Neurocrine Biosciences Inc (NBIX) 2009 Q1 法說會逐字稿

Once again we'd like to thank you for joining us today.

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

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 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 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.

Thanks. Good morning. I want to remind you of Neurocrine's Safe Harbor caution. Certain statements made in the course of this conference call that state the Company's intention, 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 is contained in the Company's SEC filings, including, but not limited to, the Company's annual report on Form 10K and quarterly reports on Form 10Q. Copies of these 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 obligations to update these forward-looking statements to reflect subsequent events or circumstances.

Thank you, Claudia. Tim?

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 of 2008 the loss was $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 and auction rate securities. This downgrade resulted in us incurring a $1.4 million other than temporary impairment charge. The second event was a noncash related increase in the CCS liability estimate relating to the reletting 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 investment balances of $86 million.

Our research and development expenses for the quarter were in line with our expectations. External development expenses were approximately $2 million for the quarter, down from $3.7 million in the prior year, with these costs focused on what's exclusively on our Elagolix program. General and 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 few accounting differences when comparing 2008 to 2009 that the reader of the financial statement should be aware of. The first during 2008 run on the building was treated as interest expense due to the 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 a deferred gain on the sale of our buildings. This accounts for approximately $700,000 of noncash other income during the first quarter of 2009.

Finally our rent expense is recorded for financial statement purposes on the straight line basis over the term of the lease. This accounting convention results in additional noncash rent expense during the first half of the lease and the noncash 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 were 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 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 a burn from operations of approximately $50 million to $55 million in 2009. We have implemented significant cost savings efforts throughout the Company which include 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 half 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 10Q today with the SEC. And with that I will turn it back over to Kevin.

Thank you very much, Tim. 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, as I will 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.

Thanks, Kevin, and good morning. I will talk about our clinical programs and 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 the so-called 603 study. Petal 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 DEXA scan results from that six months of treatment. As you know, we had very nice effectiveness results on the secondary end points 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 are 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 femur, sorry in the spine, and minus 0.28% in the femur. These numbers basically are flat, showing no clinically significant bone lose. 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 posttreatment pain data collected using the visual analog scale and the composite pelvic signs and symptoms scale revealed that subjects reported sustained improvement of endometriosis symptoms even while off medication. This is an interesting and potentially very useful observation. While there's a modest increase in scores during the six month after discontinuation, that is to say that symptoms gradually had some return toward 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 very encouraged by this and will plan on exploration of these 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 scheduled in Atlanta in October.

So as you know, in addition to the Petal study we reported top line results from the Lilac Petal study, so-called 702 study, and we shared early they are year the top line results from the first three months of this six month trial. That period corresponding 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 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 pointing including the endometriosis health profile, the patient global of (inaudible) change, [dismanaria], [dispreunia]. 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 data scales, and to better understand this we analyzed the 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 have taken this this information and we are now meeting with expert consultants to discuss a variety of methods for addressing this floor effect with the FDA. This I have reached out to the division of reproductive and 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 2/3 complete. 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, with approximately 150 subjects with major depression. According to GSK results from this study are expected in the second half of 2010. So this study is currently randomizing subjects here 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.

The Urocortin program, it 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 importance in 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 were done so in subject who were, who had stable congestive heart failure. And this was a 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 the New Zealand study is now moving into this group with Neurocrine's support, and this should provide important data on the safety, tolerability and efficacy of Urocortin 2 in this target population. Initiation of this trial is expected mid-year 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 we are interested in for movement disorders, the striatum, and this is essential for normal communication between neurons. And Neurocrine has done a lot of work to identify highly selective VMAT inhibitors that's effective in regulating dopamine in a fairly subtle way, without having impact on the other monoamines, such as serotonin or norepinephrine or a histamine. And the goal here is to reduce off-target effects and to 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, antinausea medication, such as metoclopramide.

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 is something we can move rapidly into a proof of concept study which is something that we've had -- I've had personal experience in this area. The preclinical IND enabling studies have been depleted and we expect to start the Phase I trials this summer.

Turning now to Indiplon. While as we've said we are not investing in additional clinical trial, we are now work 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 a specific unmet medical need, and we will keep you apprized 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.

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 downsizings, in each of those cases, it was on the heels of setback news, bad news from the FDA. This downsizing is not on the heels of any bad new, 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 the entire economy which I don't have tell you of you about that, we're all facing. Right now you is the time 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 VMAT inhibitor. We have very excited about this and we want to -- this drug is now ready to go into clinic. And we don't want to pause in taking into this clinic. We think we is 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 a smaller form. And what they're doing now is they're really focusing their efforts on our later stage preclinical targets that are at the highest value that we're working on now, clearly supporting the GnRH program in the backups and followons that we have, but also in our other neurologic 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. The -- I know first and foremost on everyone's mind is partnering. As we discussed last time, that we were on the phone together and also in various meetings that we meet together, this is a partnering environment that is moving much more slowly than what it traditionally does. My feeling is that it has to do with a number of the macroenvironment 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 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 at negotiations, still with multiple parties. We have a wealth of exchange of information going back and forth. They are 00 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 don't to move forward there, 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 in 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 affect the burn in 2009, but it is certainly going to affect our burn into -- through 2010 and through 2011. And so that is the reason to do it now, to do it proactively is for those out years. So with that I'd like to open it up for your questions.

