Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' First Quarter 2016 Financial Results Conference Call. My name is Ronnie, and I will be your coordinator for today. At this time all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. [Operator Instructions] I would now like to turn the presentation over to Lisa Barthelemy, Senior Director of Investor Relations at ACADIA. Please proceed.

Thank you, Ronnie, and good afternoon and welcome to ACADIA's first quarter 2016 financial results conference call. This call is being recorded and an archived copy will be available on our website at www.acadia-pharm.com through May 19, 2016. Joining me on the call today from ACADIA are Steve Davis, our President and Chief Executive Officer; Dr. Serge Stankovic, our Executive Vice President, Head of Research & Development; 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 life cycle programs and on our commercial preparations for the launch of NUPLAZID in June 2016. 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 strategy, including the timing, results or implications of clinical trials, other development efforts or regulatory approvals, the benefits or advantages to be derived from, future approval of, and the commercial potential for our product candidates, in each case, including NUPLAZID; and the future developments; launch and commercialization of NUPLAZID. 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. It's now my pleasure to turn the call over to Steve Davis, our President and Chief Executive Officer.

Thank you, Lisa, and good afternoon. Let me first take the opportunity to thank each of you for joining us on today's conference call. Today, I'll touch on our recent FDA approval and provide a brief overview of our financial results for the first quarter. Following my remarks, Serge will provide a few additional remarks regarding our approval, and our life cycle management program. Terry will then lead a more detailed review of our key commercial priorities as we prepare for launch. On April 29, NUPLAZID became the first FDA-approved medicine to treat the hallucinations and delusions associated with Parkinson's disease psychosis or PDP. As many of you know, PDP is a very debilitating condition. It's characterized by hallucinations and delusions that increase in severity and frequency over the course of disease. It is associated with significant caregiver burden, and is one of the strongest independent predictors of nursing home placement for Parkinson's disease patients. NUPLAZID represents a major paradigm shift in the treatment of PDP. As a selective serotonin inverse agonist or SSIA, it preferentially targets 5-HT2A receptors. NUPLAZID treats hallucinations and delusions without blocking dopamine receptors and therefore not impairing motor function in PDP patients. Terry and the commercial team are excited to bring NUPLAZID to physicians, patients and caregivers and we will be doing that in June as announced on Monday. Key priorities for a successful launch will be to educate healthcare providers on NUPLAZID, ensure patient access to NUPLAZID and work with payers to secure reimbursement. Terry will review these priorities in more detail later on in the call. Beyond the commercialization of NUPLAZID, we are focused on exploring the utility of pimavanserin, which is the generic name for NUPLAZID. in other neurological and psychiatric disorders of large unmet need and Serge will provide greater detail…

Thank you, Steve, and good afternoon. We are excited about the recent FDA approval of NUPLAZID. As I have mentioned on the call on Monday, we are very pleased by the clear label that describes the benefits and risks of NUPLAZID treatment and provides the information to appropriately and successfully instruct physician regarding NUPLAZID reviews. We are also pleased by the initial reaction from our investigators and opinion leaders on approval of NUPLAZID. They've shared with us how excited they are that NUPLAZID will become available to their patients. Let me now offer a few remarks regarding our lifecycle management program. We are focused on evaluating the utility of pimavanserin in other neurological and psychiatric disorders of large unmet need. Alzheimer's disease represents one of the most important opportunities for further exploration. We continue to advance our ongoing Phase II proof-of-concept study with pimavanserin in Alzheimer's disease psychosis. We expect to complete the enrollment around mid-year with top line data reading out in the fourth quarter of this year. As many of you know, psychosis is one of the most prominent non-cognitive symptoms of Alzheimer's disease and currently there is no FDA-approved treatment for this condition. Alzheimer's disease agitation is another serious condition with no FDA-approved treatment option. As a major behavioral disturbance of Alzheimer's disease, AD agitation afflicts around 40% to 50% of diagnosed patients. We are on track to initiate this Phase II study with pimavanserin in the second quarter of this year. Turning now to our plans in Europe. We have just received comments on our proposed Pediatric Investigation of Plan, or PIP, related to our planned submission of a Marketing Authorization Application, or MAA, for NUPLAZID in Europe. As you probably are aware, having an approved PIP or waver is a requirement prior to submission of MAA. Unlike the FDA, the EMEA did not grant us a waiver and we have been negotiating the requirements for a PIP. As the consequence of them not accepting our most recent proposal, we will need to push back the proposed timing of our submission of MAA from the first half of 2016. Having just received these comments, we haven't yet had opportunity to assess how long it will take to develop our response and get through the European PIP review cycle again. As soon as we have an accurate read on this, we'll update our guidance for the MAA filing. Just to be clear, this does not have anything to do with the content or form of our MAA for Parkinson's disease psychosis, where we have had productive discussions and reached alignment with the EMEA. Agreement on the PIP is simply a pre-requisite we need to resolve prior to submission of the MAA. I'll now turn the call over to Terry, who will discuss our commercial activities and priorities for NUPLAZID.

