Q1 2024 Neurocrine Biosciences Inc Earnings Call

May 1, 2024

We'll have the opportunity to ask questions during the question and answer session.

Operator: - Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask questions by pressing the Star and 1 on your telephone keypad. You may withdraw your question by pressing Star 2. Please note this call is being recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

You May register to ask questions by pressing the star one on your telephone keypad.

Register to ask questions by pressing the star one on your telephone keypad. You may withdraw your question by pressing star too please. Please note. This call is being recorded and there will be sent in by should you need any assistance. It is now my pleasure to turn the conference over to Todd <unk>, Vice President of Investor Relations. Please go ahead.

You may withdraw your question by pressing star two.

You may withdraw your question by pressing star too please. Please note. This call is being recorded and there will be sent in by should you need any assistance. It is now my pleasure to turn the conference over to Todd <unk>, Vice President of Investor Relations. Please go ahead.

Please note. This call is being recorded and I will be sent in by should you need any assistance.

Please note. This call is being recorded and there will be sent in by should you need any assistance. It is now my pleasure to turn the conference over to Todd <unk>, Vice President of Investor Relations. Please go ahead.

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

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

Good morning, everyone and welcome to Neurocrine Biosciences first quarter 2024 earnings call with me are Kevin Gorman, Chief Executive Officer, Matt Abernethy, Chief Financial Officer, Larry Roberts, Chief Medical Officer, Eric benefits, Chief Commercial Officer, and Kyle Gano, Chief business development and strategy Officer. We're also joined today.

Todd Tushla: Good morning everyone, and welcome to Neurocrine Biosciences' first quarter 2024 earnings call. With me are Kevin Gorman, Chief Executive Officer; Matt Abernethy, Chief Financial Officer; Eiry Roberts, Chief Medical Officer; Eric Benevich, Chief Commercial Officer; and Kyle Gano, Chief Business Development and Strategy Officer. We are also joined today by Dr. Jaz Singh, Neurocrine's Vice President of Psychiatry Clinical Development, which includes serving as the program lead for NBI-845, our AMPA potentiator, which recently read out positive Phase II top-line results in adults with major depressive disorder. Jaz has been at Neurocrine since 2020. Prior to joining Neurocrine, Jaz spent 14 years at Johnson & Johnson where among other things he led the clinical efforts for the esketamine program through approval. I'm sure you'll have a few questions not only for Jaz but for also Eiry and Kyle today on the 845 program.

By Dr. Jeff thing Neurocrine, Vice President of Psychiatry clinical development.

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<unk> includes serving as the program lead for MDI 845 are ample potentiate or which recently read out positive phase two topline result in adults with major depressive disorder.

<unk> includes serving as the program lead for MDI 845 are ample potentiate or which recently read out positive phase two topline result in adults with major depressive disorder. <unk> been at Neurocrine since 2020. Prior to joining Neurocrine, John spent 14 years at Johnson, <unk> Johnson, where among other things. He led the clinical efforts for the <unk>. I mean program through approval. Sure you will have a few questions not only for that also. Today on April five program.

<unk> been at Neurocrine since 2020 prior to joining Neurocrine. John spent 14 years at Johnson, <unk> Johnson, where among other things he led the clinical efforts with <unk>.

<unk> been at Neurocrine since 2020. Prior to joining Neurocrine, John spent 14 years at Johnson, <unk> Johnson, where among other things. He led the clinical efforts for the <unk>. I mean program through approval. Sure you will have a few questions not only for that also. Today on April five program.

Prior to joining Neurocrine, John spent 14 years at Johnson, <unk> Johnson, where among other things. He led the clinical efforts for the <unk>. I mean program through approval. Sure you will have a few questions not only for that also. Today on April five program.

I mean program through approval.

I mean program through approval. Sure you will have a few questions not only for that also. Today on April five program.

Sure you'll have a few questions not only for that also.

Sure you will have a few questions not only for that also. Today on April five program.

On the call today on April five program.

Today on April five program.

With introduction complete I will remind you that 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 at this point altering the call over to Kevin.

Todd Tushla: With introductions complete, I'll remind you that 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. At this point, I'll turn the call over to Kevin.

Thank you Todd good morning, everyone.

Kevin Charles Gorman: Thank you, Todd. Good morning, everyone. We've had a remarkable week and it's only Wednesday morning. We submitted two NDAs on CRINECERFONT and received an FDA approval for a new offering of INGREZZA. I'm thinking about giving the company the rest of the week off. Neurocrine has never had the opportunity to positively impact so many lives as it has today. As you will hear in greater detail from Matt, Eric, Eiry, we are making progress in every aspect of our business focused on bringing life-changing medicines forward. We have never treated as many TD and HC patients as we are treating today. We have never had a deep, a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years, several of them with the promise of disease modification.

We had a remarkable week and it's only Wednesday morning.

We've had a remarkable week and it's only Wednesday morning. <unk> received an FDA approval for a new offering of a compressor. Thinking about giving the company the rest of the week off. Neurocrine has never had the opportunity to positively impact so many lives as it has today. You will hear in greater details from Matt, Eric and <unk>, we are making progress in every aspect of our business. <unk> on bringing life changing medicines forward, we've never treated as many TV in HD patients as we're treating today, we have never had as deep a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years several of them. And with the promise of disease modification.

<unk> received an FDA approval for a new offering of the compressor.

<unk> received an FDA approval for a new offering of a compressor. Thinking about giving the company the rest of the week off. Neurocrine has never had the opportunity to positively impact so many lives as it has today. You will hear in greater details from Matt, Eric and <unk>, we are making progress in every aspect of our business. <unk> on bringing life changing medicines forward, we've never treated as many TV in HD patients as we're treating today, we have never had as deep a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years several of them. And with the promise of disease modification.

Thinking about giving the company the rest of the week off.

Thinking about giving the company the rest of the week off. Neurocrine has never had the opportunity to positively impact so many lives as it has today. You will hear in greater details from Matt, Eric and <unk>, we are making progress in every aspect of our business. <unk> on bringing life changing medicines forward, we've never treated as many TV in HD patients as we're treating today, we have never had as deep a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years several of them. And with the promise of disease modification.

Neurocrine has never had the opportunity to positively impact so many lives as it has today.

Neurocrine has never had the opportunity to positively impact so many lives as it has today. You will hear in greater details from Matt, Eric and <unk>, we are making progress in every aspect of our business. <unk> on bringing life changing medicines forward, we've never treated as many TV in HD patients as we're treating today, we have never had as deep a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years several of them. And with the promise of disease modification.

You will hear in greater details from Matt Eric in Iraq, We are making progress in every aspect of our business.

You will hear in greater details from Matt, Eric and <unk>, we are making progress in every aspect of our business. <unk> on bringing life changing medicines forward, we've never treated as many TV in HD patients as we're treating today, we have never had as deep a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years several of them. And with the promise of disease modification.

<unk> on bringing life changing medicines forward, we've never treated as many TV in HD patients as we're treating today, we have never had as deep a mid and late stage clinical pipeline and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next two years several of them.

And with the promise of disease modification.

Now we're constantly prioritizing the funding of our programs based on data we're in the enviable position to be able to support our current and future pipeline.

Kevin Charles Gorman: Now we're constantly prioritizing the funding of our programs brd on data. We're in the enviable position to be able to support our current and future pipeline. Now, a recent example of a program that will be increased will be seeing increased funding is our AMPA modulating molecule 845 as a treatment for major depression. The efficacy and tolerability seen in this trial is very compelling, and we will be meeting with FDA to further define the registration program. Now in our press release this morning and in Eiry's comments upcoming, we share more information on this trial. However, we will limit our comments on this data set, as we file additional intellectual property and protect future publication opportunities. With those brief remarks, I'd like to turn it over to my colleagues, starting with Matt.

Now a recent example of a program that will be increased will be seeing increased funding as our amp of modulating molecule 845, as a treatment for major depression.

Now a recent example of a program that will be increased will be seeing increased funding as our amp of modulating molecule 845, as a treatment for major depression. The efficacy and Tolerability seen in this trial is very compelling and we will be meeting with FDA to further define the registration program now are in our press release this morning, and an Irish combat upcoming we share more information on this trial. However, we will limit our comments on this dataset as we file additional intellectual. <unk> and protect future publication opportunities. So with those brief remarks, I'd like to turn it over to my colleagues starting with map.

The efficacy and Tolerability seen in this trial is very compelling and we will be meeting with FDA to further define the registration program now are in our press release this morning, and an Irish combat upcoming we share more information on this trial. However, we will limit our comments on this dataset as we file additional intellectual.

<unk> and protect future publication opportunities.

<unk> and protect future publication opportunities. So with those brief remarks, I'd like to turn it over to my colleagues starting with map.

So with those brief remarks, I'd like to turn it over to my colleagues starting with map.

Thanks, Kevin what does start to 2024 with continued in growth of growth our ongoing activities with Kronos ERCOT and last week's announcement of positive phase two results in major depressive disorder.

Matthew C. Abernethy: Thanks, Kevin. We'll start to 2024 with continued INGREZZA growth, our ongoing activities with CRINECERFONT and last week's announcement of positive Phase II results in major depressive disorder, the foundation to build Neurocrine into a leading neuroscience company has never been stronger. INGREZZA’s sales finished the quarter at $506 million, reflecting over 20% year-over-year growth and our third consecutive year of Q4 to Q1 sequential growth. The seasonal pair dynamics associated with reauthorization and plant changes always poses challenges impacting refill rate patients with continue to manage to disease dynamics as well once again. Consistent with our approach in previous years, we are reaffirming sales guidance and we'll reevaluate after the second quarter. As you review our financials, you can see significant year-over-year operating leverage on a non-GAAP basis of over 1,000 basis points, when excluding IT R&D investments made in the prior year.

It's been a positive phase II results in major depressive disorder. Ambition to build neurocrine into a leading neuroscience company has never been stronger and grow through sales finished the quarter at $506 million, reflecting over 20% year over year growth and our third consecutive year of Q4 to Q1 sequential growth. <unk> per dynamics associated with reauthorization and planned changes always poses challenges impacting refill rate per patient, but the team has managed through these dynamics well once again. Consistent with our approach in previous years, we are reaffirming sales guidance and we'll reevaluate after the second quarter. To review our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points when excluding IP R&D investments made in the prior year.

Nation to build Neurocrine into a leading neuroscience company has never been stronger and grow sales finished the quarter at $506 million, reflecting over 20% year over year growth and our third consecutive year of Q4 to Q1 sequential growth.

Ambition to build neurocrine into a leading neuroscience company has never been stronger and grow through sales finished the quarter at $506 million, reflecting over 20% year over year growth and our third consecutive year of Q4 to Q1 sequential growth. <unk> per dynamics associated with reauthorization and planned changes always poses challenges impacting refill rate per patient, but the team has managed through these dynamics well once again. Consistent with our approach in previous years, we are reaffirming sales guidance and we'll reevaluate after the second quarter. To review our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points when excluding IP R&D investments made in the prior year.

<unk> pair dynamics associated with reauthorization and planned changes always poses challenges impacting refill rate per patient, but the team has managed through these dynamics well once again.

<unk> per dynamics associated with reauthorization and planned changes always poses challenges impacting refill rate per patient, but the team has managed through these dynamics well once again. Consistent with our approach in previous years, we are reaffirming sales guidance and we'll reevaluate after the second quarter. To review our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points when excluding IP R&D investments made in the prior year.

So it's been with our approach in previous years, we are reaffirming sales guidance and we'll reevaluate after the second quarter.

Consistent with our approach in previous years, we are reaffirming sales guidance and we'll reevaluate after the second quarter. To review our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points when excluding IP R&D investments made in the prior year.

Review, our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points, when excluding IP R&D investments made in the prior year.

To review our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points when excluding IP R&D investments made in the prior year. The team is doing a great job generating SG&A leverage, reflecting the strength and grow the franchise.

To review our financials, you can see significant year over year operating leverage on a non-GAAP basis of over 1000 basis points when excluding IP R&D investments made in the prior year.

The team is doing a great job generating SG&A leverage, reflecting the strength burn grow the franchise.

Matthew C. Abernethy: The team is doing a great job, generating SG&A leverage, reflecting the strength of our INGREZZA franchise. These results drove significant cash flow, as we ended Q1 with over $1.9 billion in cash. We routinely evaluate what we believe will drive shareholder value and our capital allocation strategy remain intact. First, prioritizing INGREZZAgrowth. Second, preparing for Crinecerfont commercialization. Third, internally advancing on our pipeline. And fourth, assessing external opportunities.

These results drove significant cash flow as we ended Q1 with over $1 $9 billion in cash.

These results drove significant cash flow as we ended Q1 with over $1 $9 billion in cash we routinely evaluate what we believe will drive shareholder value and our capital allocation strategy remains intact first prioritizing and grows that growth second preparing for <unk>. Commercialization third internally advancing on our pipeline and fourth assessing external opportunities

We routinely evaluate what we believe will drive shareholder value and our capital allocation strategy remains intact first prioritizing and grows the growth.

Preparing for Kronos or pronged commercialization.

Commercialization third internally advancing on our pipeline and fourth assessing external opportunities as we have excess capital, we opportunistically return capital to shareholders by managing dilution and you've seen us accomplish this over the past few years, reducing our convert.

Commercialization third internally advancing on our pipeline and fourth assessing external opportunities

Third internally advancing on our pipeline and for assessing external opportunities as we have excess capital, we opportunistically return capital to shareholders by managing dilution and you've seen us accomplish this over the past few years, reducing our convertible debt from approximately 500.

Matthew C. Abernethy: As we have excess capital, we opportunistically return capital to shareholders by managing dilution and you've seen us accomplish this over the past few years reducing our convertible debt from approximately $518 million to $170 million. In a few weeks, we'll further manage dilution by retiring our May 2024 convertible notes with cash not shares. The convertible notes have a face value of $170 million and fair value as of March 31 of around $310 million. In our Q1 GAAP P&L, we recorded an $89 million charge, representing a portion of the cost to fully settle the convertible notes and upon final settlement in May, we will record the remaining cost to fully settle the convertible notes in excess of face value. With that, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

Double from approximately $518 million to $170 million. And a few weeks, we will further manage dilution by retiring our may 2024 convertible notes with cash not fair. The convertible notes have the face value of $170 million in fair value as of March 30, <unk> of around $310 million. And our Q1 GAAP P&L, we recorded $89 million charge, representing a portion of the cost to fully settle the convertible notes and upon final settlement in may. We will record the remaining cost to fully settle the convertible notes and excess of face value. With that I will now hand, the call over to Eric <unk>, Our Chief commercial Officer Eric.

Third an $18 million to $170 million.

And a few weeks, we will further manage dilution by retiring our may 2024 convertible notes with cash not fair.

And a few weeks, we will further manage dilution by retiring our may 2024 convertible notes with cash not fair. The convertible notes have the face value of $170 million in fair value as of March 30, <unk> of around $310 million. And our Q1 GAAP P&L, we recorded $89 million charge, representing a portion of the cost to fully settle the convertible notes and upon final settlement in may. We will record the remaining cost to fully settle the convertible notes and excess of face value. With that I will now hand, the call over to Eric <unk>, Our Chief commercial Officer Eric.

The convertible notes have the face value of $170 million in fair value as of March 30, <unk> of around $310 million.

The convertible notes have the face value of $170 million in fair value as of March 30, <unk> of around $310 million. And our Q1 GAAP P&L, we recorded $89 million charge, representing a portion of the cost to fully settle the convertible notes and upon final settlement in may. We will record the remaining cost to fully settle the convertible notes and excess of face value. With that I will now hand, the call over to Eric <unk>, Our Chief commercial Officer Eric.

And our Q1 GAAP P&L, we recorded an $89 million charge, representing a portion of the cost to fully settle the convertible notes and upon final settlement in may.

And our Q1 GAAP P&L, we recorded $89 million charge, representing a portion of the cost to fully settle the convertible notes and upon final settlement in may. We will record the remaining cost to fully settle the convertible notes and excess of face value. With that I will now hand, the call over to Eric <unk>, Our Chief commercial Officer Eric.

We will record the remaining cost to fully settle the convertible notes and excess of face value.

We will record the remaining cost to fully settle the convertible notes and excess of face value. With that I will now hand, the call over to Eric <unk>, Our Chief commercial Officer Eric.

With that I will now hand, the call over to Eric <unk>, Our Chief commercial Officer Eric.

Thanks, Matt.

Eric S. Benevich: Thanks, Matt. Today, May 1st, marks the seven year anniversary since the commercial launch of INGREZZA in 2017. After seven years, INGREZZAis the number one prescribed VMAT2 inhibitor for the treatment of tardive dyskinesia or TD. INGREZZAis the only treatment proven to reduce TD symptoms with simple dosing, always, one capsule, once a day and no complex titration. We're very proud of the progress we've made with INGREZZA over these past seven years. We're even more excited about the many thousands of people living with TD or Huntington's chorea that we'll be able to help in the coming years. In addition to today being the seven year anniversary of our launch, we're less than a week away from TD awareness week. Each year, TD awareness week occurs in early May, which is designated as mental health awareness month. This year, TD awareness week occurs from May 5 through 11. Please join Neurocrine, the Movement Disorders Policy Coalition, various mental health advocacy organizations, health care providers and policymakers across all 50 states in Washington DC in our efforts to spread the word and reduce the stigma of TD.

<unk> made for smart to seven year anniversary since the commercial launch of been Grubhub in 2017.

<unk> made for smart to seven year anniversary since the commercial lots of big brother in 2017. After seven years and granted is the number one prescribed <unk> inhibitor for the treatment of tardive dyskinesia a R. T. D. <unk> is the only treatment proven to reduce TD symptoms with simple dosing always one capsule once a day and no complex titration. Very proud of the progress we've made within grasp over these past seven years and we're even more excited about the many thousands of people living with TD or Huntington's chorea that we'll be able to help in the coming years. In addition to today's being the seven year anniversary of our launch we're less than a week away from TD awareness week, each year TD awareness week occur. In early May which is designated as mental health awareness month. This year TD awareness week occurs from me first through 11. So please join our friends the movement disorders policy coalition. Mental health advocacy organizations health care providers and policymakers across all 50 States and Washington D C and our efforts to spread the word and reduce the stigma of TD.

After seven years and Grubhub is the number one prescribed <unk> inhibitor for the treatment of tardive dyskinesia of RTD. Congrats on it is the only treatment proven to reduce TD symptoms with simple dosing always one capsule once a day and no complex titration.

After seven years and granted is the number one prescribed <unk> inhibitor for the treatment of tardive dyskinesia a R. T. D. <unk> is the only treatment proven to reduce TD symptoms with simple dosing always one capsule once a day and no complex titration. Very proud of the progress we've made within grasp over these past seven years and we're even more excited about the many thousands of people living with TD or Huntington's chorea that we'll be able to help in the coming years. In addition to today's being the seven year anniversary of our launch we're less than a week away from TD awareness week, each year TD awareness week occur. In early May which is designated as mental health awareness month. This year TD awareness week occurs from me first through 11. So please join our friends the movement disorders policy coalition. Mental health advocacy organizations health care providers and policymakers across all 50 States and Washington D C and our efforts to spread the word and reduce the stigma of TD.

Very proud of the progress you've made within grasp over these past seven years and we're even more excited about the many thousands of people living with TD or Huntington's chorea that we'll be able to help in the coming years. In addition to today being the seven year anniversary of our launch we're less than a week away from TD awareness week, each year TD awareness week.

Very proud of the progress we've made within grasp over these past seven years and we're even more excited about the many thousands of people living with TD or Huntington's chorea that we'll be able to help in the coming years. In addition to today's being the seven year anniversary of our launch we're less than a week away from TD awareness week, each year TD awareness week occur. In early May which is designated as mental health awareness month. This year TD awareness week occurs from me first through 11. So please join our friends the movement disorders policy coalition. Mental health advocacy organizations health care providers and policymakers across all 50 States and Washington D C and our efforts to spread the word and reduce the stigma of TD.

In early May which is designated as mental health awareness month.

In early May which is designated as mental health awareness month. This year TD awareness week occurs from me first through 11. So please join our friends the movement disorders policy coalition. Mental health advocacy organizations health care providers and policymakers across all 50 States and Washington D C and our efforts to spread the word and reduce the stigma of TD.

This year TD awareness week occurs from me first through 11. So please join our friends the movement disorders policy coalition.

This year TD awareness week occurs from me first through 11. So please join our friends the movement disorders policy coalition. Mental health advocacy organizations health care providers and policymakers across all 50 States and Washington D C and our efforts to spread the word and reduce the stigma of TD.

Mental health advocacy organizations health care providers and policymakers across all 50 States and Washington D C and our efforts to spread the word and reduce the stigma of TD.

Now onto results, our Q1 sales of $506 million represented robust year over year sales growth of 23%. Despite the typical Q1 seasonal payer challenges caused by annual reauthorization requirements and health plan switches, we continue to make good progress growing our franchise across all three business segments.

Eric S. Benevich: Now on to results. Our Q1 sales of $506 million represented robust year-over-year sales growth of 23%, despite the typical Q1 seasonal payer challenges caused by annual reauthorization requirements and health plan switches. We continue to make good progress growing our franchise across all three business segments of psychiatry, neurology and long-term care. The majority of patients, who could benefit from treatment of their TD remain as yet undiagnosed. We continue to focus on driving awareness, diagnosis and treatment with INGREZZA. For the chorea associated with Huntington's disease indication, we're about six months into that launch. The early feedback from neurologists gaining experience with INGREZZA and HD chorea has been very positive and we're making good progress there. Overall, HD chorea is a much smaller patient population. TD will always drive the lion's share of growth for INGREZZA. Just yesterday, the FDA approved the new sprinkle formulation of Ingrezza. This new formulation represents a valuable treatment option for TD or HC chorea patients with difficulty swallowing. All-in-all, INGREZZA is again off to a good start in 2024 and we carry that momentum forward into Q2.

We continue to make good progress growing our franchise across all three business segments of psychiatry, and neurology and long term care. The majority of patients who could benefit from treatment with their of their TD remain as yet been diagnosed so we continue to focus on driving awareness diagnosis and treatment with <unk> <unk> for. For the chorea associated with Huntington's disease indication, we're about six months into that launch the early feedback from neurologists gaining experience with any browser and HD Korea has been very positive and we're making good progress. There overall HD Korea is a much smaller patient population. So TD wilmar always drives the lion's share. Gross foreign breadth. Just yesterday, the FDA approved the new sprinkle formulation of aggressive this new formulation represents a valuable treatment option for TD or HD Korea patients with difficulty swallowing all in all that is again off to a good start in 2024, and we carry that momentum forward into Q2.

<unk> of psychiatry, and neurology and long term care the majority of patients who could benefit from treatment with their of their TD remain as yet been diagnosed so we continue to focus on driving awareness diagnosis and treatment with <unk> <unk> for the chorea associated with Huntington's disease indication, we're about six months into that launch.

For the chorea associated with Huntington's disease indication, we're about six months into that launch the early feedback from neurologists gaining experience with any browser and HD Korea has been very positive and we're making good progress. There overall HD Korea is a much smaller patient population. So TD wilmar always drives the lion's share. Gross foreign breadth. Just yesterday, the FDA approved the new sprinkle formulation of aggressive this new formulation represents a valuable treatment option for TD or HD Korea patients with difficulty swallowing all in all that is again off to a good start in 2024, and we carry that momentum forward into Q2.

The early feedback from neurologists, gaining experience with any browser and HD Korea has been very positive and we're making good progress. There overall HD Korea is a much smaller patient population. So TD will always drive the lion's share of growth barring breath.

Gross foreign breadth. Just yesterday, the FDA approved the new sprinkle formulation of aggressive this new formulation represents a valuable treatment option for TD or HD Korea patients with difficulty swallowing all in all that is again off to a good start in 2024, and we carry that momentum forward into Q2.

Just yesterday, the FDA approved the new sprinkle formulation of aggressive this new formulation represents a valuable treatment option for TD or HD Korea patients with difficulty swallowing all in all and Grubhub is again off to a good start in 2024, and we carry that momentum forward into Q2.

Just yesterday, the FDA approved the new sprinkle formulation of aggressive this new formulation represents a valuable treatment option for TD or HD Korea patients with difficulty swallowing all in all that is again off to a good start in 2024, and we carry that momentum forward into Q2.

Eric S. Benevich: Now, quickly on CRINECERFONT for the potential treatment of congenital adrenal hyperplasia or CAH. We've been busy staffing up and many of our headquarters and field sales leaders for our endocrinology franchise are now in place. We've been able to attract new team members with excellent experience in rare disease categories. We expect to complete hiring of the field teams in the second half of this year. Our primary focus in 2024 is on educating the CAH community on important topics, including disease state pathophysiology, understanding the challenges with current steroid treatments and new areas of research in CAH. And to that end, we have recently rolled out a new educational initiative called What the CAH? Which aims to close the gap in CAH understanding and acknowledges the frustration and challenges experienced by members of the CAH community in managing this rare genetic endocrine condition. We're excited about a potential launch of CRINECERFONT in 2025 and we're laying the foundation this year to ensure our success going forward. With that, I'll turn the call over to my colleague, Dr. Eiry Roberts, our Chief Medical Officer.

Now quickly on <unk> for the potential treatment of congenital adrenal hyperplasia or CAH, we've been busy staffing up in many of our headquarters and field sales leaders for our endocrinology franchise are now in place we've been able to attract new team members with excellent experience in rare disease categories. We.

We expect to complete hiring of the field teams in the second half of this year. Our primary focus in 2024 is on educating the CAH community on important topics, including disease pathophysiology.

We expect to complete hiring of the field teams in the second half of this year. Our primary focus in 2024 is on educating the CAH community on important topics, including disease pathophysiology understanding the challenges with current strip staring treatments and new areas of research in CAH and to that end, we recently rolled. A new educational initiative call, what the CAH, which aims to close the gap in CAH understanding and acknowledges the frustration and challenges experienced by members of the CAH community and managing this rare genetic endocrine condition. We're excited about our potential launch perhaps are pumped in 2025, and we're laying the foundation this year to ensure our success going forward. With that I'll turn the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer.

Understanding the challenges with current students starting treatments and new areas of research in CAH and to that end, we recently rolled out a new educational initiative called what the CAH, which aims to close the gap in CAH understanding and acknowledges the frustration and challenges experienced by members of the CAH community and managing this rare.

A new educational initiative call, what the CAH, which aims to close the gap in CAH understanding and acknowledges the frustration and challenges experienced by members of the CAH community and managing this rare genetic endocrine condition. We're excited about our potential launch perhaps are pumped in 2025, and we're laying the foundation this year to ensure our success going forward. With that I'll turn the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer.

Genetic endocrine condition.

We're excited about our potential launch of <unk> in 2025, and we're laying the foundation this year to ensure our success going forward.

We're excited about our potential launch perhaps are pumped in 2025, and we're laying the foundation this year to ensure our success going forward. With that I'll turn the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer.

The early feedback from neurologists, gaining experience with any browser and HD Korea has been very positive and we're making good progress there.

With that I'll turn the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer.

Overall, HD Korea is a much smaller patient population. So TD will always drive the lion's share of growth flooring breath.

Thank you Eric.

Eiry W. Roberts: Thank you, Eric. Good morning. Since our last earnings call, our clinical and regulatory teams have made tremendous progress with the pipeline. Just yesterday, we have received approval from the FDA for INGREZZA sprinkle capsules and submitted to the FDA the new drug application of CRINECERFONT for the treatment of pediatric and adult patients with classical congenital adrenal hyperplasia. Given the unmet need in CAH and the previously granted breakthrough designation for CRINECERFONT, we believe this submission may merit priority review and look forward to hearing the FDA's decision on this. In the meantime, our teams are well-prepared for all upcoming interactions with the agency. Throughout this quarter, additional details from the registrational studies of CRINECERFONT will be presented at a number of medical conferences, including ENDO in June. We look forward to sharing the posters and summaries as soon as they're publicly available. We are also working on full publication of the data in a peer-reviewed journal in the near future.

Since our last earnings call, our clinical and regulatory teams have made tremendous progress with the pipeline.

Since the last earnings call, our clinical and regulatory teams have made tremendous progress with the pipeline. Just yesterday, we received approval from the SBA for in graduate sprinkled capsules and submitted to the FDA. The new drug application of connects Dupont for the treatment of pediatric and adult patients with classical congenital adrenal hyperplasia. Given the unmet need in CAH and previously granted breakthrough designation for <unk>. We believe this submission May Merit priority review and look forward to hearing the Fda's decision on this. In the meantime, our teams are well prepared for all upcoming interactions with the agency. Throughout this quarter additional details from the Registrational studies of <unk> will be presented as a number of medical conferences, including Endo in June. We look forward to sharing the posted assemblies as soon as they are publicly available. We're also working on full publication of the data in a peer reviewed journal in the near future.

Just yesterday, the FDA approved the new sprinkle formulation of aggressive.

Just yesterday, we received approval from the FDA for in graduate sprinkled capsules.

Just yesterday, we received approval from the SBA for in graduate sprinkled capsules and submitted to the FDA. The new drug application of connects Dupont for the treatment of pediatric and adult patients with classical congenital adrenal hyperplasia. Given the unmet need in CAH and previously granted breakthrough designation for <unk>. We believe this submission May Merit priority review and look forward to hearing the Fda's decision on this. In the meantime, our teams are well prepared for all upcoming interactions with the agency. Throughout this quarter additional details from the Registrational studies of <unk> will be presented as a number of medical conferences, including Endo in June. We look forward to sharing the posted assemblies as soon as they are publicly available. We're also working on full publication of the data in a peer reviewed journal in the near future.

This new formulation represents a valuable treatment option for TD or HD Korea patients with difficulty swallowing.

