more specifics on the proportions of patients being treated at centers of excellence versus community centers and you know how these doctors are managing the glucocorticoid down titration, whether that differs at all. And then on Ingresa, as you continue to invest in the 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?

Brian Abrahams: At Neurocrine and congrats on the strong Chronicity start maybe just two quick ones from me on Chronicity can you provide any more specifics on the proportions of patients being treated at the centers of excellence versus community centers.

Brian Abrahams: And how these doctors are managing the glucocorticoid downtown duration, whether that difference at all.

Brian Abrahams: And then on <unk> 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.

Brian Abrahams: Beyond second quarter of this year. Thanks.

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

Brian Abrahams: Yes, So let me take a crack at the second question first and then.

Brian Abrahams: Tackle the Chronicity question IRA you 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 have been fair.

Brian Abrahams: 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.

Brian Abrahams: In the prepared remarks, we talked about increasing coverage in the Medicare segment for the TV market and the HD market from less than half two approximately two thirds.

Brian Abrahams: With the most recent rebate agreement.

Eric Benevich: And we're going to continue to monitor the environment. I don't think there's anything... Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc 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. 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 not accredited.

Brian Abrahams: And we're going to continue to monitor the environment.

Brian Abrahams: Don't think theres anything.

Brian Abrahams: Immediate that could happen certainly nothing that we're anticipating in terms of additional.

Brian Abrahams: Rebate agreements, but certainly if anything does happen if we enter into any additional rebate agreements, we would flag that going forward.

Brian Abrahams: But ultimately the benefit of improving access certainly accrues starting this year.

Brian Abrahams: But carries into 2026 as well so I think it sets us up well for the future.

Brian Abrahams: With regards to your question about I'll call it sources of business.

Brian Abrahams: Volume of treatment forms coming in from centers of excellence versus the community.

Brian Abrahams: Right now what we're seeing is that it's really across the board, but we have seen adoption.

Brian Abrahams: And referrals coming in from those centers of excellence, but keep in mind theres not very many of them now.

Brian Abrahams: Now Theres only nine accredited.

Brian Abrahams: Centers of excellence are accredited by the cares foundation that similar number that have most of those services, but theyre not accredited.

Eric Benevich: So we are seeing adoption and referrals also from communities. Pediatric Endocrinologist as well as Pediatric Adult Endocrinologist. And it kind of ties back to the comments that we made earlier about really seeing that chronicity is being embraced by the broader endocrinology community. Anything to add?

Brian Abrahams: So we are seeing adoption in referrals also from community.

Brian Abrahams: <unk> endocrinologists as well as pediatric adult endocrinologists and it kind of ties back to the comments that we made earlier about really.

Brian Abrahams: Seeing that there.

Brian Abrahams: Chronicity is being embraced by the broader endocrinology community anything to add.

Eric Benevich: No, just about the steroid reduction piece of the question as well. So 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 chronicity in the registration studies. And so that creates a foundation for a good opportunity to start the medicine in a patient.

Speaker Change: No just about the steroid reduction piece of the question as well.

Speaker Change: So 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 on 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 a few things that we're learning first of all I.

Speaker Change: I think there is a.

Speaker Change: Real enthusiasm about the safety and Tolerability profile that we saw with Chronicity and the registration studies and so that creates a foundation for a good opportunity to stop the medicine in the patient and the second thing is the are the labels that we achieved for the medicine, which is broad.

Eric Benevich: The second thing is the 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. 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 steroid effects. Yeah, all in all, many of these patients are just getting started on chronicity and just getting started on that journey.

Speaker Change: Description and doesn't require very specific or guided.

Speaker Change: Information on steroid reduction 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.

Speaker Change: To reduce the steroids effectively.

Speaker Change: All many of these patients are just getting started on chronicity and just getting started on that journey. So I think we'll learn more in the coming quarters.

Unknown Executive: So I think we'll learn more. Thanks very much.

Speaker Change: Thanks very much.

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

Speaker Change: We will take our next question from David <unk> with Piper Sandler Your line is open.

David Amsellem: Just staying with chronicity, 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. 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 pediatrics. Patient population, but as we went through the quarter, we saw that we're getting more treatment form referrals for those pediatric and adolescent Patients, excuse me.

Speaker Change: Thanks, just staying with Chronicity can you talk about the mix between.

Speaker Change: Starts in adults versus pediatric and adolescent patients bearing in mind that these are early days, but can you talk to.

Speaker Change: Which of these patient groups, if any year gaining more early traction in thank you.

Speaker Change: Yeah.

David: Yes, David.

David: I mentioned earlier that at the very beginning of the launch in other words. The beginning of Q1, we were seeing it was about evenly split between adults and the pediatric.

David: Patient population, but as we went through the quarter, we saw that we're getting more.

