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Acadia Pharmaceuticals Inc. (NASDAQ:ACAD)

Q3 2007 Earnings Call

November 5, 2007 5:00 pm ET

Executives

Lisa Barthelemy - IR

Uli Hacksell - CEO

Tom Aasen - CFO

Analysts

Alan Carr - Needham & Company

Ajim Tamboli - Lehman Brothers

Joe Pantginis - Canaccord Adams

David Amsellem - Friedman Billings Ramsey

Patrick Moriarty - Fortis Bank

Operator

Good day, ladies and gentlemen, and welcome to the Acadia Pharmaceuticals Third Quarter 2007 Financial Results Conference Call. My name is Melanie, and I'll be your coordinator on today. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session toward 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 Pharmaceutical, who will review the Company's forward-looking statements. Please proceed.

Lisa Barthelemy

Good afternoon, and welcome to the Acadia Pharmaceutical 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 November 19.

Before we proceed, I would like to first 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 I'll to Dr. Uli Hacksell, our Chief Executive Officer.

Uli Hacksell

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 the Acadia today are Dr. Roger Mills, our Executive Vice President of Developments, and Thomas 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, and following these remarks we will briefly review our clinical programs. We will then open the floor to your questions.

Before we begin, and 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 fire in San Diego. While many of the employees were among the large numbers temporarily displaced, we are fortunate to be able to say that our physiologist and the homes of our employees were untouched by the fires. Again, your messages and thoughts very greatly appreciated.

Now, even the third quarter, we continue to make solid progress with the ongoing clinical trials in our most advanced proprietary clinical programs. This includes the first pivot 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 had worked diligently to get the initial clinical trials fully up and running, and advanced patient enrollments.

Meanwhile, following completion of the full analysis of our Phase II Schizophrenia co-therapy trial with Pimavanserin earlier this summer, I’m excited to report that we are preparing to present this data in collaboration with Dr. Herbert Meltzer at the ACNP annual meeting to be held in Boca Raton, Florida from December 9th-13th.

Given the prominence of this meeting in the neuropsychiatric community, we believe that this is the ideal venture for the 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 14th, 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 that 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, and other CNS, 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.

Tom Aasen

Thank you, Uli. I will provide you with a brief overview of our financial results for the third quarter, was reported in our press release and Form 10-Q issued earlier today. Once again, I am 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 the 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 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 a $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 will now turn the call back over to Uli.

Uli Hacksell

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 the 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 [listing] antipsychotics, which exceed $16 billion in worldwide sales, current drugs that are used to treat schizophrenia and related disorders have substantial limitations, including severe side effects and inadequate efficacy.

We believe that good co-therapy with Pimavanserin, combined with a submaximal dose of atypical antipsychotics, 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. 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. This demonstrated important advantages of co-therapy with Pimavanserin when combined with a submaximal dose of risperidone.

These advantages included enhanced efficacy, a faster onset of antipsychotic action and an improved side effect profile. The analysis also provides additional data in support of the benefits of Pimavanserin co-therapy and has served to further increase our excitement regarding the medical and commercial potential of Pimavanserin.

Immediately following presentation on the Phase II data at the ACNP meeting, we will host an analyst and investor meeting on Friday, December 14th in New York City. 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 of our Phase III program with Pimavanserin for PDP or Phase II program with ACP-104 for schizophrenia and our other discovery and development activities. We’ll be providing further details regarding our analyst and investor meeting later on this month.

I should also note that we’re planning to have a number of additional data presentations related to our Phase II schizophrenia co-therapy trial at future medical meetings. For example, we have an abstract accepted for presentation at the 14th winter workshop on schizophrenia bi-polar disorders to be held in Montreal Switzerland in early February this next year.

In addition to presentation some of clinical data, we recently presented preclinical data, highlighting the benefits of Pimavanserin co-therapy at the 37th annual meeting of the society for neuroscience held in San Diego.

This data show that Pimavanserin potential to be a action of several of the most commonly used atypical psychotic agents in animal models predictive psychotic activity. And that we also reversed the adverse effects of these some pshychotic agents on cognitive function. This results suggest that the positive timings from clinical studies, evaluating Pimavanserin co-therapy with Risperidone maybe applicable to a wide range of antipsychotic drugs.

You may recall that the 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, but the focus on ensuring that any alliance captures the proper commercial value for ACADIA as well as strong involvements 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 in 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 Pimavanserin to pay significant drove 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 these assets, we’ll continue to proceed in Phase III development with Pimavanserin as a treatment for Parkinson's disease psychosis. Many of these targets 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 profile combining m11 muscarinic agonist, 5-HT2A inverse agonist, and D2 and D3 partial agonist provides the potential for a superior atypical and psychotic 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 this to Phase IIb trial, is a reflection of the critical need for new and the improve therapies for patients with schizophrenia and the potential for ACP-104 to provide a superior efficacy profile with enhanced cognition.

Let me briefly review the design and objectives of this product. Our Phase IIb trial is a multi-center, 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 mix and 200 mix and one placebo.

