ACADIA Pharmaceuticals Inc (ACAD) 2014 Q4 法說會逐字稿

Good day ladies and gentlemen, and welcome to ACADIA Pharmaceuticals' fourth-quarter and 2014 financial results conference call. My name is Joyce and I will be your coordinator for today.

At this time, all participants are in 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, Director of Investor Relations at ACADIA. Please proceed.

Good afternoon and welcome to ACADIA's fourth-quarter and 2014 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 12, 2015.

Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer, Steve Davis, our Executive Vice President, Chief Financial Officer and Chief Business 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 some introductory remarks 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 and our strategy, including the timing, results or implications of clinical trials or manufacturing development; 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 meetings, filings or approvals; future development, launch and commercialization of NUPLAZID; the expansion of pimavanserin into additional indications; and our future expenses, cash position and usage and growth potential. 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 will now turn the call over to Uli Hacksell, our 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.

Our performance in 2014 was highlighted by a number of important achievements. During 2014, we continued to advance our NUPLAZID program for the treatment of Parkinson's disease psychosis, or PDP, towards registration and we remain on track to submit our NDA this quarter.

We successfully completed our drug-drug interaction program and our stability program for registration batches. We also held successful pre-NDA meetings with the FDA.

Another important achievement this past year was receiving Breakthrough Therapy designation from the FDA for NUPLAZID. The designation reinforces the serious unmet medical need in PDP and the importance of our NUPLAZID program.

As you are aware, the FDA has not approved any drug for the treatment of PDP. As a selective 5-HT2A inverse agonist, NUPLAZID provides an innovative non-dopaminergic approach. We believe NUPLAZID has the potential to be the first safe and effective drug approved for the treatment of PDP.

In parallel with the advancement of our PDP program in the United States, we also have outlined the paths for registration for NUPLAZID in Europe. During 2015, we will be working on our Marketing Authorization Application for NUPLAZID for submission in Europe.

Beyond PDP, we also made important progress in the development of pimavanserin in other neurological and psychiatric areas with large unmet medical need. During 2014, we continued to enroll patients in our Phase II study with pimavanserin for Alzheimer's disease psychosis. Similar to PDP, there is no drug approved by the FDA for Alzheimer's disease psychosis.

We also have been planning for studies where new therapies are greatly needed, including schizophrenia, and sleep disturbances in Parkinson's patients. Roger will provide additional information on these studies on the call.

On the commercial front, Terry and his team continued to make significant strides in our commercial preparations for the planned launch of NUPLAZID in the United States. Terry will go into further detail on the precommercial activities later on in the call.

Turning to our finances, we significantly strengthened our balance sheet in 2014 and are well capitalized to be able to build additional value in pimavanserin's lifecycle management program and also to invest in our commercial activities.

Our accomplishments in 2014 laid a strong foundation for what we believe will be a pivotal year for ACADIA 2015 as we near the submission of our NDA, work with the FDA on the review of the NDA, and prepare for the commercial launch of NUPLAZID in the United States. On that note, I will pass the call over to Steve, who will comment on our fourth-quarter and full-year 2014 financial results.

Thank you Uli. Our financial results for the fourth quarter aligned with our strategy, and that is to build a leading US specialty CNS franchise using pimavanserin as the foundation. This strategy translates into a near-term business plan and the investments associated with that that are focused on two key objectives. First is preparing the organization for the submission, the review and the planned US launch of NUPLAZID, and our second near-term objective is building out our medical and development capabilities to further leverage pimavanserin and its lifecycle opportunities.

Turning now to the numbers, total operating expenses for the fourth quarter of 2014 were $28.6 million. R&D expenses for the quarter increased to $18.2 million from $7.9 million for the comparable quarter of 2013. This was due primarily to three factors, first increased costs related to our planned NDA submission for NUPLAZID and associated preparations for review and registration of the drug. Second was costs associated with our ongoing Phase II study in Alzheimer's disease psychosis, or ADP as we refer to it, together with our ongoing open label safety extension study. And third, as noted in the release, R&D-related stock-based compensation expenses increased by almost $1 million for the fourth quarter of 2014 over the fourth quarter of 2013.