David: Treatment form referrals for those pediatric and adolescent pages patients excuse me. So we're starting to see a trend towards.

David Amsellem: So we're starting to see a trend towards greater uptake in the younger population, which is what we We'll have to see how things shake out over the next several quarters.

David: Greater uptake in the younger population, which is what we expected to see that we'll have to see how things shake out over the next several quarters.

David Amsellem: As I said before, you know, when you've got very little data to work with, things can swing in one direction or another, but as we get more utilization, more adoptions in the community, I think we'll have This is just a snapshot of how the launch is going.

As I said before when 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 in the community I think we'll have a better sense of how how the launch is going.

David: Okay.

Anupam Rama: We'll move next to Anupam Rama with J.P. Morgan. Your line is open.

Speaker Change: Well move next to our new Palm Rama with J P. Morgan Your line is open.

Anupam Rama: Hey guys, thanks so much for taking the question and best of luck, Eiry, on everything you pursue going forward. On the Ingresa 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 OSDETO-XR? I know you pointed to that as a headwind coming into the year. How do we think about, have you stabilized your share of voice or were there other factors like PD market expansion or other factors we should be considering?

Speaker Change: Hey, guys. Thanks, so much for taking my question and best of luck, Irene and everything you pursue going forward.

Speaker Change: On the <unk> and the record number of patient starts.

Speaker Change: What should we attribute this to in terms of thinking about your share of voice gain relative to <unk> I know you pointed to that as a headwind.

Speaker Change: Coming into the year, how do we think about have you stabilized your share of voice.

Speaker Change: Or were there other factors like PD market expansion or other factors, we should be considering thanks so much.

Kyle Gano: Thanks so much. 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 in So we're starting to see the tangible benefit of that, you know, we had cautioned that when you expand the sales team in the near term, it can be disruptive, it can negatively Productivity. But as the newer representatives, you know, become more productive, and they start to level up to the level of their Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Malcolm Hoffman, Neurocrine So we're certainly pleased to see a record number of new patients starts in Q1.

Speaker Change: Yes, I mean, obviously, 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.

Speaker Change: So we're starting to see the tangible benefit of that we had cautioned that when you expand the sales team in the near term it can be disruptive and can negatively impact your productivity, but as the new the newer representatives.

Speaker Change: Become more productive and they start to level up to the to the level of there.

Speaker Change: Their colleagues that have been in the field for some period of time, 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. So we're certainly pleased to see a record number of new patient starts in Q1, but.

Kyle Gano: 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 Ingresa and the Tetrabenazine product. So, you know, between having more people in the field calling on the right accounts and doing a better job of differentiating grows, I think, really, those are the two elements. probably have the biggest impact in terms of driving those Thanks so much for taking our question.

Speaker Change: But we've also mentioned that we have implemented some newer marketing initiatives and really the idea is to.

Speaker Change: Be better at helping our customers to appreciate the meaningful differences between an breza and tetra benzene products that are out there. So.

Speaker Change: Between having more people in the field, calling on the right accounts and doing a better job of differentiating <unk> I think really those are the two elements that.

Speaker Change: Probably have the biggest impact in terms of driving those new patient starts.

Speaker Change: Thanks, so much for taking my question.

Speaker Change: Yeah.

Josh Schimmer: We'll move next to Josh Schimmer with Cantor. Your line is open. Thanks so much for taking the questions. A couple of quick ones.

Speaker Change: Well move next to Josh Shimmer with Cantor Your line is open.

Speaker Change: Great. Thanks, so much for taking the questions a couple of quarters as you're contracting for congrats contemplated the stable IRA price negotiation implementation or you have to renegotiate as you get closer to that kicking in in 2027, and then just in terms of this the record number of <unk>.

Kyle Gano: Has your contracting for Ingresa contemplated the stato IRA price negotiation implementation or will you have to renegotiate as you get closer to that kicking in in 2027? 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. Has that contribution occurred earlier than you expected or are you still waiting for a significant inflection from their contributions? Thank you.

Just trying to align that with your comments I guess around last year and early into this year that you didn't really expect to redeployed salesforce to start to contribute meaningfully until later this year.

Speaker Change: Has that contribution occurred earlier than you expected or are you still waiting for a significant inflection from their contributions. Thank you.

Kyle Gano: Maybe I'll, Josh, I'll take on 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 North Star here is to maximize patient access. And that's always been how we viewed contracting. We've done that years in the past. We've also walked away from contracting at certain time points when that was not the 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.

Speaker Change: Maybe ill.

Speaker Change: Josh This is Karl I'll take on the first question on the contracting piece.

Speaker Change: So I think if you look at our history on contracting in the past it has been really.

Speaker Change: The the Northstar here is to maximize patient access and that's always been how we viewed contracting and 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.

