Q3 2021 Neurocrine Biosciences Inc Earnings Call

Okay.

Operator: Good day, everyone, and welcome to today's Neurocrine Biosciences Report third quarter results. At this time, all participants are in a listen-only mode.

Good day, everyone and welcome to today's Neurocrine Biosciences reports third quarter result.

At this time all participants are in a listen only mode.

Operator: Later, you will have the opportunity to ask questions during the question and answer session. Please note today's call may be recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations, Todd Tushla. Please go ahead.

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

Please note todays call, maybe recorded and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Vice President of Investor Relations Todd to Sheila. Please go ahead.

Todd Tushla: Thank you, Chloe. Good afternoon, and thanks for joining our third quarter 2021 earnings call. On today's call, 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 our call today, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

Thank you Courtney and good afternoon, and thanks for joining our third quarter of 2021 earnings call on today's call, Kevin Gorman, Our Chief Executive Officer, Matt Abernethy, Our Chief Financial Officer, <unk> Roberts, our Chief Medical Officer, Eric benefits, our Chief commercial officer, and Kyle Gano, our chief business development and strategy Officer.

During our call today, we will be making forward looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially.

Todd Tushla: I encourage you to review the risk factors discussed in our latest SEC filings. After our prepared remarks, we'll go into the question-and-answer session, so please limit yourself to one question so we can get to as many questions as possible. With that, I hand the call over to Kevin Gorman. Thanks, Todd. Welcome, everyone. Good afternoon.

Encourage you to review the risk factors discussed in our latest SEC filings. After our prepared remarks, we will go into the question and answer session. So please limit yourself to one question. So we can get to as many questions as possible with that I hand, the call over to Kevin Gorman, Thanks, Todd and welcome everyone and good afternoon, I just going to start out with two brief comments first I am very.

Kevin C. Gorman: I'm just going to start out with two brief comments. First, I'm very pleased to see Ingres' continued growth. This is the second quarter in a row where we see this growth, and I anticipate we're going to have continued growth for the remainder of the year. Now, we're not yet back to the pre-COVID growth trajectory, but NRX has continued to increase. COVID's impacts are still being experienced in the field in a number of territories.

It's the same breath is continued growth. This is the second quarter in a row, where we see this growth.

And I anticipate we're going to have continued growth.

Major of the year now, we're not yet back to pre COVID-19 growth trajectory, but <unk> continued to increase coatings impacts are still being experienced in the field and the number of territories.

Kevin C. Gorman: It is not behind us, but we've adapted well. In addition, telemedicine is still being heavily utilized by healthcare professionals. But again, we are adapting well and growing our business, and Eric will talk about how we are investing behind Ingresa. Now, second, we started the year with an extremely aggressive goal to start a number of Phase II and Phase III clinical trials, and we are going to meet that goal, growing one of the most robust neuroscience pipelines in the industry. And I will highlight several of these programs. So with that, I'm going to turn it over to Matt. Thanks, Kevin.

It is not behind us, but we've adapted well.

In addition to telemedicine, that's still being heavily utilized by health care professionals.

But again, we are adapting well in growing our business and Eric will talk about how we are investing behind and grasp now second we started the year with an extremely aggressive goal to start a number of phase II phase III clinical trials, and we are going to meet that.

Growing one of the most robust neuroscience pipelines in the industry and I, we will highlight several of these programs.

With that I'm going to turn it over to Matt.

Thanks, Kevin and Chris This momentum continued with Q3 sales were $287 million, representing 13% year over year growth.

Matthew C. Abernethy: Ingressive Momentum continues with Q3 sales of $287 million, representing 13% year over year growth. We were encouraged to see Q3 new prescriptions approach pre-pandemic record levels, even with telemedicine still representing a large portion of psychiatric patient visits. Q4 is off to a solid start, and we anticipate Q4 sales of just over $300 million, reflecting strengthening demand offset slightly by seasonally elevated Q4 gross net discount.

We were encouraged to see Q3, new prescriptions approach pre pandemic record level, even with telemedicine still representing a large portion of psychiatric patients.

Q4 is off to a solid start and anticipate Q4 sales of just over $300 million, reflecting strengthening demand.

Slightly by seasonally elevated Q4 gross to net discount.

Matthew C. Abernethy: The progress we're seeing within GRESA reflects a tremendous medicine, a great team driving strong commercial execution, and, most importantly, a significant opportunity to help many more patients with TD. Looking ahead to 2022, we are seeing strong growth from Ingresa, and with Ingresa being our top capital allocation priority, we will invest an additional $100 million to expand our field sales team and continue our DTC campaign throughout the year. Additionally, beyond Ingress, we continue to invest in our growing pipeline. We expect to exit this year with 12 clinical programs with many important clinical data readouts coming over the next two years. Fundamental to both growing Ingresa and advancing our pipeline are our people.

The progress we're seeing with <unk> reflects the tremendous medicine.

<unk> team driving strong commercial execution, and most importantly, a significant opportunity to help many more patients with TD.

Looking ahead to 2022, we're seeing strong growth from <unk> and with <unk> being our top capital allocation priority, we will invest an additional $100 million to expand our field sales team and continue our DTC campaign throughout the year.

Beyond <unk>, we continue to invest in our growing pipeline.

Expect to exit this year with 12 clinical programs with many important clinical data readouts coming over the next two years.

Fundamental to both growing any browser and advancing our pipeline and our people we continue to invest in our <unk> team members and attract top talent in short growing company.

Eric S. Benevich: We continue to invest in our neurocrine team members and attract top talent to our growing company. Bottom line, we are well positioned for long-term growth, and our people will be the key to executing our strategy of becoming a leading neuroscience company. With that, I will now hand the call over to Eric Benevich.

Bottom line, we are well positioned for long term growth and our people will be the key to executing our strategy of becoming a leading neuroscience company.

With that I will now hand, the call over to Erik <unk> Erik.

Eric.

Eric S. Benevich: Thanks, Matt. Let's jump right into it. Our team executed well throughout the quarter, driving record Ingresa total prescriptions, leading to all-time high sales of $287 million. From an NRX perspective, we continue to see improvements in new patient starts. While NRX levels are not quite back to pre-pandemic levels, we have certainly seen steady improvements since the beginning of the year. All note that key performance indicators such as sales call volume, sample distribution, and speaker programs were consistently strong throughout Q3. This is a quarter that historically is a slower growth quarter due to seasonally related challenges.

Thanks, Matt, let's jump right into it or.

Our team executed well throughout the quarter driving record and graduate total prescriptions, leading to all time high sales of $287 million.

From an interest perspective, we continue to see improvements in new patient starts.

While an rx levels are not quite back to pre pandemic levels, we have certainly seen steady improvement since the beginning of the year.

I'll note the key performance indicators, such as sales call volume sample distribution speaker programs were consistently strong throughout Q3.

That historically has a slower growth quarter due to seasonally related challenges.

Eric S. Benevich: In Q3, persistence and compliance rates for Ingressa patients remained at the historically high levels we've come to expect with our medicine. And, as Matt said, we are off to a solid start in Q4, but the pandemic is still having an impact on customer access and patient flow in regions throughout the nation. In addition, psychiatrists in particular are still relying on telemedicine about half the time, which presents a challenge for TD diagnosis.

In Q3 persistence and compliance rates spring breath of patients remained at historically high levels, we do expect with our medicine.

And as Matt said, we are off to a solid start to Q4, but the pandemic is still having an impact on customer access and patient flow and regions throughout the nation.

In addition, psychiatrist in particular are still relying on telemedicine about half the time.

This presents a challenge for TD diagnosis.

Eric S. Benevich: I'd like to shift gears now to provide a bit more insight into the decision to expand our sales. We have articulated since 2017 that this is a learning launch, that we continue to learn and adapt to better meet the needs of patients and healthcare provider customers. For example, you recall in 2018, with strong uptake for Ingresa and market trends that we saw at that time, we made the decision to upsize our field force to help accelerate TD diagnosis and treatment with Ingresa.

I'd like to shift gears now to provide a bit more insight into the decision to expand our sales team.

We have articulated since 2017, but this is a learning launch that we continue to learn and adapt to better meet the needs of patients and health care provider customers.

For example, you'll recall in 2018 was strong uptake for any browser and market trends that we saw at that time, we made the decision to upsize our field force to help accelerate TD diagnosis and treatment with <unk>.

Last year, the pandemic taught us many lessons, including how to better meet the needs of our patients and the health care provider customers.

Especially those who rely more heavily on telematics.

Importantly, it was clear to us that the base of prescribers and high potential prescribers has grown larger over time as we've continued to develop the TD market.

Eric S. Benevich: Last year, the pandemic taught us many lessons, including how to better meet the needs of our patients and healthcare provider customers, especially those who rely more heavily on telemedicine. Importantly, it was clear to us that the base of prescribers and high potential prescribers has grown larger over time as we continue to develop the TD market. The key takeaway was that we needed to evolve our commercial footprint to reach and educate a growing and ever more diverse set of customers.

The key takeaway was that we needed to evolve our commercial footprint to reach and educate is growing ever more diverse set of customers to that and by Q2 of next year. We will have established two new dedicated sales teams focused on movement disorder, neurologists and providers in long term care respectively.

In total we will have three dedicated field teams across the country neurology in long term care, which we believe will constitute a more focused and effective sales force.

Eric S. Benevich: To that end, by Q2 of next year, we will have established two new dedicated sales teams focused on movement disorder neurologists and providers in long-term care, respectively. In total, we will have three dedicated field teams across psychiatry, neurology, and long-term care, which we believe will constitute a more focused and effective sales force. When our expansion is complete around Q2 of next year, there will be approximately 350 specialty salespeople across these three teams Along with the Salesforce expansion, we've been taking steps to make it easier for patients to get Ingressa by expanding our distribution network. And with this change, we continue to caution you about reliance on third-party syndicated data.

