Kevin Gorman - CEO and Director Jane Sorensen - IR David-Alexandre Gros - President, Interim CFO and COO Eric Benevich - Chief Commercial Officer Christopher O'Brien - Chief Medical Officer Kyle Gano - Chief Business Development Officer.

Sarah Weber - Piper Jaffray Brian Skorney - Robert W. Baird Mayur Somaiya - BMO Capital Markets Biren Amin - Jefferies Andrew Peters - Deutsche Bank Alan Carr - Needham Joseph Thome - Cowen and Company Jay Olson - Oppenheimer Tazeen Ahmad - Bank of America Merrill Lynch.

Welcome to today's program. [Operator Instructions]. It is now my pleasure to turn the conference over to Mr. Kevin Gorman, CEO of Neurocrine. Please go ahead..

Thank you very much and welcome, everyone. Good afternoon. I'm joined here today with Chris O'Brien, our Chief Medical Officer; Eric Benevich, our Chief Commercial Officer, DA Gros, our President and Chief Operating Officer; and Kyle Gano, our Chief Business Development Officer.

Before I go any further, I'd like Jane to read our Safe Harbor statement, please?.

Good afternoon. Certain statements made in the course of this conference call that are not historical statements may be forward-looking statements which are subject to risks and uncertainty.

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 quarterly reports on Form 10-Q and in today's press release.

Copies of these filings may be obtained by visiting the Investor Relations page on the company's website. Any forward-looking statements are made only as of today's date and we disclaim any obligation to update these forward-looking statements.

Kevin?.

Thank you, Jane. It's been a very busy and very gratifying quarter and beginning of the year for us. As all of you are well aware, INGREZZA was approved by the FDA. Very pleased with the label and the launch took place just on Monday of last week. In addition, as you know, we in-licensed Opicapone from BIAL for Parkinson's disease.

And we also had just completed a $500 million convert debt financing. So quite a busy quarter and beginning of the year. We, a little later this month, we have a pediatric Tourette's study that's going to be reading out. We obviously have no information on that today.

So the way that this call is going to work out is that, I'm going to be turning it over to DA for him to go over the financials this quarter. Then I'll be turning it over to Eric. He'll give you some color on the commercial team and then this last several days that we've been working as the drug is now being detailed out there.

I will then go to Chris O'Brien who is actually for the first time on a telephone. He's off-site right now for the rest of this week. So hopefully his connection is going to be good. And Chris is going to go over the pipeline and then Kyle is going to go over our partner AbbVie and all the work that they've been doing on elagolix.

So DA, I can pass it over to you..

Thank you, Kevin. Good afternoon, everyone and let me thank you as well for joining us on our first quarter of 2017 earnings call. We had another very productive quarter on all fronts. From the financial perspective, we ended the first quarter with $289.4 million in assets, including cash, investments and receivables of $274.4 million.

This does not include the $502.2 million in net proceeds from our recent convertible debt financing which occurred after quarter close. Our loss for the quarter was $78.3 million or a $0.90 loss per share compared to net loss of $19.3 million or $0.22 loss per share for the same period in 2016.

We did not report revenue for the quarter compared to the $15 million of revenue for the first quarter of 2016 which represented a milestone payment from AbbVie, our partner on elagolix. Drivers for the change in our financial results from the first quarter of 2016 to that of 2017, also include increases in both R&D and G&A expenses.

R&D costs were $51.9 million, representing an increase of approximately $28 million versus last year, primarily as a result of a $30 million upfront payment for in-licensing opicapone from BIAL in January which we recorded as IP R&D.

As expected, G&A costs increased significantly year-over-year and was $28.1 million, an increase of approximately $12 million versus last year, primarily due to increased precommercialization activities for INGREZZA.

Of this year-over-year increase, $7.2 million were external costs related to market research, commercial launch preparation and other professional services. In terms of internal costs, personnel-related cost increased $6.9 million quarter-over quarter, principally due to the expansion of sales, marketing and medical affairs personnel.

This change includes a $1.4 million increase in noncash share-based compensation expense. Looking forward, in terms of revenue, we expect to earn a $30 million milestone from AbbVie in the second half of this year upon filing of the first NDA for elagolix in endometriosis. In terms of expenses, our guidance from last quarter remains unchanged.

