Neurocrine Biosciences, Inc. (NBIX) Q2 2016 Earnings Report, Transcript and Summary

Good day everyone and welcome to today’s Neurocrine Biosciences Reports Second Quarter 2016 Results Conference Call. At this time all participants are in a listen only mode. Later, you will have the opportunity to ask questions during the question-and-answer session. [Operator Instructions] Please note this call maybe recorded. [Operator Instructions] It is now my pleasure to turn today's program over to Mr. Kevin Gorman, please go ahead sir.

Thank you very much and welcome everyone to our second-quarter earnings call. I'm joined today by Tim Coughlin our CFO and Chris O'Brien, our CMO. Before we get started Jane could you please read our Safe Harbor statement.

Yes, good afternoon. I want to remind you of Neurocrine's Safe Harbor cautions. Certain statements made in the course of this conference call that state the company's or management's intentions, hopes, beliefs, expectations or predictions of the future are forward-looking statements, which are subject to risks and uncertainties. Information concerning factors that could cause actual results to differ materially from those contained in or implied by the forward-looking statements is contained in the Company's SEC filings including but not limited to the company's annual report on Form 10-K and quarterly reports on Form 10-Q. Copies of these filings may be obtained by visiting the Investor Relations page on the Company's website at neurocrine.com. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances. Kevin?

Thank you Jane, it's been an extremely busy quarter for us as you can imagine we have been very busy readying our NDA submission for the valbenazine for tardive dyskinesia. In addition, very active in building out our commercial group and also our medical affairs group has been active on multiple fronts in working with the medical community who are at the forefront of treating these patients with this very serious disorder. Chris will go into that in a bit of detail. In addition we've had several milestones with our KINECT 3 and our KINECT 4 clinical programs and Chris will go into more detail there. And then finally in my opening marks, I’d also like to say that about two to three weeks ago we had a very good meeting with our partner AbbVie on our elagolix program their elagolix program I might add also and very pleased, couldn't be happier with the level of enthusiasm, the amount of commitment and the tremendous resources they are putting towards that program. It truly indicates that this is a multibillion dollar opportunity for them and it is very nice to see the team that they have working on that and how it is expanded even just since our last meeting. So what I'd like to do now is, I would like to turn this call over to Tim and he can take you through the financials.

Thanks Kevin and good afternoon everyone, thanks for dialing into a second quarter 2016 earnings call. This quarter is very straightforward from a fiscal perspective, so my comments will be brief. We had another very productive quarter as Kevin already mentioned with most of it spend on compiling and preparing the NDA as well as commercial preparation. This is reflected in the financials of the significant increase in expenses for both year-over-year and quarter over quarter numbers. From a cash perspective we ended the second quarter with over $416 million in cash, investments and receivables, a very strong financial position. Our loss for the quarter was $40.3 million or $0.46 per share this compares to loss of $24 million or $0.28 per share for the second quarter of 2015. Our net loss for the first half of 2016 was $59.5 million compared to loss of $25.2 million for the first half of 2015. When comparing expenses from 2015 to 2016 for both the standalone second quarter as well as year-to-date we’ve shown increase of $16.5 million for the quarter and $30.3 million for the first half of 2016 respectively. R&D expenses in the second quarter increased by $8.2 million over the comparable period in 2015 and there are $15.5 million year-to-date 2016 compared to 2015. The primary drivers of these increases in R&D expenses are the costs associated with completing the clinical effects in tardive dyskinesia and our NDA preparation activities. Expenses during the second quarter of 2016 including the NDA filing fee of $2.4 million as well as other scientific consulting cots which increased by almost $3 million over last year. This increase in scientific consulting was primarily related to comparing the valbenazine NDA for tardive dyskinesia. We also saw external development costs increases, clinical efforts continued across tardive dyskinesia, Tourette and our essential tremor programs. General administrative expense also increased quarter over quarter and for the first six months of 2016 compared to the same period in 2015 was up $8.4 million for the quarter and $14.8 million year-to-date. The main driver of this increase was personnel related expenses which were up approximately $8 million for six months of the year. Half of this increase was related to increased share based compensation expense. The balance of the increase in G&A cost was driven by pre-commercialization activities related to valbenazine and these costs were incurred across our Medical Science Liaison group, marketing health economics [indiscernible] and sales. Looking forward we expect overall expenses to continue to increase in each of the two remaining quarters of 2016, mainly concentrated in general and administrative expenses. In summary, another solid operational quarter highlighted by a significant progress across all facets of the company and we ended it in an excellent capital position. So with that I will conclude my prepared remarks and for those looking for additional details, our Q is on file with the SEC and for now I will turn it back over to Kevin.

