ACADIA Pharmaceuticals Inc. (ACAD) Q2 2016 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to ACADIA Pharmaceuticals’ Second Quarter 2016 Financial Results Conference Call. My name is Doris and I will be your coordinator for today. [Operator Instructions] I would now like to turn the presentation over to Lisa Barthelemy, Senior Director of Investor Relations at ACADIA. Please proceed.

Thank you, Doris. Good afternoon and welcome to ACADIA’s second quarter 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 August 18, 2016. Joining me on the call today from ACADIA are Steve Davis, our President and Chief Executive Officer; Dr. Serge Stankovic, our Executive Vice President, Head of Research and Development; and Terry Moore, our Executive Vice President and Chief Commercial 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 candidates in each case, including NUPLAZID or pimavanserin; and the future development, launch and commercialization thereof. 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. It’s my pleasure now to turn over the call to Steve Davis, our President and Chief Executive Officer.

Thank you, Lisa and good afternoon. Let me first take the opportunity to thank all of you for joining us on today’s conference call. Today, I will address three areas in my prepared remarks. First, I will touch upon to recent commercial launch of NUPLAZID for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis or PD psychosis. Second, I will discuss the important work we are conducting to execute on our comprehensive lifecycle program in the planned expansion of pimavanserin into other areas of significant unmet medical need. And third, I will review our second quarter financial results. Following my remarks, Terry will lead the review of the launch of NUPLAZID and our key commercial priorities and Serge will lead the review of our pipeline, including ongoing and planned clinical programs for pimavanserin. Let me first start by saying the past several months have been an exceptional period for ACADIA with the FDA approval of NUPLAZID on April 29, followed by our commercial launch on May 31. As many of you know, PD psychosis is a very debilitating condition. It’s characterized by hallucinations and delusions that increase in severity and frequency over the course of the disease. It is associated with significant caregiver burden and is one of the strongest independent predictors of nursing home placement for Parkinson’s disease patients. NUPLAZID is the first and only FDA approved medicine to treat the hallucinations and delusions associated with PD psychosis. The introduction of NUPLAZID represents a major paradigm shift in the treatment of patients with PD psychosis. As we all know Parkinson’s patients suffer from deterioration of a part of the brain that produces dopamine and they take dopamine replacement therapy or dopamine agonist to treat their primary motor symptoms. We believe about 40% of Parkinson’s patients suffer from psychosis, which tend to emerge in the more advanced stages of the disease. When controlled, their motor symptoms can be very challenging. Historically, drugs typically used to treat psychosis, none of which are approved for the treatment of PD psychosis, blocked dopamine and therefore can interfere with the drugs Parkinson’s patients take to treat their motor symptoms. As a first-in-class first-in-disease therapy, NUPLAZID treats hallucinations and delusions without blocking dopamine receptors and therefore does not impair motor function in these patients. While we are in the early stages, we are very excited about the progress we are making on our launch. Operationally, the launch of NUPLAZID has gone very well and we are executing on our plans to bring NUPLAZID to patients in need. Just as a reminder, our key commercial priorities are to broaden awareness in NUPLAZID to ensure patient access and work with payers to secure reimbursement. While Terry will touch upon the work we are doing here in greater detail later on in the call, I will provide you with a few highlights. We on-boarded and trained our sales specialists in April and May and deployed them at the time of launch. As a group, they bring with them extensive CNS sales experience, and they along with our medical affairs team are educating physicians on NUPLAZID. At the time of approval, we launched our NUPLAZIDconnect patient and physician support system and began receiving treatment forms from physicians and calls from patients. Along with our commercial team in the field, we are expanding awareness of NUPLAZID through a number of programs and initiatives. Our speaker program and digital and media campaigns for NUPLAZID were initiated at the time of launch and are ongoing. We also had a strong presence at medical meetings with product symposia at the American Psychiatric Association Annual Meeting held in mid-May and at the 20th International Congress of Parkinson’s Disease and Movement Disorders held in mid-June. We recently hosted a NUPLAZID national broadcast webinar featuring experts in the field of PD psychosis. Over 1,200 healthcare professionals participated in this national webinar broadcast. On the payer front, our account team began meeting with national and regional payers upon approval. The continued execution on our commercial plan will be important as we educate physicians and payers about NUPLAZID. While our top priority is the successful commercial launch of NUPLAZID, we are also conducting very important work in executing on our multiyear plans to develop pimavanserin in indications beyond PD psychosis. We have completed enrollment in our Phase 2 exploratory study with pimavanserin for Alzheimer’s disease psychosis and remain on track to announce top line results by the end of 2016. Serge will provide some additional color in a few minutes. Turning now Alzheimer’s disease agitation, we look forward to initiating this Phase 2 study with pimavanserin in the second half of 2016. In addition to Alzheimer’s psychosis and Alzheimer’s agitation, we have additional clinical starts in other indications that we will announce by the end of this year. Let me now turn to our second quarter financial results. Net product sales for the quarter were $97,000. As we previously described, physicians are able to prescribe to any patient a 30-day free trial, and the mechanism for doing this is built into the form physicians use to initiate the prescription to our new NUPLAZIDconnect site. To date, the vast majority of patients have received the 30-day free trial. Of course, when patients are taking free samples, this does not result in revenues. Having launched the drug on May 31, the $97,000 of revenues we recorded represents those patients who did not receive the free trial. And I just want to remind you that we currently recognize revenue when a specialty pharmacy dispenses NUPLAZID to a patient based on the fulfillment of their prescription or a specialty distributor sells NUPLAZID. This approach is frequently referred to at the self-through revenue recognition model and is a common practice for companies launching their first product. Total operating expenses for the second quarter of 2016 were $72 million. R&D expenses for the quarter increased to $20.5 million from $18.4 million for the comparable quarter of 2015. This increase is driven by the following factors: one, increased personnel and related cost, including stock-based compensation expense associated with our expanded R&D organization and two, increased clinical cost related to the development of pimavanserin in additional indications other than PD psychosis. These increases were partially offset by decreased manufacturing development costs. SG&A expenses increased to $50.8 million for the second quarter from $21.1 million for the comparable quarter of 2015. And this increase was driven by the following. First, increased costs related to preparations for and support of the commercial launch of NUPLAZID. Second, costs associated with hiring of our specialty sales force in April of 2016. And third, increased costs related to additional medical education programs. Let’s now turn to our cash position. We ended the quarter with $412.6 million in cash and investment securities. For the second quarter, cash and investment securities decreased to $44.6 million. And I would just like to point out a couple of non-operating cash items for the quarter. On the inflow side, we received proceeds of $14.3 million during the quarter pursuant to a settlement agreement with certain stockholders who sold shares of the company’s stock in 2013 that may have resulted in impermissible short-swing profits. On the outflow side, we paid $8 million for a regulatory milestone payment during the quarter pursuant to our license agreement with the Ipsen Group and this was in connection with the FDA approval of NUPLAZID. We expect our cash used in operations to continue to increase in future periods in connection with our commercial activities and as we continue to make the kinds of investments in our pipeline that we believe will leverage the full potential of pimavanserin. Let me now turn the call over to Terry, who will lead the discussion on the commercial launch of NUPLAZID.

