ACADIA Pharmaceuticals Inc. (ACAD) Q4 2015 Earnings Report, Transcript and Summary

Good day ladies and gentlemen and welcome to the ACADIA Pharmaceuticals Fourth Quarter and 2015 Financial Results Conference Call. My name is Sean and I'll be your conference 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.

Good morning and welcome to ACADIA's fourth 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 March 14, 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 operations, including NUPLAZID development program and commercial preparations. 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 a product candidate 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. I'll now turn the call over to Steve Davis, our President and Chief Executive Officer.

Thank you, Lisa and good morning. Let me first take this opportunity to thank all of you for joining us on today's conference call. Today we'll address three areas in our prepared remarks. First, we'll discuss our most recent operational highlights, including our NUPLAZID NDA and touch upon the work we're doing to prepare for the planned commercialization of NUPLAZID in the US. Second, we'll touch on our comprehensive lifecycle planning project and our planned expansion of pimavanserin into other areas of unmet need. And third, we'll comment on our financial results for the fourth quarter, as well as our recent follow-on offering completed last month Following my review, Serge will give a brief review of our development programs and Terry will lead a review of our pre-commercial activities for NUPLAZID and then we'll open the call up for questions. I am please to report that we had a productive fourth quarter and off to a strong start in 2016. Just to recap, following the September 2015 submission of our new NUPLAZID NDA for Parkinson's disease psychosis or PDP, in late October the FDA accepted the NDA for filing and granted priority review with a PDUFA date of May 1, 2016. Priority review accelerates the review timeline by 4 months and is granted to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. You may recall that that the FDA also designated NUPLAZID for PDP as breakthrough therapy in 2014. I understand that many of you may have questions about the NDA or our interactions with the FDA. But as we said when we submitted the NDA and as most companies do when they submit, we won't be commenting on specific interactions or communications with the FDA during the NDA review period. In addition to our regulatory activities, we remain on track with our preparations for the planned US launch of NUPLAZID upon approval and these preparations include one, our integrated disease awareness campaign for PDP which comprises educational programs with over 12,000 health care professionals, a PDP educational website targeting physicians, neurology journal and digital placements, and a strong presence at neurology and psychiatric medical meetings with the hosting of PDP educational booths. Two, the build out of our team and capabilities, highlighted by highly experienced industry veterans across the company, including commercial level manufacturing, medical affairs, quality control, compliance, access and reimbursement and field sales management. We are currently recruiting our field sales force of around 135 reps, and plan to hire them around the time of approval. We are pleased to see a very impressive depth of experience with these candidates in the fields of neurology and psychiatry. Three, in regard to our preparations, our in-depth market research with now over 1500 PDP treating physicians, together with foundational access and reimbursement work with payers. And fourth and last, the establishment of our commercial infrastructure and distribution network, which will include a central hub and specialty pharmacies in order to ensure that we meet the needs of the elderly PDP population. Terry, will provide some additional color on our pre-commercial activities later in the call. Let me now touch on our lifecycle planning project for pimavanserin, while our top priorities of course are our regulatory activities supporting the NDA and preparations for the planned launch of NUPLAZID, we remain very committed to investing in a strong top line of opportunities. Already this year we completed the lifecycle planning project we described over the last couple of quarters. This is a comprehensive project to prioritize and map out our development plans for pimavanserin in multiple indications beyond PDP and Alzheimer’s disease psychosis or ADP. As previously discussed, one new indication we are pursuing as a result of the lifecycle planning project, is Alzheimer’s disease agitation, where as we previously indicated we expect to commence our Phase II study in the first half of this year. Serge, will offer a few additional thoughts on this in a moment. As we previously indicated, there another area of high interest in the lifecycle development of pimavanserin in schizophrenia, where pimavanserin is clearly - has already demonstrated clinical utility. Schizophrenia is a very complex disorder with multiple unmet needs. Today's drugs carry significant side effects and do not adequately address some very important needs of schizophrenia patients. A large study conducted by the National Institutes of Mental Health found that 74% of patients with schizophrenia taking typical or atypical antipsychotics discontinue treatment within 18 months because of side effects or lack efficacy. We look forward to sharing with you later this year more details of our plans as they relate to schizophrenia as we execute on our lifecycle plan. To sum up, in addition to PDP, ADP, and Alzheimer’s agitation, we also have interest in multiple additional indications for pimavanserin in other areas of large unmet need and we will unveil these indications around the time we commence applicable studies. With respect to our ongoing Phase II study in Alzheimer's disease psychosis or study 019, we anticipated enrollment in this study to be completed around mid year with top line results expected in the fourth quarter of 2016. Serge, will have a few additional comments regarding the study in his remarks. Turning to Europe, as previously mentioned, we plan to submit our marketing authorization application to the EMA following our PDUFA date of May 1, 2016. Let me now touch briefly on our financial results. Our financial results for the fourth quarter, aligned with our strategy which as previously communicated is to build a leading US specialty CNS franchise, using pimavanserin as the foundation. Turning to the numbers, total operating expenses for the fourth quarter of 2015 were $45.6 million. R&D expenses for the quarter increased to $20.5 million from $18.2 million for the comparable quarter of 2014. This was primarily due to increased personnel and related costs, including stock-based compensation expense associated with our expanded R&D organization. The increase in personnel and related costs was partially offset by reduced cost related to the preparation of our NDA for NUPLAZID and manufacturing development costs incurred in the fourth quarter of 2014 not incurred in the fourth quarter of 2015. G&A expenses increased to $22.6 million for the fourth quarter from $10.4 million for the comparable quarter of 2014, reflecting our continued investment and commercial preparations for the planned US launch of NUPLAZID. Specifically these increases reflect costs incurred during the fourth quarter of 2015 associated with medical affairs, disease awareness educational programs and market research activities, also increased cost related to the build out of our commercial organization and systems, including the sales in managed markets. And lastly, G&A related stock-based compensation expense increased by $3 million for the fourth quarter of 2015 over the comparable quarter of 2014. In addition to our R&D and G&A expenses, we paid a $2.5 million milestone to the Ipsen Group in connection with the FDAs acceptance of the filing of our NDA for NUPLAZID in the fourth quarter of 2015. This payment was made pursuant to our 2006 license agreement for certain IP rights with the Ipsen Group. Let's now turn to our cash position. We ended the year with $215.1 million in cash and investment securities. In addition, we further strengthened our balance sheet this year through a follow-on offering of common stock with net proceeds of approximately $281.6 million that was completed in January. We expect that our cash used in operations will continue to increase in future periods as we prepare for the planned launch of NUPLAZID and continue to make the kinds of investments in our pipeline that we believe will leverage the full potential of pimavanserin, while maintaining a strong balance sheet. And with that, I'll now turn the call over to Serge, who will offer a comments on our development programs.