We expect G&A to increase significantly now that we will have our full commercial team in place. On the other hand, R&D costs will return to more regular baseline since our payment to BIAL was a one-time event.

In summary, this was a very busy and very strong quarter where we continued to advance our pipeline, while preparing the company for approval and commercial launch of INGREZZA. I'll conclude my prepared remarks, but for those looking for additional details, our Q is now on file..

Thank you, DA. So as you can see we're in a very good financial shape and after doing the offering. As DA said, with the increased headcount, that's going to increase our spend going forward. From that I'd say we're getting pretty close to having about 400 people in the company at this point.

We almost equally split between those in the field and those at home office. So at this point, I'd like to turn it over to Eric..

Thanks, Kevin. This a very exciting time at Neurocrine, now that we have initiated our commercial launch of INGREZZA. Starting the day we received FDA approval, we began fielding phone Inquiries from healthcare professionals into our INBRACE patient support program call center.

And within the first 24 hours, our ingrezza.com and INBRACE websites went live. Within 48 hours, we trained our medical science liaisons and payer account executive teams on the labeling. And we recently updated our speakers bureau slide materials and rolled that content out to our psychiatrist and movement disorder neurologist speakers.

They've already begun delivering peer-to-peer educational programs in support of our launch. Our sales team was in the midst of their new hire training program at the time of INGREZZA approval.

They were deployed on May 1st and have begun calling on movement disorder neurologists, psychiatrists and mid-level providers in private practice settings as well as community mental health centers across the country. These are the priority HCPs and sites of care for our sales and marketing efforts.

There's only been a week, so we'll not share any metrics yet. Besides that on a macro level, our educational material is about TD and our messages about INGREZZA as the first and only FDA approved treatment for TD are being very well received.

Feedback has been coming in from our sales force about HCP customers being excited to hear about our new product with proven efficacy and safety and convenient dosing and importantly, compatibility with common psychiatric medications that TD patients need to continue taking for their underlying psychiatric illnesses.

Our sales team is leveraging the promotional material to help the HCPs understand the full range of presentations of TD across the various body regions as well as the variety of patient types that develop TD.

Furthermore, our sales team has been introducing customers to the INBRACE program to help them understand the full suite of patient support services available to facilitate treatment initiation and maintenance.

In addition, our payer accounts team has continued meeting with a range of health plan decision makers from commercial Medicare Part D and state Medicaid plans. They have been introducing them to our labeling and the underlying clinical data as well as our pricing.

Again, it's too early to talk about metrics other than that on a macro level, these meetings have gone well.

Importantly, some payers have already begun reimbursing INGREZZA, using a provisional prior authorization process during this early launch period, prior to their formulary reviews which are expected to occur toward the end of this year or the beginning of next year.

So in summary, we're very excited at the prospect of making INGREZZA available to the many thousands of TD patients in need of an effective safe and importantly, FDA-approved breakthrough therapy. Our team has now been trained and deployed and they have begun the process of educating, raising awareness and changing behaviors.

Our initial interactions with customers have been very positive and our team is energized. I look forward to sharing more information including sales and total prescriptions during our next quarterly earnings call. And with that, I'll turn it back over to Kevin..

Thank you very much, Eric. And it is a very exciting time for us right now with this commercial launch.

Chris, could you give us an update on the pipeline?.

Happy to do so and thanks to the participants for joining the call. I echo Eric and Kevin's sentiments about the excitement that we see with so many things going on at the moment.

In particular for the medical affairs team, the upcoming American Psychiatric Association meetings later this month in San Diego give us a great opportunity to start sharing a broader depth and expanse of data as we start to analyze across the multiple studies from our TD program.

We'll be presenting additional clinical efficacy and safety data, subset analysis and for the first time, some additional PK and pharmacology Phase I-type data.

There are multiple manuscripts that have either been recently submitted or accepted or are in the works, so there will be a steady flow of data that clinicians, investors and others can look forward to seeing in the upcoming months. From a clinical development point of view, the TD program of course is moving into the next phase.

The approximately -- large number of patients that were in the, what we call the rollover study, that is the opportunity for study subjects to continue to have access to study drug through the time of commercialization now moves into the transition of the subjects having the opportunity to go on INGREZZA on a commercial basis.

