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Executives

Kevin Gorman – President and CEO

Tim Coughlin – CFO

Chris O’Brien – Chief Medical Officer

Jane Sorensen – Investor Relations

Analysts

Ian Somaiya – Piper Jaffray

Larry Smith – DLS Research

Stephen Willey – Stifel Nicolaus

Jason Napodano – Zacks Investment Research

Neurocrine Biosciences Inc. (NBIX) Q3 2010 Earnings Call October 29, 2010 8:30 AM ET

Operator

Good day, everyone and welcome to today’s program. 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)

It is now my pleasure to turn the conference over to President and CEO, Kevin Gorman. Please go ahead, sir.

Kevin Gorman

Thank you very much and good morning everyone. It’s our pleasure to be here this morning to talk with you about our third quarter earnings results and also the progress that the company’s been making to date. I’m joined this morning by Tim Coughlin our CFO and Chris O’Brien, our Chief Medical Officer and Jane Sorensen, who will now and before we get started read our Safe Harbor statement, Jane.

Jane Sorensen

Good morning. I want to remind you of Neurocrine’s Safe Harbor precautions. 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 as of today’s date and we undertake no obligation to update these forward looking statements to reflect subsequent events or circumstances, Kevin.

Kevin Gorman

Thank you, Jane. So the company looks remarkably different than the last time we spoke from a financial standpoint and also from a scientific standpoint, as we continue to progress our programs forward which Chris will be talking to you about. But first let’s get into the financials and Tim will take it from this point.

Tim Coughlin

Okay. Thank you, Kevin and good morning to all. Thank you all for joining us. After the market closed yesterday we released our third quarter earnings. It was another very good quarter for Neurocrine. In short the full impact of our recent collaboration agreements with Abbott and Boehringer Ingelheim is now evidenced in our financial results and because of these two deals our financial position has dramatically improved.

Our net income for third quarter was $3.3 million or $0.6 per share on both the basic and fully diluted earnings per share. This compares to a net loss of $8.2 million or $0.21 per share for the third quarter of last year. Our year-to-date loss is $10.5 million or $0.20 per share compared with 2009 year-to-date loss of $43.1 million or $1.11 per share. The reduction of our net loss is primarily due to the revenue recognized under the two new collaboration agreements, the personal restructuring program that we implemented in the second quarter of last year. And cost control measures across all functions within our company.

Revenue recognized under our collaboration agreement totaled $14.4 million for the third quarter of 2010. $9.2 million of this revenue is realized under the amortization of the up-front licensing fees, the remaining $5.2 million of revenue resulted from reimbursement of internal and external research and development costs.

Research and development expenses as well as G&A expenses were in line with our expectations for the quarter and year today. These expenses are significantly lower than last year’s run rate primarily due to the lower personnel related costs and across-the-board reductions in non-clinical related expenses.

In light of our improved financial position, we continue to focus on our cash burn from ongoing operations. If one were to exclude the impact of our two recent partnerships, we again met our targeted burn from operations for the third quarter that was established at the beginning of this year. We reaffirm our year-end guidance of ending the year with over $130 million in cash and investments and receivables from collaborating partners.

We expect to have an aggregate net loss in the range of $8 to $9 million. We expect expenses to be within our guidance, given the beginning of the year $43 to $46 million in total expenses. For those looking for more details around the financial results, we plan to file our 10-Q with the SEC later today. We’d be glad to entertain any financial questions during the Q&A portion of the call, before right now turn I’ll turn it back over to Kevin for the balance of the presentation.

Kevin Gorman

Thanks, Tim. As you can see that was very concise but very nice, a good financial situation to be in. As was written in there and as we’ve spoken with many of you about -- we are now aggressively pursuing our programs with our partners and then VMAT2 and Urocortin by our selves. And we are going to keep moving those programs forward, because we now have the financial wherewithal.

