Q1 2021 Neurocrine Biosciences Inc Earnings Call

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Operator: Hey, everyone, and welcome to today's Neurocrine Biosciences Reports first quarter results. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during the question and answer session. Please limit yourself to one question to ensure we get to everyone. You may continue with follow-up. Please note this call may be recorded.

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Operator: and I will be standing by if you should need any assistance. It is now my pleasure to turn the conference over.

Operator: Silver to Vice President of Investor Relations.

Todd Tushla: Relations, Todd Tushla. Please go ahead.

Todd Tushla: Thanks, Chloe. Good afternoon, and thank you for joining us on our first quarter 2021 earnings call. Here with me today is 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. I'll remind everyone that during today's call, we will be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

Hey, everyone and welcome to today's Neurocrine Biosciences reports first quarter of results.

Kevin C. Gorman: I encourage you to review the risk factors discussed in our latest SEC filings. Following our prepared remarks, we'll then head into Q&A. With that, I'll turn the call over to Kevin. Thanks, Todd. It's good talking to you all today. Our remarks will be very brief so we have plenty of time for questions this afternoon.

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

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

Please limit yourself to one question to ensure we get to everyone. You may re queue with follow up.

Please note this call maybe recorded.

The standing by if you should need any assistance and it is now my pleasure to turn the conference over to Vice President of Investor Relations Todd to Sheila. Please go ahead.

Kevin C. Gorman: As we've discussed for four years now, Q1 has always been a challenging quarter with many TD sufferers needing reauthorizations. Each year, we learn from the previous year and have improved our ability to prepare prescribers and our specialty network of pharmacies for the onslaught of these prior authorizations. However, this year, despite our best efforts, the lack of direct access and communication between prescribers, patients, and pharmacies led to a much more protracted delay in refills than we normally see. Now, while that's the bad news, the very good news is that patients did receive their refills, and we did not lose them.

Thanks, Corey good afternoon, and thank you for joining us on our first quarter 2021 and earnings call here with me today is Kevin Gorman, Our Chief Executive Officer, Matt Abernethy, Our Chief Financial Officer, I read Roberts, our Chief Medical Officer, Eric benefits, our Chief commercial officer, and Karl gain all of our Chief business development and strategy Officer.

I'll remind everyone that during today's call, we will be making forward looking statements. These statements are subject to certain risks and uncertainties and our actual results may differ materially I encourage you to review the risk factors discussed and our latest SEC filings. Following our prepared remarks, we'll then head into Q&A with that I'll turn the call over to Kevin. Thanks.

Kevin C. Gorman: Now we traditionally see looking forward that Q2 as a stronger quarter, and we expect Q2 versus Q1 sales growth to be in the range of what we saw last year, not quite as strong, but certainly there will be a great deal of growth. Now both Eric and Matt will discuss our Q1 experience in more detail in a moment. Importantly, we've made considerable progress in the number of our clinical programs. We, if you recall at the beginning of the year, I told you about our ambitious goal of starting eight new mid to late stage clinical programs this year, and Eiry is going to take you through our pipeline on this call. So without any further comments, I'd like to turn the call over to Matt. Thanks, Kevin. Good afternoon, everyone.

Yeah, it's good talking to you all today.

Our remarks will be very brief so we have plenty of time for questions. This afternoon as.

As we've discussed for for years now Q1 has always been a challenging quarter with many of TD sufferers needing reauthorization.

And each year, we've learned from the previous year and of improved our ability to prepare prescribers and our specialty network of pharmacies.

For the onslaught of these prior authorizations.

However, this year, despite our best efforts and the lack of direct access and communication between prescribers patients and pharmacies led to a much more protracted delay and refills and what we normally see.

Now while that's the bad news are.

And the very good news as patients did receive their refills and we did not lose that.

Now, we traditionally see looking forward that Q2 as a stronger quarter.

Matthew C. Abernethy: In the first quarter, Ingresa's sales were $230 million, reflecting the payer-related seasonal dynamics Kevin just mentioned and also the seasonal impact from gross to net. Importantly, the team did an excellent job ensuring patients remained on Ingresa. However, the extended insurance reauthorization process due to the pandemic resulted in a lower-than-normal refill rate per patient.

And we expect Q2 versus Q1 sales growth will be and the range of what we saw last year not quite as strong.

But certainly there will be of great deal of growth.

Now both the Eric and Matt will discuss our Q1 experience and more detail on a moment.

Importantly, we have made considerable progress on the number of our clinical programs.

We are if you recall at the beginning of year I told you about our ambitious goal of starting eight new mid to late stage clinical programs. This year and I'm I was just going to take you through our pipeline on this call.

Matthew C. Abernethy: As the quarter progressed, we saw strengthening NRX performance and commercial activity. However, although encouraged, lack of in-person care continues to impact the growth trajectory of the TD market, given that greater than 50% of patient visits to psychiatrists are still conducted virtually. As physicians and patients return to visits in person, we expect TD diagnosis rates will increase, leading to improved ingressive performance. Based upon what we've seen so far in April, we would expect, on an inventory-adjusted basis, sequential dollar growth from Q1 to Q2 to be somewhere in the ballpark of what we saw in 2020. Reflecting both improved growth to net and refill rate.

So without any further comments I'd like to turn the call over to Matt.

And Kevin Good afternoon, everyone first quarter and growth of sales were $230 million, reflecting the payer related seasonal dynamics of Kevin just mentioned and.

The seasonal impact from gross to net and.

And importantly, the team did an excellent job ensuring patients remained on and grabbed the however, the extended insurance reauthorization process due to the pandemic resulted in a lower than normal refill rate per patient.

The third quarter progressed, we saw strengthening interacts performance and commercial activity.

Although encouraged and lack of in person care continues to impact the growth trajectory of the TD market, giving greater than 50 per cent of patient visits of psychiatrists are still being conducted virtually.

Matthew C. Abernethy: We have a strong financial position with over $1.1 billion in cash and are deploying our capital towards growing Ingresa and advancing our pipeline. We increased our 2021 operating expense guidance to reflect our Ingressa-branded DTC campaign called TD Spotlight, which Eric will cover next. With that, I hand the call over to Eric Benevich, our Chief Commercial Officer.

And as physicians and patients returned to visits in person and we expect TD diagnosis rates will increase leading to improved and graduate of performance.

Based upon what we've seen so far in April we would expect on an inventory of adjusted basis sequential dollar growth from Q1 to Q2 to be somewhere in the ballpark of what we saw on 2020.

Reflecting both improved gross to net and retail rates.

Eric S. Benevich: Yeah, thanks, Matt. I'm happy to provide additional commercial insight into our Q1 performance, and today I'll keep my prepared remarks focused on Ingresa. First off, there was already a discussion of our Q1 business dynamics during Kevin's and Matt's prepared remarks.

And we've a strong financial position with over $1 $1 billion and cash and are deploying our capital towards growing and growth and advancing our pipeline.

We increased our 2021 operating expense guidance to reflect during graduate of branded DTC campaign called the T V spotlight.

Eric S. Benevich: But it's important to note right up front that we exited the quarter with more patients on Ingresa treatment than when we entered the quarter. In many ways, Q1 represented the most challenging quarter we've had since launching Ingresa just four years ago. Typically, Q1 performance is characterized by the first portion of the quarter being impacted by seasonal payer dynamics, and then an increase in new patient starts occurs over the latter part of the quarter.

Which Eric will cover next with that I hand, the call over to Eric benefit our Chief Commercial Officer Eric.

Yeah, Thanks, Matt I'm happy to provide additional commercial insight into our Q1 performance and today I'll keep my prepared remarks focused on in Gaza.

The first off there has already been discussion of our Q1 business dynamics during Kevin's and Matt's prepared remarks.

But it's important to note right up front that we exited the quarter with more patients on and graduate of treatment than when we entered the quarter.

And in many ways Q1 represented the most challenging quarter, we've had since launching and graduate of just four years ago.

Typically Q1 performance is characterized by the first portion of the quarter being impacted by seasonal payer dynamics and then an increase and new patient starts occurs over the latter part of the quarter.

Eric S. Benevich: Over the past few years, our field teams have done a great job helping patients, healthcare providers, and their office staff manage through this annual process where many continuing patients need insurance reauthorization to get their Ingressa refilled. However, the external environment was different this year.

Over the past few years, our field teams have done a great job, helping patients health care providers and their office staff manage through this annual process, where many continuing patients need insurance reauthorization to get there and graduate of refills.

Eric S. Benevich: The surging COVID-19 pandemic in January made it especially difficult to support our HCP customers and the TD patients they care for. With many clinics restricting access or even closing altogether, this limited our ability to mitigate the typical Q1 pair dynamics. In short, the pandemic exacerbated the impact of seasonal payer reauthorization requirements causing higher than normal delayed refills and treatment interruptions for many Ingresa patients. However, it was encouraging to see continued strong persistence rates throughout Q1 and that we finished the quarter with more patients treated with Ingresa than when we started, in addition to these payer and pandemic-related external factors. We saw a tick down in growth to net price as additional health plans added Ingressa to their formularies, as Matt noted.

However, the external environment was different this year the surge in COVID-19, pandemic and January made it, especially difficult to support our HCP customers and the TD patients they care for.

And with many clinics restricting access or even closed altogether. This limited our ability to mitigate the typical Q1 payer dynamics.

In short the pandemic exacerbated the impact of seasonal payer reauthorization requirements, causing higher than normal delayed refills and treatment interruptions for many and graduate patients.

However, it was encouraging to see continued strong persistence rates throughout Q1 and that we finished the quarter with more patients treated with and graduate and then when we started the quarter.

In addition to these payer and pandemic related external factors.

We saw it ticked down and gross to net price as additional health plans added and graduate to their formularies as Matt noted.

During the latter part of Q1 as COVID-19 cases waned and the H C. H C. P practices started to open up again, our field teams did an excellent job of re engaging with customers and we saw improved performance metrics across all fronts, including in person and sales calls per day per speaker programs and product sampling.

