Earnings Labs

Neurocrine Biosciences, Inc. (NBIX)

Q3 2008 Earnings Call· Tue, Oct 28, 2008

$130.31

+1.90%

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Transcript

Operator

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) Please note this call will be recorded. I’ll be standing by if you should need any assistance. It’s now my pleasure to turn the conference over to Mr. Kevin Gorman. Go ahead please.

Kevin Gorman

Management

Thank you. Welcome to our third quarter earnings call. Today, I’m joined by Tim Coughlin, our CFO; Chris O’Brien, Chief Medical Officer; and Claudia Woodward, in charge of Investor Relations. What we’d like to do today is Tim will take you through our financials, Chris will give you an update on our R&D programs; and before we’d start, I’d like to turn it over to Claudia Woodward now for our Safe Harbor Statement.

Claudia Woodward

Management

Thanks, Kevin. Good afternoon. I want to remind you of Neurocrine’s Safe Harbor Caution. Certain statements made in the course of this conference call will state the company’s or the 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 web site 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 Gorman

Management

Thank you, Claudia. Tim, can you take us through the Q3?

Tim Coughlin

CFO

Thanks, Kevin, and good day to everyone. During the third quarter of 2008, the company continues to perform on its financial plan and ended the quarter with $118 million in cash and investments. We had a loss during the quarter of $17.7 million or $0.46 per share. Our year-to-date loss is $59.8 million or $1.56 per share. This compares to a loss of $79.3 million or $2.09 per share during the first nine months of 2007. The main difference between the two periods is the cost savings we realized under a severance program enacted in the fourth quarter of 2007 and other cost saving measures implemented throughout the company. Research and development expenses decreased from the second quarter of 2008 to the third quarter of 2008 by approximately $3 million. This decrease is due to completion of the dosing portion of the 603 study during the second quarter of this year. As well as startup costs were incurred for the 702 and 703 Elagolix studies during the second quarter. General and administrative expenses were less in the previous quarter primarily due to decrease in non-cash expenses under FAS 123R. Additionally, we’ve been focusing our efforts on reducing external vendor costs which has also resulted in a decrease of G&A expense. Interest expense is consistent from period-to-period. However, income from investments decreased in the third quarter as a result of overall macroeconomic conditions. We are performing according to plan. However, during the fourth quarter of 2008, we will incur a one-time, non-cash CCs [ph] liability related to our consolidation of the company into the back building of our two-building campus. The CCs estimate anticipates the ultimate cost that we will incur to successfully lease out the entire vacated space of the front building. We have now finalized the estimate of this…

Kevin Gorman

Management

Thank you very much, Tim. It’s encouraging to see as you will note that we’ve been hitting all the numbers that we gave guidance on at the beginning of the year. And also, I believe Tim has done an outstanding job in putting our money in some of the safest securities that can be found in the turbulent markets that we’re in. What I’d like to do now is turn the rest of the conference over to Chris O’Brien as he can take you through our R&D programs. Chris O’Brien: Thanks very much, Kevin, and good day for the callers. We’ll start with the Elagolix program, the GnRH small molecule antagonist. As many of you know, we released very positive and encouraging results from the Elagolix 603 study also known as the PETAL study. We held a conference call a few weeks ago and went through the top line results from the six-month treatment period. And in that study, very happy that we hit the primary end point, the secondary end point, showing both statistical and clinical significance on these measures. In addition, the study confirmed that this really is an unmet need as the number of callers that we had that was interested in this trial and the enthusiasm of the patient’s subjects and investigators has really been palpable. We confirmed that pain reduction can be accomplished without a significant risk of bone loss, and as you know, this trial involved also a six-month no-treatment phase after the treatment period, and we still have women involved in this part of the trial. The last DEXA scan from week 48 for the last subject will be later this year and then we’ll be able to close down the study, finish the cleanup of the data, and lock the database to…

Kevin Gorman

Management

Thank you very much, Chris. So as you can see, we’re very pleased. The Elagolix program is moving briskly forward. We’re meeting our timelines. The 603 data, as we’ve discussed before, was a very successful trial. We’re moving forward with this program. It is a very high-value program for the company as we continue in discussions with multiple parties on that. As you can see, as Chris pointed out, there are a number of preclinical programs that we have working at Neurocrine and the first that you’re going to be hearing more about in our coming calls and visits is going to be on that VMAT2 program as that moves into the clinic. With respect to Indeplon, I’d just like to close with one thing that, as Chris said, we do not have final minutes from the FDA. We await those final minutes. However, even upon receipt of those final minutes, my guidance remains the same as that I do not believe there’s going to be a fundamental shift in the requirements that the agency has put in front of us at this point in time. So with that, what I’d like to do is open it up for your questions at this time.

Operator

Operator

Thank you. (Operator instructions) Our first question comes from Sapna Srivastava with Morgan Stanley. Go ahead please. Sarah Slisko – Morgan Stanley: Hi, this is actually Sarah Slisko [ph] calling in for Sapna. You said you’ll have $100 million in cash by year-end and it seems like you’re going to have three programs with your new pipeline candidate coming into the clinic in early ’09 and I was just wondering if you can discuss how you plan on prioritizing those programs and whether you think you’ll need to approach the public markets next year?

