Neurocrine Biosciences Inc. Q1 2009 Earnings Call Transcript

| About: Neurocrine Biosciences, (NBIX)

Neurocrine Biosciences Inc. (NASDAQ:NBIX)

Q1 2009 Earnings Call

May 06, 2009 08:30 am ET


Claudia Woodward - IR

Kevin Gorman - President and CEO

Tim Coughlin - CFO

Chris O'Brien - CMO


Craig Gordon - Cowen & Co.

Thomas Wei - Piper Jaffray

Brian Abrahams - Oppenheimer & Company

Jason Napodano - Zacks


It is now my pleasure to turn this call over to Mr. Kevin Gorman. Please go ahead, sir.

Kevin Gorman

Thank you very much, and welcome to our first quarter earnings call. Today, I'm joined by Tim Coughlin, our CFO and Tim will be going over our financials for the first quarter of this year. Also Chris O'Brien, our Chief Medical Officer and Chris will be giving you an R&D update. And then myself, I will follow and talk about our recent restructuring that we announced last night.

Before we get started, I would like to turn it over to Claudia Woodworth, our Head of Investor Relations to read our Safe Harbor statement.

Claudia Woodworth

Thanks. Good morning. 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 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 website at

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

Thank you, Claudia. Tim?

Tim Coughlin

Thanks, Kevin. Good morning to all. Our loss for the first quarter of 2009 was $0.51 per share based on 38.7 million weighted average shares outstanding. For the comparable period in 2008, the loss is $0.55 per share.

Our loss for the first quarter was wider than we had budgeted due to two events. The first was a Moody's downgrade in February 2009 of two of our federally-backed student loan auction rate securities. This downgrade resulted in thus incurring $1.4 million other than temporary impairment charge.

The second event was a non-cash relating increase in the CCs liability estimate relating to the re-letting of our front building. These two events accounted for approximately $0.13 difference between our budgeted and actual loss for the period. In spite of these two P&L differences, we hit our targeted end of period cash and investments balances of $86 million.

Our research and development expenses for the quarter were in line with our expectations. External developments expenses were approximately $2 million for the quarter, down from $3.7 million in the prior year, but these costs focused almost exclusively on our elagolix program.

General/administrative expenses were in line with our expectations and down from the prior year period due to severance costs incurred in 2008 and cost saving efforts throughout the company. There are a few accounting differences on account when comparing 2008 to 2009 that the reader of the financial statement should be aware of.

The first term 2008 run on the building was treated as interest expense due to our repurchase option, and was not a component of research and development or general/administrative expense. This represents an approximate shift to $2 million from interest expense in 2008 into operating expenses in the first quarter of 2009.

Second, in 2009 we have begun to recognize the deferred gain on the sale of our buildings. This accounts for approximately $700,000 of non-cash other income during the first quarter of 2009.

Finally, our rent expense is recorded for financial statement purposes on a straight line basis over the term of the lease. This accounting convention results in additional non-cash rent expense during the first half of the lease and the non-cash credit to expense during the second half of the lease. This amounted to approximately $300,000 in expense during the first quarter.

Yesterday, we announced we are terminating our deferred compensation program. Due to the size of the company, this program is cost prohibitive and amounts previously deferred in the program will be distributed to participants in accordance with the provisions of the deferred compensation plan.

We have consistently funded this plan and have consistently segregated the plan assets and liabilities on our balance sheet as long-term assets and long-term liabilities. There will be no impact to our operating cash from investments as a result of this planned termination.

Looking forward, we reaffirm our guidance of managing the company to burn from operations of approximately $50 million to $55 million in 2009. We have implemented significant cost savings efforts throughout the company, which include the yesterday's announced downsizing.

We expect this recent action to cost the company approximately $3 million in severance costs, with almost all of these costs incurred during the second quarter of 2009. On an annualized basis, these staff reductions will save the company approximately $12 million per year in salaries, benefits, laboratory costs, and other variable expenses. In closing, we plan to file our 10-Q today with the SEC.