When our expansion is complete around Q2 of next year, there will be approximately 350 <unk> specialty salespeople across these three teams along with the sales force expansion, we have been taking steps to make it easier for patients to getting revenue by expanding our distribution network and with this change we continue to caution you on <unk>.

Alliance on third party syndicated data.

The sales force and distribution expansion, along with our ongoing branded direct to consumer campaign reflects our conviction in the TV market opportunity.

While I'm tremendously proud of the collective effort has taken to get TD diagnosis rates up to around 20% today. The fact remains that.

There is much work ahead.

We have a strong belief in the long term opportunity for your browser and you see that translated into the investments, we're making in our people and marketing initiatives to meet the needs of the many patients who still need our help.

Turning to market access based on the planned formulary designs that have been published thus far we expect access to <unk> in 2022 to be similar to this year.

Eric S. Benevich: The Salesforce and distribution expansions, along with our ongoing branded Direct-to-Consumer campaign, reflect our conviction in the TD market. While I'm tremendously proud of the collective effort it's taken to get TD diagnosis rates up to around 20% today, the fact remains that there is much work ahead. We have a strong belief in the long-term opportunity for Ingresa, and you see that translated into the investments we are making in our people and marketing initiatives to meet the needs of the many patients who still need our help.

And based on what we know today, we are expecting rather than net revenue per prescription next year to be similar to 2021 rates.

Access for patients remains a critically important priority.

Launch to date greater than 85% of <unk> prescriptions have been fulfilled regardless of formulary status and we expect to carry forward. The success, we've had with access and reimbursement into 2022.

With regards to on Genesis feedback from the marketplace continues to be positive as more and more patients and prescribers are gaining initial experience with the only ones daily comps inhibitor approved in the U S.

Eric S. Benevich: Turning to market access, based on the planned formulary designs that have been published thus far, we expect access to Ingresa in 2022 to be similar to this year. And based on what we know today, we're expecting resident net revenue per prescription next year to be similar to 2021 rates. Access for patients remains a critically important priority.

In addition, we continue to leverage <unk> and <unk> together to main high access levels to our neurology customers.

In closing I'm very pleased with our team's performance under challenging circumstances and the impact that we're making for patients Q3 was a strong growth quarter and in fact represented all time highs in total prescriptions and net sales.

Even more optimistic about where we can go from here in terms of continuing to grow our franchise.

Eric S. Benevich: Launched today, greater than 85% of Ingressant prescriptions have been fulfilled, regardless of formulary status, and we expect to carry forward the success we've had with access and reimbursement into 2022. With regard to Ongentis, feedback from the marketplace continues to be positive as more and more patients and prescribers are gaining initial experience with the only once-daily Compton inhibitor approved in the U.S. In addition, we continue to leverage Fongentis and Ingresa together to maintain high access levels to our neurology customers.

So with that I'll hand, the call off to our Chief Medical Officer, Dr. Iraq's Irene.

Thank you, Eric and good afternoon to everyone on the call today.

Building on Eric's comments regarding and grants that.

Medical Affairs organization continues to focus on education, and key data generation in support of patients living with tardive dyskinesia.

In fact, we recently expanded the portion of our field team focused on education and support of advanced practice provided such as minister practitioners and physicians assistants, given the critical role that these providers play in the diagnosis and treatment of patients living with TD.

Eric S. Benevich: In closing, I'm very pleased with our team's performance under challenging circumstances and the impact we're making for patients. Q3 was a strong growth quarter and, in fact, represented all-time highs in total prescriptions and net sales. I'm even more optimistic about where we can go from here in terms of continuing to grow our franchise. So with that, I'll hand the call off to our Chief Medical Officer, Dr. Eiry Roberts.

We know that the impact TD has on the lives of patients both functionally and socially kind of also be even more important than the movements themselves and we continue to work to understand the impact through the analysis of data generated from our Registrational phase studies using the <unk>.

Eiry W. Roberts: Thank you, Eric, and good afternoon to everyone on the call today. Building on Eric's comments regarding Ingresa, our medical affairs organization continues to focus on education and key data generation in support of patients living with tardive dyskinesia. In fact, we recently expanded the portion of our field team focused on education and support of advanced practice providers, such as nurse practitioners and physician's assistants, given the critical role that these providers play in the diagnosis and treatment of patients living with T.D.

Dyskinesia impact scale or TBS.

Couldn't develop TD patient reported outcome.

At the recent Congress in October we presented analyses from the connect three study demonstrating an improvement in patient reported impact as a symptom both functional and social in subjects treated with congrats Ed.

Additionally, this analysis shows that questions within 90 days.

As a potential clinical assessment to.

Additional validation of the TD as well.

<unk> is now ongoing.

Turning to buy benzene I am pleased to announce that we are currently initiating the registrational study of <unk> for the adjunctive treatment of schizophrenia with enrollment expected to open this month.

Eiry W. Roberts: We know that the impact TD has on the lives of patients, both functionally and socially, can often be even more important than the movements themselves, and we continue to work to understand this impact through the analysis of data generated from our registrational phase studies using the Tardive Dyskinesia Impact Scale, or TDIS, a Neurocrine-developed TD patient-reported outcome. At the recent PSYCH Congress in October, we presented Tdiff's analyses from the CONNECT3 study, demonstrating an improvement in patient-reported impact of symptoms, both functional and social, in subjects treated with Ingresa.

This phase three randomized double blind placebo controlled study will enroll approximately 400 patients with schizophrenia, who have had an inadequate response to antipsychotic.

The primary outcome measure is the change in total pans score from baseline to week 10 seconds.

Secondary measures include the change in the clinical global impression severity score all CGI S and.

Change in personal and social performance scale from baseline to week 10.

We estimate this study will be complete in late 2023.

And thinking about the remainder of the year there are number of key milestones and activities to highlight.

Eiry W. Roberts: Additionally, this analysis shows that questions within the T-DISC show promise as a potential clinical assessment tool. Additional validation of the T-DISC as a clinical tool is now ongoing. Turning to valbenazine, I'm pleased to announce that we're currently initiating a registrational study of valbenazine for the adjunctive treatment of schizophrenia, with enrollment expected to open this month. This Phase 3 randomized, double-blind, placebo-controlled study will enroll approximately 400 patients with schizophrenia who have had an inadequate response to antipsychotics.

Firstly, we remain on track to share top line results from the connect HD Registrational study in Huntington's disease.

December.

In addition, we are planning to initiate by mid to late stage studies, which include the Registrational study about benzene for the treatment of dyskinesia due to cerebral palsy.

These two studies of <unk> for the treatment of cognitive impairment associated with schizophrenia.

845, sorry adequate response to treatment in major depressive disorder, MDI eighth full stake donia.

Eiry W. Roberts: The primary outcome measure is the change in total PAM score from baseline to week 10. Key secondary measures include the change in the Clinical Global Impression Severity Score, or CGIS, and Change in Personal and Social Performance Scales from Baseline to Week 10.

Gilenya in depression, and NPI 352 for focal seizure onset seizure in adults.

In total therefore, we anticipate having 12 program in mid to late stage trials as we enter into 2022.

With over 50 ongoing clinical trials and more to come this is an exciting and potentially transformational time at Neurocrine as we look forward to delivering a number of important clinical data readouts over the coming years.

Eiry W. Roberts: We estimate this study will be complete in late 2023. In thinking about the remainder of the year, there are a number of key milestones and activities to highlight. Firstly, we remain on track to share top-line results from the ConnectHD Registrational Study in Huntington's Disease in December. In addition, we're planning to initiate five mid- to late-stage studies, which include the Registrational Study of Valbenazine for the Treatment of Dyskinesia Due to Cerebral Palsy and Phase II Studies of Lubridaxostat for the Treatment of Cognitive Impairment Associated with Schizophrenia, NBI-845 for an Adequate Response to Treatment in Major Depressive Disorder, NBI-846 for Amidonia in Depression, and NBI-352 for Focal Seizure, Onset Seizure in Adults.

I would like to end by thanking all the teams across our organization and our partners outside the company for their continued hard work in support of our portfolio.

Most importantly, I would like to thank the investigators patients and their families who participate in each of our clinical trials.

I'll now turn the call back to Kevin Kevin.

Thanks Anthony.

Sums up all of our prepared remarks, so we are now ready for door questions.

Yes.

And at this moment, if you would like to ask a question. Please press. The Star then one on your Touchtone phone.

Eiry W. Roberts: In total, therefore, we anticipate having 12 programs in mid to late stage trials as we enter into 2022. With over 50 ongoing clinical trials and more to come, this is an exciting and potentially transformational time at Neurocrine, as we look forward to delivering a number of important clinical data readouts over the coming years. I would like to end by thanking all the teams across our organization and our partners outside the company for their continued hard work in support of our portfolio. And, most importantly, I would like to thank the investigators, patients, and their families who participate in each of our clinical trials. I'll now turn the call back to Kevin. Okay?

May withdraw yourself from the queue at any time by pressing the pound key.

Once again for your questions that is star one.

And we will take our first question from Neena <unk> garg with.

City.

Please go ahead.

Hey, guys. Thanks for taking my question.

I just want to understand a little bit more about where the growth in new scripts is coming from for <unk>, because it sounds like youre still seeing kind of 50% telemedicine used in the psychiatry offices.

And a similar 20% diagnosis rate can you just talk a little bit more about is that coming from just an increase in the total number of visits regardless of whether telemedicine versus in patient total number of prescribers overall is that coming more from psych versus neuro often I guess, if you could just drill down on it.

Kevin C. Gorman: Thanks, Abby. That sums up all of our prepared remarks. So we are now ready for your questions. And at this moment, if you would like to ask a question, please press the star and then one on your touchtone phone. You may withdraw yourself from the queue at any time by pressing the pound key. And once again, for your questions, that is star and one. And we will take our first question from Neena Bitritto Garg with Citi.

The dynamics that would be great.

Okay.

Eric.

Yes.

Thanks for the question Nina So, it's a little bit of everything.

I mentioned before.

We are seeing still significant use of telemedicine within psychiatry.

