ACADIA Pharmaceuticals' (ACAD) CEO Steve Davis on Q4 2016 Results - Earnings Call Transcript

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ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Q4 2016 Earnings Conference Call February 28, 2017 5:00 PM ET

Executives

Lisa Barthelemy - Director, IR

Steve Davis - President & CEO

Todd Young - EVP & CFO

Terry Moore - EVP & Chief Commercial Officer

Serge Stankovic - EVP & Head, R&D

Analysts

Jason Butler - JMP Securities

Ritu Baral - Cowen

Tazeen Ahmad - Bank of America Merrill Lynch

Paul Matteis - Leerink

Charles Duncan - Piper Jaffray

Danielle Brill - Needham & Company

Ritu Baral - Cohen & Company

Operator

Good day, ladies and gentlemen and welcome to the ACADIA Pharmaceuticals' Fourth Quarter 2016 Financial Results Conference Call. My name is Kirsten, and I will be your coordinator for today. [Operator Instructions]

I would now like to turn the presentation over to Lisa Barthelemy, Director of Investor Relations at ACADIA. Please proceed.

Lisa Barthelemy

Thanks, Kirsten. Good afternoon and welcome to ACADIA's Fourth Quarter of 2016 Financial Results Conference Call. This call is being recorded and an archived copy will be available on our website at www.acadia-pharm.com through March 14, 2017. Joining me on the call today from ACADIA are Steve Davis, our President and Chief Executive Officer; Dr. Serge Stankovic, our Executive Vice President and Head of Research and Development; Terry Moore, our Executive Vice President and Chief Commercial Officer; and Todd Young, our Executive Vice President and Chief Financial Officer.

Before we proceed, I would first like to remind you that during our call today, we will be making a number of forward-looking statements, including statements regarding our strategy, including the timing, results or implications of clinical trials, other development efforts or regulatory approval; the benefits or advantages to be derived from future approval of and the commercial potential for our product and product candidates in each case, including NUPLAZID or pimavanserin; future commercial and financial results, and the future development and commercialization of our product candidate.

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 Steve Davis, our President and Chief Executive Officer.

Steve Davis

Thank you, Lisa and good afternoon. Let me first thank each of you for joining us on today's conference call. Today, I'll focus my comments on three areas -- first, I'll briefly highlight our 2016 accomplishments; second, I'll provide a brief overview of the status for our U.S. launch of NUPLAZID; and third, I'll touch briefly on our broad clinical program with primavanserin including the recent positive Phase II data we announced in Alzheimer's Disease psychosis. Following my remarks, Todd will discuss our financial results for the quarter; Terry will provide additional color on our key commercial priorities for NUPLAZID and Serge will go into a little more detail about our clinical development programs. I'll then wrap up with 2017 priorities and we'll open it up for Q&A.

2016 was an exceptional year for ACADIA. NUPLAZID was approved by the FDA in April as the first and only treatment for hallucinations and delusions associated with Parkinson's Disease psychosis. A month later we launched NUPLAZID and commit the process of effecting the paradigm shift that NUPLAZID represents. In the fourth quarter, we announced positive results from Alzheimer's Disease psychosis from our 019 Study of primavanserin. These findings further increased our confidence in the potential primavanserin to benefit patients in multiple disease states, representing sizable, medical and commercial opportunities.

Primavanserin has now shown antipsychotic results in clinical studies in three important CNS indications; Alzheimer's Disease psychosis, Schizophrenia, and of course Parkinson's Disease psychosis. In the fourth quarter, we added four new clinical programs for Alzheimer's Disease agitation, Schizophrenia inadequate response, Schizophrenia negative symptoms and major depressive disorder. So when added to PDP and ADP, we are now pursuing the total of six indications with primavanserin. Each one of these indications independently represent the potentials that dramatically impact our long-term growth and take them together, they position ACADIA to be a strong leader in the CNS space.