With that, I will turn it back over to Kevin.

Kevin Gorman

Thank you very much. As you can see, we have undertaken a number of efforts for the past year in saving costs and keeping as much cash on hand as possible, and yesterday's as I'll talk about a little later was our most recent action.

Before I do though, I would like to turn it over to Chris O'Brien to give everyone an update.

Chris O'Brien

Thank, Kevin. Good morning. I will talk about our clinical programs to give you an update, starting first with elagolix and our GnRH antagonist for endometriosis. As you recall, we announced last fall results from the first six months of the Petal study or so-called 603 study.

Pedal study was primarily a bone study looking at the impact of elagolix treatment over a course of six months, and we reported a very favorable a DEXA scan results from that six months of treatment.

As you know, we had a very nice effectiveness results on the secondary endpoints in that trial, demonstrating the clinical benefits of elagolix. At this time, we have no access to the results of the six month after treatment. That is, we followed women both clinically for their symptom severity as well as with repeat DEXA scans at week 48. And we're very happy to say that the DEXA data at the month 12 or week 48, very consistent with what we had seen at the end of the six months of treatment, namely a negligible change for baseline in the elagolix treatment arms.

In particular, the preferred once daily dosing regimen showed a mean percent change in bone mineral density at 12 months of plus 0.19% in the spine, and minus 0.28% in the femur.

These numbers basically are flat showing no clinically significant bone loss. So very nice to see that confirmation that elagolix can be used without this long-term risk. One of the interesting things was to see what happened with the highly significant improvement in symptoms that were noted during the six month treatment interval and to see how they extended after stopping treatment.

Analysis of this additional post treatment pain data collected using the visual analog scale and the composite pelvic signs and symptom scale revealed that the subjects reported sustained improvement of endometriosis symptoms even while off medication.

This is an interesting and potentially very useful observation. While there is a modest increase in scores during the six month after discontinuation, that is to say that symptoms gradually had some return towards baseline.

In fact the mean scores did not return to baseline severity. And this observation would be consistent with an actual disease modification effect, something that we have suspected could be demonstrated with elagolix, but to date we haven't had the kind of study design that would give us this hint. So we are encouraged by this and we will plan on exploration of these disease modifying effects in the future.

We will be able to present some more detailed information around the bone aspects of this long-term Petal Study at the upcoming Endocrine Society Meeting to be held in Washington DC in June. And I will be presenting some of that data at that meeting. We have also submitted the other safety and the effectiveness data to the American Society of Reproductive Medicine, a meeting scheduled in Atlanta in October.

So as, you know, in addition to the Pedal Study, we reported top-line results from the Lilac PETAL study so called 702 Study, and we shared earlier this year the top-line results from the first three months out of this six-month trial. That period corresponded to the double-blind placebo controlled phase, and these data confirm the efficacy and safety of elagolix at the 150 and 250 milligram dose once daily.

At this point, all subjects have now completed the full six months of treatment, and we expect the final study results from this six-month period during the summer. My team is working on closing out the sites and putting the data through the QA/QC process.

As reported, clinically meaningful and statistically significant improvement was documented for both elagolix groups compared to placebo on a variety of end points including the Endometriosis Health Profile, the Patient Global Impression of Change dysmenorrhea, dyspareunia.

We also found that for two exploratory scales, when one shifts to daily assessment of so called non-menstrual pelvic pain, that we found that women with not much non-menstrual pelvic pain couldn't demonstrate much improvement.

Not surprising the so-called floor effect was evident when we looked at non-menstrual pelvic pain on daily scale and to try and better understand this, we analyzed that subset of patients with moderate-to-severe non-menstrual pelvic pain at baseline and this revealed a nice separation of elagolix from placebo on several scales.

