Neurocrine Biosciences Inc (NBIX) 2014 Q1 法說會逐字稿

Good day, everyone, and welcome to today's program. (Operator instructions.) Today's conference is being recorded.

And now it is now my pleasure to turn the conference over to Kevin Gorman. Please go ahead, sir.

Thank you very much. And welcome, everyone, to Neurocrine's Q1 earnings call. I am joined today by Tim Coughlin, our CFO, and Chris O'Brien, our Chief Medical Officer. We'll go through an update of the financials and also our R&D programs.

Before we get started, I would like Jane to read our Safe Harbor statement.

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. Tim, you want to give a financial update?

Sure. Good afternoon, everyone, and thank you for joining us today.

Our first quarter operating results were exactly what we had expected. Our net loss for the quarter was $11.8 million, or $0.17 per share. And our net loss for the first quarter of last year was $12.1 million, or $0.18 per share.

There are two main drivers in our financial results when comparing the first quarter of 2013 to the first quarter of 2014. The primary driver was lower external development costs.

During the first quarter of 2013, we had our two Phase II studies in tardive dyskinesia, Kinect 1 and Kinect 2, in the midst of recruiting and treatment. The placebo-controlled portion of both of these studies was substantially completed in December of last year, and the first quarter of 2014 has been devoted to wrapping up these two studies as well as preparing for the End of Phase II Meeting with the FDA.

Both of these efforts are more internally focused, with our employees completing a lot of the work, thus resulting in lower external development expenses than we typically see during a quarter. External development costs for the first quarter of 2014 were $2.5 million lower than the same quarter in 2013.

This decrease in external development costs was offset by an increase in share-based compensation expense. We typically grant annual equity awards in the first quarter of the year. This year we granted approximately the same number of time-based equity awards as we have in prior years.

However, because of our stock price on the date of the grant, the Black-Scholes valuation for each equity award more than doubled over 2013 levels, resulting in a significant increase in non-cash expense for the same number of awards.

Additionally, I should add that our average option burn rate over the past three years has been less than 3%, which is well below -- which is below the mean and median option burn rate for our industry group.

As a result of these higher Black-Scholes valuations, we expect our share-based compensation expense to increase to $10.8 million for all of 2014, compared to $6.8 million we expensed last year. The increase in share-based compensation expense is also the primary reason for the increase in G&A expense quarter-over-quarter.

Looking forward, we expect our R&D expenses to increase during the year as we move into Phase III development for tardive dyskinesia. Our G&A costs should remain in this relative $4.2 million range per quarter for the balance of the year.

In February, we raised approximately $133 million through a fully marketed equity offering where we placed 8 million shares of common stock. We launched the offering on February 25th and priced it the following day.

After one day of marketing, this offering was multiples oversubscribed with high quality, long focused investors. The proceeds from the offering have significantly bolstered our balance sheet, and we now expect to end 2014 with approximately $230 million in cash and investments.

Our net operating burn for 2014 remains unchanged at approximately $43 million to $47 million for the year. And our net loss remains unchanged, estimated currently at $56 million to $61 million.

Our expected loss per share has been updated to range from $0.75 to $0.81 per share based upon approximately 75 million average shares outstanding.

In closing, we plan on filing our 10-Q tomorrow with the SEC. And with that, I'll turn it back over to Kevin.

Thanks, Tim. So, early in the year, we had released the positive results from Kinect 2. And since then, we've been working diligently on all facets of the business to set the stage for pushing VMAT2, the entire program, forward.

Tim just talked about how we thought it prudent in order to raise additional capital to be able to do this. And now Chris will take us through the activities that have been taking place for the balance of this quarter to get us ready for Phase III.

Thanks, Kevin, and good afternoon. Thanks for joining the call.

So, as Tim and Kevin have mentioned, we've been intensely focused internally on getting ready for our upcoming End of Phase II Meeting for tardive dyskinesia. What that means is that we've spent the early part of this year working on closing out the safety follow up and the closeout activities around the Kinect and Kinect 2 studies.

We've spent a lot of time working on the PK/PD modeling that is the basis for our dose selection and dose justification that we will bring to the FDA in our proposal for Phase III. We've been completing some study reports, doing some additional integration of Phase I, Phase II safety datasets, and working with our regulatory and other consultants preparing for this End of Phase II meeting.