Kevin Gorman

Management

Thank you very much. We do not have any plans of approaching the public markets. Secondly is that we – with our programs, the GnRH program fully baked into our projections going forward, as we’ve said, as Tim said, we have over two years of cash in hand, is the fact that we would be completing out that Phase II program with Elagolix. Secondly is with the VMAT2 program, that is one where, as you’ve seen, we’ve been husbanding cash. We’re careful on our costs constraints. And so we will pursue that in the clinic as funds became available, external funds become available into the company but we are not talking about approaching the public markets. Sarah Slisko – Morgan Stanley: Okay. Chris O’Brien: And also, it’s fair to point out that the Urocortin program is one that we’re not funding additional clinical initiatives as we seek potential partners to that, and the GSK CRF program is a fully-funded program through GSK.

Kevin Gorman

Management

Yes. Sarah Slisko – Morgan Stanley: Great, thank you.

Operator

Operator

Thank you. Our next question comes from Brian Abrahams with Oppenheimer & Co. Go ahead please. Ryan – Oppenheimer & Co.: Hi, this is actually Ryan [ph] for Brian. Just a quick question. So given the fact you guys have the blood level exposure with the PK between the two tablets, would we see any data that would correlate the blood level exposure with the BMD changes? Chris O’Brien: You will when the 603 study is done. As I’ve mentioned before, we have extensive PK/PD modeling that will come out of this 603 trial but, because we chose to show the top line data from the six-month treatment period before the study was complete, I’m not unblinded at an individual subject level yet. But when that’s done, we will have the kind of PK modeling that will allow us to look at the relationship between Elagolix exposure, estradiol level and bone mineral density change. Ryan – Oppenheimer & Co.: Great, thank you.

Operator

Operator

Thank you. Our next question comes from Matt Duffy with BDR Research. Go ahead please. Matt Duffy – BDR Research: Hi and thanks for taking my question. Given as you guys are thinking about potential partners in the future, do you have parameters that you’re thinking about for what you think would be optimal type of partner for Elagolix?

Kevin Gorman

Management

Sure, we have there are several that one can choose with. There would be those partners that are multi-national that would take the program in all three major markets in the world. There are those that are European-specific and then others that are Japan-specific. We’re pursuing all three of those right now. You also have partners that are exclusively focused on women’s health, others that are more focused on men’s health; those that are focused in both. Right now, I can tell you that my preference would be to have a partner that would be there for the North American and European markets and would fully exploit into the women’s health indications, obviously, primarily endometriosis, uterine fibroids; and then also would go into the men’s health because the compound is positioned to go into BPH at this point in time. So that would be my optimal but, having said that, we do have situations where there are companies interested in geographic regions and also those that are interested in specific diseases. Matt Duffy – BDR Research: Okay, great. Thanks very much.

Operator

Operator

Thank you. Our next question comes from Jason Napodano with Zacks. Go ahead please. Jason Napodano – Zacks: Hi, guys. Thanks for taking the question. I’m wondering if you could comment a little bit about getting back to the partnership discussions, if things have picked up a little bit here after the PETAL data came out in September or if you think partners are still waiting for the Lilac PETAL and the 703 study to end before they really show great interest? And the second question is and I’m sorry if I missed it in your prepared remarks, but will you guys be presenting the PETAL data at any medical conferences in the future? Chris O’Brien: Let me answer the second question first, Jason. Yes, we will, if not in the near future, as you know, the lead time required for abstracts at the important meetings like the endocrinology meeting for example, is typically something like nine months. And although I’m happy to talk about the top line data that we have, but I’m really interested in having this the rest of the story, the individual patient level data, the PK/PD modeling and things that are of great scientific importance. So I would say yes, in 2009, but nothing in the next few months. Jason Napodano – Zacks: Okay.

Kevin Gorman

Management

Jason, along the lines of your first question is that our business development since the 603 data has come out and also just prior to that, our business development group is completely engaged in partnering discussions. So the 702 data will come out early next year, but there does not appear to be any waiting going on for that data. Jason Napodano – Zacks: Okay. Thank you.

Operator

Operator

Thank you. At this time, there are no further questions in queue. I’d like to turn the conference back to Kevin Gorman for any closing remarks.

Kevin Gorman

Management

Thank you. I would like to thank everyone for participating today. I think as you can see that we’ve done as we had set out at the beginning of the year to do. We’re right on track. We’re keeping a close rein on cash while keeping a very vigorous development program going with Elagolix. The data that’s being generated to date is outstanding. The program is moving along nicely as our all three of our programs, and now adding yet a next one to the queue in early of next year. In addition, we have done as good a job as I think can ever be expected in protecting our cash investments in this market, so I’m very pleased with that. So I look forward to meeting with many of you in the coming weeks and months. Thank you very much.

Operator

Operator

This concludes today’s conference call. You may disconnect your lines at any time. We thank you for joining us and enjoy the rest of your day.