We've taken this information, and we are now meeting with expert consultants to discuss a variety of methods who are addressing this floor effect with the FDA. I have reached out to the division of reproductive in neurologic products at the FDA in order to gain clarity on the best approach for initiating a Phase III program in 2010 as planned.

We will keep our shareholders informed as we progress our discussions with the FDA. This has been a particularly good division to work with and I look forward to giving you an update. As you also know, we have a 703 study, the so-called Tulip PETAL Study being conducted in Central Eastern Europe.

This trial is nearing completion of the screening period, which I expect will be at the end of the month, end of this month, and the initial randomization is now more than two-third complete. And we expect to have around 180 subjects analyzed, and top line data from this trial given this enrollment pattern should be in the fourth quarter of 2009.

We continue to get very positive feedback from not only investigators about elagolix, but in particular about women who have participated in elagolix trials, there's an increasing request for access to compassionate use and long-term treatment options. So we are exploring ways that we might approach this request.

Turning now to one of the other Phase II programs, the CRF antagonist program, as most listeners are well aware, we have CRF collaboration with GSK and multiple compounds identified through that combination were brought into clinic. The most advanced lead compound is so-called the 679 compound.

This was introduced into a Phase II trial late last year. This is a six week randomized double blind placebo controlled trial designed to assess the safety and efficacy of 679 and approximately 150 subjects with major depression. According to GSK results from the study are expected in the second half of 2010. So this study is currently randomizing subjects hear the United States.

As we also reported in the past, GSK has completed a Phase I single escalating dose trial with an additional CRF1 antagonist 529, which is potentially useful for treatment of anxiety and/or depression.

Urocortin program continues to generate a lot of interest. The literature on Urocortin 2 has continued to be very active. People are continuing to study this receptor and it is important in the cardiovascular disease. And we have been fortunate to have a collaborative working relationship with the Cardioendocrine Research Group at the Christchurch School of Medicine in New Zealand.

And through this collaboration, the Cardioendocrine Group has submitted a proposal to assess Urocortin 2 infusions for the treatment of acute decompensated heart failure or ADHF. As you know, the trials I have talked about before that we have conducted, we're done so in subjects who had stable congestive heart failure and this was the useful way of looking at the effects of Urocortin 2 infusion in a controlled environment.

But the ADHF patient, the acute decompensated patients are the actual target population, and we are very pleased that this New Zealand study is now moving into this group with Neurocrine's support and this study should provide important data on the safety, tolerability and efficacy if you are [caught into] this target population. Initiation of this trial is expected mid year of this year. They're finishing up the regulatory approval process as we speak. Things are moving ahead nicely there.

One of the new programs that we are happy to move from our preclinical group into the clinic is the Vesicular Monoamine Transporter 2 Inhibitor, VMAT2 for short. VMAT2 as you know is a protein that's concentrated in the brain, specifically in a region that we are interested in for movement disorders, the striatum and this is essential for normal communication between neuron.

And Neurocrine has done a lot of work to identify highly selective VMAT2 inhibitor that's effective in regulating dopamine levels in a fairly subtle way without having impact on other monoamine such as serotonin or norepinephrine or histamine. And the goal here is to reduce off-target effects and be able to modulate dopamine levels in patients who have hyperkinetic movement disorders.

The clinical candidate that we are bringing forward should be able to do this with particular efficacy and safety in a condition called tardive dyskinesia. This is a potentially very disabling, involuntary movement disorder that can affect the head, the face, the neck, and other body parts, and is a result of being exposed to dopamine blocking drugs such as antipsychotic medication or even antiemetic, anti-nausea medication such as metaclopramine.

This movement disorder is often said to be permanent even after stopping the dopamine blocking drug. And currently there is no approved treatment for tardive dyskinesia. So we are interested in finding a safe and effective drug for this. It's something that we can move rapidly into a proof of concept study, which is something that I've had personal experience in this area. The preclinical IND enabling studies have been completed and we expect to start the Phase I trial this summer.

