Welcome to the ACADIA Pharmaceuticals second-quarter 2015 financial results conference call. My name is Danielle and I will be your coordinator for today. [Operator Instructions]. I would now like to turn the presentation over to Lisa Barthelemy, Director of Investor Relations at ACADIA. Please proceed.

Thank you. Good afternoon and welcome to ACADIA's second-quarter 2015 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 August 20, 2015. Joining me on the call today from ACADIA are Steve Davis, our Interim Chief Executive Officer; Dr. Roger Mills, our Executive Vice President of Development and Chief Medical Officer; and Terry Moore, our Executive Vice President and Chief Commercial Officer. We will begin our call today with a business update and brief comments regarding our recently announced financial results. Following this, we will provide you with an update on our NUPLAZID development program and commercial activities and we will then open the floor to your questions. Before we proceed, I would first like to remind you that during our call today we will be making a number of forward-looking statements, including statements regarding our research and development programs and plans; our commercialization plans; our manufacturing quality systems; and our strategy, including the timing, results or implications of clinical trials or other development efforts; the benefits or advantages to be derived from, future approval of and the commercial potential for, our product candidates in each case, including NUPLAZID; the timing, content or likelihood of regulatory filings or approvals; future developments; launch and commercialization of NUPLAZID; the expansion of pimavanserin into additional indications; and our future expenses, cash position and usage. During our call today, we may use words such as anticipate, believe, could, expect, intend, may, plan, potential, predict, project, should or the negative of those terms and similar expressions that convey uncertainty of future events or outcomes, to identify these forward-looking statements. These forward-looking statements are based on current information, assumptions 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. 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. Let me now turn the call over to Steve Davis, our Interim Chief Executive Officer.

Thank you, Lisa and good afternoon. Let me first take this opportunity to thank all of you for joining us on today's conference call. Today my prepared remarks are directed at four things. First, I will update our progress relating to the preparation of manufacturing quality systems and our NDA submission. Second, I will provide an update on the work we're doing to prepare for the planned commercialization of NUPLAZID in the U.S. and our planned expansion of pimavanserin into other areas of significant unmet medical need. Third, I will discuss our recent licensing of worldwide intellectual property rights for pimavanserin to our wholly owned Swiss subsidiary. And, last, I'll comment on our financial results for the second quarter. I'm pleased to report that we remain very much on track in the preparation of our quality systems to support commercial manufacturing; and, accordingly, we remain on track to submit our NDA for NUPLAZID for Parkinson's disease psychosis in the second half of this year. As we've previously communicated, our new drug application or NDA, is complete. Upon completion of our work on the manufacturing quality systems, we will submit the NDA. Before I get into a description of pre-launch work we're doing, I'd just, as a reminder, like to emphasize that NUPLAZID has been awarded breakthrough designation by the FDA for Parkinson's disease psychosis or PDP. And importantly, as a selective serotonin inverse agonist or SSIA, NUPLAZID represents an entirely new drug class and we very much believe has the potential to be a game-changer in the treatment of PDP, where currently there is no drug approved by the FDA. To this end and in preparation for the planned commercial launch of NUPLAZID, we continue to make significant strides on multiple fronts. This includes our ongoing disease awareness campaign, the…

Thank you, Steve and good afternoon. As Steve just mentioned, we've made significant progress in advancing our preparation of manufacturing quality systems to support commercial manufacturing and supply and we remain on track to submit our NDA in the second half of this year. During the second quarter, we presented integrated data from our Phase III PDP program at the International Congress of Parkinson's Disease and Movement Disorders. These data once more demonstrate the strong efficacy of NUPLAZID in PDP across multiple measures and studies. Additionally, integrated data from two open-label safety extension studies were presented, including interim data from our ongoing Phase III open-label -015 Study. Although there were no formal efficacy endpoints in the open-label studies, persistent antipsychotic and caregiver benefit have been observed. And the data continue to support that NUPLAZID is safe and well tolerated when used chronically in patients with PDP. Indeed, as reflected in the press release issued this morning, we have published new data from the ongoing -015 Study in the Journal of the American Medical Directors Association. This is the first published report evaluating the long-term impact of antipsychotics on mortality and serious adverse events in patients with PDP. The -015 Study was designed to mimic real-world use among the greater than 400 patients enrolled. In this study, all patients received NUPLAZID 40 milligrams. Of 423 patients assessed, 357 received NUPLAZID only, while 66 patients received a currently marketed antipsychotic prescribed by their physician at some point during the study, in addition to NUPLAZID. The two groups were well matched at baseline with regard to age - a mean of 71, 72 years - and other demographic and baseline variables. In the post hoc analysis, there was a significant increase in the mortality rate of patients who received concurrent treatment with a…

