Executives
Management
Kevin Gorman - President and CEO Jane Sorensen - IR Tim Coughlin - VP and CFO Chris O’Brien - SVP and CMO
Neurocrine Biosciences, Inc. (NBIX)
Q1 2013 Earnings Call· Fri, May 3, 2013
$130.25
+1.66%
Same-Day
+2.31%
1 Week
+7.82%
1 Month
+13.78%
vs S&P
+13.84%
Executives
Management
Kevin Gorman - President and CEO Jane Sorensen - IR Tim Coughlin - VP and CFO Chris O’Brien - SVP and CMO
Analyst
Management
Sara Slifka - Morgan Stanley Irene Lau - Leerink Swann Yale Jen - Roth Capital
Operator
Operator
Good day, everyone and welcome to Neurocrine Biosciences Report First Quarter 2013 Financial 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. (Operator Instructions). Please note, this call maybe recorded and I will be standing by should you need any assistance. It’s now my pleasure to turn the conference over to Kevin Gorman. Please go ahead. Please stand by while we await our speaker.
Kevin Gorman
President and CEO
Jane Sorensen
President and CEO
Kevin Gorman
President and CEO
Tim Coughlin
Management
Kevin Gorman
President and CEO
Thanks Tim. Prior to turning it over to Chris, I would like to give an overview of our two main programs. The first AbbVie has made significant progress with Elagolix. Earlier this quarter AbbVie achieved proof of concept in the large Phase IIa trial studying uterine fibroids and based on this result they moved the compound rapidly into a six month Phase IIb study of approximately 280 women with uterine fibroids. They stated that this study will complete in the second half of 2014 and if positive they will move into Phase III by the end of 2014. Now they are also track with the Phase III endometriosis study. My understanding is they are very pleased with the conduct of that study today and continue to anticipate top line data in Q1 in next year. We are fortunate to have AbbVie as a partner they are improving their expertise and their dedication to this program. Now changing over to our VMAT2 program, that is also progressing well. We are very pleased with the conduct of each of the trials, and Chris will go into more detail on that in a moment. Enrollment of these studies started out slower than we had anticipated as we developed learnings of how to reach these patients. We are enrolling well in both trials, and at this rate that we have, we will have top line data for Kinect in Q3 with Kinect 2 reading out shortly thereafter. We will request an end of phase II meeting later this year, and depending on FDA’s schedule, continue to anticipate that we’ll hold that meeting prior to year end. Based on the date of the two studies, the two Phase IIb studies, the program remains on track to start Phase III in the first half of next…
Kevin Gorman
President and CEO
So I hope that that gives a lot of color to you now for the first on these studies and how well they are going with us. So at this point I would like to open it up for your questions please.
Operator
Operator
(Operator Instructions) Our first question comes from Sara Slifka with Morgan Stanley. Please go ahead.
Sara Slifka - Morgan Stanley
Analyst · Morgan Stanley. Please go ahead
I actually had two. First on 854, can you remind us where you are with any pre-clinical CARC work and QT work and then what was required in terms with tetrabenazine in these two areas? And then secondly, just on uterine fibroids, I know you guys are using or AbbVie is using alkaline hematin to measure blood loss. Lupron is showing I think about 80 plus percent reduction of blood loss on PBAC. So, it looks like those two measurements don’t necessarily always correlate. So with regards to alkaline hematin, what do you see as a good benefit and what do you think that AbbVie needed or wanted to see in order to move in to the Phase IIb? Chris O’Brien: So, let me start with the tetrabenazine 854 question first. So, the pre-clinical program is fairly extensive in what's been accomplished to-date. We were in the middle of our long-term talk studies, and obviously we have not started the carcinogenicity study yet, but we will be continuing our discussions with the FDA as far as what they need and want. We have had a very productive set of interactions with them in that regard so far, and our CARP program is not going to be rate limiting or critical path in us getting to NDA filing. So that's all good. With respect to tQT through QT studies, we have built in a lot of QTC assessment in our program in our Phase I work, 12-lead digital Holter analysis by outside experts et cetera, but we have not conducted the thorough QT study yet, and the reason for this is very straightforward. You need to know what you're clinical dose is, so then you can calculate the doses to take into the tQT trail, both the expected dose and a…
Operator
Operator
Thank you. We will go next to Marko Kozul with Leerink Swann. Please go ahead.