Having said that, we are going to keep a very disciplined approach to our spends and to the size of this company. We don’t plan on having any remarkable headcount growth in the foreseeable future. I’m not going to speak to you right now about the progress that we are making with them. But I’m going to leave that to Chris O’Brien. He heads of our Joint Development Committee on the Neurocrine side of the Senior Executive Team on both Abbott and our site to find the strategy of the collaboration. So Chris is going to take you through that and also we had a news just last week where we announced that we are going to be taking VMAT2 into a Phase II clinical trial at the end of this year and Chris will speak a little bit more about that. So Chris?

Chris O’Brien

Thank you, Kevin and good morning. Thanks for joining us on the call. So let’s start with -- before we get into elagolix and VMAT2, just a reminder that there is the ongoing activity with our Discovery Research Team continuing to work on a variety of internal targets, with the goal of generating compounds for us to bring into clinic and some very interesting stuff as things emerge we’ll keep you apprised.

The elagolix partnership is one that is giving us a lot of satisfaction and stimulation. Our collaboration with Abbott is going very nicely. There’s a joint project teams that involves the functional groups from both companies and they are hard at work at the moment, finishing out the design and planning aspects for the Phase II uterine fibroids, a trial which will be carried out, the collaboration between the two companies for an initial Phase II study and this disease state. And the Phase III planning for endometriosis, both of these initiatives planned for starting in the first half of 2011.

The ability to start Phase III obviously depends on reaching consensus with the division, the reproductive in neurologic products at the FDA. And as we’ve mentioned in the press release for the quarterly earnings, the end of Phase II meeting request was filed in September by Neurocrine and the FDA, Abbott and Neurocrine all work together to find dates that would work with the various schedules and the upcoming holidays. And so now we -- the FDA has offered a date in January to have the end of Phase II meeting. So that will be the basis of our discussions for the Phase III trial designs and the balance of the elagolix development program.

Now that program is now safely in the hands of Abbott. Transfer of the IND was carried out earlier this month and now they are the holders of the IND at the FDA. So that has -- things have really proceeded in a quite orderly fashion since the signing of the agreement with Abbott this past summer. And we have an excellent collaboration relationship with the partnership.

The rest of the supportive activities for elagolix are going to as planned with the carcinogenicity study, the manufacturing activities and the ancillary studies that will be carried out so that the NDA has the full complement of data necessary for filing. So for example, some of the residual drug-to-drug interaction studies and other type Phase I type activities are slated to be completed over the next two years.

The interesting piece of data that will be coming out shortly, as you know we finish the Daisy Petal or 901 study, this was the six-month trial with the placebo-controlled results announced earlier this spring. And the women in the trial finished the full six months of treatment and the additional six weeks of safety follow-up post treatment and the database has been mocked and we are finishing the QC of the data. And we will be announcing the results of that shortly and we look forward to sharing that with everyone. So that’s the elagolix program. Nice progress for the team, very hard work by all team members and a very satisfying to see this moving forward.

The VMAT2 program obviously is something that we were excited about and Kevin mentioned that in the press release from a few weeks ago, we had completed the multi-dose, repeated dose Phase I trial in healthy male volunteers. And we were very satisfied to see the consistent safety profile, the drug very well tolerated at the doses we are interested in. And most importantly for us, we saw the key PK profile that we were interested namely the limited variability that the good exposure and the nice long half-life with once a day to support once a day dosing. And the concentration time profile that we think is critical to take into patient population with the hyperkinetic movement disorders.

And so to confirm that we have assembled and filed a clinical trial application with Health Canada for our initial Phase IIa exploratory study in patients with Tardive Dyskinesia. And Health Canada obviously is reviewing that file as we speak. And assuming a favorable review and permission to proceed, we will begin the Phase II study at the end of this year. We have a small trial designed as mentioned it’s an exploratory Phase IIa case study, designed to help us understand the dose response that we would see in this population, patients with moderate to severe involuntary movement due to exposure to antipsychotic medication. As many of you know Tardive Dyskinesia prefers to a syndrome like Tardive syndrome or tardy meaning late, effects of exposure to dopamine antagonist, whether that’s an antipsychotic medication or even some of the antiemetic medication such as metocolpramide.

