ACADIA Pharmaceuticals Inc (ACAD) 2008 Q1 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals' first quarter 2008 financial results conference call. My name is Emecia, and I will be your coordinator. 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 like to turn the presentation over to Ms. Lisa Barthelemy , Director Investor Relations at Acadia who will review the company's forward looking statements. Please

Good afternoon and welcome to Acadia Pharmaceuticals' first 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 May 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 anticipated financial results and our research and development program. 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. It is now my pleasure to turn the call over to Dr. Uli Hacksell, Chief Executive Officer.

Thank you you Lisa. 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, Executive Vice President of Development, and Tom Aasen, Chief Financial Officer. I will begin today by covering some of our recent highlights, I will then ask Tom to briefly review our financial results for the first quarter, and following these remarks, we will review our clinical programs. We will then open the floor to your questions.

Our first quarter was highlighted by solid progress in our advanced clinical programs. We took another important step forward in our most advanced program with the initiation of our second Phase III pivotal trial in our program with Pimavanserin for Parkinson's disease psychosis, or PDP. We also remain on track with our first Phase III pivotal trial in this program which was initiated last year. We continue to focus on advancing on our Phase III PDP program towards registration as part of our strategy to develop and commercialize Pimavanserin for multiple indications together with a strategic partner. Meanwhile, we are also pleased to report today that we remain on track to announce top-line results from our Phase IIb schizophrenia trial with ACP-104 later this year. We're off to a busy start to the 2008 year with these and other activities and we look forward to continuing this momentum throughout the year. Above all, we remain committed to providing new therapy options that will improve the lives of patients and their families while delivering value for our stockholders. Before we review our clinical programs in more detail, let me turn the call over to Tom to discuss our recent financial results.

Thank you, Uli, and good afternoon. I will provide you with a brief overview of our first quarter 2008 financial results which were reported in our press release and Form 10-Q issued earlier today.

I'm pleased to report that our financial results for the quarter were in line with our expectations and were consistent with the increased investment and advancement we have made in our proprietary clinical pipeline. We reported a net loss of $16.4 million or $0.44 per common share for the first quarter of 2008, compared to a net loss of $12.6 million or $0.42 per common share for the first quarter of 2007.

Looking briefly at some of our components of first quarter results, our revenues totaled $806,000 for the first quarter, and were primarily comprised of revenues from our collaborations with Allergan as well as smaller scale agreements with other parties. This compared to revenues of $2.0 million for the first quarter 2007 with a decrease primarily due to completion of our agreements with Sepracor and the Stanley Medical Research Institute. Research and development expenses totaled $15.2 million for the first quarter of 2008 compared to $12.3 million for the first quarter of 2007. This increase was primarily due to increased clinical development activity associated with our advanced clinical programs including our Phase III program with Pimavanserin for PDP. External service costs totaled $7.8 million for the quarter compared to $4.8 million for the first quarter of 2007 largely reflecting costs associated with our Phase III PDP program as well as costs from our Phase IIb trial with ACP-104. General and administrative expenses totaled $3.3 million for the first quarter 2008 compared to $3.2 million for the first quarter of 2007.

Finally, regarding our cash and outlook, we continue to maintain a solid cash position closing the first quarter with a total of $106.5 million in cash and investment securities. As anticipated, our cash used in operations during the first quarter included payments for external clinical costs associated with our ACP-104 trial, which were incurred as this trial enrolled rapidly in 2007 and carried over for payment in quarter one, resulting in a decrease of $5.4 million in our accounts payable and accrued expenses during the period. Importantly, consistent with our conservative investment policy, we do not have any direct investments in auction-rate securities or securities that are collateralized by assets that include mortgages or subprime debt and our investment portfolio has not been adversely impacted by the disruption in the credit markets. Consistent with our previous guidance, we expect that our existing cash resources will be sufficient to fund our operations through 2009. I will now turn the call back over to Uli.

Thank you, Tom. Let me now review our programs in more detail.

