Neurocrine Biosciences, Inc. (NBIX) Earnings Call Transcript & Summary

Okay. We will continue with the next session. Good morning, everyone. I'm Paul Choi, the SMid cap biotechnology analyst here at Goldman Sachs. I'm very pleased to host in our next session Neurocrine Biosciences. Joining us from management is Kevin Gorman, the CEO; and we are also pleased to have Eiry Roberts, the Chief Medical Officer, with us here as well from the West Coast. It's early there. So we definitely appreciate both of you joining us here for our morning session. As with the prior sessions here at the Goldman Sachs conference, I'll kick it off with some introductory remarks, then I'll turn it over to Kevin, after which we'll go into the Q&A session. If along the way, if any clients or investors have questions for Neurocrine, please feel free to submit them through the Goldman Sachs Research portal, and time permitting at the end, we'll read 1 or 2 questions and we'll let the company respond to them. Alternatively, you can e-mail the questions to me directly. And again, if we have a minute or 2 at the end, we'll squeeze them in. And with that, I'll turn it over to Kevin for some introductory opening remarks. Kevin?

Thank you, Paul. Really appreciate the invitation from you and from Goldman Sachs here. It's a shame that we're not holding this in person because it's going to be a beautiful day just up the way at Palos Verdes today. So too bad we're not meeting out here on the West Coast. Before I get started, Eiry and I will be making some forward-looking statements, so I'd like to direct everyone to our 10-Q for the appropriate cautions and warnings on the business. Thus far, this has been a challenging year for everyone. Neurocrine, no exception. But we've been in a very fortunate position in the timing of when we're starting clinical trials, actually only having a handful of clinical trials that were ongoing at the time that COVID hit. We have gone through the, as everyone has, the shutting down, if you will, except for our research labs, but basically pulling, everyone staying at home. And now we're going through the process of bringing people back, not the least of which is our sales force going back out in the field as they've done the last couple of weeks. But in that period of time, we've been, surprisingly to me, very productive in keeping going all those things that have been under our control, which is many, in our pipeline and in our commercial organization. In addition, what we have been able to enjoy is, actually the FDA, I have to continue giving a shout out to them, just how responsive they have been with everything on their plate. We've had several very important meetings with them during this period of time, not the least of which was the approval of ONGENTYS on time. And also the meetings that we had leading up to the complete agreement with crinecerfont's adult Phase III study and having that now kicking off a little later this year. So the FDA has been a very good partner and staying right on top of things with us all through this. So where we are today, which you wouldn't have predicted when all of this broke out, is that in just the last 1.5 months, we've had 2 more products approved, which is ONGENTYS and ORIAHNN. So that is with our partner, AbbVie. So that now in 3 years, 4 products approved now. And so with that, I'll pause, and we can get into the questions and go into each one of these things in more detail.

Sure. Sounds good. And thanks for that, Kevin. Maybe we'll start with the commercial piece of the business and maybe thinking about what is your flagship product, which is INGREZZA. And can you maybe give us your updated thoughts on how you think about sustaining and driving the growth here for the franchise? Especially given the performance in the first quarter where, given all the historical puts and takes, you delivered a very nice beat there. And how you think about driving it and sustaining growth here?