We are initially going after the TD population patients with schizophrenia or schizoaffective disorder that have been treated with either typical or atypical antipsychotics. These patients after typically a few months to a few years of exposure develop increasingly disabling involuntary movements often of the mouth, the tongue, the jaw, the Face Musculature but also can involve severe hyperkinetic movement of the trunk, of the limbs. And unfortunately for many of these patients, even if they stop the medication that had started the problem, for many of these individuals their movements may not remit over time even after stopping the offending agent.

Now, for some of these patients particularly those with schizophrenia that remain effective that cannot actually get off their antipsychotic medication and to date there is no approved medication for the treatment of Tardive Dyskinesia. It affects anywhere from 200 to 500,000 patients in the U.S. alone. And so this is an important unmet medical need if you will allow me to use that phrase. So we are very excited about this, we will be looking at three doses of our study drug 98854 in this patient population, in a dose titration fashion. And once we get an indication about the low end of the effective dose range on these doses over a 12 day treatment period, we will then plan on filing the IND with the FDA in the U.S. early next in the first half of next year. And then be able to go into a additional Phase II development activities at that time.

So the clear go-no go decision should be available in the spring after Phase II exploratory study is available, [data readout] and we will proceed accordingly. So that’s the VMAT2 program. The other activities as you know we have the Urocortin 2 in clinical development activities outside of the U.S. at the moment. The so-called UNICORN trial being conducted by cardiologists in Christchurch, New Zealand is moving along nicely. The trial, its target is to enroll 50 patients with acute decompensated heart failure and currently approximately 34 subjects have been randomized. And the subpopulation -- there is a sub study within that -- it was like 10 subjects will undergo right heart catheterization. And those 10 subjects have actually been enrolled and studied.

The Data Safety Monitoring Group is happy with how things are going. And we expect to have data midyear next year for the full complement of subjects. We also have the University of Edinburgh in Scotland, conducting a series of small Phase I and Phase II trials that are focused on trying to further flesh out the attributes of the Urocortin 2 from a mechanistic point of view. Looking at ways to better characterize and further characterize the potential applications of Urocortin 2 and the appropriate cardiovascular population.

So for example, some very specialized four hour infusion studies, looking at biomarkers of vascular function and dysfunction following Urocortin 2 infusions are currently being conducted. Dosing is underway in those trials and we should have data from our colleagues in Scotland somewhat time next year as well. So Urocortin 2 moving along well and the Boehringer Ingelheim partnership with our diabetes and development program is also moving along nicely. Again that’s the discovery phase research targeting GPR119 and that collaboration is a preclinical on discovery collaboration at the moment.

So I think that we have touched on elagolix, VMAT2, Urocortin 2, GPR119. I should mention also that the 679 development program for the CRF1 antagonist continues as you may recall, we continue to add scientific support to some trials in post-traumatic stress disorder and related phenomenon that our clinical research of Phase II initiatives receiving some support from GSK and Neurocrine and the NIH and research institutes such as Emory University. But those are very long-term collaborations over a period of years. But they continue to be ongoing. So I think, Kevin, I have touched on all the areas and I will turn it back to you.

Kevin Gorman

Thank you. So in the coming few months, what we are going to have actually in the very near future as Chris said we are going to have the data -- the six-month data from the 901 study. That’s important data for two reasons. One, it will give us at least an additional hundred patients for safety out of six months. And that should bring our database of women treated over a 1000 I believe so.

Chris O’Brien

Subjects treated over…

Kevin Gorman

To a 1000 -- and as far as women that have been treated for six months it takes them to…

Chris O’Brien

So the total number of patients with endometriosis treated for at least 3 to 6 months is up in the over 650 -- I think it’s over 700 now.

Kevin Gorman

So when meeting with the agency in January, we are taking to them a very robust Phase II and Phase I program in studying this drug. The second aspect that’s important that we want to see from the Daisy Study is the durability of the response as measured by the endpoints that we have tested in here and development with the FDA and patients. And so that obviously is a very important question that needs to be answered at the six-month time point.