Eiry W. Roberts: And submitted to the FDA, the new drug application of <unk> for the treatment of pediatric and adult patients with classical congenital adrenal hyperplasia yet.

All in all and Grubhub is again off to a good start to 2024, and we carry that momentum forward into Q2.

Given the unmet need in CAH and the previously granted breakthrough designation for that fund. We believe this submission May Merit priority review and look forward to hearing the Fda's decision on this.

Given the unmet need in CAH and previously granted breakthrough designation for <unk>. We believe this submission May Merit priority review and look forward to hearing the Fda's decision on this. In the meantime, our teams are well prepared for all upcoming interactions with the agency. Throughout this quarter additional details from the Registrational studies of <unk> will be presented as a number of medical conferences, including Endo in June. We look forward to sharing the posted assemblies as soon as they are publicly available. We're also working on full publication of the data in a peer reviewed journal in the near future.

We've been able to attract new team members with excellent experience in rare disease categories.

In the meantime, our teams are well prepared for all upcoming interactions with the agency.

In the meantime, our teams are well prepared for all upcoming interactions with the agency. Throughout this quarter additional details from the Registrational studies of <unk> will be presented as a number of medical conferences, including Endo in June. We look forward to sharing the posted assemblies as soon as they are publicly available. We're also working on full publication of the data in a peer reviewed journal in the near future.

We expect to complete the hiring of the field teams in the second half of this year. Our primary focus in 2024 is on educating the CAH community on important topics, including disease pathophysiology understanding.

So after this quarter additional details from the Registrational studies with <unk> will be presented as a number of medical conferences, including Endo in June.

Throughout this quarter additional details from the Registrational studies of <unk> will be presented as a number of medical conferences, including Endo in June. We look forward to sharing the posted assemblies as soon as they are publicly available. We're also working on full publication of the data in a peer reviewed journal in the near future.

We look forward to sharing the post isn't assemblies as soon as they are publicly available.

We look forward to sharing the posted assemblies as soon as they are publicly available. We're also working on full publication of the data in a peer reviewed journal in the near future.

Eiry W. Roberts: We're also working on full publication of the data in a peer reviewed journal in the near future.

We're also working on full publication of the data in a peer reviewed journal in the near future.

Moving to the phase II pipeline I'll begin with the very encouraging positive study results of NPI eight full buy in adults with major depressive disorder.

Eiry W. Roberts: Moving to the Phase II pipeline, I'll begin with the very encouraging positive study results of NBI-845 in adults with major depressive disorder. Recall, NBI-845 was one of several Phase II ready programs in licensed as part of the Takeda collaboration. This molecule is a potent, highly-selective, potential first-in-class positive allosteric modulator of AMPA receptors, designed to induce synaptic plasticity, while maintaining a broad margin of safety relative to seizure activity. As a reminder, there have been significant advances in recent years in understanding the neurobiology of depression, with converging lines of evidence suggesting that depression is associated with impairment in enhanced synaptic plasticity. Often times, enhanced synaptic plasticity via an increase in neurotrophic factors, for example, brain derived neurotrophic factor BDNS. In fact, activation of AMPA receptors is necessary for the antidepressant effect of ketamine.

Recall NPI April five was one of several phase III ready program in licensed as part of the Takeda collaboration.

Recall NPI eight full time was one of several phase III ready program in licensed as part of the Takeda collaboration. This molecule is a potent highly selective potential first in class positive allosteric modulator. Designed to induce synaptic plasticity, while maintaining a broad margin of safety relative to seizure activity. As a reminder, there have been significant advances in recent years in understanding the neurobiology of depression with converging lines of evidence, suggesting that depression is associated with an impairment in synaptic plasticity. I have two kinds enhance synaptic plasticity via an increase in neurotrophic factors for example, brain derived neurotrophic factor bdnf. In fact activation of antigen receptors is necessary for the antidepressant effect of ketamine.

This molecule is a potent highly selective potential first in class positive allosteric modulator.

This molecule is a potent highly selective potential first in class positive allosteric modulator. Designed to induce synaptic plasticity, while maintaining a broad margin of safety relative to seizure activity. As a reminder, there have been significant advances in recent years in understanding the neurobiology of depression with converging lines of evidence, suggesting that depression is associated with an impairment in synaptic plasticity. I have two kinds enhance synaptic plasticity via an increase in neurotrophic factors for example, brain derived neurotrophic factor bdnf. In fact activation of antigen receptors is necessary for the antidepressant effect of ketamine.

Designed to induce synaptic plasticity, while maintaining a broad margin of safety relative to seizure activity.

Designed to induce synaptic plasticity, while maintaining a broad margin of safety relative to seizure activity. As a reminder, there have been significant advances in recent years in understanding the neurobiology of depression with converging lines of evidence, suggesting that depression is associated with an impairment in synaptic plasticity. I have two kinds enhance synaptic plasticity via an increase in neurotrophic factors for example, brain derived neurotrophic factor bdnf. In fact activation of antigen receptors is necessary for the antidepressant effect of ketamine.

As a reminder, there have been significant advances in recent years and understanding the neurobiology of depression with converging lines of evidence, suggesting that depression is associated with an impairment in synaptic plasticity.

As a reminder, there have been significant advances in recent years in understanding the neurobiology of depression with converging lines of evidence, suggesting that depression is associated with an impairment in synaptic plasticity. I have two kinds enhance synaptic plasticity via an increase in neurotrophic factors for example, brain derived neurotrophic factor bdnf. In fact activation of antigen receptors is necessary for the antidepressant effect of ketamine.

I have two kinds enhance synaptic plasticity via an increase in neurotrophic factors for example, brain derived neurotrophic factor bdnf.

I have two kinds enhance synaptic plasticity via an increase in neurotrophic factors for example, brain derived neurotrophic factor bdnf. In fact activation of antigen receptors is necessary for the antidepressant effect of ketamine.

In fact activation of antigen receptors is necessary for the antidepressant effects of ketamine.

In fact activation of antigen receptors is necessary for the antidepressant effect of ketamine.

Eiry W. Roberts: Last week, we announced the Savitri study met the primary endpoint with statistically significant reduction in the Montgomery asset Depression rating scale total score at day 28.

Eiry W. Roberts: Last week, we announced the SAVITRI study met the primary endpoint with statistically significant reduction in the Montgomery and Asberg Depression Rating Scale total score at day 28. The study met key secondary endpoints as well, including statistically significant reduction in the MADRS total score at day 56. In addition, NBI-845 demonstrated a strong effect size. Importantly for this mechanism of action, NBI-845 was generally well-tolerated in the study. The most common adverse event was headache, of which a majority was transient and mild in severity. There were no seizures, no serious adverse events, no psycho-mimetic or dissociative events throughout. undefinedd on these encouraging data, we plan to engage with FDA in the near future to define the path forward to registration and we'll be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress AMPA differentiators in the clinic due to issues of the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserve enormous credit for their years of research activity in this field, which led to the design of NBI-845 and the favorable profile that we've seen with this molecule to date. In addition, I want to give sincere thanks to the team working on the SAVITRI study for their diligence in delivering this high-quality outcome.

The study met key secondary endpoints as well, including statistically significant reduction in the mattress total score at day 56.

The study met key secondary endpoints as well, including statistically significant reduction in the mattress total score at day 56. In addition, NPI April five demonstrated a strong effect size. Imports at me for this mechanism of action NPI 845 was generally well tolerated in this study the most common adverse event was headache of which a majority with transient and mild in severity. There were no seizures. No serious adverse events no psychotomimetic OLED associate events throughout. Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

In addition, and beyond April five demonstrated a strong effect size.

In addition, NPI April five demonstrated a strong effect size. Imports at me for this mechanism of action NPI 845 was generally well tolerated in this study the most common adverse event was headache of which a majority with transient and mild in severity. There were no seizures. No serious adverse events no psychotomimetic OLED associate events throughout. Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

It wasn't me for this mechanism of action NPI 845 was generally well tolerated in this study.

Imports at me for this mechanism of action NPI 845 was generally well tolerated in this study the most common adverse event was headache of which a majority with transient and mild in severity. There were no seizures. No serious adverse events no psychotomimetic OLED associate events throughout. Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

Eiry W. Roberts: Most common adverse event was headache of which a majority with transient and mild in severity.

There were no seizures, no serious adverse events no psychotomimetic OLED associate events throughout.

There were no seizures. No serious adverse events no psychotomimetic OLED associate events throughout. Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

No serious adverse events no psychotomimetic OLED associate events throughout. Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward.

Based on these encouraging data we plan to engage with FDA in the near future to define the path forward to registration and we will be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

Eiry W. Roberts: Many companies before Neurocrine have tried and failed to progress potentiate. This in the clinic due to issues of toxicity and therapeutic index.

Many companies before Neurocrine have tried and failed to progress them to potentiate. This in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

Our partners at Takeda deserves enormous credit for their years of research activity in this field, which led to the design of N V. I, a full five and the favorable profile that we've seen with this molecule to date. In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

In addition, I want to give our sincere thanks to the team working on the <unk> study for their diligence in delivering this high quality outcome.

In addition to April five we also delivered positive phase II results for two separate studies Modi the long acting glucocorticoid obtained through our acquisition of UK based diurnal.

Eiry W. Roberts: In addition to 845, we also delivered positive Phase II results for two separate studies of Efmody, the long acting glucocorticoid obtained through our acquisition of the UK brd Diurnal. The Phase II study of EFMODY in adults with adrenal insufficiency and the Phase II study of EFMODY in adults and adolescents with classic CAH, both reported top-line positive results. Additionally, both studies met their respective primary and key secondary endpoints. In each study, EFMODY was well-tolerated with a safety profile consistent with published EFMODY clinical data. On top of CRINECERFONT's FDA submission and a total of three positive Phase II data readouts, we've also initiated a number of new clinical studies, which include initiation of a Phase II study of NBI-770, the oral NMDA NR2B negative allosteric modulator for major depressive disorder, initiation of a Phase I study of NBI-890, our next generation VMAT2 inhibitor and last but not least, initiation of a Phase I study of NBI-986, an M4 antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other Phase I muscarinic agonist programs, over the coming months, as they each progress through the clinic.

The phase two study of <unk> in adults with adrenal insufficiency I'm the phase II study of <unk> in adults and adolescents with classic CAH, both reported topline positive results. Additionally, both studies met their respective primary and key secondary endpoints.

The phase II study of <unk> in adults with adrenal insufficiency, and the phase II study of <unk> in adults and adolescents with classic CAH. <unk> reported top line positive results. Additionally, both studies met their respective primary and key secondary endpoints. Each study <unk> was well tolerated with a safety profile consistent with published ESMO deep clinical data. On top of <unk> NDA submission and a total of three positive phase III phase III data Readouts. We've also initiated a number of new clinical studies, which include initiation of the phase two study of <unk> 770, the oral NMDA and ought to be negative. Derek modulator for major depressive disorder. Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

<unk> reported top line positive results. Additionally, both studies met their respective primary and key secondary endpoints. Each study <unk> was well tolerated with a safety profile consistent with published ESMO deep clinical data. On top of <unk> NDA submission and a total of three positive phase III phase III data Readouts. We've also initiated a number of new clinical studies, which include initiation of the phase two study of <unk> 770, the oral NMDA and ought to be negative. Derek modulator for major depressive disorder. Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

Additionally, both studies met their respective primary and key secondary endpoints. Each study <unk> was well tolerated with a safety profile consistent with published ESMO deep clinical data. On top of <unk> NDA submission and a total of three positive phase III phase III data Readouts. We've also initiated a number of new clinical studies, which include initiation of the phase two study of <unk> 770, the oral NMDA and ought to be negative. Derek modulator for major depressive disorder. Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

In each study <unk> was well tolerated with a safety profile consistent with published ESMO deep clinical data.

Each study <unk> was well tolerated with a safety profile consistent with published ESMO deep clinical data. On top of <unk> NDA submission and a total of three positive phase III phase III data Readouts. We've also initiated a number of new clinical studies, which include initiation of the phase two study of <unk> 770, the oral NMDA and ought to be negative. Derek modulator for major depressive disorder. Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

On top of <unk> NDA submission and a total of three positive phase III phase III data Readouts. We've also initiated a number of new clinical studies, which include initiation of the phase two study of <unk> 770, the oral NMDA and ought to be negative. Derek modulator for major depressive disorder. Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

Derek modulator for major depressive disorder.

Derek modulator for major depressive disorder. Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

Eiry W. Roberts: Initiation of a phase one study of <unk> 890, our next generation <unk> inhibitor.

Initiation of the Phase one study of <unk> 890, our next generation <unk>, two inhibitor and last but not least initiation of a phase one study F. N B I 98, sick and earn full antagonist targeted for development in movement disorders. We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

Last but not least initiation of a phase one study F N B I 98, sick and earn full antagonist targeted for development in movement disorders.

We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

Looking ahead to our upcoming phase III data Readouts I'm pleased to say that we're currently on track to deliver data from MDI 568 are ultra C. Rick selective muscarinic and full agonist study as a potential treatment for schizophrenia honest the Louvre DOCSIS that as a potential.

Eiry W. Roberts: Looking ahead to our upcoming Phase II data readouts, I'm pleased to say that we're currently on track to deliver data from NBI-568, our orthoceric selective muscarinic M4 agonist study as a potential treatment for schizophrenia and for LUVADAXISTAT as a potential treatment for cognitive impairment associated with schizophrenia. We now anticipate top-line data from both these studies in third quarter 2024. In summary, I'm very proud of the progress we continue to make with the clinical portfolio of Neurocrine in order to deliver on behalf of the patients that we serve. With that, I'll hand things back to Kevin. Kevin?

Treatment for cognitive impairment associated with schizophrenia.

Treatment for cognitive impairment associated with schizophrenia, we now anticipate top line data from both these studies in Q3 2024. In summary, I'm very proud of the progress we continue to make with the clinical portfolio Neurocrine in order to deliver on behalf of the patients that we serve. With that I'll hand things back to Kevin Kevin.

We now anticipate top line data from both these studies in Q3 2024 and.

In summary, I'm very proud of the progress we continue to make with the clinical portfolio of new aircraft in order to deliver on behalf of the patients that we serve.

In summary, I'm very proud of the progress we continue to make with the clinical portfolio Neurocrine in order to deliver on behalf of the patients that we serve. With that I'll hand things back to Kevin Kevin.

With that I'll hand things back to Kevin Kevin.

Kevin: Thank you very much.

Kevin Charles Gorman: Thank you very much, Eiry. And Nikki, we're ready for questions now.

Kevin: And Nikki we're ready for questions now.

And Nikki we're ready for questions now.

Kevin: And at this time, if you would like to ask a question. Please press the star and one on your telephone keypad.

Operator: And at this time, if you would like to ask a question, please press the Star and 1 on your telephone keypad. You may withdraw your question by pressing Star 2. Once again, to ask a question, please press the Star then 1 on your telephone keypad. We'll take our first question from Tazeen Ahmad with Bank of America. Please go ahead.

Kevin: We try your question by pricing start to once again to ask a question. Please press star one on your telephone keypad.

We draw your question by pricing start to. Once again to ask a question. Please press the Star then one on your telephone keypad. We'll take our first question from <unk> Ahmad with <unk>. Of America. Please go ahead.

Once again to ask a question. Please press the Star then one on your telephone keypad. We'll take our first question from <unk> Ahmad with <unk>. Of America. Please go ahead.

We'll take our first question from Mr. Ahmad.

We'll take our first question from <unk> Ahmad with <unk>. Of America. Please go ahead.

Ahmad: Of America. Please go ahead.

Operator: Are in a listen-only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. You may register to ask questions by pressing the star and one on your telephone keypad. You may withdraw your question by pressing star two. Please note this call is being recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Todd Tushla, Vice President of Investor Relations. Please go ahead.

Of America. Please go ahead.

Ahmad: Great. Thanks, operator, good morning, guys. Thanks for taking my questions.

Tazeen Ahmad: Great. Thanks, operator. Good morning, guys. Thanks for taking my questions. The first one for me is on 845. Congrats on the data that you press released. We did get a few questions about dosing and dose response. You said that you can talk about dose response. Is there any reason mechanistically, we're not seeing a dose response still encourages positive results ultimately and moving forward in Phase III? And then, second question on the sprinkle formulation for INGREZZA. Can you just remind us what percent of patients have trouble swallowing and what kind of impact you expect that to have on sales now that you have on sales now that you have this new formulation? Thanks.

Page one study of NPI 98, six on N full antagonist targeted for development in movement disorders.

Ahmad: The first one for me is on an 845.

The first one for me is on in four or five. Congrats on the data that you press released we did get a few questions about. The other thing in dose response, I think to the extent that you can talk about dose response and is there any reason mechanistically, we're not seeing a dose response still encourage our positive results ultimately in and moving forward in phase three. And then a second question on the sprinkle formulation foreign Grad side can you just remind us what percent of patients have trouble swallowing and what kind of impact do you expect that to have on south now that you have the same formulation.

Ahmad: Congrats on the data that you press released we did get a few questions about dosing and dose response I think to the extent that you can talk about dose response.

Congrats on the data that you press released we did get a few questions about. The other thing in dose response, I think to the extent that you can talk about dose response and is there any reason mechanistically, we're not seeing a dose response still encourage our positive results ultimately in and moving forward in phase three. And then a second question on the sprinkle formulation foreign Grad side can you just remind us what percent of patients have trouble swallowing and what kind of impact do you expect that to have on south now that you have the same formulation.

We look forward to providing more information on these programs together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic.

The other thing in dose response, I think to the extent that you can talk about dose response and is there any reason mechanistically, we're not seeing a dose response still encourage our positive results ultimately in and moving forward in phase three. And then a second question on the sprinkle formulation foreign Grad side can you just remind us what percent of patients have trouble swallowing and what kind of impact do you expect that to have on south now that you have the same formulation.

Ahmad: Is there any reason mechanistically, we're not seeing a dose response still encourage is positive.

Looking ahead to our upcoming phase III data Readouts I'm pleased to say that we're currently on track to deliver data from M. Beyond 568 are ultra C. Rick selective muscarinic and full agonist study as a potential treatment for schizophrenia.

Todd Tushla: Good morning, everyone, and welcome to Neurocrine Biosciences' Q1 2024 earnings call. With me are Kevin Gorman, Chief Executive Officer; Matt Abernethy, Chief Financial Officer; Eiry Roberts, Chief Medical Officer; Eric Benevich, Chief Commercial Officer; and Kyle Gano, Chief Business Development and Strategy Officer. We're also joined today by Dr. Jas Singh, Neurocrine's Vice President of Psychiatry Clinical Development, which includes serving as the program lead for NBI-845, our AMPA potentiator, which recently read out positive Phase 2 top-line results in adults with major depressive disorder. Jas has been at Neurocrine since 2020. Prior to joining Neurocrine, Jas spent 14 years at Johnson & Johnson, where, among other things, he led the clinical efforts for the esketamine program through approval.

Positive results ultimately in and moving forward in phase three.

And then a second question on the sprinkle formulation foreign Grad side can you just remind us what percent of patients have trouble swallowing and what kind of impact do you expect that to have on south now that you'll have the same formulation.

Mr. Lowe DOCSIS start as a potential treatment for cognitive impairment associated with schizophrenia.

We now anticipate topline data from both these studies in Q3 2024.

Speaker Change: Yeah, Let me take the first one convenient thanks for that.

Eiry W. Roberts: Yes. Let me take the first one, Tazeen. Thanks for that. We haven't said anything about the doses other than one of the doses reached statistical significance. As you saw from what we released, there was improvement actually in the lab rates in both doses. As Kevin said, we really are in a position that we're talking about intellectual property and other issues here that we want to work through, before we say anything further. What I can say is, we're very encouraged by the robustness of the data both in terms of the impact on the primary and key secondary endpoints and overall the tolerability as well. As we said, there were no serious adverse events. There were no seizures, no psychotic mimetic or dissociative events throughout. The most common adverse event was headache, the majority of which were transient and mild in severity and with both doses looking like placebo in terms of their safety profile. Obviously, that's really important, given the history in this class of medications.

Speaker Change: We haven't said anything about the doses other than one of the doses reached statistical significance and as you saw from what we release.

We haven't said anything about the doses other than one of the doses reached statistical significance and as you saw from what we release. The. There was improvement actually in the mattress and both doses and so as Kevin said, we really are in the position that we're talking about intellectual property and other issues here that we want to work through before we say anything further that what I can say is we're very encouraged by the robustness of the data both in terms of the impact on lead time Liana <unk>. Secondary endpoints. On an overall at the Tolerability as well as we said you know there were no serious adverse events that were no seizures, no psychotomimetic associated events throughout and the most common adverse event. This headache, the majority of which are transient and mild in severity. Those doses looking like placebo intensive that safety profile and obviously, that's really important given the history of this class of medications.

In summary, I'm very proud of the progress we continue to make with the clinical portfolio at Neurocrine in order to deliver on behalf of patients that we serve.

The.

The. There was improvement actually in the mattress and both doses and so as Kevin said, we really are in the position that we're talking about intellectual property and other issues here that we want to work through before we say anything further that what I can say is we're very encouraged by the robustness of the data both in terms of the impact on lead time Liana <unk>. Secondary endpoints. On an overall at the Tolerability as well as we said you know there were no serious adverse events that were no seizures, no psychotomimetic associated events throughout and the most common adverse event. This headache, the majority of which are transient and mild in severity. Those doses looking like placebo intensive that safety profile and obviously, that's really important given the history of this class of medications.

Speaker Change: There was improvement actually in the mattress and both doses and so as Kevin said.

There was improvement actually in the mattress and both doses and so as Kevin said, we really are in the position that we're talking about intellectual property and other issues here that we want to work through before we say anything further that what I can say is we're very encouraged by the robustness of the data both in terms of the impact on lead time Liana <unk>. Secondary endpoints. On an overall at the Tolerability as well as we said you know there were no serious adverse events that were no seizures, no psychotomimetic associated events throughout and the most common adverse event. This headache, the majority of which are transient and mild in severity. Those doses looking like placebo intensive that safety profile and obviously, that's really important given the history of this class of medications.

With that I'll hand things back to Kevin Kevin.

We really are in the position that we're talking about intellectual property and other issues here that we want to work through fully thing to consider that but I can say is we're very encouraged by the robustness of the data both in terms of the impact on the primary and key secondary endpoints.

Kevin: Thank you very much I read and Nikki we're ready for questions now.

Kevin: And at this time, if you would like to ask a question. Please press star and one on your telephone keypad.

Todd Tushla: I'm sure you'll have a few questions, not only for Jaskaran, but also for Eiry and Kyle today on the NBI-845 program. With introductions complete, I'll remind you that 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. At this point, I'll turn the call over to Kevin.

Secondary endpoints. On an overall at the Tolerability as well as we said you know there were no serious adverse events that were no seizures, no psychotomimetic associated events throughout and the most common adverse event. This headache, the majority of which are transient and mild in severity. Those doses looking like placebo intensive that safety profile and obviously, that's really important given the history of this class of medications.

Kevin: Try your question by pressing star two.

On an overall at the Tolerability as well as we said you know there were no serious adverse events that were no seizures, no psychotomimetic associated events throughout and the most common adverse event. This headache, the majority of which are transient and mild in severity. Those doses looking like placebo intensive that safety profile and obviously, that's really important given the history of this class of medications.

Kevin: Once again to ask a question. Please press the Star then one on your telephone keypad.

Tazeen Ahmad: I'll take our first question from assessing Ahmad with Bank of America. Please go ahead.

Ahmad: Great. Thanks, operator, good morning, guys. Thanks for taking my questions.

With those doses looking like placebo in terms of the safety profile and obviously, that's really important given the history in this class of medications.

Those doses looking like placebo intensive that safety profile and obviously, that's really important given the history of this class of medications.

Speaker Change: The first one for me is on in 45.

Kevin Gorman: Thank you, Todd. Good morning, everyone. We've had a remarkable week, and it's only Wednesday morning. We've submitted two NDAs on crinecerfont and received an FDA approval for a new offering of Ingrezza. I'm thinking about giving the company the rest of the week off. You know, Neurocrine has never had the opportunity to positively impact so many lives as it has today. As you will hear in greater detail from Matt, Eric, and Eiry, we are making progress in every aspect of our business, focused on bringing life-changing medicines forward. We have never treated as many TD and HD patients as we are treating today.

Speaker Change: Congrats on the data that you press released we did get a few questions about dosing and dose response I think to the extent that you can talk about dose response.

Okay.

Eric S. Benevich: I'll tackle the second question. Hi, Tazeen. The sprinkle formulation, we estimate that 5% to 10% of people living with tardive dyskinesia or Huntington's chorea experience difficulty swallowing. This represents, we think, a nice alternative for them to be able to get treated with INGREZZA. In terms of the impact on the forecast, it's already integrated into our guidance. We expected to get approval and we issued guidance at our last earnings call in the range of $2.1 billion to $2.2 billion. It's already baked in. Thanks.

Speaker Change: Yes, I'll tackle the second question hydrazine, so the sprinkle formulation, we estimate that 5% to 10%.

Yes, I'll tackle the second question hydrazine, so the sprinkle formulation, we estimate that 5% to 10%. People living with tardive dyskinesia, or Huntington's chorea experienced difficulty swallowing. So this represents. Thank. Alternative for them to be able to get treated within <unk> and in terms of the impact on the forecast that's already integrated into our guidance. So we expect it to get approval and we issued guidance at our last earnings call in the range of $2 one to $2 2 billion. So it is already baked in.

Speaker Change: Is there any reason mechanistically are we're not seeing a dose response still encourages positive results ultimately in and moving forward in phase three.

Speaker Change: People living with tardive dyskinesia, or Huntington's chorea experienced difficulty swallowing. So this represents.

People living with tardive dyskinesia, or Huntington's chorea experienced difficulty swallowing. So this represents. Thank. Alternative for them to be able to get treated within <unk> and in terms of the impact on the forecast that's already integrated into our guidance. So we expect it to get approval and we issued guidance at our last earnings call in the range of $2 one to $2 2 billion. So it is already baked in.

Thank.

Thank. Alternative for them to be able to get treated within <unk> and in terms of the impact on the forecast that's already integrated into our guidance. So we expect it to get approval and we issued guidance at our last earnings call in the range of $2 one to $2 2 billion. So it is already baked in.

Speaker Change: And then a second question on the sprinkle formulation boring Grad side can you just remind us what percent of patients have trouble swallowing and what kind of impact do you expect that to have on sales now that you have the same formulation.

Speaker Change: Nice alternative for them to be able to get treated within grocer and in terms of the impact on the forecast that's already integrated into our guidance. So can we expect it to get approval and we issued guidance at our last earnings call in the range of $2, 1% to $2 2 billion. So it is already baked in.

Alternative for them to be able to get treated within <unk> and in terms of the impact on the forecast that's already integrated into our guidance. So we expect it to get approval and we issued guidance at our last earnings call in the range of $2 one to $2 2 billion. So it is already baked in.

Kevin Gorman: We have never had as deep a mid- and late-stage clinical pipeline, and now we have a good line of sight into a number of potentially new medicines coming into the clinic from our research group in the next 2 years, several of them with the promise of disease modification. Now, we're constantly prioritizing the funding of our programs based on data. We're in the enviable position to be able to support our current and future pipeline. Now, a recent example of a program that will be seeing increased funding is our AMPA modulating molecule, 845, as a treatment for major depression. The efficacy and tolerability seen in this trial is very compelling, and we will be meeting with FDA to further define the registration program.

Speaker Change: Yeah.

Speaker Change: Yeah, Let me take the first one to be thankful that you know, we haven't said anything about the doses other than one of the doses reached statistical significance and as you saw from what we released them they would.

Speaker Change: Okay. Thanks.

Tazeen Ahmad: Okay. Thanks.

Thank you. Our next question comes from Phil Nadeau with Cowen. Please go ahead.

Operator: Our next question comes from Phil Nadeau with TD Cowen. Please go ahead.

Speaker Change: The there was improvement actually in the last person both doses and so as Kevin said, we really are in the position that we're talking about intellectual property and other issues here that we want to work through both the Buda.

It comes from Phil Nadeau with Cowen. Please go ahead.

Phil Nadeau: Hi, good morning, Congrats on the progress thanks for taking our question with 568 data now expected next quarter.

Phil Nadeau: Hi. Good morning. Congrats on the progress. Thanks for taking my question. With the 568 data now expected next quarter, we're curious to get your most updated thoughts on what you need to see to advance that program into additional development, particularly given the competitive landscape. Give us some idea of what efficacy results you'd like to see and what safety data and tolerability data would give you confidence that 568 could compete?

Curious to get your most updated thoughts on what you need to see to advance that program into additional development, particularly given the competitive landscape give us some idea of what efficacy results you'd like to see and Whatsapp.

Speaker Change: What I can say is we're very encourage by the robustness of the data both in terms of the impact on the primary and key secondary endpoints.

Speaker Change: On an overall at the Tolerability as well as he said you know there were no serious adverse events there was no seizures.

What safety data and Tolerability data would give you confidence in that. Five six it could compete.

Safety data and Tolerability data would give you confidence that five six it could compete.

Kevin Gorman: Now, in our press release this morning, and in Eiry's comments upcoming, we share more information on this trial. However, we will limit our comments on this data set as we file additional intellectual property and protect future publication opportunities. So with those brief remarks, I'd like to turn it over to my colleagues, starting with Matt.

No Spike up and then Mexico associated events throughout and the most common adverse event, the headache or the majority of which were transient and mild in severity.

Five six it could compete.

Speaker Change: Yes. Thanks.

