ACADIA Pharmaceuticals Inc (ACAD) 2007 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to Acadia Pharmaceuticals' third quarter 2007 financial results conference call. My name is Melanie, and I'll be your coordinator for today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. (OPERATOR INSTRUCTIONS) I would now like to turn the presentation over to Ms. Lisa Barthelemy, Director of Investor Relations at Acadia Pharmaceuticals who will review the Company's forward-looking statement. Please proceed.

Good afternoon and welcome to Acadia Pharmaceuticals' third quarter 2007 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 November19.

Before we proceed, I would like first to remind you that during our call today, we will be making a number of forward-looking statements including statements regarding our anticipated financial results and our research and development programs. 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, 2006 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. It is now my pleasure to turn the call over the to Mr. Uli Hacksell our Chief Executive Officer.

Thank you, 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 the call by covering some of our recent highlights. I will then ask Tom to review our financial results for the third quarter. Following these remarks we will briefly review our clinical programs. We will then open to floor to your questions.

Before we begin, an on behalf of all of us at Acadia, I would like to thank the financial community for their support and concern for our employees during the recent fires in San Diego. While many of our employees were among the large numbers temporarily displaced, we are fortunate to be able to say that our facilities and the homes of our employees were untouched by the fires. Again, your messages and thoughts were greatly appreciated.

Now, during the third quarter we continued to make solid progress with the ongoing clinical trials in our most advanced proprietary clinical programs. This includes the first pivotal trial in our Phase III program with pimavanserin for the treatment of Parkinson's disease psychosis and our Phase IIb trial with ACP-104 for the treatment of schizophrenia. We started both of these key trials during the summer and our development teams have worked diligently to get the initial clinical sites fully up and running and advanced patient enrollments. Meanwhile, following completion of the prelim additives of our Phase II schizophrenia co-therapy trial, with pimavanserin earlier this summer, I am excited to report that we are preparing to present these data in collaboration with Dr. Herb Meltzer at the ACNP annual meeting to be held in Boca Raton, Florida from December 9, to the 13.

Given the prominence of this meeting in the neuropsychiatric community, we believe that this is the ideal venture for an issued presentation of the data highlighting the full analysis of this Phase II trial. We recognize that the attendance at the ACNP meeting is generally limited to ACNP members and designated sponsors. Therefore, we have also arranged to host an analyst and investor meeting in New York City on Friday, December 14, immediately following the ACNP meeting in order to provide the investment community with the opportunity to attend presentations on the full analysis from this exciting Phase II trial. And have access to leading clinicians in the area of schizophrenia.

In addition to the progress we have made in our advanced clinical programs, our strong balance sheet provides us with a solid foundation to advance our clinical pipeline and execute on our growth strategy. We remain dedicated to providing meaningful improvements to patients who suffer from neuropsychiatric (inaudible - highly accented language) disorders. Before we review our clinical programs and our upcoming milestones in more detail, let me turn the call over to Tom to discuss our recent financial results.

Thank you, Uli. I'll provide you with a brief overview of our financial results for the third quarter which were reported in our press release and Form 10-Q issued earlier today.

Once again, I'm pleased to report that our financial results for the quarter were in line with our expectations, reflecting the planned investment in our advanced proprietary clinical programs. We reported a net loss of 16.0 million or $0.43 per common share for the third quarter of 2007, compared to a loss of 11.3 million or $0.38 per common share for the third quarter of 2006. We continue to maintain a strong cash position, closing the third quarter with a total of $141 million in cash and investment securities. Let's briefly look at some of the components of our third quarter results.

Our revenues totaled $2.0 million for the third quarter of 2007, compared to $1.9 million for the third quarter of 2006 and were once again comprised of revenues from our collaborations with Sepracor and Allergan as well as agreements with other parties. Research and development expenses totaled $16.9 million for the third quarter of 2007 including $805,000 in stock based compensation, compared to $15.5 million for the third quarter of 2006 including 550,000 in stock based compensation. The increase in R&D expenses was primarily attributable to increased costs associated with the ongoing clinical trials in our advanced proprietary clinical programs including the Phase IIb trial in our program with ACP-104 and the pivotal Phase III trial in our program with pimavanserin for Parkinson's Disease Psychosis. External service costs increased to $9.7 million for the third quarter of 2007 from $9.0 million for the comparable quarter of 2006. General and administrative expenses totaled $2.9 million for the third quarter, and were comparable to the third quarter of 2006.

