Q3 2023 Neurocrine Biosciences Inc Earnings Call

October 31, 2023

Operator: ---Good day everyone, and welcome to the Neurocrine Biosciences reports Third Quarter results. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question, and answer session. You May register to ask questions at any time by pressing the start and one in your telephone keypad. You may withdraw yourself from the queue by pressing the pound key. 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.

Operator: Good day, everyone, and welcome to the Neurocrine Biosciences reports third quarter results. At this time, all participants are in a listen-only mode. Later you will have the opportunity to ask questions during the question-and-answer session. You may register to ask questions at any time by pressing the star and one on your telephone keypad. You may withdraw yourself from the queue by pressing the pound key. 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 Tchida, Vice President of Investor Relations. Please go ahead.

Good day everyone, and welcome to the Neurocrine Biosciences reports Third Quarter results. At this time, all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question, and answer session. You May register to ask questions at any time by pressing the start and one in your telephone keypad. You may withdraw yourself from the queue by pressing the pound key. 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 to Schloss Vice President of Investor Relations. Please go ahead.

There's reports third quarter results at this time, all participants are in a listen only mode.

Later, you will have the opportunity to ask questions. During the question and answer session you.

You May register to ask questions at any time by bridging to start in one go your telephone keypad.

You may withdraw yourself from the queue by breaking the pound key.

Please note. This call is being recorded and that will be standing by should you need any assistance.

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

Todd Tushla: Good morning. Happy Halloween, and thanks for joining Neurocrine's Q3 2023 earnings call. I'm pleased to be joined by Kevin Gorman, our Chief Executive Officer; Matt Abernethy, our Chief Financial Officer; Eiry Roberts, our Chief Medical Officer; Eric Benevich, our Chief Commercial Officer; and Kyle Gano, our Chief Business Development and Strategy Officer. During today's call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings. After prepared remarks, we're going to try and get to all of your questions. So Kevin, take it away.

Todd Tushla: Good morning. Happy Halloween, and thanks for joining Nordstrom Third Quarter 2023 earnings call. I'm please to be joined by Kevin Gorman, our Chief Executive Officer, Matt Abernethy, our Chief Financial Officer, Eiry Roberts, our Chief Medical Officer, Eric Benevich, our Chief Commercial Officer, and Kyle Gano, our Chief Business Development and Strategy Officer.

He used to be joined by Kevin Gorman, Our Chief Executive Officer, Matt Abernethy, Our Chief Financial Officer, Larry Roberts, Our Chief Medical Officer, Eric <unk>, Our Chief commercial officer, and Karl Ganoe, Our Chief business development and strategy officer during.

During today's call, we will be making forward looking statements. These statements are subject to certain risks, and uncertainties, and our actual results may differ materially. I encourage you to review the risk factors discussed in our latest SEC filings after prepared remarks, we're going to try, and get to all of your questions. So Kevin take it away.

George you to review the risk factors discussed in our latest SEC filings after prepared remarks, we're going to try and get to all of your questions. So Kevin take it away.

Kevin Gorman: Thank you, Todd, and good morning, everyone. It's been an a very, very good quarter. I'm not going to go into really any detail. I think everyone else who's going to be talking on the call will. And as always, we just want to spend as much time with your questions as possible. What I will say is that it's rare that you get to announce so much progress from a clinical standpoint with CAH, from a regulatory standpoint with the Huntington's approval, and then the outstanding work by our commercial and field medical units in bringing INGREZZA to so many patients and to having the success we're having there. That's all I really want to start out with today. So much to talk about.

Kevin Gorman-CEO: Thank you Todd, and good morning everyone. It's been a very, very good Quarter, I'm not going to go into really any detail. I think everyone else is going to be talking on the call well, and as always we just wanted to spend as much time with your questions as part as possible. What I will say is that, it's rare that you get to announce so much progress, from a clinical standpoint with CAH from irregularity, a regulatory standpoint, with the Huntington's approval, and then the outstanding work by our commercial, and field medical units, in bringing Ingrazza has so many patients into having the success, we're having that, that's all I really wanted to start out with today. So much to talk about, so what I'd like to do is I'd like to turn it over to Matt right now. Thank you.

It's been a very very good quarter I'm not going to go into really any detail.

Everyone else is going to be talking on the call world and as always we just wanted to spend as much time with your questions as part as possible. What I will say is that it's rare that you get to announce so much progress from a clinical standpoint with CAH from irregularity.

The regulatory standpoint, with the Huntington's to approval and then the outstanding work by our commercial and field medical units in bringing in Gaza has so many patients into having the success. We're having that that's all I really wanted to start out with today. So much to talk about so what I'd like to do.

Kevin Gorman: So what I'd like to do is I'd like to turn it over to Matt right now. Thank you.

As I'd like to turn it over to Matt right now thank you.

Matt Abernethy: ... Good morning. Between our positive Phase III results in CAH, record INGREZZA sales, and solid cash flow generation, we had an incredible quarter. During the quarter, INGREZZA sales were $486 million, reflecting 29% year-over-year growth. The INGREZZA commercial, marketing, and medical teams are doing an excellent job continuing to build and develop the tardive dyskinesia market. With INGREZZA net sales through Q3 at approximately $1.34 billion, we are increasing our guidance range to $1.82 to $1.84 billion. Our financial profile strengthened in Q3, resulting in non-GAAP diluted earnings per share of $1.54 and over $1.5 billion in cash at quarter end. We continue to prioritize our capital towards growing INGREZZA and both expanding and advancing our pipeline.

Matthew Abernethy - CFO: Good morning, between our positive Phase III results from CAH record and growth of sales, and solid cash flow generation, we had an incredible Quarter. During the Quarter, and growth in sales were $486 million, reflecting 29% year over year growth. The aggressive commercial marketing, and medical teams are doing an excellent job continuing to build and develop the Tardive Dyskinesia market.

During the quarter and growth in sales were $486 million, reflecting 29% year over year growth.

The aggressive commercial marketing and medical teams are doing an excellent job continuing to build and develop the tardive dyskinesia market.

With the growth in net sales, grew Q3 at approximately $1.34 billion, we are increasing our guidance range to $1.82 to $1.84 billion. Our financial profile has strengthened in Q3, resulting in non-GAAP diluted earnings per share of $1.54 cents, and over $1.5 billion in cash at Quarter end, we continued to prioritize our capital towards growing, and growth, in both expanding, and advancing our pipeline.

And over $1 $5 billion in cash at quarter end, we continued to prioritize our capital towards growing and growth.

In both expanding and advancing our pipeline.

Matt Abernethy: As we mentioned during a recent call, we will be hosting an Analyst Day on 5 December. The agenda will be focused on our R&D strategy and include preclinical and clinical pipeline updates. We will also feature a panel discussion on congenital adrenal hyperplasia, centered on addressing the challenges of current therapies for patients, caregivers, and clinicians. We look forward to seeing you, all of you in New York. With this, I will now hand the call over to Eric Benevich, our Chief Commercial Officer. Eric?

As we mentioned during the recent call, we will be hosting an analyst day on December 5th, the agenda will be focused on our R&D strategy include preclinical, and clinical pipeline update. We'll also feature a panel discussion on congenital adrenal hyperplasia, centered on addressing the challenges of current therapies for patients, caregivers, and clinicians. We look forward to seeing all of you in New York, with this I will now hand the call over to Eric Benevich, our Chief Commercial Officer, Eric.

Will also feature a panel discussion on congenital adrenal hyperplasia centered on addressing the challenges of current therapies for patients caregivers and clinicians we look forward to seeing all of you in New York with this I will now hand, the call over to Eric <unk>, Our Chief Commercial Officer Eric.

Eric Benevich: Thanks, Matt. Q3 2023 was a great quarter for INGREZZA, with both strong continued growth from our TD franchise and the initial rollout of the new HD Chorea indication, which I'll discuss later. It's been 6 years since our initial launch, and I continue to be impressed with our team's ability to help improve diagnosis and treatment rates for patients living with tardive dyskinesia, and our just-announced increase to the full-year guidance range reflects our confidence in continued strong growth. In the half dozen years since the launch, we've grown the diagnosis rate of TD from low single digits to around 35% of the prevalent population. While this is great progress, it also means that about two-thirds of the roughly 600,000 patients who suffer from TD have not yet been diagnosed, much less treated with a VMAT2 inhibitor like INGREZZA.

Eric Benevich: Thanks, Matt. Q3 2023 was a great Quarter for Ingrazza, with both strong continued growth from our TD franchise, and the initial rollout of the new HD chorea indication, which I'll discuss later. It's been six years since our initial launch, and I continue to be impressed with our team's ability to help to improve diagnosis in treatment rates in patients with Tardive Dyskinesia, and our just announced increase to the fourth year guidance rank, reflects our confident, and continuous strong growth.

It's been six years since our initial launch, and I continue to be impressed with our team's ability to help improve diagnosis, and treatment rates for patients living with Tardive Dyskinesia, and our just announced increase to the full year guidance range reflects our confidence in continued strong growth.

Our initial launch and I continue to be impressed with our team's ability to help improve diagnosis and treatment rates for patients living with tardive dyskinesia, and our just announced increase to the full year guidance range reflects our confidence in continued strong growth.

In the half dozen years since the launch, we've grown the diagnosis rate of TD, from low single digits to around 35% of the prevalent population. While this is great progress, it also means that about two thirds of the roughly 600,000 patients who suffer from TD has not yet been diagnosed, much less treated with VMAT-2 inhibitor like Ingrazza. Net, net, we clearly have much work to do to help more TD patients get a diagnosis for their uncontrollable movements, and have the option to be treated.

Eric Benevich: Net-net, we clearly have much work to do to help more TD patients get a diagnosis for their uncontrollable movements and have the option to be treated. In August, we were excited by the FDA approval of the new indication for the treatment of adults with chorea associated with Huntington's disease. Now we have an opportunity to help yet another patient community in need, the many thousands of those HD patients who today continue to suffer with untreated chorea. With approval occurring just a few short months ago, we are in the early stages of introducing INGREZZA to the HD community, but I can say that early feedback has been encouraging. Just as in TD, INGREZZA offers meaningful and differentiated benefits for HD chorea patients, including high selectivity for VMAT2, rapid and sustained efficacy, good tolerability, simple one capsule, once daily dosing, and comprehensive support programs.

Net net we clearly have much work to do to help more TD patients get a diagnosis for their uncontrollable movements and have the option to be treated.

In August, we were excited by the FDA approval of the new indication for the treatment of adults with chorea associated with Huntington's disease. Now, we have an opportunity to help yet another patient community in need, that many thousands of those HD patients who today continue to suffer with untreated chorea. With approval occurring just a few short months ago, we are in the early stages of introducing Ingrazza to the HD community, but I can say that early feedback has been encouraging.

With approval occurring just a few short months ago. We are in the early stages of introducing and graduate to the HD community, but I can say that early feedback has been encouraging.

Eric Benevich: Just as in TD, INGREZZA offers meaningful and differentiated benefits for HD chorea patients, including high selectivity for VMAT2, rapid and sustained efficacy, good tolerability, simple one capsule, once daily dosing, and comprehensive support programs.

Just as in TD, Ingrazza offers meaningful, and differentiated benefits for HD chorea patients, including high selectivity for VMAT-2, rapid, and sustained efficacy ,good tolerability, simple one capsule once daily dosing, and comprehensive support programs. These are the reasons why Ingrazza is the most prescribed VMAT-2 inhibitor, and I'm confident that these attributes will translate well to the HD chorea community.

Simple one capsule once daily dosing and comprehensive support programs. These are the reasons why and graduates the most prescribed <unk> two inhibitor and I'm confident that these attributes will translate well to the HD Korea community.

Eric Benevich: These are the reasons why INGREZZA is the most prescribed VMAT2 inhibitor, and I'm confident that these attributes will translate well to the HD chorea community. I'd like to close by congratulating our clinical development colleagues on the recent positive phase 3 results for crinecerfont in both pediatric and adult congenital adrenal hyperplasia patients. The trial results were outstanding. I believe crinecerfont, if approved, has the potential to be a paradigm-changing treatment option. Today, the standard of care utilizing supraphysiological doses of glucocorticoids to suppress excess androgen production creates unwanted side effects and long-term complications. Patients are faced with dealing with the undesirable effects of excess androgen production or the undesirable effects of chronic treatment with high-dose GCs. That's a terrible trade-off, and we believe crinecerfont can establish a new standard of care.

I'd like to close by congratulating, our clinical development colleagues on the recent positive phase III results for Crinecerfont in both pediatric, and adult congenital adrenal hyperplasia patients. The trial results were outstanding. I believe Crinecerfont, if approved has the potential to be a paradigm changing treatment option.

Today, the standard of care utilizing supraphysiologic doses of glucocorticoid to suppressed excess androgen production, creates unwanted side effects, and long term complications. Patients are faced with dealing with the undesirable effects of excess androgen production, or the undesirable effects upon a treatment with high dose GCs.

Patients are faced with dealing with the undesirable effects of excess androgen production.

<unk> T undesirable effects of chronic treatment with high dose <unk>.

That's a terrible trade off, and we believe Crinecerfont can establish a new standard of care. From a commercial perspective, we'll be diligently working to demonstrate the high value we expect Crinecerfont bring to the CAH community. While it is premature to speculate on price, early discussions with payers have been productive and recognizing the benefits that lowering excess androgens and/or reducing GC exposure can bring to patients living with this inherited orphan generic disorder. So, at this time I'll hand the call over to my colleague Dr. Eiry Roberts, our Chief Medical Officer.

Eric Benevich: From a commercial perspective, we'll be diligently working to demonstrate the high value we expect crinecerfont to bring to the CAH community. While it's premature to speculate on price, early discussions with payers have been productive in recognizing the benefits that lowering excess androgens and/or reducing GC exposure could bring to patients living with this inherited orphan genetic disorder. So at this time, I'll hand the call over to my colleague, Dr. Eiry Roberts, our Chief Medical Officer.

From a commercial perspective, we will be diligently working to demonstrate the high value, we expect <unk> to bring to the CAH community. While it is premature to speculate on price early discussions with payers have been productive and recognizing the benefits that lowering excess androgens and or reducing <unk> exposure could bring to patients.

Living with this inherited orphan genetic disorder. So at this time I'll hand, the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer. thank you and good morning. During our earnings call back in February I noted that 2023 promise to be an important year for the new European pipeline.

Living with this inherited orphan genetic disorder. So at this time I'll hand, the call over to my colleague Dr. Ivy Roberts, our Chief Medical

So at this time I'll hand, the call over to my colleague Dr. Ivy Roberts, our Chief Medical Officer.

Eiry Roberts: Thank you, and good morning. During our earnings call back in February, I noted that 2023 promised to be an important year for the Neurocrine pipeline. Today, I could not be more pleased to discuss how we are fulfilling that promise. Q3 featured several significant pipeline milestones, which I will address further, beginning with our on-time FDA approval of INGREZZA for the treatment of chorea associated with Huntington's disease. As Eric noted, the vast majority of patients with HD chorea are currently untreated. Given INGREZZA's attractive product profile and differentiated attributes, I'm confident that Eric and his team will be able to change that. To further differentiate INGREZZA, we've developed the INGREZZA Sprinkle formulation, which the FDA accepted as a new drug application last month.

