ACADIA Pharmaceuticals Inc (ACAD) 2008 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' second quarter 2008 financial results conference call. My name is Jasmine, and I'll be your coordinator for today.

(OPERATOR INSTRUCTIONS)

I would now like to turn the presentation over to Ms. Lisa Barthelemy, Director of Investor Relations at ACADIA, who will review the Company's forward-looking statements. Please proceed.

Thank you. Good morning, and welcome to ACADIA Pharmaceuticals' second quarter 2008 financial results conference call. This call is being recorded, and an archived copy will be available on our website at www.acadia-pharm.com through August 19.

Before we proceed, I would first like to remind you that during our call today we will be making a number of forward-looking statements, including statements regarding our research and development programs, our future financial results and the expected impact of our restructuring and our new Committed Equity Financing Facility. These forward-looking statements are based on current information and expectations that are inherently subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

These factors and other risks associated with our business can be found in our filings made with the SEC, including our annual report on Form 10-K for the year ended December 31, 2007 and subsequent filings. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of today's date. ACADIA disclaims any obligation to update these forward-looking statements.

I'll now turn the call over to Dr. Uli Hacksell, our Chief Executive Officer.

Thank you, Lisa, and let me take this opportunity to thank all of you for joining us on today's conference call. Also joining from ACADIA today are Dr. Roger Mills, our Executive Vice President of Development, and Tom Aasen, our Chief Financial Officer.

I will begin today by commenting on our strategic restructuring that we announced earlier this morning. I will then ask Tom to review our financial results for the second quarter and discuss the impact of the restructuring and other measures we have taken to provide added flexibility and strength for our balance sheet. Following Tom's remarks we will review our advanced programs in further detail. We will then open up the floor to your questions.

Following the disappointing results from the ACP-104 trial earlier this summer, we have completed a thorough strategic review of our product portfolio and business, and have taken decisive action. We are significantly restructuring our operations to provide additional financial flexibility and strength and to focus our resources on our most advanced candidate programs, with the top priority on our Phase III program with pimavanserin. Our strategy and priorities are very clear. We are focused on developing a portfolio of our four most advanced product candidates, consisting of two internal compounds as well as two partnered compounds that are fully funded by Allergan.

Our number one priority at ACADIA continues to be aggressively advancing our lead Phase III program with pimavanserin for Parkinson's disease psychosis, or PDP, toward registration. The key objective in this program is the successful and timely execution of the first Phase III pivotal trial. I'm pleased to report today that we remain on track for this study and anticipate reporting top-line results in about a year.

We are also continuing to progress other components of the Phase III program, including the second Phase III pivotal trial. In addition, we will continue to evaluate and position pimavanserin for broader market opportunities, including neurological and neuropsychiatric indications that are underserved by currently marketed antipsychotic drugs.

Through our collaborations with Allergan, we are also advancing two other clinical programs -- a Phase II program in chronic pain and a Phase I program in glaucoma. Most notably, Allergan is currently completing Phase II chronic pain trials with the objective to select indications for late-stage development during 2009. These collaborative clinical programs, which resulted from successful preclinical stage collaborations, are fully funded by Allergan. ACADIA is eligible to receive milestones and royalties upon progress of the programs.

In addition to our lead Phase III program with pimavanserin and the two collaborative clinical programs, we have committed resources to advance a fourth product candidate, ACP-106. This is a promising internal compound generated from our serotonin platform. We plan to complete IND-enabling studies for ACP-106 and to advance it into the clinic in 2009.

We believe our focus on this portfolio of four product candidates with primary emphasis on pimavanserin firmly positions ACADIA with multiple product and commercial opportunities and with major growth potential. While we have significantly reduced spending on earlier stage programs, we have maintained our core discovery capabilities in order to support our advanced clinical programs and collaborations and to provide opportunities to introduce additional clinical programs in the future.

We regret that the restructuring will result in a substantial reduction in our workforce, including dedicated employees who have made important contributions to ACADIA over the years. While this action was extremely painful, it's an essential step to ensure that we maintain sufficient financial flexibility and strength to advance our portfolio of product candidates and to execute on our strategic plan. We believe that ACADIA is well positioned to achieve major milestones in our advanced clinical programs during the next 12 to 18 months and build significant stockholder value in both the near and long term.

Let me now turn the call over to Tom to discuss our recent financial results and the impact of our restructuring.

Thank you, Uli, and good morning.

Let me start by providing a brief overview of our second quarter financial results, which were reported in the press release issued earlier today.

