ACADIA Pharmaceuticals Inc (ACAD) 2011 Q1 法說會逐字稿

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  • Operator

  • Good day, ladies and gentlemen, and welcome to the ACADIA Pharmaceuticals first-quarter 2011 financial results conference call. My name is Thelma and I will be your coordinator for today. (Operator Instructions). I would now to turn the presentation over to Tom Aasen, Executive Vice President and Chief Financial Officer at ACADIA. Please proceed.

  • Tom Aasen - EVP, CFO

  • Thank you. Good afternoon and welcome to ACADIA Pharmaceuticals' first-quarter 2011 financial results conference call. This call is being recorded, and an archived copy will be available on our website at www.ACADIA-Pharm.com through May 24.

  • 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. Uli will begin our call today with some introductory remarks. I will then briefly comment on our financial results for the first quarter. Following these remarks, 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 making a number of forward-looking statements, including statements regarding our and our partners' research and development programs and plans, including the timing, design, and results of clinical trials and partnering activity; the benefits to be derived from our product candidates, in each case including pimavanserin; benefits to be derived from changes to clinical trial designs; plans regarding the development of pimavanserin; and our future expenses, collaboration payments, cash position, and financial performance.

  • These forward-looking statements are based on current assumptions (technical difficulty) 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, 2010, 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 Dr. Uli Hacksell, our Chief Executive Officer.

  • Uli Hacksell - CEO

  • 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 first quarter was a busy and productive period for ACADIA. First, we continued to make solid progress in the execution of our lead Phase III program with pimavanserin in Parkinson's disease psychosis, or PDP. This program, including our ongoing pivotal Phase III trial referred to as the -020 Study, remains our top priority, and Roger will provide you with an update on our PDP program later in the call.

  • The first quarter was also highlighted by the completion of our private equity financing with a prominent base of institutional investors. This significantly strengthened our cash position and provided us with important flexibility advancing the pimavanserin program.

  • Behind pimavanserin, we also continue to make important strides in other pipeline programs, including our collaborative programs with Allergan and Meiji Seika Pharma, and our earlier-stage preclinical programs that may offer innovative disease-modifying approaches for treating Parkinson's disease and related disorders.

  • Finally, late in the first quarter, we were pleased to extend our longstanding discovery collaboration with Allergan, which is focused on glaucoma and related ophthalmic conditions. We are excited to continue what has been a very productive scientific alliance and we are grateful for Allergan's continued support.

  • Overall, we're off to a very good start to the 2011 year, and we are positioned to advance and build substantial value in our pipeline of product candidates, led by our Phase III pimavanserin program.

  • Let me now turn the call over to Tom to comment on our first-quarter financial results.

  • Tom Aasen - EVP, CFO

  • Thank you, Uli.

  • I'm pleased to report that our financial results for the quarter were in line with our expectations and continue to demonstrate our financial discipline and expense control.

  • We reported a net loss of $5.8 million, or $0.12 per common share, for the first quarter, compared to a net loss of $5.5 million, or $0.14 per common share, for the comparable quarter of 2010. Revenues totaled $435,000 for the first quarter and were comprised of revenues from our collaboration with Allergan and Meiji Seika Pharma, as well as from research grants. This compares to revenues of $2.1 million for the first quarter of 2010, which included $1.4 million in revenue from our collaboration with Biovail, which was concluded in October last year.

  • Our research and development expenses decreased to $4.4 million for the first quarter of 2011 from $5.8 million in the comparable quarter of 2010, reflecting lower external service costs associated with our Phase III program, as well as cost savings in our internal organization.

  • Our general and administrative expenses totaled $1.9 million for the quarter and were comparable to the first quarter of 2010.

  • Turning to our cash position and guidance, we closed the quarter with $45.7 million in cash and investment securities, which provides us with a solid cash runway. We expect that our existing cash resources and anticipated payments from our collaborations will be sufficient to fund our operations at least into the first half of 2013.

  • Finally, let me add that as part of our ongoing cost-saving efforts, in April we terminated our long-term lease on a facility located in Sweden, which will substantially reduce our facility expenses going forward. In connection with this termination, we made a final payment of $690,000 and issued approximately 782,000 shares of our common stock, and as a result, expect to incur a one-time charge of approximately $1.7 million in the second quarter of 2011.

  • Importantly, going forward, we anticipate that the termination of this lease will enable us to save at least $1.5 million in annual facilities and related costs.

