ACADIA Pharmaceuticals Inc (ACAD) 2013 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to ACADIA Pharmaceuticals second quarter 2013 financial results conference call. My name is Shaquana, 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 toward the end of today's call. (Operator Instructions) I will now like to turn the presentation over to Tom Aasen, Chief Financial Officer at ACADIA. Please proceed, sir.

Thank you. Good afternoon and welcome to ACADIA's second quarter financial results conference call. This call is being recorded and an archived copy will be available on our website at ACADIA-Pharm.com through August 20.

Joining me on the call today from ACADIA are Dr. Uli Hacksell, our Chief Executive Officer, and Dr. Roger Mills, our Executive Vice President of Development and Chief Medical Officer. Uli will begin our call today with some introductory remarks and then we will briefly comment on our second quarter financial results. Following this, Roger and Uli will provide you with an update on our development programs 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, including the timing, results, or implications of clinical trials or CMC development, the benefits to be derived from future approval of and the commercial potential for our product candidates, in each case including pimavanserin; the timing or likelihood of regulatory meetings, filings, or approvals; future development and commercialization of pimavanserin; the value of pimavanserin and our future expenses, cash position, and usage and growth potential.

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, including our Annual Report on Form 10-K for the year ended December 31, 2012, and other filings.

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 Uli Hacksell, our Chief Executive Officer.

Thank you, Tom. And good afternoon. Let me first take this opportunity to thank all of you for joining us on today's conference call.

The second quarter was another period of tremendous progress for ACADIA, highlighted by two key events. First, following the success of our pivotal -020 Phase III trial with pimavanserin for Parkinson's disease psychosis, or PDP, we met with the US food and drug administration in April to discuss the PDP regulatory path.

The outcome of this meeting was very positive. Importantly, the FDA agreed that data from our -020 study, together with supportive data from our other studies with pimavanserin, are sufficient to support the filing of a new drug application, or NDA, for pimavanserin. This provides an expedited path to NDA and represents another important step forward toward our goal of bringing pimavanserin to the market as an innovative therapy for Parkinson's patients who suffer from the psychosis frequently associated with this disease.

Secondly, in May we completed an equity financing which provides us with important financial flexibility to complete the remaining development in our PDP program, to accelerate precommercial activities, and to broaden the pimavanserin program. Together, we believe these two events position ACADIA to enter an exciting new phase, focused on building additional value in our pimavanserin franchise.

As Roger will share with you later, we continue to make solid progress on completing the remainder of our PDP program needed for our NDA submission. Currently, there is no FDA-approved therapy for PDP. We believe that pimavanserin's clinical profile is ideal to address this large unmet medical need and we are positioning it to become the first drug approved in the US to treat patients with PDP.

Additionally, we believe pimavanserin has broad potential and may provide a new therapy for a range of other neurological and psychiatric disorders that are poorly served by the off label use of existing antipsychotics. While pimavanserin is the most advanced asset in our product pipeline, we have several additional programs in our R&D portfolio.

Our pipeline also includes two clinical stage programs in the areas of chronic pain and glaucoma in collaboration with Allergan, and two programs in advanced preclinical stages directed at Parkinson's disease and other neurological disorders.

All of our programs emanate from discoveries made at ACADIA and offer what we believe are innovative approaches that may address large potential commercial market opportunities.

Overall, our pipeline of product candidates, led by our Phase III PDP program with pimavanserin, positions ACADIA with multiple product and commercial opportunities and significant growth potential.

Before we review our programs in a bit more detail, let me ask Tom to comment on our second quarter results.

Thank you. The second quarter financial results are consistent with our strategy to increase our R&D investment in order to aggressively advance and build value in our pimavanserin franchise.

Our revenues totaled $451,000 for the second quarter compared to $599,000 for the second quarter of 2012 and were derived from our collaborations with Allergan as well as our research grants.

