Q3 2020 Neurocrine Biosciences Inc Earnings Call

Sorry, yeah.

[music].

At this time all participants are in a listen only mode. Later, you will have an opportunity to ask questions. During the question and answer session. You may registered to ask a question at any time by pressing the star and one on your Touchtone phone. Please note. This call maybe recorded I'll be standing by should you need it.

That's it is now my pleasure to turn today's program over to Todd is to Schloss Vice President of Investor Relations. Please go ahead [noise] great. Thanks, Jamie.

And then everyone and thank you for joining our third quarter 2020 earnings call.

With me on the call is Kevin Gorman, our Chief Executive Officer, Matt Abernathy, Our Chief Financial Officer, I read Roberts, our Chief Medical Officer, Eric Deleverage, our Chief commercial officer, and Carl gain our chief business development and strategy Officer.

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

Kurt you to review the risk factors discussed in our latest FCC filings so.

Following our prepared remarks, we will open the call up for questions and ask that you. Please limit yourself to one question to give as many people as possible opportunity to participate with that I now turn the call over to Kevin Gorman. Thanks, Todd Good afternoon, everyone and thank you for joining US today, Matt Erika I read and I will be keeping our prepared remarks short to allow for the majority of the time for your questions.

Yes.

You saw from our press release this past quarter, we experienced a fairly significant impact from the pandemic on our business.

Psychiatry practices are more heavily influenced by co, but then and then other specialties.

In Q3, approximately 40% of psychiatry office since we're not seeing patients in person and as you know the majority of our call pattern has been to psychiatrist.

This is a temporary situation and the medium and long term outlook for in grassy is as robust as ever if not more so.

Now importantly, and grocers returning to its previous growth pattern is not solely dependent on the resolution of coated we're investing in the development of new techniques to assist psychiatrists in making the identification and diagnosis of TD via telemedicine and this will ultimately grows the TD market.

No late in Q3, we launched on Gentris as an adjunct of treatment in Parkinson's disease.

This is given our sales force enhance time in the movement disorder neurologists offices at the very end of Q3 and into Q4 neurologists have shown a great interest in Ontario and in addition during these office visits they learn more about ingress as attractive profile treating Pee dee.

Now as we sit here today, we are encouraged by the growth of new patient starts on and grass when we exited Q3 and the first several weeks of Q4.

However.

Our enthusiasm I think you'll agree is justifiably tempered with the rapid rise of coated nationwide depend.

Depending on the severity of covert this winter Q4 underlying sales could look similar to Q3 due to the disproportionate impact of the pandemic house on psychiatrists behavior.

We are meeting these short term challenges and we will see restored growth I am sorry.

Bottom line, the fundamentals are sound and grass. It makes a profound change in TD separate lives and the vast majority of TD sufferers are either not diagnosed are not yet being treated appropriately the opportunity in front of us remains tremendous and we are steadfastly committed to serving all TD sufferers with.

That I would like to turn the call over to Matt. Thanks.

Thanks, Kevin Good afternoon, everyone I'll keep my comments brief and not run rate all the financial information included in our earnings release to allow more time for Q1 day.

Grasses sales in the third quarter were $254 million and $248 million on an inventory adjusted basis.

This compares the inventory adjusted sales of $256 million in the second quarter.

The sequential.

Decline was driven by two items first.

First we saw a slight decline in refill rates, but the rate still remains very strong at the higher end of historical norms second new prescription slightly increase versus Q2, but continues to lag beyond Creek co bid levels, primarily due to the fact that around 40% of patient visits with psychiatrists are still being.

Doug did virtually we continue to adapt our business model to account for both in person and telemedicine business, but believed that diagnosis of TD is best done in person.

We see the slow down in growth is temporary cobalt has a clear impact on the development of the TV market, but we continue to see very high rates of compliance with their existing patients which is encouraging.

In addition, recent interacts trends have been improving but we acknowledge we're not out of the woods yet given the pandemics recent resurgence we remain excited about the medium and long term potential of INGREZZA and we'll continue to adapt in the current environment.

On the expense front, we've narrowed our 2020 expense guidance range note that we expect our investment in R&D to expand in 2021 to support our growing mid to late stage pipeline in closing within Brazil or pipeline and strong balance sheet, we remain very optimistic about our future.

We continue to build a leading neuro science company.

With that I will hand, the call over to air candidates.

Mark.

Thanks, Matt.

I'm pleased to provide an update on our Q3 commercial performance and I'll start off by saying that I'm proud of our team's continued dedication to putting diagnosis and treatment rates for patients living with tardive dyskinesia.

Well the long term opportunity for INGREZZA is as compelling as it has ever been we're adapting and executing well given the near term challenges brought on by the pandemic.

And Greg there's value to patients was evident with Q3 persistence and adherence rates for existing patients in line with the very strong historical rates, we've come to expect from INGREZZA.

As it relates to new patients in the very near term the start stop nature of the pandemic, we'll continue to have an impact on and Rx growth across the biopharmaceutical sector in general and psychiatry in particular.

The steady rate of interacts demand we saw in Q2 continued to Q3.

Although access to health care provider customers in Q3 remained challenging relative to their pre pandemic period or.

Our team continues to make progress with call volume steadily ramping up in a split of about 50 50 between in person versus virtual sales calls.

And as Matt mentioned, we have seen positive recent trends for INGREZZA, which coincided with increased customer call volume and promotional activity.

Looking ahead as we've noted before nothing can truly replace it in office face to face interaction between the health care provider in a patient.

Especially as it relates to diagnosing a movement disorder like tardive dyskinesia.

During the early months of the pandemic the top priority of providers, who is rightfully on addressing patients acute mental health needs.

Such as increase things I'd or worsening of their depressive symptoms.

And in accordance with shelter in place mandates many psychiatry practices significantly limited in person access to patients.

Or shut down entirely.

It was unclear when patients would be comfortable were even allowed to physically see a physician or an allied health professional again.

Office or clinic setting.

While trends for psychiatric outpatient in person visits are improving they weren't they are nowhere near pre pandemic levels just yet.

Syndicated data indicates that total psychiatry visits inclusive of both in person and Tele health risk.

Remained decreased by about 15% to 20% versus the pre pandemic baseline.

At the same time psychiatry, so I've been among the slowest specialties to physically returned to working in a clinic or private practice setting in part due to the adoption of telemedicine.

In fact, as Matt said earlier syndicated data show that as of October approximately 40% of all psychiatry patient visits are still conducted via telehealth.

First is about 6% across all physician specialties.

As mentioned before a tele health creates unique challenges to the diagnosis of the movement disorder, such as TD.

In addition, third party data indicate that psychiatrists are about 40% less likely to initiate new to brand prescriptions during a tele health versus an in person visits.

So the combined dynamic of lower total patient visits and a high proportion of telehealth visits in psychiatry has created a unique near term challenge for our team, which we are navigating well.

There is no doubt that tele medicine is here to stay especially in psychiatry at Neurocrine. We were in advanced of we're investing in virtual health care.

Capabilities, even before the onset of the pandemic.

And we're building what we believe will be a source of competitive advantage for us over the longer term.

While the pandemic has created many transient challenges one thing. It has done is highlight the importance of mental health today, we believe the vast majority around 80% or more patients with tardive dyskinesia remain undiagnosed.

Furthermore, the use of anti psychotic medication associated with TD incidents only continue to rise.

Well, we've made great progress over the last several years of INGREZZA. The fact remains that we still have a tremendous opportunity ahead to help even more patients.

And as the economy improves over time, we will continue to focus on T.D. educational efforts with physicians Allied healthcare professionals patients and care partners. While also investing in new techniques to accelerate diagnosis and treatment rates for the many patients who still need our help across all sites of care and visit types. This is our firm.

[music].

So switching gears dawn Gentris I can provide some qualitative insights now that we are several weeks into our lunch.

Recall that on Genesis launched in late Q3, as an add on adjunct of treatment for patients experiencing off episodes with Parkinson's disease.

In mid September we conducted a highly successful virtual launch training meeting for our field teams and we're very excited to bring this new treatment option to patients with Parkinson's.

Our early efforts are focused on physician and patient education, highlighting that on Genesis is a promising new treatment option that can help optimize leave it up between.

This is a differentiated C O M T or comps inhibitor that offers a convenient once daily dosing strong efficacy and is well tolerated.

As mentioned, we are still very early in the launch process. The receptivity from neurologists has been positive thus far.

We are seeing strong share of voice and utilization of our agenda sampling program, which is providing important product experience for both neurologists and patience <unk>.

In conjunction with the launch Weve been pleased with our improved access to neurology movement disorder practices.

We're seeing that the launch and says this helped drive higher neurology call volume for INGREZZA, which we expect to benefit our efforts and TD.

So heading into year end, we will continue to introduce on Genesis of the Parkinson's community and execute and execute against our launch plan.

Aspiration is not only to displace current comped inhibitors, but also to be prescribed earlier and earlier in the treatment paradigm head of alternative adjunct of treatments from other devices.

In summary, our team continues to do an excellent job is to manage ended up through the many near term challenges brought on by the pandemic.

One thing that hasn't changed is that we remain steadfast in our commitment to deliver on the long term potential of both INGREZZA and on Genesis.

I remain highly optimistic about our prospects.

Now I'll turn call over to my colleague I read Roberts, who will provide an update on our progress with the pipe.

Yeah.

Thank you, Eric and good afternoon to everyone.

If I can find enough data on our clinical programs.

I want to thank bounced off at Neurocrine and across all our partnership organization.

Commitments in advancing many bdcs and development programs, especially in light of the pandemic.

Conducting studies in a safe and effective names our top priority.

I was just trying to make it all this we continue to respond to adopt our approach and processes to ensure that we can safely progress our pipeline and deliver on the commitments to relieve patient suffering and enhanced lives.

I'll now provide a pipeline update beginning with the very good news in Q3 of the initiation of the catalyst study a single global Registrational study of Knesset bond for adults with the classic form of congenital adrenal hyperplasia, Oh C. H recall, we gained critical.

Alignment on the design of the single Registrational study design from the F.D.A.M. <unk> patient advocacy groups.

Opinion leaders and pay us.

We are currently deep into the initiation of the study globally I look forward to providing additional updates as the trial advances.

In addition, the phase two proof of concept pediatric study with current Estefan is back up and running off to our brief pause earlier this year due to COVID-19 and we.

We're making good progress towards the initiation of a single global registration study in pediatric patients in 2021.

It's about fantasy.

The connect H D.