G&A expenses increased to $10.4 million for the fourth quarter from $4.3 million for the comparable quarter of 2013, reflecting our continued investment in commercial preparations for the planned US launch of NUPLAZID. I should note, as we noted in the release, G&A expenses for the just-completed quarter include $2.9 million in stock-based compensation expense, which was an increase of about $1.5 million over the fourth quarter of 2013.

Let's turn to our cash position. As Uli mentioned, we significantly strengthened our balance sheet last year. In 2014, we raised $197 million in net proceeds from our public offering of common stock and closed the year with $322.5 million.

During 2014, after adjusting for changes in working capital and proceeds of stock option exercises, we burned approximately $77 million in total. For the fourth quarter, using the same adjustments, we burned approximately $25 million. We expect our cash used in operations to continue to increase in future quarters and years as we execute on our current business plan as described earlier on this call. Importantly, we believe our strong cash runway positions us to continue making the kinds of investments that we believe will leverage the full potential of pimavanserin.

Under our current plan, we anticipate our cash resources will be sufficient to fund our operations at least into the second half of 2016, and, importantly, should fund us through an approval and launch of NUPLAZID for the treatment of PDP.

Now let me turn the call over to Roger, who will provide you with an update on our NUPLAZID program.

Thank you Steve and good afternoon. Let me first start with an update of the NUPLAZID program for PDP, and then I will discuss additional studies either ongoing or in the planning phase. As Uli mentioned at the beginning of the call, we are diligently completing preparations to support the FDA review of NUPLAZID and remain on track to submit our NDA this quarter.

During 2014, we advanced our PDP program towards registration with the completion of our drug-drug interaction program and our stability program for registration batches. In line with the recent salt policy by the FDA, our dose described in the NDA will be 34 milligrams and not 40 milligrams, where 34 milligrams of pimavanserin equates to 40 milligrams of pimavanserin tartrate. To be clear, the dose hasn't changed. It's just the description of the dose that has changed.

During 2014, we also continued to conduct our ongoing Phase III open label safety extension trial referred to as the 015 study. The study will continue to run until NUPLAZID is commercially available to study participants. Through our 015 study and our Phase II extension study, we have exceeded the ICH guideline for required one-year exposures with well over 250 patients having been treated for one year or longer. And our longest single patient exposure exceeds nine years.

Analysis of data from the open label safety extension studies has shown that NUPLAZID has a favorable long-term safety and tolerability profile observed to date in patients with PDP. This provides support for the potential of pimavanserin to offer significant advantages relative to current antipsychotics used off-label for the treatment of PDP.

During 2014, we also presented data from our PDP program at key medical conferences. In December, we presented caregiver burden data from our PDP program at the 10th Annual International Congress of Non-Motor Dysfunctions in Parkinson's disease and related disorders.

Data from an analysis of Phase III PDP studies showed treatment with NUPLAZID demonstrates a significant reduction in caregiver burden compared to placebo. Research has shown that PDP is a significant cause of distress on caregivers and is a leading cause of nursing home placement among Parkinson's patients. A decrease in caregiver burden may translate into the patient being able to stay in the home environment for longer.

As we look to 2015, we plan to present data from our PDP program at a number of medical conferences during the year, including the American Academy of Neurology meeting in April and the International Parkinson's and Movement Disorder Society Congress in June.

As Uli had mentioned, one of the highlights for our team this past year was the FDA granting Breakthrough Therapy designation to NUPLAZID. The Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. For indications without an approved therapy, drugs qualifying for this designation must show a substantial and clinically meaningful effect on an important outcome when compared with placebo. We are pleased that NUPLAZID met these criteria.

We believe NUPLAZID maybe one of the first drug candidates to receive Breakthrough Therapy designation from the psychiatry division of the FDA.

During 2014, we also completed a series of interactions with regulatory agencies from multiple EU member states. These interactions were very informative and helped shape our strategy for European submission. As a result, we will be working on a submission of a Marketing Authorization Application this year and plan to submit it to the EMA around six to nine months following the submission of our NDA.