Thank you Tim as you can see there are no surprises there in our financials. Now I'd like to turn it over to Chris.

Thanks Kevin and thanks for the participants who are joining the call this afternoon. Let me start with elagolix, Kevin mentioned the recent meeting between Neurocrine and AbbVie and indeed now that the two Phase III endometriosis trials have completed the on treatment portion of the studies and the results have been shared with the Neurocrine team. We’re really happy with what we see, these confirm what AbbVie has already released namely the efficacy and safety results that are very conducive for product like this moving forward it is hard to understanding they have a fairly expensive publication plan in place and in fact I think for those who are interested at the upcoming American Society Of Reproductive Medicine, the ASRM meetings that are coming up in Atlanta, sorry Salt Lake City later this year they should be having extensive amount of data for their clinical trials with elagolix. So good progress, on track, we’re very lucky to have them as a partner and look forward to additional data to become available. Our next program to talk about is congenital adrenal hyperplasia program as we've discussed in the past, we had nice proof of concept with our initial 860 molecule, we had finding in juvenile toxicology study that we conducted which led us to elect to take a follow on molecule forward that doesn't have that finding. And we are working intently to have all the materials ready for new IND filing later this year. So that is moving along as scheduled. Third program to talk about is the essential tremor program, we successfully completed the single ascending dose Phase I study in healthy volunteers earlier this year, very pleased with what we got from that mainly the safety and PK data that we are interested in and that has allowed us to move on to the next study which is Phase I multiple ascending dose trial in healthy volunteers that study queued up at the start in the near future and the information from that trial will let us make a determination about doing into a trial in patients with the central tremor as the next study after that. So, that’s on track obviously the next piece of information from that study would be about our impression of the safety and tolerability in PK after repeated dosing of the molecule and then our interactions with the FDA going into the next studies. We have been continuing to work with our colleagues in consulting in the field of tremor and have tremendous enthusiasm from talking to them, they are very eager to get a new molecule into the clinic to help the 8 to 10 million people in the US with ET, so eager to keep that going forward. So let’s move on now to the main focus of our work, keeps all of us busy and very excited that is valbenazine program, we've made some considerable strides over the last few months by far and away as Kevin pointed out and Tim emphasized the overwhelming focus of work at every one here at Neurocrine and some of our consultants and vendors have been the NDA preparation and submission plan, it is the primary focus, we are on track and very pleased with the progress that we are making with this submission. Now, I felt that it might be useful to do as to walk through kind of the scope of some of the studies that contribute to the NDA. So I'll talk about a range of activities we’ve conducted over 20 clinical trials with valbenazine across Phase I, Phase II and Phase III and this is a very robust collection of data for safety and efficacy. The phase I study is of course are the fairly classical ones that you would do, I would emphasize that more recently we have completed some of the special types of phase I studies that one does for an NDA. So for example, a phase I study of valbenazine in subjects with no existing emphatic impairment dosed with valbenazine this helps us understand dosing metabolism and exposure and people with liver disease and this kind of data then helps the FDA Neurocrine determine dosing and people that kind of disease. We have completed a number of phase I drug interaction studies, all of these have been designed either to look at the impact of valbenazine on concomitant medication with the known enzyme dependence or vice versa, the effect of concomitant medication on valbenazine exposure and clearance and those have been completed successfully. We've also completed our phase I study on cardiac repolarization this was using supra-therapeutic doses of valbenazine in healthy volunteers and the study confirmed what we have pointed out at earlier times namely in our early phase I studies we see a slightly positive slope for the relationship of plasma concentration and QTCF. This translate into about a 3 millisecond QTCF change on 80 milligram dose. We've also confirmed that there is no clinically significant effect on QTCF in our phase II and phase III studies, we have done an extensive analysis of ECG data collected in triplicate on patients that are on long-term clinical trials as well as the placebo controlled portion of these trials and very satisfied with the output of that analysis. Talking about KINECT 3, I’ll mention the - as we speak the last subject is completing their last study visit for the KINECT 3 trial. We are very grateful to the patients obviously the caregivers, the investigators and the coordinators who have helped make this study a reality. There is no president really for this kind of large sponsor driven well controlled registration trial for TD historically, so it was - it’s really been a effort on many people's part and we’re very grateful for everything the team has done. Obviously this data is key and as I'll mention in a moment we hope to share some of this long-term efficacy and safety data