  • I'll now turn the call back over to Uli.

  • Uli Hacksell - CEO

  • Thank you, Tom. Our development pipeline consists of four product candidates, which are pimavanserin in Phase III development, as well as two partnered clinical-stage product candidates that are fully funded by Allergan, and a program in R&D track development in collaboration with Meiji Seika Pharma.

  • Our remarks today will focus mainly on our Phase III PDP program with pimavanserin. Let me start by asking Roger to provide you with an update on this program.

  • Roger Mills - EVP Development

  • Thank you and good afternoon.

  • As Uli mentioned earlier, our primary focus is on the ongoing Phase III -020 study. This study builds on the wealth of the clinical experience we've generated in our PDP program and incorporates an enhanced study design. The -020 study is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability, and safety of pimavanserin in patients with PDP.

  • This study is being conducted exclusively in North America and is expected to enroll about 200 patients over approximately 50 clinical sites. Patients initially participate in a screening phase, which includes a structured social therapy program. This is designed to help diffuse the initial anxiety that may be associated with participating in a clinical trial setting, provide additional support to patients and caregivers during the run-in to the study, and to poll initial placebo responses ahead of the baseline assessment.

  • To participate in the study, patients are required to have moderate to severe psychosis as measured by the Neuropsychiatric (technical difficulty) Inventory scale, or NPI, at screening and the Scale for the Assessment of Positive Symptoms, or SAPS, at the time of the baseline assessment. Patients must have both adequate severity and frequency of symptoms to be included in the study. Importantly, the baseline SAPS score is assessed independently from the NPI, which provides a further check and balance.

  • Patients are randomized on a one-to-one basis to two study arms and receive either 40 mg of pimavanserin or placebo once daily for six weeks. Patients also continue to receive stable doses of their existing dopamine replacement therapy used to manage the motor symptoms of Parkinson's disease.

  • The primary endpoint of the -020 study is antipsychotic efficacy as measured using nine items in the hallucinations and delusions domains of the SAPS, which best reflect the expression of psychosis in patients with Parkinson's disease. By using this refined nine-item scale, we expect to reduce data variability and enhance sensitivity in measuring the treatment response.

  • We are using an independent group of highly trained, centralized raters to assess the primary endpoint of the study. Our previous experience has shown that this independence and centralized approach helps to mitigate placebo response and leads to less variability in the data.

  • The -020 study is powered at the standard level for a pivotal study of 90% to provide statistically significant antipsychotic efficacy as measured using the nine-item SAPS. The tolerability is a key secondary endpoint in the trial and is measured using parts two and three of the Unified Parkinson's Disease Rating Scale, or UPDRS. We remain very enthusiastic with the study design for -020 study and confident that the design enhancements we've incorporated significantly improve the likelihood of achieving a successful outcome in this study.

  • I'm pleased to report we've continued to make solid progress in the -020 study. During the first quarter, we completed initiation of the base of 50 planned clinical sites, and we are continuing to enroll patients in the study.

  • We continue to be encouraged by the enthusiasm displayed by many of the investigators and the activity at the sites. We believe the prior experience that many of the investigators have had and the clinical sites have had with pimavanserin has helped contribute to the increased awareness of the -020 study.

  • With respect to timing, if the -020 study is conducted in a timeframe similar to what we experienced in our previous studies, it would suggest topline data by about mid-2012. We expect to provide specific timing for the completion of this study at a later date.

  • In addition to the -020 study, we're continuing to conduct a large Phase III open-label safety extension study, referred to as the -015 study. This study involves patients who completed previous Phase III PDP trials, as well as patients who complete the -020 study and who, in the opinion of the treating physician, may benefit from continued treatment with pimavanserin.

  • Consistent with our experience in the previous studies, we are encouraged to see a strong level of participation by patients who complete the treatment phase in the -020 study and have the opportunity to roll over into the -015 study.

  • Importantly, we're generating a large amount of valuable long-term safety data regarding the use of pimavanserin in patients with PDP. We've now reached over 400 patient years' exposure with pimavanserin in this patient population, and its growing base of clinical experience increases our confidence in the program.

  • Overall, in our Phase III and Phase II extension studies, more than 200 patients have been treated for over a year, over 80 patients for greater than two years, and our longest single patient exposure is greater than six years. We continue to be encouraged to see that many patients remain on pimavanserin for long periods of time. Importantly, our experience to date suggests that the long-term administration of pimavanserin has continued to be safe and well tolerated in this fragile elderly patient population.