As you may be familiar, the process for this type of meeting, it's a Type B meeting. And we have successfully submitted our meeting request to the FDA with the specific questions that we seek their consensus on.

Those kinds of questions relate to the nature of the Phase III trial and the Phase III program, the population of subjects that we're interested in studying, the duration of the trial, the number of subjects, the primary endpoint, the statistical methodology, the dose and dose regimen, the way we collect safety data, the scales that we use, and all the things that constitute a registration or pivotal trial.

So, that meeting request has gone in and was successfully received. And as it is a Type B meeting request, the agency regulations or guidelines are they grant that meeting within 60 days. So, we're waiting to hear exactly what date that will be in June, but looking forward to that meeting with a well-prepared set of materials.

Once we get the exact date, 30 days in advance of that meeting we submit a briefing package with all the extensive materials and details covering the things that I've just mentioned.

So, that's going on as we speak. And while that End of Phase II preparation is underway, we are also in the process of identifying qualified sites for the conduct of the Phase III trial that we plan to start in the fall.

And currently we're in the process of basically interviewing or qualifying more than 60 sites here in the US and Canada for the Phase III program. And this will put us in a good position after the End of Phase II Meeting to begin the process of working with the IRBs in signing the contracts for these sites and getting up and running for the Phase III trial in the fall.

In addition, the data from the Kinect and the Kinect 2 trial, as you know, I think we've mentioned before, have been submitted as for presentation at the International Congress of Parkinson's Disease and Other Movement Disorders.

This is the Movement Disorders Society International Congress. This is taking place in June in Stockholm, Sweden. And we will be presenting, along with our coauthors, both the Kinect 12 week data and the Kinect 2 efficacy and safety data as two posters on the 11th of June in Stockholm, Sweden.

And we look forward very much to having a chance to talk with my colleagues in the movement disorder community about these data, and see that as a good time for getting a little bit more public attention as we get ready to launch the Phase III program.

While all that's going on for tardive dyskinesia, we are also very happy we have a meeting with the FDA coming up shortly, in the next few weeks, where we are discussing the Tourette syndrome program in more detail.

As you know, we've had discussions with the FDA about the Tourette's program. And we were able to do some of our preliminary work, particularly the preclinical juvenile toxicology and other safety work, under our existing IND.

But, we want to open a new IND under the Tourette syndrome indication, and we will be discussing that with the FDA. And the plan is to open the IND in the summer and to start the clinical trials in a target population of Tourette syndrome subjects in the fall.

And so, that work is going on. We have engaged clinicians and clinical research experts in the Tourette's field in the same process of identifying and qualifying sites for a clinical trial, working on protocol details, and working on a pediatric formulation of our VMAT2 inhibitor, NBI-98854, for those non-adult trials.

So, a lot of work going on with our small group here in San Diego with very good progress. Looking forward to our interactions with the FDA over the next few weeks and moving on to getting these programs off to their next step.

The other things to mention that are non-VMAT2 related, obviously we're keen on the progress that AbbVie is making with elagolix, both the Violet Pedal study, which is the US Phase III endometriosis trial, they've completed screening and recruitment, and the so-called Solstice study, which is the primarily ex-US pivotal trial, Phase III study, in endometriosis.

And those studies are ongoing. We look forward to updates from AbbVie as they become available.

The Phase IIb fibroid trial is also well underway. And likewise, we look forward to updates from AbbVie as they become available.

In the past, we've talked a little bit about some of the activities that are occurring in our discovery research and preclinical groups, only to the sense of saying that we have a lot of activities. We, at any given time, have about eight programs that are being pursued.

As I think most people are well aware, preclinical and discovery research programs frequently are terminated because they are early stage science. And we've made actually some good progress moving a couple of compounds into late preclinical stage. And we will obviously -- when they cross that point of completing a successful GLP toxin, we're ready to open an IND. That's when we talk about them.

But, we're very pleased that, from that ongoing set of activities, we've moved a couple of programs along. And ideally, those will be something we can talk about in upcoming quarters.

So, that's VMAT2. That's elagolix. That's our preclinical activities. I think I'll pause there and turn it back over to Kevin.