Eiry Wyn Roberts: Thank you, and good morning. During our earnings call back in February I noted that 2023, promise to be an important year for the new European pipeline. Today, I could not be more pleased to discuss how we are fulfilling that promise. Q3 featured several significant pipeline milestones, which I was address further, beginning with our on time FDA approval of Ingrazza for the treatment of chorea associated with Huntington's disease.

Thank you and good morning.

During our earnings call back in February I noted that 2023 promise to be an important year for the new European pipeline.

Today, I could not be more pleased to discuss how we are fulfilling that promise. Q3 featured several significant pipeline milestones, which I was address further beginning with our on time SBA approval of <unk> for the treatment of chorea associated with Huntington's excuse me.

Q3 featured several significant pipeline milestones, which I was address further beginning with our on time SBA approval of <unk> for the treatment of chorea associated with Huntington's excuse me.

As Eric noted, the vast majority of patients with HD chorea are currently untreated. Given Ingrazza the attractive product profile, and differentiated attributes. I'm confident that Eric and his team will be able to change that. To further differentiate Ingrazza, we've developed the Ingrazza sprinkle formulation, which the FDA accepted as a new drug application last months.

Given the growth is attractive product profile and differentiated attributes I'm confident that Eric and his team will be able to change that.

To further differentiate and Greg that we've developed in graduate sprinkled formulation, which the FDA accepted as a new drug application last months.

Eiry Roberts: This potential new formulation could serve as a preferred alternative administration option for many of the tardive dyskinesia and Huntington's disease patients who have trouble swallowing or simply prefer not to take a whole capsule... With crinecerfont, I believe everyone is familiar with the outstanding top-line, statistically significant, and clinically meaningful results from our adult and pediatric phase 3 CAHtalyst studies. There is much more data to share with you that will become available over time, either in peer-reviewed journal articles or scientific conferences. During our KOL call earlier this month, Dr. Richard Auchus adeptly summarized the hope that the burden of congenital adrenal hyperplasia can someday be alleviated by a simple block and replace strategy, with the androgen excess caused by CAH managed by treatment with crinecerfont, thus providing clinicians with significantly more flexibility in treating the cortisol deficiency caused by CAH with lower levels of exogenous steroids.

This potential new formulation could serve as a preferred alternative administration option, for many of the tardive dyskinesia and Huntington's disease patients, who have trouble swallowing or simply prefer not to take the whole capsule. Turning to connect the bonds, I believe everyone is familiar with the outstanding topline statistically significant, and clinically meaningful results from our adult, and pediatric phase III CAHtalyst study.

Turning to connect the bonds I believe everyone is familiar with.

<unk> topline statistically significant and clinically meaningful results from our adult and pediatric phase III catalyst study.

There is much more data to share with you, that will become available over time, either in peer reviewed journal articles, or scientific conferences. Given our KOL call earlier this month. Dr. Rich Auchus adeptly summarized the hope that the burden of congenital adrenal hyperplasia can someday be alleviated by a simple block and replace strategy. With the androgen excess caused by CAH managed by treatment with Crinecerfont , thus providing clinicians with significantly more flexibility in treating the cortisol deficiency caused by CAH with lower levels of exogenous steroids.

Eiry Roberts: During our KOL call earlier this month, Dr. Richard Auchus adeptly summarized the hope that the burden of congenital adrenal hyperplasia can someday be alleviated by a simple block and replace strategy, with the androgen excess caused by CAH managed by treatment with crinecerfont, thus providing clinicians with significantly more flexibility in treating the cortisol deficiency caused by CAH with lower levels of exogenous steroids.

Given our Kols call earlier this month.

Dr. Rich adept please summarize the hope.

That the burden of congenital adrenal hyperplasia can someday be alleviated by a simple block and replace strategy with the androgen excess caused by CAH managed by treatment with peninsula phones, that's providing clinicians with significantly more flexibility in treating the cortisol deficiency.

Caused by CAH with lower levels of exogenous steroids.

Eiry Roberts: In our upcoming Analyst Day, as Matt mentioned, we are planning a panel discussion focused on the current burden of disease in CAH and how crinecerfont, if approved, could potentially significantly ease that burden for patients, caregivers, and clinicians. On the muscarinic front, our lead asset, NBI-568, continues to enroll very well in the phase II study in schizophrenia. In addition, the clinical trial application for NBI-570, our dual M1/M4 agonist, was accepted, and that program is currently dosing in a phase I study. These two compounds represent just the first of several muscarinic compounds that we will be advancing into the clinic over the coming months. Finally, we remain on track to deliver top-line data for both NBI-352 in focal onset seizure and for NBI-846 in anhedonia in major depressive disorder over the coming weeks.

In our outcoming Analyst Day, as Matt mentioned, we are planning a panel discussion focused on the current burden of disease in CAH and how Crinecerfont, if approved, could potentially significantly ease that burden for patients caregivers and clinicians.

On the muscarinic front, our lead asset NBI-568 continues to enroll very well in the phase II study in schizophrenia. In addition, the clinical trial application NBI-570, our dual M1/M4 agonist was accepted, and that program is currently dosing in a phase I study. These two compounds represent just the first of several muscarinic compounds, that we will be advancing into the clinic over the coming months.

In addition, the clinical trial application for <unk> five seven P M.

<unk> and <unk> agonist was accepted and that program is currently dosing in a phase one study.

These two compounds represent just the first of.

Several muscarinic compounds that we will be advancing into the clinic over the coming months.

Finally, we remain on track to deliver top line data for both NBI-352 and focal onset seizure and for NBI-846 in anhedonia in major depressive disorder over the coming weeks. It has truly been exciting times at Neurocrine this past year, and I look forward to discussing many of our pipeline programs with you at our Analyst Day, I'll stop here and turn it back to Kevin.

Eiry Roberts: It has truly been exciting times at Neurocrine this past year, and I look forward to discussing many of our pipeline programs with you at our Analyst Day. I'll stop here and turn it back to Kevin.

It has truly been exciting times at Neurocrine. This past year and I look forward to discussing many of our pipeline programs with you at our analyst day, I'll stop here and turn it back to Kevin.

Eric Benevich: Thank you, Irene. Nikki, I think we're ready for your questions now.

Kevin Gorman: Thank you, Irene. Nikki, I think we're ready for your questions now.

Thank you Airy. Nicky, I think we're ready for your questions now. And at this time, if you would like to ask a question, please press the star and one on your telephone keypad. You may withdraw your questions at any time, by pressing the pound key.

Kevin Gorman - CEO: Thank you Airy. Nikki, I think we're ready for your questions now.

Operator: And at this time, if you would like to ask a question, please press the star, and one on your telephone keypad. You may withdraw your question at any time, by pressing the pound key. Once again, to ask a question please, press the star and one on your telephone keypad. And will take our first question from Philip Nadeau. Please go ahead, your line is open.

Operator: 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 at any time by pressing the pound key. Once again, to ask a question, please press star and one on your telephone keypad. We'll take our first question from Phil Nadeau with TD Cowen. Please go ahead. Your line is open.

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

We draw your question at any time, they pricing the pound key.

Once again, John asked a question please breakfast star and one on your telephone keypad.

We will take our first question from Madhu with Cowen. Please go ahead. Your line is open.

[Analyst] (TD Cowen): Good morning. Congratulations on a very productive quarter. A question for Eric on INGREZZA. Eric, could you talk in a bit more detail about what was driving the strong sales growth in the quarter? Was it the results of the expanded sales force? Has there been any reduction in telemedicine use? Did the expanded label on Huntington's help? What were the factors that led to such a strong, strong quarter?

Phil Nadeau: Good morning. Congratulations on a very productive quarter. A question for Eric on INGREZZA. Eric, could you talk in a bit more detail about what was driving the strong sales growth in the quarter? Was it the results of the expanded sales force? Has there been any reduction in telemedicine use? Did the expanded label on Huntington's help? What were the factors that led to such a strong, strong quarter?

Philip M. Nadeau: Good morning, congratulations on a very productive quarter, question for Eric on Ingrazza. Eric could you talk a bit more detail about what was driving the strong sales growth in the quarter? What was it the results of the expanded sales force? Has there been any reduction in telemedicine use? Did the expanded label on Huntington's help? What were the factors that led to such a strong quarter?

Eric Benevich: Thanks, Phil. You know, I think it's really just carrying forward the momentum that we've been seeing throughout the year, and obviously, we're experiencing the benefits of the expanded sales team, and frankly I can say that we're growing nicely in all three of the business segments that we're in, neurology, and psychiatry and now LTC. Our DTC campaign continues to perform well.

Eric Benevich: Thanks, Phil. You know, I think it's really just carrying forward the momentum that we've been seeing throughout the year. And obviously, we're experiencing the benefits of the expanded sales team. And frankly, I can say that we're growing nicely in all three of the business segments that we're in, neurology, psychiatry, and now LTC. Our DTC campaign continues to perform well, and there's still a lot of opportunity for growth just based on the fact that the majority of patients with TD as yet remain undiagnosed and untreated. The last thing I'll say is that with regards to the HD chorea rollout, while we're excited about the opportunity to make a difference in that patient population, the impact on the current quarter is minimal.

Thanks, Phil.

I think it's really just carrying forward the momentum that we've been seeing.

Throughout the year and obviously, we're experiencing the benefits of the expanded sales team and frankly I can say that we're growing nicely in all three of the business segments that we're in neurology and psychiatry and now LTC our DTC campaign continues.

Continues to perform well.

And there's still a lot of opportunity for growth just based on the fact that the majority of patients with TD as yet remain diagnosed and untreated. The last thing I'll say is that with regards to the HD. chorea a rollout

And there's still a lot of opportunity for growth just based on the fact that the majority of patients with TD as yet remain undiagnosed and untreated. The last thing I'll say is that with regards to the HD chorea rollout, while we're excited about the opportunity to make a difference in that patient population, the impact on the current quarter is minimal.

TD as yet remain.

Diagnosed and untreated.

untreated. The last thing I'll say is that with regards to the HD. chorea a rollout

The last thing I'll say is that with regards to the HD.

Korea a rollout.

While we're excited about the opportunity to make a difference in that patient population the impact on on the current quarter is minimal.

[Analyst] (TD Cowen): Perfect. Congratulations again on a strong quarter.

Phil Nadeau: Perfect. Congratulations again on a strong quarter.

Philip M. Nadeau: Perfect. Congratulations again on the strong quarter.

Eric Benevich: Thanks, Phil.

Kevin Gorman - CEO: Thanks, Phil.

Operator: We'll move next with Chris Shibutani with Goldman Sachs. Please go ahead. Your line is open.

We'll move next with Chris Shibutani with Goldman Sachs. Please go ahead, your line is open. Great. Thank you very much I had noticed that in the updated slides you have that TD diagnosis rate. Increasing from 30% to 35% of the overall population how much higher do you think this can go and what is a potential in terms of the pace of growth.

Operator: We'll move next with Chris Shibutani with Goldman Sachs. Please go ahead, your line is open.

Chris Shibutani: Great. Thank you very much, I noticed that in the updated slides you have the TD diagnosis rate increasing from 30% to 35% of the overall population. How much higher do you think this can go, and what is a potential in terms of the pace of growth might look like going forward? Thank you.

Paul Choi: Great, thank you very much. I've noticed that in the updated slides, you have the TD diagnosis rate increasing from 30 to 35% of the overall population. How much higher do you think that this can go, and what is a potential in terms of the pace of growth might look like going forward? Thank you.

Chris Shibutani: Great, thank you very much. I've noticed that in the updated slides, you have the TD diagnosis rate increasing from 30 to 35% of the overall population. How much higher do you think that this can go, and what is a potential in terms of the pace of growth might look like going forward? Thank you.

Great. Thank you very much I had noticed that in the updated slides you have that TD diagnosis rate.

Increasing from 30% to 35% of the overall population how much higher do you think this can go and what is a potential in terms of the pace of growth.

Yeah. We haven't given guidance in terms of where we think the diagnosis rate will ultimately net out. Though, personally I can say that we're far from the peak, where we are now. Six years in, you know, we think about 35% of the TD patients have been diagnosed and that's really starting from a baseline at the time of launch in the low single digits. So we continue to increase the rate of TD diagnosis and I feel really good about the progress that we've made

Kevin Gorman - CEO: Yeah. We haven't given guidance in terms of where we think the diagnosis rate will ultimately net out. Though, personally I can say that we're far from the peak, where we are now. Six years in, you know, we think about 35% of the TD patients have been diagnosed and that's really starting from a baseline at the time of launch in the low single digits.

Eric Benevich: Yeah, we haven't given guidance in terms of where we think the diagnosis rate will ultimately net out. Though, you know, personally, I can say that we're, you know, far from, far from the peak where we are now. Six years in, you know, we think about 35% of the TD patients have been diagnosed, and that's really starting from a baseline at the time of launch in the low single digits. So you know, we continue to increase the rate of TD diagnosis, and I feel really good about the progress that we've made. But still, you know, approximately two-thirds of patients remain undiagnosed. And, you know, our research indicates that only about half the time when a patient is diagnosed with TD, are they offered treatment with a VMAT2 inhibitor.

Yes, we haven't given guidance in terms of where we think the diagnosis rate will ultimately net out though.

Personally I can say that we're far from far from the peak, where we are now six years in.

We think about 35% of the TD patients have been diagnosed and that's really starting from a baseline at the time of launch in the low single digits. So we continue to increase the rate of TD diagnosis and I feel really good about the progress that we've made.

So we continue to increase the rate of TD diagnosis, and I feel really good about the progress that we've made. But still, you know, approximately two-thirds of patients remain undiagnosed, and now our research indicates that only about half the time when a patient is diagnosed with TD, they offer treatment with a VMAT2 inhibitor.

But still you know approximately two thirds of patients remain undiagnosed and now our research indicates that only about half the time when a patient is diagnosed with TD.

Offered treatment with a <unk> two inhibitor.

Eric Benevich: And so, you know, we have room for improvement, both in terms of the diagnosis rate and in terms of the frequency of the use of INGREZZA in that patient population. So still lots of room for improvement despite the progress.

And so, we have room for improvement both in terms of the diagnosis rate, and in terms of the frequency of the use of Ingrazza in that patient population. So still lots of room for improvement despite the progress.

The frequency of the use of oven graduate in that patient population, so still lots of room for improvement despite the progress.

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

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

Eiry Roberts: Great. Thanks so much. I just wanted to clarify to Phil's question: was there any kind of one-off benefits this quarter, either from inventory or net price tracking, better than expected? And then on the focal program, as we get close to data here-

Paul Matteis: Great. Thanks so much. I just wanted to clarify to Phil's question: was there any kind of one-off benefits this quarter, either from inventory or net price tracking, better than expected? And then on the focal program, as we get close to data here-

Paul Matteis: Hi. Great. Thanks so much, I just wanted to clarify the Phil's question. Was there any kind of one-off benefits this quarter, either from inventory or net price tracking better than expected, and then on the focal program as we get closer to data year, I just wanted to ask you an open question. like, how excited are you about this asset, and how do you think about the criteria not just for what's a win in this study, like is it a P-value driven or is it more qualitative? And then what's the criteria for not just moving this forward, but taking it forward right into a Phase III. Thanks so much.

Was there any kind of one off benefits this quarter, either from inventory or net price tracking better than expected and then on the Bogo program as we get closer to data here I just wanted to ask you to open questions. Like how excited are you about this asset and how do you think about the criteria not just for what's a win in this study like you said Peter.