And to a much lesser extent within neurology.

It seems as if things have leveled off.

In terms of volume of patient visits in the psychiatry and the rate of telemedicine use.

Neena Bitritto: Hey guys, thanks for taking my question.

And in terms of how we've been able to grow.

Think that we've adapted to this environment. So it's a combination of things obviously, our salespeople have figured out who are the providers that they can actually see in person versus those that they.

Neena Bitritto: I just want to understand a little bit more about where the growth in new scripts is coming from for Ingresa because it sounds like you're still seeing kind of a 50% time.

With deep to see virtually.

Secondly.

Being adept at.

Neena Bitritto: , and telemedicine use in psychiatric offices and a similar 20% diagnosis rate. Can you just talk a little bit more about that? Where is that coming from?

Identifying new prescribers those that haven't yet.

Got it to utilize the amount two inhibitors and have access to our team.

And so I think that overall, what leaves us adapted to the environment and we continue to put resources behind helping those providers, especially in psychiatry that are primarily seeing their patients virtually to remind them of the importance of screening for TD and.

Eric S. Benevich: Unknown Speaker Is that coming from just an increase in the total number of visits, regardless of whether telemedicine versus inpatient, total number of visits, and for our subscribers overall, is that coming more from psych versus neuro offices? I guess if you could just drill down into some of those dynamics, that'd be great. [inaudible] Yeah. Thanks for the question, Nina. So it's a little bit of everything.

Aiding them with resources to help them do so and in fact, just a reminder for everyone. On this call. If you want to take a look at some of the educational content we've created.

For providers out there related to TD screening and diagnosis go to mind, TV Dot com and you'll see a number of different educational resources that we've been utilizing in the field to help providers become better at.

Eric S. Benevich: You know, as I mentioned before, we are still seeing significant use of telemedicine within psychiatry and to a much lesser extent within neurology. However, it seems as if things have leveled off in terms of the volume of patient visits to psychiatry and the rate of telemedicine use. And in terms of, you know, how we've been able to grow, I think that we've adapted to this environment. So the combination of things, obviously, our salespeople have figured out who are the providers that they can actually see in person versus those that they would need to see virtually.

Diagnosing and treating TD remotely I hope that helps.

Perfect. Thank you I appreciate it.

Okay.

And we'll move next to Paul Massoud with Stifel.

Please go ahead.

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

Hey, so bye bye bye by our math.

For next quarter, the guide that Matt provided would suggest.

Unless there is benefits from price and inventory.

A greater number of net patient adds than was seen in <unk>, even by a small amount.

Eric S. Benevich: Secondly, being adept at identifying new prescribers, those that haven't yet started to utilize IMAT2 inhibitors and have access to our team. And so I think that, you know, overall, we've just adapted to the environment, and we continue to put resources behind helping those providers, especially in psychiatry, that are primarily seeing their patients virtually to remind them of the importance of screening for TD and providing them with resources to help them do so.

I would think that just a month into the quarter you you'd probably guide optimistically, but also somewhat conservatively. So maybe can you speak to your level of confidence that demand this quarter.

Could exceed what we just saw in <unk>, assuming my math right. Thanks, so much.

Yeah sure Paul I. Appreciate the question I think your math is right. We continue to see great progress in driving <unk> continues to go up it was right below pre pandemic level.

I think that's really a testament to what the team has been able to do to engage with the health care providers and keeping sort of dyskinesia on the radar. So our level of confidence we tried to give you what we're seeing.

Eric S. Benevich: And in fact, just a reminder for everyone on this call, if you want to take a look at some of the educational content we've created for providers out there related to TD screening and diagnosis, go to mindtd.com, and you'll see a number of different educational resources that we've been using in the field to help providers become better at diagnosing and treating TD remotely.

Q4 is off to a good start in what we would expect throughout the rest of the quarter and we will continue to be transparent as we have in the past, but yes. It is.

<unk> seen good momentum in the commercial team and medical team and the entire organization is really rallying around helping.

Patients who are PD get treatment within Grubhub.

Eric S. Benevich: I hope that helps. Perfect. Thank you. I appreciate it. And we'll move next to Paul Matthews with Stifle.

Excellent. Thanks, so much.

Yes.

And well move next to Carter Gould with Barclays. Please go ahead.

Paul Matthews: Please go ahead. Hey, great. Thanks so much for taking the question. By our math for next quarter, the guide that Matt provided would suggest, unless there are benefits from price and inventory, a greater number of net patient ads than was seen in 3Q, even by a small amount. Yeah, sure, Paul. Appreciate the question. I think your math is right.

Good afternoon. Thanks for taking the question, maybe just a follow up on some of the earlier questions in terms of how you guys are thinking about your expectations for telemedicine dynamics looking into next year, given sort of the evolving.

Evolving reimbursement dynamics.

Any insight onto that front and how you're how you're thinking about that would be helpful. Thank you.

Eric S. Benevich: We continue to see great progress in driving NRX. NRX continues to go up, and it was right below pre-pandemic levels.

Yeah sure Carter I'll take that.

There is going to be new guidelines that are going to be put out by CMS.

Eric S. Benevich: And I think that's really a testament to what the team has been able to do to engage with the health care providers and keep tardive dyskinesia on the radar. So, you know, our level of confidence, we try to give you what we're seeing. We've said that Q4 is off to a good start and what we'd expect throughout the rest of the quarter. And we'll continue to be transparent as we have in the past. But yes, we're seeing good momentum, and the commercial team, and the medical team, and the entire organization are really rallying around helping, you know, patients with PD get treatment with Ingressa. Excellent. Thanks so much.

On their reimbursement, we keep saying, we anticipate that to come.

Any day or any week now and we still do.

While the public health emergency is still in place those.

Current.

The current pricing guidelines will remain in place and all of the current rules associated with the public health emergency you're going to stay in place.

Will probably be a transition time after the public health emergency is re leased before everything new starts together or whatever might be new.

We will start again.

But what the construct we work under is that we will be in the same telemedicine environment for basically most if not all of next year.

Thank you.

Okay.

And we'll take our next question from <unk>.

Eric S. Benevich: And we'll move next to Carter Gould with Barclays. Please go ahead. Good afternoon.

Amit <unk> from Bank of America. Please go ahead.

Hi, Good afternoon. Thank you for taking my question.

Carter Gould: Thanks for taking the question. Maybe just to follow up on some of the earlier questions in terms of how you guys are thinking about your expectations for telemedicine dynamics looking into next year, given sort of the evolving reimbursement dynamics. Any insight on that front and how you're thinking about that would be helpful. Yeah, sure, Carter, I'll take that.

So Kevin.

As it relates to the decision to make the hundred dollar investment that's a million dollar investment now.

Neurologists and providers of long term care why do you feel now is the right time, because I think at the beginning of the year you had talked about.

As I said, you had put into place to try to.

Minimize the effect of doctors and are mostly working from home do you think that those efforts that you put into place for your current market has been maximizing we're looking for additional outlets or are you going to be trying to work on all of these at the same time.

Kevin C. Gorman: You know, there's going to be new guidelines that are going to be put out by CMS on their reimbursement. We keep saying we anticipate that to come any day or any week now, and we still do. While the public health emergency is still in place, those current pricing guidelines will remain in place, and all of the current rules associated with the public health emergency are going to stay in place.

Yes.

You brought up a number of interesting points, there and I'm going to I'm going to address a couple of them and then I'll, let Eric chime in.

The first point that you brought up was do we think we have exhausted the.

The current prescriber base that we have been going into which is primarily psychiatrist yes space that is heavily focused on psychiatrist. We don't we do go into neurologists with the Salesforce reorganization the largest of the three teams by far will still be psychiatry, we will be increasing.

Kevin C. Gorman: There'll probably be a transition time after the public health emergency is relieved before everything new starts again or whatever might be new. We'll start again. But the construct we work under is that we will be in the same telemedicine environment for basically most, if not all, of next year. And we'll take our next question from Tazeen Ahmad from Bank of America. Please go ahead.

Our ability to call on more and go deeper with psychiatrist so no not at all do we think that we've fully penetrated.

The psychiatrist office is not even close youre right that at the beginning of the year because Q1s are so difficult we wanted to do it.

Tazeen Ahmad: Hi, good afternoon. Thank you for taking my questions. So, Kevin, as it relates to the decision to make the $100 investment, the $100 million investment now for neurologists and providers of long-term care, you know, why do you feel now is the right time? Because I think at the beginning of the year, you talked about efforts that you had put into place to try to, you know, minimize the effect of doctors, you know, mostly working from home.

You kind of like can do no harm here as we go into Q1 as Eric said really the rollout of these new teams will take place in Q2. So we are leaving in tax our territories and our sales force throughout Q1, so that we don't have that we're not adding to the disruption.

Coming up Q1.

Eric do you want to.

Yes.

I'll piggyback on your comments here. So a couple of things just to clarify so the increase of SG&A by $100 billion is.

Tazeen Ahmad: So do you think that those efforts that you put into place for your current market have been maximized, and you are now looking for additional outlets, or are you going to be trying to work on all of these at the same time?

Driven both by <unk>.

Full year spending.

Spending for DTC keep in mind. This year was only a partial year for <unk>.

As well as the sales force expansion. So it's a combination of those two initiatives.

And then getting back to sort of what's driving the bottom line is that we recognize.

Kevin C. Gorman: Yeah, Tazeen, you brought up a number of interesting points there, and I'm going to address a couple of them, and then I'll let Eric chime in. The first point that you brought up was, do we think we've exhausted the current prescriber base that we have been going into, which is primarily psychiatrists? Yes, it is heavily focused on psychiatrists, but we do go into neurologists.

As we have developed the TV market.

There continues to be an expansion of <unk>.

Hey, Matt to prescribers or Reza prescribers as well as high potential prescribers to.

To treat TD and we.

We did this analysis and we believe that there is an opportunity to reach educate and motivate.

More neurologists as well as psychiatrist.