Our R&D expenses increased to $7.1 million for the second quarter from $4.5 million for the comparable quarter of 2012, primarily due to increased costs incurred in our Phase III program for pimavanserin. We expect our R&D expenses to be substantial and increase in future periods as we continued to conduct the remaining CMC development in supporting studies in our PDP program, and incur costs associated with our Phase II Alzheimer's disease psychosis or ADP study that is planned for initiation this year.

G&A expenses increased to $2.5 million for the second quarter from $1.7 million for the comparable quarter of 2012, reflecting increased personnel cost as well as increased professional fees.

Finally, let's turn to our cash position and guidance. As Uli mentioned, during the second quarter, we completed a successful public offering, raising net proceeds of $107.9 million, which significantly strengthened our balance sheet.

We closed the second quarter with $205.5 million in cash and investment securities compared to $108 million at December 31, 2012. We used an aggregate of approximately $12 million in cash during the first half of 2013 to fund our operating activities.

Going forward, we expect our cash used in operating activities to increase in the second half of this year and beyond as we advance our PDP program toward an NDA filing, accelerate the precommercial activities, and broaden the pimavanserin program to address other indications including ADP.

We anticipate that our cash and investment securities will total at least $183 million at December 31, 2013, and that our cash usage will increase in 2014 relative to the current year. Importantly, we have a strong cash runway that we believe will enable us to continue to advance and build value in our PDP program while, at the same time, strategically broadening the pimavanserin franchise.

Let me now turn the call over to Roger, who will provide you with an update on our pimavanserin program.

Thank you, Tom, and good afternoon. The first half of 2013 was an exciting period for our pimavanserin program and for all of us here at ACADIA.

During the first quarter, Dr. Jeffrey Cummings, who is a Director of the Cleveland Clinic Lou Ruvo Center for Brain Health and the internationally renowned clinician, presented detailed results from our -020 study at the 65th American Academy of Neurology Meeting. The -020 study data showed robust and consistent efficacy of pimavanserin across a wide array of study measures.

Importantly, regardless of whether the assessments were performed by independent blinded raters, site investigators or caregivers, clear benefits of pimavanserin were observed. Consistent with previous studies, pimavanserin was safe and well tolerated in this Phase III study.

As Uli mentioned, in April, we met with the FDA. We were delighted the agency agreed they would accept and review an NDA for PDP based on data from the positive -020 study together with supportive efficacy and safety data from our other studies. We believe this reflects both the strength of the results, demonstrated in our -020 study along with supporting efficacy and safety data, and the fact that PDP is a serious unmet medical need without any approved treatment option.

With this expedited path, our team has been focused on completing the remaining elements of our pimavanserin PDP development program that are needed for submission of an NDA. This includes final aspects of the CMC development, including stability testing of pimavanserin registration batches and customary supportive studies, including drug-drug interaction studies.

As we have mentioned previously, CMC development, including stability testing, is a rate limiting activity in our PDP program. I am pleased to report that we are well underway with our preparations of manufacturing drug product registration batches, having completed the development and validation of the necessary analytical methods for the drug product. Thus, we remain on track to manufacture the registration batches and place them on stability this year.

Meanwhile, we are also conducting supportive studies which include customary short-term drug-drug interaction studies intended to provide appropriate label guidance for doctors through appropriately treat patients in this elderly population. Given our significant clinical experience with pimavanserin in PDP patients, we do not anticipate concerns in this area.

Overall, we are progressing well with these remaining NDA development activities and are on track for a planned submission near the end of 2014.

We are also continuing to conduct our Phase III PDP open label safety extension trial, referred to as the -015 study. This study has allowed us to generate a large amount of valuable, long-term safety data regarding the use of pimavanserin in patients with PDP.

In June we presented interim data from the -015 study at the 17th International Congress of Parkinson's Disease and Movement Disorders. The -015 data were based on 458 enrolled subjects from 114 sites in 14 countries. The interim analysis reflected data assembled through March 2013.