So from what you’ve heard here from Chris and Tim I think it’s very important to point out that with elagolix timelines continuing on track and that drug continuing to perform in the future with the current pipeline that we have now and investing heavily in it and moving it aggressively forward, we have the finances already in place to be able to take this current pipeline all the way through ourselves without raising any money on current timelines to the point where elagolix actually hits the market.

So it’s a very comfortable place – actually, I should say not comfortable but it’s a much better place to be and then we have for the last several years. But again make no mistake we are going to continue to enhance our pipeline and both internally and externally all the way through and we will be looking for other partnership opportunities at some of these drugs mature. And then as Chris said early next year we are going to have the results from this clinical study with the VMAT2 and that will be very important to us also.

So with that why don’t we open it up for questions now?

Question-and-Answer Session

Operator

(Operator Instructions) And we’ll take our first question from Ian Somaiya with Piper Jaffray. Your line is open.

Ian Somaiya – Piper Jaffray

Thank you. I just had a couple of questions. Just first on the Phase III trials -- have you had any preliminary discussions with the FDA regarding the endpoints? Do we anticipate any changes to the daily questionnaire as you move into the Phase III program?

Kevin Gorman

Thanks. Yeah. We have had -- obviously discussions with the agency and ultimately the final agreement occurs at the end of Phase II meeting. I think there will be no surprises. We will continue to see a division that wants us to do co-primary endpoints with dysmenorrhea and non-menstrual pelvic pain using the daily rating scale. And based on the success of Daisy Petal, I don’t think there will be anything any radical changes to that program.

Ian Somaiya – Piper Jaffray

Okay. And as you -- if I guess beyond the regulatory trials that’s already planned. Can you talk about trials that will help develop the market and where are some of the obvious challenges of treating second line endometriosis? Is the challenge that you can address through clinical trials or what other efforts are going to be required?

Chris O’Brien

Those are terrific questions. Obviously the amount of information that I can share is a little limited because this is Abbott’s program. And obviously fleshing out the data package of elagolix for endometriosis, this includes efforts to meet a broader set of market needs beyond simply regulatory requirements for an NDA. But clearly understanding long-term treatment initiatives that is treatment beyond six months, understanding some populations that might have unique needs, looking at how to address functional outcomes and impact on quality of life, productivity in the workplace, the Pharmacoeconomic arguments -- the data package that needed those are all efforts that are under discussion and planning. But the bottom line is as we’ve said all along with elagolix, the goal is to get this drug to market as quickly as possible. The initial label is for six months of treatment and nothing has changed from that initiative.

Ian Somaiya – Piper Jaffray

Okay. Just one last question and I’ll get back into queue. Just on the financial side -- can you remind us of the cost -- Phase II program that’s for elagolix and what your base are to spend there? Just trying to get an idea of how we should model spending moving into 2011.

Kevin Gorman

Okay. So, Ian, I wouldn’t use the base Phase II program for elagolix just because of the changes we had in the endpoints. So the way I’ll answer your question is, if you to look at the revenue section we have two lines. The first is sponsored research and development. That is related to reimbursement or receive for Abbott from Abbott or other collaborators, rate to expenses we have incurred. It also includes our FT reimbursement.

So the people that spent time in the program that we are able to charge up to collaborators. The second line license fees and milestones I think we’ve hit a static point on that now and we have a full quarter of both the Abbott and the BI agreements in there as well as the DSP agreement, so I don’t see that line migrating much going into the future until we start bleeding through those upfronts. That’s essentially the deferred revenue coming through the non-cash line.

The G&A line in Q1 and Q2 we were in the low 3 millions. We pushed up a little bit this quarter, but I expect this to be in the low 3 millions going forward. And then R&D is really going to be dependent upon how much Abbott gives us to work on, but our static numbers I think we’ve talked to before our base burn this year was at $43 to $46 million in expenses. And I think that if you -- since we’ve essentially unloaded the cost of the elagolix program that’s going to be replaced essentially with VMAT2 to a lesser extent for 2011. So that’s why I would kind of look at things going forward.

Operator

We’ll take our next question from Larry Smith with DLS Research. Your line is open.

Larry Smith – DLS Research

Yea. Kevin, I really agree with you what a difference a year makes.

