Lisa Barthelemy - Director of Investor Relations
Uli Hacksell - Chief Executive Officer
Roger Mills - Executive Vice President of Developments
Tom Aasen - Chief Financial Officer
Jim Birchenough - Lehman Brothers
Alan Carr - Needham
Charles Duncan - JMP Securities
Mike King - Rodman & Renshaw
Joe Pantginis - Canaccord Adams
Patrick Moriarty - Fortis
ACADIA Pharmaceuticals, Inc. (ACAD) Q1 2008 Earnings Call May 5, 2008 5:00 PM ET
Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals' First Quarter 2008 Financial Results Conference Call. My name is [Antin]. I'll be your coordinator for today. At this time, all participants are in a 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, who will review the Company's forward-looking statements. Please proceed.
Lisa Barthelemy - Director of Investor Relations
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 I 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 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, 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's now my pleasure to turn the call over to Dr. Uli Hacksell, our Chief Executive Officer.
Uli Hacksell - 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 Developments and Tom Aasen, our 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 our Phase III PDP program toward 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 are off to a busy start to the 2008 objectives 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 by 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.
Tom Aasen - Chief Financial Officer
Thank you, Uli, and good afternoon. I will provide you with a brief overview of our first quarter 2008 financial results, which we reported in our press release and Form 10-K issued earlier today.
I am pleased to report that our financial results for the quarter were inline 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 the revenues of 2.0 million for the first quarter of 2007 with the 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. The 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 cost totaled 7.8 million for the quarter compared to 4.8 million in 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 of 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 sub-prime 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 to Uli.
Uli Hacksell - Chief Executive Officer
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 II schizophrenia programs.
Let me start by discussing our Pimavanserin Phase III clinical program for PDP. PDP is a debilitating neuropsychiatric disease that occurs in up to 40% of patients with Parkinson's disease, and is characterized by disturbing hallucinations and delusions. There currently is no drug approved in the US for the treatment of PDP.
PDP often represents an inflection point in the treatment of patients with Parkinson's disease. For patients, you can't prevent them from performing many of the activities of daily living that keeps them independent and active. So family members caring for a PDP patient can be overwhelming. For a treating neurologist, managing PDP is a difficult challenge.
The progression of PDP is unrelenting and lacks remissions. In fact, PDP is the living course for patients with Parkinson's disease to enter nursing homes and is associated with greater care givers 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 effectively 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 an outstanding job of finalizing the preparations to initiate this trial on time.
We are also 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 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 these Phase III 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 reported 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. Each of the Phase III pivotal trials will be conducted in over 50 clinical sites located in the US and in Europe. The first Phase III trial has a slightly greater number of US sites than European sites, but 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 are 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 these two Phase III pivotal trials, we are conducting an open-label safety extension study. Patients who had 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 that 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 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 antipsychotic effects and was mortality tolerated. Pimavanserin also a 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 am pleased to report that ACADIA's presentation was chosen to be of special importance and interest of the attendees and was highlighted in the movement disorders 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 care givers.
Let me now turn to our two schizophrenia clinical programs beginning with our program with Pimavanserin as a co-therapy for schizophrenia. Current drugs 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 co-therapy with Pimavanserin combined with a submaximal dose of atypical antipsychotics may result in enhanced efficacy and fewer side effect relative to existing treatments thereby providing an 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 Biennial Winter Workshop on Schizophrenia and Bipolar Disorders. The presentation highlighted several advantages of co-therapy with Pimavanserin, which includes an enhanced efficacy, a faster onset of antipsychotic 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 sub-maximal dose of risperidone had significantly less increase from baseline in serum glucose levels after treatment compared to patients in the high dose risperidone plus placebo arm.
Taken together, the reductions in weight gain and glucose increase seen after effective antipsychotic treatment with Pimavanserin and a submaximal dose of risperidone suggest that this co-therapy approach has the potential to reduce the metabolic problems commonly associated with atypical and psychotics.
While the 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 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 US, as part of our strategy to develop and commercialize this drug candidate across the range of potential therapeutic indications together with the 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 consistency since we began this process, we are not providing specific details regarding our partnering discussions or potential timings. What we can say is that we believe that potential partners appreciate remarkable commercial opportunities and unique potential for Pimavanserin.