[Equity Analyst, Biotechnology] (Stifel): ... I just want to ask an open question, like, how excited are you about this asset? And how do you think about the criteria, not just for what's a win in the study? Like, is it p-value driven or is it more qualitative? And then what's the criteria for not just moving this forward, but taking it forward right into a phase 3? Thanks so much.

Paul Matteis: ... I just want to ask an open question, like, how excited are you about this asset? And how do you think about the criteria, not just for what's a win in the study? Like, is it p-value driven or is it more qualitative? And then what's the criteria for not just moving this forward, but taking it forward right into a phase 3? Thanks so much.

Dry van or was it more qualitative and then what's the criteria for not just moving this forward, but taking it forward right into a phase III. Thanks, so much.

Eric Benevich: Hey, Paul. Nice to hear from you. The quarter was very, very clean. Nice underlying growth, nothing significant to note on inventory. So really reflects both the LPC, psych, neuro team, really doing an excellent job continuing to drive diagnosis and getting patients treated with INGREZZA. So overall, very good quarter. Sets us up nicely for the rest of the year and heading into 2024. Irene?

Kevin Gorman: Yeah, Hey, Paul. Nice to hear from you. The quarter was very, very clean a nice underlying growth. Nothing significant to note on inventory. So, really reflects both the LTC psych, neuro team really doing an excellent job continuing to drive diagnosis, and getting patients treated with Ingrazza. So overall, very good quarter, sets us up nicely for the for the rest of the year, and heading into 2024. Eiry?

Nice to hear from you. Quarter was very very clean a nice underlying growth nothing significant to note on inventory. So really reflects both the LTC side neuro team really doing an excellent job continuing to drive diagnosis and getting patients treated.

Quarter was very very clean a nice underlying growth nothing significant to note on inventory. So really reflects both the LTC side neuro team really doing an excellent job continuing to drive diagnosis and getting patients treated.

And growth so overall very good quarter and sets us up nicely.

For the for the rest of the year and heading into 2024.

Eiry Roberts: Hi, Paul. First thing to say is that we remain on track to be able to release the data from the focal onset seizure study for 352 in this quarter. And we're very excited about the asset in terms of the potential benefit that it can bring for patients with focal onset seizures. It's obviously, as you know, a NAV1.6 selective agent. This study, however, is a proof of concept study, so it is a dose-finding initial study in focal onset seizures patients who have had inadequate response to up to three other treatments. And we obviously will be looking at the reduction in seizure frequency that we can see in the context of this program and this molecule.

Hi, Paul. First thing to say is that we remain on track to be able to release the data from the programs that seizure study for 352 in this quarter, and we're very excited about the asset in terms of the potential benefit that it can bring for patients with focal onset seizures. It's obviously as you know not one six selective agent

Eiry Wyn Roberts: Hi, Paul. First thing to say is that we remain on track to be able to release the data from the programs that seizure study for 352 in this quarter, and we're very excited about the asset in terms of the potential benefit that it can bring for patients with focal onset seizures.

Would you say is that we remain on track to be able to release the data from the programs that seizure study for 352 are in this quarter and we're very excited about the outset in terms of the potential benefit it can bring for patients with focal onset seizures. It's obviously as you know not one six selective agent.

It's, obviously, as you know, a Nav1.6 selective agent. This study, however, is a proof of concept study. So it is a dose finding initial study in so called seizure patients who have had inadequate response to up to three other treatments.

This study however is a proof of concept study. So it is a dose finding initial study in so called seizure patients who have had inadequate response to up to three other treatments.

We obviously will be looking at the reduction in seizure frequency that we can see in the context of this program and this molecule. And I think it is necessary in the face of the competitive space for us to be setting the bar high. we haven't talked specifically about target there given that this is a proof of concept study.

Eiry Roberts: I think it is necessary in the face of the competitive space for us to be setting the bar high. We haven't talked specifically about targets there, given that this is a proof of concept study, but we'd want to see a robust efficacy signal. Based on what we understand about this mechanism and the cell activity, obviously, that, how that relates in terms of tolerability is going to be important in our decision making as well.

We haven't talked specifically about target there, given that this is a proof of concept study, but we'd want to see a robust efficacy signal, and based on the what we understand about its mechanism in the selectivity, obviously, that, how that relates in terms of tolerability is going to be important in our decision-making as well.

But we'd want to see a robust efficacy signal and based on the what we understand about its mechanism in the cell activity, obviously that how does that relate in terms of tolerability is going to be important in our decision, making as well.

[Equity Analyst, Biotechnology] (Stifel): Great. Thanks. Congrats on the quarter.

Paul Matteis: Great. Thanks. Congrats on the quarter.

Great. Thanks, Congrats on the quarter. Our next question comes from Dustin Wei. Waves of Bank of America. Please go ahead your line is open.

Paul Matteis: Great. Thanks. Congrats on the quarter.

Operator: Our next question comes from Tazeen Ahmad with Bank of America. Please go ahead, your line is open.

Operator: Our next question comes from Tasneem Ahmad with Bank of America. Please go ahead. Your line is open.

Our next question comes from Dustin Wei.

Waves of Bank of America. Please go ahead your line is open.

Tazeen Ahmad: Hi, a couple questions from me. Irene, just to like clarify, so you will be showing data on seizure freedom, for the focal onset seizure update? I just wanna make sure that that's gonna be part of, part of the top line. And then secondly, as you think about the opportunity in, in Huntington's, I know that this year's guide does not include, very much, contribution, but, but in the grand scheme of things, how big of an opportunity for INGREZZA do you expect it to be in chorea? Thanks.

Tazeen Ahmad: Hi. A couple of questions for me. Eiry, just so I clarify, so you will be showing data on seizure freedom for the focal onset seizures update. I just want to make sure that that's going to be part of part of the top line. And then secondly, as you think about the opportunity in Huntington's, I know that this year's guide does not include very much a contribution, but in the grand scheme of things, how big of an opportunity for Ingrazza do you expect it to be in chorea? Thanks

Just kind of like clarify so you will be showing data on Fisher.

Our freedom.

Kind of focal onset seizures upbeat.

I just wanted to make sure that that's going to be part of part of the top line and then secondly.

Just think of that opportunity and and harnessing since I know that this year's guide does not include a very much a contribution but but in the grand scheme of things how big of an opportunity for <unk> do you expect it to be in Korea.

Eiry Wyn Roberts: Thanks, Tazeen. With respect to the proof of concept study, the primary input of the study is actually tolerability and safety, but we will be reporting out issues related to seizure frequency as well. So both in terms of reduction and overall seizure frequency, percentage of patients getting to a 50% reduction, and also any information we have around the seizure freedom.

Eiry Roberts: Thanks, Tasneem. With respect to the proof of concept study, the primary emphasis study is actually tolerability and safety, but we will be reporting out issues related to seizure frequency as well. So in both terms of reduction in overall seizure frequency, percentage of patients getting to a 50% reduction, and also any information we have around seizure freedom.

Thanks to the with respect to the proof of concept study. The primary endpoint. The study is actually Tolerability and safety, but we will be reporting out.

Issues related to our fleet.

Frequency as well so both in terms of a reduction in overall seizure frequency.

And these are patients getting to a 60% reduction and also any information we have around the seizure freedom.

Tazeen Ahmad: Okay, and how many patients worth of data would that be?

Tazeen Ahmad: Okay. And how many patients' worth of data would that be?

Eiry Roberts: It's 100 patients, but there are four dose levels, three active and one placebo group in the study.

Eiry Wyn Roberts: It's 100 patients, but there are four dose levels, three active, and one placebo group in the study.

Tazeen Ahmad: Okay, thanks. And then on the Huntington's?

Tazeen Ahmad: Okay. Thanks. And then on the Huntington's?

Eric Benevich: Yeah, I'll tackle that question. So, on a relative basis, the Huntington's opportunity, you know, obviously is smaller than TD. You know, we estimate the addressable population of people living with Huntington's disease and chorea at around 20,000 to 25,000. Currently, only about 20% get treated with a VMAT2 inhibitor. And so, while there is a significant opportunity to make a difference in that patient population and to increase the treatment rate, especially on a relative basis, it's still a smaller commercial opportunity than TD. And TD is going to continue to be our growth driver going into the future.

Eric Benevich: Yeah. I tackle that question. So on a relative basis, the Huntington's opportunity obviously is smaller than a TD. We estimate the addressable population of people living with Huntington's disease and in chorea around 20,000 to 25,000. Currently only about 20% get treated with a VMAT2 inhibitor.

I got that question so on a relative basis, the huntington's opportunity, obviously is smaller than a TD. We estimate the addressable population of people living with Huntington's disease and in Korea around 20 to 25000.

Currently only about 20%.

Get treated with a <unk> two inhibitor and so.

And so while there is a significant opportunity to make a difference in that patient population, and to increase the treatment rate, especially on a relative basis, it's still a smaller commercial opportunity than TD, and TD is going to continue to be our growth driver going into the future.

Commercial opportunity than a TD in PD is going to continue to be our growth driver going into the future.

Operator: Our next question comes from Brian Abrahams with BRC Capital Markets. Please go ahead.

Operator: Next question comes from Brian Abrams with RBC Capital Markets. Please go ahead.

Next question comes from Brian Abrahams with CRC capital markets. Please go ahead.

[Equity Analyst, Biotechnology] (Stifel): Thanks. It's Brian Abrams from RBC here. So just maybe continuing on Huntington's, can you maybe talk a little bit about the initial dynamics that you're seeing and maybe expand on those in terms of, you know, de novo patients versus switchers, and segments where you're seeing or expecting to see the most uptake there? And then secondarily, on the use of capital, it sounds like your primary focus remains on INGREZZA commercial growth and investment, and focusing on the internal pipeline. But maybe you can just give us an update on your latest thinking on any sort of external collaborations or other strategic opportunities outside of Neurocrine.

Brian Abrahams: Thanks. It's Brian Abrams from RBC here. So just maybe continuing on Huntington's, can you maybe talk a little bit about the initial dynamics that you're seeing and maybe expand on those in terms of, you know, de novo patients versus switchers, and segments where you're seeing or expecting to see the most uptake there? And then secondarily, on the use of capital, it sounds like your primary focus remains on INGREZZA commercial growth and investment, and focusing on the internal pipeline. But maybe you can just give us an update on your latest thinking on any sort of external collaborations or other strategic opportunities outside of Neurocrine.

Brian Abrahams: Thanks. Its Brian Abrahams from RBC here. So just maybe continuing on Huntington's, can you maybe talk a little bit about the initial dynamics that you're seeing, and maybe expand on those in terms of, the novo patients versus switchers and segments, where you're seeing or expecting to see the most uptake there? And then secondarily on the use of capital, it sounds like your primary focus remains on Ingrazza commercial growth and investment, and focusing on the internal pipeline. But maybe you can just give us an update on your latest thinking on any sort of external collaborations or other strategic opportunities, outside of Neurocrine in the past. You've been--you've kind of talked about the optionality that your balance sheet might give you there. Curious your latest views. Thanks.

So it was just maybe continuing on Huntington's can you maybe talk a little bit about the initial dynamics that youre seeing and maybe expand on those in terms of.

The novo patients versus switchers in segments, where you're seeing or expecting to see the most uptake there and then secondarily on the use of capital and it sounds like.

Your primary focus remains on an aggressive commercial growth and investment and focusing on the internal pipeline, but maybe you can just give us an update on your latest thinking on any sort of external.

Collaborations or other strategic opportunities.

[Equity Analyst, Biotechnology] (Stifel): In the past, you've kind of talked about the optionality that your balance sheet might give you there. Curious your latest views. Thanks.

Brian Abrahams: In the past, you've kind of talked about the optionality that your balance sheet might give you there. Curious your latest views. Thanks.

Outside of Neurocrine in the past you can.

You've kind of talked about the optionality that your balance sheet that might give you. There curious your latest views. Thanks.

Kevin Gorman: Hi, Brian. So when it comes to use of capital, I don't think there's been any dramatic changes in our strategy, and it's worked out quite well for us. We're going to first and foremost is to invest in INGREZZA and continue to bring this drug to as many patients as possible, and that's why you see this continued very good growth. Second, what we're doing, as you can see, and as we'll be discussing at some length in our R&D Day, is the investment in ourselves from a research standpoint. And that's going to be our transition of a company into multiple therapeutic modalities in the areas that we concentrate on, which is neuropsychiatry, neuroendocrinology, and you know, some point in the very near future, neuroimmunology.

Hi, Brian. So when it comes to use of capital, I don't think there's been any dramatic changes in our strategy and it's worked out quite well for us. We're going to first and foremost is to invest in Ingrazza and continue to bring this patient-- this drug to as many patients as possible, and that's why you see this continued very good growth. What we're doing as you can see and this will be discussing at some length in our R&D day is the investment in ourselves from a research standpoint.

Kevin Gorman - CEO: Hi, Brian. So when it comes to use of capital, I don't think there's been any dramatic changes in our strategy and it's worked out quite well for us. We're going to first and foremost is to invest in Ingrazza and continue to bring this patient-- this drug to as many patients as possible, and that's why you see this continued very good growth.

Congrats on continued to bring this patient this drug to as many patients as possible and that's why you see this continued very good growth.

What we're doing as you can see and this will be discussing at some length in our R&D day is the investment in ourselves from a research standpoint.

Second, what we're doing as you can see and as we'll be discussing at some length in our R&D Day is the investment in ourselves from a research standpoint. And that's going to be our transition of a company into multiple therapeutic modalities in the areas that we concentrate on, which is neuroscience, neuropsychiatry, neuroendocrinology, and at some point in the very near future neuroimmunology.

And that's going to be our transition of our company into a more.

Multiple.

Therapeutic modalities in the areas that we concentrate on which is neuroscience neuropsychiatry neuro endocrinology and <unk>.

And then finally, focusing on the pipeline that we currently have here, we have a number of readouts this quarter and into next year. We're going to continue to invest in those products, and probably-- not probably, what we will be investing in is going to be the submission for Crinecerfont next year, getting ready for what we believe is going to be an AdCom for the drug since it's our first therapy for these patients in 60 plus years. And then ultimately, knock on wood, the launch. So there's our priorities. There's our use of capital.

Kevin Gorman: And then finally, focusing on the pipeline that we currently have here, we have a number of readouts, this quarter and into next year. We're going to continue to invest in those, products. And probably, not probably, what we will be investing in is going to be the, submission for crinecerfont next year, getting ready for what we believe is going to be an, an ad comm, for the drug, since it's a first therapy for these patients in 60+ years, and then, ultimately, knock on wood, the launch. So there's our priorities, there's our use of capital.

Not probably what we will be investing in is going to be the submission for kronos or font next year.

Getting ready for what we believe is going to be in a in an AD com for the drug since it's our first therapy for these patients a 60 plus.

Plus years, and then ultimately knock on wood the launch so there's our priorities there is our use of capital.

Eric Benevich: Yeah, and I can comment on the question around patient types in Huntington's chorea. So, this is an opportunity that is primarily going to be driven through our neurology sales force. And, you know, they're calling on the centers of excellence for Huntington's disease, movement specialists, as well as general neurologists that treat these patients. If you think about the dynamics that I described earlier, with only about 20% of the eligible patient population currently being treated with a VMAT2 inhibitor, about half the time, they're not getting treated with anything, and about 1/3 of the time, roughly, are getting treated with antipsychotics, primarily for psych symptoms, and secondarily to help potentially improve the movements. So, the feedback we're getting so far is very positive.