Acadia's pipeline includes six clinical programs as well as several additional programs in discovery and developments. My remarks today will focus on our most advanced proprietary programs including our Phase III PDP program and our two phase two schizophrenia programs. Let me start by recapping our Pimavanserin Phase III program for PDP. PDP is a debilitating neuro psychiatric disease that occurs in up to 40% of patients with Parkinson's disease, characterized by disturbing hallucinations and delusions. There currently is no drug approved in the U.S. for the treatment of PDP. PDP often represents an inflection point in the treatment of patients with Parkinson's disease. For patients, it can prevent them from performing many of the activities of daily living that keeps them independent and active. For family members, caring for a PDP patient can be overwhelming. For a treating urologist, managing PDP is a difficult challenge. 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 it's associated with greater care giving burden and increased mortality. We believe that Pimavanserin is well positioned to be an important first-in-class treatment for PDP and may enable neurologists to effective treat the psychosis in patients with Parkinson's disease without impairing motor function. We continue to make important progress in our Phase III PDP program with Pimavanserin.

In March, we initiated our second Phase III pivotal trial with Pimavanserin as a treatment for PDP. Roger and his team did and outstanding job of finalizing the preparations to initiate this trial on time. We also are continuing to enroll patients in the first Phase III pivotal trial in this program which was initiated last year. Each of these Phase III trials is a double blind placebo-controlled study designed to evaluate the safety and efficacy of Pimavanserin in approximately 240 patients with PDP. Patients in each study (inaudible)are randomized to three different study arms, including two different doses of Pimavanserin and blind one placebo. Patients receive oral doses of Pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing (inaudible) replacement therapy. The primary endpoint of these Phase III trials is antipsychotic efficacy as measured using the scale for the assessment positive symptoms, or SAPPS. Psychosis in Parkinson's disease is manifested mainly by hallucinations and delusions. The SAPPS is supported by experts as an appropriate scale to measure the psychosis in Parkinson's disease. Motor tolerability is an important secondary endpoint in the Phase III trials and is measured using the unified Parkinson's disease rating scale, or UPDRS. Each of the Phase III pivotal trials will be conducted in over 50 clinical sites located in the U.S. and in Europe. The first Phase III trial that a slightly greater number of U.S. sites than European sites whereas the second Phase III trial will be slightly more internationally focused.

We continue to be pleased with the progress in this program, and we remain on track to report top-line results from the first Phase III trial during 2009 consistent with our earlier guidance. As expected, we were able to leverage the investment from our first trial to facilitate the initiation of our second trial. We anticipate providing more information regarding the timing of this trial at a later date. Along with these two Phase III pivotal trials, we are conducting an open label safety extension study. Patience who have completed either of the Phase III pivotal trials have the opportunity to enroll into this extension study if, in the opinion of their physician, they may benefit from continued treatment with Pimavanserin.

You may recall we also have an ongoing open-label safety extension study in connection with with our earlier Phase II PDP trial. In this extension study, 24 patients were treated with Pimavanserin for at least one year, 12 of those were treated for at least two years and several patients have now been treated for over three years with Pimavanserin. We recently presented data from our Phase II trial with Pimavanserin for PDP at the 60th American Academy of Neurology in April. The trial demonstrated that Pimavanserin had anti-psychotic effects and was more tolerantly tolerated. Pimavanserin also was safe and well tolerated in the study, thereby differentiating itself from atypical antipsychotics, which tend to worsen Parkinson's symptoms in these patients at antipsychotic doses. I'm pleased to report that Acadia's presentation was chosen to be of special importance and interest of to the (inaudible)[authorities] and was highlighted in the movement disorder scientific topic highlight session.

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 their caregivers. Let me now turn to our two schizophrenia clinical programs beginning with our program with Pimavanserin as a co-therapy for schizophrenia.

Current tracks used to treat schizophrenia and related disorders have substantial limitations, including inadequate efficacy and severe side effects. Despite these limitations, these drugs currently generate over $16 billion in annual sales. We believe that through therapy with Pimavanserin combined with a submaximal dose of atypical antipsychotics may result in enhanced efficacy and fewer side effects relative to existing treatments, thereby providing improved therapy for patients with schizophrenia and related psychiatric disorders. In February, data from Acadia's Phase II schizophrenia trial was presented at the 14th biannual winter workshop on schizophrenia and bipolar disorders. The presentation highlighted several advantages of co-therapy with Pimavanserin which includes an enhanced efficacy, the faster onset of anti-psychotic action and an improved side effect profile including less weight gain. The presentation also included data from the co-therapy trial showing that patients in the co-therapy arm combining Pimavanserin and a submaximal dose of RisperdalRisperidone have significantly less increase from baseline in serum glucose levels after treatment compared to patients in the high dose RisperdalRisperidone class placebo arm. Taken together, the reductions in weight gain and glucose increase seen after effective antipsychotic treatment with Pimavanserin and a submaximal dose of RisperdalRisperidone suggests that this co-therapy approach has the potential to reduce the metabolic problems currently associated with atypical antipsychotics.