The primary endpoint of the trial is antipsychotic efficacy as measured using the Positive and Negative Syndrome Scale, or PANSS, an industry standard rating scale commonly used in registrations schizophrenia products.

I am pleased to report that the progress today 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 presentation of preclinical data on ACP-104 at the Annual Meeting of the Society for Neuroscience. These data show that ACP-104 has a superior profile in animal models of cognitive function and proteins activity in models predictive of antipsychotic efficacy.

We remain excited about the potential of ACP-104 to be great 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 the 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 the 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 in this study are randomized to three different study arms, including two different doses of Pimavanserin 10 mg and 40 mg and one placebo arm.

Patients receive oral doses of Pimavanserin or placebo once daily for six weeks, in additional to stable doses of their existing dopamine replacement therapy. The primary endpoint of the trial is antipsychotic efficacy as measured using the scale for the assessment of positive symptoms or SAPS. Psychosis associated with Parkinson's disease is manifested mainly by positive symptoms, specifically hallucinations and delusions.

The SAPS is the 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 endpoint 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 [science] 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, partly eager to find the treatments for this debilitating disease.

I am 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 [program] in 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 trapped around these trials in a [stagged] parallel fashion and we believe that we will be able to leverage the investment from the first trial to compress the development timeframe 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 next collaboration with Allergan, we advanced our muscarinic agonist for glaucoma into the clinic.

Our productive discovery of gene continues to provide us with the robust pipeline and 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 investigation 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 continue our momentum. We remain focused on a number of key objectives that we believe provide the potential to drive significant shareholder value for Arcadia. 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 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 neuropsychiatrics and other CNS orders.

That completes our update and we will now be happy to entertain any questions that you may have.

Question-and-Answer Session

Operator

(Operator Instructions). And our first question comes from the line of Alan Carr with Needham. Go ahead.

Alan Carr - Needham & Company

Hi good afternoon everyone.

Uli Hacksell

Hi there.

Alan Carr - Needham & Company

Hi, yeah, sounds like you’re making some progress with the Pimavanserin in PDP and that you’ve that enrollment is, I guess 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 whether or not this one is going to be exactly the same as the first or you are going to – are there going to be any differences between the two trials.

Uli Hacksell

Roger, may be you can give a short-term answer to that question.

Roger Mills

Yeah, thanks Uli. So Alan, I think this will be the strategy was to position the two studies in a staggered manner, but obviously in parallel. So as we’ve been doing lot of work in getting the first study up and running, we’ve been doing the preparatory work for and that's well underway. So we will anticipate starting that study probably soon.

Alan Carr - Needham & Company

In the first half '08 probably, or even by yearend, do you think?

Roger Mills

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

Alan Carr - Needham & Company

At first half?

Roger Mills

Probably soon.

Alan Carr - Needham & Company

Okay. And I guess that we missed, but didn't ask about partnering for Pimavanserin and can -- I am wondering if you can characterize those discussions to any degree as to whether or not, are you finding any hesitation for patterning this drug because its an agent as apposed to a standalone drug or are there particular financial term that you are looking for?

Uli Hacksell

Yes, so 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 initiate this process to explore potential strategic alliances that really can help us to 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 above the commercial potential for Pimavanserin and we believe that this excitement is also evident in this captions with potential partners.

Now, when it comes to the kind of deal that we really are aiming for, it’s clearly -- we are looking for something that can help us to really complete the comprehensive registration program that will maximize the value of this opportunity on the market. And we believe that this drug has a -- 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 the deal that has the right commercial aspects in it has strong involvement and incentives both for us and our potential partners.

Alan Carr - Needham & Company

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

Uli Hacksell

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.

Alan Carr - Needham & Company

Okay. Thanks very much

Uli Hacksell

Thanks

Operator

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

Ajim Tamboli - Lehman Brothers

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

Uli Hacksell

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

Roger Mills

Yeah, thanks Uli. I think first thing is, I just want to stress is that when we did the top line data, those were very pretty comprehensive analysis that we 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 robust and striking. I think what you'll see is a broader aspect of some of the data behind the messaging that we put out to-date really reaffirming the key aspects of that the efficacy on the PANSS scale which is very clinically meaningful and was driven not by any one elements of that, but across the Board. The accelerated response that we saw and the benefits in the side effect profiles with the weight gain, prolactinemia, there will be some data on the akathisia and weight gain. So I think you are going to see written essentially the background to the messaging that we put out to-date.

Ajim Tamboli - Lehman Brothers

So I would have to assume no surprises other than the supported data we've seen the date including on the side effect profile?

Uli Hacksell

Yeah, there are no surprises that we have that which is very reassuring all our business analysis confirmed that the position that we reported early this year.

Ajim Tamboli - Lehman Brothers

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

Uli Hacksell

Yeah again Roger, I think this is a question for you.

Roger Mills

Okay, 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 are 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 another, and as I said we are very pleased, we remain very pleased with the progress in the study.