And then.

Looked at the LTC opportunity actually prior to the launch and decided at that time back in 2017.

Kevin C. Gorman: With this Salesforce reorganization, the largest of the three teams by far will still be psychiatry. We will be increasing our ability to call on more and go deeper with psychiatrists. So, not at all do we think that we've fully penetrated the psychiatrists' offices, not even close.

We didn't have the resources to cover all the different opportunities already resident in TD from day, one and so we deferred our.

Our decision to invest and focus on LTC until we got further along and have done more to develop the market opportunity and we feel the time is right.

Us too.

Essentially have dedicated resources to focus on that LTC opportunity. So it's really the changes to our sales force size and structure really driven mostly by the.

Kevin C. Gorman: You're right that at the beginning of the year, because Q1s are so difficult, we wanted to do a kind of "do no harm" as we go into Q1. As Eric has said, really, the rollout of these new teams will take place in Q2. So we are leaving intact our territories and our Salesforce throughout Q1 so that we don't have, and we're not adding to the disruption coming up to Q1. Eric, do you want to?

The development of the market.

And our need to better meet the needs of a growing and more diverse customer base.

Okay. Thank you.

Yes.

And we'll take our next question from Phil Nadeau with Cowen and company. Please go ahead.

Good afternoon. Thanks for taking our question we have one on the pipeline actually you know what that there's 12 programs that are likely to be in clinical trials by the end of the year and the press release mentions important data events over the next 12 to 24 months.

Eric S. Benevich: Yeah, yeah, I'll piggyback on your comments here. So, a couple of things. Just to clarify, Tazeen, the increase in SG&A by $100 billion is driven both by full-year spending for DTC; keep in mind this year was only a partial year for Advise, as well as the Salesforce expansion. So it's the combination of those two initiatives. And then getting back to sort of what's driving it, you know, the bottom line is that we recognize that as we have developed the TD market, there continues to be an expansion of VMAT2 prescribers or Ingresa prescribers, as well as high potential prescribers to treat TD. And we, you know, we did this analysis, and we believe that there is an opportunity to reach, educate, and motivate more neurologists, as well as psychiatrists.

It's a little unclear to us exactly when some of those trials are going to read out soon.

In particular.

Which trials are likely to read out next year in 2022, and which ones are more likely to produce 23. Thanks.

Hi, Phil So the first trial, that's going to readout is going to be in December of this year and that's going to be the huntington's.

Study that is going to readout.

The next study.

After that that's going to readout is going to be.

Facebook basically in essential tremor.

And then the last slide.

Uh huh.

He is going to be see us ws that'll be reading out later.

Next year.

Great and the others are 2023.

Yes.

Perfect. Thanks for taking our question.

Thank you.

And well move next to <unk> Rama with Jpmorgan. Please go ahead.

Okay.

Hey, guys. Thanks, so much for taking the question on Kinect HD in Huntington's disease. How are you thinking about the market dynamics. There like is this a taking share from studio market.

Eric S. Benevich: And then, we had looked at the LTC opportunity, actually, prior to the launch, and decided at that time, back in 2017, that we didn't have the resources to cover all the different opportunities for Ingresa and TD from day one. And so we deferred our decision to invest in and focus on LTC until we got further along and had done more to develop the market opportunity. And we feel the time is right.

Or based on the profile of <unk> is there potential to expand the <unk>.

<unk> for you guys. Thanks, so much.

So I guess.

So Eric I guess I'll take the question and then IRA if you want to.

Add on to it so I think the answer is a little bit of both.

We.

We've noticed that.

There are a significant number of patients with Huntington's.

And associated Korea.

With moderate to severe symptoms that could benefit from treatment with a <unk> two inhibitor, but don't for various reasons, including concerns around tolerability.

Eric S. Benevich: For us to essentially have dedicated resources to focus on that LTC opportunity. So the changes to our Salesforce size and structure are really driven mostly by the development of the market and our need to better meet the needs of a growing and more diverse customer base. Okay, thanks.

Concerns around safety.

In <unk>.

Convenience of multiple times a day dosing.

So there is opportunity for us we believe too.

<unk>.

Proportion of patients treated with a <unk> two inhibitor and there is also the opportunity to.

Eric S. Benevich: Okay, thank you.

To potentially have some patience switchover.

Phil Nadeau: And we'll take our next question from Phil Nadeau with Cohen & Company. Please go ahead. Good afternoon.

Finally.

Profile that emerges from our Huntington's trial to be attractive, which we believe it will be so so.

Phil Nadeau: Thanks for taking our question. We have one in the pipeline, actually. You note that there are 12 programs that are likely to be in clinical trials by the end of the year.

So I think it's a combination of those two things we're excited about the opportunity to.

Complete the trial unblinded the data.

Towards the end of the year and looking forward to being able to share more about what our commercial thinking is as we move into 2022.

Eiry W. Roberts: And the press release mentions important data events over the next 12 to 24 months. It's a little unclear to us exactly when some of those trials are going to read out next year, 2022, and which ones are more likely to produce data in 2023.

No I think you said it well Eric I would just build on a couple of things I mean, just two.

To make the point I mean, there are 30000 patients in the United States with Huntington's disease about 90% of them have Korea, and 70% of those moderate to severe form of Korea that merits more aggressive treatment and in spite of that we know that only 20% of patients.

Eiry W. Roberts: Hi Phil. So the first trial that's going to read out is going to be in December of this year, and that's going to be the Huntington's study that's going to be read out. The next study after that that's going to read out is going to be phase 1b, basically an essential tremor, and then the last one is going to be CSWS that will be read out later next year.

Treatment with a <unk> inhibitor and so we really believe that the amount of room for improvement there and we particularly think that the simple plex.

Flexible once a day treatment with <unk>.

Val benzene could potentially be very important for patients with huntington's disease and the reason being that these patients take many many medications often times.

Eiry W. Roberts: Great, and the others are 2023. Yeah. Perfect. Thanks for taking our question.

And also many patients who have difficulty swallowing and so the numbers of patients and the complexity of the regimen can be very important that the numbers of tablets needed to be taken and the complexity can be very important for patients and this space.

Anupam Rama: And we'll move next to Anupam Rama with J.P. Morgan. Please go ahead.

Eric S. Benevich: Hey guys, thanks so much for taking the question. On ConnectHD and Huntington's Disease, how are you thinking about the market dynamics there? Like, is this a take share from the fetal market? Or, based on the profile of Ingresa, is there potential to expand the market here for you guys? Thanks so much.

Also obviously currently.

<unk> for the treatment of Tardive Dyskinesia has no black box warning.

And so as Eric mentioned, we're very.

Good to see our results at the end of this year and to be able to discuss the how we're thinking about going forward to regulators and hopefully it's successful being able to get approval of a new thing that too.

Eric S. Benevich: So I guess I am Derek. I guess I'll take the question and then Eiry if you want to add on to it. So I think the answer is a little bit of both. We've noted that there are a significant number of patients with Huntington's and associated Chorea with moderate to severe symptoms that could benefit from treatment with a VMAP2 inhibitor but don't for various reasons, including concerns around tolerability, concerns around safety, or even convenience of multiple times a day dosing.

Approach involve anything for the treatment.

Cause disease.

And we'll take our next question from Josh <unk> with Evercore. Please go ahead.

Thanks for taking my question. So it looks like Youre branded V med tumor could share this quarter was at the low end of where its ever been to what do you attribute that and where do you see this evolve. Thanks.

Actually Josh.

I think that it's basically the same I think that if you.

Eric S. Benevich: So, there is an opportunity for us, we believe, to grow the proportion of patients treated with the DMAT2 inhibitor, and there's also the opportunity to potentially have some patients switch over if they find the profile that emerges from our Huntington's trial to be attractive, which we believe it will be. We're excited about the opportunity to complete the trial and unwind the data towards the end of the year and looking forward to being able to share more about what our commercial thinking is as we move into 2022. Irene? Yeah, I think you said it well, Eric. I'll just build on a couple of things.

If you take out the.

The competitors.

Huntington's sale, so they describe them that by dollar amount.

It's still a 65 35 market share split which is what it has been now for quite a while.

Okay. Thanks.

And well move next to Brian Abrahams with RBC capital markets. Thank you. Please go ahead.

Hey, there. Thanks, so much for taking my question.

Pipeline question for me on Bell benzene schizophrenia, you talked a little bit about that.

Upcoming phase III trial design I'm wondering if you could talk more about what influenced the design there I think a 10 week end point.

A little bit longer than we've seen other for other schizophrenia.

Eiry W. Roberts: I mean, just to make the point, I mean, there are 30,000 patients in the United States with antigen disease, about 90% of them have Korea, and 70% of those have a moderate to severe form of Korea that merits more aggressive treatment. Also, currently, Ingresa for the treatment of tardive dyskinesia has no black box warning. And so, as Eric mentioned, we're very interested in seeing our results at the end of this year and to be able to discuss further how we're thinking about going forward to regulators and, hopefully, if successful, being able to get approval of a new VMAT2 approach in valbenazine for the treatment of Huntington's disease. And we'll take our next question from Josh Schimmer with Evercore. Please go ahead.

Studies I'm wondering if that was guided by some of the anecdotal.

What are you seeing in terms of time to full effect for propel benzene or other evidence of activity and I'm curious on the on the 400 patients what's guided your powering there what are your expectations and will not be just one dose level. Thanks.

Hi, Rick.

Yeah, I'll answer some of those and some of the information we haven't actually released in the contact center.

The trial.

So.

First of all to answer the question about the study design and the primary endpoint choice.

One thing just one point just to make right upfront.

As you see in the tardive dyskinesia environment.

Josh Schimmer: Thanks for taking the question. So it looks like your branded VMAT2 market share this quarter was at the low end of where it should be.

The onset of effect in terms of <unk> impact on the movements tardive dyskinesia is that any ramp in many patients and so we have a rapid onset of effect in that setting and also in any preclinical or the data that we've generated we have seen a rapid onset of effect and so we don't anticipate meeting.