  • We believe that the favorable safety profile observed to date provides additional support for the potential of pimavanserin to offer significant advantages relative to current antipsychotics used off-label for the treatment of PDP.

  • Let me now turn the call back over to Uli.

  • Uli Hacksell - CEO

  • Thank you, Roger.

  • Our priorities are clear and our resources remain focused on advancing our Phase III PDP program. We believe that this program, including the ongoing -020 study, will allow ACADIA to significantly increase the value of pimavanserin and drive additional value for our stockholders.

  • PDP is a large unmet medical need and represents what we believe is an ideal lead indication and a 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 institutionalization among Parkinson's patients.

  • The FDA has not approved any drug to treat PDP, and neurologists currently face overwhelming challenges in managing patients with this debilitating disease. Pimavanserin provides an innovative non-dopaminergic approach to treating PDP, by selectively blocking a key serotonin receptor, the 5-HT2A receptor, which plays an important role in psychosis. We believe pimavanserin has the opportunity to be a first-in-class therapy that will effectively treat psychosis in Parkinson's patients without compromising motor control.

  • While our strategy currently focuses on advancing our Phase III PDP program towards registration, we also intend to use this program as a foundation to develop and commercialize pimavanserin for additional neurological and psychiatric disorders that are underserved by currently available antipsychotic brands. We believe there is a significant commercial potential for pimavanserin beyond PDP in a range of indications, including Alzheimer's disease psychosis, or ADP, and as a co-therapy for schizophrenia.

  • In both of these indications, we have established well-defined paths forward. In ADP, we have established a protocol for a Phase II feasibility study that we intend to pursue in the future independently or in collaboration with a partner. Because of its selective 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 new treatment for ADP that is safe, effective, and well tolerated.

  • Now turning to schizophrenia, previous interactions with the FDA have established a development path for a combination product consisting of pimavanserin and risperidone. This would build on our earlier successful Phase II co-therapy study, which demonstrated that co-therapy combining pimavanserin and a low dose of risperidone was equally effective as a standard dose of risperidone, while exhibiting a much improved side effect profile, including significantly less weight gain and a faster onset of action.

  • With ACADIA holding worldwide rights to pimavanserin as we focus on advancing our Phase III PDP program, we will consider potential opportunities that may allow us to further accelerate and broaden the development program of pimavanserin and, of course, drive increased value for our stockholders.

  • While pimavanserin is our most advanced product candidate, ACADIA also has other important programs in its pipeline. Through our longstanding alliance with Allergan, we have two clinical-stage product candidates that provide the potential for new treatment options in the areas of chronic pain and glaucoma. And through our collaboration with Meiji Seika Pharma, we are in R&D track development with AM-831, a new chemical entity that may offer an innovative approach to treating schizophrenia that importantly improves cognition, an untreated third symptom domain of this disease. Together, we are currently conducting required development studies in preparation for potential future clinical trials with AM-831.

  • Behind our four most advanced product candidates, we have additional earlier-stage discovery and preclinical programs. This includes our recently expanded discovery collaboration with Allergan focused on ophthalmology.

  • We also continue to make good progress in two preclinical programs that may pave the way for new breakthroughs in the treatment of Parkinson's disease. This includes our Nurr1 program in which we are conducting research under a grant from the Michael J. Fox Foundation and our ER-beta program, where our initial studies have also been supported by two grants from this foundation.

  • In closing, we believe that our product portfolio, led by pimavanserin, our Phase III product candidate for which we hold worldwide rights, positions ACADIA with multiple product and commercial opportunities. With the well-designed Phase III program for pimavanserin and a solid cash runway, we believe that we have a strong foundation in place to advance this late-stage product candidate and drive value for our stockholders.

  • We will now be happy to answer questions that you may have.

  • Operator

  • (Operator Instructions). Jason Napodano, Zacks Investment Research.

  • Jason Napodano - Analyst

  • Can you provide an update on what the next steps are with pimavanserin after you finish the -020 program? I know you've got some long-term safety studies that you're running and I know that the two previous programs, you had some encouraging data with the 40 mg dose. I'm wondering if there's an opportunity to file with -- using that supplemental information.

  • Uli Hacksell - CEO

  • We don't expect to be able to file with just the ongoing Phase III trial. We expect that there is a need for an additional similar Phase III study. We will, of course, also continue to have patients ongoing in the -015 study, the open-label extension study.