Importantly, the -015 data suggests that long-term administration of pimavanserin continues to be generally safe and well tolerated in its often elderly and fragile population. Although there are no formal efficacy endpoints in the -015 study, antipsychotic effect was measured at one month using the SAPS-PD scale and is assessed at all visits using the Clinical Global Impression scale to provide the investigator with information on whether patients continue to derive benefit from pimavanserin. These data suggest that the duration of antipsychotic effect may be maintained for longer than the six weeks investigated in our pivotal -020 study.

Patients who entered the -015 study from the 40 milligram treatment arm of the previous six-week efficacy studies maintained about the same mean improvement in SAPS-PD scores one month later. Those that entered from the placebo arm displayed a marked improvement in the SAPS-PD scores after one month in the -015 study. In addition, long-term CGI data indicate durability of treatment effects to patients remaining in the -015 study.

While this study continues to generate long-term safety data, we have already far exceeded ICH guidelines for required one-year exposures, with over 200 patients having been treated for one year or longer. We also have well over 100 patients who have been treated with pimavanserin for at least two years. And, through a similar extension study in connection with our earlier Phase II trial, our longest single patient exposure exceeds seven years.

We believe the findings from our -015 interim analysis provide further support for the potential of pimavanserin to offer significant advantage relative to current antipsychotics used off label for the treatment of PDP. As we continue with the remaining development activities in our PDP program, we intend to request pre-NDA meetings with the FDA later this year to discuss our plans for the NDA submission.

I think mentioned earlier, subject to changes that could result from our future interactions with the FDA, or other developments, we remain on track for targeted NDA submission near the end of 2014.

Let me now turn to our Alzheimer's disease psychosis, or ADP program, with pimavanserin. Because of its non-dopaminurgic mechanism of action and the favorable safety profile observed to date in elderly patients with Parkinson's disease, we believe that pimavanserin may also be ideally suited to address the need for a novel ADP treatment that is safe, effective, and well tolerated.

We are continuing preparations for our planned initiation of a Phase II feasibility study in ADP patients this year. In this trial, which we refer to as the -019 study, we expect to enroll about 200 patients who will be randomized on a one-to-one basis between pimavanserin and placebo and will receive treatment for 12 weeks.

We plan to assess multiple endpoints in addition to psychosis, including agitation and aggression and sleep nighttime behavior to explore the potential benefits of pimavanserin in this patient population, and to inform us on potential design enhancements to future studies in this program. We are planning to use the MPI scale -- the nursing home version -- in our ADP study.

We are very excited by the opportunity to pursue the ADP indication and we look forward to sharing more information on the design of the -019 study when it is initiated. I'll now turn the call back over to Uli.

Thank you, Roger. We are excited with the progress in our PDP program, which moves us closer to our ultimate goal of bringing innovative compounds like pimavanserin to the market to improve the lives of patients in neurological and related central nervous system disorders.

PDP represents a large unmet medical need and what we believe is an ideal lead indication on specialty market opportunity for pimavanserin. PDP is a progressive and persistent condition that occurs in an estimated 40% of Parkinson's patients and deeply affects their quality of life. It is associated with increased mortality, caregiver burden, and is the major cause of nursing home placements among Parkinson's patients.

The FDA has not approved any drug to treat PDP, and neurologists currently face difficult challenges in managing patients with this debilitating disease. We believe pimavanserin, with its well-tolerated non-dopaminurgic profile, has the opportunity to be a first in class therapy that will effectively treat psychosis in Parkinson's patients without compromising motor control.

As we continue with the remaining developments in our Phase III PDP program, we are also moving forward with initial precommercial activities to help position pimavanserin for a future product launch. While our primary focus is on our PDP program, in parallel, we are moving forward with our strategy to broaden the pimavanserin program to address other neurological and psychiatric disorders that are underserved by currently available antipsychotics.

As Roger mentioned, ADP is one such indication in which we believe pimavanserin may provide important benefits to patients. ADP affects an estimated 25% to 50% of the more than 5 million Alzheimer's patients in the US.