Let me now turn to our launch. In short, we continue to be extremely pleased with the strong progress of the launch. We continue to see solid growth and uptake of NUPLAZID and reported fourth quarter net sales of $12 million and $17.3 million for the full year 2016. During the quarter, we continue to observe a steadily growing number of patients starting therapy, together with the growing number of prescribers including repeat prescribers. We see good reimbursement on access for NUPLAZID where our Medicare formularies in our coverage by commercial plans continues to grow. These indicators are consistent with a very positive feedback we're getting from the medical community from patients and from caregivers. We hear that there are field force and market research pulsing of the medical community. Through these avenues, we've received favorable feedback from physicians on the clinical profile of NUPLAZID including its efficacy and favorable safety profile as well as on NUPLAZISconnect. Importantly, we've also heard many moving stories from patients and caregivers on how NUPLAZID is having a positive impact on their lives.

Our field forces also make significant inroads in broadening and deepening awareness of NUPLAZID. As we now started for this year, we're expanding our sales force from 133 to around 155 reps. Terry will add a little bit of additional color on that in his remarks. While we're still early in the launch, we continue to see strong foundational elements confirming our view that NUPLAZID sales will grow attractively over many years. These elements comprise for example a ground-breaking product in a first-in-class indication, good reports of efficacy and tolerability, physicians' intentions to prescribe and favorable access in reimbursement. Now let me turn briefly to our pipeline.

If the first Selective Serotonin Inverse Agonist or SSIA to be approved by the FDA, primavanserin represents not only an important advancement in PD psychosis, but also a potential important advancement in other CNS disorders. At the end of last year, we announced positive Phase II data with primavanserin in Alzheimer's Disease psychosis or AD psychosis as I noted earlier. As you're aware or would recall, the FDA has not approved any drug for the treatment of this disorder. We estimated based on scientific literature that AD psychosis supports approximately 25% to 50% of patients diagnosed with Alzheimer's Disease. The unmet need is vast.

As a back drop, atypical antipsychotics are frequently used off label to treat psychosis in these patients, but they represent suboptimal treatment option for a couple of reasons. First is meaningful safety and probability concerns and secondly, the fact that currently available antipsychotics have been shown to statistically significantly impair cognition in this patient population, making the primary symptoms of Alzheimer's Disease worse.

Data from our Study 019 show that primavanserin may achieve an antipsychotic effect without impairing cognition. We also saw a favorable tolerability profile in this elderly and throughout population that was on average about 10 years older than patients in our PD psychosis trials. We'll be advancing this program into Phase III in the second half of this year.

In support of this, we're in the process of scheduling an [indiscernible] meeting with the FDA and discuss our Phase III development program. We expect that to happen around mid-year. We also plan to present data from Study 019 in the second half of 2017. So in summary, we enter 2017 with strong momentum and we're committed to delivering strong results as the year progresses.

With that, I'll now turn the call over to Todd who will discuss our fourth quarter financial results.

Todd Young

Thank you, Steve, and good afternoon, everyone. Today, my comments will be focused on our financial results for the fourth quarter of 2016. For financial details related to our full year 2016 results, please take a look at the P&L and balance sheet included in today's press release.

For the fourth quarter of 2016, we generated net product sales of $12.0 million, with a growth to net percentage in the low 20s. As a reminder, we are still using the sell-through method for revenue recognition. Under this approach, we recognize revenue, one especially pharmacy, dispenses NUPLAZID to a patient, or when a specialty distributor sells NUPLAZID to a long-term care pharmacy or government facility.

Moving to the expense side of the P&L. Total operating expenses including cost of goods sold for the fourth quarter of 2016 were $90.2 million. R&D expenses for the quarter increased to $30.2 million from $20.5 million in the fourth quarter of 2015. This increase was primarily driven by the clinical cost related to our new studies in the area of Alzheimer's Disease, Schizophrenia and major depressive disorder, and the personnel and related cost including stock based compensation expense associated with our expanded research and development team.

SG&A expenses increased to $57.7 million for the fourth quarter from $22.6 million in the fourth quarter of 2015. This increase was primarily driven by the hiring of our specialty sales force in April of 2016 and investments we made to support NUPLAZID's commercial launch. For the fourth quarter, cash used in operations was approximately $63 million and we ended 2016 with $529 million in cash and investment securities on our balance sheet.