  • Jason Napodano - Analyst

  • Do you -- as far as the open-label study, will placebo patients be able to enroll in that study as kind of a crossover design and do you think that you'll ever present that data in the future?

  • Uli Hacksell - CEO

  • So, Roger, perhaps you can answer that.

  • Roger Mills - EVP Development

  • Yes, so the open-label study -015 has always been open to patients from whichever arm of any of the previous studies, all the current studies they've been on.

  • So, currently, we are enrolling patients from the -020 study into -015 from both arms, from both the 40 mg and from the placebo.

  • It's not an efficacy study. We are not -- we don't have efficacy parameters built into that study. It is designed for safety. But it's very, very encouraging that the key entry criteria is that the patients and, importantly, their physicians feel that the patient continues to derive benefit, and it's just very, very encouraging that we've seen, one, a high rollover from the -020 study, but also the patients -- as presented earlier, many of these patients are actually on drug for now quite a number of years. So, we're really seeing a very clear, very reasonable safety profile with the drug, and also encouraging that, clearly, physicians feel that their patients are benefiting from being on this drug long term.

  • In terms of presenting the data, we have previously presented a poster presentation of a slice of data. I can't remember when or where. It was about, maybe, a year, 18 months ago, and we are always looking at, when we do do further data slices of this study, to be able to present those at relevant scientific meetings.

  • Jason Napodano - Analyst

  • Excellent. Can you give an update of what the strategy is outside the U.S.?

  • Uli Hacksell - CEO

  • We currently have no plans to conduct additional studies outside the U.S.. We expect, of course, over time to not only get an approval in the U.S., but approvals in Europe and in Asia, but if we will do that alone or in together with a partner is still something that we haven't decided on.

  • Jason Napodano - Analyst

  • One last question for Tom. Can you remind us of the warrants that are outstanding from the raise in January and what your expectations are there, once those become exercisable, and if that's factored into your cash runway guidance?

  • Tom Aasen - EVP, CFO

  • Sure. Happy to do that. We currently have about 4.7 million warrants outstanding. The vast majority, about 4.4 million of those, were issued in connection with the private placement. They are exercisable beginning in July of this year.

  • We have certainly not factored anything related to those in our cash runway projections that we've provided. And we aren't in a position, obviously, to comment on what can happen with the warrants. But it's not in our baseline projection.

  • Operator

  • (Operator Instructions). Charles Duncan, JMP Securities.

  • Charles Duncan - Analyst

  • Thanks for taking the question. I had a question with regard to the enrollment in the pimavanserin study. You mentioned 50 sites being up and running. How many of them have actually enrolled a patient? Are they being up and running having passed the IRB or have they been enrolling patients?

  • Roger Mills - EVP Development

  • Thanks, Charles. I'll take that one. It's actually a mix. So we've got sites that obviously have been coming on over a period of time. Some have been fully up and running for longer.

  • I don't have the number of exact sites that have enrolled a patient. What I'm -- very clearly stated that we're seeing a really very high level of activity at the sites in terms of hunting the patients for prescreening, bringing patients in through the screening and into the study.

  • Charles Duncan - Analyst

  • And what -- how far along in the enrollment period will be kind of the trigger point to update the timelines with regard to that trial? You've always referred to as previous experience. Do you think you could enroll actually faster than the previous experience, given the experience of some of the sites involved in this study?

  • Uli Hacksell - CEO

  • Charles, let me ask answer the first part of your question. So, previously, we have normally updated on timing of clinical trials when we have the last patient recruited in the study. So, we may do that this time as well.

  • When it comes to timing, what we can say is we clearly have to rely on our previous experience. The design of this study is pretty similar to that in the previous studies. So we don't expect any major changes in the timing. But of course, we will need to follow up on these over time.

  • Charles Duncan - Analyst

  • Okay. And then, could you review with us -- I know you've talked about some of this in the past, but the specific feedback you received from the FDA with regard to deploying the nine items on the SAPS versus the entire SAPS test in terms of measuring antipsychotic efficacy in PDP.

  • Roger Mills - EVP Development

  • As you remember, we based the nine-item SAPS assessment on what was by far the largest database ever of patients with PDP using SAPS and our belief was that as there was an area of the SAPS, the 20-item SAPS, that really wasn't being utilized nor reflective of the symptoms that patients with PDP have.

  • So based on the baseline data, so pretreatment data from over 500 patients using SAPS who have PDP, we were able to analyze new statistical analysis to derive the nine-item scale.