Three registration study run in collaboration with the Huntington study group to assess Valbenazine special treat men. So Korea in patients with Huntington's disease, as we initiated enrollment and is progressing well.

For our Parkinson's disease genes Saturday probe ground and be I'd be.

1817.

Obtained through our collaboration with Voyager Therapeutics I list.

Earlier this month the data safety monitoring board for the restore one phase two clinical trial met and reviewed certain patient imaging data from the ongoing study.

Following this review the DSMB be requested additional patient level data and recommended a pause in dosing of patients in restore one pending review by the D.S.M.B. of these additional data.

Oh that was a de SMB informed us that patient screening for risk Dole one could continue.

Given that trial sites participating in this study are not currently screening and enrolling patients in response to COVID-19 times Dentek, we have elected to delay the planned reception of patient screening in the restore one study until the D. S. M. B is able to complete its evaluation.

This will likely occur towards year end.

Additionally, in accordance with Ft, a safety reporting requirements. We are also preparing a single expedited I N D safety report.

Turning now to N.B.I.H., two seven 104 or one no full for short the potent and highly selective Ti type calcium channel antagonist license from I. dose yet earlier this year I am pleased to announce that we are currently initiating a phase two study.

In a rare pediatric epileptic encephalopathy colds continuous spike and wave during sleep all she SWS.

She asked every west typically impacts children initially between the ages of two and four years old and manifest itself by a variety of <unk> tight.

Including atypical absolute seizures generalized tonic clonic seizures and focal seizures, so usually it though during sleep.

In addition children with C. S. W. S often present with cognitive behavioral on developmental regression or delay.

Due to the differentiated mechanism of action of this molecule when compared to non selective calcium channel inhibitors.

Treatment with one a full could lead to an enhanced benefit risk profile for patients with this rare pediatric form of epilepsy.

In addition, one of four has the potential to expand into a range of other central nervous disease areas.

We are currently working in preparation for studies in several of these areas I will provide an update on additional indications as they progress in the clinic.

Finally, and very importantly, I said included as part of our collaboration with Takeda are making good progress the lead clinical asset NB <unk> 10658, fulfil formally known as top 831 is progressing very well towards completion.

The phase two study to assess the efficacy and safety of eight full fall as a treatment for negative symptoms of schizophrenia.

We anticipate sharing results from this study in the middle of next year.

I'm proud of the progress we've made across research and development at Neurocrine as we stay laser focused on building a diverse pipeline across multiple disease states patient populations on phases of clinical development.

This pipeline has the potential to address significant unmet clinical needs that remain worldwide for patients in the fields of neurology numerous psychiatry and your endocrinology.

We continue to adapt and respond to the many twists and turns brought on by the pandemic with a primary focus at all times on ensuring the safety of our trial subjects on the effective advancement of the pipeline.

With that I'll hand back to you Kevin Kevin Thank.

Thank you very much I agree I think that does it for our prepared remarks, so what we'd like to do is use the rest of our time for your questions.

[noise] at this time, if you would like to ask a question. Please press Star then one on your Touchtone phone.

You may remove yourself from the queue at any time by pressing the pound key.

Again that is star one ask a question.

<unk> for a moment to lots of questions to queue.

We will take our first question from Josh Schimmer from Evercore.

Your line is open.

Thanks, So much I had a question on a couple of potential headwinds for a <unk>.

Excellent social distancing and face masks and they'd get motivating factor from patients sequel.

Equal treatment I'm trying to just get scared because their disease, maybe less noticeable salt and you had another quarter of inventory build when do you expect this might reverse and to what extent.

Hey, Josh good to hear from you.

I don't think we would chalk up a patient sphere associated with the return to a two and in person patient visits you know.

I think just the ease of using tell them medicine. During this pandemic to help many patients with a mental health disorders has become very convenient. So I think because they had been utilizing until a medicine prior to the pandemic. It was a much easier.

In addition, there there's clearly a concern or.

By anyone about the safety of going into offices, but I don't think that that would be chalked up is as the primary on the inventory front you know, it's really difficult to predict its something that we intentionally do not manage to Wade upticks of channel stuffing. It over the last four quarters alone I believe we've had over a 30.

Million dollar build in inventory in this quarter. Once again, we had to build of another 6 million. So.

At some point my expectation is that should and will lead back down so hard to predict how much and when so well continue to disclose inventory adjusted sales to take out that done.

Dynamic to give you guys a view as to underlying demand and a we'll we'll keep you posted but that is something you know hard.

The model would encourage you guys to think.

Think about measuring us on an inventory adjusted base says.

Okay can I just clarify the question I wasn't asking so much about patients nervous about going to the Doctor I was wondering because wearing face masks and the contract with other people. So much they don't feel the need to have to return that's cool.

Under the same same control I, just got a social optics.

Yes, I I.

I do apologize.

For for misinterpreting, the the question, but no that's not no.

Not something that we see.

As as a big headwind at this point and Josh I would just say this is Kevin that would be hard for us to know it.

That that I I don't know how that we had communicated.

This session staff loved ones and then back up to us. So you bring up something that that is hypothetical but I I don't have a way to answer at this point in time.

Got it thanks.

Our next question comes from 'cause Iain Ahmad from Bank of America. Your line is open.

Hi, good afternoon.

[noise] I'm caught it sounds Kevin I'm, just wondering to get a little bit more color. So in threeq, you eat or you're up to 48.

Hi to 56, you came in at 30.

For Twoq you know in your press release, you did say that new prescription did increase slightly in the third quarter.

That resale and persistent moderated so I'm, assuming refilling persistence rates went went lower I'm wondering if you can give some color at that those two particular items refilled persisted even this condition.

How about looking so far in Q.

And as far as geography goes are there any other specific geographies, where more doctors offices.

Our sites are open.

Relative to other parts of the country.

Yes. So you know on the new patient front, we did have a slight increase during the third quarter and the comments about the recent I guess positive trends, we've been seeing what were really exiting Q3, and then in two into Q4, but still.

Below.

Pretty endemic level so I.

I think on the on the energy front, we are encouraged I mean, the rate of diagnose TB is greater than the reduction in person. Thank you for that and I think that's a that's a the.

The team doing a great job.

There.

You know for US what is encouraging though when we look back and we get asked the question. What is your long term belief why or why are you. So bullish over the long term.

No there's a lot of qualitative aspects.

Whether it's feedback from agents rubs doctors surveys et cetera, but a couple of quantitative measures would be exiting Q1 this year.

They are two co, but we were at a record all time interacts level per week and that was really really progressing well once called <unk>, we took a step down and we pretty much as we've said on the last two calls flatline from where that step down was and now we're seeing a little bit Oh.

Coverage and how to think about that in Q4 is as Kevin said in the wintertime.

And what we're seeing with the pandemic.

Surging a bid that you would potentially have some more incremental pressure on enterprise.

In Q4.

Two levels of persistency and compliance.

It has been very encouraging to see patients them medicine through the pandemic pursue.

Persistency rate remain extremely high and ER and then also the rates of refill are still.

At a level above historical norm, so what I would say for the quarter sequentially. You know there was this stuff down largely due to a drop in compliance, but the drop slight drop and it was a bigger number and.

Operator: and Good afternoon, everyone, and welcome to today's Neurocrine Biosciences Report third quarter 2020 results. At this time, all participants are in a listen-only mode. Later, you will have an opportunity to ask questions during the question and answer session. You may register to ask a question at any time by pressing the star and one on your touchtone phone. Please note, this call may be recorded. I'll be standing by should you need assistance.

All right.

So hope that answers your question to Dean and good to hear from you as always.

Our next question comes from Paul not test from Stifle Your line is open.

Hey, great. Thanks, so much for taking my questions.

I was wondering now maybe now given these challenges and given that you know consensus it seemed to kind of model.

Operator: It is now my pleasure to turn today's program over to Todd Tuchla, Vice President of Investor Relations. Please go ahead. Great. Thanks, Jamie. Good afternoon, everyone, and thank you for joining our third quarter 2020 earnings call. Joining me on the call is Kevin Gorman, our Chief Executive Officer, Matt Abernathy, our Chief Financial Officer, Irie Roberts, our Chief Medical Officer, Eric Benevich, our Chief Commercial Officer, and Kyle Gano, our Chief Business Development and Strategy Officer. During today's call, we'll be making forward-looking statements. These statements are subject to certain risks and uncertainties, and our actual results may differ materially.

Continued strong net adds have you guys we thought.

Whether or not it makes sense to give guidance youve been on a quarterly basis or maybe for for 2021, and then separately I was kind of curious if you could just comment on that price and where that's going it looks like gross to net went up this quarter is that a trend you expect to occur.

For Q 2021, so Paul on the on the question of guidance and some tailwinds.

There still are quite a few moving parts here and that is that then you know what are the primary reasons.

Todd Tuchla: I encourage you to review the risk factors discussed in our latest SEC filings. Following our prepared remarks, we will open the call up for questions and ask that you please limit yourself to one question to give as many people as possible an opportunity to participate. With that, I now turn the call over to Kevin Gorman. Thanks, Todd. Good afternoon, everyone.

Why we haven't given guidance given guidance up until now we continue to discuss it internally and with our board of directors and so we hear you on that.

Kevin C. Gorman: Thank you for joining us today. Matt, Eric, and I will be keeping our prepared remarks short to allow for the majority of the time for your questions. As you saw from our press release this past quarter, we experienced a fairly significant impact from the pandemic on our business. Psychiatric practices are more heavily influenced by COVID than other specialties.

As far as the second half of your question there the only thing to add to what Kevin said was I mean, this is probably Paul the farthest that we've done if you listen to Kevin's prepared remarks earlier we're.

We're not claiming victory here that we could have an underlying flat. This quarter is is what you had said and nuts.

Kevin C. Gorman: In Q3, approximately 40% of psychiatry offices were not seeing patients in person, and as you know, the majority of our call pattern has been to psychiatrists. This is a temporary situation, and the medium and long-term outlook for Ingrese is as robust as ever, if not more so. Importantly, Ingresser's return to his previous growth pattern is not solely dependent on the resolution of COVID. We are investing in the development of new techniques to assist psychiatrists in the identification and diagnosis of T.D. via telemedicine, and this will ultimately grow the T.D. market.

Not accounting for what could happen with inventories so.

I do think and wanted to make sure people heard heard.

Heard that and us trying to be a bit more specific as to what could have been a base.

Based upon what we're seeing out of Kobin.

The second question on gross to net yeah. There was a pullback in net revenue per script. This quarter. It was slightly declined I think around $100 and that was largely due to contracting that we had entered into for Serbs strong access.

