Good day, everyone, and welcome to today’s Neurocrine Biosciences Reports Fourth Quarter and Year End 2013 Results. At this time all participants are in a listen-only mode, later you will have the opportunity to ask questions during the Q&A session. (Operator Instructions) Please note this call is being recorded, and I will be standing by should you need any assistance. It is now my pleasure to turn the conference over to Kevin Gorman. Please go ahead sir.

Thank you. And thank you everyone for joining us this afternoon for our earnings call. I am joined here as usual with Tim Coughlin, our CFO; and Chris O’Brien, our Chief Medical Officer. Before I get started, Jane, could you read our Safe Harbor statement?

Sure, good afternoon. 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. Before I turn it over to Tim to go over the financials for the quarter and the year-end, and then Chris to give a brief update on the programs, just a couple of words. Number one is that it has been a very good quarter for us. We’ve had a chance to discuss extensively with our investor base and all the analysts to cover us the data from the Kinect 2 study, which was very successful. And we’re quite pleased now to be taking that program into late-stage clinical trials following our End-of-Phase II meeting with the FDA just a little in the second quarter of this year. Also we’re very pleased that AbbVie continues to move ahead with both the elagolix program, both in endometriosis having both trials started, and also the uterine fibroid Phase IIb study going well. So Chris, will talk a little bit more about those, but first Tim, could you go over the financials?

Sure. Thanks, Kevin. Good afternoon to everyone. As Kevin mentioned, we made a lot of progress for the last three months, successful Kinect 2 study. We’re ramping up now for the End-of-Phase II meeting with the FDA and we continue to advance compounds closer to the clinic. From a financial perspective, we met our recently increased year-end cash target, and we also met our projected burn from operations. We ended 2013 in a very strong financial position with a $147 million in cash, investments and receivables. And that yielded essentially a net burn of $41 million for the year. We began 2013 with $188 million in the bank. Our GAAP net loss for 2013 was $46.1 million or a loss of $0.69 per share, and that compared a net income of $5 million or $0.08 per fully diluted share in 2012. Our net loss for the last quarter of 2013 was $10.6 million, $0.16 loss per share, and that compares to a net income of $9.5 million or $0.14 of income per share in the fourth quarter of 2012. When comparing both the quarterly and the annual results for the same periods in 2012, the major contributing factor in the change in operating results is a reduction in revenue earned under both the AbbVie and Boehringer Ingelheim collaboration agreements. Our active participatory efforts under both of these collaborations ended as planned during 2012. Our revenues for the fourth quarter 2013 was $700,000 and for the year – for all of 2013, it was $2.9 million and this is in line with our guidance for the year. Our R&D expenses for the past quarter were $8.9 million. For all of 2013, they were $39.2 million. That is 5% annual increase over 2012 R&D expense levels and was driven primarily by the…

Thanks, Tim. So as Tim outlined here, there are no surprises in the financials. The year went exactly as we had outlined it, albeit with bit more cash in the bank when we ended last year. So Chris, would you like to give an update on R&D? Chris O’Brien: Thank you, Kevin, and thank you for the participants on the call. As Kevin mentioned, it’s been a good quarter, not just with the Kinect 2 results, but with – across the board with our programs. With respect to elagolix and AbbVie, as Kevin mentioned, there are two ongoing Phase III trials in endometriosis. The first trial of course is primarily a U.S. trial, North American trial. And the second study is a study covering many ex U.S. countries. The details are outlined in the press release that we issued earlier this afternoon. We’re very pleased with the work that AbbVie is putting into the endometriosis and uterine fibroid program, and are very pleased, not just in the running of the clinical trials, but the supportive work with respect of health outcomes and health economics and all the ultimately necessary ingredients to get this product successfully launched. With respect to the VMAT2 program, of course the Kinect 2 results were the catalyst that were necessary for us to understand that we had addressed all those key points that a company needs to have in hand when they go into an End-of-Phase II meeting. So we have a good understanding of, who the patients that are appropriate subjects should be for Phase III trials. We have a good understanding of the study design characteristics. And then as you recall, we had a steady learning curve as we worked our way through Phase II development in tardive dyskinesia. No one has successfully registered…

Okay, great. So right now why don’t we turn it over to questions from all of you?