Thank you, Chris. So, we're very pleased with the progress that's going on, both with our partner and also our internal projects.

Just to add on a couple of things, as we go forward into our End of Phase II Meeting on TD, we've completed the manufacture of drug substance. We are manufacturing the drug product right now. As Chris said, we're also developing the pediatric formulations for going into Tourette's in addition.

And we've had good interactions with the agency, the carcinogenicity committee at the agency. And so, we've reached full agreements on the two year carc trial design -- study design, and those are kicking off. Just next month is when we'll get going with those.

And I'll remind you that we do have fast track with the TD indication. And that has led to enhanced interaction with the agency that's been very useful to us over the last couple of years.

So, with that, I'd like to open the lines up for your questions.

Thank you. (Operator instructions.) Ian Somaiya, Nomura Securities.

Just a couple of questions. First on the VMAT2, can you walk us through our base case assumption for the Phase III trial design, and then maybe highlight any areas or opportunities to accelerate the program? And then I just had one follow up.

Ian, thank you. So, the base assumption going into our discussions is that the Phase III design is a 12 week trial, placebo-controlled, one to one randomization of active and placebo.

The primary endpoint is the change in -- a change from baseline in the triple blinded video rating of the abnormal involuntary movement scale. And we'll have two doses of drug. Everybody will start on one and there's an opportunity for a single titratable fixed dose adjustment after a certain period of time.

After the 12 week, double-blind, placebo-controlled period, there is the opportunity for a continued dosing with active drug through the end of the one year time period.

And so, that's the general outline of the program. It's a study that would include a study population of moderate and severe tardive dyskinesia subjects screened by external reviewers, not the investigators, using the video screening method. And this will allow subjects into the trial with a multitude of underlying psychiatric diagnoses.

So, we're not segregating bipolar subjects, depression subjects, schizophrenia subjects. They're all potentially eligible for the trial if they have moderate and severe tardive dyskinesia. We will stratify by underlying diagnosis, but will pool them all in this trial.

Now, you asked about opportunities to accelerate the program. There are a couple of possibilities here. One is that we still don't know whether we can have a single Phase III trial or whether we would need two Phase III trials. This will be a point of discussion. Obviously, if we have one, it goes faster than if we have two.

Another question is, as Kevin mentioned, we do have fast track status on this drug. The question will be, if I have a separate kind of open-label safety trial ongoing, how much of that we'll have to complete before we submit the NDA.

So, we'll see what the division's position is on the total number of subjects that we will need for the safety dataset. That could allow us to accelerate things a little bit.

Obviously recruitment time, things that we can do to address the recruitment of subjects into the trial, could speed up how quickly we complete the pivotal study. And we are aggressively working with some external vendors and on partnering activities to aid our recruitment initiatives.

The last bit about the fast track that is important, not only does it give us opportunity for more frequent interactions with the division at the FDA, but fast track also, in certain cases, allows for a rolling submission, meaning that sometimes you can submit your efficacy data, your CMC package, and your carcinogenicity study results at slightly different time points.

So, that is something we obviously would have to have agreement from the FDA. But, it is conceivable, for example, that you could submit your clinical safety and efficacy data and your CMC data prior to a readout of the carcinogenicity study, for example. But, those are all things that we will end up discussing, and we'll let you know.

One related question, just based on the comments. I think in prior calls you have mentioned that -- the classic challenge of keeping these patients motivated or involved in a 12 week trial design. Just can you give us a sense of how you're going to make -- or how you're going to treat patients that potentially drop out?

So, obviously there are two aspects to this question. One, how do we work on retaining patients? And so, the study design is such that we've chosen good investigators that know how to engage these subjects. And they have -- so far we've seen a very good retention rate both in the six week placebo-controlled trials and the 12 week open-label extension.

Our goal here is to use those same methods going forward and offering all subjects, including those placebo subjects, the potential to get active drug out through one year. So, there is an incentive. You can't get that open-label extension unless you've completed the 12 week placebo control.

The flipside of that is more the statistical question, which is how do statistically treat subjects who are dropouts? And in this particular trial, we will be looking at the primary endpoint, that is the AIMS at multiple time points during the 12 week randomized, double-blind, placebo-controlled portion.