So you know I think that that's been our mission all along is to ensure that it is in Graz as written that a patient will ultimately we.

Kevin C. Gorman: Now late in Q3, we launched Gentis as an adjunctive treatment for Parkinson's disease. This has given our sales force enhanced time in the Movement Disorder Neurologist offices at the very end of Q3 and into Q4. Neurologists have shown a great interest in Ongentis, and in addition, during these office visits, they learn more about Ingresa's attractive profile, Treating TD. Now, as we sit here today, we are encouraged by the growth of new patient starts on Ingressa when we exited Q3 and in the first several weeks of Q4. However, our enthusiasm, I think you'll agree, is justifiably tempered with the rapid rise of COVID nationwide. Depending on the severity of COVID this winter, Q4 underlying sales could look similar to Q3 due to the disproportionate impact that the pandemic has on psychiatrists' behavior. We are meeting these short-term challenges, and we will see restored growth, I am certain. Bottom line, the fundamentals are sound.

We get a good that script and we continue to be successful in that regard, but this quarter did have to do is contracting now as you think about contracting for 2021.

Not a ER there isn't anything that we would flag to you that would give us concern around that says no material change at least at this time based upon what we know to overall net revenue per script.

See it somewhere near where it's at today. So hopefully that's helpful. Thanks.

Yeah. It is right.

Maybe but the other question.

Okay. Our next question comes from.

Iran. A men from Jefferies. Your line is open.

Yeah, Hi, guys. Thanks for taking my question maybe on INGREZZA.

How much do you think that the current script trends or related to covert versus hitting a ceiling and the TV market.

Matthew C. Abernethy: Ingressa makes a profound change in TD sufferers' lives, and a vast majority of TD sufferers are either not diagnosed or not yet being treated appropriately. The opportunity in front of us remains tremendous, and we are steadfastly committed to serving all TD sufferers. With that, I would like to turn the call over to Matt. Thanks, Kevin. Good afternoon, everyone. I'll keep my comments brief and not reiterate all the financial information included in our earnings release to allow more time for Q&A. Ingressive sales in the third quarter were $254 million and $248 million on an inventory-adjusted basis, respectively.

And in Q2, I think you you would see that.

And refills, so I'm just trying to understand the slight moderation refills in Q3, given you had coated across both quarters.

Yeah, Baron a good to hear from you and I can say without equivocation.

That the what we're seeing now is 100% due to covance a there's no ceiling effect that we're seeing with the growth of this market.

Matthew C. Abernethy: This compares to inventory adjusted sales of $256 million in the second quarter. The sequential decline was driven by two items. First, we saw a slight decline in refill rates, but the rate still remains very strong and at the higher end of the historical norm. Second, new prescriptions slightly increased versus Q2, but continue to lag beyond pre-COVID levels primarily due to the fact that around 40% of patient visits with psychiatrists are still being conducted virtually. We continue to adapt our business model to account for both in-person and telemedicine visits but believe that diagnosis of TB is best done in person. We see the slowdown in growth as temporary.

And as far as the second part of your question Jan.

Yep.

On the refill front. If you recall Q1 is always low from a re fill rate per.

Patient because they're going through that reauthorization process. So Q2 was really a recovery from a.

From a from a lowered Q1 and then as you move from Q2 to Q3. It was a slight decline, but nothing notable well. So you know I would say INGREZZA <unk>.

82 co bid from a a new patient.

Patient perspective, but as it relates to comply to persist and see you know we've not seen any anything material that we would chalk up associated with Covance and you know to your point on the question and what Kevin said and I mentioned earlier.

Matthew C. Abernethy: COVID has had a clear impact on the development of the TD market, but we continue to see very high rates of compliance with our existing patients, which is encouraging. In addition, recent NRX trends have been improving, but we acknowledge we're not out of the woods yet given the pandemic's recent resurgence. We remain excited about the medium and long-term potential of Ingresa and will continue to adapt in the current environment.

Prior to co bid were at an all time high.

A better FX.

Per week, if we had seen that flattening or declining going into Covance. We maybe would you shouldn't you're not as optimistic but what we saw prior to co visiting them what were seeing recently as call activity has increased you know our enthusiasm remains incredibly great.

Great. Thanks for taking my questions.

Eric S. Benevich: On the expense front, we've narrowed our 2020 expense guidance range. Note that we expect our investment in R&D to expand in 2021 to support our growing mid- to late-stage pipeline. In closing, with Ingresa, our pipeline, and a strong balance sheet, we remain very optimistic about our future as we continue to build a leading neuroscience company. With that, I will hand the call over to Eir Benevich. Eir? Thanks

Our next question. Our next question comes from Phil Nadeau, do kind of Cowen and company. Your line is open.

[laughter]. Thanks for taking my question, one on aggressive and want to extend a pipeline. So first southern gross in the past you've suggested that we book towards things like increases and in person visits.

Psychiatrists as a leading indicator of when an Rx could return.

Eric S. Benevich: I'm pleased to provide an update on our Q3 commercial performance, and I'll start off by saying that I'm proud of our team's continued dedication to improving diagnosis and treatment rates for patients living with Tardive Dyskinesia. While the long-term opportunity for Ingresa is as compelling as it has ever been, we're adapting and executing well given the near-term challenges brought on by the pandemic. Ingresa's value to patients was evident with Q3 persistence and adherence rates for existing patients in line with the very strong historical rates we've come to expect from Ingresa. As it relates to new patients, in the very near term, the start-stop nature of the pandemic will continue to have an impact on NRX growth across the biopharmaceutical sector in general, and psychiatry in particular. The steady rate of NRX demand we saw in Q2 continued in Q3.

Today's call is just that.

Maybe there's more complication, it's more complicated than that what do you think we use external observers should be looking at to predict.

Turning to the growth in Brazil.

On the pipeline you called it the pause and restore could you give us a bit more information about what date. It was it did you say you saw that prompted the request. Thanks.

Hi, Phil It's Eric I'll take the first part your question. So you know I I mentioned in my prepared remarks that.

Nothing really is better than an in person visits between a patient in a provider.

Especially as it relates to diagnosing and movement disorder like TV.

And we are seeing that in person visits patient visits have increased they really were a bottoming out around the April may time period and had been creeping up its still in psychiatry about 20% lower than what they were in the pre pandemic period.

Eric S. Benevich: Although access to health care provider customers in Q3 remains challenging relative to the pre-pandemic period, our team continues to make progress with call volumes steadily ramping up and a split of about 50-50 between in-person versus virtual sales calls. And, as Matt mentioned, we have seen positive recent trends for Ingresa, which coincided with increased customer call volume and promotional activity. Looking ahead, as we've noted before, nothing can truly replace an in-office, face-to-face interaction between a healthcare provider and a patient, especially as it relates to diagnosing a movement disorder like Tardive Dyskinesia. During the early months of the pandemic, the top priority of providers was rightfully addressing patients' acute mental health needs, such as increased anxiety or worsening of their depressive symptoms. And in accordance with shelter-in-place mandates, many psychiatric practices significantly limited in-person access to patients or shut down entirely.

The other complicating factor is the is the prominence in the adoption of Tele medicine in psychiatry, which provides some challenges to making a a diagnosis of TD remotely so.

So you know those things are I'm going to be indicators that you need to kind of keep an eye on one is just I'm seeing foot traffic increase in psych private practices and site clinics.

That's a that's a strong indicator.

And secondly, our ability to continue educating providers on how to look for in screen for TD when conducting a remote patient because it'd be a tele health.

And so that's been an area of focus as we mentioned earlier tele health isn't going anywhere it's going to continue to be a prominent part of psychiatry going forward and we're working hard to make sure that providers are confident and comfortable in their ability.

Eric S. Benevich: It was unclear when patients would be comfortable or even allowed to physically see a physician or an allied health professional again in an office or clinic setting. While trends for psychiatric outpatient in-person visits are improving, they are nowhere near pre-pandemic levels just yet. syndicated data indicate that total psychiatric visits, inclusive of both in-person and telehealth, remain decreased by about 15 to 20 percent versus the pre-pan At the same time, psychiatrists have been among the slowest specialties to physically return to working in a clinic or private practice setting, in part due to the adoption of telemedicine. In fact, as Matt said earlier, syndicated data show that as of October, approximately 40% of all psychiatric patient visits are still conducted via telehealth, versus about 6% across all physician specialties. As mentioned before, telehealth creates unique challenges for the diagnosis of a movement disorder such as TD. In addition, third-party data indicate that psychiatrists are about 40% less likely to initiate new-to-brand prescriptions during a telehealth visit versus an in-person visit.

To to screen for in diagnose TD remotely.

So I'll I'll turn it over for the second half of your question diary.

Hi, Phil Thanks for the question. So couple of things first of all I blinded to all of the data on the restore one study as is all of the remainder of our management team and out the results I don't know anything to that.

The finding beyond what I was able to share with you what I will say, though just to reiterate was that the D. S. M. B, we're looking at CES and no imaging information scan data.

From a patient in the restore one study.

And based on that observation.

The question did April was the dosing attempt to quit subject not to oppose in screening or a halt to the study pending <unk> ability to access additional information.

<unk> dot and the decision to not be initiate screening at this time was actually taken by us and in parallel with that we also.

Eric S. Benevich: So the combined dynamic of lower total patient visits and a high proportion of telehealth visits in psychiatry has created a unique near-term challenge for our team, which we are navigating well. There is no doubt that telemedicine is here to stay, especially in psychiatry. At Neurocrine, we were investing in virtual health capabilities even before the onset of the pandemic, and we're building what we believe will be a source of competitive advantage for us over the longer term. While the pandemic has created many transient challenges, one thing it has done is highlight the importance of mental health. Today, we believe the vast majority, around 80% or more, of patients with tardive dyskinesia remain undiagnosed. Furthermore, the use of antipsychotic medication associated with TD incidents only continues to rise.

Filing it can go.

Safety report with the FDA. So that is all I know at this point in time and I'm not able to provide that information.

That's helpful. Thank you.

Okay.

Our next question comes from Brian Forney from Baird. Your line is open.

Hey, good morning.

Are you guys, taking my question I see anything called out specifically on <unk> and was just wondering I know you had previously said that you were planning on starting the Registrational study in the second half of 2020, I'm 20, Mexico.