While we focus on advancing Pimavanserin in our Phase III PDP program, we also continue to pursue our process to explore potential strategic alliances for Pimavanserin. As we have indicated previously, this involves thoroughly evaluating our commercial opportunities for Pimavanserin with potential partners with the objective of establishing an alliance that can help to us to complete the registration program for multiple indications and optimize the value of these commercial opportunities in the market. In general terms, our vision is to retain rights to participate in the commercialization of Pimavanserin in the area of neurology in the U.S. as part of our strategy to develop and commercialize these drug candidates across a range of potential therapeutic indications together with a strategic partner. Our focus is to ensure that any alliance captures appropriate value for Acadia as well as strong involvement and incentives for both parties. As we have indicated consistently since we began this process, we're not providing specific details regarding our partnering discussions or potential timing. But we can say is that we believe that potential partners appreciate the multiple commercial opportunities and unique potential for Pimavanserin.

It is important to note that we continue to advance our Phase III PDP program with Pimavanserin toward registration. 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. We are convinced that our strategy for Pimavanserin will enable Acadia and its stockholders to realize the commercial potential of this asset. Let me now turn to our other schizophrenia clinical program which is ACP-104 as a stand-alone therapy for schizophrenia. Current treatments are generally not effective in addressing negative symptoms and are also not effective or may, in fact, worsen cognitive disturbances that are associated with schizophrenia. ACP-104's unique pharmacological profile that combines M1 muscarinic agonists, 5-HT2A inverse agonists and D 2 and D 3 partial agonist provides the potential for superior efficacy profile which may include enhanced cognition. We continue to be excited with the progress of our Phase IIb trial with (inaudible).104. As you may recall, we completed enrollment in this trial in late 2007, ahead of schedule. We have now completed the treatment phase and follow-up period for the study. As I mentioned earlier, we remain on track to report top-line results from this study later this quarter.

Let me now take a moment to review the design and primary objectives of this trial. Our Phase IIb trial is a multi-centered, double-blind placebo controlled study that is designed to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia or who are experiencing an acute psychotic episode. A total of 248 patients were enrolled in this trial and randomized to one of three study arms which include two different doses of ACP-104 and blind placebo arm. Patients underwent a six-week treatment schedule followed by a four-week follow-up period. The primary endpoint of the trial is antipsychotic efficacy as measured by the mean change from baseline to day 43 using the PANSS scale. The PANSS, which stands for positive and never negative syndrome scale is an industry standard rating scale commonly used in registration schizophrenia trials. The scale includes 30 items which measure the severity of positive and negative symptoms and general psycho pathology in patients with schizophrenia. We also will be evaluating secondary end points in the trial as well as safety and pharmacokinetic measures including VT lab blood monitoring. Cognition will be an exploratory endpoint. Our primary objectives of the trial are as follows.

First, we would like to show that ACP-104 demonstrates robust antipsychotic efficacy as measured using the PANSS scale. Second, we would like to demonstrate that ACP-104 is generally safe and well tolerated and displays a favorable side effect profile relative to that commonly seen with Clozapine. In particular, we believe that this trial will provide important data indicating whether the effects of ACP-104 on white blood cells are similar what one would typically see with placebo treated patients as compared to what is typically seen with Clozapine. In addition to these primary objectives, we he will evaluate an exploratory cognition endpoint in the study and hope to see a signal indicating cognitive benefits of ACP-104 therapy. However, it's important to note that this is an exploratory endpoint and that the trial wasn't specifically designed to study cognition.