Yes, Paul. The first quarter, as you know, is always a very challenging quarter, always will be a challenging quarter. We have learned, over the first couple of Q1s, and I'd say probably one Q1, we had some real learnings on, because you can't count that first Q1 that you're out in. But we have a lot of learnings. We put a number of initiatives in place. They really paid off. But it continues to be a tale of 2 quarters in Q1. The first half is where the physician's office and our specialty pharma network is pretty much overwhelmed with all of the prior auths and reauthorizations for the specialty medicine. And then the second half of the quarter is when they get into a more normal rhythm of getting things filled and moving along. What we've -- and it gets worse and worse with every Q1 because the drug keeps becoming more and more successful. So it's just the price that you pay for having a growing franchise like this. As we've spoken several times before, this is a highly underdeveloped market. It is still a highly underdeveloped market. It is far from being a mature marketplace. We started out with maybe 2% to 3% of TD patients, and that's about 500,000 TD patients in the U.S. being diagnosed when we launched. We think now we're in the high teens in that diagnosis. So that's good progress, but still far from being able to get the diagnosis rate up there where you would expect it to be in the 80% to 90% range. And in addition, even within that 19% or 18%, however you want to try to cut some soft numbers there, the penetration that we have into that or VMAT2 antagonist as a whole, as a class, is actually quite low. It's only about 50% into there. So even when the physicians have recognized the TD symptoms, they have had the call to action in -- they're having the discussion with the patient, and then going in to treat the patient. Only half the time are they treating with the VMAT2 antagonist. And when they do, 3 quarters of the time, it is INGREZZA, which we're very pleased about. What are they doing the other half of the time? And this is yet another challenge that's in front of us and the one that we're -- that we deal with now. They're going back to what was a default on those very few occasions and old literature with no scientific backup to it prior to having INGREZZA, which was the first treatment ever for tardive dyskinesia. They're going back to, well, I'm going to treat this by manipulating the underlying antipsychotic. So they'll do 1 or 2 of 3 things with the underlying antipsychotic, which is what causes TD. If they're not a schizophrenic patient, so they're a bipolar patient, they have major depression, substance abuse, sleep problems, which actually are utilizing antipsychotics more than the schizophrenics, schizoaffective disorder population. So if they have that as their underlying diagnosis, they'll remove the antipsychotic, thinking that removing the offending agent, TD will go away, and it does not. They will reduce the dose of the antipsychotic or they'll replace 1 antipsychotic with another. And that does not do any good for TD. It may have a very short-term effect, but in the long term, no. And there's no evidence to support doing any of that. But again, old habits are very hard to break in medicine. And so we have -- what we do now is going to continue for still years to come. I know I sound like a broken record. It's all about education, education, education. We are still educating physician and importantly, other health care professionals within their offices, the nurse practitioners, the physician assistants, in order to recognize all the features of tardive dyskinesia. And not only then once they recognize them, but to feel confident that in our training with them and utilizing a bunch of local key opinion leaders and speakers, to help them understand what movements are not TD, because that's just as important as being able to recognize TD is to recognize other movements that are not tardive dyskinesia, such as Parkinsonism, whether it's the Parkinson's or a drug-induced Parkinsonism, because if you go too high in dose with an antipsychotic, you can get a Parkinson's-like tremor going. And there are many other tick disorders that it's important that they'd be able to distinguish. And so that takes time. And we're still going to be doing that for a long, long time. Once they get past, I feel comfortable that I can recognize it. Now they have to go through what is still for many, a very uncomfortable conversation with the patient, that you have this disease. It's called tardive dyskinesia. It's irreversible. It was caused by a drug that you need to continue taking and of times, it's that physician who prescribed that drug, the antipsychotic. And then offer them a solution which is -- and hopefully, it's INGREZZA that they're offering. They can meet resistance from a patient, as you could imagine, in that the patient says is on 7 or 8 other daily drugs, and to get another one. And also the patient may resent the fact that a drug that they were already prescribed caused this. What is this drug going to cause? So that -- it's yet another level that the treating physician needs to get over themselves and get over with the patient is to then have that discussion with them and talk to them more about the benefits, obviously the risks with any medication, but INGREZZA is a well, well tolerated drug. But to go over all the benefits and really lay it out clearly for that patient. And if they're there with a loved one or caregiver, to be able to talk to them about it. And then it's ultimately up to that patient in order to take the prescription and have the drug available to them. So there you can see that there's a lot of layers to this onion. We attack them sequentially through education efforts. And then as I said, once you get all the way there, you still have a healthy number of patients that aren't being treated adequately or appropriately with a VMAT2 antagonist.

Got it. So yes, it's pretty clear. Just based on the numbers you've thrown out, Kevin, that even within the diagnosed population, there's still plenty of opportunity to ramp within that -- with that patient pool alone versus even driving the diagnosis rate, as you talked about. I want to maybe talk about another aspect of commercialization here, which is, just given the environment, what have you found the role of sort of telemedicine to be? Is it different between neurologists and psychiatrists? And as we look over the course of 2020, how does that sort of figure in terms of your commercial plan? Are you guys looking for perhaps a second wave of COVID? Is that in your plan? And do you plan to rely on telemedicine here?

Yes. So what I'll do is Eiry will be able -- I'll let her talk about just the practice there, and then I'll go into how we're handling that from a commercial aspect. But Eiry, obviously, all of our MSLs report in to her. And so she's very close to the utilization of telemedicine. Eiry?