Eiry W. Roberts: Yes. Thanks, Phil. We are really happy with the progress we've made with 568 and happy to be able to share that. In the third quarter we'll be coming forward with data. Just to remind you, this is a study of around about 200 patients. It's a dose finding study and it's done in an adaptive fashion in order to enable us to explore the full dose response here. In terms of the outcome, obviously, the primary endpoint for the study is the reduction in the PAM score relative to placebo. I think there's pretty clear precedence there in terms of what our expectations would be. We've seen a good effect size from other drugs in this class and we'd be looking for something in that kind of area in terms of the impact on the primary endpoint.

Really happy with the progress we've made this by six eight and are happy to be able to share that.

Speaker Change: With both doses looking like placebo in census that safety profile on obviously, that's really important given the history of this class of medication.

In the third quarter will be coming forward with data just to remind you. This is a study of around about 200 patients at that dose finding study and it's done in an adopted fashion in order to enable us to explore the full dose response here in.

Third quarter will be comfortable with the data just to remind you. This is a study of around about 200 patients at that dose finding study and it's done in an adoptive fashion in order to enable us to explore the full dose response here. In terms of the the outcome obviously the primary endpoint for the study is the reduction in the Pan score relative CFO and I think it's pretty clear precedent davidsons with what our expectations would be. A good effect size from other drugs in this class and we'd be looking for something in that kind of area in the sense of the impact on the primary endpoint.

Speaker Change: Yes, I'll tackle the second question licensing so the sprinkle formulation, we estimate that 5% to 10%.

Todd Tushla: Thanks, Kevin. What a start to 2024! With continued INGREZZA growth, our ongoing activities with crinecerfont, and last week's announcement of positive phase 2 results in major depressive disorder, the foundation to build Neurocrine into a leading neuroscience company has never been stronger. INGREZZA's sales finished the quarter at $506 million, reflecting over 20% year-over-year growth and our third consecutive year of Q4 to Q1 sequential growth. The seasonal payer dynamics associated with reauthorization and plan changes always poses challenges impacting refill rates for patients, but the team has managed through these dynamics well, once again. Consistent with our approach in previous years, we are reaffirming sales guidance and will reevaluate after the second quarter.

In terms of the the outcome obviously the primary endpoint for the study is the reduction in the Pan score relative CFO and I think it's pretty clear precedent davidsons with what our expectations would be we've seen a good effect size from other drugs in this class and we'd be looking for something in that kind of ariane intensive.

In terms of the the outcome obviously the primary endpoint for the study is the reduction in the Pan score relative CFO and I think it's pretty clear precedent davidsons with what our expectations would be. A good effect size from other drugs in this class and we'd be looking for something in that kind of area in the sense of the impact on the primary endpoint.

Speaker Change: People living with tardive dyskinesia, or Huntington's chorea experienced difficulty swallowing. So this represents.

Think.

Speaker Change: The alternative for them to be able to get treated within grocer and in terms of the impact on the forecast is already integrated into our guidance. So can we expect it to get approval and we issued guidance at our last earnings call in the range of $2 one to $2 2 billion.

A good effect size from other drugs in this class and we'd be looking for something in that kind of area in the sense of the impact on the primary endpoint. However, I will say that if you think about medications for diseases like schizophrenia, it's really the therapeutic index.

A good effect size from other drugs in this class and we'd be looking for something in that kind of area in the sense of the impact on the primary endpoint.

The impact on the primary endpoint, however, I will say that if you think about medications for diseases like schizophrenia, it's really the therapeutic index.

Eiry W. Roberts: However, I will say that, if you think about medication for diseases like schizophrenia, it's really the therapeutic index that's important here. And so, we'll be looking at the totality of the data including the tolerability and safety profile, which I think is critical here. Our approach of choosing a selective M4 agonist and a direct agonist rather than allosteric modulator, we believe has the opportunity to potentially differentiate, but it's all going to be about the data. We'll be looking at both the benefit that we see in terms of the PAM improvement, the tolerability profile and taking that into consideration as we make the decision to move forward.

Speaker Change: Yeah. So we.

Speaker Change: It's already baked in.

Here so. Looking at the totality of the data, including the Tolerability and safety profiles I wish I think is critical here. Our approach of choosing a selective and four agonist and a direct agonist rather than the allosteric modulator. We believe has the opportunity to potentially differentiate but it's all going to be about the data and so we'll be looking at both the benefit that we see in terms of the promised improvement the tolerability profile. Taking that into consideration as we make the decision to move forward.

We'll be looking at the totality of the data, including the Tolerability and safety profiles I wish I think is critical here.

Looking at the totality of the data, including the Tolerability and safety profiles I wish I think is critical here. Our approach of choosing a selective and four agonist and a direct agonist rather than the allosteric modulator. We believe has the opportunity to potentially differentiate but it's all going to be about the data and so we'll be looking at both the benefit that we see in terms of the promised improvement the tolerability profile. Taking that into consideration as we make the decision to move forward.

Speaker Change: Okay. Thanks.

Speaker Change: Thank you. Our next question comes from Phil Nadeau with Cowen. Please go ahead.

Our approach of choosing a selective and four agonist.

Our approach of choosing a selective and four agonist and a direct agonist rather than the allosteric modulator. We believe has the opportunity to potentially differentiate but it's all going to be about the data and so we'll be looking at both the benefit that we see in terms of the promised improvement the tolerability profile. Taking that into consideration as we make the decision to move forward.

Phil Nadeau: Hi, good morning, Congrats on the progress thanks for taking our question with 568 data now expected next quarter I'm curious to get your most updated thoughts on what you need to see to advance that program into additional development, particularly given the competitive landscape give us some idea of what efficacy results you'd like to see and.

Argon is rather than the allosteric modulator, we believe has the opportunity to potentially differentiate but it's all going to be about the data and so we'll be looking at both the benefit that we see in terms of the of the promised improvement the tolerability profile of taking that into consideration as we make the decision to move forward.

Todd Tushla: As you review our financials, you can see significant year-over-year operating leverage on a non-GAAP basis of over 1,000 basis points when excluding IP R&D investments made in the prior year. The team is doing a great job generating SG&A leverage, reflecting the strength of our INGREZZA franchise. These results drove significant cash flow as we ended Q1 with over $1.9 billion in cash. We routinely evaluate what we believe will drive shareholder value, and our capital allocation strategy remains intact. First, prioritizing INGREZZA growth; second, preparing for crinecerfont commercialization; third, internally advancing on our pipeline; and four, assessing external opportunities. As we have excess capital, we opportunistically return capital to shareholders by managing dilution, and you've seen us accomplish this over the past few years, reducing our convertible debt from approximately $518 million to $170 million.

Taking that into consideration as we make the decision to move forward.

Speaker Change: We won one last comment just the big Shout out to the muscarinic team. This is an example at Neurocrine and a very important program.

Matthew C. Abernethy: One last comment, just a big shout out to the muscarinic team. This is an example at Neurocrine, it's a very important program. We're able to really push forward the timing of when we'd expect top line data, I think by a couple of quarters. So, excellent job by Samir in the whole muscarinic team in the effort and including Jaz as well.

Phil Nadeau: What safety data and Tolerability data would give you confidence that five six it could compete.

As an example at Neurocrine and a very important program, we're able to really put forward the timing of when you'd expect top line data I think for a couple of quarters, so excellent job by Samir and the whole muscarinic team. And including jazz as well.

Speaker Change: Yeah. Thanks, So we're really happy with the progress we've made this by six eight and I'm happy to be able to share that in the third quarter will be coming forward with data just to remind you. This is a study of around about 200 patients at a dose finding study and it's done in an adoptive fashion in order to enable us to explore the full.

Well too.

Really pushed forward the timing of when you'd expect top line data I think for a couple of quarters, so excellent job by Samir and the whole muscarinic team.

For.

And including jazz as well.

Including jobs as well.

Speaker Change: Perfect. Thank you.

Phil Nadeau: Perfect. Thank you.

Speaker Change: A dose response here.

Our next question comes from Paul Matisse with Stifel. Please go ahead.

In terms of the the outcome obviously the primary endpoint for the study is the reduction in the public school relative depot, and I think it's pretty clear precedent, there and since with what our expectations would be we've seen a good effect size from other drugs in this class and we'd be looking for something in that kind of areas since.

Operator: Our next question comes from Paul Matteis with Stifel. Please go ahead.

Speaker Change: Hi, there this is Julian on for Paul Thanks, So much for taking our question.

Paul Matteis: Hi, there. This is Julian on for Paul. Thank you so much for taking our question. Just on 845, I know you're not disclosing anything on the doses, but any additional color on what you can provide for the placebo response that you saw, just thinking about moving into Phase 3, what that could potentially look like? And then on safety, I saw there's no seizures reported but the modality historically does carry an additional risk for that. So, what do you think about potential seizure risk broadly moving forward and the overall safety profile? And then lastly, one - quick one on the muscarinic. How much power do you expect to have for the individual dose arms that are at the higher receptor occupancy or in the expected active range? Thanks so much.

Julian: Just on a four five now youre not disclosing anything on the doses, but any additional color on what you can provide for the placebo response that you saw just thinking about you know moving into phase III, what that could potentially look like and then on safety. So theres no seizures reported but the modality historically does.

Just on a four five now youre not disclosing anything on the doses, but any additional color on what you can provide for the placebo response that you saw just thinking about you know moving into phase III, what that could potentially look like and then on safety saw theres no seizures reported but the modality historically does carry in <unk>. <unk> risk for that so what do you think about potential seizure risk broadly moving forward. The overall safety profile and then lastly, one quick one on the muscarinic on how much power do you expect to have for the individual dose arms. Or at the higher receptor occupancy or any expected active range. Thanks, so much.

Todd Tushla: In a few weeks, we'll further manage dilution by retiring our May 2024 convertible notes with cash, not shares. The convertible notes have a face value of $170 million and fair value as of March 31 of around $310 million. In our Q1 GAAP P&L, we recorded an $89 million charge, representing a portion of the cost to fully settle the convertible notes, and upon final settlement in May, we will record the remaining cost to fully settle the convertible notes in excess of face value. With that, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

Speaker Change: The impact on the primary endpoint, however, I will say that if you think about medications for diseases like schizophrenia, it's really the therapeutic index.

Carrying additional risk for that so what do you think about potential seizure risk broadly moving forward.

Here, so I'm really looking at the totality of the data, including the Tolerability and safety profile I wish I think is critical here.

<unk> risk for that so what do you think about potential seizure risk broadly moving forward. The overall safety profile and then lastly, one quick one on the muscarinic on how much power do you expect to have for the individual dose arms. Or at the higher receptor occupancy or any expected active range. Thanks, so much.

And the overall safety profile and then lastly, one quick one on the muscarinic on how much power do you expect to have for the individual dose arms.

The overall safety profile and then lastly, one quick one on the muscarinic on how much power do you expect to have for the individual dose arms. Or at the higher receptor occupancy or any expected active range. Thanks, so much.

Speaker Change: Our approach of choosing a selective and four agonist and a direct agonist rather than the allosteric modulator. We believe has the opportunity to potentially differentiate but it's all going to be about the data and so we'll be looking at both the benefits that we see in terms of the of the promised improvement the tolerability profile of <unk>.

That are at the higher receptor occupancy or any expected active range. Thanks, so much.

Or at the higher receptor occupancy or any expected active range. Thanks, so much.

Thanks, so much.

Speaker Change: Really quick one housekeeping item, we're going to stick to answering one question per analyst. So we can get through all the analyst questions. At this time, so I agree with you want to comment on the program.

Matthew C. Abernethy: Sorry, really quick one housekeeping item. We're going to stick to answering one question per analyst so we can get through all the analyst questions at this time. So Eiry, if you want to comment on the input program?

Quick one housekeeping item, we're going to stick to answering one question per analyst. So we can get through all the analyst questions. At this time, so I agree with you want to comment on the <unk> program.

Speaker Change: Got it thank consideration as we make the decision to move forward.

Eric Benevich: ... Thanks, Matt. Today, 1 May, marks the seven-year anniversary since the commercial launch of INGREZZA in 2017. After seven years, INGREZZA is the number 1 prescribed VMAT2 inhibitor for the treatment of tardive dyskinesia or TD. INGREZZA is the only treatment proven to reduce TD symptoms with simple dosing, always one capsule, once a day, and no complex titration. We're very proud of the progress we've made with INGREZZA over these past seven years, and we're even more excited about the many thousands of people living with TD or Huntington's Chorea that we'll be able to help in the coming years. In addition to today being the seven-year anniversary of our launch, we're less than a week away from TD Awareness Week. Each year, TD Awareness Week occurs in early May, which is designated as Mental Health Awareness Month.

We won one last comment just the big Shout out to the muscarinic team. This is an example at Neurocrine and a very important program, we're able to really put forward the timing of when you'd expect top line data for a couple of quarters, so excellent job by Samir and the whole month.

Speaker Change: I'll ask the mistake, what they put in and that's the last time, we'll do that once this is an adaptive phase II trial.

Eiry W. Roberts: Yes, I'll answer the muscarinic one very quickly, and that's the last time we do more than one. This is an adaptive Phase II trial. It's powered as such and it has sufficient power in to enable us to understand the dose response. So, we're confident in that. On the AMPA, I'll just start and I will then see if Jaz has additional things he wants to say. We were very encouraged by the tolerability profile. And as I mentioned in my prepared comments, I think Takeda deserves a lot of credit for years of work that they did in navigating the therapeutic index issue that's been a problem for AMPA kinase in the past. And the overall tolerability, both doses look like placebo in terms of the tolerability profile. So, from that perspective, I think we obviously need more data in Phase III. And as we progress, we'll learn more about the overall safety profile. Jaz, I don't know if you want to say anything further?

Domestic what they put in and that's the last time, we'll do it. This is an adaptive phase III trial. Howard. Such an anti sufficient tolerant and enable us to understand the dose response, so what confidence do not on the I'm, sorry, I'll just start times. And then Steve jobs has additional things he wants to say we were very encouraged by the Tolerability profile and as I mentioned in my prepared comments. Takeda just there's a lot of credit for. Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

This is an adaptive phase III trial. Howard. Such an anti sufficient tolerant and enable us to understand the dose response, so what confidence do not on the I'm, sorry, I'll just start times. And then Steve jobs has additional things he wants to say we were very encouraged by the Tolerability profile and as I mentioned in my prepared comments. Takeda just there's a lot of credit for. Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

Powered as such an entire sufficient powering to enable us to understand the dose response. So we're confident they're not on the I'm sorry, I'll just stop timed a little and then see if Josh additional things. He wants to say we were very encouraged by the Tolerability profile and as I mentioned in my.

Howard. Such an anti sufficient tolerant and enable us to understand the dose response, so what confidence do not on the I'm, sorry, I'll just start times. And then Steve jobs has additional things he wants to say we were very encouraged by the Tolerability profile and as I mentioned in my prepared comments. Takeda just there's a lot of credit for. Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

Such an anti sufficient tolerant and enable us to understand the dose response, so what confidence do not on the I'm, sorry, I'll just start times. And then Steve jobs has additional things he wants to say we were very encouraged by the Tolerability profile and as I mentioned in my prepared comments. Takeda just there's a lot of credit for. Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

Speaker Change: Okay.

Speaker Change: And including jobs as well.

And then Steve jobs has additional things he wants to say we were very encouraged by the Tolerability profile and as I mentioned in my prepared comments. Takeda just there's a lot of credit for. Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

Speaker Change: Perfect. Thank you.

Prepared comments I think Takeda just there's a lot of credit for years, they did and navigating the therapeutic index issue that's been a problem for them to kind of in the past.

Speaker Change: Our next question comes from Paul Matisse with Stifel. Please go ahead.

Takeda just there's a lot of credit for. Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

Yes, they do. And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

And navigating the therapeutic index issue, that's been a problem for them for kind of in the past and the overall tolerability both doses looked like placebo since that the tolerability profile so from that perspective. I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

Speaker Change: Hi, there this is Julian on for Paul. Thanks, So much for taking our question just on a four five now youre not disclosing anything on the doses, but any additional color on.

On the overall tolerability, both doses looked like placebo since that the tolerability profile so from that perspective.

Eric Benevich: This year, TD Awareness Week occurs from 5 May through 11 May. Please join Neurocrine, the Movement Disorders Policy Coalition, various mental health advocacy organizations, healthcare providers, and policymakers across all 50 states and Washington, DC, in our efforts to spread the word and reduce the stigma of TD. Now, on to results. Our Q1 sales of $506 million represented robust year-over-year sales growth of 23%, despite the typical Q1 seasonal payer challenges caused by annual reauthorization requirements and health plan switches. We continue to make good progress growing our franchise across all three business segments of psychiatry, neurology, and long-term care. The majority of patients who could benefit from treatment of their TD remain as yet undiagnosed. We continue to focus on driving awareness, diagnosis, and treatment with INGREZZA.

Steve Jobs: I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things are that.

Julian: And what you can provide for the placebo response that you saw just thinking about you know moving into phase III, what that could potentially look like and then on safety. So theres no seizures reported but you know the modality historically does carry an additional risk for that so what do you think about potential seizure risk broadly moving forward and the AUM.

I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like things like that. There were really no risk of season, we had.

There were really no risk of season, we had.

Jaz Singh: No, I think there were really no risk of seizure. We had a committee of adjudicating every event and it was very clear on the dosages.

Camilo adjudicating every event and it was very cute.

Yeah.

Goodbye.

Operator: [technical issue] And we are experiencing technical difficulties. Please remain on the line. - Okay, we have our speakers back in conference. We will take our next question from Chris Shibutani with Goldman Sachs. Please go ahead.

<unk> safety profile and then lastly, one quick one on the muscarinic on how much power do you expect to have for the individual dose arms that are at the higher receptor occupancy or any expected range. Thanks, so much they will.

And we are experiencing technical difficulties. Please remain on the line.

And we are experiencing technical difficulties. Please remain on the line. And two allocations on hold we still have technical difficulties. Please remain on the line. Good afternoon. <unk>. Okay, we have our speakers back in conference. Our next question from Chris Schaper tiny with Goldman Sachs. Please go ahead.

Julian: Really quick one housekeeping item, we're going to stick to answering one question per analyst. So we can get through all the analyst questions. At this time. So I agree with you you want to comment on the <unk> program.

Julian: Yeah.

Julian: Domestic what they put in enough spinoffs that we'll do the work.

Eric Benevich: For the chorea associated with Huntington's disease indication, we're about 6 months into that launch. The early feedback from neurologists gaining experience with INGREZZA in HD Chorea has been very positive, and we're making good progress there. Overall, HD Chorea is a much smaller patient population, so TD will always drive the lion's share of growth for INGREZZA. Just yesterday, the FDA approved a new sprinkle formulation of INGREZZA. This new formulation represents a valuable treatment option for TD or HD Chorea patients with difficulty swallowing. All in all, INGREZZA is again off to a good start in 2024, and we carry that momentum forward into Q2. Now, quickly on crinecerfont for the potential treatment of congenital adrenal hyperplasia or CAH. We've been busy staffing up, and many of our headquarters and field sales leaders for our endocrinology franchise are now in place.

Julian: As an adoptive phase II trial, it's Howard.

Julian: Howard I'll touch on it has sufficient power and can enable us to understand the dose response. So we're confident enough on the I'm, sorry, I'll just start times I'm little than Steve jobs have additional things. He wants to say we were very encouraged by the Tolerability profile and as I mentioned in my prepared.

Julian: Comments, I think Takeda to there's a lot of credit for work that they did and navigating the therapeutic index issue. That's been a problem for all kinds of costs and the overall tolerability both doses looked like placebo since that the tolerability profile.

And to allocations on hold we still have technical difficulties. Please remain on the line.

And two allocations on hold we still have technical difficulties. Please remain on the line. Good afternoon. <unk>. Okay, we have our speakers back in conference. Our next question from Chris Schaper tiny with Goldman Sachs. Please go ahead.

Speaker Change: That is a I think we obviously need more data in phase III and as we progress we'll learn more about the overall safety profile does it doesn't seem like that no.

Speaker Change: Good afternoon.

Good afternoon. <unk>. Okay, we have our speakers back in conference. Our next question from Chris Schaper tiny with Goldman Sachs. Please go ahead.

<unk>. Okay, we have our speakers back in conference. Our next question from Chris Schaper tiny with Goldman Sachs. Please go ahead.

Ranjan: And so there were really no risk of season, we had.

Speaker Change: Okay, we have our speakers back in conference.

Okay, we have our speakers back in conference. Our next question from Chris Schaper tiny with Goldman Sachs. Please go ahead.

Dan: You know a committee of Adjudicating every event and it was very cute.

Eric Benevich: We've been able to attract new team members with excellent experience in rare disease categories. We expect to complete hiring of the field teams in the second half of this year. Our primary focus in 2024 is on educating the CAH community on important topics, including disease state pathophysiology, understanding the challenges with current steroid treatments, and new areas of research in CAH. And to that end, we recently rolled out a new educational initiative called What the CAH?, which aims to close the gap in CAH understanding and acknowledges the frustration and challenges experienced by members of the CAH community in managing this rare genetic endocrine condition. We're excited about a potential launch of crinecerfont in 2025, and we're laying the foundation this year to ensure our success going forward. So with that, I'll turn the call over to my colleague, Dr.

Our next question from Chris Schaper tiny with Goldman Sachs. Please go ahead.

Chris Shibutani: Our next question from Chris <unk> with Goldman Sachs. Please go ahead.

Dan: Yeah.

Dan: Goodbye.

Chris Shibutani: Thank you very much. Good morning. On CRINECERFONT, saw the press release, NDA has been filed. Can you speak to the likelihood of a priority review and any potential timelines for that approval and launch? Thanks.

Chris Shibutani: Thank you very much good morning, <unk> saw the press release NDA has been filed can you speak to the likelihood of a priority review and any potential timelines for that approval and launch thanks.

Dan: And we are experiencing technical difficulties. Please remain on the line.

Speaker Change: But yes, I cannot speak to that and so I think as I mentioned in the.

Eiry W. Roberts: Yes, I can speak to that. And so, I think as I mentioned in light of the fact that there's significant unmet need here, the granting of the breakthrough designation and the robustness of the Phase III data packaging, both adults and pediatrics that we actually just submitted yesterday. We would hope that the FDA would consider this a priority review. Obviously, that's their final decision and we will obviously be [inaudible] -

In light of the fact that there is significant unmet need here and the granting of the breakthrough designation and the robustness of the phase III data package in both adults and pediatrics that that we actually just submitted yesterday, we would hope that the FDA would consider this a priority review obviously not their final decision and <unk>.

We would hope that the FDA would consider this a priority review obviously, that's the final decision and we will obviously communicate it.

We will obviously communicate it.

Eric Benevich: Eiry Roberts, our Chief Medical Officer.

Eiry Roberts: Thank you, Eric. Good morning. Since our last earnings call, our clinical and regulatory teams have made tremendous progress with the pipeline. Just yesterday, we received approval from the FDA for INGREZZA sprinkle capsules and submitted to the FDA the new drug application of crinecerfont for the treatment of pediatric and adult patients with classical congenital adrenal hyperplasia. Given the unmet need in CAH and the previously granted breakthrough designation for crinecerfont, we believe this submission may merit priority review and look forward to hearing the FDA's decision on this. In the meantime, our teams are well prepared for all upcoming interactions with the agency. Throughout this quarter, additional details from the registrational studies of crinecerfont will be presented at a number of medical conferences, including ENDO in June. We look forward to sharing the posters and summaries as soon as they're publicly available.

We're experiencing technical difficulties please remain on the line.

Operator: We're experiencing technical difficulties. Please remain on the line.

Hello.

Dan: And two allocations on hold we still have technical difficulties. Please remain on the line.

Luca.

Dan: Afternoon.

Luca: So as soon as we get back on you need to save something people are wondering what the house language.

Unknown: [inaudible] - as soon as we get back on, you need to say something. I mean, people are wondering what the hell is going on.

Dan: Okay, we have our speakers back in conference.

People are wondering whether helps lighten us.

Dan: Our next question from Chris Shaw with tiny with Goldman Sachs. Please go ahead.

And finally <unk>, we have our speakers in conference.

Operator: I'm sorry for the interruption. We have our speakers in conference.

Speaker Change: Hi, everybody and apologize for the technical difficulties that we're having here.

Matthew C. Abernethy: Hey, everybody, I apologize for the technical difficulties that we're having here. We’ve moved to new campus and in our new room. I know many of you visited here recently. So, apologize for that. We'll do better next time. So, let's jump back to Chris' question around likelihood of priority review.

<unk>.

And on <unk> I know many of you visited here recently, so I apologize for that will be better next time. So it will just come back to. Chris's question around the likelihood of a priority review.

I know many of you visited here recently, so I apologize for that we will be better next time, so, let's just jump back to Chris.

Chris Shibutani: Yeah, I can speak to that and so I think as I mentioned.

Chris's question around likelihood to recur.

Chris's question around the likelihood of a priority review.

Chris Shibutani: In light of the fact that there is significant unmet need here and the granting of the breakthrough designation.

Eiry Roberts: We're also working on full publication of the data in a peer-reviewed journal in the near future. Moving to the Phase 2 pipeline, I'll begin with the very encouraging positive study results of NBI-845 in adults with major depressive disorder. Recall, NBI-845 was one of several Phase 2-ready programs in-licensed as part of the Takeda collaboration. This molecule is a potent, highly selective, potential first-in-class positive allosteric modulator of AMPA receptors, designed to induce synaptic plasticity while maintaining a broad margin of safety relative to seizure activity. As a reminder, there have been significant advances in recent years in understanding the neurobiology of depression, with converging lines of evidence suggesting that depression is associated with an impairment in synaptic plasticity. AMPAkines enhance synaptic plasticity via an increase in neurotrophic factors, for example, brain-derived neurotrophic factor, BDNF.

Early review.

Yeah, I'm not sure if you had any of those bonds, Chris though.

Eiry W. Roberts: Yes. I'm not sure if you heard any of the response, Chris. So obviously, with the breakthrough designation in place and the robustness of the data that we were able to submit yesterday, it's both pediatric and adults. We look forward for a priority review will be granted by the FDA, but ultimately, that's the agency's decision. And as soon as we know anything further in our interactions with them, we'll be sure to communicate that.

Speaker Change: The robustness of the phase III data package in both adults and pediatrics that App, we actually just submitted yesterday.

Obviously with the breakthrough designation in play on the robustness of the data that we were able to submit yesterday in both pediatric and adults with a golf ball with a priority review will be granted by the FDA, but ultimately not the agency's decision and as soon as we know anything further and our interactions with the loyalty showed communicate that.

Obviously with the breakthrough designation in place on the robustness of the data that we were able to submit yesterday in both pediatric and adults when they go forward. Priority review will be gone by the MTA, but ultimately that the agency's decision on as soon as we know anything further and our interactions with the loyalty showed the communicate that.

Speaker Change: We would hope that the FDA would consider that to priority review, obviously, that's the final decision and average we will obviously communicate it.

Priority review will be gone by the MTA, but ultimately that the agency's decision on as soon as we know anything further and our interactions with the loyalty showed the communicate that.

Speaker Change: Thank you.

Chris Shibutani: Thank you.

Okay.

Operator: And your next question comes from Akash Tewari. Please go ahead. - Akash, Your line is open.

Speaker Change: We're experiencing technical difficulties please remain on the line.

Speaker Change: Thank you our next question comes from.

Thank you our next question comes from. Gosh Tiwari. Please go ahead. Your line is open.

Josh <unk>. Please go ahead.

Gosh Tiwari. Please go ahead. Your line is open.

Akash Tewari: Your line is open.

Your line is open.

Akash Tewari: Okay, sorry about that Joe for 586.

Akash Tewari: Hey, sorry about that. So, for 586 - or sorry, 568, can you talk about the benefits of having an adaptive trial design? What are they when you think about getting information from your Phase II study and potentially designing your Phase III? And then generally speaking, where does your team stand with muscarinic when it comes to titration protocols, right? Cerebral doesn't have them. Chorea does. Do you think a titration protocol is ideal for 568 when it comes to minimizing safety and maximizing efficacy? Thank you so much.

Akash Tewari: Sorry, if ive to say can you talk about the benefits of having an adaptive trial design what are they when you think about.

Sorry, if ive to say can you talk about the benefits of having an adaptive trial design what are they when you think about. Getting information from your Phase II study and potentially designing your phase III and then generally speaking where do you where does your team stand with muscular macrogenics when it comes to. Titration protocols right farewell doesn't have them. Corona does. Do you think a titration protocol is ideal for 568. When it when it comes to minimizing safety and maximizing efficacy. Thanks, so much.

Akash Tewari: Getting information from your Phase II study and potentially designing your phase III and then generally speaking where do you where does your team stand with muscarine Macrogenics when it comes to.

Getting information from your Phase II study and potentially designing your phase III and then generally speaking where do you where does your team stand with muscular macrogenics when it comes to. Titration protocols right farewell doesn't have them. Corona does. Do you think a titration protocol is ideal for 568. When it when it comes to minimizing safety and maximizing efficacy. Thanks, so much.

Speaker Change: Look at the kind of number.

Speaker Change: And so as soon as we get back on you need to save something people are wondering what the hell swung us and early traction we have our speakers in conference.

Titration protocols right farewell doesn't have them.

Titration protocols right farewell doesn't have them. Corona does. Do you think a titration protocol is ideal for 568. When it when it comes to minimizing safety and maximizing efficacy. Thanks, so much.

Eiry Roberts: In fact, activation of AMPA receptors is necessary for the antidepressant effects of ketamine. Last week, we announced the SAVITRI study met the primary endpoint with statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale total score at day 28. The study met key secondary endpoints as well, including statistically significant reduction in the MADRS total score at day 56. In addition, NBI-845 demonstrated a strong effect size. Importantly for this mechanism of action, NBI-845 was generally well tolerated in the study. The most common adverse event was headache, of which a majority were transient and mild in severity. There were no seizures, no serious adverse events, no psychotomimetic or dissociative events throughout.