Similar to PDP, there is currently no therapy approved to treat ADP in the United States. And, as with PDP, physicians frequently resort to off label use of antipsychotic medications to treat ADP. However, existing antipsychotics may exacerbate the cognitive disturbances associated with Alzheimer's disease, and are associated with numerous side effects.

In fact, all existing antipsychotic medications have a black box warning for use in elderly patients with dementia related psychosis due to an increased mortality and morbidity.

As you may recall from our earlier Phase II co-therapy trial, we believe that pimavanserin also has considerable potential in schizophrenia and related psychiatric disorders. As we advance our PDP program and initiate our Phase II ADP trial, we will continue to plan for additional status with pimavanserin in schizophrenia that can build on our positive Phase II co-therapy trial data.

Let me now touch briefly on the other programs in our pipeline. In our long-standing alliance with Allergan, we have generated two clinical stage product candidates in the areas of chronic pain and glaucoma. During the second quarter we also were pleased to announce that Allergan advanced an additional new chemical entity emerging from our collaborative research into clinical development as a potentially new treatment for glaucoma.

This program benefits greatly from Allergan's expertise and leadership in the eye care field. In addition, we continues to make progress in our two advanced preclinical programs -- our ER-beta and Nurr1 programs -- which may offer new disease modifying approaches to treating Parkinson's disease and other neurological disorders.

We have ongoing preclinical studies in our ER-beta program as a novel pain treatment supported by a grant from the National Institute on Neurological Disorders and Strokes. We are also collaborating with Dr. Rhonda Voskuh at UCLA, a recognized expert in MS and neuroprotection on research aimed at evaluating our ER-beta compound as an innovative approach to targeting neurodegeneration associated with multiple sclerosis.

In our Nurr1 program we are continuing preclinical studies under a grant from the Michael J. Fox Foundation. We expect to advance one of these compounds into development this year in preparation for future clinical studies. In closing, our success during the first half of this year sets the stage for what we believe will be an exciting new phase for ACADIA.

Our pipeline of product candidates, led by our Phase III pimavanserin program, positions ACADIA with multiple attractive products and commercial opportunities and significant growth potential. We are focused on building additional value in our pimavanserin franchise.

And, most importantly, all of us at ACADIA remain committed to advancing innovative therapies that will improve the lives of patients suffering from neurological and psychiatric disorders. Operator, you may now proceed with the Q&A session.

(Operator Instructions) Charles Duncan, Piper Jaffray.

This is Roy in for Charles. Thanks for taking the questions. Wondering if you guys could describe at all inbound interest in the payment program, either acquisition or partnering, and if you are entertaining any of that?

Our priority is currently to advance our Phase III program to registration for PDP and to build additional value in our pimavanserin franchise. We think we have great opportunities here to advance pimavanserin beyond PDP into other neurological disorders as well and this program can really build what we believe is a pipeline in a drug.

When it comes to our strategy, we are really planning to build a commercial success story around pimavanserin in the US and market pimavanserin alone. We think PDP represents a great lead indication for pimavanserin. We think that we can really successfully launch and commercialize pimavanserin with a dedicated sales force.

Outside of the US, we may consider other opportunities. We have in fact all opportunities open to us, because we have worldwide rights retained to ACADIA. So we think that we have a great future with pimavanserin and currently our focus is on building additional value in the molecule.

Okay. Great. Thank you. And recently you guys highlighted some data regarding the atypical antipsychotics and side effects from those. I wonder if you could just briefly compare what the discontinuation rates were with those compounds in those studies compared to pimavanserin. And why do patients discontinue pimavanserin and what is the rate there? Thanks.

Roger, do you want to take that?

Thanks, Uli. So what we see, obviously, in terms of looking at comparative data, there is no similar studies to the ones that we have done in PDP that are directly comparable. However, we have looked to try and get baseline -- a baseline feel for it by looking at published data using atypical and typical antipsychotics in elderly populations.

Most of that does come from the Alzheimer's population, but the safety issues and challenges are in that population are very similar to PDP. And, therefore, it's a reasonable comparison to make. And what you see is consistently you see much lower rates of discontinuation in the pimavanserin studies than you see in those studies with the atypical agents.