Thanks, Roger and good afternoon, everyone. I'm happy to report that during the second quarter of 2015, all commercial activities in preparation for our launch of NUPLAZID in the United States are progressing as planned. As I mentioned in our last quarterly call, in conjunction with Roger's team at medical affairs, we're now executing on many of the pre-commercial activities that are required to ensure the successful launch of our product. The most visible of these is our PDP disease awareness education program. Since launching this campaign at the beginning of the year, we have made significant progress in raising awareness of PDP. We have employed a multichannel approach which includes digital as well as print media. Since mid-January, our website dedicated to educating healthcare professionals about PDP has experienced over 6,300 visits by our target audience. In addition, we have had over 6,000 engagements with healthcare professionals who participated in live or Internet-based, peer-to-peer physician PDP educational programs, including on-demand podcasts and Web-based educational videos. Given that we plan to call on about 11,000 PDP prescribers, we believe these numbers represent significant progress. In addition to these activities, as Steve mentioned, our strong presence at national neurology and psychiatry association meetings over the past seven months has a resulted in well over 2,000 meeting participants visiting the ACADIA booth, most of whom were able to experience what it was like to have PDP symptoms through our virtual reality experience. And as many of you already know, in March of this year we hired and brought on board our field management team, consisting of regional sales management and managed market account teams. Since joining ACADIA, these highly experienced and seasoned leaders have made excellent progress introducing themselves to and interacting with, Parkinson's disease experts in their regions, as well as key regional and national managed care organizations. In addition to these disease awareness activities, our regional sales managers are also working closely with senior sales leadership in setting up the process for the screening and recruitment of top sales representatives in anticipation of the acceptance of the NDA filing and the potential approval of NUPLAZID the U.S.. In conjunction with these efforts in the field, internally the commercial team is continuing to establish the appropriate data management systems that are needed to successfully run a commercial organization, as well as establishing the key channels of distribution that will be needed at the time of launch for all key segments of our business. So, as we move closer to our anticipated NDA submission and acceptance of our filing, we will continue to stay focused on executing on all preparations and activities necessary to ensure that we have a successful commercial launch. And I got to tell you, we're very excited about the year ahead. So, with that, I will turn the call back over to Steve.

Great. Thanks much, Terry. So, in summary, it's been a very productive quarter for ACADIA. We continue to make important progress in advancing our NUPLAZID program toward registration, in planning for the commercial launch of NUPLAZID in the U.S.. And all of us at ACADIA have a shared sense of purpose in terms of the work we're doing to help patients with PDP. We're very well positioned to execute on our plans and look forward to keeping you updated on our progress. Operator, you may now proceed with the Q&A session.

[Operator Instructions]. And your first question comes from Paul Matteis from Leerink. Your line is open. Please go ahead.

My first one is on schizophrenia, actually. I'm wondering what your updated thinking is on the positioning of pimavanserin in this indication and if you're thinking of the compound as a maintenance-only therapy. I'm wondering, when you've talked to specialists, how comfortable you think physicians would be potentially switching a stable patient onto another, safer agent. Would they be worried about a risk of flaring their underlying condition? Thanks.

I'm going to offer just a couple of high-level remarks, then I'll turn it over to Roger. Let me just start by saying we're very interested in pursuing pimavanserin as a treatment for maintenance, as you referred to. We also are exploring the opportunity to pursue it in the treatment of acute schizophrenia as well or acute symptoms in schizophrenia. That assessment is part of the life cycle management project that I referred to earlier. We're doing really deep dive in a number of indications; schizophrenia is one of them. But as we stand here today, we have a lot of feedback from thought leaders underscoring their desire to see us explore this in maintenance. And we're, as I mentioned, also continuing to explore the potential in the acute setting as well. So, Roger, I'll just ask if you have any further thoughts on that.