As we move into the first quarter of 2017, there are underlying dynamics that we believe may impact first quarter net sales more than other quarters of the year. First, we expect to have a higher gross to net percentage in the first quarter of the year, primarily due to ACADIA's contribution to the donut hole or Medicare Part B patients. We expect our gross to net percentage in Q1 to be in the high 20% range, which should be the highest percentage for the year.

Second, we believe some patients filled prescriptions in December because they've likely reached their planned deductible [ph] or have already progressed an entire Medicare Part B donut hole for the calendar year. This phenomenon which is not uncommon in our business likely resulted in some sales being pulled into the fourth quarter, but otherwise would have naturally occurred in the first quarter of this year. Third, similar to other companies in our space, at the beginning of the year, patients are managing the changes to their Medicare plans. We began preparing for this impact for our patients months ago and have staffed NUPLAZIDconnect to make this process as easily as possible for our patients.

In terms of the expenses for the first quarter of 2017, we expect our R&D expense to be in the high $30 million and our SG&A expense to be in the high $60 million range as we continue to invest in the life cycle management of primavanserin and the NUPLAZID launch. These amounts included projected non-cash stock based compensation expense. As we drive the commercial uptake of NUPLAZID and develop primavanserin for other indications with high unmet medical needs, we expect our cash used in operations to increase in 2017 compared to 2016.

I will now turn the call over to Terry who will lead the discussion on the commercial launch of NUPLAZID.

Terry Moore

Thanks, Todd, and good afternoon, everyone. My remarks today will be focused on commercial highlights from the fourth quarter, but I want to take just a moment to reflect on a few key accomplishments in 2016 we believe that contributed to the successful launch of NUPLAZID.

First, we saw Parkinson's Disease psychosis awareness significantly increase in the months leading after the launch and we believe our prelaunch disease awareness campaign enabled us to hit the ground running in helping healthcare professionals understand the prevalent and devastating consequences of Parkinson's Disease psychosis if not treated. Once approved, we believe the FDA provided us with the product label that allows us to fully convey the value of NUPLAZID in terms of its efficacy, safety, tolerability and no-impairment of motor control.

We are also very pleased with the reimbursement in access for NUPLAZID and the recognition of the innovation and benefits our product brings to the market. Just recently, we've been recognized by several professional bodies and just to mention a couple, the American Society of Consultant Pharmacists named ACADIA as the winner of its annual Hall of Fame Award, given for significant contributions to senior care, long-term care and consultant pharmacy practice. And NUPLAZID was presented with the Award for Outstanding Product by the California Life Sciences Association.

Now, turning specifically to the fourth quarter commercial highlights; we have had a strong introduction of NUPLAZID into the marketplace and are pleased by the solid uptake we saw in our second full-quarter commercialization. The use of NUPLAZID increased across all targeted segments with regular adaption occurring among movement disorder specialists. This was expected given the high density of PD psychosis patients these additions treat. In terms of prescriber mix to-date, about two-thirds of our prescribers are neurologists, a little less than 15% are psychiatrists, and the remainder are nurse practitioners and physicians' assistants supporting these decisions. Operationally, our sales force activity is robust and we continue to have good access to physicians.

As we announced earlier this year, we are increasing the size of our long term care sales force by about 20 specialists to increase our bandwidth in long-term care -- and just a brief word about that. We knew when we launch that we would need to get some experience in the field aside launching care sales force. As we look to the future, it was clear that we should expand our bandwidth to keep up in the long term care segment of our business and we expect to deploy these additional specialists in the field in the second quarter.

Moving on to NUPLAZID brand performance in the market; we are pleased to see brand awareness continue to increase with unaided awareness going from 62% of September to 74% in December, and aided awareness increasing 76% to 88% over the same time period. Currently, NUPLAZID prescriptions are approximately 70% switches from current therapy and approximately 30% are treatment of naïve patients. We continue to make good progress regarding access and reimbursement. NUPLAZID is our Medicare formularies, coverage of NUPLAZID by commercial insurance plans increased from 35% to over 60% of covered lives and continues to grow. Importantly, the majority of plans, whether Medicare or commercial require a simple prior authorization verifying that the patient has PD psychosis.

