ACADIA Pharmaceuticals Inc (ACAD) 2006 Q3 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals third quarter 2006 financial results conference call. My name is Tony and I will be your coordinator for today. (OPERATOR INSTRUCTIONS). I would now like to turn the presentation over to Ms. Lisa Barthelemy, Director of Investor Relations at ACADIA Pharmaceuticals, who will review the Company's forward-looking statements. Please proceed, ma'am.

Good afternoon, and welcome to ACADIA Pharmaceuticals' third quarter 2006 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 20.

Before we proceed, I would like first to remind you that during our call today we will be making a number of forward-looking statements, including statements regarding our 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, 2005 and subsequent filings.

You're 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 over the call to Dr. Uli Hacksell, our Chief Executive Officer.

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

I will begin today by touching on some of our key highlights, and then ask Tom Aesen to briefly review our recent financial results. Following these remarks, Roger Mills and I will provide an update on our clinical programs and other business. We will then open the floor to your questions.

ACADIA has continued to deliver on important business and clinical milestones throughout the third quarter of 2006. We look forward to maintaining this momentum as we close out the year and off embark on a very exciting 2007.

During our second quarter conference call we focused on two of our four proprietary Phase II stage clinical programs where we have recently reported positive clinical results. These included our ACP-104 schizophrenia program, where we announced encouraging results from three initial clinical trials in patients with schizophrenia. And our ACP-103 program for the treatment of sleep maintenance insomnia, where we reported exciting results from our proof of concept clinical trial in older, healthy volunteers.

Today we will focus our update on two other proprietary Phase II programs, where we also have made very important progress this year. Our program with ACP-103 as an adjunctive therapy for schizophrenia, and our program for the treatment of Parkinson's disease psychosis.

You may recall that in late September this year we announced that we have significantly accelerated enrollment in our large Phase II adjunctive therapy trial with ACP-103 in patients with schizophrenia. I'm pleased to report today that the strong momentum in this trial has continued. We received an important milestone in this program by completing patient enrollment early in the fourth quarter, and we remain on track to report topline results from this study during the first quarter of 2007.

We are also excited with the progress in the (indiscernible) psychosis program. In this program we are building on the positive Phase II trial results that we announced during the spring this year. We continue our preparations to initiate the first pivotal trial with ACP-103 in the first half of 2007.

You'll hear later from Roger that we have had positive interactions with the FDA regarding this program, and that has provided us with increased confidence and enthusiasm for our planned pivotal Phase III program for Parkinson's disease psychosis.

In addition to the advancement of our clinical programs, we strengthened our balance sheet this year with the completion of a follow-on offering of the receipt of a second equity investment from Sepracor. Altogether our achievements thus far in 2006 provide a strong foundation for us to advance our clinical pipeline to the next level.

Before we review our clinical programs in more detail, I will ask Tom Aesen to discuss our recent financial results.

I will provide you with a brief overview of our third quarter financial results, which were reported in our press release issued earlier today.

Our financial results for the quarter continue to reflect our strategic plan to invest in our proprietary pipeline, and were consistent with the increased clinical activity in our Phase II clinical program. In particular the results for the quarter reflected the accelerated timing and related spending on our ACP-103 schizophrenia trial. Our financial results were also impacted by the settlement of a previously disclosed civil action.

We reported a net loss of $11.3 million for the third quarter of 2006 compared to a net loss of $12.3 million for the third quarter of 2005. Our cash and investment securities totaled $94.7 million at December 30, 2006, compared to $55.5 million at December 31, 2005. This increase in cash was largely attributable to net proceeds from our follow on public offering completed during the second quarter, as well as Sepracor's second equity investment during the first quarter.

Let's briefly look at some of the components of our third quarter results. Our revenues totaled $1.9 million for the third quarter, and were once again comprised primarily of revenues from our collaborations with Sepracor, Allergan and SMRI. As expected these revenues were comparable to our second quarter 2006 revenues, and reflected lower revenues from our Allergan collaborations as compared to the third quarter of 2005.

Revenues from our Sepracor and SMRI agreements were comparable quarter over recorder. Research and development expenses increased in total $16.1 million for the third quarter of 2006, including $561,000 in stock-based compensation. The increase in R&D expense compared to the third quarter of 2005 was primarily attributable to increased clinical costs associated with our proprietary Phase II clinical programs.