Kevin C. Gorman: was at the low end of, you attribute that. Actually, Josh, I think that it's basically the same. I think that if you take out the competitors' Huntington sales, as they describe them, that by dollar amount, it's still a 65-35 market share split, which is what it has been now for quite a while, and we'll move next to Brian Abrahams with RBC Capital Markets.

Longer neither do we anticipate needing long debt to get to affect in terms of the need for some form of a complex titration I'm not certainly not the case.

Brian Abrahams: Hey there, thanks so much for taking my question. A pipeline question for me on valbenazine and schizophrenia. You talked a little bit about the upcoming phase 3 trial design. I wonder if you could talk more about what influenced the design there.

Ats setting.

In terms of the if you look at the trials that have been done intensive II.

Duration of treatment out to the primary endpoint. They are actually quite variable. This is a registration study in many circumstances. The agency is clean keen to see.

Eiry W. Roberts: I think a 10-week end point is a little bit longer than we've seen for other schizophrenia studies. I'm wondering if that was guided by some of the anecdotal data you're seeing in terms of time to full effect for valbenazine or other evidence of activity. And then curious about the 400 patients. What's guided your decision to go there? What are your expectations? And will that be just one dose level

Longer.

Duration of effect out to the primary endpoint and so in a discussion with the agency we were able to land upon that primary end point of timing as being appropriate for evaluation in this setting particularly of patients who had failed.

To get adequate treatment from the anti psychotic alone.

That's the first piece in terms of the size of the study.

Eiry W. Roberts: Yeah, I'll answer some of those and some of the information we haven't actually released in the context of the trial. So, first of all, to answer the question about the study design and the primary endpoint choice, one thing, just one point, just to make right up front: as you know in the tardive dyskinesia environment, the onset of effect in terms of albinosine's impact on the movement of tardive dyskinesia is very rapid in many patients.

The steady I'll say is powered to detect a clinically meaningful reduction in the pans total score.

And.

We believe this is an appropriate size to allow us to do that very readily.

The treaty.

Treatment is effective in that setting and then.

Your final question, we haven't actually talked a great deal about.

The dosing schedule for this program right now but.

But as you'll see from the <unk>.

Eiry W. Roberts: And so we have a rapid onset of effect in that setting, and also, in any preclinical or other data that we've generated, we have seen a rapid onset of effect. So, we don't anticipate needing longer, and neither do we anticipate needing longer to get to effect in terms of the need for some form of complex titration, and that's certainly not the case in this ATS setting.

Clinicaltrials Gov posting it.

It is an active versus placebo randomized parallel group study.

That's super helpful. Thanks.

And.

Next.

Jeff.

With Morgan Stanley. Please go ahead.

Thanks for taking the question for Bell benzene in cerebral palsy, you've indicated that about 15% experience dyskinesia, how does that range of dyskinesia changed from diagnosis of cerebral palsy in early childhood versus adulthood and.

Eiry W. Roberts: In terms of the, there are, if you look at the trials that have been done in terms of the duration of treatment out to the primary endpoint, they are actually quite variable. This is a registration study, and under many circumstances, the agency is keen to see a somewhat longer duration of effect out to the primary endpoint. And so, in a discussion with the agency, we were able to land upon that primary endpoint timing as being appropriate for evaluation in this setting, particularly in patients who had failed to get adequate treatment from their antipsychotic alone.

And for the phase III that you're starting this year can you talk a little bit more about the specific subpopulation youre focusing on such as a specific age range and would you split up the adult versus pediatric patients into different studies.

We actually thanks, very much Jeff we haven't actually talked about the trial design out yet, although we have indicated that the trial will include both pediatric and adult.

Subject.

You're correct that dyskinesia due to cerebral palsy occurs in about 15% of cerebral palsy and persist into adulthood.

Eiry W. Roberts: So, that's the first piece in terms of the size of the study; the study, I'll say, is powered to detect a clinically meaningful reduction in the PAMS total score. And we believe this is an appropriate size to allow us to do that very readily if the treatment isn't effective in that setting. And then your final question, we haven't actually talked a great deal about the dosing schedule for this program right now, but as you'll see from the clinical trials dot Gov posting, it is an active versus placebo randomized parallel group study.

A proportion of that population.

And so we think it is important given the persistence of cerebral palsy into the adult population that we have the opportunity to.

Stablish, whether or not.

It can be.

Important medications are useful medication for individuals who continue to suffer with cerebral palsy, just can you get into adulthood.

In terms of the remainder of the trial design.

We are intending to start this trial later in Q4 and once the trial is posted on Clinicaltrials Gov will obviously be prepared to talk much more about the design.

Eiry W. Roberts: That's super helpful; thanks.

Jeff Hung: And we'll move next to Jeff Hung with Morgan Stanley. Please go ahead. Thanks for taking the question. For valbenazine and cerebral palsy, you've indicated that about 15% experience dyskinesia. How does that range of dyskinesia change from a diagnosis of cerebral palsy in early childhood versus adulthood?

Thank you.

And well move next.

To what Brian's corny with Baird. Please go ahead.

Hey, good afternoon, everyone and thanks for taking my question.

Just trying to get an idea of what to look for in Huntington's chorea data that you have upcoming.

I know in TD.

We maintain an advantage over our <unk> dude about safety dosing as well as sort of a perceived advantage on a numerical basis in terms of efficacy just when I look at our studios pivotal I think their improvement that I showed promote a 12, 1% to seven <unk>.

Eiry W. Roberts: And for phase three that you're starting this year, can you talk a little bit more about the specific subpopulation you're focusing on, such as the specific age range, and would you split up the adult versus pediatric patients into different studies? Thanks. We actually, thanks very much, Jeff. We haven't actually talked about the trial design as yet, although we have indicated that the trial will include both pediatric and adult subjects. You're correct that dyskinesia due to cerebral palsy occurs in about 15% of people with cerebral palsy and persists into adulthood in a proportion of that population.

Seven.

Improvement from baseline just how should we be thinking about the outcomes here in particular, given that spread has been on the market for a while and they are excluding patients with.

History with it would be not two inhibitor.

Are there any considerations to take into account in the patient population that's going to be here when we see.

The Africa or do you think.

Could be looking at the same sort of efficacy advantage here that we see in PD.

Eiry W. Roberts: And so we think it is important, given the persistence of cerebral palsy in the adult population, that we have the opportunity to establish whether or not valbenazine can be an important medication or a useful medication for individuals who continue to suffer with cerebral palsy in dyskinesia into adulthood. In terms of the remainder of the trial design, we are intending to start this trial later in Q4, and once the trial is posted on clinicaltrials.gov, we'll obviously be prepared to talk much more about the design. Thank you. And we'll move next to Brian Skorney with Baird. Please go ahead. Hey, good afternoon, everyone.

Thank you, Brian sorry, sorry.

No go ahead, I think I'm going to go ahead with that.

Sorry, Kevin.

So Brian Thanks for the question.

Thank you.

The registration trial and HD that we've designed is designed to fully elucidate.

Benefit potential benefit and the Tolerability profile of both NSE and HD and we think it will be a combination of both the efficacy that we see.

And the Tolerability and the once a day dosing and flexibility associated with that that will be important in the overview the totality of the data.

So that's the first point to make secondly in terms of the trial design. The sizing of the trial is designed in order to be able to detect.

Brian P. Skorney: Thanks for taking my question. I'm just trying to get an idea of what to look for in the Hunted Vens Korea data that you have upcoming. I know in TD, you maintain an advantage over Ostito due to both safety dosing and as well as sort of a perceived advantage on a numerical basis in terms of efficacy. Just when I look at Ostito's Pivotal, I think their improvement they showed from a 12.1 to 7.7 improvement from baseline.

Currently meaningful reduction.

To the way in which the <unk> program was.

It was designed.

Just one clarification point the exclusion of patients who have failed to respond to a <unk>. Two inhibitor is done in order to ensure that we don't have patients in the trial, who are unresponsive to that theme at two mechanism of action. Since then maybe a small proportion of pay.

Brian P. Skorney: Just how should we be thinking about the outcomes here, in particular given that the stroke's been on the market for a while and you're excluding patients who have history with a VNAT2 inhibitor? You know, are there any considerations to take into account in the patient population that's going to be here when we see the efficacy, or do you think we could be looking at the same sort of efficacy advantage here that we see in TD? Thank you, Brian. That's very, oh, sorry. Do you want me to go ahead with that? Sorry, Kevin.

<unk> touch.

Previous exposure to a V. Two inhibitor is a little different and so I just wanted to clarify that.

We're really looking forward to seeing the totality of the data, which I think includes both the tolerability profile and the efficacy that we're able to generate in this registration study and if were successful in reaching a primary endpoint then we obviously won't be going forward to discuss with regulators. How we should position that is in the treatment of patients with Huntington's disease.

Eiry W. Roberts: So, Brian, thanks for the question. I think the registration trial in HD that we've designed is designed to fully elucidate the potential benefit and the tolerability profile of valbenazine in HD. And we think it will be a combination of both the efficacy that we see and the tolerability and the once-a-day dosing and flexibility associated with that that will be important in the overall overview of the totality of the data. So, that's the 1st point to make.

Okay. Thanks, sorry, just to clarify are you, saying that you are including patients with <unk>.

Previously established.

Yes.

I have previously taken a view might turn out better just because on the on clinical trials it sounds about exclusion criteria.

The <unk>.

The exclusion Criterias and men to eliminate those who have failed to have adequate response too.

It'd be about two inhibitor.

Eiry W. Roberts: Secondly, in terms of the trial design, the sizing of the trial, it's designed in order to be able to detect a clinically meaningful reduction similar to the way in which the program was designed. Just 1 clarification point: the exclusion of patients who have failed to respond to a VMAT2 inhibitor is done in order to ensure that we don't have patients in the trial who are unresponsive to that VMAT2 mechanism of action since there may And so I just want to clarify that, but we're really looking forward to seeing the totality of the data, which I think includes both the tolerability profile and the efficacy that we're able to generate in this registration study. And if we're successful in reaching our primary endpoint, then obviously, we will be going forward to discuss with regulators how we should position this in the treatment of patients with the disease. Thanks, Eiry.