It is important to note that we continue to advance our Phase III PDP program with Pimavanserin towards registration. Many of the studies and activities that we are conducting in this Phase III program maybe leveraged to support the development of Pimavanserin in other indications. We are convinced that our strategies for Pimavanserin will enable ACADIA and the stockholders to realize the commercial potential of these assets.
Let me no 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 they are also not effective or may in fact worsen cognitive disturbances that are associated with schizophrenia. ACP-104's unique pharmacological profile the combines M1 Muscarinic agonist 5-HT2A inverse agonist and D2 and D3 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 trail with 104. As you may recall we completed enrollment in this trial in late 2007 that heads on schedule and we have now completed the treatment phase and follow-up period for the study. As I mentioned earlier, we remained 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 objective of this trail. Our Phase IIb trail is multi-centered double-blind placebo-controlled study that is designed to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia or experiencing an acute psychotic episode.
The total of 248 patients were enrolled in this trial and randomized to one of three study arms, which include two different doses of the 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 trail is antipsychotic efficacy as measured by the means change from base line to day 43 using the PANSS scale. The PANSS which stands for positive and negative syndromes scale is an industry standard rating scale commonly used in registrations schizophrenia products. The scale includes 30 items which measures the severity of positive and negative symptoms and general psychopathology in patients with schizophrenia.
We also will be evaluating secondary endpoints in the trail as well as safety and pharmacokinetics measures including VT lab monitoring. Cognition will be in exploratory endpoints.
Our primary objectives for the trial are as follows: First, we would like to show that ACP-104 demonstrates robust and psychotic 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 trail will be providing important data indicating whether the effects of ACP-104 on white blood cells are similar to what one would typically see with placebo treated patient as compared to what is typically seen with Clozapine.
In addition to these primary objectives, we will evaluate and 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 pro-cognitive activity in an animal model by Muscarinic M1 receptor dependence mechanics.
In addition, Muscarinic ACP-104 interacts with M1 5-HT2A and D2 receptors in the brain in vivo at doses that are effective in animal models or psychosis and cognition. The combined antagonism at 5-HT2A and partial agonism at D2 receptors suggests that ACP-104 may produce antipsychotic activity with minimal with extrapyramidal side effects. The findings that ACP-104 binds to and activates brain as M1 receptors in vivo support the potential utility of ACP-104 as a pro-cognitive 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 for 2008 and look forward to an exciting period ahead. As the 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. This includes, continuing to advance our Phase III PDP program with Pimavanserin towards 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 functions. Laura's experience provides a nice compliment to our board and we looked 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). 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 timelines or detail around partnership discussions. I am just wondering whether you think the PDP trials are gaining factor to getting your partnership done or do you expect to get a deal done before that trial completes in '09?
Well, thanks Jim. Great question. Let me start off 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 that we want to move forward with Pimavanserin. The PDP program, we expect to be part of a deal, a partner 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 of Pimavanserin in the US for PDP and together with a partner and then having the partner taking a major responsibility in other areas where you will require a larger sales force such as schizophrenia.
And then, Uli, just a followup on ACP-104, Not to get too bogged down on science, but there has been some preclinical data published suggesting a high affinity for 5-HT2A, 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. So I guess given that what gives you confidence in ACP-104 on the single agent and would we expect less effect on positive symptoms if in fact D2 activity is fairly weak?
Yes, it’s a very good question Jim. I think the data that presented at the Experimental Biology 2008 Meeting really addressed many of these questions. We did at that meeting showed 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 5-HT2A and Muscarinic M1 receptors. We think that the kind of partial D2 receptor interaction that we have or we know them that interaction in fact is pretty similar Abilify's interaction with D2 receptors. It’s 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 M1 activity in itself with further synergize with the D2 5-HT2A activities. In all, we believe that 104 will be quite prudent and powerful antipsychotic agent both on positive symptoms and negative symptoms and having the additional benefit of being able to improve the cognitive problems in schizophrenia.
Okay. Thanks for taking the questions Uli.
Your next question comes from line of Alan Carr with Needham. Please proceed.
Hi, good afternoon everybody.
Can you give any more detail on timeline for the PDP-trial, or is this something that is going to happen in the first half of '09 or in the second half of '09 or can you also give us an update on enrollment for this trail, where you are with that?
Yeah, so let me start off by saying that, let me provide a more detailed guidance eventually on the first PDP trial, what we can say now is just that we are on track to deliver data in 2009 from the first trial. And what I can mentioned this is something that we have also guided on previously is that we believe that the second Phase III trial maybe faster than the first one.