Turning now to indiplon. As we said we're not investing in additional clinical trials, we are now working with outside regulatory and clinical experts to address some of the outstanding questions raised in the December 2007 approvable letter. My goal is to find a path forward for indiplon, which we believe is a safe and effective medication that meets that specific unmet medical need and we will keep you apprised as to our progress with our discussions with the FDA as that emerges.

So at this point, I will stop my update on the key clinical programs and turn things back over to Kevin.

Kevin Gorman

Thank you, Chris. I would like to address now the downsizing that we just went through which is always painful. As you know in the past, we have gone through two downsizing. In each of those cases, it was on the heels of set back news, bad news from the FDA.

This downsizing is not on the heels of any bad news, I think is what, as Chris has outlined to you. We are actually moving robustly forward with several of our programs in the company.

This downsizing is really a proactive one in the face of the economic challenges that our industry and actually the entire economy which I don't have to tell any of you about that, we are all facing.

Right now, is the time that you have to husband cash, you have to put it in your highest value drivers for the company. And clearly, first and foremost, that is elagolix, and we continue to invest in elagolix. The drug has not disappointed us at all, and we are going to continue to invest heavily in elagolix.

The second as Chris told you is our VMAT2 inhibitor. We are very excited about this and this drug is now ready to go into clinic, and we don't want a pause in taking this into the clinic.

We think that we can rapidly progress this through Phase I trials and as Chris said into Phase II. And I also want to make it clear that we are not with this downsizing taking our company down to just a clinical development company.

We do have our R&D groups still together even in the smaller form and what they are doing now is they are really focusing their efforts on our later stage preclinical targets that are the highest value that we are working on now clearly supporting the GnRH program in the back ups and follow ons that we have, but also in our other neurologic targets and endocrine targets.

So as we move forward here, we are still a company dedicated to R&D. We are a company that has a very valuable asset in elagolix. I know first and foremost on everyone's mind is partnering. As we discussed last time, that we are on the phone together and also in various meetings that we meet together, this is a partnering environment that's moving much more slowly than what it traditionally does. My feeling is that it has to do with a number of the macro environment issues that are taking place.

I think quite a bit of the big pharma partners have been caught up by the directly or indirectly in M&As or they are investing quite a bit of their energy right now in mid cap type of acquisitions that are taking place. And looking at those, there's a number of opportunities. And it is actually as I think everyone can see around, it looks like a much slower partnering environment. I would expect that to pick up. But, we are undeterred by that. We continue moving forward in our negotiations still with multiple parties.

We have a wealth of exchange of information going back and forth. The parties now are getting the 12 month data for the 603 that Chris has just gone through and that is extremely interesting that there may be as we had expected consistent data with the disease modifying effects of elagolix.

So we continue to move forward there and we are going do a deal in this area, but we are going to do the deal that's the best for our shareholders as we move forward in this.

So, we undertook what is always the hardest thing that a company can do and that is a resizing of the company. So we've resized, we've reset once again. We've kept the capabilities throughout research, preclinical and clinical regulatory QA within the company. We are a leaner organization. We are going to husband our cash carefully as we move forward.

We are still at a fortunate position to have quite a bit of cash on hand. As Tim has pointed out to you, we do everything that we can here in order to keep very tight controls on our cash and we have consistently always hit our numbers or exceeded them. And I anticipate that is going to continue in the future.

Granted the downsizing we are doing now, with the added investment that we are doing in our programs isn't going to affect the burn in 2009, but it's certainly going to affect our burn through 2010 and through 2011. And so that's the reason to do it now to do it proactively is for those out years.

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

Question-and-Answer Session


(Operator Instructions). And it does look like we're going to take our first question today from the line of Craig Gordon of Cowen & Co. Please go ahead, your line is open.