Our payer mix has filled out 75% Medicare, 15% to 20% commercial and the remaining 5% to 10% VA, Tricare and Medicaid. With regard to the VA, the Department of Veterans Affairs Pharmacy Benefits and Management Services has completed their review of NUPLAZID and has recently published their criteria for use guidelines often referred to as CFU. I am pleased to report NUPLAZID is now available within the VA system. Overall, we are very pleased with our progress regarding the patient's ability to access this important medication.

Moving forward, our commercial initiatives in 2017 will be focused on accelerating and facilitating dialog between physician and patients regarding their PD psychosis symptoms through disease awareness programs. Specifically, we are initiating new direct-to-patient programs through a variety of multimedia channels. For example, we will be increasing our presence at the local community level with Parkinson's Disease, psychosis disease awareness education exhibits and physician-led education programs at patient advocacy events.

Another crucial initiative will be educating key prescribers on the benefits of NUPLAZID and differentiating NUPLAZID based on improvement efficacy without impact-to-motor symptoms and a favorable safety and tolerability profile in frail elderly patients. You will also be informed to continue to remove barriers and facilitate greater physician and patient access to NUPLAZID through NUPLAZID connect and as mentioned previously, we'll increase our presence in the long term care segment through our sales force expansion.

With that, I'll now turn the call over to Serge.

Serge Stankovic

Thank you, Terry, and good afternoon, everyone. We've made tremendous progress in advocating on our broad development plans for primavanserin. During the fourth quarter, we reported positive top line results with primavanserin in Alzheimer's Disease psychosis and initiated four new clinical programs. As Steve mentioned, we are advancing our AD psychosis program into high street.

We've conducted further analysis of data of our Phase II 019 Study. We've referred the efficacy we observed on the primary measure. Importantly, data from this study provide significant learning that it's helping shape the design of our Phase III program. We look forward to preventing 019 data in the second half of this year and commencing Phase III program later in the year.

Let me now turn to our newer clinical programs. During our third quarter call last November, I highlighted two new programs we initiated in Alzheimer's Disease agitation or AD agitation and in Schizophrenia inadequate treatment response. Let me briefly touch on each. Our ADID patient study named SERENE is a 12-week, randomized, double-blind, placebo-controlled, multi-center outpatient study, designed to examine the efficacy and safety of primavanserin in approximately 430 patients with AD agitation. The primary endpoint is the reduction in total score on the current mental [ph] agitation inventory. Similar to AD psychosis, there is no FDA drug approved for AD agitation.

Our Schizophrenia inadequate response study named ENHANCE, is a six-weeks, randomized, double-blind placebo-controlled study designed to examine the efficacy and safety of attractive use of primavanserin in about 380 patients who have an inadequate response to current antipsychotic treatment. The primary endpoint is the change from baseline to week six on the Positive and Negative Syndrome Scale or PENSS total score. Both these studies commenced in the fourth quarter and are ongoing.

Since last quarter's call, we initiated two new clinical programs in the latter part of the fourth quarter -- one in negative symptoms of Schizophrenia and another in major depressive disorder. So let me go over each of these programs. First, let's start with our study with primavanserin for negative symptoms of schizophrenia. There is currently no drug approved by the FDA for the treatment of negative symptoms of schizophrenia. Given primavanserin's highly selective pharmacological profile, positive exploratory trials with all their compliance of similar pharmacologic activity and our clinical experience with primavanserin and schizophrenia, we believe primavanserin when added on top of an atypical antipsychotic may address this unmet need and improved clinical outcomes in patients.

Last November, we initiated ADVANCE, a clinical study to allow primavanserin for alternative treatment in approximately 380 patients with negative symptoms of Schizophrenia. It is a 26-week randomized double-blind placebo-controlled multi-center study with a flexible dosing regimen between 10 and 34 milligram primavanserin. The primary endpoint of the study is the trace from baseline to week 26 on the negative symptom assessment or NSA-16 total score.

