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Neurocrine Biosciences Inc. (NASDAQ:NBIX)

Q4 2011 Earnings Call

February 8, 2012 05:00 pm ET

Executives

Kevin Gorman - President & CEO

Jane Sorenson - IR

Tim Coughlin - VP & CFO

Chris O'Brien - CMO

Analysts

Ian Somaiya - Piper Jaffray

Phil Nadeau - Cowen & Company

Jon Lecroy - MKM

Jason Napodano - Zacks

Thomas Wei - Jefferies

Operator

Good day everyone and welcome to today's Neurocrine Biosciences fourth quarter and yearend 2011 results conference call. At this time all participants are in a listen-only mode. But later you will have the opportunity to ask questions during the Q&A session. (Operator Instructions). It is now my pleasure to turn the conference over to Mr. Kevin Gorman, CEO of Neurocrine Biosciences.

Kevin Gorman

Thank you very much. Thank you all for joining us for the fourth quarter earnings call. I am joined here by Chris O'Brien, our Chief Medical Officer and Tim Coughlin our CFO. Before we get started I would like to have Jane Sorenson read our Safe Harbor statement please.

Jane Sorenson

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, believes, expectations or predictions of the future are forward-looking statements which are subject to risks and uncertainties. Information concerning factors that could cause the 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 www.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?

Kevin Gorman

Thank you, Jane. As usual Chris is going to give you an update on our clinical programs. Tim will review the fourth quarter and full-year financials and in addition Tim is going to update those financials with the financing that we closed on last month and he’ll also give you guidance on our burn for 2012. So with that Tim, why don’t you start off?

Tim Coughlin

Okay, thank you Kevin and good afternoon to all. After the market closed today, we filed our earnings for both the fourth quarter and the full calendar year of 2011. We had another good quarter and met our overall financial plan for 2011. At the beginning of 2011, we guided to net income of $37 million to $39 million. Our net income for the year was $37.6 million.

We also guided to a net cash burn of $3 million to $6 million and end 2011 with approximately $130 million in cash investments and receivables. We met both of these goals ending 2011 with a net cash burn of $4 million and with a $131.7 million in cash investments or receivables. Our net income for the fourth quarter was $1.3 million or $0.02 of income per fully diluted share compared to net income of $2.5 million or $0.04 of income per fully diluted share in the fourth quarter of last year.

Our 2011 net income of $37.6 million or $0.67 per fully diluted share compares favorably to a net loss of $8 million or a loss of $0.15 per share for 2010. This significant improvement in operating results for 2011 is a direct result of two items. The first is a full-year revenue recognition under our collaboration agreements with Abbott and Boehringer Ingelheim. These collaborations both commenced in June of 2010.

Second during 2011, we recognized $30 million of milestones under the Abbott agreement related to the Elagolix endometriosis and uterine fibroids programs. Revenue recognized under our collaboration agreements was $11.1 million in the fourth quarter of 2011 and $77.4 million for the full year.

Amortization of upfront licensing fees was $9.2 million for the quarter and $37 million for the year. Reimbursement of internal and external research and development expenses resulted in revenue of $1.9 million and $10.5 million for the fourth quarter and year-to-date 2011 respectively. Research and development costs were relatively flat year over year. Increased external development costs related to our VMAT2 Program and other research and development costs for earlier-stage programs were offset by a lower external development expenses related to Elagolix as these activities continue to transition to Abbott.

General and administrative costs decreased 6% year-over-year primarily due to lower building overhead costs and continued cost containment efforts. Other income for the fourth quarter of 2011 was $1.7 million lower than the same period in 2010. This decrease is due to a one-time investment gain of $700,000, a couple of million dollars received under the Qualifying Therapeutic Program that was part of the Healthcare Reform Bill. Both of these events occurred in fourth quarter of 2010 and this fourth quarter difference of $1.7 million explains the majority of the difference in the year-to-date change in other income.

For 2012 our financial guidance is a net loss from operations of approximately $9 million to $14 million or $0.14 to $0.21 per share based on the 66 million basic shares outstanding. Revenue for 2012 is expected to be $40 million to $45 million which include a non-cash revenue from amortization of upfront license fees of approximately $34 million. We do not expect to receive any milestones in 2012. This lack of milestone funding accounts for the majority of the decrease in revenue from 2011 to 2012.

Expenses for 2012 should approximate $55 million to $60 million. General and administrative expenses should be relatively flat year-over-year. The overall anticipated increase in expenses is driven by research and development, specifically around our VMAT2 program and earlier research programs, which we will look to accelerate both through and into the clinic.