Eiry W. Roberts: During the latter part of Q1, as COVID cases waned, and HCP practices started to open up again, our field teams did an excellent job of reengaging with customers, and we saw improved performance metrics across all fronts, including in-person sales calls, peer-to-peer speaker programs, and product sampling. Looking ahead, we expect to build on our momentum with key initiatives, including launching our first ever Ingressa-branded direct-to-consumer campaign, which we call TD Spotlight, later this month.

Looking ahead, we expect to build on our momentum with key initiatives, including launching our first ever and graduate branded direct to consumer campaign, which we call TD spotlight later this month.

In addition, we will be introducing a new and graduate the 60 milligram dose strength, which provides health care providers and their TD patients with increased flexibility by offering three effective dosing options, while maintaining the simplicity of one pill once a day dosing with no mandatory or complex titration required.

Eiry W. Roberts: In addition, we will be introducing a new Ingresa 60 milligram dose strength, which provides health care providers and their TD patients with increased flexibility by offering three effective dosing options while maintaining the simplicity of one pill, once daily dosing with no mandatory or complex titration required. We believe this will be a meaningful enhancement to our Ingresa franchise, and we're excited to roll out the new 60 milligram dose to HCPs later this quarter.

We believe this will be of meaningful enhancement to our aggressive franchise and we're excited to roll out the new 60 milligram dose to Hcp's later this quarter.

And reflecting back on where we were at this time last year much as change, but there are some things that remain the same and.

Eiry W. Roberts: In reflecting back on where we were at this time last year, much has changed, but there are some things that remain the same. Ingressa, with its attractive product profile, is still the most preferred and most prescribed VMAT2 inhibitor for TD. Our commercial team remains strong, energized, and as committed as ever, and there remains a huge unmet need to diagnose and treat the roughly 600,000 patients in the U.S. who suffer from tardive dyskinesia.

And graduate with its attractive product profile is still the most preferred and most prescribed the them at two inhibitor for T. D. R.

Our commercial team remains strong energized and as committed as ever.

And there remains a huge unmet need to diagnose and treat the roughly 600000 patients and the U S who suffer from tardive dyskinesia.

We're firmly committed to continuing to shining a spotlight on the substantial impact TD has on patients and their care partners and the meaningful benefits of treatment with Inc. Resin.

Eiry W. Roberts: We're firmly committed to continuing to shine a spotlight on the substantial impact TD has on patients and their care partners and the meaningful benefits of treatment within Grezzo. So with that, I'll look forward to answering your questions during the Q&A portion. And I'll go ahead and turn the call over to my colleague, Eiry Roberts, our chief medical officer. Thank you.

So with that I'll look for it to answering your questions. During the Q&A portion and I'll go ahead and turn the call over to my colleague Robert <unk>, Our Chief Medical Officer.

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

Eiry W. Roberts: Thank you, Eric, and good afternoon to everyone on the call. I'm happy to provide a quick update on recent progress with our clinical portfolio. At the beginning of the year, I indicated that we plan to initiate a total of eight new mid to late stage clinical programs in 2021. We're making good progress and continue to be on track with this plan, with the potential to add a ninth new program start by the end of the year for Leurodaxostat in the treatment of cognitive impairment associated with schizophrenia.

I'm happy to provide a quick update on recent progress with our clinical portfolio.

At the beginning of the year I indicated that we plan to initiate the total of eight new mid to late stage clinical programs and 2021.

We're making good progress and continue to be on track with this plan with the potential to add the ninth new program start by the end of the year the Louvre docs the stat in the treatment of cognitive impairment associated with schizophrenia.

Since the last earnings call, we have initiated two important programs, namely the pediatric Registrational study of cornice. The fund for the treatment of classic congenital adrenal hyperplasia.

Eiry W. Roberts: Since our last earnings call, we have initiated two important programs, namely the Pediatric Registrational Study of Chronesophant for the treatment of classic congenital adrenal hyperplasia and a Phase II study evaluating the efficacy and safety of the T-type calcium channel antagonist NBI-104 for the treatment of essential tremor. Essential tremor, or ET, represents the second potential indication for NBI-104 acquired through our partnership with Eidosi T-type calcium channels have been identified as having a critical physiological and pathological role in ET where abnormal oscillatory activity occurs in the brain. As a background, ET is the most common neurological movement disorder and is associated with physical and cognitive impairments, avoidance of social settings, and related difficulties that negatively impact the lives of patients. E.T.

And the phase two study evaluating the efficacy and safety of the T type calcium channel antagonists and B I, one O for for the treatment of essential tremor.

Essential tremor R. E. T represents the second of potential indication for N. B I went on for acquired through our partnership with Idose yet.

T type calcium channels have been identified as having a critical physiological and pathological role and E. T were abnormal oscillatory activity occurs in the brain.

As background <unk> is the most common neurological and movement disorder and is associated with physical and cognitive impairments avoidance of social settings and related difficulties that negatively impact the lives of patients.

E T affects approximately two five per cent of the population worldwide with the prevalence of more than 5% and adults aged 65 years or older.

Eiry W. Roberts: affects approximately 2.5% of the population worldwide, with a prevalence of more than 5% in adults aged 65 years or older. In addition, the Phase 2 study for NBI-104 in the rare pediatric epilepsy indication of continuous spike and wave during sleep continues to progress in the clinic. Shifting gears now, I'll provide an update on our Leuvidoxostat program, formerly known as NBI 844. Following a thorough review of the clinical data from the recently completed Phase 2 Interact Study, we are moving forward to initiate a Phase 2 study for the treatment of cognitive impairment associated with schizophrenia, with the goal of replicating the potential signal of cognitive improvement that we saw in the Interact Study. Cognitive impairment is an area of significant unmet need in schizophrenia, with no currently approved treatments in the United States.

In addition to.

And she'll tremor the phase two study for N. B I went on for in the rare pediatric epilepsy indication of continuous spike and way of doing sleep continues to progress and the clinic.

Shifting gears now I'll provide an update on all of the DOCSIS stock program, formerly known as N V I ate for fall.

Following a thorough review of the clinical data from the recently completed phase II Interac study, we are moving forward to initiate the phase two study for the treatment of cognitive impairment associated with schizophrenia with the goal of replicating the potential signal of cognitive improvement that we saw within the interact study.

Cognitive impairment is an area of significant unmet need and schizophrenia with no currently approved treatments in the United States. We're currently on track to initiate this new study by the end of the yes.

Eiry W. Roberts: We're currently on track to initiate this new study by the end of the year. In closing, I want to thank the many teams who are helping advance our large, growing, and diverse pipeline. With two new mid- to late-stage programs now ongoing in patience, and an additional seven more planned this year, the momentum for our pipeline is strong. So with that, I'll turn things back to you, Kevin. Thank you, Eiry.

And what I'm, saying I want to thank the many teams who are helping advance our large growing and diverse pipeline with two new mid to late stage programs now on going and patients and an additional seven more planned this year the momentum for our pipeline is strong.

So with that I'll turn things back to you Kevin.

Thank you Larry so while the operators getting the questions to that the teed up right now I'd be remiss if I didn't note that this month is mental health month and.

Kevin C. Gorman: Thank you, Eiry. So while the operator is getting the questions teed up right now, I'd be remiss if I didn't note that this month is Mental Health Month, and this week is Tardive Dyskinesia Awareness Week, or TDAW for short. This year marks the fourth year we've partnered with the mental health community to recognize TDAW by spurring conversations about TD and the importance of seeking a diagnosis and treatment. This year, 48 states and Washington, D.C. have formally declared this first week in May as TD Awareness Week, and I'm very happy that our hometown here of San Diego has done the same. So, Chloe, I think we're ready for the questions now.

And this week as tardive dyskinesia awareness week or teed off for short.

This year marks the fourth year, we've partnered with the mental health community. The recognized teed up by spring conversations about TD and the importance of seeking of diagnosis and treatment.

And this year 48 states and Washington D. C have formally declared this first weekend may S. TD awareness week, and I'm very happy that our hometown here of San Diego has done the same.

So Chloe I think we're ready for the questions now.

And with that his star and one to ask the question. He may even for move yourself by pressing the pound key.

Operator: That is the star and one to ask a question. You may remove yourself by pressing the pound key, and please limit yourself to one question.

And please limit yourself to one question to ensure we get taffy body.

Operator: Transcripts provided by Transcription Outsourcing, LLC. We're going to take our first question from, with RBC Capital, please go ahead. Hey guys, thanks so much for taking my question. So unpacking the Ingresa dynamics a little bit more, by our rough math, it looks like inventory adjusted TRX was down about 7% sequentially, which would apply about 5 to 6% lower revenue per script. And so I'm wondering if you could give us a sense of the degree of seasonality to this gross net change versus how much of this change we should expect to persist throughout the rest of the year with additional formulary access.

And we will take our first question from Brian Abrams with RBC capital. Please go ahead.

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

So unpacking, the and graduate dynamics, a little bit more by.

By a rough math it looks like inventory adjusted T. Rx were down about 7% sequentially, which of them apply about 5% to 6% lower revenue per script and so I'm wondering if you could give us a sense of the degree of seasonality to this gross to net change versus how much of this change we should expect to persist throughout the rest of the year with additional formulary access and then along.

Of the signs I'm, just curious how quickly and meaningfully you'd expect to see pull through from the DTC investment to TD diagnoses of new patient starts and whether that's baked into your second quarter of dollar growth expectations. Thanks.

Operator: And then along these lines, I'm just curious how quickly and meaningfully you expect to see pull-through from the DTC investment to TD diagnoses and new patient starts and whether that's baked into your second quarter dollar growth expectations. Thanks. Hi Brian, this is Matt.

Hi, Brian This is Matt and thank you for the question as it relates to the growth.

Matthew C. Abernethy: Thank you for the question. As it relates to gross to net dynamics, we did see an increase in discounts during the quarter. And that's largely seasonal driven by the Medicare Part D donut hole as well as copay assistance programs on the commercial side. We did have some incremental discounts come from contracting. But I would say, by and large, the majority of that gross to net discount increase should recover throughout this year.

On to net dynamics, we did see an increase and discount during.