Ajim Tamboli - Lehman Brothers

Is that weekly or biweekly?

Roger Mills

It's weekly.

Ajim Tamboli - Lehman Brothers

Weekly, okay.

Uli Hacksell

(inaudible) that we're following a very rigorous kind of blood monitoring.

Ajim Tamboli - Lehman Brothers

Right. Okay, great. And then finally, Uli, I guess, as you see think about partnering given that we have had data for few moments now for Pimavanserin, how do you weigh that versus completing a partnership versus I guess taking the program forward here in terms of timelines?

Uli Hacksell

Yes, Ajim, 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 if you want to make sure that you do the right start, it's from a commercial point of view in the area of schizophrenia. So clearly, we think that's a very interesting aspect of these discussions and that we're having now.

We've not excluded them that we may do additional schizophrenia start-ups I have said, 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.

Roger Mills

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

Ajim Tamboli - Lehman Brothers

Great. Thanks for taking the questions.

Uli Hacksell

Good.

Operator

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

Joe Pantginis - Canaccord Adams

Hi, guys, good afternoon. Thanks for taking the call.

Uli Hacksell

Hi, Joe

Joe Pantginis - Canaccord Adams

Hey, just quick question on the Phase II data, the top line data, you guys presented or made the statement that even though you couldn't get into as much detail as you can in the upcoming final data that 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?

Uli Hacksell

Do you want to answer that Roger?

Roger Mills

You want to give the background first.

Uli Hacksell

Yeah. Let me take a step back and look at schizophrenia therapy in general. So remember we have three symptom domains in schizophrenia. We have positive systems, that are the hallucinations and delusions, which are well treated by almost antipsychotic agents. Then you have the negative symptoms, which are poorly treated, or perhaps even worsen, by some of the antipsychotic drugs you see today. And the negative symptoms consist of social withdrawal etcetera 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 existing antipsychotic agents. So two of the untreated, or very poorly treated areas, of schizophrenia symptoms are the negative symptoms and the cognitive deficits And that why it's really interesting to look in particular at improvements in negative symptoms like cognitive deficits with a drug like pimavanserin.

Now, before I let Roger to 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 antipsychotic drug, in fact, worsen for example, cognition. Pimavanserin is able to reverse that effect, that negative affect on cognation and we think that cognitive aspects of Pimavanserin therapy may extend also in the negative symptom domain. So that is essentially the back ground that we have from the clinical experience with atypical antipsychotic drugs and with pharmacological experiments in the same area. Roger.

Roger Mills

Thanks Uli. I think what we saw in the Phase II study are those positioned appropriately to begin with, this was looking at the full PANSS scale in a particular population of acute schizophrenic patients. If one wishes to look specifically the negative symptoms or more probably use a more stable population and perhaps some 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 are 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 to PANSS clearly the end side of the PANSS related to negative symptoms and is really set as specific demands to look at them.

What we saw in this study was a very nice robust affect, not only on the positive symptomatology of the disease, but also, importantly, on the negative symptoms and which is 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 the different design of the study to bring those potential benefits to the full.

Joe Pantginis - Canaccord Adams

Okay great. Thanks a lot that was helpful.

Operator

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

David Amsellem - Friedman Billings Ramsey

Hi, thanks for taking my questions. So just on Pimavanserin you have right now $140 million in cash realized 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 antipsychotic or do you plan to move forward with any other indications in terms of running any exploratory studies. I am just trying to get a sense of what you plan to do in terms of clinical trials for Pimavanserin in the interim while you are trying to secure partnership?

Uli Hacksell

Again, just to reiterate of what Rogers said before, we are moving forward quite aggressively with Pimavanserin 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 to them 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.

Rogers Mills

I think it's also important that the study that we did provide a really good proof concept result and therefore I think, as you are indicating, [one good 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 the 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 partnership, so that we can specifically position further studies in order to get the maximum value when the drug hits the marketplace.

David Amsellem - Friedman Billings Ramsey

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

Rogers Mills

It is 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.

David Amsellem - Friedman Billings Ramsey

Okay. Alright, thanks.

Operator

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

Patrick Moriarty - Fortis Bank

Hi, good evening. Thanks for taking my questions. I have a quick follow-up on the ACNP data to be looked at. In terms of the efficacy you have given the responder analysis using a 20% reduction. Are you going to look at the magnitude of response in this presentation, in other words look at may be 25% , 30% PANSS reduction at the various standpoints?

Rogers Mills

We not specifically stated what we are going to present at that meeting. We have I think thought previously number of business check, obviously warm looks at the different aspects of what would be a responder, but I am not so certain that we have decided exactly what we are putting into that presentation yet.

Patrick Moriarty - Fortis Bank

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

Rogers Mills

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

Patrick Moriarty - Fortis Bank

Okay, great. Thank you

Rogers Mills

Thanks.

Operator

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

Uli Hacksell

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

Operator

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

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Source: Acadia Pharmaceuticals Q3 2007 Earnings Call Transcript
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