Speaker Change: Hi, everybody and apologize for the technical difficulties that we're having here who has moved to a new campus.

Corona does do.

Corona does. Do you think a titration protocol is ideal for 568. When it when it comes to minimizing safety and maximizing efficacy. Thanks, so much.

Do you think a titration protocol is ideal for 568.

Do you think a titration protocol is ideal for 568. When it when it comes to minimizing safety and maximizing efficacy. Thanks, so much.

Speaker Change: Yeah.

When it comes to minimizing safety maximizing efficacy. Thanks, so much.

When it when it comes to minimizing safety and maximizing efficacy. Thanks, so much.

Speaker Change: I know many of you visited here recently, so I apologize for that would be better.

Yes.

Eiry W. Roberts: Yes. I mean on the first part - on the second part first. I think we don't know until we see the data, what the optimal dosing will be for five, six days. And actually, the second question links a little bit to the first. Adaptive trials are very often done in Phase II as a means to explore broader range of doses as possible in the most limited number of patients. And so, we're very confident in that design, and it's been used many times before. It will allow us to have studied a broad range of doses within the study and that will allow us to understand from a benefit risk perspective, which is the most optimal regimen to take forward into a Phase III, if we're successful at the end of the Phase II.

Speaker Change: So let's jump back to.

As part of a second half third I think we don't know until we see the data what the optimal dosing will be bought by fixation on actually the second question linked a little bit to the third.

As part of second half I think we don't know until we see the data must be optimal dosing will be equal by fixation on actually the second question linked a little bit to the third. Adaptive trials are very often done in phase two of the need to explore launch a range of doses as possible. And then more limited number of patients. So we're very confident in our design and its being used many times before it will allow us to have studied a broad range of doses within the study. That will allow us to understand from a benefit with respect to <unk>. The most optimal regimen to take forward into 18 with successful at the end of the page.

Speaker Change: Chris's question around likelihood.

Speaker Change: Priority review.

Speaker Change: Yeah, I'm not sure if you had any response, Chris though.

<unk> adaptive trials off very often done in phase two of the need to explore a broad range of double digit profitable in Denmark limited number of patients.

Adaptive trials are very often done in phase two of the need to explore launch a range of doses as possible. And then more limited number of patients. So we're very confident in our design and its being used many times before it will allow us to have studied a broad range of doses within the study. That will allow us to understand from a benefit with respect to <unk>. The most optimal regimen to take forward into 18 with successful at the end of the page.

Speaker Change: Obviously with the breakthrough designation in play and the robustness of the data that we were able to plant yesterday in both pediatric and adults with April full with a priority review will be granted by the FDA, but ultimately not the agency's decision and as soon as we know anything further and our interactions with the loyalty shown previously.

And then more limited number of patients. So we're very confident in our design and its being used many times before it will allow us to have studied a broad range of doses within the study. That will allow us to understand from a benefit with respect to <unk>. The most optimal regimen to take forward into 18 with successful at the end of the page.

So we're very confident in that design and it's being used many times before it will allow us to have studied a broad range of doses within the study.

So we're very confident in our design and its being used many times before it will allow us to have studied a broad range of doses within the study. That will allow us to understand from a benefit with respect to <unk>. The most optimal regimen to take forward into 18 with successful at the end of the page.

Speaker Change: Thank you.

Speaker Change: Okay.

That will allow us to understand.

That will allow us to understand from a benefit with respect to <unk>. The most optimal regimen to take forward into 18 with successful at the end of the page.

Speaker Change: And your next question comes from.

A benefit with respect to <unk>, which is the most optimal regimen to take forward into 18 with successful at the end of the page.

The most optimal regimen to take forward into 18 with successful at the end of the page.

Akash Tewari: Gosh Tiwari. Please go ahead.

Eiry Roberts: Based on these encouraging data, we plan to engage with FDA in the near future to define the path forward to registration, and we'll be sure to update you as we progress forward. Many companies before Neurocrine have tried and failed to progress AMPA potentiators in the clinic due to issues of toxicity and therapeutic index. Our partners at Takeda deserve enormous credit for their years of research activity in this field, which led to the design of NBI-845 and the favorable profile that we've seen with this molecule to date. In addition, I want to give sincere thanks to the team working on the SAVITRI study for their diligence in delivering this high-quality outcome. In addition to 845, we also delivered positive phase 2 results for two separate studies of Efmody, the long-acting glucocorticoid obtained through our acquisition of UK-based Diurnal.

Okay.

Operator: Thank you. Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Akash Tewari: Your line is open.

Thank you. Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Akash Tewari: Okay.

Akash Tewari: Sorry about that Joe for 586.

Akash Tewari: Sorry, if ive to say can you talk about the benefits of having an adaptive trial design what are they when you think about.

Jay Olson: Oh, hey. Congrats on all the progress and thank you for taking our question. Yesterday, the company that acquired Prevail’s GBA1 gene therapy program announced a decision to discontinue their study in Gaucher's disease Type 2. Could you comment on the advantages of your Voyager partnered GBA1 gene therapy program in the novel capsid, which enables a single systemic injection to address both neurological and peripheral manifestations versus Prevail's program, which requires a transcranial injection? Thank you.

Jay Olson: Oh, Hey, congrats on all the progress and thank you for taking our question.

Yesterday, the company that acquired prevails GBA, one gene therapy program announced the decision to discontinue their study and groceries disease type two could you comment on the advantages of your Voyager partner GBA, One gene therapy program in our novel Capsid, which enables a single systemic injection to address both near. We're a logical and peripheral manifestations versus prevails program, which requires a trans cranial injection. Thank you.

Yesterday, the company that acquired prevails GBA, one gene therapy program announced the decision to discontinue their study and groceries disease type two could you comment on the advantages of your Voyager partnered GBA, one gene therapy program in our novel Capsid, which enables a single systemic injection to address both near.

Akash Tewari: Getting information from your Phase III study and potentially designing your phase III and then generally speaking where do you where does your team stand with modular macrogenics when it comes to.

Akash Tewari: Titration protocol right farewell doesn't have them.

Akash Tewari: Corona does.

Akash Tewari: Do you think a titration protocol is ideal for 568.

We're a logical and peripheral manifestations versus prevails program, which requires a trans cranial injection. Thank you.

Akash Tewari: When it when it comes to minimizing safety maximizing efficacy. Thanks, so much.

Eiry W. Roberts: Yes. That's - yes, you're right. And I think the - we're really pleased with the progress that we've made preclinically with our collaboration with Voyager. And as I think we mentioned earlier, we intend to take two of these new 13 therapies with the new capsids from Voyager into the clinic next year, all of the preclinical work goes successfully over the next year or so. I think as you alluded to the fact that the technology employed by Voyager gives us the opportunity to have a blood-brain barrier penetrant capsid allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases such as Gaucher's or Parkinson's disease but also fruitful effects that you might see with a disease such as Gaucher's.

Speaker Change: Yes, yes.

Thanks to the assets that you have you're right.

Akash Tewari: Yes.

Akash Tewari: As part of second half I think we don't know until we see the data and what the optimal dosing will be bought by fixation on actually the second question linked a little bit to the fifth.

And I think we were really pleased with the progress that we've made pre clinically with our collaboration with Biogen and I think we mentioned earlier, we intend to take a two of the.

And. I think the we're really pleased with the progress that we've made pre clinically with our collaboration with Biogen and I think we mentioned earlier, we intend to take a two of the. Gene therapy with the new capsid from Biogen into the clinic next year, if all of the preclinical work successfully over the next year or so. I think the then as you alluded to the fact that the technology employed by voyage. It gives us the opportunity to have a blood brain barrier penetrant cockpit allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases. Such as Gauci overall.

I think the we're really pleased with the progress that we've made pre clinically with our collaboration with Biogen and I think we mentioned earlier, we intend to take a two of the. Gene therapy with the new capsid from Biogen into the clinic next year, if all of the preclinical work successfully over the next year or so. I think the then as you alluded to the fact that the technology employed by voyage. It gives us the opportunity to have a blood brain barrier penetrant cockpit allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases. Such as Gauci overall.

Eiry Roberts: The phase two study of Efmody in adults with adrenal insufficiency and the phase two study of Efmody in adults and adolescents with classic CAH both reported top-line positive results. Additionally, both studies met their respective primary and key secondary endpoints. In each study, Efmody was well tolerated, with a safety profile consistent with published Efmody clinical data. On top of crinecerfont's NDA submission and a total of three positive phase three, phase two data readouts, we've also initiated a number of new clinical studies, which include initiation of a phase two study of NBI-770, the oral NMDA NR2B negative allosteric modulator for major depressive disorder, initiation of a phase one study of NBI-890, our next-generation VMAT2 inhibitor, and last but not least, initiation of a phase one study of NBI-986, an M4 antagonist targeted for development in movement disorders.

Akash Tewari: Adaptive trials are very often done in phase two of the need to explore broader range of double digit profitable in Denmark limited number of patients.

15 therapy with the new capsid from Biogen into the clinic next year all of the preclinical work on successfully over the next year also.

Gene therapy with the new capsid from Biogen into the clinic next year, if all of the preclinical work successfully over the next year or so. I think the then as you alluded to the fact that the technology employed by voyage. It gives us the opportunity to have a blood brain barrier penetrant cockpit allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases. Such as Gauci overall.

I think the as you alluded to the fact that the technology employed by voyage. It gives us the opportunity to have a blood brain barrier penetrant cockpit allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases.

I think the then as you alluded to the fact that the technology employed by voyage. It gives us the opportunity to have a blood brain barrier penetrant cockpit allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases. Such as Gauci overall.

Akash Tewari: So we're very confident not designed and is being used many times before.

Akash Tewari: It will allow us to have studied a broad range of services within the study.

Akash Tewari: That will allow us to understand from a benefit with respected.

Akash Tewari: Most optimal regimen to take forward into phase III. If we're successful at the end of the 8-K.

Such as Gauci overall.

Akash Tewari: Okay.

Pocketed to deepen also throughput.

Eiry W. Roberts: The Voyager technology has focused on detargeting DRGs and other areas that are potentially associated with toxicity of these approaches in the past, while allowing for transcription in areas that are important in the copies of the disease. So, we're not totally surprised by yesterday's decision Gaucher's too has central as well as peripheral effect. So, the fact that the ICM administration may not allow that to be addressed with a single administration of gene therapy. It's not surprising to us. And that's what gives us confidence with our single intravenous administration with the blood-brain barrier penetrant capsid. Obviously, we're going to need clinical data and our preclinical basis to understand that more and we'll be generating that over the coming months.

Fact that you might see with a disease that you had gone Chi and the volumes you technology has focused on.

That you might see with a disease that you had gone shape and. The Voyager technology has focused on. D targeting DRG than other areas potentially associated with toxicities of these approaches in the bar was a. Allowing for transduction in Ami that are important in the coffee to the disease. So we're not totally surprised by yesterday's decision. <unk> two <unk>. <unk> per global fast food, so the fact that the ICM at. Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

The Voyager technology has focused on. D targeting DRG than other areas potentially associated with toxicities of these approaches in the bar was a. Allowing for transduction in Ami that are important in the coffee to the disease. So we're not totally surprised by yesterday's decision. <unk> two <unk>. <unk> per global fast food, so the fact that the ICM at. Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Akash Tewari: Thank you. Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Talking targeting DRG than other areas visit intensity associated with toxicities of these approaches in Nepal.

D targeting DRG than other areas potentially associated with toxicities of these approaches in the bar was a. Allowing for transduction in Ami that are important in the coffee to the disease. So we're not totally surprised by yesterday's decision. <unk> two <unk>. <unk> per global fast food, so the fact that the ICM at. Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Jay Olson: Oh, Hey, congrats on all the progress and thank you for taking our question yes.

Jay Olson: Yesterday, the company that acquired prevails GBA, one gene therapy program announced the decision to discontinue their study and groceries disease type two could you comment on the advantages of your Voyager partnered GBA, one gene therapy program in a novel capsid, which enables a single systemic injection to address both new.

Allowing for transduction in Ami that are important in the coffee to the disease. So we're not totally surprised by yesterday's decision. <unk> two <unk>. <unk> per global fast food, so the fact that the ICM at. Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Building for at transduction in areas that are important in the coffee to the disease. So we're not totally surprised by yesterday's decision gauci to meet central as well as per global fax and so the fact that the ICM administration.

<unk> two <unk>. <unk> per global fast food, so the fact that the ICM at. Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Eiry Roberts: We look forward to providing more information on these programs, together with our other phase one muscarinic agonist programs over the coming months as they each progress through the clinic. Looking ahead to our upcoming phase two data readouts, I'm pleased to say that we're currently on track to deliver data from NBI-568, our orthosteric selective muscarinic M4 agonist study, as a potential treatment for schizophrenia, and for luvadaxistat as a potential treatment for cognitive impairment associated with schizophrenia. We now anticipate top-line data from both these studies in Q3 2024. In summary, I'm very proud of the progress we continue to make with the clinical portfolio at Neurocrine in order to deliver on behalf of the patients that we serve. With that, I'll hand things back to Kevin. Kevin?

<unk> per global fast food, so the fact that the ICM at. Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Administration may not allow that to be addressed with a single administration of gene therapy. It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Allow that to be addressed with a single administration of gene therapy.

Speaker Change: We're a logical and peripheral manifestations versus prevails program, which requires a trans cranial injection. Thank you.

It is not surprising to us and that's what gives us confidence with a single intravenous administration.

It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that more and we'll be generating out over the coming months.

Speaker Change: Yes, yes.

Speaker Change: Thanks to the asset side, yes, you're right and I think we.

The blood brain barrier penetrated capsid, obviously than a need clinical data on our preclinical data to understand that law, and we will be generating out over the coming months.

Speaker Change: We're really pleased with the progress that we've made pre clinically with our collaboration with Voyager and I think we mentioned earlier, we intend to take a two of the 13.

Speaker Change: Any benefit with the new capsid from Appalachia into the clinic next year all of the preclinical work successfully over the next year or so.

Thank you. Our next question comes from Mohit Bansal of with Wells Fargo. Please go ahead.

Operator: Thank you. Your next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Speaker Change: <unk>.

Mohit Bansal: Great. Thank you very much for taking my question. I just wanted to probe a little bit on 845. How would you - how do you think about positioning this in the depression market? Where do you think it fits in? And do you have any thought on targeting AMPA potentiation versus previous approaches of NMDA antagonist? I mean, is there a key difference there that we should be aware about when you think about the mechanisms?

Mohit Bansal: Great. Thank you very much for taking my question I, just wanted to probe a little bit on equal five.

Speaker Change: Thank the Ben as you alluded to the fact that the technology employed by voyage. It gives us the opportunity to have a blood brain barrier penetrant cockpits allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases such as <unk>.

Mohit Bansal: How would you how do you think about positioning this in the depression market, where do you think it fits in and do you have any thoughts on.

How would you how do you think about positioning this in the depression market, where do you think it fits in. Do you have any thoughts on. Targeting empower potentiation was says. Previous approaches of NMDA. NMDA antagonist I mean is that a key difference there that we should be available. When you think about the mechanisms.

Do you have any thoughts on. Targeting empower potentiation was says. Previous approaches of NMDA. NMDA antagonist I mean is that a key difference there that we should be available. When you think about the mechanisms.

Kevin Gorman: Thank you very much, Irene and Nikki. We're ready for questions now.

Mohit Bansal: Targeting empower potentiation verses <unk>.

Targeting empower potentiation was says. Previous approaches of NMDA. NMDA antagonist I mean is that a key difference there that we should be available. When you think about the mechanisms.

Speaker Change: Previous approaches of NMDA.

Previous approaches of NMDA. NMDA antagonist I mean is that a key difference there that we should be available. When you think about the mechanisms.

Operator: And at this time, if you would like to ask a question, please press star and one on your telephone keypad. You may withdraw your question by pressing star two. Once again, to ask a question, please press star and one on your telephone keypad. We'll take our first question from Tasin Ahmad with Bank of America. Please go ahead.

NMDA antagonist I mean is that a key difference there that we should be available. When you think about the mechanisms.

Speaker Change: <unk> overall.

Here at antagonist, I mean is that a key differentiator that we should be available.

Speaker Change: Talking to some people also think book.

Speaker Change: <unk> that you might be with a disease. Thank you ghansham.

When you think about the mechanisms.

Speaker Change: And I think both could you repeat the last part of the question I didn't quite get what you are asking about weighted fixed relative to other approaches like analysts can be non lending under an NDA approaches.

Eiry W. Roberts: Could I just ask you to repeat the last part of the question? I think - were you asking about where this fits the approach to breakdown NR2B NAM and are NMDA approaches?

Speaker Change: <unk> volume tiered technology has focused on.

Speaker Change: Top D targeting DRG than other areas that are potentially associated with toxicity with these approaches in the past, while allowing for at transduction in areas that are reported in the coffee specifically, so we're not totally surprised by yesterday's decision Gauci two would cause central and <unk>.

Alex: Yes in terms of Mechanistically.

Mohit Bansal: Yes. I mean in terms of mechanistically, how AMPA potentiation is expected to differentiate from NMDA impact that are out there? Thank you.

Tazeen Ahmad: Great. Thanks, operator. Good morning, guys. Thanks for taking my questions. The first one for me is on NBI-845. Congrats on the data that you press released. We did get a few questions about dosing and dose response, and to the extent that you can talk about dose response. Is there any reason mechanistically we're not seeing a dose response still encourages positive results ultimately and moving forward in phase 3? And then second question on the sprinkle formulation for INGREZZA. Can you just remind us what percent of patients have trouble swallowing and what kind of impact you expect that to have on sales now that you have this new formulation? Thanks.

Alex: How in Amp up potentiation is expect to differentiate from <unk> and <unk> that are out there. Thank you.

How am and Bob Potentiation is expect to differentiate from EM and DVR in times that are out there. Thank you.

Speaker Change: All right I'm going to ask John to others.

Eiry W. Roberts: So, I'm going to ask Jaz, do you want to give some commentary there?

Speaker Change: And so the fact that the ICM administration may not allow that to be addressed with a single administration of gene therapy.

John: The beef commentary Matt sure.

His commentary Matt sure.

Sure.

Jaz Singh: Sure. So, the AMPA mechanism is central to plasticity. The NMDA mechanism acts before so the molecules acting, you have to go down NMDA first and then downstream, you have AMPA effect by bypassing the NMDA are going straight to AMPA. Your - one of the key potential benefit is that you're not having any of the adverse events that are associated with NMDA. So, as you've seen, the NMBA antagonist that's approved to provide associated with brands that have significant adverse events and which is what the program is addressing for. But going directly to AMPA, you're really eliminating most of those adverse events with the potential of then getting the similar efficacy without any of those adverse events and consequential REMS to address it.

John: Ill mechanism is.

Ill mechanism is set. From a Q2 plasticity the NMDA. Mechanism of action before and clinical molecules acting you have to go down NMDA, forcing them downstream you have ample okay by bypassing the NMDA going straight to Pampa, you're one of the key potential benefits that you are not having Indian has in any of the adverse events that are associated with MDA. So as you've seen. The NMDA antagonist that's approved. Lotto associated with rentals and that has significant adverse events. <unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

John: Central to two classes to me the NMDA.

From a Q2 plasticity the NMDA. Mechanism of action before and clinical molecules acting you have to go down NMDA, forcing them downstream you have ample okay by bypassing the NMDA going straight to Pampa, you're one of the key potential benefits that you are not having Indian has in any of the adverse events that are associated with MDA. So as you've seen. The NMDA antagonist that's approved. Lotto associated with rentals and that has significant adverse events. <unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

Mechanism of action.

Mechanism of action before and clinical molecules acting you have to go down NMDA, forcing them downstream you have ample okay by bypassing the NMDA going straight to Pampa, you're one of the key potential benefits that you are not having Indian has in any of the adverse events that are associated with MDA. So as you've seen. The NMDA antagonist that's approved. Lotto associated with rentals and that has significant adverse events. <unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

It is not surprising to us and that's what gives us confidence with a single intravenous administration and with the blood brain barrier penetrated Cascade, obviously any clinical data on our preclinical data to understand that law, and we will be generating out over the coming months.

For example molecules acting you have to go down in EMEA for a human downstream you have ample okay.

By bypassing the NMDA going straight to Pampa.

One of the key potential benefits that you are not having any has any of the adverse events that are associated with NMDA. So as you've seen.

So as you've seen. The NMDA antagonist that's approved. Lotto associated with rentals and that has significant adverse events. <unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

The NMDA antagonist that's approved. Lotto associated with rentals and that has significant adverse events. <unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

<unk> antagonist, that's approved for auto associated with rentals and that has significant adverse events.

Eiry Roberts: Yeah, let me take the first one, Tasin. Thanks for that. You know, we haven't said anything about the doses other than one of the doses reached statistical significance. And as you saw from what we released, you know, there was improvement actually in the MADRS in both doses. And so, as Kevin said, we really are in a position that we're talking about intellectual property and other issues here that we want to work through before we say anything further. What I can say is we're very encouraged by the robustness of the data, both in terms of the impact on the primary and key secondary endpoints and, and overall at the tolerability as well. As we said, you know, there were no serious adverse events.

Lotto associated with rentals and that has significant adverse events. <unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

Thank you. Our next question comes from Mohit Bansal of with Wells Fargo. Please go ahead.

Programs addressing more by going directly to ask but you're really eliminating most of those adverse events.

<unk> is addressing more by going directly to ask what you're really looking at a motion was adverse events. With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

Mohit Bansal: Great. Thank you very much for taking my question I just wanted to probe a little bit on April five.

With the potential of them getting the similar efficacy without any of those adverse events. Consequential rems to address it.

With the potential of them getting the similar efficacy without any of those adverse events and consequential Rams to address it.

Mohit Bansal: How would you how do you think about positioning this in the depression market, where do you think it fits in.

Consequential rems to address it.

Mohit Bansal: Do you have any thoughts on.

Speaker Change: Got it.

Operator: And your next question comes from Brian Skorney with Baird. Please go ahead.

Mohit Bansal: Targeting and Bob potentiation versus previous approaches if I made an.

And your next question comes from Brian <unk> with Baird. Please go ahead.

Mohit Bansal: <unk> I mean is that a key differentiator that we should be available.

Brian: Hey, good morning team. Thanks for taking my question I guess, maybe to also ask a little bit more on a four five obviously the placebo adjusted response from trumps all but I was hoping you could at least speak to how to think about the performance of the placebo cohort relative to baseline I think looking at other phase III <unk> study as one might expect like a 12 point reduction.

Brian Sokrney: Hey, good morning, team. Thanks for taking my question. I guess maybe to also ask a little bit more on 845, obviously the placebo-adjusted response from trumps all. But I was hoping you could at least speak to how to think about the performance of the placebo cohort relative to Phase I? I think looking at other Phase II MDD studies, one might expect like a 12 point reduction at one month. Just wondering, is that in the ballpark for what you guys saw? Or is there anything to think about from trial design that would mean placebo performance substantially different from other studies?

Mohit Bansal: When you think about the mechanisms.

Speaker Change: But I can tell can you repeat the last part of the question I didn't quite get what you are asking about weighted fixed relative to other approaches like analysts can be non lending other NMDA approaches.

Eiry Roberts: There were no seizures, no psychotomimetic or dissociative events throughout, and the most common adverse event was headache, the majority of which were transient and mild in severity, and with both doses looking like placebo in terms of their safety profile. And obviously, that's really important given the history of this class of medication.

Looking at other phase II <unk> study as one might expect like a 12 point reduction at one month. I'm just wondering is that in the ballpark for what you guys saw or is there anything to think about the trial design that would make placebo perform substantially different from other studies.

Speaker Change: Yes in terms of Mechanistically.

Speaker Change: How in Amp up potentiation is expect to differentiate from EM and DVR intact.

At one month.

Wondering is that in the ballpark for what you guys saw or is there anything to think about from trial design that would make placebo performed substantially different from other studies.

I'm just wondering is that in the ballpark for what you guys saw or is there anything to think about the trial design that would make placebo perform substantially different from other studies.

Speaker Change: Thank you.

Speaker Change: I'm going to ask John to others.

This commentary meant Shaw.

Matt Abernethy: ... Yeah, I'll tackle the second question. Hi, Suzanne. So the sprinkle formulation, you know, we estimate that 5 to 10% of people living with tardive dyskinesia or Huntington's Chorea experience difficulty swallowing. So this represents, we think, a nice alternative for them to be able to get treated with INGREZZA. And in terms of the impact on the forecast, it's already integrated into our guidance. So we expect it to get approval and, you know, we issued guidance at our last earnings call in the range of $2.1 to 2.2 billion. So it's already baked in. Thanks.

Speaker Change: Yeah, I mean, we share the placebo adjusted data I would say it was a very well.

Eiry W. Roberts: Yes. I mean, we shared the placebo adjusted data. I would say that this was a very well-conducted study. And just a comment and Jaz may want to comment about the importance of this. A lot of our efforts here at Neurocrine in the recent past focused on understanding how to engage with psychs and how to run the psychiatry studies in a way that allows us to have the appropriate levels oversight. And we think that's really important. And so, I'm not going to comment on specific numbers, but I will say we were highly encouraged by the robustness of the data and the quality of the study in terms of how it has performed.

Speaker Change: Joe.

Speaker Change: Our mechanism is it's.

Genco to two plasticity the NMDA.

Adjusted study I mean, just a comment and John may want to comment about the importance of that.

Adjusted study Ah. Just a comment and John May want to comment about the importance of debt along our efforts here at Neurocrine and our. Alicia cockpit focused on understanding how to engage with sites and have kids Ramsey. Psychiatry settings in a way that allows us to have the appropriate level of oversight and we think that's reasonable. So. I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data. The quality of the study intended positives performed.

Speaker Change: Mechanism of action before its a commodity you have to go down NMDA source and then downstream you have ample okay.

Just a comment and John May want to comment about the importance of debt along our efforts here at Neurocrine and our. Alicia cockpit focused on understanding how to engage with sites and have kids Ramsey. Psychiatry settings in a way that allows us to have the appropriate level of oversight and we think that's reasonable. So. I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data. The quality of the study intended positives performed.

A lot of our effort here at Neurocrine.

The recent cockpit focused on understanding how to engage with sites and have kept Ramsey.

Speaker Change: By bypassing the NMDA going straight to Pampa.

Alicia cockpit focused on understanding how to engage with sites and have kids Ramsey. Psychiatry settings in a way that allows us to have the appropriate level of oversight and we think that's reasonable. So. I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data. The quality of the study intended positives performed.

Speaker Change: One of the key potential benefit is that you're not having Indian has to do any of the adverse events that are associated with NMDA. So as you've seen.

John: So I think that even in a way that allows us to have the appropriate level of oversight and we think that's reasonable.

Psychiatry settings in a way that allows us to have the appropriate level of oversight and we think that's reasonable. So. I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data. The quality of the study intended positives performed.

Speaker Change: So I'm.

So. I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data. The quality of the study intended positives performed.

<unk> antagonist, that's approved for auto associated with brands that have significant adverse events.

John: I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data.

I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data. The quality of the study intended positives performed.

Speaker Change: Events depressing for by going directly to ask what Youre really eliminating most of those adverse events.

Paul Matteis: Okay, thanks.

The quality of the study in Kansas is performed.

The quality of the study intended positives performed.

Operator: Thank you. Our next question comes from Phil Nadeau with TD Cowen. Please go ahead.

Speaker Change: With the potential of them getting the similar efficacy without any of those adverse events and consequential ramps to address it.

Speaker Change: Thanks Lee.

Jaz Singh: We've put in a lot of efforts to really make sure that we've got the highest quality of data that the data is robust, it's externally, internally validated and that we could actually be able to replicate it in the future. So, we feel very confident with data.

We've put in a lot of.

We've put in a lot of. Efforts to really make sure that we've got the highest quality of data and data on composites externally in terms of new validated. And that we could actually be able to replicate that in the future. So feel very confident in data.

Efforts to really make sure that we've got the highest quality of data and data bus and 16 early interim new validated.

Efforts to really make sure that we've got the highest quality of data and data on composites externally in terms of new validated. And that we could actually be able to replicate that in the future. So feel very confident in data.

Phil Nadeau: Hi, good morning. Congrats on the progress. Thanks for taking our question. With the 568 data now expected next quarter, we're curious to get your most updated thoughts on what you need to see to advance that program into additional development, particularly given the competitive landscape. Give us some idea of what efficacy results you'd like to see and what safety data and tolerability data would give you confidence that 568 could compete.

Speaker Change: Got it.

And that we could actually be able to replicate that in the future should feel very confident in data.

And that we could actually be able to replicate that in the future. So feel very confident in data.

Speaker Change: And your next question comes from Brian <unk> with Baird. Please go ahead.

Brian: Hey, good morning team. Thanks for taking my question I guess, maybe to also ask a little more on a four five obviously the placebo adjusted response from Consol, but I was hoping you could at least speak to how to think about the performance of the placebo cohort relative to baseline I think looking at other phase III <unk> study as one might expect like a 12 point reduction.

Okay.

Operator: Thank you. Your next question comes from Brian Abrahams with RBC Capital Markets. Please go ahead.

Thank you. Our next question comes from Brian Abrahams with RBC capital markets. Please go ahead.

Brian Abrahams: Hey, good morning, guys. Thanks for taking my question and congrats on the on the commercial and developmental progress. Another question on a four five I realized you can't say too much in terms of details on the data, but maybe just.

Brian Abrahams: Hey, good morning, guys. Thanks for taking my question and congrats on the commercial and developmental progress. Another question on 845. I realize you can't say too much in terms of details on the data, but maybe just bigger picture based on the profile you're seeing. How are you thinking about a go-forward plan for the drug? Is the goal to move this directly into pivotal studies? Do you think it's best suited for chronic or finite treatment and might you explore monotherapy or adjunctive treatment? Thanks.