During the quarter and that's largely seasonal driven by the Medicare part D Donut hole as well as a co pay assistance programs on the commercial side. We did have some incremental discounts come from contracting, but I would say by and large the majority of that gross to net of discount increase should.

It should recover throughout this year I believe I had guided last quarter, and we would expect of sequential down or a sequential increase and gross to net discount of around 5% and landed just north of that around 6% during the quarter. So hopefully that gives you the right line of sight there on the <unk>.

Matthew C. Abernethy: I believe I guided last quarter that we would expect a sequential down or a sequential increase in gross to net discount of around 5%. It landed just north of that, around 6% during the quarter. So hopefully, that gives you the right line of sight there.

DTC investment.

Matthew C. Abernethy: On the DTC investment, the big aspect here is to accelerate TD diagnosis and ultimately, allow more patients to have benefits with Ingresa. As you know, there's a lag time between when you do a direct-to-consumer advertising campaign and when it actually translates to patients receiving medicine. So you would expect some level of a return later this year, but more meaningfully, in 2022. Question from Paul Matisse with Stifle, please go ahead.

Aspect here is the accelerate TD diagnosis and ultimately.

Allow more patients the benefits with in Gaza.

As you know there's a lag time between when you do of direct to consumer advertising campaign and when it actually translates to patients receiving medicine. So you would expect some level of of return later this year, but more meaningfully.

In 2020 two.

Yeah.

The next question from Palm of Tea with Stifel. Please go ahead.

Great. Thanks, so much.

Matthew C. Abernethy: Great, thanks so much. I wanted to ask a little bit more about this QQ kind of, sort of guide. I'm a little bit confused by it because, you know, historically, you've talked about average precipitation fluctuating in one Q, maybe decreasing by 0.1 or 0.2. And so, let's say it decreased by 0.2. That's about a $20 million headwind. So, even right there, with the reversion of that, you can get close to what you're implying for QQ based on last year's and adjusting for inventory.

I wanted to ask moving more about the <unk> kind of sort of guide I am a little bit confused by it because you know historically, you've talked about average script per patient flow.

The waiting and <unk> may be decreasing by point of Warner 0.2, and so the let's say of decreased by point to that's about a $20 million of headwind. So even right there with the reversion of that you can get close to what you're implying for Q2 based on last year and adjusting for inventories. So I guess, maybe you could just for.

So on to that and then in terms of Q2 number and kind of guide you provided.

Matthew C. Abernethy: So, I guess maybe you could just respond to that and then, in terms of this QQ number kind of guide you provided, you know, what's behind it in terms of actual organic patient growth? Thanks. Yeah, Paul. This is Matt.

What the what's behind it in terms of actual organic patient growth.

Yeah.

Yes, Paul This is Matt happy to answer the question for you.

Matthew C. Abernethy: Happy to answer that question for you. You know, if you look back at what occurred last year, we had a tremendous Q1. We did a great job keeping patients on medicine. And then we also actually had a record number of new patients, a great trajectory, entering out of or exiting Q1 and heading into Q2. So the benefits that we saw in Q2 were really reflective of how our performance was.

You know if you look back at what occurred last year, we had a tremendous Q1, we did a great job keeping patients on medicine and then we also actually had a record number of new patients a great trajectory entering out of of exiting Q1 and heading into Q2. So the benefits that we saw.

In Q2 were really reflective of how our performance was right in the in Q1 of last year and and just to reiterate the record.

Matthew C. Abernethy: In Q1 of last year, and just to reiterate the record number of new patients, when you adjust for inventories sequentially last year, I believe that was around a $28, $29 million increase. So when you think about the different dynamics this year, as you said, we did have a bit more of an impact on refill rates per patient. But on the NRX front, we're still operating in a market where patients aren't going into clinicians' offices yet. And so that does mute the NRXs that we're able to generate.

<unk> of new patients when you adjust for inventories sequentially last year I believe those around the 28 $29 million increase so when you think about the different dynamics this year.

As you said, we did have a bit more of an impact on refill rate per patient.

But on the interest front, we're still operating in the market, where Ah patients aren't going physically into clinicians offices, yet and so that does mute the interactions that we're able to.

To to generate so we would expect to have a have a decent growth.

Matthew C. Abernethy: So we would expect to have decent growth, but getting new patient additions back up to historical pre-pandemic levels is really what's going to allow us to kick start growth. On the patient side, we actually had a bit more patients exiting the quarter than we entered, and I think that was a really positive sign.

But getting a new patient additions back up to the historical pre pandemic levels is really what's going to allow us to kick and growth on the new on the patient side, we actually had a bit more patients exiting the quarter than we entered and and I think that was a really positive sign and we expect something similar to the.

When you exit Q2.

Matthew C. Abernethy: And we expect something similar to that when you exit Q2. However, you know, our growth will be somewhat capped based upon the patients not going into the office. However, we have many tactics that Eric can illuminate that we're working on to both drive commercial activity as well as, as you can see in the DTC, engaging patients in this process. Eric, anything you want to add on the commercial side?

Or are you know our growth will be somewhat capped.

And based upon the patients not going into the office. However, we have many tactics that Eric and illuminate that we're working on to both drive commercial activity as well as and as you can see on the D. T C engaging patients and this and this process Eric anything you want to add there on the commercial side.

Probably the probably the only thing that I would add and I mentioned this in my prepared remarks, you know that normally we do see.

Eric S. Benevich: Probably the only thing that I would add, and I mentioned this in my prepared remarks, you know, that normally we do see the first portion of Q1 with a lot of focused effort around reauthorizations and getting patients going on refills. And typically, we see the second part of the quarter, new patient starts, and we did see that dynamic here this year as well, but with corruption in those refills and what we've seen in years past because of the challenges related to communication caused by the pandemic, and therefore the pickup and the lift from NRX are kicking in a little bit later in the quarter than in previous years.

The first portion of the Q1 with a lot of focused effort around the.

Re authorizations and and getting patients on going on refills and typically we see the second part of the quarter I'm more focused on a new.

The new patient starts and we didn't see that dynamic here of this year as well, but with.

With the.

The more.

Interruption in those refills and what we've seen in years past because of the challenges related to communication caused by the pandemic.

And therefore.

The Inc. The pickup and the lift from interacts is kicking in a little bit later in the quarter than maybe what we've seen in prior years. So.

Similar kinds of.

Eric S. Benevich: So similar kinds of Uh... dynamics happening, but the pattern was a little bit different this year because of the external environment and the timing of new patient starts. It makes a big difference when you think about, I don't know how many potential refills you might get over the course of a quarter.

Dynamics happening, but the pattern was a little bit different this year because of the external environment and.

And the timing of new patient starts it makes a big difference when you think about.

How many potential refills and you might get over the course of the quarter.

Yeah.

Yeah.

Students from.

Nadeau with Cowen and company. Please go ahead.

Operator: Cohen & Co.

Operator: Good afternoon. Thanks for taking my question. I'm also going to ask about the Q2 dynamics. I apologize.

Good afternoon, and thanks for taking my question and I'm also going to ask you about the Q2 dynamics I apologize.

But.

And I just want make sure I understood. What you just said so last year. It looks like the revenue actually went up by 35 $36 million, but there were inventory effects for both Q1 and Q2 of last year.

Operator: But Matt, I just want to make sure I understood what you just said. So last year, it looks like the revenue actually went up by $35 million.

Operator: but There were inventory effects from both Q1 and Q2 of last year.

Based on the comments you just made it it seems like you're saying back out the inventory effects.

Operator: Based on the comments you just made, it seems like you're saying back out the inventory effects. When we determine what the quarter over quarter growth was last year and therefore will be in Q2, is that correct? And if so, can you just repeat what that number is?

And when we determine what the quarter over quarter growth as it was last year and therefore, it will be and Q2.

Is that is that correct and if so can you just repeat what that number is and I guess the broader question is why.

Operator: And I guess the broader question is, Why not just give us specific guidance for Q2 with the revenue range? It seems like this is much more complicated than it needs to be. Yeah, thanks, Phil. Yeah, you have the numbers correct.

And why not just give a specific guidance for Q2 of the revenue range and it seems like.

This is much more complicated than it needs to be.

Yeah. Thanks, Phil Yeah, you have the numbers correct last year. There was an increase on an inventory of adjusted basis, We had 227 and Q1 and we went up to about $2 55. So that's the $28 million increase on an inventory of <unk>.

Operator: Last year, there was an increase on an inventory adjusted basis. We had 227 in Q1, and we went up to about 255. So that's a $28 million increase on an inventory adjusted basis.

Adjusted basis, you know, we felt it important to be really direct this quarter as to what we would be expecting out of the second quarter given the dynamics, we saw on Q1 and the evolving.

Operator: You know, we felt it important to be really direct this quarter as to what we would be expecting out of the second quarter, given the dynamics we saw in Q1 and the evolving landscape of the pandemic. We're going to continue to think about providing a more formal guidance; it would likely be an annual guide if and when we ever provide that guidance. But for right now, Phil, we just wanted to give as much clarity as possible but not provide an annual guide.

Landscape of the the pandemic.

You know, we're going to continue to think about providing a more formal guide it would likely be and annual guide if and when we ever provided that guidance, but for right now Phil we just wanted to to give as much clarity as possible, but not provide and annual guide.

Operator: Question from Brian Skorney with Baird. Hey, good afternoon, guys. I'm going to depart from the Q2 dynamic question for a second here and just ask a little bit about ET. We've seen some recent results on competitive Phase 2 programs in ET that showed some interesting efficacy, but it seems to have had a very lukewarm investor response due to some of the safety signals seen there. So I guess maybe you could just kind of try and help characterize in terms of what you're looking for in phase 2, what you want to see out of 104, and how to really think about an appropriate therapeutic index for an indication like central tremor. Thanks. Sure, thanks very much.

Chin from Brian's corny with Baird.

Go ahead.

Hey, good afternoon, guys I'm gonna on of depart from the the Q2 don't ask the question for a second here and and just ask a little bit of about E T.

