Neurocrine Biosciences' CEO Presents At 30th Annual JPMorgan Global Healthcare Conference - Conference Call Transcript

Neurocrine Biosciences, Inc. (NBIX)

30th Annual JPMorgan Global Healthcare Conference Call

January 12, 2012 5:00 pm ET


Kevin Gorman - President and CEO


Mike Ulz - JPMorgan Securities LLC


Mike Ulz

Good afternoon, everyone, and welcome to day four of the JPMorgan healthcare conference. I'm Mike Ulz from Geoff Meacham's biotech team here at JPMorgan. And it's my pleasure to introduce Kevin Gorman, CEO of Neurocrine.

Kevin Gorman

Thank you very much, Mike, and thank you very much, JPMorgan, for the opportunity to present here at the beginning of the year. Before I get started, I direct everyone to our Safe Harbor. I will be making forward-looking statements, and I also direct you, to a more complete set of specific risks, to our recent SEC filings.

What I would like to do and start this year out, as we start every year out, is putting up right away what are the major goals that we have planned for 2012. I list them here for you today, and these are goals that add value to the company and to shareholders, and several of them are quite aggressive. I'd like to spend a couple minutes going through them.

We have a Phase II trial, two weeks in duration, placebo controlled, in our VMAT2 inhibitor program. That Phase II study is going to read out towards the end of March this year. In addition, based on having successfully completed our three months toxicology studies in rodents and dog.

We are now going to then in the middle of this year, embark on two large Phase IIb studies in tardive dyskinesia. The first of which is going to be in schizophrenic patients. The second one will then start up in bipolar and depressed patients. A stretch is going to be that we hope, if enrollment goes well, that we're going to be able to report out by the end of this year, topline data from that first TD study in schizophrenic patients.

We are then hope to initiate another Phase II study with our VAMT2 inhibitor in a different indication, and this time Tourette's syndrome. And then working alongside our partner, Abbott Pharmaceuticals, as they have stated two days ago at this meeting, they plan on completing the large Phase II uterine fibroid study and reporting on that data later this year.

And in addition, Abbott plans on, they're on the verge of initiating the Phase III program with our drug Elagolix in endometriosis. And we'll assist them in all ways possible in doing those and moving that late-stage program forward.

In addition, in working with our collaborator in New Zealand, we were very pleased to report that, as of last week we had finished the 50 patient Phase IIb placebo controlled trial in acute congestive heart failure with our drug Urocortin 2. And we anticipate reporting that data out in February or maybe the very beginning of March.

And the finally, we have three programs that are moving along quite well, from our research group that's been very productive. These programs we are entering into IND enabling preclinical toxicology. We plan on bringing one of those forward to file the IND this year and yet another neuroscience indication area and we'll be talking about that more this year. So a very aggressive and a very busy new year for us.

Let's go back and as I present throughout the year, you will see me checking off these goals, as we go along. How did we do in 2011 in our planned milestones? We actually completed seven of the 10 that we have there. If you look at what was not completed in 2011, it was the kickoff of that Phase III endometriosis trial with Abbott. And it was also the results from that Urocortin 2 trial in Phase II. But as you see these are all going to be happening very quickly in 2012.

I'd like to take now a few minutes of your time to go through these two main programs that we have at Neurocrine. Elagolix, which was partnered with Abbott Pharmaceuticals and this features a small-molecule GnRH compound. This is a first-in-class drug. Elagolix has a number of attributes, not just one or two differentiating attributes, but several.

These are things that are of high value to patients, prescribers and payers. In addition, it's not just one compound for one indication. This is truly a pipeline within a program. Our lead compound Elagolix is simultaneously being developed in both endometriosis and uterine fibroids, as I've said. But there are a number of other women's health diseases that this is absolutely applicable for by mechanism of action in polycystic ovarian syndrome, assisted reproductive therapy are just to name a few.

In addition, we have a very robust follow-on program here. And we hope that in very near future, where ourselves and Abbott are going to be brining one of the backups into the clinic. And there is another host of indications that that could be used for.

Endometriosis, uterine fibroids, these are debilitating disease for women. Endometriosis strikes women in the prime of their life, very early, sometimes it's early as they are in their late teens. It's during the most productive points of their life. Uterine fibroids, this is again a debilitating disease. Each one of them affect 10% of the female population of reproductive age.

Women resort at the rate of nearly 400,000 women a year to that very last option that they have. And that last option is a hysterectomy. It is the goal of this program to significantly reduce the number of women that would have to go to that last option to be able to give the millions of women in the United States and around the world a therapeutic option that is safe and effective for both of these diseases.

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