(Operator Instructions) Our first question comes from Robyn Karnauskas with Deutsche Bank. Please go ahead. Alicia [ph] – Deutsche Bank: Great, thanks. This is Alicia [ph] in for Robyn. First of all, congrats on the all the VMAT success during the quarter. It’s awesome. So sort of three questions. One, just curious about your plans for communication of any further data on Kinect 1. What’s the latest kind of on the elagolix timing from AbbVie? And then I just wanted to check one thing. You said no revenues in 2014. Does that include that you will get no milestone – you expect no milestones on the elagolix in 2014 to reach the modeling some in 2015 associated with the Phase III? Thanks.

So Alicia [ph], this is Tim. We’ll start with the last question first. And that is true, we expect milestones in’ 15, I wouldn’t model anything in ‘14.

And this is Kevin. As far as the question on AbbVie, there has been – guidance has remained the same, both for the endometriosis program and the uterine fibroids program. Recently AbbVie said from the podium that the first End-of-Trial is going to be reading out in second half of this year. Alicia [ph] – Deutsche Bank: Okay. Chris O’Brien: And with respect to the…

I think that’s for Kinect 1. Chris O’Brien: Yes, Kinect 1 data. So thanks. We are continuing to do some additional analysis with the Kinect 1 data and I have submitted some abstracts and things to International Congress of Movement Disorders. If we have in a timely fashion some additional data for that meeting, that would be great. It is not a critical path element to our program going forward. We would use some additional data to help with our PK, PD modeling, but we don’t see that as a material event, and I don’t think you’ll see any public release. I think ultimately when we have these manuscripts that get out as journal articles, and that’s such a long timeline, but ultimately that should be all in that context. Alicia [ph] – Deutsche Bank: So when does the Congress of Movement Disorder? Chris O’Brien: There is this meeting by the Movement Disorder Society in June in Stockholm, Sweden in June 8 to 12. Alicia [ph] – Deutsche Bank: Great, awesome. Thanks guys, congrats.

Thank you.

Thank you. We’ll go next to Phil Nadeau with Cowen & Company. Please go ahead. Phil Nadeau – Cowen & Company: Good afternoon. Thanks for taking my questions. In the prepared remarks, you mentioned that you have nailed down the patient population to move the VMAT into Phase III. I think the last time we talked, you hadn’t yet done subgroup analysis to look how the female have performed in the different underlying etiologies, that had caused the diseases that were then treated to give rise to tetrabenazine. Have you done that analysis? How did tetrabenazine performed in different underlying diseases? Chris O’Brien: So firstly we’re not studying tetrabenazine. Phil Nadeau – Cowen & Company: I mean – sorry, not tetrabenazine, the VMAT. Chris O’Brien: So yes, Phil, thank you for that. We have done some analysis we discussed. And indeed when you look at the patient – the 60% of the subjects in Kinect 2, who had underlying schizophrenia or schizoaffective disorder, they had a statistically significant and robust separation of active from placebo on the AIMS scale and on the CGI done by the investigator psychiatrist. Likewise, the 40% of the subjects who had mood disorder including bipolar disorder, they had a statistically significant and robust separation of active from placebo and the AIMS, the CGI, and interestingly also the PGIC. And so what this is telling us, that’s an exploratory measure, the Patient Global Impression of Change, that tells us the bipolar and mood disorder patients seem to have relatively good insight into their condition and clearly distinguish between active and placebo with respect to PGIC, whereas the schizophrenia or schizoaffective disorder subpopulation in Kinect 2 looks very much like the subpopulation in the Kinect study – well, not subpopulation – in the Kinect 1 study, they…

No, they haven’t told us how they would be disclosing that data. Phil Nadeau – Cowen & Company: Okay. Do you – and you may have just answered the same question, but we never saw the Phase IIb data. Do you expect them to release the Phase IIb data at all, or is it possible that they just can run into Phase III without releasing the Phase IIb data?