Thanks, Serge, and good afternoon, everyone. We on the commercial team are equally excited about NUPLAZID's approval, and as I mentioned Monday, we believe this signifies a transformative advancement in the treatment of patients suffering from hallucinations and delusions associated with PDP. In my remarks today, I'll review pricing together with a recap of some of the matters we covered on Monday's call, including access and reimbursement, distribution and commercialization of NUPLAZID. Until today, there have been no approved therapies to treat hallucinations and delusions associated with Parkinson's disease psychosis. Now, there is NUPLAZID. And we believe its benefits can and will be very impactful on the lives of these patients. As Steve described, the disease burden on these patients is very high. For the first time, physicians can treat the hallucinations and delusions associated with PDP without impairing motor function. As reflected in our label, our Phase III data not only demonstrated a significant benefit over placebo, but at every level of response measures, we saw meaningful improvement. 65% of patients showed a greater than three-point improvement on the SAS PD, our primary endpoint and 14% of patients achieved a complete response versus 1% on placebo. For these reasons and backed by extensive research into physician and payer perceptions, we have set the price of NUPLAZID at a level we believe appropriately reflects the value of the medication. The Wholesale Acquisition Cost or WAC of NUPLAZID for a 30-day supply of 34-milligram jelly doses is $1,950. As I mentioned Monday, we are confident NUPLAZID will be reimbursed by the vast majority of payers. All of our market research indicates payers will view NUPLAZID as having a very positive advantage to patients with little impact on their own budgets, primarily because of the size of the patient population. Turning now…

Thank you, Terry. Before concluding our prepared remarks. I'd like to just say how pleased I am with the team we built. As I noted Monday, being part of a first-in-class, first-in-disease and first product launch for the company are key reasons we've been able to assemble a seasoned world-class team of professionals. And I'd just like to thank them in advance for their continued and untiring dedication as we now get NUPLAZID to the patients who will benefit from it. I'll now turn the call over to the operator to commence Q&A.

[Operator Instructions] And your first question comes from the line of Ritu Baral with Cowen.

Hi, guys. Thanks for taking the question. So, thanks for the clarity on the price. Can you speak a little bit to what you're expecting the range for gross to net to be in forward 12 months or where it may stabilize in, a few years out and also assuming this is the price that you are – that you used in your market research, based on this price, what sort of prior authorization and step at it do you expect to see as coverage ramps?

So, Ritu, I'm going to take the first part and I'll ask Terry to comment on the prior authorization part of the question. So, we're not giving guidance on gross to net. We won't be giving guidance for at least several quarters on either top line, bottom line or the significant components of revenues. We frankly just need to get some experience in the field. This is a new indication, it's a new drug, and as we've indicated, a very significant shift in, we believe potentially a very significant shift in standard of care, so we'll just need to get some experience before we'll be in a position where we feel comfortable giving that kind of guidance. So, Terry, I'll let you respond to Ritu's question about what kinds of prior authorizations we think we might expect?

Right. So, Ritu, as you know, we've done extensive research of payers and we've done it across the range including this price. And as we've stated before, we've been very pleased that the research indicates that our payer has recognized the value NUPLAZID brings to this debilitative condition. And we're also, as I said earlier, confident that we'll be reimbursed by the vast majority of payers. We believe that most commonly, we'll have a prior authorization that require nothing more than a confirmation of the PDP diagnosis. It won't be universal, but at this price range, we feel that this is going to be the most likely occurrence.

Got it. And do you have an idea as to the sort of patient who might be the early adopter? Do you expect it, in the first couple of quarters to potentially be some sort of inadequately treated switch patient or more likely newly diagnosed? What is your initial marketing message focused on?

Well, our market message revolves around our indication and the benefits we provide and it's up to the physician to decide, but clearly we have advantages over existing therapies and there are good reasons for physicians to consider switching their patients. So we're going to go out, we're going to show the benefits and we're going to help guide the physician in seeing why NUPLAZID would be their best choice.

Got it. And last question on the Alzheimer's study. The primary end point is the NPI nursing home and just sort of looking through that NPI, the way that it's scored, do you have sort of a delta in mind for a meaningful change from the overall scale? And then looking at the subscales, delusions, hallucination, agitation, aggression et cetera, which are the ones that are most important to the clinical team? That's probably a question for Serge?