Let me now turn to our program with pimavanserin for Alzheimer's disease psychosis, or ADP. We continue to advance enrollment in our Phase II 019 study, a randomized double-blind placebo-controlled trial designed to examine the efficacy and safety of pimavanserin in about 200 patients with ADP. We are excited about the design of this study. In addition to assessing the potential benefits of pimavanserin to treat psychosis, we will also be assessing other key efficacy endpoints, including agitation/aggression, sleep/nighttime behavior, as well as additional exploratory endpoints included in the cognitive status of patients. The design of this trial will allow us to explore the potential benefits of pimavanserin in this patient population and to inform us on an optimal design for future studies in this program.

We have also incorporated many study design concepts from our successful pivotal PDP trial into the 019 ADP study design. We plan to complete enrollment in the 019 study by the end of 2015.

Beyond ADP, we are planning additional studies in our pimavanserin lifecycle management program. Sleep disorders are a major and frequent problem for patients with neurological disorders. In fact, they are a major cause of disability in Parkinson's disease and are associated with other symptoms, including falls, psychosis, dementia and depression, which have a substantial impact on quality of life.

Studies suggest that nighttime sleep disturbances occur in almost 70% of Parkinson's disease patients. As you may recall, we observed significant non-sedating sleep-related benefits of pimavanserin in clinical studies, including our pivotal Phase III 020 PDP study.

Pimavanserin demonstrates a significant improvement on both nighttime sleep and daytime wakefulness on the SCOPA- sleep scale compared to placebo. We are currently planning to initiate a Phase II study with pimavanserin during the first half of this year to further explore the potential sleep benefits of pimavanserin in Parkinson's disease patients. We will provide further information on trial design at initiation of the study.

Another area that represents a large unmet medical need and a tremendous commercial opportunity for pimavanserin is schizophrenia. A study conducted by the National Institute of Mental Health which is published in the New England Journal of Medicine found that 74% of patients with schizophrenia taking typical or atypical antipsychotics discontinue treatment within 18 months because of side effects or lack of efficacy. There's a large unmet medical need for new therapies that have improved side effects and efficacy profiles. We believe pimavanserin selective blockade of the 5-HT2A receptor may enable it to be used as a monotherapy for maintenance of patients with schizophrenia. Pimavanserin avoids interaction with dopamine and other receptors which may be associated with many of the side effects caused by existing antipsychotic drugs. We are currently in the planning stages of this study and plan to initiate it during the second half of 2015.

I will now turn the call over to Terry.

Thanks Roger, and good afternoon everyone. So looking back over last year, the commercial team covered a lot of ground in preparing the market, the organization, and our lead product candidate, NUPLAZID, for launch. Early last year, we completed the hiring of our senior commercial team responsible for sales, marketing, managed markets, and sales operations. Since then, these senior leaders have done an excellent job in bringing on experienced and highly qualified commercial talent who have been very busy preparing for a successful NUPLAZID launch. I'm pleased and excited to see the caliber of people we are bringing into ACADIA, many of whom have extensive commercial experience with successful CNS brands.

You may recall that during 2014, we conducted extensive market research with over 800 PDP treating neurologists, psychiatrists and long-term care clinicians to help us understand physicians' current treatment approaches to diagnosis and treating PDP, the unmet needs as viewed by the physicians, what drives their prescribing behavior and how NUPLAZID can meet the needs of patients, caregivers and prescribers. This research confirmed the high unmet need, medical need, that exists for PDP patients and reinforced that prescribers are in need of safe and effective alternatives to the off-label use of antipsychotics that they often resort to currently.

We also completed foundational access and reimbursement research which was conducted with key decision-makers for payors covering 168 million lives. Through this work, we were able to achieve a more thorough understanding of the payor landscape. This research also provided us with insight regarding the perceived value of NUPLAZID in terms of price and formulary placement. And we were pleased to see payors respond favorably to the target -- product profile of NUPLAZID.

Throughout 2014, we conducted national and regional scientific advisory boards with leading movement disorder specialists and PDP treating psychiatrists in order to gain insight on how to position NUPLAZID to best address the needs of patients, caregivers and physicians. Because of the insights provided by these experts, we will be well prepared to launch -- we will be well prepared at launch to educate healthcare professionals regarding the potential clinical benefits of NUPLAZID.

We also made important headway in preparing commercial infrastructure and systems, including the supply chain distribution, to ensure all channels of distribution are established at the time of commercial launch. In addition to establishing internal processes and activities necessary for success, our team has worked diligently on sales force sizing. Based on extensive research, we estimate that there are around 11,000 PDP-treating physicians with the largest segment being neurologists.