Speaker Change: I think when we look at the strategy overarching has 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 thats different moving forward as <unk> does bring a complication into the story about how we view about how we view contracting maximizing patient access.

Kyle Gano: The thing that's different moving forward is IRA does bring a complication into the story 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, I-PAY moment in 2027. Now, obviously contracting that we do now is really with an eye on 2026. And in some cases you can pull forward.

Speaker Change: Yes. So this is a variable now thats part of the equation thats growing in magnitude of its significance and that is something that we have an eye on in particular for our competitors IP moment in 2027, obviously contracting that we do now is really with an eye on 2026 and <unk>.

Speaker Change: Some cases, you can pull forward into the same year, but we do look at that as something that's important for us 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: , Marc Goodeman, Paul Matteis, Jay Olson, Josh Schimmer, Chris Shibutani, David Amsellem, Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc several of the agreements that we have in place. carry us through 2025 and the entire so that does.

Speaker Change: Up to date in case any changes in our contracting approaches of change, but right now we're happy where we landed.

Speaker Change: With the expanded access here, starting this quarter and moving into the remainder of the year, Eric do you have anything to add to that yes just.

Speaker Change: In general, especially in the Medicare space.

Speaker Change: 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.

Kyle Gano: http://TheBusinessProfessor.com The second piece was really around the contribution of the expanded sales force. Was it earlier than what we expected? I would say no. It was pretty much in line. Expanded sales team hit the field in Q4. And, you know, we had said that we need a few quarters for the team to kind of hit their stride, and we saw that really manifest. with the record new patient starts, especially as we move through Q1. Keep in mind that Q1 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 re-op.

Karl: Doorstep of that IP moment as Karl described.

Karl: The second piece was really around the contribution of the expanded sales force was it earlier than what we expected I would say no.

Karl: He was pretty much in line with our expectations recall that the expanded sales team hit the field in Q4.

Karl: And we had said that we need a few quarters for the team to kind of hit their stride and we saw that really manifest.

Karl: With the record new patient starts, especially as we move through Q1 keep in mind that Q1 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 ACP and the pharmacies does consume a lot of.

Kyle Gano: So kind of working our way through that with our customers, with the ACPs 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. of the expanded team, not just more people, but also the new hires becoming more proficient. driving diagnosis. So, I'd say, right on schedule, feeling really good about the expanded team and As you said earlier, we do it. Accelerated Growth for the Balanced As we've reiterated. And maybe just to add to that real quickly, eight years into launch and to think we just had our greatest quarter in terms of new patient starts is phenomenal and I do attribute that to the team and their ability to catch up quickly and work through a very challenging Q1.

Karl: 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 its the tangible benefits of the expanded team not just more people, but also the new hires becoming more proficient in driving diagnosis and treatment with an <unk>. So.

Karl: I'd say right on schedule and feeling really good about the expanded team and.

Karl: As we said earlier, we do expect to.

Karl: To see accelerated growth for the balance of the year as we've reiterated with our guidance, maybe just add to that.

Karl: 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 I do attribute that to the team and.

Karl: Their ability to catch up quickly and work through a very challenging Q1.

Karl: Thank you.

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

Speaker Change: Well take our next question from Jay Olson with Oppenheimer. Your line is open.

Jay Olson: Oh, hey, congrats, 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.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 that you expect to leverage from the journey study? How will you apply those learnings to your next-gen VMAT2 inhibitors? And what, if any, are the implications from the recent failure of Cobenfi in ATS? Thank you. Yeah, thanks very much, Josh.

Jay Olson: Oh, Hey, congrats I refer all of the amazing achievements that she has accomplished on behalf of patients. We have a question about the journey study of <unk> for adjunctive treatment of schizophrenia clinical trials Gov shows a March 2025 completion date. So should we expect those results any day now and then as a follow up.

Jay Olson: Can you talk about the learnings you expect to leverage from the journey study how will you apply those learnings to your Nextgen <unk> two inhibitors and what if any are the implications from the recent failure of <unk> and Ats. Thank you.

Jay Olson: Yeah, Thanks, very much Josh thanks for the kind words as well I really appreciate that and.

Eiry Roberts: 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 with biology. And so we're really interested in understanding what we'll learn from that trial. We will, we will be reading out the study in the near future. I mean, we said somewhere around the middle of the year, and I think we're still on track from that, as you saw from clinical trials, .gov as well.

Jay Olson: I think in terms of the journey study, yes, it's a very important study for us in terms of learning for the <unk> platform. Then 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 and we will.

Jay Olson: We will be reading out the study in the near future I mean, we said somewhere around the middle of the year and I think we're still on track from that as yourself in clinical trials.

Eiry Roberts: 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 PANS 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.

Jay Olson: Gov as well.

Jay Olson: I think we're going to be interested in understanding.