We reported a net loss of $18.3 million, or $0.49 per common share, for the second quarter of 2008, compared to a net loss of $10.8 million, or $0.29 per common share, for the second quarter of 2007. The increase in our net loss was primarily attributable to an increased investment in our advanced clinical programs.

Let's briefly look at some of the components of our second quarter results.

Revenues totaled $177,000 for the second quarter, and, as expected, decreased relative to previous periods, primarily due to completion of our agreements with Sepracor and The Stanley Medical Research Institute, as well as lower revenues from our ongoing collaborations with Allergan.

Research and development expenses totaled $16.0 million for the second quarter of 2008, compared to $11.5 million for the second quarter of 2007. This increase was primarily due to an increase in external clinical costs associated with our advanced clinical programs, including our Phase III program with pimavanserin for PDP.

General and administrative expenses totaled $3.2 million for the second quarter of 2008, and were comparable to expenses for the second quarter of 2007.

As Uli mentioned, earlier today we announced a significant restructuring to focus our resources on our most advanced programs. This is designed to provide additional financial flexibility and strength to advance our clinical pipeline and execute on our business strategy. This restructuring involves a reduction in our total workforce of about 50%, to a total of 65 employees. We estimate that we will record charges of approximately $2 million to $2.5 million in the third quarter of 2008 in connection with the restructuring. We expect that this focus of resources on our most advanced programs, the reduction in spending on earlier stage programs and streamlining of our support functions will substantially reduce our internal operating expenses.

To give you additional color on our research and development cost structure, which is our most significant expenditure area, for the six months ended June 30, 2008, our total R&D expenses equated to an annualized level of approximately $60 million, excluding stock-based compensation. Of this total, approximately $27 million, or 45% of the costs, were associated with our internal organization, while the remaining costs represented external expenses, largely related to our clinical trials.

Following this restructuring, we expect that costs associated with our internal R&D and supporting organizations will be significantly reduced. Overall, we expect lower cash usage in the second half of 2008 relative to the first half of the year. We expect to see the full effects of the restructuring next year, and as a result we also anticipate that cash used in our operating activities during the 2009 year will be below our 2008 level.

Finally, let me put this in perspective by commenting on our cash and expected runway. We closed the second quarter with a solid cash and investment securities position of $89.6 million. We anticipate that these cash resources will now be sufficient to fund our operations into the first half of 2010. In addition, the Committed Equity Financing Facility that we announced earlier today provides us with added financial strength and leverage. We view this as a prudent vehicle to provide us with flexibility, in particular the ability for us to choose whether to access funds and the timing and amount of any financings. We now believe we are well positioned with a strong balance sheet to advance our portfolio of product candidates.

I will now turn the call back over to Uli.

Thank you, Tom.

Let me now provide an update on our most advanced programs, where we will dedicate our efforts going forward.

Let me first start by discussing the commercial opportunities for our most advanced product candidate, pimavanserin. In a series of clinical trials conducted both in patients with Parkinson's disease psychosis, PDP, and in patients with schizophrenia, pimavanserin has exhibited an attractive clinical profile, including antipsychotic efficacy, outstanding tolerability and a long duration of action. We believe these attributes make pimavanserin ideally suited to address a broad range of CNS indications with large unmet medical needs. In addition to PDP and schizophrenia, these opportunities include many other neurological and neuropsychiatric indications that are underserved by currently marketed antipsychotic drugs.

The recent focus on problems that result from the use of existing antipsychotic drugs in the elderly highlights the unmet medical need in this rapidly growing market segment. Current antipsychotic drugs have a black box warning for use in elderly patients with dementia-related psychoses and are linked to a number of problems in this population, including increased morbidity. We believe that pimavanserin's potentially favorable safety and tolerability profile will allow it to differentiate itself and compete effectively with the current antipsychotic drugs in these market segments. We believe our program with pimavanserin for PDP provides ACADIA with an attractive development path and [intro] into this market opportunity.

Let me now briefly talk about Parkinson's disease and PDP. As you are aware, it is the most common serious [movement] disorder in the world, affecting about 1% of the population over 60 years of age. The shifting global population demographic towards the elderly is likely to further expand the Parkinson's disease market. PDP is a debilitating neuropsychiatric disease in patients with Parkinson's disease, and it is characterized by disturbing hallucinations and delusions. Studies evaluating the frequency of PDP found that it occurs in up to 40% of patients with Parkinson's disease.