Yes. Thank you. The primary measure in the Alzheimer psychosis study is NPI nursing home version. But a primary end point is hallucinations and delusion combined score on the NPIs nursing home. And in the design of this study, we assume a clinically meaningful delta of three points on this combined score as clinically meaningful difference as a target to difference. We are, of course, measuring all other sub scales on the NPI-NH, agitation, aggression and others and will be, of course, evaluating that as the data becomes available.

Great. Thanks for taking all the questions, guys.

Thank you, Ritu.

Your next question comes from the line of Cory Kasimov with JPMorgan.

Hey. Good afternoon, guys. Thanks for taking my questions. The first question I have for you is from your 8-K a couple days ago, you had three recent board member resignations or at least not going up for reelection, just wondering if you can discuss the dynamics behind that?

Yeah. Sure. So I think the appropriate way to think about this is, the board had not changed much in several years and there is a good reason for that. Many of the board members, who had been on the board historically and there were several of them who had been on more than a decade, wanted to really make sure that they saw the company through to the next stage and so we were very, very pleased with their contributions. But we also recognized that as the company changes, the needs of the company change and the needs of the board change as well. And so we begin a discussion at the board level about how to best position ourselves for the future, and we recognized that we had some board members who were at a point in their career, their life, where they were ready to step off the board and roll off. They'd stayed on probably longer than they might have originally imagined. And we're very, very – just the great benefit of having had some of these people on the board, but every departure has been a part of a broader effort to make sure that we evolve the board in a way that puts us in a position where and our standard is from the top of the organization, from the bottom of the organization to the top, we have people that have the most recent and relevant experience and more cross expertise, and so we've also benefited from some additions on the board that you've seen. We brought on Ed Harrigan last fall, who was the former Head of Drug Safety and Regulatory Affairs, Global Head at Pfizer. Before that, he was Global Head of Business Development and before that, he headed the CNS drug development efforts at Pfizer. We brought on Jim Daly, who is former Chief Commercial Officer at Incyte. So, we're very pleased that we're able to attract these kinds of people. We also recognize that every board member has a certain life cycle and at a certain point, they do rotate off and that's what we've done.

Okay. And then, follow-up question on NUPLAZID. At this price point, what you expect the co-insurance burden to be for Medicare patients?

I'm going to let Terry answer that.

Well, as you know, we will be making meaningful donations to charitable foundations. And so, our hope is that they will be directed towards those services and resources to help lessen the burden significantly. So, we hope that through that effort and realize, of course, that we make donations and once we make donations, it's up to the foundation to decide how they're going to be used, that they will assist those patients to the point where the financial burden is very small.

Okay. And then, if I could just sneak one more question in, just I'm interested in your opinion on how we should think about dosing here, at least in the early months or quarters and I appreciate you're not giving any guidance on a lot of the key components of revenue right now. But do you expect that most patients will not be getting both pills per day from the outset? Should we be thinking about a good percentage of them maybe starting with one pill once a day as opposed to the two pills once a day type thing?

Yeah. It's a good question. One of the things that we – probably most people on the call are aware of this and we're certainly aware, we observe is, in the CNS therapeutic space, physicians frequently like to experiment with dose and many times, you hear the mantra many times, start low and go slow and they are usually wanting to get a sense for how well the drug is tolerated in an individual patient until they've had some experience with the drug. And so, we're not immune to that. I'm sure that's going to happen with NUPLAZID as well. We don't have a really good fix, because it's a new marketplace. There is no other drug approved and we need to get some experience in the field, in terms of just how much that will happen and what I'm pretty confident of whatever the average is per day that we start with, will go up as physicians get more and more experience with the drug. But it is a dynamic that exists in the CNS space with both psychiatrists and neurologists, we understand that and we've known that for some time and that's been a component of our planning in terms of how we're commercializing the drug.

Great. Thanks a lot for taking the questions.

Yeah. Thank you, Cory.

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

Hi, guys. This is Danielle on for Alan. Thanks for taking my questions. I just was wondering if you could go into a little more detail around the factors that you considered in determining NUPLAZID's final price.