And so the process has started and is going smoothly. We're also in the process of carrying out some of the agreed-upon post-approval projects that we have discussed with the FDA in support of the INGREZZA TD program. So that's going smoothly.

Obviously, as Kevin mentioned, we have a lot of work going on to close out the so-called T-force GREEN study, the pediatric Tourette Phase II trial. That is patients have concluded dosing, the clinical monitors are out in the field, closing out the study sites and we're looking forward to the results from the database block later this month.

So as soon as we have top line data, we plan to share that with the community once that's available later this month. We've been very happy with the conduct of the pediatric trial, the quality of the sites has been superb. The subjects that have been enrolled have been very appropriate.

The data collection for the Yale Global Tic Severity Scale has gone smoothly. And again, we're very excited to get to the point, just literally days or weeks away we'll have top line results.

As I think most people are aware, the patients that were in the pediatric study and the adult study that pursued the control projects are now in the extension study, the so-called T-Fusion study that is going extremely well.

And we're getting requests from parents, subjects, investigators to see about potential access to INGREZZA once they finish that 24-week extension study. We're hearing some very gratifying anecdotal stories about Tourette response to INGREZZA. But again, lots going on, on the Tourette front and update later this month.

The other programs also continue go well. The CAH, Congenital Adrenal Hyperplasia, study is going as planned. And we're looking forward to having some top line data from that as we again get ready to initiate the proof of concept study in patients, maybe this month, with this follow-on molecule. Let me correct that.

I said later this month, later this year for the proof of concept study starting in the second half of the year. The ET program has finished up dosing and we're in the midst of some data analysis -- we'll be able to make some decisions about next steps for that program over the next month as well.

And then finally, for the opicapone program, at this point, we're very busy looking at our partners, BIAL, to complete the transfer process and assembling the package of information that we would then bring to the FDA, the neurology division, to talk about what we have in hand from the completed Phase III studies that BIAL has conducted and to work out the path forward for what's necessary for NDA submission in the U.S, for FDA consideration.

And again, we're on track with that process. We hope to have meetings with the FDA in the second half of the year and we'll have a path forward once we get their consensus. So brief update, lots going on, very happy with progress.

And obviously, we're very pleased that INGREZZA was approved after 10 years of more than 20 trials and more than 1,000 subjects to get us to where we're today.

Kevin?.

Excellent Chris, thank you very much. Kyle, a brief update on our partner AbbVIE..

Yes, as evident from the earnings release, AbbVie has been quite busy and visible in Q1 in both endometriosis and the UF space. Presentations were made at the 3rd Congress of Society in Endometriosis and Uterine Fibroids. There were additional posters of the Society for Reproductive Investigation, ACOG, just this past weekend.

Two journal articles were also published in Q1 in the area of HUR and endometriosis and a quality life scales used for uterine fibroids. They've been very active out there, getting the data out for both endometriosis and fibroids.

We would expect increased activity as 2017 continues and leading up to the NDA's submission in Q3 for endometriosis and then with the availability of top line data for the UF program end of the year. So very good news and stream of data coming out this year in 2017 for elagolix. Kevin, I'll turn it back to you..

Thank you very much. That's our prepared remarks for today. So I'd like to open the line to questions..

[Operator Instructions]. And we'll go first to Jeff Meacham from Barclays..

This is Jason on for Jeff. Real quickly, where do you anticipate the bottlenecks moving forward for the INGREZZA sales? Is it necessarily physicians or do you think it's payers? Or if you could just describe what you think the kind of the challenges will be for moving forward? Very helpful..

Hi, this is Eric. We're really trying to take a holistic perspective on what needs to be done to develop this which is a new market. Obviously, we're investing in education around TD, as well as introducing customers to INGREZZA and that's really to generate the demand.

A big focus of our TD education is really to increase the rate of recognition and diagnosis. It's not so much that physicians don't know about TD, but like I said in my prepared comments, we're helping them to understand the range of different presentations as well as the different types of patients that develop TD.

On the flip side, we're also -- we've invested in the INBRACE program and our limited pharmacy network in order to provide the services to help make it easy to initiate and to maintain therapy.

And so, I think, between the efforts that we have with raising awareness and educating, as well as facilitating new patient treatment initiation, we're trying to be very systematic and holistic in terms of what it takes to develop a new market like this..