Eric Benevich: And I can comment on the question around patient types in Huntington's chorea. So this is an opportunity that is primarily going to be driven through our neurology sales force. And they're calling on the Centers of Excellence for Huntington's disease. Movement specialists, as well as general neurologists that treat these patients.

This is an opportunity that is primarily going to be driven through our neurology sales force.

And they're calling on the centers of excellence for Huntington's disease.

Movement specialists as well as general neurologists that treat these patients.

If you think about the dynamics that I described earlier, with only about 20% of the eligible patient population currently being treated with the VMAT2 inhibitor, about half the time, they are not getting treated with anything, and about a third of the time, roughly are getting treated with antipsychotic primarily for psych symptoms, and secondarily to help potentially improve the movements.

With only about 20% of the eligible patient population currently being treated with a <unk> two inhibitor.

About half the time, they are not getting treated with anything and about a third of the time roughly.

Are getting treated with antipsychotic primarily. For psych symptoms and secondarily to help potentially improve the movements.

For psych symptoms and secondarily to help potentially improve the movements. So the feedback we're getting so far is very positive, but as I mentioned earlier, it's very early days yet.

For psych symptoms and secondarily to help potentially improve the movements.

So the feedback we're getting so far is very positive, but as I mentioned earlier, it's very early days yet. But if you think about the types of patients that would be getting started on Ingrazza, here at the outset of our launch, obviously, de novo patients that are newly diagnosed with chorea. Certainly patients that have for various reasons in the past, declined treatment. And as I said, that's really the majority of the addressable patient pool.

Eric Benevich: But as I mentioned earlier, it's very early days yet. But if you think about the types of patients that would be getting started on INGREZZA, here at the outset of our launch, you know, obviously, de novo patients that are newly diagnosed with chorea, certainly patients that have, for various reasons in the past, declined treatment. And as I said, that's really the majority of the addressable patient pool. And then there are some patients that have tried and, for whatever reason, haven't responded well to tetrabenazine or deutetrabenazine. Either they didn't tolerate them or they weren't able to achieve an effective maintenance dose. So these are all patient types that would be considered candidates for treatment with INGREZZA.

But if you think about the types of patients that would be getting started on and <unk> got here at the outset of our launch you know obviously de novo patients that are newly diagnosed with Korea.

Certainly patients that have for various reasons in the past declined treatment and as I said, that's really the majority of the addressable patient pool.

And then there are some patients that have tried and for whatever reason have responded well to tetra benzene or do tetra benzene either they didn't. Didn't tolerate them or they weren't able to achieve an effective maintenance dose. So these are all patient types that would be considered candidates for treatment with the <unk>.

And then there are some patients that have tried, and for whatever reason have responded well to tetrabenazine or deutetrabenazine. Either they didn't tolerate them or they weren't able to achieve an effective maintenance dose.

Didn't tolerate them or they weren't able to achieve an effective maintenance dose. So these are all patient types that would be considered candidates for treatment with the <unk>.

So these are all patient types that would be considered candidates for treatment with Ingrazza. The one group that we're not pushing for really is patients that are currently doing well on treatment. So I think that there's a lot of growth opportunity within this new indication and we're excited to make a difference here in the coming months and years.

Eric Benevich: The one group that we're not pushing for really is patients that are currently doing well on treatment. So, I think that there's a lot of growth opportunity within this new indication, and we're excited to make a difference here in the coming months and years.

The one group that we're not pushing for really is patients that are currently doing well on treatment. So I think that theres a lot of growth opportunity within this new indication and we're excited to make a difference here in the coming months and years.

Brian Abrahams: Thanks. It's really helpful. Congrats again on the quarter.

Operator: Your next question comes from Aakash Tewari with Jefferies. Please go ahead.

Operator: Our next question comes from Akash Tewari with Jefferies. Please go ahead.

Biren Amin: Hi, this is Phoebe on for Aakash. Now that you have both data sets for crinecerfont, which population, pediatric or adults, will be the larger sales opportunity? And what should we be modeling for duration of response? Thank you.

Phoebe Tan: Hi, this is Phoebe on for Aakash. Now that you have both data sets for crinecerfont, which population, pediatric or adults, will be the larger sales opportunity? And what should we be modeling for duration of response? Thank you.

Akash Tewari: Hi. This is Stevie [inaudible] on for Akash. Now that you have both data sets for Crinecerfont, which population, pediatrics or adults, will be larger sales opportunity and what should we be modeling for duration of response? Thank you.

Eiry Wyn Roberts: Let me start. So in terms of the programs reading out, we believe that the unmet need is significant in both pediatric and adult patients with Crinecerfont. As Kevin alluded to, there has been no new medication, in terms of medication types that are non-steroid related for this patient population for the last 60 years, 70 years.

Okay. Let me start so intensive the programs reading out and we believe that the unmet need is significant in both pediatric and adult patients with chronic upon them.

Eiry Roberts: Let me start. So in terms of the programs reading out, we believe that the unmet need is significant in both pediatric and adult patients with crinecerfont. As Kevin alluded to, there has been no new medication, in terms of medication types that are non-steroid related for this patient population for the last 60, 70 years. And so we do believe, based on the strength and quality of the data that we've generated in this program, that there is an opportunity for crinecerfont, if approved, to fundamentally change the treatment paradigm for these patients. And so I think that we will be focused on reaching every patient that we can, both in the adult and the pediatric setting.

Let me start so intensive the programs reading out and we believe that the unmet need is significant in both pediatric and adult patients with chronic upon them.

Kevin alluded to there has been no new medication.

Tim's a medication types that are known steroid related for this patient population for the last 16 17 years.

And so we do believe based on the strength and quality of the data that was generated in this program, that there is an opportunity for Crinecerfont if approved to fundamentally change the treatment paradigm for these patients.

And so I I think that we will be focused on reaching every patient that we can, both in the adults and the pediatric setting, and our educational processes and support of both the clinicians, patients, and caregivers will actually fall in both of those areas.

Eiry Roberts: Our educational processes and support of both the clinicians, patients, and caregivers will actually fall in both of those areas.

Eric Benevich: So given the safety profile that we saw as well as the efficacy, this is something that we would expect to be chronic treatment that a patient would get on. You know, we would expect them to see the androgen control and the benefit and should be safe to have as chronic treatment, but data will show that out over time.

Kevin Gorman - CEO: So given the safety profile that we saw, as well as the efficacy, this is something that we would expect to be chronic treatment, but ah patient would get on. We would expect them to see the intravenous control and the benefit, and should be safe to have as chronic treatment data will show that out.

We would expect them to see the intergroup controlling the benefit should be safe to to have chronic treatment data will show that up.

Eiry Roberts: Just to support that, we obviously have ongoing open-label data that is generating additional safety information, several years' worth of data now in many patients. And I think the goal would be to allow the flexibility of using this drug—this medication in a chronic way if approved.

Eiry Wyn Roberts: And just the support that, we obviously have ongoing open label data that is generating additional safety information, several years' worth of data now in many patients and I think the goal would be to allow the flexibility of using this medication in a chronic way if approved.

Akash Tewari: Okay. Thank you.

Okay. Thank you.

Biren Amin: Thank you.

Phoebe Tan: Thank you.

Thank you.

Operator: Next question comes from Josh Schimmer with Cantor. Please go ahead.

Kevin Gorman: Thanks so much for taking the question, and congrats on a very strong quarter. On INGREZZA, I think in the past, even earlier this year, you indicated that the long-term care facility effort was still just getting off the ground. I think on this quarter, you indicated that there was good momentum in that segment. Can you talk a little bit about the dynamics there and what's transpired over the course of the last year, and whether that is starting to become a more meaningful contributor to revenue?

Josh Schimmer: Thanks so much for taking the question, and congrats on a very strong quarter. On INGREZZA, I think in the past, even earlier this year, you indicated that the long-term care facility effort was still just getting off the ground. I think on this quarter, you indicated that there was good momentum in that segment. Can you talk a little bit about the dynamics there and what's transpired over the course of the last year, and whether that is starting to become a more meaningful contributor to revenue?

Josh Schimmer: Thanks, so much for taking the question and congrats on a very strong quarter. On the Ingrazza, I think in the past, even earlier this year, you indicated that the long-term care facility effort, was still just getting off the ground. I think this quarter, you indicated that there was good momentum in that segment. Can you talk a little bit about the dynamics there, and what's transpired over the course of the last year, and whether that is starting to become a more meaningful contributor to revenue?

Chris I think in the past. Earlier this year he indicated that the long term care facility effort, we're still just getting off the ground I think this quarter you indicated that there was good momentum in that segment can you talk a little bit about the dynamics, there and what's transpired over the course of the last year and whether that is starting to become a more meaningful contributor to revenue.

Earlier this year he indicated that the long term care facility effort, we're still just getting off the ground I think this quarter you indicated that there was good momentum in that segment can you talk a little bit about the dynamics, there and what's transpired over the course of the last year and whether that is starting to become a more meaningful contributor to revenue.

Eric Benevich: Yeah, I do think it's a meaningful contributor to revenue, and it's certainly growing well, as I mentioned earlier. You know, certainly, I think that going into this year, you know, remember that we just launched our LTC sales force in the spring of 2022. And so we're about a year and a half into this effort. And really, the first few quarters were driving towards getting, you know, getting our targeting down, laying the foundation for TD in that space, and you have to remember that this is essentially new in long-term care.

Kevin Gorman - CEO: Yeah. I do think it's a meaningful contributor revenue and is certainly growing well, as I mentioned earlier. Certainly I think that going into this year, you know, remember that we just launched our LTC sales force in the spring of 2022. And so we're about a year and a half into this effort

Going into this year, you know remember that we just launched our LTC sales force in the spring of 2022.

And so we're about a year and a half into this effort and really the first few quarters were.

And so we're about a year and a half into this effort

And really the first few quarters were driving towards getting our targeting down, laying the foundation for a TD in that space and you have to remember that this is essentially new in long-term care. And so our team has done a really nice job, I think of educating the care teams in the long term care facilities. understanding the dynamics with LTC pharmacies, and have done a nice job of really driving diagnosis and now a treatment for Ingrazza in the long-term care segment. So as I mentioned before, it's growing nicely, and it's really part of the reason that we've had such a nice Q3.

Driving towards getting giving our targeting down laying the foundation for a P. D in that space and you have to remember that this is essentially new in long term care and so our team has done a really nice job I think of educating the care teams.

and so our team has done a really nice job I think of educating the care teams. In the long term care facilities.

Eric Benevich: Our team has done a really nice job, I think, of educating the care teams in the long-term care facilities, understanding the dynamics with LTC pharmacies, and have done a nice job of really driving diagnosis and now treatment with INGREZZA in the long-term care segment. So, as I mentioned before, it's growing nicely, and it's really, you know, part of the reason that we've had such a nice Q3.

In the long term care facilities.

Understanding the dynamics with LTC pharmacies.

And has done a nice job of really driving diagnosis treatment within grasp in the long term care segment. So as.

As I mentioned before it's growing nicely and it's really part of the reason that we've had such a nice Q3.

[Equity Analyst, Biotechnology] (Oppenheimer): Thank you.

Josh Schimmer: Thank you.

Operator: Question comes from Carter Gold with Barclays. Please go ahead.

Operator: Question comes from Carter Gould with Barclays. Please go ahead.

[Equity Analyst, Healthcare] (Barclays): Hi, this is Leon on for Carter. Congrats on a great quarter. Our question just is relating to CAH. We're wondering, what would be an appropriate medical meeting to share the data? Essentially, do we should we expect this maybe around middle of the year, perhaps at Endo? Or could we see this publication published ahead of time? Thank you.

[Analyst] (Barclays): Hi, this is Leon on for Carter. Congrats on a great quarter. Our question just is relating to CAH. We're wondering, what would be an appropriate medical meeting to share the data? Essentially, do we should we expect this maybe around middle of the year, perhaps at Endo? Or could we see this publication published ahead of time? Thank you.

Leon Wang: Hi, This is Leon on for Carter. Congrats on a great quarter. Our question just is related to CAH. We're wondering, will it be an appropriate medical meeting to share the data, essentially do we-- should we expect this maybe around middle of the year, perhaps the end of--or could we see this publication published ahead of time? Thank you.

Waiting to see a H I'm wondering what would be.

As appropriate.

Medical meeting to share the data are essentially can we should we expect this maybe around middle of the year, perhaps at anvil.

Or can we see this publication published ahead of time. Thank you.

Eiry Roberts: Yeah, a couple of comments on that. First of all, when we shared the data, you know, a month or so ago now, we shared probably approximately 5 or less than 10% of the information that we were generating. And so right now we're working on pulling together all of the remaining information from the trial and all the data that were generated. And then our goal will be to pull that together for publication and presentation as rapidly as possible, in parallel, obviously, with preparing for the NDA submission, which we will do next year. And so I think the key message, the key meetings in the Endo space include Endo, that you alluded to, together with additional pediatric meetings in both the US and in Europe.

Eiry Wyn Roberts: A couple of comments on that. First of all when we shared the data a month or so ago, now, we shared probably totally approximately 5% or less than 10% of the information that we were generating. And so right now, we're working on pulling together all of the remaining information from the trial and all the data that were generated.

So go now we should probably totally approximately five of them.

Less than 10% of the information that we were generating and so right now we're working on pulling together all of the remaining information from the trial and all the data that we've generated and then I'll go will be to pull that together for publication and presentation as rapidly as possible in parallel obviously with preparing for the NDA submission, which we will do next year.

Less than 10% of the information that we were generating and so right now we're working on pulling together all of the remaining information from the trial and all the data that we've

And then our goal will be to pull that together for publication, and presentation as rapidly as possible, in parallel, obviously, with preparing for the NDA submission, which we will do next year. And so I think the key message-- the key meetings in the endo space include endo that you alluded to together with additional pediatric meetings in both the U S and Europe. Most of those fall in from around April time next year, and those are most likely to be the meetings that we would be targeting for presentation with a full publication running in parallel with that.

And so I think the key messages the key meetings in the Endo space include Endo that you alluded to together with additional pediatric meetings in both the U S and in Europe.

Eiry Roberts: Most of those fall in from around April time next year, and those are most likely to be the meetings that we would be targeting for presentation with a full publication running in parallel with that.

And most of those fall in from around April time next year and those are most likely to be the meetings that we would be targeting for presentation. And so a publication that in parallel with that.

And so a publication that in parallel with that.

Leon Wang: Thanks. Appreciate it.

[Equity Analyst, Healthcare] (Barclays): Thanks. Appreciate it.

[Analyst] (Barclays): Thanks. Appreciate it.

Thanks appreciate it.

Operator: Your next question comes from Anupam Brahma with JPMorgan. Please go ahead.

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

Brahma with Jpmorgan. Please go ahead.

[Equity Analyst, Biotechnology] (JPMorgan): Hey, guys. Thanks so much for taking the question, and congrats on the quarter. So why you guys didn't pre-announce Q4 INGREZZA sales or provide forward-year guidance last year at the J.P. Morgan Healthcare Conference? You have taken this strategy in the past, so just wondering what we should be expecting this year in terms of the conference. Thanks so much.

Anupam Rama: Hey, guys. Thanks so much for taking the question, and congrats on the quarter. So why you guys didn't pre-announce Q4 INGREZZA sales or provide forward-year guidance last year at the J.P. Morgan Healthcare Conference? You have taken this strategy in the past, so just wondering what we should be expecting this year in terms of the conference. Thanks so much.