Can you comment on where you are with enrollment in the first trail or is half way through or no comment on that either?
Yeah Alan, this is Roger. We are not giving specific guidance to how the enrollment goes in terms of numbers and what I am 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 and on a few other preclinical candidates. Can you - what's the timeline for brining 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 interesting preclinical profiles. I would characterize them as relatively advanced lead compounds. So they are not -- have not yet been nominated as clinical candidates. So we are 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.
Okay. We were about 105 and 106 timelines for….?
Yeah, 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 call in IND-track developments.
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 characterize the safety aspect of that trial, secondary endpoint is one way you are looking for no less than placebo effects and 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?
Yeah, thanks Uli. So, Charles, the white counts go up and down especially in this population you do see that you can actually get a decrease in white cell count even in placebo patient. Difference with clozapine is that you clearly would expect to see some form of impact on white cells irrespective of the concern of agranulocytosis. So, you would expect to see cases of neutropenia clearing during the treatment phase with clozapine. It certainly would be noticeable in a number of patients that 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 followup?
Yeah, I mean within this timespan, this number of patients, you would expect to see a noticeable effect with clozapine. We would hope not to see the same effect with ACP-104 and we would hope that it more closely resemble the placebo arm, it doesn't resemble it exactly.
And did – forgive me if you've 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 runs completion.
Okay. And then if I may just go back to ACP-103, on timelines, 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 timeline or even better now that you have that data?
Maybe I can answer that since Roger wasn't here when we conducted that trial. So 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 was started 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 than that we are dealing now. Remember also that in that study – the Phase II study, we had only American sites. In the ongoing Phase III studies, we have both international studies including both the US and European sites.
Okay. And then just on the passports of the patients, Uli, are there any differences in the patient characteristics in the patients that you are enrolling now versus the ones in your Phase IIb?
They were very similar; inclusion criteria, exclusion criteria are very very – almost identical.
You may say almost, what - can you – is it something I would understand if you clarify with the almost part?
Well, actually I could not define without having the two sets of criteria here. I couldn't define whether any absolute differences between them. What I'm comfortable in saying is that there is no significant difference, clinical significant difference between the two studies, there maybe slightly different wordings from 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 go. 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 beleaver the partnership discussions but Uli you had said that in your discussions most of your partners understand the concept of the efficacy. So, I'm just wondering is – when 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 thanks, for your question. I think that we have all the times said that 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 Pimavenserin is not the only other drug for neuropsychiatric, it's also a drug for neurology and we see multiple opportunities outside the indications that we are currently pursuing. We want to evaluate and discuss all these different opportunities with different partners and make sure that at the end find the optimal formula that ensures commercial success with the drug.
Okay. So is it fair to say then 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 all taken the profile 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 have been looking at the different commercial opportunities in a tentative way I should say without going into the kind of detail that we are talking about now that’s clearly something that is part of the future of Pimavanserin.
The other big part of the rollout is we further develop the commercial activities.
Okay. All right. Thanks very much.
Thank you, Mike.
Your next question comes from the line of Joe Pantginis of Canaccord Adams. Please proceed.
Hi guys, good afternoon. Quick question on the PDP stage III, you are talking about the open-label extension study. Do you have any anecdotals or color that may be shared with us regarding maybe you are seeing a good amount of patients move into that phase or anything you might be able to share?
No, great deal in terms of using anecdotes anyway, but I think the main thing is as expected we are certainly 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. And as expected, we have seen I guess pickup of patients who have made 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 want to circle back on Pimavanserin and schizophrenia as well as some of the additional indications you could move forward into it. As you are waiting for a partnership to develop, which doesn't make sense at this point due to a small proof of principal trials with other atypicals or any other indications, is that something that would add value in a potential partnership or to a partner?
First of all, it's important to know that we are advancing Pimavanserin towards registration in the Phase III PDP program and we're building value on 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. 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's hard to say that the Phase II study, as we have outlined, really highlighted not just the proof of concept for risperidone but the proof of concept for the atypicals across the board and that's supported by our pre-clinical data.
Okay, great. Thank you.
Dr. Hacksell, please proceed to closing remarks.
Okay, so thanks again to everyone for joining us on today's call and for your continuous support. We look forward to the opportunity to update you in the future on our ongoing progress. Thank you.
Thank you for you participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.
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