Great and has Teva's kind of the earlier conversations, has that helped facilitate your conversations with payers?.

I'm not sure that I understand your question, you said Teva's earlier conversations?.

Exactly.

With their version of tetrabenazine, is that facilitated their conversations at all?.

Teva's product hasn't come into any of our payer conversation so far..

[Operator Instructions]. We'll go next to Charles Duncan from Piper Jaffray..

This is Sarah on for Charles. Congratulations on the progress this quarter. So first question is about Tourette's.

So can you just remind us what factors investors should keep in mind when looking at the pediatric data later this month? And then, will you plan to share the open label extension results in adult when those come in? Or will you share adults and peds together closer to the end of this year?.

So the second part of your question first. The extension study includes both adults and kids and its run concurrently and so when that study ends, we'll talk about what we see at that time. Remember that's an open label extension study primarily focused on safety.

We're collecting the Yale Global Tic Severity data in that trial, so we'll be happy to discuss that when that comes. But I wouldn't expect that till toward the end of the year.

As far was what to think about when we see Tourette data coming from the pediatric placebo-controlled trial, I think we talked a little bit about the Yale Global and a well-run placebo-controlled trial.

You expect to see baseline mean scores for the group of subjects in the 30-point range, that's the total tic severity score which includes both the motor and sonic tics. I can say that we do know what our blinded data looks like at baseline and the mean scores are exactly where we predict them to be in the 30, 31 range.

We'll have final numbers obviously when we report the top line results. What we would expect to see is a separation of active drug from placebo and at least historically, we know that the minimal clinically important difference that has been analyzed in the literature that says that a minimum of the opportunities clinically meaningful.

And what we would like to see is obviously something at that level or higher in the separation from placebo. One of the important things to keep in mind and I said this before, it's worth repeating, for these Phase II studies, both the adult and the pediatric study, there are 3 things we need to get from these trials.

We need to know that we've enrolled the right patients, we have a good handle on the primary endpoint and that we have the right dose of study medication. And the lead for the adult Tourette trial, [indiscernible] 80 milligram dose that we had experience with adults who had kind [indiscernible].

Not knowing whether that was correct or not for adults with Tourette's how much the available dose forms are and the adults gave you a starting point for the Phase II trial. I actually think the adult trial was successful as a Phase II trial that includes reduction in tic severity [indiscernible].

Likewise for the pediatric study, we've gone in with placebo, low-dose and high-dose for children as well as placebo, low-dose and higher dose for adolescents, at least those, who were selected based on preliminary PK data we had done in the pediatric population. With that, if it's the correct dose or not, you'll find out when we give you the data.

We'll use that data, analyze it, to develop our exposure response model which would then help us select the best dosing for a Phase III trial. Obviously, [indiscernible] inflation [indiscernible] and brought forward to the FDA to talk about what a Phase III study would look like if we were to get an NDA in the pediatric population.

So that's mainly the goal, to get the dose right, to have good a exposure [indiscernible] handle on the[indiscernible]. And if you have a good safety and tolerability profile [indiscernible] young children who have never been exposed to INGREZZA before so that's what I'm looking for.

Exposure [indiscernible] and [indiscernible] set that allow us to make decisions about Phase III..

We'll go next to Brian Skorney from Robert Baird..

I guess first is just on the commercial launch for INGREZZA. I was wondering if you guys have any thoughts on whether or not we'll be able to use IMS and Symphony Health data.

Is there any reason why scripts wouldn't be accurately captured here based on the distribution that you're using? And do you have any plans to block prescription data? And then just on the initial T-Forward results that were announced in January, I think at that time you said that it haven't been analysis of the other secondary endpoints besides the Clinical Global Impression of Change.

Just wondering if there's any update on RTRS or UTS results from the study? Understand you probably don't want to give specifics, but just maybe in terms of trends, do you think you're seeing favorable trends there that would be a good indication of efficacy?.

This is Eric. I'll handle the first part of your question which was the availability of our RX data. And since this isn't a product that's being distributed through retail or even through nonretail channels, it's being distributed through a limited pharmacy network. And so the data won't be available through Symphony or through IMS.

Kevin, do you want to handle second....

Brian, repeat again what the second part of your question was?.

I was just asking if you guys have any comments on RTRS or PGFs endpoints from T-Forward. I think at the time you said that they haven't been analyzed back in January.