Irene Lau - Leerink Swann
Analyst
Hi. Thanks for taking my questions. This is Irene in for Marko. On Elagolix in endometriosis, can you talk about the enrollment pace for the Phase III trial and what are you seeing seen from the 160 centers? Chris O’Brien: So, what AbbVie has shared with us is they’re very happy with the conduct of the phase III endometriosis trial that they are on track for reporting top line results in Q1 of 2014, as Kevin mentioned, and you know I think, I am glad that you actually brought this up. This is a good example of -- in the early days, we were running endometriosis trials, no one knew how to reach these patients for enrolment into phase II. We did a lot of work on figuring how to do patient recruitment, and we went from very slow recruitment in the early phase II studies to very rapid recruitment in the Daisy PETAL study because we had figured that out, how to use Facebook, what not to do on TV, what to do with radio, what kind of wording and imagery to use etcetera. And that’s what’s happening now with our tardive dyskinesia, no one has ever figured this out before. We are making the learnings as we go, and I think what you will see is our early phase II program progresses into phase III, you will see a refinement in the ability to reach out to these patients. But AbbVie has been very happy with the results, as I say and they say they’re on track.
Irene Lau - Leerink Swann
Analyst
Just one next question for uterine fibroids, can you talk about the Phase II B trial design in terms of the similarities and differences to the Phase II A, like patient inclusion/exclusion criteria, rationale behind the choice of background in each amount of doses? Chris O’Brien: I am not in the position to do that. Unfortunately, as we have had to sail along, this is AbbVie’s program, it’s not our program. We don’t have the details to answer those questions directly.
Kevin Gorman
President and CEO
And actually one of the reasons why we chose AbbVie as a partner was that their extensive experience and expertise in uterine fibroids. We never treated a UF patient in our entire 1000 patients that we treated. So, that is probably a much better question to be directed into AbbVie.
Operator
Operator
(Operator Instructions) We will go next to Yale Jen with Roth Capital. Please go ahead.
Yale Jen - Roth Capital
Analyst
First is that for the endometriosis, the second phase III study, is that still scheduled to start in mid-13? Do you have any colors on that? Chris O’Brien: I think that the last public statements that AbbVie made on that would be -- they did not say actually mid, they said that it would be in the second half of 2013, I think is what they last publicly stated.
Yale Jen - Roth Capital
Analyst
Okay second question is that it looks that both for Kinect and Kinect II that is roughly 50% of the patients screened that will be automated randomized. Is that what you anticipated before and is it something that you see that continuing to particularly in the Kinect 2? Chris O’Brien: So it is good observation Neil thanks we did plan about 50% screen fail rate. What we didn’t fully understand is what is the nature of screen failure and I think that it has proven to be an interesting thing. It depends on many things it depends on who the investigators are, where they draw their patients from as potential subjects and the nature of the screen failure. So sites that have their own patients, that are in the clinic that the investigator works, they tend to fail for different reasons than sites that are standalone schizophrenia trial centers that are trying to get patients from the community physicians and so we will obviously use this information going forward as we are design our Phase III trials and our recruitment methods but I would anticipate we will continue with about 50% of screen fail rate in the Kinect 2 study as we have seen in the Kinect study.
Yale Jen - Roth Capital
Analyst
And second to last question is that given that the data release seems slightly push out to the third quarter for the Kinect, do you feel comfortable that the Kinect 2 data will come out in time for potential at the end of Phase II meetings at the fourth quarter of this year? Chris O’Brien: Yes I do and from an early indication, and as I said it is a little early in the Kinect 2 to be very precise but that study seems to be going well. We actually took some learnings from the Kinect study as far as which investigators we were working with and are using those who have more direct access to patients. So that is going well and I think what we have to-date, the numbers that we have in Kinect 2 is that at this point just 13 sites have actually randomized subjects and we are planning on having all 30 sites up and running and randomizing. So I think we will see a nice upslope there that will keep us in good standing.
Yale Jen - Roth Capital
Analyst
And last question here is that you started some market analysis for the TD market. Do you have anything you can share at this moment in terms of what your current sort of view in terms of market size and other details?
Tim Coughlin
Management
Yale, this is Tim. We’ve done some qualitative work and what we’re working right now is quantitative work. And what the qualitative work shows is we’ve got basically a population of 0.5 million people here to treat. The quantitative work so far is supporting that but it’s too early and what we want to do is get a complete picture to provide a breakdown for everyone along underlying diseases, what the patient population looks like, the payer population etcetera. So when data is all collected which will be later this year, we will share a full picture complete picture with history.
Operator
Operator
Thank you. It appears we have no further questions at this time. I’ll turn it back to Kevin Gorman.
Kevin Gorman
President and CEO
Thank you very much and thank you everyone for participation today. We’re very enthusiastic about the programs that we have going and the way these programs are moving forward. Speaking specifically to VMAT2, we’re highly confident that we have the right mechanism in order to treat multiple mood disorders. We’re also very confident that we have the right compound in 854. What we needed to have in these studies is the appropriate patient population and also have an appropriate administration of the AIMS scoring system and we feel very good right now with both of these studies that we’re achieving those of also. So looking forward to sharing that data with you little later this year. So with that, we’ll be seeing at several meetings coming up and also happy to field any calls or emails that you might want to send in. Thank you.
Operator
Operator
This concludes today’s program. We do appreciate your participation. You may disconnect at any time and have a great day.