Kevin Gorman

Thanks, Larry.

Larry Smith – DLS Research

I had two quick questions. One was -- Chris, with the modified numbers or public pinpoint, do you think -- what are the advantages of asking the FDA for an SPA just to make sure that they really are on board with that endpoint? And what are the disadvantages?

Chris O’Brien

That was a good question, Larry. My feeling about FDA is it -- it depends on really two things. One, who is the division that you are working with, which division and how do they view SPA? And the second is how much uncertainty is there about whatever the issue that leads you to want an SPA. In this case we have a very good working relationship with this division. We have excellent communication with them and they been very clear about what they want. And the only issue was back when we went to the modification to the wording -- was could we remove the floor of that that we have seen with the initial scale that the FDA asked us to use.

And we have done that they seem happy and we want to lock that down at the end of Phase II. I can’t speak fully for Abbott but the assumption is an SPA, in this day and age only gives you a certain measure of comfort. They are not a guarantee and they add a measure of -- an element of time or delay of getting an SPA process and approved. So if you can achieve that at year end of your Phase II meeting and all parties are satisfied that there is consensus that there are no outstanding contentious issues then SPA really doesn’t add much value. Particularly, as I say it’s not chiseled and still moving SPA. So while we were initially perhaps interested in SPA to try to accelerate the process of getting to start of Phase III. At this point I’m not sure if it really adds much value. But again that will be up to Abbott and it will depend on how the end of Phase II discussions go.

Kevin Gorman

And the only thing that I would add to that Larry, also is that if you were developing new endpoints somewhat in the vacuum you would probably want SPA but this has been something were to a great extent, we followed the direction of the agency and what they wanted from us in these endpoints. So in that sense I think it has been a very collaborative process with this division.

Larry Smith – DLS Research

Okay. Great. And if I could ask one other question, in looking at [Vidorian, Lancastrian] and Conexa, all of them on very different products from elagolix, but the common trend is that the FDA is really putting more boxes on their list to check. So what do you and many of us certainly I was kind of surprised at the aggressiveness that the FDA took in regards to issues with each of those drugs. Are there any issues like that with elagolix that you feel you have to fully defined in the Phase III trial or are they no hidden issues like carcinogenicity or carcinogenicity in animal models?

Kevin Gorman

I don’t know what I don’t know. But today we have been very forthcoming about all of the issues. As you know early in the development program the question was could you get pain reduction without bone loss? And we knew that was a hot button for the FDA so we invested very early on in the big Petal Study looking at DEXA scan. We put a lot of money and time in getting that answer.

We also knew that theoretically a small molecule non-peptide GnRH Antagonist might cause problems like the GnRH peptide agonist and that you could get Ovarian hyperstimulation syndrome. And very early on we showed that that didn’t occur. And so now we are at the stage with a fairly well characterized Phase II molecule with around 1000 subjects exposed.

We think we have a pretty good hand on the profile of the drug particularly with regards to safety. We’ve completed virtually all of the preclinical work that will go into the NDA and the hot button that are kind of applied to all programs such as carcinogenicity and the QTC assessments, at the moment are non-issues for elagolix. We don’t have a QTC binding effect of this drug and we have not seen any ECT signal. But a proper Thorough QT Study obviously will get done during the -- in parallel with the Phase III studies to simply check that box and round up the data set.

As you know we are well into the middle of the two year carcinogenicity study. I think where month -- 14 or 15 at this point and that study has gone well, but obviously it has to be completed and the histology readout done. But to date no items of concern other than the need to complete the study. So I don’t have any secret surprises in my back pocket that I’m concerned about. But this is drug development. This is Phase II. Lots of surprises can happen when you scale up from 1000 subjects to 3000 subjects and complete the (inaudible) study, so we will see how that goes.

Chris O’Brien

And also, Larry, you do bring up -- the agency is putting higher hurdles in front of every drug that they seek regardless of drug class and the way that we handle that and especially with our history, it’s just very important to have as much transparency with the agency as humanly possible both ways and have good communication. We think we have that with this division.