And because we have multiple time points, the statistical method used here is a multiple effects repeated measure statistical model, which means that every subject contributes to the statistical analysis so that, if you have a subject who drops out at week 10 or at week six, as long as they've had an AIMS assessment, one or more AIMS assessments, they contribute to the model.

And that means you don't have to do any imputation or LOCF or anything like that. And that is becoming the -- for chronic, repeated assessment studies, that is becoming the preferred method for the FDA.

Okay. And just one question for Kevin. In our model, we continue to assume that you partner VMAT2 outside the US. Given the cash on hand, given the proximity to some of the datasets for elagolix, is that still a fair way to think about VMAT2?

We will look for a partner at the appropriate time. We're not currently actively engaging any partners. We plan on keeping this in the US completely ourselves and getting approval and marketing it here alone.

Ex-US, while we are talking to certain parties that have contacted us, do not look for a partnership from us this year.

Okay. But, just longer term strategy, is that something you're willing to comment today or just --?

No, longer term strategy, I certainly think certainly in Asia we would be partnering it, and then we'll look at Europe also.

Robyn Karnauskas.

Thanks for taking my question, and congrats on all the progress. I guess a lot of the questions in my inbox are all about the timing of the elagolix data. And I know that a lot of this is in AbbVie's hands, but here are the questions as follows.

So, number one, can you confirm that AbbVie will allow you to release top line data, or at least whether or not the trial worked or not, ahead of the second Phase II? And the second question is will that release be at the three month endpoint, which is the primary endpoint, or at the six month endpoint? And then I have others as well.

Okay. So, Robyn, you've probably, and I imagine the people who have put those questions in, have read reports where AbbVie has stated that they have concerns about the amount of data and the timing of data that they will release from that first Phase III clinical trial because there will be the second Phase III that's ongoing. And it is a subjective endpoint and they don't want to influence the placebo group there.

We're in discussion with AbbVie about the extent of the release that they will do and the timing of the release. And when I have more color on that, then I'll be able to let you know about that, or AbbVie will in their releases as we lead up to that. They do understand that the data is quite important to us, and we would like to share that with our shareholders.

The second question is that is the top line data coming at the three month primary endpoint, or is it coming at the -- after the six months of placebo-controlled? And the data that AbbVie is talking about is after the six month placebo-controlled portion of the trial has concluded.

So, the earliest we could get data, then, would be six months from like, say, end of the month plus some time? So, that would be more fourth quarter or late third quarter.

That's correct.

Okay. Then, the next question is what is the process? So, as you complete the trial, how much time typically does it take to analyze these datasets? I mean, they're pretty big studies, so could we really be talking about late this year or early into next year? How much time typically for these types of studies?

Yes. And Robyn, I could give you a good estimate about what Neurocrine would do. And I know our processes, and Chris could then talk to you about it and give you some guidance on that.

But, we're talking about AbbVie. It's our partner. We do not have insights on their processes. And so, I can't really speak to you about the timing of how quickly they can close that out for top line results and get that out.

Okay. Another question that you may not be able to answer is I know there's a lot of readouts post the six month, and that would be relevant to safety. And so, two questions there.

So, number one, what will we learn -- what is critical to learning about the side effect profile that we'll get at six months versus, say, a year? And number two, do we have any sense of what kind of readouts will occur after the six months should AbbVie allow that to be released?

And then, number three, when you think about safety, what does the FDA -- or when we will know how much safety or longer term data the FDA needs before approving the product?

So, I'll take a couple of those first ones, and then maybe Chris has a comment on the last. I don't know.

But, basically what do you want to get out of this study from a safety standpoint, and you're going to want all the typical safety measures. And we've treated patients continuously out to six months. And we've shown that we have relatively minor effects on bone, and then otherwise the drug is very well tolerated.

Now, AbbVie is going to be taking that out to 12 months of continuous dosing. So, clearly one is going to want to see what is the impact on bone now out to 12 months of continuous dosing.

And then, because they are in such large numbers now, you're also going to have the opportunity that, as with any drug, if there is any rare or unusual safety issue, then that's what -- it's in these longer, bigger trials that they can come up. But, that's true with any drug. When AbbVie would release all of that data, I have no idea on when they would release that.

In your question about longer term trials, as far as the FDA --.