  • We presented this to FDA for our intention to use that as the primary endpoint in the -020 study. The FDA agreed with us that we could utilize this as the primary endpoint based on the fact that it -- the analysis showed that it reduced variability around the data and was clearly reflective of the PDP as measured on the SAPS and had clinical utility as such.

  • Charles Duncan - Analyst

  • Roger, the other thing that you've done in this trial, which seems to be value-added in terms of reducing the noise in the placebo group, is changing the number of arms. Could you review with us the logic in that and kind of the reference material that you use -- cite to improve probability -- or the perspective of the patients in terms of their probability of getting drug?

  • Roger Mills - EVP Development

  • This relates to -- in the previous studies, we had potentially two active arms. There were two pimavanserin arms and a comparator with placebo.

  • For any patient coming into this study, therefore, there was a 66% chance of them being on an active drug, as opposed to just a third who would expect to be on placebo. In changing to two arms, you actually reduce that expectancy bias of being on an active drug to a 50%-50%.

  • If you'll remember, one of the key issues we had was clearly a marked placebo response, so this was just one element of how we built the study to try and obviously reduce that placebo response.

  • Charles Duncan - Analyst

  • Roger, with regard to the open-label participation, have there been any patients that have been through the treatment duration of sufficient time to have been given an opportunity to move over from -020 to -015, or are all those patients from the earlier studies?

  • Roger Mills - EVP Development

  • No, no. There are quite a number of patients now who have had that opportunity, and as I indicated earlier, we've had a really high sort of uptake as patients who finish the -020 and then move on to -015. It's really a very popular transition.

  • Charles Duncan - Analyst

  • And if you were to compare or if you were to really look critically at why those patients are participating in that extension phase, is it simply because they feel better or are getting benefit from the drug, or are they also getting some other form of superior care, just -- or perhaps their caregivers are being helped out a little bit?

  • Roger Mills - EVP Development

  • I think the reason for moving across is, firstly, that they feel they need treatment, and that's one of the key reasons they come into the study. Either the treatment that they've been on has been suboptimal or they want to have the option of moving into something that the investigator feels may well be beneficial to them.

  • And clearly, for patients that come through this study, they have the opportunity to take open-label pimavanserin.

  • Many of the investigators in the current study have prior experience with pimavanserin in our previous studies, and the reason they're back and working with us is they obviously feel that there is great potential with the drug. So they feel comfortable in offering the open-label study to patients who enter -020.

  • In terms of the question as to whether they get better care being on the study, all these patients in this study are patients in the United States, and therefore they expect and get in the usual circumstances First World medicine.

  • With reference to our previous studies, one of the things that we were --in terms of looking at the patients in Eastern Europe was that, in fact, they were concerned with -- in fact, they got better care from being on a study than they might have gotten with their normal practice, but in the current -020 study, that is not the case. It's patients who expect First World treatment because they're all from the United States.

  • Charles Duncan - Analyst

  • That's helpful, and then, also, with regard to that open-label participation, you've spoken several times about the duration of treatment for some of the patients that are in that study and, impressively, several -- some of them several years, but let me ask you if you anticipate a question from the FDA regarding the efficacy of pimavanserin over that time and/or perhaps the safety. Which of those two, if either of them, is something that you're really trying to come to grips with through that data or that experience in the open-label study?

  • Roger Mills - EVP Development

  • So the question regarding efficacy, the study -- it -- does not have efficacy parameters built into it. So it is not designed to deliver efficacy.

  • As I say, the duration and quite extensive duration of therapy in many patients is very encouraging because, obviously, they and their doctors feel that they're deriving benefit.

  • The focus of the study is safety. As you're aware, the huge concern for regulatory authorities for the prescribing community in general is the problems with safety of the off-label use of the atypicals in this population. And I think it's fair to say that it's an increasing awareness and increasing problem, and therefore, the safety -- this safety study is an important part of our overall profile.

  • The safety of pimavanserin efficacy is always critical. But safety is a very clear way of a very positive discrimination of pimavanserin from the atypicals that are used off-label, and therefore this is an important study to us.

  • Charles Duncan - Analyst

  • I agree with you. It is a clear point of differentiation, if it holds up.

  • Either yourself or Uli, I'm wondering if you could run through a comparison of PDP relative to ADP. I know we've talked about this potential in the past, but could you talk a little bit about the types of lesions that occur, and then the symptoms that are a result of that in the two different disease settings?