Eric S. Benevich: While we've made great progress over the last several years within GRESA, the fact remains that we still have a tremendous opportunity ahead to help even more patients. And as the economy improves over time, we will continue to focus on TD educational efforts with physicians, allied healthcare professionals, patients, and care partners while also investing in new techniques to accelerate diagnosis and treatment rates for the many patients who still need our help across all sites of care and visit sites. This is our firm commitment. So switching gears to Ongentis, I can provide some qualitative insights now that we are several weeks into our launch. Recall that Ongentis launched in late Q3 as an add-on adjunctive treatment for patients experiencing off episodes with Parkinson's. In mid-September, we conducted a highly successful virtual launch training meeting for our field teams.

Is there any change times, it's not guidance, but anything to be aware of regarding problems on that program.

Hi, Yeah, no Bryan Thanks for the question I read here, we're making good progress with the adult singles matches.

Hello.

We have initiated that study and we're right in the middle of the start that process there and as soon as we have said that <unk>.

Summation on that study you know enrollment proceeding and we will be able to give an update with respect to the pediatric registration study. We're also making good progress on aim to initiate that study during <unk> if anyone.

Thank you.

Our next question comes from a new band Rama from JP Morgan Your line is open.

Eric S. Benevich: And we're very excited to bring this new treatment option to patients with Parkinson's disease. Our early efforts are focused on physician and patient education, highlighting that Ongentis is a promising new treatment option that can help optimize levodopa treatment. Ongentis is a differentiated COMT or Compton inhibitor that offers convenient once-daily dosing, strong efficacy, and is well-tolerated.

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

Maybe just piggybacking on some of the refill questions on this slight decline that you saw were there any types of specific trends whether patient type pace. That's been on drug for a while this is a relatively new patient specific pharmacy dynamics that we should be considering on this sort of a quarter.

Quarter over quarter decline you saw in repo. Thanks, so much.

Eric S. Benevich: As mentioned, we are still very early in the launch process, but the receptivity among neurologists has been positive thus far. We are seeing strong share voice and utilization of our Ongentis sampling program, which is providing important product experience for both neurologists and patients. In conjunction with the launch, we've been pleased with our improved access to Neurology Movement Disorder Practice. Additionally, we're seeing that the launch of a new gen system has helped drive higher neurology call volume for Ingresa, which we expect to benefit our efforts in TD. So heading into year-end, we will continue to introduce Ongentis to the Parkinson's community and execute against our launch plan. Our aspiration is not only to displace current comp inhibitors but also to be prescribed earlier and earlier in the treatment paradigm ahead of alternative adjunctive treatments from other drug classes.

Yeah, Hi on apartments, Eric So we don't have that level of detail at the patient level necessarily to address those questions I think what Matt said earlier was that.

Q2 represented a historically high refill rate coming off of a relatively lower rate from Q1.

Higher than what we had seen.

In previous quarters.

During the launch Q3, essentially refill rate return to what I'd call historical norms.

Wasn't low it just wasn't historically high.

And it wasn't a significant decrease either from Q2.

So you know we continue to see high persistency and high adherence and sort of those two things combined lead us to believe that compliance within Graz remains high even during this pandemic period. So we're continuing to focus on that but as you can imagine we're also continuing to focus on driving new.

Eric S. Benevich: In summary, our team continues to do an excellent job as we manage and adapt through the many near-term challenges brought on by the pandemic. One thing that hasn't changed is that we remain steadfast in our commitment to deliver on the long-term potential of both Ingresa and Ongenta. And I remain highly optimistic about our prospects. Now, I'll turn the call over to my colleague Eiry Roberts, who will provide an update on our progress with the pipeline. Eiry?

Patient starts, which we've been pleased with as we exited Q2 and into Q3.

[noise] on upon the only other Claire clarification that provide give it provide given me a last couple of questions are when you look at our AR inventory adjusted sales the underlying trx was relatively flat.

Eiry W. Roberts: Thank you, Eric, and good afternoon to everyone. Before I provide an update on our clinical program, I want to thank our staff at Neurocrine and across all our partnership organizations for their commitment to advancing our many research and development programs, especially in light of the pandemic. Conducting studies in a safe and effective manner remains our top priority.

The dollar amount of revenue went down 6 million largely because we had been increasing to a growth reducing our net revenue per script. So there there wasn't impact reduce complaints.

He said, however, I just wanted to make sure you're looking at.

The results and that's pretty much a flattish type trx quarter adjusting for for inventory.

Eiry W. Roberts: As this pandemic evolves, we continue to respond and adapt our approach and processes to ensure that we can safely progress our pipeline and deliver on the commitment to relieve patient suffering and enhance lives. I'll now provide a pipeline update, beginning with the very good news in Q3, of the initiation of the CATALYST study, our single, global, registrational study of chronesophon for adults with the classic form of congenital adrenal hyperplasia Recall, we gained critical alignment on the design of this single registrational study design from the FDA, EMA, patient advocacy groups, key opinion leaders, and payers. We are currently deep into the initiation of the study globally and look forward to providing additional updates as the trial advances. In addition, the phase two proof of concept pediatric study with Chronosophon is back up and running after our brief pause earlier this year due to COVID-19, and we are making good progress towards the initiation of a single global registration study in pediatric patients in 2021. Moving on to Valbenazie. The CONNECT-HD Phase III Registration Study, run in collaboration with the Huntington Study Group to assess valbenazine as a potential treatment for career inpatients with Huntington's disease, has re-initiated enrollment and is progressing well for our Parkinson's Disease Gene Therapy Program, NBIB 1817, obtained through our collaboration with Voyager Therapeutics.

Got it thanks, so much for the clarification.

Our next question is from Brian eight brands from RBC capital markets. Your line is open.

Hi, guys. Thanks, so much for taking my question I was wondering if you could speak on your latest views on on use of capital.

With respect to I guess, increasing your investment in commercial investment any aggressive to get through some of the transit cobot headwinds versus progressing the pipeline for perhaps opinion leaders stage asset externally and I'm also wondering with respect to congrats are you guys seeing any impact on firms patient switching to.

Two new alternative anti psychotic treatments in certain segments, which might have fewer intrinsic motor east. Thanks.

Hi, Brian I'm going to take the a the first half of your question first and that is on the use of capital. There is no better use of our capital than supporting and Grand Mesa and being able to bring this to a as many of the TD suffers as possible I keep reiterating that we are at the very very early.

Stages of development of this market place there are still a at least 80% of the patients who have T.D. ours are undiagnosed.

That 20% that had been diagnosed only about half of them are on a on Athena to inhibitor and so they're still not being treated and what we would say would be the optimal manner for their T.D. and as we've seen with patients who had the TD are treated.

Eiry W. Roberts: A little earlier this month, the Data Safety Monitoring Board for the Restore One Phase 2 clinical trial met and reviewed certain patient imaging data from the ongoing study. Following this review, the DSMB requested additional patient-level data and recommended a pause in dosing of patients in RestoreOne, pending review by the DSMB of these additional data. Although the DSMB informed us that patient screening for RISC-V1 could continue, given that trial sites participating in this study are not currently screening and enrolling patients in response to the COVID-19 pandemic, we have elected to delay the planned resumption of patient screening in the RestoreOne study until the DSMB is able to complete its evaluation, which will likely occur towards year end.

Appropriately it is been a real life changer for those patients. So we we will continue to focus exquisitely. Our initial dollar is always on supporting INGREZZA.

Beyond that then we have on Chantix and Chantest says from the moment that we first.

Touch that we understood. This is going to be an important drug for the adjunct of treatment of Parkinson's patients and so that's what first led us into launch into secondarily a deal like that.

I would just add on Chantest is going to be something that's going to synergize real well within grass. So you can see the thinking behind our use of proceeds and then as you look at the at the development of New York and we will we will always lay our bets where the best science leads us in ARPU.

Eiry W. Roberts: Additionally, in accordance with FDA safety reporting requirements, we are also preparing a single expedited IND safety report. Turning now to NBI 827104, or 104 for short, the potent and highly selective T-type calcium channel antagonist which was licensed from my dossier earlier this year. I am pleased to announce that we are currently initiating a phase two study in a rare pediatric epileptic encephalopathy called Continuous Psych and Wave During Sleep, or CSWS. CSWS typically impacts children initially between the ages of 2 and 4 years old and manifests itself via a variety of seizure types, including atypical absence seizures, generalized tonic-clonic seizures, and focal seizures that usually occur during sleep.

Type line. So that's internal science, that's external science in our pipeline because were not going to and we are not a or in the future going to be a one a comp pound story here. We are building a world class Neuroscience company, we've got neuro psychiatry neuron.

Eiry W. Roberts: In addition, children with CSWS often present with cognitive, behavioral, and developmental regression or delay. Due to the differentiated mechanism of action of this molecule when compared to non-selective calcium channel inhibitors, treatment with 104 could lead to an enhanced benefit-risk profile for patients with this rare pediatric form of epilepsy. In addition, 104 has the potential to expand into a range of other central nervous system diseases. We are currently working in preparation for studies in several of these areas and will provide an update on additional indications as they progress in the clinic. Finally, and very importantly, the assets included as part of our collaboration with Takeda are making good progress. The lead clinical asset, NBI 1065844, formerly known as TAC 831, is progressing very well towards completion of the Phase 2 study to assess the efficacy and safety of 844 as a treatment for negative symptoms of schizophrenia.

G and Neurotechnology. She has found dating as foundation principles for US and then each one of those were building our pipeline, but rationally as we see progress in one area or another that's where we're going to lay out more and more of our back into that area are on that that compound. So in each case.

Yes, it is to move our pipeline along quickly, but rationally based on the data that we are generating each step of the way now I hope that answers.

The first part of your question the.

The second part.

Remind me.

I cut off I guess.

You Your question, Brian If I said it was with the use of more sand generation.

Typically they called it we felt was resulting in a in.

In a headwind since the I think you know that can be attributed to the previous discussion I mean, it's very clear that less than 20% of the overall population suffering from TD is currently recognized and treated appropriately and what we also know is that given the environment, we find ourselves in now.

The growth in patient suffering from newer psychotic disorder within the pandemic on outside of that it's very significant and so although there may be some sweet king of the types of psychotic the U.S I think that's highly unlikely to be having an impact right now in terms of the overall environment.

Then I mean, that's really that's really helpful. Thank you one thing I'd like to add a couple of comments.

Comments is that.

Even though we say that you know only about 20% or so of the.

C. D population has been diagnosed those that are like knows it's only about half or even offered a beam out two inhibitor.

And we're trying to change that that behavior.

Recently, the American Psychiatric Association published their updated guidelines for the treatment of schizophrenia in those guidelines, there's a section on TV.