Thank you, Steve. And good morning, everybody. Let me first review a few key regulatory dates and then I will discuss our ongoing and planned studies. As Steve mentioned, we were pleased that the FDA granted priority review for our NUPLAZID NDA, with a PDUFA date of May 1. As part of the review process, the FDA has informed us that it will convene an advisory committee meeting on March 29 to review the NUPLAZID NDA. This committee is made up of an individual panel of experts that reviews data regarding the safety and effectiveness of investigational human drugs and makes appropriate recommendations to FDA. Our team is diligently preparing for the upcoming meeting and we look forward to discussing NUPLAZID with the committee. Let's now move to our program in patients with Alzheimer disease psychosis or ADP. Psychosis is one of the most prominent non-cognitive symptoms of Alzheimer’s disease and currently there is no FDA approved treatment available to patients with ADP. We continue to advance this Phase II study and anticipate enrollment in this study to be competed around mid-year with top line data expected in the fourth quarter of 2016. With respect to our ongoing Phase II ADP study, let me first remind everyone of some of the parameters around this study. This is a randomized, double-blind placebo controlled trial designed to examine the efficacy and safety of pimavanserin in approximately 200 patients with Alzheimer disease psychosis. It is a 12 week study that is being conducted across a network of nursing homes. The primary endpoint is psychosis and we'll also assess secondary measures, including behavioral symptoms, as well as sleep and cognition. Based on current enrollment trends, we expect enrollment to be completed around the middle of this year and then to announce top line results in the fourth quarter of 2016. Turning now to our plan for the new studies. As Steve noted, and as we previously disclosed, one new indication we are pursuing is Alzheimer disease agitation. As is the case with PDP, and ADP, no drug has been approved in the United States to treat AD agitation. There are more than 5 million patients in the United States with Alzheimer disease which around half of these patients are formally diagnosed with Alzheimer disease. Among this 2.5 million patients around 40% to 50% exhibit agitation. Importantly, our new program in Alzheimer disease agitation complements our ongoing Phase II program in Alzheimer’s disease psychosis, as agitation and psychosis are both major and distinct conditions of the broader range of behavioral disturbances in Alzheimer’s disease. As noted earlier, we expect to initiate this study in the first half of 2016. Let me now turn the call over to Terry, who will provide an update on our pre-commercial activities.