  • Uli Hacksell - CEO

  • Yes, so maybe I can try to answer that question, Charles.

  • So, really, we're talking about two quite different diseases which have very different kinds of pathophysiology. In Parkinson's disease, you have a brain which -- where dopaminergic neurons are dying. In fact, when you diagnose a Parkinson's disease patient, already at that time probably at least 70% of the dopamine-producing neurons are dead. So, it's a brain which is very different from a normal brain.

  • And then, when you get PDP, you get symptoms which are very typical for Parkinson's disease patients with psychosis. You get visual hallucinations, a lot of visual hallucinations, and you get delusions of different types.

  • Now if we go to Alzheimer's disease, the initial kind of thing that is happening in terms of neurodegeneration in the Parkinson's brain is that cholinergic neurons are dying. So, those neurons that produce acetylcholine are dying. Now, after a while, the Alzheimer's patients also start to have other neurons dying, and after a while, it's a general kind of neuronal death that occurs as a result of the plaques and the tangles that are sort of the hallmark of Alzheimer's disease.

  • Interestingly, the symptoms of Alzheimer's disease psychosis are quite similar to the symptoms of Parkinson's disease psychosis, although the original or the initial pathophysiology is completely different. So, in the Alzheimer's psychosis, you see visual hallucinations again and you see delusions of different kinds. And you'll see other behavioral disturbances that are quite clear.

  • But both of these psychoses that you see in Parkinson's and Alzheimer's disease are very different from the psychosis you see in schizophrenia, for example, because in the schizophrenia patients, you see mainly auditory hallucinations. So, people hear voices. They don't see things. They hear things.

  • And you can wonder why you have these differences. I personally have the understanding that in both Alzheimer's disease and Parkinson's disease, you get such disturbances in the brain chemistry that the normal brakes that keep the serotonin system under control are not there any longer. The serotonin system starts to run amok, and you get an overstimulation of the 5-HT2A, the serotonin receptors that are related to hallucinations, and the serotonin receptors that we block by giving pimavanserin.

  • So, that's what I can say about pathophysiology and symptoms, and why we believe that, in fact, a drug like pimavanserin will be quite effective in dealing with the psychosis in these particular indications.

  • Roger Mills - EVP Development

  • Perhaps I can just add. I think, as Uli quite clearly outlined there, the fundamental pathophysiology of the two diseases is distinctly different.

  • However, in the clinical progression of both, there is a convergence of the symptomatology, so in Parkinson's disease, patients also not only get psychosis in later disease but also dementia as well, which obviously is the hallmark of Alzheimer's disease. So, you've got brain degeneration in both diseases, albeit starting -- a starting place is different. There is either a convergence of the pathways or a common trigger which occurs during that degeneration, and hence the great similarity between the two.

  • Charles Duncan - Analyst

  • Then my last question is, I know that you have limited resources both in terms of financial resource and then employees to execute, but when do you think we can hear something more about the potential to move forward in ADP or schizophrenia with the combination program? Is this going to be dependent on enrollment or actual completion of the -020 pimavanserin study in psychosis -- in And Parkinson's disease-associated psychosis?

  • Uli Hacksell - CEO

  • Charles, let me answer that by saying that we continue to believe that pimavanserin has significant potential to address a range of neurological and psychiatric conditions, including ADP and schizophrenia.

  • And while we currently have a focus on pimavanserin for Phase III, we will clearly try to use this program as a foundation to broaden pimavanserin's use into other indications at a later date.

  • As you know, in ADP, we have established a protocol for a Phase II feasibility study in [latent] schizophrenia. We have a path standard for development of a combination product and we will consider opportunities to move forward with the development into both of these indications. That is clearly something that we think is important to do at a later date.

  • Charles Duncan - Analyst

  • Would you consider that later date in the next 12 months? Or is it sometime beyond that, given the resource constraints?

  • Tom Aasen - EVP, CFO

  • Charles, this is Tom. I think right now, clearly the focus is on the PDP -020 study. I think that as we continue to progress, we will provide a little more color about our thinking in some of these other indications, but I think you can rest assured we really do see the clear synergies of our program and want to use the Phase III program as a very nice foundation to bridge into these other areas as well. But right now, clearly, the focus is on the -020 study.

  • Operator

  • Ladies and gentlemen, that concludes our Q&A session. Dr. Hacksell, please proceed to closing remarks.

  • Uli Hacksell - CEO

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

  • Operator

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