Jay Olson: The potential efficacy as measured by reduction in the pans total score, but we also have a lot of other functional endpoints and other subgroup analyses within that study, which is going to allow us to understand more about what type of patient within that population might respond best to the biology.

Jay Olson: That's represented within the <unk> two inhibition and I also think just one brief comment on the recent <unk> study as you know there are no medications.

Eiry Roberts: I also think just one brief comment on the recent CoBEMPHY study. As you know, there are no medications approved for the treatment, the adjunctive treatment of schizophrenia currently. And I think that study showed us, again, the difficulty in performing clinical research in this area. I think we're very confident in the phase two data that we generated for the 20 milligram dose and very pleased to have just started the phase three program in that setting. And I think I said your name wrong, Jay. I'm terribly sorry about that. But yeah, and thanks again for the question.

Jay Olson: <unk> for the treatment and the adjunctive treatment of schizophrenia currently and I think that study showed us again the difficulty in.

Jay Olson: Performing clinical research in this area.

Speaker Change: I'll 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 and <unk> and so the inability to show at <unk>.

Speaker Change: 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.

Speaker Change: Just one thing to add in that regard because we have been asked I know you didn't ask this but we are off does that have any implication for us with respect to our 568 program and it doesn't in any way dumping.

Speaker Change: Interest and belief in the phase III program that we have.

Speaker Change: 506 to eight in acute psychosis I think we're very confident in the phase II data that we generated for the 20 milligram dose and very pleased to have just started the.

Speaker Change: Our phase III program in that setting.

Speaker Change: You said your name wrong, Jay I'm terribly sorry about that.

Speaker Change: Yes, and thanks again for the question.

Eiry Roberts: No worries. Thank you, Eiry.

Speaker Change: No worries thank you Larry.

Corey Kasimov: We'll move next to Corey Kasimov with Evercore. Your line is open. Great. Good afternoon, guys.

Speaker Change: Yeah.

Speaker Change: Well move next to Cory <unk> with Evercore. Your line is open.

Corey Kasimov: Let me add my congrats to Eiry on a great run at Neurocrine. So, two questions on chronicity for me. One really quick one, was there any amount of, was there a material amount of inventory stocking in the first quarter? And then a second question, when could we expect to see longer-term chronicity data from your ongoing Phase 3 open label extension? And what endpoints do you believe could be positively impacted by longer-term androgen control? Thank you.

Speaker Change: Great. Good afternoon, guys, let me add my congrats to Irene on a great run at Neurocrine. So two questions on Chronicity for me one really quick one was there any amount or was there a material amount of inventory stocking in the first quarter.

Speaker Change: Then a second question.

Speaker Change: When could we expect to see longer term chronicity data from your ongoing phase III open label extension and what endpoints do you believe could be positively impacted by longer term androgen control. Thank you.

Matt Abernethy: Hey, Corey, I love inventory questions. So there was very little, there was very little stocking in the quarter from an inventory perspective.

Speaker Change: Hey, Corey.

Speaker Change: Inventory question. So there was very little.

Speaker Change: There was very little stocking in the quarter from an inventory perspective, I'll, let <unk> comment on planned upcoming data.

Eiry Roberts: I'll let Eiry comment on planned upcoming data. Yeah, and just to remind everybody, the more than 90% of the patients in the randomized trials of chronicity rolled over into the open label extensions, both on the pediatric and the adult side. And the vast majority of the patients have remained in the study ever since then, over 90%. 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.

Speaker Change: Yeah, and just to remind everybody the more than 90% of the patients in the randomized trials of Chronicity rolled over into the open label extension, both on the pediatric and the adult side.

Speaker Change: And the vast majority of the patients have remained in the study ever since then over 90% and so we are in the process of actually shutting down the U S portion of the adult open label extension study and those individuals will be rolling on to commercial product over the next few months the PD.

Eiry Roberts: 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 hormones. 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. That's very helpful. Thank you.

Speaker Change: Arctic 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.

Speaker Change: Data on both androgen control glucocorticoid levels and clinical endpoints such as metabolic endpoints.

Speaker Change: And the reproductive hormone related endpoints over the coming months at the Endo meeting in July.

Speaker Change:

Speaker Change: The newest feature is this month PFS.

Speaker Change: That's very helpful. Thank you.

Brian Skorney: We'll take our next question from Brian Skorney with Baird. Your line is open. Hey, good afternoon, everyone. Thank you for taking my question.

Speaker Change: Well take our next question from Brian <unk> with Baird. Your line is open.

Speaker Change: Hey, good afternoon, everyone. Thank you for taking my question.