I think as I mentioned in the call, there is a great dissatisfaction with the current drugs, both for patients and for doctors who are managing those patients. The current drugs are all really designed as acute therapy; and, therefore, it's - in the long term, you are carrying side effects that really are not ideal in terms of long-term management and integration of patients back into society. So there is a great need out there. And if you look at the profile pimavanserin, it really has an ideal profile to manage these patients well during that period. So, obviously in terms of somebody doing really well on the drug, then they'll probably do well on the drug. But it's a very large market and we know that there are a great number of patients and doctors who are looking for a good alternative.

And then if I can just slip in one on ADP. Can you talk a little bit about how you are enriching the patient population in the study - how severe psychosis symptoms have to be, to get into the trial? And given the pathophysiological differences of ADP, it's more of a delusion disease. Do patients need to have both delusions and hallucinations to participate in the trial? Thanks a lot.

Right, this one's straight to my court. In terms of enrichment, obviously patients have to have psychosis and it has to be documented, associated with an underlying Alzheimer's disease. We really learned a lot in the PDP program in terms of trying to manage placebo response and you do see placebo response in Alzheimer's in a similar manner. One of the keys factors was to ensure that patients really have a good ongoing problem. And if you remember from that program, we were looking for moderate to severe patients. And it's very similar to the patient population we're looking for in the ADP study. So patients have to have moderate to severe symptoms coming in. And was there a further element to your questions than that?

No, just when you think about the patient population, I guess, phenotypically - and this is probably a hard question to answer quickly - but how similar is the ADP patient population participating in this trial going to be to the patients that were in past PDP studies, when you think about the potential of the drug from one study to another?

Absolutely and I've now picked up the second part of your question. So yes, it's that, the aspect - you are absolutely spot-on there, that the - in ADP there is a greater weight of delusions forming a component of the overall psychosis compared to PDP. But interestingly, in PDP, the early expression of the disease, when the patients aren't demented, is more focused on hallucinations. But as patients with PDP become more demented, then delusions become a more prominent aspect of their psychosis. So, obviously in AD, the patients are demented almost by definition; hence, the greater expression of delusions. Importantly, in the data that we've reported on the -020 Study, when you look at the efficacy of the drug, we saw significant improvement in delusions as well as hallucinations - each of those separate. So we saw a clear, significant improvement in the delusional component of their PDP; and, hence, why we would expect to see a similar one in ADP.

I might just add to that. Paul, you were asking about the entry characteristics of patients in ADP versus PDP. And as Roger alluded to, ADP patients tend to be older and a little bit more advanced in their disease relative to the PDP population.

And your next question comes from Cory Kasimov from JPMorgan. Your line is open. Please go ahead.

I guess first things first, just to be clear, outside of the mock inspections you're planning to run, are there any other gating items that remain prior to filing the NUPLAZID NDA?

So, Cory, what we've described from the beginning - and I will just repeat it here - is there is a series of work streams that we identified initially. We've executed those work streams. They have all gone, in terms of timeline, exactly as planned. There are always things that you learn along the way. But the work has gone very much on schedule and as planned. The final piece of the work to be done will be a mock inspection. We will have successfully completed a mock inspection on the QA manufacturing front. We will also do another mock inspection on the clinical side, as well, just to make certain that we - remain very sharp and prepared there as well. So that will be the final component. Once we have successfully completed those mock inspections, we will submit. As we mentioned on the call, the NDA is ready; there's nothing else to do.

And then how are you planning to utilize the recent publication in JAMDA that you announced this morning and you discussed in your prepared comments? Is this purely going to help from a marketing standpoint, in terms of having the publication? Or are you going to attempt to get this data into the label as well?

And then I'll punt the commercial bit over to Terry. From the label, no; this is not - this was a post hoc analysis of data. It was an interesting analysis. It came from the standard oversight that we have of the study and the safety of the program. When we were looking at the data, there was a suggestion that - or it seemed to be that a lot of the deaths had associated antipsychotic use. So it actually prompted us to challenge the data and to really do that analysis. And it really is quite an interesting analysis that's come out. Just irrespective of the commercial application of it, I think it has value for the field itself, for doctors out there treating patients. This isn't just coming from an AD population; you are seeing very similar effects of the current antipsychotics in terms of the mortality and severe morbidity that they cause in the population. So for the PD population, this was the first published manuscript that's been out there describing this. At the recent Movement Disorder meeting in San Diego, there was actually a poster from the VA group that also highlighted increased mortality and morbidity in using the current agents in patients with PDP. So, much the same has happened with AD with the emergent data, it became a groundswell after a while. Then you're actually getting the same affect here in PDP. And I think, therefore, as I say once more, irrespective of the commercial, but it really will make docs think twice about using these agents in these people.