Anupam Rama: Hey, guys. Thanks so much for taking my question, and congrats on the quarter. So while you guys didn't pre-announced Q4 Ingrazza sales or provide forward year guidance last year at the JPMorgan Health Care Conference. You have taken the strategy in the past, so I'm just wondering, what we should be expecting this year in terms of of the conference? Thanks so much.

Eric Benevich: Yeah. Hi, Anupam. Nice to hear from you. You should expect similar to last year, that we're not going to be providing a Q4 update from an INGREZZA sales perspective at the JPMorgan conference in January. And we'll be providing that information during our February earnings call, where we'll provide a full financial picture, including INGREZZA sales guidance, Q4 performance, and what we expect for 2024. But we are looking forward to seeing you and spending time with you and covering a lot of ongoings associated with our pipeline.

Kevin Gorman - CEO: Yeah, Hi, Anuapam. Nice to hear from you. You should expect similar to last year, that we're not going to be providing a Q4 update from Ingrazza sales perspective at the JPMorgan Conference in January, and we'll be providing that information during our February earnings call, where we will provide a full financial picture, including Ingrazza sales guidance, Q4 performance and what we expect for 2024. But we are looking forward to seeing you, and spending time with you and covering a lot of ongoing associated with our pipeline.

You should expect similar to last year that were not going to be providing I E. Our Q4 update from our aggressive sales perspective at the JP Morgan Conference in January.

We'll be providing that information during our February earnings call, where we will provide a full financial picture, including and grow the sales guidance Q4 performance and what we expect for 2024, but we are looking forward to seeing you and spending time with you and.

Covering.

A lot of ongoing associated with our pipeline.

[Equity Analyst, Biotechnology] (JPMorgan): Thanks so much.

Anupam Rama: Thanks so much.

Operator: Next question comes from Jay Olson with Oppenheimer. Please go ahead.

[Equity Analyst, Biotechnology] (Oppenheimer): Oh, hey, congrats on another impressive quarter. Can you talk about life cycle management plans for INGREZZA, especially since you settled with Teva and Sanofi for 2040, and you currently have two new indications in clinical development? Are there additional new indications you might pursue for INGREZZA, considering the extended runway, which could go well beyond consensus estimates? Thank you.

Jay Olson: Oh, hey, congrats on another impressive quarter. Can you talk about life cycle management plans for INGREZZA, especially since you settled with Teva and Sanofi for 2040, and you currently have two new indications in clinical development? Are there additional new indications you might pursue for INGREZZA, considering the extended runway, which could go well beyond consensus estimates? Thank you.

Jay Olson: Oh! Hey. Congrats on another impressive quarter. Can you talk about lifecycle management plans for Ingrazza, specially since you settled with Teva and Sanofi for 2040. And you currently have two new indications into clinical development. Are there additional new indications you might pursue for Ingrazza considering the extended runway, which could go well beyond consensus estimates? Thank you.

You talk about lifecycle management plans for in Gaza, especially since you settled with Teva and Sanofi for 2040.

And you currently have two new indications into clinical development.

Are there additional new indications you might pursue for undergraduate considering the extended runway, which could go well beyond consensus estimates. Thank you.

Eiry Roberts: Thanks, Jay. Well, we continue to look at opportunities for INGREZZA in serving different patient groups on an ongoing basis, both from the insights that we gain from our medical team out in the field and also obviously in the clinical development setting. However, at the moment, given the breadth of everything else that we have going on in our program, in our pipeline, we are focused on two key indications, as you mentioned, which is adjunctive treatment for schizophrenia and dyskinetic cerebral palsy. We've focused on those two given that they had the highest likelihood of being successful.

Ah. Thanks, Jay we continue to look at opportunities for Ingrazza, and serving different patient groups on an ongoing basis, both from the insights that we gain from our medical team are in the field, and also, obviously, in the clinical development setting. However, at the moment, given the breadth of everything else that we have going on in our proof--in our pipeline.

Eiry Wyn Roberts: Ah. Thanks, Jay we continue to look at opportunities for Ingrazza, and serving different patient groups on an ongoing basis, both from the insights that we gain from our medical team are in the field, and also, obviously, in the clinical development setting. However, at the moment, given the breadth of everything else that we have going on in our proof--in our pipeline.

However, at the moment, given the breadth of everything else that we have going on in our proof--in our pipeline.

We are focused on two key indications as you mentioned, which is adjunctive treatment for schizophrenia, and it's dyskinetic cerebral palsy. And we are focused on those two given that they had the highest likelihood of being successful taking dyskinetic cerebral palsy first, I think in the context of the really strong data that we generated both in tardive dyskinesia and now in the chorea of Huntington's with dyskinetic cerebral palsy, being the most common childhood movement in The United States.

Being successful at taking just kinetic cerebral palsy first I think in the context of the really strong data that we generated both in tardive dyskinesia and now in the Korea Huntington.

Eiry Roberts: In taking dyskinetic cerebral palsy first, I think in the context of the really strong data that we generated, both in tardive dyskinesia and now in the chorea in Huntington's, with dyskinetic cerebral palsy being the most common childhood movement disorder in the United States, we believed it was appropriate for us to be pursuing an indication in that setting. We have a phase 3 program currently ongoing, both in the US and outside the US. Then for adjunctive treatment of schizophrenia, it was a combination of three things that drove us to that indication. The first was obviously a very key safety and tolerability program profile that we had for INGREZZA in patients with schizophrenia already from our tardive dyskinesia experience.

We believed it was appropriate for us to be pursuing an indication in that setting, and we have a phase III program currently ongoing, both in the US and outside the U.S. And then for adjunctive treatment for schizophrenia, it was a combination of three things that drove us to that indication. The first was obviously, the very key safety, and tolerability profile that we had for Ingrazza in patients with schizophrenia already from our dyskinesia experience. secondly, with some preclinical data that we had showing potential injunctive.

We believed it was appropriate for us to be pursuing an indication in that setting, and we have a phase III program currently ongoing, both in the U.S, and outside the U.S. And then for adjunctive treatment for schizophrenia, it was a combination of three things that drove us to that indication. The first was obviously, the very key safety, and tolerability profile that we had for Ingrazza in patients with schizophrenia already from our tardive dyskinesia experience.

The United States.

We believed it was appropriate for us to be pursuing an indication in that setting and we have a phase III program currently ongoing.

Both in the U S and outside the U S. And then for adjunctive treatment for schizophrenia with a combination of three things that drove us to that indication. The first was obviously.

A very key safety and Tolerability program profile that we had for <unk> in patients with schizophrenia already from a probably dyskinesia experience secondly, with some preclinical data that we had showing potential injunctive.

Secondly, with some preclinical data that we had showing potential injunctive, therapy might be beneficial from a additive or synergistic perspective on efficacy. And then thirdly, obviously, what we were hearing from the field. So we are focused on those programs right now, and getting to data as rapidly as possible on each of those. But we do continue to look at other opportunities obviously on an ongoing basis.

Eiry Roberts: Secondly, was some preclinical data that we had showing potential adjunctive therapy might be beneficial from a additive or synergistic perspective on efficacy. Then thirdly, obviously, what we were hearing from the field. So we are focused on those programs right now and getting to data as rapidly as possible on each of those, but we do continue to look at other opportunities, obviously, on an ongoing basis.

Therapy might be beneficial from a obviously, both synergistic perspective on efficacy and then thirdly, obviously, what we were hearing from the field. So we are focused on those programs right now I'm getting to data as rapidly as possible in each of those but we do continue to look at other opportunities obviously on an ongoing basis than what I would add to that is that.

Eric Benevich: And what I would add to that is that, as we said, we've got a long runway, with this, with this medication. We feel confident in our, patent position out to at least mid-2030s. And as you've seen that, with our Endo negotiations with two of the four parties, we've settled into the, the late 2030s, with them.

Kevin Gorman - CEO: And what I would add to that is that, as we said we've got a long runway with this medication. We feel confident in our patent position out to at least mid-2030's, and as you've seen that with our end of negotiations with two of the four parties, we've settled into the late 2030's with them.

With this with this medication.

I feel confident in our.

Patent position out to at least mid twenties thirties, and as you've seen that.

With our end of negotiations with two of the four parties, we've settled into the late twenties thirties with them. So.

Kevin Gorman: ... So, the only other thing I would add is that while INGREZZA has, as I said, a very long runway still left to it, our research group is highly focused on maintaining our leadership in movement disorders and in tardive dyskinesia.

Eric Benevich: ... So, the only other thing I would add is that while INGREZZA has, as I said, a very long runway still left to it, our research group is highly focused on maintaining our leadership in movement disorders and in tardive dyskinesia.

So the only other thing I would add is that, while Ingrazza has a, as I said, a very long runway still left to it. Our research group is highly focused on maintaining our leadership in movement disorders and in tardive dyskinesia.

Matt Abernethy: Super helpful. Thanks for taking the question.

Jay Olson: Super helpful. Thanks for taking the question.

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

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

Brian Abrahams: Hey, guys, this is Charlie on for Brian. Thanks for taking my question, and congrats on the quarter. So I wanted to ask about the anhedonia asset, which I believe you are still on track to give us data on in Q4. What exactly should we be looking at in terms of a clinical bar here, and what data have you generated so far that gives you confidence in this asset, that it's differentiated from previous assets that have struggled to get a strong efficacy signal? Thank you.

Charlie Moore: Hey, guys, this is Charlie on for Brian. Thanks for taking my question, and congrats on the quarter. So I wanted to ask about the anhedonia asset, which I believe you are still on track to give us data on in Q4. What exactly should we be looking at in terms of a clinical bar here, and what data have you generated so far that gives you confidence in this asset, that it's differentiated from previous assets that have struggled to get a strong efficacy signal? Thank you.

Charlie: Hey, guys. This is Charlie on for Brian. Thanks for taking my question and congrats on the quarter. So I wanted to ask about the anhedonia asset, which I believe you are still on track to give us data on in the fourth quarter. What exactly should we be looking at in terms of the clinical bar here, and what data have you generated so far that gives you confidence in this assets that is differentiate it from previous assets that have struggled to get a strong efficacy signal? Thank you.

Data have you generated so far that gives you confidence in the fact that.

Differentiate it from previous assets that have struggled to get a strong efficacy signal. Thank you.

Eiry Roberts: Yeah, thanks, Charlie. Yes, we are on track to read out the data from this anhedonia phase 2 study in this quarter. This is actually an orphan GPCR and GPR139 molecule. So, although we understand a great deal about the biology of where this target is located in the habenula, and that gives us confidence around the potential use in anhedonia, obviously, there's been very little research that's been successful in the field of anhedonia, and it's a very difficult symptom set within the range of symptoms experienced by patients with major depressive disorder.

Yeah. Thanks, Charlie. So the yes, we are on track to read out the data from this anhedonia Phase II study in this quarter. This is actually in an orphan GPCR, and GPR139 molecule. So although we understand a great deal about the biology of where this target is located in habenula and that gives us confidence around the potential use in anhedonia. Obviously, they've been very different research that's been successful in the field of anhedonia. and it's a very difficult symptom set within the range of symptoms experienced by patients with major depressive disorder and so in that.

Eiry Wyn Roberts: Yeah. Thanks, Charlie. So the yes, we are on track to read out the data from this anhedonia Phase II study in this quarter. This is actually in an orphan GPCR, and GPR139 molecule. So although we understand a great deal about the biology of where this target is located in habenula and that gives us confidence around the potential use in anhedonia. Obviously, they've been very different research that's been successful in the field of anhedonia.

This target is located in Habenula I'm not gives us.

Confidence around the potential use in on Indonesia, obviously, they've been very different research that's been successful in the field of honor Don Yeah, and it's a very difficult symptom set within the range of symptoms experienced by patients with major depressive disorder and so in that.

And it's a very difficult symptom set within the range of symptoms experienced by patients with major depressive disorder. And so in that context, this proof of concept initial study in Phase II in 88 patients is focused not only on looking at the potential impact of 846 on the anhedonia scales themselves. The DARS scale, but also on the depression scales. And so we will be interested when we read out the data to understand whether 846 has an antidepressant effect alone or whether that effect is predominantly on the scales of anhedonia.

Eiry Roberts: So in that context, this proof of concept initial study in phase 2, in 88 patients, is focused not only on looking at the potential impact of NBI-846 on the anhedonia scales themselves, the DARS scales, but also on the depression scales. We will be interested when we read out the data to understand whether NBI-846 has an antidepressant effect alone, or whether that effect is predominantly on the scales of anhedonia. In terms of setting a bar, this is a proof of concept signal-seeking study. We will be looking at the totality of the data, both from an efficacy and safety perspective, and we look forward to sharing the information when we have it available.

Context. This proof of concept initial study in phase two and 88 patients is focused not only on looking at the potential impact of eight.

846 on the Antoni scales themselves the Dod scale, but also on the depression scale and so we will be interested when we read out the data to understand whether April 6000, antidepressant effect alone or whether that effect is predominantly on the skills on a billing in.

In terms of setting a bar, this is a proof of concept signal seeking study, we'll be looking at the totality of the data both from an efficacy and safety perspective, and we look forward to sharing the information when you have it available.

Charlie: Wonderful. Thank you so much.

Yeah. Wonderful. Thank you so much.

Brian Abrahams: Wonderful. Thank you so much.

Charlie Moore: Wonderful. Thank you so much.

Wonderful. Thank you so much.

Operator: Your next question comes from Mark Goodman with Leerink Partners. Please go ahead.

Operator: Our next question comes from Marc Goodman with Leerink Partners. Please go ahead.

Drink partners. Please go ahead.

[Equity Analyst, Biotechnology] (Leerink Partners): Morning. Matt, can you talk about SG&A leverage into 2024? I mean, given that crinecerfont is really going to be a 2025 event, I was just curious how much leverage we should be expecting there. And are you still kind of guiding us to the R&D at 30% level? Thanks.

Marc Goodman: Morning. Matt, can you talk about SG&A leverage into 2024? I mean, given that crinecerfont is really going to be a 2025 event, I was just curious how much leverage we should be expecting there. And are you still kind of guiding us to the R&D at 30% level? Thanks.

Marc Goodman: Good morning, Matt can you talk about SG&A leverage into 2024, I mean. given the Crinecerfont is really going to be a 2025 event, I was just curious how much leverage we should be expecting there and are you still kind of guiding us to the R&D 30% level? Thanks.

24, given. Given the criticism, that's really can be a 2025 events I was just curious how much leverage we should be expecting there and are you still kind of guiding us to the R&D at that 30% level.

Given the criticism, that's really can be a 2025 events I was just curious how much leverage we should be expecting there and are you still kind of guiding us to the R&D at that 30% level.

Matthew Abernethy - CFO: Yeah. Hi, Marc nice to hear from you. From an SG&A perspective, you can see this year that we drove around 300 basis points of leverage and testament to the investments, we're making and how the sales team continues to drive Ingrazza sales growth.

Matt Abernethy: Yeah. Hi, hi, Mark. Nice to hear from you. From a SG&A perspective, you can see this year that we drove around 300 basis points of leverage and a testament to the investments we're making and how the sales team continues to drive INGREZZA sales growth. We'll clearly be investing behind CAH next year to prepare for a potential launch of the medication, and as you mentioned, most likely revenue starting in 2025. So that will put a little bit of pressure on our SG&A leverage, but I would say that you should anticipate some healthy SG&A leverage next year, and we'll provide more specifics when we get to our February earnings call.