Craig Gordon - Cowen & Co

Hi. Good morning. A couple of questions. You had discussed the 12 month BMD data, at that time did you also collect data on bone biomarkers.

Chris O'Brien

Yes, Craig. We do collect serum N-telopeptide. As we reported earlier, there was to real change in N-telopeptide during the six months of active treatment, and there's no real change in the six months without treatment. So for whatever reason, the subtle changes that we see in DEXA are subtle enough that there is not major movement in the serum bio marker. So no evidence of a mark change in reabsorption.

Craig Gordon - Cowen & Co

And what are your thoughts on having to prove that in deed it does have disease modifying effect?

Chris O'Brien

So that's an interesting challenge. The reason we went after an indication of pain associated with endometriosis, is because that regulatory pathway is somewhat more clear and tractable than disease modification.

There is no uniform agreement as to how one demonstrates disease modification. So, although earlier approved drugs may have had some kind of language to that effect in the label, those were based on so called second look laparoscopic procedures where you go and count the number of lesions or describe the quality of lesions et cetera.

Since that was done many years ago, that has fallen in disfavor, and there is no agreement that that would be a way to getting disease modification and the label. So, what most people believe will be necessary is that we will have bio-markers that are more reflective of the actual pathophysiology of the disease. And it is only once these bio-markers have been validated that a true disease modification claim can be made.

But a lot of work is going on not just here at Neurocrine, but around the world on endometriosis to try o get a better handle on what that might be. I was in and out of the post marketing kind of thing.

Craig Gordon - Cowen & Co

Okay. That's what I was just going to ask you. So the whole disease modifying effect would be something that will be done in the future and theoretically you could get on the market and then you continue to work on that aspect of the drug?

Chris O'Brien

Yes. There's no way I would go after that as a primary claim right now. There is too much regulatory and clinical uncertainty.

Craig Gordon - Cowen & Co

And then, I guess my last question is on the patent portfolio available, can you just refresh our memory what the patent portfolio is around that agent?

Chris O'Brien

Yeah. It's got a very solid patent portfolio. We have numerous patents on elagolix on composition-of-matter, methods of use, methods of manufacturing, that extend, that go up to a 2024 on elagolix and that's without utilizing any of our patent extensions on there.

So, within the timeframe that we are talking about, putting the drug on the market, we will not be able to use all of the patent life that we have because by law you can only have 14 years of exclusivity. So we will have all 14 years of that by the time the drug goes to market

And in addition to that, we have numerous backups and follow-on compounds, which we also add composition-of-matter or patent protection on. And then in addition to that what we have done over the years is we build a patent fence. So we've, I forget how many thousands of molecules that we have actually synthesized in this program, and we have patented around all of them. This would not be an easy area for someone to come into against the drug. But it is composition-of-matter that covers this.

Also I would like to say that we are going to, as promised, in just a little later, we will be presenting some of the data that Chris has talked about, the 603. We said that when we had the 12 months than we would be presenting that. So we will be doing that in the near future.

Craig Gordon - Cowen & Co

Great. Thank you for taking my questions.

Chris O'Brien

Thank you, Craig.


And it looks like we'll be taking our next question today from the line of Thomas Wei of Piper Jaffray. Please go ahead.

Thomas Wei - Piper Jaffray

Hi, thanks. A couple of questions here. First partnership discussions, I'm curious now that partners have had a chance to see the Lilac PETAL data, what has been the initial feedback and how has it changed their perspective on the program or should we expect that people want to definitely see the next round of data and maybe even what the FDA says in terms of end points before committing to a deal?

Kevin Gorman

Thank you, Thomas. I think first and foremost all of the partners have said that once again this data has shown that the drug is effective, and also is very well tolerated and very safe. So there's no question there. If you're asking about on the one end point, the non-menstrual pelvic pain, like ourselves certainly they are looking at that and we have had discussions with them on what is the proper path forward in order to remove that uncertainty or deal with that.