If I could just squeeze in one financial question. May be a bit premature, but is there anything you can say now about how we should be potentially thinking about the long-term tax rate for the Company, given the licensing of the IP to the Swiss subsidiary?

Yes, I'll add as much color as I can at this point. And we won't be guiding on tax rates or, frankly, other elements of earnings until way down the road. But let me tell you what I can. I think what you should expect is that we would anticipate that the tax burden that we would ultimately have would be similar to other companies in a similar situation, whose IP is domiciled outside of the United States. There's always an element, if you are selling product in the United States, there's certainly going to be an element of the economic pie that will get taxed at U.S. tax rates. And very much of it will be taxed at the rate of - where the intellectual property is domiciled. So, for us, that will be Switzerland.

And your next question comes from Charles Duncan from Piper Jaffray. Your line is open. Please go ahead.

It's good to see the good progress in the quarter. So, my question was, I actually had a couple. One is on the report in JAMDA that you announced earlier today. It seems like that's a real positive in terms of NUPLAZID safety. I read through the report and I understand some of the limitations. But what does this really say in terms of the interaction of NUPLAZID with the other antipsychotics? And what would you have anticipated in terms of patients just receiving an antipsychotic in this patient population?

I'll take that one. We haven't seen and wouldn't expect, nor have we seen, any attraction between pimavanserin and the atypicals or typical drugs. In fact, in looking at our data, the safety profile is very similar - although we don't have a comparator arm obviously in the -015 Study - when you benchmark it against other published studies, the mortality rate in our -015 Study is very similar to what you see in a long-term PD follow-up. So we're not seeing anything from pimavanserin alone. It really is a marked increase that occurred when patients were put onto the atypicals and typical agents. And, in fact, the study I referred to that was in poster format at the Movement Meeting - those patients didn't have access to pimavanserin. And when you look at the mortality increase and morbidity increase in those patients, it was just PD adding in the atypicals alone; it's very similar to what we've seen in our own study. So both of these two very recent presentations, the data really support each other, just showing that these are really not - far from - far from good drugs for these patients and harmful drugs for these patients.

That makes sense, given the black box warning for a certain patient cohorts, correct?

Yes.

And then my second question is moving over to the ADP study that is ongoing. I think that a previous question was meant to get to this. But really, I guess I'm wondering - what is the current rate-limiting step in terms of that enrollment; and, in part, because those patients were mostly or all, actually institutionalized. So what is determining enrollment rates there?

We're not giving specifics on the study, because a number of factors really influence study enrollment. The most important criteria for us is to get to the right patient in. And I think that is - that was our premise and our approach on the -020 Study in PDP. And it's the same one we're applying here in ADP. The sites are doing a good job in getting the right patients into the study and that's pleasing. They're also ensuring that the patients who are not right for the study don't get into the study. So, right now, the study is enrolling. The curve is on the up. But it's sometimes difficult within that to determine exactly where you're going to end up. And, right now, it looks as if we'll be rolling into 2016.

And then final question is regarding the current cash position and when you would anticipate the greatest spend to occur during the NDA review, in terms of hiring salesforce. Would you anticipate that before the approval or just afterwards?

Yes, I will take that. And Terry, feel free to jump in if I miss anything. I think in terms of on-boarding these sales - I'm sorry. Let me just take one step back. So as we mentioned on this call and we mentioned recently, we have now hired all of our account managers and regional sales reps. And they've actually been very active in a lot of the disease awareness work that we've been doing at these medical meetings. Another key element of their work today is preparing to bring on the entire field force. And we've done - we've not yet made a determination whether we'll bring that field force on before we get an approval of the drug or immediately after approval of the drug. The ultimate determination will be a multifactorial consideration, including some information we just don't have today. So it would be premature to make that decision. What I can tell you is we have scenario-planned, I think, every possibility we possibly can. And we certainly recognize the value of getting those people on board, in advance. In terms of the spend, it will have an impact. Obviously, once you get those people on board, there is a certain burden or burn that's associated with them. The act of getting them on board, the launch training that we'll do, et cetera - those are not dramatic costs. It's really the cost of that salesforce once they are on board. So we'll be very mindful of that. But recognizing that we have breakthrough designation, we think there's a very good chance - very, very good chance - of getting priority review. We think at the time we make that decision, we'll be very well poised. And if we determined to bring that salesforce on board before we get approval, it will be on the basis of a lot of information that supports that decision.