Finally, let me update you on our cash outlook. We believe that with our current balance sheet we are well-positioned to continue to advance our proprietary clinical pipeline and execute on our business strategy. We continue to expect that our cash and investment securities will be greater than $120 million at December 31, 2007 and that our existing cash resources including expected payments from collaborators, will be sufficient to fund our operations through 2009. I'll now turn the call back over to Uli.

Thank you, Tom. Let me now review our programs in more detail. Acadia's pipeline includes five mid- to late stage clinical programs. In our most advanced program we are in Phase III development with pimavanserin for the treatment of Parkinson's Disease Psychosis. Earlier this year, we reported positive top line results from a Phase II trial in our program with pimavanserin as a co-therapy for schizophrenia. We also have two proprietary Phase II stage clinical programs which are ACP-104 for the treatment of schizophrenia and pimavanserin for the treatment of sleep maintenance insomnia. We have retained worldwide commercialization rights for all four of these proprietary programs. In addition, we have a neuropathic pain program in Phase II clinical trials in collaboration with Allergan. My remarks today will mostly focus on our two advanced schizophrenia programs and our Phase III Parkinson's Disease Psychosis program.

Let me start by discussing our program with pimavanserin as a co-therapy for schizophrenia. Despite the commercial success of existing anti-psychotics which exceed $16 billion in worldwide sales, current drugs that are used to treat schizophrenia related disorders have substantial limitations, including sever side effects and inadequate efficacy. We believe that co-therapy with pimavanserin combined with the sub-maximal dose of atypical anti-psychotics can significantly improve the way schizophrenia and related disorders are treated today.

As mentioned earlier, we look forward to presenting data from our Phase II schizophrenia co-therapy trial with pimavanserin in collaboration with Dr. Herbert Meltzer at the upcoming 46th annual meeting of the American Society of Neuropsychopharmacology to be held in Boca Raton, Florida in December. Dr. Meltzer's presentation will highlight findings from the full analysis of our Phase II co-therapy trial. The full analysis confirmed the robustness of the top line results reported in March which demonstrated important advantages of co-therapy with pimavanserin when combined with a sub-maximal dose of Risperidone. These advantages included enhanced efficacy, the (inaudible) onset of anti-psychotic action, and an improved side effect profile. The analysis also provides additional data in support of the benefits of pimavanserin co-therapy and have served to further increase our excitement regarding the medical and commercial potential of pimavanserin.

Immediately following presentation of the Phase II data at the ACNP meeting, we will host an analyst and investor meeting on Friday, December 14, in New York. The meeting will feature presentations by Acadia and key opinion leaders of data from our Phase II schizophrenia co-therapy trial with pimavanserin along with presentations for a Phase III program with pimavanserin for PDP, our Phase II program with ACP-104 for schizophrenia, and our other discovery and development activities. We will be providing further details regarding our analyst and investor meeting later on this month.

I should also note that we are planning to have a number of additional data presentations related to our Phase II schizophrenia co-therapy trial at future medical meetings. We have an abstract accepted for presentation at the 14th Winter workshop on schizophrenia and bipolar disorders to be held in Montreal, Switzerland, in early February this year. Next year. Excuse me.

In addition to presentations of clinical data, we recently presented preclinical data highlighting the benefits of pimavanserin co-therapy at the 37th annual meeting at the Society for Neuroscience held in San Diego. (Inaudible) that pimavanserin potential to be action of several of the most commonly used atypical anti-psychotic agents in animal models predictive of anti-psychotic activity. And that they also reversed the adverse effects of these anti-psychotic agents on cognitive function. These results suggest that the positive findings from clinical studies evaluating pimavanserin co-therapy with Risperidone may be applicable to a wide range of anti-psychotic drugs.

You may recall that following completion of the full analysis of the Phase II schizophrenia co-therapy trial, we indicated that we had initiated our process to explore potential strategic alliances during the summer. This process involves thoroughly exploring our commercial opportunities with pimavanserin with a focus on ensuring that any alliance captures the proper commercial value for Acadia as well as strong involvement and incentives for both parties. Once again, you can appreciate that as we conduct our process, we are not providing specific details regarding our partnering process, discussions, or potential timing. What we can say is that we have been very pleased to see the positive and enthusiastic reaction from both the medical and Pharmaceutical communities and the strong level of interest from potential partners to evaluate this opportunity. We are also excited by the results of the full data analysis which only increased our confidence regarding the potential for pimavanserin to play a significant role in the treatment of schizophrenia and related disorders.