Let me now turn to our clinical program with primavanserin in major depressive disorder. Some atypical antipsychotics are approved as the new alternative treatment in MDD. While atypical antipsychotic can boost antidepressant's efficacy, it comes to the price of significant side effects. Preclinical and clinical evidence suggest that the blockade of 5-HT2A receptors improves the clinical effects of Selective Serotonin Reuptake Inhibitors or SSRI. As in Selective Serotonin Inverse Agonist or SSIA, preferentially targeting 5-HT2A receptors, we believe primavanserin has the potential to provide added benefit as the new alternative treatment for MDD.

Last December, we initiated CLARITY, a 10-week, randomized, double-blind, placebo-controlled multi-center study designed to examine alternative use of primavanserin 34 milligram in 188 patients with MDD who have an inadequate response to standard antidepressant therapy with either SSRI or SNRI, Serotonin-Norepinephrine Reuptake Inhibitor. The primary endpoint of the study is the change from baseline on the Hamilton Depression Rating Scale or HAM-D total score.

With five CNS indications in development, in addition to our approved PD psychosis indication, we remain deeply committed to the development of primavanserin in a wide array of CNS disorder that are underserved by the currently available therapy and represent a significant unmet need.

With that, let me now turn the call back over to Steve.

Steve Davis

Thanks so much, Serge. We'd like a strong foundation for ACADIA in 2016 and look forward to build on that momentum on 2017. In 2017, our highest priority will be to continue the strong execution of the new private launch in PDP. We will also focus heavily on the continued execution of our ongoing programs in five additional CNS indications including the commencement of our AD psychosis study in the second half of the year. These are exciting times at ACADIA.

Just one additional note I'd like to say. I know I speak on behalf of all of my colleagues at ACADIA when I say we're very pleased to advance our programs in areas where we have the opportunity to make an important difference in the lives of patients who suffer from CNS disorders.

I'll now turn the call back over to Lisa and we'll initiate the Q&A portion of the call.

Lisa Barthelemy

Thanks, Steve. At this point, we'll begin the Q&A portion of our call. We ask that each person limit themselves to one question and then re-queue with any additional questions. Kirsten, please open the call for questions.

Question-and-Answer Session

Operator

Certainly. [Operator Instructions] And your first question does come from the line of Jason Butler from JMP Securities. Your line is open.

Jason Butler

Hi. Thanks for taking the question. I'm just wondering if you could give us any additional color on the long-term care piece here and what your market research tells you about the prevalence of patients with PDP in long term care facilities are? Do you have a sense of with the new reps, how many additional patients you could be targeting? Thanks.

Steve Davis

Terry is going to answer that question.

Terry Moore

Sure. We know that there's more business in long term care than we originally estimated. We don't have a definitive number. It is clear that we believe in our sales reps interacting with long term care facilities that the number of PDP patients is greater than we originally intended. To get the number is a little bit more difficult because prescriptions are not written in that environment. There's not a code that matches up for it. But generally speaking, we've had enough time now to see that there is greater opportunity in that marketplace than we originally thought.

Jason Butler

Okay. Thanks for taking my question.

Operator

Your next question comes from the line of Ritu Baral from Cowen. Your line is open.

Ritu Baral

Hi, guys. Thanks for taking the question and nice print. Question on used patterns for the drug. Can you talk about what you've seen so far? I know it's preliminary, but so far on persistence, on treatment. You mentioned the large number of switch patients. What's driving the switch? Search for better efficacy or search for better safety?

Steve Davis

Yes. Ritu, Terry will take this question as well.

Terry Moore

The answer is both. There remains and as we expect dissatisfaction of the market with patients currently on Seroquel. We know sedation plays a big factor in terms of side effects, but we also know that physicians are not seeing the efficacy that they are looking for with Seroquel. So it is both. We know early on that we got some difficulty treating patients, but now we're seeing that bounce out where we're getting both naïve and switch patients.