Most notably, we saw an increase in external service costs, which was consistent with the acceleration in timing and patient enrollment in our Phase II schizophrenia trial with ACP-103. External service costs totaled $9.6 million for the quarter compared to $2.6 million in the third quarter of 2005, largely reflecting the heavy patient enrollment which occurred during the third quarter.

With the completion of enrollment in this trial early in the fourth quarter, we anticipate that our external service costs will decrease considerably during the fourth quarter of 2006 relative to the third quarter.

General and administrative expenses totaled $2.4 million for the third quarter of 2006, including $410,000 in stock-based compensation. Excluding the impact of stock-based compensation, G&A expenses for the third quarter were lower than the comparable period of 2005, largely reflecting lower professional fees.

As previously disclosed, we entered into an agreement in September 2006 to fully settle a civil action and this settlement resulted in the gain of 4.0 million during the third quarter of 2006. During the third quarter of 2005 we recorded a charge of $5.9 million related to this matter.

We recorded an aggregate of $971,000 of non-cash stock-based compensation during the third quarter, pursuant to Statement of Financial Accounting Standards No. 123R. This compared to $462,000 in stock-based compensation in the comparable quarter of 2005, which was recorded pursuant to the old accounting standards.

Our net loss per common share on a GAAP basis, including non-cash stock-based compensation, totaled $0.38 per share in the third quarter of 2006 compared to a net loss per common share of $0.53 per share for the comparable third quarter of 2005. We closed the quarter with a total of 29.8 million common shares outstanding.

Finally regarding our cash outlook, consistent with our previous guidance, we anticipate that our aggregate cash balances will be approximately $80 million at December 30, 2006. And that our existing cash resources, including expected payments from our collaborators, will be sufficient to fund our operations through at least mid 2008.

I will now turn the call back over to Uli.

We will now review our clinical programs in a bit more detail. ACADIA's pipeline includes five Phase II stage clinical programs, all of which are proprietary programs. We are developing ACP-103, our proprietary selective 5-HT2A inverse agonist in three clinical programs, each targeting a different indication.

First, acid therapy for Parkinson's disease psychosis. Second, as an adjunctive therapy for schizophrenia. And third, as a treatment for sleep maintenance insomnias. In our fourth proprietary Phase II program we are developing ACP-104 as a stand-alone treatment for schizophrenia. In addition to these four internal clinical programs, we have a neuropathic pain program in Phase II clinical trial in collaboration with Allergan.

As I mentioned earlier, we will focus today on two of these programs, our ACP-103 schizophrenia program and our Parkinson's disease psychosis program. I will turn over the call to Dr. Roger Mills who will cover these programs.

Good afternoon. It is my pleasure to provide you with an update on two of our Phase II clinical programs. Let me start with our schizophrenia program, where we are developing ACP-103 with an adjunctive therapy to be used in combination with other antipsychotic drugs to improve [pre-clinical] profile. We believe that adjunctive therapy with ACP-103 may result in increased efficacy, together with lower side effects relative to current treatments, thereby providing the potential to significantly improve therapy for patients suffering from schizophrenia and related psychiatric disorders.

Therefore, as Uli mentioned earlier, we're very pleased with the progress in our large Phase II adjunctive therapy trial that we're conducting in this program. In late September we announced that enrollment in this trial had accelerated dramatically, and we are significantly ahead of schedule. This strength continues, enabling us to successfully complete enrollment of 423 patients in this study early in the fourth quarter. Importantly, we remain on track to report top line results from this trial during the first quarter of 2007.

Let me take a moment to review the design of this trial and our objectives as it relates to the upcoming results. This Phase II trial is a multicenter, double-blind placebo-controlled study designed to evaluate the ability of ACP-103 when used adjunctively with low doses of each of risperidone, a commonly prescribed atypical antipsychotic drug, and Haliperidol, a typical antipsychotic drug to provide an improved therapy for patience with schizophrenia.

Patients in the trial were randomized five different study arms. Arm one, ACP-103 with low dose risperidone. Arm two, ACP-103 plus low dose Haolperidol. Arm three, low dose of risperidone plus placebo. Arm four, low dose Haolperidol plus placebo. And arm five, high dose risperidone plus placebo as a control arm.

Patients undergo a 42 day treatment schedule. The primary endpoint of this study is antipsychotic efficacy as measured on day 42 versus baseline, using the positive and negative syndrome scale, referred to as PANSS, an industry standard rating scale used in schizophrenia trials.