Yeah. I think I'll start and then, Terry or Serge, feel free to jump in if you have any additional color to add. But I think as we thought about what would be an appropriate price, we start with the recognition that again for the first time, physicians will now be able to treat hallucinations and delusions and most importantly, without impairing motor function in these very advanced patients that already have a very high disease burden, before you layer on top of that the burden of psychosis. It sometimes can be very difficult to optimize other therapies just to treat the motor symptoms and then, if you interfere with that, with an agent to treat the psychosis, that can be very complicating. We also recognize and as Terry has already mentioned and it was reflected in the label, we see a very strong benefit to patients seeing an important meaningful improvement at every level we looked at, as Terry mentioned, recognizing that that we – in 14 presented patients have complete remission or complete response. And we also felt like it was important to consider the safety and tolerability profile of the drug. We think it has a very overall favorable safety profile and tolerability profile and we thought that was an important consideration. And as you know, we've reported that in our 020 Phase III study, our pivotal study, we also demonstrated benefits on caregiver burden. So we feel like those were the most important considerations in thinking about how – what would be an appropriate value for the drug and therefore what, it should cost. We also took into consideration the fact that PDP is a relatively small condition when measured by numbers of patients, although as described, it's extraordinarily impactful on those patients. And so those were the primary things that we took into consideration in arriving at the final product. I will say, this was the consequence of a lot of work that we did to try to make it certain that we felt like the ultimate products that we landed on would be an appropriate price.

Great. Thank you.

Your next question comes from the line of Charles Duncan with Piper Jaffray.

Hi. This is [ph] Jordan Fantizi on for Charles. Thank you for taking my question and congratulations on all the recent success. So my question pertains to AD agitation. While the trial design has not yet been released, what elements do you plan to incorporate that are different from EDP study to the first timely enrollment?

Serge?

Yes. Well obviously, the most important elements that we are considering and where we were considering in designing this trial were related to control of a placebo response, potentially an ability to adequately assess patients with objective assessment of their movement on their symptoms. So, some of the measures that we used in the PDP program continue to be used in our further programs in the Alzheimer psychosis and agitation.

Great. And quick follow-up, any estimates as to when we could see data from that trial?

We wish we could, unfortunately I think it's just a little premature. And once we start the study, quite frankly, because it is a symptom that we haven't studied yet in a population that we haven't studied that symptom in, we'll want to get some enrollment information so that we feel like we have an informed view for how long the enrollment will take. But once we start this study or on the verge of starting this study, we'll be able to share more details around the protocol and size, et cetera.

Great. Thank you. Really appreciate all the details.

Thank you.

[Operator Instructions] And your next question comes from the line of Paul Matteis with Leerink.

Thanks very much for the updates and taking the questions. I really appreciate it. I wanted to ask about commercial spending. SG&A was around $28 million in the first quarter, I'm wondering what that includes with respect to sales reps and commercial infrastructure and what you see as the trajectory of SG&A spending going forward as you build out your sales force?

Yeah. Thanks for the question, Paul. So, in the first quarter, it includes very little related to the field force because we brought them on in the second quarter. So, there is very little related to that. In terms of the trajectory for SG&A, we're not giving any guidance on that at this juncture, but I do anticipate as we move further through the year, we will able to give some additional color around the expense side of things. As I mentioned, we wouldn't be guiding on the top line revenue or bottom line results or the components of that, but I do anticipate that we'll be able to get some additional color later in the year around expenses that will give us all a better sense for what to expect going forward.

Okay, thanks. That's helpful. And then a question for Terry, as a follow up to the question on co-insurance. I know there is a mechanism to help patients with out of pocket cost here. I guess I just wanted to get a sense at this annual price, what would be the co-insurance burden for the average Medicare Part D patient if he or she didn't receive assistance, just curious in the context of what that cost is and how important it is that patients are getting assistance from charities to help them with pimavanserin?

Sure, the co-insurance ranges depending on who your plan is, but it can be around, I'll just double check this, around 25% to 30%

Of the total drug cost?

Yeah, for the co-insurance.

Okay, okay, got it. And then maybe one more quick question on Alzheimer's agitation. Have you guys finalized the primary endpoint for that study? I know that there is a lot of other clinical programs ongoing here, promote Zuka and intracellulars, doing some work in a related area, wondering what you're thinking about in terms of endpoints and the degree to which the regulatory path here is established? Thanks so much.

Yeah. I'll take the first half and then I'll turn it over to Serge for additional color. You're absolutely right and we're aware that there is some discussion in the industry about what would be the appropriate endpoint. So we haven't disclosed that, but I'll ask Serge if he wants to provide any additional color in terms of kind of the options in terms of what's – what we know from what other companies have done.

All right. Yes. Obviously, the instruments and endpoints that we consider is NPI clinician [indiscernible] agitation aggression scale. And I would just add to what Steve said that we were very carefully considering this, but also took into account our interactions with the FDA in that regard and trying to guide ourselves what will be the most appropriate measure to be included in the trial.

Okay. Great. Thanks, guys. I appreciate it.

Yeah. You bet.