In addition to the Phase IIb trial, we continue to conduct supporting preclinical research and development in this program. We recently presented preclinical data on ACP-104 at the experimental biology 2008 meeting. We showed that ACP-104 has proprecognitive activity in an animal model by muscarinic M1 receptor dependence mechanism. In addition, we show that ACP-104 interacts with M1 (inaudible)[5-HT2A] and V2 receptors in the brain in vivo at doses that were effective in animal models on psychosis and cognition. The combined antagonist (inaudible),[model at 5-HT2A] and partial agonist of V2 receptors suggests that ACP-104 may produce antipsychotic activity with minimal, if any, extra paramidalextrapyramidal side effects. The finding is that ACP-104 binds to and activates brain muscarinic receptors in vivo support the potential utility of ACP-104 as a proecognitive antipsychotic in the treatment of schizophrenia. We remain very excited about the potential of ACP-104 to be a breakthrough treatment for schizophrenia and we look forward to the results from our Phase IIb trial later this quarter.

In closing, we had a productive start to 2008 and look forward to an exciting period ahead. As a CNS focused company with major growth potential, we are focused on advancing our late stage drug candidates and positioning them for commercial success. Our priorities and key objectives remain clear. These include continuing to advance our Phase III PDP program with Pimavanserin toward registration; executing on our strategy to develop and commercialize Pimavanserin for multiple indications together with a strategic partner; reporting top-line results from our Phase IIb schizophrenia trial with ACP-104 later this quarter; continuing to advance our collaborative clinical programs with Allergan. In particular, we remain excited with the potential for the drug candidates in our Phase II neuropathic pain program and we look forward to Allergan providing an update on this program at its R&D day in June.

Finally, you may have noticed our press release from earlier today announcing that Laura Brege has recently joined our board of directors. Laura is Executive Vice President and Chief Operating Officer of Onyx Pharmaceuticals, where she is responsible for sales and marketing, medical affairs, legal, business development and compliance actionspractice. Laura's experience provides a nice compliment to our board, and we look forward to working with her. That completes our update and we will now be happy to entertain any questions that you may have.

(OPERATOR INSTRUCTIONS) Please stand by for your first question. And your first question comes from the line of Jim Birchenough with Lehman Brothers. Please proceed.

Hi guys, a couple of questions. I know you don't want to provide any time lines or detail around partnership discussions, but I'm just wondering whether you think the PDP trial is a gating factor to getting a partnership done or do you expect to get a deal done before that trial completes in '09?

Thank you, Jim for your question. Let me start out by saying that we think it's important to move forward with PDP because that trial provides also a lot of help to our other potential indications and that we want to move forward with Pimavanserin. Clearly, the PDP program we expect to be part of a deal where a partner will help us to commercialize Pimavanserin in PDP as well as in other indications. You may recall that our strategy, when it comes to Pimavanserin, is to try to participate in the commercialization in the Pimavanserin in the U.S. for PDP together with a partner, and then having the partner taking a major responsibility in other areas where will you require a larger sales force, such as schizophrenia.

And then Uli, just a follow-up on ACP-104. Not to get too bogged down on science, but there's been some preclinical data published suggesting a high affinity for 5HT2A but pretty weak affinity for D2 and the authors, at least in that study, concluded that this would be better co-therapy than a stand-alone agent. Given that, what gives you confidence in ACP-104 as a single agent, and would we expect less effect on positive symptoms if, in fact, the D2 activity is fairly weak?

That's a very good question, Jim. I think the data that we presented at the experimental biology 2008 meeting really addressed many of these questions. We did at that meeting show that the doses where ACP-104 is active in animal, various types of animal models, whether they are animal models of schizophrenia or cognition, we had interactions of 104 with the relevant brain receptors, including D2, 5HT2A and muscarinic receptors. We think that the kind of partial D2 reception interaction that we have as you know that interaction in fact is pretty similar to Abilify's interaction with D2 receptors. It is a partial agonist that has slightly less efficacy than Abilify, and we are convinced that that D2 interaction is sufficient to get the strong activity on positive symptoms. In addition, we believe that the (inaudible)[M1] activity in itself will further synergize with with the D2 and 5HT2A activities. In all, we believe that 104 will be quite a potent and powerful antipsychotic agent, both on positive symptoms, on negative symptoms is and having the additional benefit of being able to improve the cognitive problems in schizophrenia.