Eiry Roberts: Yeah, thanks. So, we're really happy with the progress we've made with NBI-568, and happy to be able to share that, you know, in Q3, we'll be coming forward with data. Just to remind you, this is a study of around about 200 patients. It's a dose-finding study, and it's done in an adaptive fashion in order to enable us to explore the full dose response here. And in terms of the outcome, obviously, the primary endpoint for the study is the reduction in the PANSS score relative to placebo. And I think there's pretty clear precedent there in terms of what our expectations would be.

Brian: At one month.

Brian: Wondering is that in the ballpark for what you guys saw or is there anything to think about some trial design that would make placebo performed substantially different from other studies.

Brian Abrahams: Bigger picture based on the profile, you're seeing how he's thinking about our go forward plan for the drug is the goal to move just directly into pivotal studies do you think it's best suited for chronic are finite treatment and might you explore monotherapy or adjunctive treatment.

Bigger picture based on the profile you're seeing how are you thinking about our go forward plan for the drug is the goal to move just directly into pivotal studies do you think it's best suited for chronic are finite treatment and might you explore monotherapy or adjunctive treatment.

Brian: Yeah, I mean, we share the placebo adjusted data I would say it was a very well.

Brian: <unk> been studying and just a comment and John may want to comment about the importance of that.

Eiry W. Roberts: Kind of all of the above, actually, to be honest. I mean, we were very encouraged by the robustness of the data. And obviously, we need to engage with regulators both in the U.S. Our intent and goal would be to get into a registrational program in the most efficient way possible. And I'll ask Jaz to comment on where this would fit, just to make one comment first. I mean I think we saw a large effect size, as you saw in our presentation today, in terms of the antidepressant effect at day 28. That's early. It's not within a day like nor ketamine, but it's still very early relative to other antidepressant and that was maintained and actually continue to improve at day 56. So, that's encouraging from the perspective of a chronic therapy. And the tolerability profile to date, if you include both our preclinical data, our Phase I data and the data from this study, actually allows us to consider that very readily. Jaz, anything that you want add there?

Kind of all of the above I think capturing.

Speaker Change: To be honest I mean, we were very encouraged by the robustness of the data and obviously, we need to engage with regulators in the U S. Our intended goal would be to get into a registrational program.

To be honest I mean, we were very encouraged by the robustness of the data and obviously, we need to engage with regulators in the U S. A. In terms of goal would be to get into a registrational program. And in the most efficient way possible. And I'll ask John to comment on you know, where this would fit that just make the one common thread. I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect at day 28. It's not you know within a day light cat cat the names, but that is still very early analysis of that. The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

A lot of our effort here at Neurocrine.

Brian: Our recent cockpit focused on understanding how to engage with sites and have to Ramsey.

Eiry Roberts: We've seen a good effect size from other drugs in this class, and we'd be looking for something in that kind of area in terms of the impact on the primary endpoint. However, I will say that if you think about medications for diseases like schizophrenia, it's really the therapeutic index that's important here. And so, we'll be looking at the totality, the data, including the tolerability and safety profile, which I think is critical here. Our approach of choosing a selective M4 agonist, and a direct agonist rather than an allosteric modulator, we believe, has the opportunity to potentially differentiate, but it's all going to be about the data.

Brian: Bye bye hiseq that need in a way that allows us to have the appropriate level of oversight and if we think that's reasonable.

In terms of goal would be to get into a registrational program. And in the most efficient way possible. And I'll ask John to comment on you know, where this would fit that just make the one common thread. I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect at day 28. It's not you know within a day light cat cat the names, but that is still very early analysis of that. The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

In the most efficient way possible.

And in the most efficient way possible. And I'll ask John to comment on you know, where this would fit that just make the one common thread. I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect at day 28. It's not you know within a day light cat cat the names, but that is still very early analysis of that. The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Brian: And so on.

And I'll ask John to comment on you know, where this would fit that just make one call that third.

And I'll ask John to comment on you know, where this would fit that just make the one common thread. I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect at day 28. It's not you know within a day light cat cat the names, but that is still very early analysis of that. The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Brian: I'm not going to comment on specific numbers, but I will say, we left I encouraged by the robustness of the data.

John: I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect at day 28, that's really it's not you know within the day light Cat cat the name, but that is still very early analysis.

I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect at day 28. It's not you know within a day light cat cat the names, but that is still very early analysis of that. The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Brian: Yeah.

Brian: The quality of the study in terms of how it's performed.

Speaker Change: Thanks Lee.

It's not you know within a day light cat cat the names, but that is still very early analysis of that. The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Speaker Change: We've put in a lot of.

Speaker Change: Efforts to really make sure that we've got the highest quality of data and data on composites externally internally validated.

Pregnant and that was maintained.

The pregnant and that was maintained. That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Speaker Change: And that we could actually be able to replicate that in the future should feel very confident.

Actually continuing to improve about 56.

That should continue to improve up 56. So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Eiry Roberts: And so we'll be looking at both the benefit that we see in terms of the PANSS improvement, the tolerability profile, and taking that into consideration as we make the decision to move forward.

Speaker Change: Yeah.

So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the data from this study.

So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the <unk>. Based upon this study. Actually allows us to consider that very readily.

Speaker Change: Yes.

Speaker Change: Thank you. Our next question comes from Brian Abrahams with RBC capital markets. Please go ahead.

Matt Abernethy: Hey, one last comment. Just a big shout-out to the muscarinic team. This is an example at Neurocrine, a very important program, and we're able to, you know, really push forward the timing of when we'd expect top-line data, I think, by a couple of quarters. So, excellent job by Samir and the whole muscarinic team in the effort and including Jazz as well.

Based upon this study. Actually allows us to consider that very readily.

<unk> allows us to consider that.

Actually allows us to consider that very readily.

We rapidly.

No.

Everything out there.

Everything that were out there.

Speaker Change: Thanks, So much area and we've had pretty consistent and the only question that.

Jaz Singh: Thanks so much, Eiry. I agree with everything. The only question that can add a lot of color to is that we had different subgroups the question you were asking, but we still have to really go through them and see how those indications will play out. So, that will come in the near future. We're not really ready to talk about it today.

Speaker Change: I can't add a lot of color to is that we have different subgroups of your question you were asking but we still have two bidding.

Ken has a lot of color to is that we have different subgroups of your question you were asking but we still have to really. Go through them and see how those indications in lay up so that'll come in linear controller markedly ready to talk about it yesterday because it caused by that that means the monotherapy question. We did have some patients a month.

I'll go through them and see how those indications in lay up so that will come in the near future with markedly ready to talk about it today because it caused by that that means the monotherapy question. We did have some patients almost empty.

Go through them and see how those indications in lay up so that'll come in linear controller markedly ready to talk about it yesterday because it caused by that that means the monotherapy question. We did have some patients a month.

Phil Nadeau: Perfect. Thank you.

Operator: Our next question comes from Paul Matteis with Stifel. Please go ahead.

Brian Abrahams: And kind of all of the above I think capturing.

Okay.

Eiry W. Roberts: So, to clarify that, that means the monotherapy question. We did have some patients on monotherapy in the study. So that will be something we're considering as we go forward.

We'll be looking for things in Copel.

Paul Matteis: Hi there. This is Julian on for Paul. Thanks so much for taking our question. Just on NBI-845, I know you're not disclosing anything on the doses, but, you know, any additional color on what you can provide for the placebo response that you saw? Just thinking about, you know, moving into phase 3, what that could potentially look like. And then on safety, saw there's no seizures reported, but, you know, the modality, you know, historically does carry an additional risk for that. So, you know, what do you think about potential seizure risk broadly moving forward, and the overall safety profile? And then lastly, one quick one on the muscarinic. How much power do you expect to have for the individual dose arms that are at the higher receptor occupancy or in the expected active range?

We'll be looking at looking for things in Copel.

Brian Abrahams: I mean, we were very encouraged by the robustness of the data and obviously, we need to engage with regulators in the U S. Our intended goal would be to get into a registrational program.

Speaker Change: Thanks, Alright, thanks, guys.

Brian Abrahams: Thanks, Eiry. Thanks, Jaz.

Our next question comes from Carter Gould with Barclays. Please go ahead.

Operator: Our next question comes from Carter Gould with Barclays. Please go ahead.

Carter Gould: Hi, good morning, Thanks for taking the question, maybe just change it up a little bit.

Carter Gould: Hi, good morning. Thanks for taking the question. Maybe just change it up a little bit. I wanted to ask around just sort of when you think about the company's sort of capacity to be able to run potentially a large number of Phase III studies around neuropsych. I mean you've already got the Phase III going on with valbenazine, potentially staring down sort of AMPA moving into Phase III. Certainly, the maturation of the muscarinic portfolio and then sort of the optionality around Luvadaxi here. Does the company have that capacity to run potentially half dozen plus sort of Phase IIIs and the willingness to invest? Certainly, that doesn't seem contemplated in consensus today. Any color there would be helpful.

Brian Abrahams: In the most efficient way possible.

Carter Gould: I wanted to ask around just sort of when you think about the company sort of capacity to be able to run in a potentially a large number of phase III studies around neuro psych I mean, you've already got.

Wanted to ask around just sort of when you think about the company sort of capacity to be able to run in a potentially a large number of phase III studies around neuroscience I mean, you've already got the phase three going on with Val benzene potentially staring down sort of amp up moving into phase III. Certainly the maturation of the muscarinic portfolio and then the sort of the optionality around what accident year is the company have that capacity to run potentially half dozen plus sort of phase III and the willingness to invest certainly that doesn't seem contemplated in consensus today. Any color there would be helpful.

Brian Abrahams: And I'll ask Jack to comment on you know where this would fit that just made the one common thread.

Jack: I mean, I think we saw a large effect size as we saw in our presentation today in terms of the antidepressant effect that day 28.

We're going on with Val benzene potentially staring down sort of amp up moving into phase III.

Certainly the maturation of the granite portfolio and then the sort of the optionality around what accident year is the company have that capacity to run potentially half dozen plus sort of phase threes and the willingness to invest certainly that doesn't seem contemplated in consensus today.

Certainly the maturation of the muscarinic portfolio and then the sort of the optionality around what accident year is the company have that capacity to run potentially half dozen plus sort of phase III and the willingness to invest certainly that doesn't seem contemplated in consensus today. Any color there would be helpful.

Jack: It's not you know within a day like ketamine, but as that is still very early analysis.

Jack: Depression and that was maintained.

Paul Matteis: Thanks so much.

Matt Abernethy: Hey, sorry, really, really quick, one housekeeping item. We're going to stick to answering one question per analyst so we can get through all the analyst questions this time. So, Ira, do you want to comment on the, the AMPA program?

Jack: I actually continue to improve at day 56 does.

Jack: So that's encouraging from the perspective of a chronic therapy on the Tolerability profile to date. If you include both our preclinical data up eight one data and the data from this study.

Speaker Change: Any color there would be helpful.

Any color there would be helpful.

Speaker Change: Yeah Carter Thanks for the question and it's a good one as I said in my opening remarks, what we're constantly doing is prioritizing our programs and then keeping a close eye on our spend.

Kevin Charles Gorman: Yeah, Carter. Thanks for the question, and it's a good one. As I said in my opening remarks, what we are constantly doing is prioritizing our programs, and then keeping a close eye on our spend. It's one thing to say that we have the financial resources to do it all, which we do. However, you can't do everything. So, we are currently in the midst of putting down our thoughts on what the go-forward looks like for this program. And then with the other Phase IIs that are going to be reading out this year, that we have coming up the muscarinics and such, which is if positive, there's a well clinical investigation that we have there. So, we're going to continue to dig down into this prioritize things and make sure that we keep a good eye on what our spend looks like going forward.

Eiry Roberts: Yeah, I can do. I'll answer the muscarinic one very quickly, and then that's the last time we'll do the more than one. This is an adaptive phase 2 trial. It's a powered as such, and it has sufficient powering to enable us to understand the dose response, so we're confident in that. On the AMPA, I'll just start, and I will then see if Jas has additional things he wants to say. We were very encouraged by the tolerability profile, and as I mentioned in my prepared comments, I think Takeda deserves a lot of credit for years of work that they did in navigating this therapeutic index issue that's been a problem for AMPAkines in the past. And the overall tolerability, both doses looked like placebo in terms of the tolerability profile.

Jack: <unk> allows us to consider that.

Jack: We rapidly.

It's one thing to say that we have the financial resources to do it all of which we do.

It's one thing to say that we have the financial resources to do it all of which we do. However, if you can't do everything so we are currently. In the midst of putting downward somewhat. What the go forward looks like for this program. And then with the other phase threes that are going to be reading out this year that. That we have coming up. <unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Jack: No.

Jack: Everything out there.

Speaker Change: Thanks, So much area and we've had a consistent not only question Doug.

However, if you can't do everything so we are currently.

However, if you can't do everything so we are currently. In the midst of putting downward somewhat. What the go forward looks like for this program. And then with the other phase threes that are going to be reading out this year that. That we have coming up. <unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Speaker Change: Ken has a lot of color to is that we have different subgroups of your question you were asking but were still hasn't really.

In the midst of putting down our thoughts on what the what the go forward looks like for this program.

In the midst of putting downward somewhat. What the go forward looks like for this program. And then with the other phase threes that are going to be reading out this year that. That we have coming up. <unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

What the go forward looks like for this program. And then with the other phase threes that are going to be reading out this year that. That we have coming up. <unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Speaker Change: I'll go through them and see how those indications can play out so that that will come in the near future monopolies ready to talk about it yesterday because it caused by that that means the monotherapy question.

And then with the other phase threes that are going to be reading out this year that.

And then with the other phase threes that are going to be reading out this year that. That we have coming up. <unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

That we have coming up.

That we have coming up. <unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

<unk> and such which is positive.

<unk> and such which is positive. There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Speaker Change: Some patients on monotherapy study that.

There's a wealth of.

There's a wealth of. Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Clinical investigation that that need out there so we're going to continue that.

Speaker Change: That will be something looking at the base of Copel.

Clinical investigation that that need out there so we're going to continue that. Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Speaker Change: Thanks, all right. Thanks, guys.

Dig down into this prioritize things and make sure that we keep a good eye on what I spend it looks like going forward.

Dig down into this prioritize things and make sure that we keep a good eye on what I spend looks like going forward.

Speaker Change: Our next question comes from Carter Gould with Barclays. Please go ahead.

Eiry Roberts: From that perspective, I think we obviously need more data in phase 3, and as we progress, we'll learn more about the overall safety profile. Jas, I don't know if you want to say anything further.

Hi, good morning, Thanks for taking the question, maybe just change it up a little bit I wanted to ask around just sort of when you think about the company's sort of capacity to be able to run and potentially a large number of phase III studies around neuroscience I mean, you've already got the phase II going on with Bell benzene potentially staring down sort of amp up moving into phase III.

But to be clear with the great data that we saw on copper and then hopefully monitored daily to come on in a future phase two it is going to require a step up in investment.

Matthew C. Abernethy: But to be clear, I mean, with the great data that we saw in this program and hopefully more good data to come on a future Phase II, it is going to require a step-up in investment. But as Kevin said, it's not going to be 100% incremental. We're going to be going through the process of continuing to prioritize where we invest. But then, it is very fortunate that the quality of data that Eiry and Jaz were speaking to on study like 845, and we'll see how the muscarinic in the CIS trial readout here in the third quarter.

We monitor daily to come on in a future phase two it is going to require a step up in investment. As Kevin said, its not going to be 100% incremental we're going to be going through the process. And prioritize where we invest. It was very fortunate the quality of the data the Irene joggers feed into an eight. 845 months. Hello, Muscarinic MSCI us trial read out here in the third quarter.

Jaskaran Singh: No, I think there were really no risk of seizure. We had, you know, a committee adjudicating every event, and it was very clear there were no seizures.

As Kevin said, its not going to be 100% incremental we're going to be going through the process.

As Kevin said, its not going to be 100% incremental we're going to be going through the process. And prioritize where we invest. It was very fortunate the quality of the data the Irene joggers feed into an eight. 845 months. Hello, Muscarinic MSCI us trial read out here in the third quarter.

Operator: Goodbye. We are experiencing technical difficulties. Please remain on the line... To all locations on hold, we still have technical difficulties. Please remain on the line.

And prioritize where we invest.

And prioritize where we invest. It was very fortunate the quality of the data the Irene joggers feed into an eight. 845 months. Hello, Muscarinic MSCI us trial read out here in the third quarter.

Speaker Change: Certainly the maturation of the muscarinic portfolio and then the sort of the optionality around what accident year is the company have that capacity to run potentially half dozen plus sort of phase threes and the willingness to invest certainly that doesn't seem contemplated in consensus today.

Very fortunate the quality of the data the Irene joggers.

It was very fortunate the quality of the data the Irene joggers feed into an eight. 845 months. Hello, Muscarinic MSCI us trial read out here in the third quarter.

You might be on file and we'll see how the muscarinic MSCI US trial readout here in the third quarter.

845 months. Hello, Muscarinic MSCI us trial read out here in the third quarter.

Hello, Muscarinic MSCI us trial read out here in the third quarter.

Speaker Change: Thank you.

Carter Gould: Thank you.

Okay.

Speaker Change: Any color there would be helpful.

Operator: Our next question comes from Anupam Rama with JPMorgan. Please go ahead.

Okay.

Okay. Our next question comes from <unk>. <unk> Rama with JP Morgan. Please go ahead.

Speaker Change: Yes, Carter thanks for the question and it's a good demand as I said in my opening remarks, what we're constantly doing is prioritizing our programs and then keeping a close eye on our spend.

Speaker Change: Our next question comes from <unk>.

Our next question comes from <unk>. <unk> Rama with JP Morgan. Please go ahead.

Joshua Elliott Schimmer: M <unk> with JP Morgan. Please go ahead.

<unk> Rama with JP Morgan. Please go ahead.

Rama: Hey, guys. Thanks, so much for taking the question.

Anupam Rama: Hey, guys. Thanks so much for taking the question. Quick question on the OpEx guidance. Maybe just a little bit of color on what's driving the R&D uptick and the decrease in SG&A spend? Thanks so much.

Rama: Quick question on the Opex guidance, maybe just a little bit of color on what's driving the R&D uptick and the decrease in SG&A spend thanks, so much.

Quick question on the Opex guidance, maybe just a little bit of color on what's driving the R&D uptick and the decrease in SG&A spend thanks, so much.

Speaker Change: It's one thing to say is that we have the financial resources to do it all of which we do.

Speaker Change: However, you can't do everything so we are currently.

Speaker Change: Yeah on the RMB.

Matthew C. Abernethy: Yes. On the R&D front, it's a positive aspect. With all the progress that we've made with our partner programs, like the muscarinic collaboration, we have a milestone team that we have to make because we did certain thresholds. So for example, in the first quarter, we had a $6 million expense that's in the R&D line that's associated with some of those milestones. And I guess I forgot, Voyager as well. And then we also have more milestone payments that we triggered here in the second quarter. So, from an accounting perspective and also from a guidance perspective, we don't include that in our R&D guidance or in our P&L until those are actually achieved. So, that's the reason for the OpEx increase on R&D. And I'm sure you've also seen a reduction in SG&A spending that we also sit down for the quarter, which just looks - is basically our review of our cost br and continuing to prioritize where we put our investments. So, the increase isn't directly - I think I had a question from somebody - isn't directly related to the AMPA program, those increases will likely more translate in 2025. But for 2024, generally speaking, operating expense guidance remains intact outside of the milestone payments to our partners.

As the positive.

Yeah. With all of the progress that we've made with the program like the most preliminary data. Our collaboration we have a milestone payment. We have to make because certain thresholds. For example in the first quarter. But. The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: In the midst of putting our thoughts on what the what the go forward looks like for this program.

With all the progress that we've made with the program like the most preliminary data.

With all of the progress that we've made with the program like the most preliminary data. Our collaboration we have a milestone payment. We have to make because certain thresholds. For example in the first quarter. But. The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

And then with the other phase threes that are going to be reading out this year.

Collaboration.

Our collaboration we have a milestone payment. We have to make because certain thresholds. For example in the first quarter. But. The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Our milestone payments.

Speaker Change: That we have coming up.

Estimate because certain thresholds. So for example in the first quarter.

<unk> and such which is positive.

We have to make because certain thresholds. For example in the first quarter. But. The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: There's a wealth of.

For example in the first quarter. But. The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: Clinical investigation that that need out there so we're going to continue that.

Dollars.

But.

But. The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

The R&D line is associated with some of those milestones and I know, it's up about four inches long.

The R&D line is associated with some of those milestones and I know, it's up about four inches long. And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: Dig down into this prioritize things and make sure that we keep a good eye on what our spend looks like going forward.

And then we also have more milestone payments.

And then we also have more milestone payments. Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

[Company Representative] (Neurocrine Biosciences): Afternoon.

<unk> hundred here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance.

Here in the second quarter, so from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance. And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: But to be clear.

Speaker Change: The great thing is that we saw in program and hopefully monitoring data to come on in the future based.

And our email installed over or actually achieved.

And our email and no longer are actually achieved so that's the reason for the alternate increase on R&D. I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: It is going to require a step up in investment.

Operator: Okay, we have our speakers back in conference. We'll take our next question from Chris Shibutani with Goldman Sachs. Please go ahead.

The reason for the increase on R&D and I'm sure. You've also seen a reduction in SG&A spending also.

Speaker Change: Kevin said, its not going to be 100% incremental we're going to be going through the process.

I'm sure you've also seen a reduction in SG&A spending that we also took down for the quarter, which is Lewis. Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: Continuing to prioritize where we invest.

Paul Choi: Thank you very much. Good morning. On crinecerfont, saw the press release. NDA has been filed. Can you speak to the likelihood of a priority review and any potential timelines for that approval and launch? Thanks.

It is very unfortunate the quality of the data the Irene jobs. We're speaking to on April five we won't be held the muscarinic in Ci us trial.

For the quarter Which's Lewis.

Basically our review of our cost base.

Basically our own view of our cost base and we continue to prioritize where we put our investments so the increase isn't directly. I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Other times, where we put our investments.

Speaker Change: During the third quarter.

The increase isn't directly.

Eiry Roberts: Yeah, I can speak to that. And so I think as I mentioned, in light of the fact that there's significant unmet need here, the granting of the breakthrough designation, and the robustness of the phase 3 data package in both adults and pediatrics, that we actually just submitted yesterday, we would hope that the FDA would consider this a Priority Review. Obviously, that's their final decision, and we will obviously communicate it with you.

Speaker Change: Thank you.

I had a question from somebody that isn't directly related to the Amp program those increases will likely more.

I had a question from somebody that isn't directly related to the Amp program those increases will likely more. Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Speaker Change: Okay.

Speaker Change: Our next question comes from Pam <unk> with JP Morgan. Please go ahead.

Translate in 2025.

Translate in 2025. For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Hey, guys. Thanks, so much for taking the question.

For 2024, generally speaking operating expense guidance remains intact.

For 2024, generally speaking operating expense guidance. Outside of the mountain. Two harbors.

Pam: Quick question on the Opex guidance, maybe just a little bit of color on what's driving the R&D uptick and the decrease in SG&A Scott. Thanks, So much.

Outside of the mountain. Two harbors.

The milestone payments to our partners.

Two harbors.

Scott: Yeah on the R&D front.

And your next question comes from Marc Goodman with Leerink. Please go ahead.

Operator: And your next question comes from Marc Goodman with Leerink. Please go ahead.

All right.

With all the progress that we've made with important programs like the most Brennan Peter.

Marc Goodman: Sorry can you talk about the additional data we're going to see for Carnesi.

Marc Goodman: Eiry, can you talk about the additional data we're going to see for CRINECERFONT at ENDO in June? And then maybe we could just talk about Europe, what's the plans for Europe for CRINECERFONT and when are we going to file and what the plans are for staffing up?

Operator: We're experiencing technical difficulties. Please remain on the line.

Scott: Collaboration we have a milestone payment.

Marc Goodman: Endo in June and then maybe we could just talk about Europe, what's the plans for Europe for <unk> and when are we going to file them.

Endo in June and then maybe we could just talk about Europe, what's the plans for Europe for <unk> and when are we going to file them. The plans are for staffing up thanks.

Scott: Estimate.

Scott: Certain thresholds. So for example in the first quarter, we had a $6 million.

The plans are for stuffing up thanks.

The plans are for staffing up thanks.

Marc Goodman: Yeah, Let me take the second half.

Eiry W. Roberts: Yes. Let me take the second part first. We will - we're now working and moving to working on the lots of authorization application for Europe. And so the team will be diligently working through that. And I think once we kind of know our timing, we'll be able to communicate that in terms of when we think that will be going in. I mean, in general, the data that we'll see more information around the demographic brline characteristics, the primary and secondary endpoints and the tolerability. I mean we want to share the top line information already. And the largest amount of information will become available in the context of our full data publication and we anticipate having a full publication for both pediatric study and the adult study separately in the near future.

Scott: The R&D line is associated with some of those milestones.

Speaker Change: Well when I was working in moving to working on the E M.

Scott: For easier as well.

Scott: And then we also have more milestone payments.

[Company Representative] (Neurocrine Biosciences): Look at the hang up numbers. So as soon as we get back on, you need to say something.

Model authorization application in Europe, and so the team will be diligently working through that and I think once we kind of know what's happening we'll be able to communicate that intensity, but we think that will be going in I mean in general the data that we'll see a more information around the demographics the.

Marketing authorization application in Europe, and so the team of because we're working through that and I think once we kind of Noah I mean, they'll be able to communicate that intensity, but we think that will be going in I mean in general the basin that will see a more information around the demographics the. My tax jurisdiction. Primary and secondary endpoints and the Tolerability I mean, we've obviously shed topline information already. But under. The largest amount of information will become available in the context of outflows data publication, and we anticipate having a full publication to both pediatric study and the adult study. Currently in the near future.

Scott: Under here in second quarter, so from an accounting perspective, and also from a guidance perspective. We don't include that in our R&D guidance or in our P&L installed over are actually achieved so that's the reason for the increase on R&D and I'm sure. You've also seen a reduction in.

Paul Choi: Yeah.

[Company Representative] (Neurocrine Biosciences): I mean, people are wondering what the hell is going on.

Operator: For the interruption, we have our speakers in conference.

Baseline characteristics.

My tax jurisdiction. Primary and secondary endpoints and the Tolerability I mean, we've obviously shed topline information already. But under. The largest amount of information will become available in the context of outflows data publication, and we anticipate having a full publication to both pediatric study and the adult study. Currently in the near future.

[Company Representative] (Neurocrine Biosciences): Hey, everybody, apologize for the technical difficulties that we're having here. We've moved to a new campus and, in our new room, and I know many of you visited here recently, so apologize for that. We'll be better next time. So let's jump back to Chris's question around the likelihood of a priority review.

Primary and secondary endpoints and the Tolerability I mean, we've obviously shed topline information already.

Scott: SG&A.

Primary and secondary endpoints and the Tolerability I mean, we've obviously shed topline information already. But under. The largest amount of information will become available in the context of outflows data publication, and we anticipate having a full publication to both pediatric study and the adult study. Currently in the near future.

Scott: We also added to the balance of the quarter, which was Lewis.

Scott: Basically our own view of our cost base.

But under.

But under. The largest amount of information will become available in the context of outflows data publication, and we anticipate having a full publication to both pediatric study and the adult study. Currently in the near future.

The largest amount of information will become available in the context of Arcos data publication, and we anticipate having installed applications, both pediatric study and the adult study.

Scott: Alright.

The largest amount of information will become available in the context of outflows data publication, and we anticipate having a full publication to both pediatric study and the adult study. Currently in the near future.

Scott: But our investment so.

Scott: The increase isn't directly.

Scott: And a question from somebody that has been directly related to the <unk> program those increases will likely more.

Currently in the near future.

Eiry Roberts: Yeah, I'm not sure if you heard any of the response, Chris. So, you know, obviously, with the breakthrough designation in place and the robustness of the data that we were able to submit yesterday in both pediatrics and adults, we're very hopeful that a priority review will be granted by the FDA, but ultimately that's the agency's decision. As soon as we know anything further in our interactions with them, we'll be sure to communicate that.

Scott: Translate in 2025 for.

Speaker Change: And I'd like to take this opportunity just to add something on there in that.

Kevin Charles Gorman: Marc, I'd like to take this opportunity just to add something on here in that you're asking about filing in different regions of the world here. Obviously, the most important region of growth for us with this program is the United States. I can't express enough thanks and gratitude to the CAH team from top to bottom in filing two NDAs in the time that it would normally take the company to file one NDA. I think that a lot of changes that we've made here at Neurocrine for the better are typified by the excellence this team brought to that. That team immediately switched over into - while doing that in labor negotiations that they did for the INGREZZA SPRINKLE. That team then immediately has switched over to getting ready now. We don't know whether we're going to have an advisory committee, but we have to assume that we will for CAH. And those very same members are getting here early this morning in order to continue the preparations for doing that. So, while we have a lot of highly talented employees here, we understand that CRINECERFONT is an extremely valuable asset to us and will bring an amazing change to CAH patients’ lives. So, we're throwing everything we can at that. And we're focused right now on the U.S. market.

Scott: For 2024, generally speaking operating expense guidance.

You're asking about.

Youre asking about. <unk> filing in different regions of the World obviously, the most important region for US with this program as the United States I can't express enough banks and gravitate to the CAH team. From top to bottom in filing to MBIA, Inc, and the time that it would normally take the company to file one NDA I think that a lot of changes that we've made here at neurocrine. For the better exemplified by the absolute this team brought to that that team immediately switched over in. Two while building back in labor negotiations that they did for the ingressive Sprinkle that came then immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee. But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so. While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Filing in different regions of the World obviously, the most important region of the world for US with this program as the United States I can't express enough, thanks, and gratitude to the CAH team.