Non-cash option expense or FAS 123R expense is currently estimated approximately $6 million for 2012. Our net cash burn for 2012 is expected to be $40 million to $45 million while we expect to end the year with approximately $170 million in cash investments and receivables.

In mid-January, we completed a public offering of approximately 10.9 million shares of common stock, yielding gross proceeds of approximately $88 million. This offering was very successful, completed in less than a day with top tier long focus funds taking the overwhelming majority of the new shares.

We’ve been very pleased with post market performance of the stock as it has risen to new 52-week highs on the heels of the stock offering, a testament to the quality of the funds and the portfolio managers with whom the new shares were placed.

Now that concludes our prepared remarks on the financials and the projections for 2012. I would be glad to entertain any questions on the financials later in the call. And for those looking for additional details, our 10-K should be filed with the SEC later this week. With that I’ll turn it back over to Kevin.

Kevin Gorman

Thanks Tim. As Tim said, we couldn’t be more pleased with the conduct of the offering and how smoothly it went. We couldn’t come close to satisfying the demand that we realized in the offering and again that’s showing up in the performance of the stock since we went out. And what that additional funds allows us to do is really accelerate our VMAT2 program to a commercialization more quickly with a much more robust program than what we had planned previously and we’ve been able to see now through animal model work that we have been doing that, truly the VMAT2 compound that we have in hand with our three months talks now done is behaving quite nicely in both species.

And also it has shown us an animal model have potential impact on the underlying symptoms of schizophrenia and now we are going to be able to really track that down in our Phase II and Phase III program. The funds will also support VMAT going into an additional movement disorder indication that we hope to start later this year.

And then finally with the funds, our research group has been very active and we have several compounds now that are moving their way out of research and into development and this allows us now to take several of those compounds forward and we plan on doing that and by the end of this year to be in a position to file an IND in the completely novel neuroscience area with a novel compound. So we are looking very forward to that and as that matures this year we are going to be speaking more about that. So at this point I’d like to turn it over to Chris. So that he can give you a review of our main clinical program.

Chris O'Brien

Thanks very much Kevin and good afternoon to all. The key things to talk about of course are VMAT2 and Elogolix. The Elogolix program is obviously being driven by our partner Abbott Laboratories and we had a successful meeting with Abbot and the FDA at the end of the year and Abbot has memorialized the results of those type C discussions in the form an SPA which was submitted a few days ago and the plan as noted. The start of the endometriosis Phase III pivotal trial that should be later in Q2. So Abbott has geared up for this. The study sites have been qualified. The clinical trial materials, study medication prepared, the vendors engaged, etcetera. So things are moving ahead there and we are very excited about the start of this Phase III initiative in endometriosis.

While that's going on the uterine fibroids Phase II study has been recruiting to schedule to plan. This is a 300 subject trial. Details are publicly available at the clinicaltrial.gov for the Elagolix in Uterine Fibroids by trial and our partners have stated that they would anticipate that some data from this Phase II uterine fibroids study later this year. So Phase III endometriosis, Phase II uterine fibroids and of course in the background the usual supportive studies that round out at NDA submission are underway.

The rest of the drug-drug interaction and Phase I type studies are underway. A very intensive effort with all the resources that Abbott can bring to bear to this important health initiative. So that's the [gross] program, what gets us obviously excited and this is what Tim and Kevin have mentioned is the VMAT2 program, probably the biggest driving event for us on this program was having in hand the three month toxicology data from two species of rodent and non rodent species that became available in December. Its really hard to have that sense of confidence that you can move a molecule into long-term clinical studies until you have that under your belt and our pre-clinical toxicology group under the guidance of [Hay Goselian] they did a great job getting this done. The results were supportive of going into long-term treatment in the human and so that’s why we’re going to be able to do and I will outline that approach in just a second.

So we got that information in December. As you know prior to that we had just two weeks of toxicology data in animals and that allowed us only to do two weeks of dosing in humans. And so in order to get a jump on the program and get data as quickly as possible, after we completed the Phase I healthy volunteer studies in Canada and the small open label trial in patients in Canada we opened the IND here in the US and that allowed us to start the current randomized, doubled lined, placebo controlled, trial that we call the 1101 study.