You probably are aware many patients in one of the reasons why.

With us.

<unk> many patients failed to get to an outcome that is acceptable for them because of the issues of side effect profile and tolerability associated with the titration with Tetra benzene. So if people have had a trial of a <unk>. Two inhibitor. Then then we're not.

Necessarily excluding those individuals and if they didn't all of that criteria.

Thank you.

Okay.

And we'll move next to Chris <unk> with Goldman Sachs. Please go ahead.

Great. Thank you very much for the question you made reference to a decision by CMS as far as the payment reimbursements for 2022 being quite imminent can you clarify if you're expecting any particular changes that would have an impact on how you would execute your commercial strategy in particular, just in reviewing some of the proposed.

Eiry W. Roberts: Just to clarify, are you saying that you are including patients who have previously established a diagnosis? I have previously taken a VUMAT2 inhibitor just because in clinical trials it says that's an exclusion criteria. The exclusion criteria are meant to exclude those who have failed to have an adequate response to a Remat-2 inhibitor. As you probably are aware, many patients, and one of the reasons why, with the use of dutetrabenazine, many patients fail to get to an outcome that is acceptable for them because of the issues of the side effect profile and tolerability associated with the titration of dutetrabenazine.

Particularly for Medicare programs, I think within psychiatry mental health. There is the subdivision between audio only services versus ones that combined video the point there being that obviously video would appear to be very important for and grant can you just comment about what the scenarios that you are expecting or and the impact. Thank you.

Yeah. So I'll start out there were a number of changes that were under the public health emergency one of which is that.

Audio only audio clips video or in person.

We're reimbursed all at the same level and continue to be today. There are the changes that are in there also there is.

Eiry W. Roberts: So if people have had a short trial of a Remat-2 inhibitor, then we're not necessarily excluding those individuals if they meet all other criteria. Got it. Thank you. And we'll move next to Chris Shibutani with Goldman Sachs.

They're relieved from having a minimum number of in person.

<unk> also relieved that it has to be from a <unk>.

From a secure site that you would be.

<unk> doing your.

Telemedicine from that there would be another health professional at other sites a nurse practitioner.

Chris Shibutani: Please go ahead. Great. Thank you very much for the question. You made reference to a decision by CMS as far as payment reimbursements for 2022 are quite imminent. Can you clarify if you're expecting any particular changes that would have an impact on how you would execute your commercial strategy? In particular, just in reviewing some of the proposals on, particularly for Medicare programs, I think within psychiatry and mental health, there is a divide between audio-only services versus ones that combine video, the point there being that obviously, video would appear to be very important for INGREDSA. Can you just comment about what the scenarios that you're expecting are and their impact? Thank you. Yeah, so I'll start out.

So and also it allowed for the practice of medicine across.

State lines. So we're looking to CMS to to really take on all of those and then see what they do come out with.

As we alluded to before we're seeing very good growth with aggressive right now we've adapted to the public health emergency so I see that as as as going well for us.

But it's really too soon to tell what CMS what.

CMS is going to publish their final the physician fee schedule.

All I'm, saying is that it appears imminent.

Can I just ask what the mix of audio only versus audio and video as far as the telehealth component in psychiatry has been.

Kevin C. Gorman: There were a number of changes that were under the public health emergency, one of which was that audio only, audio plus video, or in person were reimbursed all at the same level and continue to be today. We've adapted to the public health emergency. So, I see that as going well for us, but it's really too soon to tell what CMS is going to publish as their final fee schedule for physicians. All I'm saying is that it appears imminent.

Do you have the Eric Yeah, I can't I can't report.

Claims data, but I can because it isn't.

What I can tell you is from our market research and then anecdotally hearing from our customers that.

At least in psychiatry about half of the telehealth visits our audio video and about half are.

Video or excuse me audio only.

And the audio only tends to be more predominant.

For patients that are being seen in community mental health settings.

And.

Certainly that makes it more challenging to scream for recognize TD and once again, if you go to the mines TD.

Eric S. Benevich: Can I just ask, do you know what the mix of audio only versus audio and video as far as the telehealth component in psychiatry has been? Um, do you have that, Eric? Yeah, I can't, I can't report, um, I don't have any claims data, but I can, because it isn't. What I can tell you is from our market research and then, you know, anecdotally hearing from our customers that, at least in psychiatry, about half of the telehealth visits are audio plus video, and about half are video And the audio only tends to be more predominant for patients that are being seen in community mental health settings. And, you know, certainly that makes it more challenging to screen for or recognize a TD.

Website youll see our materials that we created to help providers be more adept.

As screening for TD, regardless of whether it's an audio only call on audio plus video and how to advance the diagnostic process. So as Kevin said for 2022.

We're expecting the status quo.

Because of the extension of the public health emergency into next year and then at some point when the public health emergency is lifted those temporary waivers that Kevin described will also likely change and the upcoming publication of the CMS physician fee schedule.

Will give us some insight into what the.

Eric S. Benevich: And once again, if you go to the MINDTD website, you'll see materials that we created to help providers be more adept at screening for TD, regardless of whether it's an audio-only call, an audio plus video call, and how to advance that diagnostic process. So as Kevin said, for 2022, you know, we're expecting the status quo because of the extension of the public health emergency into next year. And then, at some point, when the public health emergency is lifted, those temporary waivers that Kevin described will also likely change.

Telehealth environment will look like post pandemic and post temporary waiver removal.

That's helpful. Thank you.

And well move next to Amit <unk> with Needham.

Please go ahead.

Hi, Good evening. Thank you for taking my question.

I had a quick follow up on the Huntington's disease Clarion study.

Do you anticipate the possibility.

PV efficacy to existing treatments for that study and then with regards to essential tremor. The phase two study readout next year.

Eric S. Benevich: And the upcoming publication of the CMS physician fee schedule will give us some insight into what the telehealth environment will look like post-pandemic and post temporary waiver removal. That's helpful. Thank you. And we'll move next to Ami Fadia with Needham, please go ahead.

What should we be looking for as a positive proof of concept in phase two.

Alright.

Thanks.

So the.

The Huntington's trial is not designed as a head to head comparator study.

Ami Fadia: Hi, good evening. Thank you for taking my question. I had a quick follow-up on the Huntington's Disease Career Study. Do you anticipate the possibility of superior efficacy to existing treatments with that study? And then, with regard to essential tremor, the Phase 2 study readout next year, what should we be looking for as a positive proof of concept in Phase 2? Thanks.

So in terms of a claim of superiority.

Not how we haven't designed that trial in order to.

Answer that question.

<unk> be no direct head to head data of ourselves versus any other <unk> two inhibitors or in a controlled way versus any other treatment. This is a placebo controlled trial.

That said as I mentioned earlier, we will be particularly interested in the totality of the data understanding both the efficacy that we're able to generate on the.

Eiry W. Roberts: So the Huntington's trial is not designed as a head-to-head comparative study. And so in terms of a claim of superiority, we are not, we haven't designed that trial in order to answer that question. And the tolerability profile in the setting of that registration study. And with those data in hand, we'll obviously move forward if we're successful in that trial. On the essential tremor study, this is actually a proof of concept study.

Huntington's Chorea score, but also other functional endpoints that are built into that study and the tolerability profile.

In the setting of that registration study and with those data cancel obviously move forward. If we're successful in that trial.

On the essential Tremor study. This is actually a proof of concept study and so it's a placebo controlled crossover study in individuals with moderate.

Eiry W. Roberts: And so it's a placebo-controlled crossover study in individuals with moderate essential tremor, and it includes 28 patients with two treatment arms. And the primary outcome measure will be the change from baseline to day 28 for each treatment period and the amplitude at peak frequency of postural tremor. So, with that in hand, looking at the within subject and the cross-subject comparison between the active treatment, 104, and placebo, we'll be able to determine the next step in terms of whether we go forward with a full registrational quality phase 2 dose finding study. Thank you. And we'll move next to David Amslam with Piper Sandler. Please go ahead. Hey Vance, given your commentary earlier in the call regarding the direction of...

Essential tremor and increased 28 patients.

It was two treatment arms on the primary outcome measure will be the change from baseline to day 28.

For each treatment period, the amplitude at peak frequency of Costco tremor, so with that in mind and looking at the within subject and the cross subject.

Comparison between the active treatment for and.

Placebo will be able to determine the <unk>.

Steph in terms of whether we go forward for a.

That's helpful.

Registrational quality phase two dose finding study.

Got it thank you.

Okay.

And we'll move next to David <unk> with Piper Sandler. Please go ahead.

Hey, Thanks, So given your commentary earlier on the call regarding the direction of net revenue per Rx in 2022 versus 2021.

David A. Amsellem: And if I were to ask you to define your net revenue per Rx in 2022 versus 2021, would it stand to reason that you'd be in a position to provide 2022 Impreza sales guidance and, I guess, provide a range regarding sales or at least a floor? How do you think about that? Thanks.

It stands to reason that you'd be in a position to provide 2022 and <unk> sales guidance.

And I guess provide a range.

Regarding.

Regarding sales or at least the floor, how do you think about that thanks.

Matthew C. Abernethy: Yeah, David, well, the time has definitely come for us to step up and provide annual guidance, and we do intend to do so. In our February call for our Q4 call, we'll give a 2022 guidance number for Ingresa, and, of course, we'll include a range that would reflect both the environment and also, you know, our latest thinking on the impact and the direct-to-consumer advertising campaign, as well as the Salesforce expansion.

Yes, David.

Time has definitely come for us to step up and provide annual guidance and we do intend to do so.

In our February call for our Q4 call, we'll give a 2022.

Guidance number four in Gaza.

Of course, we will include a range that would reflect both the environment and also our latest thinking on the impact and the direct to consumer advertising campaign as well as the sales force expansion. So.