It's also important to note that while we explore our opportunities to optimize the commercial value of this asset, we continue to proceed in Phase III development with pimavanserin as a treatment for Parkinson's Disease Psychosis. Many of the studies and activities that we are conducting in this Phase III program may be leveraged to support the development of pimavanserin in other indications. In other words, we continue to advance the development program of pimavanserin across indications.

Let me now turn to our second schizophrenia program which is ACP-104 as a stand-alone treatment for schizophrenia. ACP-104's unique pharmacological program, combining, M1 muscarinic agonists, 5-HTZA inverse agonists, and D2 and D3 partial agonist provides the potential for a superior, atypical antipsychotic efficacy profile with enhanced cognition. Current treatments are generally not effective in addressing negative symptoms and are also not effective or may in fact worsen cognitive disturbances associated with schizophrenia.

We are pleased with the progress of our ongoing Phase IIb trial that we initiated in late June this year. The environment for conducting schizophrenia trials continues to be favorable and we have seen strong interest in the trial by investigators and patients alike. We believe that the solid progress that we are experiencing with this Phase IIb trial is a reflection of the critical need for new and improved therapies for patients with schizophrenia and the potential for ACP-104 to provide a superior efficacy profile with enhanced cognition.

Let me briefly read you the design in objectives of this trial. Our Phase IIb trial is multicenter double-blind placebo controlled study designed to evaluate the safety and efficacy of ACP-104 in approximately 250 patients with schizophrenia who are experiencing an acute psychotic episode. Patients in this trial are randomized to three different study arms which include two different doses of ACP-104 administered twice daily, 100 mgs. and 200 mgs. and one placebo arm. The primary end point of the trial is anti-psychotic efficacy, as measured using the positive and negative syndrome scale, or PANSS, an industry standard rating scale commonly used in registration schizophrenia trials.

I'm pleased to report that the progress to date in this Phase IIb trial should allow us to complete the study ahead of our initial expectations. We currently anticipate reporting top line results from this trial in the third quarter of 2008. Recently, Acadia scientists also made presentations of preclinical data on ACP-104 at the annual meeting of the Society for Neuroscience. This data show that ACP-104 has a superior profile in animal models of cognitive function and potent activity in models predictive of anti-psychotic efficacy. We remain excited about the potential of ACP-104 to be a break-through treatment for schizophrenia that can address one of the largest unmet medical needs associated with the disease.

Let us now turn to another program that we are also very excited about, and that is our Phase III clinical program with pimavanserin as a treatment for Parkinson's Disease Psychosis or PDP. PDP is a debilitating neuropsychiatric disease that occurs in up to 40% of patients with Parkinson's disease. There currently is no drug approved in the United States for the treatment of PDP, despite the fact that this is a very serious condition, characterized by disturbing hallucinations and delusions. In fact, PDP is the most common factor leading to nursing home placements of patients with Parkinson's disease. We believe that pimavanserin is well positioned to be an important first in class treatment for PDP. We are pleased to have advanced this program into Phase III with the initiation of our first pivotal trial in June this year.

Let me now take a moment to review the design and objectives of this study. This Phase III trial is a multicenter, double blind and placebo controlled study that is designed to evaluate the safety and efficacy of pimavanserin in approximately 240 patients with PDP. Patients who are starting are randomized to three different study arms including two different doses of pimavanserin, 10 mgs. and 40 mgs., 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 end point of the trial is anti-psychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Psychosis associated Parkinson's disease is manifested mainly by positive symptoms specifically hallucinations and delusions. The SAPS is a widely accepted tool to measure positive symptoms and is considered the most appropriate scale to measure the psychosis in Parkinson's disease. Motoric tolerability is an important secondary end point in the trial and is measured using the Unified Parkinson's Disease Rating Scale or UPDRS.

We are pleased with the continued progress made by Roger and his team in our ongoing Phase III trial. Our development team has worked diligently to get the initial trial sites up and running, to advance recruitment of patients at clinical centers located in the U.S. We continue to bring on new trial sites including centers located throughout Europe where we anticipate recruiting patients imminently. Additionally, patients who complete the Phase III pivotal trial have the opportunity to enroll in an open label safety extension study. This allows for continued treatment of these patients while providing data to support our safety requirements. Importantly, we also see high enthusiasm from the U.S. and European investigators, or EU, to find a treatment for debilitating disease.