Thanks Steve and good afternoon everyone. I am pleased to provide an update on our ongoing commercial activities for NUPLAZID. We are executing on a commercialization plan that is focused on broadening awareness of NUPLAZID, ensuring patient access and achieving broad coverage. While it is still very early days in the launch, based on our market research and feedback from the field, it’s very gratifying to see the increased awareness of both PD psychosis and NUPLAZID as a first and only approved drug by the FDA for the treatment of hallucinations and delusions associated with PD psychosis. Market research we recently conducted showed that the number of PD psychosis treating physicians who recognize psychosis as a co-morbidity associated with Parkinson’s disease has more than doubled from where the number was prior to when we began our disease awareness campaign in 2015. This research also showed that of the PD psychosis prescribers who had been exposed to NUPLAZID information, 71% recall that NUPLAZID is the first and only FDA approved treatment for hallucinations and delusions associated with Parkinson’s disease psychosis. And among those aware of NUPLAZID, 73% are familiar with its attributes. These early results are encouraging and tell us that the core messages we want to communicate about NUPLAZID are starting to resonate with our target physician audience. I would like to emphasize that as we said before new products require market education, especially one with a new mechanism of action in a disorder where there has been no approved therapy. While it’s very, very encouraging to see our core messages resonating with our audience, it takes time for this to translate into a change in physician prescribing behavior. I would like to note that we believe the potential for strong growth over time is very attractive. The majority of our early efforts have been focused on neurologists, who are the largest segment of our target market, as well as other PD psychosis prescribing physicians, including psychiatrists and doctors and long-term care facilities as planned. We have identified over 12,000 healthcare professionals as our target audience of prescribers. Through the end of July, we had called on over 9,700 healthcare professionals. We also have multiple healthcare professional awareness efforts underway to increase NUPLAZID recognition and highlight the innovation it provides. In addition to the national broadcast webinar we hosted last month, we have conducted 130 key opinion leader led speaker programs for healthcare professionals through the end of July. These programs serve as educational peer-to-peer meetings for healthcare professionals who wish to learn more about NUPLAZID and PD psychosis. In regards to the payer landscape, our account management team has made excellent progress in contacting and meeting with the payers covering the majority of plans responsible for covering the majority of PD psychosis lives and educating them on the benefits of NUPLAZID. In terms of formulary status and placement, as we shared previously, Medicare Part D payers have 90 days from the time the product is made available to review NUPLAZID and place the product on their formularies. Commercial plans can take up to six months to nine months longer to take their formulary decisions, so it may be some time before we know our status there. Consequently, most NUPLAZID prescriptions to-date have been processed as exceptions rather than under formulary. The majority of NUPLAZID claims being adjudicated today require either a prior authorization or a medical letter of necessity. Now, I do want to caution everyone that restrictions for any of these plans may change once NUPLAZID is formula reviewed and placed on formularies of plans that have not yet made a determination. While it is still early in the launch, as we have previously stated, we believe NUPLAZID will be broadly covered with the most common prior authorization to be confirmation of PD psychosis diagnosis. Moving now to our patient and physician support system, the early anecdotal feedback on NUPLAZIDconnect has been quite positive and we are pleased that our system appears to be both patient and office staff friendly. We are also pleased to see how quickly patients are able to receive product once the physician prescribes the 30-day free trial through NUPLAZIDconnect. On average, it takes about five days to ten days between the time the physician submits the form to NUPLAZIDconnect and product ships to patients. In summary, we are energized and inspired by the Parkinson’s patient community that we serve and we are thrilled that we are able to provide a new option for patients suffering from PD psychosis. And with that, I will turn the call over to Serge.