There also is an important role played by psychiatrists and physicians in the long-term care setting. As we've stated previously, we plan to establish a specialty sales force of around 135 sales reps and plan to on-board them around the potential approval of NUPLAZID.

Of note, in January of this year, we initiated a PDP disease awareness campaign in the physician community with the launch of our website, PDPsychosis.com. This is one of several initiatives we will be implementing to better serve the educational needs of healthcare professionals regarding PDP.

So, moving forward, we are continuing to execute on all necessary preparations required to ensure we will have a successful commercial launch and are excited about the year ahead. And with that, I'll turn it back over to Uli.

Thank you Terry. The stage is set for what I believe will be a very exciting year at ACADIA and we're off to a strong start in 2015. Our priorities are clear. We plan to submit our NDA for NUPLAZID during the first quarter of 2015, continue to build out our commercial capabilities to prepare for the planned launch of NUPLAZID, and we will pursue the development of pimavanserin for other neurological and psychiatric disorders that are underserved by currently available antipsychotic drugs. We also will prepare a submission for NUPLAZID in Europe.

As far as our organization, we are expanding our existing infrastructure to support the planned launch and commercialization of NUPLAZID, including adding to our commercial structure, commercial level manufacturing, medical affairs, quality control and compliance. We have brought in highly qualified individuals with extensive experience in their functional domain and in CNS products. I am thrilled to see the high level of collaboration across functions.

Finally, before we go to questions, I would like to take the time to acknowledge our employees for their significant contributions. ACADIA's achievements in 2014 were the direct result of my colleagues' hard work, deep knowledge and dedication. We have a bright future ahead of us as we look to build a leading CNS focused biopharmaceutical company that's dedicated to bringing forward new therapies that can improve the lives of patients.

Operator, you may now proceed with the Q&A session.

(Operator Instructions). Charles Duncan, Piper Jaffray.

Hi guys. Thanks for taking the questions. Sorry for the background noise. Hopefully it will stop momentarily. Thanks for the update on the NDA timing. I had a question regarding the EMA, or the European filing. I'm wondering if -- you mentioned six to nine months. Are there any synergies that you could see in the filing to the US agency, or really what is directing the timelines of the six to nine months guidance there? Are there any rate-limiting steps or data that you need to enable that European filing?

This is Roger. I'll take this. I think the package is essentially the package, the package that we submit to FDA is essentially the package that we submit to the Europeans. And therefore, we are comfortable it's a robust package.

There are certain Europeanizations that need to be performed to meet the requirements of the EMA. But obviously, our focus, our initial focus and the principal focus, appropriately so, has been to get a robust NDA together which we will then leverage in the European theater.

Okay. And then regarding the Breakthrough Therapy designation, and I know you guys don't have much experience with this, nor does the rest of the industry or, frankly, anyone on Wall Street, but is there any chance for an accelerated review as a result of, say, that unmet medical need? Could you envision perhaps a review by the end of this year?

The process you are talking about is a priority review. That is determined by FDA at the time that they file the NDA itself. So we submit, they have two months to review that, and then they file the NDA at that time. And it's at the filing time that they determine whether a particular dossier will get a priority review.

Okay, that's helpful. Thanks for the added color. Look forward to seeing that filing.

Cory Kasimov, JPMorgan.

This is Whitney on for Cory. Can you hear me okay? Thanks for taking the questions. The first one, I was just wondering. How quickly postapproval could you turn around and launch given you're going to onboard ramp that approval?

We have a number of scenarios in place. We feel it's important that we have the approval in our hands by the time that occurs, and we have varying scenarios based on how much work will be required with our OPDP colleagues and processing the label. So, it's actually hard to pin down at this point.

Got it. Okay. And then one more question. Last quarter, I think you guys provided and you reviewed this quarter the market research you did in the US. Do you have any comparable data in the EU?

Yes, we are actually conducting much of the same research as we speak, and so we are planning on having the degree of knowledge that we have in the US in Europe as well.

Got it. Thanks for taking the questions.

Thomas Wei, Jefferies.

Thanks. Just a few questions. First on the ADP timing, I just wanted to make sure that I understood. Does that mean the data is in the first half of 2016? I know you had previously talked about maybe it being available two years after you had started the study, so that would've been more like the fourth quarter of 2015.