Yeah, Hi, Mark nice to hear from you. From an SG&A perspective, you can see this year that we drove around 300 basis points of leverage and a testament to the investments, we're making and how the sales team continues to drive.

From an SG&A perspective, you can see this year that we drove around 300 basis points of leverage and a testament to the investments, we're making and how the sales team continues to drive.

We'll clearly be investing behind CAH next year to prepare for a potential launch of the medication, and as you mentioned, most likely revenue starting in 2025, So that will put a little bit of pressure on our SG&A leverage, but I would say that, you should anticipate some healthy SG&A leverage next year, and we'll provide more specifics when we get to our February earnings call.

<unk> leverage next year, and we'll provide more specifics when we get to our February earnings call on the R&D front, yes.

Matt Abernethy: On the R&D front, yes, as we've said before, around 30% spending on R&D is what we're thinking from a capital allocation perspective. But that is really dependent upon having quality assets and those that we think can make a difference for patients and then ultimately for our shareholders. And we'll be providing more insight on some of those investments that we're making during our R&D day in early December.

On the R&D front as we've said before, around 30% spending on R&D is what we're thinking from a capital allocation perspective. But that is really dependent upon having quality assets and those that we think can make a difference for patients and then ultimately for our shareholders and we'll be providing more insight on some of those investments that we're making during our R&D Day in early December.

On some of those investments that we're making during our R&D day in early December.

Operator: Our next question comes from Jeffrey Hong with Morgan Stanley. Please go ahead.

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

[Equity Analyst, Biotechnology] (Morgan Stanley): Hi, this is Michael Rea in for Jeff Hong. Thank you for taking our question. Could you walk us through the NBI-570 M1/M4 dual agonist in the recent phase 1? I guess I just want to touch on what makes it selective for CNS, or maybe what are the differentiated strengths versus a pure M4, like NBI-568. Thanks so much.

Michael Rhee: Hi, this is Michael Rea in for Jeff Hong. Thank you for taking our question. Could you walk us through the NBI-570 M1/M4 dual agonist in the recent phase 1? I guess I just want to touch on what makes it selective for CNS, or maybe what are the differentiated strengths versus a pure M4, like NBI-568. Thanks so much.

Michael Riad: Hi. This is Michael Riad on for Jeff Hung. Thank you for taking our question. Could you walk us through the NBI-570 M1/M4 dual agonist, and the recent Phase I? I guess I just want to touch on what makes it selective for CNS or maybe what are the differentiated strengths versus a pure M4 like 5,6,8? Thanks so much.

Could you walk us through the N V I $5 70, and one in Florida dual agonist and the recent savings phase one I guess I just wanted to touch on what makes it selective for CNS or maybe what are the differentiated strengths versus a pure them for like 568. Thanks. So much.

Eiry Roberts: Yeah, thanks, Michael. So obviously we just initiated our phase 1 clinical program on 570, and we're very excited to be able to take the second of our portfolio of muscarinic agonists into the clinic. So we don't have clinical data as yet, obviously, on this asset, but it was successful in navigating toxicology, preclinical, and all of the biology necessary to enter the clinic. I mean, I think we feel very strongly that the muscarinic agonist approach in treating both neuropsychiatric and potential neurological conditions, including those impacted by cognition, would, it actually provides a very broad set of opportunities for patients moving forward.

Yeah. Thanks, Michael. So obviously, we just initiated a Phase I clinical program on 570, and we're very excited to be able to take the second of our portfolio of muscarinic agonists into the clinic. So we don't have clinical data as yet, obviously, on this asset. But it did--was successful in navigating toxicology preclinical and all of the biology necessary to enter the clinic. I mean, I think we feel very strongly that the and muscarinic agonist approach in treating both neuropsychiatric and potentially neurological conditions, including those impacted by cognex.

Eiry Wyn Roberts: Yeah. Thanks, Michael. So obviously, we just initiated a Phase I clinical program on 570, and we're very excited to be able to take the second of our portfolio of muscarinic agonists into the clinic. So we don't have clinical data as yet, obviously, on this asset. But it did--was successful in navigating toxicology preclinical and all of the biology necessary to enter the clinic.

It was successful in navigating that toxicology preclinical and all of the biology necessary to enter the clinic I mean, I think we feel very strongly that the and muscarinic agonist approach in treating both neuropsychiatric and potentially neurological conditions, including those impacted by cognex.

I mean, I think we feel very strongly that the M muscarinic agonist approach in treating both neuropsychiatric, and potentially neurological conditions, including those impacted by cognition, would it actually provide a very broad set of opportunities for patients moving forward. And in that regard, although obviously, our M4 selective 5,6,8 agent is targeted very directly to treating psychosis and schizophrenia and that M4 mechanism is now validated in the clinic with both Karuna and Cerevel's assets. are there's still a lot of room beyond and full agonism alone to a potential value for patients and so in the.

Sure.

Would it actually provides a very broad set of opportunities for patients moving forward and in that regard and although obviously all enforced selective 568 agent is targeted directly to treating psychosis and schizophrenia I'm not and boom mechanism is now validated in the clinic.

Eiry Roberts: And in that regard, although obviously our M4 selective NBI-568 agent is targeted very directly to treating psychosis in schizophrenia, and that M4 mechanism is now validated in the clinic, with both Karuna and Cerevel's assets, there is still a lot of room beyond M4 agonism alone to add potential value for patients. And so, in this first foray, we are taking M1 and M4 selectivity with a view to being able to broaden the range of indications that could be considered for this drug into those impacting cognition, as well as the psychosis-related indications that we've already studied.

With both Corona answer about outfits are there's still a lot of room beyond and full agonism alone to a potential value for patients and so in the.

There are still a lot of room beyond M4 agonism alone to add potential value for patients. And so in the In this first foray, we are taking M1 and M4 selectivity with a view to being able to broaden the range of indications that could be considered for this drug into those impacting cognition as well as the psychosis related indications that we've already studied.

In this first sorry, we are taking and one on <unk> four cell activity with a view to being able to broaden the range of indications that could be considered for this drug into those impacting cognition as well as the psychosis related indications avoiding studied.

[Senior Research Analyst, Biotechnology] (William Blair): Thank you so much. That's really helpful.

Michael Rhee: Thank you so much. That's really helpful.

Michael Riad: Thank you very much. That's really helpful.

Yeah. Your next question comes from Myles Minter with William Blair. Please go ahead. Hi, Thanks for taking my question and congrats on the quarter I think you've previously mentioned that the long term care facility in pressure opportunity as an additional 10% to 15% after market sale.

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

Operator: Our next question comes from Miles Minter with William Blair. Please go ahead.

Your next question comes from Myles Minter with William Blair. Please go ahead.

Myles Minter: Hey. Thanks for taking my question, and congrats on the quarter. I think you've previously mentioned that the long-term care facility Ingrazza opportunity as an additional 10% to 15% of the market, seems like you are penetrating better than you previously expected into that market. So has that additional TAM expectation changed at all from that 10% to 15% number? Thanks.

[Senior Research Analyst, Biotechnology] (William Blair): Hey, thanks for taking the question, and congrats on the quarter. I think you've previously mentioned that the long-term care facility and greater opportunity is an additional 10% to 15% of the market. Seems like you are penetrating better than you previously expected into that market. So does that additional TAM expectation changed at all from that 10% to 15% number? Thanks.

Myles Minter: Hey, thanks for taking the question, and congrats on the quarter. I think you've previously mentioned that the long-term care facility and greater opportunity is an additional 10% to 15% of the market. Seems like you are penetrating better than you previously expected into that market. So does that additional TAM expectation changed at all from that 10% to 15% number? Thanks.

Hi, Thanks for taking my question and congrats on the quarter I think you've previously mentioned that the long term care facility in pressure opportunity as an additional 10% to 15% after market sale.

It seems like you are kind of trading better than you had previously expected into that market start to stack additional Tam expectation.

Thank you all from that tend to take time to set them up thanks.

Eric Benevich: Yeah, our estimate is that approximately 10 to 15 percent of people living with PD are currently living in long-term care facilities. And as I mentioned, we just launched into that segment last year. So on a relative basis, it's less developed, let's say, than the psychiatry or the neurology segments, where we've been for six-plus years. But you know, we are growing nicely. I wouldn't say that it's exceeding expectations. We always had high expectations for the opportunity in LTC, and the team's doing a great job on delivering on those expectations.

Matthew Abernethy - CFO: Yeah. Our estimate is that approximately 10% to 15% of people living with TD are currently living in long-term care facilities. And as I mentioned, we just launched into that segment last year. So on a relative basis, it's less developed, let's say than the psychiatry or neurology segments where we've been for six plus years.

Where we've been for six plus years.

But we are growing nicely, I wouldn't say that it's exceeding expectations. We always had high expectations for the opportunity in LTC, and the team is doing a great job on delivering on those expectations.

Operator: Our next question comes from Yatin Suneja with Guggenheim Partners. Please go ahead.

<unk> partners. Please go ahead.

[Managing Director, Biotechnology Equity Research] (Guggenheim Securities): Hey, guys, thank you for the question. Just clarification on the FOS study. I think in the past you have sort of articulated that you would like to see about the seizure reduction of about 15% in placebo to 30% in the active, so basically implying tapping off of the effect. But today, you sort of shy away from putting those numbers, but did say that the bar is high or the efficacy should be robust. So I'm just curious, like, what is... Like, what do you mean by robust? Is it close to 50% or it's 30%? Any color that you can provide would be helpful. Thanks.

Yatin Suneja: Hey, guys, thank you for the question. Just clarification on the FOS study. I think in the past you have sort of articulated that you would like to see about the seizure reduction of about 15% in placebo to 30% in the active, so basically implying tapping off of the effect. But today, you sort of shy away from putting those numbers, but did say that the bar is high or the efficacy should be robust. So I'm just curious, like, what is... Like, what do you mean by robust? Is it close to 50% or it's 30%? Any color that you can provide would be helpful. Thanks.

Yatin Suneja: Hey, guys. Thank you for the question just a clarification on the FOS study. I think in the past, you have sort of articulated that you would like to see about seizure reduction of about 15% in placebo to 30% in the active. So basically, implying doubling off of the effect. But today, you're sort of shy away from putting those numbers, but did you say that the bar is high or the efficacy shouldn't be robust?. I'm just curious like, what is-- like, what do you mean by robust? Is it close to 50% or is 30%? Any color that you can provide would be helpful. Thanks.

The seizure reduction.

Off about 15% in placebo to 30% and the actors are basically implying up at all.

Of the of the effect, but today, you sort of shy away from putting those numbers, but did you say that the bar is high or the application shouldn't be goodbye. So I'm just curious like what is it what do you mean by real boss is it close to 50% are expected to attend and any color you can provide.

Eiry Wyn Roberts: Yeah. A placebo rate of 15% with an active treatment of 30% is about what's been seen with some other therapies that would be at the top end of the range with recent trial readouts, and so I think that's a reasonable bar. This is a proof of concept study, though and so, it's our first Phase II study, and we will be looking beyond just that seizure reduction frequency into other elements of the data to understand just how robust the information is.

Eiry Roberts: Yeah, a placebo rate of 15 with an active treatment of 30 is about what's being seen with some other therapies. That would be at the top end of the range with recent trial readouts, and so I think that's a reasonable bar. This is a proof of concept study, though, and so, you know, it's our first phase 2 study. And we will be looking beyond just that seizure reduction frequency into other elements of the data to understand just how robust the information is. Also, very importantly, in the context of this selective mechanism, is the tolerability and safety profile. And 'cause at the end of the day, we're aiming for an improvement in benefit risk for these individuals.

Yeah, a placebo rate of 15 is that an active treatment of city is about what's been seen with some other therapies that would be at the top end of the range. There's been recent trial Readouts and so I think that's a reasonable bar.

Is a proof of concept study, though and so you know it's our first phase two study and we will be looking beyond just stopped them and see that she seizure reduction.

Frequency into other elements of the data to understand just how robust. The information is also very importantly in the context of this selective mechanism is the tolerability and safety profile and because at the end of the day, we're aiming for an improvement in benefit risk for these individuals.

Frequency into other elements of the data to understand just how robust. The information

Also, very importantly in the context of this selective mechanism is the tolerability and safety profile, and because at the end of the day, we're aiming for an improvement in benefit risk for these individuals.

Operator: Our next question comes from Laura Chico with Wedbush Securities. Please go ahead.

Okay. Our next question comes from Laura Chico with Wedbush Securities. Please go ahead.

Our next question comes from Laura Chico with Wedbush Securities. Please go ahead.

[Senior Research Analyst, Biotechnology] (William Blair): Hey, good morning. Thanks very much for taking the question. Just one on INGREZZA. Has the duration on treatment continued to grow at this point? And then related to that, what are your assumptions on continued growth of antipsychotic usage going forward? Thanks very much.

Laura Chico: Hey, good morning. Thanks very much for taking the question. Just one on INGREZZA. Has the duration on treatment continued to grow at this point? And then related to that, what are your assumptions on continued growth of antipsychotic usage going forward? Thanks very much.

Laura Chico: Hey. Good morning. Thanks very much for taking the question. Just one on Ingrazza. Has the duration of treatment continued to grow at this point? And then related to that, what are your assumptions or continued growth of antipsychotic usage going forward? Thanks very much.

Uh huh. Our treatment continued to grow at that at this point and then related to that what are your assumptions on continued growth of anti psychotic usage going forward. Thanks very much.

Our treatment continued to grow at that at this point and then related to that what are your assumptions on continued growth of anti psychotic usage going forward. Thanks very much.

Eric Benevich: Laura, I didn't catch the first part of your question about treatment. Can you repeat that?

[Senior Research Analyst, Biotechnology] (William Blair): Sure. Is the duration of treatment on INGREZZA continuing to expand at this point?

Laura Chico: Sure. Is the duration of treatment on INGREZZA continuing to expand at this point?

Laura Chico: Sure, Is the duration of treatment on Ingrazza are continuing to expand at this point?

Eric Benevich: Yeah, we've had... We've been very fortunate with INGREZZA, really since the early days of the launch, that we've had very good, persistency and compliance. And the rates of persistency and compliance have been quite steady, from the early days of the launch through, really through 2023. And so we're not seeing any, big changes there, but they were already quite high, to begin with. So, you know, I think that that's one of the drivers for the continued growth of INGREZZA.

Eric Benevich: Yeah, We've had we've been very fortunate with Ingrazza, really, since the early days of the launch that we've had very good persistency and compliance. And the rates of persistency and compliance have been quite steady from the early days of the launch through-- really through 2023.

We've had we've been very fortunate with think Reza I really since the early days of the launch that we've had very good persistency and compliance.

And the rates of persistency and compliance have been quite steady.

From the early days of the launch through really through 2023.

And so we're not seeing any a big changes there, but they were already quite high to begin with. So you know, I think that that's one of the drivers for the continued growth of Ingrazza.

But they were they were already quite high.

To begin with.

So you know I think that that's one of the drivers for the continued growth of compressor.

Todd Tushla: Okay. Nicky will go onto the next question, Please.

Operator: Okay, Nikki, we'll go on to the next question, please. Our next question comes from Sumant Gulani with Canaccord. Please go ahead.

Kevin Gorman: Okay, Nikki, we'll go on to the next question, please.

Okay. Nicky will go onto the next question. Please.

Operator: Our next question comes from Sumant Gulani with Canaccord. Please go ahead.