Matthew C. Abernethy: So we're continuing to progress and gain understanding of this market. And that's something that we look forward to having those conversations in February. Thank you. And we'll move next to Kelli Shye with Jefferies. Please go ahead.

We're continuing to progress soon.

Gaining understanding of this market and that's something that we look forward to having those conversations and everywhere.

Thank you.

Yeah.

Okay.

And we'll move next to Kelly shy with Jefferies. Please go ahead.

Kelli Shye: Thank you for taking the time to answer.

Thank you for taking my question so for connect.

Kelli Shye: My question is, so for connect to trial in Huntington's disease, on a primary endpoint, the total maximum

While in Huntington disease on a primary endpoint.

Maximo chorus call from based on the previously approved <unk> inhibitor showed a two to three point of reduction I Wonder you said this is the benchmark for a clinical benefit to connect the trial.

Kelli Shye: Career Score from Baseline, the previously approved VMAT inhibitor, showed a 2 to 3 point reduction.

Kelli Shye: I wonder if this is the benchmark for the clinical benchmark.

What kind of impact.

Uh huh.

Eiry W. Roberts: It is for including the patients that are pre-exposed to VMAT inhibitors in the trial. And also, how do you think the placebo effect will change over time? Thank you.

It is fall including death.

Patients that <unk> Paulista <unk> inhibition on the trial and also.

How do you think of the placebo you factor change over time.

Thank you.

Eiry W. Roberts: So, I think, as we've previously stated, the primary endpoint for the CONNECT-HD trial is the total career score, and what you articulated in terms of the dutertrobenazine impact is indicative of a clinically relevant change in that score. Our study is adequately powered and designed in terms of the sample size to be able to identify a clinically meaningful change in that score and a reduction in that score relative to placebo. We have no reason to believe that the placebo response should change in this disorder over time, unlike other conditions such as schizophrenia and elsewhere, where there has obviously been a significant change in placebo response over time.

So I think as we've previously stated the.

Timing for the Kinect HD trial is the total credit score and the what you articulated in terms of the do Tetra benzene impact.

Is that indicative of a clinically relevant change in that score.

Our study is adequately powered and designed and 10 since the sample size to be able to identify couldn't opinion. It will change in that school and reduction in that score relative to placebo. We have no reason to believe that the placebo response should change in this disorder overtime.

Unlike other conditions, such as schizophrenia and elsewhere.

It has been.

A significant change in placebo response over time.

Eiry W. Roberts: I think I clarified a little earlier about the situation for previous exposure to VMAT2 inhibitors. This population, we believe, will be appropriate for us to be able to detect adequately the effect of valbenazine in treating the chorea associated with Huntington's disease. Just to reiterate again, we're interested in looking at the totality of the data generated from this trial, both in terms of the effectiveness of the medication and also the tolerability and profile associated with once daily use.

I think I clarified a little earlier about the situation for previous exposure to the <unk>. Two inhibitors. This population, we believe will be appropriate for us to be able to detect adequately the effect of.

I'll file benzene in tweaking the.

<unk>.

Chorea associated with Huntington's disease.

Just to reiterate again, we're interested in looking at the totality of the data generated from this trial. Both in terms of the effectiveness is the medication and also the <unk>.

Tolerability and.

Profile associated with the once a day.

Eiry W. Roberts: We also have functional endpoints built into the study, as I think I articulated earlier, and we'll be looking at the totality of that data as we read out the data at the end of this year in terms of making the decision to go forward for potential registration if we're successful. Thank you. And we'll move next to Ramo Divan with Mizuho Security. Please go ahead.

You also have functional endpoints built into this.

The study as I think I articulated earlier and.

We'll be looking at the totality of that data as we read out the data at the end of this year and Kevin's of making the decision to go forward for potential registration if we're successful.

Okay. Thank you.

And we'll move next to.

<unk> with Mizuho Securities. Please go ahead.

Ramo Divan: Great, thanks for taking my questions. Maybe just one on Agentis.

Alright, Thanks for taking my question. So maybe just one on <unk> I know, it's a smaller product maybe not talked about as much but it's only doing about $2 million or so per quarter here about a year into the launch I'm. Just curious kind of what you see might be catalysts to kind of get that product going more whether it's COVID-19 related or.

Ramo Divan: I know it's a smaller product, maybe not talked about as much, but it's only doing about two million or so per quarter here, about a year into the launch. I'm just curious what kind of catalyst might be able to kind of get that product going more, whether it's COVID-related or, you know, payer access or anything you sort of see going forward. How would you think about that maybe changing its trajectory?

Payer access or anything you're sort of ceiling forward, how we should think about that maybe changing its trajectory. Thanks.

Eric S. Benevich: Thanks. Yeah, thanks, Pamela. So I think it's okay.

Thanks, Tom.

So I think it's a combination of things obviously launching.

Eric S. Benevich: Yeah, thanks, Palma. So, I think it's a combination of things, obviously launching a new medicine in the face of a pandemic has been challenging, and, you know, certainly we've seen the ups and downs in terms of, you know, the surge of, especially the Delta variant, over the course of this year, impacting our ability to access, especially those important movement disorder specialists. And so, you know, we've seen steady progress in terms of trial and adoption, and certainly, the feedback that we've gotten from prescribers has been very positive in terms of their experience and the experience that's being read back to them by the patients.

A new medicine.

<unk>.

The face of the pandemic has been challenging.

Certainly we've seen the ups and downs in terms of.

The surge of especially the Delta Varian over the course of this year impacting our ability to access, especially those important movement disorder specialists. So.

We've.

<unk> seen steady progress in terms of <unk>.

Trial and adoption.

Certainly the feedback that we've gotten from prescribers has been very positive.

In terms of their experience and the experience is being.

Fred back to them by the patients.

Eric S. Benevich: And so, you know, we're continuing to... I think we're going to have to put our best foot forward in terms of driving initial trial and adoption with Ongentis. And I mentioned in my prepared remarks that we believe there is synergy between Ongentis and Ingresa in terms of being able to access neurology customers going forward. So what's going to drive continued growth with that product? Well, a few things.

And so we're continuing to.

Put our best foot forward in terms of driving initial trial and adoption with Genesis as I mentioned in my prepared.

Remarks that.

We believe there is synergy between <unk> and <unk> in terms of being able to.

Access.

Urology customers going forward, so what's going to drive.

Continued growth with that product well a few things one we are building out a dedicated neurology team and we think that thats going to benefit both in browser and on Genesis in those neurology practices.

Eric S. Benevich: One, we are building out a dedicated neurology team, and we think that that's going to benefit both Ingresa and Ongentis in those neurology practices. Secondly, you know, going into next year, we do believe that we will have better access to Ongentis. So, you know, we will continue to put the resources that we've built for Ingresa, the field-based reimbursement team, the basic support programs, and so on behind Ongentis and those Parkinson's patients.

Secondly.

Going into next year, we do believe that we will have.

Better access for on Genesis, though we will continue to put.

The resources that we've that we've built.

Boring breza.

Field based reimbursement team to support programs and so on.

Behind on Genesis in those Parkinson's patients.

Eric S. Benevich: And then, of course, as we continue to learn about the market and where Ongentis is fitting into practices, we'll continue to fine-tune our approach to the launch. So we feel good about the direction that it's moving in.

And then of course as we continue to learn.

<unk>.

The market and where on Genesis is spreading into practices.

We'll continue to fine tune our approach to the launch so.

So we feel good about the direction that its moving certainly.

Eric S. Benevich: We feel like the external environment, if it gets better and there's a reduction in the impact of COVID, that'll benefit Ongentis as well. Okay, thank you. And we'll move next to Miles Minter with William Blair.

Feel like the.

Environment externally if it gets better and there is a reduction in the impact of Covid that'll benefit on Genesis as well.

Okay. Thank you.

Okay.

And we'll move next to Myles Minter with clearly a player. Please go ahead.

Myles Minter: Please go ahead. Thanks for taking the question. Just back on schizophrenia, the pivotal trough for Ingressa, the 10-week end point, you mentioned that was kind of like a balance between the FDA wanting to see longer-term data from the five to sort of six weeks that we might be used for. Is that in the absence?

Thanks for taking the question just back on schizophrenia with the pivotal trial for <unk>.

10 week endpoint, you mentioned that was kind of like a balance between the FDA wanting to say longer term data from the <unk>.

So the six weeks.

We might be useful.

Is that in the absence of the need for an open label extension with that trial.

Eiry W. Roberts: of the need for an open-label extension with that trial. And also, are you enrolling patients that have expiraminal symptoms as part of their therapy? Thanks. Yeah, so there will be potentially patients with tardive dyskinesia and other extrapyramidal syndromes included in the trial. There is no exclusion associated with that.

And also are you enrolling patients that have extra pyramidal symptoms as polyps or therapy. Thanks.

Yeah.

Yes, so there will be potentially patients with.

Tardive dyskinesia another extra parameters.

<unk> syndrome is included in the trial there is no exclusion associated with that.

Eiry W. Roberts: And we are looking separately at the long-term safety and tolerability data that would be necessary in the context of a new indication for schizophrenia. One thing I will say is that, obviously, from our tardive dyskinesia program, we have a significant number of patients with schizophrenia and tardive dyskinesia who have been treated for long periods of time with Ingresa. And our safety and tolerability data are very strong, and that was one of the things that made us feel encouraged about going into the schizophrenia indication.

And we are looking separately at the.

Long term safety and Tolerability data.

Would be necessary in the context of.

A new indication for schizophrenia, one thing I will say is that obviously from a private dyskinesia program, we have a significant number of patients.

Schizophrenia, I'm, Todd Canadian who is being treated for long periods of time, we've been granted on a safety and tolerability.

Mobility data are very strong and we that was one of the things that made us encouraged about going into the schizophrenia indication.