Thank you, Terry and good afternoon everybody. We have had a very productive first half of 2016 with the FDA approval and launch of NUPLAZID. In parallel, we have also made significant progress in building our R&D capabilities to enable us to execute on the broad development plans for pimavanserin. Let me start with our efforts in Alzheimer’s disease and the two programs we are pursuing there. Similar to Parkinson’s disease, Alzheimer’s patients experienced a number of serious neuropsychiatric complications including psychosis and agitation. Today there is no FDA approved treatment available for patients with Alzheimer’s disease psychosis or Alzheimer’s disease agitation. As Steve mentioned, we have completed enrollment in our exploratory Phase 2 study with the pimavanserin in Alzheimer’s disease psychosis or AD psychosis. Just some background on this study, this study, our first in AD psychosis, is being conducted through a single site with a large network of nursing homes in the London, England area. As you are aware, the study has taken longer to enroll than we originally anticipated due in part to the logistics of having the study conducted at just one site. Let me remind you of the key parameters of this study. This is an exploratory Phase 2, 12-week randomized, double-blind, placebo controlled study designed to examine the efficacy and safety of 34 milligram pimavanserin compared to placebo in patients with AD psychosis. We enrolled 181 patients in this study. The primary endpoint is psychosis as measured by the Neuropsychiatric Inventory – Nursing Home version, subscales for hallucinations and delusions or domains A and B at study week six. We are also assessing secondary measures, including behavioral symptoms and sleep. Additionally, we are assessing Mini-Mental Status Exam over 12 weeks of treatment in order to demonstrate that pimavanserin does not have a negative impact on the cognitive status of these patients as compared to placebo. We look forward to announcing top line data from this study by the end of this year. Let me now move to Alzheimer’s disease agitation or AD agitation, a new and complementary program to our AD psychosis program. Agitation is a debilitating condition that affects approximately 40% to 50% of Alzheimer’s patients. Similar to PD psychosis and AD psychosis, AD agitation can have a major impact on the quality of life of patients and caregivers and often is a precursor to nursing home placement. Agitation presents early in the prognosis – progression of Alzheimer’s disease and earlier than psychosis symptoms, and once present, intends to be recurrent and sustained. Symptoms of agitation include verbal aggression, physical aggression and excessive motor hyperactivity. We plan to initiate a Phase 2 randomized placebo-controlled study with pimavanserin in AD agitation in the second half of 2016. As Steve noted earlier, in addition to advancing in Parkinson’s disease psychosis, Alzheimer’s disease psychosis and Alzheimer’s disease agitation, we will be announcing later this year the advancement of pimavanserin in additional indications of high unmet need. Now, let me provide you with a brief update on the status of our proposed pediatric investigation plan, or PIP for Europe. As you are aware, having an approved PIP or PIP waiver is a requirement prior to submission of our NUPLAZID market authorization application to the European Medicines Agency. We plan to resubmit our PIP to the EMA during this quarter. To that end, we already had a resubmission teleconference with the pediatric committee rapporteur and peer reviewer regarding our plan PIP submission. We will need to go through the PIP review process and obtain pediatric committee approval of our plan before we can file our MAA in Europe. Let me now turn the call back over to Steve.