That would be a good question for them actually. Phase IIa data, I wouldn’t expect to see that data anytime sooner or maybe ever. So that was just some exploratory Phase IIa study. The Phase IIb data, they do have a Publication Planning Group, that’s going – that takes all the data that’s being generated there at AbbVie, but we’re not preview [ph] to their timelines for when they will be publishing these clinical trials. Phil Nadeau – Cowen & Company: Okay. And then my last question is that, there has been a good amount of discussion of deuterated tetrabenazine that’s in development initially for Huntington’s disease but there is also some expectation that’s going to move into tardive dyskinesia. I was wondering if you’d care to compare and contrast your VMAT inhibitor with the deuterated tetrabenazine.

Yes, I think that it would be premature for us to be talking about their compound outside of Huntington’s chorea, which is where most of their work has been focused in doing a 505(b)(2) on that. I would say though that our compound has a number of advantages over tetrabenazine, so were they deuterated or undeuterated. So why don’t we wait for their programs to mature if they do, and then we can talk about it in the future. Phil Nadeau – Cowen & Company: Fair enough. Thanks for taking my questions.

Thank you. We’ll go next to Ian Somaiya with Nomura Securities. Please go ahead. Ian Somaiya – Nomura Securities: Thank you. And let me add the congratulations. It’s been great start to the year.

Thank you. Ian Somaiya – Nomura Securities: I wanted to ask you about the Phase III trial design. Is it planned to do one study with both patient populations at this point or do – need to do multiple trials? And maybe you can just speak to the duration of treatment [indiscernible] required in the studies? Chris O’Brien: Thanks Ion. So while my fantasy is that I can do one pivotal and one safety study, the reality is that we’ll probably end up with two relatively modest sized 12-week pivotal trials, and then we’ll have open label extension through those. And in parallel, we’ll probably have an additional modestly sized open label safety trial for 12 months. So two pivotals, 150 to 200 subjects each, 12 weeks in duration, placebo controlled and then one open label, just a simple safety trial for 12 months. So that at the end, we will have an NDA with a safety database of close to 1,000 subjects and we’ll exceed the ICH requirements for having more than 100 subjects with 12 months of continuous treatment. Ian Somaiya – Nomura Securities: And what are the regulatory requirements in Europe? Chris O’Brien: So we have not engaged the EMA in discussions of drug development and registration for tardive dyskinesia in Europe. That is not something that’s part of our current plan. That is something that potentially an ex U.S. partner would take on and we will leave that discussion with the EMA up to them. Ian Somaiya – Nomura Securities: Okay. And just one last question on the Tourette’s program. You mentioned moving into a Phase II study this year. Can you just speak a little bit more specific on the timing of that Phase II trial and would it support moving into Phase III trial…

So Ian, we have had a number of calls and we have a number of conversations ongoing now with a wide variety of partners, all centered around ex U.S. And so we are not in a hurry to complete a partnership here. As I’ve said before, we want to get our Phase III program kicked off and have that moving along before we turn our attention to then doing technology transfer with the partners and being able to work with them to get the programs kicked off in their territory. So my guidance to you is to not expect the deal this year out of us in this. There is not – it’s not a priority for us to do a partnership and it actually would do a disservice for our efforts both in tardive dyskinesia and in Tourette’s this year if we were to do a partnership. Ian Somaiya – Nomura Securities: Okay. Thank you so much.