Our objectives for this trial are threefold. First, we want to show that ACP-103 when used in combination with low doses of either risperidone or Haolperidol provides improved efficacy as compared to the low doses of risperidone or Haolperidol alone. Second, we want to demonstrate that the treatment arm with more ACP-103 plus low dose risperidone shows a favorable side effect profile relative to the high dose risperidone control arm.

Third, we're hoping to see an expansion of antipsychotic efficacy into the negative symptom domain with the ACP-103 treatment groups as compared to the high dose risperidone arm.

Schizophrenia and related disorders represents an enormous area of unmet medical need. Although the market for antipsychotic drugs currently exceeds $14 billion annually, and the current market leaders are multibillion dollar blockbusters, these drugs had many limitations and there remains a clear need for improved therapy.

This was demonstrated in the [KT] study which was reported last year. This showed that 74% of patients with schizophrenia discontinued their treatment within 18 months due to limitations of efficacy or intolerable side effects. We believe that our Phase II trial design provides the opportunity to demonstrate the key advantages of adjunctive therapy with ACP-103. And we're very excited for the potential for ACP-103 to improve the standard of care for patients with schizophrenia.

Let me now turn to our clinical program with ACP-103 for the treatment of Parkinson's disease psychosis. In late September we held what we believe was a positive and constructive end of Phase II meeting with the FDA with respect to this program. We were very pleased with the outcome of the meeting, which provided us with a clear understanding of the development path required to obtain registration for the Parkinson's disease psychosis indication.

Based on our interactions with FDA, we're preparing to initiate the first pivotal efficacy trial in our Phase III development program in the first half of 2007. This trial will be the first of two required efficacy trials in this Phase III program.

Importantly, the FDA has agreed to the use of our recommended study endpoints for these pivotal trials. The primary endpoint will be antipsychotic efficacy as measured by the scale for the assessment of positive symptoms, or SAPS rating scale. The tolerability will be a secondary endpoint and we measure it using the UPDRS rating scale.

We expect to enroll a total of approximately 240 patients in the first pivotal efficacy trial. This will be a multicentered, double-blind placebo-controlled study with patients randomized for three different study arms, each comprised of approximately 80 patients. The study arms will consist of two different doses of ACP-103 and one placebo group. Patients will receive all doses of ACP-103 or placebo once a day for six weeks on top of the stable doses of their dopamine replacement therapy. We're busy with the preparations for this trial, and we're on track to initiate the study in the first half of 2007.

Let me also comment on certain other aspects of our Parkinson's disease psychosis Phase III development program. Regarding the second required pivotal efficacy trial, we are currently planning to stagger this trial with our first pivotal study in order to enhance the execution, while also seeking to compress the overall development timeframe.

With regard to safety requirements, we anticipate the standard safety package will be required for this development program. We anticipate conducting open label extension studies in connection with our planned efficacy trials in order to help us meet our safety requirements. We expect to provide more information regarding the total Phase III development program following the initiation of the first pivotal efficacy trial.

Let me take a step back and address what we believe is a significant market opportunity for ACP-103 in the treatment of Parkinson's disease psychosis. The standard of care for Parkinson's disease consist of L-dopa, another dopamine replacement therapy. Whilst these treatments may address the [maturic] symptoms of the disease, up to 40% of the patients with Parkinson's disease go on to manifest psychotic symptoms. It is important to note that PD psychosis is extremely disabling, and that is the main factor leading to nursing home placement of patients with Parkinson's disease. There is currently no approved therapy in the United States for PD psychosis.

There have been numerous attempts to use existing antipsychotic drugs off-label to treat PD psychosis, though they are not well-tolerated by these patients at doses required to achieve antipsychotic effect, and are subject to a blackbox warning in the elderly population.

As part of their pharmacological profile these drugs all block the dopamine B2 receptors, the same targets in which the dopamine replacement drugs used to treat PD, exert the beneficial motor effect. This poses a major challenge for both patients and their physicians who want to address the problems of psychosis without worsening the underlying symptoms of Parkinson's disease.

ACP-103 is highly selective in its mechanism of action. It blocks 5-HT2A receptors and not the dopamine B2 receptors. ACP-103 is designed to address the combined need for antipsychotic efficacy, tolerability and safety. This is confirmed in our Phase II trial reported earlier this year, where results show that ACP-103 demonstrated [latoric] tolerability, antipsychotic effects, and safety in patients with PD psychosis.

In connection with this Phase II trial, we also have an ongoing open-label extension study which currently involves about 20 patients. 16 of these patients have now been treated with ACP-103 for over a year, of which 6 have been treated for over 18 months. We believe ACP-103 has the potential to change the standard of care for patients with Parkinson's disease.