I'm pleased to note that our Phase III development program with PDP is progressing according to plan. Given the size of this patient population in relation to schizophrenia and the fact that this is a pivotal trial, we currently expect to report top line results from this Phase III trial during 2009. As a reminder, our Phase III programming PDP consists of two pivotal efficacy trials and a standard safety package. In addition to our focus on getting the first pivotal trial fully up and running in both the U.S. and Europe, we are conducting site planning and other start-up activities in preparation for initiating the second pivotal trial. We plan to ramp these trials in a staggered, parallel fashion and we believe that we will be able to leverage the investment from the first trial to compress the development time frame for the second pivotal trial.

Along with the advancement of our clinical programs, we continue to make good progress in our collaborative programs including our Phase II program in neuropathic pain with Allergan. In addition, earlier in the third quarter, we announced that in our second collaboration with Allergan, we advanced our muscarinic agonist for glaucoma into the clinic. Our productive discovery again, continues to provide us with a robust pipeline of drug programs to fuel our development efforts.

We are proud of the significant milestones that we have achieved so far this year, including our transition to a Phase III stage company with pimavanserin, the announcement of positive results from our large Phase II schizophrenia co-therapy trial, the initiation of our Phase IIb trial with ACP-104 and the strengthening of our balance sheet. We believe that we have an exciting road ahead of us and we look forward to continuing our momentum.

We remain focused on a number of key objectives that we believe provide the potential to drive significant shareholder value for Acadia. This includes our efforts to explore potential strategic alliances to optimize the commercial opportunity around our schizophrenia co-therapy program, to advance our Phase III PDP program, and to complete our Phase IIb clinical trial with ACP-104. We also look forward to presenting the full data set from our Phase II schizophrenia co-therapy trial in December. We hope that many of you will have the opportunity to join us at our inaugural analyst and investor meeting in person or via webcast on December 14, to see this exciting data and to gain a deeper appreciation for the potential of our pipeline on next generation therapies for patients who suffer from neurophsyciatric and other CNS disorders. That completes our update and we will now be happy to entertain any questions that you may have.

(OPERATOR INSTRUCTIONS) Our first question comes from the line of Alan Carr with Needham. Go ahead.

Hi, good afternoon, everyone.

Hi, there.

Sounds like you're making some progress with the pimavanserin in PDP and that you've -- that enrollment is I guess a little bit more clear here in terms of time lines. I was wondering if you can give any more detail on when you think you might get the second one started and has your view changed as to whether or not this one is going to be exactly the same as the first or are there going to be any differences between the trials?

Roger, maybe you can give a shot at answering that question.

Thanks, Uli. Alan, we, -- the strategy always was to position the two studies in a staggered manner, but obviously in parallel. So as we have been doing a lot of work in getting the first study up and running, we've been doing the proprietary work for the second study and that's well under way. So we will anticipate starting that study fairly soon.

First half '08 probably or even by year end, do you think?

Actually, starting it, we will -- I won't give an exact time but it will be a lot faster than the end of '08, I can assure you.

First half.

Fairly soon.

Okay. And I guess I would be remiss if I didn't ask about partnering for pimavanserin. I'm wondering if you can characterize those discussions to any degree as to whether or not, are you finding any hesitation for partnering this drug because it's an adjunct as opposed to a stand-alone drug? Are there particular financial terms that you're looking for?

Let me try to answer that question. First of all, as we have indicated following the completion of the full analysis of our trial, we initiated this process to explore potential strategic alliances that really can help us optimize the value of pimavanserin. What we can say is that we have been very pleased with the positive reaction on the Phase II data from both the medical and pharmaceutical communities. And what I can tell you is that following the full analysis of the data from this trial, we are more excited than ever about the commercial potential for pimavanserin and we believe that this excitement is also evident in discussions with potential partners.

Now, when it comes to the kind of deal that we really are aiming for, it's clearly -- we're looking for something that can help us to really complete a comprehensive registration program that will maximize the value of this opportunity on the market. And we believe that this drug has a great -- represents a great commercial opportunity. I should also mention that in general terms, our strategy is to try to retain rights to participate in the commercialization in areas such as Parkinson's Disease Psychosis in the U.S. and we certainly want to end up with a deal, attach the right commercial aspects in it, has strong involvement and incentives, both for us and a potential partner.