Kevin C. Gorman: We anticipate sharing results from this study in the middle of next year. I'm proud of the progress we've made across research and development at Neurocrine as we stay laser focused on building a diverse pipeline across multiple disease states, patient populations, and phases of clinical development. This pipeline has the potential to address significant unmet clinical needs that remain worldwide for patients in the fields of neurology, neuropsychiatry, and neuroendocrinology. We continue to adapt and respond to the many twists and turns brought on by the pandemic with a primary focus at all times on ensuring the safety of our trial subjects and the effective advancement of the pipeline. With that, I'll hand it back to you, Kevin.

Is important because it recommends the.

Hey, Matt two inhibitors as first line.

Treatment for these patients where you know previously.

Before.

And Greg.

The recommendation was simply to adjust the anti psychotic regimens. So not only are we driving.

To improve the rate of Texas, but we're also driving to make sure that patients get offered the only evidence based approach to treating TD, which is the amount to specifically in Brazil.

Thank you so much.

Operator: Thank you very much, Eiry. I think that does it for our prepared remarks, so what we'd like to do is use the rest of our time for your questions. At this time, if you would like to ask a question, please press star and one on your touch-tone phone. You may remove yourself from the queue at any time by pressing the pound key.

Our next question comes from Jay Olson from Oppenheimer. Your line is open.

Oh, Hey, thanks for taking the question I appreciate your earlier comments about some of the shortcomings.

With telemedicine and the diagnosis of tardive dyskinesia.

There are other forms of virtual medicine that you can leverage to overcome those for example, do video or maybe face time videos to facilitate the diagnosis of TD and then Frontend too are you expecting a similar negative impact from.

Operator: Once again, that is star and one, ask a question. We'll pause for a moment to allow questions to queue. We will take our first question from Josh Schimmer from Evercore. Izzy, your line is open. Thanks so much.

Coated that you're seeing with INGREZZA to also impact the launch trajectory.

Operator: I have a question on a couple of potential headwinds for Ingresa. To what extent has social distancing and face masks been a demotivating factor for patients seeking treatment of tritium dyskinesia because their disease may be less noticeable as a result? And you had another quarter of inventory billed. When do you expect this might reverse, and to what extent? Thanks. Hey Josh.

On Gen. Two and can you provide any anecdotal feedback that you're getting from doctors and they start to go on.

Thank you.

Jay I'm going to just jump in very briefly and I'll, let 'em I'll, let Eric take it from there we are short hand, when we say Tele medicine, we do mean that we're talking about electronic media. So within that there is a video based but where psychiatry.

Operator: Good to hear from you. You know, I don't think we would chalk up a patient fear associated with the return to in-person patient visits. You know, I think just the ease of using telemedicine during this pandemic to help many patients with mental health disorders has become very convenient. So I think because they'd been utilizing telemedicine prior to the pandemic, it was a much easier transition. There's clearly a concern by anyone about the safety of going into offices, but I don't think that that would be chalked up as the primary reason. On the inventory front, you know, it's really difficult to predict. It's something that we intentionally do not manage to avoid the optics of channel stuffing.

Yes.

There is a significant part of that Tele medicine that is telephone only I'd say, maybe up to a a half of their tele medicine is that.

So I'll turn it over to Eric 10, embellish upon that and to answer the second part of your question about on Gen test.

Yeah, certainly a big part of our effort over the last few months in terms of helping prescribers and providers to improve there.

There their confidence in their competency in diagnosing TD via telehealth platforms has been around.

I'll call it sort of the the tips and the techniques.

We'll see it with a video plus voice, calling for a voice only call I've mentioned.

Operator: And over the last four quarters alone, I believe we've had over a $30 million build in inventory. In this quarter, once again, we had a build of another $6 million. So, you know, at some point, my expectation is that it should and will bleed back down, but it's hard to predict how much and when. So we'll continue to disclose inventory-adjusted sales to take out that expectation. It's a great dynamic to give you guys a view as to underlying demand, and we'll keep you posted. But that is something, you know, I know hard to model, but I encourage you guys to think about measuring us on an inventory-based basis. Okay, can I just clarify the question? I wasn't asking so much about patients who are nervous about going to the doctor. I was wondering if, because they're wearing face masks and they're not interacting with other people so much, they don't feel the need to have their chart of dyskinesia under the same control, just as social objects do.

Hi in psychiatry, a significant proportion of these tele health patient visits our voice only and certainly that can present, a challenge for visually oriented condition like TD.

So one of the things that we've been doing is equipping providers with the types of questions to ask a when they're talking to a patient and also on the patient side.

The things that they need to bring up with the provider if they're experiencing abnormal movements. So that they can move towards getting a more in depth assessment of their abnormal movements.

In in settings, where you have a a video component whether its xoom or even using a smartphone like face time using.

Operator: Josh, I do apologize for misinterpreting the question, but no, that's not something that we see as a big headwind at this point. And Josh, I would just say, this is Kevin. That would be hard for us to know, and I don't know how that would get communicated either to the physicians, staff, loved ones, and then back up to us. So you bring up something that is hypothetical, but I don't have a way to answer it.

Using a face time platform one of the things that we've been doing you know kind of going back to one of the earlier questions is reminding the providers when you're talking to your patient hasn't picked up their masks.

So that they can see the face more fully.

I Deeley also have someone there with the patient that can hold the camera so.

So they can see other parts of the body such as the hands or the truck I'm. So it's important to look for TD more broadly than just in the in the mouth or the job because it can occur anywhere including in the periphery. So you know certainly from providing education around how to.

How to conduct a TD assessment remotely and it's been very well received a in a number of national educational.

Operator: Got it. Thanks so much. Our next question comes from Tazeen Ahmad from Bank of America. Your line is open. Hi, good afternoon. Thank you for taking my question. On the quarter itself, Kevin, I just wanted to get a little bit more color.

Zoom zoom training programs that we've been offering.

Operator: So, in 3Q, you know, at the end of the year, it was 248 versus a roughly 256 you came in at for 2Q. Now, in your press release, you did say that new prescriptions did increase slightly in the third quarter, but refills and persistence moderated. So, I'm assuming refill and persistence rates went lower. I'm wondering if you could give some color about those two particular items, refill and persistence, you know, distribution rates, how they're looking so far in 4Q. And as far as geography goes, are there other specific geographies where more doctors' offices for psychs are open relative to other parts of the country?

And as Rick and as it relates to on Gen. Tests, certainly you know we knew when we plan to launch on Genesis in September that we'd be launching into an environment. That's you know, partly virtual and partly in person and so as I mentioned in my prepared remarks, we had a 100% virtual training.

Training meeting for our field sales team and I think the benefit of that was it for prepared them to introduce on chances to neurologists.

Virtually or in person and I will say that the percentage of neurologists center back practicing in their clinics is much higher than what we see in psychiatry the percentage of patients that they're seeing in person is much higher than what we're seeing in psychiatry and as Kevin said, having the on Genesis launch has gone.

EBITDA left in terms of our call activity and our opportunity to talk about both products with movement disorder specialists.

So thus far in its very early in our launch cycle, but.

But the feedback has been very positive about the clinical profile and labeling.

Operator: Yeah, so, on the new patient front, we did have a slight increase during the third quarter, and the comments about the recent, I guess, positive trends that we've been seeing are really exiting Q3 and then into Q4, but still below pre-pandemic levels. So, I think on the NRAC front, we are encouraged. I mean, the rate of diagnosis of PD is greater than the reduction of in-person patient visits, and I think that's the team doing a great job there. You know, for us, what is encouraging, though, when we look back and we get asked the question, "What is your long-term belief?" Why are you so bullish over the long run?

We've seen a lot of requests for samples are out there and you know we're still in the process of introducing on Genesis you know more broadly across the Parkinson's community, but we're very pleased with the receptivity in the execution of our launch thus far.

Super helpful. Thank you for all the detail.

Our next question is from Laura Chico from Wedbush. Your line is open.

Good evening. Thank you very much for taking my question I guess that's it.

Operator: And, you know, there's a lot of qualitative aspects to that, whether it's feedback from patients, reps, doctors, surveys, et cetera. Prior to COVID, we were at a record all-time NRX level per week, and that was really, really progressing well. Once COVID hit, we took a step down, and we pretty much, as we've said on the last two calls, flatlined from where that step down was, and now we're seeing a little bit of a recovery. And how to think about that in, for example, as Kevin said, in the wintertime and what we're seeing with the pandemic surging a bit, you would potentially have some more incremental pressure on N As it relates to levels of persistency and compliance, it has been very encouraging to see patients stand medicine through the pandemic. Persistency rates remain extremely high, and then also rates of refill are still at a level above historical norms.

Into new too much on the same theme, but I wanted to understand a little bit more what you have is going to be in Graz pulled.

Pullback, perhaps related more to the psychiatrist.

Being a little bit more constrained in their overwhelming <unk> overall bandwidth versus the tele medicine focus that I guess, you kind of hinted at it multiple times here.

Weve seen depression, and anxiety rates increased by about four to six act on.

I'm just wondering if this is more of a constraint on time and not necessary or need to prioritize to address certain symptoms and T.D. might be given perhaps lesser priority and then I guess kind of related to that could you just remind us what is the current split for it.

So psychiatry prescribing persist neurology, and where you see that evolving overtime. Thanks. So.

Well, let me start with the second part of your question, which is our business split and you know we've said that psychiatry, you know through the first two years of the launches.

Represented about 80% of our effort in about 80% of our our <unk> prescriptions.

And as just mentioned that neurology has been relatively less impacted by cobot 19th in psychiatry.

We have data that shows that a patient visits.

Dropped dramatically.

During the peak of the pandemic in the April may time period, and they've been creeping up but total patient visits are still about 20% less than what they were pre pandemic and of the visit it's about 40%.

Operator: So what I would say for the quarter sequentially, you know, there was a step down largely due to that drop in compliance, but the slight drop can cause a bigger number in overall TRX. Hope that answers your question, Tazeen, and good to hear from you, as always. Our next question comes from Paul Mattis from Stifle. Your line is open.

Our conducted virtually via Tele health, which is five or six times greater than most other physician specialties.

Hi tree appears to be better suited to tele health and maybe some other physician specialties and psychiatrists. So really is a adopted tele health. So I think it's a combination of the bandwidth component as well as the desire to practice via Tele health.