Thanks, Serge. In summary, it’s been incredibly productive and rewarding last several months for all of us at ACADIA as we received the FDA approval of our first medicine to treat patients with hallucinations and delusions associated with PD psychosis and worked quickly to make it available to patients. Going forward, we will continue to focus on the successful commercial launch of NUPLAZID and make investments in areas where we believe we can make a meaningful advance in patient treatment. We look forward to pursuing a broad development program with pimavanserin in areas of large unmet need. I will now turn the call over to the operator to commence the Q&A session.

[Operator Instructions] Our first question is from Ritu Baral with Cowen.

Sure. Thanks for taking the question. Steve, on the 9,700 physicians that you said that you have called on already can you help us characterize who they are a little better sort of – are they – like you said, are they mostly neurologists? Do you have those physicians stratified by tier as far as who is a high potential responder and how many of those represent the 9,700?

Yes, great question. I am going to turn that over to Terry.

Sure. Hi, Ritu. We knew ahead of time going into the launch who our high prescribers were and those were the first places we stocked. We knew that they would be the low hanging fruit that they would have the most patients and so our activity was directed there but also on other neurologists. As you heard, we had some really nice reach early on in the program, and so we’re able to get to not only neurologists but also psychiatrists and a number of key folks we identified in the long-term care environment. So we’re very pleased with the folks that we have got to and that we are seeing some of the fruits of those efforts.

What percentage of the 9,700 is low hanging fruit and how often do you plan on calling on them going forward for the near term?

Well, yes, I probably can’t give you the number in terms of giving some unnecessary guidance, but I think it’s safe to say that the majority of our prescribers are neurologists and that the frequency we’ve had on them to date has been significant.

And just to maybe add a little bit of additional color. So, we tier physicians and on our target list into three tiers, the target list is a living document so it changes. One, we revise it to reflect local information from our reps, the vast majority of which are continuing to operate in the regions or live where they are already the physicians when we hired them. And of course, you would note, diagnostic code, it’s required a lot of work – diagnostic code for PDP, it’s required a lot to work as we have described before for us to determine who is a PDP writing physician and to be able to assess them. And so recognizing that, we also – we knew that this would not be perfect. There would be some physicians who would write new clients and they are not on the list. And there will be, of course, a lot of physicians that fall in the list that won’t write new clients eventually, but recognizing all of that, we prioritize – our Tier 1 list is about 1,000 physicians, so we prioritize them. And I am not sure that it is really the way to describe them. I think I would just say, they are the highest priority. They are primarily movement disorders specialists. We know they are the ones that write, that treat Parkinson’s patients in higher volume. They, based upon our research, they are the ones that treat PDP more frequently. And so those are the ones that, of course, we prioritize highest. Terry mentioned in his remarks and as we have mentioned before, I just want to underscore two things. One is, when you have a drug that represents a potential paradigm shift, it takes time and so – and that’s what we would expect here. Very quickly though, I will say based upon our market research, based upon everything we have seen in the launch so far and I will say the launch has gone exactly or about as close to as we would have expected it possibly could be, we are right on plan with the launch. And based upon all of that, we think the potential for strong revenue growth over time is very, very attractive, but it takes a little bit of time to penetrate the market and really educate physicians on the benefits of a drug where they have had nothing in the past and it’s a very new mechanism of action.

Got it. And given how aggressive you have been on the number of calls, as we look at the SG&A for this quarter, the $50.8 million, should we see that as sort of a run rate for quarters going forward or will it creep up even from here?

There are a lot of numbers that is going to move around a lot. I wouldn’t necessarily use that as a run-rate going forward. There are a lot of expenses that we incurred with the launch precisely around the specific launch of the drug in terms of getting the sales force trained, national launch meeting etcetera. So, you have a number of kind of nonrecurring types of expenses embedded in that as well. Having said that as I mentioned in my prepared remarks, our operating expenses will continue to go up over time, we anticipate that we need to make meaningful investments, which we will be making in the further development of pimavanserin in the new indications that we have described. And we want to make certain that we are making the right investments today in the launch of the drug that we believe will pay dividends in the future.