<unk> filing in different regions of the World obviously, the most important region for US with this program as the United States I can't express enough banks and gravitate to the CAH team. From top to bottom in filing to MBIA, Inc, and the time that it would normally take the company to file one NDA I think that a lot of changes that we've made here at neurocrine. For the better exemplified by the absolute this team brought to that that team immediately switched over in. Two while building back in labor negotiations that they did for the ingressive Sprinkle that came then immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee. But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so. While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Scott: Guidance remains intact.

Scott: The milestone payments to.

Scott: Two harbors.

Scott: And your next question comes from Marc Goodman with Leerink. Please go ahead.

From top to bottom in filing to MBIA, Inc, and the time that it would normally take the company to file one.

From top to bottom in filing to MBIA, Inc, and the time that it would normally take the company to file one NDA I think that a lot of changes that we've made here at neurocrine. For the better exemplified by the absolute this team brought to that that team immediately switched over in. Two while building back in labor negotiations that they did for the ingressive Sprinkle that came then immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee. But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so. While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Paul Choi: Thank you.

Marc Goodman: If I read can you talk about the additional data we're going to see for condenser for Endo in June and then maybe we could just talk about Europe, what's the plans for Europe for <unk> and when are we going to file them.

I think that a lot of changes that we've made here at neurocrine.

Operator: I think our next question comes from Aakash Tewari. Please go ahead. Aakash, your line is open.

For the better exemplified by the absence. This team brought to that that team immediately switched over.

For the better exemplified by the absolute this team brought to that that team immediately switched over in. Two while building back in labor negotiations that they did for the ingressive Sprinkle that came then immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee. But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so. While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Two while doing back in labor negotiations that they did for the ingressive sprinkle that came that immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee.

Marc Goodman: Sorry for stuffing up thanks.

Two while building back in labor negotiations that they did for the ingressive Sprinkle that came then immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee. But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so. While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Marc Goodman: Yeah, Let me take the second half.

Speaker Change: We will win out located moving to working on the.

Biren Amin: Hey, sorry about that. So for NBI-568, or sorry, NBI-568, can you talk about the benefits of having an adaptive trial design? What are they when you think about getting information from your phase 2 study and potentially designing your phase 3? And then generally speaking, where does your team stand with muscarinics when it comes to titration protocols, right? Cerevel doesn't have them, Karuna does. Do you think a titration protocol is ideal for NBI-568 when it comes to minimizing safety and maximizing efficacy? Thanks so much.

Speaker Change: E.

Speaker Change: Marketing authorization application for Europe, and so the team there has to be working through that.

But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so.

But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so. While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Speaker Change: I think once the kind of Noah I mean, they'll be able to communicate that intensity.

Speaker Change: That will be going in I mean in general the Bacon that we'll see a more information around the.

While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we will bring an amazing change to CAH patients lives. So we're selling everything we can in the past that and we're focused right now on the U S market.

While we have a lot of well we have a lot of highly talented employees here, we understand that <unk> is an extremely valuable asset to us and we're really an amazing change of CAH patients lives. So we're throwing everything we can on the cap that and we're focused right now on the U S market.

Speaker Change: Demographics and baseline characteristics the primary.

Speaker Change: Primary and secondary endpoints and the Tolerability I mean, we've obviously shed topline information already.

Speaker Change: Under.

Speaker Change: The largest amount of information will become available in the context of Arcos data publication, and we anticipate having both applications. Both pediatric study and the adult study separately in an ASC.

Eiry Roberts: Yeah, let me answer the first part, the second part first. I think we don't know until we see the data, what the optimal dosing will be for NBI-568. And actually the second question links a little bit to the first. Adaptive trials are very, often done in phase 2 as a means to explore as broad a range of doses as possible in the most limited number of patients. And so we're very confident in that design, and it's been used many times before. It will allow us to have studied a broad range of doses within the study, and that will allow us to understand, from a benefit risk perspective, which is the most optimal regimen to take forward into a phase 3 if we're successful at the end of the phase 2.

Thank you. Our next question comes from Myles Minter with William Blair. Please go ahead.

Operator: Thank you. Our next question comes from Myles Minter with William Blair. Please go ahead.

Speaker Change: Chip.

Speaker Change: And I'd like to take this opportunity just add something on hearing that youre asking about.

Myles Minter: Hey, guys. Congrats on the quarter just a quick question on if you've tested any of your color on energy assets across the board in rabbits for preclinical Tox studies, just given one of your peer molecules got a.

Myles Minter: Hi, guys. Congrats on the quarter. Just a quick question on if you've tested any of your cholinergic assets across the board in rabbits for preclinical tox studies, just given one of your peer molecules got put on hold for seeing that signal?

Speaker Change: Filing in different regions of the World obviously, the most important region for US with this program as the United States I can't express enough, thanks, and gratitude to the CAH team.

Speaker Change: Put on hold for saying that signal.

Put on hold for saying that signal.

Myles Minter: Yeah, No I think all I can say there is that we are highly confident in the preclinical packages for each of the muscarinic agonists that was taken into the clinic and obviously those have been scrutinized by me.

Eiry W. Roberts: Yes. I think all I can say there is that we are highly confident in the preclinical packages for each of the muscarinic agonist that we've taken into the clinic. And obviously, those have been scrutinized by regulators to enable the clinical testing to start and we have not experienced that issue.

Speaker Change: From top to bottom in filing two NDA during the time that it would normally take accompanied filed one NDA I think that a lot of changes that we've made here at neurocrine.

Speaker Change: For the better exemplified by the absolute stress team brought to that that team immediately switched over.

And maybe related to enable the clinical testing EBITDA and we have not experienced that issue maybe Myles. This is called us to add to that we've completed all long term box 456 days. So the molecule looks pretty good. So we're excited.

Regulators to enable the clinical testing for Dar and we have not experienced that issue maybe Myles. This is called us to add to that we've completed all long term box 456 days. So the molecule looks pretty good. So we're excited.

Regulators to enable the clinical testing for Dar and we have not experienced that issue

Kyle Gano: Maybe Myles, this is Kyle. Just to add to that. We've completed all long-term tox four, five, six, days of the molecule looks pretty good, so we’re excited going forward.

Speaker Change: Two while building Baskin labor negotiations that they did for the ingressive sprinkle that came that immediately has switched over to getting ready now we don't know whether we're going to have an advisory committee.

Operator: Thank you. Our next question comes from Jay Olson with Oppenheimer. Please go ahead.

Sure.

Myles: To be clear <unk> rabbits.

Myles Minter: To be clear, did you use rabbits?

[Company Representative] (Neurocrine Biosciences): Oh, hey, congrats on all the progress, and thank you for taking our question. Yesterday, the company that acquired Prevail's GBA1 gene therapy program announced a decision to discontinue their study in Gaucher disease type 2. Could you comment on the advantages of your Voyager partner GBA1 gene therapy program and the novel capsid, which enables a single systemic injection to address both neurological and peripheral manifestations versus Prevail's program, which requires a transcranial injection? Thank you.

I mean.

Eiry W. Roberts: I mean in our understanding rabbits, they usually use in the reprotox setting and not in the broad toxicity. So, the species selection for our tox program are chosen on the basis of the molecules themselves and what is generally used in toxicity testing. And we have four preclinical packages, enabling first-in-human for all of the molecules that have gone into the clinic. And as Kyle alluded to that includes the longer-term chronic talks. We have not done unnecessary program beyond that what is necessary to determine the safety profile and to the clinic.

Understanding that makes the usually used in the protocol setting and not in the broad toxicities there'll be specie selection for our top programs are chosen on the basis of the molecules themselves and what is generally used enough.

Understanding obviously, usually used in the repro tox setting and not in the broad toxicity there'll be specie selection for our top programs have chosen on the basis of the molecules themselves and what is generally used in not in toxicity testing. We have full preclinical packages, enabling first in human for all of the molecules that have gone into the clinic.

But we have to assume that we will for CAH and various paying members are getting here early this morning in order to continue the preparations for doing batch so.

Speaker Change: While we have a lot of well we have a lot of highly talented employees, we understand that <unk> is.

In toxicity testing and.

We have full of preclinical packages, enabling that in human for all of the molecules that have gone into the clinic.

We have full preclinical packages, enabling first in human for all of the molecules that have gone into the clinic.

Speaker Change: We have an extremely valuable asset to us and will bring an amazing change to CAH patients lives. So we're throwing everything we can in the past that and we're focused right now on the U S market.

<unk> kind of alluded to that includes the longer term chronic tox and we have not been unnecessary.

As Kyle alluded to that includes the longer term chronic tox and we have not been unnecessary. But beyond that what. What it meant to to determine that. Safety profile to enter the clinic.

Eiry Roberts: Yes. Yeah, Jay, thanks for that. That's, yeah, you're right. And I think we're really pleased with the progress that we've made preclinically with our collaboration with Voyager. And as I think we mentioned earlier, we intend to take two of these new gene therapies with the new capsid from Voyager into the clinic next year, if all of the preclinical work goes successfully over the next year or so.

But beyond that.

But beyond that what. What it meant to to determine that. Safety profile to enter the clinic.

Speaker Change: Thank you. Our next question comes from Myles Minter with William Blair. Please go ahead.

What is left to be determined.

What it meant to to determine that. Safety profile to enter the clinic.

The safety profile to enter the clinic.

Safety profile to enter the clinic.

Myles Minter: Hi, guys congrats on the quarter and just a quick question on if you've tested any of your culinary Jake assets across the board in rabbits for preclinical Tox studies, just given one of your peer molecules got off.

Speaker Change: Thanks for the question.

Myles Minter: Thanks for the question.

Our next question comes from Jeff Hung with Morgan Stanley. Please go ahead.

Operator: Our next question comes from Jeff Hung with Morgan Stanley. Please go ahead.

Jeff Hung: Thanks for taking my question up for the upcoming Lubbock deck that data what do you need to see to advance into phase III and what kind of improvement in cognitive impairment would be clinically meaningful.

Jeff Hung: Thanks for taking my question. For the upcoming LUVADAXISTAT data, what do you need to see to advance into Phase III? And what kind of improvement and cognitive impact would be clinically meaningful? Thanks.

Myles Minter: Put on hold for saying that signal.

Eiry Roberts: I think, as you alluded to, the fact that the technology employed by Voyager gives us the opportunity to have a blood-brain barrier penetrant capsid, allows us the opportunity with an intravenous injection to treat not only the CNS effects of diseases such as Gaucher or Parkinson's disease, but also peripheral effects that you might see with a disease such as Gaucher. The Voyager technology has focused on detargeting DRGs and other areas that are potentially associated with toxicity with these approaches in the past, while allowing for transduction in areas that are important in the context of the disease. So, we're not totally surprised by yesterday's decision. Gaucher, too, has central as well as peripheral effects.

Myles Minter: <unk>.

Speaker Change: No I think all I can say there is that we are highly confident in the preclinical packages for each of the muscarinic agonist that is taken into the clinic and obviously does not include nine by our regulators.

Okay.

Eiry W. Roberts: I wonder if you could repeat that. I didn't catch the very beginning of the question.

Jeff Hung: And so I wonder if you could repeat that I didn't catch the very beginning of the question. Yes sure. So this is for move it that.

And so I wonder if you could repeat that I didn't catch the very beginning of the question. Yes sure. So this is for move it that way.

And so I wonder if you could repeat that I didn't catch the very beginning of the question.

Jeff Hung: Yes, sure. So, this is for LUVADAXISTAT. What do you need to see for the Phase III and what kind of improvement in cognitive impairment would be clinically meaningful?

What do you need to see Oh, good phase III, and what kind of improvement cognitive impairment would be clinically meaningful.

What do you need to see phase III, and what kind of improvements cognitive impairment would be clinically meaningful.

Speaker Change: Regulators to enable the clinical testing EBITDA that we have not experienced staff issue maybe Myles. This is Carl just add to that we've completed over a long term path for five six days. So the molecule looks pretty good. So we're excited.

Speaker Change: Okay, I'm going to get gas to answer that one could you can give a little bit of context about the best third phase II study that we did and obviously thinking.

Okay, I'm going to get gas to answer that one could you can give a little bit of context about the best third phase II study that we did and obviously housing is thinking about that in context setting sure. Thanks servicer in the ambition study that was done that said keep in mind.

Eiry W. Roberts: Okay. I may get Jaz to answer that one because he can give a little bit of context about the first Phase II study that we did and obviously, how we’re thinking about that in context with LUVADAXISTAT study?

Speaker Change: Thinking about that in context with the repeat study sure. Thanks servicer in the envision study that was done look that said keep in mind that the.

Speaker Change: Sure.

Speaker Change: To be clear did you use rabbits.

Jaz Singh: Sure. So, in the initial study that was done with LUVADAXISTAT, keep in mind that the study was primarily done to address negative symptoms of schizophrenia, the cognition was secondary unit. We saw a meaningful effect size of 0.3 in the data in one of the doses there. But more importantly, we saw also improvement in function. And that was, of course, that hadn't really been seen before. If we can replicate that information in the ongoing study that would be a substantial advance over - there's absolutely nothing improved over there. So I think even that is a substantial advancement and benefit to patients.

Speaker Change: I mean.

Carl: Our understanding now and they usually used in the protocol setting and not in the broad auction there'll be specie selection for our top programs have chosen on the basis that the molecules themselves and what is generally used in NAFTA and in toxicity testing and we have full.

This study was primarily done to address the negative symptoms of schizophrenia.

This study was primarily done to address the negative symptoms of schizophrenia. Competition was secondary units. We saw. Meaningful effect size of <unk>. In the data in one of the doses there. But more importantly, it's also an important improvement in function that was of course that hadn't really been seen before. If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

Competition was secondary in it.

Competition was secondary units. We saw. Meaningful effect size of <unk>. In the data in one of the doses there. But more importantly, it's also an important improvement in function that was of course that hadn't really been seen before. If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

You saw.

We saw. Meaningful effect size of <unk>. In the data in one of the doses there. But more importantly, it's also an important improvement in function that was of course that hadn't really been seen before. If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

Meaningful effect size of <unk>.

Meaningful effect size of <unk>. In the data in one of the doses there. But more importantly, it's also an important improvement in function that was of course that hadn't really been seen before. If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

In the data.

In the data in one of the doses there. But more importantly, it's also an important improvement in function that was of course that hadn't really been seen before. If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

One of the doses there.

Eiry Roberts: So the fact that the ICM administration may not allow that to be addressed with a single administration of gene therapy, it's not surprising to us, and that's what gives us confidence with our single intravenous administration with the blood-brain barrier penetrant capsid. Obviously, we're going to need clinical data and our preclinical data to understand that more, and we'll be generating that over the coming months.

But more importantly, it's also an important improvement in function.

But more importantly, it's also an important improvement in function that was of course that hadn't really been seen before. If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

Carl: Our preclinical packages, enabling human for all of the molecules that have gone into the clinic and as Kyle alluded to that includes the longer term chronic tox and we have not been unnecessary.

That hasn't really seen before so you.

We can replicate that inflammation in the ongoing study.

If we can replicate that information. The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

The ongoing study. You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

That would be a substantial advance over there is absolutely nothing approved over there so that's even better.

You bet it would be a substantial advantage over. There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

There is absolutely nothing approved over there so that's even better. Essentially advancement and benefit to patients.

Carl: We will hopefully have a roadmap beyond that.

As a substantial advancement and benefit to patients.

Essentially advancement and benefit to patients.

Carl: What is left to be determined.

Carl: The safety profile to enter the clinic.

Speaker Change: Thank you.

Jeff Hung: Thank you.

Speaker Change: Thanks for the question.

Our next question comes from Laura Chico with Bush Securities. Please go ahead.

Operator: Our next question comes from Laura Chico with Wedbush Securities. Please go ahead.

Speaker Change: Our next question comes from Jeff Hung with Morgan Stanley. Please go ahead.

Laura Chico: Hi, good morning, Thanks, very much for taking the question just one quick follow up so with respect to the April five program.

Operator: Thank you. Our next question comes from Mohit Bansal with Wells Fargo. Please go ahead.

Jeff Hung: Thanks for taking my question up for the upcoming Lubbock that data what do you need to see to advance into phase III and what kind of improvement in cognitive impairment would be clinically meaningful.

Laura Chico: Good morning. Thanks, very much for taking the question. Just one quick follow-up. So, with respect to the 845 program, what's your confidence that you've adequately explored dose ranging sufficiently to advance the program? I guess, I'm trying to understand, as you said, coming out of these FDA regulatory discussions, do you anticipate needing additional dose-ranging studies before entering a registrational program? Thank you.

Laura Chico: What's your confidence that you've adequately explored dose ranging sufficiently to advance the program I guess I'm trying to understand as you said coming out of these FDA regulatory discussions do.

What's your confidence that you've adequately explored dose ranging sufficiently to advance the program I guess I'm trying to understand as you said coming out of these FDA regulatory discussions do you anticipate needing additional dose ranging studies before entering a registrational program. Thank you.

Mohit Bansal: Great, thank you very much for taking my question. I just wanted to probe a little bit on NBI-845. How do you think about positioning this in the depression market? Where do you think it fits in? And do you have any thought on targeting AMPA potentiation versus previous approaches of NMDA R antagonist? I mean, is there a key difference there that we should be aware about when you think about the mechanisms?

Jeff Hung: Okay.

Jeff Hung: So I wonder if you could repeat that I didn't catch the very beginning of the question. Yes sure. So this is for move it back and say.

Do you anticipate needing additional dose ranging studies before entering a registrational program. Thank you.

Jeff Hung: What do you need to see phase III, and what kind of cognitive impairment would be clinically meaningful.

Speaker Change: Yeah, I'll make a couple of continental.

Eiry W. Roberts: Yes, I'll make a couple of comments and then ask Jaz to comment as well. I mean I think if you look at the preclinical data and Phase I data, there was a broad range of doses that were tested. And one of this is that Takeda did extremely well in the translational medicine space was look at pharmacodynamic effects using transcranial magnetic stimulation and also cognitive testing and other pharmacodynamic measures in the Phase I setting. And so we had a really good handle on pharmacodynamically effective doses going into the initial Phase II evaluation. And we completed a small safety study first in Phase II. And then, I think we were highly confident in the dose selected for the Phase II study that we just read out. And also, there were two doses in this study rather than just one, which is common in some Phase II setting. And so, I think in our discussions with the agency, we - there's a lot of information to support the selective doses to this point and how we might move forward. Jaz, I don't know if you want to add it?

Joe: To comment as well I mean, I think if you look at the preclinical data is based on data there was a broad range of doses that were tested and what else is the Takeda did extremely well in the translational medicine space was look at Pharmacodynamic effect.

To comment as well I mean, I think if you look at the preclinical data is based on data there was a broad range of doses that were tested and what else is the Takeda did extremely well in the translational medicine space was look at Pharmacodynamic effect and using a trough cranial magnetic stimulation and also. Cognitive testing and as a pharmacodynamic measure in phase one testing and so we had a really good on the law. Talk about how likely affected sales going into the initial phase II evaluation that we completed a small safety study in phase two and then I think we were highly confident in the dose was selected for this phase II study that we just ran out. And also there were two doses in this study rather than just one and which is common in some phase II setting and so I think in our discussions with the agency. There's a lot of information to support the selected dose is up to this point. How we might move forward Jonathan.

Speaker Change: Okay, I'm going to get gas to answer that one because he can give a little bit of context about the best third phase II study that we did and obviously thinking.

Eiry Roberts: Could I just ask you to repeat the last part of the question? I think... Were you asking about where this fits relative to other approaches, like AMPA to NMDA and other NMDA approaches?

Jeff Hung: Thinking about that in context.

Speaker Change: Sure. Thanks, Larry So in the initial study that was done that said keep in mind.

Zing trough cranial magnetic stimulation and also our cognitive testing and Pharmacodynamic measure in phase one testing and so we had a really good envelope on pharmacodynamics, we affected sales going into the initial phase II evaluation that we completed a small.

Larry: The study was primarily done to address the negative symptoms of schizophrenia. The composition was secondary units.

Mohit Bansal: Yeah. No, I mean, in terms of mechanistically, how AMPA potentiation is expected to differentiate from NMDA antagonists that are out there. Thank you.

Cognitive testing and as a pharmacodynamic measure in phase one testing and so we had a really good on the law. Talk about how likely affected sales going into the initial phase II evaluation that we completed a small safety study in phase two and then I think we were highly confident in the dose was selected for this phase II study that we just ran out. And also there were two doses in this study rather than just one and which is common in some phase II setting and so I think in our discussions with the agency. There's a lot of information to support the selected dose is up to this point. How we might move forward Jonathan.

Speaker Change: We saw.

Larry: Meaningful effect size of <unk>.

Talk about how likely affected sales going into the initial phase II evaluation that we completed a small safety study in phase two and then I think we were highly confident in the dose was selected for this phase II study that we just ran out. And also there were two doses in this study rather than just one and which is common in some phase II setting and so I think in our discussions with the agency. There's a lot of information to support the selected dose is up to this point. How we might move forward Jonathan.

Larry: In the data.

Eiry Roberts: All right. I'm gonna, Jas, you want to give your commentary there?

Larry: One of the doses there.

Larry: But more importantly, it's also an important improvement in function.

Jaskaran Singh: Sure. So, the AMPA mechanism is, you know, central to plasticity. The NMDA mechanism acts before it. So if a molecule is acting, you have to go down NMDA first, and then downstream, you have AMPA effect. By bypassing the NMDA, going straight to AMPA, one of the key potential benefit is that you are not having to do any of the adverse events that are associated with NMDA. So as you've seen, you know, the NMDA antagonist that's approved, Spravato, associated with REMS, and that has significance in adverse events, and which is what the REMS is addressing for.

Safety study first in phase two and then I think we were highly confident in the dose was selected for this phase II study that we just ran out.

Larry: It Hasnt really changed or if we can replicate that information in the ongoing study.

Larry: That would be a substantial advantage over there is absolutely nothing in there that's even better.

And also there were two doses in this study rather than just one and which.

And also there were two doses in this study rather than just one and which is common in some phase II setting and so I think in our discussions with the agency. There's a lot of information to support the selected dose is up to this point. How we might move forward Jonathan.

Which is common in some phase II testing.

Larry: As a substantial advancement and benefit to patients.

And so I think in our discussions with the agency.

There's a lot of information to support the selected dose is up to this point.

There's a lot of information to support the selected dose is up to this point. How we might move forward Jonathan.

Speaker Change: Thank you.

Speaker Change: Our next question comes from Laura Chico with Wedbush Securities. Please go ahead.

Speaker Change: How we might move forward Jonathan.

How we might move forward Jonathan.

Jonathan: Oh sure.

Jaz Singh: [inaudible].

Laura Chico: Hi, good morning, Thanks, very much for taking the question just one quick follow up so with respect to the April five program.

Okay.

Okay. Thank you.

Jaskaran Singh: By going directly to AMPA, you're really eliminating most of those adverse events, you know, with the potential of then getting the similar efficacy without any of those adverse events and consequential REMS to address it.

Laura Chico: Whats your confidence that you've adequately explored dose ranging sufficiently to advance the program I guess I'm trying to understand as you said coming out of these FDA regulatory discussions do.

Jonathan: Thank you.

Thank you.

Our next question comes from Danielle Brill with Raymond James. Please go ahead.

Operator: Our next question comes from Danielle Brill Bongero with Raymond James. Please go ahead.

Danielle Catherine Brill: Good morning, guys. Thanks, so much for that question just a quick one on <unk> grants.

Danielle Brill Bongero: Good morning, guys. Thanks so much for the question. Just a quick one INGREZZA. I was wondering if you could share the average revenue per patient in 1Q? Thank you.

Laura Chico: Do you anticipate needing additional dose ranging studies before entering a registrational program. Thank you.

Danielle Catherine Brill: Was wondering if you could share the average revenue per patient and white cap. Thank you.

I was wondering if you could share the average revenue per patient in <unk>. Thank you.

Mohit Bansal: Got it.

Speaker Change: Yeah, I'll make a couple of continental ask Joe to comment as well I mean, I think if you look at the preclinical data is based on data that the broad range of doses that were tested.

Operator: Your next question comes from Brian Scorney with Baird. Please go ahead.

Mat: Yes. The average revenue per patient, if I heard you right. Q1 is always the most challenging quarter where patients go through reauthorization. And so, as a result of that the refill rate per patient typically goes down. And so, I think that's something that we've talked about historically, which has caused pressure on our sequential growth from Q4 to Q1. And this is the third straight year where we've had sequential growth. So, the team did a really great job ensuring that patient stayed on medicine and try to close that gap for the - for those - for that refill rate. Now on net revenue per script, if you're asking on the dollar front, as I said by the call, we do expect our net revenue per script for the year for 2024 to be somewhere over 5,800 and that compares to 5,600 in 2023. And then, the last piece is we typically have seasonal pressure on gross to net in Q1 as a result of the Medicare part on the whole and commercial co-pay reset. And so, you would - you do have a bit of a higher discount, a couple of points in Q1 that then recovers in Q2 and beyond. So hopefully, that gives you the components to answer your question.

Yes, the average revenue per patient.

Yes, the average revenue per patient. Herb you Brian do. Q1 is always the most challenging quarter, where patients go through a reauthorization. As a result of that the refill rate per patient typically goes goes goes down and so. I think that that's something that. We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where we've been on for growth of the team did a really great job ensuring that patients on medicine. Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Brian Skorney: Hey, good morning, team. Thanks for taking the question. I guess maybe to also ask a little bit more on NBI-845. Obviously, the placebo-adjusted response trumps, trumps all, but I was hoping you could at least speak to how to think about the performance of the placebo cohort relative to baseline. I think looking at other phase 2 MDD studies, we might expect, like, a 12-point reduction at one month. Just wondering, is that in the ballpark for what you guys saw, or is there anything to think about from trial design that would make placebo perform substantially different from other studies?

Herb you Brian.

Herb you Brian do. Q1 is always the most challenging quarter, where patients go through a reauthorization. As a result of that the refill rate per patient typically goes goes goes down and so. I think that that's something that. We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where we've been on for growth of the team did a really great job ensuring that patients on medicine. Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Speaker Change: Q1 is always the most challenging quarter, where patients go through a reauthorization.

Q1 is always the most challenging quarter, where patients go through a reauthorization. As a result of that the refill rate per patient typically goes goes goes down and so. I think that that's something that. We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where we've been on for growth of the team did a really great job ensuring that patients on medicine. Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Speaker Change: Why don't simplification did extremely well in the translational medicine space was look at Pharmacodynamic effects and using a trough cranial magnetic stimulation and also our cognitive testing and as a pharmacodynamic measure in phase one testing and so we had a really good envelope on policy.

Brian: As a result of that the refill rate per patient typically those goes goes down and so.

As a result of that the refill rate per patient typically goes goes goes down and so. I think that that's something that. We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where we've been on for growth of the team did a really great job ensuring that patients on medicine. Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

I think that that's something.

I think that that's something that. We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where we've been on for growth of the team did a really great job ensuring that patients on medicine. Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where are we counting on for growth of the team did a really great job ensuring that patients stayed on medicine.

We've talked about historically, which has caused pressure on our sequential growth from Q4 into Q1 and this is the third straight year, where we've been on for growth of the team did a really great job ensuring that patients on medicine. Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Joe: Honestly effective is going into the initial phase II evaluation and that we completed a small safety study in phase two and then I think we were highly confident in the dose was selected for this phase II study that we just read out.

I'm trying to close that gap for the.

Eiry Roberts: Yeah, I mean, we shared the placebo-adjusted data. I would say that this was a very well conducted study, and just a comment, and Jas may want to comment about the importance of this. A lot of our efforts here at Neurocrine, in the recent past, have focused on understanding how to engage with sites and how to run these psychiatry studies in a way that allows us to have the appropriate level of oversight, and we think that's really important. And so, you know, I'm not going to comment on specific numbers, but I will say we were highly encouraged by the robustness of the data and the quality of the study in terms of how it was performed.

Tried to close that gap for the. For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Or are those for the.

For those for that refill rate now on net revenue per script. If you are asking on the dollar firm. As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Regional right now on net revenue per script, if youre asking on the dollar.

As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800.

Laura Chico: You know we are and also there were two doses in this study rather than just one which.

As I said last call, we do expect our net revenue per script for the year for 2020 for it to be somewhere over 5800 and that compares to 5600 and. In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Laura Chico: Which is common in some phase II setting and so I think in our discussions with the agency.

200, 5600 and.

In 2023, and then the last piece is we typically have seasonal pressure on growth.

Laura Chico: There's a lot of information to support the selected dose is up to this point and how.

In 2023, and then the last piece is we typically have seasonal pressure on growth. In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Laura Chico: How we might move forward Jonathan.

In Q1, as a result of the Medicare part D done all in commercial co pay reset.

In Q1, as a result of the Medicare part D done all in commercial co pay resets and so you would you have a bit of a higher discount a couple of points in Q1 that recovers in Q2 and beyond. What does that give you the components. To answer your question.

Jonathan: Oh sure.

So you would you do have a bit of a higher discount on a couple of points in Q1 that recovers in Q2 and beyond.

Jonathan: Thank you.

Jonathan: Next question comes from Danielle Brill with Raymond James. Please go ahead.

Speaker Change: Hopefully that gave you the components.

Jaskaran Singh: I agree. I think we, you know, we put in a lot of efforts to really make sure that we got the highest quality of data, that, you know, the data is robust. It's extremely, extremely validated, and that we could actually be able to replicate it in the future. So feel very confident in the data.

What does that give you the components. To answer your question.

Speaker Change: To answer your question.

Danielle Catherine Brill: Good morning, guys. Thanks, so much for that question just a quick one on <unk> grants.