But clearly there are cross divisional activities that take place in the FDA and those are coming to the floor starting in the end of phase II meeting. So we will be starting to meet some of those players within the FDA and hopefully, we can keep a good communication with them going also.

Larry Smith – DLS Research

Sounds like you thought about this. Thank you.

Kevin Gorman

Just a little bit

Operator

All right. We’ll take our next question from Stephen Willey with Stifel Nicolaus. Your line is open

Stephen Willey – Stifel Nicolaus

Hi. Good morning. Thanks for taking the question. Real quickly on VMAT2, just wondering, maybe what some of the historical efficacy endpoints have looked like here? Presumably, there is some kind of scoring or subjective assessment and I’m wondering how validated these assessments are and maybe talk about the length of the running you are going to have prior to moving patients onto drug?

Chris O’Brien

Sure. Steve, thanks. There are established skills that have been around for sometime. The main one that most people are familiar with is something called the abnormal involuntary movements scale or AIMS. And the AIMS scale is a rating scale for the intensity of the hyperkinetic movements by body region. So mouth, face, trunk, limbs and the scoring is done by a trained observer done during a structured neurologic examination. And there are many, many publications on the AIMS out there.

It’s been around for a while. It’s used across hyperkinetic syndrome. So it’s not limited to just Tardive Dyskinesia. It has been used in other involuntary movements but primarily that’s where you will see its application. You use the word validated. You know that is validated in the old -- in the traditional sense of has it been used a lot of times and accepted by regulatory authorities as an appropriate endpoint.

And to that extent, you have to say yeah. Then that is validated in a more modern terminology which is has it been constructed as an instrument from the ground up, using modern psychometric scale development techniques? No. The AIMS has been around a long time. It’s been used and widely used and is well-established in the literature and as I said, used by regulatory authorities and considered a validated instrument.

But clearly that’s part of my program at four VMAT2 as we bring the development program forward. That’s part of the discussions that we will have with the FDA at the IND stage and clearly to Kevin’s point earlier, having transparency and good communication with the appropriate division at the FDA and with the authorities at the EMA is really critical. There are initiatives to develop other scales for hyperkinetic movements and we are well aware of those.

You may recall, I mean, movement disorder neurologist by training and have actually helped develop the Parkinson’s rating instruments, the Huntington’s rating instruments in my former life. And so we’ll obviously be plugged into this and we’ll impose some measures of robust scale activities even with the AIMS.

So for example, we videotaped the structured neurologic exam and then we use the videotapes and have them rated by a blinded central review separately from the investigator, all those kinds of things will be done to make sure that there are no surprises.

Stephen Willey – Stifel Nicolaus

Helpful. Thank you.

Operator

We’ll take our next question from Jason Napodano with Zacks Investment Research. Your line is open.

Jason Napodano – Zacks Investment Research

Hi guys. Thanks for taking the question. Just a quick question on milestones, what’s the next realizable milestone on elagolix with Abbott? Is there -- I’m talking payment. Is there anything for completing end of Phase II or initiation of Phase III?

Chris O’Brien

We can’t really discuss those. They’ll become evident, very evident as we hit them. Suffice it to say that while we haven’t yet given guidance on next year formally, we don’t believe -- we believe that are ending cash balance this year will be the same as our ending cash balance next year and that’s based on milestone achievements.

Jason Napodano – Zacks Investment Research

Okay. Fair enough. Thank you.

Chris O’Brien

You’re welcome.

Operator

And we have no further questions at this time.

Kevin Gorman

Well, I want to thank everyone this morning for participating and also thanking everyone that’s been on the call for their support of the company over the last several years. We’re feeling that we are starting to turn the corner here. We haven’t turned it, we are starting to turn the corner here. And we’re going to be working diligently towards that. Just to end here, I’m going to be -- we’re going to be presenting at the Oppenheimer conference next Tuesday. I believe our talk is at 11 a.m. and at that forum, we’ll be webcasting the Q&A section of that more of a fireside chat. So I look forward to having meeting more of you there and having the opportunity to continue this dialogue. Thank you very much.

Operator

This is today’s teleconference. You may now disconnect and enjoy the rest of your day.

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