[Operator Instructions]. And your next question comes from Ritu Baral from Cowen and Company.

This is Ellie on for Ritu. Thanks for taking the question. Just wondering if you've done any newer payor work since your last update that you could enlighten us with.

We have. We've gone back out and refreshed our payor access and reimbursement work. And it's been very, very encouraging in terms of their receptivity to our product profile and the value that they see in the product. And we feel that because of the breakthrough therapy and because of the current protected class that antipsychotics now have, that we'll be very well positioned at the time of launch when it comes to formulary replacement. So, all the work we've done recently has reinforced that.

I might just annotate to that. Terry's group has been - they are very eager to launch this drug. They've done a great job, I think, in making certain that we're very - not only very well-prepared, but that we stayed very, very current. And so we're continuing to do additional payor work, additional market research, to make certain that we stay right on top of every evolving trend that would be relevant to the launch of this drug.

And have they provided any recent granularity around potential pricing considerations?

Well, we haven't really guided much on pricing, other to give some points of reference that we've used historically. But we don't feel that we're anywhere away from the sweet spot that we've determined previously. So we feel pretty good about it.

And your next question comes from Alan Carr from Needham & Company. Your line is open. Please go ahead.

I missed part of the beginning of the call, but I did catch that you were having some issues with enrolling the ADP trial. You mentioned later on that some of the issues that were - some challenges in terms of getting the right patients. I'm wondering if you could tell us a bit more about your thought process, about why not adding sites to try to accelerate this. Thanks.

Okay, Alan, I'll take this one. So in terms of - studies in this area are more challenging than studies in some other areas. But we have got steady enrollment and we have picked up on that enrollment, as you would expect, as the enrollment curve increases. So it's not that we're having particular challenges. It's just that the enrollment is not, right now, is actually where we would love it to be. But the most important thing is that, as I mentioned earlier, that we enroll the right patients. And we're seeing the site, as I mentioned, are enrolling the right patients and importantly not enrolling the patients that are the wrong ones. So, for me, that is the most important aspect of the study, is maintaining that integrity. In terms of changing two of the sites, we have really chosen the sites based on quality and the level of the expertise and experience of the staff. So, just adding another site doesn't necessarily get you that expertise and experience. Importantly, what we have done, though, is to actually expand the base of nursing homes that we're looking for patients. So we're able to access new streams of nursing homes that are actually beginning to bring patients on into the study. So, we'd rather do that than to change the staff and take risks with the study in that respect.

I might just add a very brief thought to that. Sometimes it is difficult to know exactly where you are on the enrollment curve in these things. This is a study that is not like - it wouldn't be like doing a study with a new statin, where there have been literally dozens or scores of studies done that would guide what that enrollment curve might look like. Having said that, we've done what every company would and should do when you're enrolling a study - you are constantly monitoring. Now that we're in the study, we've got some patient experience. Do we feel comfortable with entry criteria? Do we think we should make changes? Are there things that we could relax or should relax? And so, we've looked at all of those things. As Roger mentioned, we have added additional nursing homes, quite a few; but we've been very disciplined about it. We're just determined that we're going to make certain that we enroll the study in the right way and hold to the standard there. And that is taking a little bit longer than we would have liked. But the good news is, the enrollment curve is continuing to increase. And we're very confident that we'll enroll the study and it will be a high-quality study.

In terms of adding nursing homes, it sounds like you are working, in essence, to add sites, if you call a nursing home a site. Can you give us a sense of - well, actually, can you remind me how many nursing homes you started off with and then I guess how much that's grown since you've been running the trial? Thanks.

Yes, actually, I don't have those, the numbers. The initial pool was right about 100 nursing homes in the network that was already established. I don't have the numbers. It's a good number of additional nursing homes, over a wider geographical area; all still based, though, around the London region.

Thank you. There are no further questions at this time. Mr. Davis, please proceed to closing remarks.

Great, thank you. So, thanks again to everyone for joining us on today's call and for your continued support. We look forward to updating you in the future on our ongoing progress.