Thank you, Serge and good morning, everyone. I'll kick this off by saying, I am very pleased with what we've accomplished in 2015 and I believe we are well positioned to execute on our 2016 business plan and the potential launch of NUPLAZID. With our PDUFA date being around two months away, my remarks will focus on our near term launch readiness with some detail regarding our strategy and tactical plans for distribution of product. I am happy to report that we're on track with our launch preparations. Let me start by sharing with you little more detail regarding the distribution channels, we plan to use for the commercialization of NUPLAZID in the US. The average age of a PDP patient is 74 years old. We also know that this frail and elderly population often has challenges in managing daily living activities. Therefore we needed to provide a program that would work for these patients that was easy to understand and that would help ensure that PDP patients who may benefit from NUPLAZID if approved can get the medicine. In order to best facilitate this access, we will be using a provider and patient support hub, specialty pharmacies and specialty distributors as our channels for distribution. Another important element of access of course is getting NUPLAZID on formularies. As you know antipsychotics are in a protected class and by CMS mandate all protected class drugs must be reviewed and placed on Medicare formularies within 90 days of product approval. Although adding a new antipsychotics to commercial formularies is not mandatory, it’s very common for them to follow suit with this class of drugs, although timeframe for review can be longer. So just to provide you with little more color on our distribution access programs, let me offer a few thoughts and how this will work. In supporting the PDP patient and their caregivers both the hub and the specialty pharmacies will be involved in assisting providers and payers and navigating the benefits, investigation, and prior authorizations and if required, assisting in the appeal process. We've done extensive planning in the distribution channels and are on track to have both the hub and specialty pharmacies operational prior to the time of approval. I am also pleased to report that on the manufacturing front with our first rounds of manufacturing campaign successfully completed, we are now building up our inventory for launch in 2016. Now shifting gears to our external efforts, our HR and sales management team has just wrapped up our six month long screening, recruitment and interview process and we are now well poised to take a next step in making contingent offers to sales specialist and I have to say I've been quite impressed with the level of talent of the individuals who are seeking to join ACADIA. So as you can see, we're making significant progress as we move closer to our anticipated approval of NUPLAZID and we're very excited about the days ahead. So moving forward, we'll continue to stay focused on executing on all preparations and activities necessary to ensure we'll have successful and commercial – a successful commercial launch. I'll now turn the call over to Steve.

Thanks a lot Terry. In summary, 2016 will be pivotal year for ACADIA as we prepare to launch our first drug product for Parkinson's disease psychosis in the US and as we execute on our development program with pimavanserin in multiple other areas of unmet need, in transition to an integrated pharmaceutical company. It’s an exciting time to be at ACADIA. Before I close with my remarks, I'd like to just acknowledge the tireless efforts and outstanding contributions our employees who bring us to where we are today. However ACADIA remain deeply committed to bringing forward medicines in CNS that can make a meaningful impact on the lives of patients and the family members who care for them everyday. Operator, you may now proceed with the Q&A session.

Thank you. [Operator Instructions] Your first question comes from the line of Ritu Baral from Cowen and Company. Your line is open.

Hi, guys. Thanks for taking the question; apologies for the background noise. Can you give us an update on your interactions and talks with payers on coverage so far? What conclusions if any do you think they will come to around prior authorization requirements or is the – is there any potential for step edits given the lack of approved options for PDP right now? And I have a follow-up.

Yes. Great, Ritu. I am going to let Terry answer that question. But before he does, I'll just want to preface it by saying, as we said many times, we won't be announcing pricing on NUPLAZID until we get to the launch of the drug. But having said that, I'll turn it over Terry, and he can maybe add just a little bit of color to your question.

Hi. Great, thanks. Hi, Ritu. As you know we've done extensive pricing research with payers over last 18 months. And based on this research with decision makers which now represent over 3 million covered lives, the payers have indicated that they understand the unique benefits of the product and what it can offer to patients and therefore are comfortable with the prices commensurate with its value. In terms of prior authorization and step edits, I think it’s certainly something that is a possibility, especially given the case that we'll be going through specialty pharmacy system.