Got it. Last question, hopefully this is going to be a quick one. Is the PIP the only rate-limiting event to you filing in Europe? Do you have clarity on not needing any comparative control data for CHMP?

Serge, do you want to take that question?

Yes, absolutely. The answer is yes, obtaining an agreement on pediatric investigation and plan. It is a rate-limiting factor for our filing. Everything else, we had meetings with the EMA and we have a good understanding on moving forward with the filing once we obtain the agreement.

Great. Serge, Terry, Steve, thanks for taking all the questions.

You bet, Ritu.

Our next question is from the line of Charles Duncan with Piper Jaffray.

Hi guys. First of all, probably old news in the lines of Wall Street, but congratulations on a transformational quarter.

Thanks.

Thanks Steve. Three quick questions one on the NUPLAZID launch, one on ADP and one on ADA, on the NUPLAZID launch just maybe stepping back, what do you think what – if you just look at the key operating metrics for tracking sales force productivity as well as NUPLAZID adoption, what’s the thing that you are watching for internally or that you might be able to talk about in the future besides prescriptions or revenue?

Well, let me start and Terry feel free to jump in if you like. Let me just start by saying it’s easy, of course we are monitoring information every day and we are getting a lot of data every day. It would be very tempting and very easy during the course of the launch to over-interpret the data and change course prematurely. What I would say is what we are seeing so far is really played out just about exactly as we thought it would. Of course, there are some things that will evolve differently than we anticipated. But from an overall perspective, it’s really operating just about exactly as planned. So the important thing is to stay very much on plan and continue. We had a lot of time to prepare for this launch. We understand the marketplace better than anyone on the planet. And the important thing is just to continue on track, continue executing, making certain that we are both executing at an appropriate depth, that is frequency of calls on the physicians that are on the higher on our priority list or at the higher tier, but also establishing breadth. We need to get the word out. We haven’t hit all the physicians on our target list. We need to do that. We have hit more neurologists and psychiatrists. So we will be expanding our reach even broader there. So there are a number of things that we need to do to continue on track. But a little over 60 days into the launch, I would say everything has gone very well so far. Terry, you have anything to add?

No, I think making sure that physicians are getting a high quality message. As I shared, we are encouraged that early on, even with the frequency we have had at 60 days, there is message recall that tells us that the message is resonating. Those are key things we want to look at. It’s a matter of getting the right message to the right physician with the right amount of frequency. And we are off to a very good start there.

Super, that’s helpful. Perhaps one or two for Serge in terms of the future, on the ADP program Serge, I know that you didn’t design it and it’s been a challenging program, but let me ask you what you would be looking for beyond the obvious statistical significant difference in NPI and perhaps what would you have done differently with ADP even before knowing the data out of ADP?

Well, it’s obviously looking at things in retrospect is always easy, so I will try to be very cautious about making certain judgments in absence or not being in a real situation at the time of the design of the study. What I would say first of all, very important question. We are doing this study to learn about the patients, about the suitable design and the patient profile that is the responder. So to your question, what I will be looking for, in addition to just a simple statistical analysis is exactly that, looking at the profile of patients that have responded to treatment and have benefited from treatment and try to tease out characteristics of those patients and what we can learn from the future trials in that respect. Obviously, this trial is done in an environment of nursing homes and implication of that is that there is a certain severity of disease of these patients and they are advancing in their disease. We will be looking at the benefits in that patient and maybe looking at if there are any differences in terms of severity of disease and symptoms and advancement of cognitive symptoms and how response is. So there is a number of things that we are really looking forward to learn from this study that we will be able to apply into our further studies in these indications. Another thing that we are looking with a great interest is as we are measuring a number of behavioral symptoms, we will be looking for signals of benefit in agitation sleep and other symptoms so that we can actually learn a little bit more in terms of the benefits of pimavanserin in other neuropsychiatric symptoms.

Okay, that’s helpful. And last question is regarding ADA, I am wondering if you can provide any rough order of magnitude thoughts on the design for timing of that study, I imagine we will hear details when it’s actually listed on ClinTrials, but thoughts on sizing or timing on that?

Well, we will be as you said, announcing that at the time of the initiation of the study. But I mean this AD agitation study will not in terms of its size or in terms of the duration of recruitment, will not differ from the other studies that you have been seeing already being conducted in Phase 2 programs that other companies have been pursuing.

That’s helpful. Thanks for the added information. Congrats on a good quarter.

Thank you.

Thanks Charles.

Our next question is from the line of Bert Hazlett with Ladenburg.