To answer your question.

Danielle Catherine Brill: I'm wondering if you could share the average revenue per patient and white cap. Thank you.

Speaker Change: Thank you. Our next question comes from <unk> <unk> with Guggenheim. Please go ahead.

Operator: Thank you. Our next question comes from Yatin Suneja with Guggenheim. Please go ahead.

Danielle Catherine Brill: Yes, the average revenue per patient.

Good morning, This is Dan Morefield, Yadkin and thanks for taking our question.

Unknown: Good morning. This is Thelma for Yatin. And thanks for taking our question. So, you recently initiated a Phase I study with the next-generation VMAT2 inhibitor. I'm just curious, what are the key differentiating properties of this agent versus INGREZZA? And what do you want to see from the Phase I? Thank you.

Danielle Catherine Brill: I heard you right.

Thanks for taking our question. Yeah, Lisa <unk> with the next generation of Lima, clean EBITDA and <unk>. Just curious what kind of a key deciding taking properties of DSA Gen versus being guide. And what do you want to see from the phase one thank you.

Speaker Change: Q1 is always the most challenging quarter, where patients go through a reauthorization and so on.

Operator: Thank you. Our next question comes from Brian Abrams with RBC Capital Markets. Please go ahead.

Daniel: Eddie from Tim <unk> with the next generation of Lima, clean EBITDA and just curious what type of a QD fitting taking properties of DSA Gen device has been great.

Yeah, Lisa <unk> with the next generation of Lima, clean EBITDA and <unk>. Just curious what kind of a key deciding taking properties of DSA Gen versus being guide. And what do you want to see from the phase one thank you.

Speaker Change: As a result of that the refill rate per patient typically goes goes goes down and so.

Brian Abrahams: Hey, good morning, guys. Thanks for taking my question, and congrats on the commercial and developmental progress. Another question on NBI-845. I realize you can't say too much in terms of details on the data, but maybe just bigger picture based on the profile you're seeing, how are you thinking about a go-forward plan for the drug? Is the goal to move this directly into pivotal studies? Do you think it's best suited for chronic or finite treatment? And might you explore monotherapy or adjunctive treatment? Thanks.

Just curious what kind of a key deciding taking properties of DSA Gen versus being guide. And what do you want to see from the phase one thank you.

Daniel: What do you want to see from the phase one thank you.

And what do you want to see from the phase one thank you.

Danielle Catherine Brill: I think that that's something that.

Danielle Catherine Brill: We've talked about historically, which has caused pressure on our sequential growth from Q4 to Q1 and this is the third straight year, where are we counting on for growth of the team did a really great job instrumentation paid on medicine.

Lisa: Yeah, So I'm not quite sure I fully heard the question interesting.

Eiry W. Roberts: Yes. S,o I'm not quite sure I fully heard the question, it's breaking up. But I think it was about our next-generation VMAT2 inhibitor. We're pretty excited about getting this module into the clinic. As you can imagine, INGREZZA valbenazine is an incredibly well performing module. So, in terms of finding a next generation that can potentially be even better is about really, really high. And so - but we're very happy with the molecule that we have in hand right now. We're just starting to Phase I. In that Phase I setting, obviously, we'll be invested in the tolerability, PK profile and how that might differentiate from valbenazine and that would include the potential for using tardive dyskinesia indication, but obviously beyond that into other neuropsychiatric disorders. And as we get some of that information, we understand the potential areas of differentiation, we'll be more specific about that.

Our next generation <unk> inhibitor that we're pretty excited about getting this molecule into the clinic is that as you can imagine in graduate about bending the unions and incredibly well performing molecule.

Our next generation <unk> inhibitor that we're pretty excited about getting this molecule into the clinic is that as you can imagine in graduate of Val <unk> is an incredibly well performing molecule. So. In terms of finding a next generation that can potentially be embedded above really really high. So, but we're very happy with the molecule that we have in mind right. Now we're just starting phase one in a phase one setting obviously will be interested in the tolerability PK profile. How that might differentiate from athene. And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other newer psychiatric disorders. As we get some of that information and we understand the potential areas of differentiation.

Danielle Catherine Brill: I'm trying to close that gap for the.

Danielle Catherine Brill: Or those are not refill rate now on net revenue per script as youre asking on the dollar.

<unk>.

So. In terms of finding a next generation that can potentially be embedded above really really high. So, but we're very happy with the molecule that we have in mind right. Now we're just starting phase one in a phase one setting obviously will be interested in the tolerability PK profile. How that might differentiate from athene. And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other newer psychiatric disorders. As we get some of that information and we understand the potential areas of differentiation.

In terms of finding a next generation that can potentially be embedded about really really high and that so but we are very happy with the molecule that we have in mind right. Now we're just starting phase one in a phase one setting obviously will be interested in the tolerability PK profile and how that might differentiate from Val benzene.

In terms of finding a next generation that can potentially be embedded above really really high. So, but we're very happy with the molecule that we have in mind right. Now we're just starting phase one in a phase one setting obviously will be interested in the tolerability PK profile. How that might differentiate from athene. And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other newer psychiatric disorders. As we get some of that information and we understand the potential areas of differentiation.

Eiry Roberts: ... Kind of all of the above, I think, actually, to be honest. I mean, we were very encouraged by the robustness of the data, and obviously, we need to engage with regulators first in the US. Our intent and goal would be to get into a registrational program, in the most efficient way possible. And I'll ask Jas to comment on, you know, where this would fit, but just make one comment first. I mean, I think we saw a large effect size, as we saw in our presentation today, in terms of the antidepressant effect at day 28. That's early. It's not, you know, within a day, like, you know, ketamine, but it's still very early relative to other antidepressants, and that was maintained, and actually continued to improve up to day 56.

Danielle Catherine Brill: As I said last call, we do expect our net revenue per script for the year for $2000 for it to be somewhere over 58 under than that Theres 200.

So, but we're very happy with the molecule that we have in mind right. Now we're just starting phase one in a phase one setting obviously will be interested in the tolerability PK profile. How that might differentiate from athene. And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other newer psychiatric disorders. As we get some of that information and we understand the potential areas of differentiation.

Danielle Catherine Brill: In 2023, Nevertheless pieces, we typically have seasonal pressure on growth.

How that might differentiate from athene. And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other newer psychiatric disorders. As we get some of that information and we understand the potential areas of differentiation.

And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other new York like gastric.

Danielle Catherine Brill: In Q1, as a result of the Medicare part D done on commercial co pay resets and so.

And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other newer psychiatric disorders. As we get some of that information and we understand the potential areas of differentiation.

Danielle Catherine Brill: So you would you have a bit of a higher discount a couple of points in Q1 that that recovers in Q2 and beyond.

And as we get some of that information and we ended up essentially the differentiation.

As we get some of that information and we understand the potential areas of differentiation.

Smaller.

Danielle Catherine Brill: Hopefully that gave you the components.

Operator: Thank you. Your next question comes from Sumant Kulkarni with Canaccord. Please go ahead.

Speaker Change: To answer your question.

Oh.

Yeah. Thank you. Our next question comes from demand Killarney with Canaccord. Please go ahead.

Speaker Change: Thank you. Our next question comes from <unk> <unk> with Canaccord. Please go ahead.

Thank you. Our next question comes from demand Killarney with Canaccord. Please go ahead.

Speaker Change: Thank you. Our next question comes from Yadkin County Highways Guggenheim. Please go ahead.

Dawn Killarney: Good morning, Thanks for taking my question on your Phase one studies for $5, 67% to 69% 70 muscarinic agonists of any differences in enrollment criteria by age and are any of those being specifically in order to Doug.

Sumant Kulkarni: Good morning, thanks for taking my question. On your Phase I studies for 567, 69 and 70 muscarinic agonists, are there any differences in enrollment criteria by age? And are any of those being specifically run in older adults?

Eiry Roberts: So that's encouraging from the perspective of a chronic therapy. And the tolerability profile to date, if you include both our preclinical data, our Phase 1 data, and the data from this study, actually allows us to consider that very readily. Jas, what, anything you might want to add there?

Speaker Change: Good morning, This is Dan natoli, asking and thanks for taking our question.

Dan Natoli: We recently initiated a phase one study with the next generation of Bema clean EBITDA and just curious what type of activity heading taking purposes of DSA Gen device has been great.

Killarney: Yeah, I mean, so the initial studies for each of those that were just starting out are in healthy subjects of the kind of the new.

Eiry W. Roberts: Yes. I mean - so the initial studies for each of those that we're just starting up are in healthy subjects of the kind of normal age range, not including elderly subjects. However, each of those plans is designed in order to address specific questions relating to those molecules. And so we do understand that, particularly, with those molecules that impact both M4 and M1, that cognition can be an important part of the potential indication space moving forward. And so similarly to what was done for 568, we will be exploring those molecules in older subjects at some point during the plan to enable us to be ready for the chosen Phase II path forward.

Speaker Change: And what do you want to see from the patron. Thank you.

Matt Abernethy: Thanks so much, Irene. I agree with everything you said. I think the only question that can add a lot of color to is that we had different subgroups to the question you were asking, but we still have to really go through them and see how those indications will play out. So that will come in the near future. We're not really ready to talk about it yet today.

And no age range, not including elderly subjects. However, each of those plants is designed in order to address specific questions relating to those molecules. So we do understand that particularly for those. Molecules that impactful and board and and one that cognition can be an important part of the potential indications base moving forward and so similarly to what we've got a full five eight. We'll be exploring those molecules in <unk>. Older subjects at some point during the plan to enable us to be ready for the chosen phase II portfolio.

<unk> age range, not including elderly subjects. However, each of those plants is designed in order to address.

Speaker Change: Yes.

Speaker Change: I'm not quite sure please read the questions.

Speaker Change: Our next generation <unk> inhibitor that we're pretty excited about getting this molecule into the clinic is that as you can imagine in graduate about Pan India is an incredibly well performing molecule.

Doug: Any questions relating to those molecules and spin, we do understand that particularly for those.

So we do understand that particularly for those. Molecules that impactful and board and and one that cognition can be an important part of the potential indications base moving forward and so similarly to what we've got a full five eight. We'll be exploring those molecules in <unk>. Older subjects at some point during the plan to enable us to be ready for the chosen phase II portfolio.

Molecules that impactful and board and and Wahid that cognition can be an important part of the potential indications base moving forward and so similarly to what we've done 4568, we will be exploring those molecules in.

Molecules that impactful and board and and one that cognition can be an important part of the potential indications base moving forward and so similarly to what we've got a full five eight. We'll be exploring those molecules in <unk>. Older subjects at some point during the plan to enable us to be ready for the chosen phase II portfolio.

Eiry Roberts: So to clarify that, that means the monotherapy question. We did have some patients on monotherapy in this study.

Speaker Change: So.

Speaker Change: In terms of finding a next generation that can potentially be even added about really really high and that cell, but they are very happy with the molecule that we have in hand right. Now we're just starting phase one in a phase one setting obviously will be interested in that tolerability PK profile and how that might differentiate from <unk>.

Matt Abernethy: Right.

Eiry Roberts: That will be something we're considering as we go forward.

Matt Abernethy: Yeah. Yeah.

Marc Goodman: Thanks, Irene. Thanks, Jas.

We'll be exploring those molecules in <unk>. Older subjects at some point during the plan to enable us to be ready for the chosen phase II portfolio.

Operator: Our next question comes from Carter Gold with Barclays. Please go ahead.

Older subject.

Older subjects at some point during the plan to enable us to be ready for the chosen phase II portfolio.

At some point during the plan to enable us to be ready for the chosen phase II portfolio.

Carter Gould: Good morning. Thanks for taking the question. Maybe to change it up a little bit, I wanted to ask around just sort of when you think about the company's sort of capacity to be able to run, you know, potentially a large number of Phase 3 studies around neuropsych. I mean, you've already got the Phase 3 going on with valbenazine, potentially staring down sort of AMPA, moving into Phase 3, certainly the maturation of the muscarinic portfolio and then sort of the optionality around luvadaxistat here. Is the company, you know, have that capacity to run potentially, you know, a half dozen plus sort of Phase 3s? And the willingness to invest, certainly that doesn't seem contemplated in consensus today. Any color there would be helpful.

Speaker Change: And that would include the potential for use in tardive dyskinesia is an indication, but obviously beyond that into other New York like gastric as been noted and as we get some of that information and we understand the potential areas of differentiation.

Speaker Change: Thank you.

Sumant Kulkarni: Thank you.

Our next question comes from Evan <unk> with BMO. Please go ahead.

Operator: Next question comes from Evan Seigerman with BMO. Please go ahead.

Evan David Seigerman: Hi, guys. Thank you so much for taking the question I haven't really heard much recently on your pushed core up in growth in the long term care market, maybe highlight what youre doing in this space is this used to be a pretty big part of the narrative or at least where we were gonna see and grab the growth. Thank you.

Evan Seigerman: Hi, guys. Thank you so much for taking the question. I haven't really heard much recently on your push for INGREZZA in the long-term care market. Maybe highlight what you're doing in this space as this used to be a pretty big part of the narrative or at least where we were going to see INGREZZA growth? Thank you.

Speaker Change: Yes.

Speaker Change: Okay.

Speaker Change: Thank you. Our next question comes from cement Killarney with Canaccord. Please go ahead.

Speaker Change: Yes. Thanks for the question, it's still an important part of the aggressive growth story, frankly, and we're seeing good progress across all three of our business segments in psychiatry, and neurology and long term care.

Eric S. Benevich: Yes. It's still an important part of the INGREZZA growth story. Frankly, we're seeing good progress across all three of our business segments in psychiatry, neurology and long-term care. We've been in the long-term care segment now for coming up on two years. I'm really pleased with the growth that we're seeing and the progress that the team is making. Today, long-term care is contributing approximately equal to neurology in terms of our overall business. And so, we're going to continue to develop that segment. And the only other thing that I would add is that on a relative basis, it's earlier in the overall development phase, commercially speaking that is in the sense that we've been in psychiatry and neurology now for seven years with INGREZZA and less than two years in long-term care. So, there's still a lot of HCPs that are learning about drug-induced movement disorders in tardive dyskinesia and becoming more familiar with INGREZZA as the most prescribed most preferred VMAT2 inhibitor. So, we'll continue to see good growth coming out of long-term care going forward.

Cement Killarney: Good morning, Thanks for taking my question on your Phase one studies for 567%, 69% 70, muscarinic agonists of any differences in enrolment criteria by age and are any of those be specifically run in order to date.

Kevin Gorman: Yeah, Carter. Yeah, Carter, thanks for the question. And it's a good one. As I said in my opening remarks, what we are constantly doing is prioritizing our programs and then keeping a close eye on our spend. It's one thing to say that we have the financial resources to do it all, which we do. However, you can't do everything. So we are currently in the midst of putting down our thoughts on what the go forward looks like for this program. And then with the other phase twos that are going to be reading out this year that we have coming up, the muscarinic and such, which is, if positive, there's a wealth of clinical investigation that we have there.

Speaker Change: We've been in the long term care segment now for coming up on two years and really pleased with the <unk>.

We've been in the long term care segment now for coming up on two years and really pleased with the growth that we're seeing and the progress the team is making. Today, our long term care is contributing approximately equal to the barology in terms of our overall business and so we're going to continue to develop that that segment and the only other thing that I would add is that on a relative basis. It's earlier in the overall. Development phase. Commercially speaking that is in a sense that we've been in psychiatry and neurology now for seven years within Rosa and less than two years in long term care. So there's still a lot of hcp's that are learning about broken tooth movement disorders, and product dyskinesia and becoming more familiar. Here with Grubhub as the most prescribed most preferred beam at two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Cement Killarney: Yeah, I mean, so the initial studies for each of those that we've been signing up are in healthy subjects of the kind of the.

Growth that we're seeing and the progress the team is making.

Today, our long term care is contributing approximately equal to neurology in terms of our overall business and so we're going to continue to develop that that segment and the only other thing that I would add is that on a relative basis. It's earlier in the overall.

Cement Killarney: And no age range, not including elderly subjects. However, each of those plans is designed in order to address specific questions relating to those molecules and so we do understand that particularly with those.

Today, our long term care is contributing approximately equal to the barology in terms of our overall business and so we're going to continue to develop that that segment and the only other thing that I would add is that on a relative basis. It's earlier in the overall. Development phase. Commercially speaking that is in a sense that we've been in psychiatry and neurology now for seven years within Rosa and less than two years in long term care. So there's still a lot of hcp's that are learning about broken tooth movement disorders, and product dyskinesia and becoming more familiar. Here with Grubhub as the most prescribed most preferred beam at two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Cement Killarney: Molecules that impactful and ball and and one that cognition can be an important part of the potential indication space moving forward and so similarly to what we've done for 568, we will be exploring those molecules in.

Development phase commercially speaking that is in a sense that we've been in psychiatry and neurology now for seven years within browser and less than two years in long term care. So there's still a lot of hcp's that are learning about broken due to movement disorders and <unk>.

Development phase. Commercially speaking that is in a sense that we've been in psychiatry and neurology now for seven years within Rosa and less than two years in long term care. So there's still a lot of hcp's that are learning about broken tooth movement disorders, and product dyskinesia and becoming more familiar. Here with Grubhub as the most prescribed most preferred beam at two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Commercially speaking that is in a sense that we've been in psychiatry and neurology now for seven years within Rosa and less than two years in long term care. So there's still a lot of hcp's that are learning about broken tooth movement disorders, and product dyskinesia and becoming more familiar. Here with Grubhub as the most prescribed most preferred beam at two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Kevin Gorman: So we're going to continue to dig down into this, prioritize things, and make sure that we keep a good eye on what our spend looks like going forward.

Cement Killarney: Older subjects.

Cement Killarney: Some point during the plan to enable us to be ready for the chosen 82 possible ways.

Dyskinesia, and becoming more familiar with and grocer as the most prescribed most preferred beam at two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Matt Abernethy: But to be clear, I mean, with the great data that we saw in this program and, you know, hopefully more good data to come on a future Phase 2, it is going to require a step up in investment. But as Kevin said, it's not going to be 100% incremental. We're going to be going through the process of continuing to prioritize where we invest. But, yeah, it is very fortunate to have the quality of data that Eiry, Jas were speaking to on a study like NBI-845, and we'll see how the muscarinic in the CIAS trial read out here in Q3.

Speaker Change: Thank you.

Here with Grubhub as the most prescribed most preferred beam at two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Cement Killarney: Our next question comes from Evan <unk> with BMO. Please go ahead.

Evan: Hi, guys. Thank you so much for taking the question I haven't really heard much recently on your pushed core oven rather than the long term care market, maybe highlight what youre doing in this space is this used to be a pretty big part of the narrative or at least where we were gonna see and read the growth. Thank you.

Speaker Change: Thank you.

Evan Seigerman: Thank you.

Our next question comes from OUI ear with Mizuho. Please go ahead.

Operator: Our next question comes from Uy Ear with Mizuho. Please go ahead.

Louis: Hi, Good morning, guys. This is lee on for <unk>. Thanks, So much for taking our question. So we were under the impression that April five to differentiate on cognition do you still believe this is the case policy do you expect a four five to differentiate can it also differentiate on onset of action.

Uy Ear: Hi, good morning, guys. This is Leo on for Uy. Thanks so much for taking our question. So, we were under the impression that 845 could differentiate on cognition. Do you still believe this is the case? How else do you expect 845 to differentiate? Could it also differentiate on onset of action?

Speaker Change: Yes. Thanks for the question, it's still an important part of the <unk> story, frankly, and we're seeing good progress across all three of our business segments in psychiatry, and neurology and long term care.

Carter Gould: Thank you.

Operator: Our next question comes from Anupam Rama with JP Morgan. Please go ahead.

Speaker Change: Yes, we think that we're just going through all the information from the Tri wheel you said top line today, I mean, I think it will be once they understand the full datasets and the totality of the data we'll be able to comment more around where we think that can truly differentiate and will be designed well jobs will be designing.

Eiry W. Roberts: Yes. We're just going through all the information from the trial. We also shared the top line today. I mean, I think we'll be - once we understand data sets and the totality of the data, we'll be able to comment more around where we think this can truly differentiate and will be designed. Well, Jaz will be designing the Phase III trial appropriately so that we can ensure that we always like to do here that we bring the best options to patients that we possibly can.

Eiry Roberts: Hey, guys. Thanks so much for taking the question. Quick question on the OpEx guidance. Maybe just a little bit of color on what's driving the R&D uptick and the decrease in SG&A spend. Thanks so much.

Speaker Change: We've been in the long term care segment now for coming up on two years ago with these with the <unk>.

Speaker Change: Both that we're seeing and the progress that the team is making.

Speaker Change: Today, our long term care is contributing approximately equal to neurology in terms of our overall business and so we're going to continue to develop that.

Matt Abernethy: Yeah. On the R&D front, it's a positive aspect. With all the progress that we've made with our partner programs, like the muscarinic specific data, collaboration, we have a milestone payment that we have to make because we hit certain thresholds. So, for example, in Q1, we had a $6 million expense that's in the R&D line that's associated with some of those milestones, and I guess I forgot Voyager as well. And then we also have more milestone payments that we triggered here in Q2. So from an accounting perspective, and also from a guidance perspective, we don't include that in our R&D guidance or in our P&L until those are actually achieved. So that's the reason for the OpEx increase on R&D.

The phase III trial and appropriately so that we can ensure that we always like to do here to bring the best option to patients that we possibly can.

The phase III trial and appropriately so that we can ensure that we always like to do here. The best option to patients that we possibly can.

Speaker Change: That segment and the only other thing that I would add is that on a relative basis. It's earlier in the overall.

The best option to patients that we possibly can.

Speaker Change: Development phase commercially speaking that is in a sense that we've been in psychiatry and neurology now for seven years within Rosa and less than two years in long term care. So there's still a lot of hcp's that are learning about broken tooth movement disorders.

Thank you. Our next question comes from David Hong with Citigroup. Please go ahead.

Operator: Thank you. Our next question comes from David Hoang with Citigroup. Please go ahead.

David Hoang: Hi, there thanks for fitting me in.

David Hoang: Hi there. Thanks for fitting me in. So, I just had a question on the 770 molecule. This is, I think, the NMDA NR2B allosteric modulator. What would be your expectations there around that mechanism and drug profile and how could that differentiate from what you're seeing with 845? Thanks so much.

David Hoang: So I just had a question on the 770 molecule. This is I think the MBA and are to be allosteric modulator or what would be your expectations, there around that mechanism and drug profile and how could that differentiate from what youre seeing with 84 five thanks so much.

So I just had a question on the 770 <unk> molecule. This is I think the MBA and are to be allosteric modulator or what would be your expectations, there around that mechanism and drug profile and how could that differentiate from what youre seeing with 84 five thanks so much. Thank you.

Speaker Change: Product dyskinesia, and becoming more familiar with <unk> as the most prescribed most preferred remap two inhibitor. So we'll continue to see good growth coming out of long term care going forward.

Speaker Change: Thank you.

Thank you.

Speaker Change: Sure so.

Eiry W. Roberts: Jaz, do you want to comment on that?

Speaker Change: Thank you.

Speaker Change: And actually.

Jaz Singh: Sure. So, NR2B NAM mechanism is a validated mechanism for treatment of depression or potential efficacy even in treatment of system depression. So, the initial study we're looking at is understanding the dose and whether we can determine efficacy. Once we have some data from the Phase I, Phase II studies, we will be able to much better to be able to profile in aware what the efficacy safety profile looks like and how best to position it for further growth.

Matt Abernethy: I'm sure you've also seen the reduction in SG&A spending that we also took down for the quarter, which is. It's basically our review of our cost base and continuing to prioritize where we put our investments. So, the increase isn't directly. I think I had a question from somebody, isn't directly related to the AMPA program. Those increases will likely more translate in 2025. But for 2024, generally speaking, operating expense guidance remains intact outside of the milestone payments to our partners.

<unk>.

Uy Ear: Our next question comes from OE ear with Mizuho. Please go ahead.

Matt. Validated mechanism for or. In our compression or potential efficacy. Treatment resistant depression. Initial studies, we're looking at. Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be a much bigger pool. Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

It is validated mechanism or <unk>.

Validated mechanism for or. In our compression or potential efficacy. Treatment resistant depression. Initial studies, we're looking at. Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be a much bigger pool. Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

In our compression or change.

In our compression or potential efficacy. Treatment resistant depression. Initial studies, we're looking at. Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be a much bigger pool. Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

Even.

Uy Ear: Hi, Good morning, guys. This is lee on for <unk>. Thanks, So much for taking our question. So we were under the impression that four five to differentiate on cognition do you still believe this is the case how else do you expect a four five to differentiate can it also differentiate on onset of action.

Treatment resistant depression.

Treatment resistant depression. Initial studies, we're looking at. Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be a much bigger pool. Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

The initial study we're looking at.

Initial studies, we're looking at. Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be a much bigger pool. Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be much thinner pool.

Understanding the dose and whether we can determine efficacy once we have data from the phase one phase two studies will be a much bigger pool. Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

Profile, where what the safety profile looks like and how best to position it.

Profile and aware, what the efficacy safety profile looks like and how best to position before. Yes.

Speaker Change: Yes, we think that we're just going through all the information from the Tri wheels, you said top line today, I mean, I think it will be less than tangible datasets and the totality of the data we'll be able to comment more around where we think that can truly differentiate and will be designed well jobs will be designing.

Okay.

Yes.

Thank you with almost snacks tweeted.

Operator: Thank you. We'll then move on the next with Ami Fadia with Needham. Please go ahead.

Amit <unk> with Needham. Please go ahead.

Amit: Hi, Good morning, Thanks for squeezing me in.

Ami Fadia: Hi, good morning, Thanks for squeezing me in. I had a quick question on 845. The trial design mentions that patients would have had to have failed the prior treatment? Was that just SSRI or SNRI? Or were there other modalities that patients were either already on a background therapy or have failed at? Thank you.

Speaker Change: The phase III trial and appropriately so that we can ensure that as we always like to do here and bring.

Needham: I had a quick question on April five.

Operator: ... And your next question comes from Mark Goodman with Leerink. Please go ahead.

I had a quick question on April five. John design mentioned that patients. Would've had to athene prior treatment. What that chest, SSRI or SNRI or were there other. Modalities that patients are either already on his background therapy or have framed it. Thank you.

Needham: The trial design mentioned that patients.

John design mentioned that patients. Would've had to athene prior treatment. What that chest, SSRI or SNRI or were there other. Modalities that patients are either already on his background therapy or have framed it. Thank you.

Amit: Would have had to athene prior treatment.

Speaker Change: Bring the best option to patients that we possibly can.

Marc Goodman: Yes, Irene, can you talk about the additional data we're gonna see for crinecerfont at ENDO in June? And then maybe we could just talk about Europe. What's the plans for Europe for crinecerfont, and when are we gonna file, and what the plans are for staffing up? Thanks.

Would've had to athene prior treatment. What that chest, SSRI or SNRI or were there other. Modalities that patients are either already on his background therapy or have framed it. Thank you.

What that chest, SSRI or SNRI or were there other.

What that chest, SSRI or SNRI or were there other. Modalities that patients are either already on his background therapy or have framed it. Thank you.

Modalities that patients are either already on his background therapy or have been debt. Thank you.

Modalities that patients are either already on his background therapy or have framed it. Thank you.

Uy Ear: Thank you. Our next question comes from David Hong with Citigroup. Please go ahead.

Eiry Roberts: Yeah. Let me take the second part first. We're now working on moving to working on the marketing authorization application for Europe, and so the team will be diligently working through that. And I think once we kind of know our timing, we'll be able to communicate that in terms of when we think that will be going in. I mean, in general, the data that we'll see are more information around the demographics, the baseline characteristics, the primary and secondary endpoints, and the tolerability. I mean, we've already shared the top line information already, but and the largest amount of information will become available in the context of our full data publication.

David Hoang: Hi, there thanks for fitting me in.

Speaker Change: Thank you answer the question.

Jaz Singh: Thank you, to answer the question so, the study requires patients who have had non-response to at least one antidepressant. And that could be any that they've taken. We didn't have any specific restrictions as to which one. So, what was seen in the study was a combination of SSRIs, SNRIs, use of conjunctive antipsychotics with propiontis. It's a mix of what the standard of care looks like.

David Hoang: Just had a question on the 770 molecule. This is I think the MBA and are to be allosteric modulator.

The study required patients to have at non sponsored NIS, one antidepressant and that could be any associated and we didn't have any specific restrictions as to which ones.

David Hoang: Would be your expectations, there around that mechanism and construct profiling out to that differentiate from.

And we didn't have any specific restrictions as to which ones. So what was. <unk>. A combination of ssris or cinryze. Jonathan I'll take audience. Beyond <unk>. It makes us what percent of care looks like.

Speaker Change: So what was.

So what was. <unk>. A combination of ssris or cinryze. Jonathan I'll take audience. Beyond <unk>. It makes us what percent of care looks like.

Speaker Change: What youre seeing with 84 five thanks, so much.

<unk>.

<unk>. A combination of ssris or cinryze. Jonathan I'll take audience. Beyond <unk>. It makes us what percent of care looks like.

A combination of Ssris as Sunrise.

A combination of ssris or cinryze. Jonathan I'll take audience. Beyond <unk>. It makes us what percent of care looks like.

Speaker Change: And I'm not sure so.

Jonathan: Jonathan I'll take audience.

Jonathan I'll take audience. Beyond <unk>. It makes us what percent of care looks like.

Speaker Change: And actually now.

Beyond <unk>.

Beyond <unk>. It makes us what percent of care looks like.

Jonathan: It makes us what percent of care looks like.

David Hoang: Validated mechanism or consumer.

It makes us what percent of care looks like.

David Hoang: Or depression or <unk>.

Jonathan: Thank you.