The progression of PDP is unrelenting and lacks remissions. In fact, PDP is the leading cause for patients with Parkinson's disease to enter nursing homes and is associated with greater caregiver burden and increased mortality. There currently is no drug approved in the US for the treatment of PDP. And the Michael J. Fox Foundation recently reported that non-motor symptoms, such as psychosis, is one of the most important areas of unmet need in the management of patients suffering from Parkinson's disease. We believe pimavanserin is well positioned to be an important first-in-class treatment for PDP and may enable neurologists to effectively treat the psychosis in patients with Parkinson's disease without impairing motor function.

We continue to be pleased with the progress in our Phase III PDP program with pimavanserin. As you may recall, this development program consists of two ongoing Phase III pivotal studies as well as an open label safety extension study and supporting NDA-enabling studies. Each of the Phase III pivotal trials is double-blind placebo-controlled study designed to evaluate the safety and efficacy of pimavanserin in approximately 240 patients with PDP. Patients in study are randomized to three different study arms, including two different doses of pimavanserin and one placebo arm. Patients receive oral doses of pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy.

The primary endpoint of the Phase III study and trials is antipsychotic efficacy, as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Psychosis in Parkinson's disease is manifested mainly by hallucinations and delusions. The SAPS is supported by experts as an appropriate scale to measure the psychosis in Parkinson's disease.

Motoric tolerability is an important secondary endpoint in the Phase III trials and is measured using the Unified Parkinson's Disease Rating Scale, or UPDRS. The pimavanserin Phase III program is the top priority for our development organization, and the key focus is placed on the successful and timely execution of the first Phase III pivotal trial. We continue to be excited with the progress in this study.

We are continuing to enroll patients in this trial, which is being conducted at over 50 clinical sites located in the US and internationally. I'm pleased to report that we remain on track with enrollment in this trial and anticipate reporting top-line results during the third quarter of 2009.

We also continue to advance our second Phase III pivotal trial, which began enrolling patients earlier this spring. This trial is slightly more internationally focused than the first Phase III pivotal trial, with a majority of the clinical sites located throughout Europe. We are continuing to bring trial sites online and recruit patients in this study.

Along with these two Phase III pivotal studies, we are conducting an open-label safety extension study, which is designed to provide us with important long-term safety information. Patients who have completed either of the Phase III pivotal trials have the opportunity to enroll in this extension study if, in the opinion of their physician, they may benefit from continued treatment with pimavanserin.

We also have an ongoing open-label safety extension study in connection with our earlier Phase II PDP trial. In this extension study, 24 patients have been treated with pimavanserin for at least one year. Twelve of those have been treated for at least two years, and several patients have now been treated for over 42 months.

In addition to these studies, we are conducting a range of supporting NDA-enabling studies as well as formulation and production activities with pimavanserin as part of our goal to advance this program toward registration.

In all, we believe that our Phase III program will demonstrate the ability of pimavanserin to treat psychosis in patients with PDP while allowing for optimal motor control. As a result, pimavanserin may offer the opportunity to improve the quality of life for patients and for their caregivers.

As I mentioned earlier, our strategy for pimavanserin is designed to advance pimavanserin toward registration for PDP and to leverage our Phase III program to develop and commercialize pimavanserin for multiple indications. Pimavanserin provides major commercial potential and is ACADIA's lead program. It is important that we realize the appropriate value for pimavanserin.

As we progress our Phase III program and complete the first Phase III clinical trial expected next year, we believe that we have the opportunity to increase the value of pimavanserin significantly. While we may continue to entertain partnering opportunities for pimavanserin as we proceed in Phase III, we are well positioned, with sufficient financial resources and with a strong development team, to advance this asset through completion of the first Phase III trial to ensure that we realize the appropriate value of these assets. As we have indicated previously, our strategy is to establish a partnership for pimavanserin to enable us to facilitate commercialization, to broaden the market opportunities and to maximize the commercial potential of these assets.

Now let me turn to our collaborative Phase II program in chronic pain with Allergan. We are excited with the progress in this program, as highlighted by Allergan at their R&D Day in early June. Allergan provided an update and preliminary results from several Phase II trials with the lead antagonist AGN-818, where they have explored doses up to 60 mg b.i.d. They reported that over 550 patients have been dosed with this product candidate to date in the Phase II program and that it has been very well tolerated.

Allergan announced positive proof-of-concept results in the human (inaudible) pain study. Additionally, they reported positive [efficacy signals] in two or three additional chronic pain trials on low-dose cohorts in the areas of fibromyalgia and irritable bowel syndrome. Higher dose cohorts are in progress, and data is expected in mid 2009 to enable Allergan to select doses and indications for late-stage development.