Got it. And my follow-up has to do with your planned agitation study. What are you currently thinking about that, either trial size or design and what other trials conducted in the past are you sort of looking towards - looking to as examples or proxy?

So Ritu, the - so the question was regarding our agitation study, what are we thinking in terms of trial size and design. And I'll ask Serge if he has any additional color. Let me just preface that by saying, when we get to the point of initiating that study, we'll then talk about trial design at that stage. But Serge if you want to offer just some very general comments about overall size that you know, in the CNS arena, is that unfortunately you don’t have many opportunities to do a 30 or 50 patient study and look at the biomarker. So these studies do tend to be kind of a meaningful size and duration and Serge you can – if you want to offer just a couple of comments along those lines that would be great.

Yes. I'd be happy to. This is a Phase II trial. We are currently in the process of finalizing the protocol and obviously having all necessary discussion externally around it. The size of the trial will be approximately what we have seen both with Parkinson disease psychosis, as well as with the Alzheimer psychosis trial. So it’s approximately of that size. It will obviously depend on the number of treatment arms as we include in the trial and so on.

Great. Thanks for taking the questions.

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

Hey. Good morning, guys. Thank you for taking my question. I am curious that if pimavanserin were approved with a box warning for use in elderly patients, I guess first of all would you expect or do you anticipate you could get a box warning there? But I guess more importantly if you do, what kind of commercial impact do you believe that might have? And then I have one follow-up. Thanks.

Yes, great. Thanks, Cory. So forgive me, but I have to start and answer this with preface that as we noted we're not going to commenting on any specific interactions or communication with FDA during the review process. But what I can do is refer to things that we said prior to submission. And I guess just one other caveat before I get to the substance of your question, and that is first, I just want to note, particularly as we're in review that, as is the case with our drug and any other drug, a very important thing is to be certain that physicians in the medical community have an appropriate understanding of the benefits and risks of drug that they are prescribing. Now having said that, we said many times, we don’t know if we'll have the box warning or not, and all of that will depend on whether we in the FDA think that that’s an appropriate thing for the medical community and for patients. What we do know is that today all anti antipsychotics have a warning based on a retrospective data [ph] analysis of 17 clinical studies of antipsychotics. This was the study done by FDA. And while we – as I mentioned don’t know, if we'll have a box warning or not, we have done a significant amount of research in the medical community to understand their view of a box warning and I'll ask Terry to comment little bit more on this in a second. But the short answer is, we do not believe there is a significant commercial impact on having a box warning or not and we've done a lot of research, testing both labels with a warning and without. And Terry I'll just ask if you have any additional color you'd like to add to that.

Sure. Good morning, Cory. The research that we've done has been extensive and what it showed is that when physicians force rank the attributes that are most important to them when making a prescribing decision, first and foremost is not impacting motor control, was their antipsychotic. Number two, is almost always that it’s an approved indication. When we look for the black box warning, it fell way down the list and oftentimes was more than half way down the list in terms of their concern about using a black box product, as you can imagine they are using them today. So our research indicated that it was not a concern to these folks.

Okay. Great. That’s helpful. And then my follow-up is probably for Terry as well and that’s now that you’ve started some market education efforts, wondering if you can share any early learning’s from them, really anything that is different maybe than what you were thinking in terms of disease awareness, potential hurdles before you kind of embarked on these efforts?

Well, it’s a great question. As you know, we are creating a new treatment paradigm and so part of that was to gain an understanding of whether or not there was an awareness of PDP. And I can tell that our program to date is been very successful because its really brought together a number of elements, one of which is that physicians when they are aware of PDP have a strong urgency to treat, what we found is that oftentimes the physician is not asking, the caregiver is not telling and oftentimes the patient isn’t sharing. So our PDP efforts have been geared at making sure that those three entities are connected and that’s a little bit different than some of other campaigns I've been associated with where it was mostly just the disease itself, in this case it involves the disease, the caregiver and the physician.

Okay. Great. Thanks for taking the questions and good luck with the panel.

Thank you.

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

Hi. Thanks for taking my questions. Wonder if you could talk a bit more about some of the work along the lines of potential label expansion looking at other indications. I know that you said that you weren't going to disclose the identity of these until you start them. But I wonder if you can give us a sense of the scale, how many of these there might be and then also if you can comment on the burn for 2016?