So I'm just wondering if you guys have taken a look at those results, if you had any kind of general comments on how they looked?.

Yes, so the data would be part ultimately of some publication plans later this year. But we have looked at those data and there are supportive trends that help us know that INGREZZA can reduce tics in adults. And we will work out the path forward as we get them..

We'll go next to Ian Somaiya from BMO Capital..

Couple of questions, first I know it's early days and you probably don't want to speak to how the launch is going, but maybe if you can just speak to you what type of launch metrics you will -- do plan to share in future quarters, just given the lack of visibility we will have from a scripts standpoint? And then I have a follow-up..

Yes, Ian. So I mentioned in my previous comments that we're planning on sharing sales and total prescriptions..

Just from a standpoint of patients or progress you're making from a payer standpoint, anything along those lines that you would be willing to share or want to share?.

I think, as Eric had said that we would be talking that the payers we would imagine getting on formulary actually late this year or towards Q1, Q2 of next year depending on the payer type there, so I'm not so sure there's anything meaningful that we can talk about along those lines in probably not for quite some time..

Okay and just from a formulary standpoint, what the -- the formulary's tend to meet every 90 days or so, just curious why you think it's going to take you into the new year to get included?.

I'll provide a little bit of context here. So Medicare Part D plans are required by statue to conduct formulary reviews of new drugs within 180 days or 6 months and typically they take about 5 to 6 months before they do a formal review. Commercial plans, there's no time requirement and same thing for Medicaid.

So generally, what you see with new drug launches is depending on the type of drug, that you know the formulary reviews start kicking in around 6 months out after the launch and can take upwards of a year.

Generally plans also want to get a sense of what the volume looks like and what the demands going to look like for the product as they're making their -- setting their formulary reviews and their coverage policies. So I think it gives you a sense of the timing, we're going out with our accounts team.

We're having initial clinical conversations with these formulary decision-makers. Then we'll be going back in and doing more thorough full clinical presentations as the year goes by. And they'll be looking at what the demand looks like and setting up those formulary committee reviews in the coming months.

So I think we'll have a better sense of what all of this looks like as we get into the summer and into the fall.

But the other thing that I can say is that formulary coverage isn't the same thing as getting reimbursed and certainly, we expect that INGREZZA will be reimbursed initially during this early launch phase before formulary reviews have occurred, it's generally going to be on a on prior authorization process and that’s what we're starting to see.

That there is coverage, plans are starting to pay for INGREZZA and generally, as we've said previously, most prior authorizations would look like a confirmation that the patient has a diagnosis of tardive dyskinesia..

Okay.

And just one final question, I know you've mentioned the increased spending related to market research, just was hoping you could share some of the highlights from the market research and maybe how its helping you target physicians better?.

In terms of targeting for physicians, we've primarily focused our effort on psychiatrists that are office based as well as on the subset of neurologists that are focused on movement disorders. And in addition, another high-priority call point for us is community mental health centers. And the mid-levels and the staff that work at those facilities.

We just launched, I guess it was last week and the feedback we've gotten so far from our team is that those initial conversations are going very well, that the customers are excited to hear about the first and only treatment option.

I don't anticipate that we'll be making any adjustments to our targeting this early, but so far, it seems like the target list is spot on..

We'll go next to Tazeen Ahmad from Bank of America..

This is Steve Chen [ph] on for Tanzeen Ahmad. Congrats on the progress.

Now that you've had the T-Forward data for a little bit more time now, do you guys have any additional insights on why we saw stat improvement on the CGI scale, but not the YGTSS scale? And my follow-up is, following the $500 million or so cash raise, just how should we think about your priorities going forward, now you know is it really focusing on the kind of business, bring out elagolix and opicapone data or are you guys thinking about more deals? Then what kind of areas of interest might those deals be in?.

Why don't we take -- DA will take the second question first and then Chris can chime in on the first question..

Thanks for the question. In terms on our focus, our focus continues to be our operations. So obviously, the launch of INGREZZA as well as advancing the pipeline. In terms of business developments, we're always scanning the horizon and looking for opportunities, both proactively and reactively.

Obviously, as you saw, we did a transaction earlier this year with opicapone and having raised the capital, now it gives us some flexibility if we were to find another drug like opicapone. But the priority and what we focus on is the operations.