in upcoming scientific meetings later this year. The KINECT 4 study is a one your open-label safety study in patients with tardive dyskinesia as you may be aware of the enrolment for the study closed earlier this year, patients will continue - the subjects will continue in this trial throughout the year this is not a rate limiting gatekeeping step for NDA submission this is something that can continue to run even after NDA submission. Now, with KINECT 3 and KINECT 4 studies, although they were up to one year duration, we continue to have requests from investigators and from subjects and caregivers that subjects be given an opportunity to have continued access to valbenazine so we set up the study that we called the rollover study if you look on clinicaltrials.gov it's NBI-98854-1506, this was a really good opportunity not only to help patients of course but to continue to gather additional safety data over extended periods of time. So it's conceivable that patients will have access to valbenazine up until the time of product launch, [indiscernible] it gets approved as planned. So that study is going well and subjects will continue to have an opportunity to involve in that study up until the time of approval. Obviously all of the data that comes from these phase I and phase II and phase III studies is incorporated into the NDA and I know people often ask me what's the label going to look like and what is the dosing language and the risk language and all that obviously has to come from the review process with the FDA, recall that we do have a breakthrough therapy designation, we have had considerable discussion and interactions with this psychiatric revision at the FDA that process of communication has been going quite well but at the end of the day it comes down to their review of the entice safety and efficacy package as to whether the drug not only gets approved but what language goes in the label, so we’ll need to wait and see how that unfolds. Obviously in parallel to the tardive dyskinesia effort is our Tourette syndrome program and we have the two ongoing placebo-controlled phase II trials the T-Force study also known as the 1505 study in adults with Tourette and the T-Force GREEN study the 1501 study those are about going well very happy a little surprised that the adult study was recruiting a little faster than I thought it would that's going well so we should have data - topline data by end of the year if things continue to go well for that study. And for the T-Force GREEN study we’re continuing to bring on the sites that we had identified, so we're not quite complete in getting them all up and running due to some of the challenges and working with academic institutions and local IRBs. But that is going well, recruiting is going well, I'm very happy with the characteristics of the kids with TS that are joining this study as well as the adults. They have moderate to severe Tourette Syndrome based on the Global Tic Severity Scale they are very appropriate candidates for these clinical trials. And so far, we’re very pleased with the safety and tolerability of enrolment in these studies. That T-Force GREEN study we would expect topline data sometime around turn of the year depending on how the rest of recruitment goes. Now, we also got feedback from the Tourette investigators, Tourette Syndrome subjects and their caregivers, families that they wanted to access to valbenazine after participating in placebo-controlled trial so we designed and have just now implemented the 1601 study called T-Fusion and I think this was in our press release last week and should pop on clinicaltrials.gov shortly we don't control when it gets posted but it should be sometimes in the next few days I would think if you want some more details. This is an extension study for children or adults with Tourette that have been completed the T-Force or the T-Force screen study they can roll over into the T-Fusion study as an extension trial and so we're really happy about that as our investigators and subjects. So, that's the summary of the valbenazine clinical trial activity. It’s worth also pointing out as Kevin mentioned the medical affairs group has been very busy, our field based MSLs have been calling on scientific leaders throughout the country getting learning from them kind of what’s the state-of-the-art of what's happening in TD diagnosis and then management they have been sharing the information from the what’s been published about valbenazine from our recent publications as well as the recent presentations that the American Academy of Neurology, American Psychiatric Association and the Movement Disorder Society we've also submitted I should mention or in the process of submitting some additional presentations that we hope will be accepted for upcoming scientific meetings later in the second half of this year, these are presentations regarding long-term efficacy of valbenazine, long-term safety of valbenazine and additional work on pharmacology and pharmacokinetics so some, a rich of trove of information that is being prepared for public dissemination. So, they will continue to work, the medical affairs team is quite busy for MSLs publication, health economics and outcomes and a variety of other activities. Well, I think probably what I should do is stop there Kevin and…

So, thank you Chris your group along with regulatory have done an outstanding job in keeping all of our programs on track moving them forward while simultaneously putting together the NDA submission and I might add simultaneously getting ready for a potential advisory committee meeting which we don't know whether we would have or not but we have to plan well in advance as we've done in being ready for that. Right now, I would like to open it up for questions.