Thank you very much. My question is with regard to your gross margins, a number of other ones have been answered already, but my question is with regard to gross margin, at what point should we see kind of a normalization of the gross margin and is that ten months out, is it seven months out and at what rough level would you expect that to stabilize?

Yes. Thanks Bert for the question. So in the early days, as I am sure everyone on this call has experienced and as we said before, gross to that starts out – it can be very high, but then settles down. COGS, same thing, it can start out very high and then settles down. So the cost of goods that we reported for the quarter were $526,000 on $97,000 of revenues. So obviously, we are experiencing what you often experience as you got a certain embedded costs or fixed costs. And then you also have occasionally non-recurring costs that gets loaded into those numbers, particularly in the early days of the launch. The important thing as we think about gross margins and we think about COGS is that what we anticipate once the dust settles is pharmaceutical type margins for small molecules and so that is in the single-digits. So that’s what we anticipate, it’s a nine step synthesis. It’s a very straightforward manufacturing process. So we would anticipate very customary small molecule pharmaceutical margins going forward. In terms of the amount of time it will take for the dust to settle as we get there, it’s really premature for us to say. It’s a function of the ramp and when we get there. But the timeframe that you suggested of months or approaching a year or even beyond, that’s probably the right way to think of it. This won’t take years to settle down into a more predictable range, but it will take some months at least.

Thank you. And then just one more question on the sales force, obviously you seem to be progressing along a course where you are comfortable with the traction, at what point do you really assess how the productivity and the size of the sales force, is it six months out, is it 1 year out, is it in terms of inflection point to scale it up or not?

Terry, you want to take that question?

Yes. So as Steve mentioned, we are reshaping the way these patients are being treated. It takes time. So we want to give it the right amount of time to be able to see our effectiveness and it’s the repetition of calls that’s getting out of the right doctor. So it’s early, early days. And it would be really hard to predict at what point we would try to consider making a change.

Okay. Thanks.

I would just echo Terry’s comments and just say we monitor day by day just where we are. And so as I said earlier and as Terry just said, we don’t want to be reactive or over-interpret very, very early returns, but we want to also make certain that we are staying right on top of things and making sure we are making the best use of information we have. So you can count on us to continue doing that through the remainder of the launch.

I guess I just have one more if I still can. Any sense in terms of patients that have received the new script or have paper script any sense of the percentage of those that are already taking some type of antipsychotics versus those that are newly diagnosed?

Yes, I mean, the short version, Terry, you can chime in if you like. The short answer is it’s too early for us to read anything into – that’s exactly the kind of thing that we monitor, but it’s just way too early to make any sense of that.

Okay, thanks again.

Our next question is from the line of Cory Kasimov with JPMorgan.

Hey, guys. Good afternoon. Thanks for taking the questions. Couple of them for you. I guess, first of all, with regard to the NUPLAZID launch, I realized it’s obviously very early, but are you seeing any kind of emerging trends with who the early adopters are or in what settings they treat patients in these initial days of the launch? And are you able to get any kind of anecdotal patient feedback at this point?

Again, Terry, jump in if you have additional color, but I would say, well, first of all, I think it’s just too early to really have identified any meaningful trends. I will say that we are getting a lot of positive anecdotal feedback as we should. I mean, honestly, I would be concerned if we weren’t getting that. I don’t think I would read too much into the fact that we’re getting it. But we are. We are getting some very positive feedback. And again, that’s – it’s anecdotal evidence. It’s helpful, it’s nice, it’s motivating to the team, but I just wouldn’t read too much into that at these early, early stages.

Okay, understood. And then the follow-up question is with regard to the ADB trial and whether you think you will be able to tease out enough information from this study to effectively make a go/no go decision for Phase 3. And when we do see that data is that going to be a 6-week data or a 12-week data or both?

Serge, do you want to take that question?

Yes, absolutely. Let me take the second part. It will be the entire duration. So, we will have – primary endpoint is at 6 weeks, but we will have a 12-week data as well. So, the information we have will encompass the entirety of the study and all the endpoints that we prospectively defined. In regard to first, it is very difficult in absence of seeing the data to make any qualifications on whether one can make the decisions or not. What I would say with confidence is that we will – we have – we will have a sufficient amount of data to make determination of whether we are seeing a positive signal or not. And based on that to make certain decisions whether to move forward, repeat the experiment under different conditions or maybe not.

Okay, great. Thanks. Appreciate taking the questions.

Thank you, Cory.

Our next question is from the line of Tazeen Ahmad with Bank of America.