There was also a recent paper that was published from the group, actually here at UCSD in San Diego, with [Diller Jeste's] group looking at the use of antipsychotic agents in -- for any reason in people over the age of 40. So that wasn't just in elderly neurodegenerative conditions, but even younger schizophrenic patients. The key factor was that patients were over the age of 40. And you see a fairly high -- I don't have the figure in front of me, but it was a very high rate of discontinuations in using the antipsychotic agents mostly for adverse events.

With our pimavanserin studies, I think it's important to not just look at the individuals but look overall at the population and the amount of long-term data that we've been able to generate, which I think speaks loudly to the tolerability that you see with pimavanserin in this late stage Parkinson's population.

In terms of discontinuations due to adverse events, I think it was around about 19%, 20%. And that really can be for not adverse events related to the drug, but just adverse events -- events that occur in people's lives over that period where the doctors, at that point, may feel it appropriate to try and just get on and manage that condition without the restrictions of being in a clinical trial.

The other major reason that you see for patients discontinuing are really events changing in their lives. We require a caregiver to accompany patients to every visit. And, over time, that can become burdensome. Or the caregiver, who is the spouse, may in fact die themselves. So life events are one of the key factors that leads to patients discontinuing in the study.

Okay. Thank you.

Thomas Wei, Jefferies.

Thanks. Just had a couple of questions. First on the European process. When do you expect to begin discussions with European regulators about a pimavanserin filing? And how long do you think process like that would take to get a decision?

And then on stability testing, I just wanted to get a better understanding of the amount of stability data that you need for filing. Is that your decision to make or is that something that the FDA tells you during those pre-NDA meetings? Thanks.

So for the European process, obviously, we put together a fairly large and comprehensive background package that we supplied to the FDA and that will form the basis of the approach to European authorities. That includes pretty extensive analysis of the efficacy data combined with the totality of the safety data that we have.

It's a little different in Europe. The package just needs adapting for the European environment that, as you know, the difference is -- there are many similarities between the agencies, but there are also some differences. And we will focus it specifically for the European process.

In terms of the next steps, the next steps will be to approach individual member states to be able to discuss the program and the results and the implications of those results. And we will then take guidance from those individual countries as to the next steps. But we would envisage that the clarity of the efficacy and safety that we see will be apparent in those meetings. (multiple speakers) In terms of timing, we would expect those to take place this year.

Alan Carr, Needham.

Hi, it's actually Mark on for Alan. Thanks for taking our questions.

I just wanted to ask a little bit about the stages that you guys are thinking about for prepping for commercial launch. What might be going on now? What might be going on after it year-end and going forward, how you guys are thinking about that build-out occurring?

So we are clearly thinking a lot about the precommercial phase. We are in the process of recruiting a chief commercial officer. And we have already started with the pre-commercialization work.

That includes numerous things like traditional market research, education and outreach, and other activities such as branding, everything aimed as positioning us for successful launch. And in the next periods before launch, we will clearly provide much more visibility on what we are doing here. I think this gives you a little bit of the feel that we are -- have in fact started the processes, that they are well underway and that we really intend to make everything possible to ensure that we will have a very successful launch of pimavanserin.

Okay. Thank you very much.

Bert Hazlett, ROTH Capital.

Thanks for taking the questions. Just to follow up on Europe and then just one more broader pipeline question, in terms of Europe, have you decided strategically whether -- how you're going to proceed, whether you were going to proceed alone or whether or not you would proceed with a partner in that geography?

And then, secondly, a pipeline question. You mentioned you wanted to -- your goal is to move one program into the clinic -- the Nurr1 or the ER-beta. Is that a choice that is resource constrained? Or is that a goal based on the maturity of the program, or could you potentially move both of them if everything worked out? Thanks.

Yes. So the first question is clearly that we -- what we want to do now is to build value in the program. And we build that by moving forward in Europe. We have no need to partner urgently in Europe. That's the important thing for us.