<unk> seen some recent results on competitive phase two programs and E. T. The showed some interesting efficacy, but seems to have had a very lukewarm investor response due to some of the safety signals seen there. So I guess, maybe you can just kind of try and help characterize in terms of what youre looking for and phase two of what you want to see out of one O for and how to really think about and appropriate therapeutic index for and.

And like the central tremor. Thanks.

Sure. Thanks, very much that's a that's great and I'm happy to answer that so.

Eiry W. Roberts: Sure, thanks very much. That's, that's great. I'm happy to answer that.

So in terms of Youre right in terms of the recent Readouts and essential tremor, I think given the prevalence of the disorder and the and.

Eiry W. Roberts: So in terms of recent readouts in essential tremor, I think given the prevalence of the disorder and the age of the population as well, the therapeutic index and the safety profile for new medications are very important in this, in this realm. What I can say is that, with 104 up to this point, we're very pleased with the profile that we saw in terms of tolerability in the healthy subject data that was generated in the phase one environment.

Our age of the population as well of the therapeutic index and the safety profile for new medications and it's very important and this and this route and what I can say is one of with a one O for up to this point, we're very pleased with the profile that we saw in terms of Tolerability and the healthy subject day to that was generated and.

And the phase one environment. So that is encouraging for us as we enter into the this first phase two study.

Eiry W. Roberts: So that is encouraging for us as we enter into this first phase two study. The study itself is a proof of concept study, actually, which will be taking place in 28 14 of those subjects are under the age of 65, and 14 will be over 65, and that study is being conducted currently in Europe, which just started. What we thought was important was to get some objective efficacy and tolerability data in that older population as early as possible.

The study itself is that study and.

Of concept study and actually which are it will be taking place and 28.

The 14 of the subjects on under the age of 65, and 14 will be over 65 mm and thus studies being conducted currently in Europe, just stop it and.

And what we thought was important was to get some objective efficacy and tolerability data in the older population as early as possible and so from that point of view, we will have good information exiting the study the other element of the design, which we believe as powerful as this is of crossover study. So there will be and opportunity to look at it but within.

Eiry W. Roberts: And so from that point of view, we will have good information exiting this study. The other element of the design, which we believe is powerful, is that this is a crossover study. So there will be an opportunity to look at a within-subject change comparing 104 to placebo in that setting. And we are looking at, in addition to obviously more quality of life-type outcomes, we are looking at objective measures in terms of the actual amplitude of tremor at the end of the 28-day period. And so we will have both objective and more subjective measures of efficacy in the study, in addition to, obviously, an initial look at tolerability.

And subject change comparing one O for at two placebo in that setting and we are looking at are in addition to obviously a more quality of life type of outcomes. We are looking at objective measure in terms of the the actual amplitude of tremor at.

The end of the 28 day period, and so we will have both objective and more subjective measures of the efficacy and the study in addition to and obviously an initial look at Tolerability.

Yeah.

And from Josh Shimmer from Evercore ISI. Please go ahead.

Great. Thanks very much.

Regards to your comment that 50% of psychiatry visits are still telehealth and feels like that number it's been bouncing around a little bit there have there been any.

Recent trends or updates into the second quarter to start to normalize that and then.

Operator: Question from Josh Schimmer from Evercore ISI

For your for the DTC campaign that you were planning to have you.

Operator: Core ISI, please go ahead. Thanks very much. With regard to your comment that 50% of psychiatric visits are still telehealth, it feels like that number has been bouncing around a little bit. Have there been any recent trends or updates in the second quarter to start to normalize that? And then separately for the DTC campaign that you're planning, have you tried any pilot approaches to gauge what kind of an impact a DTC campaign might have on Ingress adoption? Thanks very much.

Tried any pilot.

And approaches to gauge what kind of and impact of DTC campaign might have on and grit of adoption. Thanks very much.

Yes, so I'll tackle both of those questions and so yes the there.

And there are different syndicated data sources out there that give estimates for the the.

Use of telehealth and across different physician specialties, and what we've seen from the data and what where and what we hear directly from our customers and through our field sales team is dead on.

The use of telehealth and psychiatry is substantially higher than it is in the other specialties, including neurology.

And.

Even though it's not as high as what it was let's say last summer or fall more.

Eric S. Benevich: Even though it's not as high as what it was, let's say, last summer or fall, more than half of all patient visits in psychiatry still are via telehealth, either video plus voice or voice only. And so to that end, you know, we've certainly made great strides in adapting our business model and our educational content to accommodate providers that are seeing their patients remotely. And in fact, I would encourage you if you want to learn more to visit mindtd.com, m-i-n-d-t-d.com.

More than half of all patient visits and psychiatry still are of the telehealth, either video plus voice or voice only.

And so to that and you.

We've certainly made great strides in adapting our business model and our educational content to accommodate providers that are seeing their patients remotely and in fact I would encourage you. If you want to learn more to the visit mind T. D. Dot com M. I N D. The ash T D Dot com.

And Youll see some of the tools and resources that have been developed in conjunction with thought leaders in neurology and psychiatry.

Eric S. Benevich: And you'll see some of the tools and resources that have been developed in conjunction with thought leaders in neurology and psychiatry to help them become more comfortable and adept at recognizing and diagnosing TD during virtual patient visits.

Let them become more comfortable and adept at recognizing and diagnosing TD in a virtual patient visits.

And so.

And telehealth is.

Eric S. Benevich: Telehealth is certainly prominent today, and we think it'll continue to be so in the future. And we've made great strides in terms of our ability to adapt to that new mode of delivering health care. And then, with regard to the spotlight, the TD Spotlight campaign, the way that we're thinking about it is that this is a process of really developing the market over time. Early on in the launch, a lot of the educational focus that we had with patients and their care partners was via outreach through patient advocacy organizations. And then, you know, as we progressed, you may recall that we launched an unbranded disease state educational TV campaign called Talk About TD. That's been on the air for about two years.

Certainly prominent today, we think of those continue to be prominent and the future and where we've made great strides in terms of our ability to adapt to that into into that new mode of delivering health care.

And then with regards to the.

Spotlight.

The TD spotlight campaign.

And the way that we're thinking about it is that this is a.

Process of really developing the market overtime on early on and the launch of a lot of the educational focus that we had with patients and their care partners was the.

Outreach through the patient advocacy organizations.

And then you know as we progressed you may recall that we launched in the unbranded disease State educational PV campaign called talk about TD, that's been on the air for about two years.

And we were very pleased with the response to it in terms of our website visits registrations to receive more information et cetera.

Eric S. Benevich: And we were very pleased with the response to it in terms of website visits, registrations to receive more information, et cetera. And importantly, we've been monitoring all along how we're doing in terms of raising awareness among the target population of patients that are on antipsychotics experiencing these abnormal movements. And we've seen over time that awareness of TD and the understanding of TD and its relationship to their underlying psychiatric illness and the medications that treat their psychiatric illness have increased.

And importantly, we've been monitoring all along.

And how we're doing in terms of raising awareness.

With the target population of patients that are on and Psychotics experiencing these abnormal movements and we've seen over time.

That awareness is increase the of TD and the understanding of the TD and its relationship to their underlying psychiatric illness, and the medications that treat their psychiatric illness and so we felt like it was a we were at the point, where it made sense the transition.

Eric S. Benevich: And so we felt like it was – we were at the point where it made sense to transition into a broader campaign that incorporated not only the TD educational component but also the idea of treatment. And in fact, our market research indicates the number one reason that patients don't pursue treatment for their TD is that they're unaware that there are treatment options. So we're excited about the opportunity to launch the TD Spotlight campaign later this month, and we're very optimistic based on the testing and the work that we did to show it to thought leaders in the psychiatric and neurology community as well as patient advocacy groups that it'll be an effective way of helping to once again allow TD sufferers to get effective treatment. Bitritto Garg from Citi, please go ahead.

Into a broader campaign.

And that incorporates not only the TD educational component, but also of introducing the idea of treatment and in fact on market research indicates the number one reason that patients don't.

Pursue treatment for their TD is are unaware that they are of treatment options.

And so we're excited about the opportunity to launch the TD spotlight campaign later this month.

And we're very optimistic based on the testing and the work that we did too.

To to show it to thought leaders and and and the psyche.

Psychiatric and neurology community as well as the patient advocacy groups that it'll be the effective way of helping to once again.

Allow TD sufferers to get effective treatment.

<unk> from the tree tow garg from Citi. Please go ahead.

Hey, guys. Thanks for taking my question, then I apologize if somebody already asked about this earlier, but just.

Operator: Hey guys, thanks for taking my question. And I apologize if somebody already asked about this earlier, but just on the Crenesifront, the pediatric study for CAH, I saw that that was posted. And so the primary endpoint there is change from baseline in serum and serum androcystin dione versus glucocorticoid burden reduction in the adult study. So, I guess, can you just walk us through kind of the rationale there in terms of the different endpoints? Great. Yes, thanks very much for the question.

Just on the sort of front the pediatric study for C. H I thought the thought was posted and some of the primary end point. There is a change from baseline and serum and serum interest and down versus the glucocorticoid burden reduction and the adult study. So I guess can you just walk us through kind of the rationale there.

In terms of the different endpoints.

Yes, thanks very much for the question we were very excited to launch the Kronos upon the pediatric Registrational trial and and doing so we gained insight into the design and the background and that the trials and globally for.

Eiry W. Roberts: Yes, thanks very much for the question. We were very excited to launch the Chronosophon Pediatric Registrational Trial, and in doing so, we gained insight into the design and background of that trial globally from many of our key stakeholders, including regulators, patients, clinicians, and payers. And as a result of that, and in determining the primary and secondary endpoints, I think it's important to note that both the hormone levels, particularly androgen levels, and the glucocorticoid dose remain very important in pediatric patients in the treatment of their congenital adrenal hyperplasia.

And many of.

Of all key stakeholders, including regulators patients and clinicians payers and.

And as the result of that and and in determining the primary and secondary endpoints I think it's important to note that for the hormone levels, particularly androgen levels and the glucocorticoid dose remain very important and pediatric patients and the treatment of that connects the font of that.