Thanks for taking the question, Uli.

Your next question comes from the line of Alan Carr with Needham.

HI, good afternoon everybody.

Hi.

Can you give any more detail on the time line for the PDP trial? Is this something that is going to happen first half of '09 or the second half of '09? Can you also give us an update on enrollment for this trial, where you are with that? The first one.

Yes, let me start out by saying that we may provide more detailed guidance eventually on the first PDP trial. What we can say now is that we are on track to deliver data in 2009 from the first trial, and what I can mention, and this is something that we have also guided on previously, is that we believe that the second Phase III trial may be faster than the first one.

Can you comment on where you are with enrollment in the first trial? Is it half-way through? Or no comment on that, either?

Alan, this is Roger. We're not giving specific guidance as to how the enrollment goes in terms of numbers. What I'm comfortable saying is that the enrollment is going according to plan.

Okay, and can I ask you about -- you had quite a number of posters at that experimental biology meeting on a few other preclinical candidates. Can you -- what's the time line for bringing those into the clinic?

What I can say about these other drugs, which, by the way, are quite interesting since they represent the most selective muscarinic agonists that act on M1 receptors that are known to mankind, and they have quite an interesting preclinical profile. I would characterize them as relatively advanced lead compounds. So they are not -- have not yet been nominated as clinical candidates, so we have not yet nominated them and said that we want to move on with preclinical development. On the other hand, they are not very far away from that stage.

What about 105 and 106? Time lines for --

Yes, those compounds are, as you are aware, in preclinical development, so we have not yet moved them into clinical trials, but we are pursuing them in -- as we (inaudible)IND drug development.

Okay. Thanks very much.

Your next question comes from the line of Charles Duncan with JMP Securities. Please proceed.

Hi guys, thanks for taking the call and congrats on a good quarter of progress. I had a quick question on ACP-104. You characterized the safety aspect of that trial as secondary endpoint as one that you're looking for no worse than placebo effects on kind of white blood cells, versus Clozapine effects. Given the patient characteristics, can you give us a sense as to what you would expect in terms of the placebo impact on white blood cells?

You want to take that, Roger?

Yes. Thanks, Uli. So Charles, white counts go up and down, especially in this population you do see that you can actually get a decreasing white cell count, even in placebo patients. The difference with Clozapine is that you clearly would expect to see some form of impact on white cells, irrespective of the concern over agranular cytosis. So you'd expect to see cases of neutropenia occuring during the treatment phase with Clozapine. It certainly would be noticeable in the number of patients we have in the study. What we would expect to see, and hope to see in this population is that the white cell counts of those patients receiving 104 more closely resemble that seen as -- in the placebo group in the study.

Okay. So in terms of timing, within the drug exposure, or also in the four-week follow-up?

Yes. Within the time span, this number of patients, you would expect to see a noticeable effect with Clozapine and we would hope not to see the same effect with ACP-104 and we would hope as (inaudible) rollout that it more closely resembles the placebo arm. If iIt doesn't resemble it exactly.

And did -- forgive me if you said this before. Did you have a DSMB type monitoring board on this trial, and have they seen that data?

We did have a DSMB. They did see the data during the study, and the study ran to completion.

Okay, and then if I may just go back to ACP-103, on time lines, I understand why you want to get that trial done before you set expectations, but could you remind us on the time to enrollment for the previous -- for the Phase II and kind of if you think that you could at least hit that time line or even better now that you have that data.

Maybe I can answer that since Roger wasn't here when we conducted that trial. You may recall that we had many fewer sites at that trial, but also, of course, fewer patients. It was a total of 60 patients that were studied in that trial. It took about a year from when we really got started, and we had around 10 sites or so that really recruited. So, we're talking about a very different scale that we are doing now. Remember also that in that study, Phase II study we had only American sites. In the ongoing Phase III studies we have both international studies including both U.S. and European sites.

Okay, and then besides the passports of the patients, Uli, are there any differences in the patient characteristics, in the patients that you're enrolling now versus the ones in your Phase IIb.

No, they're very similar. Inclusion criteria, exclusion criteria are very, very -- almost identical.

When you say almost, can you -- is it something I would understand if you clarified the almost part?