Eiry Roberts: Eiry, congratulations on your pending retirement. So maybe I'd also love to ask you a question just from your comment on the 5-6-8 Phase 3 plans. It sounds like you wouldn't necessarily write off an opportunity for 5-6-8 in an adjunctive therapy setting. So I'm just wondering, you know, and obviously you're doing a commercial leg up. If you had a successful Phase 3 study in that setting with Kubenzi failing, is there a study design that you see that would be worth pursuing for 5-6-8? Not sure if you think the risperidone subgroup analysis is a real effect or if there's some other unique design you would think about pursuing.

Speaker Change: Congratulations on your pending.

Speaker Change: Retirement, so maybe.

I also want to ask your question just from your comment on the Fox XP Phase III plans. It sounds like you wouldn't necessarily right often opportunity for 568, and an adjunctive therapy settings. So I'm just wondering obviously your commercial lineup. If you had a successful phase III study in that setting with Gabelli filing is there a study design that you see that wouldn't be.

Speaker Change: Worked for selling for project shape not sure. If you think of the Risperidone subgroup analysis in the rail or some.

Speaker Change: Some other unique design.

Speaker Change: When you think about persona.

Kyle Gano: Brian, this is Kyle. Maybe I'll start this question, and Eiry and I can tag team a bit on this. I think what we've seen from the early CoBEMPHE launch is that 70-80% 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 monotherapy type of setting. So that'd be kind of point number one. Number two is I think what we've seen for CoBEMPHE from BMS and others that have worked in this space, we have our own data that we'll be having be available around the first half of this year.

Speaker Change: Brian This is Kevin maybe I'll start this question Irene I can tag team had been on this I think what we've seen from the early <unk> launches that 70, 80% of patients are taking the therapy from a model therapy perspective, maybe there is some overlap there as patients transition from one medicine. The next and there is some overlap of two medicines, but for the most part it seems like.

Speaker Change: It's used in a in a monotherapy type of setting so that'd be kind of point number one number two is I think what we've seen <unk> from.

Speaker Change: From BMS and others that have worked in this space, 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, but I think there's still a lot of learnings there that can be applied.

Kyle Gano: 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 learnings from that will be plowed back into our next generation compounds. But when it comes to the muscarinics themselves, we think that there is a significantly large opportunity, standalone with the acute studies that we have planned for the registrational program, and then moving into other indications, in particular later this year with 5-6-8 into bipolar mania.

Speaker Change: And thought about for the future. That's why we're excited about running this study and seen the results for <unk>.

Speaker Change: <unk> in this space. So we can get a feel for that and the learnings from that we'll be plowed back into our next generation compounds.

Speaker Change: But when it comes to the muscarinic themselves. We think that there is a significantly large opportunity standalone with the acute studies that we have planned for the Registrational program and then moving into other indications in particular later this year with 506 eight in the bipolar mania and that's our current strategy.

Kyle Gano: And that's our current strategy.

Marc Goodman: We'll move next to Marc Goodman with Lear Inc. Partners. Your line is open. Yeah, Matt, with Ingresa, you've talked about 5800 as the ASP that we should be thinking about for this year. Obviously, that number's changed, if you could give us a sense of what the new number is.

Speaker Change: Well move next to Marc Goodman with Leerink partners. Your line is open.

Speaker Change: Yes, Matt within grasp that you've talked about 5800 is the ESP 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 I read definitely we'll all Miss you maybe just a question for you excluding $5 six eight can you talk about the rest of <unk>.

Matt Abernethy: And then, Eiry, definitely, we'll all miss you. Maybe just a question for you. Excluding 568, can you talk about the rest of the Muscarinic portfolio and where we are? Thanks. Yeah, Marc, I think I've gotten away from getting into the nuances of the exact net revenue per script for, you know, a handful of quarters now. But I 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.

Speaker Change: Muscarinic portfolio and where we are.

Mark: Yes, Mark.

Mark: I've gotten away from getting into the nuances of the exact net revenue per script for handful of quarters now, but I guess the guidance that I would give you is you typically see an improvement in gross to net going from Q1 to Q2.

Mark: 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.

Eiry Roberts: Thanks, and thanks, Marc.

Mark: Thanks, and thanks knock on the remainder of the muscarinic.

Eiry Roberts: On the remainder of the muscarinic portfolio, just to remind you, we have 570, which is a dual M1-M4 agonist, 569, which is an M4 preferring agonist, and 567, which is an M1 preferring agonist. And then our own internally discovered 986, which is an M4 antagonist as a potential treatment for dystonias 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 570, 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.

Mark: Portfolio just to remind you we have $5 70, which is a dual <unk> four agonist 569, which is an M for preferring agonist and 567, which is M. One preferring agonist and then our own internally discovered them.

Mark: 986, which is an end for antagonist as a potential treatment for.

Mark: Dystonias and Parkinson's tremor with respect to the agonist.

Mark: Actually including the <unk> antagonist as well all of those medicines.