Net congenital adrenal hyperplasia, however in pediatric patients the androgen levels are of very significant importance because of issues such as growth and at the developmental aspect of the development of patients and the pediatric age group and so with that in mind.

Eiry W. Roberts: However, in pediatric patients, androgen levels are of very significant importance because of issues such as growth and other developmental aspects of the development of patients in that pediatric age group. And so, with that in mind, the primary endpoint for the study is the four-week androgen level and other hormone levels. In addition, you'll see from the design of the study, though, that we are still very interested in the six-month glucocorticoid dosing level for these pediatric patients.

The primary endpoint for the study is the full week androgen level on of the hormone levels. In addition, you'll see from the design of the study that we are still interested and very much and the six months, our glucocorticoid dosing level for these pediatric patients and and we will be similarly.

Following the ability to reduce the overall glucocorticoid dosing for patients in the context of treatment with the fairness of the fun. So the the endpoints overall aligned very closely with those within the pediatric and the adult program, it's just that and the pediatric setting the the full week measurement of androgen levels as the price.

Eiry W. Roberts: And we will be, similarly, following the ability to reduce the overall glucocorticoid doses for patients in the context of treatment with crinesophon. So, the endpoints overall align very closely with those within the adult program. It's just that in the pediatric setting, the four-week measurement of androgen levels is the primary.

And me.

Operator: Question from Jay Olsen with Oppenheimer, please go ahead. All right, thanks for taking...

And from Jay Olson with Oppenheimer. Please go ahead.

Hello, and thanks for taking the question.

Since you grew and Greg.

Operator: Thanks for taking the question. Since you grew Greza pretty rapidly to a billion dollars, nearly a billion dollars in annual revenues last year, just on TD and just in the US, and now you have another indication on the way, potentially, in Huntington's Korea and potentially a new market in Japan. And you've got two other new indications you'll be studying in neurology and psychiatry.

Pretty rapidly $2 billion, nearly $1 billion and annual revenues last year, just on TD and just in the U S. And now you have another indication on the way potentially in the Huntington's chorea and potentially new market in Japan, and you've got two other new.

Patients, you'll be studying and neurology and psychiatry can you talk about how important those are for the future growth of Inc. Rosa and how long it might take to get the $2 billion and can you get to $2 billion on TD alone and the U S or do you need the new geographies and the new indications. Thank you.

Kevin C. Gorman: Can you talk about how important those are for the future growth of Greza and how long it might take to get to $2 billion? And can you get to $2 billion on TD alone in the US, or do you need new geographies and new indications? Thank you.

Yes, so Jay Thanks for the question we are you know.

Kevin C. Gorman: Yeah, Jay, thanks for the question. We, you know, We haven't talked about what we believe is the ultimate market revenue that can be attained here. TD, as Eric said, the vast majority of patients have yet to be diagnosed, let alone be treated appropriately. As a matter of fact, with the 20% or so that have been diagnosed, only half of them are being treated with a VMAT-2 antagonist at this point.

We haven't talked about what we believe is the ultimate market.

The revenue that can be that can be attained here.

T D.

As Eric said, the vast majority of patients have yet to be diagnosed the little alone be treated appropriately as a matter of fact with the 20% or so that have been diagnosed only half of them are being treated with the vivat to antagonist at this point so even within the diagnosed population right now that small fraction of the total.

Kevin C. Gorman: So even within the diagnosed population right now, that small fraction of the total population you should have a doubling of the amount of patients who are on Medicare. One of the things that that we had talked about early on, and you'll remember, you've been covering us for quite a while here, was that there, we believe that there were going to be a number of indications for the VMAT2 mechanism, and that's coming to fruition at this, and so we we look to constantly extend to the number of different patient types that this mechanism is going to be important in managing the diseases and disorders uh... and and i think we've got several very important ones here uh... and you know the the the last thing that i i would say here is is that that actually extends to almost everything in our that when we go after a target, we're generally going after it, not just for a single disease state, but we're going after it because we think it's in a very important biological for a number of disease states.

Population you you should have a doubling of the amount of patients who are who are on medication.

On one of the things that that we had talked about early on and you'll remember you've been covering us for quite a while here.

Was that there we believe that they were going to be a number of indications for the the mat to mechanism and that's coming to fruition at this point and so we look to constantly extend to the number of different patient types that this mechanism is going to be important and managing the diseases and disorders.

Orders.

And and I think we've got several very important ones here.

And you know the.

The the the last thing that I I would say here is is that that actually extends to almost everything and our franchise.

And at when we go after a target where generally.

And going after it and not just for a single disease state, but we're going after it because we think it's and then a very important biological system for a number of disease States and that's both with our internal programs and with the ones that we are we do with partnering.

Kevin C. Gorman: And that's both with our internal programs and with the ones that we do with partners. So Eric, do you have anything to add? No, I mean, other than just reinforcing that, you know, the TD market alone represents a significant, http://www.cdc.gov.uk, J.P. Morgan, please go ahead. Hey guys, thanks so much for taking the question.

So Eric do you have anything to add the.

No I mean other than just reinforcing that.

T D market alone.

Represents significant potential for us.

As yet mostly undeveloped market. There are many patients that are diagnosed and untreated and we're certainly excited about the mechanism of beam at too and its potential utility in additional disease areas, and neurology and psychiatry and the potential to help many more patients and so.

Operator: Um, maybe I just want to ask a little bit more of a clarifying type of question, sort of in the 2Q dynamic. With everything, Matt, that you've kind of said about how we should be thinking about 2Q and up to last year, you're essentially guiding to like a mid 250s kind of high 250s kind of range for. You could confirm that. And then why wouldn't it be greater than what you saw last year?

That's what gives us a lot of energy and passion.

Two on new Palm Rama from J P. Morgan. Please go ahead.

Hey, guys. Thanks for taking the question and me.

And I just like.

The little bit more of a clarifying the type of question and sort of my congrats on <unk>.

Everything Matt that you've kind of said about how we should be thinking about <unk> and I'll get to.

Last year, you're essentially guiding to like the.

He kind of high tech fees.

Range per well.

And you could confirm that and then why wouldn't it be greater than you saw last year.

Of the script trends that you're seeing exiting one.

Operator: of the script transcript that you're seeing exiting 1-2. What's holding you back from saying, you know what? The quarter is going to be better than what we observed last year? Yeah, yeah, you're breaking up a little bit Anupam, but I think I made my way through what you were asking. In general, yes, in the 250s is what we would be anticipating based upon what we're seeing right now. You know, the piece that I know is difficult to understand.

Like what withholding holding you back from saying you know what the quarter was one of the better than what we observed last year.

Okay.

You were breaking up a little bit on a pump, but I think I made my way through what you were asking.

In general, yes in the and the two fifties as and.

The two fifties as what we would be anticipating based upon what we're seeing right now.

You know the piece of that.

I know, it's difficult to understand but our performance last year of for example, and Q1 is what drove our Q2 results Q2 was a derivative of Q1.

Matthew C. Abernethy: But our performance last year, for example, in Q1, is what drove our Q2 results. Q2 is a derivative of Q1 activity. And in Q1, we had record numbers of new patients last year. So you added the new patients, heavily concentrated in the back half of the quarter last year, and then you got a full quarter of refill rates from those patients. Now, when you think forward to what happened last year in Q3, that's when the impact from the patients not going in person into the offices really kicked in.

The activity and in Q1, we had record numbers of new patients last year. So you added the new patients.

Heavily concentrated in the back half of the the.

The quarter last year, and then you get a full quarters of refill rates from those.

From those patients now when you think forward into what happened last year and Q3, that's when the impact from and tell them the patients not going and person into the offices really kicked in and so those about where those were activities that were being done in Q2 and that.

Matthew C. Abernethy: And so those were activities that were being done in Q2 and that showed up in our Q3 revenue in a more pronounced way. So similarly this year, what we saw in Q1, we did see nice growing new patient additions. We also saw record levels of commercial activity.

Road up and our Q3.

The revenue more and a more pronounced way. So similarly this year, what we saw on Q1, we did see nice growing on new patient additions. We also saw record levels of commercial activity. So our expectation is yes, we performed pretty well and Q1.

Matthew C. Abernethy: So our expectation is, yeah, we performed pretty well in Q1. Our NRXs should continue to improve in Q2, and that should set you up for a much better Q3 or Q4 as compared to what we saw last year. So it's a delayed reflection in our sales results. And all of that is with the assumption that this improving environment for COVID continues in the direction that it has been going. We all hope so.

R R interacts and our interactions should continue to improve in Q2 and that should set you up for a much better Q3 of our Q4 as compared to what we saw last year.

So it's a it's a delayed of reflection and our sales results.

And all of that is with the assumption that this improving environment for COVID-19 continues and the direction that is that it has been going which of.

And we all hope.

Okay.

The next to Carter Gould with Barclays. Please go ahead.

Operator: Next to Carter Gould with Barclays, please go ahead. Great. Thanks.

Great. Thanks for taking the questions.

I guess first on the on the on the DTC campaign.

Operator: Great, thanks for taking the questions. I guess first on the DTC campaign, it sounds like you're kind of characterizing this as sort of a natural evolution of your broader awareness and education campaign. But I guess why now in terms of just specifically in timing? And does this come with sort of like a predetermined or a finite magnitude or length?

I just wanted to it sounds like you're kind of characterizing this as I sort of of natural evolution of of your of your broader awareness and education campaign.

But I guess the.

And I guess you know I.

I guess why now in terms of just specifically on timing and is this going to come with sort of like a pre determined or of finite magnitude or length or should we just consider this sort of business as usual going forward as we think about your SG&A spend thank you.

Eric S. Benevich: Or should we just consider this sort of business as usual going forward as we think about your SG&A spend? Thank you. Yeah, so I guess I would agree that the way that we know that we're thinking about it is a natural evolution in terms of our overall effort to reach, educate, and motivate patients and their care partners. We've been trying and piloting different types of initiatives over the last four years, and we felt like we were at the point where it made sense to transition into a broader campaign that introduced the concept of Ingressa directly to patients. This was a decision that we made some time ago, but we're just rolling it out now.