Hi, good afternoon. Thanks for taking my questions. Maybe one on the two trials that are upcoming for Alzheimer’s psychosis versus Alzheimer’s agitation, how do doctors define the differences between the two conditions based on your understanding right now?

Serge, you want to take that?

Yes. Well, the Alzheimer’s psychosis is manifested by psychotic symptoms, and that predominantly means actually delusions and hallucinations in Alzheimer’s patients. Agitation, as I mentioned earlier, is manifested by hyperactivity, verbal or physical aggressivity, so it’s a completely different quality. So, it is – in the clinical practice, there is a bit of an overlap of these symptoms. Although agitation symptoms tend to occur earlier in the progression of Alzheimer’s disease compared to psychotic symptoms, there is an overlap, particularly in later stages. So, the distinction between these two syndromes and classes of symptoms are fairly, fairly clear.

Is it the case that if left untreated, that patients with agitation can advance to having psychosis?

Well, obviously, the prognosis is overall for progression of disease in Alzheimer’s would be worse if agitation is left untreated and the patient is left untreated, but it’s a natural course of disease that many patients progress toward psychotic symptoms over time. The matter is more in a speed of progression rather than evolution.

I see. So, I guess I am asking if it’s the case that you ultimately have approvals in Alzheimer’s agitation as well as Alzheimer’s psychosis, could it be the case that if you have efficacious treatment in the agitation population that the potential population in psychosis might be smaller because you are treating people earlier. Is that the right way of thinking about it?

It’s a very interesting question. I am not sure I have a straightforward answer for you on that. Obviously, treating agitation would help, but we have a background, underlying neuropathologic process that is progressing. So, it’s hard to say that just reading agitation would necessarily obviate occurrence of other symptoms.

Okay. And then I am sorry if you mentioned this at the beginning of the call, but I just want to confirm that IMS or Wolters Kluwer or the vendors are not tracking the scripts. Is that the case?

Yes, that is correct.

Okay. Alright, thank you.

Thank you, Tazeen.

[Operator Instructions] We have a question from the line of Alan Carr with Needham & Company.

My questions, to follow-up on that last one, since we won’t have IMS or Symphony I guess can you give us your plans on guidance or maybe number of patients on drug that sort of thing? Also, what are your expectations for compliance and discontinuation rates? And I guess the last one, payer split here, you had some expectations there heading into the launch. Are those evolving at all yet? Thanks.

Sorry, Alan. Just – Alan, your first question, I am sorry, I was trying to take a note. What was your first question?

The first one is around what sort of metrics you might be able to provide for us around number of patients. I mean, I understand you wouldn’t – you haven’t so far in this call, but do you plan to do that in the future, what’s your plans on that and guidance and that sort of thing?

Yes, yes, no, thanks. Thanks. So, we have said previously, we won’t be guiding on top line, bottom line or major components for at least several quarters. I do think there will be a point where we will probably find providing some semi-quantitative information could be helpful. It’s not now. I mean, at this point, things are still just moving around so much. It just wouldn’t be helpful. It would be – its hard for us to resist the temptation to over-interpret it, and I just don’t think it would be helpful at all. But there probably will be a point in time, I can’t say whether that’s covered lives or number of patients or number of new starts with any given timeframe, et cetera. And I can’t say exactly when, I wish I could give you a more satisfying answer, but what I can fully committed to is at a certain point where we feel like some of that kind of information will be helpful, we will be happy to share it. I mean our general philosophy is to try to be as transparent as possible. When we don’t disclose information, it’s always a good reason for it. It’s really because we just feel like it’s not helpful, it wouldn’t be beneficial. So but as soon as we feel like we can provide some of that information we will.

Okay. Thanks. Expectations around compliance and discontinuation rates, I guess?

Yes. So I think in terms of compliance and continuation rates, we recognize that this is kind of virgin territory. We are the first drug approved to treat PDP. There is a little bit of uncertainty, to be honest with you. What I can tell you is and I am just going to repeat what I have said before, we have cautioned people to say – to recognize that the movement medications that Parkinson’s patients take tend to reflect very high compliance rates because if they don’t take that medication, they know it immediately. And they are taking them several times a day. And keeping – maintaining that right balance of dopamine is a very fine balance, sometimes particularly in more advanced stages of the disease. So there is a very strong consequence of not taking your medication. And so they are pretty very highly compliant with it. When you look at Parkinson’s patients and you look at their compliance rates of other medications they take, they tend to be a little bit higher than norm, but much closer to kind of what the norm is for other drugs. And so it’s not uncommon to see compliance rates when we step outside of that, that window when we look at compliance rates for antidepressants, for that matter for and cholinesterase inhibitors or other drugs. You tend to see compliance rates that are more in the 50%, 60%, 70% range. And so it’s unclear to us to be honest with you, exactly where it will fall on that spectrum, it’s one of the things that as you would expect, that we have factored into our detailed plan and factored into our commercial plan to make certain that we emphasize how important it is. This is a chronic disorder. You will have it the rest of your life and to say how important it is, to stay on top of therapy. But it’s one of the things that we will just have to see as it evolves. And then, the last point you asked about was the payer split. And as Terry mentioned, it’s skewed a little bit more towards Medicare in these early days. And again, I just want to underscore, a lot of these things are moving around a lot. This can move around a lot more, but a little bit towards Medicare than what our market research would have indicated at this very, very early stage.