[Operator Instructions] And we will take our first question from Geoff Meacham with Barclays. Please go ahead.

This is Evan [ph] on Geoff. Thanks so much for taking my question and congrats on the progress. I just think one, regarding the safety, and I'm sure you - we talked about this a lot but with the recent not so recent CRLs for the Teva product, what are some of the things that you’re doing proactively to ensure that you don't have a similar safety issue. I know the molecules are slightly different but how should we think about kind of the high-level safety test forward them?

Evan just to be clear the complete response letter that Teva got wasn't specifically a safety issue it was as I understand it, it was a question about had the metabolites of SD-809 been adequately characterized and we understand they have a plan in place to address that question. That's a nonissue for us because our molecule is quite different and we don't have any unknowns of about our metabolites, those have been characterized from the very beginning of our pre-clinical program through our IND opening interactions with the FDA and in every step along the way those have been discussed data provided and clarified so that is a nonissue for us.

And I guess just one with the central tremor program, what’s really the gating factor in the second trial that you need to see to move into help unsick patients?

I'm looking for making sure that I have adequate to characterized the PK profile of repeated doses that I know kind of what the variability of it exposure is, obviously we do a lot of work in animal model and parasite systems et cetera to project what we think exposure is with humans and how clearance will be but I want be able to predict quite accurately what kind of exposure range I’m going to get, make sure that I'm within safety margins that I need to be given the amount of preclinical data that’s available and that I'm in a exposure range of our drug that I think reflects what we saw in our animal models of the central tremor that we have adequate exposure to really make a proof of concept assessment. So, whenever you go from a single dose to a repeated dose, say a week of dosing, you really need to have that well characterized before you go into patients otherwise that proof of concept may have been a study that’s not informative.

We will take our next question from Ian Somaiya with BMO. Please go ahead.

I have four questions if you don't mind I'm just going to state them all because I'm going to forget otherwise. First, if you just share with us sort of your thoughts on regulatory review timeline should be expect an eight-month clock for valbenazine in TD. Second, from a sort of a commercial viewpoint challenges in developing this market given you're going to be first to get approval. Third, from a dosing standpoint, do you expect there to be any overlap with Tourette, so any - I know you haven't disclosed the exact doses in the Tourette phase II trial. And Chris what are your goes for the Tourette program, are they same for adults and the adolescence trial?

Good question, thank you. Maybe we can share these a little bit, the first one the review timeline, as I think you are aware most drugs that are granted breakthrough therapy designation do receive what's called priority review. So as you correctly pointed out eight months reflects the initial two-month and the clock and then the six month review cycle. So we would - we have requested that, we would assume that that is highly probable but it is always a decision that is made by the FDA once they have the NDA in hand. So we won't know that for sure until they actually let us know what our PDUFA date is. So that would be the anticipated timeline. The second question was about market challenges for TD and I'm happy to talk about but let Tim or Kevin talk about it.

So we’re doing all the work right now, we look at it as an action opportunity, right now we are out with our MSL teams, I’ll say conditioning the prescribers and educating advising we’re doing all the work from a payer standpoint, health economics. So we'll be well prepared at the point of approval to launch into this market. When we look at how the uptick is going to be we've always said this is in a three year to peak but we will have I should say after couple of years if we stick to our timelines in the clinic, we'll have Tourettes as a fast follower. So we’re excited about the opportunity. There are a lot of patients out there, but again, when we look at the TD market, the question we get most from the investment community is what's the pricing going to be, and our response has been consistent. We will tell you the pricing once we get the approval. So we look at it as a significant opportunity. It’s an untapped market and we have a - we believe a lot of demand, and that's been reflected in some of the rollover clinical trials that Chris is running as our current rollover studies are almost nearing capacity, we may have to enlarge it.