So what we do now by moving forward first with the understanding the regulatory requirements there is to simply move the program forward and create additional value. At a later point in time, we may decide to partner or we may not. And we have both options open to us.

When it comes to the pipeline pressure, clearly the decision to move one or both into development will be dependent on how the programs are progressing. We are likely to do it with one compound, not with both, but we will see. Clearly, if both of them show exciting results, we could move both of them forward, for sure.

(Operator Instructions) George Zavoico, MLV.

Good afternoon, Uli and Roger and Tom, and thank you for taking my questions. And congratulations on an absolutely terrific quarter. Two questions.

In your call, in your prepared remarks in you mentioned that the raise that you got in the last quarter would help accelerate development. But then I understand, of course, the constraints for the stability testing, you can't really accelerate that.

But you mentioned having said that you would accelerate the program, you left the target time of 4Q of next year or by the end of next year as to when you would do the NDA. So precisely how do you intend to actually accelerate the development towards commercialization?

Hi, George. It's Tom. I can take it and start on it.

I think the key thing we were mentioning is the building additional value. What we want to do is utilize this time period that we have while we are doing the CMC work to do as much as we can possibly in creating value in the compound.

That's why what we are doing is, in addition to making sure we put all resources into finishing the NDA program, we are also doing the precommercial and accelerating those activities so we can position ourselves for the market launch of the product in PDP. But I think equally importantly, we are putting a lot more effort as well into the related lifecycle extension activities.

So we are going through -- in the ADP study, to start with, the one that we will initiate this year to make sure we can design that in a way that it is very optimal that will allow us to really explore the potential of that. And as you heard from Roger, we are expanding that in a way that will allow us to really explore a number of potential effects of the drug in that population and, also have the flexibility in the schizophrenia area as well to be able to continue the planning there.

We expect to talk more about that as we move into next year. So our idea is to really use this time optimally and build additional value.

You certainly have your hand full with those additional indications.

Next question to Roger. The long-term durability that you mentioned in the -015 study, especially with the efficacy, you mentioned that you had -- the endpoint was approving or at least remaining stable. Is there a way you could leverage that?

I mean, since they are not actually -- the efficacy endpoints are not really part of the study, can you leverage that and put that into the label? Because that would certainly help in the commercialization side. And it would certainly help in getting physicians more excited about the drug that they might already be.

So it's not something that we would expect to be covered in the labeling in the US. It's not a primary objective of the study and, therefore, I wouldn't expect that that would be the case.

However, it is an important aspect of the drug. I think it really speaks to the reason people are staying on the drug for so long. It's not just because it is well tolerated. It's because they feel they are benefiting and their doctors feel they are benefiting.

The fact is that the good tolerability merely ensures that they get the option to be able to continue on the drug. But really the key factor for being on the -015 study is that the patients and doctor feel that the patients are continuing to get continued benefit. And I think that's really the strength of those data.

So I'm very pleased when -- it wasn't the intention for the study, but I'm very pleased when I look at the data to be able to see that we get this continued benefit.

You are learning a lot from that, obviously, on this other stuff that you weren't expecting, because it wasn't designed for it. But are you considering, once you have approval, perhaps going into a Phase IV study to really look at this a little bit more closely? Because with this kind of improvement, you might ultimately see a survival benefit.

I think there are many aspects of -- that are very interesting to explore with the drug in the Phase IV arena. We have concentrated a little bit earlier on the additional indications, but I think there is still a wealth of benefit that one would expect to see with the drug in the indication of PDP.

And I think one of the key elements of our Phase IV development of the drug will be to explore these and really tease them out. Potential in terms of improving survival, but certainly one would expect to really explore the potential for delaying or avoiding the need for nursing home care.

Fabulous. Good luck with all that. And, again, congratulations on the terrific quarter and thank you for taking my questions.

Juan Sanchez, Ladenburg.