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

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

Yes, Craig. Do collect serum [antipeptide]. As we reported earlier there was to real change in antipeptide during the six months of active treatment and there's no change in the six months without treatment. So for whatever reason, the subtle changes that we see in DEXA scan are subtle enough there's not a major movement in the serum biomarker. So no evidence of a mark change in reabsorption.

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

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, etc. 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 in the label. So, what most people believe will be necessary is that we will have biomarkers that are more reflective of the actual pathophysiology of the disease, and it is only once these biomarkers 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 to get a better handle on what that might be. I was going to postmarketing kind of thing.

That's what I was going to ask you. So the whole disease modifying factor would be something that would be done if the future, theoretically could get on the market and then you continue to work on that aspect of the drug.

Yes, there's no way I would go after that at the primary claim right now, there's too much regulatory and clinical uncertainly.

And then I guess my last question is on the patent portfolio of Elagolix. Can you just refresh our memory what the patent portfolio is around that agent?

Yes. It has got a very solid patent portfolio. We have numerous patents on Elagolix, on composition of matter, methods of use, manufacturing, that extend that go out to 2024 on Elagolix, and that's without utilizing any of our patent extensions on there. So within the time frame 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 14 years of that by the time the drug goes to market. In addition to that, we have numerous backup and followon compounds, which we also have composition of matter patent protection on, and in addition to that, what we have done over the years is we build a patent fence.

So we have 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 Chris has talked about, the 603. We said that when we had the 12 months done we would be presenting that, so we will be doing that in the near future.

Great. Thank you for taking my questions.

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.

Thanks. A couple of questions here, first on partnership discussions. I'm curious now that partner versus 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 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?

Thank you, Thomas. 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 tolerate and very safe. So there's no question there. If you are 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 would it -- 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, different ways of approaching this. And as Chris has said it is 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. So as we get more clarity, we will let you know. It doesn't cast [a pall] over the partnerships, but it is certainly something we need to take care of and the partners are aware of that.

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

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. Because it was -- 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 really are -- they asked different kind of questions and had a different calibration, if you will you. So, what, the three kinds of approaches to deal with this is: one, to 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, then you don't hold them to that standard as a primary end point. A sub -- a corollary version of is that only enroll subjects who have moderate or severe symptoms at baseline into the trial. And we've had some experience with that in an earlier study.

The second bucket is not use 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 warts on it, but there has been a lot of experience with it, and a few drugs have been approved on the basis of the monthly scale already. And 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 pragmatic individual. I will do whatever the agency is comfortable with, that I think has -- that will 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're 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 an SPA if we needed to do that, so that we have some greater regulatory certainty going into the Phase III program in 2010.

And I just two last questions. The third bucket 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?

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, least expensive path to regulatory clarity, and that would be without a Phase II study without an additional study. And I've already mentioned there at least two or three options were 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. As far as the cash burden, let me turn it back to Tim.

Also I would just like to add one other thing, as we have mapped out, if the agency would like to go to a weekly scale, we have mapped out that. We can certainly do a Phase II study in that and that would not significantly affect our timelines and still be ready to start Phase III in 2010 as planned. Thomas, the cash that -- the structuring that we have done and even if there would be any additional trials beyond the ones that we have going right now, they would -- 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 give on partnering has been the same all along. I don't talk about timing, but it is -- we are not going to start a phase III program without a partner on board.

Thanks.

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

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

Yes, Brian. Sorry, the press release we have so little space to put everything in there. It is not terribly different than what we reported at the six month top line results. At 12 months, the 75 BID group and 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 131 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 no surprise that those groups are similar since they're both on no treatment.

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

Never, no. Never. Again the number that is we get are plus or minus half percent, which is just the normal noise of 30-year-old women and DEXA scan.

Sure. Definitely. Thanks for taking my questions.

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.

Hi, guys. Thanks for getting me in. Just a question on Urocortin 2 and the collaboration with the cardioendocrine research group. Can you 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?

Thanks, Jason, one of the 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 key creative ways of generating additional clinical data to keep the program moving. We actually have either 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 kind 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 jump start a few additional activities over the upcoming months. As far as partnership discussions, I will let Kevin --

Yes, 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 CRF 2 receptor as an agonist. 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 be large very expensive trials and outside of our area of focus.

So we -- to comment, we have people who are interested in Urocortin.

Yes, we do have several interested in Urocortin, right now our focus is exclusively on Elagolix and partnering that.

Okay. Thank you.

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 is to due to them we are able to continue moving Elagolix on its timelines. 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 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.