And what I would add to what Tim has said and Chris a little bit in his opening remarks is that, we're really working closely with the scientific leaders out there and it's not just talking to them, it’s listening to them and what they have to say, there has been a lot of learnings there and there is a lot of enthusiasm from them. Really though, our MSL team needs to then and what they’re doing now is working with them and now going deeper down in into where a lot of your prescribing physicians are going to be in, utilizing our scientific leaders to help with access there in education that's going on there. So, both from a publication standpoint, from the one-on-one meetings, from group meetings, and then eventually through medical education, we’ll be going deeper and deeper into the marketplace.

The main challenge is, there has been no treatment for Tardive Dyskinesia. There has been a disincentive to diagnose Tardive Dyskinesia and therefore, it's been kind of a hidden entity and we know there, the patients are there. We see them, they enroll in our trials, we go out and look for them and we find them. So the educational piece will be, as Tim said, kind of a slow, steady rise as we are successful in that realm.

And I'm going to take number three just real quickly, and then let Chris finish off and as far as the dosing overlap at Tourette syndrome, Ian, where that sure you are coming from and where it’s important is will safety database from the TD program be able to translate over into the Tourettes program and yes, it will.

Yes. To the extent that, for adults, the adults are completely overlapping. All the long-term safety data that we have for adults with PD is very much supportive of adults with Tourettes. We’ve made appropriate adjustments to doses for the children and adolescents in our pediatric program, based on basically body size. So there is a corresponding adjustment of dose there. But we haven't disclosed the details of that. And then obviously kids are not just small adults, so they have their own unique safety requirements and if I were the FDA, I’d want more safety data on - from the kid’s studies than I would need from the adult studies.

What is the regulatory path in adults versus the adolescents or kids?

Yes. So obviously that has to be agreed to with the FDA and what we’ve discussed with them to date is that we will bring them data from these 2 phase II studies and depending on how robust the efficacy is and what the safety profile is, that will determine what our options are going forward. I mean you could imagine in the best case scenario, the adult process would be quite a bit quicker if you believe that the long-term Tardive Dyskinesia safety data would support that TS market than as an SNDA basically far Tourettes, that would be a lot faster and less onerous a submission than a full program. The kids program, I would expect that to be a more traditional safety and efficacy package. Now, their last question was on my goals for Tourettes, I wasn't quite sure.

Yes, I mean, I think you sort of answered that, just in terms of, if the goals were the same for the Phase II program in adults versus the adolescent population?

So, yes, I think we addressed that.

And we'll take our next question from Charles Duncan with Piper Jaffray. Please go ahead.

Hi, guys. Thanks for taking the question and thanks for the thorough overview. In the prepared remarks, I just had a couple of quick questions, one of them, though, is kind of a clarification on Valbenazine NDA filing plan. So I was wondering if you were talking about filing the NDA by the end of the year or seeing it perhaps accepted for review by the end of this year.

Charles, I think that the terminology, the only difference between this press release and then the other press releases, all we did was we are using the appropriate language. I think we got into a shorthand previously. It has nothing to do with timelines or expectation changes. What a sponsor does is submits the NDA, what the FDA does is accepts it for filing. So we’re just using the appropriate regulatory language.

But Charles, you picked up on the nuance that we thought people would pick up on. So let’s use a two-month cycle after you submit to file and we anticipate having both of those happen this year.

Okay, super. I appreciate the clarification. And then I'm not sure, but Ian may have asked this question. Wondering if you could provide us any additional color you’ve heard in terms of feedback on TD awareness and I guess what I'm really wondering is have you heard any new concerns or different concerns regarding psychiatrist recognition of TD or at least being more focused on psychiatric stabilization over TD burden or do you think that they are willing to use an effective tool like Valbenazine could be?