Yes, so I.

And I guess I would agree that.

It makes the way that we know what the we're thinking about it is a natural evolution in terms of our overall effort to reach educate and motivate patients and their care partners.

We've been.

Trying and and piloting different types of initiatives over the last for years and we felt like we were at the point, where it made sense and transition into a broader campaign.

And that introduced the concept of and graduate directly to patients and this was the decision that we made some.

Some time ago.

But we're just rolling it out now.

In terms of you know is there going to be sort of a finite cycle for this the.

Eric S. Benevich: In terms of, you know, is there going to be sort of a finite cycle for this? The way that we're looking at it is we're going to be carefully monitoring the effectiveness of the ad campaign, you know, looking at key performance metrics, etc. And then making adjustments as we go forward. Normally, when you look at the lifecycle of a branded ad campaign, it's effective for a few years.

The way that we're looking at is we're gonna be carefully monitoring.

The effectiveness of the AD campaign.

Looking at key performance metrics et cetera.

And then making adjustments as we go forward.

Normally when you look at the lifecycle of a branded AD campaign, it's effective for a few years and so I wouldn't expect a TD spotlight to be any different sometimes it could be extended and refreshed, but ultimately you know we're gonna be I'm looking at this as an important lever.

Eric S. Benevich: And so I wouldn't expect a TD Spotlight to be any different. Sometimes they could be extended and refreshed, but ultimately, you know, we're gonna be looking at this as an important lever for educating and motivating patients to talk to their doctors. And, you know, certainly we're very optimistic about the way that we developed the campaign and the way that the testing results came out. And we'll look forward to rolling it out later. Miles Mentor with William Blair, please go ahead.

For.

<unk> and motivating patients to talk to the Doctor.

And certainly we're very optimistic about the way that we develop the campaign and the the way that the the testing results came out.

And we look forward to to rolling it out later this month.

Yeah.

Yeah.

And that's next to Myles Minter with William Blair. Please go ahead.

Operator: Hey, thanks for taking the question. It's just a question about luprodaxostat and cognitive impairment in schizophrenia. I'm very curious about the type of patients you're going to be enrolling in that trial. Are they stable on all other symptoms and predominantly have cognitive symptoms?

Hi, Thanks for taking the questions.

And on the laser DOCSIS stat and cognitive impairment schizophrenia.

I'm very curious about the path of price and chill going to be enrolling in that trial a day stifle on all of the symptoms and predominantly have cognitive symptoms and the guidance of being and meeting with regulators before you start that trial of I, just understand and there's a little bit of conjecture.

Eiry W. Roberts: And are you going to be meeting with regulators before you start that trial? I just understand there's a little bit of conjecture around that matrix endpoint. There's a lot of talk in academic circles about whether it's the right one to use, and there's no formal FDA guidance here, to my knowledge.

Around the matrix and client one of the torque and academic circles about whether it's the right one for us and there is no formal FDA God and see it to my knowledge.

Eiry W. Roberts: So any call you can provide there would be great. Yeah, thanks for the question.

Any color you can provide that would be great.

Yeah. Thanks for the question.

Yes, we have been obviously had a lot of that spend a lot of effort analyzing the information coming out of the interact study and.

Eiry W. Roberts: Yeah, thanks for the question. So, obviously, we have obviously spent a lot of time analyzing the information coming out of the interact study. And just as a reminder, the cognitive measures included in the interact study, which were responsible for the positive signal that we saw there, were secondary endpoints, and it was the back, the brief assessment of cognitive symptoms, and the scores. And those two measures are something a little different; one is actually a kind of a pure score that's generated by the patient themselves and the clinician.

And just as a reminder, the cognitive measures included in the interact study, which were responsible for the positive signals that we saw the with secondary endpoints and it was the back of the brief assessment of cognitive symptoms on the school is on those two measures measure something a little dip.

And one is actually a kind of an appeal of score and that's generated by the patient themselves on the clinician and the skull and is more of a functional our interpretation of the cognitive impairment and includes the caregiver as well and so what we want most.

Eiry W. Roberts: And the scores are more of a functional interpretation of the cognitive impairment and include the caregiver as well. And so what we were most struck by in the finding from the interact study, which encouraged us to move forward into the next generation of testing here, was the fact that we saw the signal in both of those measures. And to our knowledge, that has not been demonstrated in the context of a clinical trial before.

Struck by and the finding from the interact study, which encouraged us to move forward into the next generation of testing here was the fact that we saw the signal and both of those measures and to our knowledge that has not been demonstrated in the context of the clinical trial before and as you quite rightly said the data in the.

Eiry W. Roberts: As you quite rightly said, the data in this field has been very mixed, with negative and few, very few positive signals on the matrix or the backs historically. So with that in mind, we are designing a study essentially to replicate, an attempt to replicate, that finding, using those appropriate endpoints, and at an appropriate time, we will then engage with the agency then to understand, if successful, the path forward for registration.

Field has been very mixed with negative and a few very few positive signals on the matrix or the back historically and.

So we got in mind, we are designing a study essentially to replicate and attend.

And to replicate that finding and using those appropriate endpoints and other and appropriate time and will then engaged for the agency then to understand if successful the path forward into a registration plan.

And so I think the the key goal and our minds right now is that we're intrigued by the signal. We saw we recognize the very significant unmet medical need and cognitive impairment schizophrenia and.

Eiry W. Roberts: And so I think the key goal in our minds right now is that we're intrigued by the signal we saw, we recognize the very significant unmet medical need for cognitive impairment within schizophrenia, and we're seeking, as rapidly as possible, to replicate that finding and work out whether it's really a real disease.

And we're seeking to as rapidly as possible and replicate that finding and work out whether it's really a real finding.

Yeah.

The question from the mill.

For the Vaughan with Mizuho Securities. Please go ahead.

Operator: There's a question from Vamil Devon with Mizzou Health Securities. Please go ahead.

Great. Thanks for taking the questions and the.

Operator: Great, thanks for taking the questions and the color that you provided so far on the 2Q dynamics. I guess maybe one other product which I think has maybe covered as much as Magentis has been approved for about a year. I know you didn't launch until September or so, but can you maybe just share any details there about kind of the progress you had with that product? I don't think you had a great preliminary position a few months ago. I'm just curious if you made progress there and sort of how the initial sort of reception has been for that product in the market. Thank you.

Color the provided so far on the <unk> dynamics I guess, maybe one other on.

Got it which I think if maybe covered as much as and dentists have been approved for about a year and we didn't launch until September. So can you maybe just share any details there around kind of the progress you have of that product and I don't forget grateful and the position three months ago. I'm. Just curious have you made progress there and sort of.

How the initial sort of reception has been the that product to the market.

Yeah.

Yeah, I'll I'll I'll give some of some insights there and then perhaps IRA you might want to had some on some color.

Eric S. Benevich: Yeah, I'll, I'll give you some, some insight there. And then, you know, perhaps, Eiry, you might want to add. So, yes, from a timing perspective, you know, we launched Ongentis right at the end of Q3, really, effectively, the beginning of Q4, and we recognized that launching a product during a pandemic environment was less than optimal, but we also felt obligated because we had an improved product. We had sufficient commercial supply and patients that could benefit, and so we, you know, we pressed forward.

Yes from a timing perspective.

We launched on <unk> right at the end of of Q3 really effectively at the beginning of Q4 and.

And we recognize that launching a product during a pandemic environment was less than optimal but we also felt the obligated we have and improve product we had sufficient commercial supply and the patients that could benefit and so we you know we press forward.

The fact that so many of these practices are limited in terms of their ability to see patients and person.

Eric S. Benevich: The fact that so many of these practices are limited in terms of their ability to see patients in person does hamper the initial trial and adoption of Ongentis, but it's not unexpected. And certainly, you know, we recognize that it would be challenging to introduce Ongentis in this environment.

And does hamper the.

The initial trial and adoption of on <unk>, but it's not unexpected and certainly we recognize that it would be challenging to introduce on Genesis and in this environment. The feedback that we're getting from from neurologists and from Parkinsons specialist is very favorable.

Eric S. Benevich: The feedback that we're getting from neurologists and from Parkinson's specialists is very favorable. They, you know, the feedback that I'm hearing is that they really are pleased with the convenience of the once daily dosing. In many instances, the efficacy is stronger than what they might have expected.

They you know the feedback that I'm hearing is that they really.

Are pleased with the convenience with the once daily dosing.

And in many instances the efficacy of stronger than what they might have expected.

And certainly you know we continue to see steady growth week from weak in terms of the number of new patient starts.

Eric S. Benevich: And certainly, you know, we continue to see steady growth week from week in terms of the number of new patients starting. Importantly for us, Ongentis also creates an opportunity for us to get additional time with neurologists for Ingresa and PD. And so we're leveraging both products when we are in front of neurologists.

Accordingly for us on Genesis also creates an opportunity.

For us to get additional <unk>.

<unk> withdrawal largest for in Gaza, and PD and <unk>.

So we're leveraging on both products when we are in front of neurologists.

So.

We're now two quarters into the launch and.

Eric S. Benevich: So... We're now two quarters into the launch, and as with all new branded products, they don't have coverage from a payer perspective when you launch. So our payer team has been very busy presenting on GenTest to the various Medicare and commercial, and Medicaid formulary committees. From a Medicare perspective, we launched right after the bid cycle, and so for 2021. So effectively, the expectation is that you would see GenTest added to Medicare formularies in 2022.

And as with all new branded products and they don't have coverage from a payer perspective, when you watch so our payer team has been very busy and presenting on gen tests for the various Medicare and commercial and Medicaid formulary committees.

For my Medicare perspective.

We launched a right after the bid cycle and so on.

For 2021, so effectively.

The expectation is that you would see on Genesis added to Medicare Formularies, and 2022 for commercial and for Medicaid that would occur throughout the.

Eric S. Benevich: For commercial and for Medicaid, that would occur throughout the year of 2021. So near term, you know, we're continuing to help our customers in terms of securing approval for those prescriptions through the formulary exceptions process. And then as we move through the year and into next year, we'll see what that pattern looks like for coverage from especially a Medicare perspective.