I think Robyn asked two questions. One was about the longer term data.

So, at the end of 12 months of continuous treatment, because of the legacy safety concerns for drugs like Lupron, the FDA had said do some post treatment follow up for potentially up to 12 months after stopping treatment.

And so, that's simply to make sure there is no lingering or residual adverse events or bone changes or anything that they needed to be aware of. Whether that truly needs to be 12 months or six months, that remains to be seen. And that's obviously something that AbbVie will discuss with the agency.

As far as the size of the safety dataset, we haven't been involved with direct discussions with the FDA since the end of our collaboration and partnership. So, I honestly don't know whether AbbVie has had any additional discussions. That would be a good question to ask them.

Thomas Wei, Jefferies.

Just on the VMAT Phase III program, a few housekeeping things just in your proposal. How many patients did you propose? What do you think the estimated timeline there is? And what are you latest thoughts on seeking an SPA? And then I had a follow on the primary endpoint.

So, let me do those in reverse order, Thomas. Thanks.

I don't plan on asking for an SPA. We don't have very -- there are not a lot of contentious issues here on the study design. And this division doesn't have a long track record of using SPAs. And so, hopefully that's not a path that we need to go down. We should seek consensus at the End of Phase II meeting and get good agreement to the trial design and endpoints and statistical methods.

As far as the sample size, there's always a balance. There's three or four competing forces. You want enough patients to contribute to your safety dataset. You don't want so many patients that you're grossly overpowered. And you want a reasonable timeline for recruitment and completion of the study. And finally, you want enough data to have interpretable efficacy and safety information to guide clinicians in a product label.

And so, I believe that, for a Phase III trial, that balance is somewhere around 200 subjects for a single trial. The question is how many total subjects will we need for our overall NDA filing. And that's something we'll seek agreement on from the FDA at the meeting in June.

And the timeline for that, as I mentioned, the meeting in June, IRB and study site contracting and activities over the summer, starting the pivotal program in the fall. And the rough estimate that we've mentioned for a trial of this size is probably -- from start to finish, that is all the data done and all the study subjects closed out, probably about 18 months. So, we've said 2016 NDA.

And what about ICH guidelines for safety exposure on chronic treatment? Is that not a good guideline for --?

Well, of they're good guidelines. I would never argue with the ICH guidelines. But, there is some flexibility particularly for an indication which, while not orphan disease, is still relatively uncommon, unmet medical need.

And as you may be aware, the FDA has guidance documents which outline the kinds of situations where, for example, a single pivotal trial can serve as adequate evidence of efficacy if there is supportive efficacy data from other sources like a good Phase IIb study.

We expect that our NDA will probably have just under 1,000 subjects in our safety dataset, and will certainly well exceed the ICH guidelines for more than 100 subjects with one year of continuous treatment.

So, we'll exceed the guidelines for three and six months and 12 months of exposure. Just the overall package may be not the 1,500 that you often hear people referring to. But, again, that's always a negotiation with the regulatory authorities.

When I look at the proposal, I guess a couple of other things I'm a little bit uncertain about that might be -- may or may not be potential risks. And I guess I'd love to get your sense.

The assessment of depression, suicidality, how detailed are you going to be in looking at that and trying to get the black box removed?

And then, on the primary endpoint of the triple blinded, scrambled consensus assessment of the AIMS videos, is there any risk there that the FDA does not accept that, that either because of the lack of concordance with the investigator-assessed AIMS or the reduced dynamic range of video scoring, is that something we should at all be concerned about?

So, let me answer that first. This division in particular, FDA in general, are actually very good supporters of blinded central rating. And we've had good interactions with our ex-FDA consultants and our regulatory experts and our clinicians.

I'm quite comfortable going in with this proposal. And I don't see this as being any riskier than any other aspect of going into Phase III. I think it's -- we're in very good shape with respect to that.

Now, we do a lot of work to show that the kinds of changes that we document with the AIMS are corroborated by other scales and other methods. This is not a standalone. So, we have fairly robust corroboration by looking at -- for example, the psychiatrists that are onsite, they do the CGI, the Clinical Global Impression of Change.