Do you sense any hesitation by potential partners in letting you all participate?

I don't -- as I said before, we don't want to go into specific details of our process or these discussions. What I can say is again, that we are excited and we see excitement from our potential partners as well.

Thanks very much.

Thanks.

Our next question comes from the line of Ajim Tamboli with Lehman Brothers, go ahead.

Good afternoon. So on the pimavanserin presentation at the ACNP meeting, following the data you've released to date, what incremental details can we expect to receive in December?

Roger, do you want to take a shot on that?

Yes. Thanks, Uli. I think first thing that I just want to stress is that when we did the top line data, those were actually pretty comprehensive analyses that we had done prior to that. So those -- the messaging that we've put out there to date is being confirmed by the additional analysis that we have done. A lot of it was just robustness checking. I think what you'll see is a broader aspect of some of the data behind the messaging that we put out there to date, really reaffirming the key aspects of that, the efficacy on the pound scale, which is very clinically meaningful and was driven not by any one element of that but across the board, the accelerated response that we saw and the benefits in the side effect profiles with the weight gain, (inaudible) anemia, there will be some data on the (inaudible) and weight gain. I think you're going to see essentially the background to the messaging that we put out to date.

I'd have to assume no surprises other than the support data we've seen including on the side effect profile.

Yes, there's no surprises that we have there, which is very reassuring. All of our business analyses confirmed the position that we reported earlier this year.

Okay. Great. And then on the ACP-104 Phase IIb trial in schizophrenia, can you tell us how many patients have been dosed to date and what the weekly blood monitoring requirements are and whether we've seen additional dose -- additional cases of leukopenia and any suggestion of agranulocytosis?

Again, Roger, I think this is a question for you.

Thanks, Uli. We are not giving specific information on the numbers of patients that are enrolled in this study. Apart from saying that we are very pleased with the performance on the study and we're very pleased with the progress that we are making there. And I think as Uli mentioned earlier, we expect to report top line results in the third quarter of next year, of '08. In terms of the monitoring in the study, we're doing a pretty standard monitoring which does include hematological data and that is pretty standard and we're moving along. As I said, we're very pleased, we remain very pleased with the progress in the study.

Is that weekly or biweekly.

It's weekly.

Weekly. Okay. And finally--.

If I can just add, that we are following a very rigorous count on blood monitoring.

Okay. Great. Then, finally, Uli, I guess as you thing about partnering, given that we've had data for a few months now for pimavanserin, how do you weigh that versus completing a partnership versus I guess taking the program forward here in terms of time lines?

As I have said many, many times, I think it's ideal to have a commercial partner involved in the design of the complete Phase III program. From a commercial point of view. Because you want to make sure that you do the right study, strong, from a commercial point of view in the area of schizophrenia. So clearly, we think that's a very interesting aspect of these discussions that we are having. Now, we are not excluded, in that we may do an additional schizophrenia study ourselves, but again, I think the ideal kind of scenario is to think -- to have a partner helping us to complete the registration studies that will enable us to maximize the commercial opportunity around pimavanserin.

And also may I add, Uli, that we have the Parkinson's program already ongoing. Not only are we continue to generate important clinical data, but we also have the rest of the Phase III program which is occurring in parallel with that clinical program designed obviously to provide a package registration at the end.

Great. Thanks for taking the questions.

Our next question comes from the line of Joe Pantginis with Canaccord Adams.

Good afternoon. Thanks for taking the call.

Hi, Joe.

Just a quick question. On the Phase II data, the top line data, you guys presented or made the statement that it -- even though you couldn't get into as much detail as you can in the upcoming final data, that it significantly impacted the negative symptoms. I was just wondering -- I know you can't get into the specifics now, but can you give us why it's important relative to what other treatments have not been able to show in impacting negative symptoms?

Do you want to answer that, Roger?

You want to give the background first?

Yes. So let me take a step back then and look after schizophrenia therapy in general. Remember, we have three different symptom domains in schizophrenia. We have positive symptoms, that is the hallucinations and delusions that are well treated by almost all anti-psychotic agents. Then you have the negative symptoms which are poorly treated, or perhaps even worse by some of the anti-psychotic drugs you see today. And the negative symptoms consist of social withdrawal, et cetera, and apathy in general. And then you have the third symptom domain which is the cognitive deficit induced by the disease and probably worsened by all the existing anti-psychotic agents.