Ritu Baral

And persistence?

Steve Davis

I think it's just pretty mature for us to do that. It's one of the more difficult things to really pin down with any drug, but particularly it's the launch stage and I think we just don't have enough data yet to really be able to speak to that.

Ritu Baral

Understood. Thanks for taking the questions.

Operator

Your next question comes from the line of Tazeen Ahmad from Bank of America Merrill Lynch. Your line is open.

Tazeen Ahmad

Hi. Thanks for taking my question. Steve, just wanted to get a little bit of color on what you were talking on about, about the donut hole sort of resetting at the beginning of the year. I know you're not giving out guidance, but directionally, how should we be thinking about when Q results in terms of the potential for the ramp up we saw between your first quarter and your second quarter versus what we should expect to see in terms of uptake for this quarter if you can?

Steve Davis

Sure, Tazeen. Todd is going to respond to that question.

Todd Young

Yes, Tazeen. As I mentioned, we're expecting a high 20% gross to net in Q1. That is driven by the donut hole resetting for all of our patients on January 1. That Medicare impact is based on the calendar year. So as a patient has the standard benefit under Medicare, there are first prescription for a drug and not any drug, not just ours, the first $400 they have to pay are the deductible. Then they go into an obligation to pay 25% of the next -- approximately $3,300 and then they reach into a part where we start to have to pay on a portion of the drug cost and that's the donut hole. As we flow through the course of Q1, all of our patients that we had entering the year already on therapy, we'll be giving refills and they will enter the donut hole again. That's what they did when they got their first bottle score up earlier in 2016. As a result, we will have this higher Medicare obligation in Q1 that essentially as that patient exits the donut hole which is after having a little over $8,000 in prescription to drug costs across all the drugs they're taking, our liability, the donut hole goes away. That's why I said on the prepared remarks we're expecting Q1 to be our highest growth in that percentage as a result of that donut hole calendar year reset.

Tazeen Ahmad

Do you expect any lingering results heading into 2Q for some patients?

Todd Young

Sure. As you think about new patients that adapt new [indiscernible] over the course of the quarter, we will have this every quarter of the year. There will be certain patients that are entering the donut hole and there will be certain patients that exit the donut hole. This is not purely a Q1 phenomenon. We had this in Q4 of last year and then Q3. It's just that as many of our patients are taking other prescriptions, the timing of their entering and exiting the donut hole will defer based on their overall financial profile for their drugs. That being said, we expect more in Q1 just because we have those entering the year who are already on therapy.

Tazeen Ahmad

Okay, thanks.

Operator

And your next question comes from the line of Paul Matteis from Leerink. Your line is open.

Paul Matteis

Thanks you so much for taking my question. I appreciate it. Ahead of the FDA meeting on Alzheimer's psychosis, I was wondering if you could expand upon what your expectation is regarding the size of the safety database in that indication and how much of the safety data you think is leverageable in PDP versus how much new safety data do you think you need in the broader demand to population given of course the black box warning and the meta analysis done any typicals? Thanks so much.

Steve Davis

Serge?

Serge Stankovic

Yes. As Steve mentioned, we are in the process of scheduling the FDA meeting and preparing our proposals for the discussion with the FDA. Therefore, it's a bit premature for us to discuss the specifics of the proposal that we will make with the FDA. But to respond to part of your question, I think we certainly believe that our totality of the safety database we accumulated so far in Parkinson's Disease psychosis as well so far in Alzheimer's Disease psychosis will contribute substantively to the overall safety database that we will be proposing for the development in Alzheimer's Disease psychosis. And we also do not believe that the class box warning that exist for all antipsychotics is in any way impediment for us to pursue and achieve this indication.

Paul Matteis

Thanks, Serge. If I can just clarify quickly, are you just proposing a single pivotal study?

Serge Stankovic

As I said, we have developing program and we are at this point not discussing publicly our proposal until we actually have a meeting with the FDA and discuss specifics and agree on the program.

Paul Matteis

Okay, I totally understood. Thanks very much.