Mark: <unk> currently through Phase one studies.

Mark: <unk> five <unk>, we will be completing phase one in the very near future and starting a phase II study by the end of this year in acute psychosis and that will be the next phase III start for us from that platform and then as 569 and 567 complete their phase one studies, we will be talking more.

Eiry Roberts: And then as 569 and 567 complete their phase one studies, we'll be talking more about that and the potential next steps there, including any potential phase two starts in the foreseeable future. Thanks.

Mark: That and the potential next steps there, including any potential phase two starts in the foreseeable future.

Mark: Thanks.

Shawn Vlamin: We'll take our next question from Shawn Vlamin with Morgan Stanley. Your line is open.

Sean: Well take our next question from Sean <unk> with Morgan Stanley. Your line is open.

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

Speaker Change: Hey, this is Mike <unk> on for Shaun London. Thank you for taking our questions and congrats sorry for all the impact you made.

Speaker Change: Thinking about in Gaza Tivos set of guidance suggests a good amount of patients can come to us out of this year, but the data that was presented at <unk>. So half the patients don't reach that therapeutic dose on us that our XR.

Speaker Change: Thinking about that how do you see the aceto drop off market evolving and do you think that some proportion of those drop offs can switch to Gaza and help the new patient starts.

Kyle Gano: Thanks.

Speaker Change: Yeah.

Kyle Gano: 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 40 and 80 milligrams of Ingresa 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 Ingresa can bring to patients You know, it's highly, 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 Yeah, the only other thing that I would...

Speaker Change: We were very encouraged by the information that we recently released and published regarding the therapeutic dosing and I'd just remind you that obviously with the 40 and 80 milligrams of <unk> in Gaza, we stopped dosing at a therapeutic dose level continue throughout that patients' period.

Speaker Change: Time on the medicine.

Eric Benefits: 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 <unk> and the value that <unk> can bring to patients.

Eric Benefits: As we said highly effective including in the data that we recently published on long term data and more elderly population as well.

Eric Benefits: And uniquely selective in terms of its <unk> two inhibition.

Eric Benefits: We have the broadest set of data that we believe in patient populations that can.

Eric Benefits: Experience value and so we're focused on that and are continuing to educate around that.

Eric Benefits: Yes, the only other helpful that I want to add.

Kyle Gano: The only thing I would add, just to piggyback here, is that the majority of patients that we see starting on Ingresa have.

Eric Benefits: The only thing I would add just to piggyback here is that the majority of patients.

Eric Benefits: That we see starting on <unk> have been and continue to be.

Unknown Executive: newly died Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc You know, we continue to make progress with For more information, please visit www.ISGlobal.org. I appreciate that. Thanks.

Eric Benefits: Newly diagnosed and newly treated there isn't a lot of switching that happens in the beam out to market and.

Eric Benefits: We haven't seen that dynamic really change that much over time. So we continue to make progress with diagnosis and motivating treatment, but for the most part the patients that are starting a browser or.

Eric Benefits: Getting started on the <unk> for the first time.

Eric Benefits: I appreciate that thanks.

Ash Verma: We'll move next to Ash Verma with UBS. Your line is open. Hi, congrats from my side as well. Just on Impreza, 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? And just secondly, what was the percentage increase in the Salesforce footprint, if you can remind us, and when do you expect that benefit to start to approve? Thanks. Yeah, I got the first part of your question in terms of the pull through effort.

Speaker Change: Well move next to Ash pharma with UBS. Your line is open.

Hi, Congrats from my side as well just on and Greg maybe can you talk about any pull through on these new contracting or the Medicaid <unk> pulmonary access that you mentioned when does that happen like that.

Speaker Change: <unk> or is that more of a <unk> or later in the year and just secondly.

Speaker Change: What does the bus engaging piece and the sales force and if you can remind us.

Speaker Change: When do you when do you expect that benefit to start to accrue.

Speaker Change: Yes, I got the first part of your question in terms of the pull through effort can you repeat the second part.

Ash Verma: Can you repeat the second part? Yeah, like what was the percentage increase in the sales force footprint? And when do you expect that benefit to start to accrue?

Speaker Change: Yes, like what was the percentage increase in the sales force footprint.

Speaker Change: And when do you expect that benefit to start to accrue.

Kyle Gano: Well, I'll take on the second part first. We didn't give exact headcount numbers when we did the expansion in Q4 of last year. But, you know, it was a substantial increase of our psychiatry 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 patients starts, we saw in Q1. With regards to pull through, yes, you know, certainly our, 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 non personal promotion, our sales are aware of where there's been an ad of Ingressa onto a formulary.

Speaker Change: Okay, well I'll take on the second part first.

Speaker Change: We didn't give exact head count numbers when we did the expansion in Q4 of last year.