Now let me turn the call back to Uli.

As you can see, we remain very enthusiastic about the prospects for these two proprietary clinical programs and the opportunities we have to address large unmet medical needs in these areas. Let me now provide a brief overview of our other two proprietary Phase II stage programs which we covered in more detail during our second quarter call.

I will start with ACP-104, our second schizophrenia program. ACP-104 combines an atypical and psychotic profile with the added potential benefit of enhanced cognition, thereby addressing one of the major challenges in treating schizophrenia today. Early in the third quarter we announced positive results from three initial clinical studies of ACP-104 in patients with schizophrenia. The results show that ACP-104 is safe and well-tolerated up to repeated dosing up to 600 mg per day. Initial signals of antipsychotic effects were observed within the tolerated dose range of ACP-104 despite a limited 14 day treatment duration.

The results from these studies provided us with a strong foundation to prepare for more advanced [basal] studies in this program. We are currently preparing for a planned Phase IIb trial in patients with schizophrenia. We anticipate this to be a multiarmed study, including two doses of ACP-104, and one placebo group was about 80 patients per arm. The study will involve a 42 day treatment schedule with the use of industry standard rating scales to assess clinical endpoints for positive and negative symptoms in schizophrenia. We expect to initiate this trial in the first half of 2007.

Let me next turn to our fourth proprietary clinical program in which we're developing ACP-103 as a next generation treatment for sleep maintenance insomnias. During the second quarter we announced exciting results from the prove of concept clinical study conducted in older healthy volunteers. We continued to plan the next trial in this program to evaluate the efficacy of ACP-103 in patients with sleep maintenance insomnia. We expect to initiate this study during the first half of 2007.

In addition, to the important progress in our Phase II clinical programs, we have continued to advance our pre-clinical programs and expand our extensive portfolio of discovery assets. As you are aware, ACADIA has a very strong (indiscernible) platform that has provided us with several optimized pre-clinical compounds with potential [especa] for follow on drugs to ACP-103.

In another program we have generated an exciting series of late stage discovery compounds with potential as proved cognitive antipsychotics. These compounds differ structurally from ACP-104, but like ACP-103 they combine muscarinic agonists with actions on dopamine and serotonin receptors. We have also made significant progress in the optimization of our [CB1] antagonist.

Finally, we recently announced that ACADIA is helping to establish Abbey Pharmaceuticals, the startup biotechnology company focused on medications for substance abuse. The new company is led by Dr. Mark Brann, ACADIA's founder, who stepped out of his role as President and CEO of ACADIA.

Abby will seek external financing after which ACADIA plans to establish a collaboration with Abbey that would provide access to certain of our technology and drugs (indiscernible) assets that may have applications in the field of substance abuse. We see there is certainly interesting potential opportunity to realize additional value from our drug discovery platform in areas outside of our reported focus.

I want to take this opportunity to personally thank Mark for the enormous contributions he has made to ACADIA. We wish him the very best in his new role, and we look forward to the opportunity to collaborate with Mark as he heads up his new company.

As we look to close out 2006, our priorities are clear and we remain focused on meeting our key objectives. We will continue to drive forward our proprietary clinical programs, and prepare for later stage development in select programs. This is truly an exciting time for all of us at ACADIA as we seek to transition ACADIA from a mid stage R&D Company to a later stage R&D company.

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

(OPERATOR INSTRUCTIONS). Charles Duncan, JMP Securities.

Congratulations on a quarter of good progress. I had a couple of questions on ACP-103, the pivotal program that you're talking about in Parkinson's disease associated psychosis. Let's see. You had it sounds like a positive meeting at the end of Q3. What activities are going on now to prepare for the start of the clinical program in the first half of 1H. Is that a protracted timeline, or are there current clinical studies or toxicological studies are needed to get that program started?

I will ask Roger to answer this question. I think it is important for you to realize that the kind of information that we are providing today is very much focused on the next pivotal clinical trial. But of course, we're also planning for the whole development program. Please, Roger.

Really, this is the first time that this indication has been pursued. Most importantly we wanted to ensure that we had a thorough plan for the development program, including the pivotal trials. Also, we had to have the necessary interactions with the regulatory authorities to gain agreement for moving forward.

Having had that one now in the position of preparing for the studies, initially the [Leaf] study, but putting that together into an operational plan and obviously looking at sites that we can run the studies in.