Steve Davis

Thank you.

Operator

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

Unidentified Analyst

Hi, guys. This is Shaun [ph] for Cory Kasimov. Thanks for taking my question and congratulations for the performance this quarter. Just a brief question on some of your ongoing Phase II trials. Specifically the Alzheimer's agitation and the Schizophrenia trial with the negative symptoms, I noticed that these are Stage II trials, but the patient population is quite large and they're quite a straightforward trial design. I was wondering if you could comment on whether or not there is a chance that these two trials could potentially be pivotal?

Serge Stankovic

Yes. Thank you for the question. First of all, let me just say that in principle, our position is when we are conducting the Phase II trials, or that we try to design a robust trial that will be capable of giving us definitive conclusions in terms of the potential of primavanserin in terms of both safety and efficacy. Therefore, this trial indeed are sized up as similar that Phase III trials would be. These are well-controlled trials, placebo-controlled on the side that certainly may be a part of the pivotal program for approval if trials are positive. So we do certainly expect that they're positive and the data justify our pursuit of indication that these trials will be part of the submission.

Unidentified Analyst

Okay. Thank you. That's helpful.

Operator

Your next question comes from the line of Salveen [ph] from Goldman Sachs. Your line is open.

Unidentified Analyst

Hi. Congrats on all the progress and thanks for taking my questions. This is Carey [ph] on the line for Salveen. Yes, just quickly, maybe just going to the AD psychosis study, that readout, what are some potential design modification and strategies to mitigate placebo risk particularly at the later time points in the study? Thank you.

Serge Stankovic

Well, I will just repeat what we've been saying and what I mentioned earlier that 019 study results are really a treasure to information that we are using in shaping and designing our Phase III program. To that effect, we will earn quite a bit of specific design features for the next program both in terms of what would we do in control of the placebo response, how would we think about the duration of efficacy and response and many other elements. At this point, we are refraining for publicly discussing that for a number of reasons -- notwithstanding competitive reasons -- but also until we actually have a discussion with NDA and settle on the design of those programs. It's pretty immature for us to speak and provide the details of what we are proposing.

Operator

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

Charles Duncan

Hi guys. Thanks Steve and team Acadia congratulations on a great quarter. I also had one question, which has two parts one is commercial. With regard to Terry's comments he listed our four, I think initiatives in '17. And I'm wondering if he could pick one, could it be long term care or disease awareness that he would like us to focus on in terms of driving growth for '17 and then for Serge with five potential label expanding trials going on it. If you could provide some insights on where there's been most interest thus far or if, which one has the highest probability of success in your view given the rationale and the clinical data? That's about it.

Steve Davis

Sure. We're going to go with Terry's question first.

Terry Moore

Alright. So in terms of key growth drivers, the long-term care effort is really -- our intentions are to keep up with what we believe is there. We know where to get business there, but we don't feel that we'll meet the current potential. The key drivers moving forward I think are disease awareness with patients and speaking with physicians is going to be a key driver. And really, we cannot let up on the repetition that necessary to cause a paradigm shift for patients being on unapproved NUPLAZID. That requires as we said before, time and it's going to be very important that we continue to differentiate the product based on the price merit and what it brings to the party. But party equation now is clearly making sure that patients are aware that their symptoms are associated with Parkinson's disease and that they speak to their physicians about it.

Steve Davis

Terry, just to clarify one point; I think you said in long-term care, you said like we wouldn't be able to keep up with the potential. I think what you were saying is, if we didn't expand the long-term care sales force, we might not be able to keep up with the potential.

Terry Moore

That's what I meant.

Steve Davis

We might do that to maintain the balance.

Terry Moore

Thank you.

Steve Davis

Okay, Serge?

Serge Stankovic

Charles, a great question. Thank you for asking that. I do want to actually think back more than a year, we went through a very disciplined and tedious process in terms of thinking through our life cycle management opportunities. And ultimately settled on to life cycle plan pimavanserin that the principal requirement for all this is that there is a real unmet need.