Thank you. We’ll go next to Thomas Wei with Jefferies. Please go ahead. Thomas Wei – Jefferies & Co: Thanks. So I had a couple of questions just on, first, the reanalysis of the Kinect 1 data using the changes that you made to the AIMS endpoint in Kinect 2. Can you just remind us what the timing of that reanalysis is, and how we should set our expectations around that? Do you think it’s reasonable for us to expect the 50 milligram dose to actually become statistically significant now at week six? Chris O’Brien: Thanks, Thomas. So a couple of points. You may be aware – and forgive me if I – my recall is not precise and it’s after we saw the initial Kinect 1 results, the top line week six results, we did have the opportunity to go back and do a blinded central raters video scoring of the Kinect 1 data at week six. And we haven’t obviously published that or talked about it in the kind of widespread way, but internally we saw a very nice separation of 50 milligrams from placebo at weeks six p-value of less than 0.05 using the same, just a simple comparison of all those subjects on 50 milligrams who had a week six AIMS score available compared to the placebo subjects at week six with an AIMS score. And that separation was very nice. Now, that was done with a single rater doing a sequential scoring. That is the baseline scores of all the subjects’ videos and then the week six scores of all the subject videos. What I think you’re referring to is if we take the methodology that was applied to the Kinect 2 study, after our Scientific Advisory Board had put. We will rescore Kinect 1…

Thank you. We’ll go next to Charles Duncan with Piper Jaffray. Please go ahead. Charles Duncan – Piper Jaffray: Thanks guys for taking my questions, and congratulations on the recent data. So most of my questions has been asked, but I am wondering if you could – I am not sure if I missed this, the timing of the Phase III, you talked about in the start. And then thank you very much for the sizing of it or general sizing. Would you anticipate that to wrap up by the end of 2015?

So in general for these three month trials with a few hundred patients, we are looking at about an 18 month process. I say about because no one has ever recruited this many tardive dyskinesia patients for a registration trial. So I can’t give you any kind of precision on that estimate. What we have said publicly in our documents is that we anticipate NDA filing in 2016. So that’s the working foundation from where we stand today, and obviously as we move along we’ll get greater precision. Charles Duncan – Piper Jaffray: And then what are your plans around communicating kind of the results of the End-of-Phase II. I imagine you’ll wait till your End-of-Phase III meeting with FDA. I imagine you’ll wait to get the minutes, but will you come out and help us understand what the final protocol design is? Chris O’Brien: Well absolutely, you are correct, often times the FDA tends to include little nuggets in their official minutes 30 days later. And it’s not at all as exactly 30 days. So in general companies are reluctant to speak out before they have something official in hand. The surest information you have of course is when we post the Phase III trial design information on clinicaltrials.gov. And that’s done before any patient is actually randomized. So you’ll see that at the beginning of the study as the worst case scenario. Charles Duncan – Piper Jaffray: Then regarding the Tourette’s syndrome program, again I am not sure if I missed it, but you mentioned moving into clinical studies at the end of the year. Are there any experiments that you’re doing, if you will, in the pre-clinical setting? Are they more [indiscernible] type things, whereby you need to just complete the work? Are there any key questions or hurdles to moving in the clinical? Chris O’Brien: The main one that stands between us and opening an IND for Tourette’s syndrome is completing the pre-clinical juvenile toxicology project. So the in-life phase of that is done, but the post study work done by the outside toxicology contract research organization and that takes months. And so getting those final reports reviewed, audited, signed off and then the package assembled and then the meeting request for the FDA for a pre-IND meeting, that’s what’s going on right now. And then once that’s done, then we get the IND package assembled and submitted, as I said sometime Q3-ish depending on the timing of the FDA. And we would start that Phase II study in the fall. Charles Duncan – Piper Jaffray: And then my last question perhaps for Kevin, regarding commercial plans in the States. I heard from an earlier question that ex U.S. partnering could occur after you kicked off the Phase III, but U.S. plans would be to move forward and perhaps commercialize product to yourself?

Yes, our plans are to commercialize this product in the United States in both, tardive dyskinesia and Tourette’s syndrome. It’s very focused prescriber base. The size of the markets are ideal for a company of mid-sized – small growing to mid-sized biotech company, such as ourself. And we’ve built the sales force before. We can do it again. We’ve reclaimed all of that institutional knowledge in-house. So we will slowly and gradually build up our commercial organization in here as the program moves forward. Charles Duncan – Piper Jaffray: It makes sense to me in kind of what I thought your plan was, but I just want to check that, to make sure it hadn’t changed. Thanks for taking the questions.