Hi, Paul. Thanks for having us today, and hi to everybody. So yes, I think telemedicine is obviously very important, particularly in the context of this COVID-19 pandemic that we find ourselves in. But I think it's fair to say that telemedicine has been important for psychiatrists, at least, for a long period of time already. And in fact, even in terms of looking at the psychiatric societies and the regulators, they were interested in finding paths and ways to enable telepsychiatry more for the psychiatric patient and the prescriber, even before the COVID-19 environment. What I think we found, though, is that in the face of COVID-19, there's been a real acceleration in terms of approving acceptable methods of diagnosis and rating scales and things of that sort. And so from that point of view, it's really made it much easier and more straightforward for the psychiatrists to be able to build that subsequently for the interactions that they're having with their patients around telemedicine. That is different in the neurologist's office. I think we had not seen the same degree of telemedicine use in the neurology office. And in fact, although there is a change to adopting that, and we are seeing that as we work with the neurologists both in supporting INGREZZA and also with our program of molecules that we have in the pipeline, it is slower. And indeed, we are seeing that neurologists are quite keen to get their patients back into the clinic. And in fact, as we start to open some of our studies again, we're finding that neurologists are more open to that and open to -- obviously, when it's appropriate and safe to do so, to having the patients back in its clinic. But I mean, I think the other thing that's really interesting about telemedicine is particularly video-based telemedicine. And the way in which a lot of these offices are managing this is that they have -- the physician may not be in the office. But there is an opportunity for patients to come to a video-based environment. And so they can then interact with their clinician in that way. Well, of course, in a usual psychiatry interview and interaction, you don't have a great deal of eye contact between the patient and the prescribing physician because it's a listening disorder in a lot of circumstances and a listening practice. And so here, we're having a situation where people are straight away starting to potentially see movements in the face and differences that they might not have seen before as they're interacting with their patients. And so actually, I think it's a really great opportunity for a disorder like tardive dyskinesia. And we know that there are efforts that we're involved with and that we're helping to promote to look at video protocols that go beyond obviously looking at the face and enabling the involvement of carers or partners or relatives in the process as well. So I do think this is here to stay for us. I think it's a great opportunity. I think it will evolve, obviously, as more patients do get back into the clinic at the -- after the pandemic has hopefully resolved. But as an opportunity, I think it's a really great one for us, and we're capturing it in every way we can through our Medical Affairs organization, education and also through our commercial organization. Kevin, I don't know what you wanted to add there.

Yes. So from a commercial standpoint, Paul, telemedicine is, and the utilization of it by psychiatrists particularly, is nothing new to us. We realize that the time of launch that psychiatrists use telemedicine more than any specialty does. We went into it, looking at it, understanding it and I would say back then, as we looked at it, understood it, talked to physicians, really educated ourselves up on it, started exploring ways that we can take advantage of that, if you will, as an educational tool and also as a way to assist the physician. There were a couple of real barriers back then. Number one, because of the rules, the laws involved, the patient had to go to a special center that had all the link-ups and the secure line to go into the physician's portal. And number two, that the rules governing reimbursement for the physician were pretty stringent and a number of them, to give you an idea, is that if the doctor is along anywhere in a state line, they can't get reimbursed by treating a patient that's just over that state line. Well, CMS reacted very quickly when the pandemic broke out. They relieved a lot of these rules so that the patient can just use their smartphone, can use their computer, so they can interact that way with the physician. The rules for reimbursement were eased quite a bit, as were several dozen other rules. Now let's see how those stick, number one. But what we have been able to do since we did all that previous work and understood telemedicine quite well, as our field force worked from home, we then tapped into all those learnings. We were able to take all of the materials that the sales force uses in an in-office discussion with the providers to having that all digital. And that all happened in less than a week with our sales team. And they did an incredible job. As we said on our Q1 call, which we delayed so that we could see what April was looking like, because the pandemic and our pulling the field out really only happened in the last couple of weeks of Q1, we wanted to be able to give investors more of a flavor of what are we seeing in the midst of all this. Because you could have imagined that as your sales team, as offices were closing up and even telemedicine at times wasn't being utilized, the -- their ability, their touches in with the doctors and their offices dropped precipitously, dropped about 70%, like everyone else was, there for a while. And the fear would be, well, what's that going to say for sales? And what is it going to say, particularly with new diagnoses and new prescriptions? What we found was that it was nowhere near that. New scripts held up quite well. Refills held up exceptionally well. We've seen that quarter-over-quarter, year-over-year now, patients and their physicians really understand and appreciate the effectiveness of this drug. So once they are on it, they stay on it at a very, very high level. But it was that NRx piece. That was the one that we needed to see, and we saw that it held up, like I say, exceptionally well. And so then we held our earnings call at that point in time to do that. We keep rolling out more initiatives. We -- as Eiry said, there's no going back from this. So even as our reps are going out slowly into the field and it's discontinuous around the country, it's discontinuous within states, within particular regions, it's basically dictated by about 2 things. It is dictated by whatever the state and local laws are at the time, and it's dictated by the practices themselves. Are they open? If they are open, welcoming in sales reps. And there -- you don't just want to go in. You have to be going in when you can actually offer the value-added service. Is the practice -- they may welcome the rep in, but is the practice open enough so that you can still meet with several members of the practice, do the educational forms, the in-services that we do and be able to have a meaningful dialogue there? One thing that I will say about telemedicine, like Eiry had said. So the office is -- to complete that thought, the offices are still doing a mixture of both in person and telemedicine. And so therefore, the reps are doing quite a mixture still of maybe a couple of days a week out in the field and then the other times at home. Telemedicine is interesting in twofold. As Eiry said, you're -- the physician is actually able to focus on the patient, and they can see the oral-buccal-lingual movements that comprise probably about 85%, 90% of TD patients have those. But in addition, there's another phenomenon that takes place here that the doctor's office isn't telling us. Their no-shows have gone down a lot. So normally, if they were having in-office visits, they have a lot of patients that just don't show up to their visit. But on telemedicine, it's far less than that. And what we've also found is that even though our call numbers are down, the quality of the interaction with the physician and their staff via video is actually very high. You spend more time with them than you normally would in an in-office visit. So there's going to be trade-offs, but it's here to stay. So that's good. We will optimize both as time goes on.