So looking at five indications that we are pursuing, it's very difficult for me to say which one is favored. Obviously we all have our own biases in terms of one or the other indications. But each of these indications, we look at them as significant need and certainly a great potential for pimavanserin and try to remain unbiased and neutral in executing the program, so that we can ultimately evaluate how much of the potential can be realized including the clinic. I'm sorry it maybe a little disappointing to not give you any favorites, but that's really the truth of the matter.

Charles Duncan

No worries regarding the crystal ball, congrats on a good quarter. Thanks for the added color.

Steve Davis

Thanks, Charles.

Operator

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

Danielle Brill

Hi guys, this is Danielle on for Alan thanks for the question. I was just wondering if you could comment on MAA status and whether there have been any developments on ex-US strategy.

Steve Davis

I'll take a stab at that. Serge jump in if I miss anything. So on the MAA, what we have reported previously is that we frame shifted that submission. And we made the determination once we got the -019 results and with ADP and determine that given the -- where we stand in Europe relative -- thinking through our patent life versus the tenure data exclusivity that we have, we felt like it would be. We'll be in a better position to frame shift that submission to try to position ourselves so that we have the potential to capture more patients for more indications within that timeframe.

So we haven't given any further guidance in terms of when we will, but we said at the time that our expectation is the next datapoint that we'll evaluate will be when we start getting some data back from these studies that are ongoing now. So that's going to be a while. But once we do that, we'll access again and decide whether we think that' the right time.

Danielle Brill

Great. Thank you.

Serge Stankovic

Just to add in respect to started we did receive agreements and approval on the pediatric investigation or plan which was last administrative check that we needed to have for approval. So from that perspective, we are ready for submission at any point when the decision is made to do so.

Danielle Brill

Thank you.

Operator

Your next question comes from the line of Ritu Baral from Cohen. Your line is open.

Ritu Baral

Hi guys. Thanks for taking the follow up. I wanted to just ask about what you are seeing as far as trends on time to say look for the prescriptions in the launch and since we last spoke have there been any changes overall on say the most severe or more strict, pre-authorization requirements? Like what's the highest bar is out there if you continue to make progress with payers. And then Serge, is there any way that you can comment on enrollment for SERENE and ENHANCE. I know it's early, but maybe number of sites that are open enthusiasm for enrolment amongst [indiscernible] is that you see?

Steve Davis

Ritu, we're going to actually take your last question first. Serge you want to address that?

Serge Stankovic

Yes. Ritu, it's very early in the program to comment on the enrollment. We're still really monitoring that. But I do, I can say that there is quite a bit of enthusiasm that we are seeing with the investigators to be part of the programs. So from that perspective in terms of identifying investigational sites both in the U.S. and globally, as we are doing these trials globally other than depression trial which is only done in United States. We have quite a bit of enthusiasm there. But we do want to see a few more months of recruitment to access how really the recruitment is going and to project and provide some guidance in terms of the duration of the trial and how long it will take.

Steve Davis

Terry, you take the first question.

Terry Moore

Ritu, this is Terry. In terms of the timing, it takes about five to 10 days on average when the physician puts in the form to us for the patients to receive the 30 day free trial. And the adjudication process does occur in that timeframe in the most part.

Steve Davis

Then I think another part of her question just progress on the payer front in terms of restrictions ever since.

Terry Moore

Right. Today the majority of plans are requiring nothing more than a simple verification of the PDP diagnosis. So that trend continues.

Steve Davis

And there is roughly about 60% of plans that have now put formulary in the commercial space, that's what our targeted plans for Medicare.

Ritu Baral

And what's the strictest pre-auth that you guys have seen so far.

Terry Moore

The strictest is then requiring an MMSE examination or sometimes they step into a Seroquel prescription first those are generally the most restrictive.

Ritu Baral

Yeah. Got it. Thank you for taking all the follow-up.

Operator

We have no further questions at this time Mr. Davis. Please proceed the closing remarks.

Steve Davis

Just like to say thanks again to everyone for joining us on today's call and for your continued support. We look forward to updating you on our future progress.

Operator

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

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