Operator: Hey, great. Thanks so much for taking the time to answer my questions. You know, I was wondering now, maybe given these challenges and given that, you know, consensus has seemed to kind of muddle around Continued strong net patient ads, have you guys thought at all whether or not it makes sense to give guidance even on a quarterly basis or maybe for 2021? And then separately, I was kind of curious if you could just comment on net price and where that's going. It looks like gross to net went up this quarter.

And as I mentioned in my prepared remarks at least early on in the pandemic physicians really focusing on the acute psychiatric consequences of the pandemic, meaning.

Exacerbation of anxiety or depressive symptoms, but as we move forward certainly our teams have become more comfortable reminding their customers that TD hasn't gone anywhere. These patients are still exists experiencing at <unk> <unk>.

The disability associated with movements in the stigma.

Operator: Is that a trend you expect to occur as well in 4Q in 2021? So, Paul, on the question of guidance, it's a fair one. There still are quite a few moving parts here, and that has been, you know, one of the primary reasons why we haven't given guidance up until now. We continue to discuss it internally and with our board of directors. And so we hear you on that. As far as the second half of your question. Yeah, the only thing to add to what Kevin said was, I mean, this is probably, Paul, the farthest that we've gone. If you listened to Kevin's prepared remarks earlier, we're not claiming victory here.

And so we found a way to become more comfortable are encouraging and reminding and teaching the providers to continue to screen for TD.

And I think that that's part of the reason that we've seen an uptick in.

In interacts and new patient starts as we exited Q2 and into Q3 to be completed.

And Laura.

As we said before the psychiatrists, where the ones that had used parallel <unk> much more than any other specialty before the pandemic they have used that continuously.

Continuously much more during the pandemic and we anticipate these levels to fall substantially from where they are now, but they will again be utilizing it more than the other specialties well, which is why we've we've spent the effort prior and certainly during this and after this pandemic in order to be able.

Operator: That we could have an underlying flattest quarter is what he said, and that's not accounting for what could happen with inventory. So I do think and want to make sure people hear what we've heard. We've heard that, and we are trying to be a bit more specific as to what could happen based upon what we're seeing out of COVID. The second question on the net.

To tap into that as a as a way to actually increase the availability.

Of ingress and the diagnosis of T.D. in Tele health.

Operator: Yeah, there was a pullback in net revenue per script this quarter. It was slightly down, I think around $100, and that was largely due to the contracting that we had entered into for strong access. So, you know, I think that that's been our mission all along to ensure that if Ingress is written, that a patient will ultimately get that script. And we continue to be successful in that regard. But this quarter did have to do with contracting. Now, as you think about contracting for 2021, there isn't anything that we would flag to you that would give us concern around access, and no material change, at least at this time, based upon what we know about overall net revenue per script. You could see it somewhere near where it is today.

That's helpful. And then I guess, maybe just one quick follow up how far away are you from actually putting into place. Some of these new tele medicine initiatives and what metrics would be most useful to gauge their impact. Thanks very much. So that's there.

There are a number of these and they should have some are very short term in nature. Some are you know medium term in nature of the short term ones have just begun to be rolled out as we've been discussing earlier today at a banking conference and then the longer term ones are playing a more long game here.

Operator: So hopefully that's helpful, Paul. Thanks. Yeah, it is.

Our next question comes from.

From David Amsellem from Piper Sandler Your line is open.

Hey, Thanks, So just a couple so first on on Justice I know these are early days in the in the launch but can you give us a sense of the kinda into patients.

You're pulling in or these patients who have been exposed to Iran feel empty inhibitors in the past are you getting more theory Nixon's patients who are on other kinds of adjunctive therapies.

Operator: Can I, I'm going to go ahead and take the next question. Okay, our next question comes from Byron Amin from Jeffrey's. Your line is open. Yeah, hi guys, thanks for taking my questions. Maybe on Ingresa, how much do you think that the current script trends are related to COVID versus hitting a ceiling in the TD market? And in Q2, I think you saw a step up in refills. So I'm just trying to understand the slight moderation and refills in Q3 given we had COVID across both quarters. Baron, good to hear from you. And I can say without equivocation that what we're seeing now is 100% due to COVID. There's no ceiling effect that we're seeing with the growth of this market.

And then.

Secondly, can you just remind us in Huntingtons chorea, what's the penetration is of the female two inhibitors and that's a thing and just frame up for us how you're thinking about the <unk>.

Underlying patient opportunity for that Benazir. Thanks, David I'll take the first part just to say that it is way too early days for us They really comment on where it's coming from I would just say that.

Or without a wealth of data to being look through.

Through it it was our anticipation pride launch that it wouldn't be coming from other cookie inhibitors or for patients who wouldn't normally be put on a comp T inhibitor at that point in time and now that the docs are using the latest one IRA you want to take the second yeah. So with respect to Huntingtons did.

Operator: As far as the second part of your question, Yeah, Baron, on the refill front, if you recall, Q1 is always low from a refill rate per patient because they're going through that reauthorization process. So Q2 was really a recovery from a lower Q1, and then as you move from Q2 to Q3, it was a slight decline, but nothing notable. So I would say, Ingresa, it does have sensitivity to COVID from a new patient perspective, but as it relates to compliance or persistency, we've not seen anything material that we would chalk up associated with COVID. And, you know, to your point on the question and what Kevin said, and I mentioned earlier, you know, prior to COVID, we were at an all-time high of N or X per week. If we had seen that flattening or declining going into COVID, you know, we maybe would be sitting here not as optimistic. But with what we saw prior to COVID and then what we're seeing recently as call activity has increased, you know, our enthusiasm remains incredibly high. Great.

He said about 30000 patients in the United States have huntingtons about 90% of those have Korea. Some so with about 70 of those being moderate to severe nature in the disease.

Even though I think it's very clear that the not to inhibition is helpful. In patients with Huntington's disease, only about 20% of valuable patients. Currently we see the treatment of currently available female two inhibitors and much of that is predicated on some of the challenges of the current events.

Double medicines, both intensive and challenging titration schedule is multiple.

Doses acquired during the day I know he for patients with that Korea. That's all we can be a significant challenge sometimes so we have had a.

Significant amount of interest in all about managing trial and not me God and we're very encouraged by what we hope Valbenazine, we'll be able to bring for patients with Huntington's disease and in particular, the investigator group has been very enthusiastic and will they tease with how we were able to get back up and running with the trial off do you.

Operator: Thanks for taking my question. Our next question comes from Phil Nadeau from Cowan & Company. Your line is open. Good afternoon, thanks for taking my question.

The Cove, it and just to remind you RBC and graduate to date has been well tolerated has a very simple dosing regimen with no black box warning in that differentiates us from the company that would be not to.

Operator: So first on Ingresa, in the past, you've suggested that we should look towards things like increases in in-person visits at psychiatrists as a leading indicator of when an NREC could return. Maybe there's more complication. It's more complicated than that.

Not a disease state.

Hey, let's take your questions before having close.

Let's see here.

Operator: What do you think we as external observers should be looking at to predict a return to growth in GRESA? And second, on the pipeline, you called it pause and restore. Could you give us a bit more information about what data the DSMB saw that prompted the request? Thanks. Hi Phil. It's Eric.

Our next question comes from.

<unk> retail guard from Citi. Your line is open.

Hi, guys. Thanks for taking my question I was just wondering if you could talk a little bit more about whats needed for the xenon program to move that forward give any update recently and also if you could just explain a little bit about the rationale for testing.

Operator: I'll take the first part of your question. So, you know, I mentioned in my prepared remarks that nothing really is better than an in-person visit between a patient and a provider, especially as it relates to diagnosing a movement disorder like TD, and we are seeing that in-person patient visits have increased they really were bottoming out around the April-May time period and have been creeping up but still in psychiatry are about 20% lower than what they were in the pre-pandemic period, The other complicating factor is the prominence in the adoption of telemedicine in psychiatry, which provides some challenges to making a diagnosis of TD remotely. So, you know, those two things are going to be indicators that you need to kind of keep an eye on.

Nothing that program in <unk>, no local epilepsy as well thanks.

Yes, so just a couple of comments there I think communicated earlier in the quarter that Oh, we had submitted the I N D to the FDA for a phase two study in patients do they see any a. on to the agency.

Come back and requested some additional non clinical data that they required to support the dose justification and not pediatric trial. So what were doing.

Now is compiling a response to the agency and working with the agency to understand how we generate that additional nonclinical data onempower level working on how we can hopefully get a pediatric trial initiated sometime next year. In addition, the give.

Operator: One is just seeing foot traffic increase in psych private practices and psych clinics; that's a strong indicator, and secondly, our ability to continue educating providers on how to look for and screen for TD when conducting a remote patient visit via telehealth. As we mentioned earlier, telehealth isn't going anywhere. It's gonna continue to be a prominent part of psychiatry going forward, and we're working hard to make sure that providers are confident and comfortable in their ability and willing to screen for and diagnose TD remotely. So I'll turn it over to the second half of your questions, Eiry. Hi Phil.

And the mechanism of action here, the fact that in spoke onset seizures in adult.

Sodium channel antagonist stop showing some circumstances <unk> limited in many circumstances due to the fact that they are not most of the drugs currently available non selective and that requires a pretty significant don't achieve any efficacy where again and are encouraged by the fact that this highly selective Nok 1.6.

Tagging it could demonstrate significant benefit in not that population and we're moving ahead with planning to.

To implement a study in adults Socolow said, let's see.

The near future.

Operator: Thanks for the question. So there are a couple of things. First of all, I am blinded to all of the data on the RestoreOne study, as is all of the remainder of our management team. And as a result, I don't know anything further about the findings beyond what I was able to share with you. What I will say, though, just to reiterate, was that the DSMB was looking at certain neuroimaging information, scan data, from patients in the RestoreOne study and, based on their observation, requested a pause in the dosing of subsequent subjects, not a pause in screening or a halt to the study, pending their ability to access additional information and review that. The decision to not reinitiate screening at this time was actually taken by us.

Okay.

Our last question will be from Evan Seeger, Ben from Credit Suisse. Your line is open.

Hi, guys. Thank you so much for taking the question I. Appreciate you squeezing me in just one so you know I know, we had a really positive vaccine data today, which could help with the commercial dynamics fragrance, but given the population more broadly probably won't be inoculated until mid year should we expect continued softness in fourth quarter and into the first half.

The next year or are you seeing or do you think you'll be able to overcome that with some of the elements and initiatives that you've been described on this call. Thank you so much and thanks.

Ah Evan I I really was gratified I think as many people were to see the data that came out of out of Pfizer and we we hold high hopes that that data continues from that trial.