So two of the untreated or very poorly treated areas of schizophrenia symptoms are the negative symptoms and the cognitive deficits. That's why it's clearly interesting to look in particular at improvements in negative symptoms like cognitive deficits with a drug like pimavanserin.

Before I let Roger answer your question, I should also mention that in the data that we presented at the Neuroscience meeting just recently, we showed that while all the atypical anti-psychotic drugs in fact worsened, for example cognition, pimavanserin is able to reverse that effect, that negative effect on cognition and we think that that cognitive aspect of pimavanserin therapy may extend also into the negative symptom domain. So that is essentially the background that we have from the clinical experience with atypical anti-psychotic drugs and with pharmacological experiments in the same area. Roger?

Thanks, Uli. I think what we saw in the Phase II study, I'll just position it appropriately to begin with, was looking at the four pan scale in a particular population of acute schizophrenic patients. If one wishes to look specifically at the negative symptoms, one would probably use a more stable population and perhaps one would want to use a more specific scale, such as the SANS scale, which is the negative side of the SAPS scale that we're using in Parkinson's. And you would specifically design a study to really highlight those aspects and this study wasn't specifically designed for that reason.

However, within the overall aspect of PANSS, clearly the end side of the PANSS relates to negative symptoms. And as Uli said, there's specific domains that look at that. What we saw in this study was a very nice robust effect, not only on the positive symptomatology of the disease, but also importantly on the negative symptoms which are very encouraging for us. So we didn't see one particular element driving the results. It was across the spectrum of the disease that one saw a benefit. But in terms of highlighting that in further development, one would probably wish to use a more specific scale and a different design of the study to bring those potential benefits to the fore.

Thanks a lot. That was helpful.

Our next question comes from the line of David Amsellem with Friedman, Billings, Ramsey.

Thanks for taking my questions. So just on pimavanserin, you have right now $140 million in cash. Realize that you are looking for the right commercial partner to be in place. But in the interim, do you envision running any additional, say, Phase IIb type studies, say, with other atypical anti-psychotics, or do you plan to move forward with any other indications in terms of running any exploratory studies? I'm just trying to get a sense of what you plan to do in terms of clinical trials for pimavanserin in the interim, while you're trying to secure a partnership?

Again, just to reiterate what Roger said before, we are moving forward quite aggressively with pimavanserin in Phase III clinical studies for Parkinson's Disease Psychosis. We think what we do in that registration program will benefit pimavanserin development for other indications as well. So we haven't indicated what kind of additional studies we may do in the future. We haven't said that we may not do anything else. But again, that's something that we are thinking about, clearly.

I think it's also important that the study that we did provided a really good proof of concept result and therefore, I think as you are indicating, one could look at doing other specific drugs to combine with. But I think as Uli had mentioned earlier, it's important that as we embark on further studies, that we do so with a view to maximizing the value of this compound in the marketplace. And that's a very -- one of the key elements of why we are looking at partnerships so that we can specifically position further studies in order to get the maximum value when the drug hits the marketplace.

Okay. And then a second question, if I may, on pimavanserin. Can you say what portion of the sites and the Phase III study in PDP are U.S. versus ex-U.S.?

It's close to 50%, a little more in the U.S. in the first study, but it's pretty close to sort of 50/50 overall.

All right. Thanks.

Our final question comes from the line of Patrick Moriarty with Fortis.

I have a quick follow-up on the ACNP data to be looked at. In terms of the efficacy, you've given the responder analysis using the 20% reduction. Are you going to look at the magnitude of response in this presentation, in other words, look at maybe 25, 30% PANSS reduction at the various time points?

We've not specifically stated what we are going to present at that meeting. We have I think, I know we've talked about it previously, done a number of robustness checks, obviously one looks at the different aspects of what would be a responder, but I'm not so certain that we have decided exactly what we're putting into that presentation yet.

Is it possible to comment on the robustness of the response then?

Only that we are comfortable that the result we have reported is confirmed as we said earlier, all the results are confirmed by the various robustness checks that we've done.

Okay. Great. Thank you.

Thanks.

Ladies and gentlemen, that does conclude our question-and-answer session for today. Dr. Hacksell, please proceed to closing remarks.

So thanks again everyone for joining us on today's call and for your continued support. We look forward to the opportunity to update you in the future on our ongoing process. Thanks.

Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Have a good day.