Good day, everyone and welcome to Neurocrine Biosciences Second Quarter Earnings 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. It’s now my pleasure to turn the conference over Kevin Gorman, President and CEO. Please go ahead, sir.

Thank you. And thank you everyone for joining. It’s pleasure to be here in this morning to talk about our Q2 earnings and update you on the programs. With me this morning is Tim Coughlin, our CFO; and Chris O’Brien, our Chief Medical Officer. We will be going over the financials and then we will give you an update on our R&D programs. But before we do that, Jane could you please read our Safe Harbor statement.

Yes. Good morning. I want to remind you of Neurocrine’s Safe Harbor caution. 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. Our financials are right in line with guidance and Tim why don’t you take everyone through it.

Sure. Thanks, Kevin and good morning, everyone. Appreciate you joining us for our second quarter earnings call today. Our second quarter 2014 again that our financial plan with a net loss for the quarter of $13.4 million or $0.18 per common share outstanding. Our second quarter loss did increase over the first quarter loss of 2014 and we expect this trend to continue through the year. Research and development cost will increase as a result of initiating Phase III development of VMAT2 inhibitor NBI-98854 and tardive dyskinesia as well as the commencement of our clinical efforts with the same compound in Tourette’s syndrome. In addition there are other compounds for different targets and separate disease stage and other stages of pre-clinical work that are being shipped at GLP pre-clinical studies. The GLP studies are significantly more expensive than a non-GLP testing. Our year-to-date loss is $25.2 million with $0.35 per share, this compares to $24.3 million or $0.36 per share in the first half of 2013. The increase in year-to-date net loss for the prior year is primarily driven by an increase of share-based compensation expense of $2.4 million when compared to the first six months of 2013 and a decrease in revenue under license fee amortization of $1.4 million. This was offset by a lower development cost which reduced by $2.8 million for the first half of 2014 compared to 2013. As I already mentioned these external development costs such as GLP, our pre-clinical GLP testing, GMP manufacturing of API and finished good products, clinical trial related expenditures et cetera will rise through the rest of 2014 and continue to increase into 2015. We expect our research and development cost increase steadily through the rest of the year. We expect our G&A cost to remain relatively constant at $4.2 million per quarter for the balance of 2014 or approximately $17 million for the entire year of 2014. In 2015, we expect G&A cost to rise as our commercial efforts related to VMAT2 will begin in August. Our cash position remains strong and in the second quarter with $0.25 billion in the bank, or in 2014 with at least $230 million in cash and investments with no debt. We filed our 10-Q yesterday after market close and that filing contains additional information about the quarter. I will try to keep my comments brief, it is relatively straight for quarter from a financial standpoint and we will go ahead and attain any questions in Q&A but for now, I will turn it back over to Kevin.

Thank you, Tim. So Chris is now going to talk about our pipeline. Particularly, VMAT2 you know that at the end of the June, we had an end of Phase II meeting with the FDA and I am pleased to say that with a very collaborative and very productive meeting that we had. You’ve read the highlights in the press release and now Chris is going to go through some details for you. Chris O’Brien: Thanks Kevin and good morning to the participants, thanks for calling in today. As Kevin pointed out, at the very end of June, we had our Type-B meeting, end-of-phase II meeting with the FDA and the division participants, a review team were very engaged. We got the detailed preliminary written comments before the meeting in response to our briefing package and we had an opportunity to focus on the important topics at the end of phase II meeting. We got our official meeting units back a just couple of days ago and a lot of us know that at this call. The key take homes from the meeting were after extensive review of the clinical that we had in hand to date, I think Phase I and Phase II studies that have been completed as well as the support of pre-clinical and manufacturing data. We reached a good understanding of what they need to see in an NDA application for tardive dyskinesia. And to satisfy that NDA requirement, we will be conducting a single pivotal clinical trial, Phase III trial with the placebo-controlled in tardive dyskinesia. And in discussing the nature of that trial, the protocol includes several important key features. One is we had agreement on the population patients, the patients that will be rolled in Phase III are identical to the patients that…

Thanks, Chris. And just to add on what Chris was saying in that program and in parallel with the clinical team’s discussion with the FDA. There has been CMC discussions with the FDA and those are all progressing really well with no issues going on there, so the CMC is tightly buttoned up also. As far as the AbbVie meeting also there I am pleased to say that we were there as they were closing in on the agreement for the acquisition to Shire and there certainly doesn’t appear to be any distraction from the team or any movement within the team thus far based on that acquisition. So, with that I would like to open it up for questions.

(Operator Instructions). And we will take our first question from Robyn Karnauskas with Deutsche Bank. Please go ahead. Your line is open.

Thanks. This is Mohit for Robyn. Thanks for taking my question and congratulation on the progress. So, my first question is like just wanted to learn about your discussions with FDA around the fact that one pivotal trial will be sufficient for the filing, what were the FDA comments around that?