Speaker Change: But.

Speaker Change: It was a substantial increase of our psychiatry footprint and as I mentioned before we do think that it is starting to.

Speaker Change: See tangible benefits here in the market.

Speaker Change: Primarily manifest as a record number of new patient starts we saw in Q1.

Speaker Change: With regards to pull through yes, certainly are.

Speaker Change: Our plan of action has always been when we have.

Speaker Change: Formulary win we.

Speaker Change: We attempt to pull it through and the way that that translates is certainly through personal and non personal promotion. Our sales teams are aware of where there's been an add of <unk> onto our formulary, they're aware of the hcp's that are having more patients underneath that plan and there is sure to communicate those changes.

Kyle Gano: They're aware of the HCPs that are having more patients underneath that. 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 beginning of April. 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 people. Existing patients already on treatment under that plan, they're already covered, they have a certain number of authorized refills, if the new patient starts where there's a little less headwinds, because it's now But just to be clear on how the financials flow on this, we will take a more immediate hit to growth than that, starting in Q2, and the benefit from the new patient additions, as Eric mentioned, too, will accrete over time.

Speaker Change: And with regards to this most recent formulary win that process has already started as of the beginning of April So we're going to.

Speaker Change: Continued to leverage when we do have increases in formulary coverage, but the way to think about it is it really benefits new patient starts.

Speaker Change: Existing patients are already on treatment under that plan. They already covered they have a certain number of authorized refills is the new patient starts where theres a little less headwinds because it's now on formulary.

Speaker Change: But just to be clear on how the financials flow on this.

Speaker Change: We'll take a more immediate hit to gross in that starting in Q2 and the benefit from the new patient additions as Eric mentioned too will accrete over time. So it typically takes two to three or four quarters to get to a place where.

Kyle Gano: So it typically takes, you know, 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.

Speaker Change: Your ROA ROI positive, but it is something that is as we mentioned and as Karl mentioned strategically important for us to continue to.

Speaker Change: To be a major player in this market.

Speaker Change: Thanks.

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

Speaker Change: We will take our next question from Mohit Bansal with Wells Fargo. Your line is open.

Speaker Change: Hi, This is Jerry now on from wellhead, Congrats on a great quarter first I wanted to ask a clarification question on <unk>.

Mohit Bansal: I'm from Mohit. Congrats on the great quarter. First I wanted to ask a clarification question on Ingresa growth to net. I think previously you guys have said 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 3 program for 5-6-8, 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 2 beyond the selection of just one dose?

Speaker Change: I think previously you guys have said that you would expect some tailwind from the lower phasing of rebate under part D. Redesign I was wondering if that was any bit of a factor. This year and then wanted to ask on the phase III program for 568, how are you thinking about the number of sites.

Speaker Change: Ex U S sites, and then any other changes and how those studies will be run versus the phase two beyond the suction I'm just one dose.

Matt Abernethy: Thank you. 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 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 Ingress and for the company going forward. Eiry, do you want to comment on 516? Yeah, 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.

Speaker Change: Yes from the Med D design change on the mandatory rebate that was a slight benefit of call it like 1%.

Speaker Change: And that was a tailwind entering into 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 <unk> for the company going forward I do want to come in in place yes.

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 U S. Only study.

Eiry Roberts: And as you mentioned, it is a single dose level of 20 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 two, which we can talk more about once the full program is up and running. The number of sites doesn't increase substantially, which I think is really important. Because if you remember, our phase two was a study that was run over a number of sites and a relatively complex adaptive trial design.

Speaker Change: For the phase III.

Speaker Change: You mentioned it is a single dose level of 20 milligrams, one to one randomization with placebo so very simple in design.

Speaker Change: And we are taking all the learnings that we achieved from the phase two which we can talk more about once the full program is up and running.

Speaker Change: 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 in a relatively complex adaptive trial design. So we think the simplicity of the phase III program that we had is that we've designed and are implementing will be beneficial for us moving forward.

Myles Minter: So we think the simplicity of the phase three program that we've designed and are implementing will be beneficial for us moving forward. We'll move next to Myles Minter with William Blair. Your line is open.

Speaker Change: Well move next to Myles Minter with William Blair. Your line is open.

Myles Minter: Thanks and offer my congratulations to Eiry as well for a great career there at Neurocrine. Just on Osservamptor, 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've seen 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? Yeah, so thanks. Thanks, Myles. A couple of questions there. Let me get to the number of studies. First of all, within the registration package for osovampator, there are three key studies, the two short term randomized placebo control studies and one longer term open label study, which is obviously essential to enable us to look at longer term safety.

Speaker Change: Thanks.

Speaker Change: My congratulations to IRA as well for great career, there at Neurocrine.

Speaker Change: Just on <unk>.