Hi, guys. How are you doing? Only one question on the drug to drug interaction. I understand this is a low-risk trial for you guys, but theoretically speaking, is there any specific drug pimavanserin could interact with? Whenever we see the final results, we should be happy about those results, yes?

I think, in terms of drug-drug interactions, as you mentioned, they are obviously a low risk for us. I think it's -- that one of the challenges of studying any novel drug in a population like this is that they are relatively sick individuals to even enter into the study. And, therefore, it means that there are many other concomitant medications coming in.

And, therefore, we have looked at the -- in terms of the population over the long period of time that patients have been on the study, there are a multitude of other agents for many different other diseases that the patient is taking. So in terms of that, we are not expecting to see anything that is a major hurdle for the drug. And, in fact, we would expect, as you have rightly said, that they are low risk studies.

Charles Duncan, Piper Jaffray.

Hi, guys. Thanks for taking the follow-up. Lots of back and forth between calls, so apologize if this has been asked. My question is regarding the ADP trial. I realize it's a Phase II and that in some ways it is hypothesis generating.

But given all the work you have done with PDP and the design enhancements that you learned that worked, such as a run-in period and the independent reviewers and modified SAPS, what set of those, call it, design enhancements do you anticipate using in ADP? Or are you going to make it a much more broadly accepting trial?

I think in terms of the exploratory aspects of it, it's more in the endpoints rather than the method of running the study.

Okay.

As you rightly point out, we have learned a great deal in the PDP arena which obviously led to the spectacular results we had with the -020 study. It's worthwhile noting that the brief psychosocial therapy that we used in that running period that just alluded to was actually originated from Alzheimer's. So very clearly, we will be using that in the run in to the study in a similar manner, and at the two points, one is to manage patients through the screening period, but importantly, to draw the placebo response ahead of the baseline in that study.

And then, secondly, I think we very clearly showed that it is important to limit the number of raters that one is using to keep to a small group of highly trained raters who are able to perform the assessments on a very regular basis, thereby reducing variability and increasing specificity of how they employ the scales. And that's obviously something that we will be looking -- or are looking; not will be, but are looking to employ in the -019 study.

Okay. And, Roger, also, perhaps you could provide us a little sense as to whether or not you folks plan to have any price presence at the upcoming World Parkinson's Conference? Could there be additional maybe cuts of the data?

Actually I'm trying to remember which conferences specifically we are presenting at. But we will be presenting at certainly a few more conferences this year.

In terms of slices, I don't think we'll have any additional slices to present. We have done a pretty comprehensive presentation of the -020 data, and this year I think we will just be really ensuring that we get those data in for that by the relative relevant people are able to hear those data and question us regarding them.

Super. And then my final question is perhaps for Uli. This goes way back to diligence conducted many, many years ago, but I want to talk to you about medicinal chemistry.

We have not recently heard about any, call it, backup compounds or other approaches in terms of lifestyle or lifecycle extension. I know that you looked at alternative scaffolds a long time of go ago in terms of this basic mechanism, but do you have pretty good tie up on alternatives approaches to this mechanism, to the targeting? And if someone wanted to get at it, they might have to buy that entire IP?

So first of all, you have a good memory. We had a backup compound for ACP-106. We still have that compound. But we are not pursuing it actively currently.

We believe that really the way to do a lifecycle management of pimavanserin is to work with pimavanserin for different kind of indications, both in the neurology and psychiatry fields. We think that's a very good strategy because of the extensive and deep IP protection we have for the molecule which really provides us with many, many years of exclusivity on the market.

And since we don't see any competition really coming up that can sort of challenge us, I think even at the horizon, we don't see anything. So we think that what we should do -- what is the smart way of doing, is really to establish ourselves on the market. And that will make it very difficult for someone to come in and present us with a serious challenge for a long, long time ahead.

So we have a unique situation with pimavanserin in that sense. And I think that moving broadly into the neurology and psychiatry piece with pimavanserin is the right way to really broaden and fully explore this opportunity.

That makes sense to me. Thanks for the added color.

Dr. Hacksell, please proceed to closing remarks.

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

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