Obviously, Charles, that is an intense focus, a lot of the market research that is going on right now and also what the medical affairs teams is engaged in discussions with docs out there. I think you correctly identified three key pieces that in the psychiatrist community, the question is, what is the most important thing and it has been and probably always will be the most important thing is stabilizing the underlying psychiatric condition. Then the next question is, is TD recognized and the third question is, is the risk benefit of managing TD in keeping with the need to keep psychiatric stabilized. And I tell you, if you go out and talk to 100 docs or psychiatrists, you’ll find examples where you’ll find some docs say TD doesn't exist anymore, we don't see it. You’ll find other docs say, this problem is more pervasive than I ever realized it was. I’m seeing TD is commonly now as I did 20 years ago, but it’s just not as severe. You’ll then see docs that say, yes, my patients have TD, but I don't want to do anything that is going to destabilize them and obviously that was a key focus of our trial designs is that we had a simple once-a-day add-on medication that required no changes in underlying therapy and we showed no worsening of psychiatric state. So, once you talk to docs about what Valbenazine has shown in trials to date, that is when as Kevin said, they start to get excited about it. They say, you mean, I can use something that’s once-a-day, easy to use and you’ve shown me videos about the phenomenology of what Tardive Dyskinesia is. I can do this safely. Then, their attitude changes. But this is obviously part of what has to happen for successful launch of the drug.

Okay, that's helpful. I appreciate that Chris. And my last question is just jumping over to the Tourette Syndrome program, I’m so kind of wondering as you look at the pediatric disease versus, say, the adolescent or adult disease, are you detecting any or do you have any additional information in terms of ideology or really severity and the potential for effective treatment with Valbenazine?

So, I think, as we’ve discussed before, Charles, we believe the ideology of Tourettes in kids and adults is the same. What we don't understand is as most children outgrow their disruptive tics, by the time they are in adulthood, some don't. And we don't fully understand the why of that. Is there an underlying difference in pathophysiology? I don't know. But we think Tourettes and Tics, they all have the potential to respond to VMAT2 inhibition with Valbenazine, regardless of whether they are adults or kids and that's what these trials are designed to do. I haven't, I have no reason to believe that a six-year-old kid versus a 16-year-old adolescent versus a 36-year-old adult with tics would not respond to the appropriate dose of Valbenazine. Anecdotally, we are hearing that in these phase II trials, patients are doing better. Obviously they are blinded, placebo-controlled trials, but I am not, I don't think that's a big hurdle or a big issue. Of all the things I worry about, that's not one of them.

I think qualitatively, Chris, the characteristics of the people getting in the trials are?

Yes. One thing that we've been, and I think I mentioned this maybe on our last call, we look carefully at the blinded baseline data to make sure that the patient characteristics are appropriate for these studies and would support the calculations and sample size estimates that we did for the trials and they are spot-on. Historically, these successful trials have yielded global tics and variety scores at baseline in the 30 range and we are spot-on. So very nice mix of patients so far.

That's terrific. That really addresses the question that I had, because I was a little bit concerned about the risk of readouts in adults for perhaps quality patients, but I think you’ve got it nailed. You nailed the answer. Thanks.

And we'll take our next question from Brian Skorney with Robert Baird. Please go ahead.

Hey, good afternoon, guys. Thanks for taking the question. I guess my question also is around the Tourette studies and the path forward. I know in the recent press release on the initiation of the open-label, you indicated planning for Phase III study next year, you guys are usually pretty conservative in your communications and I think that was the first time that you’ve explicitly mentioned Phase III plants and I'm just wondering what we should take that to mean in terms of what you are seeing data wise right now, what's driving the decision and comfort level to start talking publicly about a Phase III, is there anything in terms of anecdotal feedback from the Phase II studies in Tourettes or is it primarily driven by what you saw it from the long-term safety data from the open-label TD study, any color there would be helpful?

I guess I wouldn't over interpret it, Brian that the logical conclusion of having two placebo-controlled trials and then additional long-term open-label safety studies will put us in a position to have a discussion with the FDA in the early part of next year and that’s when we would seek to clarify what additional studies would need to be done for adults, what if any, what additional studies would need to be done for pediatrics, if any, what the design of those trials would look like, what would constitute an adequate Phase III package, et cetera. So I wouldn't over-read it, obviously you asked about anecdotal or even well-controlled data, we are very pleased with the information that's come out of the TD program and now that we’re in the process of assembling and getting ready to submit the NDA, we have had a chance to look in depth at integrated safety and efficacy data across multiple studies. So if anything, I'm even more enthusiastic today than I was six months ago about the TD program. Obviously, that’s nice to know thinking about Tourettes, but particularly in the pediatric population, that really is something you have to have data, you have to sit down with the FDA and ideally, that would be in 2017, we’d reach some kind of plan of agreement with the FDA and I would hope that would include a Phase III steady in kids.