Great. Maybe one of the other aspects, as people think about INGREZZA's growth over the intermediate to longer-term is the potential application in Huntington's here. So for either Kevin or for Eiry, can you maybe talk about how you think about the opportunity here? Is that major driver, in your view, of INGREZZA growth?

Yes. So Huntington's is not as large of an opportunity, let's say, as TD, but it's still a very important one for us. There's about 30,000 Huntington's patients in the United States. 90% of them suffer from movements, the chorea associated with Huntington's, and yet only a small fraction of them still today are treated with VMAT2 antagonist. And there are several that are approved in the market for Huntington's disease, and several of them are actually generic. So it's a different marketplace that we go into. But nevertheless, those features of INGREZZA that make it the dominant VMAT2 inhibitor of choice in the TD population, they're applicable straight over into the Huntington's population also, those aspects of INGREZZA. And I can let Eiry speak about that.

Yes. So that's absolutely right. And if you think about the profile of INGREZZA and you think about the challenges that Huntington's patients face, the fact that it is a simple once-a-day treatment paradigm and that the escalation system is very simple as well, with just 1 week at the 40 milligrams then escalating to 80 milligrams. It's really -- we shouldn't underestimate the advantage for patients of a once-a-day treatment. Because obviously, the chorea can often affect people's ability to swallow, particularly later in the disorder. And as a result, having to take multiple -- medication multiple times a day and having to change the dosing over time as many times as the VMAT2s might require is -- can be a real problem. And so -- and then in terms of the overall tolerability profile labeling of INGREZZA right now without the black box warning. That's also another differentiator that we see right now in -- for INGREZZA as a VMAT2 in the treatment of Huntington's. With respect to our study, we did put the Phase III registration study on pause in collaboration with the Huntington Study Group and our investigative group around the United States a couple of months ago as a result of the COVID-19 pandemic. We've been in constant contact with the -- our investigative sites in the Huntington Study Group, and I am pleased to say that we are putting together the plans to reopen enrollment in that study. It will vary around different parts of the country, obviously, depending on local regulations and the comfort level of the individual investigative sites because primarily, our primary focus is on the safety for patients and for the investigative sites themselves, followed obviously, secondly, by data integrity and the importance that has to being able to deliver a full registration package at the completion of the study.

Great. Obviously, investors spend a lot of time thinking about INGREZZA, but there are other, obviously, aspects to the Neurocrine story. And Kevin, you earlier talked about you're getting yet another product approved earlier this year, which is ONGENTYS for Parkinson's disease. Can you provide us maybe an update? You decided to delay the launch there on that. And just kind of how you're thinking about launch timing, sort of what are sort of the next steps that you want to clarify before deciding to go to your go-to-market strategy here?