Speaker Change: Thank you Ethan.

Operator: Thank you. Our next question comes from David Amsellem with Piper Sandler. Please go ahead.

David Hoang: Treatment resistant depression.

And our next question comes from David Zalman with Piper Sandler. Please go ahead.

David Hoang: Mitchell cellulose yes.

And our next question comes from David Julian with Piper Sandler. Please go ahead.

David Hoang: The dose and whether we can determine efficacy once we have some data from the phase one phase two studies will be much better.

David Julian: Thanks, Heather the CAH focus question with kinetics, having it.

Eiry Roberts: And we anticipate having a full publication for both pediatric study and the adult study, separately, in the near future.

David A. Amsellem: Thanks. I have a CAH focused question. With crinetics having its data coming up for its orally CTH antagonist. Just wanted to get your thoughts on how you're thinking about that agent and more broadly, the potential for coexistence of multiple novel agents in the broader CAH space? Thank you.

David Hoang: Profiles and aware with efficacy safety profile looks like and how best to position before.

David Julian: Data coming up for its oral ACTH antagonist, just wanted to get your thoughts on.

Data coming up for its oral ACTH antagonist, just wanted to get your thoughts on. How are you thinking about that agent and more broadly the potential for coexistence of multiple novel agents. In the broader <unk>. CAH space. Thank you.

Kevin Gorman: And Mark, I'd like to take this opportunity just to add something on here, in that, you know, you're asking about filing in different regions of the world here. Obviously, the most important region in the world for us with this program is the United States. I can't express enough thanks and gravity to the CAH team, from top to bottom in filing 2 NDAs in the time that it would normally take a company to file 1 NDA. I think that a lot of changes that we've made here at Neurocrine, for the better, are typified by the excellence this team brought to that. That team immediately switched over, into, while doing that in label negotiations that they did for the Ingrezza sprinkle. That team then immediately has switched over to getting ready now.

David Hoang: Yes.

David Julian: How are you thinking about that agent and more broadly the potential for coexistence of multiple novel agents.

How are you thinking about that agent and more broadly the potential for coexistence of multiple novel agents. In the broader <unk>. CAH space. Thank you.

Speaker Change: Thank you <unk>.

David Hoang: <unk> with Needham. Please go ahead.

In the broader.

In the broader <unk>. CAH space. Thank you.

Speaker Change: CAH space. Thank you.

CAH space. Thank you.

Needham: Hi, Good morning, Thanks for squeezing me in.

Speaker Change: Well I mean couple of bank first thing I think it's really great to see so much focused on trying to bring new medicines to patients living with congenital adrenal hyperplasia, both pediatric and adults.

Eiry W. Roberts: Well, I mean, a couple of things. First thing, I think it's really great to see so much focus on trying to bring new medicines patients living with congenital adrenal hyperplasia, both pediatric and adults. It's been a long time coming, I mean, 70 years in the making before getting to the CRINECERFONT data. So, we kind have a flow of CRINECERFONT playing in that space as well. And I think that's great. The second thing is, we're very focused on CRINECERFONT right now. We obviously are ahead. We have very robust Phase III data in both pediatric and adult patients. And as you heard, we just submitted our NDA yesterday. And so we're waiting to see the crinetics information on the NCR2 agonist. And I think that patients with CAH have so few options that additional research in this area is always a good thing. And we're looking forward to our opportunity to serve this patient population hopefully in the very near future.

Needham: I had a quick question on April five.

Needham: The trial design mentioned that patients.

Needham: Would've had to obtained prior treatment.

Speaker Change: What that chest, SSRI or SNRI or were there other.

It's been a long time coming I mean, 70 years in the making before getting to the connected pump basis, though we kind of a flow of kinetics or playing in that space as well and I think that's great.

It's been a long time coming I mean, 70 years in the making to go or getting to interconnect the pump basis. So we kind of a flow of kinetics or playing in that space as well and I think that's great. Second thing is you know we're very focused on connected cars right. Now. We obviously are ahead, we have very robust phase III data in both pediatric and adult patients and as you said, we just submitted our NDA as yesterday and so. We're waiting to see the. Kinetics information on the M and he knows Banksia too. And I think the P. Patients with CAH have so few options that additional research in this area is always a good thing and we're looking forward to our opportunities is the fifth patient populations hopefully in the very near future.

Speaker Change: Modalities Pascal patients are either already on his background therapy or have been debt. Thank you.

Second thing is you know, we're very focused on connected pump right. Now. We obviously are ahead, we have very robust phase III data in both pediatric and adult patients and as you said, we just submitted our NDA as yesterday and so.

Second thing is you know we're very focused on connected cars right. Now. We obviously are ahead, we have very robust phase III data in both pediatric and adult patients and as you said, we just submitted our NDA as yesterday and so. We're waiting to see the. Kinetics information on the M and he knows Banksia too. And I think the P. Patients with CAH have so few options that additional research in this area is always a good thing and we're looking forward to our opportunities is the fifth patient populations hopefully in the very near future.

Speaker Change: Thank you answer the question.

Speaker Change: The study required patients to have at launch sponsors NIS, one AD impressions and that could be any associate and we didn't have any specific restrictions as to which ones.

Kevin Gorman: We don't know whether we're going to have an advisory committee, but we have to assume that we will for CAH. And so the very same members are getting here early this morning in order to continue the preparations for doing that. So, while we have a lot of highly talented employees here, we understand that crinecerfont is an extremely valuable asset to us and will bring an amazing change to CAH patients' lives. So we're throwing everything we can at that, and we're focused right now on the US market.

We are waiting to see the.

We're waiting to see the. Kinetics information on the M and he knows Banksia too. And I think the P. Patients with CAH have so few options that additional research in this area is always a good thing and we're looking forward to our opportunities is the fifth patient populations hopefully in the very near future.

Speaker Change: So what was.

Kinetics information on a M and Union bank tier two.

Kinetics information on the M and he knows Banksia too. And I think the P. Patients with CAH have so few options that additional research in this area is always a good thing and we're looking forward to our opportunities is the fifth patient populations hopefully in the very near future.

Speaker Change: <unk>.

Speaker Change: It's a combination of ssris as Sunrise.

And I think the.

And I think the P. Patients with CAH have so few options that additional research in this area is always a good thing and we're looking forward to our opportunities is the fifth patient populations hopefully in the very near future.

Speaker Change: Attentive analytic onyx.

Patients with CAH.

Patients with CAH have so few options that additional research in this area is always a good thing and we're looking forward to our opportunities is the fifth patient populations hopefully in the very near future.

Speaker Change: Beyond phase.

<unk> option that additional research in this area is always a good thing and we're looking forward to our opportunities existed patient population hopefully in the very near future.

Speaker Change: The mix of 1% of care look like.

Speaker Change: Thank you.

Speaker Change: And our next question comes from David Zalman with Piper Sandler. Please go ahead.

Thank you and I will now turn the call over to Kevin Gorman for closing remarks.

Operator: Thank you. And I will now turn the call over to Kevin Gorman for closing remarks.

David Zalman: Thanks, Heaven CAH focused question with kinetics, having it.

Operator: Thank you. Our next question comes from Miles Minter with William Blair. Please go ahead.

Kevin C. Gorman: Thank you very much you know what.

Kevin Charles Gorman: Thank you very much. You know what I'm struck by from all of the questions this morning is it reaffirms the perception that we all have here and what we're experiencing each day. I would say in over 32 years with the company, I've never seen us in a better position than we are today from every aspect of the company. We're talking about from commercial all the way to late-stage clinical trials and NDA submissions. And then clearly into our mid-stage, which 845 has proven itself and then now into our Phase I program. And even several of the questions we're reaching back into what you will learn over the next 24 months is one heck of a robust research pipeline that's making its way into the clinic.

David Zalman: Data coming up for its oral ACTH antagonist, just wanted to get your thoughts on.

Kevin C. Gorman: I was struck by some of the questions. This morning is it reaffirms.

You know what I'm struck by some of the questions. This morning is it reaffirms the. The perception that we all have here and what we're experiencing each day I would say in over 32 years with the company I've never seen us in a better position than we are today from every aspect of the company, we're talking about from commercial. All the way through late stage clinical trials and NDA submissions and then clearly into our mid stage, which eight four filed has proven itself and then now into our phase one programs and even several of the questions we're reaching back into. What you will learn over the next 24 months. One heck of a robust. Recent pipeline, that's making its way into the clinic.

Myles Minter, Ph.D.: Hey, guys. Congrats on the quarter. Just a quick question on if you've tested any of your cholinergic assets across the board in rabbits for preclinical tox studies, just, you know, given one of your peer molecules got put on hold for seeing that signal. Thanks.

David Zalman: How are you thinking about that agent and more broadly the potential for coexistence of multiple novel agents.

Kevin C. Gorman: The perception that we all have here and what we're experiencing each day I would say I mean over 32 years with the company I've never seen.

The perception that we all have here and what we're experiencing each day I would say in over 32 years with the company I've never seen us in a better position than we are today from every aspect of the company, we're talking about from commercial. All the way through late stage clinical trials and NDA submissions and then clearly into our mid stage, which eight four filed has proven itself and then now into our phase one programs and even several of the questions we're reaching back into. What you will learn over the next 24 months. One heck of a robust. Recent pipeline, that's making its way into the clinic.

David Zalman: In the broader.

David Zalman: CAH space. Thank you.

Absent a better position than we are today from every aspect of the company. We're talking about from commercial all the way through late stage clinical trials and NDA submissions and then clearly into our mid stage, which aid for file has proven itself and then now into our phase one.

Speaker Change: Well I mean couple of bank per Se I think it's really great to see so much focused on trying to bring new medicines to patients living with congenital adrenal hyperplasia, both pediatric and adult.

Eiry Roberts: Yeah, no, I think all I can say there is that we are highly confident in the preclinical packages for each of the muscarinic agonists that we've taken into the clinic, and obviously, those have been scrutinized by regulators to enable the clinical testing to start, and we have not experienced that issue.

All the way through late stage clinical trials and NDA submissions and then clearly into our mid stage, which eight four filed has proven itself and then now into our phase one programs and even several of the questions we're reaching back into. What you will learn over the next 24 months. One heck of a robust. Recent pipeline, that's making its way into the clinic.

Speaker Change: It's been a long time coming I mean, 70 years in the making or getting into connected update is that we kind of applaud kinetics or playing in that space as well and I think that's great.

Programs and even several of the questions, we're reaching back into.

Kevin Gorman: Yeah, maybe, Miles, with this, Kyle, just add to that. We've completed all the long-term tox 4, 5, 6, 8, so the molecule looks pretty good, so we're excited to move that program forward.

Speaker Change: Second thing is we're very focused on connected cars right. Now. We obviously are ahead, we have very robust phase III data in both pediatric and adult patients and as you said, we just submitted our NDA yesterday and so.

What you will learn over the next 24 months is.

What you will learn over the next 24 months. One heck of a robust. Recent pipeline, that's making its way into the clinic.

One heck of a robust.

One heck of a robust. Recent pipeline, that's making its way into the clinic.

Myles Minter, Ph.D.: To be clear, did you use rabbits?

Recent pipeline, that's making its way into the clinic.

Speaker Change: The best days of Neurocrine, there are in front of us by far I have no doubt about that.

Eiry Roberts: I mean, in our understanding, rabbits are usually used in the repro tox setting and not in the broader toxicity. So the species selection for our tox programs are chosen on the basis of the molecules themselves and what is generally used in that, in toxicity testing. And we have full preclinical packages enabling this in human for all of the molecules that have gone into the clinic. And as Kyle alluded to, that includes the longer term chronic tox. We have not done unnecessary or, you know, program beyond that, what is necessary to determine the safety profile to enter the clinic.

Kevin Charles Gorman: The best days of Neurocrine are in front of us by far. I have no doubt about that. I want to remind you, what we talked about at great length in our R&D day, and what we outlined is that we understand that in - we're tackling difficult diseases, and these are psychiatric diseases that we're tackling that are very difficult. And one of the ways that we do that is we attack them with multiple mechanisms. And in addition, we choose mechanisms that can have multiple disease applications. Thus far, this is proofing to working out for us. Is it going to guarantee 100% success? No. But will it ensure success? Absolutely. And so, that's how we're conducting ourselves. And I really appreciate all the questions this morning. We look forward to talking to you about all of our pipeline projects and INGREZZA and INGREZZA SPRINKLE going forward. And thank you very much.

Before I have no doubt about that. I want to remind you what we talked about at great length in our R&D day. And what we outlined is that we understand that and we're tackling difficult diseases. And these are psychiatric diseases that we're tackling that are very difficult. And one of the ways that we do that as we attack them with multiple mechanisms and. And in addition, which is a mechanism that can have multiple disease applications. Thus far and this is proving to to working out for us is it going to guarantee you 100% success. Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

Speaker Change: We are waiting to see the.

I want to remind you what we talked about at great length in our R&D day.

Speaker Change: Kinetic information on a M and NCR too.

I want to remind you what we talked about at great length in our R&D day. And what we outlined is that we understand that and we're tackling difficult diseases. And these are psychiatric diseases that we're tackling that are very difficult. And one of the ways that we do that as we attack them with multiple mechanisms and. And in addition, which is a mechanism that can have multiple disease applications. Thus far and this is proving to to working out for us is it going to guarantee you 100% success. Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

Speaker Change: And I think that.

What we outlined is that we understand that and we're tackling difficult diseases.

And what we outlined is that we understand that and we're tackling difficult diseases. And these are psychiatric diseases that we're tackling that are very difficult. And one of the ways that we do that as we attack them with multiple mechanisms and. And in addition, which is a mechanism that can have multiple disease applications. Thus far and this is proving to to working out for us is it going to guarantee you 100% success. Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

Speaker Change: Patients with CAH.

Speaker Change: You option that additional research in this area is always a good thing and we're looking forward to our own specific patient populations hopefully in the very near future.

And these are psychiatric diseases that that we're tackling that are very difficult and one of the ways that we do that as we attack them with multiple mechanisms.

And these are psychiatric diseases that we're tackling that are very difficult. And one of the ways that we do that as we attack them with multiple mechanisms and. And in addition, which is a mechanism that can have multiple disease applications. Thus far and this is proving to to working out for us is it going to guarantee you 100% success. Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

And one of the ways that we do that as we attack them with multiple mechanisms and. And in addition, which is a mechanism that can have multiple disease applications. Thus far and this is proving to to working out for us is it going to guarantee you 100% success. Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

And in addition, which is a mechanism that can have multiple disease applications.

And in addition, which is a mechanism that can have multiple disease applications. Thus far and this is proving to to working out for us is it going to guarantee you 100% success. Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

Speaker Change: Thank you and I will now turn the call over to Kevin Gorman for closing remarks.

As far as this is proving to to working out for US is it going to guarantee a 100% success.

Kevin C. Gorman: Thank you very much.

Kevin C. Gorman: What I'm struck by from all of the questions. This morning is it reaffirms the.

Yes.

Kevin Gorman: Thanks for the question.

Speaker Change: Milligan insurer success absolutely.

Well and ensure success absolutely and so that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and it ramps up and aggressive sprinkled going forward and I. Thank you very much.

Operator: Our next question comes from Jeff Hung with Morgan Stanley. Please go ahead.

So that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and and wraps up an aggressive sprinkled going forward and I. Thank you very much.

Kevin C. Gorman: The perception that we all have here and what we're experiencing each day I would say I mean over 32 years with the company I've never seen us in a better position than we are today from every aspect of the company, we're talking about from commercial.

Marc Goodman: Thanks for taking my question. For the upcoming luvadaxistat data, what do you need to see to advance into phase III, and what kind of improvement in cognitive impairment would be clinically meaningful? Thanks.

Speaker Change: And this does conclude today's program. Thank you for your participation you may disconnect at anytime.

Eiry Roberts: I'm sorry. I wonder if you could repeat that? I didn't catch the very beginning of the question.

Kevin C. Gorman: All the way to late stage clinical trials and NDA submission.

Operator: And this does conclude today's program. Thank you for your participation. You may disconnect at any time.

Thank you for your participation you may disconnect at anytime.

Marc Goodman: Yeah, sure. So this is for luvadaxistat. What do you need to see-

Kevin C. Gorman: Then clearly into our mid stage, which a four hour. It has proven itself and then now into our phase one program and even several of the questions we're reaching back into.

Eiry Roberts: Oh, okay.

Marc Goodman: to advance to phase III, and what kind of improvement in cognitive impairment would be clinically meaningful?

Eiry Roberts: Okay, I'm going to get Jas to answer that one, because he can give a little bit of context about the first phase II study that we did, and obviously how we're thinking about that in the context of those peak studies.

Kevin C. Gorman: What you will learn over the next 24 months.

Kevin C. Gorman: One heck of a robust.

Kevin C. Gorman: Recent pipeline, that's making its way into the clinic.

Jaskaran Singh: Sure. Thanks, Irene. So in the initial study that was done with luvadaxistat, keep in mind that the study was primarily done to address negative symptoms of schizophrenia, and the cognition was secondary in it. We saw, you know, a meaningful effect size of 0.3 in the data in one of the doses there. But more importantly, you saw also improvement in function. That was, of course, that hadn't really been seen before. If we can replicate that information in the ongoing study, that would be a substantial advance over... There's absolutely nothing approved over there. So I think even that's, you know, it's a substantial advancement and benefit to patients.

Kevin C. Gorman: The best days of Neurocrine, there are in front of us.

Speaker Change: I have no doubt about that.

Speaker Change: I want to remind you what we talked about at great length in our R&D day.

Speaker Change: And what we outlined is that we understand that and we're tackling difficult diseases.

Speaker Change: And these are psychiatric diseases that that we're tackling that are very difficult and one of the ways that we do that as we attack them with multiple mechanisms.

Speaker Change: And in addition, which is a mechanism that can have multiple disease applications.

Speaker Change: As far as this is proving to to working out for US is it going to guarantee a 100% success.

Marc Goodman: Thank you.

Speaker Change: Yes.

Speaker Change: But we'll and ensure success absolutely.

Operator: ... The question comes from Laura Chico with Wedbush Securities. Please go ahead.

Speaker Change: So that's how we're conducting ourselves and I really appreciate all the all the questions. This morning look forward to talking to you about all of our all of our pipeline projects and impress us an aggressive sprinkled going forward and I. Thank you very much.

[Analyst 1]: Hi, good morning, and thanks very much for taking the question. Just one quick follow-up. So with respect to the 845 program, what's your confidence that you've adequately explored dose ranging sufficiently to advance the program? I guess I'm trying to understand, as you said, coming out of these FDA regulatory discussions, do you anticipate needing additional dose ranging studies before entering a registrational program? Thank you.

[Analyst]: Hi, good morning, and thanks very much for taking the question. Just one quick follow-up. So with respect to the 845 program, what's your confidence that you've adequately explored dose ranging sufficiently to advance the program? I guess I'm trying to understand, as you said, coming out of these FDA regulatory discussions, do you anticipate needing additional dose ranging studies before entering a registrational program? Thank you.

Speaker Change #100: And this does conclude today's program. Thank you for your participation you may disconnect at any time.

Speaker Change #100: Goodbye.

Speaker Change #100: [music].

Eiry Roberts: Yeah, I'll make a couple of comments and then ask Jas to comment as well. I mean, I think if you look at the preclinical data and the phase 1 data, there was a broad range of doses that were tested. One of the things that Takeda did extremely well in the translational medicine space was look at pharmacodynamic effects using transcranial magnetic stimulation and also cognitive testing and other pharmacodynamic measures in the phase 1 setting. So we had a really good handle on pharmacodynamically effective doses going into the initial phase 2 evaluation. We completed a small safety study first in phase 2, and then I think we were highly confident in the doses selected for the phase 2 study that we just read out.

Eiry Roberts: You know, and also there were 2 doses in this study rather than just 1, which is, you know, common in some phase 2 settings. And so I think in our discussions with the agency, there's a lot of information to support the selected doses up to this point and how we might move forward. Jas, I don't know if you want to add anything there.

Matt Abernethy: I don't have anything to add.

Eiry Roberts: Oh, sure.

Operator: Thank you. Our next question comes from Danielle Brill with Raymond James. Please go ahead.

Danielle Brill: Good morning, guys. Thanks so much for the question. Just a quick one on INGREZZA. I was wondering if you could share the average revenue per patient in Q1. Thank you.

Matt Abernethy: Yeah. The average revenue per patient, if I heard you right, Q1 is always the most challenging quarter where patients go through reauthorization. And so as a result of that, the refill rate per patient typically goes down. And so, I think that that's something that we've talked about historically, which has caused pressure on our sequential growth from Q4 to Q1. And this is the third straight year where we've had sequential growth, so the team did a really great job ensuring that patients stayed on medicine and tried to close that gap for that refill rate.

Matt Abernethy: Now, on net revenue per script, if you're asking on the dollar front, as I said last call, we do expect our net revenue per script for the year for 2024 to be somewhere over $5800, and that compares to $5600 in 2023. Then the last piece is we typically have seasonal pressure on gross net in Q1 as a result of the Medicare Part D donut hole and commercial copay resets. So, you do have a bit of a higher discount, a couple points in Q1 that then recovers in Q2 and beyond. So hopefully that gives you the components to answer your question.

Operator: Thank you. Our next question comes from Yatin Suneja with Guggenheim. Please go ahead.

[Analyst 1]: Good morning. This is Thelma for Yatin, and thanks for taking our question. So you recently initiated a phase I study with the next generation of VMAT2 inhibitor. I'm just curious, what are the key differentiating properties of this agent versus INGREZZA? And what do you want to see from the phase I? Thank you.

[Analyst]: Good morning. This is Thelma for Yatin, and thanks for taking our question. So you recently initiated a phase I study with the next generation of VMAT2 inhibitor. I'm just curious, what are the key differentiating properties of this agent versus INGREZZA? And what do you want to see from the phase I? Thank you.

Eiry Roberts: Yeah. So, I'm not quite sure I fully heard the question, breaking up but I think it was about our next-generation VMAT2 inhibitor. We're pretty excited about getting this molecule into the clinic as, as you can imagine, INGREZZA valbenazine is an incredibly well-performing molecule. And so in terms of finding a next generation that can potentially be even better, the bar is really, really high. And, so but we're very happy with the molecule that we have in hand right now. We're just starting the phase 1. In that phase 1 setting, obviously, we'll be interested in the tolerability, PK profile and how that might differentiate from valbenazine. And that would include the potential for use in childhood dyskinesia as an indication, but obviously beyond that, into other neuropsychiatric disorders.

Eiry Roberts: As we get some of that information and we understand the potential areas of differentiation, we'll obviously speak more about that.

Operator: Thank you. Our next question comes from Sumant Kulkarni with Canaccord. Please go ahead.

[Analyst 1]: Good morning. Thanks for taking my question. On your Phase 1 studies for 567, 569, and 570 muscarinic agonists, are there any differences in enrollment criteria by age, and are any of those being specifically run in older adults?

[Analyst]: Good morning. Thanks for taking my question. On your Phase 1 studies for 567, 569, and 570 muscarinic agonists, are there any differences in enrollment criteria by age, and are any of those being specifically run in older adults?

Eiry Roberts: Yeah, I mean, so the initial studies for each of those that we're just starting up are in healthy subjects of the kind of, a normal, age range, not including elderly subjects. However, each of those plans is designed in order to address the specific questions relating to those molecules. And so we do understand that, particularly for those, molecules that impact both, M4 and M1, that cognition can be an important part of the potential indication space moving forward. And so similarly to what was done for NBI-568, we will be exploring those molecules in, older subjects, at some point during the plan to enable us to be ready for the, chosen Phase 2 path forward.

[Analyst] (Medium): Thank you.

Operator: Our next question comes from Evan Steigerman with BMO. Please go ahead.

Evan Seigerman: Hi, guys. Thank you so much for taking the question. I haven't really heard much recently on your push for INGREZZA in the Long-Term Care market. Maybe highlight what you're doing in this space, as this used to be a pretty big part of the narrative, or at least where we were going to see INGREZZA growth. Thank you.

Eric Benevich: Yeah, thanks for the question. It's still an important part of the Ingrezza growth story. You know, frankly, we're seeing good progress across all three of our business segments in psychiatry, neurology, and long-term care. You know, we've been in the long-term care segment now for coming up on two years and really pleased with the growth that we're seeing and the progress that the team is making. Today, long-term care is contributing approximately equal to neurology in terms of our overall business. And so, you know, we're going to continue to develop that, that segment.

Eric Benevich: The only other thing that I would add is that, on a relative basis, it's earlier in the overall development phase, commercially speaking, that is, in the sense that, you know, we've been in psychiatry and neurology now for seven years with INGREZZA and less than two years in Long-Term Care. So there's still a lot of HCPs that are learning about drug-induced movement disorders and tardive dyskinesia and becoming more familiar with INGREZZA as the most prescribed, most preferred VMAT2 inhibitor. So we'll continue to see good growth coming out of Long-Term Care going forward.

Evan Seigerman: Thank you.

Operator: Our next question comes from Uy Ear with Mizuho. Please go ahead.

Uy Ear: Hi, good morning, guys. This is Leo on for Uy. Thanks so much for taking our question. So we were under the impression that 845 could differentiate on cognition. Do you still believe this is the case? How else do you expect 845 to differentiate? Could it also differentiate on onset of action? Thanks.

Eiry Roberts: Yeah, we're just going through all the information from the trial. We obviously shared the top line today. I mean, I think we'll be... Once we understand the full data set and the totality of the data, we'll be able to comment more around where we think this can truly differentiate, and we'll be designing. Well, Jaskaran will be designing the phase three plan appropriately so that we can ensure that, as we always like to do here, that we bring the best options to patients that we possibly can.

Operator: Thank you. Our next question comes from David Hong with Citigroup. Please go ahead.

[Analyst] (Citigroup): Hi there. Thanks for fitting me in. So I just had a question on the 770 molecule. This is, I think, the NMDA NR2B allosteric modulator. What would be your expectations there around that mechanism and, and drug profile, and how could that differentiate from, you know, what you're seeing with 845? Thanks so much.

Eiry Roberts: Do you want to comment on that?

Eric Benevich: Sure. You know, the NR2B mechanism is a validated mechanism for treatment of depression or, you know, potentially efficacy in treatment-resistant depression. The initial study we're looking at is understanding the dose and whether we can determine efficacy. I think once we have some data from the phase 1, phase 2 studies, we'll be able to much better be able to profile in a rare what the efficacy safety profile looks like and how best to position it forward for further growth.

Operator: Thank you. We'll go next with Ami Shahia with Medium. Please go ahead.

[Analyst] (Medium): Hi, good morning. Thanks for squeezing me in. I had a quick question on 845. The trial design mentions that patients would have had to have failed the prior treatment. Was that just SSRI or SNRI, or were there other modalities that patients were either already on as background therapy or had failed it? Thank you.

Eric Benevich: Thank you again for the question. The study required patients to have had, you know, non-response to at least one antidepressant, and that could be any that they've taken. We didn't have any specific restrictions as to which ones. What was seen in the studies was a combination of SSRIs, SNRIs, use of adjunctive antipsychotics with bupropion. It's a mix of what the standard of care looks like.

[Analyst] (Medium): Thank you.

Operator: Our next question comes from David Zeilin with Piper Sandler. Please go ahead.

David Amsellem: Thanks. I have a CAH-focused question. With Crinetics having its data coming up for its orally ACTH antagonist, just want to get your thoughts on how you're thinking about that agent and, and more broadly, the potential for coexistence of multiple novel agents in the broader CAH space. Thank you.

Eiry Roberts: ... Well, I mean, a couple of things. First thing, I think it's really great to see so much focus on trying to bring new medicines to patients living with congenital adrenal hyperplasia, both, you know, pediatric and adult. It's been a long time coming, I mean, 70 years in the making before getting to the crinecerfont data. So we kind of applaud Crinetics for playing in that space as well, and I think that's great. The second thing is, you know, we're very focused on crinecerfont right now. We obviously are ahead. We have very robust phase 3 data in both pediatric and adult patients. And, as you heard, we just submitted our NDAs yesterday. And so, you know, we're waiting to see the Crinetics information on the NCR2 antagonist.

Eiry Roberts: I think that, you know, patients with CAH have so few options that additional research in this area is always a good thing. You know, we're looking forward to our opportunity to serve this patient population, hopefully in the very near future.

Operator: Thank you. And I will now turn the call over to Kevin Gorman for closing remarks.

Kevin Gorman: Thank you very much. You know, what I'm struck by from all of the questions this morning is it reaffirms the perception that we all have here and what we're experiencing each day. I would say in over 32 years with the company, I've never seen us in a better position than we are today, from every aspect of the company. We're talking about from commercial all the way to late stage clinical trials, and NDA submissions, and then clearly into our mid stage, which NBI-845 has proven itself, and then now into our phase 1 programs. And even several of the questions we're reaching back into what you will learn over the next 24 months is one heck of a robust research pipeline that's making its way into the clinic.

Kevin Gorman: The best days of Neurocrine are in front of us, by far. I have no doubt about that. I want to remind you what we talked about at great length in our R&D day. And what we outlined is that we understand that we're tackling difficult diseases, and these are psychiatric diseases that we're tackling that are very difficult. And one of the ways that we do that is we attack them with multiple mechanisms. And in addition, we choose mechanisms that can have multiple disease applications. So thus far, this is proving to working out for us. Is it going to guarantee 100% success? No. But will it ensure success? Absolutely. And so that's how we're conducting ourselves, and I really appreciate all the questions this morning.

Kevin Gorman: look forward to talking to you about all of our pipeline projects and INGREZZA and INGREZZA sprinkles going forward. And I thank you very much.

Operator: This does conclude today's program. Thank you for your participation. You may disconnect at any time.

Q1 2024 Neurocrine Biosciences Inc Earnings Call

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