I thought I have one other last question and I am hoping I can slip in here. When you say positive anecdotal feedback, what does that mean, does that mean that physicians and patients are happy with the efficacy or safety profile, can you elaborate on that?

Yes. I would say – I will give the first response and Terry may have a couple of others. One of the things that you always worry about when you launch a drug is will the experience that physicians and patients have outside of a control clinical trial be similar to what you saw in the controlled clinical trial. And I would say and again, this is anecdotal feedback, but based upon the anecdotes that we have had and frankly based upon all the data that we are evaluating, we are very pleased to see it appears both on the side effects and tolerance side as well as on the efficacy side, everything is supportive of the profile that we – that the drug demonstrated in clinical trials. That’s not always the case. So that’s very helpful and the anecdotes have been very consistent with the kind of anecdotes that we had and the kind of experience we had in the clinic. We have had reports of – and I want to be really careful about this, but in the clinical studies we know that we saw about 14% of patients had complete remission. We have had some reports of even in these early days of patients that have reported a complete remission. Again, it’s an anecdote. I wouldn’t make too much of that, but it’s an example of the kinds of things that are lining up that we are seeing or we are hearing about in the marketplace that are consistent with what we saw in the clinic.

I would just tag. One of the things I find interesting is we do have physicians report back to us that they are very pleased with what they are seeing in terms of efficacy. But what I find interesting is that they are reporting that the caregiver is reporting that they see the difference at home and that they are reporting that to the physician. So, it’s encouraging – it’s early days, obviously, that the benefits are seen through the eyes of the caregiver and that’s something that we were hoping was going to happen.

Yes, you bet, Alan. And just again I just want to reiterate, it’s these early, early days, it’s so difficult to really know how much of these are tea leaves and how much of these things will prevail. It is the point of the launch where people tend to be excited. We tend – they tend to communicate more, etcetera. And so again, I would put all of this under the umbrella of I would be concerned if we weren’t getting some of these kinds of responses. It’s very gratifying to hear it, but I just want to emphasize two things. I am just going to repeat what I said earlier in the call – that one it takes time to really get the message across and for that to translate into what physicians actually do. It takes time and we expect it to take time here. The other thing, the other corollary of that is, I do think and we continue to think that the overall potential for strong revenue growth with this drug is very, very attractive and so the long-term prospects we think are very, very good, but I just want to caution you that it will take time. Great. Thanks very much.

And our last question is from the line of Robert LeBoyer with Aegis Capital.

I am looking at the revenues for the quarter and taking into account the 30-day promotional special and the cost of the drug, I am backing out the number of patients that are probably taking it and wondering if that’s a reasonable approximation or if that’s just completely invalid or somewhere in between?

That’s a great question, Robert. I would really strongly caution you against trying to back into it, because one of the things that would be – that would significantly impact that is things like the gross to net adjustment, which again in these early, early days is going to be a lot higher, because you have got a certain amount of embedded cost that gets distributed over such a tiny number. And so I just think it’s really hard to do that. The one thing that I will just underscore is the vast majority of patients are starting with a 30-day free trial. And so what you are seeing and what is for a grand total of 30 days is representative of – that number is composed of patients that didn’t get the free trial and almost all do, but not all. And so I just – I wish that I could be more helpful to you, but I would strongly caution you against trying to read too much into that number. To be honest with you, we thought it could very well be zero, but we knew zero is something really, really nominal and kind of meaningless in that first month, because almost all the patients who are starting are on the 30-day free trial.

Okay, understood. Thank you very much.

Yes. You bet.

And Mr. Davis, please proceed with closing remarks.

Well, thanks again to everyone for joining us on today’s call and for your continued support. We look forward to updating you in the future on our ongoing progress.

Ladies and gentlemen, this does conclude today’s conference call. You may now disconnect.