I think, as we said, we would expect enrollment by the end of the year, which would put data within the first half of next year, around midyear.

Okay, that's helpful. And then I did want to get an update on what your latest thinking is about the black box warning that exists on the atypical antipsychotics for use in elderly patients with dementia, and how you feel about that in relation to NUPLAZID following your pre-NDA meeting, and also if you do get a black box warning, what you think the commercial implications of that would be.

This is Roger. I'll take the first half and then punt your last question over to Terry. With regards to black box warning, that is something that will be part of the review. The FDA will review our data for obviously efficacy and safety. Clearly, with the warnings in the current antipsychotic labels, it will be something they will look at closely with regard to the specific safety of the drug.

However, in our review of the data and in completing that review for the NDA, we have not seen any signals that would suggest that we have similar problems. The drug appears to have a very good safety profile in a particularly fragile population with multiple concomitant medications. However, clearly, we submit the NDA, the FDA will review it and if they have some concerns on that, I'll come back to it and we will discuss them during that review cycle.

Terry, do you want to add anything on the commercial implications?

Yes. As you know, the Center for Medicare and Medicaid Services has an initiative that is targeting the inappropriate use of antipsychotics, especially in dementia patients in the nursing home setting. The key word here is that it's looking for inappropriate use. The CMS initiative excludes patients with schizophrenia, Huntington's, and Tourette's in their calculations. And from our standpoint, given the novelty of the molecule, the product profile, the demographics of the patients in our studies and that we anticipate an FDA approval in this indication, we are actually very optimistic about this. And net-net for us, we think all this is going to add up to a positive.

And I think there are two reasons. We have certainly the extremely well differentiated clinical profile and we also have a completely different mechanism of action with NUPLAZID.

This is Steve Davis. I might just add to that while certainly it could happen, we think it would be a little bit odd for the FDA to give approval in an indication and then a black box warning for that same population. So the fact that those drugs are not approved in PDP or for that matter for ADP has probably a bearing on that as well.

That's helpful. And then just lastly, on that CMS initiative, I'm glad you brought that up. Do you know how many Parkinson's patients are in a long-term care facility and what percentage of those patients have psychosis?

It's hard to really nail it down because, as you know, there's not a diagnosis code and the drugs that are used are used for other things other than Parkinson's psychosis, so it's really hard to nail it down. We think about 20% of our business resides in the long-term care setting. We think that many of them with Parkinson's disease are likely to have psychosis given the fact that it's the key contributor to their institutionalization in the first place.

So, in terms of raw numbers, we estimate around 20%, and we won't know specifically how many until we get in there, but we anticipate a large majority will.

Very helpful. Thanks very much.

(Operator Instructions). Ritu Baral, Cowen.

Hi guys. Thanks for taking the question. Back to the market research, have you guys done any updated market research for the year, especially if there have been any major changes in coverage plans? Have there been any major change in coverage plans that would affect NUPLAZID? And if so, how would that change any sort of commercial strategy?

So to date, we've continued to update our commercial access and reimbursement strategy. We've not seen any signals that things are changing that would affect us.

Right now, what are you assuming that the breakout in treatment is for PDP amongst the generic antipsychotics, seroquel and clozapine?

I'm not sure I understand your question. Could you elaborate a little bit?

Yes, just the breakout between how patients are treated right now between the different treatment options currently approved. (multiple speakers)

(multiple speakers) the most frequently used generic antipsychotic and that clozapine is barely used at all. It has about that's less than 2% of the total scripts. We know that there is some use of Abilify, which will become generic I think very, very soon.

I'll just also add that we know that physicians, through our market research, are very dissatisfied and very conflicted when it comes to using the atypical antipsychotics they have available today. So the research that we've done points to the fact that they are eager to have an alternative that will allow them to have the ability to treat the psychosis without impacting motor control.

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Obviously it's very important to realize that although Seroquel is the most frequently used generic antipsychotic for these patients, it has had a great problem to show any efficacy in controlled clinical trials. So that is of course a major problem with that drug in addition to the problems related to in the black box warning.

Do you anticipate, with Abilify going generic, that its use in PDP would increase, and would you have to sort of detail against that drug differently versus the other two?