The study was started in the fall with recruitment and we ended up finishing randomization of subjects in December and I am happy to report that we have one subject left to finish our treatment tomorrow. So the studies has moved along well. Of course we have some additional post-treatment safety follow ups to do with the subject that were randomized and we will then put that data through the QA QC clean and scrub process and the un-blinding will occur in March and we will be reporting top line data towards the end of March. So far the study has gone very well. We have had excellent investigators at ten sites here in the US. There have been no safety signals from the trial in terms of drug related serious adverse events and we are very pleased with the conduct of the trial to date.

So that two week randomized placebo controlled crossover trial, it’s worth making a comment about this study. The primary endpoint is the validated and gold standard scale for dyskinesia, namely the abnormal and involuntary movement scale or AIMS and what we will be reporting out and what you can anticipate is we will be preparing the AIMS score at the end of one treatment period to the AIMS score at the end of the other treatment period. Of course the subjects are randomized. They even get randomized on-drug for two weeks and then placebo for two weeks or vice versa.

And we are also studying two different two doses of A54 VMAT2 inhibitor. This report then will be a comparison of the AIMS score on-drug versus the AIMS score off-drug regardless of order of exposure and the active will be compared to the placebo period. What we expect is that the AIMS total score, which is anywhere from 0 to 28, will show a significant difference between placebo and active treatment periods.

And to give you an idea of kind of how the numbers work, so subjects with moderate or severe tardive dyskinesia have been randomized into this trial. The inclusion criteria included an AIMS score of at least 9, with at least two of the body regions having scores of 3. That is a moderate. And what I can tell you is that to-date, in a blinded fashion, I can look at what the baseline scores are and they’re coming in at around 15. Obviously, we don’t have the final number until the study is done and the data is all scrubbed. But that’s very reassuring. That tells me we’ve been successful in recruiting patients with at least moderate or severe TD and because it’s a within a subject comparison trial, there is a cost-over trial, we expect a smaller, placebo effect than one normally sees in a parallel group, of placebo control trial.

If you look in the literature, parallel group placebo control trials with tardive dyskinesia typically have it in the 20% to 30% placebo effect if you will. When we think of the cross over trial, this will be smaller and we had designed the study with 90% power to detect statistical data set and clinically meaningful difference between treatment groups.

So that kind of puts you a context to think of it. So by the time end of March comes along when we reported top line results, you have a way of interpreting that data set. Assuming that trial is positive and supports this validated mechanism of action for treatment of hyperkinetic movements, we will rapidly move in to setting up and implementing the next Phase 2 trial and this next trial, of course can be a three-month duration treatment, now that we’ve the long-term [tox] to support it.

And in this trial we would be doing two phase 2b studies. First will be in schizophrenic patients with moderate possibility of TD and I am anticipating about a 120 subject trial looking at several doses of our study drug, with treatment over 12 weeks and because of the way the style of the trial is designed and these electronic date captured, I am anticipating that if the recruitment goes well we will be able to report top line data out from that trial towards the very end of this year.

The second study will start in a staggered fashion after the schizophrenia trials and that will be in a population of patients with bipolar disease or depression who have tardive dyskinesia of moderate to severe state and that will be otherwise a very similar design study., The primary difference as Kevin hinted at in the schizophrenia trials we will also include the standardized assessments for schizophrenia such as the PANSS. And this will allow us to look at the impact of our study drug on the underlying schizophrenia symptoms while we are looking at tardive dyskinesia as a primary end point.

We also will for the bipolar and depression population have a Hamilton rating scale more appropriate for measuring depression So a lot of work is getting set as we start to qualify sites, investigator sites for those Phase II studies. We are doing some intensive work to make sure that we have high quality investigators and that we learn as much as we can from this crossover study to prepare us for those Phase IIb studies. Meanwhile, while that's all going on we are waiting for our friends and academic colleagues in Christchurch, New Zealand to report out on the Urocortin 2 data from the Unicorn trial in patients with acute decompensated heart failure. The final subject of the 50 in the study population underwent treatment in December, came back in late January for a safety follow-up visit and now we are awaiting that group to finish going through that data and tell us whether this was a positive study or not.

So as soon as we get those results obviously we will share that publicly. So that’s an update on Elagolix with Abbott. We met two for tardive dyskinesia at Neurocrine and the Unicorn, Urocortin 2 study in New Zealand and if there are questions I’ll be more than happy to answer them during the Q&A.

Kevin Gorman

Thanks Chris. So as you can see we've got a lot going on this year, I mean just in the next 12 months we’re going to have initiated a Phase III program, read out for Phase II trials of launching new program out of research and the clinical development, so a lot for us to do this year.