The year of 2021.

Near term, we're continuing to help our customers in terms of securing approval for those prescriptions through the formulary exceptions process and then as we move through the year and into next year, we will see.

What that pattern looks like for coverage from especially of Medicare perspective, I really have anything to add.

And what I've just that is just the echo what Eric said in terms of for all Medical Affairs organization out and the field Sydney as we've engaged with neurologists surround the first set of experiences with on Gen tests, and we are hearing and.

Eiry W. Roberts: Eiry, do you have anything to add? Yeah, what I would just add is just to echo what you said.

Feedback consistent with what we might have anticipated from what we've learned from B, all and Europe when.

Eiry W. Roberts: Yeah, what I would just add is just to echo what Eric said in terms of, for our medical affairs organization out in the field, certainly as we've engaged with neurologists around their first set of experiences with Ongentis, we are hearing feedback consistent with what we might have anticipated from what we'd learned from Bial in Europe when Ongentis was launched there, that the efficacy profile that clinicians are experiencing for their patients.

And on Genesis was launched and that the and the efficacy profile of that that clinicians are experiencing for their patience and tends to be and.

Maybe the better than was experienced in the clinical trial, setting and and the the in terms of Tolerability that day that the patient experiences and defaulting and are in a reasonable way and and.

Regardless of also have a trial that we have ongoing now to generate real world data and evidence for patients within the United States and receiving on Gen. Two so that's called the up the on study and it's currently enrolling on the enrollment and that program is going very well, which I think it also reflects the interest and and for patient Central finished.

Operator: Next to Paul Choi with Goldman Sachs. Please go ahead.

Operator: Please go ahead. Hi everyone, this is Charlie on behalf of Paul.

Operator: Thank you so much for taking our questions. Just a quick one from us going back to NBI 104. You say enrollment is progressing; we were just wondering how that enrollment is progressing, what rates you are seeing currently, and when we might be able to see some pediatric epilepsy data from that study in 104. Thank you. Yes, so that study is ongoing. We have centers open in the United States and a couple of centers in Europe as well.

And the experience with the medication.

The next to Paul Choi with Goldman Sachs. Please go ahead.

Hi, everyone and this is Charlie on for Paul. Thank you. So much for taking our questions. Just a quick one from us going back to MPI one of them for you say with the and enrollment progressing we were just wondering how that enrollment is progressing what rates are you seeing currently and when we might be able to see some pediatric epilepsy.

The data from that study of one of them for thank you.

Yes, so that cash study is ongoing and we.

Eiry W. Roberts: Yes, so that study is ongoing. We have centers open in the United States and a couple of centers in Europe as well. We expect data from that study, which is a 24-patient study, would be available sometime next year. And as we continue to progress with that study, we can give updates as required.

<unk> centers open and the United States and a couple of centers in Europe, as well and we.

We have guided that the data from that study, which is the 24 patient study would be available sometime next year and as we continue to progress of that study, we can give updates as the as required.

Yeah.

Eiry W. Roberts: I think you cut out. I know we're moving to David if you're on. Hi, can you hear me?

Great. Thank you so much.

Yeah.

Yes.

Hello.

I think you cut out I know, we're we're moving to David if you're on.

Yeah.

Hi can you hear me.

Yeah, Hi.

Yes.

Operator: Yeah, hi. Okay, sorry about that. I didn't hear the operator.

Okay, sorry about that I didn't hear the operator.

[laughter], Okay, alright, well, alright, that's kind of and it wasn't made them.

Operator: Okay. All right. Well, all right. I thought it wasn't me then.

Well just real quick.

Operator: Okay, well, just real quick. Just looking at the trajectory of Ingressa, and then just looking at the trajectory of Tevez-Ostetto, it kind of struck me that, you know, it seems, just looking at the volume trajectory, that Ingressa has struggled a little more amid the pandemic compared to Ostetto. It's not lost on me that Ostetto, of course, is approved in Huntington's Chorea. But, you know, is there an explanation for that?

Just looking at the trajectory of and grass.

And then just looking at the trajectory of tethers the sterno.

And kind of struck me that you know the.

It seems just looking at the volume trajectory of that and grasses and struggled a little more amid the pandemic compared to a set of it's not lost on me that instead of courses approved and Huntington's Korea, but.

Is there an explanation for that is it simply just the.

Sterno has huntington's and the label and the.

Kevin C. Gorman: Is it simply just that Ostetto has Huntington's in the label and Ingressa doesn't? Or is there another reason why it seems that, you know, Ingressa has seemed to struggle more over the past year, whereas Ostetto perhaps hasn't? I would say that there is the dynamic that they do have the Huntington's indication.

Congrats on it doesn't or is there another reason why it seems that and <unk>.

RSO has seem to struggle more over the past year, whereas perhaps hasn't.

Okay.

I would say that there is of the dynamics that they do have the they do have the.

Huntington's indications.

What also I would I would state is that neurologists came back into the office seeing patients full time.

Kevin C. Gorman: What also I would state is that neurologists came back into the office seeing patients full-time actually a while ago, so there are better than 90% of the patients' visits in the neurology office are in person. And as we talked about, that's not been the case with the psychiatrists. So, you know, basically, I think that may account for the differences that we've seen during the pandemic.

Actually a while ago.

So theres better than 90% of the patients and assets and the neurology offices.

Our in person the.

And as we talked about that's not been the case with the psychiatrist so.

Basically I think that May account for the difference is that that we've seen during the pandemic, we've always been and the market leader, we continue to be and the market leader and.

Kevin C. Gorman: We've always been the market leader. We continue to be the market leader, and everything that we do here is to retain that dominant position.

Everything that we do here is to retain that dominant position.

Operator: Sessions from Mark Goodman with SVB. Yeah, hi, Matt, can you give us a sense of how we should be thinking about net price products for the full year? Obviously, there's a big step up, and in the core.

And from Marc Goodman with SBB Leerink. Please go ahead.

Yeah, Hi, Matt can you give us a sense of how we should be thinking about net.

Price per Rx for the full year, obviously, it was a big step up and.

And in the quarter, but and.

And I don't know, Kevin maybe just some kind of nearing the end of the call here can you talk about and you look auto a little bit and whether you are just comfortable with.

Operator: But and I don't know, Kevin, maybe just since I'm kind of nearing the end of the call here, can you talk about Eli Golitz a little bit and whether you're just comfortable with everything that AbbVie's doing and what's going on there? It just seems like that product's not really doing much. Thank you. Yeah, I'll take the first one.

Everything that Abbvie is doing and and what's going on there. It just seems like that product is not not really doing much. Thank you.

The I'll take the first one.

The the last question first is that I think that we all have expected and we continue to expect to see much better performance out of out of <unk> for the indications now and the two indications that it's approved for.

Kevin C. Gorman: The last question first is that, I think that we all have expected and we continue to expect to see much better performance out of Elegolics for the indications now, the two indications that it's proven for. But it has been taking longer than any of us would have thought for that to start picking up. It is completely in AbbVie's hands, and they continue to invest in it. We're just, unfortunately, much like you; we're waiting to see what happens with that drug.

That has been taking longer than what any of us would of thought for that too to start picking up.

It is completely and Abbvie has hands.

They continue to invest and it we're just unfortunately much like you we're waiting to see what happens.

With that drug I do have to say that it is addressing two very important.

Kevin C. Gorman: I do have to say that it addresses two very important disorders, endometriosis and uterine fibroids. And I do have to say that we still have a lot of faith in that drug. It is a very good medication.

Orders and.

And then to be Treehouses, and uterine fibroids and I do have to say that we still have a lot of belief and that drug and it's a very good medication.

Matt Yeah on the net revenue per T. Rx, what I would expect is something like I said earlier similar to last year last year was around 5600, I would expect this year would shake out around call. It 5500, 5600, so somewhere in the 55 hundreds of.

Matthew C. Abernethy: Matt. Yeah, on the net revenue per TRX, what I would expect is something like I said earlier, similar to last year. Last year was around 5600. I would expect this year to shake out around call it 5500 to 5600. So somewhere in the 5500, our range is what we would be anticipating right now based upon what we saw in the quarter as well as contracts that we have with payers in place. Anisha with Guggenheim.

The range is what we would be anticipating right now based upon what we saw on the quarter as well as contracts that we have with payers and.

And place.

Operator: Gook in time, please go ahead.

Chin from teens nature with Guggenheim. Please go ahead.

Operator: Hi, everyone. This is Evan Taddeo on behalf of Yatin.

Hi, everyone. This is ebb and patio on for you and congrats on the quarter and thanks for taking our question.

Operator: Congratulations on the quarter and thanks for taking our questions. If you get positive data in the Coria in Huntington study, would this be enough to support filing? And what else, if anything, would you need from this program to file?

If you get positive data and the Korea and Huntington study.

Would this be enough to support filing and what else if anything would you need from this program to file.

Eiry W. Roberts: Thanks. Thanks, it's Irie here. So,

Thanks, Ivy Hill. So our goal is to complete the study and read out the results and to your point if positive and if were successful that we plan to go forward to the agency with the supplemental NDA submission for Huntington and Korea and.

Eiry W. Roberts: Thanks, it's Eiry here. So our goal is to complete this study and read out the results, and to your point, if positive and if we're successful there, we plan to go forward to the agency with the supplemental NDA submission for Huntington's career. In addition, we do have an open label, longer-term tolerability study ongoing in parallel, which would, and additional safety information would be added to the agency.

And in addition, we do have and open label are low.

On the term Tolerability study ongoing in parallel which would adopt additional safety information with the added to the package.

Operator: Operator, this is a question from Laura Chico with Wetbush Securities. Please go ahead.

And from Laura Chico with Wedbush Securities. Please go ahead.

Thanks, very much for taking the question I just wanted to follow up I don't think I heard the south but what is the typical duration for folks on treatment now I guess relative to what it was pre pandemic. It sounded like there were a lot of efforts made to keep folks on therapy. During this quarter and then <unk>.