And that is a more three dimensional tool that is done by the onsite clinician psychiatrist, and that encompasses a broader scope of what's happening with these patients than simply a dyskinesia rating. You see that as not only corroborative evidence, but the magnitude of change that we're taking about.

Who we consider a responder, for example, on the CGI is someone who's been scored as either very much improved or much improved. And that turns out -- is fairly tightly linked to someone who's had at least a 50% reduction in their video AIMS score.

So, these are robust changes with a marked separation from placebo. So, I think we're in good shape with respect to those things.

Your other question was about?

Thomas, you had another part to your question?

The first part of it?

It's okay. I can follow up later on that. I don't want to belabor my questions. Thanks very much.

Phil Nadeau, Cowen and Company.

First on the VMAT2 and the Tourette's trial, in the prepared remarks I think you mentioned that you were going to go after a specific target population in Tourette's. Can you give us your preliminary thoughts of who makes up that target population and how it's defined?

Sure. Yes. So, Tourette's, as you know, is generally a pediatric disorder with the onset range being three to 21. By definition, 21 is the cutoff. Obviously, adults have Tourette's, but most people with tic disorder and Tourette syndrome are in the kind of eight to 16 year range.

And so, our interest is, in fact, going after pediatrics. That's why we've done all this preclinical safety work to support our ability to do chronic dosing in young children. And while we obviously haven't started those studies, my estimate is that we will be in the six to 18 year old age range, since that's kind of the most common.

Earliest onset is age six. The average onset age at diagnosis is eight. And by the time you're 18, you're moving into adulthood.

And then, second is on elagolix in uterine fibroids. The press release mentions that the Phase IIb is ongoing there. Do you have any clarity from AbbVie when that trial might complete and what their data disclosure strategy is going to be?

So, I can tell you what's on Clinicaltrials.gov. The uterine fibroid Phase II program is slated as that the completion of the clinical portion associated with the primary assessment says July of this year. And that's that 520 or so subjects.

Kevin's shaking his head.

Yes, that's a part of Clintrials.gov that AbbVie has yet to update with that trial, because they doubled the size of the trial but they left the July date in there.

That's right.

That date can't be correct any longer, we don't think. And AbbVie at some point, I'm sure, is going to update that.

We do a back of the envelope and we see it as being early next year is when that trial could readout with its top line. But, AbbVie has not yet updated Clintrials.gov, but I'm sure they will be.

And have they communicated to you in any way whether they're going to release these data? I know we really haven't seen the Phase IIa data, so I'm wondering if we'll get to see the Phase IIb.

Yes. As it is with the Phase III program, that is a part of our discussions with them in order to find out exactly what amount of data and when they plan on releasing in the US program also.

(Operator instructions.) Marko Kozul, Leerink.

This is [Dee Dee] in for Marko Kozul. So, I just have one quick question. In looking at the Kinect 2 trial, did you use a central reading process to screen patients? And if yes, what was the screen failure rate in Kinect 2 versus Kinect?

So, in both Kinect and Kinect 2, we used a central review process to screen patients to assure that they met the inclusion criteria of moderate or severe tardive dyskinesia.

The screen fail rate in Kinect and Kinect 2 was virtually identical. And that screen failure could be because they didn't meet the TD requirement, but it also could be because they had unstable medical condition, laboratory abnormalities, prohibited concomitant medications, etc.

So, the screen fail rate for the two trials was about 50%. And of that 50% who screen failed, about half of them were because they either didn't have tardive dyskinesia, they had some other movement disorder, or they didn't have moderate or severe tardive dyskinesia. And that was pretty much the same in both trials.

And at this time I would like to turn the call back over to Mr. Kevin Gorman.

Thank you very much, everyone. Thank you for joining us today.

We're going to -- as you've heard, particularly in Chris's group, there's a lot of work going on right now to get the Phase III program in TD kicked off and the phase -- and then get into the children and Tourette's syndrome.

We'll keep you apprised at the upcoming meetings on our progress going forward. And in our Q2 earnings call, we'll have a discussion at that point since we should have the FDA minutes from our End of Phase II meeting at that point. Then we can really map out for you what the Phase III program is going to look like.

So, thank you once again, and look forward to getting together with you all.

And thank you, everyone, for joining us today. We do appreciate everyone's participation. This does conclude today's conference. You may disconnect at any time.