It’s worth noting that on a couple of these programs as we said before, the plan that we have is to retain the VMAT2 rights in North America all the way through commercialization. This is a very attractable market that we believe we can handle ourselves. And at the appropriate time, we will bring on a partner in rest of the world, that's not something we plan on doing right away, because even though it’s an outside US partner that we would be bringing on, it nevertheless would slow our efforts within the United States and we are in a position, a very strong position now to take this forward quite away ourselves. So we are not any hurry to bring that partner on until we’ve advanced the program more.

And then finally, with the Urocortin 2, as Chris said we should be getting those results also this quarter and if those are very strong results then we will take the time and the efforts in order to out license that program to a strong cardiovascular company. If negative, obviously, we won’t; and if they are not really that strong we’ll probably only spend limited efforts initially and looking for a partner we have much more valuable activities that our Business Development Group and Chris have to get to this year in that, because we do hope to move the VMAT2 into its Phase III clinical programs next year. And so that’s what quite a bit of our internal focus is on.

So with that, I would like to open it up for the questions now.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question comes from Ian Somaiya with Piper Jaffray. Please go ahead.

Ian Somaiya - Piper Jaffray

Thank you very much. Chris thank you for all the comments related to the VMAT2 Phase II and how you think about it; I was really hoping to get your thoughts on the other product Elagolix and how should we think about the uterine fibroids results which, if you could give us a timing, but I would expect them to be really some point to this year. Just you know what is the goal of the study and how should we think about the trial and what you would consider to be successful results?

Chris O'Brien

Thanks Ian. So on clinicaltrials.gov, you will see that the primary endpoint for that study is uterine bleeding and that is in this particular case measured by a quantitative method called alkaline hematin which basically cauterizing the amount of blood loss during menses and the threshold for heavy or excessive uterine bleeding is the criterion that must be met for a woman with fibroids to be in the trial. So, what you would anticipate sponsor for Abbott reporting is the reduction in alkaline hematin as a primary endpoint. It is also important to remember that again as you can see our clinicaltrials.gov that this is an early Phase II study. So we are looking at multiple doses and regimens of Elagolix as a way of helping them understand how they want to use this going forward.

Ian Somaiya - Piper Jaffray

And then I just had question on the guidance, the range 55 to 60, I am assuming the variability for delta is specifically related to R&D, can you just help us understand what would drive a R&D number; that’s in the low end or the high end of that fine layer in delta?

Tim Coughlin

Well, it’s really going to depend, it’s $5 million range there and it really depends upon timing and because its so narrow, it’s just how fast things get done, how fast enrolment goes and when certain things hit, I mean if we have certain programs and we can move little more quickly, it’s going to be at the higher end of that range. If they move, basically how we think they are going to move it will be in the mid-point; if they move a little bit slower, it will be at the lower end. But you know 5 million is a pretty narrow range; I think when you look across you know it’s 10% of the burn.

Operator

Thank you. Our next question comes from Phil Nadeau with Cowen & Company. Please go ahead.

Phil Nadeau - Cowen & Company

First on the VMAT2 inhibitor, I find your comments on the lack of SEs in the current trial pretty encouraging. Can you talk a little bit more about that, and specifically in the Xenazine trials did the AEs appear within the first two weeks or was there a real increase in depressing the suicidality early in the Xenazine trials?

Chris O'Brien

Hi Phil thanks. So the Xenazine trials in Huntington’s chorea, and then the general literature about Tetrabenazine, report acute times of adverse events that are basically what you see if you have excessive dopamine depletion, pre-synaptically So things like akathisia, motor restlessness or Parkinsonism or sedation, you don’t see depression in a short-term trial with clinically reasonable doses of these drugs.

And the suicidality, that’s a little bit, you know if you go and look at the published Xenazine trials that were done as effort by Prestwick, you will see that there is no suicidality that is associated with the drug. There was a suicide in a Phase II trial patient with Huntington’s disease and as you know, you may know Huntington’s disease has a very high background rate of suicide related primarily to the disinhibition not depression, the impulse control problems in the study notes, a devastating disease.

And so the basic statement there is, where we guide we don’t see any of that; we don’t think that’s going to be an associated problem with our growth for a whole bunch of reason which we can talk about in some other time perhaps. But, we think we have addressed some of those risks with our specific molecular ways designed in those. I would not expect to see things like depression or suicidality in a short term to the crossover trial, obviously with long duration trials you have a better chance of picking up low frequency events in the larger population and hence our urgency to do 12 week, a 120 subject trials as way of demonstrating safety and tolerability.