We believe that our collaborative [antagonists] provide considerable commercial potential and address large unmet medical needs within the chronic pain market that is over $3 billion today and growing rapidly.

In addition to this Phase II collaborative program, we have two other collaborations ongoing with Allergan. In our second collaboration, Allergan is conducting Phase I studies with a small molecule product candidate for glaucoma. Our third discovery collaboration with Allergan involves joint research efforts in the area of pain and may be expanded to include additional discovery efforts in ophthalmology.

Behind our pimavanserin Phase III program and the collaborative clinical programs with Allergan we have additional programs in preclinical developments. While we have substantially reduced our resources (inaudible) to our earlier stage programs, we are focused on advancing one additional product, ACP-106, to the clinic. ACP-106 originated from our serotonin discovery efforts and is currently in IND-track development. We intend to complete the IND-enabling studies and advance this compound into the clinic next year. We believe that ACP-106 has a promising profile and may enable ACADIA to pursue a range of potential CNS indications.

In summary, with a clear focus on a portfolio of our four most advanced product candidates, led by pimavanserin, ACADIA is positioned with multiple product and commercial opportunities, a solid financial foundation and an exciting future. We will move forward with a streamlined and strong organization that includes a strong leadership team, a highly experienced R&D team, with significant development, regulatory and core discovery expertise, and a solid supporting infrastructure.

Our strategy and priorities are clear. First, we will continue to push forward aggressively our Phase III program with pimavanserin for PDP towards registration. Importantly, we remain on track to report top-line results from the first Phase III study during the third quarter of 2009. Meanwhile, we will continue to evaluate and position pimavanserin for broader market opportunities, including neurological and neuropsychiatric indications that are underserved by currently marketed antipsychotics.

Second, our collaborative clinical programs with Allergan continue to advance. We look forward to Allergan completing the ongoing Phase II chronic pain trials in the mid-2009 time frame.

And, finally, we also expect to advance ACP-106 into clinical development next year.

We believe that ACADIA is well positioned to achieve major milestones in our advanced clinical programs during the next 12 to 18 months and give significant shareholder value in both the near and long term.

This completes our presentation, and we will now be happy to answer questions that you may have.

(OPERATOR INSTRUCTIONS)

And your first question comes from the line of Alan Carr. You may go ahead.

Hi. Good morning, everyone.

Good morning.

Good morning.

I wonder if you could clarify the pimavanserin strategy overall. I detect a change in tone in the press release on partnering strategy in schizophrenia. And I believe you also mentioned looking into other indications for pimavanserin. Could you expand on that, too?

Okay. Let me first say that there's a lot of potential for pimavanserin. Our strategy clearly has been and remains to advance pimavanserin towards an initial filing and approval for Parkinson's disease psychosis and to leverage our ongoing Phase III program to develop and commercialize pimavanserin for multiple indications outside of PDP and schizophrenia, which in themselves represent underserved markets. We believe that pimavanserin is a great molecule in terms of its ability to differentiate in an advantageous way as compared to the currently used antipsychotic drugs.

We think that we are at a very exciting stage with pimavanserin, and we have three upcoming milestones in the program as we report the first Phase III efficacy data next year. We want, of course, to ensure that we get the right value for pimavanserin, but at the same time we will naturally continue to entertain partnering discussions. But we are well positioned both financially and with a great team to advance pimavanserin through completion of the first efficacy studies.

So you'll explore potential other indications if a partnership does not come to fruition, and after you complete, or around the time of completing Parkinson's disease program, or --?

So let me clarify that for you. We believe that the ongoing Parkinson's disease effort is a great starting point for other kinds of explorations outside PDP. Let me just take one example that I mentioned already in the initial comments here. There is a lot of problems with the use of antipsychotic drugs in the elderly, and there is a black box warning, in fact, for use of antipsychotics in the elderly with demented-related psychosis. We think that pimavanserin will be able to differentiate itself for that whole market where there is a tremendous unmet medical need.

In the neuropsychiatric area we have already demonstrated in a Phase II study that pimavanserin as a co-therapy can provide a number of advantages as compared to existing antipsychotic drug therapy. So we clearly believe that over time we will have the opportunity to explore pimavanserin thoroughly. And, really, our strategy remains to do that with a partner that can help us to commercialize pimavanserin through the whole spectrum of opportunities that exist.