Did you think about, given that this is an indication that hasn't been pursued in the past, did you think about pursuing a special protocol assessment? And if not, do you feel like you have the full agreement of the FDA and understanding of the outcome measures?

That is an interesting point. The whole area of the SBAs. We looked at our options here and we do not believe that the SBA was the best approach for us to move forward with this program -- really for a number of reasons.

Firstly, it is a pretty straightforward development path. FDA in interactions with us has indicated that they will accept the duration of treatment, the population we proposed, the general trial design for Phase III development, including the endpoints. We didn't feel there was a particular need to undergo a SBA process there, especially bearing in mind that in recent conferences noted from -- sponsors often ended up with time delays, and in many cases more conservative trial design under that process. We felt we had a pretty clear path forward and a straightforward agreement.

It sounds like there wasn't much point of debate between you and the agency, and you got the full benefit of their guidance?

Correct.

Then last question along these lines. Can you give us a little bit more color on the scope of the second study?

In terms of the second study -- not really wanting to go into details on that study to date, as we really preparing for the first study. What we would intend to do is to stagger that in timing versus the first study, so that we can ensure successful start to that first study, and take the learnings into the second study so that we can compress the overall timeline.

There might be a different set of clinical questions that you're trying to answer in the second study than in the first?

We would anticipate a pretty standard II study development here.

Eun Yang, Jefferies.

I have like several questions. The first two questions is this Phase III study for ACP-103 for Parkinson's disease, the planned Phase III, how long will it take to complete the study?

Roger, if you want to comment on that.

We're actually looking at starting this in the first half of 2007. We're not providing specific guidance right now on the timing of the trial. I probably suggest that you refer to industry standards for trials of this magnitude.

The second question is on ACP-103 as an adjunctive therapy. We're looking at top line Phase II data in the first quarter of next year. And I'm just wondering what your plan is for Phase III, would you actually look into partnering the drug before you initiate Phase III or you would go into Phase III with or without a partner?

We're sticking to our strategy here, which involves that indications where you need large salesforces. So that is schizophrenia and sleep maintenance insomnia. We intend when we have completed the Phase II programs to start to explore potential strategic alliances with a partner that can help us to complete the Phase III program, that can help us really optimize the value of the drug on the market.

Now with the completion and getting the results from this large Phase II study with ACP-103 as an adjunctive therapy in schizophrenia, we think that we have reached a point in time where we can start to explore potential partnerships. That is our strategy currently.

But just hypothetically, if you cannot find a partner with a favorable terms, would you actually move into Phase III on your own?

It is a very hypothetical question. First of all, we expect and hope that we will get exciting data from the ACP-103 study. We think that with the design of that study, we address the key questions that really can illustrate the advantages as of ACP-103 and clearly provide potential partners with a meaningful value proposition. We're confident that we can move forward with our planned strategy.

The last question is you mentioned three different things that you're looking for in that study, the ACP-103 in adjunctive therapy. First one was ACP-103 in combination with a low-dose of risperidol or [Haliperidol] showing superior efficacy versus a low-dose of those drugs.

And then second was a favorable side effect. And third was looking at the negative psychotic symptoms versus the high dose of risperidol. I just want to clarify, when you look at the superior efficacy in combination versus a low dose of either drug, at that point would you actually look at a kind of equivalent or noninferior efficacy versus high dose, the regular dose of risperidol?

I think in the design of this study, what we really tried to do was first to show that we get an enhanced efficacy when it comes to positive systems when we add ACP-103 on the top of low-doses of these drugs. It remains to be seen whether that enhanced efficacy will be the same as we have seen from the high dose of risperidol. That is clearly the control arm in the study.

The key reason to include the high dose of risperidone though is to make sure that this is a good trial so that we have good antipsychotic kind of response in the study. What we want to demonstrate in the ACP-103 arms is again that we get a dose (indiscernible) effect demostrated. That we get more efficacy on positive symptoms with ACP-103 than you see when we treat these low-doses with placebo. And also that we get an expansion of the efficacy into the negative symptoms domain, something which I think is very, very important if you consider the unmet medical need in current schizophrenia therapy.

Your assumption there is the low-dose of either Halperidol or risperidol he would not say efficacy in the negative symptoms.

We expect to see more efficacy when we add ACP-103 to the low doses.

Okay. This is a pure hypothetical question again. Let's just say when you compare ACP-103 in combination with a low dose of either drug, we mentioned, it shows that it is better than low doses of either drug, but when you look at the efficacy it is not as good as a high dose of risperidol. If that is the case, would you say that the study failed to show -- some of its objective?