Operator: Our next question comes from Sumant Kulkarni with Canaccord. Please go ahead.

[Managing Director, Biotechnology Equity Research] (Guggenheim Securities): Morning. Thanks for taking my question. So assuming all goes well on an eventual approval for crinecerfont and CAH, how do you expect that market to play out perhaps a couple of years after you've launched in the US? And is there anything that precludes the use of a CRF1 receptor antagonist in combination with an ACTH antagonist, for example?

Sumant Kulkarni: Morning. Thanks for taking my question. So assuming all goes well on an eventual approval for crinecerfont and CAH, how do you expect that market to play out perhaps a couple of years after you've launched in the US? And is there anything that precludes the use of a CRF1 receptor antagonist in combination with an ACTH antagonist, for example?

Sumant Kulkarni: Good morning, Thanks for taking my question. So assuming all goes well on an eventual approval for Crinecerfont and CAH, how do you expect that market to play out perhaps a couple of years after you've launched in the U.S. and is there anything that precludes the use of a CRF1 receptor antagonist in combination with an ACTH antagonist, for example?

Eiry Wyn Roberts: Yeah. I can't really comment on the market and maybe Eric might want to make a comment there. With respect to the second part of your question, though, I mean, that combination has not been studied together. Obviously that would need to happen before we make any comment on clinical implication of combined therapy.

Eiry Roberts: Yeah, I can't really comment on the market, and maybe Eric might want to make a comment there. With respect to the second part of your question, though, I mean, that combination has not been studied together. Obviously, that would need to happen before we could make any comment on the clinical implication of combined therapy. Mechanism of action would be somewhat similar in terms of the direct reduction of androgens for both an ACTH inhibitor and a CRF1 antagonist. And I think what we've seen so far in our data is that treatment with crinecerfont can result in a very substantial and clinically relevant reduction in androgens alone. And so I think in the context of need for combination, we do not have evidence of that up to this point.

Yeah, I constantly coming on the market and maybe Eric Mike might want to make a comment there with respect to the second part of your question No. I mean that combination has not been studied together, obviously that would need to happen before we could make any comment on clinical indication of of a combined therapy mechanism of action.

Mechanism of action would be somewhat similar in terms of the direct reduction of androgen for both an ACTH inhibitor and CRF1, antagonist. And I think what we've seen so far and our data is that treatment with Crinecerfont can result in a very substantial and clinically relevant reduction in androgens alone, and so I think in the context of need for combination, we do not have evidence of that up to this point.

Sumant Kulkarni: Thank you.

We do not have evidence about up to this point.

[Managing Director, Biotechnology Equity Research] (Guggenheim Securities): Thank you.

Sumant Kulkarni: Thank you.

Eric Benevich: Yeah, it's, you know, obviously very early with regards to commercial plans. But what I will say is that we're very excited about the opportunity to potentially make a meaningful difference within the CAH community. You know, we estimate that there's between 20,000 and 30,000 people living in the US currently with classic CAH. Similar number in Europe. The standard of care today is suboptimal. It's high dose, super physiologic glucocorticoids to suppress the excess androgens. And so these patients are faced with a difficult conundrum: either having excess androgens or living with high GC exposure and the consequences of that.

Eric Benevich: Yeah. It's obviously, very early with regards to commercial plans. But what I will say is that we're very excited about the opportunity to potentially make a meaningful difference within the CAH community.

We estimate that there's between 20,000 and 30,000 people living in the U.S. currently with CAH, similar number in Europe. The standard of care today is suboptimal. It's high dose, supraphysiologic glucocorticoid to suppress the excess androgens. And so these patients are faced with a difficult conundrum, either having excess androgens or living with high GC exposure, and the consequences of that.

And so these patients are faced with a difficult conundrum. Either having excess androgens or are living with high GC exposure and the consequences of that.

Either having excess androgens or are living with high GC exposure and the consequences of that.

Eric Benevich: So, you know, I believe that crinecerfont offers a real shift in the treatment paradigm, which would directly reduce the androgen excess in patients and enable the reduction of super physiologic GC doses. Obviously, we've got a lot of work to do to build the market, but that's what we're good at, and we've demonstrated that with INGREZZA and TD.

And so, you know, I believe that Crinecerfont offers a real shift in the treatment paradigm, which would directly reduce the androgen excess in patients and enable the reduction of supraphysiologic GC doses. So, obviously, we've got a lot of work to do to build the market but, that's what we're good at and we've demonstrated that with Ingrazza and TD.

Which would directly reduce the androgen excess in patients and enable the reduction of of Super physiologic GSE doses. So.

Obviously, we've got a lot of work to do to build the market but.

That's what we're good at and we've demonstrated that with <unk> and T D.

[Analyst] (Aiera): Thanks.

Sumant Kulkarni: Thanks.

Thanks. Your next question comes from David . So I'm with Piper Sandler. Please go ahead. Thanks, just a couple of quick pipeline question. So on N. B is 770, an M D D. A. License from Takeda when are you going to be in position to disclose the mechanism of that asset.

Sumant Kulkarni: Thanks.

Our next question comes from David Amsellem with Piper Sandler. Please go ahead. Thanks, just a couple of quick pipeline question. So on N. B is 770, an M D D. A. License from Takeda when are you going to be in position to disclose the mechanism of that asset.

Operator: Our next question comes from David Amsellem with Piper Sandler. Please go ahead.

Operator: Our next question comes from David Anzelm with Piper Sandler. Please go ahead.

Your next question comes from David <unk>.

So I'm with Piper Sandler. Please go ahead.

Eiry Wyn Roberts: Thanks. Just a couple of quick pipeline questions. So on NBI-770, and MDD, those in license from Takeda, when are you going to be in position to disclose the mechanism of that asset? And then secondly, any thoughts on the M1 the selected M1, and what your general thoughts are on the potential utility of selectively targeting M1 in psychiatric disorders? Thank you.

[Managing Director, Biopharma Research] (Piper Sandler): Thanks. Just a couple of quick pipeline questions. So on NBI-770 and NBD, that's been licensed from Takeda, when are you gonna be in position to disclose the mechanism of that asset? And then secondly, any thoughts on the M1, the selective M1, and what your general thoughts are on the potential utility of selectively targeting M1 in psychiatric disorders? Thank you.

David Amsellem: Thanks. Just a couple of quick pipeline questions. So on NBI-770 and NBD, that's been licensed from Takeda, when are you gonna be in position to disclose the mechanism of that asset? And then secondly, any thoughts on the M1, the selective M1, and what your general thoughts are on the potential utility of selectively targeting M1 in psychiatric disorders? Thank you.

Thanks, just a couple of quick pipeline question. So on N. B is 770, an M D D. A.

License from Takeda when are you going to be in position to disclose the mechanism of that asset.

And secondly, any thoughts on the M. One the selected them one and what your general thoughts are on the.

The potential utility of selectively targeting.

All right. I'll take the second part first, M1 agonist I think we're excited about the prospect of being able to bring forward an M1 preferring agonist in due course. I think there's been quite a lot of research in the past in this field. It's not clear that all the molecules have been of the quality they've been able to go forward appropriately in clinical development. So I don't really think the paradigm has been tested fully. and police and the range of indications could be quite broad ranging from cognition are in both neurological disorder to some degree of a potential in the psychiatric space with respect to 717 intensive.

All right. I'll take the second part first, M1 agonist I think we're excited about the prospect of being able to bring forward an M1 preferring agonist in due course. I think there's been quite a lot of research in the past in this field. It's not clear that all the molecules have been of the quality they've been able to go forward appropriately in clinical development. So I don't really think the paradigm has been tested fully. And the range of indications could be quite broad, ranging from cognition in both neurological disorders to some degree of potential in the psychiatric space.

And secondly, I took disorders. Thank you. Okay.

Okay.

Eiry Roberts: I'll take the second part first. M1 agonist, I think we're excited about the prospect of being able to bring forward an M1 preferring agonist in due course. I think there's been quite a lot of research in the past in this field. It's not clear that all the molecules have been of the quality that have been able to go forward appropriately in clinical development, so I don't really think the paradigm's been tested fully. And the range of indications could be quite broad, ranging from cognition in both neurological disorders to some degree of potential in the psychiatric space.

So I'll take the second part first and one agonist I think we're excited about the prospect of being able to bring forward and N. One preferring agonist in due course, I think theres been quite a lot of research in the past in this field are it's not clear that all the molecules have been of the quality they've been able to go forward appropriately in clinical development. So I don't.

Do you think the paradigm test and police and the range of indications could be quite broad ranging from cognition are in both neurological disorder to some degree of a potential in the psychiatric space with respect to 717 intensive.

And the range of indications could be quite broad, ranging from cognition the both neurological disorders to some degree of potential in the psychiatric space.

Eiry Roberts: With respect to NBI-770, in terms of that program, we actually have just completed the Phase 1 and are entering Phase 2, hopefully in the near future in the United States, in major depressive disorder. We have not as yet disclosed the direct mechanism of action there. And obviously, once we get to being in the clinic in Phase 2 here, we'll consider whether or not to do that at that point in time.

With respect to 770, in terms of that program, we actually have just completed the Phase I, and are entering Phase II, hopefully in the near future in The United States in major depressive disorder, we have not as yet disclosed the direct mechanism of action there, and obviously, once we get to being in the clinic in Phase here, we'll consider whether or not to do that at that point in time.

Consider whether or not to do that at that point in time. Yeah. Yeah.

Yeah.

Eric Benevich: Nikki, let's go on to the next question, please.

Todd Tushla: Nikki, let's go on to the next question, please.

Operator: We'll move next with Mohit Bansal with Wells Fargo. Please go ahead.

Operator: And we'll move next with Mohit Bansal with Wells Fargo. Please go ahead.

All the way to Wells Fargo. Please go ahead.

[Analyst] (Aiera): Hi, this is Serena on for Mohit Bansal. Thanks for taking my question. Wanted to ask about the reimbursement prospects for crinecerfont, and if you can help us understand what factors payers might take into account beyond shortening of chronic steroid use. For example, if there's any therapies like puberty blockers in the pediatric population that crinecerfont could help, mitigate use of, and how this would differ between the adults and pediatric population. Thank you.

[Analyst] (Wells Fargo): Hi, this is Serena on for Mohit Bansal. Thanks for taking my question. Wanted to ask about the reimbursement prospects for crinecerfont, and if you can help us understand what factors payers might take into account beyond shortening of chronic steroid use. For example, if there's any therapies like puberty blockers in the pediatric population that crinecerfont could help, mitigate use of, and how this would differ between the adults and pediatric population. Thank you.

Serena: Hi. This is Serena on for Mohit Bansal. Thanks for taking our question. I wanted to ask about the reimbursement prospects for Crinecerfont and if you can help us understand what factors payers might take into account beyond shortening of chronic steroid use. For example, if there's any therapies like puberty blockers in the pediatric population that Crinecerfont could help mitigate use of and how this would differ between the adults and pediatric population? Thank you.

<unk>. Thanks for taking my question wanted to ask about the reimbursement prospects or connector fine and if you can help us understand what doctors payers might take into account beyond shortening of chronic steroid use.

For example, if they thought he therapies like puberty blockers in the pediatric population I couldn't answer if I could help.

Mitigate used up and how that's a difference ah different between adults and pediatric population. Thank you.

Eiry Roberts: Yeah, I mean, I think it is. It's obviously very early to be talking about reimbursement in a very specific way. What is very clear from the discussions that we've had up to this point with KOLs, payers, and regulators around the world is that the impact of long-term steroid use is detrimental in this patient population, particularly at super physiologic doses. So the reduction in steroids that we have already been able to demonstrate in the context of our phase 3 program, we believe is very impactful and meaningful in the context of all the key stakeholders that will be supporting crinecerfont's use.

Eiry Wyn Roberts: Yeah. I mean, I think, it's obviously very early to be talking about reimbursement in a very specific way. What is very clear from the discussions that we've had up to this point with KOLs, payers and regulators around the world is that the impact of long-term steroid use is detrimental in this patient population, particularly at supraphysiologic doses.

The impact of long term steroid use is detrimental in this patient population that are particularly at Super physiologic doses.

And so the reduction in steroid that we have already been able to demonstrate in the context of our Phase III program, we believe is very impactful and meaningful for in the context of all the key stakeholders that will be supporting Crinecerfont's use.

Eiry Roberts: Beyond that, obviously, we have ongoing clinical data that we're generating that will focus on some of the other, functionally related endpoints and, clinical endpoints in this space that are relevant, including metabolic bone and in pediatrics, growth and development. And so as those emerge, I think they will be helpful and useful in the context of these discussions, but, it is really very early days.

Beyond that, obviously, we have ongoing clinical data that we're generating that will focus on some of the other functionally related endpoints, and clinical endpoints in this space that are relevant, including metabolic bone and in pediatrics growth and development. And so as those emerge, I think they will be helpful and useful in the context of these discussions, but it is really very early days.

And in Pediatrics growths on development.

And so as those emerge I think they will be helpful and useful in the context of these discussions but it is really very early days.

[Analyst] (Aiera): Thank you.

[Analyst] (Wells Fargo): Thank you.

Okay. Our next question comes from Ash Birla with UBS. Please go ahead.

Serena: Thank you.

Operator: Our next question comes from Ash Verma with UBS. Please go ahead.

Our next question comes from Ash Birla with UBS. Please go ahead.

[Analyst, Biotechnology Equity Research] (UBS): Hi, thanks for taking my question. Just on margin, I mean, looking beyond the next few years, just in the long term, like, where do you see operating margin shaking out? And have you considered providing a formal long-term outlook on this? Thanks.

Ash Verma: Hi, thanks for taking my question. Just on margin, I mean, looking beyond the next few years, just in the long term, like, where do you see operating margin shaking out? And have you considered providing a formal long-term outlook on this? Thanks.

Ash Verma: Hi. Thanks for taking my question. Just on margin, I mean, looking beyond the next few years, just in the long run, like where do you see operating margin shaking out, and have you considered providing a formal long-term outlook on this? Thanks.

Matthew Abernethy - CFO: This is clearly something that we discuss quite frequently with our Board in terms of what our priorities are, in terms of financial profile over the long run. You provided a guide at this point, but clearly you can see we're on a path of generating improved operating income.

Eric Benevich: This is clearly something that we discuss quite frequently with our board in terms of what our priorities are in terms of financial profile over the long run. We've not provided a guide at this point, but clearly you can see we're on a path of generating improved operating income. You can see the SG&A leverage, but I'd say from an R&D perspective, we're committed to continue to invest at a very similar rate from a percentage perspective as we are today in R&D to continue to build our pipeline and develop medicines to help patients here in the future. So we're not gonna provide a specific guide, but know we are intending to drive operating leverage through SG&A margin improvement. Nikki, let's take a couple more questions.

So this is clearly something that we discuss quite frequently with our board in terms of what our priorities are in terms of our financial profile over the long run you provided.

Our guide at this point, but clearly you can see we're on a path of generating improved.

You can see the SG&A leverage, but I'd say from an R&D perspective, we're committed to continue to invest at a very similar rate from a percentage perspective as we are today in R&D to continue to build our pipeline and develop medicines to help patients here in the future. So we're not going to provide a specific guide, but know we are intending to drive operating leverage through SG&A margin improvement.

From a percentage perspective as we are today.

R&D to continue to build our pipeline and develop medicines to help them.

Ah patients here in the future. So we're not going to provide a specific guide, but no. We are intending to drive operating leverage through SG&A margin improvement.