And the financing was done in order to help support the operations and to grow the company, but right now, there is no immediate plan and we did not do the financing with an eye towards a transaction..

So Chris, do you want [indiscernible]..

With respect to looking at T-Forward study data, as I mentioned, we're actually pretty happy with the information that we've got from the adult Tourette placebo-controlled trial. Clearly we saw an improvement in tics.

The Yale is the gold standard and we feel that the efforts that we put in place to get consistent application of the Yale by our investigators, as well as reduced variability around the scoring have paid off.

I think the thing that's interesting and you may be aware, that there's a nice separation of INGREZZA from placebo during the early weeks of the adult trial and through week 6. What we saw was is the loss of p-value at week 8 more or less reflects that we had some discontinuation in adults on the 80 milligram INGREZZA dose.

And there was some sleepiness as a side effect at that dose and we lost the statistical power for week 8 and clearly the drug's effective in reducing tics. The question is, is it the right dose for this population? And how do we want to think about dosing going forward if we were to proceed with an additional adult clinical trial.

As I mentioned, a lot of effort will be put over the next month or so looking at exposure response analysis and happiness, make some decisions not only for the pediatric Phase III trial, but if we want to do anything else going forward..

We'll go next to Biren Amin from Jefferies..

Can you just tell us how many of the 124 adult patients in the Tourettes's trial transitioned to the extension phase and given I think the company previously stated that they would not move forward with the adult indication, what's the objective in evaluating these patients longer term, given you have long term safety data at the 80-milligrams dose with the TD patient population?.

I was just going to say that you're not in the office and haven't been for the past week so I'm not sure that you have that data in front of you as you might normally have. And certainly none of us do about how many are actually in the extension study. But then, I'll leave the rest to you, Chris..

I can say the actual, when I left prior to vacation, the adults entering the extension study is actually pretty high. I don't have the exact number, but it's something in the 80% range elected to continue in the extension phase. And as I mentioned, the anecdotal feedback has been good.

Let me just frame -- you made a point about that we elected not to proceed with the adult. To be clear, we've always been interested in generating data on adults with Tourette's. But it's very clear that from an FDA-regulatory-registration point of view, since 80% or more of Tourette patients are pediatric any NDA would be a pediatric NDA.

And so, we'll continue to pursue looking at data around adults, but I would never anticipate that the NDA would be for adults, because the primary indication is pediatrics.

So we continue to explore how best to generate data and help potentially to guide clinicians about adults and we'll have those conversations with the FDA, but our main priority at this point is to determine what is the best path forward for doing the Phase III study in pediatrics in conjunction with the FDA's input..

And I guess, given the focus on pediatrics, first, what gives you the confidence that you've got the right dose? I think you haven't disclosed the doses in the pediatric trial.

But I guess, what gives you confidence that those doses are correct? And then second, how many patients in the pediatric study transitioned to the extension?.

To the second part of that question, that number is higher than the adult, it's 90% or so if I recall correctly, has elected to proceed into the extension phase.

But the point to emphasize is, do we actually -- do I have confidence that we have the right dose? And we certainly had the right dose to go into a Phase II, dose ranging kind of exploratory trial in a new population.

Whether that's the right dose to take in the Phase III, I won't know until I see the data, I finish the exposure response analysis, et cetera. So we were very happy with our PK model which allowed us to go from that T-Force Phase Ib study into a Phase II, T-force green study.

But whether that's the ultimately the right dose, will really have to come from the unblinded results and the exposures response analysis. For all I know, we may say, yes, that was a good Phase II study, we've eliminated one dose and we've modified the second dose or something. That's what the Phase II study is really to help us determine.

So very confident in our PK model getting into the Phase II study, but we need to wait till we see the results on the exposure response analysis to know about our confidence going into our Phase III study..

And we can go next to Andrew Peters from Deutsche Bank..

I guess, the first one, thanks again for the color on some of your initial conversations with payers and the formulary process.

I just wanted to understand kind of from your perspective, do you view that as a limiting step right now in terms of uptake and would you expect to see an inflection in use once kind of those -- INGREZZA is formulary given your comments around the prior authorization prior to that, patients are getting drug and going onto drugs.

So just wanted to get your view on the importance of formulary access.