Uli, if I can just add in here, we see this as just a natural aspect of the development program of pimavanserin with the potential wide utility that the drug has. Having demonstrated efficacy in psychosis in a particular elderly population with Parkinson's disease, it's natural as we look forward to the future to look at expanding that so we can maximize the value of the efficacy of the drug in these populations. I think, as Uli just indicated, the atypical antipsychotics have been black box for use in elderly patients with dementia, and recently that has just been extended to the typical drugs, as well. So there's an emerging issue relating to safety of using agents in these populations. With our excellent safety profile and efficacy, we're in a great position to exploit the opportunity.

Okay, thanks. And one quick question on Kingsbridge, do you plan on drawing down any of those funds this year?

Alan, what I can say is we have no specific plans related to it. As I mentioned, we have a solid cash position as we stand today. We have strengthened the runway through the restructuring effort we announced. We also thought that it would be very prudent to have a facility like in this place, provides us with great financial flexibility as we continue to go forward, and additional leverage, not only as it relates to our financial position but also opportunities as relates to partnering, as well. But, as I mentioned, no specific plans as I stand today regarding the facilities. It's just very nice to have, and it gives us broad flexibility.

Thanks very much.

Your next question comes from the line of Jim Birchenough. You may proceed.

Hi. Actually, this is Ryan Martinson here for Jim.

Hi.

Hi. Just a few questions. One is I know you've mentioned that you are going to be still pursuing partnership opportunities, but I wanted to ask, with the restructuring for today, does that suggest that partnership may not actually be around the corner, especially given if you were going to get significant upfronts and expense sharing with a partnership, why you would be probably cutting so aggressively.

Let me first say, then, that we are not committing specifically on timing of partnerships, as we have consistently said. But I think the key thing is that we want to ensure the right value for pimavanserin by moving aggressively forward towards the first efficacy data with PDP that we will expect to report in the third quarter next year. We think it's the right thing to really maximize the value of pimavanserin and progressively move the whole program towards registration. And that will also provide a great help for really broadening the commercial opportunity of pimavanserin.

I think, if I could add to it, I think a lot of companies in our position, it's an inevitable issue that faces companies like ACADIA as your pipeline matures. In our case we have significant opportunities in the earlier stage. You're forced to make those priorities and difficult choices, and I think we clearly want to ensure that we have a strong focus around those four portfolio opportunities and that we can maximize the potential of those.

And it was important to do that that we would reduce our spending on the earlier stage efforts, but I think importantly keep that kind of core capability so we're planning for success. So as the four opportunities continue down the road and get maximized we can then have that capability to introduce program number five and six down the road. But I think we as well as others respond to the conditions that exist, and want to ensure we maintain the strongest possible financial position and flexibility as we move forward, and a very, very solid runway.

Okay, thanks. And in terms of broadening indications for pimavanserin, as you suggested, are there any plans for any smaller pilot studies for these potential other indications?

We have not scheduled any additional efficacy studies with pimavanserin, but we are certainly looking into the potential of doing such studies. I don't know if you want to comment on that, Roger.

Yes, we haven't got any studies that are penciled in to start, but we're actually looking at the opportunities, what designs one would use in particular areas and what would be the best studies and best endpoints, etc., etc., so just pretty standard planning. But right now I don't have anything penciled in to start.

Okay. Thanks for taking my questions.

Thank you.

Your next question comes from the line of Mike King. You may proceed.

Thanks for taking my questions. I had just a couple of brief ones. I know the release on the financing facility says that there is no specific set-asides or requirements for the use of proceeds, but would you imagine that the majority of those funds, should they be raised, be directed at pimavanserin?

Yes, Mike, what we can say, first of all, this is that -- I think you're probably familiar with the facility -- it's one that provides broad flexibility. The Company can pick and choose if it wants to use it, when it wants to use it and in what time and amounts over a three-year term. So we see it as just another sort of opportunity to keep that flexibility, leverage and strength as we move forward. Clearly I would say that any funds we have, including the existing cash, are focused on advancing that portfolio of the four most advanced product opportunities right now. So most of our proceeds of any money that we have today are all being devoted to our most advanced programs.

Okay, fair enough. And then I'm wondering, Uli, if you could just give us your views on ACP-106. It seems like the insomnia market is fairly crowded, and generic Ambien out there. Just what is going to be different and special about ACP-106 that you think will differentiate it from the current crop of marketed drugs as well as those that are currently moving through the pipeline?