Eiry W. Roberts: Beautiful. Thanks for the question. And we'll move next to Charles Duncan with Cantor Fitzgerald, please go ahead. Yeah, good afternoon, Kevin and team. Thanks for taking the question. I had a question on the pipeline and Valbenet's theme, particularly along the lines of Connect HD.

Beautiful thanks for the question.

And we'll move next to Charles Duncan with Cantor Fitzgerald. Please go ahead.

Yeah, good afternoon, Ken.

Kevin and team. Thanks for taking the question congrats on the new new patient adds this quarter had a question on the pipeline and Bell Ben It's seen particularly along the lines of connect HD.

Charles Duncan: I think that I heard Irie talking about taking a look at the totality of data, but could we

Thanks, Ed I heard Ivory tower.

King about taking a look at the totality of data, but could we could we assume that it's possible that you'd be filing an S. NDA next year for.

Unknown Speaker: Unknown Speaker Could we assume that it's possible that you'd be filing an SNDA next year for Connect HD data? And then back to Miles' question regarding valbenazine in schizophrenia?

With positive Kinect HD data and then back to Myles question regarding <unk> in schizophrenia, I guess I'm wondering if you could provide a little bit more color on what you think modulates the timing to data.

Eiry W. Roberts: I guess I'm wondering if you could provide a little bit more color on what you think modulates the timing of data. Is that simply enrollment or something? On the first question associated with Huntington's disease, we will read out the data at the end of this year, and then, with positive data in hand, if we're successful, we'll go forward to the agency to consider as rapidly as possible being able to submit a regulatory application in the U.S. for that indication. Yeah, I'm just really trying to better understand the timing of data. I think it was mentioned 23 times. And I think you said it completely late at 23.

Said simply enrollment or something else.

Okay.

On the first question associated with Huntington's disease.

We will read out the data at the end of this year and then with positive data in hand, if we're successful we will go forward to the agency to consider as rapidly as possible being able to.

Submit.

The regulatory application in the U S for that indication.

On the Ats side.

Can you just repeat the question so I make sure I understood what you were asking.

Yes, I'm, just really trying to better understand timing to data I think it was mentioned 23 and I think you said complete late in 2000, and so I'm just trying to wonder what is the biggest factor that you're considering for that time.

Eiry W. Roberts: And so I'm just trying to wonder what the biggest factor that you're considering for that time. Yeah, I mean, I think we are just starting this trial and opening for enrollment this month. We will obviously be moving as rapidly as possible on this global trial to enroll as rapidly as possible. I think our date of late 2023 is our first guess around enrollment, and we'll clearly update you on that as we go through the trial. Okay, thank you.

Yes, I mean, I think we are just starting this trial an opening for enrollment this month.

We will obviously be moving as rapidly as possible on this global trial to enroll as rapidly as possible I think.

Date of late 2023.

First guests around enrollment and we'll clearly update you on that as we go through the trial.

Okay. Thank you.

Yatin Suneja: And we'll move to our next question. Yatin Suneja with Guggenheim.

Alright.

And well move to our next question, Yeah, Tuna, Tunisia with Guggenheim. Please go ahead.

Eddie: Please go ahead. Yeah, guys, thanks for squeezing me in. This is Eddie on for Yatin.

Hey, guys. Thanks for squeezing me in this is Eddie on for Yacht and I was just a quick follow up on Huntington's. If you are successful on what are the other gating factors.

Eddie: Just a quick follow-up on Huntington's. If you are successful, what are the other gating factors for filing, and sort of how quickly can we see approval here? And then on the Xenon 352 collaboration, which we haven't really talked about, how are you thinking about prioritizing the focal versus sort of pediatric indications for that asset? And sort of what's the optimal regulatory path forward for both the US and the EU?

And for filing and sort of how quickly can we see approval here and then on the xenon <unk> collaboration, which we haven't really talked about how are you thinking about prioritizing the focal versus sort of pediatric indications.

For that asset and sort of what's the optimal regulatory path forward there for both the U S and the EU.

Eddie: So on the HD trial first, I think we haven't really signaled very much about the path to our regulatory filing as yet. We've been focused very much on the generation of the data and the release of the data at the end of this year.

Okay.

So only HD trials.

I think we haven't really signals very much about the path to <unk>.

Regulatory filing as yet when you've been focused very much on the generation of the data.

Really the data at the end of this year and obviously after that once we have.

Eiry W. Roberts: And obviously, after that, once we have shared those data and had the opportunity to interact with the regulatory authority, we'll have a much better handle on the timing and path forward there. With respect to approval, obviously, we don't comment on timings of approval at this stage. With respect to the trial, I'm sorry.

Sure those daycare and had the opportunity to interact with regulatory authority will have a much better handle on the timing and path forward there.

With respect to approval, obviously, we don't comment on timing of approval.

At this stage.

Okay.

I'm sorry.

Yes, just to be specific.

Since the data were to be positive our assumption would be we would be filing an NDA sometime next year just to make sure that.

Clear.

Matthew C. Abernethy: Yeah, just to be specific, if the data were to be positive, our assumption would be we would be filing an SMDA sometime next year, just to make sure that's. [inaudible] Okay, thank you. Thanks for that clarification, Matt.

Yes.

Okay. Thank you thanks for that clarification, Matt.

With respect to <unk> I think we're excited about the opportunity for this highly selective not one six inch.

EBITA in both the rare pediatric epilepsy of SG&A and also potentially in focal onset seizures.

With respect to the design of our.

SG&A trial.

Making every patient in this program.

Eiry W. Roberts: With respect to 3-5-Q, I think we're excited about the opportunity for this highly selective NAV1.6 inhibitor in both the rare pediatric epilepsy of SCN8A and also potentially in focal onset seizures. And we're hopeful that that would provide us a rapid path forward toward interaction with the regulators. On the focal onset side, obviously, we're initiating a Phase 2 study, and in both cases, I think the unmet need is very significant. It's a little early on the Phase 2 side for that program to be able to say how that would stack up against the SCN8A indication, but we're really focused on delivering data as rapidly as possible in both settings.

So this is a placebo controlled trial from the outset.

Our goal is to be able to demonstrate it.

We were able to demonstrate effectiveness of mistaken that cat that we have a trial that's appropriately designed to be able to look at efficacy even in this setting.

And we're hopeful that that would provide us.

A rapid path forward towards interaction with the regulators on the focal onset side, obviously, we're initiating a phase II study.

<unk>.

In both cases, I think the unmet need is very significant.

I mean, the focal onset seizures environment, it's really because of the fact that a lot of patients do not get adequate response to currently available treatments.

So.

Excited here as well about the opportunity to bring a more selective agents into the space and to do it in a way that enables us to be.

Selective at the.

If successful in delivering.

Efficacy in outcomes for patients.

It's a little early on the phase III site for that program to be able to say, how that would stack up against the <unk> indication, but but.

Chloe: Thanks, Chloe. We'll take one last quick question. All right, we'll move lastly to Laura Chico with Wedbush Securities. Please go ahead.

Really focused on delivering data as rapidly as possible in both settings.

Clearly we will take one last quick question.

All right, we'll move lastly to Laura Chico with Wedbush Securities. Please go ahead.

Laura Chico: Hey, thanks very much for fitting me in here. I guess I have one question just with regard to a number of the ANDA filings that have come through recently. Just with respect to not only generic AUSIDO challengers but also generic INGRESA challengers, I'm wondering if you could comment at all on maybe how you're thinking about not necessarily patent protection but the longer-term pricing strategy for INGRESA in an environment with generic competition.

Hey, Thanks, very much for fitting me in here I guess I have one question just with regards to a number of the NDA filings that have come through recently.

Just with respect to not only generic challengers, but two generic aggressive challengers I'm wondering if you could comment at all upon maybe how youre thinking about not necessarily patent protection, but the longer term pricing strategy for <unk> in an environment with <unk>.

Laura Chico: And it also seems obvious like you're making a number of investments in future Valbenazine indications. So I'm not sure if you could kind of talk about your confidence at all in terms of navigating that. Thank you.

Generic competition and it also seems obviously like Youre, making a number of investments in future Val benzene indications. So I'm not sure if you could kind of talk.

Talk to your confidence at all in terms of navigating that thank you.

Yeah.

So.

Kevin C. Gorman: So, Laura, the ANDA filings that have been made against both products are basically business as usual. This is nothing unusual. We're handling them in the normal course of business. We have patent protection on a resident that goes many years out, you know. At a minimum, I would say out to about 2032 with some expansions, but we have a number of patents in the Green Book that can take us longer than that.

The the NDA filings.

That have been made against both products basically.

As usual.

This is nothing unusual we're handling them in the normal course of business, we have patent protection.

On an aggressive that goes many years out.

At a minimum I would say out to about 2032 with some extension, but we have a number of patents in the green book that can take us longer than that so we don't see any challenges to our business on their horizons at all.

Kevin C. Gorman: So we don't see any challenges to our business in the near horizons at all. Thanks very much. So in closing, I would like to thank everyone for joining us today. We look forward to seeing you, hopefully, in person, at several of the upcoming meetings later this year and early next year. And I think, as you can see from today, that we're making very good progress against all our goals. And even amid the challenges that have existed out there, this is something that we've adapted to, both with Ingressa and our pipeline.

Thanks very much.

Yeah.

Okay.

So.

Closing I would like to thank everyone.

For joining us today.

We look forward to seeing you as hopefully in person at several of the upcoming meetings.

In the.

Later this year and early next year.

I think as you can see from today.

Yes.

We're making very good progress against all of our goals.

Even amid the challenges that have existed out there. This is something that we've adapted to both with in Grubhub and our pipeline and we look forward to having even more.

Kevin C. Gorman: And we look forward to having even more rapid progress in the future. So, thank you, everyone. This does conclude today's program. Goodbye. Thank you for your participation. You may disconnect at any time.

Rapid progress in the future. So thank you everyone.

This does conclude today's program Goodbye here for your participation you may disconnect at any time.

Okay.

Okay.

Yes.

[music].

Okay.

Yeah.

[music].