And then just secondly, on the Tourette's study, I know you described the adult study as a successful trial, just wanted to understand if in the pediatric study you saw kind of similar trends but not quite statistical significance on the primary endpoint, would you still plan to move the program into a pivotal study, just kind of based on everything that you're seeing or -- I guess what's the bar for a go, no-go decision there, is it statistical significance or how do you think about that?.

Chris, I'll take first crack at the second question just by saying that, I think we have high confidence not only in this Tourette's trial but we have even higher confidence that this mechanism is at work in Tourette.

So I don't think you'll see, outside of seeing -- of having a safety signal which we've not seen any hint of thus far in kids, I don't think there's a no-go decision here.

If the trial reads out and we don't hit the P.05, you have to look at the whole trial and then we'll make a determination on which is the best path forward whether there's another Phase II or whether we did get enough data out of this study that we would want to talk to the FDA about going into a pivotal program.

But there really is not a no-go decision that I would anticipate coming out of this trial.

Chris, you have anything to add to that?.

Now you got it, thank you..

Yes, the first question was about formulary coverage and I guess I would frame it up as obviously payers and utilization management affect all new drug launches nowadays, it's not unique to INGREZZA.

But certainly, we try to be transparent with payers and meeting with them in advance of approval, introducing them to the company, to our pipeline having conversations about PD.

Now that we're on the other side of approval, we're reintroducing ourselves, going through the labeling and setting up more in-depth conversations around the clinical profile that's emerged. You asked about, whether or not we would expect to see an inflection, I don't know if I would describe it that way.

What I would say is that over time, plans will have the chance to review INGREZZA, set their policies. And what would it generally mean is that prescriptions, the processes get set and the prescriptions would be filled on a faster basis, rather than on a sort of a case-by-case basis. When you have a policy, that means you can actually implement it..

We can go next Alan Carr from Needham..

Couple of them, one, staying with the theme with pediatric Tourette, assuming you do go forward, can you give us a sense of your initial thoughts on design and timing for this trial especially keeping in mind that that it is in kids? And then also, what's your expectations around gross to net both in the short term and long term for INGREZZA?.

Chris, you want to handle the first one?.

I may have missed a word was it? Can you restate the question for me?.

I just was wondering if you could characterize for us what you think the design of the Phase III program in Tourette's, what that might look like assuming you do go forward with it? And if there's any added characteristics to it because it is in kids?.

So thanks, Alan. We have a regulatory precedent that's been established by other drugs and sponsors that have worked with the psychiatry division at the FDA for Phase III trials. So typically, you'll see these are 6-week placebo-controlled trials followed by some kind of extension period. And I don't expect anything really different.

Our Phase II study with T-Force Green trial was designed in consultation with the FDA. And we would expect just some additional discussion about if there are any other scales they want added, if there are additional kind of safety data they want collected.

But for the most part as we already incorporated all of the things that they think are important for a well-controlled trial in the pediatric population..

Okay and then your comments on gross to net in the short term or long term for INGREZZA?.

It's DA. In terms of gross to net, we're not providing guidance at this time. So....

[Operator Instructions]. We will go next to Joseph Thome from Cowan and Company..

The first one on INGREZZA, when can we expect that the 80-milligram pill will be available? And do you anticipate any issues regarding reimbursement due to the pricing of the 40-milligram pill? And then second question on opicapone, do you have any data maybe on patient uptake following launch in Europe that we can maybe extract to what we could possibly see going forward in the U.S?.

We'll go with your second question first, Kyle. You've been tracking that..

Yes, from our information that's been made available to us from BIAL, they've launched in the U.K. and in Germany. Obviously a lot different environment in Europe than it is in the U.S. in terms of both pricing and reimbursement but what we understand is that the uptake has been very good in both of those countries.

And we will be able to provide greater details as the year goes on and they launch into other countries in Europe..

And then I believe that the part of your question, first part of your question was related to the 80-milligram capsule. And we've said publicly that we're going to be filing a supplemental NDA this summer. And we expect the 80-milligram capsule to be available before the end of the year, priced substantially similar to the 40-milligram capsule.

We've been proactive in our conversations with payers about the availability -- future availability of the 80-milligram capsule and the intended pricing. And I can say that, so far that message has been well received..

We'll go next to Jay Olson from Oppenheimer..