Speaker Change: The two phase III studies that are listed on clinical trials Gov. Just wondering about the powering assumptions for those trials given that show on our patient savings on the smaller end from what we're seeing from <unk>.

Speaker Change: <unk> 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.

Speaker Change: Yeah. So thanks, Thanks miles a couple of questions. There, let me get to the number of steady festival within the registration package for at least a bump until there are three key studies. The two short term randomized placebo control studies and one longer term open label study, which is obviously essential.

Speaker Change: And to enable us to look at longer term safety.

Eiry Roberts: With respect to the powering and the subject number, this is a could be quite a long conversation, but let me make it short. We 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 while 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.

Speaker Change: With respect to the powering.

Speaker Change: On the subject number this is a.

Speaker Change: Could be quite a long conversation, but let me make it short.

Speaker Change: One of the things we worry most about in the context of major depressive disorder studies is a placebo effect and obviously.

Speaker Change: The 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 III studies.

Speaker Change: Is adequately powered and appropriately powered to measure an effect size is significantly smaller than that which we saw in phase II. So we're highly confident in the size of the study we have limited the size of the studies because of our take on <unk>.

Eiry Roberts: 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 studies.

Speaker Change: Funding of the research in this area about the balancing act between increased subject numbers driving increased placebo response and increased risk of failed study.

Laura Chico: Thanks for the question. We'll move next to Laura Chico with Wedbush. Your line is open. Good afternoon. I just wanted to revisit real quick on the Ingress of Patient Numbers, and congrats on the record ad here. I'm not sure if you could also comment a little bit more about persistency and discontinuation rates. I 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? And then, separately, I'm just curious, with the R&D day and the second half here, any highlights to share in terms of how we should be thinking about the potential focus of the event?

Speaker Change: Thanks for the questions.

Speaker Change: Okay.

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

Speaker Change: Yeah.

Speaker Change: Good afternoon, I, just wanted to revisit real quick on the congrats the patient numbers and congrats on the record adds here.

Speaker Change: Not sure. If you could also comment a little bit more about persistency and discontinuation rates I think Eric you mentioned that reauthorization was challenging but are there any differences in the duration of treatment depending on the channel from which patients are originating say long term care versus sake.

Speaker Change: Then separately I'm, just curious with the R&D day in the second half year and highlights to share in terms of how we should you should be thinking about the potential focus of event. Thank you.

Eric Benevich: Thank you. Yeah, with regards to the question around patient persistency, generally, it's been very study 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 Treated by a psychiatrist, a neurologist, or more recently, I did comment that this was a, you know, a challenging Q1, a little bit more challenging perhaps than we've seen in anecdotally feedback from the customers was that the reauthorization was a bit more challenging from their perspective and we saw slightly higher drop-offs and delayed refunds.

Speaker Change: Yes with regards to the question around patient persistency generally its been very.

Speaker Change: Steady from the early days of the launch through the most recent cut that we looked at.

Speaker Change: And we haven't seen any real differences in persistency across the different channels, whether the patients being.

Speaker Change: Treated by psychiatrists and neurologists or more recently coming in through long term care I.

Speaker Change: I did comment that this was a.

Speaker Change: A challenging Q1, a little bit more challenging perhaps than what we've seen in years past anecdotally feedback from the customers was that the reauthorization process.

Speaker Change: 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 and so that's really what gives us the.

Eric Benevich: Unknown Executive, Ami Fadia, Ashwani Verma, Leonid Timashev, Neurocrine Biosciences Inc So that's really what gives us the, you know, sort of the confidence.

Speaker Change: Sort of the confidence and conviction in the acceleration of our growth given the the uptick that we saw with new patients in Q1, but overall no. We're not seeing any real differences in patient persistency by segment.

Unknown Executive: given the But overall, no, we're not seeing any real differences in patient And this does conclude the question and answer portion of our call. I would now like to turn it back to Kyle Gano for any additional or closing remarks. 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 Ingresa, re-accelerating new patient starts, improving access for healthcare providers and the patients they serve, successfully launching Chronicity and initiating multiple Phase III studies.

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

Kyle Gano: Thanks, everyone I know, we didn't get to all of your questions for those of you that missed will be following up with you individually, but thanks to 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 an groza re accelerating new patient starts improving access for health care providers and the patients they serve.

Kyle Gano: <unk> successfully launched synchronicity and initiating multiple phase III studies.

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

Kyle Gano: <unk> never been in a stronger position and we will continue to remain focused on execution and the evolution of the pipeline as we move through the remainder of the year. So looking forward to seeing all of the upcoming conferences or on your latest zoom call. So looking forward to speaking with you soon thanks so much.

Speaker Change: 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.

Kyle Gano: Yeah.

Kyle Gano: Hum.

Kyle Gano: Hum.

Kyle Gano: Okay.