And as Chris has said, we're having conversations with the agency. These aren't in isolation. We've spoken to our partners about it. We have gotten their best advice on it. So we are working with them to work through this. This is not a deal breaker for any of our partners at this point. And we continue to exchange information, different cuts of data, different ways of looking at it, different ways of approaching this.

And as Chris has said, it's a simple floor effect that you have with this daily scale. There's multiple ways to go after it in order to solve it. We are open to any of those multiple ways and that's what we are discussing with the agency. And, so as we get more clarity, we'll let you know. It doesn't catch the pole over the partnerships but it is certainly something that we need to take care of and the partners are also aware of that.

Thomas Wei - Piper Jaffray

Maybe now that you've had a time to think about what the different options are to deal with this non-menstrual pelvic pain measure. Can you at least outline for us what some of the different options are that are on the table for Phase III trials? What are you going to propose to the FDA?

Chris O'Brien

What we are talking with partners and agency and our expert consultants about are really three general categories of how one can address this interesting observation. The scale that was used on a daily basis is very different than the scale that was used on a monthly basis even though they both share the same name of so-called non-menstrual pelvic pain.

They asked different kinds of questions and had a different calibration if you will. So, the three kinds of approaches to deal with this is one could be a statistical one, where you simply analyze the population of subjects that you see differently if they don't have non-menstrual pelvic pain to begin with and you don't hold them to that standard as a primary end point.

A corollary version of that is only enrolled subjects who have moderate or severe symptoms that based on into the trial. And we've had some experience with that, in an earlier study.

The second bucket is not use the daily scale, and in fact there is, there are recommendations that one should either go back to the monthly scale, the original B&B scoring system, which has some wards on it but there has been a lot of experience with it. And a few drugs have been approved on basis of the monthly scale already.

Finally there is interest in a weekly scale as a way of getting more frequent assessment of pain that bridges the gap between a monthly and a daily scale. I'm a fairly Prague gnat ebbing individual. I will do whatever the agency is comfortable with that perform reasonably well statistically. So all of those options are on the table, and we'll continue to discuss with our consultants and the divisions and see what they are most comfortable with.

The goal as we have stated before is to get to an end of Phase II meeting to have some increased certainty about this agreement with the agency, and if needed I would again as I have discussed before, I would consider SPA if we needed to do that so that we have some greater regulatory certainty going into the Phase III program in 2010.

Thomas Wei - Piper Jaffray

The third bucket that you mentioned there would that require some additional studies to validate a weekly scale? Do you actually plan on doing that in advance of an end of Phase II meeting, and then just curious on the cash front with the restructuring and completion of the Phase II program for elagolix. How long should we anticipate the current cash would last for?

Chris O'Brien

Before I turn the cash question back to Kevin and Tim, just a comment on that assumption that you made. The decision about what we do before going to an end of Phase II meeting will be contingent upon the discussions that I have with the division. So my primary interest is to find the shortest and least expensive path to regulatory clarity and that would be without a Phase II study without an additional study. As already mentioned there at least two or three options where we can do that without having to do any additional trials. But obviously I will listen very carefully to what the FDA says and respond accordingly.

Now as far as the cash burn, let me turn it back to Kevin.

Kevin Gorman

And also I would just like to add one other thing is that, as we've mapped out, if the agency would like to go to a weekly scale, we've mapped out that. We can certainly do a Phase II study in that and that would not significantly affect our time lines and still be ready to start Phase III in 2010 as planned.

Thomas, the structuring that we've done and even if there would be any additional trials beyond the ones that we have going right now, we still have greater than two years of cash on hand and certainly we have cash to get well beyond our end of Phase II meeting.

The guidance that I gave on partnering has been the same all along. I don't talk about timing, but if we're not going to start a Phase III program without a partner on board.

Thomas Wei - Piper Jaffray



And it does look like our last question today is going to come from the line of Brian Abrahams of Oppenheimer & Company. Please go ahead.