Sure. We're real pleased with the label that we got for ONGENTYS from the agency. It displayed even -- there were a number of data sets that we wanted to have in there that sometimes may have been thought to be, "Boy, that's a reach to get those in." But the agency was very supportive of putting those in there because it helps even more guide the physician in their decision to use ONGENTYS. So we're real happy about that. ONGENTYS is going to be an important drug for the Parkinson's population. Because what it's going to do is it optimizes the gold standard for the treatment of Parkinson's disease, and that's levodopa as the gold standard. And what we -- just to backtrack, levodopa is never given alone. Levodopa in the -- there's about 1 million Parkinson's patients in the U.S., 800,000 of them are given levodopa/carbidopa in combination. And about 600,000 of them are having a problem with off times. And that's our patient population, is that 600,000 there. The COMT inhibitors that were created many, many, many years ago never fulfilled the promise of what COMT inhibition is. And COMT is an enzyme that in the periphery, breaks down levodopa such that it can't cross the blood-brain barrier now. It's not available to the synapse. Carbidopa, which is always used when prescribing levodopa, that breaks down another -- or that inhibits another enzyme, dopamine decarboxylase. That breaks down levodopa so that it can't reach its target in the periphery. So they're already taking care of 1 enzyme. You need to take care of both enzymes in order to optimize. And so that's what COMT inhibition brings to the patients. What our drug, ONGENTYS, brings to those patients is the fact that it's given once a day. So you can give it at nighttime and then it will -- with your last dose of levodopa/carbidopa for the day, and that will allow your levodopa to be functioning all the way through the night and into the morning so that you wake up without an extreme slowness or even potentially being frozen. And then you take your next dose of levodopa/carbidopa, and that lasts you all the way through the day. Significant reduction in off time without any appreciable on time with troublesome dyskinesia because of too much levodopa in the synapse. It was not ideal timing in the middle, when we got our approval, to be able to launch ONGENTYS for a variety of reasons. While we were ready with all the training materials, the sales team had done their at-home training already. We were going to be bringing them all together in 1 place. There would have been well over 300 field representatives coming together in 1 place then to do the entire launch meeting to get further training. Obviously, you can't do that. All of the offices were closed. There was -- the neurology offices were very buttoned up tight. And that's who is going to be the prescribers of ONGENTYS, our movement disorder specialists, neurologists, and those, we call on all of them throughout the entire United States right now with INGREZZA. So that was not ideal to be able to try to launch there. But in addition, our partner, BIAL, who invented the drug, had an approval of it nearly 3 years ago throughout Europe. They're 100% responsible for our supply chain. And they had an incident at one of their manufacturing facilities in Europe. And so that then, we already had our launch supplies, but what that put into question is when is our resupply? Can we absolutely depend on when the resupplies are coming throughout 2021? Because you never want to be in a situation where you've launched a drug, and then now you may not be able to resupply the drug, and you have patients on drug and you may not be able to keep them on drug. So as I've said at the beginning of the year, in January, when first announcing this, I said that it's going to be in June, July time frame, in closely contact with BIAL that we'll find out exactly the status, and then we can give you an exact timing of when we would launch. I don't have that yet here in just about mid-June. So it remains that I'm saying later this year is the best that I can do right now in giving that kind of guidance.

Great. Yes, I think it makes sense to mitigate that risk first before going to market. That's totally logical there. So in addition to ONGENTYS and INGREZZA and your GnRH franchise, you potentially have a fourth leg here, which is in CAH. And maybe bringing back Eiry to the conversation here, just this past weekend was the ENDO Meeting. I was wondering, can you maybe talk a little bit about the data you presented there with regard to crinecerfont, which is the new name for 74788? And how has that informed your discussions with the FDA and the EMA, given that this potentially can be a global product in terms of the trial design?