Got you. And then if I could just ask one more question, I guess in the essential tremor program, I know you guys have been a little tightlipped about mechanism, so I'm just wondering in terms of the SAD, MAD studies, when and where do you think we might see those presented and when and where do you think we might start cutting a little guidance on structure of the molecules and mechanism?

Yes. I think that the Phase I studies were probably not going to be presenting those really anywhere. What will happen and when we will start discussing the mechanism is probably going to be after we have created some data, proof of concept data in the human population.

And we will take our next question from Anupam Rama with JP Morgan. Please go ahead.

Hi, guys. [indiscernible] Thanks. First of all the additional color and support of Phase I studies with development, maybe just a follow-up on the cardiac repolarization study, wondering if you could give a little more color on the patient context there, whether the studies were in sort of normal volunteers or maybe there are confusions that could have had some, might have been at risk TD patients, whether there is an inclusion of [indiscernible] and whether data from some of the supportive studies might be presented at a meeting prior to feedback from the FDA.

Thanks, Eric. So I think I did say that the cardiac repolarization study that we did wasn't healthy volunteers, not patients with Tardive Dyskinesia. It was with super therapeutic dosing, but I did not disclose the details there. And it is unlikely that I’ll publish that kind of information, that is part of obviously the FDA review, it's just one piece of an overall safety, cardiac safety package. In contrast, the data from our Phase II and Phase III trials in patients with TD is so remarkable, because of the extensive amount of data we have, and more than three quarters, around three quarters of the patients that we have in our trials actually are on concomitant medications that have known potential to QT. So drugs like Paxil for example over some of the anti-psychotics. And so nobody has ever done a large example, control trial of QTCS and these subjects in this kind of population. So we think this is really interesting. Obviously, we are pleased with the lack of any safety signals seen so far and I would love to publish that as soon as we can, and I've already mentioned that we hope to publish some of this long-term safety data later this year at upcoming scientific meetings and then in manuscript shortly thereafter.

Okay, great, thanks. And maybe just a follow-up in Tourettes, just to check the box, is it unreasonable to expect you presume that T4 and T4s might be registration enabling or really you should be thinking that as opposed to Phase III event?

Right now, I am calling them for what they are, they are both Phase II placebo-controlled trials, and it would be the conservative position is that for at least in children, where there is no long term adequate safety database of Valbenazine in children, one would anticipate going on to a more typical Phase III program for registration. Now, in contrast for adults, you could conceive of the TD safety database being sufficiently supportive to support an SNDA of Tourettes, but again it depends on the quality of the data and I'm just talking out of my mouth right now and that I haven't sat down with the FDA and have that discussion yet. So I really can't - I can't tell you what the FDA is thinking and obviously I will do what they want us to do, and so that discussion will come out after we have data.

Great. Thanks much guys.

And we will take our next question from Phil Nadeau from Cowen and Company. Please go ahead.

Good afternoon and thanks for taking my questions. A few commercial questions. At last year's analyst meeting, you said that you thought there were about 250,000 to 300,000 moderate to severe Tardive Dyskinesia patients. As you’ve done your work with physicians and kind of rolled up your sleeves, have you seen any reason to address those numbers, do they still seem accurate?

We've always tried to stay Phil on the conservative side, and so the 250 to 300,000 is really staying in the most conservative situation where we’re looking at actual ICD9 codes. Now, we do know that physicians, it takes them a long time, if ever to actually put a formal diagnosis of TD on there, but we still think that’s the best number for us to use. Others completely independently from us have used much higher numbers, some exceeding 1 million total TD patients there, but we are going to stick with that 300,000 patients that have moderate to severe TD. And I don't mean that to say that at the end of the day, when we get together with the FDA and knock on wood, we are discussing labeling, we have treated in our clinical program IL patients also, so I'm not saying that we're restricted just to moderate to severe, but that's all going to be part of the label negotiations.