I think it's important here to realize that drugs of this type, like pimavanserin and ACP-106, have multiple opportunities in many different indication areas in the neurological and neuropsychiatric markets. This is a huge market. And we think that 106 really is optimally suited to be complementary to pimavanserin. We think it can be explored in areas where we for one reason or another are unable to explore pimavanserin. Such market opportunities clearly include sleep, but also many, many other indication areas. So it's the breadth of the kind of opportunity provided by this mechanism of action that makes us excited about moving forward both with pimavanserin and with ACP-106.

Okay, thanks very much.

Your next question comes from the line of Charles Duncan. You may proceed.

Good morning, guys. Thanks for taking my question. Most of my question's been asked. But one remaining question that I have is on pimavanserin and increasing visibility on that program. You say that you are moving aggressively towards 103, or with 103, moving it to registration. But can you help us understand really what that means in terms of what you're doing now relative to what you would have done to perhaps move that program along quicker?

Well, I think that we are moving very aggressively by essentially doing the required Phase III clinical studies and all the other NDA-enabling studies that are required for registration. This includes a lot of work, including CMC work, including other NDA-enabling studies. And we are moving forward with all of these programs. And we think it will benefit all other indications as well over time.

Yes, I think just to add to that, Uli, if I may, I mean, we have a full Phase III program up and running, and that consists of three major clinical trials. Obviously the focus always goes on to the two pivotal studies, but, as Uli indicated earlier on the call, we also have a third study, which is a long-term safety study capturing patients from both of those two pivotal studies. So it is a large clinical program. It is up and running and is going on plan. Behind that, as he has just said, we have the full supporting infrastructure that goes into an NDA, with many different activities that often are below the horizon but are important to pursue to achieve that NDA. So this is a full program, and it's going along according to plan.

So this is going to be a pretty tight package, call it, in a year from now, or a little bit less, and assuming success in the Phase III pretty much ready to go in terms of a filing?

The program is designed to provide an NDA package which will be acceptable to FDA and other regulatory authorities. We've not given guidance as to when that package will be available. As Uli has indicated, we are looking at results from the first study to come in in Q3 next year.

And can you -- is there anything you can do to make that Q2 or Q1? I know that there is a certain dosing timeline, but how are -- how's the experience going with enrollment, etc.?

It's going well. As I just said, the program is on track. In terms of accelerating it, that's pretty standard. So in everything we do in these studies you're always looking to accelerate the program and bring additional patients on more rapidly. So that's an ongoing process for the many different aspects, from small to larger things, that we adapt and we bring into the program as it runs. So we, just to confirm, if we can accelerate it to Q2, we most certainly will do.

How many clinical sites are currently enrollment -- enrolling patients?

We have over about 50 in the first study. In the second study some of the international sites are still coming onboard. But, as I say, we're getting enrollment which is on target.

Okay. All right. Thanks for the added color.

Thank you.

Your last question comes from the line of Patrick Moriarty. You may proceed.

Hi. Good morning. I just have a few follow-up questions, if I may. First, with respect to pimavanserin, did you see anything or get any feedback in partnering talks that would lead you to make this announcement now moving towards PDP versus the schizophrenia market? And then, related to that, without the ongoing or without ongoing development in other areas, will you have enough patients for the NDA filing in terms of the integrated summary of safety?

Yes, so let me start with the first question. We have all the time focused in on PDP as the indication where we think that ACADIA can move forward very aggressively. That doesn't imply that we don't think schizophrenia is an interesting indication for pimavanserin. As I indicated previously, we certainly think that we have shown already in Phase II that when we add pimavanserin to a low dose of risperidone we get a number of advantages as compared to standard doses of risperidone, and we believe that with that kind of profile to treat schizophrenia, we have a great commercial opportunity with pimavanserin, as well.

In addition to that, I can say that we don't comment specifically on our discussions with -- partnering discussions. But our opinion on PDP and on schizophrenia and on related indications has not changed. What I can say is that over time we -- the more we have dived into the neuropsychiatric and neurological indication areas, the more we have become aware of the huge opportunity that exists for pimavanserin, not only in PDP and schizophrenia, but also outside these indications.

Okay. And (inaudible) safety, will you have enough patients to file based on the Phase III program?

We would anticipate that we will have a safety database which will be adequate for filing.

Okay. Thank you.

Thank you.

Sir, you have no questions at this time. Dr. Hacksell, please proceed for closing remarks.

I just want to thank again everyone for joining us on today's call and for your continued support, and we look forward to the opportunity to update you again in the future on our ongoing progress. Thank you.

Thank you for attending in today's conference. This concludes the presentation. You may now disconnect. Good day.