I think that the ideal outcome would be that we showed similar efficacy as high dose risperidone. That would be -- if we could demonstrate all the key things here that we could show a dose sparing effect that provided us with the full efficacy on positive symptoms, expanded efficacy into the negative symptoms domain, had fewer side effects, those are the three things that we would love to see from the study.

Now as you are aware, there's always a spectrum of (indiscernible). And let's not speculate on these outcomes until we have the results. But what I think is important to state here is that we are very excited and believe very much in this study.

Joe Pantginis, Canaccord Adams.

First on the Phase II data coming out in Q1. Maybe just if you can help us manage the expectations a little more. First, how are you looking to release the data, like in a press release? Also when you say topline data, I just wanted to be sure what that topline data will consist of. Is it just the primary endpoint? And in that same vein, should there be any potential say open question from the primary endpoint in that study? When we look to see additional data come out to hopefully explain any potential questions?

Maybe you can answer that, Roger.

Initially we will be providing topline results for the trial. That will be PANSS score for each of the arms. We would expect that to be followed by a presentation of data at a suitable meeting. But we haven't yet selected either a venue nor a timing for that.

Then if I could just follow up quickly with ACP-104, because you mentioned regarding the filing or safety packages, etc. Can you just remind us at this point what your safety package is to date? You had the [talks] packages in two species, etc.

Yes. We have -- what we have reported on when it comes to ACP-104 are the three studies that we reported on this year in patients where we did -- looked at the total of more than 70 patients and demonstrated safety and tolerability of these drugs that we gave.

You are all set with -- okay, yes, that is super. Thank you very much.

William Ho, Banc of America Securities.

Congratulations on getting that trial enrolled early. My question is with regards to ACP-103 in schizophrenia. I am just wondering how well-tolerated is that trial, the statistical significance in the primary and secondary endpoints, and what kind of magnitude of effect are you assuming?

Do you want to answer that, Roger?

This is a large study, 423 patients in this study. It is powered to show around a 15% decrease in the PANSS score. This is set as a predetermined -- sort of a minimal clinically relevant response.

You would expect to see significance in all the primary and secondary endpoints? It is well powered for that?

You are going to see it with the primary.

Pardon?

It is powered for the primary.

(OPERATOR INSTRUCTIONS). Ajim Tamboli, Lehman Brothers.

Just to follow-up on the last question, between which arms is the powering to show -- is the trial powered to show a difference between, or is it simply from baseline?

Powered from baseline.

From baseline. Okay. I think you mentioned the open-label extension study with 20 patients. I just want to follow up on that and see if you guys have seen anything there in terms of safety (inaudible)?

There's nothing specific in that study. It is pretty straightforward with patients on drug for periods of no undue signals in that study that we have seen.

In terms of the ACP-103 trial design, or I guess Phase III design in Parkinson's disease psychosis, in your discussions with the FDA, I guess what were they -- what are they looking for in terms of a safety program there in terms of -- (multiple speakers).

Essentially it is just a pretty standard safety program following the ITH safety guidelines. Obviously, it is, no, it is not down to absolute numbers, but that is roughly in the region at 1,500 patients who are exposed to clinically relevant doses, about 3 to 600 of these treated for six months, and around 100 treated for 12 months.

Would that be something all of which they would want to see prior to filing or is that to be done as a Phase IV program?

One would anticipate that that is within the package of file.

Finally, I will just ask I guess a strategic question. Assuming successful results with ACP-103 in schizophrenia, and then partner interest following that -- pursuant to that, would you guys -- and maybe this is question for you, Uli -- do you see yourselves perhaps doing some additional work that could allow for the use of 103 as maybe a combination follow on product to an existing product, or would you -- are you guys focused on doing it as adjunctive therapy at this point?

It is a very interesting question that you have. It would all depend on what kind of agreement that we would get together with the potential partner in this area. Clearly our path for ACP-103 is quite clear. First we move on aggressively with ACP-103, that covers Parkinson's disease psychosis.

Then when we have the data from the ongoing schizophrenia adjunctive therapy trial, we will go out and start to explore potential partnerships. At the same time we continue to study ACP-103 for sleep maintenance insomnia. We think that we really get an opportunity to optimize the value for ACP-103. It is an interesting drug because of its safety profile, and that safety profile really permits us to move this broadly in different indication areas. And we're quite excited about that.

There are no further questions in queue. Dr. Hacksell, please proceed with closing remarks.

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

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