No, the liabilities are the same, and so we feel that, because we are so novel, that we really don't think there will be competition based on the approved indication and the benefits we bring to the patient.

Got it. And last question and I'll hop back in the queue. Any additional details you can give us on the upcoming schizophrenia trial?

Let us come back to that perhaps. What Roger related to in the introduction is basically what we want to say. It's going to be a maintenance study, and we want to come back when we are closer to the initiation of the study with all the details.

We haven't finalized the design as of yet. We are obviously working through that process, but where we will be positioning it is in the management of patients in their outpatient status, where most schizophrenia patients are treated for most of the time, but treated inadequately and treated in a way which, for many of them, causes concern from toxicities from the available drugs.

We believe the profile of pimavanserin offers a real opportunity to really be a game-changer in the long-term management of schizophrenia patients. And that's what we wish to explore and exploit through the schizophrenia program.

Great. Just one last question, I apologize. Someone just send me a request to follow up on the salt rule for a little more color on the new salt rule and the dosing change.

So, it's something that I -- it's actually brought FDA in line with the Europeans. But when we started out, we were using 40 milligrams of pimavanserin, but that was the tartrate salt, so in line with the policy, you have to position that dosage in line with the freebase. Fortunately for us, it's a nice round number, so it will be 34 milligrams instead of 40 milligrams. But it's the same thing. It's the same tablet, the same dose, and we would expect the same efficacy and the same safety.

So, it's essentially just a labeling change? No additional analyses or anything would need to be done?

Absolutely. It's no different. It's exactly the same, exactly the same tablet. So we do not anticipate any changes.

Great. Thanks for taking all the questions. Appreciate your patience.

Bert Hazlett, Ladenburg.

Thank you for taking the questions as well. I have one or two regarding ADP and the indication. At this point, would you expect the Phase II endpoints that you are examining in terms of psychosis to be the Phase III endpoints that you consider in psychosis? The reason why I'm asking that is is there an opportunity or is there a consideration at least for you to maybe pivot with the program more towards an agitation or aggression endpoint as you consider pimavanserin's use in that setting?

We've always positioned it, and it is, it's a proof of concept study. We've not examined the utility of pimavanserin in this population to date. The NPI -- the primary endpoint we are looking at obviously relates to the psychosis naturally with the intent, original intent, of the molecule, but also with the data that we see in other indications. So hence why we are focused on psychosis.

However, the NPI is a well accepted and understood scale. It offers the opportunity to look at different aspects of the constellation of symptoms that these patients have, including aggression and agitation. So yes, obviously at the end of this program -- at the end of the study, we'll look at the data when it comes out. It may well be that we continue pursuing down the psychosis route, or we continue down the psychosis route and also consider pursuing agitation/aggression as an indication for the drug. But it will all depend on the data. We will look at it carefully and obviously make appropriate judgments based on that and regulatory consultations in accordance.

Thank you for that. And just a question. We've talked about timing of that indication and data readout sometime in the first half of 2016. What type of turnaround, assuming success? And again, I know we are reaching in terms of timing because there are a lot of unknowns. But what type of turnaround should we expect from the end of Phase II and the data readout and your ability to glean information from that study until you might move into Phase III? Is it six months? Is it a year? How long can that take between Phase II and Phase III?

I think you probably summarized where you said that it's something more variable. It depends on the data; it depends on a number of factors; it depends on interactions with regulatory authorities. What I can say is obviously with a good, positive study, we will be pursuing the appropriate path as expeditiously as we can.

Okay, thank you. And any color with regard to the European authorities with regard to ADP? I know we've talked a lot about PDP with the EU, but have you had much discussion along the lines of what might be acceptable with regard to ADP as well in the EU and the rest of the world?

Not to any extent. I think the need, the unmet need, is the same whether you're in the European theater or in the US. And as part of our development, we will interact accordingly with the authorities at appropriate timings.

Okay. Thank you.

Jason Butler, JMP Securities.

Thanks for taking the question. I just wanted to ask a question about the trial that you plan to run in sleep disturbances in PD patients. Acknowledging you don't want to go into too many details on trial design until you start the trial, I'm just wondering if you could maybe put into some broad perspectives how you think about the endpoints for that trial relative to the sleep endpoints you assessed in the last Phase III PDP trial for pimavanserin.