Thanks, Charles. Chris O’Brien: Thanks, Charles.

Thank you. (Operator Instructions) Our next question comes from Marko Kozul with Leerink Partners. Please go ahead. Marko Kozul – Leerink Partners: Hi, guys. Congrats on your progress this year. I just have a super quick one maybe for Chris. For elagolix in uterine fibroids, can you comment or share maybe your thoughts for the ongoing Phase IIb trials potentially serving as one of two pivotal registration trials? Certainly when we look at the study, it looks like it’s sized for the lower end of the range in terms of a potential pivotal for that indication? Thanks. Chris O’Brien: Thanks, Marko Kozul. It’s an interesting and speculative kind of question that in general that would be unlikely, but when you’re dealing with a common non-life threatening condition, generally the Agency is pretty firm on having two well-controlled pivotal trials that are informed by a Phase II trial, but having said that elagolix having been used in so many women with endometriosis, there is a very large safety database and that would be the kind of the discussion that AbbVie would have to have with the Agency. And that wouldn’t happen in – I don’t think until they had an End-of-Phase II meeting when they had all the data from both cohorts of the uterine fibroid study in hand. It would depend on the magnitude of the data, how closely the FDA thought that that protocol would mimic what they would require in Phase 3 etcetera. Marko Kozul – Leerink Partners: Terrific. Thanks for taking the question.

Thank you. We’ll go next to David Friedman with Morgan Stanley. Please go ahead. Yigal Nochomovitz – Morgan Stanley: Hi, good afternoon. This is Richard Horowitz [ph] standing in for David. Thanks for taking the question. Two more on the uterine fibroids program. The first is regarding the Phase IIb ongoing. Could you provide some additional perspectives on the secondary endpoints which you feel are the most relevant in your assessment, by my count account about 20 secondaries. And then secondly, in regards to timing for the Phase III, could you potentially comment on that? Thank you. Chris O’Brien: Thanks. So for the second question, I can’t comment on the timing of the Phase 3 other than it depends on getting the Phase IIbs done and the Phase II meeting. What AbbVie has said publicly is that they were talking about 2015 as the timing for End-of-Phase III start, but again I have no unique insight. You would have to ask AbbVie on that. Now as far as the secondary endpoints, you are exactly correct that there is a long list of exploratory secondary endpoints, very appropriate for our Phase II study as you are trying to determine, what are the things that you are going to want to make key secondary endpoints for inclusion into the label of a commercial product. And so AbbVie and people at AbbVie who were previously at TAP Pharmaceuticals, they were the ones – pioneers who worked out what are the appropriate endpoints for uterine fibroid drug registration trial. And clearly for the U.S. uterine bleeding is the primary endpoint either measured through a semi-objective measure like alkaline hematin or one of the other measures that pictorial representation of blood loss. From a secondary point of view, I think the ones that rise to the top would be pain and quality of life measures. You can see they are also looking at things like uterine size and fibroid size. I don’t think those have very much bang for the buck in terms of FDA. Those are interesting things, but if you are asking my opinion, I would say they tend to fall a little bit lower down the list. It’s all about blood loss and pain and quality of life. They are also obviously investing a lot of work into looking at things like productivity, the health and economic kinds of things that will ultimately be very useful when interacting with the payors. Yigal Nochomovitz – Morgan Stanley: Thank you very much.

Thank you. We’ll go next to Robert Hazlett with ROTH Capital. Please go ahead. Robert Hazlett – ROTH Capital: Thanks. So a lot of ground has been covered in Q&A. Most of my stuff has been covered up. I just want to ask a strategic question. I guess if you see success with elagolix, does that potentially get you to act more aggressively in any way shear perform with the VMAT2 program either with Tourette’s or with TD or does it cause you to think more broadly about VMAT2, where the VMAT2 program in its development in terms of potentially considering Europe for yourself or other broader indications down the road, just a little color strategically in terms of what elagolix success might mean for the other programs?