I had a question about the INGREZZA launch and just in terms of the specific steps that you're taking in order to facilitate the initiation of therapy either through the availability of starter kits or through your INBRACE program.

Can you describe to us how you're ensuring that product is getting into the hands of the patients? And then I had a follow-up question on opicapone..

What I can do is describe to you in a little bit more detail how the INBRACE program works, but essentially treatment forms gets faxed in to our INBRACE program. And the first thing that happens is that the staff will do a benefit verification to determine whether or not there's coverage from the plan.

If there isn't, they can work with the provider on completing and submitting a prior authorization. As I mentioned earlier, often this is just a confirmation that the patient has diagnosis of tardive dyskinesia. In addition, there are other support services that are available.

For example, for commercially insured patients, we can buy down their co-pay to 0. And we also offer product support which comes in the form of a welcome call from a psychiatric nurse to the patient, talking to them about TD, informing them about INGREZZA, what to expect from treatment, that sort of thing.

We also have what's called the INGREZZA start program which is essentially for patients that have their treatment initiation form submitted into the system and are experiencing a delay in getting coverage. We can ship out free product to get them started on treatment.

So you mentioned in your question about samples, we also are offering product samples in physician offices which accept them.

Not all practices nowadays are accepting physical samples, so between the samples that are being placed in the offices and the INGREZZA start program, there's sort of 2 different ways that a patient can get initiated on a free trial of medication while we're working through the -- any reimbursement issues to get them covered from their health plan..

That's super helpful.

Just on opicapone, you mentioned the meetings you plan to have with the FDA later this year, can you just talk about how the development plans might look if you get the green light to go ahead with the Phase III study? How large do think that study would be, how long would it take, how much would it cost?.

With respect to what's known about placebo-controlled trials for an add-on therapy, with wearing off in Parkinson's patients using [indiscernible], the path is really quite clear. There's a lot of expertise on how to run these trials and very clear guidance on what the FDA has expected in the past from other sponsors.

So typically these studies are 16 to 24 weeks of placebo-controlled trial depending on the anticipated affects size and usually several hundred patients. And then, there often may be -- there may or may not be an open label extension after that depending on what's known about the mechanism of the drugs, the vulnerability of the population.

In our case, we have 2 very good studies that BIAL has run in Europe and in fact there is also an additional study that BIAL's partner Ono is running in Japan. That would all constitute large adequate well-controlled trials. So it's our hope that the FDA would find these adequate for an NDA submission.

But if they do require some data from North American patients, that would most likely be a single trial similar to the trial that I just described. So it's something obviously that we have to discuss with the FDA to get their input, see what their specific concerns and needs are.

And depending on the size, 200 person, 300 person that has a big impact on the cost of running [indiscernible] study. But typically these trials, they can vary from $15 million to $30 million depending on how big and how long and how many study centers..

We'll go next to Tazeen Ahmad with Bank of America..

If you're able to share or maybe I missed it earlier, can you just let us know what the discontinuation rate was for adults in T-Forward and what that rate was for the pediatric patients in T-Force?.

Yes, that will be part and parcel of publications that we'll be coming out with as Chris said on the adult study later this year and then peds at the appropriate time.

You want to add anything else, Chris?.

No, that's it. Just from a general point of view, as I mentioned, the discontinuation rate was higher in adults than it was in our TD population in adults and we've been very happy that there's been very little discontinuation of the pediatric populations..

And there are no further questions at this time. I'd like to turn it back to you for any closing comments..

Thank you very much. As you can see, there's a lot going on at Neurocrine. As busy as the clinical and regulatory group had been with INGREZZA and getting its approval in TD, that's how busy the commercial group now is with INGREZZA. But that doesn't mean that the clinical and the regulatory groups get to take any time off.

Between Tourette's, opicapone, CAH and ET, they're just as busy or busier than ever. And in addition with the research group, as we've always pointed out, they are the ones who have designed these drugs that we've been talking about today.

And they are just as active with anywhere from 8 to 10 different programs that are ongoing at any one time and we expect to see the fruits of that later this year, in addition. So in closing, I'd like to thank you all for your attention and I look forward to meeting you at meetings throughout the next several months. Take care and goodbye..

Thank you, everyone. This does conclude your teleconference for today. We appreciate your participation. You may disconnect at any time..