Phil Nadeau - Cowen & Company

And those Dopamine depletion side effects, would those have shot-up in the two weeks?

Chris O'Brien

Yes.

Phil Nadeau - Cowen & Company

And then my second question is on the SPA, that Abbott has decided to get; I guess I am still a little unclear as to why they are going after the SPA; it seems like you guys at Neurocrine had really nailed down most of the major design elements of the Phase III like a year ago; and it doesn’t seem like any of those really have been changed by Abbott, so why do they feel the formality of an SPA is necessary?

Kevin Gorman

The FDA recommended. The bottom line is, there are a lot of ways to skin a cat and Abbott went through the process of making sure they were comfortable addressing all the details that they wanted to address. And at the end of the series of the end of Phase II and the two additional Type C meetings, they were addressed and the trial design is what Abbott wanted and the agency is happy with that and so basically memorialize all these things in an SPA.

Operator

Our next question comes from Jon Lecroy with MKM. Please go ahead.

Jon Lecroy - MKM

One, does the quarter’s delay in Elagolix for endometriosis is the way you are sort of timing for when the drug could launch in the US?

Kevin Gorman

The timings for the drug are ones that are dictated by Abbott and so Abbott’s guidance is on their website was from an October presentation they gave and October 21 I believe is when that presentation is on there and they show there that NDA filing is in 2015 and then in 2016 they anticipate an approval.

Jon Lecroy - MKM

And then any update on the uterine fibroids enrollment, is that going quickly?

Kevin Gorman

It’s going well too. It’s going exactly to plan.

Jon Lecroy - MKM

Okay. And then just a little bit on the VMAT. Do you expect placebo differences depending on when the drug was dosed or I guess I am asking is there a residual effect of the drug that might go over into placebo in patients that are started on drug for the first two weeks.

Chris O'Brien

Jon, you have asked a good question. The half life of the drug is such that since I am comparing only the end of the first two weeks to the end of the second two weeks, there will be no drug on board. It’s completely washed out within that first seven to eight days. So and we know that when you stop this drug, the hyperkinetic movement start to remerge after a few days, after a week or so. So this study is specifically designed so that it is not a problem in terms of pharmacokinetic exposure. You don’t see anything at the end of that placebo two-week period. Now there is another subtle carry over type effect, that is a behavioral effect, not a pharmacologic effect. And so that simply, the sequence effect of being in a trial and that obviously you can’t avoid that but we have a large enough sample size that we think that we can you know, we will still be able to show a nice separation of active from placebo.

Jon Lecroy - MKM

So are you expecting a similar delta from base line for the placebo group regardless of when they are dosed?

Chris O'Brien

So I think it will be interesting. You know I don’t know. We’ll see. It will be interesting to see how much sequence effect is there. We have a whole of series of analysis prepared to help us answer those questions. The primary comparison just so we are clear is simply aims at the end of the active period, the aims at the end of the placebo period. There is no change from baseline calculation there at all.

Jon Lecroy - MKM

Okay and then on your according to, can you talk a little bit about any discussions you’ve had with pharma, potential partners or how you think the demand for this if it works would be?

Kevin Gorman

Well, we’ve had contact with several companies that are in the Acute Decompensated Heart Failure space. If you know that that has been a much more difficult space. So there is about a handful half dozen that are really seriously in that space. They know when these results are coming out there. They have got a familiarity with the program. So the way we are working with all of them is when the results are out. Then we will be re-contacting.

Jon Lecroy - MKM

Okay. And have you thought about market potential for a drug like this?

Kevin Gorman

No. Actually we haven’t. As you know we haven’t invested one dime in this program for almost five years now, since we restructured the company. So this is really something that as I said before, if the results are very good then we will go out and out-license and by out-licensing, I mean just that. It won’t be a collaborative effort like all of our other partnerships are. It will be a throughout licensing.

Operator

(Operator Instructions) We will go next to Jason Napodano with Zacks. Please go ahead.

Jason Napodano - Zacks

Hi guys. Just a quick question on the Phase II VMAT 2 program. I understand the crossover design but there is two doses in there. So Chris can you, just give me a sense of what the dose range, it’s a pretty wide range 12.5 and then up to 50, can you give me a sense of what you are looking for with that dose, with those doses?