Well actually, it's more that -- I couldn't define without having the two sets of criteria here. I couldn't define whether there are any absolute differences between them. What I'm comfortable in saying is, there's no significant differences in -- a clinical significant difference between the two studies. There may be slightly different wordings in the criteria, but off the top of my head now, I couldn't tie that down for you. So I think it's fair to assume it's a very similar population.

Okay,good deal. Thanks for the added color.

Thank you, Charles.

Your next question comes from the line of Mike King with Rodman & Renshaw. Please proceed.

Thanks for taking my question and good afternoon, guys. Many of my questions have been answered. I just wanted to go back, and again, not to belabor the partnership discussions, but Uli, you had said that in your discussions, most of your partners get -- understand the concept of the efficacy, so I'm just wondering, is -- what do you need to move to the next step? If they understand the benefit of co-therapy, then what is it that needs to bring them to the table, do you think?

First of all, Mike, thank you for your question. I think that we have all the times in this process we want to make sure that we optimize the potential for Pimavanserin. So these processes involve thoroughly evaluating the development and commercial plans and opportunities across a wide range of indications. You should recall that Pimavanserin is not only a drug for neuropsychiatry, it is also a drug for neurology. We see opportunities outside the indications that we are currently pursuing, and we want to evaluate and discuss all these different opportunities with different partners, and make sure that we in the end find the optimal formula that ensures commercial success with the drug.

Okay, so is it fair to say that you really have to have a meeting of the minds of the two companies, not only about schizophrenia but about the whole spectrum of different indications that the drug might eventually find itself in?

Very well put, Mike.

Okay, thanks. And then, have you taken the profile of Pimavanserin in front of any kind of formulary committee or committees to see what value a formulary committee might see in the compound in terms of add-on therapy?

We have not done that formally, but we are -- have been looking at the different commercial opportunities, in a tentative way, I should say, without going into the kind of detail that you're talking about. That's clearly something that is part of the future of Pimavanserin.

That will be part of the rollout as we further develop the commercial activities.

Okay. Great. Thanks very much.

Thank you, Mike.

Your next question comes from the line of Joe Pantginis with Canaccord Adams. Please proceed.

Hi, guys, good afternoon. A quick question on the PDP Phase III. You were talking about the open-label extension study. Do you have any anecdotes, or color to maybe share with us regarding, maybe you're seeing a good amount of patients move into that phase or anything you might be able to share?

Not a great deal in terms of amusing anecdotes, anyway, but I think the main thing is, as expected, we certainly are looking at the original Phase II study and moving into the long-term study we did there. So we did expect to have a high uptake of patients moving out of the pivotal program, the two pivotal studies into the long-term follow-up. As expected, we've seen a good pickup of patients who have moved into that long-term study.

Great, thanks a lot, that's helpful.

(OPERATOR INSTRUCTIONS) Your next question comes from the line of Patrick Moriarty with Fortis. Please proceed.

Hi, good afternoon, thanks for taking my question. I just wanted to circle back, most of my questions have been answered. I wanted to circle back on Pimavanserin in and schizophrenia as well as some of the additional indications you could move forward into it. As you're waiting for a partnership to develop, does it make sense at this point to do small proof of principle trials with other atypicals or any other indications? Is that something that would add value in a potential partnership, or to a partner?

Well, I think -- first of all, it's important to note that we are advancing Pimavanserin for its registration in the Phase III PDP program. We are building in this asset every day. The enabling studies that we are conducting as part of the PDP program will benefit all other development opportunities in related indications, including schizophrenia and other indications. And clearly, as we indicated, we want to establish a strategic alliance that sort of covers all different opportunities for Pimavanserin in both neurology and neuropsychiatry. Clearly, we have looked at development programs for these different opportunities as well. And the sort of strategic intent is to develop those with a partner, but we haven't excluded the possibility of doing additional studies in the future.

I think it it's fair to say that the Phase II study is, as we have outlined, really highlighted not just the proof of concept for RRisperdone, but as a proof of concept for the atypicals across the board and that's supported by our preclinical data.

Okay, great. Thank you.

Thank you.

Dr. Hacksell, please proceed to closing remarks.

Okay, so thanks again for 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 progress. Thank you.

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