Yes. I think, so two separate questions. Let me first take the kind of scale of the – or scope and scale of the lifecycle management program. What we had previously said I'll just repeat here, is that in addition to PDP and ADP and AD agitation, there will be multiple other indications that we'll be pursuing. As you alluded to and as mentioned we won't be revealing the precise identity of those until we get to the point of starting new studies. But as you can imagine, we look - the kind of things we've looked at include everywhere that antipsychotics are used either on label or off label today and everywhere that is stated in the literature that would support the use of blocking 5-HT2A. So the kind of – we have an abundance of opportunities here. There is a lot of very interesting ways to go with the drug and some very significant unmet medical needs. Beyond that we haven’t described a precise scope or the number of indications we'll go after, but what I can tell you is we did a very comprehensive job of looking at everything and mapped everything out all the way from biochemistry through payer work and I think have a very - an abundance of opportunities there. As it relates to burn rate, we won't be giving any guidance this year, as we're going through the PDUFA date and planned launch of the drug. As we previously indicated we won't be guiding on top and bottom line for at least several quarter, past the launch of the drug and as it relates to burn, we won't be giving precise guidance, at least through the launch of the drug and then at that point once we have a better feel for the precise timing and the investments we've made we'll give some general guidance for year end cash at that point in time.

And what I am wondering is that, are you talking about half dozen more indications beyond Alzheimer's, the two Alzheimer's indications in PDP and maybe a sense of timing, how many of these might start this year? And then maybe I can understand why you might not guide on revenue or G&A, but maybe R&D you can comment on?

So just to try to give you as much color as I can around the precise plans, we do anticipate beyond AD, so PDP, ADP, AD agitation, we do anticipate starting additional studies this year and we expect that to – I would think of that in the – between the end of this year and possibly rolling into early next year in the two to three additional indications, we'll give you general idea of the kinds of – of the kind of magnitude that we're envisioning. And I will say that, it’s important to get moving with the indications that we plan to pursue with pimavanserin because in the CNS arena studies do as we mentioned earlier take a bit of time. The reason shifting back to burn, the reason we're not trying to give more precise guidance at this point is because we think it’s important to get to the PDUFA date and get to a launch of the drug and then at that point in time we'll be able to give a little bit more guidance. But hopefully at least on the R&D front, it gives you a general idea of the kind of the scope of what we plan to do this year.

Great. Thanks very much.

Thanks, Alan.

Your next question – pardon me, your next question comes from Paul Matteis from Leerink. Your line is open.

Great. Thanks very much. I have a couple of quick questions. My first one is on your thinking surrounding lifecycle management. I am wondering how or why I guess schizophrenia is still so high on your list? You are going after PDP which seems like an area where you could price the drug at a pretty nice premium given no on label alternatives and that is the same case of other dementia psychoses. Whereas in schizophrenia you'd be positioning the drug as an adjunctive treatment and it is a highly genericized market. So just wondering how you are thinking about reconciling the two when you prioritize indications? And then I have a quick follow-up.

Yes. So thanks for the question, Paul. And you've hit – I am glad you mentioned that, you hit right on a very important aspect of this molecule. And as went through the lifecycle planning process, we recognized that we'll start in a certain Zip Code, I am going to call it in terms of pricing in PDP and we were cognizant of the fact that other – there are lot other things we could do, some of them might be in the same Zip Code and some of might be very Zip Codes. And so it’s important to recognize that if we are in a different Zip Code then they would have to be – that just have to be a consideration. And what I can tell you is all of the things that we're considering, I would consider in the same Zip Code. And there are some very significant unmet needs within schizophrenia. You are absolutely right, and we said it many times, that there is nothing approved in PDP, nothing in ADP, nothing AD agitation. Schizophrenia there are multiple drugs approved, of course, most of the generic as you mentioned. There remain however significant unmet needs within schizophrenia that we think are very attractive. The kinds of things that are unmet today include negative symptoms, there is nothing to treat, the negative symptoms of schizophrenia and there is very little options as it relates to patients that don’t fully respond to current therapy. Clozaril is approved for residual symptoms that patients – for patients who don’t fully respond to current antipsychotics, that’s another very significant unmet need. And so these are very different kinds of need that I am describing than are addressed by the existing antipsychotics. So for instance in the case residual symptoms many times you have physicians who administer one atypical antipsychotic and if patients don't fully respond they add another atypical antipsychotic that really works in virtually the same way to the first drug. So it’s just underscores how significant the need there is. So as I mentioned there are some - a number of very meaningful unmet needs within schizophrenia. We're very cognizant of the fact that there are lot of generics there, but as I mentioned we take a very careful look and identified areas that we think are most important. Moving outside of schizophrenia for just a brief second, the same dynamics you described apply elsewhere as well in some of the other areas where the atypical antipsychotic have previously been approved and we've been very mindful in those areas as well and identified the types of unmet needs that again are in the same Zip Code as I've described previously.