Brian Abrahams - Oppenheimer & Company

Hi guys. This is Brian in for Brian. Thanks for taking my question. Just very quickly, do you guys release the data from the 150 once a day to 400? Do you have guys also have the data from the twice a day, 75 milligram group?

Chris O'Brien

Yes, Brian. Sorry, you know the press release we have so little space to put everything in there. It's not terribly different than what we reported at the six month top line results. At 12 months, the 75 bid groups and it looks very similar to the 150 qd group, but remember they're all six months without treatment, and so you have. I think we had about 130 subjects at month 12. So you recall we went from randomizing 252 subjects at baseline. We went to 168 subjects at month six and 130 or 31 subjects at month 12 and essentially it is flat.

But again there's no surprise. It basically demonstrates what we've been trying to show that there is no residual or long-term bone loss effect after stopping elagolix. Not a surprise elagolix, when you stop the drug, estradiol levels tend to return to normal within a few days, and ovulation begins within a few weeks. So, it is, you know, it is no surprise that those groups are similar since they're both on no treatment.

Brian Abrahams - Oppenheimer & Company

So, for the 75 twice a day group, there wasn't a progress beyond the lower bound that you guys mentioned?

Chris O'Brien

No, never. The number that is we get are plus or minus half percent kind of which is just the normal noise of 30-year-old women and DEXA scans.


And it does appear, we have one more question, this one coming from the line of Jason Napodano from Zacks. Go ahead, your line is open.

Jason Napodano - Zacks

Hi, guys, thanks for getting me in. Just a question on Urocortin 2 and the collaboration, with the Cardioendocrine Research Group, can you kind of outline a little bit that collaboration and what costs you have associated with work that they're doing? And the second question relating to that are you still free or still looking to partner that molecule for later stage work?

Chris O'Brien

Thank, Jason. One of things I am trying to do, Urocortin is a very potent and well tolerated drug. But with our resource constraints I have been looking for creative ways of generating additional clinical data to keep the program moving. We actually have either a collaborations that are active or are starting up now with three different academic centers around the world.

And this one in New Zealand has been a long standing one, Dr. Mark Richards and his group there. And they're doing a pilot study of 50 subjects comparing Urocortin 2 infusion or, to standard of care. And this study is being done at their expense. However, we are providing support in terms of protocol, study drug, placebo, regulatory documents, toxicology reports, all of the other kinds of things that we can do that don't cost us money but allow the collaboration to continue.

So, you'll hear more about that if we are successful in some of these other academic centers of trying to jumpstart a few additional activities over the upcoming months. As far as partnership discussions I will let Kevin.

Kevin Gorman

Yeah, as we said before, we are not a cardiovascular company; we got into this because of the mechanism being a CRF mechanism acting at the CRF2 receptor as Antagonist. And so yes, we will be looking for a partner on this because these are going be moving this forward beyond what we have done is going to be large very expensive trials and outside of our area of focus.

Jason Napodano - Zacks

So we have people who are interested in Urocortin?

Kevin Gorman

Yeah, we do have several that are interested in Urocortin. Right now our focus is explicitly on elagolix and partnering that.

Kevin Gorman

Thank you. Okay, well that brings us to the end of our time. Again I would like to thank everyone. And particularly what I would like to do is I would like to thank our employees for all their dedication and excellent work. It's through them that we are able to continue moving elagolix on its time lines. It's through their hard work and efforts that we are going to have that drug ready for Phase III trials in 2010. And it's through the sacrifices that we've had to make here that we have got now greater than two years of cash to continue us on hand to move the company forward.

I would like to thank them, and I would like to thank all of you for your attention this morning. Good bye.


And once again we'd like to thank you for joining us today. This does conclude your teleconference and you may disconnect at any time.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to All other use is prohibited.


If you have any additional questions about our online transcripts, please contact us at: Thank you!