Most of the comments were based on the understanding of what constitutes adequate to well controlled trials and we reviewed the Kinect 2 results and obviously that was a very robust trial conducted in a manner that could be considered adequate to well controlled. Obviously that’s subject to the normal scrutiny and review that occurs at the time of the NDA. So, we all are waiting for their final detailed review that occurs after the NDA submission but the Kinect 2 study could constitute one of the, one adequate to well controlled trial.

Got it, that’s helpful. And then will there be a dose escalation phase in this Phase III trial or all patients will start of fixed dose from day one?

It’s a fixed dose parallel group trial.

And then I mean the last one is like, just wanted to make sure that I got it right on Violet Petal Study, so the timelines for data readout are the end of the 2014 and AbbVie will communicate to the street, right?

That is correct. AbbVie will communicate with the street until regular customary process of bringing the database, unlocking and then unwinding. We imagine that that’s going to somewhere at the very end of the year or early next year in January. But again that timing is completely up to AbbVie and discussions with them on the extent of disclosure that they will be getting and providing to the Street at that point in time.

And we will take the next question from [indiscernible] with Cowen. Please go ahead. Your line is open.

I was hoping for a bit more clarity on the choice of dose for Phase III in particular in the light of Kinect data and the 50 milligram dose to a 100 milligram dose and the variability for sometimes at the end of the trial. So is it why is the safety profile looks pretty good even at a 100 milligram, why not go for a higher dose. And also what should we expect from the 40 milligram dose in the Phase II trial?

So a couple of things, just to comment about use of the word variability. In these studies, the variability that we start with sometime with sorting out is not related to a drug. The variability with our drug is very predictable PK is very nice, good bioavailability, good predictable exposure. The variability comes in the struggle in the early Phase II studies was around who was doing the AIMS and how they did it. And that’s what we spent so much time working on and while we ended up with the blinded central video raters that we used in Kinect 2 and that we will use in Kinect III. So once that’s done, the variability goes away. Secondly also to the other point, we spent extensive effort of viewing our exposure response data and working with our FDA curtailments we found that we had a very clear story that is you need a certain amount of exposure to get a response. And if you are going to be a responder, you respond robustly once you have that exposure. It is very clear that as you go up on exposure for example, exposure seen with doses of 100 milligrams, you get no incremental benefit, no additional benefit. You just get more exposure and at a small level although the drug was as you said visibly well tolerated, we see some signs that kind of exposure for a long-term usage probably not where that are appropriate. But the main driver of our dose selection is that exposures over 75 milligrams or 80 milligrams don’t get you anything, you don’t get additional benefit. And for tardive dyskinesia, what you see is somewhere in the range of 60% of subjects become profound responders with a marked reduction in tardive dyskinesia. And you get some percentage of patients, 20% of patients who are kind of non-responders and about 10% of patients somewhere in that range, 10% or 20% are partial responders. But increasing exposure doesn’t change that once you get over a certain threshold. What we found is that the FDA really wants to see a minimal effective dose and maximum effective dose. And what we were able to show them with our data is that patients getting dosed at 25 milligrams are comparable to placebo. At 50 milligrams yes we have a good number of responders, but not the maximum number of responders. Once you get up to that 75 milligram, 80 milligram exposure range, you are pretty much maxed out. And so that’s why we were able to reach an agreement with them that we with our data from Phase II and with additional data from these two doses at Phase III we will have a complete spectrum of minimal effective dose and maximum effective dose. And 100 doesn’t get you anymore, 25 is like placebo and 40 and 80 are perfect balance.

And so what were to happen you have to keep both doses, what if something that happens to the 40 milligram dose?

That’s a good point. We do not have to get both doses. Our expectation is that we will do our hypothesis testing with the 80 milligram dose first, and then with the 40 milligram dose. And we do not have to hit both.

Okay. So if we were to kind of 40 milligram to sale, you still can file with 80 milligram?

Yes.

And it appears we have no further questions at this time. I will turn the program back over to our presenters for any closing remarks.

Yes, thank you very much everyone for joining us this morning. Just to sum up, as you can see, we are real pleased with the outcome of our end of Phase II meeting. The hard work that the clinical group put in the Phase I and Phase II portions of this program have really paid off and the agency appreciated that. With Fast Track that allows us to have continued communication with the division and to again build on the relationship that we have with the activation as Chris said they are very engaged and very communicative at this point. So, and obviously we have a big data event with AbbVie that’s coming up at the end of the year and so we are very much looking forward to that. So, over the next six months, we are going to look forward to seeing you, we have a number of conferences Morgan Stanley in September and Nomura in early November, Jefferies over in London in mid-November and then Piper and Deutsche Bank and Oppenheimer going through the rest of November and December and then finally JP Morgan in January. So, at all those conferences, we are going to be able to keep you I think quite up to date with the lot of communication and disclosures from the company as we move forward with these programs and others. So, with that I thank you very much for your attention and look forward to meeting with all of you in the coming months.

This concludes today’s program. Thank you for your participation. You may disconnect at any time.