Ash Verma: Thank you.

Todd Tushla: Nikki, let's take a couple more questions.

Operator: We'll move next with Ami Fadia, with Needham. Please go ahead.

Operator: We'll move next with Ami Fadia with Needham. Please go ahead.

[Senior Research Analyst, Biotechnology] (Needham & Company): Hi, good morning. Congratulations on the strong quarter. I wanted to follow up on the NBI-352 asset. Can you elaborate on what other aspects of the study beyond obviously the seizure rate reduction and safety data that would be important to watch when you announce the data? And could you lay out some sort of scenarios or what is the likely next development stage?

Ami Fadia: Hi, good morning. Congratulations on the strong quarter. I wanted to follow up on the NBI-352 asset. Can you elaborate on what other aspects of the study beyond obviously the seizure rate reduction and safety data that would be important to watch when you announce the data? And could you lay out some sort of scenarios or what is the likely next development stage?... Should you see strong safety and efficacy somewhere around kind of that bar that you laid out of, you know, say, 15% placebo, but then the drug that's about 30%, would that allow you to go directly into pivotal trials? Thanks.

Eiry Wyn Roberts: Hi. Good morning. Congratulations on the strong quarter. I wanted to follow up on 352 assets. Can you elaborate on what other aspects of the study beyond obviously the seizure rate reduction, and safety data that would be important to watch when you announce the data? And can you lay out some sort of scenarios, or what is the likely next developing stage? Should you see strong safety and efficacy somewhere around kind of that bar that you laid out of, say, 15% placebo, but then the drug does about 30%. Would that allow you to go directly into a pivotal trials? Thanks.

T five two assets.

Can you elaborate on what other aspect of the study beyond all the king of seizure reduction.

And safety data that would be important to watch when you announced the data and do they have some set of scenarios or what what is the likely next developing stage.

Kevin Gorman: ... Should you see strong safety and efficacy somewhere around kind of that bar that you laid out of, you know, say, 15% placebo, but then the drug that's about 30%, would that allow you to go directly into pivotal trials? Thanks.

<unk> seen strong safety and efficacy somewhat around kind of that bar that you laid out.

Just want to see both of them, but that's about 10%.

Would that allow you to go directly into a pivotal trial.

Eiry Roberts: Yeah, I mean, we're focused right now on really just getting to the data and reading out the data. I think, what I mentioned is that we will have, safety and tolerability information. We will also have, the information focused on understanding the impact of NBI-352 at the dosage in this study on, seizure, both seizure frequency, seizure freedom, and, responders in terms of the ability to reach a 50% reduction in seizures. That's really the totality of the data from this study. And, you know, it'll depend on how the, the strength of the, of the information that we read out as to what our next steps are.

Yeah. I mean, we're focused right now on really just getting to the data and reading out the data. I think what I mentioned is that we will have safety and tolerability information. We will also have the information focused on understanding the impact of 352 at the doses in the study on seizure, both seizure frequency, seizure freedom and responders in terms of ability to reach a 50% reduction in seizures. That's really the totality of the data from this study and you know, it'll independent on how the strength of the information that we read out as to what our next steps are.

Seizure, both seizure frequency she seizure freedom and responders in terms visibility.

Reach a 50% reduction in seizures, and that's really the totality of the data from this study and you know independent on how the strengthening of the information that we readout as to what our next steps are.

Todd Tushla: Nikki, let's take two more questions.

Todd Tushla: Nikki, let's take 2 more questions.

Nikki, let's take two more questions.

Operator: We have Uy Ear with Mizuho. Please go ahead.

Operator: Next, we have Uri with Mizuho. Please go ahead.

Thanks, Wastefully ear with Mizuho. Please go ahead.

[Analyst, Biotechnology Equity Research] (Mizuho Securities): Hey, guys. Thanks for taking my questions and congrats on the good quarter. So my question is, could you sort of speak a little bit about the timing of the R&D Day and whether this has related in any way to any change of your level of confidence in the upcoming data readout for any of the studies, particularly the two that will read out at the end of this year? Thanks.

Uy Ear: Hey, guys. Thanks for taking my questions and congrats on the good quarter. So my question is, could you sort of speak a little bit about the timing of the R&D Day and whether this has related in any way to any change of your level of confidence in the upcoming data readout for any of the studies, particularly the two that will read out at the end of this year? Thanks.

Uy Ear: Hey, guys. Thanks for taking my questions, and congrats on the good quarter. So my question is could you sort of speak a little bit about the timing at the R&D day, and whether this has related in any way to any change of your level of confidence in the upcoming data read out for any of the studies, particularly the two that we'll read out at the end of this year? Thanks.

And congrats on the good quarter and so my question is could you sort of speak a little bit about the timing at the R&D day, and whether that has related in any way with your any change of cough.

Confidence in the upcoming data readout for any of the studies, particularly due.

Two that was laid out at the end of this year.

Todd Tushla: Hey, hey, Uri, this is Todd. Yeah, the Analyst Day is going to be on 5 December, and it's really a two-pronged agenda, as outlined in our earlier comments. The first part is on R&D strategy and vision, and our chief scientific officer, Dr. Jude Onye, is gonna lead that discussion on that day. Then the second part will be focused on CAH and really helping the analyst community understand the burden of disease and treatment challenges today, and how crinecerfont, if approved, could potentially help out with those patients and those and the people who care for them.

Todd Tushla: Hey. This is Todd. Yeah. The Analyst Day is going to be on December 5th, and it's really a two-pronged agenda is outlined in our earlier comments. The first part is on R&D strategy and vision, and our Chief Scientific Officer. Dr. Jude Onyia, is going to lead that discussion on that day.

And then the second part will be focused on CAH and really helping the analyst community understand the burden of disease and treatment challenges today, and how Crinecerfont, if approved, could potentially help out with those patients, and the people who care for them.

And how pronounced upon if approved could potentially.

Help out with those patients.

The people who care for them. So we don't have a really clear expectations, we're not expecting to unveil data from from either of the studies that we've discussed.

Uy Ear: Thanks.

Eric Benevich: So to set really clear expectations, we're not expecting to unveil data from either of the studies that we've discussed. That's not gonna be part of the R&D Day in terms of an unveiling or a long-term financial guidance. It's clearly this is something we haven't done in over 10 years, I believe. And I think we've got a great pipeline, and we have a great team and look forward to meeting with all of you here in a few weeks.

Matthew Abernethy - CFO: So that's a really clear expectation. We're not expecting to unveil data from either of the studies that we've discussed. That's not going to be part of the R&D Day in terms of an unveiling or a long term financial guidance. It's clearly--this is something that's been--we haven't done in over 10 years I believe, and I think we've got a great pipeline, and we have a great team and look forward to meeting with all of you here, in a few weeks.

Discuss that's not going to be part of the R&D day in terms of an unveiling or our long term financial guidance. It's clearly. This is something that's been.

This is something that's been.

Haven't done in over 10 years I believe. And I think we've got a great pipeline and we have a great team and look forward to meeting with all of you here in a few weeks. And I think we've got a great pipeline and we have a great team and look forward to meeting with all of you here in a few weeks.

And I think we've got a great pipeline and we have a great team and look forward to meeting with all of you here in a few weeks.

Todd Tushla: Thanks, Uri.

[Analyst, Biotechnology Equity Research] (Mizuho Securities): Thank you.

Uy Ear: Thank you.

Todd Tushla: So, Nikki, let's take one last question.

Todd Tushla: Thanks Uy. Nikki let's take one last one last question.

Todd Tushla: Thanks Uy.

Todd Tushla: Thanks. Nikki let's take one last one last question.

Uy Ear: Thanks.

Todd Tushla: Nikki, let's take one last one last question.

Operator: We'll take our last question from Evan Seigerman with BMO Capital Markets. Please go ahead.

Operator: We'll take our last question from Evan Seigerman with BMO Capital Markets. Please go ahead

[Analyst, Biotechnology Equity Research] (BMO Capital Markets): Hi there, this is Connor McKay on drive-in. Thanks for taking our question, and congrats on a great quarter. I just had one follow-up on the TD market opportunity. You guys mentioned that, 65% of patients who are undiagnosed, you expect that to shrink, you know, going forward. I'm just curious about that patient profile and what you expect for the percentage of those newly diagnosed patients, how many of them will be then treated? Is the expectation that it'll still be around roughly half, or do you expect that to grow? Thank you.

Conor MacKay: Hi there, this is Connor McKay on drive-in. Thanks for taking our question, and congrats on a great quarter. I just had one follow-up on the TD market opportunity. You guys mentioned that, 65% of patients who are undiagnosed, you expect that to shrink, you know, going forward. I'm just curious about that patient profile and what you expect for the percentage of those newly diagnosed patients, how many of them will be then treated? Is the expectation that it'll still be around roughly half, or do you expect that to grow? Thank you.

Conor MacKay: Hello. This is Conor MacKay on for Evan. Thanks for taking my question and congrats on a great quarter. I just had one follow up on the TD market opportunity. You guys mentioned that 65% of patients who are undiagnosed do expect that to shrink going forward. I'm just curious about that patient profile and what you expect for the percentage of those newly diagnosed patients, how many of them will be then treated. Is the expectation that it'll still be around roughly half or do you expect that to growth? Thank you.

TB market opportunity.

You guys mentioned that 65% of patients who are undiagnosed do you expect that.

To shrink going forward I'm, just curious about that.

That patient profile and what you expect for a percentage on those newly diagnosed patients how many of them will be I've been treated with the expectation that that's going to be around directly or do you expect that type of growth. Thank you.

Eric Benevich: I'll start with the second part of your question first. You know, I do think that the percent of patients that are diagnosed, that are offered treatment with a VMAT2 inhibitor has grown over time. If you think about it, at the time that we launched INGREZZA, VMAT2 inhibitors were not available, and the standard of care back then was either watchful waiting to see if the symptoms worsened over time or, you know, what I call the three Rs: remove, replace, or reduce the antipsychotic. In some cases, patients were treated with benztropine, which is inappropriate. So, if you sort of compare and contrast, you know, the rate of offering VMAT2 treatment in the early days of the launch where we are today, obviously we've made progress.

Matthew Abernethy - CFO: I'll start with the second part of your question first. I do think that the percent of patients that are diagnosed that are offered treatment with VMAT2 inhibitor has grown over time. If you think about it, at the time that we launched Ingrazza, VMAT2 inhibitors were not available, and the standard of care back then was either watchful waiting to see if the symptoms worsened over time, or you know, what I call the three R's remove, replace or reduce the antipsychotic. In some cases, patients were treated with benztropine, which is inappropriate.

Has grown over time, if you think about it at the time that we launched in Gaza B.

B Mab two inhibitors were not available and.

The standard of care back then was either watchful waiting to see if the symptoms worsened over time or you know what I call. The three r's remove or replace or reduce the out of psychotic in some cases patients were treated with Vince.

So, if you sort of compare and contrast, the rate of offering VMAT2 treatment in the early days of launch to where we are today, obviously, we've made progress. However, are still half the time, patients are not offered VMAT2 inhibitor, and so I expect that that will continue to improve over time, specially as we continue to leverage the updated APA guidelines. And so, between driving diagnosis, and treatment with VMAT2 inhibitors, we're going to continue to make a difference for the hundreds of thousands of people living with TD today that are currently undiagnosed and untreated.

If you sort of compare and contrast. Great of offering be Matt to treatment in the early days of launch where we are today. Obviously, we've made progress. However are still half. The time patients are not offered a b mab two inhibitor and so I expect that that will continue to improve over time, especially as we continue to leverage the. Great of offering be Matt to treatment in the early days of launch where we are today. Obviously, we've made progress. However are still half. The time patients are not offered a b mab two inhibitor and so I expect that that will continue to improve over time, especially as we continue to leverage the.

Great of offering be Matt to treatment in the early days of launch where we are today. Obviously, we've made progress. However are still half. The time patients are not offered a b mab two inhibitor and so I expect that that will continue to improve over time, especially as we continue to leverage the.

Eric Benevich: However, still half the time, patients are not offered a VMAT2 inhibitor, and so I expect that that will continue to improve over time, especially as we continue to leverage the updated APA guidelines. And so, you know, between driving diagnosis and treatment with VMAT2 inhibitors, we're gonna continue to make a difference for the hundreds of thousands of people living with TD today that are currently undiagnosed and untreated.

Our updated <unk> guidelines and so you know between driving.

Diagnosis and treatment with we met two inhibitors, we're going to continue to make a difference for the hundreds of thousands of people living with TD today that are currently undiagnosed and untreated.

Todd Tushla: Thank you.

Conor MacKay: Thank you.

Conor MacKay: Thank you. so I'd like to make just a brief a closing statement.

Conor MacKay: Thank you.

Kevin Gorman: So I'd like to make just a brief closing statement. You know, this quarter, as we all started out saying, you know, what a tremendous quarter. You don't get many quarters like this, but one has to put it in perspective, that the regulatory approval, the Phase 3 success, and 2 Phase 3 clinical trials, and the continued success with INGREZZA are years in the making. These aren't just things that we did this quarter. And when you think back on the challenges that have that have hit our entire industry over the last several years, it makes a tremendous quarter even all that more remarkable. So I'm very proud of the teams that have been involved in all of these successes. And I'm looking forward to having our R&D Day, or Analyst Day.

Kevin Gorman - CEO: So I'd like to make just a brief a closing statement. This quarter, as we all started out saying, what a tremendous quarter. You don't get many quarters like this, but one has to put it in perspective that, the regulatory approval the Phase III success in two Phase III clinical trials, and the continued success with Ingrazza are years in the making. These aren't just things that we did this quarter. And when you think back on the challenges that have hit our entire industry over the last several years, it makes a tremendous quarter even all that more remarkable.

You know that this quarter as we all started out saying what a trend this quarter.

You don't get many quarters like this but one has to put it in perspective.

At the end.

The regulatory approval of the phase three success in two phase III clinical trials and the continued success with our in browser are years in the making these arent just things that we did this quarter and when you think back on the challenges that have Ah.

Net of the hit our entire industry over the last several years it makes a tremendous quarter, even all that more remarkable.

So I'm very proud of the teams that have been involved in all of these successes. And I'm looking forward to having our R&D Day or Analyst Day, we use them interchangeably, because I think it's going to be a very good time for us to get a little more in depth with you and to be able to give you a bit of an idea on the vision that we have for the future. And with the current state that we have, I think we are extremely well positioned to deliver well into the 2030s with our company as being a leader in neuroscience.

Of the teams that have been involved in all of these successes.

And I'm looking forward to having our R&D day or analyst day, I will use them interchangeably, because I think it's going to be a very good time for us to get a little more in depth with you and to be able to give you a bit of an idea on the vision that we have for the future and with the.

Kevin Gorman: We use them interchangeably. Because I think it's gonna be a very good time for us to get a little more in-depth with you and to be able to give you a bit of an idea on the vision that we have for the future. And with the current state that we have, I think we are extremely well-positioned to deliver well into the 2030s with our company as being a leader in neuroscience. With that, thank you very much, and look forward to talking to you all later.

The current state that we have I think we are extremely well positioned.

With that, thank you very much, and look forward to talking to you all later.

Operator: This does conclude today's program. Thank you for your participation. You may disconnect at any time. Goodbye!

Operator: And this does conclude today's program. Thank you for your participation. You may disconnect at any time. Good bye.

Goodbye. [music].

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