Yes. It’s a good question. Elagolix success obviously this year would be transformational for this company, but on the aspect of how it will directly affect what we’re doing in VMAT, we are putting 100% of the resources that we have or that we could envision right now into tardive dyskinesia and Tourette’s syndrome. If there is anything more that we could be doing with our VMAT2 inhibitor at this point, we would be doing it. Access to capital is not a question, we just – right now, we are putting all of our capital towards TD and TS right now. We have a very even active backup program within the VMAT2 program that we don’t talk about, but we have numbers of other molecules and a lot of research going on in order to fully understand this system. I think only the very surface of the VMAT2 system has been scratched biologically at this point in time. There is a lot of understanding that we’re developing here. And there could be a wealth of other things to do within the VMAT2 system, both with the compound that we currently have in late-stage development and potentially with backup compounds that we have moving along. I think that what success with elagolix eventually which we’re highly confident of is going to allow us to move other programs that we haven’t currently talked about even more aggressively. Robert Hazlett – ROTH Capital: And the assumption is that those would be again more in the VMAT2 related areas and CNS-related indications?

The other programs that we haven’t talked about are on neuro endocrinology focus as is – which is the focus of the company. Chris O’Brien: Either neuro or endocrinology.

Either neuro or endocrinology. Chris O’Brien: Yes. Robert Hazlett – ROTH Capital: Thanks. We’re hoping for a success on a lot of levels, so we can see those. Thanks.

Yes. Okay.

Thank you. We’ll go next to Jon LeCroy with MKM Partners. Please go ahead. Jon LeCroy – MKM Partners: Thanks. Just a couple of quick follow-ups on elagolix. So the timing for the first elagolix Phase III what month are you expecting that to fully wrap up so we can...

I can only go by clinicaltrials.gov that AbbVie has there, Jon. And it says the final data collection is in September of. Chris O’Brien: August.

August, I am sorry – of August of this year. And it’s going to be completely up to AbbVie then how quickly they then disseminate that data, when that wraps up. Jon LeCroy – MKM Partners: And you are assuming they are going to disseminate that and not wait for all of the trials together?

My assumption is that they will disseminate that and that is based on the fact of how they’ve disseminated their Phase III data with the Hep C program, where they’ve had numerous Phase III trials and they’ve reported each one out as it’s come – as the data has become available. Jon LeCroy – MKM Partners: Okay. And then as far as your milestones on Phase III data, what needs to be completed for those?

Our milestones are not based on completion of activities, they are based on the initiation of activities. So we’ve already been paid our milestones for the initiation of Phase III in endometriosis. So our milestone stream will pick up again. We anticipate to pick up again in 2015, but we’re precluded in talking in specifics what those events will be. Jon LeCroy – MKM Partners: Okay. And then is the uterine fibroid Phase III start moving into ‘15, a slip relatively to what you were thinking a few months ago?

No. That’s what we had anticipated a few months ago. Jon LeCroy – MKM Partners: Okay, thanks. That’s it.

Thank you, Jon.

Thank you. It appears we have no further questions at this time. I’ll turn it back to Mr. Gorman.

Well, thank you very much everyone. And like I think Chris outlined to you, the last several weeks and the next few months here going into Q2, there is going to be a lot of work that we’re laying the foundation that is going to be coming to fruition in the second half of this year in all of our programs that we have. And I hope to be talking to you about additional programs in the not too distant future that we have going. At our next earnings call, you can anticipate that we’ll probably be talking about the results of our End-of-Phase II meeting at that point in time. So we’ll have a little bit in our next... Chris O’Brien: No. We have a Q2 end meeting, so that our earnings call would be at...

Earnings call will be in Q3. Chris O’Brien: Yes.

Yes. So it will be – we’ll have some more color for you on the End-of-Phase II meeting on our next earnings call. So thank you very much and I look forward to talking to you in our non-deal road shows and also at the conferences coming up. Take care.