Got it, okay. And do you have a sense of what proportion of that population would be accessible to you. So, for example, seeing your physician or not institutionalized?

Yes, it's a great question, because this is a fragmented population, some are being seen by private practice psychiatrists, others are being seen by private practice neurologists, some are in community mental health clinics is where they’re receiving their care, others are in long-term care facilities. They transition from any of those in and out of a hospital setting and then you have those that are in the VA setting that are also in the prison system. So where we are going to focus our efforts on is where we think the highest value patients are and so we're not going to be trying to spread ourselves too thin across all of those initially upon launch.

Okay, good. And then just touching on something that - your comments there of the fragmented nature of the treating community, who do you think is the most appropriate physician to detail, would it be psychiatrist or movement disorder clinics or neurologists, kind of based on your preliminary work, which one of those groups sees a lot of patients, but then also seems almost moving to right for TD medicine?

Yeah. And with all of the additional work that we've done over the last couple of years, and especially valuable is having and actually externally facing MSL group out there, it’s still we believe that the vast majority of our details are going to be the psychiatrists and then that would be followed by neurologists.

And we will take another question from Biren Amin from Jefferies. Please go ahead.

Yes. Thanks for taking my questions guys. Just to start on Valbenazine, did you guys have your pre-NDA meeting with FDA and on Valbenazine and if so, can you share any thoughts from that meeting?

Yes, we did. It went well.

Great. And then I guess on the QT comments on the call, did you compare Valben to [indiscernible] in the study and can you tell how it performed in relation to [indiscernible]?

Yes, we did and [indiscernible] did what it is supposed to do and Valbenazine and did what I said it did, so it’s no surprises.

And can you maybe provide a long-term update regarding safety and whether you continue to see a lack of signal?

Yes absolutely, that's correct.

Okay. And then just I guess on labeling, Chris, with the 40 mg dose, do you anticipate getting that on label, given the 80 mg CGI mist?

Obviously, that is a discussion that comes with the FDA. Based on all the work that we've done, discussion with ex-FDA consultants and our understanding of what the division has said to us so far, one would assume that we would have both doses, but I wouldn't know until it’s - the ink is on the paper.

Got it. And then just one last question. Maybe for you, Tim, I may have missed it in your prepared comments, but did the company incur a $2.8 million NDA filing fee in the quarter? Did I hear that correctly?

It was 2.4 and just so we are clear, before we can start submitting anything, we have to pay that money. So we haven’t pressed the button efficiently yet. But we put certain documents in and before you can put document one and you have to pay the total.

And how far in advance, you have to pay the total?

When you want to submit the first document.

This concludes the time allotted for question-and-answers. I will now turn it back to our speakers for any additional or closing remarks.

Thank you very much. I really appreciate all the questions and the attention today. What I’d like to close with is that here in Neurocrine, when we begin any program at the very earliest stages of research, we always put patients first and wanting to make sure that we’re bringing something of very high value to patients. Obviously, as the program goes forward, the patient comes into an even sharper focus. And now, as you can imagine with Valbenazine, that is very much the case. It actually guides everything that we’re doing at this point, and maybe not in such obvious ways. We want to put the highest quality NDA together that we can and that is such that the FDA is going to have as easy a time reviewing this document and to give us the quickest timeline that we can, so that we can provide this to patients. We’ve invested heavily in our MSL force, our medical affairs force, because we want to make sure that the appropriate amount of medical education is taking place in order to smooth the entry of the first medicine for Tardive Dyskinesia out there and we have been working with payers and engaging them because we want to make sure that we have the broadest access for patients, not only at the time of launch, but as we continue to move along, we want patients to have access to this drug. And then finally, within our marketing and our nascent sales group at this point in time, we want to be able to put together a commercial organization that understands the needs of not only that patient, but their families and their caregivers. So we really are guided by that fundamental philosophy that we start with every program and I have to tell you it’s very gratifying I’m sure among everyone in the company and the guys in this room here, how gratifying it is to see that coming to fruition. So with that, I would like to thank you for your attention and I hope everyone is having a good summer and we look forward to seeing you at meetings that come up late summer and into the fall. Take care.

This does conclude today’s call. We appreciate your participation. You may disconnect at any time and have a wonderful day.