Operator: And in parallel with that, we are also filing a single safety report with the FDA. So that is all I know at this point in time, and I'm not able to provide any other information. That's helpful, thank you. Our next question comes from Brian Skorney from Baird. Your line is open. Hey, good morning.

As good as it did and also from the other vaccine and therapeutic trials that are going on right now.

What what you're asking is is that and I'll answer it.

In respect to Q4 is the fact that as.

Cove in the society's goes through the waxing and waning waxing aspects of covert infections.

We have pointed out here that the the psychiatry community is particularly affected by that.

The <unk> like the rest of society, the psychiatry community will adapt to this over time independent.

Operator: Good afternoon, guys. Thank you for taking my question. I didn't see anything called out specifically on Cronosophon and was just wondering, I know you had previously said that you were planning to start the registrational study in the second half of 2020 and about the impacts of COVID, you know. Is there any change to that guidance or anything to be aware of regarding the progress of that program? Yeah. No, Brian, thanks for the question. It's Eiry here.

A vaccine and as we've tried to tell you here today.

Today that we.

We are adapting to that type of environment within the psychiatry community also so that even through the continued use of tele medicine, we're going to actually turn that from a disadvantage to an advantage incrementally over time.

Operator: We're making good progress with the adult single registration study globally. We have initiated that study, and we're right in the middle of the startup process there. And as soon as we have further information on that study and, you know, enrollments are proceeding, we will be able to give an update. With respect to the pediatric registrational study, we're also making good progress and aim to initiate that study during. All right, thank you. Our next question comes from Anupam Rama from J.P. Morgan. Your line is open.

As as the overall crisis lessens over time with or without vaccines or the timing of vaccines.

We anticipate that our business will can will then return to growth.

What we are being on this call I think is a is one that were very measured and where with our optimism.

We have a great belief in this drug in our ability to serve these patients and in being able to get where we had talked about before and covert to ever ever strike that we're still at the very beginning so that's in there is a wonderful opportunity for patients.

Operator: Hi guys, thanks so much for taking the question. Maybe just piggybacking on some of the refill questions on the slight decline that you saw. Were there any types of specific trends, whether patient type, you know, a patient that's been on drugs for a while versus a relatively new patient, or specific pharmacy dynamics that we should be considering on this sort of quarter-over-quarter decline you saw in refills? Thanks so much. Yeah, hi Anupam, it's Eric.

And then our business in front of us So I I do kind of disassociate the two even though the two are are put together.

Great. Thank you.

That does conclude our question and answer portion of the call I will now turn the program back over to Kevin Gorman for any additional or closing remarks. Thank you very much and I really did enjoy our conversation that we had here today you know it as sitting here in November I'm I'm.

Operator: So we don't have that level of detail at the patient level necessarily to address those questions. I think what Matt had said earlier was that Q2 represented a historically high refill rate coming off of a relatively lower rate from Q1, higher than what we had seen in a previous course. During the launch, Q3 essentially, the refill rate returned to what I'd call the historical norm. It wasn't low, it just wasn't historically high, and it wasn't a significant decrease either from Q2.

[laughter].

2020, coming to a coming to an end here and in several weeks and I got to say the least this has been highly unusual year up but.

But I am very proud of NERC Heinz employees and our partners throughout everything that we and you have had to endure during this period of time.

But I remain very optimistic about our future.

If you haven't heard it while we do well we do still certainly are aware that the covance situation that we face is going to is going to be something that we're going to be dealing with here through Q4.

Operator: So, you know, we continue to see high persistency and high adherence, and sort of those two things combined lead us to believe that compliance with Ingresa remains high even during this pandemic period. So we're continuing to focus on that, but as you can imagine, we're also continuing to focus on driving new patient starts, which we've been pleased with as we exited Q2 and into Q3. Anupam, the only other clarification that I'd provide given the last couple of questions is when you look at our inventory adjusted sales, the underlying TRX was relatively flat. The dollar amount of revenue went down $6 million largely because we had an increase in debt, a gross net, reducing our net revenue per script, so there was an impact from the reduced compliance rate.

But the bottom line as ingress as a crucial therapy for the well being of TD suffers and as you've heard over and over from me on other calls this call. We're only at the beginning to serve this patient population.

During this pandemic you've seen that we've been able to add a number of promising potential medicines to our pipeline and carry these into the clinic.

And this pipeline is a balanced pipeline from stage of development, but it's also a highly diversified pipeline by mechanism and by disease States and that gives us great hope that we're going to be a very successful going forward with this pipeline and continuing to add.

To it and that's I think the Iraq had said to you there's a number of opportunities for many of the compounds in this pipeline in a variety of diseases.

Operator: Thanks so much for the clarification. Our next question is from Brian Abrahams from RDC Capital Markets. Your line is open.

So we're working through the transient near term effects of this environment, but our commitment and our optimism for our patients and our business is absolutely unchanged. There remains high and I look forward to talking with you all in the coming weeks at different virtual banking meetings and in our one on one calls thank you again.

Operator: Hey guys, thanks so much for taking my question. I was wondering if you could speak on your latest views on the use of capital with respect to, I guess, increasing your investment in commercial investment in Ingresa to get through some of the transient COVID headwinds versus progressing the pipeline versus perhaps bringing in a later stage asset externally. And I'm also wondering, with respect to Ingresa, are you guys seeing any impact from patients switching to new alternative antipsychotic treatments in certain segments, which might have fewer intrinsic motor AEs? Thanks. Hi Brian.

And very much.

This does conclude todays program. Thank you for your participation you may just.

[noise].

Operator: I'm going to take the first half of your question first, and that is on the use of capital. There is no better use of our capital than supporting Ingressa and being able to bring this to as many of the TD sufferers as possible. I keep reiterating that we are at the very, very early stages of the development of this marketplace. There are still at least 80% of the patients who have TD who are undiagnosed. Of those 20% that have been diagnosed, only about half of them are on a VMAT2 inhibitor, and so they're still not being treated in what we would say would be the optimal manner for their TD. And as we've seen with patients who've had their TD treated appropriately, it has been a real life changer for those patients. So we will continue to focus exquisitely on our initial dollars always on supporting Ingressa. Beyond that, then, we have Ongentis, and Ongentis was from the moment that we first touched it.

Operator: We understood this was going to be an important drug for the adjunctive treatment of Parkinson's patients, and so that's what first led us into Ongentis. Secondly, a deal like that showed us that Ongentis was going to be something that's going to synergize really well with Ingresa. So you can see the thinking behind our use of proceeds.

Operator: And then as you look at the development of Neurocrine, we will always lay our bets where the best science leads us in our pipeline. So that's internal science, that's external science in our pipeline. Because we're not going to, and we are not in the future, going to be just one compound story here.

Operator: We are building a world-class neuroscience company. We've got neuropsychiatry, neurology, and neuroendocrinology as the foundation principles for us. And in each one of those, we're building our pipeline, but rationally. As we see progress in one area or another, that's where we're going to lay more and more of our bets on that area or that compound. So in each case, the goal is to move our pipeline along quickly and rationally based on the data that we are generating at each step of the way. Now, I hope that answered the first part of your question. The second part. Remind me. I could answer that,

Operator: Your question, Brian, if I understood you correctly, was whether the use of more second-generation or atypical antipsychotics we thought was resulting in a headwind, so to speak. I think, you know, to reiterate just the previous discussion, I mean, it's very clear that less than 20% of the overall population suffering from TD is currently recognized and treated appropriately. And what we also know is that given the environment we find ourselves in now, Unknown Speaker, the growth in patients suffering from neuropsychiatric disorders within the pandemic and outside of that is very significant. And so although there may be some switching of the types of antipsychotics that are used, I think that's highly unlikely to be having an impact right now in terms of the overall environment. And then Eric, Unknown Speaker. That's really, that's really helpful.

Operator: Thank you. Unknown Speaker One thing I'd like to add on top of Eiry's comments is that, even though we say that, you know, only about twenty percent of the population has been diagnosed. For those that are diagnosed, only about half are even offered a VMAT2 inhibitor, and we're trying to change that behavior. Recently, the American Psychiatric Association published their updated guidelines for the, and in the guidelines, there's a section on This is important because it recommends the use of BDMAT2 inhibitors as first-line therapy, treatment for these patients, whereas before, and Greta Thunberg, the recommendation was simply to adjust the antipsychotic regimen.

Operator: So, not only are we driving to improve the rate of Tdexis, but we're also driving to make sure that patients get offered the only evidence-based approach to treating Td, which is DMAT2s and specific... Thank you so much. Our next question comes from Jay Olson from Oppenheimer. Your line is open.

Operator: Well, hey, thanks for taking the questions. I appreciate your earlier comments about some of the shortcomings with telemedicine and the diagnosis of tardive dyskinesia. Are there other forms of virtual medicine that you can leverage to overcome these? For example, Zoom video or maybe FaceTime videos to facilitate the diagnosis of T.D.? And then for Ongentis, are you expecting a similar negative impact from COVID that you're seeing with Ingresa to also impact the launch trajectory of Ongentis?

Operator: And can you provide any anecdotal feedback that you're getting from doctors and patients during the launch? Thank you. Jay, I'm going to just jump in very briefly, and I'll let Eric take it from there. In shorthand, when we say telemedicine, we do mean that we're talking about electronic media. So within that, there is a video base.

Operator: But with psychiatrists, there is a significant part of that telemedicine that is telephone only. And I'd say maybe up to half of their telemedicine is that. So I'll turn it over to Eric to embellish upon that and to answer the second part of your question about ungenerous. Yeah, certainly a big part of our effort over the last few months in terms of helping prescribers and providers to improve their confidence and their competency in diagnosing TD via telehealth platforms has been around, I'll call it sort of the tips and the techniques. Associated with a video plus voice call or a voice only call.

Operator: In psychiatry, a significant proportion of these telehealth patient visits are voice-only. And certainly, that can present a challenge for a visually-oriented condition like TD. So one of the things that we've been doing is equipping providers with the types of questions to ask when they're talking to a patient, and also, on the patient's side, the things that they need to bring up with the provider if they're experiencing abnormal movements so that they can move towards getting a more in-depth assessment of their abnormal movements. In settings where you have a video component, whether it's Zoom or even using a smartphone like FaceTime, using a FaceTime platform, one of the things that we've been doing, you know, kind of going back to one of the earlier questions, is reminding the providers, when they're talking to their patients, to have them take off their masks so that they can see the face more fully. Ideally, you should also have someone there with the patient that can hold the camera so they can see other parts of the body, such as the hands or the trunk.