Operator: Thanks very much for taking the question. I just wanted to follow up. I don't think I heard this asked, but what is the typical duration for folks on treatment now relative to what it was pre-pandemic? It sounded like there were a lot of efforts made to keep folks on therapy during this quarter. And then you've kind of answered this question a little bit throughout the call, but I just wanted to maybe more explicitly ask, what gives you confidence in the size of the addressable TD market as it stands now? Thanks very much. So, I'll take a first crack at it.

You've kind of answered this question a little bit throughout the call, but I just wanted to maybe more explicitly ask what gives you confidence and the size of the addressable TV market and as it stands now thanks very much.

So I'll take a first crack at this.

Laura then and then Eric can chime in the.

Kevin C. Gorman: So I'll take a first crack at this, Laura, then Eric can chime in. Then, we have always seen great persistence and adherence to our drug. Back when we launched it, we looked at these patients and the psychiatric patients and set up all the medications they're on. What's the average duration that they're on? And I'll use a rough shorthand that they would take them about 50% to 60% of the time.

We have always seen.

Great persistence and adherence to our drug.

Back when we launched it.

We had looked at these patients and.

The psychiatric patients and set up all of the medications there on what's the average duration.

And I'll use of rough shorthand that they would take them about 50% to 60% of the time, so that means and a six.

Kevin C. Gorman: So that means six to a little over seven months out of the year, they're on their medications. And that doesn't mean just their antidepressants, anxiolytics, antipsychotics, not just their mental health meds but all of their meds, whether it be diabetes meds, cardiovascular meds, or whatnot. In our clinical trials, these patients were on an average of seven daily medications. So, we didn't expect Ingresa to perform any better than that.

And a little over seven months out of the year there on their medications and that doesn't mean, just their antidepressant anxiolytic antipsychotic and not just their mental health.

Net but all of their meds.

Other it would be diabetes, meds, cardiovascular meds or whatnot these and our clinical trials. The these patients were on an average of seven daily medications.

So we didn't expect and aggressive perform any better than that we just thought this was a feature of this patient population.

Kevin C. Gorman: We just thought this was a feature of this patient population. However, we were very pleased to see that the adherence and persistence of patients right from the get-go were much, much better than that. I would say that probably for the first two years of our launch, I said this wasn't going to work, maybe just the fact that it's a new drug and there are so few new drugs that are introduced into this patient population.

However, we were very pleased to see that.

And the adherence and persistence of patients right from the get go was much much better than that.

I would say that probably for the first two years of our launch I said this this isn't going to last.

It is maybe just the the.

The fact that it's a new drug and there's still a few new drugs that are introduced into this patient population.

But then after years three and years for where it has continued and like that it truly is the fact that.

Kevin C. Gorman: But then after years three and years four where it has continued like that, it truly is the fact that this is a very simple drug for a very complicated set of patients. And I think that's very much appreciated by the patients and their caregivers, and the physicians and the other advanced practice practitioners. Yes, there was a blip in Q2 of last year just as the pandemic hit, just as our sales force had to go totally virtual, and as we had discussed in previous calls.

This is the.

This is a very simple drug for a very complicated set.

Set of patients and I think thats very much appreciated.

By the patients and their caregivers and the and the physicians and and the other.

Advanced practice.

The practitioners.

No.

Yes, there was a there was a blip in Q2 of last year, just as the pandemic hit just as we put on our sales force had the had to go totally virtual and.

And as we had discussed in previous calls. They then did the only thing that they could do at that moment in time is make sure that the patients who are on drug and that continuity of care state and they did an excellent job of.

Kevin C. Gorman: They did the only thing that they could at that moment in time to make sure that the patients who were on the drug, continuity of care stayed, and they did an excellent job of that.

That so we did even above and extremely high baseline of persistence inherent saw a bit of and increase there.

Kevin C. Gorman: So we did, even above an extremely high baseline of persistence here, it saw a bit of an increase there. That increase, I said, was not sustainable because our efforts had to go back into generating new patients for the drug. And so we saw that go back to what the very high historical norm was in Q3 and Q4. Q1 was a completely different situation.

That increase I said is not sustainable because our our efforts had to go back into.

On generating new patients to.

Two of the drug and so we saw that go back to what the very high historical norm was.

In Q3 and Q4.

Q1 was the completely different situation you did have an interruption and the number of refills.

Eric S. Benevich: You did have an interruption in the number of refills there, so it took longer than what it normally takes. But there's no reason for us to believe that now, and as we've said, we exited with more patients on Ingresen than we exited Q4 on. So there's no reason to expect that we're not going to continue with that extremely high rate of adherence and persistence. Yeah, I'll tackle the second part of your question. But I do want to add to Kevin's comment here, really two things.

It just took longer than what it normally takes but there's no reason for us to believe that that now and as we've said, we exited with more patients on and graduate and then what we exited Q4 on so there's no reason to expect that we're not going to continue with that.

Extremely high rate of of it.

Parents and persistence.

Yes, I'll tackle the second part of your question, but I do want to tack on to Kevin's comment here of really two things one.

The persistence numbers that we saw on Q1 were consistent with what we'd seen in prior quarters and remain very high.

Eric S. Benevich: One, the persistence numbers that we saw in Q1 were consistent with what we'd seen in prior quarters and remain very high. And one other thing that we've looked at is we've tracked the persistence of various cohorts of patients really from the very beginning of the launch. And so looking at patients that might have started in 2018 versus patients that started in 2019, we haven't seen any meaningful differences in terms of the expected duration of treatment, and that continues really all the way to the present.

And one of the thing that we've looked at is.

We've tracked the persistence of various cohorts of patients believed from the very beginning of the launch and so looking at patients that might have started in 2018 versus patients that started in 2019 haven't seen any meaningful differences in terms of the expected duration of treatment and.

And that continues really all the way to the present in terms of what gives us confidence around the market size.

Eric S. Benevich: In terms of what gives us confidence around the market size, you might have heard me mention, you know, that we're currently estimating that the TD market is around 600,000 patients. How do we get to that number? Well, there are a number of different things.

You might have heard me mentioned that we're estimating currently that the TV market is around 600000 prevalent patients.

How do we get to that number.

Well, there's a number of different things certainly we continue to look at the various prevalence publications in the peer reviewed literature that all point towards numbers and that range or even higher.

Eric S. Benevich: Certainly, we continue to look at the various prevalence publications in the peer-reviewed literature that all point to numbers in that range or even higher. Additionally, we continue to do market research with healthcare providers. And importantly, we're seeing an increasing trend in terms of the number of TD patients they think they have in their practice. We look at claims databases, and we're certainly seeing an uptrend in terms of the claims related to TD treatment. And really, what's the underlying driver here?

We continue to do market research with health care providers and importantly.

We're seeing an increasing trend in terms of the number of TD patients. They think they have and their practices.

We look at claims databases, and we're certainly seeing an uptrend in terms of the claims related to TD treatment.

And <unk>.

And really what's the underlying driver here and there continues to be and increased use of Ana psychotics.

Kevin C. Gorman: There continues to be an increased use of antipsychotics, which are associated with causing TD. So these are all indicators for us that give us confidence that the size of the prevalent population is at least as big as we think it is. And importantly, for us... Our near-term focus remains to drive recognition and diagnosis and bridge the gap between the diagnosed population and the TD treated population. The Prevalent Population, and as Kevin mentioned... Of those that are diagnosed today, only about half even get offered a VMAT-2 inhibitor, so there's a lot of upside potential for us to not only improve diagnosis but to improve the rate of people that are treated for their TD, and that's really the core part of our mission.

Associated with the causing T D.

And so these are all.

You know indicators for us that give us confidence that the size.

Size of the prevalent population is at least as big as we think it is and importantly, you know for.

For us our near term focus and it remains to drive.

The recognition and diagnosis and bridge the gap between the diagnosed population and the TD treated population.

Excuse me the prevalent population and as Kevin mentioned.

Of those that are diagnosed today only about half even get offered of the mat two inhibitor. So theres a lot of upside potential for us.

To not only improve diagnosis, but to improve the rate of people that are treated for.

For their TD and that's really the core part of our mission.

Yeah.

Yeah.

So that brings us to the end of.

Of our call.

I think what you what you've heard this afternoon.

Kevin C. Gorman: So that brings us to the end of our call. I think what you've heard this afternoon is the fact that we have a total belief, and it's based in data, that we have a growing market here, that we have a patient population needlessly suffering. Probably 80%, at least, of TD patients are needlessly suffering.

Is the fact that we have a.

Total belief and it's based in data that we have.

We are growing.

The market here that we have a patient population that is.

Needlessly suffering probably 80% at least of TD patients are needlessly suffering so that is where our mission lives that is what we're going to work on and we are using every avenue.

Kevin C. Gorman: So that is where our mission lies. That is what we're going to work on. And we're using every avenue that we have at our disposal in order to do that. You've seen a lot of the efforts that we put in place over the last four years. You've seen us treat, take this marketplace physicians four years ago denied that even TD existed. Now there are a great number of TD patients that are on treatment and being helped in every aspect of their lives.

We have at our disposal in order to do that you've seen a lot of that efforts that we put in place over the last for years, you've seen us treat takes us marketplace from something that.

On.

Physicians for years ago denied that even TD <unk>.

Existed.

And now.

And there are.

Right number of TD patients that are on on treatment and being helped and every aspect of their life that is going to continue and that will only grow.

Kevin C. Gorman: That is going to continue, and that will only grow over time. And that's what we're dedicated to. And we're going to keep going with that. So with that, I would like to thank you all for your attention today. And we look forward to talking to you in the near future.

Over time, and that's what we're dedicated to and we're going to keep going with that so with that I would like to thank you all for your attention today and we look forward to talking to you.

In the near future.

Okay.

Operator: This concludes today's program. Thank you for your participation.

And today's program. Thank you for your participation you may disconnect at any time.

[music].

And.

Yeah.

Okay.

[music].

Operator: Thank you for your participation. You may disconnect at any time.

Operator: [inaudible] [inaudible]