Your final question comes from the line of Robert Hazlett with Ladenburg.

Thank you. Thank you for taking the questions. I have a couple actually. Maybe you touched on this, but Serge, could you perhaps discuss the cycle time for the EU decision to be revisited and how long do you expect to be able to turn the proposal around to them and what their requirements are to review that proposal again?

So, yes, I will be happy to. It is a bit variable depending on what route we ultimately decide to take in regard to their current feedback and decision. We could potentially go through the appeal route or we could go into a new cycle of review proposing a new plan and it's the generally cycle goal when feedback on 30 days review, 60 days, 90 days, so up to 120 days of – at this point of this, we receive a feedback, we have some discussion and react to it. So, it really depends. I would just say that where we are right now, we have a very much better understanding of each other's position in this respect and where we are, so we would anticipate that it would be somewhat easier to come to resolution on what would be the pediatric investigational program. But we also have to take into account the how big are these requirements considering that this program is unrelated to the indication that we will be filing on this Parkinson's disease psychosis.

Absolutely, go ahead.

I'm sorry, just to add a little bit of additional color, so unfortunately, this is not going to be instantaneous and we literally just got the notification yesterday. So, we do need a little bit of time to digest and determine how we are going to resolve it from here. It will get resolved, but it will take a little bit of time – the cycles on this PIP are not instantaneous, as Serge alluded to. They do take a little bit of time. So as soon as we have clarity on how long they will ultimately take, we'll will provide that, but today we need a little bit more time to process.

And just, but the rest of the plan with regard to the EU and the rest of the potential for filing seems to be in order? Those are my words, I'd love you to characterize that?

Yes. We went through a process of consultations and discussions. We have very good discussions and alignment in terms of what would be the content of our MAA for Parkinson's disease psychosis. So from that perspective, we are ready to file.

Okay. Thank you. And just, one or two marketing comments, questions. Terry, perhaps could you discuss sampling and the sampling strategy broadly that you plan to employ with NUPLAZID?

Right. So, we will have a sampling program in place. We'll do this via sales reps and also through our NUPLAZID Connect. We feel it's very important that physicians have the drug in their hands as soon as possible and that they can – in their hands use it on their patients. So, all of our sales reps will have samples and as I said, we can make them available through our NUPLAZID Connect.

Okay.

Just maybe to add a little bit of color there too, it's an important part of the program. As Terry mentioned, we want to make certain that we can facilitate or enable physicians to get patients on drug, but particularly at a drug launch where you tend to see more sampling than later in the process, because one of the things that we want to address is the adjudication period. Those tend to be longer at launch than they do once we have a well-worn path. So, there will be a period of time where we'll have probably more sampling in the early days than we would expect later.

That's right.

Okay. That's helpful. Thank you. And with regard to NUPLAZID, it's a little bit unusual in that – you do have what I would call an installed base of not a small number of patients that are already taking other atypicals, and I would think that one of the early goals would be to convert that installed base from the atypicals that are more challenging to NUPLAZID, which is on label. And as you think about that group in particular, what are the pushes and pulls there? What do you think seem to be the main hurdles to getting the adoption of that already installed base?

Well, I think the first premise that we have to establish is that we can only talk about our product. We cannot do comparative detailing to a product that's not approved. So, it's important that we go to great lengths to explain and educate the physicians on the benefits of NUPLAZID. We know that it's a branding mechanism of action, it's the first approved, we have a lot of tailwinds going for us, but it is a paradigm shift. And so, we want to make sure that physicians understand this new alternative compared to what has been used previously. And we know from extensive market research that what they've been using previously has been unsatisfactory. So, for us, we're going to go in with our message and education and help guide them on the benefits of NUPLAZID, but we will not be able to directly talk about the competition.

Maybe just to add one more thought there. What we've described is based upon extensive research that we've done and some obviously very extensive interactions with opinion leaders in the medical community. And what we've described is we think that – we just recognize that anytime you have a paradigm shift, anytime you have a new – a potentially new standard of care, it takes a while in the early days to make that movement. We see it – there are numerous other examples where companies have been in a similar position. That's what we see. The things that I'd like to emphasize is, I do think that we have a very attractive opportunity for strong revenue growth over time, so it will take a little bit of time in the early days, but I do think that this is a – it's a very, very important medicine, we're treating a very significant unmet need, and I do think over time that will be reflected, most importantly in the patients who are receiving benefit from it, but that will also be reflected in revenues to us over time.

Okay. Thank you for the color.

Thank you.

And there are no more questions at this time. Mr. Davis, please proceed to closing remarks.

I'll just say thanks again for – 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 continued progress.