Operator: So it's important to look for TD more broadly than just in the mouth or the jaw because it can occur anywhere, including in the periphery. So certainly, we've been providing education around how to conduct a TD assessment remotely, and it's been very well received in a number of national educational programs. Zoom training programs that we've been offering. And as it relates to Ongentis, certainly, you know, we knew when we planned to launch Ongentis in September that we'd be launching it into an environment that's partly virtual and partly in person. And so, as I mentioned in my prepared remarks, we had a 100% virtual training meeting for our field sales team, and I think the benefit of that was that it prepared them to introduce Ongentis to neurologists virtually or in person. And I will say that the percentage of neurologists that are back practicing in their clinics is much higher than what we see in psychiatry. The percentage of patients that they're seeing in person is much higher than what we see in psychiatry.

Operator: And as Kevin said, having the Ongentis launch has given a lift in terms of our call activity and our opportunity to talk about both products with movement disorder specialists. So thus far, it's very early in our launch cycle, but the feedback's been very positive about the clinical profile and the labeling. We've seen a lot of requests for samples out there, and we're still in the process of introducing gentis more broadly across the Parkinson's community, but we're very pleased with the receptivity and the execution of our launch thus far. Super helpful. Thank you for all the details. Our next question is from Laura Chico from Wedbush. Your line is open.

Operator: Good evening. Thank you very much for taking my question. I guess not to continue too much on the same theme, but I wanted to understand a little bit more.

Operator: What sense do you have is the INGRESA pullback perhaps related more to the psychiatrist being a little bit more constrained in their overall bandwidth versus the telemedicine focus? And I guess you kind of hinted at it multiple times here, but we've seen depression and anxiety rates increase by about four to six times. So I'm just wondering if this is more of a constraint on time and a necessary or need to prioritize to address certain symptoms, and TD might be given perhaps lesser priority. And then, kind of related to that, could you just remind us what the current split is in terms of psychiatric prescribing versus neurology and where you see that evolving over time? Thanks.

Operator: Let me start with the second part of your question, which is our business split. And, you know, we've said that psychiatry, through the first three years of the launch, represented about 80% of our effort and about 80% of our prescriptions, and, as I just mentioned, neurology has been relatively less impacted by COVID-19 than psychiatry. We have data that shows that patient visits dropped dramatically during the peak of the pandemic in the April-May time period, and they've been creeping up, but total patient visits are still about 20% less than what they were pre-pandemic, and of those visits, about 40% are conducted virtually via telehealth, which is five or six times greater than most other physician specialties. Psychiatry appears to be better suited to telehealth than maybe some other physician specialties, and psychiatrists have really adopted telehealth.

Operator: So I think it's a combination of the bandwidth component as well as the desire to practice via telehealth. And as I mentioned in my prepared remarks, at least early on in the pandemic, physicians were really focusing on the acute psychiatric consequences of the pandemic, meaning exacerbation of anxiety or depressive symptoms. But as we've moved forward, certainly, our teams have become more comfortable reminding their customers that TD hasn't gone anywhere. However, these patients are still experiencing abnormal movements, the disability associated with the movements, and the stigma.

Operator: And so we found a way to become more comfortable encouraging and reminding and teaching the providers to continue to screen for TD. And I think that that's part of the reason that we've seen an uptick in NRX and new patient starts as we exited Q2 and into Q3. Thank you. And Laura, as we said before, the psychiatrists were the ones that used Tal-Al much more than any other specialty before the pandemic.

Operator: They have used it continuously much more during the pandemic, and we anticipate these levels to fall substantially from where they are now. But they will, again, be utilizing it more than the other specialties will, which is why we've made the effort prior and certainly during this and after this pandemic in order to be able to tap into that as a way to actually increase the availability of Ingressa and the diagnosis of TD in telehealth. That's helpful.

Operator: I guess maybe just one quick follow-up question. How far away are you from actually putting into place some of these new telemedicine initiatives, and what metrics would be most useful to gauge their impact? Thanks very much. There are a number of these initiatives; some are very short term in nature, some are, you know, medium term in nature. The short term ones have just begun to be rolled out, as we discussed earlier today at a banking conference, and then the longer term ones are playing the more long game here. Our next question comes from David Anselam on behalf of Piper Sandler. Your line is open. Hey, thanks. So just a couple.

Operator: So first on JENTIS, I know these are early days in the launch, but can you give us a sense of the kind of patient you're pulling in? Are these patients who have been exposed to or on CRMT inhibitors in the past, or are you getting a more varied mix of patients who are on other kinds of adjunctive therapies? And then secondly, can you just remind us in Huntington's Chorea what the penetration is of VMAT2 inhibitors in that setting and just frame up for us how you're thinking about the underlying patient opportunity for valbenazine. Thanks. Yeah, David. I'll take the first part.

Operator: Just to say that it is way too early days for us to really comment on where it's coming from. I would just say that without a wealth of data to look through, it was our anticipation prior to launch that it would be coming from other Compti inhibitors or for patients who would normally be put on a Compti inhibitor at that point in time. Now the docs are using the latest one, Eiry, do you want to take the second one? Yeah, so with respect to Huntington's disease, about 30,000 patients in the United States have Huntington's, and about 90% of those have Chorea of some sort, with about 70 of those being moderate to severe later in the disease. Even though I think it's very clear that VMAT2 inhibition is helpful in patients with Huntington's. Only about 20% of eligible patients currently receive them. Currently Available VMAP2 Inhibitors

Operator: And much of that is predicated on some of the challenges of the currently available medicines, both in terms of challenging titration schedules, multiple doses required during the day, and obviously, for patients with a career, this can sometimes be a significant challenge. So we have had a significant amount of interest in our valbenazine trial in that regard. And we're very encouraged by what we hope valbenazine will be able to bring for patients with Huntington's disease. In particular, the investigative group has been very enthusiastic, and we were very pleased with how we were able to get back up and running with the trial after we were paused for COVID. And just to remind you, obviously, Ingreza to date has been very well tolerated, has a very simple dosing regimen with no black box warning, and that differentiates it from the currently available VMAP2 inhibitors in that. Jamie, let's take a few more questions before Kevin closes. Okay, let's see this.

Operator: Our next question comes from Neena Bitritto Garg from Citi. Your line is open. Hi guys, thanks for taking my question. I was just wondering if you could talk a little bit more about what's needed for the Xenon program to move that forward, given the recent update, and also if you could just explain a little bit about the kind of rationale for testing that program in adult vocal epilepsy as well. Thanks. Yeah, so just a couple of comments there.

Operator: We had, I think, communicated earlier in the quarter that we had submitted the product to the FDA for a phase two study in patients with SCN8A. And the agency had come back and requested some additional non-clinical data that they required to support the dose justification in that pediatric trial. So what we're doing now is compiling a response to the agency and working with the agency to understand how we generate that additional non-clinical data. And, in parallel, we're working on how we can hopefully get a pediatric trial initiated sometime next year. In addition, given the mechanism of action here and the fact that in focal onset seizures in adults, sodium channel antagonists are beneficial in some circumstances but limited in many circumstances.

Operator: [inaudible] We're again encouraged by the fact that this highly selective NAV1.6 antagonist could demonstrate significant benefit in that population, and we're moving ahead with planning to implement a study in adult focal onset epilepsy in the near future. Thanks. Our last question will be from Evan Seigerman from Credit Suisse. Your line is open.

Operator: Hi guys, thank you so much for taking the question. I appreciate you squeezing me in. Just one.

Operator: So, you know, I know we had really positive vaccine data today, which could help with the commercial dynamics for Ingresa. But given that the population more broadly probably won't have been inoculated until midyear, should we expect continued softness in the fourth quarter and into the first half of next year? Or are you seeing, or do you think you'll be able to overcome that with some of the telemedicine initiatives that you've been describing on this call? Thank you so much. Yeah, thanks, Evan.

Operator: I really was gratified, as many people were, to see the data that came out of Pfizer. And we hold high hopes that the data from that trial will continue to look as good as it did, and also from the other vaccine and therapeutic trials that are going on right now. What you're asking is, and I'll answer it in respect to Q4, is the fact that as COVID in societies goes through the waxing, waning, waxing aspects of COVID infections.

Operator: We have pointed out here that the psychiatric community is particularly affected by this. Like the rest of society, the psychiatric community will adapt to this over time, independent of a vaccine. And as we've tried to tell you here today, that... We're adapting to that type of environment within the psychiatry community also so that even through the continued use of telemedicine, we're going to actually turn that from a disadvantage to an advantage incrementally over time. As the COVID crisis lessons over time with or without vaccines or the timing of vaccines.

Operator: We anticipate that our business will then return to growth. What we're being on this call, I think, is one that we're very measured, and we're with our optimism. We have a great belief in this drug, in our ability to serve these patients, and in being able to get where we had talked about before, and COVID has ever struck that we're still at the very beginnings of this, and there's a wonderful opportunity for patients and then our business in front of us, so I do kind of disassociate the two even though the two are put together. All right, thank you.

Operator: That does conclude our question and answer portion of the call. I will now turn the program back over to Kevin Gorman for any additional or closing remarks. Thank you very much, and I really did enjoy our conversation that we had here today. You know, sitting here in November, I'm looking at 2020 coming to an end here in several weeks.

Kevin C. Gorman: And to say the least, this has been a highly unusual year, but I am very proud of Neurocrine's employees and our partners for everything that we and you have had to endure during this period of time. But I remain very optimistic about our future. If you haven't heard it, while we do, while we are still certainly aware that the COVID situation that we face is going to be something that we're going to be dealing with here through Q4. But the bottom line is vingressa is a crucial therapy for the well-being of TD sufferers.

Kevin C. Gorman: And as you've heard over and over from me on other calls, this call, we're only at the beginning to serve this patient population. During this pandemic, you've seen that we've been able to add a number of promising potential medicines to our pipeline and carry these into the clinic. And this pipeline is a balanced pipeline by stage of development, but it's also a highly diversified pipeline by mechanism and by disease state. And that gives us great hope that we're going to be very successful going forward with this pipeline and continuing to add to it. And as I think Irie had said to you, there are a number of opportunities for many of the compounds in this pipeline in a variety of diseases. So, we're working through the transient, near-term effects of this environment, but our commitment and our optimism for our patients and our business is absolutely unchanged. It remains high,

Kevin C. Gorman: And I look forward to talking with you all in the coming weeks at different virtual banking meetings and in our one-on-one calls. Thank you again very much. This does conclude today's program. Thank you for your participation. You may disconnect.