Yes. Thanks, Paul. Well, yes, it's a very exciting week for us actually, and Dr. Rich Auchus, who is our principal investigator on the Phase II proof-of-concept dose-finding study for crinecerfont in adult patients presented the full data set at the ENDO Meeting online on Monday. We had a few challenges. I think the ENDO site crashed a couple of times and things like that. And so it's obviously not an ideal situation, but we would love to do that in person, but we were very pleased with the outcome and with the data. So there's really 3 things that we were most pleased about. The first was, obviously, in that dose-finding study, we looked at 4 cohorts of 14 days of dosing of crinecerfont in adult patients with congenital adrenal hyperplasia caused by 21-hydroxylase deficiency. And the patient population in that study, it's important to note as well, was one where they were already on superphysiologic doses of steroids to control their disease. But even in the face of those high-dose steroids, they had essentially uncontrolled disease as measured by high levels of 17-hydroxyprogesterone at entry into the study. And what we were most impressed with was we saw across all dosing cohorts a very meaningful reduction of the 17-hydroxyprogesterone and ACTH levels, which are key biomarkers or biomarker hormone levels that are representative of the disease control. In addition, though, we were really pleased to see a very clear dose response on the downstream androgen, androstenedione levels. And if you think about the implications of congenital adrenal hyperplasia in terms of clinical outcomes of patients, the androgen levels, including androstenedione, testosterone for women, those are really important in terms of being related to the problems that patients experience with congenital adrenal hyperplasia, such as growth abnormalities and final height abnormality in pediatrics. Then subsequently, a lot of the infertility, hirsutism and acne and other significant issues that patients experience. And so it was really great to see, in a patient population that was essentially coming in poorly controlled, that we could get good control of those hormone levels in just after 14 days of dosing. So with those data in hand -- and particularly, the other thing I'd add is that the cohort 4, which was the highest dose that we tested of 100 milligrams twice a day, we had -- a 75% of that population had at least a 50% reduction in all of those hormones across the board, and 60% has a mean reduction of the androstenedione level. So very encouraging data. With those data in hand, obviously we've had that for a little while, we were able to interact with the regulators. Kevin mentioned earlier that we got to agreement and finalization of a single Phase III pivotal study in adults with the FDA and then had interactions in Europe to enable us to go forward in Europe as well. And we're now working on implementing that Phase III study, which we will be starting in the second half of this year. We haven't talked a lot about the study design for the Phase III study as yet. Fairly soon, that will be in clinicaltrials.gov, and people will be able to see that in a lot more clarity. I will say, however, though, that the hormone levels themselves, the 17-hydroxyprogesterone, ACTH and androstenedione, will remain a very important part of what we're looking at in this patient population moving forward. It's how clinicians and patients manage their disease day-to-day. And so -- but in addition, given that the only current and available treatment is high-dose steroids for these patients, we're also very keen to be able to understand in the context of our next study how we can reduce those high levels of steroids for patients while still maintaining control of the hormones because everybody knows, in CAH, as in other diseases like congestive pulmonary disease or rheumatoid arthritis, long doses of -- high doses of steroids -- long periods of time, high doses of steroids can really be problematic in terms of obesity, metabolic syndrome, osteoporosis and other really bad clinical sequelae. So we want to be able to address that as well.

Yes. And so Paul, the goal of the Phase III program, as Eiry just said, we have a drug that we've shown now can actually treat the underlying disease itself. Now what we have to show is that the treatment for that disease that we want to bring that, if you will, under control to bring those high doses of steroids that they have to take down significantly. And this -- the CAH program, this is where we hope that, that's going to internationalize Neurocrine. There's approximately 30,000 patients in the United States who have CAH. There is about the same number over in Europe. That's a very tractable set of patients, especially in Europe, for us since they keep such good databases on those patients since there's only a few centers of excellence there. So we see that as that where we are today as a company, we can now go into Europe, not only just from Eiry's organization in clinical development, but into the commercial organization as well. And Eiry can also say just a couple of words. That's the adult population. But what is crucial is being able to treat the children as early as possible. And that's in our Phase II that we have ongoing. And Eiry, if you're willing to take a moment there?

Yes. So we do have -- thank you, Kevin. We also have a Phase II dose-finding proof-of-concept study ongoing in pediatric subjects as well. And we had put that study on pause as part of the COVID-19 pandemic response as well. But we're working to reopen the sites there right now as well there's a lot of interest in continuing to get additional patients into that study. However, in parallel with that study being ongoing, we've already been working on our registration plan for pediatrics. It is a very important part of the plan. That will also be a global effort. And we're moving that forward as rapidly as we can based on both the data that we saw this week and any learning that we're able to get from that -- the pediatric proof-of-concept study. We've no reason to believe that the disease is different in pediatrics from in adults and so we do believe that the adult data will be highly applicable to supporting the pediatric indication as well.

Great. Unfortunately, we've come up on time here. So we'll have to end it on that note. My thanks again to Kevin and Eiry and Neurocrine for participating here in the Goldman Sachs Health Care Conference, and we'll have to end it on that. Thank you very much, Kevin and Eiry.

Thank you. Thank you. Take care. Bye.

Thank you, Paul. Take care.