Okay. That’s helpful on your thinking. And then maybe I could just ask a quick follow-up on the AD agitation study and commercial positioning. I'm wondering in how you are thinking about concomitant use of SSRIs in AD agitation, given that this drug works pretty much only through 5-HT2A, it seems like the impact on synaptic serotonin for pimavanserin would actually be pretty similar to an SSRI in a certain way. And I know that is somewhat of an oversimplification. But when you think about this mechanistically, how are you considering the use of concomitant medicines in the AD agitation setting? Thanks again.

Yes, yes. So I am going to let Serge answer that. The question is in the AD agitation arena, how do we think of pimavanserin, relative to the potential use of SSRIs in that population. Serge, do you want to add some color there?

Yes. I certainly probably will let Terry address the commercial aspects of that, but as from the medical point of view, I think that concomitant use of SSRIs and pimavanserin would be possible obviously as pimavanserin in itself mechanistically could potentiate a positive effect of the SSRIs. However, we are – we'll be testing monotherapy obviously and in Alzheimer agitation and expect full effects from pimavanserin to be evaluated in that paradigm.

Would you want to stratify SSRIs as a variable in that study, Serge?

Yes, that’s certainly a consideration for us, and like I said we are currently in the process of finalizing our protocol and have an external and internal discussion and certainly we'll consider that in our thinking.

Okay, great. Thank you.

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

Hi, guys. Thanks for taking the question. I had two quick questions for you. First is regarding the upcoming Adcom. I know that you are not talking about the interactions you had with the agency. But in preparing for the upcoming Adcom, what do you think is going to be the bulk of questions, would it be around safety or efficacy?

Yes. So Charles, forgive me again we're not going to comment on our specific interactions. But as we said before, we certainly - the kinds of things that you would expect to be discussed at Adcom, include Qt signal which we discussed previously, again we have a small Qt signal that’s in the same range of a lot of other approve drugs including other antipsychotics. We would expect a box warning to also be a topic of discussion or that’s the kind of thing that we would imagine would be. And then beyond that, I think you and everyone on the call understands how the advisory committee process works. And our job is to be prepared for every meaningful avenue of inquiry. And so that’s what we've done and I think we're in very good position now and as Serge mentioned, eagerly awaiting the panel.

Okay. That’s helpful. And then second question is on ADP versus AD agitation, I guess I am kind of wondering about the pacing of the AD agitation that you anticipate that trial relative to ADP. Is it easier to understand AD agitation versus ADP? I mean, what do you think about the enrollment rates and then the endpoint analysis for AD agitation versus AD psychosis?

So as it relates to enrollment rates, one of the things that we mentioned previously is this is a population we haven’t studied the drug in. It’s a new indication, there is nothing approved. And so as we commence the AD agitation study, we won't be predicting at that moment in time how long it will take to enroll. And so, I think we just need to get some enrollment experience there and as we seen in ADP when you're studying a drug in these new populations, its not as if we're developing another statin and its petty predictable just how the enrollment will go. One important distinction though that I'll draw between ADP and AD agitation, is if you go back to actually the PDP again, one of the key design features of that study was the fact that we had central raters and that provides for some additional level of consistency in the process and particularly in CNS rehab high placebo rates, its important to have that kind of consistency. In ADP because all of the patients are in nursing home care, it wasn’t possible to establish at that time that study was started video links that were used in PDP to enable those central raters. And so the study was designed around this very dense network of nursing homes in the greater London area in order to facilitate again a small group of central raters that literally go out and meet – go to the patient as opposed to doing the evaluation over a video link. So with AD agitation we would not – it will be a different entry criteria. We will not be limited in the same way to having – having to operate in a constrained geographical area. And so that’s one of the constraints that has impacted the enrollment in ADP that we would not anticipate coming into play in the AD agitation study.

It’s helpful, Steve. Thanks for the added color.

Thank you, Charles.

Sir, we have no questions at this time. [Operator Instructions]

Okay. It sounds like we are at the end of the questions. I just want to thank everyone again for joining us on today's call and for your continued support. We'll look forward to updating you in the future on our ongoing progress.