So, in terms of sleep, we do know obviously that sleep is a major factor in patients with these neurodegenerative conditions in PD and in AD. We showed in an early Phase II study in healthy normal volunteers using polysomnography, PSG, that there was a clear improvement. These were slightly older healthy normal adults who weren't complaining of sleep problems but got improved sleep with the drug versus placebo, a significant improvement. In the light of that, in the PDP studies, given that sleep is an inherent problem associated with PD, we did incorporate the SCOPA sleep scales which is designed for Parkinson's into those studies.

As you know, we showed significant improvement in nighttime sleep and in the 020 study, in fact we showed a corresponding improvement in terms of daytime wakefulness. Obviously, if you're awake at night, there's more chance of you be sleepy during the day. So it's encouraging to see that the nighttime sleep benefits were also accompanied by an improvement in the amount of time awake during the day. And obviously sleep in itself, not just lack of sleep but the impact it has on the patient in many other aspects, not the least including falls.

So, moving forward and looking specifically at that area, all our PDP studies were never -- there was no enrollment criteria that related to sleep impairment. It was just take all comers in effect with the PDP, and if it came with sleep, then we looked at it. But in fact, as we've said, many of these patients showed sleep impairments we were able to share benefits.

But really given this consistent benefit we've seen with the drug and given the problems that patients have with sleep, it does make sense for us to explore this further. What we want to do is in initial studies to really look at a more objective endpoint using PSG again, but in a patient population of PD that is enriched for sleep, so it's not -- the entry criteria will not just be PD but it will be patients with PD who have marked sleep disturbance. So, this will be a program targeted at a particular population of PD patients that have sleep impairment to come in.

In terms of the details, I think, as we said earlier, we'll give you specifics when we start the study, but it's something we are actually quite really looking forward to doing.

Okay, great. And then I guess just following on from that, will you look at different aspects of sleep, for example induction versus maintenance? And will you take in -- will you assess circadian function as well?

The drug is not a sedative, so we wouldn't expect patients -- it's not a drug that sends you to sleep better. There might be a benefit. If you are sleeping -- if your overall sleep cycle is better, then there's less concern going to sleep, you might get to sleep better, but importantly sleep maintenance.

And one of the problems for PD patients is they wake up in the night. They are not the most agile of people, given the underlying condition that they have, especially those with psychosis, and they have real problems on top of that. So they get up in the night, and it's dark, and they can sort of -- you can see where the falls can come from. They can trip over things. They can really harm themselves during the night. So it is that sleep maintenance, and it really is in a way rebooting the sleep computer to get an improved profile through the night. And I think it's something that may not just be nice to have, but may confer a benefit in these patients.

Okay, great. Thank you very much for taking my questions.

Alan Carr, Needham.

Hi guys. It's actually Mark on for Alan. Thanks for taking my questions. I was wondering if you could -- I have two and they're unrelated, but I will just put them both out there. If you could give us any details on what we might be seeing in various medical conferences this year. I think you highlighted two in the script. And I was wondering if you had any updates on programs with Allergan. Thanks.

This is Roger. Just in terms of conferences, we will be looking at a number of things, really just additional slices of data that we have from the clinical trials but also we will be presenting some data that really comes from some of the work that's been in preparation for the commercial launch of the drug in terms of looking from the market research, pulling out particular aspects of that, which is a rather nice almost byproduct of what it's intended for, but it really will help give flavor to the particular challenges that these patients have.

For the data, there's nothing which is dramatically new from our own database, from our own studies. But obviously, as we combine the data for the NDA and as is required in integrated summaries, there is some really nice data that just show the consistency of effect, and also the consistency of the safety of the drug. So, we will be looking at slices of that at various meetings.

And when it comes to the question related to the Allergan programs, I just want to report that we have one Phase II stage program for chronic pain, and we have a second program for glaucoma, which is a Phase I stage. Both of them are interesting programs. It's too early yet for us to speculate on what the outcome of the Activis and Allergan discussions will be related to these programs, but it's certainly something that we will keep a close eye on.

All right. Thanks for taking my questions.

Thank you. So I don't think there are any additional questions, 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. Thank you very much.

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