Chris O'Brien

Absolutely. So the goal with this two week study was to secure efficacy as well as understand kind of what the low end of minimally effective dose kind of might be. So that when I go into my parallel group long-term trials, I haven’t informed an intelligent basis of dose selection. And so we did that by a 50 mg dose, was very well tolerated by healthy volunteers in the small open label patient trial. We believe that that dose is above that which is necessary for efficacy. So that was kind of a really strong shot on goal to see the effect.

The 12.5 milligram dose is at the low end, where we think it’s just above that minimally effective dose and it would be extremely informative if that worked as well as 50 or didn’t work or only worked at half the patients that will help me with my dose selection. But when the trial is set up, when the subject is randomized, they’re basically forward pass, they can go. Placebo in 12.5 or 12.5 in placebo, placebo 50 or 50 then placebo. And so nobody is getting both drugs, both doses. It’s just active versus placebo. And with eight subjects in each of those four arms, it shows you kind of the magnitude of the set value we expect. It doesn’t have to be a very big trial and a crossover designed to weed out for a statistical and clinically significant separation.

Operator

Thank you. We will go next to Thomas Wei of Jefferies. Please go ahead.

Thomas Wei - Jefferies

Thanks. Just a couple of questions, first on the VMAT2 program. Can you say it all on a blinded basis maybe what you’re seeing in terms of safety, anything unusual there that might be expected simply or even not?

Chris O'Brien

Hi Thomas. So, far I’ve obviously reviewed every piece of clinical chemistry in ECG and lab data that’s come in. So there are no safety signals to-date in a blinded fashion. We had no treatment related SAEs. So that’s good. I’ve seen the adverse events that you see in any study and there are all the usual stuff. There is nothing that catches my eye as being unusual. I mean, in every trial, particularly in CNS, you’re going to see headache, fatigue, nausea, headache, fatigue, nausea and so that’s all. So we’ll have to wait till the binders broke in to really have a comment, but nothing unusual.

Thomas Wei - Jefferies

And with the VMAT2 inhibitor, can you just remind us from the early dosing work that you’ve done, where had you figured out that you did start seeing some of the problems that have emerged with Xenazine? What sort of window do you have dosing wise do you think?

Chris O'Brien

I think it’s pretty good. In our Phase I studies, what I considered signs of pharmacology or things like trouble focusing your attention, sedation and we saw that with single dose, healthy volunteers at 150 milligrams and in a couple healthy volunteers after repeated dosing for 8 days at 100 milligrams. My guess is the clinically relevant dose to be monitored 25 milligram range. So we have very broad (inaudible).

Thomas Wei - Jefferies

And can you remind me what the PK; is it linear through this whole dose range and is there overlap at the edges between those who are dosed at 25 milligrams on a multi-dose basis and those who are dosed at 100 milligrams on a multi-dose basis?

Chris O'Brien

So the first is very dose proportional, it’s a very well behaved molecule, good exposures in narrow coefficient variation. As you would expect with a long half-life drug, once you reach a steady state, there is -- I may have misunderstood your question, but let's say for example at a single dose of a 100 milligrams can overlap or actually just barely overlap with maybe as a 50 milligram repeated dose, but just barely there.

Thomas Wei - Jefferies

And then just long-term on the uterine fibroids program, can you confirm that that still is the primary strategy for European regulatory approval? And can you also remind me what you said about whether or not this set of Phase II data that we’re going to get is sufficient to go directly in Phase III trials?

Chris O'Brien

I really can't comment on Abbott’s strategies. And maybe Kevin has a point.

Kevin Gorman

Yeah, I would say that Abbott is still doing a lot of work over in Europe as they are in the United States on uterine fibroids. So we’ll leave it to them when they will talk about that and as far as we’re aware of this Phase II that they are doing with uterine fibroids is to set up a true dose response to Phase IIb clinical trials with uterine fibroids to follow.

Operator

Thank you. It appears we have no further questions at this time. I’ll turn it back to Kevin Gorman for any closing remarks.

Kevin Gorman

Thank you very much and we’re going to be looking forward to the two Phase II clinical trial results that we’re going to be having this quarter. The one in VMAT2 on the 32 patient study in March and then sometime between now and March to get the Phase II results on Urocortin 2. We’ll be speaking at several conferences over the next two months, so we look forward to meeting all of you there and presenting that data as it comes through. So once again, thank you very much for your attention and we will be presenting data shortly. Take care.

Operator

This conclude today’s program. We appreciate your participation. You may disconnect at any time. Have a great day.

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